Food and Nutrition Service
Forest Service
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Geological Survey
Land Management Bureau
National Park Service
Employee Benefits Security Administration
Mine Safety and Health Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Federal Aviation Administration (FAA), DOT.
Final rule; removal.
The FAA is removing Airworthiness Directive (AD) 2023-13-07, which applied to certain Saab AB, Support and Services Model SAAB 340B airplanes. AD 2023-13-07 required amending the applicable airplane flight manual (AFM) by incorporating a temporary revision (TR) to reduce the maximum take-off weight (MTOW). The FAA issued AD 2023-13-07 to address the possibility of flight in an uncertified envelope, which could result in reduced structural capability and reduced controllability of the airplane. Since the FAA issued AD 2023-13-07, a determination was made that affected airplanes can be safely operated up to the initially published MTOW. Accordingly, AD 2023-13-07 is removed.
This AD becomes effective April 18, 2024.
• For EASA material, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
Shahram Daneshmandi, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 206-231-3220; email
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by removing AD 2023-13-07, Amendment 39-22492 (88 FR 43052, July 6, 2023) (AD 2023-13-07). AD 2023-13-07 applied to certain Saab AB, Support and Services Model SAAB 340B airplane. The NPRM was published in the
The FAA received no comments on the NPRM or on the determination of the cost to the public.
Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551
Since the FAA issued AD 2023-13-07, Saab provided evidence demonstrating that affected airplanes can be operated safely up to the initially published MTOW of 30,000 pounds. Therefore, the FAA is issuing this AD to remove AD 2023-13-07, and the FAA did not receive any adverse comments or useful information about this AD from U.S. operators that necessitates waiting 30 days for relief from this requirement. Accordingly, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days.
The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.
This AD removes all actions of AD 2023-13-07. Therefore, the requirements of AD 2023-13-07 are terminated.
This AD adds no costs. This AD removes AD 2023-13-07 from 14 CFR part 39; therefore, operators are no longer required to show compliance with that AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority.
The FAA determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective April 18, 2024.
This AD replaces AD 2023-13-07, Amendment 39-22492 (88 FR 43052, July 6, 2023) (AD 2023-13-07).
This AD applies to Saab AB, Support and Services (formerly known as Saab AB, Saab Aeronautics) Model SAAB 340B airplanes, certificated in any category, as identified in European Union Aviation Safety Agency (EASA) AD 2023-0121, dated June 13, 2023: airplanes not having SAAB modification 2571 (extended wingtip modification) embodied and having GE Aviation Systems LTD (Dowty Propellers) installed.
Air Transport Association (ATA) of America Code 51, Standard practices/structures.
This AD terminates all requirements of AD 2023-13-07.
For more information about this AD, contact Shahram Daneshmandi, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 206-231-3220; email
None.
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects a final rule published by the FAA in the
Effective date 0901 UTC, May 16, 2024. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.
A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, the final rule, this final rule correction, and all background material may be viewed online at
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Colby Abbott, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a final rule for Docket No. FAA-2023-1735 in the
This action does not alter the alignment of the amended V-78 or V-171 beyond the removal of the airway segment in V-171 between the Terra Haute, IN, VORTAC and the Peotone, IL, VORTAC which was included, in error, in the final rule.
Accordingly, pursuant to the authority delegated to me, the V-171 airway description in the regulatory text section of the rule in Docket No. FAA-2023-1735, as published in the
From Lexington, KY; INT Lexington 251° and Louisville, KY, 114° radials; Louisville; to Terre Haute, IN. From Peotone, IL; INT Peotone 281° and Joliet, IL, 173° radials; to Joliet. From Nodine, MN; INT Nodine 298° and Farmington, MN, 124° radials; to Farmington. From Alexandria, MN; INT Alexandria 321° and Grand Forks, ND, 152° radials; to Grand Forks.
Social Security Administration (SSA).
Final rule.
We are finalizing our proposed regulation to revise the time period that we consider when determining whether an individual's past work is relevant for the purposes of making disability determinations and decisions. We are revising the definition of past relevant work (PRW) by reducing the relevant work period from 15 to 5 years. Additionally, we will not consider past work that started and stopped in fewer than 30 calendar days to be PRW. These changes will reduce the burden on individuals applying for disability by allowing them to focus on the most current and relevant information about their past work. The changes will also better reflect the current evidence about worker skill decay and job responsibilities, reduce processing times, and improve customer service. This final rule also includes other minor revisions to our regulations related to PRW.
This final rule will be effective on June 8, 2024.
Mary Quatroche, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, 3rd Floor (East), Altmeyer Building, Baltimore, MD 21235-6401, (410) 966-4794. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our internet site, Social Security Online, at
The Social Security Act (Act) defines disability as the inability to engage in any substantial gainful activity (SGA) by reason of any medically determinable physical or mental impairment which can be expected to result in death, or which has lasted or can be expected to last for a continuous period of not less than 12 months.
We use a five-step sequential evaluation process to determine whether an individual who has filed an initial claim for Supplemental Security Income (SSI) or Old-Age, Survivors, and Disability Insurance (OASDI) benefits is disabled.
This final rule will affect how we evaluate disability claims at steps four and five of the sequential evaluation process because we consider the individual's PRW at both of these steps. At step four of the sequential evaluation process, we consider the individual's work history and whether, given their RFC, they could perform any of their PRW either as they actually performed it or as it is generally performed in the national economy.
At step five of the sequential evaluation process, we again refer to an individual's work history to determine whether an individual's impairment(s) prevents them from adjusting to other work that exists in significant numbers in the national economy, considering their RFC and the vocational factors of age, education, and work experience. To support a determination or decision at step five of the sequential evaluation process, we use the medical-vocational profiles
Once an individual is found disabled and receives benefits, we may periodically conduct a continuing disability review (CDR) to determine whether the individual continues to be disabled.
On September 29, 2023, we published a notice of proposed rulemaking (NPRM) in the
We also proposed to remove a sentence in 20 CFR 404.1565(a) and 416.965(a) that explained that the intent of our work experience rules is to “insure that remote work experience is not currently applied.” The NPRM included a full discussion of how the proposal would affect steps four and five of the sequential evaluation process, rationale for the proposed revisions, and an analysis of its effects.
In this final rule, we are adopting the NPRM's proposed revisions, discussion, rationale, and analysis in full, with the modifications described below.
We are adopting our original proposal with some modifications. The regulatory text in this final rule differs slightly from the regulatory text we proposed in the NPRM, due to: (1) an inadvertent error; and (2) public feedback submitted in response to our questions in the NPRM. We detail these changes below.
In the NPRM, we proposed to remove a sentence in 20 CFR 404.1565(a) and 416.965(a) that explains that the intent of our work experience rules is to “insure that remote work experience is not currently applied.” However, the sentence inadvertently remained within the proposed regulatory text in 20 CFR 416.965(a). We published a correction document on December 1, 2023, affirmatively removing that sentence from the proposed regulatory text of the NPRM.
In the NPRM we solicited feedback on whether we should revise our requirements so that individuals completing the work history forms do not need to report jobs held for a short period of time.
• The final rule language for 20 CFR 404.1560(b)(1) and 416.960(b)(1), now reads: “Definition of past relevant work.”
• We are adding 20 CFR 404.1560(b)(1)(i) past relevant work is work that you have done within the past five years that was substantial gainful activity and that lasted long enough for you to learn to do it (see § 404.1565(a)). We will not consider work to be past relevant work if you started and stopped it in fewer than 30 calendar days (see § 404.1560(b)(1)(ii)). We are making parallel revisions in 20 CFR 416.960(b)(1)(i).
• We are adding 20 CFR 404.1560(b)(1)(ii) When we state that we consider past relevant work and work experience (see § 404.1565), 30 calendar days means a period of 30 consecutive days, including weekends, starting from the first day of work. When we consider whether work lasted 30 calendar days, we generally do not consider the total number of hours or days worked during that period, or whether the work was full-time or part-time. The 30 calendar days requirement is separate from the consideration of substantial gainful activity or whether you worked long enough to learn how to do the work, although the work performed during the 30 calendar days may count toward the time needed for you to learn to do the work. The 30 calendar days requirement also applies if you were self-employed or an independent contractor; we will consider whether you were engaged in the same type of work for 30 calendar days, even if individual work assignments or contracts each lasted fewer than 30 calendar days. We are making parallel revisions in 20 CFR 416.960(b)(1)(ii).
• We are revising in 20 CFR 404.1565(a) from the prior text, “If you have no work experience or worked only `off and on' or for brief periods of time during the five-year period, we generally consider that these do not apply,” to read in the final rule as, “If you have no work experience or you did work that started and stopped in a period of fewer than 30 calendar days (see § 404.1560(b)(1)(ii)) during the five-year period, we generally consider that these do not apply.” We are making parallel revisions in 20 CFR 416.965(a).
We are adding this minimum 30-calendar-day threshold in response to feedback we solicited in the NPRM. To clarify our intent with this addition to the rule, we are providing two examples.
In the event of an invalidation of any part of this rule, our intent is to preserve the remaining portions of the rule to the fullest possible extent. In particular, we intend the revision of the reduction of the relevant work period for PRW in 20 CFR 404.1560, 404.1565, 416.960, and 416.965 from 15 to 5 years to be severable, as that revision explains our new rule and functions independently of the other changes reflected in this final rule. We also intend the addition of the sentence in 20 CFR 404.1560(1)(i) and 416.960(1)(i) that: “We will not consider work to be past relevant work if you started and stopped it in fewer than 30 calendar days” along with the revision of the sentence in 20 CFR 404.1565(a) and 416.965(a) that accounts for the new 30 calendar day period (
Finally, we intend the removal of the sentence in 20 CFR 404.1565(a) and 416.965(a) that explains the intent of our work experience rules is to “insure that remote work experience is not currently applied” to be severable, as that revision clarifies our rule and functions independently of the other changes reflected in this final rule.
We have long recognized that a gradual change occurs in most jobs in the national economy, so that after a certain period of time it is not realistic to expect that skills and abilities an individual acquired while performing these jobs continue to apply.
Changing the relevant work period from the prior 15 years to 5 years and setting a minimum time period of 30 calendar days for performing work will better account for the diminishing relevance of work skills over time and reduce the burden on individuals applying for disability. This change will allow us to improve the quality of the information we receive by eliminating the individual's need to recall and consistently report detailed information about less recent work or work performed for less than 30 calendar days, reduce the time spent filling out work history forms, and reduce wait times for a determination or a decision. Accordingly, this change will improve customer service and adjudicative efficiency.
This final rule will achieve several goals. First, this final rule will allow individuals to focus on the most current and relevant information about their past work.
In summary, by eliminating an individual's need to recall and report detailed information about less recent work, we anticipate this final rule will allow us to improve the quality of the information we receive; will significantly reduce burden on the individual from filling out work history forms; and will reduce case processing and waiting times. These outcomes will overall offer a better customer experience for individuals applying for disability and will increase our adjudicative efficiency. For a more detailed explanation of how we expect this final rule to achieve these objectives, please refer to the Justification for Change section in the NPRM.
We solicited comments on the proposed rule and received 99 public comments on our NPRM from September 29, 2023, through November 28, 2023. Of the total comments, 89 are available for public viewing at
• Individuals;
• Over 20 groups submitting comments on behalf of their organizations, such as (but not limited to) the Center on Budget and Policy Priorities, Homeless Action Center, International Association of Rehabilitation Professionals, National Association of Disability Representatives, National Council of Disability Determination Directors, and National Organization of Social Security Claimants' Representatives; and
• Ranking Congressional Members from the Subcommittee on Social Security and Subcommittee on Worker and Family Support.
The vast majority of commenters supported the proposal in the NPRM. Some commenters agreed with the proposal but recommended changes, either in this final rule or in future rulemakings. Several other commenters disagreed with the proposal. We carefully considered these comments, which we summarize and respond to below. We addressed only issues raised by comments that were within the scope of this rulemaking.
Further, several commenters said that individuals often do not remember intricate details about jobs they performed 10 to 15 years ago, particularly information regarding the rate of pay, the number of months they worked, and the physical and mental demands of the job they performed. These commenters opined that the need to provide such information about work an individual performed many years earlier often results in their providing us with incomplete or inaccurate work history reports. Moreover, some commenters opined that when individuals have difficulty accurately recalling the physical and mental requirements of a past job, they are more likely to estimate the demands of their past work incorrectly.
Commenters identifying themselves as disability representatives confirmed that in their experience, individuals often have a vague recollection of job information going back 15 years, making it necessary for these representatives to spend a great deal of time with their clients helping them recall, evaluate, and report job duties from a decade or more ago. Additional commenters stated that, as representatives, they commonly need to correct prior work history information that their clients initially provided during earlier steps in the adjudication process.
Some commenters said that difficulty remembering prior work is exacerbated when an individual suffers from a brain injury, memory loss, or a cognitive or other mental health impairment. Many commenters agreed that allowing individuals to focus on only the most recent 5 years of work history would increase the accuracy of information provided to us. Another commenter noted that adopting a 5-year relevant work period would make associated work history reporting forms shorter and easier for individuals to complete.
Additionally, several commenters conveyed that inaccurate or imprecise recounting of information about work history submitted to us increases the work for our adjudicators, often resulting in the need for us to engage in lengthy development to gather accurate and precise information. A few commenters expressed the opinion that the mistakes on the work history forms, even after our efforts to correct them, may still result in individuals being denied benefits due to “insufficient evidence” because the individuals were unable to provide the amount of detail about their past work required by the Act and our rules.
Additional commenters said the proposal would help more vulnerable populations, such as those facing housing deprivation, loss of belongings, and other crises.
We do not agree with the fourth comment regarding education and the relevant work period. When we consider whether recently completed education would permit an individual to enter directly into skilled or semiskilled work other than PRW, we have long stated that such education is only relevant for 5 years.
Regarding the comments on age, we note that we do not consider age when we assess whether an individual can perform their PRW. However, the Act requires us to consider age, in addition to other factors, which we do at the final step of the sequential evaluation processes when we consider whether an individual can perform other work.
Other commenters said we should not ask about or consider work performed for fewer than 3 months or 90 days. Some commenters asserted that a job performed for less time may constitute an unsuccessful work attempt. One commenter stated that employers often set a 90-day probationary period for new employees to assess if an individual can satisfactorily perform the job. Another commenter alleged that 3 months was the amount of time needed by the average person to learn all the skills required to perform a job adequately and that less time would not provide enough of an opportunity for an individual to learn the job or gain transferable skills. The commenter further asserted that making our adjudicators consider the relevance of such jobs is a waste of time and disincentivizes individuals from attempting to work.
A few commenters said that even if we would no longer consider work performed for less than 1 or 3 months, we should still collect some information about work performed for fewer than 3 months, as it may be evidence showing a limitation in an individual's ability to perform work activities.
However, we disagree with the rationale offered for the suggestion that we should not consider any work performed for less than 3 months. While the commenter linked this suggestion to an unsuccessful work attempt, a 3-month period has no special significance under our rules for unsuccessful work attempts,
Therefore, in this final rule, as discussed above, we are adding two paragraphs to our rules in 20 CFR 404.1560(b)(1)(i) and (ii) and 416.960(b)(1)(i) and (ii) and revising a sentence in 20 CFR 404.1565(a) and 416.965(a) to state that work an individual started and stopped in fewer than 30 calendar days is not PRW. We will consider “30 calendar days” as a period of 30 consecutive days, including weekends, starting from the first day of work. When we consider whether work lasted 30 calendar days, we generally do not consider the total number of hours or days worked during that period, or whether the work was full-time or part-time. The 30 calendar days requirement is separate from the consideration of substantial gainful activity or whether the individual worked long enough to learn how to do the work, although the work performed during the 30 calendar days may count toward the time needed for the individual to learn to do the work. The 30 calendar days requirement also applies if the individual was self-employed or an independent
We are also revising our Forms SSA-3368-BK (Disability Report—Adult) and SSA-3369-BK (Work History Report) to include an instruction that individuals should not list work information for jobs that started and stopped in fewer than 30 days.
A few commenters suggested that we reduce the burden on individuals completing our forms by removing some detail from the questions we ask on the Form SSA-3369-BK. Some other comments suggested we revise our forms in specific ways, such as adding space for claimants to provide more information, describing terms being used, and analyzing the forms for literacy level.
Other commenters suggested alternative, streamlined language for existing questions, and several commenters proposed additional questions. For example, some commenters said we should ask whether an individual had trouble completing tasks in their jobs, or whether they received special accommodations to complete their past work. Another commenter asked us to request more narrative, detailed responses in several areas rather than using questions in check-box format. Several commenters asked us to collect more information about the mental demands of an individual's past work. One commenter said we should add questions about specific supervisory duties, such as hiring and firing, evaluating worker performance, and assigning work. Other commenters suggested we add questions to determine whether work involved modified job tasks, accommodations, or a supported work environment, and whether a job ended because of the individual's impairments.
However, we are making changes to the form consistent with the comments that we should collect more detailed information about an individual's work history by revising the relevant questions accordingly. To collect more information about the mental demands of an individual's past work, we are revising questions about tasks performed, supervisory duties, tools and equipment used, writing, and social interactions in a typical workday or workweek.
We are also adding a question to Forms SSA-3368-BK and SSA-3369-BK asking an individual to explain how their impairment(s) would affect their ability to do each job. As well, we are revising Form SSA-3369-BK to include an explanation and examples of how to report the number of hours and minutes an individual stood, walked, and performed other activities in a day. Similarly, we changed a question to ask individuals to describe what tasks they did in a typical workday instead of what they did “all day.”
On the Form SSA-3368-BK, we continue to ask individuals receiving Supplemental Security Income (SSI) payments whether they received vocational rehabilitation, work accommodations, or other support services to continue performance of a job. We also continue to ask individuals whether their most recent work ended because of their impairments, and whether their employer changed their work duties at some point before the work ended.
We are not adding questions to Form SSA-3369-BK to determine whether work other than an individual's most recent work ended because of their impairments or involved accommodations. Adding such a question could inject unnecessary complexity into Form SSA-3369-BK because it and other forms, such as Form SSA-821 (Work Activity Report—Employee), collect information that routinely allows adjudicators to determine whether an individual received accommodations in a given job and whether a work attempt was unsuccessful.
We note that more detailed information about all the changes we are making to the forms cited here can be found in the Information Collection Request documentation, which we will upload to
Other commenters suggested that we simplify the disability application process by capturing an individual's complete work history on Form SSA-3368-BK, ending use of Form SSA-3369-BK altogether, or by making Form SSA-3369-BK available to submit electronically.
We have long relied on individuals to provide information about their past work, and think it is appropriate to continue that process.
Pre-filling forms can reduce burden in certain circumstances, and some of the unintended consequences could potentially be mitigated. Ultimately, though, at this time we conclude that the time, operational, technological, and burden-to-respondent costs of remediating errors stemming from an incomplete or incorrect prefill would outweigh the benefits of a prefill approach. Given these concerns, we do not think prepopulating forms is possible or advisable at this time.
While we do provide individuals with an advance copy of their records, including work history and medical information, at the hearings level of the disability process, this is not a parallel to the commenter's request for prepopulated forms. At the hearings level, the records we provide contain both the information that the individual reported to us at the initial application and reconsideration stages of the disability process, as well as our own historical wage reporting data. Thus, a large portion of those records is simply resharing information the individual already gave us themselves, while the wage data, as previously explained, is more limited, may be incomplete, may lag (particularly since it comes from IRS), and may include employer names with which the individual is unfamiliar. In contrast, the commenter was asking for us to pre-fill the initial work history forms for them, which is entirely different.
We also disagree with the suggestion that we discontinue our use of Form SSA-3369-BK. Our use of Form SSA-3368-BK is intended to reduce the overall information collection burden for many individuals because we use Form SSA-3369-BK only when an individual had two or more jobs during the relevant work period. Revising the relevant work history period from 15 years to 5 years in this final rule will increase the likelihood that we will capture individuals' complete work histories on Form SSA-3368-BK, eliminating the need to complete a separate Form SSA-3369-BK. For situations where there were two or more jobs during the preceding 5-year period, though, Form SSA-3369-BK will still be useful and appropriate.
Commenters provided a range of diverse suggestions regarding our prior and proposed new burdens, both for Form SSA-3369-BK (which we explicitly asked about) and Form SSA-3368-BK (which we did not). One commenter, a legal aid organization, noted that in its experience individuals often required far longer than our estimated average time burden to complete Forms SSA-3368-BK and SSA-3369-BK, even with its assistance. This commenter disputed our estimate that the revised Form SSA-3368-BK would take 80 minutes to complete, on average, and that the revised Form SSA-3369-BK would take 40 minutes on average, citing a continuing “high information burden” under the new final rules. One commenter stated the prior 60-minute estimate we used prior to this final rule would still remain accurate because individuals would respond to the shorter relevant work period by taking more time to provide more accurate information about their past jobs.
In contrast, other commenters stated we had not lowered the burden estimate enough. These commenters offered new time burden approximations of 20 or 30 minutes instead of our 40-minute estimate for Form SSA-3369-BK. Finally, one commenter indicated that, while this rule change should warrant a reduction in time burden, it would be difficult to quantify the amount of the reduction.
A few commenters opposed the proposal to use the 5-year relevant work period in the no work profile. One commenter said the rationale in the NPRM would better support revising all of the profiles so that they all consider no more than 5 years of work history, while another commenter said we should continue to consider 15 years of work history for the no work profile. A few commenters asked that we no longer consider the profiles at all, while another commenter supported keeping the profiles because they provide additional avenues for claimants to be allowed disability benefits. One commenter opined that the proposed new no work profile was unsupported, because information from the BLS' ORS and Occupational Employment Statistics (OES) shows there are millions of jobs in the national economy that an individual with no work experience and no high school education could do.
We also appreciate the comments that suggested additional changes to the current profiles. Although we are not adopting these suggestions in this final rule, we may consider further revisions to the profiles in a future rulemaking.
We disagree with the comments stating that we should no longer use the arduous unskilled work and lifetime commitment profiles because they require consideration of work performed for more than 5 years. The high exertional and nonexertional demands of work considered under these profiles are likely to remain consistent throughout the period considered, including for work performed during the relevant work period. The information we have in these claims is therefore current, more likely to be accurate, and unlikely to require additional development. We may, however, consider further revisions to these profiles in a future rulemaking proceeding.
We also disagree with the comments stating that we should retain consideration of 15 years of work history for the no work profile, and that we should no longer consider the no work profile at all. Although one commenter asserted that information from BLS showed there were millions of jobs in the national economy that an individual with no work experience and no high school education could do, we do not find this comment persuasive. The purpose of the no work profile is to reflect the vocational disadvantage of remaining out of the workforce for an extended period of time due to the effects of a severe medically determinable impairment(s) together with the combination of being of older age and not completing high school. The BLS data cited by the commenter opposing the no work profile does not reflect information about all the vocational factors included in the no work profile. The commenter's data also do not address how being out of the work force for an extended period of time affects the ability to work.
We acknowledge that several rules in the medical-vocational guidelines direct outcomes based on an individual's work experience. Specifically, some rules direct an outcome of “not disabled” where an individual has acquired skills from their PRW that will transfer to other work.
However, although the Act requires us to consider an individual's work experience,
In addition, our Office of the Chief Actuary (OCACT) projected that this final rule will produce a net reduction in scheduled Old-Age and Survivors Insurance (OASI) benefits of approximately $6.3 billion over fiscal years 2024 through 2033, which will reduce the financial stress on another important Federal insurance program (although, per the information provided in the “Anticipated Transfers to Our Program,” overall this regulation does result in significant net costs to the Trust Funds. Please see this section in the preamble of this final rule for complete transfer figures relating to the regulation).
We similarly disagree that the Austrian study cited by the commenter provides evidence that we have understated the potentially depressing effect of the rule on payroll taxes. By citing this particular study, the commenter assumes that if we did not implement this final rule and increase the number of allowances, many of the affected individuals would return to work (“nearly one for one”), and would thus contribute more taxes. However, this assumption cannot be made based on the evidence provided. The Austrian disability program's criteria do not align with ours, and the jobs available in the United States national economy may not match Austria's either. For example, even the strictest Austrian disability rule allowed applicants with up to 50 percent capacity to receive benefits, while the United States does not grant disability benefits to individuals who demonstrate such high work capacity. Given these differences in disability criteria and the type of work available in the national economy, it is not appropriate to extrapolate the results of the Austrian study to potential outcomes for us. Indeed, the article's authors themselves state that their findings may not be most relevant for other countries such as the United States.
For the above reasons, and because of the long-established, meticulous, and well-supported nature of OCACT's work, we are confident that OCACT's projections on the financial effects of this final rule are reasonable and of the correct magnitude.
In response to the commenter who cited the subregulatory instruction (POMS), we note this comment appears to reflect a misunderstanding. The subregulatory instruction the commenter cited relates to a topic that is different from the relevant work period.
Ultimately, when weighing the above considerations and the anticipated advantages this final rule will offer to disability applicants, such as better reflecting the diminishing relevance of unused work skills over time, improving customer service, and making our adjudication process more efficient, we find the cost of this rule is justified by the overall benefits to the public.
These figures indicate the commenter was correct in their assertion about the need for an RIA, but we disagree with the commenter's characterization that we did not conduct the necessary RIA analyses at the NPRM stage. While we did not provide a separate RIA document, our NPRM included the elements of an RIA that were relevant to our proposal, such as our reporting of the OCACT estimated costs, our analysis of transfer impacts and administrative costs, our explanation of the assumptions underlying the NPRM, and our touching on alternatives to our proposal. While not a separate RIA document, these analyses from the NPRM fulfill our obligations to review the direct effects of the rulemaking. Nevertheless, for ease of readers, we are consolidating these RIA elements into a separate document and publishing them in the
Regarding any federalism issues, the NPRM included our determination that the proposed rule would not have sufficient federalism implications to warrant the preparation of a federalism assessment, and thus further analysis in this area is not required. This final rule includes that same determination.
We consulted with the Office of Management and Budget (OMB), and OMB determined that this final rule meets the criteria for a section (3)(f)(1) significant regulatory action under E.O. 12866, as supplemented by E.O. 13563 and amended by E.O. 14094, and is subject to OMB review.
OCACT estimates that implementation of this final rule will result in an increase in scheduled SSDI benefits of $22.2 billion, a net reduction
The Office of Budget, Finance, and Management estimates that this final rule will result in net administrative savings of $1 billion for the 10-year period from FY 2024 to FY 2033. The administrative savings are primarily driven by time savings from evaluating work over a shorter period for initial claims, reconsideration requests, and hearings processed in our field offices, State disability determination services, and hearings offices. In addition, due to a shorter PRW period, we expect fewer disability reconsiderations, and hearings requests over the 10-year period, leading to sizeable administrative savings. Savings are offset by administrative costs stemming from systems updates and training costs upon implementation, and post-eligibility actions for additional beneficiaries and non-disabled dependents thereafter.
This final rule will reduce the obstacles that individuals with significant physical or mental impairments face in their efforts to obtain the crucial benefits our disability programs provide. Our experience indicates that individuals often find it difficult to gather and provide accurate information about their work histories, and that those difficulties tend to increase when they are asked to provide detailed information about work performed in the more distant past. Reducing individuals' need to gather and report information about work performed beyond a 5-year relevant period will increase the likelihood we will have a complete and accurate work history report. As discussed in the Paperwork Reduction Act section below, we estimate a minimum of 938,735 hours of time savings in direct paperwork burden experienced by claimants as well as additional time-savings associated with the overall process of completing the relevant forms. In addition, we estimate opportunity costs of this time-savings to be at least $62,049,205 annually.
As discussed in the preamble, our process for determining if an individual is disabled includes evaluating whether the individual, given their RFC, can perform their PRW. If an individual can perform their past work, then we will determine they are not disabled. By reducing the relevant work period to 5 years, there are likely, on the margins, individuals who held jobs longer than 5 years in the past who may still be able to perform those jobs today. Under the prior rules the individual would be found not disabled; however, under this final rule change the individual would be allowed. A subset of these individuals who would have previously been found not disabled could have worked in the absence of benefits. This reduction in labor force participation imposes some social costs to the public (OCACT estimates $1.5-$2.5 billion in reduced earned income by wage earners over the next 10 years). However, as discussed in the preamble, the projected increase in allowances represents only a relatively small percentage and the potential social cost of reduced employment generated by this final rule is likely to be quite low.
Pursuant to the Congressional Review Act (5 U.S.C. 801
The Director of OMB has waived the requirements of section 263 of the Fiscal Responsibility Act of 2023 (Pub. L. 118-5) pursuant to section 265(a)(2) of that Act.
We analyzed this final rule in accordance with the principles and criteria established by E.O. 13132 and determined that this final rule will not have sufficient federalism implications to warrant the preparation of a federalism assessment. We also determined that this final rule will not preempt any State law or State regulation or affect the States' abilities to discharge traditional State governmental functions.
We certify that this final rule will not have a significant economic impact on a substantial number of small entities, as it affects individuals only. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.
SSA already has existing OMB PRA-approved information collection tools relating to this final rule: Claimant's Work Background (HA-4633, OMB No. 0960-0300); Work History Report SSA-3369, OMB No. 0960-0578); and Disability Report—Adult (SSA-3368, OMB No. 0960-0579). This final rule provides for a shorter work history requirement than we previously required; therefore, we expect this rule will significantly reduce public reporting burdens associated with these forms. The sections below report our current public reporting burdens for these existing OMB-approved forms and project the anticipated burden reduction and new burden figures after implementation at the final rule stage. We will obtain OMB approval for the revisions to the collection instruments concurrently with the effective date of this final rule.
The following chart shows the time burden information associated with this final rule:
The following chart shows the theoretical cost burdens associated with this final rule:
SSA submitted a single new Information Collection Request which encompasses the revisions to all three information collections (currently under OMB Numbers 0960-0300, 0960-0578, and 0960-0579) to OMB for the approval of the changes due to this final rule. After approval at the final rule stage, we will adjust the figures associated with the current OMB numbers for these forms to reflect the new burden. We are soliciting comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize the burden on respondents, including the use of automated techniques or other forms of information technology. If you would like to submit comments, please send them to the following locations:
Office of Management and Budget, Attn: Desk Officer for SSA, Fax Number: 202-395-6974, Email address:
Social Security Administration, OLCA, Attn: Reports Clearance Director, Mail Stop 3253 Altmeyer, 6401 Security Blvd., Baltimore MD 21235, Fax: 410-966-2830, Email address:
You can submit comments until May 20, 2024, which is 30 days after the publication of this notice. However, your comments will be most useful if you send them to SSA by May 20, 2024, which is 30 days after publication. To receive a copy of the OMB clearance package, contact the SSA Reports Clearance Officer using any of the above contact methods. We prefer to receive comments by email or fax.
Administrative practice and procedure, Blind, Disability benefits, Old-Age, survivors and disability insurance, Reporting and recordkeeping requirements, Social security.
Administrative practice and procedure, Reporting and recordkeeping requirements, Supplemental Security Income (SSI).
The Commissioner of Social Security, Martin O'Malley, having reviewed and approved this document, is delegating the authority to electronically sign this document to Faye I. Lipsky, who is the primary
For the reasons set out in the preamble, we amend 20 CFR parts 404 and 416 as set out below:
42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a) and (h)-(j), 422(c), 423, 425, and 902(a)(5); sec. 211(b), Pub. L. 104-193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(b) * * *
(1)
(ii)
(a)
(b)
Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), (c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C. 421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and (p), and 1383b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 note, and 1382h note).
(b) * * *
(1)
(ii)
(a)
(b)
Office of Foreign Assets Control, Treasury.
Publication of one directive.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing a Burma Sanctions Directive in the
Directive 1 under Executive Order 14014, “Prohibitions Related to Financial Services to or for the Benefit of Myanma Oil and Gas Enterprise,” was issued on October 31, 2023.
OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Compliance, 202-622-2490.
This document and additional information concerning OFAC are available on OFAC's website:
On February 10, 2021, the President, invoking the authority of,
In E.O. 14014, the President found the situation in and in relation to Burma, and in particular the February 1, 2021, coup, in which the military overthrew the democratically elected civilian government of Burma and unjustly arrested and detained government leaders, politicians, human rights defenders, journalists, and religious leaders, thereby rejecting the will of the people of Burma as expressed in elections held in November 2020 and undermining the country's democratic transition and rule of law, constitutes an unusual and extraordinary threat to the national security and foreign policy of the United States and declared a national emergency to deal with that threat.
Section 1 of E.O. 14014 blocks all property and interests in property that are in the United States, that hereafter come within the United States, or that are or hereafter come within the possession or control of any United States person of any foreign person determined by the Secretary of the Treasury, in consultation with the Secretary of State, to, among other things, be a political subdivision, agency, or instrumentality of the Government of Burma.
On October 31, 2023, OFAC issued Directive 1 under E.O. 14014, “Prohibitions Related to Financial Services to or for the Benefit of Myanma Oil and Gas Enterprise.” In Directive 1, the Director of OFAC, in consultation with the Department of State, determined that the Myanma Oil and Gas Enterprise (MOGE) is a political subdivision, agency, or instrumentality of the Government of Burma, and that the following activities by a U.S. person are prohibited on or after December 15, 2023, except to the extent provided by law, or unless licensed or otherwise authorized by OFAC: The provision, exportation, or reexportation, directly or indirectly, of financial services to or for the benefit of MOGE or its property or interests in property.
The text of Directive 1 under E.O. 14014 is provided below.
Pursuant to sections 1(a)(iv), 1(b), and 8 of Executive Order 14014, “Blocking Property With Respect to the Situation in Burma” (the “Order”), the Director of the Office of Foreign Assets Control (OFAC) has determined, in consultation with the Department of State that the Myanma Oil and Gas Enterprise (MOGE) is a political subdivision, agency, or instrumentality of the Government of Burma, and that the following activities by a U.S. person are prohibited on or after December 15, 2023 except to the extent provided by law, or unless licensed or otherwise authorized by OFAC:
the provision, exportation, or reexportation, directly or indirectly, of financial services to or for the benefit of MOGE or its property or interests in property.
All other activities with MOGE or involving MOGE's property or interests in property are permitted, provided such activities are not otherwise prohibited by law, the Order, or any other sanctions program implemented by OFAC.
Except to the extent otherwise provided by law or unless licensed or otherwise authorized by OFAC, the following are also prohibited: (a) any transaction that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions contained in this Directive; and (b) any conspiracy formed
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the Ohio River at 11 a.m. on April 14, 2024, at mile marker 6.2 to mile marker 13.3, through 11:59 p.m. on April 20, 2024. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by an ongoing response and salvage operation after 26 barges broke free from a facility. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Pittsburgh (COTP) or a designated representative.
This rule is effective without actual notice from April 18, 2024 through April 20, 2024. For the purposes of enforcement, actual notice will be used from April 14, 2024, until April 18, 2024.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LTJG Eyobe Mills, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publishing an NPRM would be “impracticable, unnecessary, or contrary to the public interest”. Around 11:30 p.m. on April 12, 2024, 26 barges broke free from their fleeting area. The location of 25 out of 26 barges have been identified. One barge is unaccounted for. Immediate action is needed to respond to the potential safety hazards associated with the barge breakaway. It is impracticable to publish an NPRM because we must establish this safety zone by April 14, 2024.
Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port (COTP) Marine Safety Unit (MSU) Pittsburgh has determined that potential hazards associated with the ongoing response and salvage operations starting April 14, 2024, will be a safety concern for anyone on the Ohio River between mile marker 6.2 to mile marker 13.3. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the location of the last barge is identified and salvage operation efforts are underway.
This rule establishes a safety zone from 11 a.m. April 14, 2024, through 11:59 p.m. on April 20, 2024. The safety zone will cover all navigable waters within the Ohio River from mile marker 6.2 to mile marker 13.3 The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the location of the last barge is identified, and salvage operation efforts are underway. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on size, location, and duration of the safety zone. This safety zone impacts 7.1-mile stretch on the Ohio river from April 14, 2024, through April 20, 2024. Moreover, the Coast Guard will issue Local Notice to Mariners and Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission from the COTP to transit the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only 7 days that will prohibit entry within 7.1 river miles on the Ohio River. It is categorically excluded from further review under paragraph L60(c) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Marine safety, Navigation (water), Reporting, Recordkeeping requirements, and Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or the COTP's representative on Channel 16 or at 412-670-7288. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Coast Guard, Department of Homeland Security (DHS).
Temporary final rule.
The Coast Guard is establishing a temporary security zone on the Detroit River, in the vicinity of Detroit, MI. This zone is intended to restrict vessels from a portion of the Detroit River for the security of the spectators and participance of the 2024 NFL Draft from the public, and surrounding waterways from terrorist acts, sabotage or other subversive acts, accidents, or other causes of a similar nature. Persons and vessels are prohibited from entering into, transiting
This regulation is effective from 8 a.m. on April 25, 2024, through 6 p.m. April 27, 2024, and will be enforced during event times.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Tracy Girard, Waterways Division, Sector Detroit, Coast Guard; telephone (313) 568-9564, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard was notified with insufficient time to accommodate the comment period. Delaying the effective date of this rule to wait for the comment period to run would be impracticable and contrary to the public interest because it would prevent the COTP Detroit from keeping the public and public figures safe from known and unknown threats.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1. The COTP has determined that potential risks are associated with the event. These hazards include potential security threats, violent or disruptive public disorder, delivery of a weapon of mass destruction, launch of a stand-off attack weapon, or delivery of an armed assault force. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the security zone throughout the duration of the event.
This rule establishes a security zone that will be in effect from 8 a.m. on April 25, 2024, through 6 p.m. on April 27, 2024, and enforced during event times. The security zone will encompass all U.S. navigable waters of the Detroit River that are within the following boundary to the shore: Starting from a point at 42°19′32.88″ North Latitude and 083°2′45.48″ West Longitude and proceeding South-Southeast until intersecting a point at position 42°19′27.06″ North Latitude and 083°2′43.56″ West Longitude; thence proceeding East-Northeast until intersecting a point at 42°19′31.26″ North Latitude and 083°2′28.8″ West Longitude; thence proceeding North-Northwest until intersecting a point at position 42°19′37.38″ North Latitude and 083°2′31.26″ West Longitude.
The duration of the zone is intended to protect the spectators and participants from potential risks in these navigable waters during the event. Entry into, transiting, or anchoring within the security zone is prohibited unless authorized by the COTP, Sector Detroit, or a designated representative. The COTP or his designated representative may be contacted via VHF Channel 16.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and duration of the security zone. The majority of vessel traffic will be able to safely transit prior to and immediately after the security zone enforcement period, which will impact only portions of the Detroit River in Detroit, MI for a period of 12 hours per day. Vessels will be able to transit around the security zone on the Detroit River. Under certain conditions, moreover, vessels may still transit through the security zone only when permitted by the COTP.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the security zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please call or email the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a security zone lasting 12 hours per day that will prohibit entry within all U.S. navigable waters of the Detroit River within a Detroit River that are within the following boundary to the shore: Starting from a point at 42°19′32.88″ North Latitude and 083°2′45.48″ West Longitude and proceeding South-Southeast until intersecting a point at position 42°19′27.06″ North Latitude and 083°2′43.56″ West Longitude; thence proceeding East-Northeast until intersecting a point at 42°19′31.26″ North Latitude and 083°2′28.8″ West Longitude; thence proceeding North-Northwest until intersecting a point at position 42°19′37.38″ North Latitude and 083°2′31.26″ West Longitude. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(2) The security zone is closed to all vessel traffic, except as may be permitted by the COTP Detroit or his designated representative.
(3) The “designated representative” of the COTP is any Coast Guard commissioned, warrant, or petty officer who has been designated by the COTP to act on his behalf. The designated representative of the COTP will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The COTP or his designated representative may be contacted via VHF Channel 16.
(4) Vessel operators desiring to enter or operate within the security zone shall contact the COTP or his designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the security zone must comply with all directions given to them by the COTP or a designated representative.
Office of Governmentwide Policy (OGP), General Services Administration (GSA).
Final rule.
GSA is issuing a final rule amending the Federal Management Regulation (FMR) to update the regulations concerning Federal Advisory Committee Management. This action is necessary to clarify FACA requirements and incorporate legislative and policy changes that have occurred since the regulation was last updated in July of 2001.
Ms. Lorelei Kowalski, Director, Committee Management Secretariat, Office of Asset and Transportation Management, Office of Government-wide Policy, at 202-208-6035 or email at
The Federal Advisory Committee Act (FACA or “the Act”), as amended, 5 U.S.C. chapter 10, (codified at 5 U.S.C. 1001
The Act not only formalized a process for establishing, operating, overseeing, and terminating these advisory bodies, it also created the Committee Management Secretariat (“Secretariat”), a GSA Office whose task it is to provide oversight on the FACA program, work with executive branch agencies and departments regarding compliance with the Act, and report on executive branch activities under the Act. The GSA's authority for administering FACA is contained in sec. 7(c) (codified at 5 U.S.C. 1006(c) of the Act and Executive Order (E.O.) 12024 (42 FR 61445; 3 CFR, 1977 Comp., p. 158). E.O. 12024 delegated to the Administrator of General Services almost all of “the functions vested in the President by the Federal Advisory Committee Act”. GSA's authority includes “prescrib[ing] administrative guidelines and management controls applicable to advisory committees, and, to the maximum extent feasible, provid[ing] advice, assistance, and guidance to advisory committees to improve their performance.” The Administrator of General Services delegated all of their FACA-related responsibilities to the Secretariat. See 41 CFR 102-3.100. Executive orders and congressional revisions have clarified the application of the Act in 1993, 1997, 1998, 2010, and 2019. There have also been a number of Presidential actions that further clarified the operation of Federal advisory committees, particularly with respect to advisory committee membership.
This final rule amends the FMR to update current policy and legislative requirements; help ensure that regulations concerning Federal Advisory Committee Management are user-friendly; clarify and update key roles; increase transparency, diversity, equity, access, accessibility, and inclusion throughout advisory committee processes and procedures; update the language regarding merger; and implement process improvements as proposed with changes published on November 2, 2023, at 88 FR 75248. It is also based on suggestions for improvement from other Federal agencies and interested parties, including public comments, which are detailed in section II.B. of this document. This final rule is intended to improve the clarity of regulations concerning management and operation of Federal advisory committees in the executive branch, which will in turn enhance the performance of advisory committees.
Section 102-3.40 is revised to reflect a legislative change that was made by the Intelligence Authorization Act for Fiscal Year 2010 (Pub. L. 111-259), which states that the Director of National Intelligence may determine that, for reasons related to national security, FACA is not applicable to advisory committees of the Office of the Director of National Intelligence.
To make regulations concerning Federal Advisory Committee Management more user-friendly—and ultimately enhance the performance of advisory committees—GSA is removing certain language and information from part 102-3.
Similarly, GSA is removing certain language from 41 CFR 102-3.130 that is already captured in other regulations or policies governing the appointment, compensation, or reimbursement of advisory committee members, staff, experts, and consultants. For example, the Office of Personnel Management (OPM) establishes policy for
Consistent with the agency's responsibility to “prescribe administrative guidelines and management controls applicable to advisory committees,” sec. 7(c) (codified at 5 U.S.C. 1006(c)), GSA is adding two key roles at 41 CFR 102-3.25. The Act refers to a chair of each advisory committee, see sec. 10 (codified at 5 U.S.C. 1009), but does not define the contours of that role so GSA added a definition for a “chairperson.” GSA is also adding a definition for a “Group Federal Officer” to capture a key role that some agencies use to support their FACA programs, as GSA believes it is helpful to formally recognize what continues to be a key role for some agencies. GSA is also clarifying the definitions and responsibilities of the following existing key roles:
• The Secretariat in 41 CFR 102-3.100 to reflect a more comprehensive description of actual Secretariat activities, update terminology, and recognize a government-wide interagency group that was created after GSA published a final rule in 2001, see Federal Advisory Committee Management, 66 FR 37727 (July 19, 2001) (hereinafter “2001 Final Rule”).
• The agency head in 41 CFR 102-3.105 regarding their role with advisory committee charters and members.
• The Committee Management Officer (CMO) in 41 CFR 102-3.115 to help clarify the full scope and importance of the CMO, including acknowledgment of common actions implemented by CMOs across the executive branch in managing their agency's Federal advisory committee program.
• The Designated Federal Officer (DFO) in 41 CFR 102-3.120 to better reflect the central function of the DFO under the Act—including ensuring compliance with the Act, serving as a point of contact for members of the public, and maintaining appropriate record keeping and reporting of committee activities.
Overall, these revisions will improve the clarity of FACA-related responsibilities, which will in turn enhance the performance of advisory committees.
The Act states that advisory committees must be “fairly balanced in terms of the points of view represented and the functions to be performed.” Section 5(b)(2), (c) (codified at 5 U.S.C. 1004(b)(2), (c)). Further, the Act's “legislative history makes clear that the fairly balanced requirement was designed to ensure that persons or groups directly affected by the work of a particular advisory committee would have some representation on the committee.”
While the Act itself does not provide instructions on how agencies are to attain fairly balanced committee membership, the legislative history indicates that the Act, “[i]n the interest of economy and organization,” places “substantial power in [the implementing agency] to establish guidelines for advisory committees and to direct the agencies' use of them.” 118 Cong. Rec. 16302 (1972) (statement of Rep. Moss) (referring to responsibilities that initially belonged to the Office of Management and Budget, which were later transferred to GSA in E.O. 12024); 118 Cong. Rec. 16305 (1972) (statement of Rep. Fascell) (referring to responsibilities that were eventually transferred to GSA and stating that the Act “is explicit and without any ambiguity as to the kind of authority [that the implementing agency] would have in making the guidelines”); and 118 Cong. Rec. 30280 (1972) (statement of Sen. Roth) (recognizing that the Act would “offer[ ] improved tools for the management of committees by [the implementing agency]”).
Over the past forty years, GSA has issued regulatory requirements and subregulatory guidance on how to ensure fairly balanced committee membership. Since 1983, GSA's regulations have required agencies to consider a “cross-section” of “interested” persons and groups with demonstrated professional or personal qualifications or experience to contribute to the “functions” and tasks to be performed. See Federal Advisory Committee Management, 48 FR 19324 (Apr. 28, 1983). In response to comments, that language evolved over time, before settling in 1989 on the formulation that exists in the current regulatory text: that agencies must consider “a cross-section of those directly affected, interested, and qualified, as appropriate to the nature and functions of the committee,” which should “include persons with demonstrated professional or personal qualifications and experience relevant to the functions and tasks to be performed” by the advisory committee. See Federal Advisory Committee Management, 54 FR 41215 (Oct. 5, 1989). Further, in 2001, GSA responded to a commenter seeking further guidance on how to achieve fairly balanced committee membership by including an Appendix that encouraged agencies to consider several factors, including (1) the advisory committee's mission; (2) the geographic, ethnic, social, economic, or scientific impact of the advisory committee's recommendations; (3) the types of specific perspectives required, such as those of consumers, technical experts, the public at-large, academia, business, or other sectors; (4) the need to obtain divergent points of view on the issues before the advisory committee; and (5) the relevance of State, local, or Tribal Governments to the development of the advisory committee's recommendations. See 2001 Final Rule, 66 FR 37727, 37740.
Consistent with the agency's responsibility to “prescribe administrative guidelines and management controls applicable to advisory committees, and . . . [to] provide advice, assistance, and guidance to advisory committees to improve their performance,” sec. 7(c) (codified at 5 U.S.C. 1006(c))—and in an effort to help committees to actually attain fairly balanced membership—GSA has long required agencies to submit “a description of the agency's plan to attain balanced membership,” 48 FR 19324 (Apr. 28, 1983). More recently, in an effort to collect more substantive information regarding an agency's plan to attain a fairly balanced membership, GSA released guidance to the FACA community in 2011 on “Preparing Membership Balance Plans” (MBPs). See
GSA is now updating the regulatory language pertaining to the MBP (specifically at 41 CFR 102-3.60) to reflect GSA's longstanding guidance as described above. Furthermore, in response to feedback from agencies and consistent with recent Presidential Actions supporting diversity, equity, inclusion, and accessibility,
By seeking out individuals for potential membership that have relevant professional and/or lived experience with topics likely to come before the advisory committee, agencies can help to ensure that those insights and experiences inform and enhance the committee's work. See Syreeta Skelton-Wilson et al., “Methods and Emerging Strategies to Engage People with Lived Experience,” Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services (Dec. 20, 2021),
Further, GSA is updating the rules and principles that apply to the management of advisory committees (specifically at 41 CFR 102-3.95 and 102-3.140), including (a) clarifying that adequate committee support includes access to adequate virtual meeting capabilities and access to communication modes that are more inclusive; (b) encouraging agencies to be as transparent, equitable, inclusive, accessible, and timely as possible when providing public access to committee activities and materials; and (c) fostering active engagement, participation, and expression from all committee members and any member dissenting opinions, as applicable. These changes will help improve public access to advisory committees and membership engagement, which will in turn enhance the performance of advisory committees.
Finally, GSA is improving public access to advisory committee meetings through amendments to 41 CFR 102-3.65, 102-3.150, and 102-3.165. The Act specifies that meeting notices shall be published in the
The Act instructs the Administrator of General Services to conduct an annual “review of the activities and responsibilities of each advisory committee,” in part “to determine . . . whether the committee should be merged with other advisory committees.” Section 7(b) (codified at 5 U.S.C. 1006(b)). Historically, merger of advisory committees has been infrequent. More recently, however, merger has become a more routine occurrence during the consultation process. Accordingly, to appropriately account for that trend, GSA is adding the term “merge” throughout part 102-3—namely, to sections that apply to actions taken by an agency in the establishment, reestablishment, renewal, operation, and termination of Federal advisory committees.
The Act identifies certain information that must be included in the charter for each committee. See sec. 9 (codified at 5 U.S.C. 1008). Over a decade ago—consistent with the Administrator's responsibility to “provide advice, assistance, and guidance to advisory committees to improve their performance,” sec. 7(c) (codified at 5 U.S.C. 1006(c))—GSA issued guidance on Preparing Federal Advisory Committee Charters, available at:
Further, GSA is revising the charter amendment process. The current regulatory process for amending charters (per the 2001 Final Rule) stipulates two separate processes for amendments—one that applies to minor changes, and the other that applies to major changes. Those processes, however, are identical except for a requirement to consult with the Secretariat as to any major changes. Although GSA's intent was to forgo the need for consultation with the Secretariat if the changes were truly minor, there has been confusion in the FACA community regarding what specifically constitutes a minor amendment. Further, this confusion has resulted in a number of agencies choosing to consult with the Secretariat on all charter amendments. Accordingly, to eliminate confusion, GSA is consolidating the charter amendment sections into a singular process in 41 CFR 102-3.80. In addition, consistent with GSA's priority of increasing transparency with respect to advisory committee activities (as explained above), GSA is requiring that agencies post notice of the amendment to the relevant advisory committee website (if one exists).
The Act requires each agency head to “establish uniform administrative guidelines and management controls for advisory committees established by that agency.” Section 8(a) (codified at 5 U.S.C. 1007(a)). In recent years, the FACA community has inquired about appropriate content for those guidelines. In response, GSA is revising 41 CFR 102-3.125 to clarify some of the operational components that agency administrative guidelines should reflect—such as specifying the content of committee bylaws and providing instructions on how to identify, calculate, and document advisory committee costs.
GSA is adding a new subpart on severability at 41 CFR 102-3.190, which states that all provisions included in
Regulations concerning Federal Advisory Committee Management do a number of things—from outlining public notification requirements to explaining the role of an agency head. Overall, each constituent element in part 102-3 operates independently to help ensure that standards and uniform procedures govern the establishment, operation, administration, and duration of advisory committees. See sec. 2(b)(4) (codified at 5 U.S.C. 1002(b)(4)).
Accordingly, if any particular provision in part 102-3 were to be stayed or invalidated by a reviewing court, the remaining provisions would continue to function effectively for advisory committees. For example, if 41 CFR 102-3.75 on charter requirements were invalidated, that would not make 41 CFR 102-3.155, which lists the requirements for facilitating an advisory committee meeting that is closed to the public, unworkable. Likewise, if 41 CFR 102-3.60(b)(3) on attaining fairly balanced membership were invalidated, that would not prevent an agency from relying on the definitions in 41 CFR 102-3.25 to understand what “committee staff” means.
Further, any cross-references that appear throughout part 102-3 are duplicative and are intended only to make the regulations more user-friendly. Invalidation of a particular provision that is cross-referenced elsewhere will not materially alter the provision that contains the cross-reference.
In summary, removal of any particular provision from part 102-3 would not render the entire regulatory scheme unworkable. Thus, GSA considers each of the provisions in part 102-3 to be separate and severable from one another. In the event of a stay or invalidation of any particular provision, it is GSA's intention that the remaining provisions shall continue in effect.
The proposed rule was published in the
This final rule will have a cost impact on the Federal Government; however, it will not impact the private sector or State, local, or Tribal Governments, as it relates solely to agency administration and management. GSA has already incorporated a number of the changes into the consultation process that occurs between the agencies and GSA, the government-wide training for agencies and personnel involved with advisory committee work, and routine interactions regarding agency committee management programs.
GSA conducted an economic analysis of the proposed changes and determined that during the first and subsequent years after publication of the rule, there are compliance costs associated with the final rule. GSA estimates the overall total additional undiscounted cost of this final rule to be $7,007,404 over a ten-year period. See section VI.A (providing a full breakdown of compliance costs). There are numerous benefits described throughout section I—including implementing legislative updates; helping to ensure that regulations concerning Federal Advisory Committee Management are user-friendly; clarifying and updating key FACA roles; increasing transparency, diversity, equity, access, accessibility, and inclusion throughout advisory committee processes and procedures; updating language regarding merger; and implementing process improvements with respect to advisory committee charters and agency administrative guidelines. It is intended that overall, this final rule will improve the clarity of regulations concerning management and operation of Federal advisory committees in the executive branch, which will in turn enhance the performance of advisory committees.
E.O.s 12866, 13563, and 14094 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. E.O. 14094 supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in E.O. 12866 and E.O. 13563. OMB's Office of Information and Regulatory Affairs (OIRA) has designated this rule as a significant regulatory action and, therefore, it was subject to review under sec. 6(b) of E.O. 12866.
OIRA has determined that this rule is not a “major rule” under 5 U.S.C. 804(2). Title II, subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (codified at 5 U.S.C. 801-808), also known as the Congressional Review Act or CRA, generally provides that before a rule may take effect, unless excepted, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. This rule is excepted from CRA reporting requirements prescribed under 5 U.S.C. 801 as it relates to agency management or personnel under 5 U.S.C. 804(3)(B).
GSA certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
GSA has determined, based on an economic model, that there are compliance costs associated with the final rule. The following section is a list of activities related to regulatory familiarization and compliance that GSA anticipates will occur. Compliance activities would take place in the FACA community and would consist of amending charters, revising guidelines, training, and outreach for diversity, equity, inclusion, access, and accessibility. These assumptions were generated based on internal GSA expertise. GSA estimates this cost by multiplying the time required to conduct the compliance activity by the estimated compensation. GSA calculates the estimated hourly compensation using OPM's 2023 General Schedule (GS) Rest of United States Locality Pay Table and the full fringe benefit cost factor.
GSA estimates it will take 25 government employees on average with a GS-14 step five average hourly rate of $86.12/hour, three hours each in years 1 to 10 to amend charters with updated information from this rule. Therefore, GSA estimates the total estimated cost for this part of the final rule per year to be $6,459 (= [25 employees] × [$86.12/hour] × [3 hours]).
GSA estimates it will take 57 government employees, CMOs with a GS-15 step five average hourly rate of $101.30/hour, four hours each in year 1 to update guidelines with updated information from this final rule. Therefore, GSA estimates the total estimated cost for this part of the final rule to be $23,096 (= [57 employees] × [$101.30/hour] × [4 hours]).
GSA estimates it will take 987 government employees, DFOs with a GS-12 step five average hourly rate of $61.29/hour, 0.5 hours each in year 1 to update guidelines with updated information from this final rule. Therefore, GSA estimates the total
GSA estimates it will take 57 government employees, CMOs with a GS-15 step five average hourly rate of $101.30/hour, 0.5 hours each in year 1 to deliver training related to changes with this final rule. Therefore, GSA estimates the total estimated cost for this part of the final rule to be $2,887 (= [57 employees] × [$101.30/hour] × [0.5 hours]).
GSA estimates it will take 1,552 government Full-Time Equivalents (FTEs) with a GS-12 step five average hourly rate of $61.29/hour 0.5 hours each in year 1 to receive training related to changes with this final rule. Therefore, GSA estimates the total estimated cost for this part of the final rule to be $47,561 (= [1,552 FTEs] × [$61.29/hour] × [0.5 hours]).
GSA estimates it will take government employees with a GS-13 step five average hourly rate of $72.88/hour four hours per membership slot, in years 1 to 10 to conduct additional outreach in identifying 1,050 new members that may be able to participate in new Federal advisory committees—ultimately to help ensure that committee membership is fairly balanced. Therefore, GSA estimates the total estimated cost for this part of the final rule per year to be $306,096 (= [1,050 membership slots] × [$72.88/hour per government employee] × [4 hours]).
GSA estimates it will take government employees with a GS-13 step five average hourly rate of $72.88/hour) 0.5 hours per membership slot in year 1, to conduct additional outreach in identifying 31,931 new members that may be able to participate in U.S. Department of Health and Human Services grant review Federal advisory committees—ultimately to help ensure that committee membership is fairly balanced. Therefore, GSA estimates the total estimated cost for this part of the final rule to be $1,163,566 (= [31,931 membership slots] × [$72.88/hour per government employee] × [0.5 hours]).
GSA estimates it will take government employees with a GS-13 step five average hourly rate of $72.88/hour) one hour per membership slot in years 1 and 2 to conduct additional outreach in identifying 17,937 new members that may be able to participate in non-grant review Federal advisory committees—ultimately to help ensure that committee membership is fairly balanced. Therefore, GSA estimates the total estimated cost for this part of the final rule per year to be $1,307,249 (= [17,937 membership slots] × [$72.88/hour] × [1 hour]).
GSA estimates the total government costs to be $7,007,404 for years 1 to 10. A breakdown of the total estimated government costs by year is provided in the table below.
The overall total additional undiscounted cost of this final rule is estimated to be $7,007,404 over a ten-year period. A summary of the estimated costs calculated for a ten-year period at a 3- and 7-percent discount rate is provided in the table below. GSA did not identify any cost savings based on the impact of the final rule.
The preferred approach is to take the process laid out in the analysis above. However, GSA has analyzed one alternative to the preferred process. As an alternative, GSA could decide not to update regulations concerning Federal Advisory Committee Management; however, that alternative would leave outdated and unclear content in the regulations, which would continue to cause confusion, impede accessibility and transparency by not encouraging the expansion of outreach and meeting access to the public, and waste government time and resources by forcing agencies to seek clarification on sections that contain unclear and unnecessary language. In light of those concerns, GSA rejects the alternative.
The final rule does not contain any information collection requirements that require the approval of the OMB under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Advisory committees, Governmental property management.
Therefore, GSA revises 41 CFR part 102-3 to read as follows:
40 U.S.C. 486(c); 5 U.S.C. chapter 10; and E.O. 12024, 42 FR 61445, 3 CFR, 1977 Comp., p. 158.
This part provides the policy framework and establishes minimum requirements that must be used by agency heads and Federal officers in applying the Federal Advisory Committee Act, as amended (FACA or “the Act”), 5 U.S.C. chapter 10, to advisory committees they establish and operate. In addition to listing key definitions underlying the interpretation of the Act, this part establishes the scope and applicability of the Act and outlines specific exclusions from its coverage. This part is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person, including any advisory committee or officer, member, employee, agent, or contractor of any advisory committee.
FACA governs the establishment, operation, administration, and termination of advisory committees within the executive branch of the Federal Government. The Act defines what constitutes a Federal advisory committee and provides general procedures for the executive branch to follow for the operation of these advisory committees. In addition, the Act is designed to assure that the Congress and the public are kept informed with respect to the number, purpose, membership, activities, recommendations, outcomes, and cost of advisory committees through reporting requirements. These requirements form the basis for implementing the Act at both the agency and Government-wide levels.
The following definitions apply to this part:
These are the policies to be followed by Federal departments and agencies in establishing and operating advisory committees consistent with the Act:
(a)
(b)
(c)
(d)
(1)
(2)
(e)
(a) In general, the requirements of the Act and the policies of this part do not apply to subcommittees of advisory committees that report to a parent advisory committee and not directly to a Federal officer or agency. However, this section does not preclude an agency from applying any provision of the Act and this part to any subcommittee of an advisory committee.
(b) If a subcommittee reports directly to a Federal officer or agency, it is no longer functioning as a subcommittee. In that case, the subcommittee must be chartered as a new advisory committee, must comply with all of the requirements of this part, and will be counted as a chartered advisory committee at an agency.
(c) Unless required by statute or Presidential directive, the creation and operation of subcommittees must be approved by the agency establishing the parent advisory committee in coordination with the DFO.
In addition to the committees created by the National Academy of Sciences, Engineering, and Medicine and the National Academy of Public Administration (except as covered by subpart E of this part), the Central Intelligence Agency, and the Federal Reserve, the following are examples of committees or groups that are not covered by the Act or this part:
(a) Any advisory committee established or utilized by the Office of the Director of National Intelligence, if the Director of National Intelligence determines that for reasons of national security such advisory committee
(b) Committees specifically exempted by statute;
(c) Committees created by non-Federal entities and not actually managed or controlled by the executive branch;
(d) Groups assembled where attendees provide individual advice to a Federal official(s);
(e) Groups assembled to exchange facts or information with a Federal official(s);
(f) Any committee composed wholly of full-time or permanent part-time officers or employees of the Federal Government and elected officers of State, local, and Tribal governments (or their designated employees with authority to act on their behalf), acting in their official capacities. The purpose of such a committee must be solely to exchange views, information, or advice relating to the management or implementation of Federal programs established pursuant to statute, that explicitly or inherently share intergovernmental responsibilities or administration (see guidelines issued by the Office of Management and Budget (OMB) on sec. 204(b) of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1534(b), and OMB Memorandum M-95-20, dated September 21, 1995, available on the Committee Management Secretariat website);
(g) Any committee composed wholly of full-time or permanent part-time officers or employees of the Federal Government;
(h) Local civic groups whose primary function is that of rendering a public service with respect to a Federal program;
(i) Groups established to advise State or local officials;
(j) Any committee established to perform primarily operational as opposed to advisory functions. Operational functions are those specifically authorized by statute or Presidential directive, such as making or implementing Government decisions or policy. A committee designated operational may be covered by the Act if it becomes primarily advisory in nature; and
(k) Any committee established, created, managed, and staffed by the government of a foreign country; or any committee created, managed, and staffed by an executive branch agency to advise or make recommendations to a government official, government group, or government agency of a foreign country.
Requirements for establishing and terminating advisory committees vary depending on the establishing entity and the source of authority for the advisory committee. This subpart covers the procedures associated with the establishment, renewal, reestablishment, merger, and termination of advisory committees. These procedures include, but are not limited to, consulting with the Secretariat, preparing and filing an advisory committee charter, publishing notice in the
FACA identifies four sources of authority for establishing an advisory committee:
(a)
(b)
(c)
(d)
(a) An advisory committee automatically terminates two years after its date of establishment unless:
(1) The statutory authority used to establish the advisory committee provides a different duration or termination, either stated in or implied by operation of the statute;
(2) The President or agency head determines that the advisory committee has fulfilled the purpose for which it was established and terminates the advisory committee earlier;
(3) The President or agency head determines that the advisory committee is no longer carrying out the purpose for which it was established and terminates the advisory committee earlier; or
(4) The President or agency head renews the advisory committee not later than two years after its date of establishment, renewal, or reestablishment in accordance with § 102-3.60. If the President or an agency needs an advisory committee that was terminated, it can be reestablished in accordance with § 102-3.60.
(b) When an advisory committee terminates, the agency shall notify the Secretariat of the effective date of the termination.
(a)
(b)
(1)
(2)
(3)
(i)
(ii)
(iii)
A notice to the public in the
(a)
(b)
No advisory committee may meet or take any action until a charter has been filed by the CMO or by another agency official designated by the agency head.
(a)
(1) The agency head;
(2) The standing committees of the Senate and the House of Representatives having legislative jurisdiction of the agency, the date of filing with which constitutes the official date of establishment for the advisory committee;
(3) The Library of Congress; and
(4) The Secretariat, indicating the date the charter was filed in accordance with paragraph (a)(2) of this section.
(b)
(c)
An advisory committee charter is intended to provide a description of an advisory committee's mission, goals, and objectives. The charter must contain the following information:
(a) The advisory committee's official designation (official name);
(b) The legal authority that permits the advisory committee to be established;
(c) The objectives and the scope of the advisory committee's activities;
(d) A description of the duties for which the advisory committee is responsible and specification of the authority for any non-advisory functions;
(e) The agency or Federal officer to whom the advisory committee submits its recommendations;
(f) The agency responsible for providing the necessary support to the advisory committee, including the name of the President's delegate, agency, or organization responsible for fulfilling the reporting requirements of sec. 6(b) of the Act (codified at 5 U.S.C. 1005(b)), if appropriate;
(g) The estimated annual costs to operate the advisory committee in dollars and person years (full time equivalents or FTE);
(h) The role of the DFO;
(i) The estimated number and frequency of the advisory committee's meetings;
(j) The period of time necessary to carry out the advisory committee's purpose(s);
(k) The planned termination date, if less than two years from the date of establishment of the advisory committee;
(l) The estimated number of advisory committee members, the expertise or experience required, and the anticipated advisory committee member designations;
(m) Whether subcommittees may be created, by whom, and how they operate under the chartered advisory committee;
(n) The relevant recordkeeping disposition schedule(s); and
(o) The date the charter is filed in accordance with § 102-3.70.
The agency head is responsible for amending the charter of an advisory committee. Amending any existing advisory committee charter does not constitute renewal of the advisory committee under § 102-3.60. The procedures for making changes and filing amended charters will depend upon the authority basis for the advisory committee, as stated in paragraphs (a) through (c) of this section:
(a)
(b)
(1) First consult with the Secretariat and explain the purpose of the changes and why they are necessary. The Secretariat will notify the agency when the consultation process is complete.
(2) Upon receiving notice from the Secretariat that the consultation is complete, file the amended charter as specified in § 102-3.70, and notify the public as specified in paragraph (c) of this section.
(c)
This subpart outlines specific responsibilities and functions to be carried out by the U.S. General Services Administration (GSA), the agency head, the CMO, and the DFO under the Act.
Agencies are encouraged to apply the following principles to the management of their advisory committees:
(a)
(b)
(c)
(d)
(a) The responsibilities of the Administrator under sec. 7 of the Act (codified at 5 U.S.C. 1006) have been delegated by the Administrator to the Committee Management Secretariat within GSA's Office of Government-wide Policy.
(b) The Secretariat carries out its responsibilities by:
(1) Engaging in consultations with agencies on the establishment, re-establishment, renewal, merger, and termination of discretionary advisory committees;
(2) Prescribing guidance applicable to advisory committees;
(3) Assisting other agencies in implementing and interpreting the Act;
(4) Conducting an annual comprehensive review of Government-wide advisory committee accomplishments, costs, benefits, and other indicators to measure performance;
(5) Developing and providing Government-wide training regarding the Act and related statutes and principles;
(6) Supporting the Interagency Committee on Federal Advisory Committee Management and FACA Attorney Council to improve compliance with the Act;
(7) Designing and maintaining a FACA database to facilitate data collection, reporting, and use of information required by the Act;
(8) Preparing regulations on Federal advisory committees;
(9) Identifying performance measures that may be used to evaluate advisory committee accomplishments; and
(10) Providing recommendations for transmittal by the Administrator to Congress and the President regarding proposals to improve accomplishment of the objectives of the Act.
When a committee is utilized by or established by an agency, the agency head must:
(a) Comply with the Act, this part, and other applicable laws and regulations;
(b) Issue administrative guidelines and management controls providing the details that advisory committee staff need to implement during the creation, operation, and termination of their Federal advisory committees;
(c) Designate a CMO;
(d) Designate a DFO for each advisory committee and its subcommittees;
(e) Approve the advisory committee charters for establishments, renewals, re-establishments, or mergers;
(f) Provide a written determination stating the reasons for closing any advisory committee meeting to the public, in whole or in part, in accordance with the exemptions set forth in the Government in the Sunshine Act, 5 U.S.C. 552b(c);
(g) Review, at least annually, the need to continue each existing advisory committee, consistent with the public interest and the purpose or functions of each advisory committee;
(h) Determine that rates of compensation for members (if they are paid for their services) and staff of, and experts and consultants to advisory committees are justified and that levels of agency support are adequate;
(i) Develop procedures to assure that the advice or recommendations of advisory committees will not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee's independent judgment;
(j) Assure that the interests and affiliations of committee members are reviewed for conformance with applicable conflict of interest statutes, regulations issued by the U.S. Office of Government Ethics including any supplemental agency requirements, and other Federal ethics rules;
(k) Appoint or invite individuals to serve on committees, unless otherwise provided for by a specific statute or Presidential directive; and
(l) Provide the opportunity for reasonable participation, including accessibility considerations, by the public in advisory committee activities, subject to § 102-3.140 and the agency's guidelines.
The chairperson of an independent Presidential advisory committee must:
(a) Comply with the Act, this part, and other applicable laws and regulations;
(b) Consult with the Secretariat concerning the designation of a CMO and DFO; and
(c) Consult with the Secretariat in advance regarding any proposal to close any meeting in whole or in part.
In addition to implementing the provisions of sec. 8(b) of the Act (codified at 5 U.S.C. 1007(b)), the CMO will carry out all responsibilities delegated by the agency head and manage the agency FACA program. Management includes consulting with the Secretariat on Federal advisory committees, as delegated by the agency head; tracking charter establishments, renewals, re-establishments, mergers, amendments, and terminations; coordinating the agency Annual Comprehensive Review within their agency and with the Secretariat; providing training for agency staff supporting the FACA program; working with GFOs, as appropriate, and DFOs; attending GSA Government-wide FACA training and recommending this training to agency staff, as appropriate; and attending Interagency Committee on Federal Advisory Committee Management meetings. The CMO should create and maintain an agency website to further the public's understanding of the agency's FACA program. The CMO also should ensure that secs. 10(b), 12(a), and 13 of the Act (codified at 5 U.S.C. 1009(b), 1011(a), and 1012, respectively) are implemented by the agency to provide for appropriate recordkeeping. Records to be kept by the CMO include, but are not limited to—
(a)
(b)
(c)
(d)
(a) The agency head or, in the case of an independent Presidential advisory committee, the Secretariat, must designate a Federal officer or employee who must be either full-time or permanent part-time, to be the DFO for each advisory committee and its subcommittees, who must:
(1) Ensure that their committee activities comply with the Act, this part, their agency administrative procedures, and any other applicable laws and regulations;
(2) Approve or call all meetings of the advisory committee or subcommittee;
(3) Approve the agenda, except that this requirement does not apply to a Presidential advisory committee;
(4) Attend all advisory committee and subcommittee meetings for their duration;
(5) Fulfill the requirements under sec. 10(b) of the Act (codified at 5 U.S.C. 1009(b));
(6) Adjourn any meeting when he or she determines it to be in the public interest;
(7) Chair any meeting when so directed by the agency head;
(8) Maintain information on advisory committee activities and provide such information to the public, as applicable; and
(9) Ensure advisory committee members and subcommittee members, as applicable, receive the appropriate training (
(b) The DFO should ensure a public facing website is created and maintained (that complies with the requirements of relevant sections of the Rehabilitation Act of 1973, as amended, 29 U.S.C. 794) for each advisory committee, and include information such as: the advisory committee charter; relevant laws, regulations, and guidance; advisory committee member rosters and subcommittee member rosters, as applicable;
An agency's administrative guidelines provide the details that advisory committee staff need to implement FACA requirements during the creation, operation, and termination of their advisory committees.
(a)
(b)
(1) Provide instructions on how to identify, calculate, and fully document advisory committee costs; and
(2) Ensure agency committee cost records match the data reported to Congress and the public through the FACA database.
In developing guidelines to implement the Act, this part, and other applicable laws and regulations at the agency level, agency heads should address the following issues:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
This subpart establishes policies and procedures relating to meetings and other activities undertaken by advisory committees and their subcommittees. This subpart also outlines what records must be kept by Federal agencies and what other documentation, including advisory committee minutes and reports, must be prepared and made available to the public.
(a) The agency head for a discretionary or non-discretionary advisory committee established or utilized by that agency, or the chairperson for an independent Presidential advisory committee, must ensure that:
(1) Each advisory committee meeting is held at a reasonable time and in a manner or place accessible to the public and includes consideration of affected communities, as appropriate, as well as facilities or technology that are readily accessible to and usable by persons with disabilities, consistent with the requirements set forth in relevant sections of the Rehabilitation Act of 1973, as amended, 29 U.S.C. 794;
(2) The physical meeting room is sufficient to accommodate advisory committee members, advisory committee or agency staff, and a reasonable number of interested members of the public. If electronic forums are used, agencies should opt for technology features that are compliant with relevant sections of the Rehabilitation Act, as amended, 29 U.S.C. 794, accommodate advisory committee members, advisory committee or agency staff, and allow for maximum participation by members of the public, as appropriate;
(3) Any member of the public is permitted to file a written statement with the advisory committee, whether or not the statement is related to a specific meeting;
(4) Any member of the public may speak to or otherwise address the advisory committee if the agency's guidelines so permit; and
(5) Any advisory committee meeting conducted in whole or part through any electronic medium (such as a teleconference or through a virtual platform) meets the requirements of this subpart.
(b) The
If a subcommittee provides advice or recommendations directly to a Federal officer or agency, or if its advice or recommendations will be adopted by the parent advisory committee without further deliberations by the parent advisory committee, then the subcommittee's meetings must be conducted in accordance with the requirements of this subpart.
(a) A notice in the
(1) The name of the advisory committee (or subcommittee, if applicable);
(2) The time, date, physical place (and/or instructions to connect electronically), and purpose of the meeting;
(3) Whether meeting registration is required;
(4) A summary of the agenda, and/or topics to be discussed and instructions on how to access meeting materials;
(5) A statement whether all or part of the meeting is open to the public or closed; if the meeting is closed in whole or in part, state the reasons why, citing the specific exemption(s) of the Government in the Sunshine Act, 5 U.S.C. 552b(c);
(6) Instructions for submitting written comments, and oral comments if permitted;
(7) Instructions on how to submit a request for physical meeting or electronic meeting accommodations consistent with the requirements of E.O. 13166 and relevant sections of the Rehabilitation Act, as amended, 29 U.S.C. 794; and
(8) The name and telephone number (or email) of the DFO or other responsible agency official, or agency electronic mailbox for the committee, to contact for additional information concerning the meeting.
(b) In exceptional circumstances, such as a national emergency or natural disaster, the agency or an independent Presidential advisory committee may give less than 15 calendar days notice, provided that the reasons for doing so are included in the advisory committee meeting notice published in the
(c) In addition to the
To close all or part of an advisory committee meeting, the DFO must:
(a)
(b)
(c)
(d)
The following activities of an advisory committee are excluded from the procedural requirements contained in this subpart:
(a)
(b)
(a) The agency head or, in the case of an independent Presidential advisory committee, the chairperson must ensure that detailed minutes of each advisory committee meeting, including one that is closed or partially closed to the public, are kept. The chairperson of each advisory committee must certify the accuracy of all minutes of advisory committee meetings.
(b) The minutes must include:
(1) The time, date, and place (or electronic format) of the advisory committee meeting;
(2) A list of the persons who were present at the meeting, including advisory committee members and staff, agency employees, and members of the public who presented oral or written statements;
(3) An accurate description of each matter discussed and the resolution, if any, made by the advisory committee regarding such matter; and
(4) Copies of each report or other materials received, issued, or approved by the advisory committee at the meeting.
(c) The DFO must ensure that minutes are certified for accuracy by the chairperson within 90 calendar days of the meeting to which they relate. Agencies should post the meeting minutes on the agency advisory committee website (if one exists) not later than 14 calendar days after the meeting minutes have been certified.
Timely access to advisory committee records is an important element of the public access requirements of the Act. Section 10(b) of the Act (codified at 5 U.S.C. 1009(b)) provides for the contemporaneous availability of advisory committee records that, when taken in conjunction with the ability to attend committee meetings, provide a meaningful opportunity to comprehend
(a)
(b)
(c)
(d)
(e)
This subpart provides guidance to agencies on compliance with sec. 15 of the Act (codified at 5 U.S.C. 1014). Section 15 establishes requirements that apply only in connection with a funding or other written agreement involving an agency's use of advice or recommendations provided to the agency by the National Academy of Sciences (NAS) or the National Academy of Public Administration (NAPA), if such advice or recommendations were developed by use of a committee created by either academy. For purposes of this subpart, NAS also includes the National Academy of Engineering, the National Academy of Medicine, and the National Research Council. Except with respect to NAS committees that were the subject of judicial actions filed before December 17, 1997, no part of the Act other than sec. 15 applies to any committee created by NAS or NAPA.
(a)
(1) The committee was not subject to any actual management or control by an agency or officer of the Federal Government; and
(2) In the case of NAS, the academy certifies that it has complied substantially with the requirements of sec. 15(b) of the Act (codified at 5 U.S.C. 1014(b)); or
(3) In the case of NAPA, the academy certifies that it has complied substantially with the requirements of sec. 15(b) (1), (2), and (5) of the Act (codified at 5 U.S.C. 1014(b)(1), (2), and (5), respectively).
(b)
(c)
(1) The academy has adopted policies and procedures that comply with the applicable requirements of sec. 15 of the Act (codified at 5 U.S.C. 1014); and
(2) To the best of the authorized representative's knowledge and belief, these policies and procedures substantially have been complied with in performing the work required under the agreement.
All provisions of this part are separate and severable from one another. If any
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2024 total allowable catch of Pacific cod by catcher vessels using trawl gear in the Central Regulatory Area of the GOA.
Effective 1200 hours, Alaska local time (A.l.t.), April 16, 2024, through 1200 hours, A.l.t., June 10, 2024.
Abby Jahn, 907-586-7416.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR parts 600 and 679.
The A season allowance of the 2024 Pacific cod total allowable catch (TAC) apportioned to catcher vessels using trawl gear in the Central Regulatory Area of the GOA is 3,828 metric tons (mt) as established by the final 2045 and 2025 harvest specifications for groundfish in the GOA (89 FR 15484, March 4, 2024).
In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the A season allowance of the 2024 Pacific cod TAC apportioned to catcher vessels using trawl gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 3,328 mt and is setting aside the remaining 500 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the Central Regulatory Area of the GOA.
While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod by catcher vessels using trawl gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notification providing time for public comment because the most recent, relevant data only became available as of April 12, 2024.
The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
Fish and Wildlife Service, Interior.
Notification of final policies.
We, the U.S. Fish and Wildlife Service (Service), announce the updated planning policies, 602 FW 1-4, for the National Wildlife Refuge System (Refuge System). The purpose of the policy revisions is to update the Refuge System's refuge management by incorporating landscape conservation plans and consideration of climate change and other anthropogenic forces in refuge management.
The policies were effective April 1, 2024.
The revised planning policies are available at
Julie Henning, Chief, Branch of Conservation Planning and Policy, National Wildlife Refuge System, via email at
We are announcing the availability of four updated National Wildlife Refuge System (Refuge System) planning policies. The purpose of the policy revisions is to update the Refuge System's refuge management by incorporating landscape conservation planning and design and consideration of climate change and other anthropogenic forces in refuge management. The Refuge System's authority for these policies comes from the Refuge System Administration Act
Refuge planning sets the broad vision for refuge management and determines goals, objectives, strategies, and actions to ensure refuges are managed consistently with a refuge's purposes; the Refuge System's mission and goals; the Administration Act, as amended; the Alaska National Interest Lands Conservation Act (for Alaska refuges); and all other applicable laws and regulations. The four planning policies the Service updated are: Refuge Planning Overview (602 FW 1), Land Protection Planning (602 FW 2), Comprehensive Conservation Planning (602 FW 3), and Step-down Planning (602 FW 4).
• 602 FW 1, Refuge Planning Overview, describes the Service's overall policy and goals for refuge planning and how the Refuge System incorporates climate adaptation and resiliency into refuge planning. The policy also describes how the Refuge System coordinates with Federal, State, and local agencies; Tribes; Alaska Native Corporations (ANCs); Alaska Native Organizations (ANOs); the Native Hawaiian Community; territories; and other partners and stakeholders in refuge planning.
• 602 FW 2, Land Protection Planning, describes the Service's overall policy and goals for land protection planning and establishes who is responsible for different steps of the process. The policy provides an overview of the Service's land protection planning process, including coordination with partners, land acquisition, and minor and major refuge boundary modifications.
• 602 FW 3, Comprehensive Conservation Planning, describes the Service's overall policy and goals for comprehensive conservation planning, and establishes who is responsible for different steps of the process. The policy provides an overview of the requirements for developing comprehensive conservation plans (CCP), including CCPs for new refuges; CCP scope and content; and coordination with partners. Finally, it provides guidance for reviewing and updating CCPs.
• 602 FW 4, Step-down Planning, describes the Service's overall policy and goals for step-down planning, and establishes who is responsible for different steps of the process. The policy provides an overview of the requirements for developing step-down plans, including how they are integrated with CCPs; consideration of the National Environmental Policy Act; and coordination with partners. Finally, it provides guidance for reviewing and updating step-down plans.
Many of the planning and natural resource regulations and policies guiding the Refuge System were developed following passage of the Improvement Act more than 20 years ago. Much has changed since then, and there is a need to consider climate change and other anthropogenic forces more explicitly and effectively in Refuge System management. The Service must also incorporate landscape planning and design into its planning policies. These are just a few of the drivers that led to convening five chartered national Service teams to update existing or develop new natural resource regulations, policies, and handbooks for the Refuge System. The Service's Conservation Planning team is comprised of Service planning subject matter experts from across the agency's Regions.
At draft stage, these policy updates were distributed for internal Service review throughout all Regions and programs in August 2022. We provided an opportunity for State engagement through the Association of Fish and Wildlife Agencies in February 2023. Additionally, we hosted national webinars and provided opportunity for engagement by Tribal leaders, ANCs, ANOs, and the Native Hawaiian Community in February 2023. In September 2023, we made the draft policies available for public comment for 30 days via a
The authority for this action is the National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd-668ee).
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend the Fort Lauderdale-Hollywood International Airport, FL (FLL), Class C airspace by subdividing the southwest corner of Area E to reduce the lateral boundary of the FLL Class C airspace. The FAA is proposing this amendment to enhance safety and enable more efficient operations for non-participating aircraft operations at North Perry Airport, FL (HWO). Additionally, this action makes multiple minor editorial amendments to the airspace description.
Comments must be received on or before June 17, 2024.
Send comments identified by FAA Docket No. FAA-2024-0053 and Airspace Docket No. 23-AWA-5 using any of the following methods:
*
*
*
*
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Brian Vidis, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify terminal airspace as required to preserve the safe and efficient flow of air traffic in the Fort Lauderdale, FL area.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see
Class C Airspace is published in paragraph 4000 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
Fort Lauderdale-Hollywood International Airport (FLL), FL, is located three miles southwest of the city of Fort Lauderdale, FL. North Perry Airport (HWO), FL, is located five miles west of the city of Hollywood, FL, and six- and one-half miles southwest of FLL. HWO has 8 flight schools and more than 250 general aviation aircraft based there.
Miami Airport Traffic Control Tower (ATCT) has hosted several meet-and-greet meetings and other in-person discussions with local aircraft owners and flight schools. During these discussions, local operators expressed safety concerns to Miami ATCT about Visual Flight Rules (VFR) aircraft arriving and departing HWO from the west. Specifically, for aircraft who remain outside of the FLL Class C airspace and Miami Class B airspace, and not receiving Air Traffic Control (ATC) services. These aircraft fly toward and converge on a common point that is an area southwest of where the north-south portion of United States (U.S.) Route 27 intersect a 15 nautical mile (NM) radius of Miami International Airport, which is the southwest corner of Area E, of the FLL Class C airspace (Convergence Point). These aircraft fly below the Miami Class B airspace and converge on the Convergence Point while remaining outside of the FLL Class C airspace. Aircraft naturally funnel to the Convergence Point which causes a high congestion of aircraft operations. Additionally, flight school aircraft commonly transition between HWO and the charted practice areas, alert areas A-291B and A-291C, that also contribute to additional aircraft near the Convergence Point.
Miami ATCT made recommendations to subdivide Area E of the FLL Class C into two parts along a line beginning at lat. 26°05′22″ N, long. 080°26′02″ W; moving southeast to lat. 26°01′38″ N, long. 080°23′44″ W. The floor of Class C airspace southwest of this line would be raised from 1,500 feet mean sea level (MSL) to 2,600 feet MSL; reducing the vertical size of Area E by 1,100 feet. This 1,100-foot reduction of Class C airspace would become Class E airspace. This modification would allow aircraft transitioning to and from HWO, from the west, additional Class E airspace to maneuver near the Convergence Point. This would reduce aircraft congestion and significantly increase safety while still providing adequate Class C airspace for operations arriving and departing FLL.
The FAA is proposing an amendment to 14 CFR part 71 by updating the Fort Lauderdale-Hollywood International Airport, FL, Class C airspace description as published in FAA Order JO 7400.11H, Airspace Designations and Reporting Points (see the attached chart).
The FAA proposes to subdivide Area E of the FLL Class C airspace into two areas along a line extending between lat. 26°05′22″ N, long. 080°26′02″ W and lat. 26°01′38″ N, long. 080°23′44″ W. The portion of Area E northeast of this proposed subdivision boundary would remain with a floor of 1,500 feet MSL and a ceiling of 4,000 feet MSL. The FAA proposes to create a new area southwest of the subdivision boundary with a floor of 2,600 feet MSL and a ceiling of feet 4,000 MSL. This proposed new area would be referred to as “Area H”. As amended, Area E would extend upward from 1,500 feet MSL to 4,000 feet MSL, and Area H would extend upward from 2,600 feet MSL to 4,000 feet MSL. Additionally, the FAA proposes to add an exclusion to Area H that excludes the overlying Miami Class B airspace from Area H.
The FAA also proposes to make a minor correction to the first line of the description's text header, listing just the city and state location of the airport. This change follows the FAA's current airspace description formatting requirements.
The FAA further proposes a technical amendment to a geographic coordinate in the description of Area E. This minor amendment to the geographic coordinate more accurately describes the intersection of where Area E meets U.S. Route 27. Updating this coordinate does not change the boundary of Area E, but rather increases the accuracy of the road due to digital precision survey. The proposal would amend the geographic coordinate from “lat. 26°06′02″ N, long. 080°26′27″ W” to “lat. 26°05′22″ N, long. 080°26′02″ W.”
Additionally, the FAA would make a minor editorial change to the Area C description to clarify that Area C excludes the overlying Miami Class B airspace.
Federal agencies consider impacts of regulatory actions under a variety of executive orders and other requirements. First, Executive Order 12866 and Executive Order 13563, as amended by Executive Order 14094 (“Modernizing Regulatory Review”), direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify the costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. The current threshold after adjustment for inflation is $177 million using the most current (2022) Implicit Price Deflator for the Gross Domestic Product.
In conducting these analyses, the FAA has determined that this proposed rule: will result in benefits that justify costs; is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866, as amended; will not have a significant economic impact on a substantial number of small entities; will not create unnecessary obstacles to the foreign commerce of the United States; and will not impose an unfunded mandate on State, local, or Tribal governments, or on the private sector.
Regulatory Impact Analysis
Local aircraft owners and flight schools expressed safety concerns to Miami ATCT for VFR aircraft arriving and departing HWO from the west. Specifically, these concerns apply to aircraft who are remaining outside of the FLL Class C airspace and Miami Class B airspace, and not receiving Air Traffic Control (ATC) services. These aircraft fly toward and converge on a
This action proposes to amend the Fort Lauderdale-Hollywood International Airport, FL (FLL), Class C airspace by subdividing the southwest corner of Area E and returning a portion of Class C airspace to become Class E airspace. This modification would allow aircraft transitioning to and from HWO, from the west, additional Class E airspace to maneuver near the Convergence Point. This would reduce aircraft congestion while still providing adequate Class C airspace for operations arriving and departing FLL.
Reducing congestion has two impacts: reducing aircraft operating expenses as well as enhancing safety. Aircraft that would fly through the proposed modified area could use a shorter route of flight which would result in a small reduction of operating expenses. Additionally, reducing congestion would enhance safety by increasing the volume of airspace that these aircraft (aircraft who do not receive ATC services and remain outside of the FLL Class C airspace and Miami Class B airspace) can use, thus giving aircraft the opportunity to spread out more, reducing the potential for mid-air collisions.
The Regulatory Flexibility Act (RFA) of 1980, (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) and the Small Business Jobs Act of 2010 (Pub. L. 111-240), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
This action proposes to amend the Fort Lauderdale-Hollywood International Airport, FL (FLL), Class C airspace by subdividing the southwest corner of Area E and returning a portion of Class C airspace to become Class E airspace. These proposed modifications are intended to reduce aircraft congestion and increase safety while still providing adequate Class C airspace for operations arriving and departing FLL. Therefore, the FAA proposes to certify that the rule will not have a significant economic impact on a substantial number of small entities. The FAA welcomes comments on the basis for this certification.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.
The FAA has assessed the potential effect of this proposed rule and determined that it would improve safety and is consistent with the Trade Agreements Act.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or Tribal government or the private sector to incur direct costs without the Federal government having first provided the funds to pay those costs. The FAA determined that the proposed rule will not result in the expenditure of $177 million or more by State, local, or Tribal governments, in the aggregate, or the private sector, in any one year.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The information collections that are required by this rule are already approved in OMB control number 2120-0749. The FAA has determined that there would be no new requirement for information collection associated with this proposed rule.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F: “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify the Class D airspace extending upward from the surface to and including 2,600 feet mean sea level (MSL) and establish Class E airspace extending upward from 700 feet above the surface at Sacramento Mather Airport, Sacramento, CA. Additionally, this action proposes administrative modifications to update the airport's Class D airspace legal description. These actions would support the safety and management of instrument flight rules (IFR) and visual flight rules (VFR) operations at the airport.
Comments must be received on or before June 3, 2024.
Send comments identified by FAA Docket No. FAA-2024-0184 and Airspace Docket No. 23-AWP-69 using any of the following methods:
*
*
*
*
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Nathan A. Chaffman, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3460.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would modify Class D airspace and establish Class E airspace at Sacramento Mather Airport, Sacramento, CA, to support IFR and VFR operations at the airport.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Class D and Class E5 airspace designations are published in paragraphs 5000 and 6005, respectively, of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is proposing an amendment to 14 CFR part 71 to modify the Class D airspace and establish Class E airspace extending upward from 700 feet above the surface at Sacramento Mather Airport, Sacramento, CA.
The Class D surface area is comprised of a 4.5-mile radius of the airport. This airspace should be modified to include an extension centered on the 061° bearing from the airport, extending 1.8 miles beyond the existing radius. This extension would better contain departing IFR operations while utilizing the Runway (RWY) 4 Left (L) and 4 Right (R) obstacle departure procedures (ODP) until reaching the base of adjacent controlled airspace.
Class E airspace extending upward from 700 feet above the surface should be established to appropriately contain arriving IFR operations below 1,500 feet above the surface and departing IFR operations until reaching 1,200 feet above the surface at Sacramento Mather Airport. The airport utilizes the Sacramento very high frequency omnidirectional range/tactical air navigation (VORTAC) Class E airspace for some of its procedure containment, but that airspace is not sufficient in containing the Area Navigation (RNAV) (Global Positioning System [GPS]) RWY 22L approach at Sacramento Mather Airport. The point at which an arriving aircraft is expected to descend below 1,500 feet above the surface when flying the approach is within the hold-in-lieu of procedure turn holding pattern for the approach. The location of that point requires that the entirety of the holding area be contained within Class E airspace extending upward from 700 feet above the surface.
Finally, the FAA proposes administrative modifications to the airport's Class D legal description. The
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial, and unlikely to result in adverse or negative comments. It therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,600 feet MSL within a 4.5-mile radius of Sacramento Mather Airport, and within 1.9 miles either side of the 061° bearing from the airport, extending from the 4.5-mile radius to 6.3 miles northeast of the airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from 700 feet above the surface within a 6.8-mile radius of the airport from the 075° bearing clockwise to the 210° bearing, and within 2.8 miles northwest and 2.4 miles southeast of the 054° bearing extending from the airport to 12.7 miles northeast, and within 6 miles northwest and 9 miles southeast of the 054° bearing extending from 12.7 miles northeast of the airport to 24.3 miles northeast, and that airspace within 2.8 miles either side of the 234° bearing extending from the airport to 10.9 miles southwest of the airport.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Iowa State Implementation Plan (SIP) to include recent changes to the Linn County Code of Ordinances. The revisions to this rule include updating definitions and references to federal rules, revising methods and procedures for performance test/stack test and continuous monitoring systems, and making minor clarifications and grammatical changes. These revisions do not impact the stringency of the SIP or have an adverse effect on air quality. The EPA's proposed approval of this rule revision is being done in accordance with the requirements of the Clean Air Act (CAA).
Comments must be received on or before May 20, 2024.
You may send comments, identified by Docket ID No. EPA-R07-OAR-2024-0130 to
Bethany Olson, Environmental Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-7905; email address:
Throughout this document “we,” “us,” and “our” refer to the EPA.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2024-0130, at
The EPA is proposing to approve revisions to the Iowa SIP received on October 17, 2022. The state withdrew certain provisions of the request on February 7,2024. The revisions are to Linn County Code of Ordinances Chapter 10, Article III “Air Qualtiy”. The CAA allows authorized states to delegate portions of the Act's implementation and enforcement to local governments such as Linn County. The revisions to the Iowa SIP incorporate updated definitions and references to federal rules, revised methods and procedures for performance test/stack test and continuous monitoring systems, and minor clarifications and grammatical changes.
EPA proposes to find that these revisions meet the requirements of the Clean Air Act, do not impact the stringency of the SIP, and do not adversely impact air quality. The full text of the rule revisions as well as EPA's analysis of the revisions can be found in the technical support document (TSD) included in this docket.
The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. Linn County provided public notice on this SIP revision from April 1, 2022, to May 2, 2022, and received no comments. In addition, as explained above and in more detail in the technical support document which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
The EPA is proposing to amend the Iowa SIP by approving the State's request to revise Linn County Code of Ordinances, Chapter 10. We are processing this as a proposed action because we are soliciting comments on this proposed action. Final rulemaking will occur after consideration of any comments.
In this document, the EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Linn County Air Quality Ordinance, Chapter 10, with an effective date of May 14, 2022, which regulates air quality in Linn County. The EPA has made, and will continue to make, these materials generally available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The Iowa Department of Natural Resources did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons stated in the preamble, the EPA proposes to amend 40 CFR part 52 as set forth below:
42 U.S.C. 7401
(c) * * *
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) seeks comment on a proposal to adopt a new Emergency Alert System (EAS) event code for the delivery of critical messages to the public over television and radio about missing and endangered persons.
Comments are due on or before May 20, 2024 and reply comments are due on or before June 17, 2024.
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated in this document. Comments and reply comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See
•
•
• Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See
•
Theodore Marcus of the Office of Intergovernmental Affairs, Consumer and Governmental Affairs Bureau, at
This is a summary of the Commission's Notice of Proposed Rulemaking (
This matter shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's
The
The Providing Accountability Through Transparency Act, Public Law 118-9, requires each agency, in providing notice of a rulemaking, to post online a brief plain-language summary of the proposed rule. The required summary of the
1. This NPRM, initiates a proceeding to amend § 11.31(e) of the Emergency Alert System (EAS) rules to adopt a new EAS event code for missing and endangered person incidents, “MEP”, and seeks comment on this proposal. The proposed new MEP event code will allow for the coordination of and uniformity in the transmission of “Ashanti Alerts” associated with persons missing or abducted from states, territories, or Tribal communities that fall outside of AMBER Alert notification criteria to the public. While of a widespread concern, the issue of missing and endangered person is particularly prevalent in Tribal communities, where American Indian and Alaska Native people are at a disproportionate risk of experiencing violence, murder, or vanishing. The Commission proposes and seeks comment on whether adding a MEP event code to the EAS to trigger missing and endangered person alerts would serve the public interest by furthering the goal of the Ashanti Alert Act to disseminate information to the public that protects law enforcement officials, and the public at large.
2. The EAS and Wireless Emergency Alerts (WEA) systems are used to distribute tens of thousands of warnings to the public every year, providing critical notice of emergencies ranging from severe weather events, such as tornados and hurricanes, to natural disasters, such as tsunamis and wildfires, to civil emergencies, such as AMBER alerts and law enforcement warnings. These emergency alerts provide critical information and empower affected communities to take appropriate action and aid public safety officials in their efforts to address emergencies. Will having a coordinated and uniform missing and endangered person alert network help public safety officials and others investigating the number of such incidents? Will it benefit the public? The Commission seeks comment on these proposals.
3. Of particular relevance to this proceeding, the EAS Protocol currently utilizes a three-character “event code” to describe the nature of the alert (
4.
5. EAS Participants have discretion as to whether they issue EAS alerts other than the National Alert. As with other non-Presidential alerts, EAS Participants' carriage of missing and endangered person alerts and use of the MEP event code would be voluntary. Would EAS Participants be more likely to retransmit missing and endangered person alerts with a dedicated MEP event code?
6. The EAS distributes messages in one of two ways. The first method is through a broadcast-based, hierarchical alert message distribution system in which an alert message originator at the local, state or national level encodes (or arranges to have encoded) a message in the EAS Protocol. The alert is then broadcast from one or more EAS Participants, and subsequently relayed from one station to another until all affected EAS Participants have received the alert and delivered it to the public. This process of EAS alert distribution among EAS Participants is often referred as the “daisy chain” distribution architecture. Because this EAS architecture has been in place since the inception of the EAS, it is often referred to as the “legacy EAS.” The second method of distribution is an IP-based process. Since June 30, 2012, authorized emergency alert authorities have been able to distribute EAS alerts over the internet to EAS Participants (who in turn deliver the alert to the public) by formatting those alerts in the Common Alerting Protocol (CAP) and delivering those alerts through the FEMA-administered Integrated Public Alert and Warning System (IPAWS). This process for distributing alerts to EAS Participants represents the “CAP-based” EAS. Both the legacy and CAP-based EAS architectures are designed so that EAS Participants deliver to the public the alert content they receive from the EAS sources they monitor. Further, the EAS architecture and equipment is designed to operate automatically, without any intervention from the EAS Participant, both to minimize the risk of operator error and to facilitate EAS operation at unattended stations. EAS alerts delivered over the IPAWS can contain detailed text files, non-English alerts, or other content-rich data that is not always available in EAS alerts delivered via the broadcast-based daisy chain. Do missing and endangered person alerts or “Ashanti Alerts” routinely contain extra text files or other data-rich content that would benefit from the capabilities of IPAWS? Would it have a negative impact on the value of a dedicated MEP event code that such data-rich content may not be delivered to all EAS Participants, depending on how they receive the alert?
7.
8.
9. Would having an MEP event code be consistent with BJA's guidance, and allow for the issuing of “Ashanti Alerts”,
10. Several states, territories, and Tribal governments already have Ashanti Alert plans, Ashanti Alert Act compliant plans, missing and endangered person plans, or have legislative proposals for such plans. Additionally, there are regional alert networks that operate independently of
11. Currently, alert originators who issue missing and endangered person alerts that do not meet the criteria of an AMBER Alert use a variety of event codes to issue such alerts. The “Local Area Emergency” and “Law Enforcement Warning” event codes are the most commonly used event codes for these incidents. The Commission seeks comment on the distribution methods states, territories, and Tribal governments currently employ to deliver alerts for missing and endangered persons or “Ashanti Alerts”. To the extent they use different distribution methods to deliver these alerts, do the various distribution methods detract from the effectiveness of the alerts? To what extent do EAS Participants retransmit generic event codes, such as Civil Emergency Message (CEM) or Law Enforcement Warning (LEW) under which non-AMBER missing and endangered person alerts are currently sent? Will creating a specific MEP event code for missing and endangered persons be beneficial to alert originators who may use it and EAS Participants who may retransmit it? Would a dedicated MEP event code help ensure that Ashanti Alerts and related outreach are undertaken in a consistent manner nationally?
12. Will creating such an event code facilitate the transmission of Ashanti Alerts and thus promote the establishment, development, enhancement, and integration of a national communications network to provide assistance to regional and local search efforts for missing adults, as called for in the Ashanti Alert Act? The Ashanti Alert Act encourages states, territories, and Tribal governments to develop or enhance their Ashanti Alert or missing and endangered person plans. It also seeks to facilitate the integration of those plans into a national network to assist and optimize regional and local search efforts for missing or endangered adults. By adopting a new “MEP” event code, will it facilitate the rapid and coordinated delivery of alert notifications about missing and endangered persons to the public in a uniform and consistent manner? The Commission seeks comment on this approach.
13. What actions have states, territories, and Tribal governments taken to educate the public on missing and endangered person and Ashanti Alerts and the appropriate responses to those alerts. Are there model Public Service Announcements (PSAs) in use that educate the public about missing and endangered persons or Ashanti Alerts? How often have such alerts been activated and through what means or media have they been issued? How has the public reacted to these alerts? Provide examples of all available public responses to missing and endangered person and Ashanti Alerts that have been delivered since the adoption of the Ashanti Alert Act and BJA's Ashanti Alert guidance.
14. Would the adoption of MEP as a dedicated EAS event code encourage EAS Participants to deliver missing and endangered person alerts, including Ashanti Alerts? Would MEP as a dedicated EAS event code provide a central and organizing element for missing and endangered person and Ashanti Alert plans across the nation and, thus, facilitate the work of the National Ashanti Alert Network? How might the public respond to an MEP event code? Would establishing MEP as a dedicated EAS event code allow law enforcement to provide a warning that the public recognizes immediately as an alert for a missing or endangered person? Would a dedicated event code convey the appropriate sense of urgency to the public and galvanize the public awareness necessary to aid in the finding of missing or endangered adults? Would a dedicated event code facilitate consistent and effective public outreach educating the public to recognize and respond to “Ashanti Alerts”?
15. Would the availability of a dedicated EAS event code would promote the adoption or enhancement of Ashanti Alerts or missing and endangered person alerts throughout the nation? Would a dedicated EAS event code help integrate existing plans into a coordinated national network? Would the ability of law enforcement agencies to use existing EAS distribution networks alleviate any burden associated with designing and implementing individual missing and endangered person or Ashanti Alert plans? Would the implementation of a dedicated EAS event code encourage states and Tribal governments that do not have missing and endangered person or Ashanti Alert plans to adopt one? Are there widely-recognized “best practices” for Ashanti Alert plans? If so, to what extent would the adoption of the proposed MEP event code enhance the effectiveness of those “best practices”?
16. Currently, EAS Alerts are limited to the geographic contours and service areas of broadcasters and cable service providers. Are there any geographic or service area limitations that would pose challenges to the effectiveness of missing and endangered person alerts, including Ashanti Alerts, which—per statutory requirements—must be delivered to “geographic areas that the missing adult could reasonably reach, considering the circumstances and physical and mental condition of the missing adult, the modes of transportation available to the missing adult, and the circumstances of the disappearance?” How should the term “reasonably” be construed in this context and how does such construction impact EAS Participants' ability to disseminate these alerts? Are there differences between EAS Participants (
17. Has the lack of a dedicated EAS event code impeded the adoption of missing and endangered person or Ashanti Alert plans? Would utilizing the EAS structure help integrate existing plans into a coordinated national framework? Would integrating existing missing and endangered person and Ashanti Alert plans into the EAS structure help individual states, territories, and Tribal governments work together when missing adults have been, or potentially have been transported across state lines, as envisioned by the Ashanti Alert Act?
18. Would a dedicated EAS event code help save the lives? For example, would using a dedicated EAS event code facilitate faster information sharing and dissemination of information to the public? Could it potentially provide an additional path of communication to others who may be best positioned to quickly provide assistance, including the media and off-duty public safety official? Could this save lives, not just of those whose disappearance prompts an alert but of others who might otherwise be harmed by the emergency? Comment are sought on potential benefits and cost reductions.
19.
20.
21.
22. The Commission seeks comment to ensure that missing and endangered person alerts, including Ashanti Alerts, will provide for the protection of the civil liberties and sensitive medical information of missing adults as required by the Ashanti Alert Act. Are there any particular privacy or other civil liberties concerns that should be considered in implementing the proposed MEP event code? How can alerts comply with all applicable federal, state, Tribal and local privacy laws and regulations? Are there particular standards that should be adopted in order to provide protections against domestic violence? Comments are sought on these and any other safety, privacy and civil liberties concerns.
23.
24. The Commission proposes allowing EAS Participants to implement the new event codes on a voluntary basis through new equipment programmed to contain the code or through a software upgrade to install the code into equipment already in place. This approach has been taken in the past when adopting other new EAS event codes, and the record does not reflect any basis to take a different approach. Comments are sought on this approach.
25.
26. Would the adoption of a dedicated EAS event code help facilitate a partnership similar to AMBER Alerts? Is statistical information concerning AMBER Alerts relevant to missing and endangered person alerts? Is it reasonable to expect the success rate for missing and endangered person alerts, including Ashanti Alerts, to be similar to AMBER Alerts? Would the adoption of a dedicated EAS event code reduce the time to find a lost or abducted person?
27. The Commission believes that adopting a dedicated EAS event code, “MEP”, presents technical issues similar to the ones the Commission encountered when creating “BLU Alert” codes, and that the alert codes could be implemented by EAS Participants via minimally burdensome and low-cost software downloads. For those reasons, the Commission expects that the same costs would apply to the adoption of an MEP event code for missing and endangered persons and concludes that the implementation costs for adding a dedicated MEP event code would be approximately $12 million, adjusted for inflation. Comments are sought on this analysis and on the cost to EAS equipment manufacturers to create software updates, test these updates, supply them to their customers, oversee these updates, and provide any related customer support.
28. EAS Participants are required to have equipment that would be capable of being upgraded by software to accommodate EAS modifications. Could a new event code be bundled with a software upgrade that EAS Participants would install during the regular course of business? Comments are sought on this analysis.
29. Are there costs or benefits that should be considered that are not captured in the above discussion? If commenters disagree with these analysis or calculations, they should specify alternative methods and the specific technical bases for such alternatives. The Commission seeks comment on whether there are alternative or additional measures that could be taken to improve the introduction of missing and endangered person alerts, including Ashanti Alerts, over the EAS to promote the important public policy objective of enabling a rapid and coordinated response to incidents involving missing and endangered persons.
30. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Federal Communications Commission (Commission) has prepared an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the
31.
32.
33.
34. Next, the type of small entity described as a “small organization” is generally any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2020, there were approximately 447,689 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.
35. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand. U.S. Census Bureau data from the 2017 Census of Governments indicate there were 90,075 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number, there were 36,931 general purpose governments (county, municipal, and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment populations of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, the Commission estimates that at least 48,971 entities fall into the category of “small governmental jurisdictions.”
36.
37.
38. Based on Commission data as of November 2021, there were approximately 5,060 active licenses in the Broadband PCS service. The Commission's small business size standards with respect to Broadband PCS involve eligibility for bidding credits and installment payments in the auction of licenses for these services. In auctions for these licenses, the Commission defined “small business” as an entity that, together with its affiliates and controlling interests, has average gross revenues not exceeding $40 million for the preceding three years, and a “very small business” as an entity that, together with its affiliates and controlling interests, has had average annual gross revenues not exceeding $15 million for the preceding three years. Winning bidders claiming small business credits won Broadband PCS licenses in C, D, E, and F Blocks.
39. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these, it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard at this time.
40.
41. According to Commission data as of December 2021, there were approximately 4,211 active
42. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these services, at this time it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard.
43.
44. The Commission's small business size standards with respect to WCS involve eligibility for bidding credits and installment payments in the auction of licenses for the various frequency bands included in WCS. When bidding credits are adopted for the auction of licenses in WCS frequency bands, such credits may be available to several types of small businesses based average gross revenues (small, very small and entrepreneur) pursuant to the competitive bidding rules adopted in conjunction with the requirements for the auction and/or as identified in the designated entities section in Part 27 of the Commission's rules for the specific WCS frequency bands.
45. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these services, at this time it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard.
46.
47. According to Commission data as of December 2021, there were approximately 224 active 700 MHz Guard Band licenses. The Commission's small business size standards with respect to 700 MHz Guard Band licensees involve eligibility for bidding credits and installment payments in the auction of licenses. For the auction of these licenses, the Commission defined a “small business” as an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years, and a “very small business” an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. Pursuant to these definitions, five winning bidders claiming one of the small business status classifications won 26 licenses, and one winning bidder claiming small business won two licenses. None of the winning bidders claiming a small business status classification in these 700 MHz Guard Band license auctions had an active license as of December 2021.
48. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these services, at this time it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard.
49.
50. According to Commission data as of December 2021, there were approximately 2,824 active Lower 700 MHz Band licenses. The Commission's small business size standards with respect to Lower 700 MHz Band licensees involve eligibility for bidding credits and installment payments in the auction of licenses. For auctions of Lower 700 MHz Band licenses the Commission adopted criteria for three groups of small businesses. A very small business was defined as an entity that, together with its affiliates and controlling interests, has average annual gross revenues not exceeding $15 million for the preceding three years, a small business was defined as an entity that, together with its affiliates and controlling interests, has average gross revenues not exceeding $40 million for the preceding three years, and an entrepreneur was defined as an entity that, together with its affiliates and controlling interests, has average gross revenues not exceeding $3 million for the preceding three years. In auctions for Lower 700 MHz Band licenses seventy-two winning bidders claiming a small business classification won 329 licenses, twenty-six winning bidders claiming a small business classification won 214 licenses, and three winning bidders claiming a small business classification won all five auctioned licenses.
51. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these services, at this time it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard.
52.
53. According to Commission data as of December 2021, there were approximately 152 active Upper 700 MHz Band licenses. The Commission's small business size standards with respect to Upper 700 MHz Band licensees involve eligibility for bidding credits and installment payments in the auction of licenses. For the auction of these licenses, the Commission defined a “small business” as an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years, and a “very small business” an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. Pursuant to these definitions, three winning bidders claiming very small business status won five of the twelve available licenses.
54. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these services, at this time it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard.
55.
56. According to Commission data as December 2021, there were approximately 4,472 active AWS licenses. The Commission's small business size standards with respect to AWS involve eligibility for bidding credits and installment payments in the auction of licenses for these services. For the auction of AWS licenses, the Commission defined a “small business” as an entity with average annual gross revenues for the preceding three years not exceeding $40 million, and a “very small business” as an entity with average annual gross revenues for the preceding three years not exceeding $15 million. Pursuant to these definitions, 57 winning bidders claiming status as small or very small businesses won 215 of 1,087 licenses. In the most recent auction of AWS licenses 15 of 37 bidders qualifying for status as small or very small businesses won licenses.
57. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these services, at this time it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard.
58.
59. In light of the use of wireless frequencies by BRS and EBS services, the closest industry with an SBA small business size standard applicable to these services is Wireless Telecommunications Carriers (
60. According to Commission data as December 2021, there were approximately 5,869 active BRS and EBS licenses. The Commission's small business size standards with respect to BRS involves eligibility for bidding credits and installment payments in the auction of licenses for these services. For the auction of BRS licenses, the Commission adopted criteria for three groups of small businesses. A very small business is an entity that, together with its affiliates and controlling interests, has average annual gross revenues exceed $3 million and did not exceed $15 million for the preceding three years, a small business is an entity that, together with its affiliates and controlling interests, has average gross revenues exceed $15 million and did not exceed $40 million for the preceding three years, and an entrepreneur is an entity that, together with its affiliates and controlling interests, has average gross revenues not exceeding $3 million for the preceding three years. Of the ten winning bidders for BRS licenses, two bidders claiming the small business status won 4 licenses, one bidder claiming the very small business status won three licenses and two bidders claiming entrepreneur status won six licenses. One of the winning bidders claiming a small business status classification in the BRS license auction has an active license as of December 2021.
61. The Commission's small business size standards for EBS define a small business as an entity that, together with its affiliates, its controlling interests and the affiliates of its controlling interests, has average gross revenues that are not more than $55 million for the preceding five (5) years, and a very small business is an entity that, together with its affiliates, its controlling interests and the affiliates of its controlling interests, has average gross revenues that are not more than $20 million for the preceding five (5) years. In frequency bands where licenses were subject to auction, the Commission notes that as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Further, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. Additionally, since the Commission does not collect data on the number of employees for licensees providing these services, at this time it is not able to estimate the number of licensees with active licenses that would qualify as small under the SBA's small business size standard.
62.
63. The SBA small business size standard for this industry classifies businesses having 1,500 or fewer employees as small. U.S. Census Bureau data for 2017 show that there were 3,054 firms in this industry that operated for the entire year. Of this total, 2,964 firms operated with fewer than 250 employees. Thus, under this size standard, the majority of firms in this industry can be considered small. Additionally, according to Commission data as of December 2021, there were 4,477 active EBS licenses. The Commission estimates that the majority of these licenses are held by non-profit educational institutions and school districts and are likely small entities.
64.
65.
66.
67. The SBA small business size standards and U.S. Census Bureau data classify radio stations and television broadcasting separately and both categories may include both noncommercial and commercial stations. The SBA small business size standard for both radio stations and television broadcasting classify firms having $41.5 million or less in annual receipts as small. For Radio Stations, U.S. Census Bureau data for 2017 show that 1,879 of the 2,963 firms that operated during that year had revenue of less than $25 million per year. For Television Broadcasting, U.S. Census Bureau data for 2017 show that 657 of the 744 firms that operated for the entire year had revenue of less than $25,000,000. While the U.S. Census Bureau data does not indicate the number of non-commercial stations, it is estimated that under the applicable SBA size standard the majority of noncommercial educational broadcast stations and public broadcast stations are small entities.
68. According to Commission data as of March 31, 2022, there were 4,503 licensed noncommercial educational radio and television stations. In addition, the Commission estimates as of March 31, 2022, there were 384 licensed noncommercial educational (NCE) television stations, 383 Class A TV stations, 1,840 LPTV stations and 3,231 TV translator stations. The Commission does not compile and otherwise does not have access to financial information for these stations that permit it to determine how many stations qualify as small entities under the SBA small business size standards. However, given the nature of these services, it is presumed that all noncommercial educational and public broadcast stations qualify as small entities under the above SBA small business size standards.
69.
70. The Commission estimates that as of December 31, 2023, there were 4,444 licensed commercial AM radio stations and 6,663 licensed commercial FM radio stations, for a combined total of 11,107 commercial radio stations. Of this total, 11,105 stations (or 99.98%) had revenues of $41.5 million or less in 2022, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Database (BIA) on January 9, 2024, and therefore these licensees qualify as small entities under the SBA definition. In addition, the Commission estimates that as of December 31, 2023, there were 4,286 licensed noncommercial (NCE) FM radio stations, 1,967 low power FM (LPFM) stations, and 8,927 FM translators and boosters. The Commission however does not compile, and otherwise does not have access to financial information for these radio stations that would permit it to determine how many of these stations qualify as small entities under the SBA small business size standard. Nevertheless, given the SBA's large annual receipts threshold for this industry and the nature of radio station licensees, the Commission presumes that all of these entities qualify as small entities under the above SBA small business size standard.
71. The Commission notes that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations must be included. This estimate, therefore, likely overstates the number of small entities that might be affected by the action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, another element of the definition of “small business” requires that an entity not be dominant in its field of operation. The Commission is unable at this time to define or quantify the criteria that would establish whether a specific radio or television broadcast station is dominant in its field of operation. Accordingly, the estimate of small businesses to which the rules may apply does not exclude any radio or television station from the definition of a small business on this basis and is therefore possibly over-inclusive. An additional element of the definition of “small business” is that the entity must be independently owned and operated. Because it is difficult to assess these criteria in the context of media entities, the estimate of small businesses to which the rules may apply does not exclude any radio or television station from the definition of a small business on this basis and similarly may be over-inclusive.
72.
73.
74. As of December 31, 2023, there were 1,380 licensed commercial television stations. Of this total, 1,261 stations (or 91.4%) had revenues of $41.5 million or less in 2022, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on January 9, 2024, and therefore these licensees qualify as small entities under the SBA definition. In addition, the Commission estimates as of September 30, 2023, there were 383 licensed noncommercial educational (NCE) television stations, 379 Class A TV stations, 1,878 LPTV stations and 3,121 TV translator stations. The Commission, however, does not compile and otherwise does not have access to financial information for these television broadcast stations that would permit it to determine how many of these stations qualify as small entities under the SBA small business size standard. Nevertheless, given the SBA's large annual receipts threshold for this industry and the nature of these television station licensees, the Commission presumes that all of these entities qualify as small entities under the above SBA small business size standard.
75.
76.
77.
78.
79.
80.
81. The SBA small business size standard for Wired Telecommunications Carriers classifies firms having 1,500 or fewer employees as small. U.S. Census Bureau data for 2017 show that 3,054 firms operated in this industry for the entire year. Of this number, 2,964 firms operated with fewer than 250 employees. Based on this data, the majority of firms in this industry can be considered small under the SBA small business size standard. According to Commission data however, only two entities provide DBS service—DIRECTV (owned by AT&T) and DISH Network, which require a great deal of capital for operation. DIRECTV and DISH Network both exceed the SBA size standard for classification as a small business. Therefore, the Commission must conclude based on internally developed data, in general DBS service is provided only by large firms.
82.
83. The Commission estimates that broadcast and cable providers may need one hour to download and install a software update specific to the MEP event code. EAS Participants are currently required to have equipment that would be capable of being upgraded by software to accommodate EAS modifications such as those proposed in the
84.
85. The rule changes contemplated by the
86.
Radio, Television.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 11 to read as follows:
47 U.S.C. 151, 154(i) and (o), 303(r), 544(g), 606, 1201, 1206.
The revision reads as follows:
(e) * * *
Forest Service, Agriculture (USDA).
Notice of meetings.
The Central Idaho Resource Advisory Committee (RAC) will hold public meetings according to the details shown below. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act, as well as make recommendations on recreation fee proposals for sites on the Salmon-Challis National Forest, within Custer and Lemhi counties, consistent with the Federal Lands Recreation Enhancement Act.
An in-person and virtual meeting will be held on May 14, 2024, 9:00 a.m., Mountain Daylight Time (MDT), and on May 30, 2024, 9:00 a.m. MDT.
All committee meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
These meetings will be held in-person at the Challis Community Events Center, located at 411 Clinic Road, Challis, Idaho 83226. The public may also join the meetings virtually via telephone or video conference. Committee information and details about the meetings, including links to access the meetings, can be found on the advisory committees web page at
Amy Baumer, Central Idaho RAC Coordinator, by phone at 208-756-5100 or via email at
The purpose of the meeting is to:
1. Hear from Title II project proponents and discuss Title II proposals,
2. Make funding recommendations on Title II projects.
3. Discuss the proposed Salmon-Challis National Forest Recreation Fee Proposal;
4. Make recommendations on recreation fee proposals;
The agenda will include time for individuals to make oral statements of three minutes or less. To be scheduled on the agenda, individuals wishing to make an oral statement should make a request in writing at least three days prior to the meeting date. Written comments may be submitted to the Forest Service up to 14 after the meeting date listed under
Please contact the person listed under
USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family and parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the committee. To ensure that the recommendations of the committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
April 16, 2024 9:00 a.m.-9:30 a.m. ET.
On April 16, 2024 the Board will meet virtually.
This meeting will be closed to the public.
The International Broadcasting Advisory Board (Board) will conduct a meeting closed to the public at the time listed above. Board Members (Kenneth Jarin (Chair), Luis Botello, Jamie Fly, Jeffrey Gedmin, Michelle Giuda, Kathleen Matthews, and Under Secretary Elizabeth Allen (Secretary of State's Representative)), the acting Board Secretary, the Executive Secretariat to the Board, and recording secretaries will attend the closed meeting.
The acting Board Secretary (who also serves as U.S. Agency for Global Media's General Counsel) has certified that, in his opinion, exemptions set forth in the Government in the Sunshine Act, in particular 5 U.S.C. 552b(c)(2), (6) and (9)(B), permit closure of this meeting.
The Board approved the closing of this meeting by recorded vote.
The purpose for closing the meeting is so that the IBAB may deliberate on and, if necessary, vote on matters pursuant to its authority under 22 U.S.C. 6205 [relates to exemptions (2), (6), and (9)(B)].
In the event that the time, date, or location of this meeting changes, USAGM will post an announcement of the change, along with the new time, date, and/or place of the meeting on its website at
Although a separate federal entity, USAGM prepared this notice and will continue to support the Board in accordance with 22 U.S.C. 6205(g).
Persons interested in obtaining more information should contact Oanh Tran at (202) 920-2583.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that polyester textured yarn (yarn) from India was not sold in the United States at less than normal value (NV) during the period of review (POR) January 1, 2022, through December 31, 2022.
Applicable April 18, 2024.
Samantha Kinney, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2285.
On January 25, 2024, Commerce published in the
The product covered by this
We determine that the following weighted-average dumping margin exists for the POR:
Because Commerce received no comments on the
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Because the respondent's weighted-average dumping margin or importer-specific assessment rate is zero or
For entries of subject merchandise during the POR produced by the respondent for which it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the respondent will be equal to the weighted-average dumping margin established in the final results of this administrative review (
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or increase in the amount of antidumping duties by the amount of the countervailing duties.
This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a violation subject to sanction.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable April 18, 2024.
Bob Palmer or Faris Montgomery, Office VIII (Germany), Paul Kebker or Dylan Hill, Office IV (India), Sofia Pedrelli or Samantha Kinney, Office II (Qatar), or Colin Thrasher, Office V (Trinidad and Tobago), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-9068, (202) 482-1537, (202) 482-2254, (202) 482-1197, (202) 482-4310, (202) 482-2285, and (202) 482-3004, respectively.
On March 5, 2024, the U.S. Department of Commerce (Commerce) initiated countervailing duty (CVD) investigations of U.S. imports of melamine from Germany, India, Qatar, and Trinidad and Tobago (the investigations).
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination in a CVD investigation until no later than 130 days after the date on which Commerce initiated the investigation if: (A) the petitioner makes a timely request for an extension of the period within which the determination must be made; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make the preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On April 4, 2024, Cornerstone Chemical Company, the petitioner in the investigations, timely requested that Commerce postpone the preliminary determinations in the investigations.
In accordance with 19 CFR 351.205(e), the petitioner submitted its requests for postponement of the preliminary determinations in the investigations 25 days or more before the scheduled date of the preliminary determinations and stated the reasons for its requests. Commerce finds no compelling reason to deny the requests. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determinations in the
Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determinations in the investigations will continue to be 75 days after the date of the preliminary determinations.
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
Pursuant to section 6(c) of the Educational, Scientific and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, asamended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301), we invite comments on the question of whether instruments of equivalent scientific value, for the purposes for which the instruments shown below are intended to be used, are being manufactured in the United States.
Comments must comply with 15 CFR 301.5(a)(3) and (4) of the regulations and be postmarked on or before May 8, 2024. Address written comments to Statutory Import Programs Staff, Room 41006, U.S. Department of Commerce, Washington, DC 20230. Please also email a copy of those comments to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability; notice of intent.
NMFS announces the availability of the Final Atlantic Highly Migratory Species (HMS) Essential Fish Habitat (EFH) 5-Year Review (Final HMS EFH 5-Year Review) and intent to initiate Amendment 17 to the 2006 Consolidated HMS Fishery Management Plan (FMP) to modify HMS EFH descriptions and designations. The purpose of the Final HMS EFH 5-Year Review is to gather relevant new information and determine whether modifications to existing EFH descriptions and designations are warranted, in compliance with the requirements of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and implementing regulations. NMFS has determined that modifications to EFH descriptions and designations are warranted.
The Final HMS EFH 5-Year Review will be available on April 18, 2024. Data contributions for inclusion in Draft Amendment 17 to the 2006 Consolidated HMS FMP must be received by July 17, 2024.
Electronic copies of information related to the Final HMS EFH 5-Year Review, including the Final HMS EFH 5-Year Review, may be obtained on the HMS Management Division website at:
Please submit data contributions via email to
Jennifer Cudney,
Atlantic HMS fisheries (tunas, billfish, swordfish, and sharks) are managed under 2006 Consolidated HMS FMP and its amendments pursuant to the Magnuson-Stevens Act (16 U.S.C. 1801
The Magnuson-Stevens Act includes provisions concerning the identification and conservation of EFH (16 U.S.C. 1801
Under the current 2006 Consolidated HMS FMP as amended, NMFS uses a two-phase process to review and consider updates to HMS EFH. Phase 1 includes the development of a draft 5-year review, the public comment process, and the publication of a final 5-year review. Phase 1 is initiated approximately 5 years after publication
EFH 5-year reviews evaluate published scientific literature, unpublished scientific reports, information solicited from interested parties, and previously unavailable or inaccessible data. NMFS announced the initiation of this review and solicited information for this review from the public in a
The final document, developed as part of Phase 1, considers fishing effects, non-fishing effects, environmental changes, and management changes for all HMS, which include tunas (bluefin, bigeye, albacore, yellowfin, and skipjack), sharks, swordfish, and billfishes (blue marlin, white marlin, sailfish, roundscale spearfish, and longbill spearfish). It analyzes new information and data not previously included in recent updates to Atlantic HMS EFH, or has become available since publication of our previous EFH action (Amendment 10).
NMFS analyzed the information gathered through the EFH review process in this final 5-year review and determined that revision of EFH is warranted. As such, NMFS will initiate Phase 2, which will include the development of Amendment 17 to the 2006 Consolidated HMS FMP. In reviewing literature since 2017, new data and scientific information emerged for certain HMS that warrant revision to those species' EFH geographic boundaries. For other HMS, new data and scientific information were either unavailable or it was determined that the new data and scientific information did not warrant revisions to their EFH geographic boundaries. However, in Amendment 17, NMFS will also review and, if necessary, update EFH boundaries based on data added to existing EFH datasets (
The 5-year review process (including public comment) has indicated that updates to the methodology used to designate EFH geographic boundaries are appropriate. The current EFH methodology was first applied in Amendment 1 to the 2006 Consolidated HMS FMP in 2009, and HMS EFH geographic boundaries have not been updated using this methodology since Amendment 10. Minor technical changes to the kernel density estimation methodologies will be implemented to reduce bias that results from how multiple, discrete datasets are combined into one composite data structure. This 5-year review also identified a method to compare oceanographic data to point data, in order to derive a series of habitat metrics for each species and environmental variable. This information can be used to increase the specificity of EFH text descriptions for species, if appropriate.
The Final HMS EFH 5-Year Review analyzed whether updates to analyses concerning fishing and non-fishing activities, including impacts of climate change, were warranted. New scientific information concerning adverse effects of fishing on EFH was not identified. NMFS therefore recommends that no substantive changes be made to the evaluation of those effects included in the 2017 EFH review and update. However, the 2017 EFH review and update included a spatial analysis of observer data to evaluate bottom longline interactions with coral. This analysis should be updated in Phase 2 to incorporate any new information that might be available from the observer program.
As part of this 5-year review process, NMFS analyzed the scientific literature to identify new activities that could adversely affect EFH and to determine whether updates to previously analyzed activities that adversely affect EFH were warranted. NMFS did not identify scientific information suggesting the need to include new activities (
As part of this 5-year review process, NMFS analyzed the scientific literature to identify information relevant to Habitat Areas of Particular Concern (HAPC). NMFS did not identify scientific information or data suggesting that existing HAPCs should be changed or removed. However, it is likely that NMFS will reevaluate EFH boundaries for the species in Phase 2 based on the availability of seven more years of published literature, data and other information since publication of the previous 5-year review in 2015 and/or Final Amendment 10 in 2017. Existing boundaries of HAPCs may also need to be evaluated and changed to ensure they fall within any adjustments of HMS EFH. Based on the results of this 5-year review, NMFS recommends further consideration of a new HAPC for white sharks in the New York Bight.
As Phase 2 of this process, Amendment 17 to the 2006 Consolidated HMS FMP, will consider all 10 EFH components, including individual species EFH descriptions, EFH conservation and enhancement recommendations for fishing and non-fishing effects on EFH, and identification of HAPCs, as well as scientific feedback and public comment. NMFS is seeking data contributions for Phase 2 of the EFH review process, the development of Draft Amendment 17 to the 2006 Consolidated HMS FMP. Data contributions will be considered for inclusion in analyses used to update HMS EFH boundaries, and should include the following information: species name, date and time, geographic location information, tag information (if any), length, weight, sex, and life stage information.
National Marine Fisheries Service (NMFS), National Oceanic and
Notice of a public meeting.
The South Atlantic Fishery Management Council (Council) will hold a meeting via webinar of its Snapper Grouper Private Angler Advisory Panel (AP) to discuss permitting and education alternatives for the private recreational component of the snapper grouper fishery.
The AP meeting will be held from 2 p.m. until 4:30 p.m. on Tuesday, May 7, 2024.
The meeting will be held via webinar. Webinar registration is required. Details are included in
Kim Iverson, Public Information Officer, SAFMC; phone: (843) 302-8440 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
Meeting information, including the webinar registration link, online public comment form, agenda, and briefing book materials will be posted on the Council's website at:
At this meeting, the AP will review guidance from the March 2024 Council meeting and further address a series of permit and education topics posed by the Council.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.
NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to the New London Pier Extension Project at Naval Submarine Base (SUBASE) New London in Groton, Connecticut. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.
Comments and information must be received no later than May 20, 2024.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service and should be submitted via email to
Rachel Wachtendonk, Office of Protected Resources, NMFS, (301) 427-8401.
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth. The definitions of all applicable MMPA
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
On August 21, 2023, NMFS received a request from the Navy for an IHA to take marine mammals incidental to pile driving and removal activities associated with the New London Pier Extension Project at SUBASE New London in Groton, Connecticut. Following NMFS' review of the application, the Navy submitted a revised version on January 31, 2024. The application was deemed adequate and complete on February 2, 2024. The Navy's request is for take of six species of marine mammals by Level B harassment and for take of harbor seals, gray seals, and harp seals by Level A harassment. Neither the Navy nor NMFS expects serious injury or mortality to result from this activity; therefore, an IHA is appropriate.
The Navy is proposing the partial demolition and extension of pier 31 at SUBASE New London in Groton, Connecticut (figure 1). The existing pier 31 would be partially demolished and then an 81-foot (ft), or 24.7-meter (m), extension would be constructed. This project would also include the demolition of an existing small access ramp for pier 17. The proposed project includes impact and vibratory pile installation and vibratory pile removal. For a portion of the piles, an auger drill would be used inside the pipe casing to lift sediment.
Sounds resulting from pile driving and removal may result in the incidental take of marine mammals by Level A and Level B harassment in the form of auditory injury or behavioral harassment. Underwater sound would be constrained to the Thames River and a small portion of the Long Island Sound and would be truncated by land masses in the river. The purpose of this project is to extend the existing pier 31 to provide two berths for a submarine platform that is approximately 80 ft (24.4 m) longer than the existing submarines. Construction activities would start in December 2024 and last 12 months.
The proposed IHA would be effective from December 1, 2024, through November 30, 2025. Vibratory and impact pile driving and auger drilling are expected to start in December 2024 and take 242 days over a span of 12 months. All pile driving and removal would be completed during daylight hours.
The project is located at SUBASE New London in Groton, Connecticut, which is located approximately 6 miles (mi), or 9.5 kilometers (km), up the Thames River from Long Island Sound. Project activities would occur at the existing piers 31 and 17.
The pier 31 extension would include the removal of 28 16-inch (in), or 0.41-m, fiberglass reinforced plastic fender piles. The pier 17 demolition would include the removal of 20 14-in (0.36-m) concrete encased steel H-piles and 10 timber piles. Existing piles would be removed by the deadpull method, with timber piles being cut at the mudline and all other piles being removed with the vibratory hammer if deadpull is unsuccessful. Once the existing piles are removed, 20 36-in (0.91-m) steel pipe piles and 60 16-in (0.41-m) fiberglass reinforced plastic fender piles would be installed to support the pier 31 extension and pier 17 quaywall. The installation and removal of a temporary work trestle supported by 60 14-in (0.36-m) steel H-piles would be completed to support permanent pile installation. Temporary and permanent piles would be initially installed with a vibratory hammer followed by an impact hammer to embed them to their final depth. For a portion of the piles, an auger drill would be used inside the pipe casing to lift sediment. Table 1
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).
Sections 3 and 4 of the IHA application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs;
Table 3 lists all species or stocks for which take is expected and proposed to be authorized for this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is anticipated or proposed to be authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species or stocks and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. 2022 SARs. All values presented in table 3 are the most recent available at the time of publication (including from the draft 2023 SARs) and are available online at:
As indicated above, all six species (with six managed stocks) in table 3 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur. All species that could potentially occur in the proposed project area are included in table 3-1 of the IHA application. While North Atlantic right whale (
White-sided dolphins of the Western North Atlantic Stock are found in temperate and sub-polar waters of the North Atlantic, primarily in continental shelf waters to the 100-m depth contour from central West Greenland to North Carolina (Hayes
The Navy conducted a 3-year marine mammal survey from the mouth of Thames River to just north of SUBASE from 2017 through 2019, using line-transect methods. Atlantic white-sided dolphins were not documented (Tetra Tech, 2019) but are likely to occur near the mouth of the river and out into Long Island Sound during the fall, with peak abundance in October (Northeast Ocean Data, 2019).
The common dolphin is found world-wide in temperate to subtropical seas. In the North Atlantic, common dolphins are found over the continental shelf between the 100-m and 2,000-m isobaths and over prominent underwater topography and east to the mid-Atlantic Ridge (Hayes
Common dolphins are expected to occur in the vicinity of the project area in Long Island Sound in moderate numbers but were not found in the Navy's Thames River study (Tetra Tech, 2019).
Harbor porpoise occur along the US and Canadian east coast (Hayes
Harbor porpoise have not been documented in the Thames River (Tetra Tech, 2019) but are likely to occur near the mouth of the river and out into Long Island Sound during the fall, with peak abundance in December (Northeast Ocean Data, 2019).
Gray seals in the project area belong to the western North Atlantic stock. The range for this stock is from New Jersey to Labrador. Current population trends show that gray seal abundance is likely increasing in the U.S. Atlantic EEZ (Hayes
Monthly observations over the 3-year marine mammal survey yielded a total of three sightings of individual gray seals (Tetra Tech, 2019). No seals were observed hauled out onshore (Tetra Tech, 2019) and there are no known haulout areas within the Thames River (Navy, 2018). Gray seals are common in Long Island Sound from September through June (Medic, 2005).
Harbor seals are found in all nearshore waters of the North Atlantic Ocean and adjoining seas above about lat. 30 ° N (Burns, 2009). In the western North Atlantic, harbor seals are distributed from the eastern Canadian Arctic and Greenland down the east coast of the United States (Hayes
Harbor seals are central-place foragers (Orians and Pearson, 1979) and tend to exhibit strong site fidelity within season and across years, generally forage close to haulout sites, and repeatedly visit specific foraging areas (Grigg
Harbor seals are the most commonly observed marine mammals in the Thames River. Monthly observations over the 3-year marine mammal survey yielded a total of 12 sightings of individual harbor seals (Tetra Tech, 2019). Most of the sightings were in the inner portion of the river, north of the I-95 Bridge. No seals were observed hauled out onshore (Tetra Tech, 2019), and there are no known haulout areas within the Thames River (Navy, 2018). Harbor seal populations have increased in Connecticut since the 1980s and they are common in Long Island Sound from September through June (Medic, 2005).
Harp seals are highly migratory and occur throughout much of the North Atlantic and Arctic Oceans (Hayes
Harp seals are not known to regularly occur in the Thames River as previous surveys have not recorded their presence (Tetra Tech, 2019). However, two harp seals were identified in March and one harp seal in April 2019 by Mystic Aquarium staff. On both occasions they were observed hauled out on the finger piers of the marina at SUBASE (Navy, 2019a). Harp seals are also expected to occur within Long Island Sound from January through May (Hayes
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities (
The pinniped functional hearing group was modified from Southall
For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information.
This section provides a discussion of the ways in which components of the specified activity may impact marine mammals and their habitat. The Estimated Take of Marine Mammals section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take of Marine Mammals section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and whether those impacts are reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
The marine soundscape is comprised of both ambient and anthropogenic sounds. Ambient sound is defined as the all-encompassing sound in a given place and is usually a composite of sound from many sources both near and far. The sound level of an area is defined by the total acoustical energy being generated by known and unknown sources. These sources may include physical (
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10 to 20 dB from day to day (Richardson
In-water construction activities associated with the project would include vibratory pile removal, impact and vibratory pile driving, and auger drilling within pipe casings. The sounds produced by these activities fall into one of two general sound types: impulsive and non-impulsive. Impulsive sounds (
Impact hammers operate by repeatedly dropping a heavy piston onto a pile to drive the pile into the substrate. Sound generated by impact hammers is characterized by rapid rise times and high peak levels, a potentially injurious combination (Hastings and Popper, 2005). Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. The vibrations produced also cause liquefaction of the substrate surrounding the pile, enabling the pile to be extracted or driven into the ground more easily. Vibratory hammers produce significantly less sound than impact hammers. Peak sound pressure levels (SPLs) may be 180 dB or greater, but are generally 10 to 20 dB lower than SPLs generated during impact pile driving of the same-sized pile (Oestman
The likely or possible impacts of the Navy's proposed activity on marine mammals could involve both non-acoustic and acoustic stressors. Potential non-acoustic stressors could result from the physical presence of the equipment and personnel; however, any impacts to marine mammals are
The introduction of anthropogenic noise into the aquatic environment from pile driving is the primary means by which marine mammals may be harassed from the proposed activity. In general, animals exposed to natural or anthropogenic sound may experience physical and psychological effects, ranging in magnitude from none to severe (Southall
NMFS defines a noise-induced threshold shift (TS) as a change, usually an increase, in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2018). The amount of threshold shift is customarily expressed in dB. A TS can be permanent or temporary. As described in NMFS (2018), there are numerous factors to consider when examining the consequence of TS, including, but not limited to, the signal temporal pattern (
Depending on the degree (elevation of threshold in dB), duration (
Many studies have examined noise-induced hearing loss in marine mammals (see Finneran (2015) and Southall
The amount and onset of TTS depends on the exposure frequency. Sounds at low frequencies, well below the region of best sensitivity for a species or hearing group, are less hazardous than those at higher frequencies, near the region of best sensitivity (Finneran and Schlundt, 2013). At low frequencies, onset-TTS exposure levels are higher compared to those in the region of best sensitivity (
Relationships between TTS and PTS thresholds have not been studied in marine mammals, and there is no PTS data for cetaceans, but such relationships are assumed to be similar to those in humans and other terrestrial mammals. PTS typically occurs at exposure levels at least several decibels above that inducing mild TTS (
Installing piles for this project requires either impact pile driving or vibratory pile driving. For this project, these activities could occur at the same time, and there would be pauses in activities producing the sound during each day. Given these pauses, and that many marine mammals are likely moving through the ensonified area and not remaining for extended periods of time, the potential for TS declines.
Disturbance may result in changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); or avoidance of areas where sound sources are located. Pinnipeds may increase their haul out time, possibly to avoid in-water disturbance (Thorson and Reyff, 2006). Behavioral responses to sound are highly variable and context-specific and any reactions depend on numerous intrinsic and extrinsic factors (
Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators (
Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficient to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well studied through controlled experiments and for both laboratory and free-ranging animals (
The Navy's construction activities could have localized, temporary impacts on marine mammal habitat by increasing in-water sound pressure levels and slightly decreasing water quality. However, since the focus of the proposed action is pile driving, a minimal amount of net habitat loss is expected, as pier 31 would only be extended 87 ft (26.5 m). Construction activities are localized and would likely have temporary impacts on marine mammal habitat through increases in underwater sounds. Increased noise levels may affect acoustic habitat (see masking discussion above) and adversely affect marine mammal prey in the vicinity of the project area (see discussion below). During pile driving activities, elevated levels of underwater noise would ensonify the project area where both fishes and marine mammals may occur and could affect foraging success. Additionally, marine mammals may avoid the area during construction; however, displacement due to noise is expected to be temporary and is not expected to result in long-term effects to the individuals or populations.
Temporary and localized reduction in water quality would occur because of in-water construction activities as well. Most of this effect would occur during the installation and removal of piles when bottom sediments are disturbed. The installation of piles would disturb bottom sediments and may cause a temporary increase in suspended sediment in the project area. In general, turbidity associated with pile installation is localized to about 25-ft (7.6-m) radius around the pile (Everitt
The proposed activities would not result in permanent impacts to habitats used directly by marine mammals outside of the actual footprint of the extended pier 31. The total seafloor area affected by pile installation and removal is a very small area compared to the vast foraging area available to marine mammals in the Thames River and Long Island Sound. Pile extraction and installation may have impacts on benthic invertebrate species primarily associated with disturbance of sediments that may cover or displace some invertebrates. The impacts would be temporary and highly localized, and no habitat would be permanently displaced by construction. Therefore, it is expected that impacts on foraging opportunities for marine mammals due to the demolition and expansion of pier 31 would be minimal.
It is possible that avoidance by potential prey (
Sound may affect marine mammals through impacts on the abundance, behavior, or distribution of prey species (
Fish utilize the soundscape and components of sound in their environment to perform important functions such as foraging, predator avoidance, mating, and spawning (
Fish react to sounds which are especially strong and/or intermittent low-frequency sounds, and behavioral responses, such as flight or avoidance are the most likely effects. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. The reaction of fish to noise depends on the physiological state of the fish, past exposures, motivation (
SPLs of sufficient strength have been known to cause injury to fishes and fish mortality (summarized in Popper
Fish populations in the proposed project area that serve as marine mammal prey could be temporarily affected by noise from pile installation and removal. The frequency range in which fishes generally perceive underwater sounds is 50 to 2,000 Hz, with peak sensitivities below 800 Hz (Popper and Hastings, 2009). Fish behavior or distribution may change, especially with strong and/or intermittent sounds that could harm fishes. High underwater SPLs have been documented to alter behavior, cause hearing loss, and injure or kill individual fish by causing serious internal injury (Hastings and Popper, 2005).
The greatest potential impact to fishes during construction would occur during impact pile driving. However, the duration of impact pile driving would be limited to the final stage of installation (“proofing”) after the pile has been driven as close as practicable to the design depth with a vibratory driver. In-water construction activities would only occur during daylight hours, allowing fish to forage and transit the project area in the evening. Vibratory pile driving and auger drilling could elicit behavioral reactions from fishes such as temporary avoidance of the area but is unlikely to cause injuries to fishes or have persistent effects on local fish populations. Construction also would have minimal permanent and temporary impacts on benthic invertebrate species, a marine mammal prey source. In addition, it should be noted that the area in question is low-quality habitat since it is already highly developed and experiences a high level of anthropogenic noise from normal SUBASE operations and other vessel traffic.
The area impacted by the project is relatively small compared to the available habitat in the remainder of the Thames River and Long Island Sound, and there are no areas of particular importance that would be impacted by this project. Any behavioral avoidance by fish of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the nearby vicinity. As described in the preceding, the potential for the Navy's construction to affect the availability of prey to marine mammals or to meaningfully impact the quality of physical or acoustic habitat is considered to be insignificant.
This section provides an estimate of the number of incidental takes proposed for authorization through the IHA, which will inform NMFS' consideration of “small numbers,” the negligible impact determinations, and impacts on subsistence uses.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance, which: (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
Authorized takes would primarily be by Level B harassment, as use of the acoustic (
For acoustic impacts, generally speaking, we estimate take by considering: (1) acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available (
NMFS recommends the use of acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
The Navy's proposed activity includes the use of continuous (vibratory pile driving and auger drilling) and impulsive (impact pile driving) sources, and therefore the RMS SPL thresholds of 120 and 160 dB re 1 μPa are applicable.
These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS' 2018 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.
The sound field in the project area is the existing background noise plus additional construction noise from the proposed project. Pile driving generates
Transmission loss (
This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6-dB reduction in sound level for each doubling of distance from the source (20 × log
The intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. In order to calculate the distances to the Level A harassment and the Level B harassment sound thresholds for the methods and piles being used in this project, NMFS used acoustic monitoring data from other locations to develop proxy source levels for the various pile types, sizes and methods (table 6). Generally, we choose source levels from similar pile types from locations (
For this project, up to three vibratory hammers may operate simultaneously. When two noise sources have overlapping sound fields, there is potential for higher sound levels than for non-overlapping sources because the isopleth of one sound source encompasses the sound source of another isopleth. In such instances, the sources are considered additive and combined using the rules of decibel addition. For addition of two simultaneous sources, the difference between the two sound source levels is calculated, and if that difference is between 0 and 1 dB, 3 dB are added to the higher sound source levels; if the difference is between 2 and 3 dB, 2 dB are added to the highest sound source levels; if the difference is between 4 and 9 dB, 1 dB is added to the highest sound source levels; and with differences of 10 or more dB, there is no addition. For simultaneous usage of three or more continuous sound sources, the three overlapping sources with the highest sound source levels are identified. Of the three highest sound source levels, the lower two are combined using the above rules; then, the combination of the lower two is combined with the highest of the three. The calculated proxy source levels for the different potential concurrent pile driving scenarios are shown in table 7.
The ensonified area associated with Level A harassment is more technically challenging to predict due to the need to account for a duration component. Therefore, NMFS developed an optional User Spreadsheet tool to accompany the Technical Guidance that can be used to relatively simply predict an isopleth distance for use in conjunction with marine mammal density or occurrence to help predict potential takes. We note that because of some of the assumptions included in the methods underlying this optional tool, we anticipate that the resulting isopleth estimates are typically going to be overestimates of some degree, which may result in an overestimate of potential take by Level A harassment. However, this optional tool offers the best way to estimate isopleth distances when more sophisticated modeling methods are not available or practical. For stationary sources, like pile driving, the optional User Spreadsheet tool predicts the distance at which, if a marine mammal remained at that distance for the duration of the activity, it would be expected to incur PTS. Inputs used in the optional User Spreadsheet tool, and the resulting estimated isopleths, are reported below.
In this section, we provide information about the occurrence of marine mammals, including density or other relevant information that will inform the take calculations, and describe how the information provided is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and proposed for authorization. Density estimates come from Northeast Ocean Data (2023) for cetaceans and from the U.S. Navy Marine Species Density Database (Navy, 2017) for pinnipeds. To determine the incidental take estimate within each harassment zone, the following equation was used:
A subset of the species (Atlantic white-sided dolphin, common dolphin, and harbor porpoise) do not occur within the Thames River and have only been observed in the Long Island Sound. For these species, the area from the mouth of the Thames River to the furthest extent of the harassment zone in the Long Island Sound was used to determine the incidental take estimate within that zone.
Atlantic white-sided dolphins do not occur within the Thames River but they occur occasionally in the Long Island Sound. Monthly surveys conducted in the Thames River from 2017 through 2019 did not record the presence of Atlantic white-sided dolphins (Tetra Tech, 2019). The average density of Atlantic white-sided dolphins in the Long Island Sound is 0.022 individuals per km
The largest Level A harassment zone for Atlantic white-sided dolphins extends 65 m from the sound source (table 9) and is entirely contained within the Thames River. Therefore, no take by Level A harassment is anticipated or proposed for authorization.
Common dolphins do not occur within the Thames River but they occur occasionally in the Long Island Sound. Monthly surveys conducted in the Thames River from 2017 through 2019 did not record the presence of common dolphins (Tetra Tech, 2019). The average density of common dolphins in the Long Island Sound is 0.15 individuals per km
The largest Level A harassment zone for common dolphins extends 65 m from the sound source (table 9) and is entirely contained within the Thames River. Therefore, no take by Level A harassment is anticipated or proposed for authorization.
Harbor porpoises do not occur within the Thames River but they occur occasionally in the Long Island Sound. Monthly surveys conducted in the Thames River from 2017 through 2019 did not record the presence of harbor porpoises (Tetra Tech, 2019). The average density of harbor porpoises in the Long Island Sound is 0.32 individuals per km
The largest Level A harassment zone for harbor porpoises extends 2,191 m from the sound source (table 9) and is entirely contained within the Thames River. Therefore, no take by Level A harassment is anticipated or proposed for authorization.
For concurrent activities, the largest Level A harassment zone for harbor porpoises extends 26.2 m from the sound source and the largest Level B harassment zone extends 10,000 m from the sound source (table 9), and is contained within the Thames River. Therefore, no take by Level A or Level B harassment is anticipated or proposed for authorization from concurrent activities.
Harbor seals are present in the project vicinity including the Thames River from September through May. Monthly surveys conducted in the Thames River from 2017 through 2019 recorded 12 sightings of individual harbor seals (Tetra Tech, 2019). Seals were not observed on the shore and there are no harbor seal haulouts within the project vicinity. Two different density estimates were used to calculate harbor seal take. A density of 0.049 individuals per km
The largest Level A harassment zone for harbor seals extends 984 m from the sound source (table 9). Using the equation given above, the calculated estimated take by Level A harassment for harbor seals would be 1. However, due to the consistent presence of phocid pinnipeds at the SUBASE over the last several years, NMFS conservatively proposed increasing the estimated take by Level A harassment to one per 30 days of pile driving resulting in an estimated 8 harbor seals by Level A harassment over the course of the project.
Gray seals are present in the project vicinity including the Thames River from March through June. Monthly surveys conducted in the Thames River from 2017 through 2019 recorded three sightings of individual gray seals (Tetra Tech, 2019). Seals were not observed on the shore and there are no gray seal haulouts within the project vicinity. Two different density estimates were used to calculate take of gray seals. A density of 0.049 individuals per km
The largest Level A harassment zone for gray seals extends 984 m from the sound source (table 9). Using the equation given above, the calculated estimated take by Level A harassment for gray seals would be 1. However, due to the consistent presence of phocid pinnipeds at the SUBASE over the last several years, NMFS conservatively proposed increasing the estimated take by Level A harassment to one per 30 days of pile driving resulting in an estimate of 8 takes of harbor seals by Level A harassment over the course of the project.
Harp seals are present in the project vicinity from January through May and are much rarer in the Thames River then the other two seal species. Harp seals were not observed during monthly surveys conducted in the Thames River from 2017 through 2019 (Tetra Tech, 2019). However, two harp seals were identified in March 2019 and one harp seal in April 2019 by Mystic Aquarium staff. On both occasions they were hauled out on the finger piers of the marina at SUBASE (Navy, 2019a). The average density of harp seals in the Long Island Sound is 0.278 individuals per km
The largest Level A harassment zone for harp seals extends 984 m from the sound source (table 9) and is entirely contained within the Thames River. Harp seals do not have a density estimate for within the Thames River; therefore, given the sightings of this species hauled out at SUBASE, NMFS proposes increasing the estimated take by Level A harassment to one per 30 days of pile driving during the period in which harp seals could occur in the river. This results in an estimate of 5 takes of harp seals by Level A harassment over the course of the project.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting the activity or other means of effecting the least practicable adverse impact upon the affected species or stocks, and their habitat (see 50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, NMFS considers two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned), the likelihood of effective implementation (probability implemented as planned), and;
(2) The practicability of the measures for applicant implementation, which may consider such things as cost, and impact on operations.
In addition to the measures described later in this section, the Navy proposes to employ the following mitigation measures:
• The Navy would ensure that construction supervisors and crews, the monitoring team, and relevant Navy staff are trained prior to the start of activities subject to the proposed IHA,
• For those marine mammals for which incidental take has not been authorized, in-water pile installation/removal would shut down immediately if such species are observed within or entering the Level B harassment zone.
• If take reaches the authorized limit for any species, pile installation/removal will shut down immediately if these species approach the Level B harassment zone to avoid additional take.
The following proposed mitigation measures would apply to the Navy's in-water construction activities:
The Navy must establish shutdown zones and Level B harassment monitoring zones for all pile driving activities. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine animal (or in anticipation of an animal entering the defined area). Shutdown zones are based on the largest Level A harassment zone for each pile size/type and driving method, and behavioral monitoring zones are meant to encompass Level B harassment zones for each pile size/type and driving method, as shown in table 12. A minimum shutdown zone of 10 m would be required for all in-water construction activities to avoid physical interaction with marine mammals. Proposed shutdown zones for each activity type are shown in table 12.
Prior to pile driving, shutdown zones and monitoring zones would be established based on zones represented in table 9. Protected Species Observers (PSOs) would survey the shutdown zones and surrounding areas for at least 30 minutes before pile driving activities start. If marine mammals are found within the shutdown zone, pile driving would be delayed until the animal has moved out of the shutdown zone, either verified by an observer or by waiting until 15 minutes has elapsed without a sighting. If a marine mammal approaches or enters the shutdown zone during pile driving, the activity would be halted. Pile driving may resume after the animal has moved out of and is moving away from the shutdown zone or after at least 15 minutes has passed since the last observation of the animal.
All marine mammals would be monitored in the Level B harassment to the extent of visibility for the on-duty PSOs. If a marine mammal for which take is authorized enters the Level B harassment zone, in-water activities would continue and PSOs would document the animal's presence within the estimated harassment zone.
If a species for which authorization has not been granted, or for which the authorized takes are met, is observed approaching or within the Level B harassment zone, pile driving activities would be shut down immediately. Activities would not resume until the animal has been confirmed to have left the area or 15 minutes has elapsed with no sighting of the animal.
The placement of PSOs during all pile driving and removal activities (described in detail in the Proposed Monitoring and Reporting section) will ensure that the Thames River and portion of the Long Island Sound is visible during pile installation.
Monitoring must take place from 30 minutes prior to initiation of pile driving activities (
Soft-start procedures are believed to provide additional protection to marine mammals by providing warning and/or giving marine mammals a chance to leave the area prior to the impact hammer operating at full capacity. For impact driving, an initial set of three strikes will be made by the hammer at reduced energy, followed by a 30-second waiting period, then two subsequent three-strike sets before initiating continuous driving. Soft start will be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of 30 minutes or longer.
Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present while conducting the activities. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
Marine mammal monitoring must be conducted in accordance with the Monitoring Plan and section 5 of the IHA. A Marine Mammal Monitoring Plan would be submitted to NMFS for approval prior to commencement of project activities. Marine mammal monitoring during pile driving and removal must be conducted by NMFS-approved PSOs in a manner consistent with the following:
• PSOs must be independent of the activity contractor (for example, employed by a subcontractor) and have no other assigned tasks during monitoring periods;
• At least one PSO must have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;
• Other PSOs may substitute education (degree in biological science or related field) or training for experience; and
• The Navy must submit PSO Curriculum Vitae for approval by NMFS prior to the onset of pile driving.
PSOs must have the following additional qualifications:
• Ability to conduct field observations and collect data according to assigned protocols;
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and,
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary. The Navy will employ up to five PSOs. PSO locations will provide an unobstructed view of all water within the shutdown zone(s), and as much of the Level A harassment and Level B harassment zones as possible. PSO locations may include the pile installation/extraction barge, shore-based locations (such as pier 17 or pier 32), small boats, and the mouth of the Thames River.
Monitoring would be conducted 30 minutes before, during, and 30 minutes after pile driving/removal activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven or removed. Pile driving/removal activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than 30 minutes.
PSOs would use approved data forms to record the following information:
• Dates and times (beginning and end) of all marine mammal monitoring.
• PSO locations during marine mammal monitoring.
Construction activities occurring during each daily observation period, including how many and what type of piles were driven or removed and by what method (
• Weather parameters and water conditions.
• The number of marine mammals observed, by species, relative to the pile location and if pile driving or removal was occurring at time of sighting.
• Distance and bearings of each marine mammal observed to the pile being driven or removed.
• Description of marine mammal behavior patterns, including direction of travel.
• Age and sex class, if possible, of all marine mammals observed.
• Detailed information about implementation of any mitigation triggered (such as shutdowns and delays), a description of specific actions that ensued, and resulting behavior of the animal if any.
The Navy proposes to conduct hydroacoustic monitoring, or sound source verification (SSV), of all pile installation and removal methods. Data will be collected for a representative number of piles (at least 10 percent and up to 10 of each different type of pile) for each installation or removal method. Hydrophones would be placed at locations 10 m (33 ft) from the noise source and, where the potential for Level A harassment exists, at a second representative monitoring location at an intermediate distance between the cetacean and phocid shutdown zones. Hydroacoustic monitoring results may be used to adjust the size of the Level A and Level B harassment and monitoring zones after a request is made
• For underwater recordings, a stationary hydrophone system with the ability to measure SPLs will be placed in accordance with NMFS most recent guidance for the collection of source levels.
• Hydroacoustic monitoring would be successfully conducted for at least 10 percent and up to 10 of each different type of pile and each method of installation (table 13). Monitoring would occur at 33 feet (10 m) from the noise; at a location intermediate of the pinniped and cetacean Level A (PTS onset) zones; and occasionally near the predicted harassment zones for Level B (Behavioral) harassment. The resulting data set would be analyzed to examine and confirm SPLs and rates of transmission loss for each separate in-water construction activity. With NMFS concurrence, these metrics may be used to recalculate the limits of the shutdown, Level A (PTS onset), and Level B (Behavioral) disturbance zones, and to make corresponding adjustments in marine mammal monitoring of these zones. Hydrophones would be placed using a static line deployed from a stationary (temporarily moored) vessel. Locations of hydroacoustic recordings would be collected via global positioning system. A depth sounder and/or weighted tape measure would be used to determine the depth of the water. The hydrophone would be attached to a weighted nylon cord or chain to maintain a constant depth and distance from the pile area. The nylon cord or chain would be attached to a float or tied to a static line.
• Each hydrophone (underwater) will be calibrated at the start of each action and will be checked frequently to the applicable standards of the hydrophone manufacturer.
• Environmental data will be collected, including but not limited to, the following: wind speed and direction, air temperature, humidity, surface water temperature, water depth, wave height, weather conditions, and other factors that could contribute to influencing the airborne and underwater sound levels (
• The chief inspector will supply the acoustics specialist with the substrate composition, hammer/drill model and size, hammer/drill energy settings, depth of drilling, and boring rates and any changes to those settings during the monitoring.
• For acoustically monitored construction activities, data from the continuous monitoring locations will be post-processed to obtain the following sound measures:
○ Maximum peak pressure level recorded for all activities, expressed in dB re 1 μPa.
Mean, median, minimum, and maximum RMS pressure level in [dB re 1 μPa].
Mean duration of a pile strike (based on 90 percent energy criterion).
Number of hammer strikes
Mean, median, minimum, and maximum single strike SEL in [dB re μPa
○ Cumulative SEL as defined by the mean single strike SEL + 10*log
○ Median integration time used to calculate SPL RMS.
○ A frequency spectrum (pressure spectral density) (dB re μPa
○ Finally, the cumulative SEL will be computed from all the strikes associated with each pile occurring during all phases,
• For vibratory driving/extraction/drilling: duration and frequency spectrum of vibratory driving per pile; mean, median, and maximum sound levels (dB re: 1 µPa): root mean square sound pressure level (SPL
A draft marine mammal monitoring report would be submitted to NMFS within 90 days after the completion of pile driving and removal activities. It would include an overall description of work completed, a narrative regarding marine mammal sightings, and associated PSO data sheets. Specifically, the report must include:
• Dates and times (begin and end) of all marine mammal monitoring.
• Construction activities occurring during each daily observation period, including the number and type of piles driven or removed and by what method (
• PSO locations during marine mammal monitoring.
• Environmental conditions during monitoring periods (at beginning and end of PSO shift and whenever conditions change significantly), including Beaufort sea state and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon, and estimated observable distance.
• Upon observation of a marine mammal, the following information: (1) name of PSO who sighted the animal(s) and PSO location and activity at time of sighting; (2) time of sighting; (3) identification of the animal(s) (
• Number of marine mammals detected within the harassment zones, by species.
• Detailed information about any implementation of any mitigation triggered (
If no comments are received from NMFS within 30 days, the draft final report would constitute the final report. If comments are received, a final report addressing NMFS comments must be submitted within 30 days after receipt of comments.
The Navy shall also submit a draft hydroacoustic monitoring report to NMFS within 90 days of the completion of required monitoring at the end of the project, including data in a tabular spreadsheet format (Microsoft Excel or similar). The report will detail the hydroacoustic monitoring protocol and summarize the data recorded during monitoring. The final report must be prepared and submitted within 30 days following resolution of any NMFS comments on the draft report. If no comments are received from NMFS within 30 days of receipt of the draft report, the report shall be considered final. If comments are received, a final report addressing NMFS comments must be submitted within 30 days after receipt of comments. All draft and final hydroacoustic monitoring reports must be submitted to
• Hydrophone equipment and methods: recording device, sampling rate, distance (m) from the pile where recordings were made; depth of recording device(s).
• Type and size of pile being driven, substrate type, method of driving during recordings (
• Whether a sound attenuation device is used and, if so, a detailed description of the device used and the duration of its use per pile.
• For impact pile driving: number of strikes and strike rate; depth of substrate to penetrate; pulse duration and mean, median, and maximum sound levels (dB re: 1 μPa); SPL
• For vibratory driving/extraction/drilling: duration and frequency spectrum of vibratory driving per pile; mean, median, and maximum sound levels (dB re: 1 μPa): SPL
• One-third octave band spectrum and power spectral density plot.
• General Daily Site Conditions
○ Date and time of activities.
○ Water conditions (
○ Weather conditions (
In the event that personnel involved in the construction activities discover an injured or dead marine mammal, the Navy shall report the incident to the Office of Protected Resources (OPR), NMFS and to the regional stranding coordinator as soon as feasible. If the death or injury was clearly caused by the specified activity, the Navy must immediately cease the specified activities until NMFS is able to review the circumstances of the incident and determine what, if any, additional measures are appropriate to ensure compliance with the terms of the IHA. The IHA-holder must not resume their activities until notified by NMFS. The report must include the following information:
• Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);
• Species identification (if known) or description of the animal(s) involved;
• Condition of the animal(s) (including carcass condition if the animal is dead);
• Observed behaviors of the animal(s), if alive;
• If available, photographs or video footage of the animal(s); and,
• General circumstances under which the animal was discovered.
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the discussion of our analysis applies to all the species listed in table 3, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. There is little information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity.
Pile driving activities have the potential to disturb or displace marine mammals. Specifically, the project activities may result in take, in the form of Level A harassment and Level B harassment from underwater sounds generated from pile driving and removal. Potential takes could occur if individuals are present in the ensonified zone when these activities are underway.
The takes from Level B harassment would be due to potential behavioral disturbance, and TTS. Level A harassment takes would be due to PTS. No mortality or serious injury is anticipated given the nature of the activity, even in the absence of the required mitigation. The potential for harassment is minimized through the
Take would occur within a limited, confined area (the Thames River and a small section of the Long Island Sound) of the stocks' ranges. Level A harassment and Level B harassment would be reduced to the level of least practicable adverse impact through use of mitigation measures described herein. Further, the amount of take proposed to be authorized is extremely small when compared to stock abundance, and the project is not anticipated to impact any known important habitat areas for any marine mammal species.
Take by Level A harassment is authorized to account for the potential that an animal could enter and remain within the area between a Level A harassment zone and the shutdown zone for a duration long enough to be taken by Level A harassment. Any take by Level A harassment is expected to arise from, at most, a small degree of PTS because animals would need to be exposed to higher levels and/or longer duration than are expected to occur here in order to incur any more than a small degree of PTS. Additionally, and as noted previously, some subset of the individuals that are behaviorally harassed could also simultaneously incur some small degree of TTS for a short duration of time. Because of the small degree anticipated, though, any PTS or TTS potentially incurred here would not be expected to adversely impact individual fitness, let alone annual rates of recruitment or survival.
Behavioral responses of marine mammals to pile driving at the project site, if any, are expected to be mild and temporary. Marine mammals within the Level B harassment zone may not show any visual cues they are disturbed by activities or could become alert, avoid the area, leave the area, or display other mild responses that are not observable such as changes in vocalization patterns. Given the limited number of piles to be installed or extracted per day and that pile driving and removal would occur across a maximum of 242 days within the 12-month authorization period, any harassment would be temporary.
Any impacts on marine mammal prey that would occur during the Navy's proposed activity would have, at most, short-term effects on foraging of individual marine mammals, and likely no effect on the populations of marine mammals as a whole. Indirect effects on marine mammal prey during the construction are expected to be minor, and these effects are unlikely to cause substantial effects on marine mammals at the individual level, with no expected effect on annual rates of recruitment or survival.
In addition, it is unlikely that minor noise effects in a small, localized area of habitat would have any effect on the stocks' annual rates of recruitment or survival. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activities will have only minor, short-term effects on individuals. The specified activities are not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts.
In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:
• No serious injury or mortality is anticipated or authorized;
• The intensity of anticipated takes by Level B harassment is relatively low for all stocks and would not be of a duration or intensity expected to result in impacts on reproduction or survival;
• No important habitat areas have been identified within the project area;
• For all species, the Thames River and Long Island Sound are a very small and peripheral part of their range and anticipated habitat impacts are minor; and
• The Navy would implement mitigation measures, such as soft-starts for impact pile driving and shut downs to minimize the numbers of marine mammals exposed to injurious levels of sound, and to ensure that take by Level A harassment, is at most, a small degree of PTS.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
As noted previously, only take of small numbers of marine mammals may be authorized under sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
Table 11 demonstrates the number of animals that could be exposed to received noise levels that could cause Level B harassment for the proposed work at SUBASE. Our analysis shows that less than 1 percent of each affected stock could be taken by harassment. The numbers of animals proposed to be taken for these stocks would be considered small relative to the relevant stock's abundances, even if each estimated taking occurred to a new individual—an extremely unlikely scenario.
Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals would be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to the Navy for conducting the New London Pier Extension Project at SUBASE in Groton, Connecticut, between December 1, 2024, and November 30, 2025, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed IHA can be found at:
We request comment on our analyses, the proposed authorization, and any other aspect of this notice of proposed IHA for the proposed New London Pier Extension Project. We also request comment on the potential renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform decisions on the request for this IHA or a subsequent renewal IHA.
On a case-by-case basis, NMFS may issue a one-time, 1-year renewal IHA following notice to the public providing an additional 15 days for public comments when: (1) up to another year of identical or nearly identical activities as described in the Description of Proposed Activity section of this notice is planned; or (2) the activities as described in the Description of Proposed Activity section of this notice would not be completed by the time the IHA expires and a renewal would allow for completion of the activities beyond that described in the
• A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond 1 year from expiration of the initial IHA).
• The request for renewal must include the following:
(1) An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor (
(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The South Atlantic Fishery Management Council (Council) will hold a meeting via webinar of its Outreach and Communications Advisory Panel (AP) to discuss the educational component of Amendment 46 to the Snapper Grouper Fishery Management Plan for the South Atlantic. The amendment addresses permitting and education requirements for private recreational anglers targeting species in the snapper grouper management complex.
The AP meeting will be held from 10 a.m. until 12 p.m., EST on Wednesday, May 8, 2024.
The meeting will be held via webinar. Webinar registration is required. Details are included in
Kim Iverson, Public Information Officer, SAFMC; phone: (843) 302-8440 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
Meeting information, including the webinar registration link, online public comment form, agenda, and briefing book materials will be posted on the Council's website at:
During the meeting, the AP will review guidance from the March 2024 Council meeting, further address the education component of Snapper Grouper Amendment 46 addressing permitting and education requirements for private recreational fishermen targeting snapper grouper species, and provide recommendations for Council consideration.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council (Council) will
The meeting will be held Tuesday, May 7, 2024, from 8:30 a.m. to 4 p.m., EDT, and Wednesday, May 8, 2024, from 8:30 a.m. to 3 p.m., EDT.
The meeting will take place virtually, via webinar. Registration information will be available on the Council's website by visiting
Mr. Ryan Rindone, Lead Fishery Biologist, Gulf of Mexico Fishery Management Council;
The meeting will begin with Introductions and Adoption of Agenda, Scope of Work, review and approval of Minutes and Meeting Summary from the February 2024 SSC meeting.
Following, the SSC will work on developing the Terms of Reference for Gulf of Mexico
The SSC will review the National Academies of Sciences Equity and Environmental Justice Evaluation and the Equity and Environmental Justice Regional plan. The SSC will then review and discuss Alternative Assessment Methods for Gulf Stocks, including presentations and background documentation to support SSC discussion. Lastly, the SSC will receive an overview of the SSC Reorganization and Application Process and will receive public comment at the end of the day before any items under Other Business are discussed.
The meeting will be broadcast via webinar. You may register for the webinar by visiting
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
Although other non-emergency issues not on the agenda may come before the Scientific and Statistical Committees for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Scientific and Statistical Committee will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take-action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to Kathy Pereira, (813) 348-1630, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of committee renewal.
Notice is hereby given of the 2-year renewal of the Marine Fisheries Advisory Committee (MAFAC), effective April 9, 2024.
Heidi Lovett, Acting Designated Federal Program Officer, MAFAC, 301-427-8034; email
As required by section 14(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. 1013(a)(2), and after consultation with the General Services Administration, the Secretary of Commerce has determined that the renewal of the MAFAC is in the public interest. MAFAC was established by the Secretary of Commerce (Secretary) on February 17, 1971, to advise the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. This Committee advises and reviews the adequacy of living marine resources policies and programs to meet the needs of commercial and recreational fisheries, aquaculture, seafood trade, environmental, consumer, academic, tribal, governmental, and other national interests. The Committee and its charter must be renewed every 2 years from the date of the last renewal.
The Committee will function solely as an advisory body and in compliance with provisions of the Federal Advisory Committee Act. Copies of the Committee's renewal charter have been filed with the appropriate committees of the Congress and with the Library of Congress. The charter can be accessed online at
Commodity Futures Trading Commission.
Notice of renewal.
The Commodity Futures Trading Commission (Commission) is publishing this notice to announce the renewal of the Market Risk Advisory Committee (MRAC). The Commission has determined that the renewal of the MRAC is necessary and in the public's interest, and the Commission has consulted with the General Services Administration's Committee Management Secretariat regarding the MRAC's renewal.
Tamika Bent, MRAC Designated Federal Officer, at 646-746-3930 or
In support of the Commission's mission of promoting the integrity, resilience, and vibrancy of the U.S. derivatives markets through sound regulation as well as the monitoring and management of systemic risk, the MRAC's objectives and scope of activities are to conduct public meetings, advise, and submit reports and recommendations to the Commission on: (1) systemic issues that impact the stability of the derivatives markets and other related financial markets; and (2) the impact and implications of the evolving market structure of the derivatives markets and other related financial markets. The MRAC will operate for two years from the date of renewal unless the Commission directs that the MRAC terminate on an earlier date. A copy of the renewal charter will be posted on the Commission's website at
U.S. Consumer Product Safety Commission.
Notice of availability.
The Consumer Product Safety Commission (Commission or CPSC) is announcing the issuance of final guidance for CPSC's application of the Value per Statistical Life in the agency's analyses of benefits and costs and, in particular, for its regulatory analysis.
Alex Moscoso, Associate Executive Director, Directorate for Economic Analysis, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; telephone: 301-504-7782; email:
The Value per Statistical Life (VSL) is a widely used parameter in benefit-cost analysis, including regulatory analysis, that represents an individual's willingness to pay for reducing their risk of fatality. VSL values a reduction of fatality risk in monetary terms for purposes of benefit-cost analysis; it is not an attempt to place a value on any individual life. In regulatory analysis, government economists typically apply VSL as a standardized and transparent measure of the welfare impact from policies that reduce or increase fatalities.
CPSC's Directorate for Economic Analysis (EC) is responsible for conducting all economic analyses for the agency, which includes regulatory analyses. A regulatory analysis may include an analysis of benefits and costs of a proposed regulation. EC regularly uses VSL in its regulatory analyses of CPSC regulations. While the U.S. Office of Management and Budget (OMB) and other executive branch agencies and departments have published guidelines on the application of VSL,
On March 24, 2023, CPSC published a Notice of Availability (NOA) in the
• Removed the recommendation that high and low values should be used for child VSL in sensitivity analyses. Instead, the Final VSL Guidance recommends that the decision for what variables to test in a sensitivity analysis be done on a case-by-case basis, as is currently practiced in CPSC.
• Added further discussion on the normative frameworks used for the rationale of recommending a separate VSL for children.
• Added further discussion on alternative methods for estimating VSL and provided the reasons why CPSC did not recommend them.
This document establishes and describes the final guidelines on the application of VSL in CPSC's analysis of benefits and costs and regulatory analysis. Specifically, this final guidance establishes a standard method for estimating VSL as well as guidelines for adjusting VSL for inflation, changes in real income (
This final guidance prescribes a VSL estimate specifically for children, which differs from other established VSL guidance. Other government economists have applied a uniform VSL to all fatalities that fall within the scope of the regulation being assessed.
New research shows a higher willingness to pay for risk reduction in children's fatality risk than adults.
The purpose of this final guidance is to: (1) provide background on relevant work CPSC has done to understand the issue of child VSL; (2) describe the current practice of using VSL in regulatory economics, both at CPSC and in other government agencies; (3) explain CPSC's reason for issuing VSL guidelines; and (4) publish CPSC guidelines for VSL. Additional details were provided in the NOA that presented CPSC's Proposed Draft Guidance for Estimating the Value per Statistical Life (88 FR 17826) and the accompanying staff briefing package.
This final guidance does not discuss the valuation or averted costs associated with reducing non-fatal injuries. Some Federal agencies and departments estimate the values or averted costs associated with reducing the risk of non-fatal injuries as a function of VSL. CPSC, however, determines the averted costs associated with non-fatal injuries through its Injury Cost Model, independent of VSL.
VSL is usually derived from willingness to pay studies. These studies either use surveys to investigate individuals' willingness to exchange their own income for a change in their own mortality risk, or they examine real world behavior that reflects this trade-off, such as the change in income associated with a change in job-related risk. The framework of such studies requires participants to assess their own, or a situation's, risk of fatality and then place a monetary value on a change to that risk. Individual willingness to pay estimates from these studies are then converted to a VSL estimate by dividing by the risk change. For example, if a group of 10,000 individuals were willing to pay $900 each to reduce their risk of death by 0.01 percent in a given year, then in the aggregate that group of individuals would be willing to spend $9 million
These studies usually estimate the value that adults place on reducing their own risk of fatality. Inherently, individuals' willingness to pay is a function of their real income, wealth, and other personal factors, as well as the characteristics of the risk. A majority of the studies other agencies have used to estimate VSL are wage-risk studies examining labor market data for working age adults. This approach is not transferable to children, who are not part of the labor market, do not control financial resources, and may not understand or be able to express their willingness to pay for such reductions. As such, the revealed preference literature is limited to a few, lower-quality averting behavior studies for valuation of mortality risks to children.
Assigning the same VSL for adults and children ignores evidence that society values the safety of children more than adults. Failing to acknowledge the importance of child safety within society, and the research on individuals' willingness to exchange money to reduce fatality risks to children that aligns with these societal preferences,
Inasmuch as CPSC is tasked with protecting consumers from unreasonable risk of death and injuries from consumer products, many of the benefits of the agency's regulations are the reduction of risk from death among children.
In 2018, Industrial Economics Inc. (IEc) conducted a criteria-driven literature review of studies estimating a VSL for children and drafted a report for CPSC that described its findings. IEc found that “[t]he number of studies that explore the value of reducing children's risks has increased substantially in recent years. The results of these studies are diverse, but generally suggest that the value individuals place on reducing risks to children is greater than the value of reducing risks to adults.” In 2019, a group of co-authors that included a subset of the authors of the IEc report published an update of this criteria-driven literature review in a peer-reviewed journal with some modifications from the 2018 report.
The literature reviews applied two sets of criteria.
The selection criteria
1. Written in English;
2. Publicly available;
3. Data collected within the past 30 years;
4. Data collected in a high-income country;
5. Values a change in risk (not a change in life expectancy); and
6. Estimates willingness to pay (not willingness to accept compensation).
The evaluation criteria
1. Data collected more recently;
2. Data collected in the United States;
3. Based on a national sample;
4. Based on a probabilistic sample (not a convenience sample); and
5. Provides evidence of validity.
The literature reviews found five publications that satisfied many of the evaluation criteria. These studies suggest the VSL for children exceeds the VSL for adults by a factor of 1.2 to 2.9, with a midpoint of roughly 2. The five studies and their estimates of children's VSL as a ratio to adult VSL are listed in table 1.
Since
The U.S. Environmental Protection Agency (EPA), U.S. Department of Transportation (DOT), and U.S. Department of Health and Human Services (HHS) each have formal guidelines for the use of VSL within their agency. EPA derives its estimates from 26 studies, of which 21 are wage-risk studies.
These estimates are similar, even though the three agencies each reviewed the literature at different times using different criteria, and hence included different studies in developing their estimates. These estimates are also very
CPSC's VSL guidelines (stated in section VI) state that:
1. CPSC will use HHS's VSL estimates for adults.
2. CPSC will double the adult VSL to establish the child VSL.
3. CPSC will account for both the change in the general price index (inflation) and in real income using the method in HHS's
4. When estimating VSL for future years, CPSC will increase the VSL by the expected growth in real earnings and discount the resulting benefit values to reflect the time value of money, consistent with its approach for all cost and benefits estimates.
These guidelines and their sources are summarized in table 3.
CPSC staff developed these VSL guidelines, including the recommendation of a separate VSL for children, along two normative frameworks. The Commission then published the draft VSL guidelines for public comment. Staff analyzed these comments to develop the Commission's final VSL guidelines as presented here.
The first normative framework applied by staff is CPSC's established approach to valuing premature deaths: CPSC employs estimates of individuals' willingness to pay for their own reductions in mortality risk (
The second framework applied by staff is CPSC's mission to protect the public against the unreasonable risks of injuries and deaths associated with consumer products. Rulemaking is one tool CPSC uses to carry out its mission. The rulemaking process entails CPSC staff assembling a technical briefing package for the Commission's consideration, which may encompass a regulatory analysis. The Commission makes it determinations based on its governing statutes, such as section 9 of the CPSA which requires that “the benefits expected from the rule bear a reasonable relationship to its costs.” 15 U.S.C. 2058(f)(3)(E). In adopting this Final Guidance to guide staff and CPSC's future regulatory analyses, the Commission facilitates efficient rulemaking to further its safety mission and specific statutory responsibilities.
CPSC developed this Final Guidance for VSL considering both of these frameworks and comments received on the Draft Guidance for VSL. CPSC also publishes this Final Guidance as a form of standardizing best practices for components of its regulatory analysis.
By developing and publishing guidelines for using VSL in regulatory analysis, CPSC provides for regulatory analyses that appropriately and consistently measure the benefits from reduced fatality risk, including when children's mortality is considered and ensures transparency by sharing these guidelines with the public. CPSC establishes these guidelines with the objective of streamlining the estimation process and making its application consistent and clear across regulations and time periods.
These guidelines thus establish the source, base value, and method of CPSC's application of VSL in regulatory analyses. The guidelines also establish a ratio of child VSL to adult VSL for CPSC to use in valuing reduced children's fatality risk in formal regulatory analysis, as opposed to limiting its use to sections of the sensitivity analysis as the Commission has done in the past. These guidelines will ensure there is no ambiguity on which value to use in regulatory analysis, nor in how to adjust for inflation and changes in real income, or whether to discount VSL-related benefits.
Following publication in the
Overall, five commenters support approaches that value fatal risk reductions for children differently from adults, and three commenters do not
Two commenters voiced support for alternative adjustments to mortality valuation estimates for children. First, Dr. Adam Finkel of the University of Michigan lauded CPSC's efforts to offer a separate mortality valuation estimate for children. The commenter asserted that improvements could be made to the methods employed to estimate willingness to pay for mortality risk reductions; however, he did not recommend a specific alternate estimate of mortality risk values for children. Second, Lisa Robinson of the Harvard T.H. Chan School of Public Health provided comments supporting mortality risk valuation that specifically addresses how values may vary for children but noted such estimates should be conducted (1) “at least in sensitivity analysis” (
CPSC acknowledges two limitations of its chosen approach. The first relates to the framework for valuing mortality risks to children. The studies used to derive the multiplier evaluate parents' WTP to reduce risk for their own children. This framing differs from the standard welfare economic framing, where individuals are assumed to be the best judge of their own well-being. As discussed in Robinson et al. (2019), eliciting a child's WTP for their own risk reduction is problematic.
Like the use of WTP, the alternatives for valuing avoided child fatalities suggested by Ms. Robinson also have strengths and limitations. Standard derivation of VSLY (or vQALY) divides an estimate of VSL by the discounted number of remaining life years (or QALYs), accounting for age-specific survival probabilities, for the mean age of sampled individuals in the stated and revealed preference studies informing an agency's preferred VSL estimate. Analysts then multiply estimates of the VSLY or vQALY by the life years or QALYs lost from premature fatality. More life years are lost due to a child fatality than an adult fatality, resulting in different values for avoiding each type of death. While computationally straightforward to apply, this approach requires several strong assumptions.
First, in the case of vQALYs, the construction of QALYs “assumes that how individuals value health states (measured as changes in health-related quality of life, or HRQL) is independent of the duration of the state, the age at which they are experienced, and the individual's remaining life expectancy” (Robinson and Hammitt 2013).
Second, this approach assumes that the VSLY (or vQALY) is constant through time (
We note that application of a VSLY or vQALY could result in results comparable to the simpler doubling of values for children, depending largely on the age of the affected population, the selected approach (
We are not aware of any regulatory agency currently using VSLYs or vQALYs in primary estimates of benefits or costs. One department, U.S. Department of Health and Human Services (HHS), uses the VSLY to estimate the value of mortality risk reductions in sensitivity analysis. But like other agencies, HHS uses a uniform VSL in its primary estimate.
Finally, while measurements like VSLY or inverse “U” make it possible to generate estimates for each age of childhood, CPSC would then need to project the number of deaths at each age for the prospective study period. While CPSC staff is confident this could be done for two subpopulations—adults and children—staff are less confident that there will be enough data to consistently forecast incidents for every individual age of childhood. Accordingly, if these alternate approaches were used, the Commission might have to base some of its rules on projections supported by only a handful of historical death records.
Weighing the strengths and limitations of the available options for differentiating the value of risk reductions for children and adults, CPSC concludes that the application of a multiplier derived from available WTP literature is preferable to valuing lost life years for affected individuals using a VSLY or vQALY. The advantages of relying solely on WTP studies, despite the small number of high-quality studies, and the resulting sharply delineated difference in the value of mortality risk reductions for adults and children, outweighs the advantages of an approach that results in more gradual declines in value as children age but requires several strong assumptions to construct a VSLY or vQALY and potentially unavailable data on the age distribution of children affected by proposed regulations.
Furthermore, since the filing of comments on the Draft Guidance, OMB has updated its guidance for benefit-cost analysis.
The valuation of health outcomes for children and infants poses special challenges. It is rarely feasible to measure a child's willingness to pay for health improvement, and adults' concern for their own health is not necessarily relevant to valuation of child health. For example, the wage premiums demanded by workers to accept hazardous jobs are not necessarily appropriate to use for regulations that accomplish health gains for children. Some studies suggest that parents may value children's health more strongly than their own health. Although this parental perspective has been a promising research strategy, it may need to be expanded to include a societal interest in child health and safety.
Where the primary objective of a regulation is to reduce the risk of injury, disease or mortality among children, [agencies] may develop a benefit-cost analysis to the extent that valid monetary values can be assigned to the primary expected health outcomes. For
CPSC's new guidelines are consistent with OMB's current recommendation that monetary values for children deserve “special” attention and should be no lower than that of adults.
Related to Ms. Robinson's comment, one anonymous commenter recommended that CPSC justify its statement “that society prioritizes the safety of children over the adult population and invests significantly in child safety” by citing IEc (2018) or Robinson et al. (2019). The commenter believes these sources provide greater support than the market size of the child safety industry.
The first normative framework presented by Ms. Robinson describes CPSC's typical approach to valuing premature deaths: CPSC employs estimates of individuals' willingness to pay for their own reductions in morality risk (
The second framework presented by Ms. Robinson is relevant in this context as well. CPSC is guided by its mission “to protect the public against unreasonable risks of injury associated with consumer products.” 15 U.S.C. 2051(b)(1). Rulemaking is one tool CPSC uses to carry out its mission. Neither agency mandates nor statutory obligations compel the Commission to endorse or reject proposed rules solely on benefit-cost analysis outcomes. At very most, CPSA is required to find in some rulemakings that “the benefits expected from the rule bear a reasonable relationship to its costs,” where “benefits or costs that cannot be quantified in monetary terms” are considered. 15 U.S.C. 2058(c)(1), (f)(3)(E). Therefore, policymakers also may consider effects not captured in economic analysis.
Regulatory analysts frequently operate in data-limited environments and must assess the quality and applicability of a limited number of studies or data sources. Given the importance of accurately characterizing mortality valuation for children, CPSC explored the available literature for children's VSL to assess the weight of evidence on this topic. CPSC concludes that the existing literature, including the literature cited in the NOA seeking comment on the Draft Guidance as well as in this Notice, provides sufficient evidence for an adjustment to the VSL for children that is consistent with societal preferences for protection of children's health.
Importantly, while VSL estimates may differ across countries, there is not strong evidence that the relationship between children and adult VSLs similarly differ. The literature reviews by IEc and Robinson et al. focused on high income countries to minimize economic factors that would strongly influence the valuation of mortality risks. We note that if the two studies conducted abroad (in France and Italy) were excluded from the reviews, the result would be a range of ratios from 1.6 to 2.9 and a
Finally, risks managed by CPSC include both acute and chronic injury-based values that can lead to a fatality. CPSC does manage risk for traumatic injuries and death, such as strangulation from window covering cords and tip overs from clothing storage units. But CPSC has a broad mandate to prevent death and injuries from all types of hazard scenarios associated with consumer products. For instance, the Commission has a rule (codified at 16 CFR part 1307) that prohibits the use in children's toys of certain types of phthalates that can cause adverse effects on male reproductive development. CPSC likewise sets regulations on the amount of lead in children's toys to address long-term and recurring health complications from lead poisoning. We encourage researchers to conduct U.S.-based studies estimating willingness to pay for risk reductions in the context of all types of injuries resulting from consumer products.
The stated preference literature is more prevalent in this study area and stated preference studies have been employed in many instances by Federal agencies in mortality valuation. The review studies cited by CPSC in crafting its recommendations—IEc (2018) and Robinson et al. (2019)—take care to address potential limitations of the stated preference literature. IEc (2018) highlighted the scope tests performed in each study examining WTP sensitivity to magnitude changes in risk, specifically, whether results were consistent with WTP increasing with larger risk reductions and if the increase was proportional. For example, if a study found a group of individuals willing to pay $900 to reduce their risk of death by 0.01 percent, then a proportional response would be the same group willing to paying $1,800 to reduce their risk of death by 0.02 percent. Two of the five available studies passed its scope test. The other three studies exhibited sensitivity but either lacked proportionality or did not report a ratio. However, the other relative strengths of these three studies (explained in full detail in Section 4.1.2. in IEc (2018)) merits their inclusion. We note that insensitivity to scope would not necessarily result in biased estimates of the ratio between VSL for children and adults. Overall, the literature provides evidence of elevated willingness to pay for risk reductions to children.
Two other commenters, Drs. Blomquist and Finkel, also support the use of sensitivity analyses reflecting both sets of VSL estimates; however, these commenters do not comment on whether the primary estimates should reflect the conventional VSL or the adjusted VSL for children.
CPSC acknowledges that a stepwise adjustment to the child VSL results in a pattern in which risks for 17 and 18 year olds are valued using estimates that differ considerably. While the strength of available research supports an adjustment for children, there is a weaker literature base to support adjustments for more refined age bins (or single-year ages). In Section 4.2.2 of IEc (2018), the authors discuss variation in values by age of the child. Most studies on children's risks considered broad age ranges approximating those recommended by CPSC for adjustments (
[Only] some of these studies provide evidence that WTP may vary by the age of the child. For fatal risk reductions, two surveys suggest that estimated WTP declines with the age of the child (Gerking, Dickie, and Veronesi 2014, skin cancer survey; Hammitt and Haninger 2010); but two surveys find no significant impact (Alberini and Ščasný 2011; Gerking, Dickie, and Veronesi 2014, leukemia survey). Hammitt and Herrera (2017) do not report whether WTP differs by children's age.
As researchers publish on this topic in future years, CPSC will consider whether available research supports more granular adjustments by the age of the child. Current research supports an adjustment for a broad definition of children, consistent with the recommendations in CPSC's Final Guidance.
Further, values frequently differ across ages in benefit-cost analysis. For example, cost of illness estimates may reflect higher treatment expenditures for children than adults for a particular illness or injury. These averages represent our best assessment of the value of these outcomes, even if expenditures for one child may be lower than expenditures for one adult.
In this section we state CPSC's final VSL guidelines, as determined by the Commission following consideration of the public comments described above. CPSC made the following changes to its VSL guidance from its Draft Guidance published in March 2023:
• Removed the recommendation that high and low values should be used for child VSL in sensitivity analyses. Instead, the Final VSL Guidance recommends the decision for what variables to test in a sensitivity analysis to be done on a case-by-case basis, as is currently practiced in CPSC.
• Added further discussion on the normative frameworks used for the
• Added further discussion on alternative methods for estimating VSL and provided the reasons why CPSC did not recommend them.
Aside from these changes, the guidelines did not substantively change from the Draft Guidance.
First, the Final VSL Guidance specifies how to determine the VSL for both adults and children. Next, it describes how to determine when adjustments to the VSL are needed and how to make them. Finally, this guidance provides an example scenario that illustrates how to apply the guidelines.
CPSC should use the most recent VSL from HHS to value expected fatality risk reductions for individuals that are 18 years or older. As of this document, HHS recommends a central VSL estimate of $13.0 million in 2023 dollars at 2023 income levels. As explained in greater detail further into these guidelines, CPSC should update that value as needed, following the HHS guidance.
CPSC recommends HHS's estimate because its value is based on a more recent review of the literature that applies extensive selection and evaluation criteria that reflects the evolution of best practices. It includes newer studies that better reflect current societal preferences, as revealed preference literature has progressed significantly in recent years. Moreover, the studies considered by HHS encompass fatalities stemming from both traumatic injuries and illnesses, aligning with the spectrum of potential death causes from consumer products that CPSC is responsible for mitigating. For these reasons, CPSC aligns its VSL estimate with HHS. If the HHS estimate or methodology significantly changes in the future, CPSC will evaluate changes to the estimate and the basis for any changes.
These guidelines recommend doubling the value CPSC uses for adult VSL to represent child VSL. CPSC should apply this child VSL to mortality risk reductions likely to accrue to any individual younger than 18 years old uniformly and not modify this value for any other characteristics. This valuation aligns with the findings from recent reviews, that child VSL has been valued between 1.2 to 2.9 times more than adult VSL (table 1) in peer-reviewed literature. The approximate midpoint of this range is the source for doubling the adult VSL to represent child VSL.
There are other estimations of VSL that could potentially be used to derive a child VSL, such as value per statistical life year (VSLY) estimates or an “inverse U” that peaks in middle age such as that reported in Aldy and Viscusi (2008). These alternatives for valuing avoided child fatalities have strengths and limitations.
Standard derivation of VSLY (or vQALY) divides an estimate of VSL by the discounted number of remaining life years (or QALYs), accounting for age-specific survival probabilities, for the mean age of sampled individuals in the stated and revealed preference studies informing an agency's preferred VSL estimate. Analysts then multiply estimates of the VSLY or vQALY by the life years or QALYs lost from premature fatality. More life years are lost due to a child fatality than an adult fatality, resulting in different values for avoiding each type of death. While computationally straightforward to apply, this approach requires several strong assumptions.
First, in the case of vQALYs, the construction of QALYs “assumes that how individuals value health states (measured as changes in health-related quality of life, or HRQL) is independent of the duration of the state, the age at which they are experienced, and the individual's remaining life expectancy” (Robinson and Hammitt 2013). In practice, these assumptions are unlikely to hold in all cases.
Second, this approach assumes that the VSLY (or vQALY) is constant through time (
We note that application of a VSLY or vQALY could result in comparable results as a doubling of values for children, depending largely on the age of the affected population, the selected approach (
We are not aware of any regulatory agency currently using VSLYs or vQALYs in primary estimates of benefits or costs. HHS uses the VSLY to estimate the value of mortality risk reductions in sensitivity analysis. A uniform VSL is used in its primary estimate. See, for example, HHS (2022) Tobacco Product Standard for Characterizing Flavors in Cigars, available at
Finally, while measurements like VSLY or inverse “U” make it possible to generate estimates for each age of childhood, CPSC would then need to project the number of deaths at each age for the prospective study period. While CPSC is confident it can do this for two subpopulations—adults and children—we are less confident that there will be enough data to consistently forecast incidents for every individual age of childhood. Some CPSC safety rules may rely on projections derived from only a handful of historical death records.
Weighing the strengths and limitations of the available options for differentiating the value of risk reductions for children and adults, CPSC concludes that the application of a multiplier derived from available WTP literature is preferable to valuing lost life years for affected individuals based using a VSLY or vQALY. The advantages of relying solely on WTP studies, despite the small number of high-quality studies, and the resulting sharply delineated difference in the value of mortality risk reductions for adults and children, outweighs the advantages of an approach that results
Therefore, CPSC aligns its child estimates with those ratios in the IEc study and Robinson et al. (2019).
When applying VSL in regulatory analysis, the values must be adjusted for inflation, changes in real income, and the time value of money (discounting). This subsection describes the approach CPSC should take for each. This subsection also provides an example to illustrate these methods.
VSL should be adjusted to the most recent calendar year that has full inflation and real income data available, using the approach described in HHS (2021) and the accompanying Excel workbook. This method accounts for both the change in prices and real income and is summarized below.
VSL(year y) = VSL(year x) × (P(year y) ÷ P(year x)) × (I(year y) ÷ I(year x))
where
year y = specified dollar year of the analysis (year to which VSL is being inflated)
year x = year that is the basis for the initial VSL
P = price index for year x or y using the Consumer Price Index
I = real income in year x or y using BLS Weekly Earnings
e = income elasticity of VSL, assumed to be 1.0
When using this formula, CPSC uses the `annual average' of the most recently completed year for the Consumer Price Index and the Weekly Earnings (P and I).
CPSC updates VSL estimates using the most recent `annual average' of reported indices—and not inflate to a partial year—for both prices and real incomes. For example, as of the drafting of this guidance document in March 2024, 2023 is the most recent year that has all 12 months' CPI indices reported.
CPSC regularly performs prospective regulatory analyses that project a proposed or final regulation's impact into the future. Throughout the study period of a prospective regulatory analysis, VSL estimates should be adjusted to account for expected changes in real income. Regarding inflation, best practice throughout the Federal Government is to calculate future costs and benefits in constant real dollars for a specific dollar year, and not project inflation in future years. CPSC will follow the HHS Guidance from HHS for this adjustment. This method is summarized below.
For real income growth rate, HHS relies on the estimate that the Congressional Budget Office (CBO) uses in its most recent Long-Term Budget Outlook. As of the time of this draft guidance document, the most recent published outlook is from 2023, and it reports an annual growth in real earnings per worker of 1.0 percent from 2023 to 2053. CPSC should use this estimate as its real income growth (g) in its prospective regulatory analyses until CBO updates the value in a future Long-Term Budget Outlook. At that time, CPSC would use the updated real income growth rate estimate. If CPSC has a prospective regulatory analysis that goes beyond the projection window from CBO (
Many regulatory analyses include a sensitivity analysis as a supplement to the primary benefit-cost analysis. Often, these sensitivity analyses will alter the value of one or more of the variables in the primary analysis and describe the impact that change has in the estimated total benefits or total costs. CPSC should continue its practice of including a sensitivity analysis that adjusts input variable estimates that have a significant impact on the outputs of the analysis or have a great deal of uncertainty associated with them, on a case-by-case basis for each regulatory analysis. The sensitivity analysis could include adjusting adult and child VSL.
CPSC regularly performs prospective regulatory analyses that project a proposed or final regulation's impact into the future. In its prospective analyses, CPSC considers the time value of money by applying an annual discount rate to all monetized costs and benefits.
An argument can be made that discounting prevented deaths may be inappropriate because unlike money, a life saved today does not have an opportunity cost to be invested for more lives saved in the future, therefore a life saved today should be worth as much as a life saved 10 years into the future. However, the same resources that would have been used to save those lives could have been invested to earn a higher payoff in future lives saved from an alternative policy. In addition, there is a professional consensus that future health effects, including both benefits and costs, should be discounted at the same rate.
For these reasons, CPSC should apply discount factors to monetized benefits using VSL in its prospective regulatory analyses.
This section provides an example to illustrate the guideline's application of child VSL, adjustments for inflation and changes in real income, and discounting. This example adjusts HHS's 2013 VSL value into 2023 dollars, doubles the adjusted VSL to get the child VSL, and then accounts for changes in real income for a prospective 10 years.
First, the 2013 VSL value of $9.0 million must be inflated to 2023 dollars. The average annual consumer price index for the base year of 2013 is 232.957, and for the target year of 2023 is 304.702. The average annual real income index for the base year of 2013 is 333, and for the target year of 2023 is 367. Last, the income elasticity of VSL according to HHS is 1.0. These data points are used below to show the calculation to adjust VSL from 2013 dollars to 2023 dollars.
The adjusted VSL is $13.0 million. This is the value that would be used in a regulatory analysis based in the year 2023 and in 2023 dollars. If the analysis is measuring prevented deaths among children, the analysis would use double this value, $26.0 million in 2023 dollars, to estimate benefits from a reduction in fatality risk for children.
For a prospective analysis, the VSL should increase throughout the years at the rate of real annual growth of earnings per worker. CBO estimates this real annual growth rate to be 1.0 percent from 2023 to 2053. Table 3 shows the adjusted VSL for adults over a 10-year prospective analysis.
Table 5 shows the adjusted VSL for children over a 10-year prospective analysis.
These VSL values would be multiplied by the estimated number of reduced deaths due to the rule to generate monetized estimates from a reduction in fatality risk. The monetized estimates would then have a discount rate applied to them for each year to account for the time value of money.
Notice is hereby given that the Delaware River Basin Commission will hold a public hearing on Wednesday, May 8, 2024. A business meeting will be held the following month on Wednesday, June 5, 2024. Both the hearing and the business meeting are open to the public. The public hearing will be conducted virtually, and the business meeting will be held in person.
Written comments on matters scheduled for hearing on May 8, 2024 will be accepted through 5 p.m. on Monday, May 13, 2024.
The public is advised to check the Commission's website periodically during the ten days prior to the hearing date, as items scheduled for hearing may be postponed if additional time is needed to complete the Commission's review. Items also may be added up to ten days prior to the hearing date. In reviewing docket descriptions, the public is asked to be aware that the details of projects may change during the Commission's review, which is ongoing.
After all scheduled business has been completed and as time allows, the business meeting will be followed by up to one hour of Open Public Comment, an opportunity to address the Commission off the record on any topic concerning management of the basin's water resources outside the context of a duly noticed, on-the-record public hearing.
There will be no opportunity for additional public comment for the record at the June 5, 2024 business meeting on items for which a hearing was completed on May 8, 2024 or a previous date. Commission consideration on June 5, 2024 of items for which the public hearing is closed may result in approval of the item as proposed, approval with changes, denial, or deferral. When the Commissioners defer an action, they may announce an additional period for written comment on the item, with or without an additional hearing date, or they may take additional time to consider the input they have already received without requesting further public input. Any deferred items will be considered for action at a public meeting of the Commission on a future date.
Other individuals in need of an accommodation as provided for in the Americans with Disabilities Act who
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before May 20, 2024.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Sara Starke, 202-987-0391.
The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
This discretionary grant falls under the streamlined grant process, 1894-0001, which waives the 60-day comment period (Pub. L. 104-13, Section 3505(a)(2)).
This collection is being submitted under the Streamlined Clearance Process for Discretionary Grant Information Collections (1894-0001). Therefore, the 30-day public comment period notice will be the only public comment notice published for this information collection.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before June 17, 2024.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection
The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
l.
m.
n. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
o.
p.
q. The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that on April 5, 2024, Western Area Power Administration submitted a tariff filing per 10 CFR 903.23: CRSP_WestConnect_WAPA215-20240404 to be effective 6/1/2024.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application to amend the project boundary for the Kingsley Dam Hydroelectric Project No. 1417 (project). The project is located on the North Platte and Platte Rivers in Garden, Keith, Lincoln, Dawson, and Gosper counties, in south-central Nebraska. Commission staff has prepared an Environmental Assessment (EA) for the proposed action.
The EA contains the staff's analysis of the potential environmental effects of the proposed action and concludes that approving the proposed project boundary amendment for the project, Commission staff's recommended measures, would not constitute a major Federal action significantly affecting the quality of the human environment.
The Commission provides all interested persons with an opportunity to view and/or print the EA via the internet through the Commission's Home Page (
You may also register online at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595, or
Any comments must be filed by May 13, 2024.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Jon Cofrancesco at 202-502-8951 or
In accordance with the National Environmental Policy Act of 1969
All interested individuals and entities are invited to attend one or both of the public meetings. The dates and times of the public meetings are listed below.
Commission staff will be moderating the meetings. The meetings will begin promptly at their respective start times listed above. At the start of the meeting, staff will provide further instructions regarding the meeting setup, agenda, and how participants can provide their comments and questions during the meeting. Oral comments will initially be limited to five minutes in duration. These meetings are posted on the Commission's calendar located on the internet at
For further information, contact Marybeth Gay at
This is a supplemental notice in the above-referenced proceeding of Sol Madison Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before June 17, 2024. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
On October 27, 2020, the Commission adopted the
In order to gain a complete understanding of the current service offerings of each competitive ETC receiving legacy high-cost support for mobile wireless services, the Commission adopted rules that require each such competitive ETC to file an initial report containing information and certifications about its current mobile service offerings in each of its subsidized service areas and how it is using legacy support and whether it is offering mobile services in its subsidized service areas at rates that are reasonably comparable to those charged in urban areas.
A revision to the currently approved information collection requirements under OMB 3060-1291 is necessary in order to remove a requirement that applies only to the annual reports that must be filed by competitive ETCs receiving legacy high-cost support for mobile wireless services information requirement, which was inadvertently included in the information collection under OMB 3060-1291 as previously approved by OMB.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before June 17, 2024. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Data from the FCC Form 350 is extracted for inclusion in the subsequent license to operate the station.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents,
Written PRA comments should be submitted on or before June 17, 2024. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
Written comments and recommendations for the proposed information collection should be submitted on or before May 20, 2024.
Comments should be sent to
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) go to the web page
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this
Section 17.4 includes third party disclosure requirements. Specifically, section 17.4 requires the owner of any proposed or existing antenna structure that requires notice of proposed construction to the Federal Aviation Administration (FAA) to register the structure with the Commission. This includes those structures used as part of the stations licensed by the Commission for the transmission of radio energy, or to be used as part of a cable television head-end system. An antenna structure must be registered with the Commission if the antenna structure is taller than 200 feet above ground level or may interfere with the flight path of a nearby airport or heliport. Section 17.4(f) provides that antenna structure owners shall immediately provide to all tenant licensees and permittees notification that the structure has been registered. This may be done by providing either a copy of Form 854 or a link to the FCC antenna structure registration website. This notification may be done electronically or via paper mail.
Section 17.4(g) requires antenna structure owners to display the Antenna Structure Registration Number in a conspicuous place that is readily visible near the base of the antenna. This rule specifically requires that the Antenna Structure Number be displayed so that it is conspicuously visible and legible from the publicly accessible area nearest the base of the antenna structure along the publicly accessible roadway or path. Where an antenna structure is surrounded by a perimeter fence, or where the point of access includes an access gate, the Antenna Structure Registration Number should be posted on the perimeter fence or access gate. Where multiple antenna structures having separate Antenna Structure Registration Numbers are located within a single fenced area, the Antenna Structure Registration Numbers must be posted both on the perimeter fence or access gate and near the base of each antenna structure. If the base of the antenna structure has more than one point of access, the rule requires that the Antenna Structure Registration Number be posted so that it is visible at the publicly accessible area nearest each such point of access. The registration number is issued to identify antenna structure owners in order to enforce the Congressionally mandated provisions related to the owners.
Sections 17.48 and 17.49 contain reporting and recordkeeping requirements. Section 17.48(a) requires that antenna structure owners immediately report outages of top steady burning lights or flashing antenna structure lights to the FAA, if not corrected within 30 minutes. Upon receipt of the outage notification, the FAA will issue a Notice to Airmen (NOTAM), which notifies aircraft of the outage. Consistent with FAA requirements, if a lighting outage cannot be repaired within the FAA's original NOTAM period, section 17.48(a) further requires the antenna structure owner to notify the FAA of that fact and provide any needed updates to its estimated return-to-service date. The rule also requires antenna structure owners to continue to provide these updates to the FAA every NOTAM period until its lights are repaired.
Section 17.49 requires antenna structure owners to maintain a record of observed or otherwise known extinguishments or improper functioning of structure lights for two years and provide the records to the Commission upon request.
Section 20.21(f)(1)(iv)(A)(2)—In order to ensure that consumers are properly informed about which devices are suitable for their use and how to comply with our rules, the Commission required that all Consumer Signal Boosters certified for fixed, in-building operation include a label directing consumers that the device may only be operated in a fixed, in-building location. The Verizon Petitioners state that this additional labeling requirement is necessary to inform purchasers of fixed Consumer Signal Boosters that they may not lawfully be installed and operated in a moving vehicle or outdoor location. We recognize that our labeling requirement imposes additional costs on entities that manufacture Consumer Signal Boosters; however, on balance, we find that such costs are outweighed by the benefits of ensuring that consumers purchase appropriate devices. Accordingly, all fixed Consumer Signal Boosters, both Provider-Specific and Wideband, manufactured or imported on or after one year from the effective date of the rule change must include the following advisory (1) in on-line point-of-sale marketing materials, (2) in any print or on-line owner's manual and installation instructions, (3) on the outside packaging of the device, and (4) on a label affixed to the device: “This device may be operated ONLY in a fixed location for in-building use.”
Section 1.1307(b)(1)—Radiofrequency (RF). This rule requires that a label is affixed to the transmitting antenna that provides adequate notice regarding potential RF safety hazards and references the applicable FCC-adopted limits for RF exposure. Provider Reporting Requirement: In order to facilitate review of wireless providers' behavior regarding Consumer Signal Boosters, the R&O requires that on March 1, 2015, and March 1, 2016, all nationwide wireless providers publicly indicate their status regarding consent for each Consumer Signal Booster that has received FCC certification as listed in a Public Notice to be released by the Wireless Telecommunications Bureau 30 days prior to each reporting date. For each listed Consumer Signal Booster, wireless providers should publicly indicate whether they (1) consent to use of the device; (2) do not consent to use of the device; or (3) are still considering whether or not they will consent to the use of the device.
Registration Requirements: Section 20.21(a)(2)—The rules require signal booster operators to register Consumer Signal Boosters, existing and new, with their serving wireless providers prior to operation. This is a mandatory requirement to continue or begin operation of a Consumer Signal Booster. The registration requirement will aid in interference resolution and facilitate provider control over Consumer Signal Boosters. The information collection contained in section 20.21(a)(2) affects individuals or households; thus, there are impacts under the Privacy Act. However, the government is not directly collecting this information and the R&O directs carriers to protect the information to the extent it is considered Customer Proprietary Network Information (CPNI).
Section 20.21(h)—By March 1, 2014, all providers who voluntarily consent to the use of Consumer Signal Boosters on their networks must establish a free registration system for their subscribers. At a minimum, providers must collect (1) the name of the Consumer Signal Booster owner and/or operator, if different individuals; (2) the make, model, and serial number of the device; (3) the location of the device; and (4) the date of initial operation. Otherwise, the Commission permits providers to develop their own registration systems to facilitate provider control and interference resolution, providers should collect only such information that is reasonably related to achieving these dual goals. Wireless providers may determine how to collect such information and how to keep it up-to-date. Section 90.219(d)(5)—This rule requires operators of Part 90 Class B signal boosters to register these devices in a searchable on-line database that will be maintained and operated by the Wireless Telecommunications Bureau via delegated authority from the Commission. The Commission believes this will be a valuable tool to resolve interference should it occur.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collections described below (OMB Control No. 3064-0018).
Comments must be submitted on or before June 17, 2024.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, Regulatory Counsel, 202-898-3767,
Proposal to renew the following currently approved collection of information:
1.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995, invites the general public and other Federal agencies to take this opportunity to comment on the request to renew the existing information collections described below (OMB Control No. 3064-0213). The notice of the proposed renewal for this information collection was previously published in the
Comments must be submitted on or before May 20, 2024.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Manny Cabeza, Regulatory Counsel, 202-898-3767,
Proposal to renew the following currently approved collection of information:
1.
The total estimated annual burden for this information collection is 401 hours, which is a decrease of 56 hours from the 2021 information collection submission (457 hours). This decrease is a result of a reduction in the estimated annual number of respondents.
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the
Comments must be received by June 17, 2024.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:
William N. Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies to publish a 60-day notice in the
1.
CMS did not previously estimate several costs for implementing the provisions of MIPPA related to MSPs as well as costs related to MSPs that were longstanding costs inherent to the Medicaid program that predated MIPPA. To address that oversight, we estimate such burden in this collection of information request. We also estimate burden and savings associated with the provisions in the MSP final rule. Such burden was set out in the Regulatory Impact Analysis section of the final rule.
The MSPs are essential to the health and well-being of those enrolled, promoting access to care and helping free up individuals' limited income for food, housing, and other life necessities. Through the MSPs, Medicaid pays Medicare Part B premiums each month for over 10 million individuals and Part A premiums for over 700,000 individuals. State Medicaid agencies receive applications and adjudicate eligibility for MSP coverage.
MIPPA created new requirements for states to leverage the Medicare Part D Low-Income Subsidy (LIS) program to help enroll likely-eligible individuals in MSPs, and the MSP final rule expanded those requirements. States use information collected by the Social Security Administration on the LIS application (transmitted to states with the consent of an individual completing an application) to determine eligibility for the MSPs. Under the MSP final rule, the state Medicaid agency accepts and verifies the information provided on the LIS application (to the extent allowable under the MSP final rule); communicates with the applicant or the authorized representative about any additional information needed to make an MSP determination; makes the MSP eligibility determination; enrolls the individual in an MSP, if eligible; and informs the individual about the rights and responsibilities for applying for full Medicaid eligibility. Applicants include anyone who chooses to apply for LIS and provides consent for their application to be considered for MSPs.
In addition to building on MIPPA and strengthening the LIS pathway for enrolling in MSPs, the MSP final rule streamlined MSP eligibility and enrollment processes, reduced administrative burden on states and applicants, and increased enrollment and retention of eligible individuals.
2.
Form CMS-R-285 provides the necessary information regarding the prior state or local government employment to process the individual's request for premium Part A reduction based on their employment by a state or local government. The form is completed by the state or local government employer on behalf of the individual seeking the Medicare premium reduction. The SSA, CMS' agent for processing Medicare enrollments and premium amount determinations, will use this information to help determine whether a beneficiary meets the requirements for reduction of the Part A premium. The form is owned by CMS but not completed by CMS staff.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final decision withdrawing approval of PEPAXTO (melphalan flufenamide), for injection, equivalent to 20 milligrams (mg) base/vial, once every 28 days, under the new drug application (NDA) 214383, held by Oncopeptides AB (Oncopeptides). The Commissioner of Food and Drugs' (the Commissioner's) designee issued the decision, and a summary of responses to public comments. The Commissioner's designee issued this decision following the Center for Drug Evaluation and Research's (CDER) proposal to withdraw approval of PEPAXTO, Oncopeptides' appeal of the proposed withdrawal, a meeting between the designee and Oncopeptides, a public comment period on the proposed withdrawal, and an advisory committee that CDER convened and consulted on issues related to the proposed withdrawal.
Approval of PEPAXTO is withdrawn as of February 23, 2024.
Anuj Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-796-3600,
On February 26, 2021, FDA approved NDA 214383 for PEPAXTO (melphalan flufenamide) for injection, for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody (triple class refractory). FDA approved PEPAXTO under the accelerated approval pathway, pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(c)) and 21 CFR 314.510, based on evidence of the drug's effect on an intermediate clinical endpoint that was considered reasonably likely to predict the drug's clinical benefit.
As a condition of PEPAXTO's approval, the sponsor was required to complete a postapproval confirmatory trial to verify and describe the clinical benefit of PEPAXTO. The postapproval confirmatory trial, Trial OP-103, failed to meet the primary endpoint of progression-free survival superiority compared to the control arm and demonstrated a lower median overall survival compared to the control arm.
On September 22, 2022, an Oncologic Drugs Advisory Committee (ODAC) meeting was held to discuss the results of Trial OP-103. The committee discussed issues that were ultimately related to the withdrawal, including the progression-free survival results, overall survival results, dosing concerns, subpopulation considerations, and the benefit-risk profile of PEPAXTO for the patient population for which the drug was indicated. The ODAC voted 14 to 2 that the benefit-risk profile of PEPAXTO was not favorable for the patient population for which the drug was indicated.
On July 7, 2023, pursuant to the expedited withdrawal procedures under section 506(c)(3)(B) of the FD&C Act, CDER provided due notice to Oncopeptides of the proposal to withdraw approval of PEPAXTO on two independent grounds: (1) the postapproval confirmatory trial failed to verify clinical benefit and (2) the evidence demonstrates that the drug is not shown to be safe or effective under its conditions of use. CDER's notice provided Oncopeptides with an explanation for the proposed withdrawal, and advised Oncopeptides that it had the opportunity for a written appeal to and a meeting with the Commissioner, or the Commissioner's designee, regarding CDER's proposal.
On July 26, 2023, Oncopeptides submitted a letter indicating an intent to appeal the proposal to withdraw approval and requesting a meeting with the FDA Commissioner or the Commissioner's designee with respect to the proposed withdrawal of approval.
On August 4, 2023, Oncopeptides submitted its written appeal of CDER's proposal to withdraw approval of PEPAXTO. On August 9, 2023, Dr. Peter Marks, Director, Center for Biologics Evaluation and Research, notified the parties that the Commissioner had designated him to serve as the Commissioner's designee under section 506(c)(3)(B) of the FD&C Act. CDER submitted a response to Oncopeptides' written appeal on September 8, 2023, and Oncopeptides replied to CDER's response on September 19, 2023. On September 29, 2023, CDER submitted a response to Oncopeptides' September 19, 2023, correspondence. On October 2, 2023, Oncopeptides and CDER met with the Commissioner's designee, and both Oncopeptides and CDER submitted additional information requested by the designee after the meeting.
Consistent with the expedited withdrawal procedures under section 506(c)(3)(B) of the FD&C Act, CDER issued on August 25, 2023, a Notice of Opportunity for Public Comment on its proposal to withdraw PEPAXTO; the comment period remained open until September 25, 2023. The September 22, 2022, ODAC meeting had previously discussed and provided recommendations on issues with respect to the withdrawal of PEPAXTO.
On February 23, 2024, after reviewing the record and considering the arguments on appeal, the Commissioner's designee issued a final decision finding the grounds for withdrawal were met and that withdrawal was appropriate, withdrawing approval of PEPAXTO.
FDA has thus withdrawn approval of the following NDA:
Withdrawal of approval of PEPAXTO (NDA 214383) was effective February 23, 2024; the withdrawal includes all amendments and supplements to the application. As discussed in the decision of the Commissioner's designee, FDA has withdrawn approval of the PEPAXTO NDA for reasons of safety or effectiveness.
Section 505(j)(7) of the FD&C Act (21 U.S.C. 355(j)(7)) requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book,” available at
Persons with access to the internet may obtain the final decision at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that LENMELDY (atidarsagene autotemcel), approved on March 18, 2024, manufactured by Orchard Therapeutics (Europe) Ltd., meets the criteria for a priority review voucher.
Myrna Hanna, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that LENMELDY (atidarsagene autotemcel), manufactured by Orchard Therapeutics (Europe) Ltd., meets the criteria for a priority review voucher.
LENMELDY (atidarsagene autotemcel) is indicated for treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy.
For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments (including recommendations) on the collection of information by May 20, 2024.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports regulations governing FDA expedited programs for serious conditions. These provisions are set forth in 21 CFR part 312, subpart E and are intended to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory
To assist respondents with the information collection, we developed Agency guidance entitled “Guidance for Industry Expedited Programs for Serious Conditions—Drugs and Biologics” (May 2014). The guidance is a resource for information on FDA's policies and procedures related to the following expedited programs for serious conditions: (1) fast track designation; (2) breakthrough therapy designation; (3) accelerated approval; and (4) priority review designation, and describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. The guidance addresses the applicability of expedited programs to rare diseases, clarification on available therapy, and additional detail on possible flexibility in manufacturing and product quality. It also clarifies the qualifying criteria for breakthrough therapy designation, provides examples of surrogate endpoints and intermediate clinical endpoints used to support accelerated approval, and priority review.
In addition, we developed Agency guidance entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions,” (February 2019) describing the criteria for participation in the Regenerative Medicine Advanced Therapy (RMAT) program. The RMAT expedited program was approved as part of the 21st Century CURES Act, signed December 13, 2016. An RMAT product is intended to treat, modify, reverse, or cure serious or life-threatening diseases or conditions, and preliminary clinical evidence indicate that the drug has the potential to address unmet medical needs for such diseases or conditions. This is a Center Biologics Evaluation and Research (CBER) program and is included as an expedited program available for serious conditions.
For a sponsor or applicant who seeks fast track, priority, breakthrough, RMAT or accelerated approval designation review, approval is required to submit a request showing that the drug product: (1) is intended for a serious or life-threatening condition and (2) has the potential to address an unmet medical need, demonstrate substantial improvement over available therapy, or fill an unmet need to be approved based on a surrogate endpoint. We expect that most information to support a designation request will have been gathered under existing requirements for preparing an investigational new drug (IND), new drug application (NDA), or biologics license application (BLA). If such information has already been submitted to us, the information may be summarized in the designation request. A designation request should include, where applicable, additional information not specified elsewhere by statute or regulation. For example, additional information may be needed to show that a product has the potential to address an unmet medical need where an approved therapy exists for the serious or life-threatening condition to be treated. Such information may include clinical data, published reports, summaries of data and reports, and a list of references. The amount of information and discussion in a designation request should be sufficient to permit a reviewer to assess whether the criteria for fast track, priority, breakthrough, RMAT or accelerated approval designation have been met.
After we make an expedited programs designation, a sponsor or applicant may submit a premeeting package that may include additional information supporting a request to participate in certain expedited programs. The premeeting package serves as background information for the meeting and should support the intended objectives of the meeting. As with the request for expedited programs designation, we expect that most sponsors or applicants will have gathered such information to meet existing requirements for preparing an IND, NDA, or BLA. These may include descriptions of clinical safety and efficacy trials not conducted under an IND (
The guidance documents are available on our website at
In the
FDA estimates the burden of this collection of information as follows:
Based on FY 2022 receipts, we estimate that for Center for Drug Evaluation and Research (CDER) products, 81 respondents will submit 124 requests for priority review designation annually, and we assume 30 hours are needed to prepare such a request. We estimate 71 respondents will submit 77 requests for breakthrough designation annually, and we assume 70 hours are needed to prepare such a request. We estimate that 235 respondents will submit 277 requests for fast-track designation requests annually, and we assume 60 hours are required to prepare such a request. We estimate 26 respondents will submit 33 accelerated approval designation requests annually and we assume 100 hours are required to prepare such a request. Finally, CDER received 165 pre-meeting package submissions from 163 respondents. We assume 100 hours are needed to prepare a pre-meeting package.
Similarly, also based on FY 2022 receipts, we estimate that for CBER products, 8 applicants will submit 8 requests for priority review designation annually, and we assume 30 hours are required to prepare such a request. We estimate 15 respondents will submit 17 requests for breakthrough designation annually, and we assume 70 hours are needed to prepare such a request. We estimate that 64 respondents will submit 78 requests for fast-track designation annually, and we assume 60 hours is required to prepare such a request. We also estimate 33 respondents will submit 35 requests for RMAT designation annually and assume that 60 hours are needed to prepare each RMAT designation request. Finally, CBER received 283 pre-meeting package submissions from 146 respondents. We assume 100 hours are needed to prepare a pre-meeting package.
Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate by 143 responses and 10,350 hours to reflect actual submissions we have received. We attribute these changes to increased interest in the expedited programs, new expedited programs, and an increase in the number of submissions we received over the last few years.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Request for public comment.
This notice seeks public comment to update the Health Center Loan Guarantee Program lender and servicer eligibility criteria in accordance with OMB Circular A-129. The original notice of lender eligibility criteria for the Health Center Loan Guarantee Program was published in the Commerce Business Daily on January 7, 2000.
Submit comments no later than May 20, 2024.
Electronic or written comments should be submitted through the Bureau of Primary Health Care (BPHC) Contact Form (new users must request access) or to 5600 Fishers Lane, Rm. 16N-20, Rockville, MD 20857, no later than 30 days after the publication date.
Mary Lou Ojeda, Lead Public Health Analyst, or Valerie Green, Loan Specialist, BPHC, Office of Policy and Program Development, Strategic Initiatives, HRSA, 5600 Fishers Lane, Rm. 16N-20, Rockville, MD 20857, 301-594-4300, or the BPHC Contact Form.
Title XVI, part A of the Public Health Service Act established the authority for the Department of Health and Human Services to guarantee the principal and interest on certain loans made by non-Federal lenders. Under this authority, the Health Center Loan Guarantee Program guarantees up to 80 percent of the outstanding principal and interest on eligible loans for the construction, renovation, and modernization of medical facilities that are operated by health centers funded under the Public Health Service Act. These health centers, which are community-based private nonprofit or public entities, provide primary health care services for medically underserved populations. The approximately 1,400 organizations that receive funding are located in urban and rural communities throughout the nation.
HRSA's BPHC administers the Health Center Loan Guarantee Program, which has a total current lending authority of $825 million. Under the Program, lender and servicer eligibility requirements have been established, with participation open to eligible non-Federal lenders. Consistent with the policies set forth in OMB Circular A-129, this notice provides interested parties information regarding eligibility criteria for participating as a lender or servicer in the Loan Guarantee Program. Specifically, to participate in the Program, a lender or servicer must: (a) Be regulated or certified and in good standing with a Federal financial institution regulatory agency, or furnish satisfactory evidence of adequate financial and capital condition showing that the lender has (i) a minimum adjusted net worth of $250,000, or (ii) at least $50,000 in working capital plus 1 percent of the total volume in excess of $25 million in guaranteed loans originated, serviced, or purchased during the lender's prior fiscal year, up to a maximum required adjusted net worth of $2.5 million, and one or more lines of credit with a minimum aggregated of $1 million; (b) Not be currently debarred or suspended from participation in any United States government contract or delinquent on a debt owed to the United Stated government or any agency or instrumentality thereof; (c) Be able to obtain and submit proof of fidelity/surety bonding and/or errors and omissions insurance with the Federal Government as a loss payee if the lender has previously had questionable performance under Federal guarantee programs or is not regulated by the Federal Government or certified by the U.S. Department of the Treasury; (d)
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The cooperative agreement applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the cooperative agreement applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, and/or contract proposals the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities.
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Comments are to be submitted on or before July 17, 2024.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-2425, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the
Comments are to be submitted on or before July 17, 2024.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-2426 to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the
Comments are to be submitted on or before July 17, 2024.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-2427, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Fish and Wildlife Service, Interior.
Notice; extension of public comment period.
We, the U.S. Fish and Wildlife Service (Service), announce that we are extending the comment period for the public to review a draft habitat conservation plan (HCP) and a draft environmental action statement and low-effect screening form. These documents are associated with the Colton/San Bernardino Regional Tertiary Treatment and Water Reclamation Authority and San Bernardino Municipal Water Department's application under the Endangered Species Act for a permit
The comment period for the revised HCP and draft environmental action statement, notice of which published on March 28, 2024 (89 FR 21539
•
•
For more information about submitting public comments, see our March 28, 2024, notice.
Karin Cleary-Rose, by phone at (760) 332-2070 or by email at
On March 28, 2024 (89 FR 21539), we, the U.S. Fish and Wildlife Service (Service), announced that we received an application from the Colton/San Bernardino Regional Tertiary Treatment and Water Reclamation Authority and San Bernardino Municipal Water Department (applicants) for an incidental take permit under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
With this notice, we are extending the public comment period (see
U.S. Geological Survey, Department of the Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the U.S. Geological Survey (USGS) is proposing to renew an information collection.
Interested persons are invited to submit comments on or before June 17, 2024.
Send your comments on this information collection request (ICR) by mail to USGS, Information Collections Clearance Officer, 12201 Sunrise Valley Drive, MS 159, Reston, VA 20192; or by email to
To request additional information about this ICR, contact Erin Korris by email at
In accordance with the PRA (44 U.S.C. 3501
We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How the agency might minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personally identifiable information (PII) in your comment, you should be aware that your entire comment—including your PII—may be made publicly available at any time. While you can ask us in your comment to withhold your PII from public review, we cannot guarantee that we will be able to do so.
In general, the National Structures Dataset (NSD) has been populated with the best available national data. This data has been exposed for initial improvement by TNMCorps volunteers via the online Map Editor (the instrument). In addition, the data goes through a tiered-editing process, which includes peer review and advanced editors. At each stage the data is passed through an automatic “magic filter” to look for data issues before being submitted into the NSD. In addition, data goes through sampling for quality assurance procedures.
Data within the NSD is available to the USGS as well as to the public at no cost via The National Map and US Topo.
Data quality studies in 2012, 2014, and 2018 showed that the volunteers' actions were accurate and exceeded USGS quality standards. Volunteer-collected data showed an improvement in both location and attribute accuracy for existing data points. Completeness, or the extent to which all appropriate features were identified and recorded, was also improved.
An agency may not conduct or sponsor, nor is a person required to respond to, a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the PRA (44 U.S.C. 3501
In notice document 2024-07106 beginning on page 24030 in the issue of Friday, April 5, 2024, make the following correction:
On page 24030, in the third column, in the 15th line, “June 4, 2024” should read “July 5, 2024”.
Bureau of Land Management, Interior.
Notice of realty action.
The Bureau of Land Management (BLM) proposes a non-competitive (direct) sale of 307.5 acres of public lands in Sweetwater County, Wyoming, to PacifiCorp. The sale would allow PacifiCorp to gain ownership of the property, which is adjacent to the PacifiCorp Jim Bridger power plant and property owned by PacifiCorp. The sale would be subject to applicable provisions of the Federal Land Policy and Management Act of 1976, as amended (FLPMA), and BLM regulations. The appraised fair market value for the sale parcel is $115,000.
Interested parties must submit written comments no later than June 3, 2024.
Mail written comments to the BLM Rock Springs Field Office, Field Manager, 280 Highway 191 N., Rock Springs, Wyoming, 82901.
Lisa Aleshire, Realty Specialist, BLM, Rock Springs Field Office, at the above address, by telephone 307-352-0238 or by email
The following public lands have been examined and found suitable for sale in accordance with criteria established in Section 203 of FLPMA:
T. 21 N., R. 101 W., sec. 36, E1/2NE1/4, W1/2SW1/4NE1/4SW1/4, SW1/4NW1/4NW1/4SW1/4, S1/2NW1/4SW1/4, S1/2SW1/4, E1/2SE1/4, SW1/4SE1/4.
The area described contains 307.5 acres, according to the official plat of survey of the said land on file with the BLM.
The sale of the parcel is in conformance with the BLM Rock Springs Field Office approved Green River Resource Management Plan (August 8, 1997), which identifies the parcel as suitable for disposal in Appendix 8-1.
A parcel-specific Environmental Assessment (EA) numbered DOI-BLM-WY-D040-2022-0013-EA has been conducted in connection with this sale. A copy of the EA is available online at:
Regulations at 43 CFR 2711.3-3(a) allow the direct sale of public lands without competition when a competitive sale is not appropriate and the public interest would best be served by a direct sale. In this case, a competitive sale is not appropriate because the subject lands contain BLM authorized rights-of-way and improvements that directly support the Jim Bridger Power Plant owned by PacifiCorp, rendering the land unusable by the public.
Upon publication of this notice in the
The temporary segregation will terminate upon: (1) issuance of a conveyance document, (2) publication
The conveyance document, if issued, will be subject to the following terms, conditions, and reservations:
1. A right-of-way thereon for ditches or canals constructed by the authority of the United States, Act of August 30, 1890 (43 U.S.C. 945).
2. All mineral deposits in the lands so conveyed and to it, or persons authorized by it, the right to prospect for, mine and remove such deposits from the same under applicable law and regulations to be established by the Secretary of the Interior, together with all necessary access and exit rights.
3. All valid existing rights issued prior to conveyance.
4. An appropriate indemnification clause protecting the United States from claims arising out of the conveyee's use, occupancy, or operations on the conveyed lands.
5. Additional terms and conditions that the authorized officer deems appropriate.
In addition to publication in the
Any adverse comments regarding the sale parcel will be reviewed by the BLM Wyoming State Director or other authorized official of the Department of the Interior, who may sustain, vacate, or modify this realty action in whole or in part. In the absence of any timely filed objections, this realty action will become the final determination of the Department of the Interior.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Comments, including names and street addresses of respondents, will be available for public review at the BLM Rock Springs Field Office during regular business hours, except holidays.
Bureau of Land Management, Interior.
Notice of decision approving lands for conveyance.
The Bureau of Land Management (BLM) hereby provides constructive notice that it will issue an appealable decision approving conveyance of the surface estate in certain lands to Danzhit Hanlaii Corporation for the Native village of Circle, pursuant to the Alaska Native Claims Settlement Act of 1971 (ANCSA). The subsurface estate in the same lands will be conveyed to Doyon, Limited, when the surface estate is conveyed to Danzhit Hanlaii Corporation.
Any party claiming a property interest in the lands affected by the decision may appeal the decision in accordance with the requirements of 43 CFR part 4 within the time limits set out in the
You may obtain a copy of the decision from the Bureau of Land Management, Alaska State Office, 222 West Seventh Avenue, #13, Anchorage, AK 99513-7504.
Abby Muth, Land Law Examiner, BLM Alaska State Office, 907-271-3345, or
As required by 43 CFR 2650.7(d), notice is hereby given that the BLM will issue an appealable decision to Danzhit Hanlaii Corporation. The decision approves conveyance of the surface estate in certain lands pursuant to ANCSA (43 U.S.C. 1601,
Aggregating approximately 2,035 acres.
The decision addresses public access easements, if any, to be reserved to the United States pursuant to sec. 17(b) of ANCSA (43 U.S.C. 1616(b)), in the lands described above.
The BLM will also publish notice of the decision once a week for four consecutive weeks in the Fairbanks Daily News-Miner newspaper.
Any party claiming a property interest in the lands affected by the decision may appeal the decision in accordance with the requirements of 43 CFR part 4 within the following time limits:
1. Unknown parties, parties unable to be located after reasonable efforts have been expended to locate, parties who fail or refuse to sign their return receipt, and parties who receive a copy of the decision by regular mail which is not certified, return receipt requested, shall have until May 20, 2024 to file an appeal.
2. Parties receiving service of the decision by certified mail shall have 30 days from the date of receipt to file an appeal.
Parties who do not file an appeal in accordance with the requirements of 43 CFR part 4 shall be deemed to have waived their rights. Notices of appeal transmitted by facsimile will not be accepted as timely filed.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The associated funerary objects were removed from Merrick County, NE.
Repatriation of the associated funerary objects in this notice may occur on or after May 20, 2024.
Taylor Ronquillo NAGPRA Project Manager, University of Nebraska State Museum, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, the 12 associated funerary objects are two boxes of burial soil (total weight 10 kg), one metal blade, one worked stone, two ceramic sherds, five faunal bones, and one faunal tooth. This material was excavated by Karl Reinhard in 1992 with the University of Nebraska State Museum working under contract to the Bureau of Reclamation during the construction of the Fullerton Canal project. The Palmer Site was a historic Skidi Pawnee earth lodge village. The soil samples were from burial [mound] 4. The material was excavated from the Palmer Site, Merrick County, NE.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the associated funerary objects described in this notice.
The University of Nebraska State Museum has determined that:
• The 12 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the associated funerary objects described in this notice and the Pawnee Nation of Oklahoma.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the associated funerary objects in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The associated funerary objects were removed from Douglas County, NE.
Repatriation of the associated funerary objects in this notice may occur on or after May 20, 2024.
Taylor Ronquillo NAGPRA Project Manager, University of Nebraska State Museum, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, the five associated funerary objects are three sherds, one stone gorget, and one stone pendant. The human remains associated with these associated funerary objects were listed in a Notice of Inventory Completion published in the
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the associated funerary objects described in this notice.
The University of Nebraska State Museum has determined that:
• The five objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the associated funerary objects described in this notice and the Ponca Tribe of Nebraska.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the associated funerary objects in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Phillips, KS.
Repatriation of the human remains in this notice may occur on or after May 20, 2024.
Taylor Ronquillo NAGPRA Project Manager, the University of Nebraska State Museum, University of Nebraska-Lincoln, 645 N 14th St., Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the University of Nebraska State Museum.
Human remains representing, at minimum, one individual were removed from Phillips, KS. This individual was removed from site 14PH004, Woodruff Ossuary. Woodruff Ossuary is a Missouri River Basin Survey Site: Missouri Basin Project and Inter-Agency Archeological and Paleontological Salvage Program, Smithsonian. The donor and date of acquisition for the individual is unknown. The individual is estimated to be a juvenile of an unknown sex. The individual is determined to be Woodland based on the archeological record. No associated funerary objects are present.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: geographical information and historical information.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the University of Nebraska State Museum has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Pawnee Nation of Oklahoma.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The associated funerary objects were removed from Cedar County, NE.
Repatriation of the associated funerary objects in this notice may occur on or after May 20, 2024.
Taylor Ronquillo, NAGPRA Project Manager, University of Nebraska State Museum, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
The three associated funerary objects are one copper bracelet and two pieces of charred wood. These three associated funerary objects were discovered together in box A1041 in the basement of Nebraska Hall on April 10, 2017, by Patricia (Trisha) Patton. This material was donated to UNSM by R.B. Cumming in 1941. The human remains associated with these associated funerary objects were listed in a Notice of Inventory Completion published in the
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the associated funerary objects described in this notice.
The University of Nebraska State Museum has determined that:
• The three objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the associated funerary objects described in this notice and the Ponca Tribe of Nebraska.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the associated funerary objects in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The associated funerary objects were removed from Custer County, NE.
Repatriation of the associated funerary objects in this notice may occur on or after May 20, 2024.
Taylor Ronquillo NAGPRA Project Manager, University of Nebraska State Museum, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, the seven associated funerary objects are one lot of sherds (seven), four lots of chipped stones (44), one lot of beads (two), and one shell. The human remains associated with these associated funerary objects were listed in a Notice of Inventory Completion published in the
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the associated funerary objects described in this notice.
The University of Nebraska State Museum has determined that:
• The seven objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the associated funerary objects described in this notice and the Ponca Tribe of Nebraska.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the associated funerary objects in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum University of Nebraska-Lincoln has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from the City of Fulton, Callaway County, MO.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after May 20, 2024.
Taylor Ronquillo, NAGPRA Project Manager, University of Nebraska State Museum, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing at least five individuals have been reasonably identified. The one associated funerary object is a faunal bone. The five adult individuals make up four crania, five mandibles, one vertebra, four hand elements, five foot elements, and 29 adult teeth. The poor-to-fair preservation resembles material from known Woodland sites in Nebraska. The human remains were found by Darling K. Greger and loaned to the museum by Dr. H.B. Ward in 1908. These remains were excavated from a mound on the east bank of the Aux Vasse River (Creek), east of [City of] Fulton, Calloway County, Missouri.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The University of Nebraska State Museum has determined that:
• The human remains described in this notice represent the physical remains of five individuals of Native American ancestry.
• The one object described in this notice is reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the human remains and associated funerary objects described in this notice and The Osage Nation.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after May 20, 2024.
Taylor Ronquillo, University of Nebraska State Museum, Morrill Hall, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of the consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at least, two individuals have been reasonably identified. No associated funerary objects are present. These items were discovered in the basement of Nebraska Hall in box A2050 on November 1, 2016. Based on material culture, this is a mixed site that includes Central Plains Tradition, Oneota, and Omaha cultural traditions. The individual was excavated from Stanton County, Indian Creek Village Site in 1938.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
The University of Nebraska State Museum has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Ponca Tribe of Nebraska.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The associated funerary objects were removed from Sarpy County, NE.
Repatriation of the associated funerary objects in this notice may occur on or after May 20, 2024.
Taylor Ronquillo NAGPRA Project Manager, University of Nebraska State Museum, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, the six associated funerary objects are rim sherds. The human remains associated with these associated funerary objects were listed in a Notice of Inventory Completion published in the
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the associated funerary objects described in this notice.
The University of Nebraska State Museum has determined that:
• The six objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the associated funerary objects described in this notice and the Ponca Tribe of Nebraska.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the associated funerary objects in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nebraska State Museum has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Dawson County, NE.
Repatriation of the human remains in this notice may occur on or after May 20, 2024.
Taylor Ronquillo, NAGPRA Project Manager, University of Nebraska State Museum, 645 N 14th Street, Lincoln, NE 68588, telephone (402) 472-6592, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Nebraska State Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at least, one individual have been reasonably identified. This individual was donated to UNSM by N.D. Hungerford in 1875. Written on the cranium of the individual are the words “Farnam, NE”. Based on the lack of records UNSM considered this writing to document the excavation location as the Village of Farnam, Dawson County, Nebraska. A note was left on the skull that stated “Portion of Cheyenne Skull, Farnam, Hungerford 1875”. “Hungerford” may be the family surname of the collector.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
The University of Nebraska State Museum has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Northern Cheyenne Tribe of the Northern Cheyenne Indian Reservation, Montana.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after May 20, 2024. If competing requests for repatriation are received, the University of Nebraska State Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The University of Nebraska State Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
Employee Benefits Security Administration, Labor.
Notice of exemption.
This document contains a notice of exemption issued by the Department of Labor (the Department) from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This exemption extends for three years the exemptive relief provided by PTE 2021-01, which allows certain qualified professional asset managers within the corporate family of Deutsche Bank AG (Deutsche Bank), including DWS Investment Management Americas Inc. (DIMA or the Applicant), and certain current and future affiliates of Deutsche Bank (each a DB QPAM), to continue to rely on the exemptive relief provided by Prohibited Transaction Exemption (PTE) 84-14 (PTE 84-14 or the QPAM Exemption), notwithstanding the 2017 judgment of conviction against DB Group Services (UK) Limited (DB Group Services), as described below.
The exemption will be in effect for a period of three years, beginning on April 18, 2024, and ending on April 17, 2027.
Mr. Frank Gonzalez and Ms. Blessed Chuksorji-Keefe of the Department at (202) 693-8553 and (202) 693-8567, respectively. (These are not toll-free numbers.).
The Applicant requested an individual exemption pursuant to ERISA section 408(a) in accordance with the Department's exemption procedures set forth in 29 CFR part 2570, subpart B.
Furthermore, the Department cautions that this individual exemption only provides exemptive relief from Section I(g) of PTE 84-14 for the DB QPAMs with respect to the U.S. Conviction. This exemption does not affect the requirement for the DB QPAMs to adhere to all conditions of PTE 84-14 as amended on April 3, 2024, effective June 17, 2024.
Based on the Applicant's adherence to all the conditions of PTE 2021-01
1. Deutsche Bank is a publicly held global banking and financial services company headquartered in Frankfurt, Germany.
2. Deutsche Bank has several affiliated asset managers, including: DIMA, a Delaware corporation; RREEF America L.L.C. (RREEF), a Delaware limited liability company; DWS Alternatives Global Limited (Global), an entity based in London, United Kingdom; and DWS Investments Australia Limited (DIAL), an entity based in Sydney, Australia.
3. The DB QPAMs are part of the DWS Group (formerly Deutsche Asset Management), a separate, publicly listed financial services firm that is majority-owned by Deutsche Bank. According to DIMA, the DWS Group is in a separate corporate ownership line than DB Group Services, the convicted entity,
4. The DB QPAMs provide discretionary asset management services in reliance on PTE 84-14 to Covered Plans under two DWS business lines: (1) Alternatives (including the Liquid Real Assets, Direct Real Estate and Private Equity businesses) and (2) Active Institutional. Collectively, DB QPAMs provide discretionary asset management services to ERISA-covered plans, governmental plans and IRAs as follows:
a.
b.
c.
5. The rules set forth in ERISA Section 406 and Code Section 4975(c)(1) proscribe certain “prohibited transactions” between plans and certain parties in interest with respect to those plans.
6. Under the authority of ERISA Section 408(a), the Department has the authority to grant an exemption from such “prohibited transactions” in accordance with the procedures set forth in the exemption procedure regulation
7. PTE 84-14 exempts certain prohibited transactions between a party in interest and an “investment fund” (as defined in Section VI(b) of PTE 84-14) in which a plan has an interest if the investment manager satisfies the definition of “qualified professional asset manager” (QPAM) and additional conditions of the exemption. PTE 84-14 was developed and granted based on the essential premise that broad relief could be afforded for all types of transactions in which a plan engages only if the commitments and the investments of plan assets and the negotiations leading thereto are the sole responsibility of an independent, discretionary manager.
8. Section I(g) of PTE 84-14 prevents an entity that may otherwise meet the definition of QPAM from utilizing the exemptive relief provided by the QPAM Exemption for itself and its client plans if that entity, an “affiliate” thereof,
9. On April 23, 2015, the Fraud Section of the Criminal Division and the Antitrust Division of the United States Department of Justice filed a one-count criminal information in the U.S. District Court for the District of Connecticut (the District Court) charging DB Group Services, a Deutsche Bank indirect wholly-owned subsidiary based in London, United Kingdom, with one count of wire fraud in violation of Title 18, United States Code, Section 1343 for its role in manipulating the United States Dollar based LIBOR. Pursuant to a plea agreement (the Plea Agreement), DB Group Services entered a guilty plea in the District Court relating to the conduct described therein (including the conduct described in any of the exhibits thereto), and on April 18, 2017, the District Court entered a judgment against DB Group Services that required remedies that are materially the same as those set forth in the Plea Agreement. The Conviction, effective on April 18, 2017, would have triggered DIMA's disqualification under Section I(g) of PTE 84-14 without the exemption described in more detail below.
10. On January 8, 2021, Deutsche Bank entered into a deferred prosecution agreement (DPA) with the U.S. Department of Justice in which Deutsche Bank agreed to pay more than $87 million to resolve criminal charges for violations of the Foreign Corrupt Practices Act (FCPA) and a commodities fraud scheme. Although the DPA did not result in ineligibility under Section I(g) of PTE 84-14 at that time, the Department believes it is important that Deutsche Bank's Covered Plan clients are aware of the DPA and Deutsche Bank's admissions of culpability. The DPA's resolution included criminal penalties of $85,186,206, criminal disgorgement of $681,480, victim compensation payments of $1,223,738. In addition to the $87,091,424 paid to the U.S. Department of Justice, Deutsche Bank also paid $43,329,622 to settle related charges brought by the U.S. Securities & Exchange Commission.
11. In the DPA, Deutsche Bank admitted, accepted, and acknowledged that, among other things, it was responsible under United States law for the acts of its officers, directors, employees, and agents, as charged. The charges stem from a scheme to conceal corrupt payments and bribes made to third-party intermediaries by making false entries on Deutsche Bank's books and records and related internal accounting control violations, and a separate scheme to engage in fraudulent and manipulative commodities trading practices involving publicly traded precious metals futures contracts. The FCPA misconduct occurred between 2009 and 2016, and the Commodities fraud misconduct occurred between 2009 and 2013.
12. On October 11, 2011, DIMA requested an administrative exemption from the Department (the First Request) to allow certain DB QPAMs to continue utilizing the relief set forth in PTE 84-14 notwithstanding the then impending criminal conviction of a Deutsche Bank affiliate in South Korea (DSK), under Korean law for spot/futures-linked market price manipulation (the Korean Conviction). Specifically, on January 25, 2016, the Seoul Central District Court (the Korean Court) convicted DSK of violations of certain provisions of Articles 176, 443, and 448 of the Korean Financial Investment Services and Capital Markets Act (FSCMA) for spot/futures linked market manipulation in connection with the unwinding of an arbitrage position that in turn caused a decline in the Korean market. Upon the entering of the Korean Conviction, the Korean Court sentenced DSK to pay a criminal fine of 1.5 billion South Korean Won (KRW). Furthermore, the Korean Court ordered Deutsche Bank AG to forfeit KRW 43,695,371,124, and DSK to forfeit KRW 1,183,362,400.
13. In response to DIMA's First and Second Requests, the Department granted several temporary short-term exemptions to provide sufficient time for the Department to (a) analyze the facts underlying each of the criminal convictions to determine whether Covered Plans would be harmed; and (b) determine whether long-term relief was appropriate. In this regard, the Department proposed and granted PTEs 2015-15,
14. On December 12, 2018, Korea's Seoul High Court for the 7th Criminal Division (the Seoul High Court) reversed the Korean Court's decision and declared the defendants not guilty, obviating the need for exemptive relief related to the Korean Conviction.
15. The three-year effective periods provided by PTE 2017-04 and PTE 2021-01 were justified by the magnitude, gravity, duration, and pervasiveness of the misconduct relating to the criminal prosecutions by U.S. and foreign authorities. Importantly, the shorter terms of exemptive relief enabled the Department to review the DB QPAMs' compliance efforts periodically to ascertain whether any adjustments to the exemption's conditions were necessary for the Department to make a finding that continuation of exemptive relief to the DB QPAMs remained in the interest of, and protective of the rights of, Covered Plans.
16. The Department included a set of conditions in PTE 2021-01 that are designed to protect Covered Plans that entrust their assets for investment by the DB QPAMs despite the serious nature of the criminal misconduct underlying the U.S. Conviction. DIMA states that DB QPAMs have demonstrated a clean compliance record that the DB QPAM's independent auditor, Fiduciary Counselors Inc. (the Independent Auditor), confirmed after it examined the DB QPAMs compliance programs and culture through the course of six audits. According to DIMA, the DB QPAMs have demonstrated a strong culture of compliance through:
a. Continued compliance with applicable ERISA regulatory requirements, as reflected by the consistent results of six audits performed by the Independent Auditor over more than six years;
b. Continued compliance with other applicable regulatory requirements;
c. A thorough training module dedicated to ERISA, reviewed, and approved by the Independent Auditor, mandatory for all in-scope employees, at the outset of their employment and then on a periodic basis;
d. Centralized, focused, and comprehensive ERISA policies and procedures relating to ERISA and the Code, generally, as well as the specific
e. Effective internal compliance processes, including testing and monitoring of DB QPAMs, with continuous improvement; and
f. Not being subject to any regulatory or judicial findings that a DB QPAM failed to meet the requirements of ERISA during the entire six-year period.
17.
18. In its application for exemptive relief, and as further described in the notice of proposed exemption, DIMA represented that while exemptions other than PTE 84-14 may apply with respect to certain transactions, PTE 84-14 is particularly important for securities and other instruments that may be traded on behalf of Covered Plans, now or in the future, on a principal basis, such as real estate investments (including purchases and sales, leases and financings), corporate debt, municipal debt, other US fixed income securities, Rule 144A securities, non-US fixed income securities, non-US equity securities, US and non-US over-the-counter instruments (
19. DIMA represented that because counterparties are familiar and comfortable with PTE 84-14 for a broad variety of transactions, PTE 84-14 is generally the most commonly used prohibited transaction exemption that counterparties generally rely on as the backup exemption for all transactions. According to DIMA, counterparties may provide less advantageous pricing or may not bid at all where the Covered Plan's investment manager is not a QPAM.
20. DIMA represented that plan fiduciaries expend significant resources, including time and money, in selecting asset managers for their plans. DIMA stated that forcing Covered Plan clients to terminate their chosen managers because the managers no longer have access to the broad coverage and efficiencies of PTE 84-14 will cause such plans to incur a number of additional costs. Additionally, according to DIMA, Covered Plan clients will incur direct transaction costs from liquidating and reinvesting their portfolios, which costs and harms are discussed below.
21. According to DIMA, the costs and harms to Covered Plans resulting from the DB QPAMs' inability to rely on PTE 84-14 can best be described by discussing the following services for which the DB QPAMs rely on PTE 84-14. DIMA provided the following statements in support of its application:
a.
i. Approximately six to eight months and thousands of dollars to find, evaluate, choose, and engage a new manager;
ii. Consulting fees to search for a new private manager of approximately $30,000 to $40,000;
iii. Approximately 25-50 hours of additional client time to evaluate alternative new managers;
iv. Legal fees to review/negotiate new management agreement and guidelines of approximately $10,000 to $30,000;
v. Transaction costs for direct real estate of between 30-100 bps in direct transaction costs for early liquidation (
vi. Early liquidation discounts for direct real estate of between 10-20% (
vii. Transaction costs for non-direct real estate in other portfolios of between 20-60 bps in direct transaction costs for liquidation (
b.
22. According to DIMA, given the institutional nature of the underlying accounts, these strategies may involve a wide range of asset classes and types, including: (1) US and foreign fixed income (Treasuries, Agencies, corporate bonds, asset-backed securities, mortgage and commercial mortgage-backed securities, deposits); (2) US and foreign mutual funds and ETFs; (3) US and foreign futures, (4) currency; (5) swaps (interest rate and credit default); (6) US and foreign equities; and (7) short term investment funds.
23. According to the Applicant, terminating a plan's chosen manager under any strategy involves various costs, including loss of the investor's preferred manager, transaction costs, search costs and legal costs, with the particular cost turning on the strategy and the assets in which it invests. Estimated costs for the Active Institutional strategy are as follows:
a. Consulting Fees of between $30,000 to $40,000 for a new manager search;
b. Approximately 25-50 hours of additional client time to evaluate new managers, assuming the task is handled by an institutional board of trustees, plan committee or similar group of individuals;
c. Legal Fees of approximately $10,000 to $30,000 to review/negotiate new management agreement and
d. Transaction Costs of approximately 8.0 bps for liquidations (
e. Legal Costs to negotiate each new futures, cleared derivatives, swaps, or other trading agreement of between approximately $15,000 and $30,000.
24. The Department notes that this exemption includes protective conditions that allow Covered Plans to continue to utilize the services of DB QPAMs if the Covered Plans determine that it is prudent to do so. In this regard, this exemption allows Covered Plans to avoid cost and disruption to investment strategies that may arise if such Covered Plans are forced, on short notice, to hire a different QPAM or asset manager because DB QPAMs are no longer able to rely on the relief provided by PTE 84-14 due to the U.S. Conviction.
25. In the notice of proposed exemption, the Department invited all interested persons to submit written comments and/or requests for a public hearing with respect to such notice, which were due by February 8, 2024. Additionally, the Department requested comments from Covered Plans, the DB QPAMs, and the public as to the specific costs or harms, if any, that would flow from denial of the exemption, and data from the Applicant that identifies and quantifies in dollar amounts any valuable investment opportunities that plans would have to forego, and the basis for concluding that those investments would no longer be available to Covered Plans on advantageous terms from the DB QPAMs or other financial service providers. The Department specifically requested comments from Covered Plans, the DB QPAMs, and the public as to the specific “opportunity cost” of having assets “invested in cash pending reinvestment with a new manager.” In this regard, the Department requested information validating that there is no way to avoid investing assets in cash during the transition to a new manager and information quantifying the costs of having assets uninvested during such a transition using objective assumptions. Lastly, the Department requested comments whether the Applicant should be required to provide information regarding adverse regulatory actions (
26. The Department received three written comments: one from an anonymous submitter; one from an individual financial consultant (Consultant); and one from the Applicant. The Department did not receive a request for a public hearing pertaining to the notice of proposed exemption. The comments are as follows:
The exemption is also subject to the DB QPAMs' adherence to Section III(j), which requires the QPAMs to indemnify and hold harmless their Covered Plan clients for any actual losses resulting directly from a DB QPAM's violation of ERISA's fiduciary duties, the prohibited transaction provisions of ERISA and the Code, and a breach of contract; or any claim arising out of the failure of such DB QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of a violation of Section I(g) of PTE 84-14 other than the Conviction. The Department included the protections of Section III(j) in order to ensure that Covered Plans were adequately protected in the event the DB QPAMs violated applicable laws or their contractual obligations to their clients. Section III(j) also makes it easier for Covered Plan clients to change managers if Covered Plan fiduciaries determine it is prudent to do so, given Deutsche Bank's long history of corporate malfeasance.
Finally, the exemption requires additional reporting and notice obligations designed to create a culture of compliance and transparency. Section III(m) requires Deutsche Bank to designate a compliance officer responsible for ensuring compliance with the policies and procedures and training requirements of the exemption, and for performing an annual review to determine the effectiveness of the policies and procedures and training. The compliance officer is required to produce an annual report setting forth, among other things, instances of noncompliance and the correcting action taken to address them. The exemption also requires the DB QPAMs to provide notice of the exemption and the conduct leading to disqualification under Section I(g) to all Covered Plans, and to maintain the records required in order to prove the QPAMs' compliance with the conditions for relief. The independent auditor's reports, the compliance officer's annual reports, and
The NERA Report lists various adverse impacts of the costs and harms associated with the denial of the exemption, with estimates ranging as high as 20.68 percent for certain investments. The NERA Report concludes that it could not identify any benefits to Covered Plans from the denial of the exemption that would outweigh the costs associated with such denial. The Davanzo Statement provides a list of the direct and indirect costs that may be incurred when an investment manager's portfolio is transitioned to another replacement manager, and the less liquid the asset class involved in the termination, the higher the costs, which will directly impact Covered Plans' participants. The Davanzo Statement distinguishes between a criminal conviction of the asset manager and that of its affiliated entity, noting that the majority of asset management subsidiaries of financial institutions operate with significant autonomy from the parent company, and such asset management subsidiaries, which frequently have separate risk and control functions, are structured among other things to demonstrate their independence from their parent companies. Lastly, the Davanzo Statement concludes that Covered Plans (and their beneficiaries) would incur significant costs associated with the investment manager's termination despite that it was an affiliate's illegal actions and not the manager's conduct that caused the denial of the QPAM Exemption.
In its comment, the Applicant states that the exemption application's mention of the opportunity costs of investing in cash pending reinvestment with a new manager was merely intended to differentiate such costs from costs such as consulting fees, legal fees, liquidation costs, and similar transaction costs. The NERA Report expounds on opportunity costs generally, explaining that opportunity costs due to a change in investment managers refer to the loss of value that could have been gained during the transition between managers, such as potential return lost due to not being fully invested in desired asset classes, which the NERA Report estimates to be up to 3.75 percent.
The Applicant states that the granting of the exemption should not depend upon regulatory actions, other than the conviction that necessitated the request for relief. According to the Applicant, doing so is an unwarranted expansion of the QPAM Exemption as currently existing, as well as inconsistent with the Department's stated objectives in creating the QPAM Exemption. The Applicant states that the named fiduciaries for Covered Plans are responsible for selecting an investment manager after a careful and rigorous diligence process, and that material regulatory investigations and settlements are disclosed to shareholders in Deutsche Bank's Annual Reports as appropriate. DIMA states that plans' fiduciaries and their consultants receive, and have access to, information from multiple sources: they are provided with presentations and ask questions during the due diligence phase and during regular update meetings, they receive Form ADV and Form BD, they have access to Deutsche Bank's Form 20-F and Annual Reports, and they have access to news reports.
In addition, the Applicant disagrees that regulatory actions such as civil settlements should prevent applicants from obtaining individual QPAM exemptions. Although the Applicant notes that that the disclosure of such regulatory actions is now required by the Department in its amended procedural regulation, such disclosure is not applicable to DIMA with respect to this particular application because the application for this exemption was filed with the Department prior to April 8, 2024.
The Department's position is that the mere existence of such a regulatory action, the target of which is a DB QPAM or an affiliate of the DB QPAM, will not necessarily preclude a finding by the Department that exemptive relief from Section I(g) meets the statutory standard under ERISA Section 408(a). The Department notes that, pursuant to its exemption procedure regulation, during the pendency of an application for exemption with the Department, an applicant must promptly notify the Department if they discover that any fact or representation changes during this period, anything occurs that may affect the continuing accuracy of any such fact or representation, or if a material fact or representation has been omitted from the exemption application.
Section III(b) of the notice of proposed exemption provides in pertinent part that [italics added]:
Apart from a non-fiduciary line of business within Deutsche Bank, the DB QPAMs (including their officers, directors, agents other than DB Group Services, and employees of such QPAMs) did not receive direct compensation, or knowingly receive indirect compensation, in connection with the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA . . .
The Applicant states that none of the Prior Exemptions contained the italicized language relating to a single individual and a non-fiduciary business within Deutsche Bank, and that the language to added to Sections III(a) and (b) of the proposed exemption is in error. Furthermore, the Applicant states that the italicized language is not supported by the facts of the U.S. Conviction or the DPA and should be deleted.
Applicant's Comment Regarding Revision to Section III(a). Section III(a) of the notice of proposed exemption provides in pertinent part that:
. . . [T]he DB QPAMs (including their officers, directors, agents other than DB Group Services, and employees of such QPAMs) did not know or have reason to know of, and did not participate in the criminal conduct of DB Group Services that is the subject of the U.S. Conviction
The Applicant states that the condition suggests that “the subject of . . . the 2021 DPA” was criminal conduct of DB Group Services even though the DPA was entered into between the Department of Justice and Deutsche Bank.
Other than with respect to employee benefit plans maintained or sponsored for its own employees or the employees of an affiliate, DB Group Services will not act as a fiduciary within the meaning of ERISA Sections 3(21)(A)(i) or (iii) or Code Sections 4975(e)(3)(A) and (C) with respect to ERISA-covered plan and IRA assets; provided, however, that DB Group Services will not be treated as violating the conditions of this exemption solely because they acted as investment advice fiduciaries within the meaning of ERISA Section 3(21)(A)(ii) or Code Section 4975(e)(3)(B).
The Applicant requests that the language, “or because DB Group Services employees may be double-hatted, seconded, supervised or otherwise subject to the control of a DB QPAM, including in a discretionary fiduciary capacity with respect to the DB QPAM clients” be added to the end of Section III(g) of the proposed exemption, above. According to the Applicant, the quoted language appears at the end of Section III(g) in PTE 2021-01 and it should have been included in Section III(g) of the proposed exemption as well. The Applicant explains that like many foreign banks, Deutsche Bank uses foreign service companies, like DB Group Services, to hire and pay employees who then work for, and are supervised by, other entities in the Deutsche Bank controlled group. According to the Applicant, DB Group Services provides employees to the DB QPAMs, which are then responsible for the employees' training, supervision, compliance, etc., as if they were employed by such affiliates.
The Applicant submitted to the Department its definition for the term double-hatted, which the Applicant defines as “. . . the process of employing a person in one company, such as a service company, but actually having the person perform functions and duties for another affiliated company, which supervises such person's performance.” Further, the Applicant submitted to the Department its definition for the term seconded employees, which the Applicant defines as “a person who is seconded from one company to another is on the payroll of the first company but performs job duties and is supervised by the second company.”
Other than with respect to employee benefit plans maintained or sponsored for its own employees or the employees of an affiliate, DB Group Services will not act as a fiduciary within the meaning of ERISA Sections 3(21)(A)(i) or (iii) or Code Sections 4975(e)(3)(A) and (C) with respect to ERISA-covered plan and IRA assets; provided, however, that DB Group Services will not be treated as violating the conditions of this exemption solely because (1) they acted as investment advice fiduciaries within the meaning of ERISA Section 3(21)(A)(ii) or Code Section 4975(e)(3)(B); or (2) DB Group Services employees perform work on behalf
The Applicant requests the Department to replace the sixty calendar days requirement with a four-month period for the provision of such notices, as the Department provided in PTE 2017-04 and PTE 2021-01. The Applicant's request is based on its view that this exemption must be consistent with the soon to expire PTE 2021-01, and the “inevitable delivery difficulties that must be corrected . . . to ensure proper and complete delivery of notices.”
The Applicant requests that this condition be deleted or amended to delete the 30-day requirement, because: (1) The condition in Section III(u) has not been imposed upon any previous applicant; (2) the requirement poses significant logistical difficulties in practice; (3) whether a record is necessary to demonstrate fulfillment of the exemption is a subjective determination, requiring knowledgeable personnel to collect, review, and organize all potentially relevant documents; (4) the breadth of potential relevancy could render the document request extremely voluminous; (5) depending on the nature of the documents, there could be privacy, confidentiality, or similar concerns to consider and address before production; (6) and the necessary diversion of resources from normal operations for such un undertaking is not in the best interest of Covered Plans or their participants or beneficiaries. Furthermore, according to the Applicant, the proposed exemption already requires retention of records pertaining to exemption transactions, and as such the exemption's relief becomes unavailable if Section III(u) is not met.
“The DB QPAM(s) must provide the Department with the records necessary to demonstrate that each condition of this exemption has been met within 30 days of a request for the records by the Department except that the Department may extend the 30-day deadline, in its sole discretion, upon the submission of a written extension request by the DB QPAM(s) that specifically describes why additional time is necessary to submit the records.”
On January 8, 2021, Deutsche Bank entered into a deferred prosecution agreement (DPA) with the U.S. Department of Justice in which Deutsche Bank agreed to pay more than $130 million to resolve criminal charges for violations of the Foreign Corrupt Practices
The Applicant states that Deutsche Bank agreed to pay $87,091,424 to the U.S. Department of Justice in connection with the DPA rather than $130 million—the $130 million amount included the settlement with the U.S. Securities and Exchange Commission of $43 million, which did not involve a civil penalty.
The attention of interested persons is directed to the following:
(1) The fact that a transaction is the subject of an exemption under ERISA Section 408(a) and/or Code Section 4975(c)(2) does not relieve a fiduciary or other party in interest or disqualified person from certain other provisions of ERISA and/or the Code, including any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of ERISA Section 404, which, among other things, require a fiduciary to discharge their duties respecting the plan solely in the interest of the participants and beneficiaries of the plan and in a prudent fashion in accordance with ERISA Section 404(a)(1)(b); nor does it affect the requirement of Code Section 401(a) that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries;
(2) As required by ERISA section 408(a), the Department hereby finds that the exemption is: (a) Administratively feasible for the Department; (b) in the interests of Covered Plans and their participants and beneficiaries; and (c) protective of the rights of the Covered Plans' participants and beneficiaries.
(3) This exemption is supplemental to, and not in derogation of, any other ERISA provisions, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive for determining whether the transaction is in fact a prohibited transaction.
(4) The availability of this exemption is subject to the express condition that the material facts and representations contained in the application accurately describe all material terms of the transactions that are the subject of the exemption and are true at all times.
Accordingly, after considering the entire record developed in connection with the Applicant's exemption application, the Department has determined to grant the following exemption under the authority of ERISA section 408(a) in accordance with the Department's exemption procedures set forth in 29 CFR part 2570, subpart B.
(a) The term “Covered Plan” means a plan subject to ERISA Title I, Part 4 (an ERISA-covered plan) or a plan subject to Code Section 4975 (an IRA), in each case, with respect to which a DB QPAM relies on PTE 84-14, or with respect to which a DB QPAM (or any Deutsche Bank affiliate) has expressly represented that the manager qualifies as a QPAM or relies on PTE 84-14 (the QPAM Exemption). A Covered Plan does not include an ERISA-covered Plan or IRA to the extent the DB QPAM has expressly disclaimed reliance on QPAM status or PTE 84-14 in entering into its contract, arrangement, or agreement with the ERISA-covered plan or IRA. Notwithstanding the above, a DB QPAM may disclaim reliance on QPAM status or PTE 84-14 in a written modification of a contract, arrangement, or agreement with an ERISA-covered plan or IRA, where: the modification is made in a bilateral document signed by the client; the client's attention is specifically directed toward the disclaimer; and the client is advised in writing that, with respect to any transaction involving the client's assets, the DB QPAM will not represent that it is a QPAM and will not rely on the relief described in PTE 84-14.
(b) The term “DB QPAM” or “DB QPAMs” means DWS Investment Management Americas, Inc. and any current and future Deutsche Bank asset management affiliates that (i) qualify as a “qualified professional asset manager” (as defined in PTE 84-14, Section VI(a)), (ii) rely on the relief provided by PTE 84-14, and (iii) with respect to which Deutsche Bank is an “affiliate” (as defined in PTE 84-14, Section VI(d)(1)). The term “DB QPAM” excludes DB Group Services (UK) Limited.
(c) The term “Deutsche Bank” or “DB” means Deutsche Bank AG, a publicly held global banking and financial services company headquartered in Frankfurt, Germany.
(d) The term “Exemption Period” means the period of time beginning on April 18, 2024, and ending on April 17, 2027.
(e) The term “U.S. Conviction” means the judgment of conviction against DB Group Services (UK) Limited (DB Group Services), a Deutsche Bank “affiliate” (as defined in PTE 84-14, Section VI(d)), entered on April 18, 2017, by the United States District Court for the District of Connecticut, in case number 3:15-cr-00062-RNC, for one (1) count of wire fraud, in violation of 18 U.S.C. 1343. For all purposes under this exemption, “conduct” of any person or entity that is the “subject of the [U.S. Conviction]” encompasses the factual allegations described in Paragraph 13 of the Plea Agreement filed in the District Court in Case Number 3:15-cr-00062-RNC.
(f) The term “2021 DPA” means the Deferred Prosecution Agreement entered on January 8, 2021, between Deutsche Bank and the U.S. Department of Justice to resolve the U.S. government's investigation into violations of the Foreign Corrupt Practices Act and a separate investigation into a commodities fraud scheme.
(g) Wherever found, any reference in this exemption to “the best knowledge” of a party, “best of [a party's] knowledge,” and similar formulations of the “best knowledge” standard, will be deemed to mean the actual knowledge of the party and the knowledge which they would have had if they had conducted their reasonable due diligence required under the circumstances into the relevant subject matter. If a condition of the exemption requires an individual to provide certification pursuant to their “best knowledge,” then such individual, in order to make such certification, must perform their reasonable due diligence required under the circumstances to determine whether the information such individual is certifying is complete and accurate in all respects. Furthermore, with respect to an entity other than a natural person, the “best knowledge” of the entity includes matters that are known to the directors and officers of the entity or should be known to such individuals upon the exercise of such individuals' due diligence required under the circumstances.
The DB QPAMs will not be precluded from relying on the exemptive relief provided by Prohibited Transaction Exemption 84-14 (PTE 84-14)
(a) The DB QPAMs (including their officers, directors, agents other than DB Group Services, and employees of such QPAMs) did not know or have reason to know of, and did not participate in the criminal conduct of DB Group Services that is the subject of the U.S. Conviction or the criminal conduct of Deutsche Bank that is the subject of the 2021 DPA. Further, any other party engaged on behalf of the DB QPAMs who had responsibility for, or exercised authority in connection with the management of plan assets did not know or have reason to know of and did not participate in the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA. For purposes of this exemption, “participate in” or “participated in” refers not only to active participation in the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA, but also applies to knowing approval of the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA or knowledge of the conduct without taking active steps to prevent the conduct, including reporting the conduct to the individual's supervisors and the Board of Directors;
(b) The DB QPAMs (including their officers, directors, agents other than DB Group Services, and employees of such QPAMs) did not receive direct compensation, or knowingly receive indirect compensation, in connection with the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA. Further, any other party engaged on behalf of the DB QPAMs who had responsibility for, or exercised authority in connection with the management of plan assets did not receive direct compensation, or knowingly receive indirect compensation, in connection with the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA;
(c) The DB QPAMs do not currently and will not in the future employ or knowingly engage any of the individuals that participated in the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA;
(d) At all times during the Exemption Period, no DB QPAM will use its authority or influence to direct an “investment fund” (as defined in Section VI(b) of PTE 84-14) that is subject to ERISA or the Code and managed by a DB QPAM in reliance of PTE 84-14, or with respect to which to which a DB QPAM has expressly represented to a Covered Plan that it qualifies as a QPAM or relies on the QPAM Exemption, to enter into any transaction with DB Group Services, or to engage DB Group Services to provide any service to such Covered Plan, for a direct or indirect fee borne by such Covered Plan, regardless of whether such transaction or service may otherwise be within the scope of relief provided by an administrative or statutory exemption;
(e) Any failure of the DB QPAMs to satisfy PTE 84-14, Section I(g) arose solely from the U.S. Conviction;
(f) A DB QPAM did not exercise authority over the assets of any plan subject to Part 4 of Title I of ERISA (an ERISA-covered plan) or section 4975 of the Code (an IRA) in a manner that it knew or should have known would: Further the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA; or cause the DB QPAM or its affiliates to directly or indirectly profit from the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA;
(g) Other than with respect to employee benefit plans maintained or sponsored for its own employees or the employees of an affiliate, DB Group Services will not act as a fiduciary within the meaning of ERISA Sections 3(21)(A)(i) or (iii) or Code Sections 4975(e)(3)(A) and (C) with respect to ERISA-covered plan and IRA assets; provided, however, that DB Group Services will not be treated as violating the conditions of this exemption solely because: (1) they acted as investment advice fiduciaries within the meaning of ERISA Section 3(21)(A)(ii) or Code Section 4975(e)(3)(B); or (2) DB Group Services' employees perform work on behalf of a DB QPAM that is solely responsible for the management and oversight of the DB Group Services' employee's day to day activities performed on behalf of such QPAM, including the employee's performance, training, and terms of employment (including compensation, promotions, and benefits), including any such employees acting in a discretionary fiduciary capacity with respect to the DB QPAM clients;
(h)(1) Each DB QPAM must continue to maintain, adjust (to the extent necessary), implement, and follow written policies and procedures (the Policies). The Policies must require and be reasonably designed to ensure that:
(i) The asset management decisions of the DB QPAM are conducted independently of the corporate management and business activities of DB Group Services;
(ii) The DB QPAM fully complies with ERISA's fiduciary duties and with ERISA's and the Code's prohibited transaction provisions, as applicable with respect to each Covered Plan and does not knowingly participate in any violation of these duties and provisions with respect to Covered Plans;
(iii) The DB QPAM does not knowingly participate in any other person's violation of ERISA or the Code with respect to Covered Plans;
(iv) Any filings or statements made by the DB QPAM to regulators, including, but not limited to, the Department, the Department of the Treasury, the Department of Justice, and the Pension Benefit Guaranty Corporation, on behalf of or in relation to Covered Plans are materially accurate and complete to the best of such QPAM's knowledge at the time;
(v) To the best of the DB QPAM's knowledge at the time, the DB QPAM does not make material misrepresentations or omit material information in its communications with such regulators with respect to Covered Plans or make material misrepresentations or omit material information in its communications with Covered Plans;
(vi) The DB QPAM complies with the terms of the exemption;
(vii) Any violation of or failure to comply with a requirement in subparagraphs (h)(1)(ii) through (h)(1)(vi) is corrected as soon as reasonably possible upon discovery or as soon after the QPAM reasonably should have known of the noncompliance (whichever is earlier) and any such violation or compliance failure not so corrected is reported upon the discovery of such failure to so correct, in writing, to the head of compliance and the DB QPAM's general counsel (or their functional equivalent) of the relevant DB QPAM that engaged in the violation or failure, and the independent auditor responsible for reviewing compliance with the Policies. A DB QPAM will not be treated as
(2) Each DB QPAM must maintain, adjust (to the extent necessary) and implement a training program (the Training) that is conducted at least annually for all relevant DB QPAM asset/portfolio management, trading, legal, compliance, and internal audit personnel. The Training must:
(i) At a minimum, cover the Policies, ERISA and Code compliance (including applicable fiduciary duties and the prohibited transaction provisions), ethical conduct, the consequences for not complying with the conditions of this exemption (including any loss of exemptive relief provided herein), and prompt reporting of wrongdoing;
(ii) Be conducted in-person, electronically or via a website by a professional who has been prudently selected and who has appropriate technical training and proficiency with ERISA and the Code to perform the tasks required by this exemption; and
(iii) Be verified, through in-training knowledge checks, “graduation” tests, and/or other technological tools designed to confirm that personnel fully and in good faith participate in the Training;
(i)(1) Each DB QPAM must submit to an audit conducted annually by an independent auditor who has been prudently selected and who has appropriate technical training and proficiency with ERISA and the Code to evaluate the adequacy of each DB QPAM's compliance with the Policies and Training conditions described herein. The audit requirement must be incorporated in the Policies, and the first audit must cover the period that begins on the first day this exemption is effective, if granted. Each audit must be completed no later than six (6) months after the corresponding audit's ending period;
(2) Within the scope of the audit and to the extent necessary for the auditor, in its sole opinion, to complete its audit and comply with the conditions described herein, and only to the extent such disclosure is not prevented by state or federal statute, or involves communications subject to attorney client privilege, each DB QPAM and, if applicable, Deutsche Bank, will grant the auditor unconditional access to its business, including, but not limited to: its computer systems; business records; transactional data; workplace locations; training materials; and personnel. Such access is limited to information relevant to the auditor's objectives, as specified by the terms of this exemption;
(3) The auditor's engagement must specifically require the auditor to determine whether each DB QPAM has developed, implemented, maintained, and followed the Policies in accordance with the conditions of this exemption and has developed and implemented the Training, as required herein;
(4) The auditor's engagement must specifically require the auditor to test each DB QPAM's operational compliance with the Policies and Training. In this regard, the auditor must test a sample of each QPAM's transactions involving Covered Plans that is sufficient in size and nature to afford the auditor a reasonable basis to determine such QPAM's operational compliance with the Policies and Training;
(5) For each audit, the auditor must issue a written report (the Audit Report) to Deutsche Bank, and the DB QPAM to which the audit applies that describes the procedures performed by the auditor in connection with its examination on or before the end of the relevant period described in Section III(i)(1) for completing the audit. The auditor, at its discretion, may issue a single consolidated Audit Report that covers all of the DB QPAMs. The Audit Report must include the auditor's specific determinations regarding:
(i) The adequacy of each DB QPAM's Policies and Training; each DB QPAM's compliance with the Policies and Training; the need, if any, to strengthen such Policies and Training; and any instance of the respective DB QPAM's noncompliance with the written Policies and Training described in Section III(h) above. The DB QPAM must promptly address any noncompliance and promptly address or prepare a written plan of action to address any determination by the auditor regarding the adequacy of the Policies and Training and the auditor's recommendations (if any) with respect to strengthening the Policies and Training of the respective QPAM. Any action taken or the plan of action to be taken by the respective DB QPAM must be included in an addendum to the Audit Report (and such addendum must be completed before the certification described in Section III(i)(7) below). In the event such a plan of action to address the auditor's recommendation regarding the adequacy of the Policies and Training is not completed by the time the Audit Report is submitted, the following period's Audit Report must state whether the plan was satisfactorily completed. Any determination by the auditor that the respective DB QPAM has implemented, maintained, and followed sufficient Policies and Training must not be based solely or in substantial part on an absence of evidence indicating noncompliance. In this last regard, any finding that a DB QPAM has complied with the requirements under this subparagraph must be based on evidence that the particular DB QPAM has actually implemented, maintained, and followed the Policies and Training required by this exemption. Furthermore, the auditor must not rely solely on the Annual Report created by the compliance officer (the Compliance Officer) as described in Section III(m) below, as the basis for the auditor's conclusions in lieu of independent determinations and testing performed by the auditor as required by Section III(i)(3) and (4) above; and
(ii) The adequacy of the most recent Annual Review described in Section III(m);
(6) The auditor must notify the respective DB QPAM of any instance of noncompliance identified by the auditor within five (5) business days after such noncompliance is identified by the auditor, regardless of whether the audit has been completed as of that date;
(7) With respect to each Audit Report, the DB QPAM's general counsel, or one of the three most senior executive officers of the line of business engaged in discretionary asset management services through the DB QPAM with respect to which the Audit Report applies, must certify in writing, under penalty of perjury, that such signatory has reviewed the Audit Report and this exemption; and that, to the best of such signatory's knowledge at the time, such DB QPAM has addressed, corrected, or remedied any noncompliance and inadequacy or has an appropriate written plan to address any inadequacy regarding the Policies and Training identified in the Audit Report. Such certification must also include the signatory's determination that, to the best of such signatory's knowledge at the time, the Policies and Training in effect at the time of signing are adequate to ensure compliance with the conditions of this proposed exemption, and with the applicable provisions of ERISA and the Code. Notwithstanding the above, no person who knew of, should have known of, or participated in the criminal conduct that is the subject of the U.S. Conviction or the 2021 DPA may provide the certification
(8) The Audit Committee of Deutsche Bank's Supervisory Board is provided a copy of each Audit Report, and a senior executive officer with a direct reporting line to the highest-ranking compliance officer of Deutsche Bank must review the Audit Report for each DB QPAM and certify in writing and under penalty of perjury that such officer has reviewed each Audit Report. Deutsche Bank must provide notice to the Department if there is a switch in the committee to which the Audit Report will be provided. With respect to this subsection (8), such certifying executive officer must not have known of, had reason to know of, or participated in, the criminal conduct that is the subject of the U.S. Conviction (or the 2021 DPA), unless such person took active documented steps to stop the misconduct underlying the U.S. Conviction (or the 2021 DPA);
(9) Each DB QPAM provides its certified Audit Report by electronic mail to:
(10) Each DB QPAM and the auditor must submit the following document(s) to OED via electronic mail to
(11) The auditor must provide the Department, upon request, for inspection and review, access to all the workpapers created and utilized in the course of the audit, provided such access and inspection is otherwise permitted by law; and
(12) Deutsche Bank must notify the Department of a change in the independent auditor no later than two (2) months after the engagement of a substitute or subsequent auditor and must provide an explanation for the substitution or change including a description of any material disputes between the terminated auditor, and Deutsche Bank or any of its affiliates;
(j) Throughout the Exemption Period, with respect to any arrangement, agreement, or contract between a DB QPAM and a Covered Plan, the DB QPAM agrees and warrants:
(1) To comply with ERISA and the Code, as applicable with respect to such Covered Plan; to refrain from engaging in prohibited transactions that are not otherwise exempt (and to promptly correct any prohibited transactions in accordance with applicable rules under ERISA and the Code); and to comply with the standards of prudence and loyalty set forth in ERISA Section 404 with respect to each such Covered Plan to the extent that section is applicable;
(2) To indemnify and hold harmless the Covered Plan for any actual losses resulting directly from a DB QPAM's violation of ERISA's fiduciary duties, as applicable, and of the prohibited transaction provisions of ERISA and the Code, as applicable; a breach of contract by the QPAM; or any claim arising out of the failure of such DB QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of a violation of Section I(g) of PTE 84-14 other than the Conviction. This condition applies only to actual losses caused by the DB QPAM's violations. Actual losses include, but are not limited to, losses and related costs arising from unwinding transactions with third parties and from transitioning Plan assets to an alternative asset manager as well as costs associated with any exposure to excise taxes under Code section 4975 as a result of a QPAM's inability to rely upon the relief in the QPAM Exemption.
(3) Not to require or otherwise cause the Covered Plan to waive, limit, or qualify the liability of the DB QPAM for violating ERISA or the Code or engaging in prohibited transactions;
(4) Not to restrict the ability of such Covered Plan to terminate or withdraw from its arrangement with the DB QPAM with respect to any investment in a separately managed account or pooled fund subject to ERISA and managed by such QPAM, with the exception of reasonable restrictions, appropriately disclosed in advance, that are specifically designed to ensure equitable treatment of all investors in a pooled fund in the event such withdrawal or termination may have adverse consequences for all other investors. In connection with any of these arrangements involving investments in pooled funds subject to ERISA entered into after the effective date of this exemption, the adverse consequences must relate to a lack of liquidity of the underlying assets, valuation issues, or regulatory reasons that prevent the fund from promptly redeeming a Covered Plan's investment, and such restrictions must be applicable to all investors in the pooled fund on equal terms and effective no longer than reasonably necessary to avoid the adverse consequences;
(5) Not to impose any fees, penalties, or charges for such termination or withdrawal with the exception of reasonable fees, appropriately disclosed in advance, that are specifically designed to prevent generally recognized abusive investment practices or specifically designed to ensure equitable treatment of all investors in a pooled fund in the event such withdrawal or termination may have adverse consequences for all other investors, provided that such fees are applied consistently and in like manner to all such investors;
(6) Not to include exculpatory provisions disclaiming or otherwise limiting liability of the DB QPAM for a violation of such agreement's terms. To the extent consistent with ERISA Section 410, however, this provision does not prohibit disclaimers for liability caused by an error, misrepresentation, or misconduct of a plan fiduciary or other party hired by the plan fiduciary who is independent of Deutsche Bank and its affiliates, or damages arising from acts outside the control of the DB QPAM; and
(7) Within 60 calendar days after this exemption's effective date, each DB QPAM must provide a notice of its obligations under this Section III(j) to each Covered Plan. For Covered Plans that enter into a written asset or investment management agreement with a DB QPAM on or after 60 calendar days from this exemption's effective date, the DB QPAM must agree to its obligations under this Section III(j) in an updated investment management agreement between the DB QPAM and such clients or other written contractual agreement. This condition will be deemed met for each Covered Plan that received a notice pursuant to PTE 2017-04 or PTE 2021-01 that meets the terms of this condition. This condition will also be met where the DB QPAM has already agreed to the same obligations required by this Section III(j) in an updated investment management agreement between the DB QPAM and a Covered Plan. Notwithstanding the above, a DB QPAM will not violate the condition solely because a Covered Plan client refuses to sign an updated investment management agreement;
(k) Within 60 days after the effective date of this exemption, each DB QPAM provides notice of the exemption as published in the
(l) The DB QPAMs must comply with each condition of PTE 84-14, as amended, with the sole exception of the violation of PTE 84-14 Section I(g) that is attributable to the U.S. Conviction. If, during the Exemption Period, an affiliate of a DB QPAM (as defined in Section VI(d) of PTE 84-14) is convicted of a crime described in Section I(g) of PTE 84-14 (other than the U.S. Conviction), relief in this exemption would terminate immediately;
(m)(1) Deutsche Bank continues to designate a senior compliance officer (the Compliance Officer) who will be responsible for compliance with the Policies and Training requirements described herein. The Compliance Officer previously designated by the DB QPAM(s) under PTE 2021-01 may continue to serve in the role of Compliance Officer provided they meet all the requirements of this Section. Notwithstanding the above, no person who knew of, or should have known of, or participated in the criminal conduct that is subject of the U.S. Conviction (or the 2021 DPA), by any party, may be involved with the designation or responsibilities required by this condition, unless the person took active documented steps to stop the criminal conduct that is subject of the U.S. Conviction (or the 2021 DPA). The Compliance Officer must conduct an annual review for each twelve-month period, beginning on this exemption's effective date, (the Exemption Review) to determine the adequacy and effectiveness of the implementation of the Policies and Training. With respect to the Compliance Officer, the following conditions must be met:
(i) The Compliance Officer must be a professional who has extensive experience with, and knowledge of, the regulation of financial services and products, including under ERISA and the Code; and
(ii) The Compliance Officer must have a direct reporting line to the highest-ranking corporate officer in charge of compliance for asset management;
(2) With respect to each Annual Review, the following conditions must be met:
(i) The Annual Review includes a review of the DB QPAM's compliance with and effectiveness of the Policies and Training and of the following: any compliance matter related to the Policies or Training that was identified by, or reported to, the Compliance Officer or others within the compliance and risk control function (or its equivalent) during the previous year; the most recent Audit Report issued in connection with PTE 2017-04 or PTE 2021-01 or this exemption; (B) any material change in the relevant business activities of the DB QPAMs; and (C) any change to ERISA, the Code, or regulations related to fiduciary duties and the prohibited transaction provisions that may be applicable to the activities of the DB QPAMs;
(ii) The Compliance Officer prepares a written report for each Annual Review (each, an Annual Report) that: (A) summarizes their material activities during the preceding year; (B) sets forth any instance of noncompliance discovered during the preceding year, and any related corrective action; (C) details any change to the Policies or Training to guard against any similar instance of noncompliance occurring again; and (D) makes recommendations, as necessary, for additional training, procedures, monitoring, or additional and/or changed processes or systems, and management's actions on such recommendations;
(iii) In each Annual Report, the Compliance Officer must certify in writing that to the best of their knowledge at the time: (A) the report is accurate; (B) the Policies and Training are working in a manner which is reasonably designed to ensure that the Policies and Training requirements described herein are met; (C) any known instance of noncompliance during the preceding year and any related correction taken to date have been identified in the Annual Report; and (D) the DB QPAMs have complied with the Policies and Training and/or corrected (or is correcting) any known instances of noncompliance in accordance with Section III(h) above;
(iv) Each Annual Report must be provided to: (A) the appropriate corporate officers of Deutsche Bank and each DB QPAM to which such report relates, and (B) the head of compliance and the DB QPAM's general counsel (or their functional equivalent) of the relevant DB QPAM; and must be made unconditionally available to the independent auditor described in Section III(i) above;
(v) Each Annual Review, including the Compliance Officer's written Annual Report, must be completed within three (3) months following the end of the period to which it relates;
(n) Each DB QPAM will maintain records necessary to demonstrate that the conditions of this exemption have been met, for six (6) years following the date of any transaction for which the DB QPAM relies upon the relief in the exemption;
(o) During the Exemption Period, Deutsche Bank: (1) immediately discloses to the Department any Deferred Prosecution Agreement (a DPA) or a Non-Prosecution Agreement (an NPA) with the U.S. Department of Justice, entered into by Deutsche Bank any of its affiliates in connection with conduct described in Section I(g) of PTE 84-14 and/or ERISA section 411; and (2) immediately provides the Department any information requested by the Department, as permitted by law, regarding the agreement and/or conduct and allegations that led to such agreement;
(p) Within 60 days after the effective date of this exemption, each DB QPAM, in its agreements with, or in other written disclosures provided to Covered Plans, clearly and prominently informs Covered Plan clients of the Covered Plan's right to obtain a copy of the Policies or a description (Summary Policies), which accurately summarizes key components of the QPAM's written Policies developed in connection with this exemption. If the Policies are
(q) A DB QPAM will not fail to meet the terms of this exemption, solely because a different DB QPAM fails to satisfy a condition for relief described in Sections III(c), (d), (h), (i), (j), (k), (l), (n) and (p) or if the independent auditor described in Section III(i) fails to comply with a provision of the exemption, other than the requirement described in Section III(i)(11), provided that such failure did not result from any actions or inactions of Deutsche Bank or its affiliates;
(r) Deutsche Bank imposes its internal procedures, controls, and protocols to reduce the likelihood of any recurrence of conduct that is the subject of the U.S. Conviction and the 2021 DPA;
(s) All the material facts and representations set forth in the Summary of Facts and Representations are true and accurate;
(t) With respect to an asset manager that becomes a DB QPAM after the effective date of the exemption by virtue of being acquired (in whole or in part) by DB or a subsidiary or affiliate of DB (a “newly-acquired DB QPAM”), the newly-acquired DB QPAM would not be precluded from relying on the exemptive relief provided by PTE 84-14 notwithstanding the U.S. Conviction as of the closing date for the acquisition; however, the operative terms of the exemption shall not apply to the newly-acquired DB QPAM until a date that is six (6) months after the closing date for the acquisition. To that end, the newly acquired DB QPAM will initially submit to an audit pursuant to Section III(i) of this exemption as of the first audit period that begins following the closing date for the acquisition. The period covered by the audit must begin on the date on which the DB QPAM was acquired; and
(u) The DB QPAM(s) must provide the Department with the records necessary to demonstrate that each condition of this exemption has been met within 30 days of a request for the records by the Department except that the Department may extend the 30-day deadline, in its sole discretion, upon the submission of a written extension request by the DB QPAM(s) that specifically describes why additional time is necessary to submit the records.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before May 20, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Michael Howell by telephone at 202-693-6782, or by email at
The Senior Community Service Employment Program (SCSEP), is a community service and work-based training program for older workers. The program provides subsidized, work-experience training for low-income persons 55 or older who are unemployed and have poor employment prospects. SCSEP national grants are awarded through a competitive process; State and territorial grants are awarded through a formula outlined in the OAA-2016 section 506 (b-c). The dual goals of the program are to promote useful community service employment activities and to move SCSEP participants into unsubsidized employment, so that they can achieve economic self-sufficiency.
The Department is required to collect the information in order to comply with the OAA statutory and regulatory requirements. The information is also necessary for grantee performance accountability and program management. For additional substantive information about this ICR, see the related notice published in the
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before May 20, 2024.
You may submit comments identified by Docket No. MSHA-2024-0006 by any of the following methods:
1.
2.
3.
4.
S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.
The petitioner states that:
(a) The mine extracts coal by room and pillar method of mining and utilizes three continuous miner sections producing coal five to six days a week.
(b) The mine has personnel underground 24 hours a day, 7 days per week.
(c) The mine is ventilated by one, Jeffrey model 8HUA117, 1,500 horsepower (hp) and 880 revolutions per minute (rpm), mine fan.
(d) The fan operates at approximately 9 inches of water gauge and moves approximately 695,000 cubic feet per minute.
(e) The mine liberates 635,000 cubic feet of methane every 24 hours as of September 8, 2023.
(f) Currently, the mine fan stops every 31 days to check the fan signal device.
(g) If fan outage last longer than 1, 3, or 48 hours, then the fan is required to run 1, 2, or 3 hours before a certified examiner can re-enter the mine to conduct the required examinations.
(h) It is unfavorable to stop the fan and disrupt the ventilation due to the mine liberating methane and personnel being underground 24 hours a day, 7 days a week, making it impossible to schedule a time when the fan stoppage signal can be checked without miners in the underground.
The petitioner proposes the following alternative method:
(a) The main fine fan shall be provided with a fan alarm signal system consisting of the following:
(1) A ridged plastic tubing protected by steel conduit extending from the fan ductwork to a Photohelic gauge and chart recorder to continuously monitor the fan operating pressure. An automatic fan signal is activated when the fan pressure falls below 50 percent of the normal operating pressure (which currently equals 4.5 inches of water gauge) as measured by the Photohelic gauge. This alarm shall be visible and audible in the dispatcher's office.
(2) A Pyott Boone Belt model #1048 TA monitors the fan. When the fan loses electrical power, the Belt Boss sends a signal to the dispatch office which sounds an alarm. This additional alarm provides a backup in the event the Photohelic gauge or its contacts fail to automatically signal.
(b) The automatic fan signal device shall be tested every seven days by manually operating a valve (Ham-Let valve) near the Photohelic gauge and fan pressure recording chart reducing the pressure on the water gauge to simulate a fan stoppage, causing the activation of the fan signal.
(c) The actuation of the fan alarm shall be verified by a responsible person at the location where the responsible person is always on duty when anyone is underground.
(d) Once this seven-day test of the alternative method has been successfully repeated for four consecutive weeks, the test frequency shall change to every 31 days.
(e) The automatic fan signal device and signal alarm shall be tested every six months by stopping the fan to ensure that the automatic signal device causes the alarm to activate when the fan shuts down.
(f) By the end of the shift on which the test of the automatic fan signal device is completed, person(s) performing the test shall record the test result of the test in a secure book. The record book shall be retained at a surface location at the mine for one year and shall be made available for inspection by an Authorized Representative of the Secretary.
(g) Within 60 days of the Proposed Decision and Order (PDO) granted by
The petitioner asserts that the alternate method proposed will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.
Office of Management and Budget, Executive Office of the President.
Notice of availability of the OMB Final Sequestration Report to the President and Congress for FY 2024.
OMB is issuing the
April 12, 2024.
The OMB Sequestration Reports to the President and Congress are available on-line on the OMB home page at:
Thomas Tobasko, 6202 New Executive Office Building, Washington, DC 20503, Email address:
Section 251(d)(2) of the Balanced Budget and Emergency Deficit Control Act of 1985 requires the Office of Management and Budget (OMB) to issue a Final Sequestration Report 15 days (excluding weekends and holidays) after the enactment of 2024 appropriations. This report meets that requirement and finds that, for fiscal year 2024, enacted appropriations are at or below the defense and non-defense caps after accounting for cap adjustments. As a result, a sequestration of discretionary budget authority is not required in 2024.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the National Aeronautics and Space Administration (NASA) announces a meeting of the NASA Advisory Council (NAC).
Wednesday, May 8, 2024, 9:30 a.m. to 5 p.m. eastern time; and Thursday, May 9, 2024, 9 a.m. to 12 p.m. eastern time.
NASA Headquarters 300 E St. SW, Washington, DC 20546, Virtual and WebEx.
Ms. Lisa M. Hackley, Administrative Officer, NASA Headquarters, Washington, DC 20546, 202-358-1947,
This meeting will only be available by Webex or telephonically for members of the public. If dialing in via toll number, you must use a touch-tone phone to participate in this meeting. Any interested person may join via Webex on Tuesday, May 8th at
The agenda for the meeting will include reports on the following NAC priority focus areas:
The agenda for the meeting will also include reports from the following NAC committees:
It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
2:00 p.m., Thursday, April 4, 2024.
1255 Union Street NE, Suite 500, Washington, DC 20002 or via Zoom.
Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public.
Regular Board of Directors meeting.
The General Counsel of the Corporation has certified that in her opinion, one or more of the exemptions set forth in the Government in the Sunshine Act,
Jenna Sylvester, Paralegal, (202) 568-2560;
Nuclear Regulatory Commission.
Acceptance for docketing; opportunity to request a hearing and to petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) is considering an application for the renewal of Facility Operating License No. NPF-62, which authorizes Constellation Energy Generation, LLC (CEG, the applicant) to operate Clinton Power Station, Unit 1 (CPS). The renewed license would authorize the applicant to operate CPS for an additional 20 years beyond the period specified in the current license. The current operating license for CPS expires on April 17, 2027.
A request for a hearing or petition for leave to intervene must be filed by June 17, 2024.
Please refer to Docket ID NRC-2024-0046 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
•
•
•
•
Chris Tyree, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3754; email:
The NRC has received an application from CEG, dated February 14, 2024 (ADAMS Package Accession No. ML24045A023), filed pursuant to section 103 of the Atomic Energy Act of 1954, as amended (the Act), and part 54 of title 10 of the
The NRC staff has determined that CEG submitted sufficient information in accordance with 10 CFR 54.19, 54.21, 54.22, 54.23, 51.45, and 51.53(c), to enable the staff to undertake a review of the application, and that the application is, therefore, acceptable for docketing. The current Docket No. 50-461 for Facility Operating License No. NPF-62 will be retained. The determination to accept the LRA for docketing does not constitute a determination that a renewed operating license should be issued and does not preclude the NRC staff from requesting additional information as the review proceeds.
Before issuance of the requested renewed license, the NRC will have made the findings required by the Act and the Commission's rules and regulations. In accordance with 10 CFR 54.29, the NRC may issue a renewed license on the basis of its review if it finds that actions have been identified and have been or will be taken with respect to: (1) managing the effects of aging during the period of extended operation on the functionality of structures and components that have been identified as requiring aging management review; and (2) time-limited aging analyses that have been identified as requiring review, such that there is reasonable assurance that the activities authorized by the renewed licenses will continue to be conducted in accordance with the current licensing basis and that any changes made to the plant's current licensing basis will comply with the Act and the Commission's regulations.
Additionally, in accordance with 10 CFR 51.95(c), the NRC will prepare an environmental impact statement as a supplement to the Commission's NUREG-1437, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants,” dated June 2013 (ADAMS Accession No. ML13106A241). In considering the LRA, the Commission must find that the applicable requirements of subpart A of 10 CFR part 51 have been satisfied, and that any matters raised under 10 CFR 2.335 have been addressed. Pursuant to 10 CFR 51.26, and as part of the environmental scoping process, the staff intends to hold public scoping meetings. Detailed information regarding the environmental scoping meetings will be the subject of a separate
Within 60 days after the date of publication of this notice, any person (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. If a petition is filed, the presiding officer will rule on the petition and, if appropriate, a notice of a hearing will be issued.
Petitions must be filed no later than 60 days from the date of publication of this notice in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this
A State, local governmental body, federally recognized Indian Tribe, or designated agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h) no later than 60 days from the date of publication of this notice. Alternatively, a State, local governmental body, federally recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
For information about filing a petition and about participation by a person not a party under 10 CFR 2.315, see ADAMS Accession No. ML20340A053 (
All documents filed in NRC adjudicatory proceedings including documents filed by an interested State, local governmental body, federally recognized Indian Tribe, or designated agency thereof that request to participate under 10 CFR 2.315(c), must be filed in accordance with 10 CFR 2.302. The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases, to mail copies on electronic storage media, unless an exemption permitting an alternative filing method, as further discussed, is granted. Detailed guidance on electronic submissions is located in the “Guidance for Electronic Submissions to the NRC” (ADAMS Accession No. ML13031A056) and on the NRC's public website at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public website at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at
Participants who believe that they have good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted in accordance with 10 CFR 2.302(b)-(d). Participants filing adjudicatory documents in this manner are responsible for serving their documents on all other participants. Participants granted an exemption under 10 CFR 2.302(g)(2) must still meet the electronic formatting requirement in 10 CFR 2.302(g)(1), unless the participant also seeks and is granted an exemption from 10 CFR 2.302(g)(1).
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket, which is publicly available at
Information about the license renewal process can be found under the Nuclear Reactors icon at
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
1.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 11, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 10, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 9, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 10, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 9, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 12, 2024, it filed with the Postal Regulatory Commission a
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form C (17 CFR 239.900) is used by issuers offering securities in reliance on the crowdfunding exemption in Section 4(a)(6) (15 U.S.C. 77d(a)(6)) of the Securities Act of 1933 (“Securities Act”) (15 U.S.C. 77a
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
The MSRB filed with the Commission a proposed rule change consisting of amendments to MSRB Rule G-47, on time of trade disclosure (the “proposed rule change”). The proposed rule change would codify certain existing interpretive guidance and retire certain other existing interpretive guidance, add new time of trade disclosure scenarios, and make technical clarifications.
If the Commission approves the proposed rule change, the MSRB will announce the effective date of the proposed rule change in a regulatory notice to be published on the MSRB website no later than 30 days following Commission approval. The effective date will be no later than nine months following Commission approval.
The text of the proposed rule change is available on the MSRB's website at
In its filing with the Commission, the MSRB included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The MSRB has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
MSRB Rule G-47 requires brokers, dealers, or municipal securities dealers (“dealers”) to disclose to customers, at or prior to the time of trade, all material information known or available publicly through established industry sources. More specifically, MSRB Rule G-47 requires dealers selling a municipal security to a customer, or purchasing a municipal security from a customer, to disclose to the customer, orally or in writing, at or prior to the time of trade, all material information known about the transaction, as well as information about the municipal security that is reasonably accessible to the market. This obligation exists for both unsolicited and recommended transactions as well as primary and secondary market transactions.
MSRB Rule G-47 Supplementary Material .03 contains examples of information that may be material in specific scenarios and therefore requires time of trade disclosures to a customer. The list of specific scenarios is non-exhaustive and other information not listed in MSRB Rule G-47 Supplementary Material .03 may be material to customers depending upon the specific scenario. In addition to the specific disclosure scenarios listed in MSRB Rule G-47 Supplementary Material .03, various items of MSRB interpretive guidance list other scenarios that could require a time of trade disclosure obligation to a dealer transacting with a customer.
In summary, the proposed rule change would amend MSRB Rule G-47 to:
• Clarify in section (a) of MSRB Rule G-47 that a dealer is not obligated to disclose material information in violation of insider trading rules or procedures;
• Amend and simplify the definition of material information in subsection (b)(ii) of MSRB Rule G-47 and make a conforming amendment to Supplementary Material .01(a);
• Codify into Supplementary Material .03 existing interpretive guidance pertaining to market discount and to zero coupon or stepped coupon securities;
• Add a clarifying example of factor bonds as bonds that prepay principal in Supplementary Material .03(i); and
• Add three new disclosure scenarios to Supplementary Material .03.
The proposed rule change would also retire interpretive guidance on conversion costs and secondary market insurance and consolidate existing inter-dealer time of trade disclosure guidance into a single piece of interpretive guidance.
The proposed rule change would redesignate the existing language of MSRB Rule G-47(a) as subsection (i) and add a new subsection (ii) to MSRB Rule G-47(a) clarifying that information that may be material to the transaction would not be required to be disclosed to the customer if, pursuant to the dealer's policies and procedures regarding insider trading and related securities laws, such information is intentionally withheld from the dealer's registered representatives who are engaged in sales to and purchases from customers. It would be beneficial to the market to clarify this point in the text of MSRB Rule G-47 given that it is not the MSRB's intent for dealers to violate securities regulations.
MSRB Rule G-47(b)(ii) defines the term “material information” and explains that information is considered
The proposed rule change would codify and retire November 2016 interpretive guidance on market discount (the “Market Discount Guidance”).
The proposed rule change would also codify and retain April 1982 interpretive guidance pertaining to municipal securities with zero coupons or stepped coupons (the “Zero or Stepped Coupon Guidance”).
The proposed rule change would retire two pieces of interpretive guidance that the MSRB believes have become outdated. The first interpretive guidance to be retired is interpretive guidance from August 1988 (the “Conversion Cost Guidance”) stating that transfer agents for some interchangeable securities charge fees for the conversion of registered certificates to bearer form, which can be substantial and, in some cases, prohibitively expensive.
The second piece of interpretive guidance to be retired is guidance from March 1984 on secondary market insurance (the “Secondary Market Insurance Guidance”).
MSRB Rule G-47 Supplementary Material .03(i) lists bonds that prepay principal as a specific scenario which may be material and require disclosure at or prior to the time of trade. More specifically, the scenario lists the fact that the security prepays principal and the amount of unpaid principal that will be delivered on the transaction as a scenario that may be material and require a time of trade disclosure. The proposed rule change would add factor bonds to Rule G-47 Supplementary Material .03(i) as an example of a bond that prepays principal. Factor bonds are bonds for which partial distributions are processed by a proportional return of principal to each bondholder. After the partial distribution, the factor must be applied to the face value to determine interest payments as well as the principal amount for each future transaction. Factor bonds, by their terms, are already subject to this scenario and therefore this addition does not add or remove any disclosure burdens but instead simply provides an example of a potential disclosure
The proposed rule change would add three new disclosure scenarios to MSRB Rule G-47 Supplementary Material .03's non-exhaustive list of specific scenarios that could be material and require a time of trade disclosure. Specifically, these three new scenarios are yield to worst, the unavailability of the official statement, and the fact that continuing disclosures are not available.
Exchange Act Rule 15c2-12
Under certain circumstances, dealers currently have obligations to inform new issue customers by trade settlement regarding the availability or unavailability of the official statement under MSRB Rule G-32(a)(i) or (a)(iii)(A). The MSRB believes that the fact that an official statement is not available could be material to a new issue investor in making an investment decision and therefore should be included in MSRB Rule G-47's list of scenarios that could trigger a time of trade disclosure. As a result, new clause (s) of MSRB Rule G-47 Supplementary Material .03 would accelerate the timing for this disclosure to a point in time where this information would be available to the customer while making such investment decision, rather than merely by settlement of the transaction and thus after such decision has been made.
Dealers generally would be able to rely, for purposes of proposed clause (s), on information posted on EMMA as of the time of trade of a new issue municipal security with regard to whether an official statement is unavailable or available only from the underwriter. In the case of a customer trade by a dealer (other than the underwriter of the municipal security) occurring prior to the posting on EMMA of the official statement or any statement about the official statement's availability,
Continuing disclosure documents and related information submitted by issuers and obligated persons to EMMA's continuing disclosure service are made available on the EMMA website.
Dealers generally would be able to rely on such information posted on EMMA by the underwriter regarding an issuer's or other obligated person's continuing disclosure undertaking for purposes of MSRB Rule G-47 Supplementary Material .03(t) unless the dealer has knowledge to the contrary.
The MSRB believes that the fact that continuing disclosures are not required to be made available to a customer on EMMA, which is where a customer would typically go to review such information prior to trading a municipal security, will generally be material and therefore should be included in time of trade disclosures provided to a customer. On occasion, an issuer or obligated person may undertake to provide continuing disclosures not contemplated by Exchange Act Rule 15c2-12
The proposed rule change would consolidate three pieces of existing interpretive guidance relating to inter-dealer time of trade disclosure into one standalone interpretive guidance in order to better streamline time of trade disclosure guidance.
The MSRB believes that the proposed rule change is consistent with Section 15B(b)(2) of the Exchange Act,
The MSRB believes the proposed rule change is consistent with Section 15B(b)(2)(C) of the Exchange Act
Furthermore, the MSRB believes that consolidating its rulebook by removing interpretive guidance that is outdated or has already been incorporated into the rulebook will facilitate transactions in municipal securities, as well as facilitate compliance with MSRB rules, by reducing the need for industry participants to cross reference multiple sources.
Section 15B(b)(2)(C) of the Exchange Act
In reaching this conclusion, the MSRB was guided by the MSRB's Policy on the Use of Economic Analysis in MSRB Rulemaking.
The proposed rule change is intended to benefit investors by requiring disclosure of additional information that is easily and readily accessible to dealers. The proposed rule change is also intended to benefit dealers by reducing their burden through clarification of the existing rule requirements and eliminating unnecessary compliance time and paperwork.
The proposed rule change would provide several benefits for dealers and investors. First, the MSRB believes that the proposed rule change would streamline the process for dealers and clarify the existing rule so that dealers would better understand what disclosures must be disclosed to an investor at the time of trade, and thus would eliminate unnecessary compliance time and paperwork and reduce the burden on regulated entities. These include a clarification that the time of trade disclosure obligation in MSRB Rule G-47 does not require dealers to disclose material information to their customers that is intentionally withheld, based on a dealer's policies and procedures regarding insider trading. Furthermore, consolidating certain interpretive guidance and retiring six pieces of interpretive guidance would streamline the rulebook by consolidating existing guidance into the text of the rulebook and facilitate compliance by reducing the number of sources a dealer must review when complying with MSRB Rule G-47. Finally, the MSRB believes the proposed disclosure codification with three newly specified supplementary material paragraphs (continuing disclosures by an issuer, unavailability of an official statement in a new issue and the yield to worst) would benefit investors by helping to ensure that such information, which is easily and readily accessible to dealers, is disclosed to investors.
The MSRB believes that dealers would incur some costs because of the proposed rule change. These costs include the one-time upfront costs related to revising related policies and procedures as well as ongoing costs such as compliance costs associated with maintaining and updating relevant disclosures. This would be especially true for the three new time of trade disclosure obligations to be codified in MSRB Rule G-47 where dealers have a new responsibility to disclose readily accessible information to customers.
The MSRB believes that dealers would not incur any, or only negligible, costs from proposed changes such as codifying existing interpretive guidance into MSRB Rule G-47, since dealers are presumably already in compliance with the existing interpretive guidance and relevant MSRB rules. The MSRB believes that dealers may also have additional costs associated with recordkeeping in relation to the disclosure requirements. Overall, the MSRB believes the aggregate upfront and ongoing costs relative to the baseline would be minor, and the expected aggregate benefits to investors and dealers accumulated over time should exceed the total costs.
The MSRB believes that the proposed rule change would neither impose a burden on competition nor hinder capital formation, as the proposed rule change would be applicable to all dealers and is not expected to erode protection for investors and issuers. The proposed rule change would improve the municipal securities market's operational efficiency and promote regulatory certainty by providing dealers with a clearer understanding of regulatory obligations that are incorporated into the rule text. Although the benefits to investors
The MSRB considered and assessed two reasonable regulatory alternatives but determined the proposed rule change is superior to these alternatives. One alternative the MSRB considered was for MSRB Rule G-47 to pivot to an entirely principles-based approach when determining what information is considered material and therefore must be disclosed to investors at or before the time of trade. An entirely principles-based approach would provide an overarching objective for dealers to consider when determining whether specific information should be provided at the time of trade but would not provide specific examples of situations where, depending on the facts and circumstances, information could be material. By comparison, dealers currently are provided with a list of fifteen specific scenarios contained in MSRB Rule G-47 Supplementary Material .03 that could be material, depending on the facts and circumstances, to assist them in their compliance efforts, and the proposed rule change would add three additional disclosure scenarios. The MSRB determined the alternative to adopt an entirely principles-based approach to be inferior to the proposed rule change, which would provide dealers with the latitude to make a judgement on what is material while also offering specific examples. This alternative would also defeat the original purpose of creating MSRB Rule G-47 in 2013 to consolidate the previously issued guidance into rule language without substantively changing the existing obligations.
Another alternative the MSRB considered was to restructure MSRB Rule G-47 to provide a detailed and prescriptive listing of required time of trade disclosures without the primary principles-based requirement set forth in MSRB Rule G-47(a). This alternative would eliminate any gray area that may currently exist because compliance personnel currently must weigh the general principle set forth in MSRB Rule G-47(a) with the Supplementary Material and any applicable interpretative guidance.
The MSRB sought comment on draft amendments to MSRB Rule G-47 in a request for comment that was published on February 16, 2023 (the “Request for Comment”).
In addition to items related to MSRB Rule G-47 on time of trade disclosure, the Request for Comment solicited comment on time of trade disclosure obligations with respect to 529 savings plans as well as on draft amendments to MSRB Rule D-15, defining the term sophisticated municipal market professional. Comments received in response to time of trade disclosure obligations with respect to 529 savings plans as well as those received in response to the draft amendments to MSRB Rule D-15 will be addressed through separate initiatives. The BDA Letter and SIFMA Letter were directly responsive to the proposed rule change and the two letters are summarized below by topic, with MSRB responses provided.
The Request for Comment solicited comments on draft rule text that would clarify that MSRB Rule G-47(a) does not require dealers to disclose to their customers material information that, pursuant to the dealer's policies and procedures regarding insider trading and related securities laws, is intentionally withheld from the dealer's registered representatives who are engaged in sales to and purchases from a customer.
SIFMA specifically states that it appreciates the MSRB clarifying that it is not the MSRB's intent to require dealers to violate dealer processes that have been established to facilitate compliance with another obligation in order to comply with MSRB Rule G-47.
The MSRB agrees with SIFMA that the intent of MSRB Rule G-47 is not to require dealers to violate their policies and procedures designed to address insider trading and related securities laws in order to comply with MSRB Rule G-47, and the proposed rule change will make this clear on its face.
The Request for Comment solicited comments on draft rule text that would codify existing interpretive guidance on market discount, zero coupon, and stepped coupon securities into MSRB Rule G-47 Supplementary Material .03 as features of a security that may be material in specific scenarios and therefore trigger a time of trade disclosure.
The BDA Letter states that BDA is generally not opposed to the proposed rule change as it relates to MSRB Rule G-47 as many of the proposed changes reflect codification or reorganization of existing guidance or practices and would not impose significant new burdens.
The time of trade disclosures relating to market discount, zero coupon or stepped coupon securities are currently contained within interpretive guidance. Therefore, dealers should be on notice as to the potential materiality of these security features. The MSRB believes that consolidating material time of trade disclosure scenarios into MSRB Rule G-47 would be a benefit to the market. Furthermore, while information on market discount, zero coupon or stepped coupon securities may be obvious to market professionals, it is less likely to be obvious to retail investors toward which MSRB Rule G-47 is primarily oriented. However, in connection with disclosure related to market discount, dealers would not be required pursuant to the provisions of the proposed rule change to provide customers with more detailed or personalized information, or to provide any information that could constitute tax advice.
The Request for Comment solicited comments on retiring existing interpretive guidance relating to conversion costs and secondary market insurance. The Request for Comment noted that the substance of the Conversion Cost Guidance relating to interchangeable securities is not a common occurrence in the marketplace anymore and therefore should be retired. The Request for Comment noted that this guidance is currently reflected in MSRB Rule G-47 Supplementary Material .03(e). The Request for Comment also noted that the Secondary Market Insurance Guidance states that the fact that a security has been insured or arrangements for insurance have been initiated will affect the market price of the security and is material and must be disclosed to a customer at or before execution of a transaction in the security. Additionally, the Secondary Market Insurance Guidance explained that a dealer should advise a customer if evidence of insurance or other credit enhancement features must be attached to the security for effective transference of the insurance or device. The Request for Comment noted that the MSRB believes that it is not common practice to require such evidence of insurance for effective transference.
SIFMA states that it agrees that evidence of insurance generally is not required to be attached to a security for effective transfer and that there are no aspects of the guidance that the MSRB proposes to retire that should be retained in any way.
The MSRB agrees with SIFMA and BDA that the guidance to be retired in the proposed rule change would not impose significant burdens and that the guidance no longer retains utility due to its current codification within MSRB Rule G-47 or the fact that it has become outdated.
The Request for Comment solicited comments on a technical amendment to add factor bonds as an example of a type of bond that prepays principal under MSRB Rule G-47 Supplementary Material .03(i). The Request for Comment noted that MSRB Rule G-47 Supplementary Material .03(i) already covers bonds that prepay principal as a feature that could trigger the time of trade disclosure obligation.
The SIFMA Letter states that SIFMA is concerned about the proposed increase in scope of time of trade disclosures and that requiring time of trade disclosure about items such as factor bonds would add compliance risks and burdens.
MSRB Rule G-47 Supplementary Material .03(i) already lists bonds that prepay principal as a disclosure scenario. Adding factors bonds as an example of a bond that prepays principal does not add any new burden or disclosure scenario, as factor bonds are bonds that prepay principal and therefore are already within the scope of this provision. Furthermore, while this information may be obvious to market professionals, it is less likely to be obvious to retail investors toward which MSRB Rule G-47 is primarily oriented.
The Request for Comment solicited comments on the addition of three new disclosure scenarios to MSRB Rule G-47 Supplementary Material .03. Specifically, the three new disclosure scenarios discussed in the Request for Comment were the unavailability of the official statement, whether the issuer is required to make continuing disclosures, and yield to worst.
SIFMA states that it is concerned that the proposed increase in scope of time of trade disclosures and requiring time of trade disclosure about the availability of an official statement and yield to worst calculations would add compliance risks and burdens, and that time of trade disclosure of obvious information, on the contrary, obfuscates material information.
The MSRB appreciates the concerns raised by SIFMA and BDA. However, the MSRB believes that unavailability of the official statement, the fact that continuing disclosures are not available and yield to worst are all material information that would impact an investor's decision to transact in specific municipal securities, and therefore should be included in the time of trade disclosures. Furthermore, while there could be additional costs for dealers to comply with the new disclosure scenarios, the MSRB believes that the costs would be minimal and not outweigh the need to disclose material information to investors.
In response to the concerns raised by SIFMA and BDA, the MSRB narrowed the scope of the disclosure scenario relating to the unavailability of the official statement as it was described in the Request for Comment. The proposed rule change would limit this disclosure scenario to sales to customers of new issue municipal securities which would be consistent with current requirements under MSRB Rule G-32.
The Request for Comment solicited comments on draft rule text that would have required a dealer purchasing a municipal security from a customer to obtain sufficient information about the securities that is not otherwise readily available to the market so that it can accurately describe the securities when the dealer reintroduces them into the market.
In response, SIFMA states that it believes this guidance to be outdated and that the information environment in the municipal securities market is fundamentally different today than when the original guidance was published, thanks in large measure to the work of the MSRB and its EMMA website.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 12f-3 (“Rule”), which was originally adopted in 1955 pursuant to Sections 12(f) and 23(a) of the Act, and as further modified in 1995, sets forth the requirements to submit an application to the Commission for termination or suspension of unlisted trading privileges in a security, as contemplated under Section 12(f)(4) of the Act. In addition to requiring that one copy of the application be filed with the Commission, the Rule requires that the application contain specified information. Under the Rule, an application to suspend or terminate unlisted trading privileges must provide, among other things, the name of the applicant, a brief statement of the applicant's interest in the question of termination or suspension of such
The information required to be included in applications submitted pursuant to Rule 12f-3 is intended to provide the Commission with sufficient information to make the necessary findings under the Act to terminate or suspend by order the unlisted trading privileges granted a security on a national securities exchange. Without the Rule, the Commission would be unable to fulfill these statutory responsibilities.
The burden of complying with Rule 12f-3 arises when a potential respondent, having a demonstrable bona fide interest in the question of termination or suspension of the unlisted trading privileges of a security, determines to seek such termination or suspension. The staff estimates that each such application to terminate or suspend unlisted trading privileges requires approximately one hour to complete. Thus each potential respondent would incur on average one burden hour in complying with the Rule.
The Commission staff estimates that there could be as many as 24 responses annually for an aggregate burden for all respondents of 24 hours. Each respondent's related internal cost of compliance for Rule 12f-3 would be $242, or the cost of one hour of professional work of a paralegal needed to complete the application. The total annual internal cost of compliance for all potential respondents, therefore, is $5,808 (124 responses × $242/response).
Compliance with the application requirements of Rule 12f-3 is mandatory, though the filing of such applications is undertaken voluntarily. Rule 12f-3 does not have a record retention requirement
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
On December 9, 2020, the Commission updated the content of national market system (“NMS”) information that is required to be collected, consolidated, and disseminated as part of the national market system under Regulation NMS. Second, the Commission amended the method by which “consolidated market data,” as now defined, is collected, consolidated, and disseminated by introducing a decentralized consolidation model with competing consolidators, which replaces the centralized consolidation model that relies on exclusive securities information processors (“exclusive SIPs”).
The amendments, as adopted, establish seven new collections of information.
1.
2.
3.
4.
5.
6.
7.
These collections of information are necessary to further the national market system objectives set forth in Section 11A(a)(1) of the Exchange Act. Without Rules 603 and 614, the Commission would be unable to fulfill these statutory responsibilities.
The staff estimates that 8 entities may register as competing consolidators and therefore are subject to the collection of information described in paragraph 1 through 5 above. The staff estimates that there are 19 entities that are subject to the collection of information described in paragraph 6 above. The staff estimates that there are 17 entities that are subject to the collection of information described in paragraph 7 above. The staff estimates that the aggregate annual compliance burden for the industry is 35,715 hours and $45,611,043.
Compliance with Rules 603 and 614 is mandatory. Competing consolidators are required to keep and preserve at least one copy of all documents, including all correspondence, memoranda, papers, books, notices, accounts, and such other records as shall be made or received by it in the course of its business as such and in the conduct of its business. Competing consolidators must keep these documents for a period of no less than five years, the first two years in an easily accessible place. This requirement is consistent with current SEC rules for SROs. The Form CC and amendments to the effective national market system plan(s) will not be confidential; they will be posted on the Commission's public website. Competing consolidators will make available to subscribers consolidated market data products, which therefore will not be confidential. Competing consolidator records will be available to the Commission and other regulators. The reports and reviews of competing consolidators will be published on competing consolidator websites and will not be confidential. Finally, the exchanges and associations will make available to competing consolidators and self-aggregators quotation and transaction information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
The proposed rule change would revise OCC's schedule of fees to update the maximum contingent Operational Loss Fee listed in OCC's schedule of fees in accordance with OCC's Capital Management Policy. Proposed changes to OCC's schedule of fees are included as Exhibit 5 to File Number SR-OCC-2024-004. Material proposed to be added to OCC's schedule of fees as currently in effect is underlined and material proposed to be deleted is marked in strikethrough text. All capitalized terms not defined herein have the same meaning as set forth in the OCC By-Laws and Rules.
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
The purpose of this proposed rule change is to revise OCC's schedule of fees to update the maximum aggregate Operational Loss Fee that OCC would charge Clearing Members in equal shares in the unlikely event that OCC's shareholders' equity (“Equity”) falls below certain thresholds defined in OCC's Capital Management Policy.
The proposed fee change is designed to enable OCC to replenish capital to comply with Rule 17Ad-22(e)(15) under the Exchange Act, which requires OCC,
OCC's Capital Management Policy includes OCC's replenishment plan.
In the unlikely event those thresholds are breached, OCC would charge an Operational Loss Fee in an amount to raise Equity to 110% of OCC's Target Capital Requirement, up to the maximum Operational Loss Fee identified in OCC's schedule of fees less the amount of any Operational Loss Fees previously charged and not refunded.
The RWD Amount and, in turn, the Adjusted RWD Amount are determined annually based on OCC's corporate budget, the assumptions articulated in the RWD Plan, and OCC's projected effective tax rate.
Since the allocation of the Operational Loss Fee is a function of the number of Clearing Members at the time of the charge, the maximum Operational Loss Fee per Clearing Member is subject to fluctuation during the course of the year. However, if the proposed Operational Loss Fee were charged to 103 Clearing Members, the number of Clearing Members as of December 13, 2023, for example, the maximum Operational Loss Fee per Clearing Member would be $1,766,990.
OCC would also update the schedule of fees to reflect the levels of Equity at which OCC would charge the Operational Loss Fee according to the thresholds defined in the Capital Management Policy, as well as the level of Equity at which OCC would limit the Operational Loss Fee charged, based on OCC's current Target Capital Requirement.
OCC proposes the fee change to be effective immediately upon filing, because the Board approved the Adjusted RWD Amount upon which the Operational Loss Fee is based for 2024. Notwithstanding the immediate effectiveness, OCC would not make the fee change operative until after the time required to self-certify the proposed change with the Commodity Futures Trading Commission (“CFTC”).
OCC believes the proposed rule change is consistent with the Act
OCC also believes that the proposed Operational Loss Fee would result in an equitable allocation of fees among its participants because it would be equally applicable to all Clearing Members. As the Commission has recognized, OCC's designation as a SIFMU and its role as the sole covered clearing agency for all listed options contracts in the U.S. makes it an integral part of the national system for clearance and settlement, through which “Clearing Members, their customers, investors, and the markets as a whole derive significant benefit . . . regardless of their specific utilization of that system.”
In addition, OCC believes that the proposed rule change is consistent with Rule 17Ad-22(e)(15)(iii), which requires that OCC establish, implement, maintain and enforce written policies and procedures reasonably designed to identify, monitor, and manage OCC's general business risk, including by maintaining a viable plan, approved by the Board and updated at least annually, for raising additional equity should its equity fall close to or below the amount required under Rule 17Ad-22(e)(15)(ii).
OCC also believes that the proposed fee change is consistent with Section 19(g)(1) of the Act,
Section 17A(b)(3)(I) of the Act
Written comments were not and are not intended to be solicited with respect to the proposed rule change and none have been received.
Pursuant to Section 19(b)(3)(A)(ii)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Vanessa Countryman, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to file number SR-OCC-2024-004 and should be submitted on or before May 9, 2024.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 236 (17 CFR 230.236) under the Securities Act of 1933 (15 U.S.C. 77a
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view background documentation for this information collection at the following website:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form D (17 CFR 239.500) is a notice of sales filed by issuers making an offering of securities in reliance on an exemption under Regulation D (17 CFR 230.501
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend Equity 7, Section 114(f), as described further below.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend the list of exchange-traded products (“ETPs”) that may be designated as a “Qualified Security”
The Exchange currently offers certain fees and rebates under the DLP Program, which applies to transactions in a Qualified Security by one of its DLPs associated with its DLP Program market participant identifier (“MPID”). The Exchange proposes to amend Equity 7, Section 114(f)(1)(A) to add securities listed on Nasdaq pursuant to Nasdaq Rules 5711,
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes it is reasonable, equitable, and not unfairly discriminatory to expand the list of securities that may be designated as a Qualified Security to include securities listed on Nasdaq pursuant to Nasdaq Rules 5711, 5713, and 5715, as long as it has at least one DLP. The Exchange believes that its proposal to expand the list of securities that may be designated as a Qualified Security to include securities listed on Nasdaq pursuant to Nasdaq Rules 5711, 5713, and 5715, as long as it has at least one DLP, is reasonable because the DLP Program encourages better market quality and ETPs currently listed on Nasdaq pursuant to Nasdaq Rule 5711 as well as ETPs that may be listed on Nasdaq pursuant to Nasdaq Rules 5711, 5713, and 5715 in the future would benefit from support from a market quality perspective, like the other ETPs currently included in the list of securities that may be designated as a Qualified Security in Equity 7, Section 114(f)(1)(A). As noted above, the Exchange recently listed shares of the iShares Bitcoin Trust and the Valkyrie Bitcoin Fund under Nasdaq Rule 5711(d) (Commodity-Based Trust Shares) and the Exchange believes the DLP Program will be beneficial to these new ETPs. The Exchange believes that the proposal is equitable and not unfairly discriminatory because the expanded list of securities that may be designated as a Qualified Security under the DLP Program would allow for more ETPs to be designated as Qualified Securities and thereby allow more DLPs to receive incentives under the DLP Program. In addition, Nasdaq believes that the proposal stands to improve the quality of the Nasdaq market, to the benefit of all market participants.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem rebates or fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its rebates and fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with
The Exchange uses incentives, such as the rebates of the DLP Program, to incentivize market participants to improve the market. In this instance, the Exchange is proposing to expand the list of securities that may be designated as a Qualified Security to include securities listed on Nasdaq pursuant to Nasdaq Rules 5711, 5713, and 5715, as long as it has at least one DLP, in an effort to support market quality and reward additional DLPs with incentives under the DLP Program.
The Exchange notes that participation in the DLP Program is entirely voluntary and, to the extent that registered market makers determine that the rebates are not in line with the level of market-improving behavior the Exchange requires, a DLP may elect to deregister as such with no penalty. The Exchange does not believe that the proposed change places an unnecessary burden on competition and, in sum, if the changes proposed herein are unattractive to market makers, it is likely that the Exchange will lose participation in the DLP Program as a result. The Exchange does not believe that the proposal represents a burden on competition among Exchange members, or that the proposal will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its existing Trading Collar risk control for Equity Members
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these
The Exchange prevents all incoming orders, including those marked as Intermarket Sweep Orders (“ISO”), from executing at a price outside the Trading Collar price range as described in Exchange Rule 2618(b). The Trading Collar prevents buy orders from trading or routing at prices above the collar and prevents sell orders from trading or routing at prices below the collar. The Exchange proposes to expand the ability of Equity Members to adjust the Trading Collar.
The Exchange's default behavior is to calculate the Trading Collar price range for a security by applying the numerical guidelines for Clearly Erroneous Executions or a specified dollar value established by the Exchange.
In less liquid securities, the Trading Collar has, in a few instances, prevented Equity Members from accessing an order resting on the MIAX Pearl Equities Book
In response to Equity Member feedback, the Exchange proposes to expand the ability to override the Exchange's default behavior to address the scenario outlined above. Specifically, the Exchange proposes to expand Exchange Rule 2618(b)(1)(F) to include Limit Orders and Pegged Orders, in addition to Market Orders (current behavior). The Exchange proposes to also amend Exchange Rule 2618(b)(1)(F) to allow Equity Members to select a dollar value lower (current behavior), higher, or equal to the Exchange-specified percentages and dollar value on an order-by-order basis. In other words, Equity Members may select a dollar value equal to, more, or less conservative than the Exchange's specified percentages and dollar value. This proposed rule change would allow Equity Members to select their own dollar value to calculate the Trading Collar, enabling them to access an order that may otherwise be outside the Trading Collar if the Trading Collar was calculated based on the Exchange's specified percentages and dollar value. Importantly, the proposed rule change would not only allow Equity Members to select a dollar value more aggressive than the Exchange's defaults, but also more conservative in cases where they seek to apply a tighter Trading Collar in line with their risk appetite. The ability to override the Exchange's specified percentages and dollar value would be completely voluntary and all orders would continue to be subject to other risk protections provided by the Exchange regardless of the width of the Trading Collar, as described below.
As a preliminary matter, the Exchange notes that no order would be executed outside of the prescribed Price Bands pursuant to the Plan to Address Extraordinary Market Volatility (the “LULD Plan”).
In addition, to help Equity Members manage their risk, the Exchange also offers other risk controls that authorize the Exchange to take automated action if a designated limit for an Equity Member is breached. Each of these risk controls are described under Exchange Rule 2618 and provide Equity Members with enhanced abilities to manage their risk when trading on the Exchange. The Exchange also requires Limit Order Price Protection for all Limit Orders. Under Exchange Rule 2614(a)(1)(ix), Limit Order Price Protection provides that a Limit Order to buy (sell) will be rejected if it is priced at or above (below) the greater of a specified dollar and percentage away from a certain reference described in the Rule. Equity Members may customize the specified dollar and percentage values on an MPID and/or per session basis. If an Equity Member does not provide a specified dollar and percentage values for their order(s), the Exchange's specified dollar and percentage values will be applied. Limit Order Price Protection will be applied when an order is first eligible to trade. In other words, a Limit Order would be rejected and not placed on the MIAX Pearl Equities Book where it would be priced outside of the Limit Order Price Protection range described above. Meanwhile, all order types are subject to the Trading Collar. Like Limit Order Price Protection, the Trading Collar is applied upon entry. Unlike Limit Order Price Protection, under which an order would be rejected, an order subject to the Trading Collar may be accepted upon entry and routed or executed at
The following examples describe the proposed functionality and how it would interact with the Limit Order Price Protection. Assume for all of the below examples that the previous day's official closing price of $1.00 is being used as the Trading Collar Reference Price because there is no consolidated last sale. Also assume the Trading Collar dollar value is $0.15 resulting in a Trading Collar range of $0.85 to $1.15, and there is no national best bid or offer for the security.
The first example shows how the proposed functionality would allow an incoming order to access a resting order that would otherwise have been blocked by the Trading Collar. The Exchange receives a displayed Limit Order to buy 10 shares at $0.83 (Order 1). Order 1 is posted to the MIAX Pearl Equities Book and displayed at $0.83. The Exchange then receives a second displayed Limit Order to buy 10 shares at $0.84 (Order 2). Order 2 is posted to the MIAX Pearl Equities Book and displayed at $0.84. The Exchange now receives a Limit Order to sell 20 shares at $0.80 (Order 3), with custom Trading Collar dollar value of $0.17, resulting in a Trading Collar range of $0.83 to $1.17 ($0.02 wider than the Exchange specified Trading Collar dollar value of $0.15). Assume that Orders 1, 2, and 3 all pass the Limit Order Price Protection check. Order 3 would execute against Order 2 at $0.84 for 10 shares and then execute against Order 1 at $0.83 for 10 shares. Order 3 is able to execute against Orders 1 and 2 because they are within range of Order 3's custom Trading Collar dollar value. If the Exchange's specified Trading Collar value has been used, Order 3 would not have been able to execute against Orders 1 and 2 because they would have been outside the Trading Collar range.
This second example shows an incoming order failing the Limit Order Price Protection check and being rejected, although its custom Trading Collar dollar value would have allowed it to trade with contra-side interest on the MIAX Pearl Equities Book. Assume the same facts as the above example with the only difference being Order 3 also includes a specified Limit Order Price Protection dollar and percentage values of $0.05 and 10%, respectively, as provided by Exchange Rule 2614(a)(1)(ix)(B). Order 3's Limit Order Price Protection range is calculated as follows: Official Closing Price minus the greater of the dollar-based value ($0.05) or the Official Closing Price multiplied by the percentage value ($1.00 +/− $0.10 = $0.90 to $1.10). Although Order 3's custom Trading Collar dollar value would have allowed it to trade with Orders 1 and O2, Order 3 would fail the Limit Order Price Protection check and be rejected.
The Exchange proposes, however, to not allow Equity Members to select their own dollar value to calculate the Trading Collar for orders eligible to participate in the Exchange's Opening Process. The Exchange recently proposed to apply the Trading Collar to the Opening Process under Exchange Rule 2615,
The Exchange also proposes to make non-substantive corrections to Exchange Rule 2618. First, the Exchange proposes to capitalize a reference to “Numerical Guidelines” in Exchange Rule 2618(b)(1). Second, the Exchange proposes to correct a cross-reference in Exchange Rule 2618(b)(1)(D). Third, the Exchange proposes to make references to the term “dollar values” singular in Exchange Rule 2618(b)(1)(F). This is because the Exchange only uses a single dollar value when calculating the Trading Collar. None of these changes impact or alter the operation of Exchange Rule 2618(b). Each is designed solely to correct non-substantive errors, making the rule easier to understand and avoid potential investor confusion.
The Exchange does not guarantee that the risk settings in this proposal are sufficiently comprehensive to meet all of an Equity Member's risk management needs. Pursuant to Rule 15c3-5 under the Act,
Due to the technological changes associated with this proposed change, the Exchange will issue a trading alert publicly announcing the implementation date of the proposed enhancements to its risk controls set forth herein. The Exchange anticipates that the implementation date will be in the second or third quarter of 2024.
The proposed rule change is consistent with Section 6(b) of the Act,
Exchange Rule 2618(b)(1)(F) currently provides the ability to override the Exchange's default behavior for Market Orders only, where Equity Members may select on an order-by-order basis a dollar value lower than the Exchange specified percentages and dollar value. This proposal seeks to expand that ability under Exchange Rule 2618(b)(1)(F) to include Limit Orders and Pegged Orders and allow Equity Members to select a dollar value lower (current behavior), higher, or equal to the Exchange specified percentages and dollar value on an order-by-order basis. Importantly, the proposed rule change would not only allow Equity Members to select a dollar value more aggressive than the Exchange's defaults, but also more conservative in cases where they seek to apply a tighter Trading Collar in line with their risk appetite.
Allowing Equity Members to select a dollar value more or less conservative than the Exchange's specified percentages and dollar value is being proposed in response to an Equity Member request to be able to access an order in less liquid securities that may be resting on the MIAX Pearl Equities Book at prices outside the Trading Collar, as described above. The proposal would, therefore, promote just and equitable principles of trade because it would provide Equity Members with additional flexibility in constructing a Trading Collar (tighter or wider) that better suits their risk appetite when they seek to access such resting liquidity. The proposal would allow Equity Members to modify the Trading Collar on an order-by-order basis so that they may access an order resting on the MIAX Pearl Equities Book that would otherwise be priced outside of the Trading Collar due to the Exchange's default behavior.
An Equity Member's decision to select a dollar value other than the Exchange's specified values would be completely voluntary. Equity Members would be free to take no action and rely on the Exchange's specified percentages or dollar value as they may do today for Market Orders.
Market participants' ability to adjust risk settings to a more restrictive range, like Trading Collars, is not unique. As discussed above, Exchange Rule 2618(b)(1)(F) currently provides Equity Members the ability to constrict the Trading Collar for Market Orders. Market participants' ability to adjust risk settings to a more permissive range is also not unique. Today, for Limit Order Price Protection, Exchange Rule 2614(a)(1)(ix)(B) permits Equity Members to customize the specified dollar and percentage values used under Limit Order Price Protection.
This proposal is in response to a limited and specific scenario when the prior day's Official Closing Price is used as the Trading Collar Reference Price because no consolidated last sale price was disseminated during Regular Trading Hours on trade date. In such case, the Official Closing Price may be stale and result in an order in a less liquid security to be resting at a price outside the Trading Collar. The Exchange believes this in an infrequent occurrence. Nonetheless, the proposed functionality would be available generally and not for only this limited scenario. However, the Exchange believes that Equity Members would continue to rely on the Exchange's default behavior and Trading Collars in most, if not all, other trading scenarios.
The proposal furthers the objectives of Section 6(b)(5)
Further, the proposal protects investors and the public interest because such an order would continue to be subject to other risk controls and protections offered by the Exchange. For example, Limit Order Price Protection process will continue to apply, even in cases where an Equity Member selects a custom dollar value to calculate the Trading Collar price range. To further help Equity Members manage their risk, all other risk controls offered by the Exchange that authorize the Exchange to take automated action if a designated limit for an Equity Member is breached will also continue to apply. Each of these risk controls provide Equity Members with enhanced abilities to manage their risk when trading on the Exchange. The proposal also protects investors and the public interest because no order would be executed outside of the prescribed Price Bands pursuant to the LULD Plan.
Lastly, the Exchange believes its proposal to not allow Equity Members to select their own dollar value to calculate the Trading Collar for orders eligible to participate in the Exchange's Opening Process is reasonable. This portion of the proposal promotes just and equitable principles of trade because no orders rest on the MIAX Pearl Equities Book until the completion of the Opening Process and continuous trading has begun. Until that time, there would be no orders resting on the MIAX Pearl Equities Book at a price that would otherwise be outside of the Trading Collar that an Equity Member may seek to access.
The non-substantive corrections to Exchange Rule 2618 protect investors and the public interest, as well as remove impediments to and perfects the mechanism of a free and open market and a national market system because each is designed solely to correct non-substantive grammatical errors, making the rule easier to understand and avoid potential investor confusion. None of
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange believes its proposal will not impose any burden on inter-market competition because it would provide Equity Members with additional flexibility in constructing a Trading Collar that better suits their risk appetite when they seek to access resting liquidity that may be resting outside of the Trading Collar because it was calculated based on the prior day's Official Closing Price, which may not reflect the current trading characteristics of the security. The proposal would serve to improve access to less liquid securities priced outside the Trading Collar, improving the liquidity on the Exchange and potentially the Exchange's market quality. The proposal would impose no burden on intra-market competition because each risk setting would be applied to all Equity Members' orders equally.
The non-substantive corrections to Exchange Rule 2618 would not impact competition because such changes would not enhance or alter the Exchange's ability to compete, but rather, make the rule easier to comprehend, reducing the potential for inadvertent investor confusion.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of GEORGIA dated 04/12/2024.
Issued on 04/12/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 20264B and for economic injury is 202650.
The State which received an EIDL Declaration is Georgia.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before May 8, 2024.
Send comments identified by docket number FAA-2023-1824 using any of the following methods:
•
•
•
•
Deana Stedman, AIR-646, Federal Aviation Administration, phone (206) 231-3187, email
This notice is published pursuant to 14 CFR 11.85.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition; denial of application for exemption.
FMCSA announces its denial of an application for exemption, filed by the Florida Department of Highway Safety and Motor Vehicles (FLHSMV), from the commercial driver's license (CDL) skills testing regulation requiring the three-part CDL skills test to be administered and successfully completed in the following order: pre-trip inspection, basic vehicle control skills, and on-road skills. The FLHSMV applied for an exemption to allow the tester, at their discretion, to continue testing an applicant who fails the pre-trip inspection or basic vehicle controls segments of the CDL skills test and allow the applicant to come back at a later date to retake the failed segment(s) only. After reviewing the application and the comments submitted to the docket, the Agency has determined the record does not show that granting the exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent the exemption.
Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; 202-366-2722;
To view comments, go to
To view documents mentioned in this notice as being available in the docket, go to
If you do not have access to the internet, you may view the docket by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted and determines whether granting the exemption would likely maintain a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305(a)). The Agency must publish its decision in the
Under 49 CFR 383.133(c)(6) of the FMCSRs, States must administer a three-part CDL skills test to applicants for CDLs in the following order: (1) pre-trip inspection, (2) basic vehicle control skills, and (3) on-road skills.
The FLHSMV requested an exemption from the requirement in 49 CFR 383.133(c)(6). The state of Florida operates as a third-party testing state, where nearly all CDL skills tests are conducted by third-party testers. If an applicant fails one segment of the test, they cannot attempt the next segment(s) and must return on a different day to retake all three parts of the test. The FLHSMV requested an exemption to allow the tester, at their discretion, to continue testing an applicant who fails the pre-trip inspection (step 1) or basic vehicle controls (step 2) segments of the test and allow the applicant to come back at a later date to retake only the failed segment(s). The applicant stated that the most failed segment of the test is the pre-trip inspection, and, if the exemption is granted, the tester could continue to test basic vehicle control skills and on-road skills in this instance. If the CDL applicant passed these other portions of the test, they could return at a later date and retake just the pre-trip inspection portion of the test. The exemption applicant further stated that, if granted, the exemption would allow compliance staff to better utilize their time and resources in completing the required monitoring of third-party testers.
The FLHSMV believes that an equivalent or greater level of safety will be maintained because the decision to continue with the test would reside with the certified experienced testers. The FLHSMV also noted that, with the implementation of the Federal Entry-Level Driver Training regulations, most applicants being tested have been certified as proficient in operating commercial motor vehicles (CMVs), having completed behind-the-wheel training that prepares them to safely operate a CMV during the on-road portion of the CDL skills test.
On December 5, 2023, FMCSA published FLHSMV's application and requested public comment [88 FR 84387]. The Agency received 30 comments; 19 in opposition, 8 in support, and 3 others expressed no position either for or against the exemption request. Of the 19 commentors opposed to granting the exemption, 17 were individuals and two were trucking companies. Tim Kordula provided the following comment that captured the concerns raised in most of the opposing comments: “The American Association of Motor Vehicle Administrators or (AAMVA), along with the FMCSA has done [its] research into the methodology behind why the tests are performed the way they are. An applicant failing the pre-trip and then being allowed to continue is not only unsafe but irresponsible. The FMCSA rules set forth . . . a pre-trip must be done and the driver must be sure the vehicle is in good operating order PRIOR (sic) to moving the vehicle. Allowing the test to continue goes against that rule as well as what the CDL schools are trying to teach.”
Of the eight commenters filing in support, three were from industry trade associations: the Commercial Vehicle Training Association (CVTA), the National Tank Truck Council (NTTC), and the American Bus Association (ABA). CVTA commented that the additional flexibility that the exemption would give Florida's CDL testing program would help address skills testing delays. According to CVTA, citing a study of cumulative data from 33 states, “These delays put jobs on hold for 258,744 drivers and resulted in over $1 billion in lost wages for these drivers.” CVTA's comment was referring to an independent economic analysis commissioned by CVTA and published in 2019. CVTA further stated “As a result, federal and state governments missed out on an estimated loss of $234 million in forgone income taxes and $108 million in forgone state and local sales taxes that could have been generated in the absence of skills testing delays.” CVTA added that skills testing delays can cause a new driver's skills to deteriorate.
The NTTC agreed with CVTA, noting that if the petition is approved, skills testers in Florida will be able to devote less time to areas in which drivers have already shown they are competent, increasing the efficiency of the CDL credentialing process. According to NTTC, “Given the well documented commercial driver shortage, it is imperative that we reduce barriers to individuals attaining the proper credentials for operating commercial vehicles.”
ABA commented in support of granting the exemption, stating “in providing additional flexibility to the testing protocol, testing delays will be mitigated as students will only need to take portions of the test they did not pass, freeing up vital resources for the administration of additional evaluations.” ABA continued its comment with “This will also
FMCSA reviewed the FLHSMV application and the public comments and denies the exemption request. The Agency believes that conducting the elements of the CDL skills test in the required order (
The sequence of the skills test ensures that an applicant has demonstrated sufficient knowledge and skills to safely attempt the next step in the testing process. The current regulations also provide flexibility, in that generally, applicants are not required to retake portions of the test which have been successfully completed. Moreover, with the implementation of the Federal Entry-Level Driver Training (ELDT) requirements, the Agency believes SDLAs should see a reduction in the percentage of applicants who fail portions of the CDL skills test.
For the above reasons, FLHSMV's exemption application is denied.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of availability of the Northeast Corridor Project Inventory.
FRA is publishing the 2024 Northeast Corridor (NEC) Project Inventory (2024 NEC Project Inventory), which is a requirement of the Federal-State Partnership for Intercity Passenger Rail Program for projects on the Northeast Corridor (FSP-NEC). FRA was required to publish the NEC Project Inventory not later than one year after the enactment of the Infrastructure Investment and Jobs Act, also known and the Bipartisan Infrastructure Law (BIL), and every two years thereafter.
Applicable April 18, 2024.
The NEC Project Inventory can be found at:
For additional information, please contact Bryan Rodda, Chief, Amtrak and Northeast Corridor Capital Planning Division at email:
The FSP was reauthorized and revised in the BIL, title II, U.S.C. 22106 and 22307, Public Law 117-58 (2021); codified at 49 U.S.C. 24911. Under the FSP, the Secretary of Transportation (Secretary) is directed to develop and implement a program for issuing grants, on a competitive basis, to fund projects that reduce the state of good repair backlog, improve performance, or expand or establish new intercity passenger rail service, including privately operated intercity passenger rail service if an eligible applicant is involved. The FSP also requires the Secretary to, among other things, develop and publish an NEC Project Inventory to: (1) create a predictable project pipeline that will assist Amtrak, States, and the public with long-term capital planning, and (2) use the NEC Project Inventory when selecting projects located on the NEC for FSP funds. 49 U.S.C. 24911.
In compliance with the above, FRA is publishing the 2024 NEC Project Inventory, which will be available on April 18, 2024, at:
Issued in Washington, DC.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Goodyear Tire & Rubber Company (Goodyear), who acquired Cooper Tire & Rubber Company (Cooper Tire), has determined that certain Cooper Discoverer SRX replacement passenger car tires do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139,
Send comments on or before May 20, 2024.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and submitted by any of the following methods:
•
•
•
• Comments may also be faxed to (202) 493-2251.
Comments must be written in the English language and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
All comments and supporting materials received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the fullest extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at
DOT's complete Privacy Act Statement is available for review in a
Jayton Lindley, General Engineer, NHTSA, Office of Vehicle Safety Compliance, (325) 655-0547,
This notice of receipt of Goodyear's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any Agency decision or other exercise of judgment concerning the merits of the petition.
• For tires manufactured on or after September 1, 2009, each tire must be labeled with the tire identification number required by 49 CFR part 574 on the intended outboard sidewall of the tire.
• Except for retreaded tires, if a tire does not have an intended outboard sidewall, the tire must be labeled with the tire identification number required by 49 CFR part 574 on one sidewall and with either the tire identification number or a partial tire identification number, containing all characters in the tire identification number except for the date code and, at the discretion of the manufacturer, any optional code, on the other sidewall.
In support of its petition, Goodyear submits the following reasoning:
According to Goodyear, the subject tires “meet or exceed” the applicable FMVSS performance requirements and the noncompliance does not affect “the performance of the tires or the safe operation of the vehicles on which they are installed.”
Additionally, in the event of a field action, the noncompliant TIN marking could be included in the notification letter sent to the consumer.
Goodyear cites the following previously granted inconsequentiality petitions which it says pertain to noncompliances that are similar to the subject noncompliance:
• Bridgestone Firestone North America Tire, LLC, Grant of Petition for Decision of Inconsequential Noncompliance; 71 FR 4396 (January 26, 2006).
• Cooper Tire & Rubber Company; Grant of Application for Decision of Inconsequential Noncompliance; 63 FR 29060, (May 27, 1998).
Goodyear concludes that the subject noncompliance is inconsequential as it relates to motor vehicle safety and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject tires that Goodyear no longer controlled at the time it determined that the noncompliance existed. However,
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Continental Tire the Americas, LLC (“CTA”), has determined that certain Continental VanContact A/S tires do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139,
Send comments on or before May 20, 2024.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and submitted by any of the following methods:
•
•
•
• Comments may also be faxed to (202) 493-2251.
Comments must be written in the English language and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
All comments and supporting materials received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the fullest extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at
DOT's complete Privacy Act Statement is available for review in a
Jayton Lindley, General Engineer, NHTSA, Office of Vehicle Safety Compliance, (325) 655-0547.
CTA has determined that certain Continental VanContact A/S tires do not fully comply with the requirements of paragraph S5.5(b) of FMVSS No. 139,
This notice of receipt of CTA's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any Agency decision or other exercise of judgment concerning the merits of the petition.
Approximately 419 Continental VanContact A/S tires, size LT 245/70R17 119/116 Q, manufactured between May 31, 2020, and May 22, 2021, are potentially involved.
CTA explains that the noncompliance is that the tire size designation on both sidewalls of the subject tires, is missing the tire size prefix “LT” and, therefore, does not fully comply with paragraph S5.5(b) of FMVSS No. 139. Specifically, the tire size on the subject tires' sidewalls read “245/70R17 119/116 Q,” however, they should read “LT 245/70R17 119/116 Q.”
Paragraph S5.5(b) of FMVSS No. 139 includes the requirements relevant to this petition. Each tire must be marked on each sidewall with the tire size designation as listed in the documents and publications specified in S4.1.1 of the standard.
The following views and arguments presented in this section, “V. Summary of CTA's Petition,” are the views and arguments provided by CTA. They have not been evaluated by the Agency and do not reflect the views of the Agency. CTA describes the subject noncompliance and contends that the noncompliance is inconsequential as it relates to motor vehicle safety.
In support of its petition, CTA submits the following reasoning:
CTA says that other than the missing tire size designation marking on both sidewalls, the subject tires contain all other required markings and meet the performance requirements of FMVSS No. 139.
CTA states its belief that the missing markings do not impact the operational safety of the tires. CTA adds that the subject tire sidewalls contain the correct markings for the Load Index and load capacities for single and dual fitments and that “there is no higher load tire specified for size 245/70R17 in the [Tire and Rim Association] yearbook or the European Tyre and Rim Technical Organization, thus the tires could not mistakenly be placed in an overloaded application.”
CTA contends that the granting of a petition submitted by Michelin North America Incorporated describes a similar noncompliance to the one affecting the subject tires and therefore, supports the granting of its petition.
CTA also says that the subject tires were installed on “pre-serial production vehicles” that were not sold to end consumers or released into the replacement tire market. Additionally, CTA says that all remaining CTA inventory will be destroyed and that “no additional tires will be manufactured or sold with the noncompliance.”
CTA concludes that the subject noncompliance is inconsequential as it relates to motor vehicle safety and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
In response to email correspondence from NHTSA on November 7, 2022, CTA clarified that Rivian owned, controlled, and operated the subject vehicles and the tires were sent to Toyota Arizona Proving Grounds for Prototype vehicle testing.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject tires that CTA no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after CTA notified them that the subject noncompliance existed.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on special permit applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before May 20, 2024.
Record Center, Pipeline and Hazardous Materials Safety Administration U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC.
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for modification of special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before May 3, 2024.
Record Center, Pipeline and Hazardous Materials Safety Administration U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before May 20, 2024.
Record Center, Pipeline and Hazardous Materials Safety Administration U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC.
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice by clicking on the following link
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 810 Vermont Ave. NW, Washington, DC 20420, (202) 266-4688 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Veterans Rural Health Advisory Committee will hold its face-to-face meeting at the Cumberland County Library, Pate Room, 300 Maiden Lane #5032, Fayetteville NC 28301 on Tuesday, April 30, 2024, through Wednesday, May 1, 2024. The meeting will convene at 9:00 a.m., Eastern Standard Time (EST) each day and adjourn at 5:00 p.m. (EST). The meeting sessions are open to the public. Additionally, a meeting link is available for individuals who cannot attend in person and would like to join online through Microsoft Teams,
The purpose of the Committee is to advise the Secretary of VA on rural health care issues affecting Veterans. The Committee examines programs and policies that impact the delivery of VA rural health care to Veterans and discusses ways to improve and enhance VA access to rural health care services for Veterans.
The agenda will include updates from Department leadership; the Executive Director, VA Office of Rural Health; and the Committee Chair; as well as presentations by subject-matter experts on general rural health care access.
Public comments will be received at 4:15 p.m. on May 1, 2024, 2023. Interested parties should contact Mr. Paul Boucher, by email at
Environmental Protection Agency (EPA).
Final rule.
Under the Clean Air Act, the Environmental Protection Agency (EPA) is establishing new, more protective emissions standards for criteria pollutants and greenhouse gases (GHG) for light-duty vehicles and Class 2b and 3 (“medium-duty”) vehicles that will phase-in over model years 2027 through 2032. In addition, EPA is finalizing GHG program revisions in several areas, including off-cycle and air conditioning credits, the treatment of upstream emissions associated with zero-emission vehicles and plug-in hybrid electric vehicles in compliance calculations, medium-duty vehicle incentive multipliers, and vehicle certification and compliance. EPA is also establishing new standards to control refueling emissions from incomplete medium-duty vehicles, and battery durability and warranty requirements for light-duty and medium-duty electric and plug-in hybrid electric vehicles. EPA is also finalizing minor amendments to update program requirements related to aftermarket fuel conversions, importing vehicles and engines, evaporative emission test procedures, and test fuel specifications for measuring fuel economy.
This final rule is effective on June 17, 2024. The incorporation by reference of certain publications listed in this regulation is approved by the Director of the Federal Register beginning June 17, 2024. The incorporation by reference of certain publications listed in this regulation is approved by the Director of the Federal Register as of March 27, 2023.
EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2022-0829. All documents in the docket are listed on the
Michael Safoutin, Office of Transportation and Air Quality, Assessment and Standards Division (ASD), Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: (734) 214-4348; email address:
Entities potentially affected by this rule include light-duty vehicle manufacturers, independent commercial importers, alternative fuel converters, and manufacturers and converters of medium-duty vehicles (
This list is not intended to be exhaustive, but rather provides a guide regarding entities likely to be affected by this action. To determine whether particular activities may be regulated by this action, you should carefully examine the regulations. You may direct questions regarding the applicability of this action to the person listed in
This regulatory action was supported by influential scientific information. EPA therefore conducted peer review in accordance with OMB's Final Information Quality Bulletin for Peer Review. Specifically, we conducted peer review on six analyses: (1) Optimization Model for reducing Emissions of Greenhouse gases from Automobiles (OMEGA 2.0), (2) Advanced Light-duty Powertrain and Hybrid Analysis (ALPHA3), (3) Motor Vehicle Emission Simulator (MOVES), (4) The Effects of New-Vehicle Price Changes on New- and Used-Vehicle Markets and Scrappage; (5) Literature Review on U.S. Consumer Acceptance of New Personally Owned Light-Duty Plug-in Electric Vehicles; (6) Cost and Technology Evaluation, Conventional Powertrain Vehicle Compared to an Electrified Powertrain Vehicle, Same Vehicle Class and OEM. All peer reviews were in the form of letter reviews conducted by a contractor. The peer review reports for each analysis are in the docket for this action and at EPA's Science Inventory (
The Environmental Protection Agency (EPA) is finalizing multipollutant emissions standards for light-duty passenger cars and light trucks and for Class 2b and 3 vehicles (“medium-duty vehicles” or MDVs) under its authority in section 202(a) of the Clean Air Act (CAA), 42 U.S.C. 7521(a). The program establishes new, more stringent vehicle emissions standards for criteria pollutant and greenhouse gas (GHG) emissions from motor vehicles for model years (MYs) 2027 through 2032 and beyond.
Section 202(a) requires EPA to establish standards for emissions of air pollutants from new motor vehicles which, in the Administrator's judgment, cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare. Standards under section 202(a) take effect “after such period as the Administrator finds necessary to permit the development and application of the requisite technology, giving appropriate consideration to the cost of compliance within such period.” Thus, in establishing or revising section 202(a) standards designed to reduce air pollution that endangers public health and welfare, EPA also must consider issues of technological feasibility, the cost of compliance, and lead time. EPA also considers safety, consistent with CAA section 202(a)(4), and may consider other factors, and in previous vehicle standards rulemakings as well as in this rule, has considered impacts on the automotive industry, impacts on vehicle purchasers/consumers, oil conservation, energy security, and other relevant considerations.
This final rule follows a Notice of Proposed Rulemaking published on May 5, 2023.
Since 1971, EPA has, at Congress' direction, been setting emissions standards for motor vehicles. The earliest standards were for light-duty vehicles for hydrocarbons, nitrogen oxides (NO
Despite the significant emissions reductions achieved by these and other rulemakings, air pollution from motor vehicles continues to impact public health, welfare, and the environment. Motor vehicle emissions contribute to ozone, particulate matter (PM), and air toxics, which are linked with premature death and other serious health impacts, including respiratory illness, cardiovascular problems, and cancer. This air pollution affects people nationwide, as well as those who live or work near transportation corridors. In addition, the effects of climate change represent a rapidly growing threat to human health and the environment, and are caused by GHG emissions from human activity, including motor vehicle transportation. Addressing these public health and welfare needs will require substantial additional reductions in criteria pollutants and GHG emissions from the transportation sector. Recent trends and developments in vehicle technologies that reduce emissions indicate that more stringent emissions standards are feasible at reasonable cost and would lead to significant improvements in public health and welfare.
Addressing the public health impacts of criteria pollutants (including particulate matter (PM), ozone, and NO
The transportation sector is the largest U.S. source of GHG emissions, representing 29 percent of total GHG emissions.
In addition to and separate from this final rule, the Administration has recognized the need for action to address climate change. Executive Order 14008 (“Tackling the Climate Crisis at Home and Abroad,” January 27, 2021) recognizes the need for a government-wide approach to addressing the climate crisis, directing Federal departments and agencies to facilitate the organization and deployment of such an effort. On April 22, 2021, the Administration announced a new target for the United States to achieve a 50 to 52 percent reduction from 2005 levels in economy-wide net greenhouse gas pollution in 2030, consistent with the goal of limiting global warming to no more than 1.5 degrees Celsius by 2050 and representing the U.S. Nationally Determined Contribution (NDC) under the Paris Agreement. These actions, while they do not inform the standards established here, serve to underscore the importance of EPA acting pursuant to its Clean Air Act authority to address pollution from motor vehicles.
EPA is establishing both criteria pollutant and GHG standards in this rulemaking given the need for additional reductions in emissions of these air pollutants to protect public health and welfare and based on EPA's assessment of the suite of available control technologies for those pollutants, some of which are effective in controlling both GHGs and criteria pollutant emissions. Under these performance-based emissions standards, manufacturers have the discretion to choose the mix of technologies that achieve compliance across their fleets. EPA's modeling provides information about several potential compliance paths manufacturers could use to comply with the standards, based on multiple inputs and assumptions (
The Administrator finds that the standards herein are consistent with EPA's responsibilities under the CAA and appropriate under CAA section 202(a). EPA has carefully considered the statutory factors, including technological feasibility and cost of the standards and the available lead time for manufacturers to comply with them. Our analysis for this action supports the conclusion that the final standards are technologically feasible and that the costs of compliance for manufacturers will be reasonable. The standards will result in significant reductions in emissions of criteria pollutants, GHGs, and air toxics, resulting in significant benefits for public health and welfare. We also estimate that the standards will result in reduced vehicle operating costs for consumers and that the benefits of the program will exceed the costs. Based on EPA's analysis, it is the agency's assessment that the standards are appropriate and justified under CAA section 202(a).
Over five decades of setting standards, EPA has developed extensive expertise in assessing the availability of new and existing technologies to control pollution from motor vehicles. In some cases, EPA has adopted standards based on its judgment that the industry could further develop and commercialize technologies. In others, EPA has based standards on the further deployment of existing technologies, rather than on the further development of new technologies. Both approaches are consistent with EPA's general authority for emissions standards under section 202(a)(1)-(2), although Congress has specified under 202(a)(3) that for heavy-duty criteria standards the Administrator should identify the greatest degree of emissions reduction achievable, taking into consideration certain factors.
In 2000, EPA adopted the Tier 2 standards, which required passenger vehicles to be 77 to 95 percent cleaner (and encouraged certification of zero-emitting vehicles through the establishment of “Bin 1”, which is now referred to as “Bin 0”).
EPA has also consistently set GHG emission standards applicable to light-duty vehicles pursuant to CAA section 202(a), beginning with the 2010 rule, and continuing through subsequent rulemakings in 2012, and 2021.
In designing the scope, structure, and stringency of these standards, the Administrator again considered a comprehensive array of updated, real-world information related to advancements in vehicle emissions control technologies. These include previous standards and their impacts on emissions control technologies; the activities, investments, and plans of manufacturers and other entities regarding the adoption of new technologies related to vehicle emissions control; trends in technology adoption by vehicle owners and operators, including individual consumers and fleets; and related legal requirements and government incentives, including most notably Congress's recent actions in the Bipartisan Infrastructure Law (BIL) and the Inflation Reduction Act (IRA). This action continues EPA's longstanding approach of establishing an appropriate and achievable trajectory of emissions reductions by means of performance-based standards, for both criteria pollutant and GHG emissions, that can be achieved by employing feasible and available emissions-reducing vehicle technologies for the model years for which the standards apply.
CAA section 202(a) directs EPA to regulate emissions of air pollutants from new motor vehicles and engines, which in the Administrator's judgment cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. While standards promulgated pursuant to CAA section 202(a) are based on application of technology, the statute does not specify a particular technology or technologies that must be used to set such standards; rather, Congress has authorized and directed EPA to adapt its standards to emerging technologies. Thus, as with prior rules, EPA has assessed the feasibility of the standards considering current and anticipated progress by automakers in developing and deploying new technologies. The levels of stringency for the standards established in this rule continue the trend of increased emissions reductions which have been adopted by prior EPA rules. For example, the Clean Air Act of 1970 required a 90 percent reduction in emissions, which drove development of entirely new engine and emission control technologies such as exhaust gas recirculation and catalytic converters, which in turn required a switch to unleaded fuel and the development of major new infrastructure to support the delivery and segregated distribution of a different fuel. Similarly, the 2014 Tier 3 standards achieved reductions of up to 80 percent in tailpipe criteria pollutant emissions by requiring cleaner fuel as well as improved catalytic emissions control systems.
Compliance with the EPA GHG standards over the past decade has been achieved through both the application of advanced technologies to internal combustion engine (ICE) vehicles as well as the increasing adoption of electrification technologies. Notably, as the EPA GHG standards have increased in stringency, automakers have relied to
Separately from this final rule, the Administration has recognized the recent industry advancements in zero-emission vehicle technologies and their potential to bring about dramatic reductions in emissions. Executive Order 14037 (“Strengthening American Leadership in Clean Cars and Trucks,” August 5, 2021) identified a goal for 50 percent of U.S. new vehicle sales to be zero-emission
As an important addition to the suite of control technologies that can reduce emissions, zero- and near-zero emission cars and trucks can simultaneously reduce both criteria pollutant and GHG emissions by a large margin. Production and sale of these vehicles is already occurring both domestically and globally, due to significant investments from automakers, increased acceptance by consumers, added support from Congress and state governments, and emissions regulations in other countries. EPA recognizes that these industry advancements, along with the additional support provided by the BIL and the IRA, represent an important opportunity for achieving the public health goals of the Clean Air Act. Recognizing that these technologies reduce both criteria pollutant and GHG emissions and are already forming an increasing portion of the fleet, EPA finds it appropriate to coordinate new standards for both criteria pollutants and GHG in a single rulemaking, rather than continuing its prior approach of coordinating the standards but setting them in separate regulatory actions.
In the U.S., recent trends in PEV production and sales show that demand continues to increase. Even under current standards, BEVs and PHEVs are becoming a rapidly increasing part of the new vehicle fleet. On a production basis, PEVs are growing steadily, expected to be 11.8 percent
Before the IRA became law, analysts were already projecting that significantly increased sales of PEVs would occur in the United States and in global markets. For example, in 2021, IHS Markit predicted a nearly 40 percent U.S. PEV share by 2030.
Recent analyses of the market penetration of plug-in electric vehicles have been completed that include the effects of the IRA. Researchers from Harvard University, MIT, and Cornell University examined the effects of subsidies and tax incentives provided by the BIL and the IRA to promote plug-in electric vehicle sales and the deployment of charging infrastructure. This study predicted plug-in electric vehicle sales shares of 55 to 58 percent in 2030 when both sales and infrastructure subsidies and incentives were considered.
Accompanying this trend has been a proliferation of announcements by automakers in the past several years, signaling a rapidly growing shift in product development focus toward electrification. For example, in January 2021, General Motors announced plans to become carbon neutral by 2040, including an effort to shift its light-duty vehicles entirely to zero-emissions by 2035.
On August 5, 2021, many major automakers including Ford, GM, Stellantis, BMW, Honda, Volkswagen, and Volvo, as well as the Alliance for Automotive Innovation, expressed continued commitment to their announcements of a shift to electrification, and expressed their support for the goal of achieving 40 to 50 percent sales of zero-emission vehicles by 2030.
In comments on the proposal, submitted in July 2023, manufacturers reiterated their continued commitment to electrification. Ford, for example, stated “Ford is all-in on electrification. We are investing more than $50 billion through 2026 to deliver breakthrough electric vehicles (EVs)” and expressed their support for a 2032 endpoint of approximately 67 percent PEVs.
In the second half of 2023, some automakers announced changes to previously announced investment plans and made statements suggesting increased attention to PHEVs or HEVs in their future product plans. For example, in mid-2023, Ford paused construction (and then restarted construction in
EPA acknowledges these recent announcements regarding investment plans. We have carefully considered these announcements, in light of the larger universe of information about manufacturer plans including comments submitted by the manufacturers on this rulemaking and our ongoing engagement with the manufacturers. Overall, EPA finds that these recent announcements do not reflect a significant change in manufacturer intentions regarding PEVs generally or specifically through the 2027-2032 timeframe of this rule. We also take into consideration that sales of PEVs have increased dramatically in recent years so periods where demand and supply of vehicles are temporarily misaligned (either creating shortages or an over-supply of vehicles) is not unexpected. Ford has since restarted construction of its plant;
Electrification plans are not limited to light-duty vehicles. Electrification of MDVs is also increasing rapidly, primarily within the area of last-mile delivery. MDV delivery vans using dedicated battery-electric vehicle (BEV) architectures are beginning to enter the U.S. market, with the first mass-produced models having become available for MY 2023 and additional production volume and models announced for MY 2024. Initial dedicated BEV van chassis have been predominantly targeted towards parcel delivery and include the GM BrightDrop Zevo 400 and Zevo 600; and the Rivian EDV 500 and EDV 700.
Numerous commitments to purchase all-electric medium-duty delivery vans have also been announced by large fleet owners including FedEx,
Investments in PEV charging infrastructure have likewise grown rapidly in recent years and are expected to continue to climb. According to BloombergNEF, total cumulative global investment in PEV charging reached almost $55 billion in 2022 and was estimated to reach nearly $93 billion in 2023.
As described in the next section, the U.S. government is making large investments in infrastructure through the Bipartisan Infrastructure Law
Taken together, these developments indicate that proven technologies such as BEVs and PHEVs are already poised to become a rapidly growing segment of the U.S. fleet, as manufacturers continue to invest in these technologies and integrate them into their product plans, and infrastructure continues to be developed. Accordingly, EPA considers these technologies to be available and feasible for controlling motor vehicle emissions, and expects that these technologies will likely play a significant role in meeting the standards for both criteria pollutants and GHGs.
At the same time, EPA anticipates that a compliant fleet under the final performance-based emissions standards will include a diverse range of technologies. The advanced gasoline technologies that have played a fundamental role in meeting previous standards will continue to play an important role going forward
A particular consideration with regard to the increased penetration of zero-emission vehicle technology is Congress' passage of the Bipartisan Infrastructure Law (BIL)
The BIL became law in November 2021 and includes a wide range of programs and significant funding for infrastructure investments, many of which are oriented toward reducing GHG emissions across the U.S. transportation network, upgrading power generation infrastructure, and making the transportation infrastructure resilient to climate impacts such as extreme weather. Notably, in support of light-duty zero-emissions transportation, the BIL included $7.5 billion in funding for installation of public charging and other alternative fueling infrastructure. This will have a major impact on feasibility of PEVs across the U.S. by improving access to charging and other infrastructure, and it will further support the Administration's goal of deploying 500,000 PEV chargers by 2030. It also includes $5 billion for electrification of school buses through the Clean School Bus Program, providing for further reductions in emissions from the heavy-duty sector.
The IRA became law in August 2022, bringing significant new momentum to clean vehicles (PEVs and fuel cell electric vehicles (FCEVs)) through measures that reduce the cost to purchase and manufacture them, incentivize the growth of manufacturing capacity and onshore sourcing of critical minerals and battery components needed for their manufacture, incentivize buildout of public charging infrastructure for PEVs, and promote modernization of the electrical grid that will power them. It includes significant consumer incentives of up to $7,500 for new clean vehicles (Clean Vehicle Credit or Internal Revenue Code (IRC) 30D, and Commercial Clean Vehicle Credit or IRC 45W) and up to $4,000 for used vehicles (Used Clean Vehicle Credit or IRC 25E). These credits will have a strong and immediate impact on the upfront affordability of these vehicles for a wide range of customers, including buyers at over 10,000 dealers that have registered to offer the 30D or
With respect to sourcing of critical minerals and battery components, and building a secure supply chain for clean vehicles and refueling infrastructure, the IRA also includes provisions that will greatly reduce reliance on imports by strongly supporting the continued development of a domestic and North American supply chain, as well as securing sources among Free Trade Agreement (FTA) countries and other trade partners and allies. Manufacturers who want their customers to take advantage of the Clean Vehicle Credit (30D) must assemble the vehicles in North America, must meet a gradually increasing value requirement for sourcing of critical minerals from U.S. or free-trade countries, and battery components from within North America, and cannot utilize content acquired from foreign entities of concern (FEOCs).
Incentives provided by the IRA, along with manufacturers' strategies to meet consumer demand, are expected to result in even greater adoption of electrification technologies. Our No Action case (
EPA is establishing new emissions standards for both light-duty and medium-duty vehicles. The light-duty vehicle category includes passenger cars and light trucks consistent with previous EPA criteria pollutant and GHG rules. In this rule, heavy-duty Class 2b and 3 vehicles are referred to as “medium-duty vehicles” (MDVs) to distinguish them from Class 4 and higher vehicles, which remain under the heavy-duty program. EPA has not previously used the MDV nomenclature, referring to these larger vehicles in prior rules as light-heavy-duty vehicles,
The program consists of several key elements: more stringent emissions standards for GHGs, more stringent emissions standards for criteria pollutants, changes to certain optional credit programs, durability provisions for light-duty and medium-duty electrified vehicle batteries, warranty provisions for both electrified vehicles and diesel engine-equipped vehicles, and various improvements to several elements of the existing light-duty and medium-duty programs.
For both light- and medium-duty vehicles, the levels of stringency established by this rule continue the trend over the past 50 years (for criteria pollutants) and over the past 14 years (for GHGs) of EPA establishing numerically lower performance-based emissions standards in recognition of both the continued threat to human health and welfare from pollution and continued advancements in emissions control technology that make it possible to achieve important emissions reductions at a reasonable cost. EPA has also continued its longstanding approach of allowing manufacturers flexibilities, such as averaging, banking and trading, to reduce their cost of reducing emissions while producing a diverse fleet meeting consumers' varied preferences. In addition to advanced ICE technologies, including hybrid electric vehicles, the feasibility assessment for this rule recognizes the increasing availability of zero and near-zero tailpipe emissions technologies, including PEVs, as cost-effective compliance technologies. The technological feasibility of PEVs is further supported by the economic incentives provided in the IRA and the auto manufacturers' stated plans for significantly increasing the production of zero and near-zero emission vehicles, including PEVs, independent of this rule. This increased feasibility of PEVs, in addition to ICE and advanced ICE technologies, is one of the factors EPA considered in setting the stringency of the standards.
Through the public comment process, EPA heard from a wide range of stakeholders and individuals who provided a diversity of views on a broad range of issues, including stringency and pace of the standards; availability and readiness of the industry to support the needs of electrified vehicles (such as battery critical minerals, charging infrastructure, electric grid, and consumer acceptance); and specific elements of EPA's analysis (such as potential PEV adoption rates, battery costs, BIL and IRA impacts, and other areas). As part of their comments, many stakeholders, including NGOs, industry groups, and others, provided detailed technical analyses for EPA to consider.
Many commenters strongly supported the proposal overall. Comments from organizations representing environmental, public health, and consumer groups, as well as numerous state and local governments and associations, emphasized the importance of air pollution emissions reductions to protect public health and welfare and combat climate change, and noted that emissions reductions are especially critical in communities overburdened by air pollution. Many of these commenters recommended adopting the strongest standards possible for both GHGs and criteria pollutants. Some of these commenters supported light-duty GHG standards even more stringent than the proposal's most stringent alternative. Similarly, automakers that produce only electric vehicles (including Tesla, Rivian, and Lucid) and commenters representing the electric vehicle industry also expressed strong support for the proposal, with some of these stakeholders also advocating standards more stringent than the proposal's most stringent alternative. Automotive suppliers largely expressed strong support for performance-based standards for GHG and criteria pollutants. Some suggested that the GHG standards should phase-in more gradually, relying on increased ICE technology in the near term. Suppliers also strongly supported the proposed particulate matter (PM) emissions standard, attested to the feasibility and readiness of gasoline particulate filter technology expected to be used to meet the standard, and urged that the standard be phased in even sooner than proposed. Several commenters provided supportive data on development of the battery supply chain, critical minerals, grid readiness, and charging infrastructure.
Comments from automakers that historically have produced primarily ICE vehicles, such as comments by the Alliance for Automotive Innovation (hereafter referred to as “the Alliance”) as well as comments by several individual automakers, generally expressed the auto industry's strong commitment to the goals of the proposed rule and to the transition to zero emission vehicles, as well as their support for continued efforts to reduce emissions from ICE vehicles that will continue to be produced during the transition to electrification. Many auto companies described their significant R&D investments in clean transportation and their corporate commitments to carbon neutrality and transitioning their vehicle offerings to electrified vehicles. The Alliance and many auto companies expressed their concern that the proposed standards would be very challenging to meet. A common theme was that the proposed GHG standards
The United Auto Workers (UAW) expressed support for the transition to a cleaner auto industry and believes that regulations that push the industry to adopt cleaner technologies are important to create a strong domestic manufacturing base. Both UAW and the United Steelworkers expressed concern regarding the pace of the proposed standards and its possible effects on employment. These organizations believed that the pace of technology transition under the proposed standards could lead to job disruptions and lower-quality jobs, and generally suggested that EPA pursue GHG standards that phase in more gradually over a longer time period. The United Steelworkers expressed strong support for the proposed PM standard.
In contrast to the strong support expressed by many state and local governments described above, several other state and local governments and a group of state Attorneys General expressed strong concerns with the proposal. These comments included that they question EPA's authority to set standards that would promote production of electric vehicles, believe there are significant hurdles to widespread EV adoption, and otherwise raise concerns with various aspects of EPA's analysis.
Commenters representing the fuels industry (petroleum and/or biofuels) expressed many concerns with the proposal, in particular the levels of increased BEV penetrations projected. Other themes included questions regarding EPA's Clean Air Act authority related to electric vehicles and fleet averaging, concerns about dependence on imports of critical minerals, concerns about grid reliability, infrastructure needs, and safety. Many of the fuel industry commenters recommended that EPA adopt a life cycle analysis approach to setting standards and give greater consideration to the role of low carbon fuels.
Utility organizations generally indicated that the proposal sends appropriate signals to support continued infrastructure buildout. Investor-owned utilities believe they can accommodate localized power needs at the pace of customer demand, provided customer engagement and enabling policies are in place. Not-for-profit electric cooperatives serving rural areas and underserved communities highlighted the substantial grid upgrade investments needed to support increased transportation electrification and urged EPA to account for these costs.
EPA has thoroughly considered the public comments, including the data and information submitted by commenters, as well as our updated analysis based on this public record and the best available information. This preamble, together with the accompanying Response to Comments (RTC) document, responds to the comments we received on the proposed rule. This final rule reflects the input we received through the public comment process and is also supported by updated analyses for which EPA considered the most recent and best available technical and scientific data.
The following sections summarize at a high level each of the standards and program provisions finalized in this rule. Section III of this preamble includes a more detailed discussion of each of these elements and how we considered public comments and updated information in determining the final standards and program provisions.
EPA is establishing GHG standards for both light-duty vehicles and medium-duty vehicles for MYs 2027 through 2032 that are more stringent than the prior standards applicable under the 2021 rule. For light-duty vehicles, EPA is finalizing standards that increase in stringency each year over a six-year period, from MYs 2027-2032. The standards are projected to result in an industry-wide average target for the light-duty fleet of 85 grams/mile (g/mile) of CO
In the NPRM, EPA requested comment on the proposed light-duty GHG standards as well as three alternatives: a more stringent alternative (Alternative 1), a less stringent alternative (Alternative 2), and an alternative that landed at the same stringency as the proposal in MY 2032 but provided a linear ramp rate from MY 2027 to 2032 (Alternative 3). Alternative 3's linear ramp rate had less stringent light-duty GHG standards than the proposed standards for MYs 2027-2031.
As discussed in this section above, in public comments, various stakeholders had opposing views on the light-duty GHG standards stringency alternatives.
Based on our consideration of the public comments and our updated technical analysis, EPA is finalizing light-duty GHG standards that land at the same stringency level as proposed in MY 2032 but have a relatively more linear ramp rate of standards stringency, one that is more gradual in the early years from MYs 2027-2031. Specifically, the final standards are the proposal's Alternative 3 footprint CO
For medium-duty vehicles, EPA is revising the existing standard for MY 2027 given the increased feasibility of GHG emissions reducing technologies in this sector in this time frame. EPA's standards for MDVs increase in stringency year over year from MY 2027 through MY 2032. EPA is finalizing MDV GHG standards that land at the same stringency as the proposal in MY 2032, but which have a more gradual rate of stringency in the early years compared to the proposed standards. These changes are responsive to comments from manufacturers that recommended additional lead time in early years of the program. When phased in, the MDV standards are projected to result in an average fleet target of 274 grams/mile of CO
EPA emphasizes that its standards are performance-based, and manufacturers are not required to use particular technologies to meet the standards. There are many potential pathways to compliance with the final standards manufacturers may choose that involve different mixtures of vehicle technologies. The technology pathway in our central case
EPA also sought comment on whether the standards should continue to increase in stringency for future years, such as through MY 2035. While a few commenters supported extending standards to MY 2035, many commenters raised concerns with setting standards beyond 2032, pointing to considerable uncertainty in projecting out ten or more years the state of the BEV market and supporting conditions, such as charging infrastructure buildout, given that the proposal had projected high penetrations of BEVs. Other commenters suggested that if standards were extended beyond MY 2032, that some form of mid-course review could be necessary given the increased uncertainty. In consideration of these comments and recognizing the increased uncertainty around emissions technology developments and costs in the MYs 2033-2035 timeframe, EPA is establishing standards in this action for MYs 2027 through 2032.
The light-duty CO
EPA has reassessed certain credit programs available under the existing GHG programs considering the agency's experience with the program implementation to date, trends in technology development, recent related statutory provisions, and other factors. EPA is revising the air conditioning (A/C) credits program in two ways. First, for A/C system efficiency credits under the light-duty GHG program, EPA is limiting the eligibility for these voluntary credits for tailpipe CO
EPA is also sunsetting the off-cycle credits program for light-duty vehicles as follows. First, EPA is phasing out menu-based credits by reducing the menu credit cap year-over-year until it is fully phased out in MY 2033. Specifically, EPA is setting a declining menu cap of 10/8/6/0 grams per mile (g/mile) for non-BEVs over MYs 2030-2033 such that MY 2032 would be the last year manufacturers could generate optional off-cycle credits. Second, EPA is eliminating the 5-cycle and public process pathways for generating off-cycle credits starting in MY 2027. Third, EPA is limiting eligibility for off-cycle credits only to vehicles with tailpipe emissions greater than zero (
EPA is not reopening its averaging, banking, and trading provisions, which continue to be a central part of its fleet average standards compliance program, and which help manufacturers to employ a wide range of compliance paths. EPA is also not reopening its existing regulations which sunset in MY 2024 light-duty multiplier incentives for BEVs, PHEVs and fuel cell vehicles. EPA is revising multiplier incentives previously in place for MDVs for MY 2027 (established in the heavy-duty Phase 2 rule) to end the multipliers one model year earlier, such that MY 2026 is the last year that MDV multipliers will be in effect. EPA is also finalizing regulatory text to ensure that compliance with vehicle GHG emissions standards continues to be assessed based on vehicle emissions. Under this final rule, BEVs and the electric operation of PHEVs will continue to be counted as zero g/mile in a
Finally, EPA is establishing provisions for small volume manufacturers (
EPA is finalizing more stringent emissions standards for criteria pollutants
For all light-duty vehicles and gasoline medium-duty vehicles, EPA is finalizing a particulate matter (PM) standard of 0.5 mg/mile and a requirement that the standard be met across three test cycles, including a cold temperature (−7°C) test. This standard revises the existing PM standards established in the 2014 Tier 3 rule. Through the application of readily available emissions control technology and requiring compliance across the broad range of driving conditions represented by the three test cycles, EPA projects the standards will reduce tailpipe PM emissions from ICE vehicles by over 95 percent. In addition to reducing PM emissions, the standards will reduce emissions of mobile source air toxics.
EPA is finalizing in-use standards for medium-duty vehicles with high gross combination weight rating (GCWR), changes to medium-duty vehicle refueling emissions requirements for incomplete vehicles, and several NMOG+NO
EPA is establishing new requirements related to battery durability for PEVs, substantially as proposed. As described in more detail in section III.G.2 of this preamble, the importance of battery durability in the context of PEVs is well documented and has been cited by several authorities in recent years. Because electrified vehicles are playing an increasing role in automakers' compliance strategies, their durability and reliability are important to achieving the full useful life for which emissions reductions are projected under this program. To this end we are establishing battery durability monitoring and performance requirements for light-duty PEVs and battery durability monitoring requirements for medium-duty PEVs. In addition, the agency is including PEV batteries and associated electric powertrain components under existing emission warranty provisions. Relatedly, EPA is also finalizing the addition of two new grouping definitions for PEVs (monitor family and battery durability family), new reporting requirements, and a new calculation for the PHEV charge depletion test to support the battery durability requirements. The background and content of the battery durability and warranty provisions are outlined in section III.G.2 of this preamble.
EPA is finalizing various improvements to the current light-duty program to clarify, simplify, streamline and update the certification and testing provisions for manufacturers. These improvements include: Clarification of the certification compliance and enforcement requirements for CO
This section summarizes our analyses of the rule's estimated emission impacts, costs, and monetized benefits, which are described in more detail in sections V through VIII of this preamble. EPA notes that, consistent with CAA section 202, in evaluating potential standards we carefully weighed the statutory factors, including the emissions impacts of the standards, and the feasibility of the standards (including cost of compliance in light of available lead time). We monetize benefits of the standards and evaluate costs in part to enable a comparison of costs and benefits pursuant to E.O. 12866, but we recognize there are benefits that we are currently unable to fully quantify and monetize. EPA's practice has been to set standards to achieve improved air quality consistent with CAA section 202, and not to rely on cost-benefit calculations, with their uncertainties and limitations, as identifying the appropriate standards. Nonetheless, our conclusion that the monetized estimated benefits exceed the estimated costs of the final program reinforces our view that the standards are appropriate under section 202(a).
The standards will result in substantial net reductions of emissions of GHGs and criteria air pollutants in 2055, considering the impacts from light- and medium-duty vehicles, power plants (
These GHG emission reductions will make an important contribution to efforts to limit climate change and subsequently reduce the probability of severe climate change related impacts including heat waves, drought, sea level rise, extreme climate and weather events, coastal flooding, and wildfires. People of color, low-income populations and/or indigenous peoples may be especially vulnerable to the impacts of climate change (see section VIII.J.2 of this preamble).
The decreases in vehicle emissions will reduce traffic-related pollution in close proximity to roadways. As discussed in section II.C.8 of this preamble, concentrations of many air pollutants are elevated near high-traffic roadways, and populations who live, work, or go to school near high-traffic roadways experience higher rates of numerous adverse health effects, compared to populations far away from major roads. An EPA study estimated that 72 million people live near truck freight routes, which includes many large highways and other routes where light- and medium-duty vehicles operate.
The changes in emissions of criteria and toxic pollutants from vehicles, EGUs, and refineries will also impact ambient levels of ozone, PM
Climate benefits are monetized using estimates of the social cost of greenhouse gases (SC-GHG), which in principle includes the value of all climate change impacts (both negative and positive), however in practice, data and modeling limitations naturally restrain the ability of SC-GHG estimates to include all the important physical, ecological, and economic impacts of climate change, such that the estimates are a partial accounting of climate change impacts and will therefore, tend to be underestimates of the marginal benefits of abatement. In our proposal, EPA used interim Social Cost of GHGs (SC-GHG) values developed for use in benefit-cost analyses until updated estimates of the impacts of climate change could be developed based on the best available science and economics. In response to recent advances in the scientific literature on climate change and its economic impacts, incorporating recommendations made by the National Academies of Science, Engineering, and Medicine (National Academies, 2017), and to address public comments on this topic, for this final rule we are using updated SC-GHG values. EPA presented these updated values in a sensitivity analysis in the December 2022 Oil and Gas Rule RIA which underwent public comment on the methodology and use of these estimates as well as external peer review. After consideration of public comment and peer review, EPA issued a technical report in December 2023 updating the estimates of SC-GHG in light of recent information and advances. This is discussed further in section VIII.E.1 of this preamble and RIA Chapter 9.
EPA estimates that the total benefits of this action far exceed the total costs with the annualized value of monetized net benefits to society estimated at $99 billion through the year 2055, assuming a 2 percent discount rate, as shown in Table 8.
The annualized value of vehicle technology costs is estimated at $40 billion. Notably, this rule will result in significant savings in vehicle maintenance and repair for consumers, which we estimate at an annualized value of $16 billion (note that these values are presented as negative costs, or savings, in the table). EPA projects generally lower maintenance and repair costs for electric vehicles and those societal maintenance and repair savings grow significantly over time. We also estimate various impacts associated with our assumption that consumers choose to drive more due to the lower cost of driving under the standards, called the rebound effect (as discussed further in section VIII of this preamble and in Chapters 4, 8 and 9 of the RIA). Increased traffic noise and congestion costs are two such effects due to the rebound effect, which we estimate at an annualized value of $1.2 billion.
EPA also estimates impacts associated with fueling the vehicles under our standards. The rule will provide significant savings to society through reduced fuel expenditures with annualized pre-tax fuel savings of $46 billion. Somewhat offsetting those fuel savings is the expected cost of EV chargers, or electric vehicle supply equipment (EVSE), of $9 billion.
This rule includes other benefits not associated with emission reductions. Energy security benefits are estimated at an annualized value of $2.1 billion. The drive value benefit, which is the value of consumers' choice to drive more under the rebound effect, has an estimated annualized value of $2.1 billion. The refueling time impact includes two effects: time saved refueling for ICE vehicles with lower
Note that some costs are shown as negative values in Table 8. Those entries represent savings but are included under the “costs” category because, in past rules, categories such as repair and maintenance have been viewed as costs of vehicle operation; as discussed above, under this rule we project significant savings in repair and maintenance costs for consumers. Where negative values are shown, we are estimating that those costs are lower under the final standards than in the No Action case.
As described in section VII of this preamble and RIA Chapter 7, EPA conducted an air quality modeling analysis of a light- and medium-duty vehicle policy scenario in 2055. The results of that analysis found that in 2055, consistent with the emission inventory results presented in section VII of the preamble,
EPA estimates the average upfront per-vehicle cost for manufacturers to meet the light-duty standards to be approximately $1,200 on average over the six-year rulemaking period between MYs 2027-2032, and range from about $200 in MY 2027 to about $2,100 in MY 2032, as shown in Table 9.
For medium-duty vehicles, EPA estimates the average upfront per-vehicle cost for manufacturers to be approximately $1,400 over the six-year rulemaking period between MYs 2027-2032 and range from an average cost of about $100 in MY 2027 to about $3,300 in MY 2032, as shown in Table 10.
In addition, the standards will result in significant savings for consumers from fuel savings for all vehicles and, for PEVs, reduced vehicle repair and maintenance. These lower operating costs will offset the upfront vehicle costs. The annualized retail fuel savings, which include fuel taxes and therefore represents the amount consumers will save through 2055, are estimated at $57 billion at a 2 percent discount rate, see section VIII.C of this preamble. These savings are in addition to the already mentioned savings associated with reduced maintenance and repair costs (See section VIII.B of this preamble and Chapter 4 of the RIA).
Elevated concentrations of greenhouse gases (GHGs) have been warming the planet, leading to changes in the Earth's climate that are occurring at a pace and in a way that threatens human health, society, and the natural environment. While EPA is not making any new scientific or factual findings with regard to the well-documented impact of GHG emissions on public health and welfare in support of this rule, EPA is providing in this section a brief scientific background on climate change to offer additional context for this rulemaking and to help the public understand the public health and environmental impacts of GHGs.
Extensive information on climate change is available in the scientific assessments and the EPA documents that are briefly described in this section, as well as in the technical and scientific information supporting them. One of those documents is EPA's 2009 Endangerment and Cause or Contribute Findings for Greenhouse Gases Under section 202(a) of the Clean Air Act (CAA) (74 FR 66496, December 15, 2009). In the 2009 Endangerment Finding, the Administrator found under section 202(a) of the CAA that elevated atmospheric concentrations of six key well-mixed GHGs—CO
The 2009 Endangerment Finding also documented, together with the extensive scientific and technical evidence in the supporting record, that climate change touches nearly every aspect of public welfare
In 2016, the Administrator issued a similar finding for GHG emissions from aircraft under section 231(a)(2)(A) of the CAA.
Since the 2016
1 IPCC, 2023: Summary for Policymakers. In: Climate Change 2023: Synthesis Report. Contribution of Working Groups I, II and III to the Sixth Assessment Report of the Intergovernmental Panel on Climate Change [Core Writing Team, H. Lee and J. Romero (eds.)]. IPCC, Geneva, Switzerland, pp. 1-34, doi:10.59327/IPCC/AR6-9789291691647.001.
The most recent information demonstrates that the climate is continuing to change in response to the human-induced buildup of GHGs in the atmosphere. These recent assessments show that atmospheric concentrations of GHGs have risen to a level that has no precedent in human history and that they continue to climb, primarily because of both historical and current anthropogenic emissions, and that these elevated concentrations endanger our health by affecting our food and water sources, the air we breathe, the weather we experience, and our interactions with the natural and built environments. For example, atmospheric concentrations of one of these GHGs, CO
The assessment literature demonstrates that modest additional amounts of warming may lead to a climate different from anything humans have ever experienced. The 2022 CO
The NCA4 found that it is very likely (greater than 90 percent likelihood) that by mid-century, the Arctic Ocean will be almost entirely free of sea ice by late summer for the first time in about 2 million years.
Every additional increment of temperature comes with consequences. For example, the half degree of warming from 1.5 to 2 °C (0.9 °F of warming from 2.7 °F to 3.6 °F) above preindustrial temperatures is projected on a global scale to expose 420 million more people to extreme heatwaves at least every five years, and 62 million more people to exceptional heatwaves at least every five years (where heatwaves are defined based on a heat wave magnitude index which takes into account duration and intensity—using this index, the 2003 French heat wave that led to almost 15,000 deaths would be classified as an “extreme heatwave” and the 2010 Russian heatwave which led to thousands of deaths and extensive wildfires would be classified as “exceptional”). It would increase the frequency of sea-ice-free Arctic summers from once in 100 years to once in a decade. It could lead to 4 inches of additional sea level rise by the end of the century, exposing an additional 10 million people to risks of inundation as well as increasing the probability of triggering instabilities in either the Greenland or Antarctic ice sheets. Between half a million and a million additional square miles of permafrost would thaw over several centuries. Risks to food security would increase from medium to high for several lower-income regions in the Sahel, southern Africa, the Mediterranean, central Europe, and the Amazon. In addition to food security issues, this temperature increase would have implications for human health in terms of increasing ozone concentrations, heatwaves, and vector-borne diseases (for example, expanding the range of the mosquitoes which carry dengue fever, chikungunya, yellow fever, and the Zika virus, or the ticks which carry Lyme, babesiosis, or Rocky Mountain Spotted Fever).
The NCA4 also evaluated a number of impacts specific to the United States. Severe drought and outbreaks of insects like the mountain pine beetle have killed hundreds of millions of trees in the western United States. Wildfires have burned more than 3.7 million acres in 14 of the 17 years between 2000 and 2016, and Federal wildfire suppression costs were about a billion dollars annually.
EPA modeling efforts can further illustrate how these impacts from climate change may be experienced across the United States. EPA's Framework for Evaluating Damages and Impacts (FrEDI)
Some GHGs also have impacts beyond those mediated through climate change. For example, elevated concentrations of CO
These scientific assessments, the EPA analyses, and documented observed changes in the climate of the planet and of the United States present clear support regarding the current and future dangers of climate change and the importance of GHG emissions mitigation.
Particulate matter (PM) is a complex mixture of solid particles and liquid droplets distributed among numerous atmospheric gases which interact with solid and liquid phases. Particles in the atmosphere range in size from less than 0.01 to more than 10 micrometers (µm) in diameter.
Most particles are found in the lower troposphere, where they can have residence times ranging from a few hours to weeks. Particles are removed from the atmosphere by wet deposition, such as when they are carried by rain or snow, or by dry deposition, when particles settle out of suspension due to gravity. Atmospheric lifetimes are generally longest for PM
Particulate matter consists of both primary and secondary particles. Primary particles are emitted directly from sources, such as combustion-related activities (
There are two primary NAAQS for PM
We received comments on the proposal that referenced EPA modeling of ambient concentrations in 2032 that indicates that the primary annual PM
Ground-level ozone pollution forms in areas with high concentrations of ambient NO
The processes underlying ozone formation, transport, and accumulation are complex. Ground-level ozone is produced and destroyed by an interwoven network of free radical reactions involving the hydroxyl radical (OH), NO, NO
When ambient VOC concentrations are high, comparatively small amounts of NO
The primary NAAQS for ozone, established in 2015 and retained in 2020, is an 8-hour standard with a level of 0.07 ppm.
States with ozone nonattainment areas are required to take action to bring those areas into attainment. The attainment date assigned to an ozone nonattainment area is based on the area's classification. The attainment dates for areas designated nonattainment for the 2008 8-hour ozone NAAQS are in the 2015 to 2032 timeframe, depending on the severity of the problem in each area. Attainment dates for areas designated nonattainment for the 2015 ozone NAAQS are in the 2021 to 2038 timeframe, again depending on the severity of the problem in each area.
Oxides of nitrogen (NO
Sulfur dioxide (SO
EPA most recently completed a review of the primary SO
Carbon monoxide (CO) is a colorless, odorless gas formed by incomplete combustion of carbon-containing fuels and by photochemical reactions in the atmosphere. Nationally, particularly in urban areas, the majority of CO emissions to ambient air come from mobile sources.
Diesel exhaust is a complex mixture composed of particulate matter, carbon dioxide, oxygen, nitrogen, water vapor, carbon monoxide, nitrogen compounds, sulfur compounds and numerous low-molecular-weight hydrocarbons. A number of these gaseous hydrocarbon components are individually known to be toxic, including aldehydes, benzene and 1,3-butadiene. The diesel particulate matter present in diesel exhaust consists mostly of fine particles (<2.5 µm), of which a significant fraction is ultrafine particles (<0.1 µm). These particles have a large surface area which makes them an excellent medium for adsorbing organics and their small size makes them highly respirable. Many of the organic compounds present in the gases and on the particles, such as polycyclic organic matter, are individually known to have mutagenic and carcinogenic properties.
Diesel exhaust varies significantly in chemical composition and particle sizes between different engine types (heavy-duty, light-duty), engine operating conditions (idle, acceleration, deceleration), and fuel formulations (high/low sulfur fuel). Also, there are emissions differences between onroad and nonroad engines because the nonroad engines are generally of older technology. After being emitted in the engine exhaust, diesel exhaust undergoes dilution as well as chemical and physical changes in the atmosphere. The lifetimes of the components present in diesel exhaust range from seconds to months.
The most recent available data indicate that millions of Americans live in areas where air toxics pose potential health concerns.
Emissions sources impacted by this rulemaking, including vehicles and power plants, emit pollutants that contribute to ambient concentrations of PM, ozone, NO
Additionally, because children have increased vulnerability and susceptibility for adverse health effects related to air pollution exposures, EPA's findings regarding adverse effects for children related to exposure to pollutants that are impacted by this rule are noted in this section. The increased vulnerability and susceptibility of children to air pollution exposures may arise because infants and children generally breathe more relative to their size than adults do, and consequently may be exposed to relatively higher amounts of air pollution.
Information on environmental effects associated with exposure to these pollutants is included in section II.D of the preamble, information on environmental justice is included in section VIII.I of the preamble and information on emission reductions and air quality impacts from this rule are included in sections VI and VII of this preamble.
Scientific evidence spanning animal toxicological, controlled human exposure, and epidemiologic studies shows that exposure to ambient PM is associated with a broad range of health effects. These health effects are discussed in detail in the Integrated Science Assessment for Particulate Matter, which was finalized in December 2019 (2019 p.m. ISA), with a more targeted evaluation of studies published since the literature cutoff date of the 2019 p.m. ISA in the Supplement to the Integrated Science Assessment for PM (Supplement).
EPA has concluded that recent evidence in combination with evidence evaluated in the 2009 p.m. ISA supports a “causal relationship” between both long- and short-term exposures to PM
As discussed extensively in the 2019 p.m. ISA and the Supplement, recent studies continue to support a “causal relationship” between short- and long-term PM
The 2019 p.m. ISA concluded a “causal relationship” between long-term PM
A large body of studies examining both short- and long-term PM
Studies evaluated in the 2019 p.m. ISA continue to provide evidence of a “likely to be causal relationship” between both short- and long-term PM
Since the 2009 p.m. ISA, a growing body of scientific evidence examined the relationship between long-term PM
Building off the decades of research demonstrating mutagenicity, DNA damage, and other endpoints related to genotoxicity due to whole PM exposures, recent experimental and epidemiologic studies focusing specifically on PM
For the additional health effects categories evaluated for PM
In addition to evaluating the health effects attributed to short- and long-term exposure to PM
For both PM
For UFPs, which have often been defined as particles less than 0.1 µm, the uncertainty in the evidence for the health effect categories evaluated across experimental and epidemiologic studies reflects the inconsistency in the exposure metric used (
The 2019 PM ISA cites extensive evidence indicating that “both the general population as well as specific populations and life stages are at risk for PM
This section provides a summary of the health effects associated with exposure to ambient concentrations of ozone.
For short-term exposure to ozone, the Ozone ISA concludes that respiratory effects, including lung function decrements, pulmonary inflammation, exacerbation of asthma, respiratory-related hospital admissions, and mortality, are causally associated with ozone exposure. It also concludes that metabolic effects, including metabolic syndrome (
For long-term exposure to ozone, the Ozone ISA concludes that respiratory effects, including new onset asthma, pulmonary inflammation and injury, are likely to be causally related with ozone exposure. The Ozone ISA characterizes the evidence as suggestive of a causal relationship for associations between long-term ozone exposure and cardiovascular effects, metabolic effects, reproductive and developmental effects, central nervous system effects and total mortality. The evidence is inadequate to infer a causal relationship between chronic ozone exposure and increased risk of cancer.
Finally, interindividual variation in human responses to ozone exposure can result in some groups being at increased risk for detrimental effects in response to exposure. In addition, some groups are at increased risk of exposure due to their activities, such as outdoor workers and children. The Ozone ISA identified several groups that are at increased risk for ozone-related health effects. These groups are people with asthma, children and older adults, individuals with reduced intake of certain nutrients (
The most recent review of the health effects of oxides of nitrogen completed by EPA can be found in the 2016 Integrated Science Assessment for Oxides of Nitrogen—Health Criteria (Oxides of Nitrogen ISA).
In evaluating a broader range of health effects, the 2016 ISA for Oxides of Nitrogen concluded that evidence is “suggestive of, but not sufficient to infer, a causal relationship” between short-term NO
The 2016 ISA for Oxides of Nitrogen concluded that people with asthma, children, and older adults are at increased risk for NO
This section provides an overview of the health effects associated with SO
For long-term SO
Consistent associations between short-term exposure to SO
Information on the health effects of carbon monoxide (CO) can be found in the January 2010 Integrated Science Assessment for Carbon Monoxide (CO ISA).
Controlled human exposure studies of subjects with coronary artery disease show a decrease in the time to onset of exercise-induced angina (chest pain) and electrocardiogram changes following CO exposure. In addition, epidemiologic studies presented in the CO ISA observed associations between short-term CO exposure and cardiovascular morbidity, particularly increased emergency room visits and hospital admissions for coronary heart disease (including ischemic heart disease, myocardial infarction, and angina). Some epidemiologic evidence is also available for increased hospital admissions and emergency room visits for congestive heart failure and cardiovascular disease as a whole. The CO ISA concludes that a causal relationship is likely to exist between short-term exposures to CO and cardiovascular morbidity. It also concludes that available data are inadequate to conclude that a causal relationship exists between long-term exposures to CO and cardiovascular morbidity.
Animal studies show various neurological effects with in-utero CO exposure. Controlled human exposure studies report central nervous system and behavioral effects following low-level CO exposures, although the findings have not been consistent across all studies. The CO ISA concludes that the evidence is suggestive of a causal relationship with both short- and long-term exposure to CO and central nervous system effects.
A number of studies cited in the CO ISA have evaluated the role of CO exposure in birth outcomes such as preterm birth or cardiac birth defects. There is limited epidemiologic evidence of a CO-induced effect on preterm births and birth defects, with weak evidence for a decrease in birth weight. Animal toxicological studies have found perinatal CO exposure to affect birth weight, as well as other developmental outcomes. The CO ISA concludes that the evidence is suggestive of a causal relationship between long-term exposures to CO and developmental effects and birth outcomes.
Epidemiologic studies provide evidence of associations between short-term CO concentrations and respiratory morbidity such as changes in pulmonary function, respiratory symptoms, and hospital admissions. A limited number of epidemiologic studies considered copollutants such as ozone, SO
Finally, the CO ISA concludes that the epidemiologic evidence is suggestive of a causal relationship between short-term concentrations of CO and mortality. Epidemiologic evidence suggests an association exists between short-term exposure to CO and mortality, but limited evidence is available to evaluate cause-specific mortality outcomes associated with CO exposure. In addition, the attenuation of CO risk estimates which was often observed in co-pollutant models contributes to the uncertainty as to whether CO is acting alone or as an indicator for other combustion-related pollutants. The CO ISA also concludes that there is not likely to be a causal relationship between relevant long-term exposures to CO and mortality.
In EPA's 2002 Diesel Health Assessment Document (Diesel HAD), exposure to diesel exhaust was classified as likely to be carcinogenic to humans by inhalation from environmental exposures, in accordance with the revised draft 1996/1999 EPA cancer guidelines.
In the absence of a cancer unit risk, the Diesel HAD sought to provide additional insight into the significance of the diesel exhaust cancer hazard by estimating possible ranges of risk that might be present in the population. An exploratory analysis was used to characterize a range of possible lung cancer risk. The outcome was that environmental risks of cancer from long-term diesel exhaust exposures could plausibly range from as low as 10
Noncancer health effects of acute and chronic exposure to diesel exhaust emissions are also of concern to EPA. EPA derived a diesel exhaust reference concentration (RfC) from consideration of four well-conducted chronic rat inhalation studies showing adverse pulmonary effects. The RfC is 5 µg/m
It is important to note that the Diesel HAD also briefly summarizes health effects associated with ambient PM and discusses EPA's then-annual PM
Since 2002, several new studies have been published which continue to report increased lung cancer risk associated with occupational exposure to diesel exhaust from older engines. Of particular note since 2011 are three new epidemiology studies that have examined lung cancer in occupational populations, including, truck drivers, underground nonmetal miners, and other diesel motor-related occupations. These studies reported increased risk of lung cancer related to exposure to diesel exhaust, with evidence of positive exposure-response relationships to varying degrees.
In light of the growing body of scientific literature evaluating the health effects of exposure to diesel exhaust, in June 2012 the World Health Organization's International Agency for Research on Cancer (IARC), a recognized international authority on the carcinogenic potential of chemicals and other agents, evaluated the full range of cancer-related health effects data for diesel engine exhaust. IARC concluded that diesel exhaust should be regarded as “carcinogenic to
Light- and medium-duty engine emissions contribute to ambient levels of air toxics that are known or suspected human or animal carcinogens or that have noncancer health effects. These compounds include, but are not limited to, acetaldehyde, benzene, 1, 3-butadiene, formaldehyde, naphthalene, and polycyclic organic matter. These compounds were all identified as national or regional cancer risk drivers or contributors in the 2019 AirToxScreen Assessment.
Acetaldehyde is classified in EPA's IRIS database as a probable human carcinogen, based on nasal tumors in rats, and is considered toxic by the inhalation, oral, and intravenous routes.
The primary noncancer effects of exposure to acetaldehyde vapors include irritation of the eyes, skin, and respiratory tract.
EPA's Integrated Risk Information System (IRIS) database lists benzene as a known human carcinogen (causing leukemia) by all routes of exposure, and concludes that exposure is associated with additional health effects, including genetic changes in both humans and animals and increased proliferation of bone marrow cells in mice.
A number of adverse noncancer health effects, including blood disorders such as preleukemia and aplastic anemia, have also been associated with long-term exposure to benzene.
There is limited information from two studies regarding an increased risk of adverse effects to children whose parents have been occupationally exposed to benzene.
EPA has characterized 1,3-butadiene as carcinogenic to humans by inhalation.
In 1991, EPA concluded that formaldehyde is a Class B1 probable human carcinogen based on limited evidence in humans and sufficient evidence in animals.
The conclusions by IARC and NTP reflect the results of epidemiologic research published since 1991 in combination with previous and more recent animal, human, and mechanistic evidence. Research conducted by the National Cancer Institute reported an increased risk of nasopharyngeal cancer and specific lymphohematopoietic malignancies among workers exposed to formaldehyde.
Health effects of formaldehyde in addition to cancer were reviewed by the Agency for Toxic Substances and Disease Registry in 1999, supplemented in 2010, and by the World Health Organization.
In June 2010, EPA released a draft Toxicological Review of Formaldehyde—Inhalation Assessment through the IRIS program for peer review by the National Research Council (NRC) and public comment.
Naphthalene is found in small quantities in gasoline and diesel fuels. Naphthalene emissions have been measured in larger quantities in both gasoline and diesel exhaust compared with evaporative emissions from mobile sources, indicating it is primarily a product of combustion.
Acute (short-term) exposure of humans to naphthalene by inhalation, ingestion, or dermal contact is associated with hemolytic anemia and damage to the liver and the nervous system.
Naphthalene also causes a number of non-cancer effects in animals following
The term polycyclic organic matter (POM) defines a broad class of compounds that includes the polycyclic aromatic hydrocarbon compounds (PAHs). One of these compounds, naphthalene, is discussed separately in section II.C.7.vii of the preamble. POM compounds are formed primarily from combustion and are present in the atmosphere in gas and particulate form as well as in some fried and grilled foods. Epidemiologic studies have reported an increase in lung cancer in humans exposed to diesel exhaust, coke oven emissions, roofing tar emissions, and cigarette smoke; all of these mixtures contain POM compounds.
Animal studies demonstrate that exposure to benzo[a]pyrene is also associated with developmental (including developmental neurotoxicity), reproductive, and immunological effects. In addition, epidemiology studies involving exposure to PAH mixtures have reported associations between internal biomarkers of exposure to benzo[a]pyrene (benzo[a]pyrene diol epoxide-DNA adducts) and adverse birth outcomes (including reduced birth weight, postnatal body weight, and head circumference), neurobehavioral effects, and decreased fertility. The inhalation RfC for benzo[a]pyrene is 2 × 10
Locations near major roadways generally have elevated concentrations of many air pollutants emitted from motor vehicles. Hundreds of studies have been published in peer-reviewed journals, concluding that concentrations of CO, CO
A large-scale review of air quality measurements in the vicinity of major roadways between 1978 and 2008 concluded that the pollutants with the steepest concentration gradients in vicinities of roadways were CO, ultrafine particles, metals, elemental carbon (EC), NO, NO
For pollutants with relatively high background concentrations relative to near-road concentrations, detecting concentration gradients can be difficult. For example, many carbonyls have high background concentrations because of photochemical breakdown of precursors from many different organic compounds. However, several studies have measured carbonyls in multiple weather conditions and found higher concentrations of many carbonyls downwind of roadways.
In the past 30 years, many studies have been published with results reporting that populations who live, work, or go to school near high-traffic roadways experience higher rates of numerous adverse health effects, compared to populations far away from major roads.
Numerous reviews of this body of health literature have been published. In a 2022 final report, an expert panel of the Health Effects Institute (HEI) employed a systematic review focusing on selected health endpoints related to exposure to traffic-related air pollution.
For several other health outcomes there are publications to suggest the
Numerous studies have also investigated potential mechanisms by which traffic-related air pollution affects health, particularly for cardiopulmonary outcomes. For example, some research indicates that near-roadway exposures may increase systemic inflammation, affecting organ systems, including blood vessels and lungs.
As described in section VIII.I of the preamble, people who live or attend school near major roadways are more likely to be people of color and/or have a low SES. Additionally, people with low SES often live in neighborhoods with multiple stressors and health risk factors, including reduced health insurance coverage rates, higher smoking and drug use rates, limited access to fresh food, visible neighborhood violence, and elevated rates of obesity and some diseases such as asthma, diabetes, and ischemic heart disease. Although questions remain, several studies find stronger associations between air pollution and health in locations with such chronic neighborhood stress, suggesting that populations in these areas may be more susceptible to the effects of air pollution.
The risks associated with residence, workplace, or school near major roads are of potentially high public health significance due to the large population in such locations. We analyzed several data sets to estimate the size of populations living or attending school near major roads. Our evaluation of environmental justice concerns in these studies is presented in section VI.D.3 of this preamble.
Every two years from 1997 to 2009 and in 2011 and 2013, the U.S. Census Bureau's American Housing Survey (AHS) conducted a survey that includes whether housing units are within 300 feet of an “airport, railroad, or highway with four or more lanes.”
In examining schools near major roadways, we used the Common Core of Data from the U.S. Department of Education, which includes information on all public elementary and secondary schools and school districts nationwide.
EPA also conducted a study to estimate the number of people living near truck freight routes in the United States, which includes many large highways and other routes where light- and medium-duty vehicles operate.
EPA's Exposure Factor Handbook also indicates that, on average, Americans spend more than an hour traveling each day, bringing nearly all residents into a high-exposure microenvironment for part of the day.
This section discusses the welfare effects associated with pollutants affected by this rule, specifically particulate matter, ozone, NO
Visibility can be defined as the degree to which the atmosphere is transparent to visible light.
EPA is working to address visibility impairment. Reductions in air pollution from implementation of various programs associated with the Clean Air Act Amendments of 1990 provisions have resulted in substantial improvements in visibility and will continue to do so in the future. Nationally, because trends in haze are closely associated with trends in particulate sulfate and nitrate due to the relationship between their concentration and light extinction, visibility trends have improved as emissions of SO
In the Clean Air Act Amendments of 1977, Congress recognized visibility's value to society by establishing a national goal to protect national parks and wilderness areas from visibility impairment caused by manmade pollution.
EPA has also concluded that PM
The welfare effects of ozone include effects on ecosystems, which can be observed across a variety of scales,
Ozone can produce both acute and chronic injury in sensitive plant species depending on the concentration level and the duration of the exposure.
The Ozone ISA presents more detailed information on how ozone affects vegetation and ecosystems.
The Integrated Science Assessment for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter—Ecological Criteria documents the ecological effects of the deposition of these criteria air pollutants.
Terrestrial, wetland, freshwater, and estuarine ecosystems in the United States are affected by nitrogen enrichment/eutrophication caused by nitrogen deposition. These effects, though improving recently as emissions and deposition decline, have been consistently documented across the United States for hundreds of species and have likely been occurring for decades. In terrestrial systems nitrogen loading can lead to loss of nitrogen-sensitive lichen species, decreased biodiversity of grasslands, meadows and other sensitive habitats, and increased potential for invasive species. In aquatic systems nitrogen loading can alter species assemblages and cause eutrophication. For a broader explanation of the topics treated here, refer to the description in Chapter 6 of the RIA.
The sensitivity of terrestrial and aquatic ecosystems to acidification from nitrogen and sulfur deposition is predominantly governed by the intersection of geology and deposition. Prolonged exposure to excess nitrogen and sulfur deposition in sensitive areas acidifies lakes, rivers, and soils. Increased acidity in surface waters creates inhospitable conditions for biota and affects the abundance and biodiversity of fishes, zooplankton and macroinvertebrates and ecosystem function. Over time, acidifying deposition also removes essential nutrients from forest soils, depleting the capacity of soils to neutralize future acid loadings and negatively affecting forest sustainability. Major effects in forests in the past have included a decline in sensitive tree species, such as red spruce (Picea rubens) and sugar maple (Acer saccharum).
Building materials including metals, stones, cements, and paints undergo natural weathering processes from exposure to environmental elements (
Emissions from producing, transporting, and combusting fuel contribute to ambient levels of pollutants that contribute to adverse effects on vegetation. Volatile organic compounds (VOCs), some of which are considered air toxics, have long been suspected to play a role in vegetation damage.
Research suggests an adverse impact of vehicle exhaust on plants, which has in some cases been attributed to aromatic compounds and in other cases to nitrogen oxides.
This section III of the preamble outlines the final GHG and criteria pollutant standards and related provisions that are included in the rulemaking.
Throughout this section and elsewhere in this FRM, EPA uses the following conventions to identify specific vehicle technology types and groupings, also depicted schematically in Figure 2.
• ICE vehicle: a vehicle powered by an internal combustion engine (ICE).
• Electrified ICE vehicle: a vehicle powered by an ICE and any amount of powertrain electrification (includes MHEV, HEV, PHEV).
• MHEV: Mild Hybrid Electric Vehicle.
• HEV: Hybrid Electric Vehicle (or strong hybrid).
• PHEV: Plug-in Hybrid Electric Vehicle (or near-zero emission vehicle).
• BEV: Battery Electric Vehicle.
• FCEV: Fuel Cell Electric Vehicle.
• PEV: Plug-in Electric Vehicle (refers collectively to BEVs and PHEVs).
• Hybrid: refers collectively to HEVs and MHEVs.
• Zero-emission vehicle: refers collectively to BEV and FCEV.
• Electrified vehicle: refers to any vehicle with powertrain electrification.
EPA is establishing emissions standards for both light-duty vehicles and medium-duty (Class 2b and 3) vehicles. The light-duty vehicle category includes passenger cars, light trucks, and medium-duty passenger vehicles (MDPVs), consistent with previous EPA GHG and criteria pollutant rules.
Additionally, in the context of the criteria pollutant program, the abbreviation LDV refers to light-duty vehicles that are not otherwise designated as a light-duty truck (LDT) or medium-duty passenger vehicle (MDPV). This final rule also amends the definition of MDPV. Light-duty (unabbreviated) refers to LDV, LDT and MDPV combined. LDT with a number following (
EPA is finalizing new standards for both light- and medium-duty vehicles for emissions of GHGs, hydrocarbons plus oxides of nitrogen (NO
EPA notes that it is not finalizing the proposed standards for high GCWR MDVs that would have required compliance with engine-based criteria pollutant emissions standards under EPA's heavy-duty engine standards under 40 CFR part 1036 rather than meeting MDV chassis-based standards. Instead, we are finalizing one of the alternatives for high GCWR MDV criteria pollutant emissions standards on which we solicited comment, specifically, as discussed in section III.D of this preamble, additional in-use standards that are comparable to those recently adopted by California.
This section provides an overview of the prior rules and the standards structures for EPA's light-duty GHG emissions standards, medium-duty GHG emissions standards, and criteria pollutant emissions standards for both light- and medium-duty vehicles.
EPA has issued four rules establishing light-duty vehicle GHG standards, which EPA refers to in this rule based on the year in which the relevant final rule was issued, as shown in Table 11.
The GHG standards have all been based on fleet average CO
For medium-duty vehicles,
The MDV standards are also attribute-based. However, they are based on a “work factor” attribute rather than the footprint attribute used in the light-duty vehicle program. Work-based measures such as payload and towing capability are two key factors that characterize differences in the design of vehicles, as well as differences in how the vehicles are expected to be regularly used. The work factor attribute combines vehicle payload capacity and vehicle towing capacity, in pounds (lb), with an additional fixed adjustment for four-wheel drive vehicles. This adjustment accounts for the fact that four-wheel drive, critical to enabling heavy-duty work (payload or trailer towing) in certain road conditions, results in additional vehicle weight. The GHG standards and work factor are calculated as follows:
Coefficients a and b represent the mathematical slope and offset, respectively, that define the work-factor-based standards.
Under this approach, CO
Since 1971, EPA has, at Congress' direction, been setting emissions standards for motor vehicles. The earliest standards were for light-duty vehicles for hydrocarbons, nitrogen oxides (NO
Most recently, in 2014, EPA adopted Tier 3 emissions standards, which required a further reduction of 60 to 80 percent of emissions (depending on pollutant and vehicle class). Unlike GHG standards, criteria pollutant standards are not attribute-based. The Tier 3 rule included standards for both light-duty and medium-duty vehicles. Similar to the prior Tier 2 standards, Tier 3 established “bins” of Federal Test Procedure (FTP) standards, shown in Table 13 Each bin contains a milligrams per mile (mg/mile) standard for non-methane organic gases (NMOG) plus oxides of nitrogen) or NMOG+NO
Manufacturers select, or assign, a standards bin to each vehicle model and vehicles must meet all of the standards in that bin over the vehicle's full useful life. Each manufacturer must also meet a fleet average NMOG + NO
The Tier 3 rule also established more stringent criteria pollutant emissions standards for MDVs. The Tier 3 MDV standards are also based on a bin structure, but with generally less stringent bin standards and with less stringent NMOG+NO
EPA has also established supplemental Federal test procedure (SFTP) standards for light- and medium-duty vehicles, as well as cold temperature standards for CO and HC. These standards address emissions outside of the FTP test conditions such as at high vehicle speeds and differing ambient temperatures. EPA did not reopen the current SFTP standards in this rulemaking.
This section summarizes the statutory authority for the final rule. Statutory authority for the standards EPA is finalizing is found in CAA section 202(a)(1)-(2), 42 U.S.C. 7521 (a)(1)-(2), which requires EPA to establish standards applicable to emissions of air pollutants from new motor vehicles and engines which in the Administrator's judgment cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare. Section 202(a)(3) further addresses EPA authority to establish standards for emissions of NO
Section III.B.1 of the preamble overviews the text of the relevant statutory provisions read in their context. We discuss the statutory definition of “motor vehicle” in section 216 of the Act, EPA's authority to establish emission standards for such motor vehicles in section 202, and authorities related to compliance and testing in sections 203, 206, and 207.
Section III.B.2 of the preamble addresses comments regarding our legal authority to consider a wide range of technologies, including electrified technologies that completely prevent vehicle tailpipe emissions. EPA's standard-setting authority under section 202 is not limited to any specific type of emissions control technology, such as technologies applicable only to ICE vehicles; rather, the Agency must consider all technologies that reduce emissions from motor vehicles—including technologies that allow for complete prevention of emissions such as battery electric vehicle (BEV) technologies—in light of the lead time provided and the costs of compliance. Many commenters supported EPA's legal authority to consider such technologies. At the same time, the final standards do not require the manufacturers to adopt any specific technological pathway and can be achieved through the use of a variety of technologies, including without producing additional BEVs to comply with this rule.
Section III.B.3 of the preamble summarizes our responses to certain other comments relating to our legal authority, including whether this rule implicates the major questions doctrine, whether EPA has authority for its Averaging, Banking, and Trading (ABT) program, and whether EPA properly considered BEVs as part of the class of vehicles for GHG regulation. We discuss our legal authority and rationale for battery durability and warranty separately in section III.G.2 of the preamble. Additional discussion of legal authority for the entire rule is found in section 2 of the RTC. EPA's assessment of the statutory and other factors in selecting the final standards is found in section V of this preamble, and further discussion of our statutory authority in support of all the revised compliance provisions is found in their respective sections of the preamble.
Title II of the Clean Air Act provides for comprehensive regulation of emissions from mobile sources, authorizing EPA to regulate emissions of air pollutants from all mobile source categories, including motor vehicles under CAA section 202(a). To understand the scope of permissible regulation, we first must understand the scope of the regulated sources. CAA section 216(2) defines “motor vehicle” as “any self-propelled vehicle designed for transporting persons or property on a street or highway.”
Congress delegated to the Administrator the authority to identify available control technologies, and it did not place any restrictions on the types of emission reduction technologies EPA could consider, including different powertrain technologies. By contrast, other parts of the Act explicitly limit EPA's authority by powertrain type,
We turn now to section 202(a)(1)-(2), which provides the statutory authority for the final standards in this action. This section governs EPA's authority to establish standards for light-duty vehicles, as well as to establish GHG standards for heavy-duty vehicles. For vehicles meeting the statutory definition of heavy-duty vehicles, section 202(a)(3) provides additional and more specific criteria governing adoption of certain criteria pollutant emissions standards under section 202(a)(1); we discuss these additional criteria following our general discussion of section 202(a)(1)-(2).
Section 202(a)(1) directs the Administrator to set “standards applicable to the emission of any air pollutant from any class or classes of new motor vehicles or new motor vehicle engines, which in his judgment cause, or contribute to, air pollution which may reasonably be anticipated to endanger public health or welfare.” This core directive has remained the same, with only minor edits, since Congress first enacted it in the Motor Vehicle Pollution Control Act of 1965.
The statute directs EPA to define the class or classes of new motor vehicles for which the Administrator is making
In 2009, EPA made an endangerment finding for GHG and explicitly stated that “[t]he new motor vehicles and new motor vehicle engines . . . addressed are: Passenger cars, light-duty trucks, motorcycles, buses, and medium and heavy-duty trucks.” (74 FR 66496, 66537, December 15, 2009)
For purposes of establishing GHG emissions standards, EPA has regarded passenger cars, light, medium, and heavy-duty trucks each as its own class and has then made further sub-categorizations based on weight and functionality in promulgating standards for the air pollutant. EPA's class and categorization framework allows the Agency to recognize real-world variations in how vehicles are designed to be used, as well as the lead time and costs of emissions control technology for different vehicle types. It also ensures that consumers can continue to access a wide variety of vehicles to meet their mobility needs, while enabling continued emissions reductions for all vehicle types, including to the point of completely preventing emissions where appropriate.
In setting standards, CAA section 202(a)(1) requires that any standards promulgated thereunder “shall be applicable to such vehicles and engines for their useful life (as determined under [CAA section 202(d)], relating to useful life of vehicles for purposes of certification), whether such vehicle and engines are designed as complete systems or incorporate devices to prevent or control such pollution.”
While emission standards set by EPA under CAA section 202(a)(1) generally do not mandate use of particular technologies, they are technology-based, as the levels chosen must be premised on a finding of technological feasibility. EPA must therefore necessarily identify potential control technologies, evaluate the rate each technology could be introduced, and its cost. Standards promulgated under CAA section 202(a) are to take effect only “after such period as the Administrator finds necessary to permit the development and application of the requisite technology, giving appropriate consideration to the cost of compliance within such period.”
Although standards under CAA section 202(a)(1) are technology-based, they are not based exclusively on technological capability. Pursuant to the broad grant of authority in section 202, when setting emission standards, EPA must consider certain factors and may also consider other relevant factors and has done so previously when setting such standards. For instance, in the
Rather than specifying levels of stringency in section 202(a)(1)-(2), Congress directed EPA to determine the appropriate level of stringency for the standards taking into consideration the statutory factors therein. EPA has clear authority to set standards under CAA section 202(a)(1)-(2) that are technology forcing when EPA considers that to be appropriate,
We now turn to the more specific statutory authority for the heavy-duty criteria pollutant standards found in section 202(a)(3). This more specific statutory authority applies only for heavy-duty vehicles, which include light-duty trucks (LDTs) that have gross vehicle weight ratings above 6,000 pounds and all MDVs.
We now turn from section 202(a) to overview several other sections of the Act relevant to this action. CAA section 202(d) directs EPA to prescribe regulations under which the “useful life” of vehicles and engines shall be determined for the purpose of setting standards under CAA section 202(a)(1). Useful life standards for LDV and MDV are described in 40 CFR 86.1805-17.
Additional sections of the Act provide authorities relating to compliance, including certification, testing, and warranty. Under section 203 of the CAA, sales of vehicles are prohibited unless the vehicle is covered by a certificate of conformity, and EPA issues certificates of conformity pursuant to section 206 of the CAA. based on pre-sale testing conducted either by EPA or by the manufacturer. The Federal Test Procedure (FTP or “city” test) and the Highway Fuel Economy Test (HFET or “highway” test) are used for this purpose. Compliance with standards is required not only at certification but throughout a vehicle's useful life, so that testing requirements may continue post-certification. To assure each vehicle complies during its useful life, EPA may apply an adjustment factor to account for vehicle emission control deterioration or variability in use. EPA also establishes the test procedures under which compliance with the CAA emissions standards is measured. EPA has also developed tests with additional cycles (the so-called 5-cycle tests) which are used for purposes of fuel economy labeling, SFTP standards, and extending off-cycle credits under the light-duty vehicle GHG program. The regulatory provisions for demonstrating compliance with emissions standards have been successfully implemented for decades, including compliance through our Averaging, Banking, and Trading (ABT) program.
Under CAA section 207(a), manufacturers are required to provide emission-related warranties. The generally applicable emission-related warranty period for new LD vehicles and engines under section 207(i)(1) is 2 years or 24,000 miles. For components designated by the Administrator as “specified major emission control component[s]” under section 207(i)(2), the warranty period is 8 years or 80,000 miles. The emission-related warranty period for HD engines and vehicles under CAA section 207(i)(1) is “the period established by the Administrator by regulation (promulgated prior to November 15, 1990) for such purposes unless the Administrator subsequently modifies such regulation.” CAA section 207 also grants EPA broad authority to require manufacturers to remedy
Having provided an overview of the key statutory authorities for this action, we now elaborate on the specific issue of the types of control technology that are to be considered in setting standards. EPA's position on this issue is consistent with our position in our prior GHG and criteria pollutant rules, and with the historical exercise of the Agency's authority over the last five decades, including under section 202(a)(1)-(2) as well as section 202(a)(3)(A). That is, EPA's standard-setting authority under section 202(a)(1)-(2) is not
In response to the proposed rulemaking, the agency received numerous comments on this issue, specifically on our consideration of BEV technologies. Comments of regulated entities relating to these technologies, and those of many stakeholders, were often technical and policy in nature; for example, relating to the pace at which manufacturers could adopt and deploy such technologies in the real world or the pace at which enabling infrastructure could be deployed. We address these comments in detail in section III.C and III.D of this preamble and sections 3 and 17 of the RTC and have revised the standards from those proposed after consideration of comments.
A few commenters, however, alleged that the agency lacked statutory authority altogether to consider BEVs because they believed the Act limited EPA to considering only technologies applicable to ICE vehicles or to technologies that reduce, rather than altogether prevent, pollution. EPA disagrees. The constraints they would impose have no foundation in the statutory text, are contrary to the statutory purpose, are undermined by a substantial body of statutory and legislative history, and are inconsistent with how the agency has applied the statute in numerous rulemakings over five decades. The following discussion elaborates our position on this issue; further discussion is found in section 2 of the RTC.
The text of the Act directly addresses this issue and unambiguously provides authority for EPA to consider all motor vehicle technologies, including a range of electrified technologies such as fully-electrified vehicle technologies without an ICE that achieve zero vehicle tailpipe emissions (
While the statute also imposes certain specific limitations on EPA's consideration of technology, none of these statutory limitations preclude the consideration of electrified technologies, a subset of electrified technologies, or any other technologies that achieve zero vehicle tailpipe emissions. Specifically, the statute states that the following technologies cannot serve as the basis for the standards: first, technologies which cannot be developed and applied within the relevant time period, giving appropriate consideration to the cost of compliance; and second, technologies that “cause or contribute to an unreasonable risk to public health, welfare, or safety in [their] operation or function.” CAA section 202(a)(2), (4).
Having discussed what the statutory text does say, we note what the statutory text does not say. Nothing in section 202(a)(1)-(2) distinguishes technologies that prevent vehicle tailpipe emissions from other technologies as being suitable for consideration in establishing the standards. Moreover, nothing in the statute suggests that certain kinds of electrified technologies are appropriate for consideration while other kinds of electrified technologies are not.
ICE vehicles are equipped with alternators that generate electricity and batteries that store such electricity. The electricity in turn is used for numerous purposes, such as starting the ICE and powering various vehicle electronics and accessories. More specifically, electrified technology is a vital part of controlling emissions on all new motor vehicles produced today: motor vehicles rely on electronic control modules for controlling and monitoring their operation, including the fuel mixture (whether gasoline fuel, diesel fuel, natural gas fuel, etc.), ignition timing, transmission, and emissions control system. In enacting the Clean Air Act Amendments of 1990, Congress itself recognized the great importance of this particular electrified technology for emissions control in certain vehicles.
Indeed, many of the extensive suite of technologies that manufacturers have devised for controlling emissions rely on electrified technology and do so in a host of different ways. These include technologies that improve the efficiency of the engine and system of propulsion, such as the electronic control modules, electronically-controlled fuel injection (for all manners of fuel including but not limited to gasoline, diesel, natural gas, propane, and hydrogen), and automatic transmission; technologies that reduce the amount of ICE engine use such as engine start-stop technology and other idle reduction technologies; add-on technologies to control pollution after it has been generated by the engine, such as gasoline three-way catalysts, and diesel selective catalytic reduction and particulate filters that rely on electrified technology to control and monitor their performance; non-engine technologies that rely on electrified systems to improve vehicle aerodynamics; technologies related to vehicle electricity production, such as high efficiency alternators; and engine accessory technologies that increase the efficiency of the vehicle, such as electric coolant pumps, electric steering pumps, and electric air conditioning compressors. Because electrified technologies reduce emissions, EPA has long considered them relevant for regulatory purposes under Title II. For example, EPA has relied on various such technologies to justify the feasibility of the standards promulgated under section 202(a), promulgated requirements and guidance related to testing involving such technologies under section 206, required manufacturers to provide warranties for them under section 207, and prohibited their tampering under section 203.
Certain vehicles rely to a greater extent on electrification as an emissions control strategy. These include (1) hybrid vehicles, which rely principally on an ICE to power the wheels, but also derive propulsion from an on-board electric motor, which can charge batteries through regenerative braking, and feature a range of larger batteries than non-hybrid ICE vehicles;
EPA's interpretation also accords with the purpose and primary operation of section 202(a), which is to reduce emissions of air pollutants from motor vehicles that are anticipated to endanger public health or welfare.
The surrounding statutory context further highlights that Congress intended section 202 to lead to reductions to the point of complete pollution prevention. Consistent with section 202(a)(1), section 101(c) of the Act states “A primary goal of this chapter is to encourage or otherwise promote reasonable Federal, State, and local governmental actions, consistent with the provisions of this chapter, for pollution prevention.”
This reading of the statute accords with the practical reality of administering an effective emissions control program, a matter in which the Agency has developed considerable expertise over the last five decades. Such a program is necessarily predicated on the continuous development of increasingly effective emissions control technologies. In determining the standards, EPA appropriately considers updated data and analysis on pollution control technologies, without
For all these reasons, EPA's consideration of electrified technologies and technologies that prevent vehicle tailpipe emissions in establishing the standards is unambiguously permitted by the Act; indeed, given the Act's purpose to use technology to prevent air pollution from motor vehicles, and the agency's factual finding based on voluminous record evidence that BEV technologies are the most effective and available technologies for doing so, the Agency's consideration of such technologies is compelled by the statute. Because the statutory text in its context is plain, we could end our interpretive inquiry here. However, we have taken the additional step of reviewing the extensive statutory and legislative history regarding the kinds of technology, including electric vehicle technology, that Congress expected EPA to consider in exercising its section 202(a) authority. Over six decades of Congressional enactments and statements provide overwhelming support for EPA's consideration of electrified technologies and technologies that prevent vehicle
As explained, section 202 does not specify or expect any particular type of motor vehicle propulsion system to remain prevalent, and it was clear to Congress as early as the 1960s that ICE vehicles might be inadequate to achieve the country's air quality goals. In 1967, the Senate Committees on Commerce and Public Works held five days of hearings on “electric vehicles and other alternatives to the internal combustion engine,” which Chairman Magnuson opened by saying “The electric [car] will help alleviate air pollution and urban congestion. The consumer will benefit from instant starting, reduced maintenance, long life, and the economy of electricity as a fuel. . . . The electric car does not mean a new way of life, but rather it is a new technology to help solve the new problems of our age.”
Since the earliest days of the CAA, Congress has also emphasized that the goal of section 202 is to address air quality hazards from motor vehicles, not to simply reduce emissions from internal combustion engines to the extent feasible. In the Senate Report accompanying the 1970 CAA Amendments, Congress made clear EPA “is expected to press for the development and application of improved technology rather than be limited by that which exists” and identified several “unconventional” technologies that could successfully meet air quality-based emissions targets for motor vehicles.
Moreover, Congress believed that the motor vehicle emissions program could achieve enormous emissions reductions, not merely modest ones, through the application and development of ever-improving emissions control technologies. For example, the Clean Air Act of 1970 required a 90 percent reduction in emissions, which was to be achieved with less lead time than this rule provides for its final standards.
Since that time, Congress has continued to emphasize the importance of technology development to achieving the goals of the CAA.
Congress also directed EPA to phase-in certain section 202(a) standards in CAA section 202(g)-(j).
Similar to EPA's ABT program, these statutory phase-in provisions also evaluated compliance with respect to a manufacturers' fleet of vehicles over the model year. More specifically, CAA section 202(g)-(j) each required a specified percentage of a manufacturer's fleet to meet a specified standard for each model year (
In enacting the Energy Independence and Security Act of 2007, Congress also recognized the possibility of fleet-average standards. The statute barred Federal agencies from acquiring “a light duty motor vehicle or medium duty passenger vehicle that is not a low greenhouse gas emitting vehicle.”
The recently-enacted IRA
This statutory and legislative history, beginning with the 1960s and through the recently enacted IRA, demonstrate Congress's historical and contemporary commitment to reducing motor vehicle emissions through the application of increasingly advanced technologies. Consistent with Congress's intent and this legislative history, EPA's rulemakings have taken the same approach, basing standards on ever-
As previously discussed, beginning in 2010, EPA has set vehicle and engine standards under section 202(a)(1)-(2) for GHGs.
EPA has long established performance-based emissions standards that anticipate the use of new and emerging technologies. In each of EPA's earlier GHG rules, as in this rule, EPA specifically considered the availability of electrified technologies, including BEV technologies.
The above analysis of the statutory text, purpose and history, as well as EPA's history of implementing the statute, demonstrate that the agency must, or at a minimum may, appropriately consider available electrified technologies that completely prevent emissions in determining the final standards. In this rulemaking, EPA has done so. The agency has made the necessary predictive judgments as to potential technological developments that can support the feasibility of the final standards, and also as to the availability of supporting infrastructure and critical minerals necessary to support those technological developments, as applicable. In making these judgments, EPA has adhered to the long-standing approach established by the D.C. Circuit, identifying a reasonable sequence of future developments, noting potential difficulties, and explaining how they may be obviated within the lead time afforded for compliance. EPA has also consulted with other organizations with relevant expertise such as the Departments of Energy and Transportation, including through careful consideration of their reports and related analytic work reflected in the administrative record for this rulemaking.
Although the standards are supported by the Administrator's predictive judgments regarding pollution control technologies and the modeled potential compliance pathway, we emphasize that the final standards are not a mandate for a specific type of technology. They do not legally or de facto require a manufacturer to follow a specific technological pathway to comply. Consistent with our historical practice, EPA is finalizing performance-based standards that provide compliance flexibility to manufacturers. While EPA projects that manufacturers may comply with the standards through the use of certain technologies, including a mix of ICE vehicles, advanced ICE, HEVs, PHEVs, and BEVs, manufacturers may select any technology or mix of technologies that would enable them to meet the final standards.
These choices are real and valuable to manufacturers, as attested to by the historical record. The real-world results of our prior rulemakings make clear that industry sometimes chooses to comply with our standards in ways that the Agency did not anticipate, presumably because it is more cost-effective for them to do so. In other words, while EPA sets standards that are feasible based on our modeling of potential compliance pathways, manufacturers may find what they consider to be better pathways to meet the standards and may opt to comply by following those pathways instead.
For example, in promulgating the 2010 LD GHG rule, EPA modeled a technology pathway for compliance with the MY 2016 standards. In actuality, manufacturers diverged from EPA's projections across a wide range of technologies, instead choosing their own technology pathways best suited for their fleets.
In support of the final standards, EPA has also performed additional modeling demonstrating that the standards can be met in multiple ways. As discussed in section IV.F-G of the final rule preamble and Chapter 2 of the RIA, while our modeled potential compliance pathway includes a mix of ICE, HEV, PHEV and BEV technologies, we also evaluated several examples of potential technology packages and potential compliance pathways. These include sensitivity analyses that account for the implementation of the Advanced Clean Car II program, lower and higher battery costs, faster and slower BEV acceptance, no credit trading, lower BEV production, and no additional BEV production beyond the No-Action case.
In this section, EPA summarizes our response to certain other comments relating to our legal authority. These include three comments relating to our legal authority to consider certain technologies discussed in section III.B.1 of this preamble above: whether this rule implicates the major questions doctrine, whether EPA has authority for its Averaging, Banking, and Trading (ABT) program, and whether EPA erred in considering BEVs as part of the same class as other vehicles in setting the standards. We separately discuss our legal authority and rationale for battery durability and warranty in section III.G.2-3 of the preamble.
EPA does not agree that this rule implicates the major questions doctrine, as that doctrine has been elucidated by the Supreme Court in
First, as we explain in section III.B.2 of the preamble, the statute provides clear Congressional authorization for EPA to consider updated data on pollution control technologies—including BEV technologies—and to determine the emission standards accordingly. In section 202(a), Congress made the major policy decision to regulate air pollution from motor vehicles. Congress also prescribed that EPA should accomplish this mandate through a technology-based approach, and it plainly entrusted to the Administrator's judgment the evaluation of pollution control technologies that are or will become available given the available lead-time and the consequent determination of the emission standards. In the final rule, the Administrator determined that a wide variety of technologies exist to further control GHGs from light- and medium-duty vehicles—including various ICE, hybrid, PHEV, and BEV technologies—and that such technologies could be applied at a reasonable cost to achieve significant reductions of GHG emissions
Second, the agency is not invoking a novel authority. As described above, EPA has been regulating emissions from motor vehicles based upon the availability of feasible technologies to reduce vehicle emissions for over five decades. EPA has regulated GHG emissions since 2010 and criteria pollutant emissions since the 1970s. Our rules have consistently considered available technology to reduce or prevent emissions of the relevant pollutant, including technologies to reduce or completely prevent GHGs. Our consideration of zero-emitting technologies specifically has a long pedigree, beginning with the 1998 National Low Emission Vehicle (NLEV) program. The administrative record here indicates the industry will likely choose to deploy an increasing number of vehicles with emissions control technologies such as PHEV and BEV, in light of new technological advances, the IRA and other government programs, as well as this rule. That the industry will continue to apply the latest technologies to reduce pollution is no different than how the industry has responded to EPA's rules for half a century. The agency's factual findings and resulting determination of the degree of stringency do not represent the exercise of a newfound power. Iterative increases to the stringency of an existing program based on new factual developments hardly reflect an unprecedented expansion of agency authority.
Not only does this rule not invoke any new authority, it also falls well within EPA's traditionally delegated powers. Through five decades of regulating vehicle emissions under the CAA, EPA has developed great expertise in the regulation of motor vehicle emissions. The agency's expertise is reflected in the comprehensive analyses present in the administrative record. The courts have recognized the agency's authority in this area.
Third, this rule does not involve decisions of vast economic and political importance exceeding EPA's delegated authority. To begin with, commenters err in characterizing this rule as a ban on gasoline engines or a zero-emission vehicle mandate. That is false as a legal matter and a practical matter. As a legal matter, this rule does not mandate that any manufacturer use any specific technology to meet the standards in this rule; nor does the rule ban gasoline engines. And as a practical matter, as explained in section IV.F-G of the preamble and Chapter 2 of the RIA, manufacturers can adopt a wide array of technologies, including various ICE, HEV, PHEV, and BEV technologies, to comply with this rule.
Specifically, EPA has concluded that the standards could be met by additional PHEVs and has identified several additional compliance pathways, with a wide range of BEVs, that can be achieved in the lead-time provided and at a reasonable cost. In all of these pathways, manufacturers continue to produce gasoline engine vehicles. Indeed, EPA's central case modeling shows that over 84 percent of the on-road fleet will still use gasoline or diesel in 2032, and 58 percent will in 2055. Moreover, the adoption of additional control technologies, including BEVs, are complementary to what the manufacturers are already doing regardless of this rule. As explained under section I.A.2 of the preamble, the production of new PEVs is growing steadily, and even without this rule, is expected to reach 11.8 percent of U.S. light-duty vehicle production for MY 2023,
Manufacturers have made significant commitments regarding increased production of PEVs as well as supporting announcements that the vast majority of their research and development funding will go towards PEVs, not ICE. These efforts are spurred by a wide range of factors, including the IRA, decreasing costs of producing electric vehicles and their batteries, and more protective GHG standards and EV requirements established by other jurisdictions. To the extent that commenters are concerned about vehicle electrification, that phenomenon is already occurring and accelerating regardless of this final rule. As such, the
The regulatory burdens of this rule are also reasonable and not different in kind from prior exercises of EPA's authority under section 202. The regulated community of vehicle manufacturers in this rule was also regulated by earlier rules. In terms of costs of compliance for regulated entities, the average costs per-vehicle in the final year of the phase-in ($2,100 in MY 2032) fall within the range of prior rules, for example less than that of the 2012 rule ($2,400 in MY 2025).
While section 202 does not require EPA to consider consumer impacts, the agency recognizes that consumer acceptance of new pollution control technologies can affect the adoption of such technologies. As such, EPA carefully evaluated these issues. In the final rule, EPA considered the upfront costs associated with purchasing cleaner vehicles as well as the costs of operating such vehicles over their lifetime. EPA found that lower operating costs for vehicles substantially outweigh the increased technology costs of meeting the standards over the life of the vehicles. EPA also carefully designed the final rule to avoid any other kinds of disruptions to purchasers. For example, we recognize that light- and medium-duty vehicles represent a diverse array of vehicles and use cases, and we carefully tailored the standards to ensure that purchasers could obtain the kinds of vehicles they need. We also recognized that vehicles require supporting infrastructure (
We acknowledge the rule may have other impacts beyond those on regulated entities and their customers (for purposes of discussion here, referred to as “indirect impacts”). But indirect impacts are inherent in section 202 rulemakings, including past rulemakings going back half a century. As the D.C. Circuit has observed, in the specific context of EPA's Clean Air Act Title II authority to regulate motor vehicles, “[e]very effort at pollution control exacts social costs. Congress . . . made the decision to accept those costs.”
EPA carefully analyzed indirect impacts and coordinated with numerous Federal and other partners with relevant expertise, as described in sections III.I-J of the preamble.
EPA also carefully evaluated many indirect impacts outside of the net benefits assessment and we identified no significant indirect harms and the potential for indirect benefits. Based on our analysis, EPA projects that this rulemaking will not cause significant adverse impacts on electric grid reliability or resource adequacy, that there will be sufficient battery production and critical minerals available to support increasing electric vehicle production including due to large increases in domestic battery and critical mineral production, that there will be sufficient lead-time to develop charging infrastructure, and that the rule will have significant positive national security benefits. We also identified significant initiatives by the Federal government (such as the BIL and IRA), State and local government, and private firms, that complement EPA's final rule, including initiatives to reduce the costs to purchase PEVs; support the development of domestic critical mineral, battery, and PEV production; improve the electric grid, and accelerate the establishment of charging infrastructure.
These and other kinds of indirect impacts, moreover, are similar in kind to the impacts of past EPA motor vehicle rules. For example, this rule may reduce the demand for gasoline and diesel for light-duty and medium-duty vehicles domestically and affect the petroleum refining industry, but that has been the case for all of EPA's past GHG vehicle rules, which also reduced demand for liquid fuels through advances in ICE engine and vehicle technologies and corresponding fuel efficiency. And while production of PEVs does rely on a global supply chain, that is true for all motor vehicles, whose production rely extensively on imports, from raw materials like aluminum to components like semiconductors; addressing supply chain vulnerabilities is a key component of managing any significant manufacturing operation in today's global world. Further, while PEVs may require supporting infrastructure to operate, the same is true for ICE vehicles; indeed, supporting infrastructure for ICE vehicles has changed considerably over time in response to environmental regulation, for example, with the elimination of lead from gasoline, the provisioning of diesel exhaust fluid (DEF) at truck stops to support selective catalytic reduction (SCR) technologies, and the introduction of low sulfur diesel fuel to support diesel particulate filter (DPF) technologies.
As with prior vehicle rules, many indirect impacts are positive:
Moreover, many of the indirect impacts find close analogs in the impacts Congress itself recognized and accepted. For instance, in 1970 Congress debated whether to adopt standards that would depend heavily on platinum-based catalysts in light of a world-wide shortage of platinum,
In sum, the final rule is a continuation of what the Administrator has been doing for over fifty years: evaluate updated data on pollution control technologies and set emissions standards accordingly. The rule maintains the fundamental regulatory structure of the existing program and iteratively strengthens the standards from its predecessor rules. The consequences of the rule are analogous to and not different in kind from those of prior rules. And while the rule is associated with indirect impacts, EPA comprehensively assessed such impacts and found that the final rule does not cause significant indirect harms as alleged by commenters and on balance creates net benefits for society. We further discuss our response to the major questions doctrine comments in section 2 of the RTC.
In any event, the CAA authorizes EPA to establish an ABT program and fleet average standards.
ABT and fleet average standards are also consistent with other provisions in Title II, including those related to compliance and enforcement in CAA sections 203, 206, and 207. Commenters who alleged inconsistency with the compliance and enforcement provisions fundamentally misapprehend the nature of EPA's motor vehicle program and the ABT regulations, where compliance and enforcement do in fact apply to individual vehicles consistent with the statute. It is true that ABT allows manufacturers to meet emissions standards by offsetting emissions credits and debits for individual vehicles. However, individual vehicles must also continue to themselves comply with in-use standards applicable on a vehicle-by-vehicle basis throughout that vehicle's useful life. As appropriate, EPA can suspend, revoke, or void certificates for individual vehicles. Manufacturers' warranties, which are mandated under CAA section 207, apply to individual vehicles. EPA and manufacturers perform testing on individual vehicles, and recalls can be implemented based on evidence of non-conformance by a substantial number of individual vehicles within the class. We further discuss our response to this comment, including detailed exposition of each of the relevant statutory provisions, in RTC section 2.
As discussed in section III.B.1 of the preamble, Congress required EPA to prescribe standards applicable to the emission of any air pollutant from any class or classes of new motor vehicles, which in his judgment cause, or contribute to, air pollution which endangers public health and welfare. Congress defined “motor vehicles” by their function: “any self-propelled vehicle designed for transporting persons or property on a street or highway.”
In making the GHG Endangerment Finding in 2009, EPA defined the classes of motor vehicles and engines as “Passenger cars, light-duty trucks, motorcycles, buses, and medium and heavy-duty trucks.”
Some commenters nonetheless contend that BEVs fall outside of EPA's regulatory reach under this provision because they do not cause, or contribute to, air pollution which endangers human health and welfare. That misreads the statutory text. As we explained above in regard to ABT, section 202(a)(1)'s focus on regulating emissions from “class or classes” indicates that Congress was concerned by the air pollution problem generated by a class of vehicles, as opposed to from individual vehicles. Accordingly, Congress authorized EPA to regulate
These commenters also misunderstand the broader statutory scheme. Congress directed EPA to apply the standards to vehicles whether they are designed as complete systems or incorporate devices to prevent or control pollution. Thus, Congress understood that the standards may be premised on and lead to technologies that prevent pollution in the first place. It would be perverse to conclude that in a scheme intended to control the emissions of dangerous pollution, Congress would have prohibited EPA from premising its standards on controls that completely prevent pollution, while also permitting the agency to premise them on a technology that reduces 99 percent of pollution. Such a nonsensical reading of the statute would mean that the availability of technology that can reduce 99 percent of pollution could serve as the basis for highly protective standards, while the availability of a technology that completely prevents the pollution could not be relied on to set emission standards at all. Such a reading would also create a perverse safe harbor allowing polluting vehicles to be perpetually produced, resulting in harmful emissions and adverse impacts on public health, even where available technology permits the complete prevention of such emissions and adverse impacts at a reasonable cost. That result cannot be squared with section 202(a)(1)'s purpose to reduce emissions that “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare,”
Commenters' suggestion that EPA define the class to exclude BEVs would also be unreasonable and unworkable.
Finally, the commenters' argument is factually flawed. All vehicles, including BEVs, do in fact produce vehicle emissions. For example, all BEVs produce emissions from brake and tire wear, as discussed in RIA Chapter 7.2.1.4. Furthermore, BEVs have air conditioning units, which may produce GHG emissions from leakages, and these emissions are subject to regulation under the Act, for instance, as described in section III.C.5 of the preamble. Indeed, EPA has consistently regulated GHG emissions from LD vehicle refrigerants since 2010 through A/C credits. Thus, even under the commenter's reading of the statute, BEVs would be part of the class for regulation.
This section III.C of this preamble provides details regarding EPA's GHG standards and related program provisions under this rulemaking.
For light-duty vehicles, EPA is finalizing standards that land at the same footprint target CO
For medium-duty vehicles, EPA is finalizing work factor-based GHG standards that land at the same stringency as the proposal in MY 2032, but which have a more gradual rate of stringency increase from MYs 2027-2031 than the proposed standards in order to provide additional lead time for compliance. EPA is also phasing in a work factor upper cutpoint at or above 5,500 lb work factor, coinciding with the removal of the proposed 22,000 lb maximum GCWR cap used in the calculation of the work factor. These changes are responsive to concerns from manufacturers over inadequate lead time and comments addressing the targets for the higher capability vehicles. Section III.C.3 of this preamble provides
For light-duty vehicles, the final standards will further reduce the fleet average GHG emissions target levels by nearly 50 percent from the MY 2026 standards. For MDVs, the standards represent a reduction of 44 percent compared to the current MY 2026 standards, which is the final year for Phase 2 standards applying to Class 2b and Class 3 vehicles now that we are finalizing a revised MY 2027 MDV GHG standard.
Additional GHG program provisions are discussed in sections III.C.4-III.C.9 of this preamble, including averaging, banking, and trading, air conditioning system requirements, phase out of off-cycle credits, treatment of PEVs and FCEVs in the GHG fleet average, and interim alternative standards for small volume manufacturers.
While the final standards are more stringent than the prior standards, EPA applied numerous conservative approaches throughout our analysis (as identified in sections III and IV of this preamble and throughout the RIA) and the final standards additionally are less stringent than those proposed during the first several years of implementation leading to MY 2032. The Administrator concludes that this approach is appropriate based on his evaluation of the record and within the discretion provided under and consistent with the text and purpose of CAA section 202(a)(1)-(2).
Since MY 2012, EPA has adopted attribute-based standards for passenger cars and light trucks. The CAA has no requirement to promulgate attribute-based standards, though in past rules EPA has relied on both universal and attribute-based standards (
EPA has implemented footprint-based standards since MY 2012 by establishing two kinds of standards— fleet average standards determined by a manufacturer's fleet makeup, and in-use standards that will apply to the individual vehicles that make up the manufacturer's fleet. Under the footprint-based standards, each manufacturer has a CO
Each manufacturer has separate footprint-based standards for cars and for trucks. EPA did not reopen the provision for separate standard curves for cars and trucks. EPA also did not reopen the existing regulatory definitions of passenger cars and light trucks; we will continue to reference the NHTSA regulatory class definitions as EPA has done since the inception of the GHG program.
In the proposal, EPA requested comment on its methodology for establishing the slopes for the car and truck curves. As discussed further below, upon evaluating the comments, EPA is finalizing our proposed approach of establishing the car and truck footprint curve slopes, as well as the offset between the car and truck footprint standards curves.
In the NPRM, we discussed a methodology for determining the shape of the footprint-based curves for cars and for trucks (a more detailed description of the truck curve as it relates to the car curve, and a discussion of the empirical and modeling data used in developing these offsets is presented in RIA Chapter 1.1.3.2). In general, the slopes of the car and truck curve were reduced for the proposed standards and the alternatives along with a decreased offset between the car and truck curves. We proposed these changes based on our evaluation of updated data, finding that reduced slopes were consistent with manufacturers' increased adoption of more advanced emissions control technologies to meet more stringent standards, as well as our policy goal that manufacturers comply with the emissions standards by adopting advanced emission control technologies as contemplated by the statute, as opposed to engaging in intentional upsizing or downsizing of their fleets.
EPA received a range of comments on the proposed slopes of the car and truck curves.
In its comments, NADA expressed opposition to EPA's consideration of electric vehicles in the derivation of the flatter footprint curve slopes. In contrast, many commenters recommended flattening the curves or setting a flat (zero slope) curve for both cars and trucks. ICCT suggested that EPA should establish an even flatter and “neutral” slope that does not incentivize upsizing. As we explain further below, the proposal and our final decision to flatten the footprint curves is not dependent on any manufacturer adopting BEVs or any other electric vehicle technologies. Rather, vehicles with more advanced control technologies of any kind to meet more stringent emission standards will inherently show less sensitivity of CO
Comments related to the magnitude of the truck offset were also mixed. The
The intent of the proposed AWD offset was to separately and explicitly account for the tailpipe CO
Taking all of these comments into consideration, and for the reasons explained above (and in the RTC), EPA considers the proposed approach for determination of the slope of the car and truck curves, appropriate. Therefore, we are finalizing the shape of the footprint curves as proposed, and as discussed in further detail below.
When setting GHG standards, EPA recognizes the current diversity and distribution of vehicles in the market and that Americans have widely varying preferences in vehicles and that GHG control technology is feasible for a wide variety of vehicles. This is one of the primary reasons for adopting attribute-based standards and is also an important consideration in choosing specific attribute-based standards (
The slopes in the latter years of this rulemaking period are flatter than those of prior standards. This is by design and reflects a continuation of the proportional reduction in targets that has been a fundamental feature of EPA's prior footprint standards, in which as program stringency is increased year over year, the g/mile change is greater for larger footprints than for smaller footprints.
Having discussed our rationale for the flatter slopes, we turn now to change in the truck offset. As noted above, the truck offset consists of both an AWD and a utility offset (which we consider here to include towing and hauling capability). All-wheel drive (AWD) is one of the defining features for crossover vehicles (typically, small to mid-size CUVs,
The light truck classification consists of crossovers (ranging from compact up through large crossovers), sport utility vehicles and pickup trucks. Many crossover vehicles and SUVs exhibit similar towing capability between their 2WD and AWD versions (there are some exceptions in cases where AWD is packaged with a larger more powerful engine than the base 2WD version). However, full size pickup trucks are the light-duty market segment with the most towing and hauling capability.
As proposed, EPA is finalizing that the truck curve be based on the car curve (to represent the base utility across all vehicles for carrying people and their light cargo), but with the additional allowance of increased utility (including AWD) that distinguishes these vehicles used for more work-like activity. EPA determined a relationship between gross combined weight rating (GCWR) (which combines the cumulative utility for hauling and towing to a vehicle's curb weight) and required engine torque. EPA then used its ALPHA model to predict how the tailpipe emissions at equivalent test weight (ETW) (curb weight + 300 pounds) would increase as a function of increased utility (GCWR) based on required engine torque and assumed modest increases in vehicle weight and road loads commensurate with a more tow-capable vehicle.
EPA also assessed the relative magnitude of tow rating across the light truck fleet as a function of footprint. Vehicles with the greatest utility are full size pickup trucks, while light trucks with the least utility tend to be the smaller crossovers, with an increased tow or haul rating near zero. As a result, EPA is finalizing an offset for the truck curve, compared to the car curve, that increases with footprint. That is, as the footprint of the truck increases, we expect that on average its utility would increase proportionally, and therefore the truck curve has a steeper slope than the car curve. Figure 1-9 in RIA Chapter 1 shows the general trend of increased tow rating with increasing footprint. Put more simply, bigger trucks generally have more utility than smaller trucks, so bigger trucks get a bigger utility offset.
In summary, the truck curve is, mathematically, the sum of the scaled AWD and utility-based offsets to the car curve. A more thorough description of the truck curve as it relates to the car curve, and a discussion of the empirical and modeling data used in developing these offsets is presented in RIA Chapter 1.1.3.2.
The cutpoints are defined as the footprint boundaries (low and high) within which the sloped portion of the footprint curve resides. Above the high, and below the low, cutpoints, the curves are flat. The rationale for the setting of the original cutpoints for the MYs 2017-2025 standards was based on analysis of the distribution of vehicle footprint for the 2008 fleet and is discussed in the 2012 proposal
EPA is finalizing, as proposed, an increase to the lower cutpoint for the car curve by 1 square foot per year from MY 2027 through MY 2030 from 41 to 45 square feet. This will provide relatively slightly less stringent targets for the smallest vehicles (compared to the structure of the MY 2023-2026 footprint targets), which we believe is important so as not to disincentivize manufacturers from offering these smallest vehicles which are among the cleanest vehicles. EPA received only supportive comments for the increase of the car lower cutpoint; one commenter requested this change to be immediate. The upper cutpoint for cars (56 feet) will remain unchanged.
EPA also is finalizing, as proposed, a change in the upper cutpoint for trucks. This cutpoint is 74 square feet for the MYs 2023-2026 standards, and under this final rule will decrease by 1.0 square foot per year from MYs 2027 through MY 2030, to a level of 70.0 square feet for MY 2030 and later. EPA is making this change in upper truck cutpoint to ensure no loss of emissions reductions in the future through continued upsizing of the truck fleet. EPA reviewed sales data from recent model years comparing the average footprint of full-size pickup trucks with the upper truck cutpoint. As the upper cutpoint for trucks increased (under past rules) from 66.0 square feet in MY 2016 to 69.0 square feet in MYs 2020-2021, we have observed the average footprint of full-size pickup trucks increasing similarly. The truck size trend and its relationship to the upper cutpoint is detailed in RIA Chapter 1.1.3.4. Because we have observed the trend of trucks upsizing up to the cutpoint, our goal is to bring the upper cutpoint back down to a level that represents a balance between setting an appropriate CO
We consider the MY 2030 and beyond upper truck cutpoint of 70.0 square feet to be appropriate. EPA's assessment is that it is feasible for trucks greater than 70.0 square feet to meet the CO
Some automakers were opposed to the reduction in the upper cutpoint for the truck footprint curve, although several NGOs supported the change in helping to counter the observed trend in upsizing and the associated increase in emissions. EPA agrees that a reduction in the cutpoint (more accurately, returning it close to the current level) should help mitigate the incentive for continued upsizing as a compliance mechanism. EPA notes that the final cutpoint value does not prevent any manufacturer from producing vehicles that have a larger footprint to satisfy customer demand. Rather, it simply ensures that the standards themselves do not incentivize manufacturers to upsize vehicles larger than the upper cutpoint as a compliance strategy. Moreover, as with any CO
Based on the review of the comments related to cutpoints for car and truck curves, EPA is finalizing as proposed the changes to the lower car cutpoint and the upper truck cutpoint. We are implementing the revised cutpoints in a gradual manner over four years to allow manufacturers time to adjust to changes in the relative stringency of CO
EPA is setting separate car and light truck standards—that is, vehicles defined as passenger vehicles (“cars”) have one set of footprint-based standards curves, and vehicles defined as light trucks have a different set.
Figure 7 and Figure 8 show the finalized car and truck curves, respectively, for MY 2027 through MY 2032. Included for reference is the current MY 2026 (No Action) curve for each.
As discussed in section III.C.2.ii of the preamble, the slope of the car curve is significantly flatter in 2027 and continues to flatten progressively each year through 2032. The truck curve, largely driven by the allowance for towing utility, has a similar shape as in past rulemakings although its slope also flattens progressively each year from 2027 through 2032.
EPA is finalizing more stringent standards for MYs 2027-2032 that are projected to result in an industry-wide average target for the light-duty fleet of 85 g/mile of CO
Since the first GHG rule in 2010, EPA's feasibility assessments have consistently considered the full range of technologies available to reduce GHG emissions.
As in our past GHG rules, EPA has analyzed the feasibility of achieving the final CO
The derivation of the 85 g/mile estimated industry-wide target for MY 2032 noted in the previous paragraph is based on EPA's updated fleet mix projections for MY 2032 (approximately 30 percent cars and 70 percent trucks, based on AEO 2023), and is described further in section IV.D of this preamble. EPA aggregated the estimates for individual manufacturers based on projected production volumes into the fleet-wide averages for cars, trucks, and the entire fleet.
Table 19 shows the overall fleet average target levels for both cars and light trucks that are projected for the final standards. A more detailed breakdown of how each manufacturer could potentially choose to achieve the projected CO
EPA has estimated the overall fleet-wide CO
EPA is finalizing standards that set increasingly stringent levels of CO
One important change between the proposed standards and the final standards is related to the phaseout of two optional credit flexibilities: off-cycle credits and A/C leakage credits. As discussed in section III.C.5-6 of this preamble, EPA is finalizing a phase-down of A/C refrigerant-based credits from MY 2027-2030, and thereafter (for MY 2031 and beyond), we are retaining a small optional A/C leakage credit. EPA is finalizing a phase-out of the off-cycle credits which is slower than what we proposed. EPA also is finalizing its proposal to eliminate off-cycle credits and A/C efficiency credits for BEVs beginning in MY 2027.
As with prior rulemakings, our consideration of the level of the standards is based in part on EPA's projection of average industry-wide CO
Table 22 shows the adjusted targets for cars and trucks based on our modeling of the final standards.
In general, the structure of the final standards allows an incremental phase-in to the MY 2032 level and reflects consideration of the appropriate lead time for manufacturers to take actions necessary to meet the standards. The technical feasibility of the standards is discussed in section IV.A of this preamble and in the RIA Chapter 3.6. Note that MY 2032 is the final MY in which the CO
In the NPRM, EPA requested comment on two additional issues regarding the structure of the program: (1) whether the timeframe for the standards should extend beyond MY 2032, and (2) whether there is merit to considering alternative pathways for compliance with the EPA program. This section discusses EPA's consideration of the public comments received on these two topics.
EPA requested comment on whether the trajectory (
A few commenters supported setting standards through MY 2035 as part of this rulemaking. These commenters believed standards through 2035 would set a clear market signal that would provide certainty to manufacturers in their long-term emissions reduction targets. Such commenters also believed that EPA should set standards that achieve zero emissions by 2035 and pointed to consistency with the ACC II program which has been adopted by California and several other states.
Other commenters believed that EPA ultimately should set standards beyond MY 2032, but that it should be done as part of a separate future rulemaking effort. Some commenters believed that EPA should not set standards through MY 2035 as part of this rule, but it was important to them that the final standards are sufficiently stringent through MY 2032 to ensure that the U.S. is on track to reach a zero emissions target by 2035.
Most commenters did not support extending standards beyond MY 2032 at this time. Many of these commenters pointed to the lack of certainty in how the EV market and supporting conditions (like infrastructure) will develop beyond MY 2032. Other commenters suggested that if standards were extended beyond MY 2032, that some form of a mid-course review might be necessary given what they perceived as significant uncertainty in that longer time frame. Other commenters believed that EPA's standards through MY 2032 were important in establishing a trajectory of emission reductions upon which EPA could come back with a future rule to establish appropriate standards for MYs 2033 and beyond. EPA understands commenters' concerns about uncertainty out to the MY 2035 timeframe, and believes it is appropriate to consider standards for MY 2033 and beyond in a future rulemaking. Thus, after considering all of these comments, EPA is finalizing standards for MYs 2027 through MY 2032 for both light-duty and medium-duty vehicles.
While EPA believes the standards are appropriate for light-duty vehicle manufacturers on an overall industry basis, we recognize that some companies today only sell BEVs and others have made public announcements for plans for various advanced technologies, including near-zero and zero-emission vehicle product launches (as discussed in section I.A.2.ii of this preamble) that may lead to CO
EPA sought public comments on whether there might be merit in establishing additional ways in which the program could provide for alternative compliance pathways that could encourage manufacturers to achieve even lower CO
The current program includes additional provisions that we did not reopen and so will continue to be implemented during the timeframe of this rule. We describe them briefly here for informational purposes.
Consistent with the requirement of CAA section 202(a)(1) that standards be applicable to vehicles “for their useful life,” the MY 2027-2032 vehicle standards will apply for the useful life of the vehicle.
The existing program also requires certain test procedures over which emissions are measured and weighted to determine compliance with the GHG standards. These procedures are the Federal Test Procedure (FTP or “city” test) and the Highway Fuel Economy Test (HFET or “highway” test). EPA is making only minor changes to the GHG test procedures in this rulemaking. Namely, EPA will require manufacturers to use the same Tier 3 test fuel already specified for demonstrating compliance with criteria pollutant standards, as described in the next section. We are also revising the fleet utility factor for plug-in hybrid electric vehicles as described in section III.B.8 of the preamble and referencing an updated version of SAE J1711 to reflect the latest developments in measurement procedures for all types of hybrid electric vehicles as described in section IX.I of the preamble.
Within the structure of the footprint-based GHG standards, EPA is also finalizing that gasoline powered vehicle compliance with the standards be demonstrated on Tier 3 test fuel. The previous GHG standards for light-duty gasoline vehicles are set on the required use of Indolene, or Tier 2 test fuel. Tier 3 test fuel more closely represents the typical market fuel available to consumers in that it contains 10 percent ethanol. EPA had previously proposed an adjustment factor to allow demonstration of compliance with the existing GHG standards using Tier 3 test fuel but did not adopt those changes (85 FR 28564, May 13, 2020). This rule does not require an adjustment factor for tailpipe GHG emissions, but rather requires manufacturers to test on Tier 3 test fuel and use the resultant tailpipe emissions directly in their compliance calculation. Such an adjustment factor is not required because the technology penetrations, feasibility, and cost estimates in this rule are based on compliance using Tier 3 test fuel.
Both the Tier 3 and these Tier 4 criteria pollutant standards were based on vehicle performance with Tier 3 test fuel; as a result, manufacturers currently use two different test fuels to demonstrate compliance with GHG and criteria pollutant standards. Setting new GHG standards based on Tier 3 test fuel is intended to address concerns regarding test burden related to using two different test fuels and using a test fuel which is dissimilar to market fuels. Accordingly, we expect this change to streamline manufacturer testing and reduce the costs of demonstrating compliance with the final rule.
The difference in GHG emissions between the two fuels is small but significant. EPA estimates that testing on Tier 3 test fuel will result in about 1.66 percent lower CO
EPA is applying the change from Indolene to Tier 3 test fuel for demonstrating compliance with GHG standards starting in model year 2027. This is the same year as the new standards in this final rule begin, and we expect this model year alignment will facilitate a smooth transition for manufacturers. We accordingly allow manufacturers to continue to rely on the interim provisions adopted in 40 CFR 600.117 through model year 2026. These interim provisions address various testing concerns related to the arrangement for using different test fuels for different purposes. At the same time, we recognize that transitioning to a new test fuel is a change from how things have worked in the past, so we are providing additional flexibilities during the early years of the transition. Namely, manufacturers may optionally carry-over Indolene-based test results for model years 2027 through 2029.
For manufacturers that rely on Indolene-based test results in model years 2027 through 2029, we require a downward adjustment by 1.66 percent to GHG emission test results (
We separately proposed to apply an analogous correction for the opposite arrangement—testing with Tier 3 test fuel to demonstrate compliance with a GHG standard referenced to Indolene test fuel (85 FR 28564, May 13, 2020). We did not separately finalize the provisions in that proposed rule, and there is no longer a need to consider that provision now that vehicles are to be tested with the Tier 3 test fuel to demonstrate compliance with GHG standards.
Similar considerations apply for measuring fuel economy, both to meet Corporate Average Fuel Economy (CAFE) requirements and to determine values for fuel economy labeling. In this case, EPA is applying the calculation adjustments described in the 2020 proposal. This is necessary because fuel economy standards are set through a different regulatory process that has not been updated to accommodate the change to Tier 3 test fuel. These adjustments include: (1) New test methods for specific gravity and carbon mass (or weight) fraction of Tier 3 test fuel to calculate emissions in a way that accounts for ethanol blending while also remaining consistent with the calculations used to establish the CAFE standards, (2) a revised equation for calculating fuel economy that uses an “R-factor” of 0.81 to account for the difference in engine performance between Tier 3 and Tier 2 test fuels, and (3) amended instructions for calculating fuel economy label values based on 5-cycle values and derived 5-cycle values.
To reiterate, for the GHG compliance program, we are evaluating GHG compliance with standards that are set using Tier 3 fuel starting in MY 2027; therefore, any vehicles that continue to be tested on Indolene, will need to have the results adjusted to be consistent with results on Tier 3 fuel. For the CAFE standards, we are continuing to evaluate fuel economy compliance with standards that are established on Indolene; therefore, any vehicles that are tested on Tier 3 fuel will need to have the results adjusted to be consistent with results on Indolene. Similar to the CAFE fuel economy standards, we are keeping the fuel economy label consistent with the current program; therefore, any vehicles that are tested on Tier 3 fuel will need to have the results adjusted to be consistent with results on Indolene.
EPA is adopting the following (Table 23) to address fuel-related testing and certification requirements through the transition to the new standards. As noted above, for both GHG and fuel economy standards, vehicle manufacturers may choose to test their vehicles with either Indolene or Tier 3 test fuel through MY 2026. Manufacturers must certify all vehicles to GHG standards using Tier 3 test fuel starting in MY 2027; however, manufacturers may continue to meet fuel economy requirements through MY 2029 for any appropriate vehicles based on carryover data from testing performed before MY 2027.
The Alliance for Automotive Innovation requested EPA continue to allow automakers the option to retest on E0 for the litmus assessment
The Alliance for Automotive Innovation (AAI) submitted comments that are nearly identical to the comments they submitted for the original 2020 Tier 3 Test Fuel NPRM. AAI submitted five specific comments on this rulemaking, each of which we have addressed in this FRM:
• Do Not Adjust the Tailpipe CO
• Set the R-Factor Equal to 1.0 for CAFE Performance on E10: EPA is finalizing an R-Factor of 0.81 based on the technical analysis provided in the 2020 Tier 3 Test Fuel NPRM.
• Delay E10 Phase-in, Allow Optional E0 Testing and Carryover of E0 Data and Revisit Any Adjustment as a Part of the Next CAFE/GHG Rulemaking: EPA accepted AAI's recommendation and is finalizing the Tier 3 test fuel change as part of this GHG standard setting rulemaking. In addition, this FRM includes provisions for phase-in of Tier 3 test fuel and the carry-over of data during the phase-in.
• Address the Impact of the E10 Transition on 5-cycle Testing and Litmus Test: EPA accepted this recommendation and has included provisions for addressing 5-cycle testing and the litmus test in this FRM.
• Consider Fuel Economy and Environmental Performance Labeling Impacts: EPA has considered impacts to the label and has included specific provisions in this FRM to address the use of E10 for vehicle testing and the resultant label values.
Several other commenters advised that adjusting CO
See section 6.3 of the RTC for a more detailed discussion of comments related to test fuel for fuel economy measurements.
Medium-duty vehicles (8,501 to 14,000 pounds GVWR) that are not categorized as MDPVs utilize a “work-factor” metric for determining GHG targets. Unlike the light-duty attribute metric of footprint, which is oriented around a vehicle's usage for personal transportation, the work-factor metric is designed around work potential for commercially oriented vehicles and accounts for a combination of payload, towing and 4-wheel drive equipment.
We received comments from the Alliance for Automotive Innovation (Alliance), GM, Ford, and Stellantis that opposed changes to the work factor definition that capped GCWR within the WF calculation to no greater than 22,000 pounds. Both the Alliance and Stellantis opposed the GHG standards for MDV, stating that were too stringent and with Stellantis further characterizing the standards as “infeasible”. The Alliance and Stellantis specifically cited a 37 percent reduction in GHG from MY 2028 through MY 2032 as too stringent, and that the assumption of 98 percent electrification of van applications within the technology feasibility analysis for the proposal was too high. Stellantis requested that the Agency include PHEV technology for MDVs within its analysis for the final rule. Conversely, ICCT and ACEEE commented that too few MDV BEVs were included within the analysis and argued for more stringent GHG standards for MDV.
Taking all of these comments into consideration, and for the reasons explained below (and in the RTC), we are finalizing the coefficients of the 2032 GHG standards as proposed for work factors less than 5,500 pounds, and we are finalizing the following changes relative to the proposal:
1. We have eliminated the proposed GCWR cap within the work factor equation and have returned to a definition and equation for work factor identical to the one used chassis-certified Class 2b and 3 vehicles under the Heavy-duty Phase 2 GHG Program. Instead, we modified the structure of the MDV GHG standards directly and introduced a flattening of standards above specific work factor set-points.
2. We are finalizing a more gradual and evenly-spaced change in GHG stringency from MY 2027 through 2031.
3. The flattening of standards above specific work factor set-points is phased-in gradually from MY 2028 through 2030.
Our GHG standards for MDVs continue to be entirely chassis-dynamometer based and continue to be work-factor-based as with the previous Heavy-duty Phase 2 standards. We are not finalizing our proposed 22,000-pound GCWR limit within the work factor equation. EPA had proposed this provision with the goal of preventing increases in the GHG emissions not fully captured within the loads and operation reflected during chassis dynamometer GHG emissions testing. Automaker commenters expressed concern that the proposal would disrupt vehicle categories, particularly when taking into consideration updates to the MDPV definition (see section III.E of this preamble). In response to comments, we are finalizing changes to the CO
• At or above a work factor of 8,000 pounds in 2028.
• At or above a work factor of 6,800 pounds in 2029.
• At or above a work factor of 5,500 pounds for model years 2030 and later.
The final standards will continue to use the same work factor (WF) and GHG target definitions (81 FR 73478, October 25, 2016). The testing methodology does not directly incorporate any GCWR (
Final MDV GHG standards for model years 2027 and later are shown in Table 24 and Table 25.
The MDV target GHG standards are compared to the previous Heavy-duty (HD) Phase 2 gasoline standards in Figure 10. For MY 2027, we are finalizing a revision to the HD Phase 2 standards under which gasoline MDVs are subject to fuel-neutral standards identical to the HD Phase 2 diesel standards. MY 2027 standards for diesel MDV remain identical to HD Phase 2. EPA believes the revised MY 2027 MDV standard for gasoline MDV is reasonable given the significant advances in clean vehicle technology since our assessment at the time of the HD Phase 2 rule in 2016. In our assessment conducted during the development of HD Phase 2, we found only one manufacturer had certified HD BEVs through MY 2016, and we projected limited adoption of electric vehicles into the market for MYs 2021 through 2027. However, as discussed in section IV.C.1 of this preamble and RIA Chapter 3.1, there are now a wider range of feasible technology options for manufacturers to apply to the MDV fleet. In addition to ICE-based technologies, manufacturers are actively increasing their PHEV and BEV vehicle offerings in the MDV
We further believe that the revised MY 2027 standard is feasible on a fuel neutral basis, compared to the prior standards under the HD Phase 2 program that established separate standards for gasoline and diesel MDVs, with diesel MDVs subject to a more stringent standard than gasoline. This is consistent with the approach that we have taken within the LD program, where GHG standards are fuel neutral and include BEVs. Improvements in ICE technology, in particular HEV and PHEV technology and the use of dedicated hybrid engines in those applications, have narrowed the differences between gasoline and diesel GHG for both MDV and LD. This fuel-neutral approach also extends to our treatment of MDV BEVs. We anticipate that manufacturers will comply with MDV GHG standards in part through increased averaging of BEV MDV as their sales increase over the timeframe of our rule.
We are finalizing standards in MY 2032 comparable to what was proposed except with the previously noted differences in calculating work factor and CO
Table 26 shows overall fleet average target levels for both medium-duty vans and pickup trucks that are projected for the standards. A more detailed break-down of the projected CO
For the Heavy-duty (HD) GHG Phase 2 rule, EPA adopted credit multipliers through MY 2027 for vehicles that qualified as “advanced technology” (
In our assessment conducted during the development of HD GHG Phase 2, we found only one manufacturer had certified HD BEVs through MY 2016, and we projected “limited adoption of all-electric vehicles into the market” for MYs 2021 through 2027.
While we did anticipate that some growth in development of these technologies would occur due to the credit incentives in the HD GHG Phase 2 final rule, we did not expect the level of innovation observed since we finalized the rule in 2016, the IRA or BIL incentives, or that California would adopt the Advanced Clean Trucks (ACT) rule at the same time these advanced technology multipliers were in effect. We therefore proposed phasing out multipliers for PHEV, BEV and FCEV technologies one year earlier than provided in the Phase 2 rule such that the multipliers would be eliminated in MY 2027.
EPA received comments both in support of and in opposition to its proposal to eliminate MDV multiplier incentives for MY 2027 vehicles. Some auto industry commenters opposed the elimination of the multipliers for MY 2027 as they believed the multipliers are important to address market uncertainties and that changes in the multipliers could be disruptive to manufacturers' planning and development cycles already underway. Other commenters supported EPA's proposal to remove multipliers for MY 2027 believing that multipliers are no longer necessary given the rapid advancement of BEVs in the MDV market and given their concern that multipliers erode the emissions benefits of the program and could result in emissions backsliding.
EPA has considered these comments (as discussed further in section 3.1.8 of the RTC). We believe that, if left as is, the MY 2027 MDV multiplier credits may allow for backsliding of emission reductions expected from non-advanced technology vehicles for some manufacturers in the near term (
In the proposal, EPA also requested comment on phasing down the MDV multipliers for MYs 2025 and 2026. Upon considering public comments, we have decided not to make any changes to the multiplier levels for MYs 2025-2026. While one auto manufacturer supported a phase-down of the MY 2025-2026 multipliers, another manufacturer raised the concern that changes to the multipliers in MY 2025-2026 would not provide sufficient lead time for manufacturers who have been planning to utilize the multipliers in their compliance plans for those model years. Given that MY 2025 has already begun and that MY 2026 begins as early as nine months from this final rule, EPA believes it would not be appropriate to change the MY 2025 or 2026 multipliers. Therefore, the MDV MY 2025-2026 multipliers will remain in effect as established under the Phase 2 rule.
Averaging, banking, and trading (ABT) is an important compliance flexibility that has long been built into various highway engine and vehicle programs (and nonroad engine and equipment programs) to support emissions standards that, through the introduction and application of new technologies, result in reductions in air pollution. EPA is explaining the ABT provisions of the GHG program as background information, as we did not reopen the existing provisions in 40 CFR 86.1865-12.
EPA's first mobile source program to feature averaging was issued in 1983
ABT can help to address issues of technological feasibility and lead time, as well as considerations of cost. In many cases, ABT supports the ability of automakers to comply with standards in a manner that is more economically efficient and possibly with less lead time. This provides important environmental benefits and at the same time it increases flexibility and reduces costs for the regulated industry. Furthermore, by encouraging automakers to exceed minimum requirements where possible, the ABT program encourages technological innovation, which makes further reductions in fleetwide emissions possible. The light-duty ABT program for GHG standards includes existing provisions initially established in the 2010 rule for how credits may be generated and used within the program. The ABT provisions of 40 CFR 86.1865-12 include credit carry-forward, credit carry-back (also called deficit carry-forward), credit transfers (within a manufacturer), and credit trading (across manufacturers). The MDV GHG program includes similar ABT provisions. EPA received comments from vehicle manufacturers and environmental organizations generally supporting the continuation of the ABT provisions to allow a wide array of vehicles to be produced providing that no particular technologies are forced.
Credit carry-forward refers to banking (saving) credits for future use, after satisfying any needs to offset prior MY debits within a vehicle category (car fleet or truck fleet). Credit carry-back refers to using credits to offset any deficit in meeting the fleet average standards that had accrued in a prior MY. The regulation at 40 CFR 86.1865-12 allows a manufacturer to have a deficit at the end of a MY (after averaging across its fleet using credit transfers between cars and trucks)—that is, a manufacturer's fleet average emissions level may fail to meet the manufacturer's required fleet average standard for the MY, for a limited number of model years. The CAA does not specify or limit the duration of such credit provisions. In previous rules, EPA chose to generally adopt 5-year credit carry-forward and 3-year credit carry-back provisions
Transferring credits in the GHG program under 40 CFR 86.1865-12 refers to exchanging credits between the two averaging sets—passenger cars and light trucks—within a manufacturer. For example, credits accrued by overcompliance with a manufacturer's car fleet average standard can be used to offset debits accrued due to that manufacturer not meeting the truck fleet average standard in a given model year.
The ABT provisions are an integral part of the vehicle GHG program, and the agency expects that manufacturers will continue to utilize these provisions into the future, as they give manufacturers an important tool to resolve any potential lead time and cost issues. EPA's annual Automotive Trends Report provides details on the use of these provisions in the GHG program.
Vehicle air conditioning (A/C) contributes to vehicle emissions in two ways. The first is indirect emissions of GHG exhaust emissions resulting from the increase in fuel consumption needed to operate an AC system. The second is direct emissions of hydrofluorocarbon (HFC) greenhouse gases of refrigerant via leakage from the A/C system. EPA has addressed the first mechanism through the use of credits to encourage manufacturers to make efficiency improvements to their A/C systems to reduce fuel consumption and the associated GHG emissions. EPA has also addressed the second mechanism through a credit provision, providing manufacturers credits for using lower
As noted above, there are two mechanisms by which A/C systems contribute to the emissions of GHGs: through leakage of hydrofluorocarbon (HFC) refrigerants into the atmosphere (sometimes called “direct emissions”) and through the consumption of fuel to provide mechanical power to the A/C system (sometimes called “indirect emissions”).
In past rules, EPA adjusted the stringency of the light-duty CO
For MDVs, EPA adopted a somewhat different approach to address A/C refrigerant emissions. In the Phase 1 rule, rather than indirectly regulating HFCs through offering a credit, EPA directly regulated HFCs through a refrigerant leakage standard.
The previous light-duty vehicle A/C indirect emissions reduction credits in 40 CFR 86.1868-12, which EPA also commonly refers to as A/C efficiency credits, are based on a technology menu with a testing component to confirm that the technologies provide emissions reductions when installed as a system on vehicles. The menu includes credits for improved system components and air recirculation settings designed to reduce the A/C load on the IC engine.
EPA is finalizing its proposal that beginning with MY 2027, A/C efficiency credits are eligible only for vehicles equipped with IC engines. Thus, BEVs will no longer be eligible for A/C efficiency credits after MY 2026.
The Alliance for Automotive Innovation (AAI) and some vehicle manufacturers provided comments opposing the elimination of A/C efficiency credits for BEVs. Some of these commenters noted the importance of more efficient A/C systems for BEVs in improving overall BEV efficiency. Other commenters including NGOs supported EPA's proposal and specifically supported the decision not to apply A/C efficiency credits to BEVs
The A/C efficiency credits are based on emissions reductions from ICE vehicles. They correspond to motor vehicle emissions reductions that occur when the A/C systems on ICE vehicles are operated more efficiently, which in turn reduces their use of electricity produced by the alternator and engine, and which in turn reduces pollution emitted by the motor vehicle engine. The credits provided an incentive for manufacturers to increase the efficiency of their A/C systems and in turn reduce the pollution emitted by the vehicle engine. The amount of the credits was determined based on our technical analysis of the emissions produced by an ICE engine and how A/C efficiency improvements could reduce such emissions. In turn, while the credits were optional, EPA established the GHG standards accounting for the level of credits that manufacturers could potentially obtain.
Currently, BEVs are generating credits even though the credits are based solely on improvements to ICE vehicles, and not representative of emissions reductions for BEVs. That is, BEVs completely prevent engine emissions. Thus, improving A/C efficiency does not and is not needed to further decrease vehicle engine emissions. Moreover, the amount of the credits EPA previously determined based on ICE vehicle emissions has no real-world correlation to BEVs. Allowing BEVs to generate A/C efficiency credits is therefore not technically sound as it is unrelated to controlling emissions from the vehicle. Instead, they are receiving a windfall of credits that fails to correspond to any real-world reduction in vehicle emissions, a problem which increases in significance as the manufacturers choose to produce an increasing number of BEVs.
When EPA first established A/C efficiency credits in the 2010 rule, BEV sales were relatively small, and EPA anticipated that BEVs would be required eventually to reflect a portion of carbon emissions from upstream electricity generation in compliance results. However, as discussed in section III.C.7 of this preamble, EPA has concluded it is appropriate to measure compliance with vehicle emissions standards solely by reference to vehicle emissions and is thus removing the MY 2027 date previously specified in the regulations for including upstream emissions in compliance calculations for BEVs. In addition, the ability of BEVs to generate A/C credits has contributed to manufacturers reporting BEV emissions as less than zero, which is not representative of actual vehicle emissions and can be a source of confusion. For example, in the latest Trends report, Tesla, which sells only BEVs, reported a fleet average performance value of negative 23 g/mile including 18.2 g/mile of A/C credits.
EPA notes that its approaches for A/C efficiency credits and off-cycle credits, discussed in detail in section III.C.6 of this preamble, differ even though the types of emissions the credits are designed to address (
EPA's MDV GHG work factor-based program does not include A/C system efficiency provisions,
The previous light-duty vehicle A/C credits program in 40 CFR 86.1867-12 that was adopted in the 2012 rule also included credits for low refrigerant leakage systems and/or the use of alternative low global warming potential (GWP) refrigerants rather than hydrofluorocarbons (HFCs). Under the prior program, the potential available A/C leakage credits are larger than the A/C efficiency credits. The prior program caps refrigerant related credits for passenger cars and light trucks, respectively, at 13.8 and 17.2 g/mile when an alternative refrigerant is used and 6.3 and 7.8 g/mile in cases where an alternative refrigerant is not used. Although the credits program has been voluntary since its inception, the standards were adjusted to reflect the anticipated use of the credits and the program has been effective in achieving its goal of increasing the use of low GWP refrigerants and low leak technologies. Since EPA established the refrigerant-based credits, low GWP refrigerant HFO-1234yf has been successfully used by many manufacturers to claim the full refrigerant replacement credits. As of MY 2022, 97 percent of new vehicles used the low GWP refrigerant.
In December 2020, the American Innovation and Manufacturing (AIM) Act (42 U.S.C. 7675) was enacted. The AIM Act, among other things, authorizes EPA to phase down production and consumption of HFCs in specific sectors and subsectors, including their use in vehicle A/C systems. The AIM Act has sent a strong signal to all vehicle manufacturers that there is no future for using high GWP refrigerants in new vehicles. In October 2023, in response to the AIM Act, EPA finalized the Technology Transitions Rule which
Some commenters, including NGOs and states, were generally supportive of the proposal to eliminate A/C leakage credits given the AIM Act's provisions on phasing out high GWP refrigerants, although some of these commenters also supported regulatory changes to support the continued use of low leak technologies. Other comments from auto manufacturers expressed concerns with the proposal to end A/C leakage credits altogether in MY 2027, as they believed this change would have a significant impact on the effective stringency of the standards. Some auto manufacturers who supported the proposal's Alternative 3 (linear ramp rate) stringency as the right direction also commented that in order to address concerns about lead time in the early years, the program should also slow the phase-down of both off-cycle and A/C leakage credits. Some auto manufacturers also recommended that EPA should retain A/C leakage credits in the program as a way to continue to incentivize the lowest GWP refrigerants below the threshold established in the EPA Technology Transitions Rule.
EPA has carefully considered these public comments and reconsidered its proposal for A/C leakage credits in the context of our updated technical analysis. We are retaining a small credit to further incentivize vehicle refrigerants below the threshold established in the EPA Technology Transitions Rule which prohibits refrigerants above a GWP of 150. Since much of the light-duty vehicle fleet is already using the HFO-1234yf refrigerant which has a GWP of 1, EPA also believes this credit will provide an incentive for manufacturers to not backslide, for example, by moving in the future to a GWP that approaches the Technology Transitions Rule threshold. In addition, EPA believes this credit will continue to incentivize low leak systems along with the use of very low GWP refrigerants. EPA has scaled back its existing A/C leakage credits to capture a credit value that represents the use of vehicle A/C refrigerants of less than 150 GWP. Specifically, for MY 2031 and beyond, manufacturers may earn A/C leakage credits of up to 1.6 g/mile for cars and 2.0 g/mile for light trucks. EPA's calculation methodology for these A/C credits can be found in RIA Chapter 3.6.
We also agree with auto industry commenters that it is important to provide additional lead time in the early years of the program. Therefore, we are finalizing a phase-down of A/C leakage credits from MY 2027-2031. Specifically, the available A/C leakage credits will phase down as shown in Table 28.
For MDVs, EPA had proposed to eliminate the MDV leakage standard in MY 2027. EPA received comments from some stakeholders, including the California Air Resources Board, that the MDV leakage standard should be retained as it provides additional GHG reductions. While recognizing that the Agency's Technology Transitions Rule will provide significant climate benefits by phasing out refrigerants above a GWP of 150, CARB pointed out that there are still benefits that the MDV leakage standard can achieve to ensure low leak systems regardless of the refrigerant used. In response to these comments, and for the reasons described above on the importance of a continued role for preventing emissions from A/C equipment in the vehicle program (recognizing that both LD and HD vehicles are subject to regulations to control leaks), EPA is retaining the existing MDV refrigerant leakage standard that was established under the Phase 2 program. The current MDV leakage standard requires that loss of refrigerant from A/C systems may not exceed a total leakage rate of 11.0 grams per year or a percent leakage rate of 1.50 percent per year, whichever is greater. This leakage standard applies regardless of the refrigerant used in the A/C system. (See 81 FR 73742, October 25, 2016 and 40 CFR 86.1819-14(h)).
Starting with MY 2008, EPA started employing a “five-cycle” test methodology to measure fuel economy for purposes of new car window stickers (labels) to give consumers better information on the fuel economy they could more reasonably expect under real-world driving conditions.
Under EPA's regulations through MY 2026, there are three pathways by which a manufacturer may accrue light-duty vehicle off-cycle technology credits.
A second pathway allows manufacturers of light-duty vehicles to use 5-cycle testing to demonstrate and justify off-cycle CO
EPA designed the off-cycle program to provide an incentive for new and innovative technologies that reduce real world CO
Since MY 2012, the program has successfully encouraged the introduction and use of a variety of off-cycle technologies, especially menu technologies under the light-duty program. The use of several menu technologies has steadily increased over time, including engine stop-start, active aerodynamics, high efficiency alternators, high efficiency lighting, and thermal controls that reduce A/C energy demand. The program has allowed manufacturers to reduce emissions by applying off-cycle technologies, at lower overall costs, compared to the technologies that would have otherwise been used to provide reductions over the 2-cycle test, consistent with the intent of the program. Since MY 2012, the quantity of off-cycle credits generated by manufacturers steadily increased over time. In MY 2022, the industry averaged 9.2 g/mile of credits with more than 95 percent of those
The program has had mixed results for 5-cycle and public process pathways. There have been few 5-cycle credit demonstrations, and the public process pathway has been challenging due to the complexity of demonstrating real-world emissions reductions for technologies not listed on the menu. The public process pathway was used successfully by several manufacturers for high efficiency alternators, resulting in EPA adding this technology to the off-cycle menu beginning in MY 2021.
EPA proposed a phase-out of the off-cycle program for light-duty vehicles as follows: (1) by setting a declining menu cap starting with the 10 g/mile cap currently in place for MY 2027 and then phasing down to 8.0/6.0/3.0/0.0 g/mile over MYs 2028-2031 such that MY 2030 would be the last year manufacturers could generate credits; (2) by eliminating the 5-cycle and public process pathways starting in MY 2027; and (3) by limiting eligibility for off-cycle credits to vehicles with tailpipe emissions greater than zero (
EPA received a range of comments on the off-cycle program proposal. Comments received from environmental NGOs, consumer groups, and many states were generally supportive of the proposed phase-out of the off-cycle credits program, and many of these commenters expressed concerns that the off-cycle credits are not achieving the real-world reductions reflected by the current menu values. Comments received from auto manufacturers expressed concern about the phase-out of the off-cycle credit program as they believe the off-cycle program provides an important additional pathway for vehicle technologies that they believe reflect real-world CO
Upon considering this range of public comments, EPA is finalizing a phase-out of off-cycle menu credits over the MY 2030-2033 timeframe as a reasonable way to bring the program to an end. Specifically, EPA is extending the phase-out of off-cycle menu credits, compared to our proposal, to provide a longer transition period. As discussed in the proposal (section III.B.6 of the draft preamble) and above, the off-cycle credit program was originally designed both to give an incentive for new and innovative technologies, and to provide additional flexibility for manufacturers in meeting the standards. Moreover, as with AC credits, the level of the standards was determined in light of the availability of these credits.
EPA now finds that the off-cycle program has achieved its goal of incentivizing the adoption of innovative technologies for ICE-based vehicles to reduce emissions that might otherwise not have been adopted. EPA also recognizes that, as some commenters argue, the credit values for implementing specific technologies are outdated and may no longer be reflective of the real-world emissions impact of the off-cycle technologies. These concerns are only heightened by the increase of BEVs in the market and the increased stringency of the standards (which makes off-cycle credits a greater proportion of compliance). For these reasons, and as explained further below, EPA finds it appropriate to phase out the off-cycle program, including finalizing its proposal to eliminate the 5-cycle and the public process pathways for off-cycle credits beginning in MY 2027 for both light-duty and medium-duty vehicles.
At the same time, EPA recognizes that there will be a substantial number of ICE-based vehicles sold under these standards which would benefit from off-cycle technologies that reduce emissions and we recognize that manufacturers may have made substantial use of off-cycle credits in their planned compliance strategies, a concern which is heightened by the increase in stringency of the standards. For these reasons, and consistent with our past practice of taking the availability of credits into account in determining the appropriate level of the standards, we judge that it is appropriate to adopt a slower phase-out of the off-cycle credits to provide a smoother transition and reduce concerns about lead time for the early years of the program. Specifically, instead of the proposed menu cap phase-out of 10/8/6/3/0 g/mile in MYs 2027-2031, EPA is finalizing provisions that retain the 10 g/mile menu cap through MY 2030, with a phase-out of 8/6/0 g/mile in MYs 2031-2033. The final phase-out of the menu cap is shown in Table 31.
EPA is also finalizing its proposal to limit eligibility of off-cycle credits to vehicles equipped with an IC engine beginning in MY 2027; thus, BEVs will no longer be eligible for off-cycle credits beginning in MY 2027. The off-cycle menu credits were established based on
Previously, the cap was applied to individual manufacturers by dividing the credits generated by a manufacturer's entire vehicle production to determine an average credit level for the model year. As was proposed, EPA is finalizing that starting in MY 2027, the denominator will include only eligible vehicles (
Also, as discussed in detail in section III.C.8 of this preamble, EPA is revising the utility factor for PHEVs. While PHEVs will remain eligible for off-cycle credits under EPA's eligibility criteria, EPA is finalizing, as a reasonable approach for addressing off-cycle credits for PHEVs, to scale the calculated credit value for PHEVs based on the vehicle's assigned utility factor. For example, if a PHEV has a utility factor of 0.3, meaning the vehicle is estimated to operate as an ICE vehicle 70 percent of the vehicle's VMT, the PHEV will earn an off-cycle credit that is 70 percent of the full value to properly account for the value of the off-cycle credit corresponding to expected engine operation. This calculation methodology corrects errors in the way we described how to apply a utility factor correction for PHEV off-cycle credits in the proposed rule. As was the case in the previous program, individual vehicles can generate more credits than the fleetwide cap value but the fleet average credits must remain at or below the applicable menu cap.
EPA believes that phasing out the off-cycle program is generally consistent with EPA's standards and the direction it appears the industry is headed in changing their vehicle mix toward vehicle electrification technologies. EPA originally created the off-cycle program both to provide flexibility to manufacturers and to encourage the development of new and innovative technologies that might not otherwise be used because their benefits were not captured on the 2-cycle test. EPA believes the off-cycle credits program has successfully served these purposes. However, the credits were based on estimated emissions improvements for ICE vehicles which at the time accounted for the vast majority of vehicles produced. Now with the industry focusing most R&D resources on vehicle electrification technology development and increasing production, as discussed in auto industry comments (see RTC section 3.3) and sections I.A.2 and IV.C.1 of this preamble,
In addition, the off-cycle credits were initially small relative to the average fleet emissions and standards. For example, in the 2012 rule, EPA established menu credits of up to 10 g/mile, a relatively small value compared to a projected fleet-wide average compliance value of about 243 g/mile in MY 2016 phasing down to 163 g/mile in MY 2025.
Initially, EPA addressed the uncertainty surrounding the precise emissions reductions from equipping vehicle models with off-cycle technologies by making the initial credit values conservative, but the values may no longer be conservative, and may even provide more credits than appropriate for later MY vehicles. Because off-cycle credits effectively displace two-cycle emissions reductions, EPA has long strived to ensure that off-cycle credits are based on real-world reductions and do not result in a loss of emissions reductions overall. EPA received
In the 2010 rule, for MYs 2012-2016, EPA measured compliance based on tailpipe emissions for the electric-only portion of operation of BEVs/PHEVs/FCEVs up to a per-company cumulative production cap.
In this rule, EPA is making the current treatment of PEVs and FCEVs through MY 2026 permanent, as proposed. EPA is including only emissions measured directly from the vehicle in the vehicle GHG program for MYs 2027 and later, consistent with the treatment of all other vehicles. For purposes of measuring compliance with tailpipe emissions standards, emissions from electric vehicle operation will be measured based on tailpipe emissions. Vehicles with no IC engine (
A fleet utility factor provides a means of accounting for a PHEV's operation using electricity, known as the charge depleting mode, with respect to the total mileage that a PHEV travels. The distance traveled by a PHEV driver in charge depleting mode is dependent on two significant factors. The first is the size or capacity of the battery. Typically, a PHEV with a larger battery will have greater charge depleting range, all other vehicle attributes equal. The second important factor is the driver's propensity to charge the battery. SAE J2841 states explicitly that the UF represented in the SAE standard assumes that a PHEV is fully charged at least once per day. Recent data and literature have identified that the current utility factor curves overestimate the fraction of driving that occurs in charge depleting operation. Vehicle operators are not charging their
EPA is finalizing its proposed change to the light-duty vehicle PHEV Fleet Utility Factor (FUF) curve used in CO
EPA received many comments regarding the proposed change to the PHEV fleet utility factor (FUF). Many NGOs and state air organizations supported a change to the fleet utility factor based on the available data, third party analyses, and EPA's analysis. These commenters noted that the current SAE J2841-based utility factor provides too much credit because actual CO
In contrast, the Alliance for Automotive Innovation (AAI) and several of its member companies recommended that EPA retain the current SAE J2841-based utility factor. The comments from industry noted the importance of PHEVs as a bridge technology to BEVs. These commenters hypothesized that future PHEVs would be operated in a manner better reflected by the SAE-based UF, based on their projections that future PHEVs will have increased range and power, as the result of the CARB's ACC II requirements, and that future expansions of charging infrastructure and increasing consumer familiarity with PHEVs will lead to consumers charging PHEVs more frequently. In addition, AAI and some of the vehicle manufacturers commented on the quality of the data used to support the proposed PHEV FUF, the California Bureau of Automotive Repair (BAR) data, and the analytical methods that EPA applied, for example, stating the data set was not statistically significant and not a valid representation of current or future PHEV activity. Industry and academic commenters also commented that the data set was skewed towards vehicles that had recently relocated to the state of California that had potentially been operated over long distances without charging. Several commenters also believed that the proposed FUF was not a better representation of the PHEV FUF as compared to the SAE J2841-based FUF and should therefore not be finalized. Finally, AAI, vehicle manufacturers and an academic coalition recommend that if a new FUF is appropriate, then instead of finalizing a revised FUF in this rule, EPA should work collaboratively with the Department of Transportation, Department of Energy, Society of Automotive Engineers, and vehicle manufacturers to develop an alternative.
EPA carefully considered all the comments we received in response to the proposed revised FUF. In addition, and as noted below, we have received an updated set of data from BAR representing an additional year of PHEV activity. Also, in response to comments received, we duplicated and expanded the statistical analysis of all the available data to address the technical analysis concerns raised in comments.
EPA agrees with commenters on the importance of PHEVs as a technology that might be best suited to meet the needs of some consumers, particularly over the timeframe of this rulemaking. PHEVs have the potential to reduce vehicle GHG emissions, but the degree to which that potential is realized depends on whether they are charged
While EPA used BAR data from October 2022
Figure 12 shows an overlay of points from the BAR data, representing individual vehicle models, together with the current and final FUF curves from Figure 11, labeled “SAE J2841 FUF” and “FUF finalized”, respectively. The finalized FUF curve represents a modest change of about 11 percent from SAE J2841 FUF curve.
EPA's assessment of the updated BAR data, consistent with our analysis of the BAR data used for the NPRM, is that the current FUF based on SAE J2841 lies above the vast majority of charge depleting operation of current PHEV models and associated activity. While it may be that an even lower curve than we are finalizing might more appropriately reflect current real-world usage, based on our updated analysis and comments received, EPA is
First, the agency determined that a curve shape with a generally increasing slope and which asymptotically approaches its upper limit is appropriate. Specifically, the BAR data clearly supports EPA's, and SAE's, conclusion that the potential for greater charge depleting operation increases as a function of a PHEV's estimated charge depleting range. At the same time, it is reasonable to conclude that increases in FUF should diminish continuously as range increases in value (
Second, having determined the appropriate shape of the curve, EPA has chosen a position of the curve (along the FUF-axis, vertically) that appropriately balances the evidence from the typical use of PHEV's today with the consideration of factors that are expected to increase charge depleting operation in the future. Several vehicle manufacturers and the Alliance for Automotive Innovation (AAI) asserted that “growth in charging infrastructure coupled with higher capability PHEVs means that the current utility factor will be representative for future PHEVs and should remain unchanged.”
EPA also recognizes that charging infrastructure is expected to become more widely available, and vehicle manufacturers can have a significant influence on PHEV operation through increased customer understanding of PHEV technology, supportive infrastructure, such as assistance in home charging installation and manufacturer provided charging cables, advertising which focuses on PHEV technology and internet resources, such as instructional videos and FAQ's, that help their customers maximize their vehicle's all electric operation and reduce GHG emissions. Because the current SAE utility factor assumes that PHEVs are fully charged once per day, manufacturers may have had less motivation to ensure that their customers were completely familiar with PHEV technology or that the customers had access to the appropriate infrastructure. While the data on current PHEV activity could support further revisions to the fleet utility factor, EPA is setting a FUF for future model years based on our expectations about charging and PHEV performance that will occur in those future years. We are also taking into consideration the views of automakers that the improvements they anticipate in product design (such as range), consumer education and awareness, and charging convenience with expanded infrastructure will result in PHEV activity that is similar to the finalized FUF. In light of manufacturer plans to improve PHEV technology and the potential for improved customer knowledge and infrastructure, EPA is finalizing the PHEV fleet utility factor as proposed.
At the same time, EPA is committed to an ongoing evaluation of future PHEV FUF data to assess whether the revised FUF is in fact adequately representative of future PHEV operation, as a result of future PHEV designs and consumer charging behavior, or if there is merit in further adjusting the FUF. EPA will take a multipronged approach to monitor, assess and, if warranted, potentially adjust the FUF through a future rulemaking action. First, EPA will continue to gather and monitor publicly available data such as that made available by California BAR. EPA will also collect, and monitor data extracted from available in-use PHEV testing and may further supplement the data set through other data gathering mechanisms, such as work done by the Department of Energy or independent contractors and researchers. Although vehicle manufacturers chose not to submit data as part of their public comments, EPA believes that with additional time it is reasonable to project that vehicle manufacturers can gather the same type of data, and in greater quantities, on their own PHEV models than available to EPA through the California BAR; we encourage auto manufacturers to share such data with EPA to inform this future assessment. Thus, second, EPA encourages researchers and other stakeholders, including manufacturers, to supplement the publicly available data by providing data directly to EPA for inclusion in an updated analysis. These first and second steps will form the basis for an assessment of how well future PHEV activity is represented by the FUF established in this final rule, and whether there is merit for proposing adjustments through a future rulemaking. Finally, EPA will engage with stakeholders to share results of our assessments, and to hear from stakeholders who may have their own data and analysis to share, for example, through public forums. If EPA determines that changes to the FUF are warranted, we will engage with stakeholders on technical details such as the shape of the FUF curve and the appropriate timing for its implementation. Stakeholders will also be encouraged to independently assess the publicly available data and provide individual conclusions. This process could also be an opportunity for stakeholders to provide input on changes to additional future program elements (for example, the possibility for manufacturers to submit data directly to EPA as part of the compliance process to a inform model level specific FUF). If such evaluation were to support a proposed revision to the FUF, EPA could initiate a future rulemaking to revise the FUF for MY 2031.
Furthermore, at the time of this final rule, MY 2025 vehicle production has already commenced. This means that manufacturers have approximately two years of lead time to address the revised standards and provisions finalized in this final rule. While lead time is addressed in many ways throughout this rulemaking, such as the year over year change in emission standard stringency and extensions of the phase-down of off-cycle and air conditioning leakage
CARB recently set minimum performance requirements for PHEVs in their ACC II program. These requirements include performance over the US06 test cycle and a minimum range and are meant to set qualifications for PHEVs to be included in a manufacturer's ZEV compliance. EPA received comments that it should adopt ACC II for PHEVs. ACC II is a suite of emissions standards that includes a ZEV mandate and other tools EPA is not using in this rule and it would not be appropriate to take only the PHEV portions of ACC II. EPA is not adopting the range and US06 performance requirements or fleet penetration limits that are included in the CARB ACC II ZEV provisions. EPA agrees that PHEVs meeting the performance provisions required by CARB in ACC II have the potential to provide greater environmental benefits as compared to other PHEVs that are less capable. However, unlike the ACC II program, the GHG program in this rulemaking is performance-based and not a ZEV mandate. In that regard, EPA believes that it is appropriate to have a robust GHG compliance program for PHEVs that properly accounts for their GHG emissions independent of a PHEV's range or capability over the US06 test cycle. We are addressing the issue of ensuring appropriate GHG compliance values for PHEVs through the revised PHEV fleet utility factor as described in section III.C.8 of this preamble; EPA is not adopting design requirements for PHEVs, that is, we are not adopting minimum range requirements or specifying minimum capability over any prescribed test cycles.
EPA's prior light-duty GHG program included unique provisions for small volume manufacturers (SVMs), defined as manufacturers with annual U.S. sales of less than 5,000 vehicles per year. In the 2012 rule, EPA adopted regulations allowing SVMs to petition EPA for alternative standards, recognizing the unique challenges SVMs could face in meeting the primary program standards in the timeframe of the MY 2017-2025 standards. There are currently four SVMs who have applied for, and been approved, less stringent, alternative standards: Aston Martin, Ferrari, Lotus, and McLaren.
EPA believes it is appropriate to transition away from unique SVM standards and bring SVMs into the primary program. Although in the 2012 rule EPA provided SVMs with the opportunity to comply with manufacturer-specific standards which are substantially less stringent than the primary program, in EPA's judgment, developments in both the vehicles market and the market for credits warrants a transition for these manufacturers to the primary compliance program. When EPA established the SVM alternative standards option in the 2012 rule, certain legacy ICE technologies were the primary CO
As a reasonable way to transition SVMs into the primary program, EPA is finalizing a phase-in schedule over MYs 2027 to 2031 that will require SVMs to comply with primary program standards, but with additional years of lead time compared to larger volume manufacturers and compared to the proposed schedule for SVMs.
This additional lead time approach is similar to the approach EPA used in the 2012 rule to provide additional lead time to intermediate volume manufacturers.
Importantly, SVMs will continue to remain eligible to use the ABT 5-year credit carry-forward provisions, allowing SVMs to bank credits in these intermediate years to further help smooth the transition from one step change in the standards to the next. EPA is, however, prohibiting any SVM opting to use the additional lead time allowance from trading credits generated under the additional lead time standards to another manufacturer. These credit provisions are already in place as part of the current SVM alternative standards, and EPA did not reopen them in this rulemaking. EPA believes that credit banking along with the staggered phase down of the standards will help SVMs meet the standards, recognizing that they have limited product lines. As with the SVM alternative standards, SVMs will have the option of following the additional lead time pathway with credit trading restrictions or opt into the primary program with no such restrictions. Once opted into the primary program, however, manufacturers will no longer be eligible for the alternative standards.
Environmental and public health organizations commented in support of our approach for phasing the SVMs into the primary program. They agreed with EPA's conclusions that transitioning SVMs into the primary program is consistent with the recent announcements and developments in the business models of the SVMs who have previously been approved less stringent standards.
EPA received comments from the SVMs opposing changes to the alternative standards approach, based on what they view as challenges in their ability to average across limited product lines, access to technology, limited volumes, and their position in the market compared to larger OEMs. EPA has carefully considered these comments and has concluded that it is appropriate to provide SVMs an extended phase in before meeting the standards of the primary program.
SVMs commented that they would not be able to comply without the purchase of credits and that they felt there was uncertainty in purchasing credits and that it was unfair to have a standard that, in their view, required the purchase of credits. EPA notes that it has modeled reasonable compliance paths for the SVMs. EPA has also modeled a “no credit trading” scenario which identifies a reasonable compliance path for the SVMs even if no automaker is willing to sell credits, a situation which we consider very unlikely to occur (especially in light of the surplus credits generated by EV-only manufacturers). EPA views these modeling results as confirmatory of, but not necessary to, our judgment that the standards are feasible and appropriate for SVMs, and we also note that these compliance paths were modeled under the conservative assumption that SVMs must meet the final standards without any additional lead time allowance. EPA also notes that the current regulatory structure offers SVMs substantial compliance flexibilities. SVMs have alternative standards for MY 2021 of between 308 and 377 g/mile, well above the primary program standards.
EPA anticipates that internal combustion engine (ICE) vehicles will be a significant part of new vehicle sales for years to come. As the vehicle fleet ages, ICE-based vehicles will remain in-use throughout the analysis period for this final rule with an estimated 84 percent of the light- and medium-duty fleet continuing to burn fossil fuel in calendar year 2032 (see Chapter 8.2 of the RIA). EPA intends for its criteria pollutant emissions standards program to continue to obtain feasible and significant reductions in criteria pollutant
EPA is finalizing changes to criteria pollutant emissions standards for both light-duty vehicles and medium-duty vehicles
For light-duty vehicles, EPA is finalizing more protective NMOG+NO
NMOG+NO
EPA is finalizing a PM standard of 0.5 mg/mile for light-duty vehicles and MDV that must be met across three test cycles (−7°C FTP, 25°C FTP, US06), a requirement for PM certification tests at the test group level, and a requirement that every in-use vehicle program (IUVP) test vehicle is tested for PM. The 0.5 mg/mile standard is a per-vehicle cap, not a fleet average. (Note that EPA discusses later in this section the background and history of per-vehicle cap standards and fleet-average standards). There are some differences in the final program from what was originally proposed, including the provision of additional lead time through a more gradual phase-in. Details are provided in section III.D.3 of this preamble.
EPA is finalizing CO and HCHO emissions requirement changes for light-duty vehicles and MDVs including transitioning to emissions caps (as opposed to bin-specific standards), a requirement that CO emissions caps be met across four test cycles (25°C FTP, HFET, US06, SC03), and a CO emissions cap for the −7°C FTP that is the same for all light-duty vehicles and MDVs. There are changes to the requirements from what was proposed. Details are provided in section III.D.4 of this preamble.
The Agency received significant comments on proposed programmatic elements related to high GCWR MDVs. Significant changes were made in response to comments. The Agency is finalizing proposed Alternative 2 in order to address emissions from high GCWR MDVs. Please refer to section III.D.5 of the preamble for a summary of comments, summary of the proposed alternatives, and a detailed description of the final program.
EPA is finalizing a refueling standards change to require incomplete MDVs to have the same on-board refueling vapor recovery standards as complete MDVs. See section III.E.6 of this preamble.
EPA is not finalizing new requirements for the control of enrichment on gasoline vehicles. The agency will continue to gather data on the circumstances under which vehicles use enrichment in the real world, as well as estimates of the impact on emissions inventories due to command enrichment. In addition, we will continue to review AECD applications to ensure that the AECD process is being used appropriately. EPA may revisit additional enrichment controls in a future rulemaking. Additional discussion is found in section III.E.8 of this preamble.
The final standards allow light-duty vehicle 25°C FTP NMOG+NO
EPA is finalizing the same criteria pollutant emissions standards for small volume manufacturers (SVM) as for large manufacturers but with a delayed phase-in to provide additional lead time to implement the standards. See section III.E.10 of this preamble for details.
Useful life standards for light-duty vehicles and MDV are described in 40 CFR 86.1805-17.
EPA's initial emission standards were established as per vehicle (“cap”) standards, with new standards often phased in as an increasing percentage of the fleet over time, to allow for gradual deployment of new technologies. Over the last two decades, EPA has found that fleetwide average standards can also be an effective approach for reducing emissions. Fleetwide average standards enable and encourage manufacturers to develop and deploy a variety of new technologies which may be more appropriate for specific segments of their fleet. As with ABT generally, fleetwide averaging allows greater flexibility and can incentivize overcompliance in some segments, which can benefit manufacturers, consumers and the environment (as new technologies are developed and deployed). However, fleetwide average standards may require additional testing requirements, since the specific level of emissions is important, not merely the meeting of a per vehicle standard. EPA has historically used cap standards for PM and CO, while it has historically used fleet average standards for NMOG+NO
EPA received a wide range of comments from a broad spectrum of stakeholders regarding the scope and stringency of the proposed criteria pollutant standards. NGOs, states, public health organizations, suppliers and a supplier trade association were strongly supportive of EPA finalizing the most protective criteria pollutant standards possible while vehicle manufacturers and their trade association, the Alliance for Automotive Innovation (AAI), voiced concerns regarding the stringency of the standards, the lack of need for additional emissions reductions, lack of alignment with CARB ACC II, phase-in timing and feasibility. Support for the revised standards included references to the significant public health impacts stemming from vehicle emissions, especially in communities with environmental justice concerns, and references to the need for assistance in attaining the NAAQS. Vehicle manufacturers stated that more stringent criteria pollutant standards would be a distraction from their efforts to electrify the light- and medium-duty fleets. Vehicle manufacturers also commented that they had extensive collaboration with the California Air Resources Board (CARB) during the development of CARB's recently finalized Advanced Clean Car II (ACC II) standards and industry broadly recommended that EPA adopt the ACC II program in lieu of our proposed standards.
The phase-in of the revised criteria pollutant standards is an important facet of our program. EPA received comments from many states, NGOs, and suppliers to finalize the most stringent standards at the earliest opportunity, while auto manufacturers generally commented that additional lead time was necessary. EPA addressed these comments for the final program as described below.
The criteria pollutant phase-in for light-duty vehicles applies to the NMOG+NO
Light-duty vehicle criteria pollutant phase-in schedules are shown in Table 33. Manufacturers comply with phase-in scenarios based on the projected number of vehicles sold or produced for sale in the United States in a given model year. LDV and LDT1-2 (GVWR ≤ 6000 lb) vehicles follow a 20, 40, 60, 100 percent phase-in schedule. LDT3-4 (GVWR 6001-8500 lb) and MDPV may follow either a default phase-in that steps to 100 percent in MY 2030 that provides a full four years of lead time as required by CAA section 202(a)(3)(C), or they may choose to follow an early phase-in schedule that ramps from 20 percent to 100 percent from MY 2027 to 2030. If a manufacturer chooses the early phase-in schedule, its LDV, LDT1-2, LDT3-4, and MDPV fleets are averaged together as one group. This scenario could be advantageous for a manufacturer as it allows lower emitting vehicles from one category to help with compliance in another. Credits from Tier 3 and new credits earned in Tier 4 are described in section III.D.2.v of the preamble.
Vehicles that are not part of the phase-in percentages are considered interim vehicles, which must continue to demonstrate compliance with all Tier 3 regulations with the exception that all vehicles (interim and those that are part of the phase-in percentages) contribute to the Tier 4 light-duty vehicle NMOG+NO
For small vehicle manufacturers (SVM),
EPA received comments from the Alliance for Automotive Innovation (AAI) as well as some of its members regarding the proposed phase-in. AAI noted that had EPA adopted the CARB ACC II program, the proposed phase-in would have been more acceptable, however, because EPA had proposed new standards and test procedures the risk to a manufacturer's compliance planning is higher. AAI and manufacturers also commented that the agency should provide more time to meet the new standards.
EPA continues to believe that the proposed criteria pollutant program is feasible and appropriate and has chosen not to adopt the CARB ACC II criteria pollutant program. With respect to phase-in, we have provided an additional year of phase-in in response to manufacturer concerns. As we elaborate further below in our discussion of specific requirements and in the RTC, we have separately assessed the reasonableness of this phase-in schedules for each of the requirements subject to it and found the schedule to be reasonable. For example, most vehicle manufacturers have considerable experience with additional PM controls, and some are already installing GPFs in the United States for sale outside of the country. Regarding alignment or full-scale adoption of the ACC II criteria pollutant program, although the goals of CARB's ACC II program are generally similar to the goals of EPA's NMOG+NO
The MDV phase-in for criteria pollutant standards, including the NMOG+NO
Default compliance phase in is required in a single step in MY 2031 for these final criteria pollutant standards. Under default compliance, MDV may not carry forward Tier 3 NMOG+NO
Finalized refueling standards for incomplete vehicles phase in on a different schedule as described in section III.D.6 of this preamble. The in-use standards for high GCWR MDV begin in MY 2031 regardless of whether or not a manufacturer opts for early compliance.
EPA is finalizing new NMOG+NO
The previous Tier 3 fleet average NMOG+NO
EPA is finalizing light-duty vehicle and MDV fleet average NMOG+NO
For instance, the final NMOG+NO
The final bin structure for light-duty vehicles and MDVs set in this rule is shown in Table 36. The upper six bins (Bin 75 to Bin 170) are only available to MDV. For light-duty vehicles, the final bin structure removes the two highest Tier 3 bins (Bin 160 and Bin 125) and adds new bins such that the bins increase in 5 mg/mile increments from Bin 0 to Bin 70. The highest two bins are removed to remove the dirtiest vehicles from the future fleet and including bins from 0 to 70 in increments of 5 mg/mile offers manufacturers more resolution in meeting the fleet-average standard. For MDV, the final bin structure also moves away from separate bins for Class 2b and Class 3 vehicles, adopting light-duty vehicle bins along with higher bins only available to MDV. In part due to comments received from MDV manufacturers, the final MDV-only bins have been harmonized with bins used for compliance with California chassis-certified MDV standards with the exception of elimination of any bins higher than Bin 170. The highest bin was also changed from Bin 160 to Bin 170 to better align with the California ACC II program and to serve as a cap on MDV emissions.
Bins are used to meet in the NMOG+NO
Vehicles that are not part of the phase-in percentages described in section III.D.1 of the preamble are considered Interim Tier 4 vehicles and may only use Tier 3 bins, or in the case of MDV, may also use Tier 3 bins and transitional Tier 4 MDV bins defined in 40 CFR 86.1816-18 (bin 175 and 150 for Class 3 vehicles, and bin 125, 100, 85, 75 for all medium-duty vehicles). Note that transitional Tier 4 MDV bins apply only to Interim Tier 4 vehicles in model years 2027 through 2030, and not to fully phased in Tier 4 vehicles.
EPA received comments on bin structure. The Alliance for Automotive Innovation (AAI) and GM commented that EPA should align its bin structure with CARB's ACC II program. AAI also recommended adding bins 35, 45 and 90. Small volume manufacturers requested that Bin 125 remain available to them until MY 2035.
In response to these comments EPA is finalizing a bin structure that adopts a full suite of bins from 0 to 70 for light-duty vehicles and MDV, and bins 75, 85, 100, 125, 150, and 170 for MDV. EPA's response to the bin-related SVMs comments can be found in section III.D.10 of the preamble.
EPA is updating the smog scores used on the Fuel Economy and Environment Label
We received no comments on the proposal for smog scores, and we are finalizing structures that are consistent with the proposal but also reflect the fact that we are finalizing almost twice as many Tier 4 NMOG+NO
For MY 2027-2029, EPA is finalizing a smog score schedule that aligns with the Tier 3 smog score schedule starting with MY 2025. This will allow the Tier 3 and Tier 4 bin structures to work together during the Tier 4 phase-in period, during which there will be a mix of Tier 3 and interim Tier 4 vehicles. Table 37 shows the MY 2025 and forward Tier 3 Smog Scores and Tier 3/LEV III bins in the first two columns, and the MY 2027-2029 Tier 4 Smog Scores and Tier 4/LEV IV bins are shown in the last two columns.
For MY 2030 and later, we are maintaining the smog ratings from MY 2027-2029 for bin 40/ULEV 40 and lower bins and distributing the higher bins evenly through a smog score of 2. The interim LEV IV Bin 125 will be assigned a smog score of 1. Table 38 shows the smog score rating schedule for MY 2030 and later.
We selected MY 2030 as the time to shift the smog scores because that is the final year for phasing in the Tier 4 criteria standards in 40 CFR 86.1811-27 for vehicles subject to fuel economy labeling requirements. An exception applies for small volume manufacturers, which may continue to meet Tier 3 standards through model year 2031. This leaves the possibility that small volume manufacturers will certify their vehicles to bin standards that are higher than the bin standards specified for MY 2030 and later. As described in 40 CFR 600.311(g), manufacturers that certify vehicles to bin standards that are higher than any values we specify automatically apply a smog score of 1 for those vehicles. As a result, small volume manufacturers certifying their vehicles to Bin 125 or Bin 160 in model years 2030 and 2031 will apply a smog score of 1 for those vehicles. If they certify their vehicles to any other bins, the smog scores apply as described in Table 38. Note as an example that all manufacturers certifying to Bin 70 standards in MY 2030 and 2031 would use a smog score of 2, whether they are meeting Tier 3 Bin 70 standards or Tier 4 Bin 70 standards, and all manufacturers certifying to Bin 50 standards in MY 2030 and 2031 would use a smog score of 4, whether they are meeting Tier 3 Bin 50 standards or Tier 4 Bin 50 standards.
EPA is establishing NMOG+NO
The final NMOG+NO
For LDV and LDT1-2 (GVWR ≤6,000 lb), the NMOG+NO
For LDT3-4 (GVWR 6001-8500 lb) and MDPV, the NMOG+ standard offers manufacturers two alternative schedules shown on the right side of Table 39. The default schedule steps down from 30 mg/mile to 15 mg/mile in 2030 and provides 4 years of lead time and 3 years of standards stability, as required by the Clean Air Act (CAA) for heavy-duty vehicles. For lead time and standards stability, LDT3-4 and MDPV (as well as MDV) are considered heavy-duty vehicles. As with LDV, the final standards reflect EPA's judgment that about the feasibility of significant further reductions of NMOG+NO
The second alternative is an optional “early” schedule that declines from 30 mg/mile in 2026 (Tier 3) to 15 mg/mile in 2032, matching the schedule required for LDV and LDT1-2. The declining fleet average reflects the likelihood of increased electrification in the fleet over that time period. For example, if the industry introduces BEVs into these vehicle classes at the rate projected by our central case modeling and if ICE vehicles remain at 30 mg/mile (Tier 3), the declining fleet average standard provides approximately 10 percent additional compliance margin for emissions of NMOG+NO
Vehicles that are not part of the phase-in percentages described in section III.D.1 of the preamble are considered interim vehicles, which must continue to demonstrate compliance with all Tier 3 regulations with the exception that all vehicles (interim and those that are part of the phase-in percentages) contribute to the Tier 4 light-duty vehicle NMOG+NO
There are two incentives for choosing the early schedule: The first incentive is that the manufacturer has until 2032 to reach 15 mg/mile instead of 2030. The second incentive is that NMOG+NO
For small vehicle manufacturers (SVM), we are finalizing an NMOG+NO
EPA received comments from many stakeholders with a wide range of inputs including supportive comments for the proposed standards and recommendations for program modifications for the final rule. NGOs such as the Environmental Defense Fund (EDF), American Lung Association and others provided strong support for the proposed NMOG+NO
EPA has responded to these comments by setting a higher (less stringent) final fleet average. The higher fleet average is informed by several factors, including the adoption of somewhat less stringent GHG standards as compared to the proposal, the inclusion of PHEVs in the projected compliance GHG pathway, and the potential for vehicle manufacturers to make improvements to their ICE powertrains in addition to electrification. EPA has decided to not discount PHEV emissions based on their estimated all electric range. While the determination of the utility factor for PHEVs is covered in section III.C.8 of the preamble, it is clear to EPA that there is considerably more engine on operation in charge depleting mode in the real world for current PHEVs than is captured on-cycle. In other words, as the result of vehicle design, operating conditions and/or environmental conditions, many current PHEVs demonstrate engine operation that is not captured in PHEV UF. While the utility factor may be appropriate for crediting a PHEV for GHG compliance, we have concluded it is not appropriate for PHEVs for several reasons. First, we know that criteria pollutants emission levels are influenced by more factors that GHG emissions, depending not only on whether the engine is on or off, but also the operating and environmental conditions under which the engine starts and runs. The existing and proposed PHEV UF does not adequately capture or reflect the specific operating conditions under which the engine starts or the environmental conditions, both of which have significant impact on criteria pollutant emissions. In addition, we note that criteria pollutant standards are orders of magnitude more stringent than GHG standards and as a result accuracy in the utility factor down to the milligram per mile becomes important. It may be possible in the future to have sufficiently accurate information about PHEV operation to adjust criteria pollutant emissions performance to reflect CD operation, and PHEV operation may change in the future as more PHEVs become ACC II compliant, but at this time EPA has decided not to discount emissions based on utility factor, although as noted we have adopted a less stringent final fleet average standard in part due to including PHEVs as a potential compliance pathway.
Since technologies are available to further reduce NMOG+NO
The final NMOG+NO
The final 25 °C FTP NMOG+NO
EPA is finalizing a requirement that manufacturers submit an engineering evaluation indicating that common calibration approaches are utilized at high and low altitudes for −7 °C FTP NMOG+NO
EPA is replacing the existing −7 °C FTP NMHC fleet average standard of 300 mg/mile for gasoline-fueled LDV and LDT1, and 500 mg/mile fleet average standard for LDT2-4 and MDPV, with a single NMOG+NO
Since −7 °C FTP and 25 °C FTP are both cold soak tests that include TWC operation during light-off and hot running operating, EPA is finalizing the application of Tier 3 25 °C FTP NMOG+NO
EPA is finalizing that −7 °C FTP NMOG+NO
The final MDV NMOG+NO
Note that the phase-in percentages from section III.D.1.ii of this preamble also apply. MDV that are not part of the phase-in percentages summarized in section III.D.1.ii of the preamble are considered interim vehicles, which must continue to demonstrate compliance with all Tier 3 standards and regulations with the exception that all vehicles (interim and those that are part of the phase-in percentages) contribute to the Tier 4 MDV NMOG+NO
Certification data show that for MY 2022-2023, 75 percent of sales-weighted Class 2b/3 gasoline vehicle certifications were below 120 mg/mile in FTP and US06 tests (see RIA Chapter 3.2.5). Diesel-powered MDVs designed for high towing capability (
The final MDV NMOG+NO
EPA is not finalizing SVM MDV standards that differ from large manufacturer MDV standards.
If a manufacturer has a fleet mix with relatively high sales of MDV BEV, that will ease compliance with MDV NMOG+NO
The final standards require the same MDV numerical standards be met across all four test cycles, the 25 °C FTP, HFET, US06 and SC03, consistent with the approach for light-duty vehicles described in section III.D.2.iii of the preamble. This would mean that a manufacturer certifying a vehicle to bin 75 would be required to meet the bin 75 emissions standards for all four cycles.
Meeting the same NMOG+NO
Several Tier 3 provisions will end with the elimination of the HD-SFTP and the combining of bins for Class 2b and class 3 vehicles. First, Class 2b vehicles with power-to-weight ratios at or below 0.024 hp/pound may no longer replace the full US06 component of the SFTP with the second of three sampling bags from the US06. Second, Class 3 vehicles may no longer use the LA-92 cycle in the HD-SFTP calculation but will instead have to meet the NMOG+NO
The final MDV 25 °C FTP NMOG+NO
EPA is also setting a new −7 °C FTP NMOG+NO
For Tier 3 certification of −7 °C FTP NMHC, manufacturers must submit an engineering evaluation indicating that common calibration approaches are utilized at high and low altitudes. For Tier 4 certification, this requirement continues for −7 °C FTP NMOG+NO
Since −7 °C FTP and 25 °C FTP are both cold soak tests that include TWC operation during light-off and hot running operating, EPA is finalizing the application of Tier 3 25 °C FTP NMOG+NO
EPA is finalizing that −7 °C FTP NMOG+NO
Additional discussion on the feasibility of the proposed standards can be found in RIA Chapter 3.2.
Similar to the existing criteria pollutant program, NMOG+NO
EPA is allowing light-duty vehicle (LDV, LDT, MDPV) 25 °C FTP NMOG+NO
EPA is allowing MDV (Class 2b and 3 vehicles) 25 °C FTP NMOG+NO
As noted in section III.E of this preamble, EPA is broadening the definition of MDPV to include passenger vehicles that could potentially fall outside the prior definition, especially as a result of increased weight from electrification. We have concluded that the newly designated MDPVs should be included in the light-duty program considering their size and function, but we recognize that this recategorization may reduce the number of electric vehicles that would otherwise have been available to factor into each manufacturer's strategy for meeting MDV standards. To help manufacturers transition to meeting the Tier 4 MDV
EPA is finalizing changes to the current Tier 3 p.m. standards and requirements. These changes include a more protective standard for the 25 °C FTP and US06 test cycles, and the addition of a cold PM standard for the existing cold temperature test (−7 °C FTP) presently used for CO and NMHC (40 CFR 1066.710). As proposed, the same numerical standard of 0.5 mg/mile and the same certification test cycles are being finalized for light-duty vehicles (LDV, LDT, and MDPV) and MDV, as shown in Table 43 for light-duty vehicles and Table 44 for MDV. The standard for −7 °C testing applies only to gasoline-fueled and diesel-fueled vehicles.
As with NMOG+NO
The current Tier 3 p.m. standards capture only a portion of vehicle operation and a narrow and benign set of environmental conditions. EPA has observed that PM emissions increase dramatically during cold temperature cold-starts and high engine power conditions not captured by Tier 3 p.m. test cycles. While several vehicles in the current fleet demonstrate emissions performance that could comply with the standards at 25 °C, EPA projects that to meet the −7 °C PM standard manufacturers will choose to adopt a combination of Gasoline Particulate Filters (GPF) and BEVs as the most practical and cost-effective means to control PM emissions.
GPF is a mature and cost-effective technology and current GPF designs (
In support of the final PM standards, EPA conducted robust and detailed characterizations of GPF performance. EPA quantified PM, elemental carbon (EC) and polyaromatic hydrocarbon (PAH) emissions, with and without the GPF installed, and assessed GPF impact on GHG emissions and vehicle performance. EPA demonstrated no measurable GPF influence on GHG emissions and only slight impact on vehicle performance with a properly sized GPF. PM emissions were typically reduced by over 95 percent, EC emissions were typically reduced by over 98 percent, and filter-collected PAH emissions were typically reduced by over 99 percent. The detailed characterization of GPF benefits is discussed Chapter 3.2.6.2 of the RIA.
The final numerical standard (0.5 mg/mi) and the three applicable test cycles (25 °C FTP, US06, −7 °C FTP) are the same as proposed in the NPRM. The phase-in of the standard, however, is more gradual, as discussed in the section III.D.1 of the preamble.
Commenters expressed opposing views on the stringency, feasibility and need of the proposed PM standard. NGOs, EJ groups, and states urged the strongest possible standards given the significant health benefits, especially important for near-roadway exposures and in communities overburdened by air pollution, and the need for reductions to attain the PM NAAQS. A 2023 remote sensing study by ICCT shows that while gaseous emissions decreased, per-vehicle PM emissions decreased and then increased from 2005 to 2022, likely due to more vehicles using GDI (gasoline direct injection) technology in recent years. Automotive suppliers provided strong support for the proposal, noting the maturity of GPF technology and the current manufacturing of GPF-equipped vehicles in the U.S. for export to meet strict PM standards in Europe and China. Suppliers attested to having sufficient production capacity. The United Steelworkers commented that GPFs can easily and affordably be applied to light-duty vehicles and MDV in the U.S. and supported requiring this technology. An analysis from the Manufacturers of Emissions Control Association (MECA), a supplier trade association, shows that a regulatory control strategy that includes a combination of electric vehicle penetration and best available exhaust controls for PM (
The Alliance for Automotive Innovation (AAI) and several vehicle manufacturers argued that the proposed PM standard would divert investments from electrification and urged adoption of a less stringent standard, specifically CARB's ACC II LEV IV standard of 1 mg/mile. Vehicle manufacturers commented that they had worked closely with CARB in the development of the 1 mg/mile standard and that EPA had not appropriately justified why a lower standard than that adopted by CARB is required. However, a few major OEMs supported the standard but asked for more lead time for application of GPFs across various models considering the level of effort needed to meet the collective sets of standards of this multipollutant rulemaking. Several OEMs raised concerns about measuring tailpipe PM emissions below 0.5 mg/mile, especially at −7 °C.
As we outlined in section II of the preamble, we are setting more stringent PM standards because of the health and environmental effects associated with exposure to PM
EPA considered industry comments recommending adoption of CARB's 1 mg/mile standard instead of our proposed 0.5 mg/mile standard. CARB adopted the 1 mg/mile standard as part of their 2013 LEV III program and set a phase-in starting in MY 2025. The 1 mg/mile PM standard was confirmed as part of CARB's recently finalized LEV IV program. In the time since the original 1 mg/mile standard was adopted by CARB there have been several important developments. The first is the development and proliferation of GPFs. At the time LEV III was finalized, GPFs were not in installed in significant numbers of vehicles and the technology was in relative infancy. Since that time, it is estimated that nearly 100 million GPFs have been installed in vehicles as the result of stringent PM standards in other countries. The feasibility of meeting more stringent PM standards has increased significantly since CARB originally adopted their 1 mg/mile standard. At the same time that CARB confirmed their PM standard for MY 2025 and beyond, they also established a ZEV mandate which will result in additional significant and guaranteed PM reductions. EPA is maintaining performance based GHG standards, and as such, cannot expect the same national PM reductions expected by California from the whole of its ACC II program absent a more stringent federal PM program.
Several commenters recommended that EPA adopt additional fuel controls in lieu of setting more stringent PM standards. The commenters noted that a change in fuel properties could provide PM emissions reductions from the entire gasoline vehicle in-use fleet. EPA agrees that adjusted fuel properties can provide widespread and important PM reductions and for this reason solicited comment on a possible additional future approach for reducing PM through new fuel controls (see section IX of the preamble in the NPRM, “Consideration of Potential Fuels Controls for a Future Rulemaking”). However, EPA does not consider these strategies as interchangeable alternatives. As noted in the proposal and in RTC section 19, the CAA has a separate and distinct set of requirements for engaging in fuels regulations. Indeed, section 211(c)(2)(A) provides that fuel may not be regulated
Furthermore, EPA's authority to adopt fuel controls involves a distinct provision of the CAA with its own technical and legal requirements. As we noted in the NPRM (88 FR 29397), changes to fuel controls are beyond the scope of this rulemaking. EPA does however recognize the potential benefits of fuel property changes to reduce emissions from the in-use fleet and we will consider the information we received in response to our solicitation of comments on this topic in the context of possible future regulatory action.
The final PM standard phases in with the finalized criteria pollutant phase-in schedule described in section III.D.1 of the preamble. The finalized phase-in is more gradual than proposed to address manufacturer lead time concerns about applying GPFs across ICE product lines, and the need to install PM sampling equipment into some cold test facilities. The finalized phase-in reaches 100 percent in 2030 for LDV and LDT1-2 vehicle categories, 2030 for LDT3-4 and MDPV, and 2031 for MDV. Section III.D.1 of the preamble provides phase-in percentages, including default and optional early phase-in schedules.
Commentors submitted opposing views on phase-in. For LDV and LDT1-2, EPA proposed a phase-in of 40/80/100 percent in 2027/2028/2029 and requested comment on accelerating the phase-in for PM relative to other criteria pollutants because of the availability of GPF technology.
Automotive suppliers urged a faster phase-in than proposed, attesting to the maturity of GPF technology, abundant manufacturing capacity, widespread use of GPF in other markets (2017 in Europe, 2020 in China, and 2023 in India), and manufacturers building GPF vehicles in the U.S. for export to other countries. MECA, Advanced Engine Systems Institute (AESI), and Alliance for Vehicle Efficiency (AVE) recommended a phase in of 60/90/100 percent in 2027/2028/2029 for LDV and LDT1/2.
Most manufacturers asked for either a longer phase-in schedule than proposed, arguing that it takes time to integrate GPFs into various product lines, or adopting CARB's 1 mg/mile standard without −7 °C testing through the ACC II phase-in. Some U.S. market trucks and SUVs do not have similar versions in other markets where GPFs are in widespread use, which would require additional engineering effort to apply GPFs to these vehicles. Also, some manufacturers noted that their cold test laboratories are not presently equipped with PM sampling equipment.
EPA is finalizing a more gradual criteria pollutant phase-in (including PM) than proposed to provide manufacturers with additional lead time, but less time than some manufacturers recommended in their comments. Although larger U.S. vehicles may not have similar versions in other countries that use GPF technology, these vehicles tend to have the most packaging space available for a GPF, somewhat mitigating the need for additional lead time. We also note that BEVs are an alternative technology for complying with the standards and in light of our projections for BEV penetration (even under the No Action scenario), some manufacturers may find that BEV technology is sufficient to satisfy the phase-in for LDV and LDT1-2, at least in 2027. Under the default phase-in scenario, manufacturers have until 2030 to comply with the final PM standard for LDT3-4 and MDPV, and until 2031 to comply with the final PM standard for MDV. EPA decided not to adopt CARB's PM standard through the ACC II phase-in because EPA is not adopting a ZEV mandate as the CARB standards use, because the 0.5 mg/mile PM standard is feasible at reasonable cost, and because controlling PM in cold temperatures and other off-cycle operation important.
The PM standard that EPA is finalizing will require vehicle manufacturers to produce vehicles that emit PM at or below GPF-equipped levels of PM. The final rule does not require that GPF hardware be used on ICE vehicles, but rather reflects EPA's judgement that it is feasible and appropriate to achieve the final PM standard considering the availability of this technology. EPA projects that manufacturers will choose to employ a combination of GPF technology on ICE vehicles and BEV technology as the most practical and cost-effective pathways for meeting the standard, especially in −7 °C FTP and US06 test cycles.
To establish the level of the PM standard, EPA conducted a test program that included multiple ICE vehicle types, powertrain technologies, and GPF technologies. Much like other emissions controls, GPFs have seen considerable development since their initial introduction and have provided significantly improved effectiveness. EPA evaluated available technologies with respect to the emissions benefits, including two generations of GPF technology.
A PM test program was conducted using five chassis dynamometer test cells at EPA, Environment and Climate Change Canada (ECCC), and FEV North America Inc., and five test vehicles (2011 F150 Ecoboost, 2019 F150 5.0L, 2021 F150 Powerboost HEV, 2021 Corolla 2.0L, 2022 F250 7.3L) tested in stock and GPF configurations. These test vehicles include a passenger car, three Class 2a trucks, and one Class 2b truck. The two generations of GPFs include series production MY 2019 and series production MY 2022 models, catalyzed and bare substrates, and close-coupled and underfloor GPF installations. Details of the vehicles and test procedures are described in Chapter 3.2.6.2.1 of the RIA. Results from the test program are summarized in Figure 13. The study demonstrates that internal combustion engine-based light-duty vehicles and MDV equipped with GPFs currently in series production in Europe and China (
In Figure 13, tests without GPFs are shown in black, tests with MY 2019 GPFs are shown in gray, and tests performed with MY 2022 GPFs are shown in stripes. The top of each bar represents the highest measurement set mean of one vehicle in one laboratory and the bottom of each bar represents the lowest measurement set mean. The tops of the black bars are off scale in this figure, but their values are indicated with numbers above the bars.
The striped bars include PM measurements from two vehicles: A 2021 F150 Powerboost HEV (Class 2a vehicle) retrofit with a MY 2022 bare GPF in the underfloor location, and a 2022 F250 7.3L (Class 2b vehicle) retrofit with two MY 2022 bare GPFs, one for each engine bank, in the underfloor location.
Results in Figure 13 show that vehicles equipped with MY 2022 GPFs met the 0.5 mg/mile standard in all three test cycles with a very significant compliance margin. The MY 2022 GPFs showed high filtration efficiencies generally over 95 percent. The mean of test sets with MY 2022 GPF are over 95 percent lower than the mean of non-GPF test sets in each of the three test cycles. The results show some non-GPF vehicles could meet the 0.5 mg/mile standard without GPF on the 25 °C FTP and US06 cycles, but no non-GPF vehicles could meet the standard in the −7 °C FTP test cycle. All vehicles with GPF met the standard for all test cycles except the MY 2019 GPFs failed to meet the standard in the US06 because passive GPF regeneration occurred as a result of high exhaust gas temperatures (GPF inlet gas temperature greater than 600 °C) and these older generation GPFs rely on stored soot for high filtration efficiency. GPF regeneration oxidizes stored soot and reduces GPF filtration efficiency during and immediately after the regeneration, especially on the older generation GPFs. The results support the conclusion that a 0.5 mg/mile PM standard over the −7 °C FTP, 25 °C FTP, and US06 test cycles is feasible and appropriate.
The −7 °C FTP test cycle is crucial to the final PM standard because it addresses uncontrolled cold PM emissions in Tier 3 vehicles, and absent the −7 °C FTP test, vehicles would not achieve PM reductions commensurate with what GPF technology offers across a wide range of operating conditions. This is illustrated by the bottoms of the black bars in Figure 13 that show some vehicles without GPFs satisfy the 0.5 mg/mile standard in the 25 °C FTP and US06 cycles, but fail dramatically at −7 °C (an important real-world temperature), with the same being true at other important off-cycle vehicle operation. Without the −7 °C FTP test cycle, vehicles would not have low PM under all operating conditions.
The US06 cycle is a similarly crucial part of the final PM standard because it induces passive GPF regeneration in all vehicle-GPF combinations (
Older GPF technology does not exhibit high PM filtration during and immediately after GPF regeneration. Older GPF technology can have filtration efficiency as low as 50 percent, as opposed to generally more than 95 percent demonstrated by the MY 2022 GPFs shown in Figure 13. Without the US06 test cycle, manufacturers could employ older GPF technology with poor PM control during high load operation. Average US06 p.m. from the MY 2019 GPFs is 15 times higher than average US06 p.m. from the MY 2022 GPFs from the data shown in Figure 13.
MDVs are certified at higher test weights and road load coefficients than light-duty vehicles, but measurements show that series production MY 2022 GPF technology enables meeting the 0.5 mg/mile standard equally well on MDV as light-duty vehicles, with compliance margins of over 100 percent. Measurements comparing PM from a Class 2b vehicle with a current technology GPF (MDV MY 2022 F250 7.3L with MY 2022 GPF) to a Class 2a vehicle with a current technology GPF (LDV MY 2021 F150 Powerboost HEV with a MY 2022 GPF) are shown in Figure 14. Further measurements support the same conclusion for Class 3 vehicles.
As was the case for light-duty vehicles, the −7 °C FTP test cycle is crucial to the final PM standard because it addresses uncontrolled cold PM emissions in Tier 3, and absent the −7 °C FTP test, MDV would not achieve PM reductions commensurate with what MY 2022 GPF technology offers across a wide range of operating conditions. Without the −7 °C FTP test cycle, MDV would not have low PM under all operating conditions.
Furthermore, as was the case for light-duty vehicles, the US06 cycle is a similarly crucial part of the PM standard. High load operation, which is common on MDVs, induces passive GPF regeneration and GPF regeneration can cause elevated emissions if MY 2022 GPF technology is not used. The full US06 cycle results in GPF regeneration across different vehicle-GPF combinations. The LA-92 cycle, which was used instead of the US06 cycle for certification of Tier 3 Class 3 vehicles, usually does not induce GPF regeneration. Therefore, to capture high load operation and passive GPF regeneration in a test cycle, the full US06 cycle is required for all light-duty vehicles and MDV in the final PM standard.
GPF inlet gas temperatures measured on the MY 2022 F250 7.3L during sampled US06, sampled hot LA-92, and −7 °C FTP test cycles, are shown in Figure 15. Fast soot oxidation begins in a GPF around 600 °C.
Additional tests performed with the MY 2022 F250 with MY 2022 GPFs using test weight and road load coefficients from a MY 2022 F350 Class 3 vehicle show that even with the higher test weight and road load, the GPFs did not undergo substantial regeneration in the LA-92 cycle. Without requiring the US06 as a certification cycle for MDV, the GPF may not undergo GPF regeneration and as a result, low PM emissions, which new GPF technology offers, would not be ensured during high load operation,
Under the final standards, Class 2b vehicles with power-to-weight ratios at or below 0.024 hp/pound will no longer replace the full US06 component of the SFTP with the second of three phases (the highway phase) of the US06 for PM certification. Class 2b vehicles with low power-to-weight ratios will now use the full US06 test cycle, which represents high load operation in urban and highway use. If a vehicle is unable to follow the trace, it should use maximum accelerator command to follow the trace as best it can, and doing so will not result in a voided test. This procedure mimics how vehicles with low power-to-weight tend to be driven in the real world.
Also, Class 3 vehicles will not use the LA-92 for PM certification, as they did in Tier 3. Instead, Class 3 vehicles will have to meet the 0.5 mg/mile PM standard across the same three test cycles as light-duty vehicles and other MDV: −7 °C FTP, 25 °C FTP, and US06.
GPF technology is both mature and cost effective. In this rulemaking, unlike some prior vehicle emissions standards including those adopted in the Clean Air Act of 1970, the technology necessary to achieve the standards has already been demonstrated in production vehicles. It has been used in series production on all new pure gasoline direct injection (GDI) vehicle models in Europe since 2017 (WLTC and RDE test cycles) and on all pure GDI vehicles in Europe since first registration of 2019 (WLTC and RDE test cycles) to meet Europe's emissions standards. All gasoline vehicles (GDI and PFI) in China have had to meet similar standards in the WLTC since 2020, and in the WLTC and RDE starting in 2023. All pure GDI vehicles in India have also had to meet similar GPF-forcing standards starting in 2023. GPFs like the MY 2022 GPFs described by Figure 13 and Figure 14 are being used in series production by U.S., European, and Asian manufacturers, and several manufacturers currently assemble vehicles equipped with GPF in the U.S. for export to other markets. While EPA believes that the prolific application of GPFs outside of the United States supports our feasibility assessment of GPF technology, we are not adopting more stringent PM standards to mimic other countries, but rather for the well documented health and environmental benefits from reduced PM emissions. In addition, while some commenters interpreted EPA's reference to GPF technology in other countries as implying a reduced level of effort to adapt the technology to U.S. applications, once again, EPA only means to show that the technology is in widespread use in other areas of the world, which demonstrates a high degree of technical feasibility.
Further details and discussion of test vehicles, GPFs, test procedures, and results are provided in the RIA Chapter 3.2.6.
AAI and several manufacturers requested removal of the −7 °C FTP PM standard, exemption of GPF-equipped vehicles from the −7 °C FTP PM standard, or the option to attest to meeting the −7 °C FTP PM standard in lieu of test data. After consideration, EPA is not finalizing the three recommendations.
EPA is requiring the −7 °C FTP test cycle because it is a crucial part of the PM standard that addresses uncontrolled cold PM emissions in Tier 3, and absent the −7 °C FTP test, vehicles would not achieve appropriate and feasible PM reductions across a wide range of operating conditions. For example, the 2021 Corolla in the EPA test program emits 0.1 mg/mile in the 25 °C FTP and 3.5 mg/mile in the −7 °C FTP.
EPA decided against exempting GPF-equipped vehicles from the −7 °C FTP PM standard because the purpose of the standard is to require low tailpipe emissions, not to force a certain device onto vehicles. If a poor GPF design were added to a non-GPF vehicle with low PM emissions in the 25 °C FTP and US06, it could still easily fail the −7 °C FTP and other operating conditions. Poor GPF designs can have very low filtration efficiencies (
The decision not to allow indefinite attestation to the −7 °C FTP PM standard was made because of the critical importance of this test in ensuring that vehicles achieve appropriate and feasible PM emissions reductions across a wide range of operating conditions. Based on manufacturer comments, however, EPA is finalizing an option for manufacturers to attest to meeting the −7 °C FTP PM standard for MY 2027 and MY 2028 vehicles. This option applies to vehicles at or below 6000 lb GVWR, early phase-in schedule vehicles between 6001-8500 lb GVWR, and early phase-in schedule vehicles between 8501-14,000 lb GVWR, and provides manufacturers with extra time to integrate PM samplers into their cold test cells if they do not already have them. Manufacturers are still responsible for ensuring that vehicles comply with the −7 °C FTP PM standard, and EPA may conduct testing to confirm whether vehicles meet the standard, so manufacturers must have confidence in their attestation.
Although EPA decided against removing the −7 °C FTP PM standard, exempting GPF-equipped vehicles from the −7 °C FTP PM standard, and allowing indefinite attestation, it is finalizing PM relief in several areas: (1) The finalized criteria pollutant phase-in is more gradual than proposed (section III.D.3.ii of the preamble); (2) manufacturers do not have to perform −7 °C FTP PM testing for IUVP, although EPA may check that vehicles meet the standard (section III.D.3.vi of the preamble); (3) all GPF OBD requirements proposed in the NPRM were dropped in favor harmonizing with the CARB approach to GPF OBD (section III.D.3.vii of the preamble); (4) temporary relief is provided on the criteria that trigger an IUCP (in-use confirmatory testing program, section III.G.4.ii of the preamble); and (5) manufacturers may attest to meeting the −7 °C FTP PM standard for MY 2027 and MY 2028 vehicles, although EPA may check that vehicles meet the standard (above paragraph, section III.D.3.iii of the preamble). We adopted these relief provisions after consideration of comments and we believe that with these provisions, the PM standard represents a feasible and appropriate means of reducing PM emissions from light-duty and medium-duty vehicles.
EPA did not propose and is not finalizing changes to PM test procedures because the Agency does not believe that test procedure changes are required to measure PM for the final PM standard. Current test procedures outlined in 40 CFR parts 1065 and 1066 allow robust gravimetric PM measurements well below the PM standard of 0.5 mg/mile, as demonstrated by EPA and other laboratories.
Repeat measurements in EPA laboratories at different levels of PM below 0.5 mg/mile are shown in Figure 16 for vehicles (dark bars), a spark aerosol generator (stiped bar), and tunnel blanks (light bars). The size of the error bars, which represent plus/minus one standard deviation, relative to the measurement averages at and below 0.5 mg/mile demonstrates that the current measurement methodology is sufficiently precise to support a 0.5 mg/mile standard. No changes to 40 CFR part 1065 and 1066 procedures are required, but it is important to use good engineering judgment when transitioning to measuring PM below 0.5 mg/mile. This includes consideration of filter media selection, removal of static charge from filter media, dilution factor, filter media flow rate, using a single filter for all phases of a test cycle, robotic weighing, and minimizing contamination from filter handling, filter screens and cassettes.
EPA also notes that many manufacturers have submitted, and certified the validity of, PM test data below 0.5 g/mile to date. Over 20 percent of MY 2021-2024 light-duty vehicle federal PM certification test results are below 0.5 mg/mile. We recognize that test-to-test variability may be of greater concern to manufacturers for the revised standard, but based on the round robin test results described in III.D.3.iv of the preamble and RIA Chapter 3.2.6, and the test-to-test repeatability results shown in Figure 16, we conclude that should not be a significant issue for certification.
Some manufacturers raised concerns over the ability to reliably measure PM below 0.5 mg/mile. EPA engaged with several manufacturers in technical discussions on PM measurement capability during the development of this rule and will continue to assist and advise manufacturers on best practices for measuring PM at low levels. As a result of these conversations, EPA recognizes that current manufacturer PM test capability is commensurate with the Tier 3 level of the standards, but in some labs, changes may be needed to reliably measure PM below 0.5 mg/mile. Manufacturers may want to consider using power-free gloves, avoiding clothing that sheds lint or dust, not leaning over exposed filters on workbenches, using sticky pads in clean room entranceways, wearing shoe covers to reduce dirt being tracked into the clean room, and regular clean room cleaning. Other elements may be less obvious, like grounding technicians while they handle filters, grounding work benches, etc. These practices are important not just in the PM clean room, but anywhere that filters are handled, such as when they are loaded and unloaded into PM sampling equipment.
EPA's discussions with manufacturers focused on the importance of using PTFE membrane sample filters with FEP (fluorinated ethylene propylene), PMP (polymethyl pentene) or similar support rings (40 CFR 1065.170). Such filters minimize gas-phase artifact but require good static charge removal during weighing using alpha-emitter static charge removal or other techniques with similar effectiveness (40 CFR 1065.190). Discussions with manufacturers included improving signal-to-noise ratio by using the lower half of the allowable dilution factor range (40 CFR 1066.110), elevating filter face velocity (FFV) to a velocity approaching the maximum allowable 140 cm/s, and loading one filter per test instead of one filter per phase (40 CFR 1066.815). Further elements of good measurement procedure include control of temperature, dewpoint, grounding, using HEPA-filtered dilution air, using an effective coarse particle separator (40 CFR 1065.145) and good filter handing procedures (40 CFR 1065.140 and 1065.190). Laboratories may also consider using robotic auto-handling for weighing (40 CFR 1065.190) and background correction (40 CFR 1066.110), although the tests demonstrating the ability to measure below 0.5 mg/mile in the test program summarized in section III.D.3.iii of the preamble did not use background correction and only one of three organizations used robotic auto-handling. EPA welcomes additional industry interaction as manufacturers prepare their facilities to measure PM at the final standard and will be happy to share best practices and help improve PM measurement capability. Further discussion of PM measurement below 0.5 mg/mile is detailed in Chapter 3.2.6 of the RIA.
EPA is finalizing that PM emissions be certified over −7 °C FTP, 25 °C FTP, and US06 cycles with at least one Emissions Data Vehicle (EDV) per test group for light-duty vehicles and MDV certifying to the new 0.5 mg/mile standard. As described toward the end of section III.D.3.iii of this preamble, EPA is finalizing an option for manufacturers to attest to meeting the −7 °C FTP PM standard for MY 2027 and MY 2028 vehicles. Also, since BEVs do not have tailpipe emissions, they are not subject to the tailpipe PM standard being finalized.
This level of PM certification testing matches the requirement to certify gaseous criteria emissions at the test group level and ensures that the final PM standard of 0.5 mg/mile is met across a wide range of ICE technologies. The requirement to certify PM emissions at the test group level is an increase in testing requirements relative to Tier 3, where PM emissions were certified at the durability group level.
EPA is updating the instructions to select a worst-case Tier 4 test vehicle from each test group by considering −7 °C FTP testing along with the other test cycles (40 CFR 86.1828-01). This contrasts with the Tier 3 approach where manufacturers selected worst-case test vehicles separate from −7 °C FTP testing and then selected a test vehicle for −7 °C FTP testing from those test vehicles included in the same durability group. The change in selecting a worst-case test vehicle from each test group is being made because concern for emissions from −7 °C FTP testing is on par with concern for emissions from other test cycles. As a practical matter, it becomes possible to include consideration of emissions from −7 °C FTP testing because we are amending 40 CFR 86.1829-15 to require manufacturers to submit emission data for PM and other pollutants from −7 °C FTP testing for each test group.
EPA solicited comment on whether to revert to pre-production PM certification at the durability group level in 2030 for light-duty vehicles and in 2031 for MDV after PM control technologies have been demonstrated across a range of ICE technology and AAI was supportive of this concept. After consideration, EPA decided that it would be appropriate to review PM certification relief if it were part of a comprehensive review of certification test burden for all criteria pollutants. Such a review would appropriately consider how to select worst-case vehicles for certification testing if manufacturers demonstrate compliance based on testing vehicles from every test group for some standards and testing vehicles only based on the durability group for other standards. EPA has not begun such a comprehensive review at this time but will consider whether and when such a review would be appropriate to undertake.
The final 25 °C FTP PM standard applies equally at high-altitude conditions (1520-1720 meters) as at low-altitude conditions (0-549 meters). Modern engine management systems can use idle speed, engine spark timing, valve timing, and other controls to offset the effect of lower air density on exhaust catalyst performance at high altitude conditions and GPF filtration of elemental carbon does not diminish at high altitude conditions.
EPA is finalizing a requirement that manufacturers submit an engineering evaluation indicating that common calibration approaches are utilized at high and low altitude conditions for −7 °C FTP PM.
Since EPA is finalizing that SVMs must meet the same criteria pollutant emissions standards as large manufacturers, although with a delayed phase-in, SVMs must provide PM test data when certifying to the Tier 4 p.m. standard.
In addition to pre-production certification, the final PM standard
Since GPF technology is a key enabler for meeting the final PM standard in vehicles with an internal combustion engine, OBD monitoring of GPFs is important. If a vehicle uses a GPF, the OBD system must detect GPF-related malfunctions, store trouble codes related to detected malfunctions, and alert operators appropriately.
EPA is finalizing that manufacturers follow the latest CARB OBD requirements, which at this time are the California 2022 OBD-II requirements in Title 13, section 1968.2 of the California Code of Regulations, finalized on November 22, 2022. Following section 1968.2(e)(17), manufacturers propose GPF OBD plans and CARB reviews the manufacturer plans on a case-by-case basis. This provides flexibility relative to diesel PM trap (DPF) monitoring requirements described in section 1968.2(e)(15).
EPA had proposed GPF OBD requirements unique from those of CARB, but manufacturers commented that certain aspects of the EPA OBD requirements were difficult to achieve and that manufacturers had already certified GPF diagnostics with CARB. Harmonizing with CARB's current requirements resolves potential conflicts of having two sets of GPF OBD requirements and addresses manufacturer concerns about the difficulty of achieving the EPA-proposed diagnostics. Therefore, EPA is not finalizing our proposed GPF OBD requirements, and instead is finalizing that manufacturers follow the latest CARB GPF OBD requirements. EPA plans to continue to work with CARB on developing increasingly robust OBD for GPFs. Broader discussion of OBD system requirements is found in section III.H of this preamble.
As proposed, EPA is designating the GPF as a specified major emission control component, which brings with it a warranty period of 8 years or 80,000 miles of use (whichever first occurs), as detailed in section III.G.6 of the preamble.
GPF direct manufacturing cost (DMC) is estimated using an updated cost model described in RIA Chapter 3.2.6.4. The cost model estimates DMC of bare GPF(s) in their own enclosures (cans) installed downstream of the TWC(s). This configuration results in a similar or slightly higher system cost as compared to an aftertreatment system that uses catalyzed GPF(s) to replace TWC(s) in the close-coupled position just downstream of the first TWC(s). The updated GPF DMC model is used in FRM OMEGA analyses. Indirect costs including R&D and markup are calculated separately by OMEGA.
The updated GPF DMC model is based on the model used in the NPRM but uses a larger GPF swept volume ratio (GPF volume to engine displacement volume) of 0.80 instead of 0.55 in the NPRM, and uses 2022 dollars instead of 2021 dollars. The larger swept volume ratio is based on an expanded GPF/vehicle database, input from a GPF supplier, and an ICCT PM/GPF fact sheet released in November 2023.
AAI and several manufacturers raised the issue of GPF cost, including the cost to re-design vehicles to accommodate GPFs. In response to these comments, the Agency updated the NPRM GPF cost model to estimate GPF cost as accurately as possible using the latest available information. The Agency is also finalizing a more gradual criteria phase-in to provide manufacturers with additional time to add GPFs to existing designs and in some cases add them together with vehicle re-design or the introduction of new models. We believe the updated GPF cost information and the more gradual phase-in supports that the final PM standard can be met at a reasonable cost.
EPA is finalizing the light-duty vehicle CO and formaldehyde (HCHO) per vehicle emissions standards (caps) shown in Table 45. The CO caps are 1.7 g/mile in the 25 °C FTP, HFET, and SC03 test cycles, 9.6 g/mile in the US06, and 10.0 g/mile in the −7 °C FTP. The HCHO cap is 4 mg/mile in the 25 °C FTP. EPA is finalizing that the same Tier 3 25 °C FTP useful life standard applies to all the emissions caps shown in Table 45.
The final standards contrast with Tier 3 bin-specific standards for the FTP (1.0 g/mile for Bins 20 and 30, 1.7 g/mile for Bins 50 and 70, 2.1 g/mile for Bin 125, and 4.2 g/mile for Bin 160), a 4.2 g/mile standard for the SFTP, a 10.0 g/mile −7 °C FTP CO cap for LDV and LDT1, a 12.5 g/mile −7 °C FTP CO cap for LDT2-4 and MDPV, and a 4 mg/mile FTP HCHO bin-specific standard for Bin 20 through Bin 160. In Tier 3 the −7 °C FTP CO caps applied only to gasoline-fueled vehicles, while the 10.0 g/mile cap being finalized applies to gasoline-fueled and diesel-fueled vehicles.
The majority of the CO and HCHO standards in Table 45 are the same as those EPA proposed with the exception of the level of the US06 standard, which has been increased from 1.7 g/mile to 9.6 g/mile.
The 1.7 g/mile CO cap for the 25 °C FTP is less stringent than the Tier 3 25 °C FTP bin specific standard for Bin 20 and Bin 30, but overall, the 1.7 g/mile CO cap is somewhat more stringent than Tier 3 because it applies to three cycles instead of one, and because it is more stringent than the Tier 3 25 °C FTP bin specific standard for Bin 125 and Bin 160.
The 1.7 g/mile CO cap for the 25 °C FTP, HFET, and SC03 cycles is feasible because most current production light-duty vehicles already meet the cap and existing aftertreatment technology can be applied to the remaining light-duty vehicles that do not already meet the standard during the phase-in period described in section III.D.1.i of the
The final US06 cap was increased from the proposed value of 1.7 g/mile to 9.6 g/mile for several reasons. While EPA recognizes that CO is a pollutant with significant health risks, the United States does not currently have any nonattainment areas for CO. EPA also considered the current Tier 3 SFTP CO standards. The current Tier 3 US06 CO emissions are captured as part of the Supplemental Federal Test Procedure (SFTP). The SFTP is a composite standard which is the numerically weighted result of CO emissions from the FTP, SC03 and US06 tests.
In addition, several vehicle manufacturers, and the Alliance for Automotive Innovation (AAI) expressed significant concern in meeting the 1.7 g/mile standard over the US06 test cycle. Commenters noted that test-to-test variability may be higher in the US06 than in other cycles, and the proposed US06 CO standard would most likely require significant engine and aftertreatment redesign and/or substantially reduced use of enrichment. Industry commenters recommended that EPA finalize a US06 CO standard of 9.6 g/mile aligned with current Tier 3 standards and the California ACC II standard. The International Council for Clean Transportation (ICCT) noted in their comments the steady historical decline in CO emissions in the United States as the result of previous emissions standards.
With consideration of the current air quality needs, current Tier 3 standards, and the comments received, EPA has concluded that it is appropriate to eliminate the SFTP structure but adopt 25 °C FTP, HFET, SC03 standards of 1.7 g/mile, and a US06 CO standard of 9.6 g/mile. This US06 standard is less stringent than proposed but more stringent than the current implicit US06 limits under Tier 3 SFTP standards for vehicles meeting 1.7 g/mile on the FTP and SC03.
The final 25 °C FTP CO standard applies equally at high-altitude conditions (1520-1720 meters) as at low-altitude conditions (0-549 meters). Modern engine management systems can use idle speed, engine spark timing, valve timing, and other controls to offset the effect of lower air density on exhaust catalyst performance at high altitude conditions.
EPA is finalizing a minor increase in stringency in the −7 °C FTP CO standard in that all light-duty vehicles will have to meet a 10.0 g/mile cap instead of 10.0 g/mile for LDV and LDT1 and a 12.5 g/mile cap for LDT2-4 and MDPV. All light-duty vehicle and MDPV MYs 2022-2024 certifications already meet the finalized 10.0 g/mile cap with at least a 40 percent compliance margin, demonstrating the feasibility of this final standard. Additionally, −7 °C FTP CO testing at EPA using a MY 2019 Ford F150 5.0L and a MYs 2021 Toyota Corolla 2.0L show these vehicles also meet the final standard by large compliance margins, so there is no question about the feasibility of this standard.
The final −7 °C FTP CO standard applies equally at high-altitude conditions as at low-altitude conditions. Modern engine management systems can use idle speed, engine spark timing, valve timing, and other controls to offset the effect of lower air density on exhaust catalyst performance at high altitude conditions.
EPA is finalizing that −7 °C FTP CO emissions be certified with at least one Emissions Data Vehicle (EDV) per test group for light-duty vehicles certifying to the 10.0 g/mile standard instead of one EDV per durability group as in Tier 3.
EPA is finalizing a HCHO cap of 4 mg/mile in the 25 °C FTP, which has the same stringency as the Tier 3 bin-specific 4 mg/mile standard for Bin 20 through Bin 160, (
The final 25 °C FTP HCHO standard applies equally at high-altitude conditions (1520-1720 m) as at low-altitude conditions.
EPA is finalizing the MDV CO and formaldehyde (HCHO) per vehicle emissions standards (caps) shown in Table 46. The CO caps are 3.2 g/mile in the 25 °C FTP, HFET, and SC03 test cycles, 25 g/mile in the US06 (
This contrasts with Tier 3 bin-specific standards for the FTP (3.2-7.3 g/mile depending on bin and class), bin-specific standards for the HD-SFTP (4.0-22.0 g/mile depending on bin and class), no −7 °C FTP standard, and a 6 mg/mile FTP HCHO bin-specific standard for all bins over bin 0. The 10.0 g/mile cap at −7 °C applies to gasoline-fueled and diesel-fueled vehicles.
The majority of the final MDV standards for CO and HCHO shown in Table 46 are the same as what EPA proposed with the exception of the US06 standard, which has been increased from 3.2 g/mile to 25 g/mile.
The 3.2 g/mile CO cap for the 25 °C FTP is equal to the stringency of some Tier 3 bins and more stringent than others. EPA did not receive adverse comments on the feasibility of the 3.2 g/mile standard for the 25 °C FTP, HFET, and SC03 test cycles.
The MDV US06 cap was increased from the proposed value of 3.2 g/mile to 25 g/mile for similar reasons identified above for light-duty vehicles. While EPA recognizes that CO is a pollutant with significant health risks, the United States does not currently have any non-attainment areas for CO. The current Tier 3 US06 CO emissions are captured as part of the Supplemental Federal Test Procedure (SFTP). The SFTP is a composite standard which is the numerically weighted result of CO emissions from the FTP, SC03 and US06 tests. The current Tier 3 SFTP CO cap is 12 g/mile. Because the Tier 3 US06
EPA received comments from several vehicle manufacturers and AAI expressing significant concern in meeting the 3.2 g/mile standard over US06 test cycle. Commenters noted that test-to-test variability may be higher in the US06 than in other cycles, and the proposed US06 CO standard would most likely require significant engine and aftertreatment redesign and/or substantially reduced use of enrichment. Industry commenters recommended that EPA finalize a US06 CO standard of 25 g/mile to better align with current Tier 3 standards and the California ACC II standard.
With consideration of the current air quality needs, current Tier 3 standards and the comments received, EPA has concluded that it is appropriate to set a US06 CO standard that is more stringent than the current Tier 3 SFTP standards for cleaner bins, albeit, under the revised program structure of eliminating SFTP requirements.
The final 25 °C FTP CO standard applies equally at high-altitude conditions (1520-1720 meters) as at low-altitude conditions (0-549 meters). Modern engine management systems can use idle speed, engine spark timing, valve timing, and other controls to offset the effect of lower air density on exhaust catalyst performance at high altitude conditions.
EPA is finalizing a new 10.0 g/mile MDV CO cap for the −7 °C FTP because CO emissions increase in cold temperatures but there were no MDV cold CO standards included in Tier 3 . Testing of a 2022 F250 7.3L in the −7 °C FTP at EPA showed average CO emissions of 2.7 g/mile CO, demonstrating that a 10.0 g/mile standard is feasible for MDV. Present-day MDV gasoline engine aftertreatment technology allows fast catalyst light-off followed by closed-loop A/F control and excellent emissions conversion on Class 2b and 3 vehicles.
The final −7 °C FTP CO standard applies equally at high-altitude conditions as at low-altitude conditions. Modern engine management systems can use idle speed, engine spark timing, valve timing, and other controls to offset the effect of lower air density on exhaust catalyst performance at high altitude conditions.
EPA is finalizing that −7 °C FTP CO emissions be certified with at least one Emissions Data Vehicle (EDV) per test group for MDV certifying to the 10.0 g/mile standard instead of one EDV per durability group as in Tier 3.
EPA is finalizing a HCHO cap of 6 mg/mile in the 25 °C FTP, which has the same stringency as the Tier 3 FTP HCHO 6 mg/mile bin-specific standard for all bins over bin 0.
The final 25 °C FTP HCHO standard applies equally at high-altitude conditions (1520-1720 meters) as at low-altitude conditions (0-549 meters).
The Agency proposed requiring high GCWR MDVs, defined as MDV with a gross combination weight rating (GCWR) above 22,000 pounds, to be subject to heavy-duty engine certification instead of chassis-certification for criteria air pollutant standards. Within the proposed rule, the Agency asked for comment on three alternatives to engine certification of high GCWR MDV:
• MDV above 22,000 pounds GCWR would comply with the MDV chassis dynamometer standards with the introduction of additional engine-dynamometer-based standards over the Supplemental Emissions Test as finalized within the Heavy-duty 2027 and later standards;
• MDV above 22,000 pounds GCWR would comply with the MDV chassis dynamometer standards with additional in-use testing and standards comparable to those used within the California ACC II;
• Introduction of other test procedures for demonstration of effective criteria pollutant emissions control under the sustained high-load conditions encountered during operation above 22,000 pounds GCWR.
We received comments from the Alliance for Automotive Innovation supporting implementation of Alternative 2 for MDV in the final rule. Similarly, Stellantis requested that MDV comply with California ACC II provisions in lieu of engine certification. Alternative 2 fully addresses the Agency's concern that NO
As part of ACC II and LEV IV programs, California established in-use testing requirements for chassis certified LEV IV MDV with a GCWR greater than 14,000 pounds using PEMS-based moving average window (MAW) in-use standards.
In January 2023, the Agency finalized MAW in-use test procedures and NO
The Federal 2B-MAW procedures for diesel engines are based upon two 300-second moving average window (MAW) operational bins. Bin 1 represents extended idle operation and other very low (≤6 percent) load operation where exhaust temperatures may drop below the optimal temperature for aftertreatment function. Bin 2 represents higher load operation (>6 percent). The California 3B-MAW procedures differ chiefly by dividing Bin 2 into Bin 2 and Bin 3, with Bin 2 representing operation from 6 percent to 20 percent load and Bin 3 having operation at greater than 20 percent load.
Within the Federal in-use procedures, CO
In June 2023, a final agreement was signed by representatives of the California Air Resources Board (CARB), the Truck and Engine Manufacturers Association, Cummins, Daimler Truck, General Motors, Hino, Isuzu, Navistar, PACCAR, Stellantis, and Volvo.
The agency is not finalizing the proposed provisions for requiring MY 2030 engine-certification to light-heavy-duty engine standards under 40 CFR part 1036 for high GCWR MDV (GCWR above 22,000 pounds), however the final rule retains engine certification as an option for high GCWR MDV. See section III.D.5.iv of the preamble for further description of the option to certify engines under 40 CFR part 1036. The remainder of this section describes the in-use provisions required for high-GCWR MDV chassis certification 40 CFR part 86, subpart S, and 40 CFR part 1036, subparts B, E, and F.
The agency is finalizing in-use standards for MY 2031 and later high GCWR MDVs consistent with the California provisions for certification and in-use standards for chassis certified medium-duty vehicles (MDV) based on moving average windows (
The applicability and feasibility of 2B-MAW standards to high GCWR diesel MDV is based upon EPA's previous analysis of in-use 2B-MAW standards for MY 2027 and later light-heavy-duty diesel engines.
The final in-use test procedures and standards for high GCWR MDV are based upon Federal heavy-duty in-use test procedures and standards for light-heavy-duty engines with changes that include:
• Optionally allow FCL to be derived entirely from chassis dynamometer testing, emissions measurement and OBD data collection.
• Addition of optional 3B-MAW standards, procedures calculations for high GCWR diesel MDV. Note that Federal 3B-MAW standards incorporate California's full-phase-in CF of 1.5.
• Addition of 1B-MAW standards for high GCWR gasoline MDV.
The high GCWR gasoline MDV standards are summarized in Table 47. High GCWR diesel 3B-MAW standards and off-cycle bin definitions are summarized in Table 48 and Table 49. High GCWR diesel 2B-MAW standards and off-cycle bin definitions are
The final rule includes the option for engine-based certification to emission standards for both spark-ignition and compression-ignition (diesel) engines, and complete and incomplete vehicles (see 40 CFR 1036.635). Engine certification would require compliance with all the same engine certification criteria pollutant requirements and standards as for MY 2027 and later engines installed in heavy-duty vehicles above 14,000 pounds GVWR, including the 2023 rule's NO
Spark-ignition medium-duty vehicles generally operate with volatile liquid fuel (such as gasoline or ethanol) or gaseous fuel (such as natural gas or liquefied petroleum gas) which have the potential to release high levels of evaporative and refueling hydrocarbon (HC) emissions. As a result, EPA has established evaporative emission standards at 40 CFR 86.1813-17 that apply to vehicles operated on these fuels. Refueling emissions are evaporative emissions that result when the pumped liquid fuel displaces the vapor in the vehicle tank. Without refueling emission controls, most of those vapors are released into the ambient air. The HCs emitted are a function of ambient temperature, fuel temperature, and fuel volatility.
Light-duty vehicles, light-duty trucks, and chassis-certified complete medium-duty vehicles at or below 14,000 pounds GVWR have been meeting evaporative and refueling requirements for many years. ORVR requirements for light-duty vehicles started phasing in as part of EPA's National Low Emission Vehicle (NLEV) and Clean Fuel Vehicle (CFV) programs in 1998.
As proposed, the agency is requiring that incomplete medium-duty vehicles meet the same on-board refueling vapor recovery (ORVR) standards as complete vehicles. Incomplete medium-duty vehicles have not been required to comply with the ORVR requirements to date because of the potential complexity of their fuel systems, primarily the filler neck and fuel tank.
Since then, the agency has newly assessed both current ORVR-equipped vehicles and their incomplete versions. Based on our updated assessment, the agency believes that the fuel system designs are almost identical, with only the ORVR components removed for the incomplete version. The complete and incomplete vehicles appear to share the same fuel tanks, lines, and filler tubes. The original thought that extensive differences between the original manufacturer's designs and the upfitter modifications to the fuel system would be required have not been observed. Therefore, the agency believes that all incomplete vehicles can comply with the same ORVR standards as complete vehicles with the addition of the same ORVR components on the incomplete vehicles to match the complete vehicles. Commenters uniformly affirmed the appropriateness of adopting the proposed refueling standards.
We are finalizing, as proposed, a new refueling emission standard for incomplete vehicles 8,501 to 14,000 pounds GVWR, along with corresponding testing and certification procedures. The new standard is 0.20 grams HC per gallon of dispensed fuel (0.15 grams for gaseous-fueled vehicles), which is the same as the existing refueling standards for other vehicles.
We are applying the refueling standards for new incomplete vehicles starting with model year 2030. This meets the statutory obligation to allow four years of lead time for new emissions standards for criteria pollutants for vehicles above 6,000 pounds GVWR. This schedule also complements the optional alternative phase-in provisions adopted in our final rule setting these same standards for vehicles above 14,000 pounds GVWR (88 FR 4296, January 24, 2023). Those alternative phase-in provisions allowed
See the preamble to the proposed rule
The proposed rule requested comment on amendments that would account for fuel vapors vented to evaporative or refueling canisters from vehicles with pressurized tanks just prior to fuel cap removal for a refueling event. Most commenters suggested that we follow the approach used by California ARB to require an engineering evaluation to demonstrate that refueling canisters have enough capacity to handle these “puff losses” in addition to the vapor directed to the refueling canister during the refueling emission test. Two commenters recommended changing the measurement procedure for refueling emissions as the most effective way to ensure that vehicles with pressurized fuel tanks would not have increased emissions resulting from puff losses. See the section 7.4 of the Response to Comments for a detailed discussion of the comments.
The existing refueling test procedures require vehicle stabilization with no fuel tank pressure before the vehicle enters the Sealed Housing for Evaporative Determination (SHED) for emission measurement. In contrast, the regulation includes a partial refueling test in which EPA may test a vehicle using a streamlined procedure. The partial refueling test requires driving followed by stabilizing the vehicle for one to six hours before the refueling test, without removing the fuel cap. The partial refueling test calls for the fuel cap removal (and tank depressurizing, as applicable) within two minutes of sealing the SHED for the refueling test. This approach includes the canister loading from puff losses, though it does not include SHED measurement to ensure that vapors from depressurizing are vented to the canister. Nevertheless, EPA testing using the existing partial refueling test can confirm with testing that refueling canisters are properly sized to control refueling emissions from vehicles with pressurized fuel tanks.
We are adopting a requirement for manufacturers to attest in their application for certification that their vehicles with pressurized fuel tanks will meet emission standards when tested over the partial refueling emission test. We would expect manufacturers to use their engineering analysis from certifying their vehicles for California ARB to meet this requirement.
The running loss test at 40 CFR 86.134-96(g)(1)(xvi) describes how manufacturers may rely on pressurized fuel tanks as a design strategy. We are amending those provisions to align with the conclusions described in the preceding paragraphs to ensure sufficient canister capacity for pressurized systems.
The amendments described in this section apply on the effective date of this rule. These changes do not require additional lead time because standards already apply for testing with partial refueling test, and California ARB already requires manufacturers to make the demonstration we are adding in this final rule. We also want to adopt the provision related to pressurized fuel tanks without delay to correspond with industry practice for certain vehicles. The requirement to vent puff losses to the canister has been the industry practice for several years, not least because California ARB has adopted this same requirement.
A commenter requested that we address an ambiguity regarding the fuel specifications for testing flexible fuel vehicles, both medium-duty vehicles and heavy-duty vehicles above 14,000 pounds GVWR. The commenter also suggested that we revisit the specification for light-duty vehicles, which is for the test fuel to be based on splash blending ethanol with 9 psi RVP neat gasoline. We recognize that flexible fuel vehicles today will be refueled with some combination of E10 gasoline and a high-level ethanol fuel. The scenario of splash blending ethanol with an E0 fuel is no longer something that in-use vehicles will experience. We are therefore revising the refueling test fuel specification for flexible fuel vehicles to align with the test fuel specification for evaporative emission testing at 40 CFR 86.1810-17(h). The refueling test fuel will instead be Tier 3 gasoline (E10 with RVP at 9 psi). This same conclusion applies for refueling tests with heavy-duty vehicles subject to standards under 40 CFR 1037.103.
EPA is finalizing three NMOG+NO
EPA is finalizing NMOG+NO
EPA's final bin-specific standards are shown in Table 53. The bins are somewhat different than the ACC II bins. EPA is not finalizing Bin 125 (that is part of CARB ACC II) to be consistent with EPA's Tier 4 bin structure
For Step 1, PHEVs with Cold Start US06 all-electric range of at least 10 miles are exempt from the standard. For Step 2, PHEVs with Cold Start US06 all-electric range of at least 40 miles are exempt from the standard.
CARB testing identified several existing PHEVs that started on the US06 and met the PHEV HPCS standard by a small margin, demonstrating the feasibility of the standard.
In response to manufacturer comments, EPA is finalizing more bins to provide additional resolution to manufacturers. AAI recommended that EPA extend Step 1 requirements for larger vehicles through MY 2032 and not adopt Step 2. A major manufacturer also requested that EPA not adopt Step 2 for vehicles above 6000 lb GVWR. AAI recommended that manufacturers be allowed to attest to the standard to reduce test burden.
After considering the recommendations, EPA is going forward with both Step 1 and Step 2 and is requiring manufacturers to provide data demonstrating compliance with the standard because according to our modeling of the future fleet and input from AAI and manufacturers, PHEVs may play a significant role in the future vehicle fleet and that would make PHEV HPCS an important operating mode. However, the Agency is providing manufacturers with an extra year to comply with Step 1 and Step 2, relative to the CARB program, to give manufacturers more time to implement design changes necessary to meet the standard.
EPA is finalizing NMOG+NO
EPA is finalizing an early driveaway standard that is derived from the CARB ACC II program.
The bins that EPA is finalizing are slightly different than the ACC II bins. Specifically, EPA is not finalizing Bin 125 as found in CARB ACC II and is finalizing bins from 0 to 70 in increments of 5 to provide manufacturers with additional resolution in certifying test groups to meet the standard.
The modified 25 °C FTP phase 1 is being finalized with tighter speed tolerances than proposed in response to a concern from AAI that without a tighter speed tolerance, a test driver may drive off sooner than the 8 seconds and to ensure the vehicle is fully stopped while the transmission is placed into gear. The speed tolerance of a regular 25 °C FTP test is ±2 mph beyond the lowest or highest point on the trace within 1.0 second of the given time, as described in Part 1066.425(b)(4)(i). For an early driveaway test, EPA is finalizing that vehicle speed may not exceed 0.0 mph until 7.0 seconds and vehicle speed between 7.0 and 7.9 seconds may not exceed 2.0 mph. This reduces the possibility of a test driver driving off significantly earlier than 8 seconds without setting unrealistic requirements on the test driver and doesn't significantly skew the trace to drive-off times larger than 8 seconds. Table 55 below illustrates how the tighter speed tolerance impacts allowable vehicle speed.
Vehicles are exempt from the early driveaway bin standards if the vehicle prevents engine starting during the first 20 seconds of a standard 25 °C FTP test and the vehicle does not use technology (
AAI requested the option to attest to the early drive away provision and recommended a tightening of the speed tolerance during the first seven seconds. EPA is requiring certification test data on the dearly driveaway standard because of the importance of this condition in real-world operation. EPA is finalizing the tighter speed tolerance described above in response to AAI's comment.
EPA is finalizing a third provision defined by the CARB ACC II program that addresses NMOG+NO
Tier 3 vehicles achieve low start emissions when soak times are short because the engine and aftertreatment are still hot from prior operation. Start emissions after long soak periods are addressed by the 12+ hour soak of the 25 °C FTP, which requires vehicles to quickly heat the catalyst and sensors from an engine at ambient temperature. The mid-temperature intermediate soak provision addresses emissions from intermediate soak times where the engine and aftertreatment have cooled but may still be warmer than ambient temperature.
The intermediate soak mid-temperature starts standards being finalized by EPA are shown in Table 56. EPA is finalizing bins that are closely aligned with ACC II bins. EPA is finalizing a bin structure that includes all CARB ACC II bins except Bin 125 and includes bins from 0 to 70 in increments of 5. EPA is not finalizing Bin 125 because EPA is eliminating this bin from the list of bins available to light-duty vehicles (section III.D.2.i of the preamble). The inclusion of bins from 0 to 70 is to provide manufacturers with additional resolution in certifying test groups to meet the standard.
EPA is requiring manufacturers to submit data for the 40-minute soak requirement that is taken between 39-41 minutes and is allowing manufacturers to attest to meeting the standards at all other soak times using linear interpolation between 10 minutes and 12 hours.
At this time, EPA is not finalizing new requirements for the control of enrichment on gasoline vehicles. While we recognize the potential for increases in some vehicle emissions during enriched operation, we also are cognizant of the substantial engineering effort that it would take some manufacturers to eliminate enrichment at all engine speeds and operating conditions, in the same time frame as meeting the other criteria pollutant and GHG requirements of this final program. In light of our recognition of both the potential emissions reductions and engineering effort, the agency plans to continue to investigate this issue and may decide to revisit enrichment controls in a future rulemaking. EPA plans to take a multipronged approach to inform a potential future regulatory action. The agency will continue to gather data on the circumstances under which vehicles use enrichment in the real world. This will include additional EPA-conducted test programs as well as the potential for manufacturer-provided data. EPA also plans to assess the frequency of vehicle activity that results in enrichment, such as trailer towing and other high load, high speed operation. Based on our assessment of measured emissions increases, the circumstances under which enrichment occurs, and the frequency of enrichment, EPA will update our estimates of the impact on emissions inventories due to command enrichment. As part of this process, EPA will also engage with the auto manufacturers and other stakeholders to continue to assess the technologies available to eliminate enrichment under the broadest area of vehicle operation, as well as powertrain development effort, emissions control technology options, lead time and costs. In addition, EPA will continue to review AECD applications to ensure that the AECD process is being used in the manner it was intended. EPA plans to initiate this technical work and stakeholder outreach soon after the release of this final rule, and based on this technical work the Agency may initiate a new rulemaking related to this issue within the next two to three years.
Commenters expressed opposing views on the proposed elimination of the allowance of the use of commanded enrichment. NACAA (National Association of Clean Air Agencies) supported the proposed elimination of enrichment for its health benefits. MECA (Manufacturers of Emissions Control Association) attested to the readiness of technology to support the proposed elimination. While several manufacturers supported the proposal, other OEMs also voiced strong concern with a prohibition on enrichment. Some OEMs argued that eliminating enrichment would require significant powertrain revisions, divert investment from electrification, and/or result in a substantial reduction in engine power.
EPA had proposed a prohibition of commanded enrichment because enrichment results in highly elevated engine-out emissions and reduced effectiveness of the aftertreatment system, causing elevated emissions of carbon monoxide, hydrocarbons, PM, and air toxics including ammonia and PAH, during this operation.
EPA is finalizing the identical criteria pollutant emissions standards for small volume manufacturers (SVMs) as for large manufacturers but is delaying the phase-in of the standards for SVM until 2032 to provide additional lead time to implement the standards.
The phase-in schedule of criteria pollutant standards for SVMs and large manufacturers is discussed in section III.D.1 of the preamble. The criteria pollutant phase-in applies to NMOG+NO
Declining fleet average NMOG+NO
Since EPA is finalizing a requirement that SVMs must meet the same criteria pollutant emissions standards as large manufacturers, although with a delayed phase-in, in Tier 4 SVMs must provide PM test data, and other criteria pollutant test data, for certification.
EPA is not finalizing SVM MDV standards that differ from large manufacturer MDV standards.
EPA received comments from several stakeholders regarding the proposed criteria pollutant standards. Vehicle manufacturers, including those formally identified as SVMs noted that EPA had traditionally provided more time to meet the final standards and that the same on-going challenges remain for them, including challenges such as limited product lines with which to fleet average, infrequent vehicle redesigns, and lower priority support from the supplier base.
In the Tier 3 rulemaking, EPA established provisions for small volume manufacturers and for those small
EPA is finalizing two modifications to the MDPV definition starting in MY 2027 to address passenger vehicles that could potentially fall outside the prior definition. First, EPA is including in the MDPV definition any pickup at or below 14,000 pounds GVWR with a work factor at or below 4,500 pounds except for pickups with a fixed interior length cargo area of eight feet or larger which would continue to be excluded from the MDPV category.
The second updated MDPV definition modification is to include in the MDPV category any pickups with a GVWR below 9,500 pounds and a fixed interior length cargo area of less than eight feet regardless of whether the vehicle work factor is above 4,500 pounds. Pickups at or above 9,500 pounds up to 14,000 pounds GVWR with a work factor above 4,500 pounds are included as MDPVs only if their fixed interior length cargo area is less than six feet.
Historically, there has been a clear distinction between pickups in the light-duty vehicle category and those in the medium-duty category. Light-duty pickups were those pickups with a GVWR at or below 8,500 pounds and they generally had a GVWR below 8,000 pounds. MD pickups were those pickups that were at or above 8,501 pounds and all such vehicles currently have a GVWR above 9,900 pounds.
Comments regarding the change in MDPV definition were received from the three manufacturers that have significant product offerings in this space: Ford, GM and Stellantis, as well as the Alliance for Automotive Innovation. Comments included suggested changes to the GVWR and work factor thresholds. EPA adopted two specific recommended changes to the work factor and GVWR thresholds, which are reflected above in the final definition values. In addition, commenters made recommendations for the implementation timing of the definition change, suggesting implementation should be delayed to MY 2030 or that manufacturers should be allowed to opt into the new definition, as well as some specific regulatory text change to provide further clarification for the definition change, such as how the cargo area length should be measured.
Table 57 summarizes the revised MDPV definition in terms of what vehicles will not be covered as MDPVs under EPA's changes to the qualifying criteria.
EPA is also clarifying that MDPVs will include only vehicles with seating behind the driver's seat such that vehicles like cargo vans and regular cab pickups with no rear seating will remain in the MDV category and subject to work factor-based standards regardless of the changes to the MDPV definition.
As described in section III.D.2.v of the preamble, we are also adopting an interim provision allowing manufacturers to use credits generated by MY 2027 through 2032 battery electric vehicle (BEV) or fuel cell electric vehicles (FCEV), qualifying as MDPVs, to be used for certifying MDV to the NMOG+NO
Prior to MY 2027, a manufacturer may optionally place vehicles that are brought into the MDPV category by the updated MDPV definition revisions into the light-duty vehicles program rather than have those vehicles remain in the MDV program. EPA is finalizing the definition change to be effective starting with MY 2027. However, to ensure the program is compliant with applicable CAA lead time and stability requirements, manufacturers that are building MDPVs that are captured by the expanded definition and are opting for the default schedule will continue to be subject to Tier 3 standards through model year 2030. Details for the final Tier 4 criteria pollutant phase-in are discussed in section III.D.1. In the meantime, manufacturers will continue to certify those vehicles to the Tier 3 standards for medium-duty vehicles in 40 CFR 86.1816-18.
EPA's historic regulatory structure for pickup trucks has been firmly grounded in the products available to consumers and the utility that the vehicles manufacturers have produced. Light-duty pickup GVWRs have been significantly less than the 8,500 pound threshold for LDVs and class 2b and 3 pickups have been built with GVWR's well above 9,000 pounds. In addition, consumers without the need for the additional utility offered by medium-duty pickups, have sound reasons for buying the light-duty versions. Medium-duty pickups, as compared to their light-duty counterparts, tend to be higher priced, less fuel efficient, less maneuverable, and may also have a harsher ride when unloaded due to more capable suspensions. The emissions regulatory structure promulgated by EPA has recognized the substantially different utility offered by these two historically different regulatory classes. However, there are two distinct changes that precipitating EPA's decision to expand the MDPV definition. First, EPA recognizes that light-duty pickup trucks that are electrified could exceed the 8,500 pound threshold, but do not have the same utility traditionally provided by this regulatory class. Secondly, EPA believes that there is the possibility that the pickup market could shift from light-duty versions to medium-duty versions of pickups due to consumer preference for ICE-based pickups. To meet this consumer demand, manufacturers may be inclined to produce pickups which, much like the EV's, exceed the 8,500 pound GCWR threshold, but do not offer the same utility as traditional vehicles in the higher weight class. At this time, EPA is not finalizing fundamental changes to its program that will result a large portion of medium-duty pickups into the light-duty program to address this possibility due to the potential disruption such an approach would have both for the vehicle industry and for consumers needing highly capable work vehicles. EPA plans to monitor vehicle market trends over the next several years to identify any new trends that could potentially lead to the loss of emissions reductions, and if so, to explore appropriate ways to address such a situation.
In an effort to illustrate and quantify the design-related GHG emissions impacts of medium-duty pickups compared to their light-duty counterparts, EPA generated emissions test data for a Ford F-150 and an F-250. For this example, the medium-duty F-250 emitted 170 g/mile more than the light-duty F-150 when operating at similar speeds and loads (RIA Chapter 1.2.1). The GHG emission difference observed in the data indicates that light to medium load operation results in much higher CO
In the NPRM, EPA sought comment on alternatives for the light- and medium-duty GHG standards levels, as well as the phase-ins. For light-duty GHG standards, we sought comment on a range of light-duty GHG stringency alternatives in addition to the proposed standards. We sought comment on the medium-duty GHG standards for different model years and other aspects of the MDV standards structure. In addition, we sought comment on alternative phase-in schedules for criteria pollutant standards. EPA received comments suggesting alternative levels of stringency and phase-in schedules for the light- and medium-duty standards, for GHG and criteria pollutants. EPA discusses how we assessed comment on these issues and arrived at the final standards and phase-in schedules in sections III.C, III.D, and V of this preamble. EPA further considered comments on alternatives to the level and phase-in scheduled for the standards, which we discuss in RTC section 3.3 (GHG) and section 4.1(criteria pollutants). In the following discussion, we principally discuss the alternatives we considered for the light-duty GHG standards.
For the light-duty GHG standards, EPA sought comment on three alternatives. The proposal's alternatives included a more stringent alternative (Alternative 1), a less stringent alternative (Alternative 2), and an alternative (Alternative 3) that ended at the same level as the proposed standards in 2032, but provided a more linear ramp rate in the standards with the least stringent standards across all alternatives for MYs 2027-2029. As discussed in section III.C.2 of this preamble, based on our updated analysis and in consideration of the public comments, EPA is basing its final standards on the proposal's Alternative 3, and we are also extending the phase-down of certain credit flexibilities to address lead time concerns.
In considering the appropriate light-duty GHG standards for this final rule, EPA has also considered two alternatives, one more stringent (Alternative A) and one less stringent (Alternative B).
The final standards will result in an industry-wide average emissions target of 85 g/mile of CO
Figure 19 compares the projected targets for the final standards and Alternatives A and B with the MY 2026 standard (labeled as the No Action case).
For Alternative B, consistent with the final standards, EPA applied different flexibility provisions than under the proposed standards (Alternative A) based on public comments of concerns about lead time for model years 2027-2029. Specially, we revised the proposal's phase-out of two flexibilities: air conditioning (A/C) HFC leakage credits and off-cycle credits. From MY 2026 allowable levels, maximum A/C leakage credits will phase down starting in MY 2027 to a value of 1.6 g/mile for cars and 2.0 g/mile trucks for MY 2031 and later. The cap for off-cycle menu credits will phase down over three model years from the 10 g/mile maximum (for ICE vehicles only) in 2030 to 0 g/mile in 2033. Alternative A maintains the phase-out of HFC leakage credits and off-cycle credits as originally proposed in the NPRM.
Below, we compare the targets again, but in this case we have adjusted (upward) the targets to account for credit flexibilities available to manufacturers. These adjusted targets are meant to provide a common basis for comparing program stringencies between alternatives that have differing levels of credit flexibilities. It should be noted that in EPA's technical assessment, we assume that manufactures will take advantage of credit flexibilities that are cost-effective, and the availability of flexibilities can influence projected compliance costs and technology penetrations even when the footprint target CO
Figure 20 compares the adjusted targets for the final standards and Alternatives A and B with the MY 2026 standard (labeled as the No Action case), consistent with the values reflected in Table 63 in which we have shifted the fleet average footprint targets upward to account for the expected application of compliance flexibilities (off-cycle, A/C efficiency and A/C leakage credits). Compared to Alternative A (the proposed standards), the adjusted CO
EPA considered criteria pollutant standards alternatives within the context of the GHG alternatives outlined above. For each potential set of GHG standards and associated projected technology application, the agency considered if a vehicle manufacturer could comply with both the GHG standards and the final criteria pollutant standards, given a projected mix of technologies. First, as noted in section II.D.2 of the preamble, the agency is finalizing a numerically higher (less stringent) final NMOG+NO
Several changes to electric vehicle test procedures are implemented with this rule. This section reviews the general testing requirements that continue to apply to BEVs and PHEVs, and then describes specific changes to these requirements.
To comply with EPA labeling requirements, manufacturers and EPA perform testing of light-duty BEVs to determine miles per gallon equivalent (MPGe) and electric driving range. PHEVs are also tested to determine charge-depleting range. The results of these tests are used to generate range and fuel economy values published on the fuel economy label.
BEV testing consists of performing a full charge-depleting test using the multi-cycle test (MCT) outlined in the 2017 version of SAE standard J1634, Battery Electric Vehicle Energy Consumption and Range Test Procedure. The multi-cycle test consists of 8 cycles: Four urban dynamometer driving schedule (UDDS) cycles, two highway fuel economy test (HFET) cycles, and two constant speed cycles (CSCs).
The MCT generates unadjusted city (UDDS) and highway (HFET) two-cycle test results. These results are adjusted to 5-cycle values which are then published on the fuel economy label. EPA regulations allow manufacturers to multiply their two-cycle test results using a defined 0.7 adjustment factor or determine a BEV 5-cycle adjustment factor by running all of the EPA 5-cycle tests (FTP, HFET, US06, SC03, and 20 °F FTP). This adjustment is performed to account for the differences between vehicle operation observed on the two-cycle tests and vehicle operation
PHEVs include both an internal combustion engine and an electric motor and can be powered by the battery or engine or a combination of both power devices. Charge depleting operation is when the electric motor is primarily propelling the vehicle with energy from the battery. Charge sustaining operation is when the internal combustion engine is contributing energy to power the vehicle and maintain a specific state of charge. PHEVs are tested in both charge depleting and charge sustaining operation to determine the electrical range capability of the vehicle and the charge sustaining fuel economy.
PHEV charge depletion testing consists of performing a single cycle charge depleting UDDS test and a single cycle charge depleting HFET test. These tests are specified in the 2010 version of SAE Standard J1711, Recommended Practice for Measuring the Exhaust Emissions and Fuel Economy of Hybrid-Electric Vehicles, Including Plug-In Hybrid Vehicles. The result of these tests is the actual charge depleting distance the vehicle can drive. The actual charge depleting distance is multiplied by a 0.7 adjustment factor to determine the 5-cycle charge depleting range. The UDDS and HFET distances are averaged to determine an estimated all-electric range for the vehicle. Unlike SAE Standard J1634 which is applied to BEVs, SAE Standard J1711 does not specify a methodology for determining UBE when performing charge depleting tests on PHEVs.
As proposed, EPA is making several changes to the testing requirements to support new battery durability and warranty requirements for light-duty and medium-duty BEVs and PHEVs (see section III.G.2 of the preamble).
Compliance with battery durability requirements will require additional testing of BEVs and PHEVs by manufacturers to be performed during the vehicle's useful life and will require additional reporting to demonstrate that the vehicles are meeting the durability standard.
Manufacturers of BEVs and PHEVs will be required to develop and implement an on-board battery state-of-health monitor and demonstrate its accuracy through in-use vehicle testing. For this testing, the tests will be based on the currently used charge depletion tests performed for range and fuel economy labeling of light-duty BEVs and PHEVs, with the addition of the recording of the vehicle monitor value and comparison of the results from the charge depleting test to the monitor value reported by the vehicle. Specifically, light-duty and Class 2b and 3 BEVs will be tested according to the MCT to determine the vehicle's UBE and range. PHEVs will be tested according to the single cycle UDDS and HFET test to determine the vehicle's charge depleting UBE and range. Class 2b and 3 BEVs and PHEVs will be tested at adjusted loaded vehicle weight (ALVW),
Manufacturers also will be required to demonstrate that the vehicles are meeting the durability requirements at certain points during their useful life. For this purpose, manufacturers will collect and report onboard state-of-health monitor values from a large sample of in-use vehicles, as described further in section III.G.2 of this preamble. This will not involve additional dynamometer testing but only acquisition of monitor data from in-use vehicles.
Due to the lack of a UBE calculation in SAE J1711, to determine UBE for PHEVs, an additional calculation is performed after completion of the PHEV charge depleting test. Under PHEV charge depletion testing, net ampere-hours are measured to determine when the vehicle is no longer depleting the battery, indicating that the vehicle has switched to a mode in which it is maintaining rather than depleting the battery charge. This event marks the conclusion of the charge depletion test but does not result in determination of UBE. To determine UBE for a PHEV, manufacturers will measure the DC discharge energy of the PHEV's rechargeable energy storage system (RESS,
In the proposal, EPA sought comment regarding this methodology for determining UBE for PHEVs. EPA received comments from the Alliance for Automotive Innovation regarding the use of the 2010 version of J1711 for determining the net energy change during PHEV charge depletion testing. The Alliance recommended EPA update the referenced SAE Standard from the 2010 version to the 2023 version of J1711. After reviewing the revisions to J1711, EPA concurs with the Alliance and agrees that the J1711 reference should be updated from the 2010 to the 2023 version. The 2023 version of J1711 has updated the measurements and calculation methodology to determine the Net Energy Change (NEC) for the propulsion battery. These changes address the concerns raised by commentors regarding using only the average voltage measured at the beginning and end of each charge depleting cycle. The updated J1711 standard includes specifications for measuring the DC discharge energy of the propulsion battery or logging the propulsion battery voltage over a vehicle communication network.
EPA also sought comment regarding use of the method described for light-duty vehicles with SAE J1711 for determining UBE for Class 2b and 3 PHEVs. EPA did not receive any comments regarding using SAE J1711 for determining UBE for Class 2b and 3 PHEVs. As EPA has concluded the updated 2023 version of SAE J1711 is appropriate for use for LDVs and LDTs, EPA is also adopting this standard for testing PHEVs to determine the UBE for Class 2b and 3 PHEVs.
EPA also sought comment on whether to perform the tests on Class 2b and 3 PHEVs at ALVW as proposed, or at loaded vehicle weight (LVW), which is curb weight plus 300 pounds. EPA also did not receive any comments regarding testing Class 2b and 3 PHEVs at ALVW and as such is finalizing the agency's proposal to test Class 2b and 3 PHEVs at ALVW when performing charge depletion tests to determine battery UBE and calculate SOCE.
EPA also sought comment regarding the proposed use of the 2017 version of SAE J1634 for determining UBE for class 2b and 3 BEVs. EPA received comments from Mercedes-Benz AG, Rivian, and the Alliance regarding the use of the 2017 version of SAE J1634. Mercedes-Benz AG and the Alliance suggested EPA update to the 2021 version of SAE J1634 from the 2017 version. Rivian submitted comments noting they generally support EPA's proposed approach to EV test procedures, including the proposed use of the 2017 version of SAE J1634 for determining UBE for Class 2b and 3 BEVs. Mercedes-Benz and the Alliance are concerned with the time required to perform MCT
In January 2023, EPA updated the BEV 5-cycle test procedures and updated the SAE J1634 reference from the 2012 version to the 2017 version of SAE J1634.
EPA also sought comment on whether to perform charge depleting tests on Class 2b and 3 BEVs at ALVW as proposed, or at loaded vehicle weight (LVW), which is curb weight plus 300 pounds. Rivian provided comments supportive of testing Class 2b and 3 BEVs at ALVW using the 2017 version of J1634. EPA is finalizing our proposal to test Class 2b & 3 BEVs on the MCT at ALVW using the 2017 version of J1634 to determine UBE.
This section describes the battery durability monitoring and performance requirements and the warranty requirements we are finalizing for BEVs and PHEVs. As we explained in the proposal, BEVs and PHEVs are playing an increasing role in vehicle manufacturers' compliance strategies to control emissions from LD and MD vehicles. The battery durability and warranty requirements support BEV and PHEV battery durability and thus support achieving the GHG and NMOG+NO
At the outset we note that some commenters, including the Alliance for Automotive Innovation (“the Alliance”) questioned EPA's authority to adopt durability and warranty requirements for batteries in BEVs.
The regulation of battery durability is clearly within the Agency's authority. EPA's authority to set and enforce durability requirements for emission-related components like batteries is an integral part of its Title II authority. Durability requirements ensure that vehicle manufacturers and the vehicles they produce will continue to comply with emissions standards set under 202(a) over the course of those vehicles' useful lives. Such authority arises both out of section 202(a)(1) and 202(d) (relating to a vehicle's useful life) and section 206(a)(1) and 206(b)(1) (relating to certification requirements for compliance). As is described in detail in the following section, EPA has exercised its authority to set emission durability requirements across a variety of emission-related components for decades.
Similarly, EPA also has clear statutory authority to set warranty standards for BEVs and PHEVs. Section 207(a) and (i) provide clear statutory authority for the warranty requirements. In fact, EPA has already set emission warranty requirements under section 207(a) in 2010 for all components that are used to obtain GHG credits that allow the manufacturer to comply with GHG standards, which includes BEV, PHEV, and hybrid batteries.
In general, BEV batteries, just like batteries in PHEVs and other hybrid vehicles, are emission-related components for two reasons, thus providing EPA authority to set durability and warranty requirements applicable to them. First, they are emission-related by their nature. Durability and warranty requirements for batteries are not, to use the Alliance's analogy, like requiring a warranty for a vehicle component like a vehicle's “infotainment system” that has no relevance to a vehicle's emissions. Integrity of a battery in a vehicle with these powertrains is vital to the vehicle's emission performance; integrity of its “infotainment system” is not. It is wrong to say that the very component that allows a vehicle to operate entirely without emissions is not emission-related.
Second, for warranty and durability purposes, EPA has historically implemented requirements based on an understanding that “emission-related” refers to a manufacturer's ability to comply with emissions standards, regardless of the form of those standards. For standards to be meaningfully applicable across a vehicle's useful life, EPA's assessment of compliance with such standards necessarily includes an evaluation of the performance of the emissions control systems, which for BEVs (and PHEVs) includes the battery system both when the vehicle is new and across its useful life. This is particularly true given the averaging form of standards that EPA uses for GHG and NMOG+NO
In addition to EPA's general authority to promulgate durability requirements under sections 202 and 206, EPA has additional separate and specific authority to require on-board monitoring systems capable of “accurately identifying for the vehicle's useful life as established under [section 202], emission-related systems deterioration or malfunction.” Section 202(m)(1)(A).
The Alliance suggests that EPA does not have authority to set durability or warranty requirements because BEV batteries are not emission-related for two reasons. First, the Alliance argues that because BEVs do not themselves emit, EPA does not have authority to set vehicle specific standards for them, and EPA's warranty and durability authorities rely on EPA's ability to set vehicle specific standards. But EPA does have the authority to set standards for BEVs as they are part of the “class” of regulated vehicles. See section III.B.1 of the preamble and RTC section 2 for EPA's full analysis of the relevant statutory provisions. In addition, EPA has traditionally set vehicle-specific standards for BEVs. For instance, LD BEVs, like other LD vehicles, are subject to vehicle-specific, in-use GHG standards. And LD BEVs, like other LD vehicles, also certify to a vehicles-specific bin for NMOG+NO
The Alliance argues second that a component only counts as emission-related if its failure would allow the vehicle to continue operating, but with higher emissions. But nothing in the statute imposes such a limitation. Moreover, while it is true that the failure of a battery would cause the vehicle to stop operating, the same is true for some other vehicle components that have also historically been subject to durability requirements. For instance, EPA has set durability requirements for diesel engines (see 40 CFR 86.1823-08(c)), failure of which could cause the vehicle to stop operating. Similarly, Congress explicitly provided that electronic control modules (ECMs) (described in the statute as “electronic emissions control units”) are “specified major emissions control component[s]” for warranty purposes per section 207(i)(2); failure of ECMs can also cause the vehicle to stop operating, and not necessarily increase the emissions of the vehicle.
The Alliance is also mistaken in suggesting that there is no way for EPA to require an emission-less vehicle
We intend for the battery durability and warranty requirements finalized in this rule to be entirely separate and severable from the revised emissions standards and other varied components of this rule, and also severable from each other. EPA has considered and adopted battery durability requirements, battery warranty requirements, and the remaining portions of the final rule independently, and each is severable should there be judicial review. If a court were to invalidate any one of these elements of the final rule, as discussed further below, we intend the remainder of this action to remain effective, as we have designed the program to function even if one part of the rule is set aside. For example, if a reviewing court were to invalidate the battery durability requirements, we intend the other components of the rule, including the GHG and NMOG+NO
As we explain above, for manufacturers who choose to produce PEVs, durable batteries are important to ensuring that the manufacturer's overall compliance with fleet emissions standards would continue throughout the useful life of the vehicle. The battery durability and warranty provisions EPA is finalizing help assure this outcome. At the same time, we expect that, even if not strictly required, the majority of vehicle manufacturers would still produce vehicles containing durable batteries given their effect on vehicle performance and the competitive nature of the industry. Available data indicates that manufacturers are already providing warranty coverage similar to what is required by the final durability and warranty requirements.
Moreover generally, the battery durability and warranty requirements resemble many other compliance provisions that facilitate manufacturers'
Substantially as proposed, this rulemaking implements battery durability monitoring and performance requirements for light-duty BEVs and PHEVs, and battery durability monitoring requirements for Class 2b and 3 BEVs and PHEVs, beginning with MY 2027.
As described in the proposal and in the introductory section above, EPA is introducing battery durability requirements for several reasons and in accordance with its authority under the Clean Air Act. As required under CAA section 202(a)(1) (“Such standards shall be applicable to such vehicles and engines for their useful life”), EPA emissions standards are applicable for the full useful life of the vehicle. Accordingly, EPA has historically required manufacturers to demonstrate the durability of engines and emission control systems on vehicles with ICE engines and has also specified minimum warranty requirements for ICE emission control components. Without durability demonstration requirements, EPA would not be able to assess whether manufacturers producing vehicles originally in compliance with relevant emissions standards would remain in compliance over the course of the useful life of those vehicles.
For decades, EPA has required vehicle manufacturers to demonstrate that their vehicles will continue to comply with any relevant emissions standards over the course of their useful life.
EPA has already identified the high-voltage battery in hybrid vehicles as a technology warranting specific durability requirements. Specifically, EPA's regulations already require manufacturers of HEVs and PHEVs to account for potential battery degradation that could result in an increase in CO
Today's final rule continues EPA's longstanding policy of ensuring durability for emissions control components and builds upon the existing durability requirements for batteries. Recognizing that PEVs, including both PHEVs and BEVs, are playing an increasing role in automakers' compliance strategies, and that emissions credit calculations are based on mileage over a vehicle's full useful life, EPA similarly has the authority to set requirements ensuring that manufacturers with PEVs in their fleet will continue to comply with relevant emissions standards over the course of those PEVs' useful lives. Under 40 CFR 86.1865-12(k), credits are calculated by determining the grams/mile each vehicle achieves beyond the standard and multiplying that by the number of such vehicles and a lifetime mileage attributed to each vehicle (
For instance, although lithium-ion battery technology has been shown to be effective and durable in currently manufactured BEVs and PHEVs, it is also well known that the energy capacity of a battery will naturally degrade to some degree with time and usage. This degradation can result in some reduction in electric driving range as the vehicle ages. Excessive battery degradation in a PHEV could lead to higher fuel consumption and increased criteria pollutant tailpipe emissions, while a degraded battery in a BEV could impact its ability to deliver the lifetime mileage expected. This effectively becomes an issue of durability if it reduces the utility of the vehicle or its useful life, and EPA will closely track developments in this area and propose modifications as they become necessary.
The importance of battery durability in the context of zero- and near-zero emission vehicles, such as BEVs and PHEVs, has been cited by several authorities in recent years. In their 2021 Phase 3 report,
EPA concurs with the emerging consensus that battery durability is an important issue. The ability of a zero-emission vehicle to achieve the expected emission reductions during its lifetime depends in part on the ability of the battery to maintain sufficient driving range, capacity, power, and general operability for a period of use comparable to that of any other vehicle. Durable and reliable electrified vehicles are therefore critical to ensuring that projected emissions reductions are achieved by this program.
GTR No. 22 was developed with extensive input, leadership, and participation from EPA and thus it reflects what EPA considers to be an appropriate framework and set of requirements for ensuring battery durability. EPA therefore considers its integration into the context of this rulemaking to be an appropriate pathway to establishing needed durability standards. In the absence of GTR No. 22, EPA would find it appropriate to adopt a very similar (if not identical) battery durability program, but we also recognize the value for U.S. automakers in adopting requirements that are consistent with international market requirements. Thus, the requirements and general framework of the battery durability program under this rule are largely identical to those outlined in GTR No. 22 and broadly parallel the GTR in terms of the minimum performance requirements, as well as the hardware, monitoring and compliance requirements, the associated statistical methods and metrics that apply to determination of compliance, and criteria for establishing battery durability and monitor families. EPA is incorporating the April 14, 2022, version of GTR No. 22 by reference, except for some naming conventions and procedural changes required to adapt the GTR to EPA-based testing and compliance demonstration, and modification of some specific provisions (for example, not requiring an SOCR monitor).
EPA requested comment on all aspects of the proposed battery durability program, particularly with respect to: The minimum performance requirements, the testing and compliance requirements for Part A and Part B, and the possibility of adopting more stringent or less stringent battery durability standards. EPA has carefully considered the public comments in finalizing the requirements of the durability program.
Several commenters, including several proponents or manufacturers of zero-emission vehicles, expressed support for the provisions and their intent of promoting battery durability. For example, Tesla stated that durability
Some commenters, such as the Alliance for Automotive Innovation (“the Alliance”), questioned EPA's authority to establish battery durability and warranty requirements. The Alliance, however, also agreed that battery degradation monitors and performance requirements are important tools for battery operation and state of health, and provided recommendations for modifying the program. Comments relating to authority are addressed in the introductory section above.
Positions varied regarding how the proposed durability and warranty program based on GTR No. 22 should exist alongside the California Air Resources Board (CARB) ACC II durability and warranty program (referred to here as the “CARB program”). Some commenters stressed the differences between the proposed durability program and the CARB program and stated that it would be difficult for OEMs to comply with two different sets of requirements. Commenters within this group suggested a variety of solutions, including: aligning certain aspects of the proposed program with the CARB program; adopting the CARB program instead of the proposed program; or accepting compliance with the CARB program in lieu of compliance with the proposed program. Volkswagen, Volvo, and the Southern Environmental Law Center strongly encouraged EPA to fully harmonize with CARB, while similarly, BMW recommended adopting a single national approach. In contrast, Nissan and a coalition of environmental NGOs supported adoption of GTR No. 22 as proposed. The Alliance for Automotive Innovation stated that both CARB and EPA should align with global best practices. Mercedes, several environmental NGOs and state organizations recommended that EPA should align with the CARB regulation to avoid conflicting regulatory requirements; Mercedes specifically recommended that EPA allow voluntary compliance with CARB's durability program in lieu of EPA's program. CARB recommended adopting the CARB durability provisions as well as the full suite of consumer assurance provisions under ACC II. Others more generally recommended that EPA work with CARB to modify aspects of the CARB program.
Regarding comments that EPA should work with CARB to modify aspects of the CARB program, EPA considers modification of the CARB program to be outside the scope of this rulemaking. Regarding recommendations that EPA should adopt certain specific provisions of the CARB program (for example, inclusion of a battery reserve capacity declaration, phase-in of monitor accuracy tolerance, exempting shorter-range BEVs or PHEVs from requirements, number of decimal places for the monitor, OBD requirements and data parameters, basis on percentage points vs. percent, etc.), EPA believes that the CARB program and the proposed program based on GTR No. 22, in their entirety, are similarly effective, but that each program achieves that effectiveness by operating as a whole, and taking an a la carte approach of moving specific requirements from the context of one program into the context of another would compromise the integrity of either program. For this reason, EPA is generally not taking an approach of adopting specific individual elements of the CARB program at this time.
However, EPA agrees with commenters' concerns that complying with both CARB and EPA durability programs may require more effort than complying with only one. Some commenters suggested that a solution to many of the issues regarding harmonization with the CARB program could be solved if EPA were to accept compliance with the CARB program in lieu of the federal program. EPA continues to believe that it is possible for manufacturers to comply with both programs simultaneously, as manufacturers that sell in California and so have to comply with the CARB program will often also have to comply with GTR No. 22 in other international jurisdictions, which is very similar to the EPA program. However, EPA also considers the CARB durability program, when viewed in its entirety with its metrics and performance requirements, to be no less effective than the EPA durability program.
Accordingly, EPA will accept manufacturer compliance with the entirety of the CARB ACC II durability program in lieu of the EPA durability program. To utilize this optional pathway, manufacturers must declare their intention to do so, in which case their compliance with the CARB durability program will be deemed as compliance with the EPA durability program. Regardless of whether a manufacturer chooses to follow the CARB or the EPA program for the purpose of satisfying EPA battery durability requirements, failure to comply with the chosen program will result in the same credit loss penalty as under the EPA program. EPA considers the addition of the option to comply with the CARB durability program in lieu of the EPA durability program to be responsive to the various requests to adopt certain specific elements of the CARB program.
EPA also requested comment on the inclusion of a requirement for an SOCR monitor and associated reporting requirements as specified in GTR No. 22. Automakers expressed general support for basing the MPR on a metric of usable energy, or SOCE, as specified in GTR No. 22. Several expressed specific opposition to a range-based metric or SOCR, while some NGOs encouraged use of both SOCE and SOCR. EPA continues to assess that SOCE is sufficient at this time as a basis for the MPR, and notes that at this time GTR No. 22 requires only that an SOCR monitor be implemented and does not use it for enforcement of the MPR. EPA continues to consider the addition of an SOCR monitor in a future rulemaking but at this time is electing not to include this requirement in the final standard, as proposed.
Some commenters expressed uncertainty over whether the EPA program includes the virtual mileage provision of GTR No. 22, which accounts for use of the battery for purposes other than propulsion of the vehicle (
A variety of comments were received regarding minimum performance requirements (MPR) and their enforcement. Some commenters considered the requirements to be too stringent, while others suggested that they could be more stringent. VW recommended that EPA should adopt a single performance requirement of 70 percent at 8 years/100k miles. Tesla supported the proposed MPR as reasonable and achievable, while also advocating for a flexible approach allowing the manufacturer to use good engineering judgment in determining the statistically adequate and representative use of vehicle data. Tesla also supported the decision not to implement an MPR for MDVs.
In response to comments suggesting that the minimum performance requirement (MPR) is too stringent and/or will add significant cost to the vehicle, EPA disagrees. As noted and cited previously, the MPR is very similar to warranty coverage already provided by vehicle manufacturers, indicating that the MPR described in the proposal is already largely being achieved and can continue to be achieved. In developing GTR No. 22, some stakeholders noted that a performance standard that is appropriate in the context of warranty may not necessarily be appropriate in the context of durability requirements, because the corrective action for a warranty failure is limited to the individual vehicles that fail, while the corrective action for a durability failure would involve every vehicle in a durability group. That is, a warranty performance standard is typically determined and remedied on an individual vehicle basis while a durability performance standard is determined and remedied on a durability group basis. However, EPA notes that (a) in the context of failure to meet the battery durability requirement, it is not requiring recall and repair of every battery in a failed durability group, and (b) the GTR specifies that a durability group meets the durability standard even when up to 10 percent of the vehicles in a durability group sample fail the Part B durability determination, without requiring recall and replacement of the battery in those vehicles. Thus, a given performance requirement in the context of the final durability program only becomes more binding than the same standard in the context of warranty if more than 10 percent of vehicles are failing the standard. Given the cost of battery repair and replacement, EPA expects that manufacturers would consider such a high warranty replacement rate to be unacceptable and so are designing batteries to avoid that outcome. EPA therefore continues to consider the durability performance standard to be appropriate and is not modifying the MPR at this time.
Some commenters recommended that EPA adopt only the 8-year, 100,000 mile requirement of the MPR, and not the 5 year, 62,000 mile requirement. EPA acknowledges that GTR No. 22 allows the possibility of local jurisdictions adopting either or both of the requirements. EPA agrees that requiring only the later requirement may reduce test burden. However, EPA also expects that the 5 year requirement will promote battery designs that degrade in a more or less linear fashion over their useful life (as opposed to a battery design that degrades more rapidly in earlier years, which would tend to increase the potential impact of lost range capacity on the total mileage the vehicle can attain over its life). Also, the 5-year requirement allows for an earlier compliance decision if a vehicle is on track to fail the 8-year standard. In EPA's view, these substantial compliance benefits outweigh the added burdens of additional testing. For these reasons we are retaining the 5-year requirement in the program.
The Alliance recommended that, in section 86.1815 of the regulatory text, that we replace the term “electric vehicles” with “BEVs and PHEVs” to exclude FCEVs from monitoring and durability requirements. Fuel cell vehicles were not included within the technical analysis or scope of GTR No. 22 and EPA has not as yet determined that the monitoring and durability requirements developed under GTR No. 22 are appropriate for FCEVs. Accordingly, EPA has made the requested change to section 86.1815.
The Alliance also requested clarification on whether or not the durability and monitoring requirements are tied to the Tier 4 phase-in per section 86.1815. EPA clarifies that the battery durability and warranty standards for light-duty vehicles under 6,000 pounds begin in model year 2027 and for medium-duty vehicles begin when first certified for Tier 4. See section 86.1815.
Regarding the durability test sample of at least 500 vehicles under Part B of the EPA program, the Alliance noted that distribution of some durability groups of PEVs across the U.S. may be insufficient to support the proposed sample characteristics, and proposed to keep the current sample size of 500 vehicles, but require that no more than 50 percent of the vehicles in the sample be registered in the same region. EPA agrees that, particularly in the early years of the program, some durability groups may be unevenly distributed across the U.S. and is modifying the sample requirements per this suggestion.
The SAVE Coalition recommended that we revise section 86.1815(a) to specify that the monitor should be viewable by the owner of the vehicle, as specified in GTR No. 22, rather than the customer, as specified in section 86.1815(a), to accommodate situations such as autonomous transportation services, where the customer of the autonomous service is not the owner of the vehicle. EPA agrees that “customer” may be ambiguous in this application; however, we also believe that using the term “owner” might be interpreted as excluding lessees or other parties with a legitimate interest in the state of health of the battery. EPA is clarifying the regulatory text by changing “customer-accessible” to “operator-accessible.” As the customer of a fully autonomous transport service is not an operator, EPA believes that this modification addresses the commenter's concern.
Some commenters requested clarification as to whether the removal of compliance credits earned by vehicles that fail the durability requirement applies only to GHG credits earned, or also to NMOG+NO
EPA also clarifies that Annex 3 of GTR No. 22 applies only in jurisdictions where WLTP is used. The quantities that represent UBE
As finalized, the battery durability requirements consist of two primary components as shown in Table 64. The first component is a requirement for manufacturers to provide a customer-readable battery state-of-health (SOH) monitor for both light-duty and Class 2b and 3 BEVs and PHEVs. The second component is the definition of a minimum performance requirement (MPR) for the SOH of the high voltage battery, applicable only to light-duty BEVs and PHEVs. HEVs and FCEVs are not included in the scope of GTR No. 22 or the durability program.
Manufacturers will be required to install a battery SOH monitor which estimates, monitors, and communicates the vehicle's state of certified energy (SOCE) as defined in GTR No. 22, and which can be read by the vehicle operator. This requires manufacturers to implement onboard algorithms to estimate the current state of certified energy of the battery, in terms of its current usable battery energy (UBE) expressed as a percentage of the original UBE when the vehicle was new. The state of certified range (SOCR) monitor defined in GTR No. 22 will not be required.
For light-duty BEVs and PHEVs, the information provided by this monitor will be used for demonstrating compliance with a minimum performance requirement (MPR) which specifies a minimum percentage retention of the original UBE when the vehicle was new. As shown in Table 65, under the final rule, light-duty BEV and PHEV batteries will be subject to an MPR that requires them to retain no less than 80 percent of their original UBE at 5 years or 62,000 miles, and no less than 70 percent at 8 years or 100,000 miles.
In alignment with GTR No. 22, which does not currently subject UN ECE Category N vehicles of Category 2 (work vehicles that primarily carry goods) to the MPR requirement, Class 2b and 3 PEVs will not be subject to the MPR. The developers of GTR No. 22 chose not to set an MPR for Category 2 PEVs at the time, largely because the early stage of adoption of these vehicles meant that in-use data regarding battery performance of these vehicles was not readily available. MPR requirements for category 2 PEVs were therefore reserved for possible inclusion in a future amendment to the GTR, but monitoring requirements were retained to allow information on degradation to be collected from these vehicles to help inform a future amendment. For similar reasons, EPA is retaining the monitor requirement for Class 2b and 3 PEVs but is not requiring the MPR.
Compliance with the new battery durability requirements will require manufacturers to perform testing beyond what is currently required. Previously, light-duty vehicle manufacturers were required to perform range testing on BEVs and PHEVs only to provide information to inform the EPA fuel economy label, and not for vehicle certification. Class 2b and 3 vehicles did not have the labeling requirement and therefore often did not undergo this testing. Under the new program (as described more fully in section III.G.1 and below), manufacturers of both light-duty and Class 2b and 3 BEVs and PHEVs will perform testing to determine and report the vehicle's UBE when new. In addition, at points during the useful life of the vehicle, manufacturers will demonstrate through in-use vehicle testing that the SOCE monitor meets an accuracy standard.
Manufacturers will group the PEVs that they manufacture into monitor families and battery durability families as defined in GTR No. 22 (and described in more detail in section III.G.3 of this preamble). As described further below, monitor families must comply with a monitor accuracy requirement, and battery durability families must comply with the applicable MPR. Because determination of compliance in either case depends on reference to a certified UBE value, this value must be determined at time of certification. Since the testing program that is currently performed for fuel economy labeling purposes does not necessarily determine such a value for all vehicle configurations that would need it for durability compliance purposes, additional testing of vehicles that would not otherwise need to be tested for labeling purposes may need to be performed at time of certification.
For both light-duty and medium-duty vehicles, as described in the “Part A” monitor accuracy provisions outlined in GTR No. 22, manufacturers will be required to meet a standard for accuracy of their on-board SOCE monitors. To determine the accuracy of the monitors, vehicles from each monitor family shall be recruited and procured in-use at each of 2 years and 4 years after the end of production of that monitor family for a model year. The onboard monitor values for SOCE shall be recorded, and each vehicle shall then be tested to determine actual (measured) UBE capability of the battery. As described in section III.G.1 of the preamble, for this testing EPA will require the 2017 version of SAE Standard J1634 for determining UBE for BEVs, and the 2023 version of SAE J1711 for determining UBE for PHEVs. The UBE measured by the test will be used to calculate the measured SOCE of the battery, as the measured UBE divided by the certified UBE. The measured SOCE shall be compared to the value reported by the SOCE monitor prior to the test. The accuracy of the SOCE monitor must not be in error more than 5 percent above the measured SOCE, as defined and determined via the Part A statistical method defined in GTR No. 22. See 40 CFR 86.1811-27, 86.1845-04(g) and 86.1839-01(c) for detailed specifications.
For light-duty vehicles, in a similar manner to the “Part B” compliance provisions of GTR No. 22, once having demonstrated Part A accuracy for the SOCE monitor of vehicles within a monitor family, manufacturers shall demonstrate compliance with the MPR by collecting the values of the onboard SOCE monitors of a statistically adequate and representative sample of in-use vehicles, in general no less than 500 vehicles from each battery durability family that shares that monitor family, and reporting the data and results to EPA. The manufacturer shall use good engineering judgment in determining that the sample is statistically adequate and representative of the in-use vehicles comprising each durability family, subject to specific provisions in the regulation and approval by EPA. Manufacturers may obtain this sample by any appropriate method, for example by over-the-air data collection or by other means. A battery durability family passes if 90 percent or more of the monitor values read from the sample are at or above the MPR.
In the case that a monitor family fails the Part A accuracy requirement, the manufacturer will be required to recall the vehicles in the failing monitor family to bring the SOCE monitor into compliance, as demonstrated by passing the Part A statistical test with vehicles using the repaired monitor. In the case that a durability family fails the Part B durability performance requirement, the
For Part B, GTR No. 22 does not specify a means of data collection. EPA anticipates that many manufacturers might collect this data via means such as telematics (remote, wireless queries) which is becoming increasingly present in new vehicles, or any other sampling technique which accurately collects data from the number of vehicles outlined in the GTR. For example, vehicle manufacturers may choose to physically connect to the required number of vehicles and read the SOCE values directly in lieu of remote, telematics-based data collection. The data collection method used for Part B must identically report the same quantities that were collected for the purpose of the monitor accuracy test under Part A.
Unlike GTR No. 22, EPA is not requiring a state of certified range (SOCR) monitor in addition to an SOCE monitor. In the proposal we noted that some of the organizations and authorities that have examined the issue of battery durability have recognized that monitoring the state of a vehicle's full-charge driving range capability (instead of or in addition to UBE capability) as an indicator of battery durability performance may be an attractive option because driving range is a metric that is more directly experienced and understood by the consumer. GTR No. 22 requires manufacturers to install a state of certified range (SOCR) monitor in addition to an SOCE monitor but it is not required to be customer facing, and its information is collected only for information gathering purposes. Additional discussion of the decision to not include an SOCR monitor in the EPA program is provided in RTC section 16.
Additional background on UN GTR No. 22 and the California Air Resources Board battery durability and warranty requirements may be found in RIA Chapter 1.3.
EPA is also finalizing new warranty requirements for BEV and PHEV batteries and associated electric powertrain components (
For light-duty BEVs and PHEVs, EPA is designating the high-voltage battery and associated electric powertrain components as specified major emission control components according to our authority under CAA section 207(i)(2), which assigns a warranty period of 8 years or 80,000 miles for components so designated.
For medium-duty (Class 2b and 3) BEVs and PHEVs, we are establishing a warranty period of 8 years or 80,000 miles for the battery and associated electric powertrain components on these vehicles, according to our authority under CAA section 207(i)(1). The program will provide warranty coverage for the emission control components on Class 2b and 3 BEVs and PHEVs equal to that for the same components on light-duty BEVs and PHEVs.
EPA believes that this practice of ensuring a minimum level of warranty protection for emissions-related components on ICE vehicles should be extended to the high-voltage battery and other electric powertrain components of BEVs and PHEVs for multiple reasons. Recognizing that BEVs and PHEVs are playing an increasing role in manufacturers' compliance strategies, the high-voltage battery and the powertrain components that depend on it are emission control devices critical to the operation and emission performance of BEVs and PHEVs, as they play a critical role in reducing the emissions of PHEVs and in enabling BEVs to operate with zero tailpipe emissions as well as to reduce fleet average emissions, as discussed earlier. Further, EPA anticipates that compliance with the program is likely to be achieved with larger penetrations of BEVs and PHEVs than under the previous program. Although the projected emissions reductions are based on a spectrum of control technologies, in light of the cost-effective reductions achieved, especially by BEVs, EPA anticipates most if not all automakers will include credits generated by BEVs and PHEVs as part of their compliance strategies, even if those credits are obtained from other manufacturers; thus this is a particular concern given that the calculation of credits for averaging (as well as banking and trading) depend on the battery and emission performance being maintained for the full useful life of the vehicle. Additionally, warranty provisions are a strong complement to the battery durability requirements described in III.G.2. We believe that a component under warranty is more likely to be properly maintained and repaired or replaced if it fails, which would help ensure that credits granted for BEV and PHEV sales represent real emission reductions achieved over the life of the vehicle.
In the proposal, EPA requested comment on all aspects of the proposed warranty provisions for light-duty and medium-duty PEVs, batteries, and associated electric powertrain components.
The Alliance commented that warranty requirements should remain at the discretion of individual OEMs rather than be specified by regulation, and that designation of BEV batteries and associated components as specified major emission control components is not consistent with the statute. The commenter asserted that BEVs do not have emissions and therefore our inclusion of BEV components of any kind under the Administrator's authority to specify warranty requirements for emissions-related components is not appropriate. EPA's response to any questions of authority to set durability or warranty requirements for BEV batteries is in the introductory section. Below we provide additional discussion of our authority to establish warranty requirements specifically.
For light-duty vehicles, CAA section 207(i)(1) specifies that the warranty period is 2 years or 24,000 miles of use (whichever first occurs), except for specified major emission control components (SMECC) described in 207(i)(2), for which the warranty period is 8 years or 80,000 miles of use (whichever first occurs). For all other vehicles, which would include medium-duty vehicles (MDVs), CAA 207(i)(1) specifies that the warranty period shall be the period established by the Administrator. For both light-duty and medium-duty vehicles, the Administrator is establishing a warranty period of 8 years and 80,000 miles.
For light-duty vehicles, 207(i)(2) specifically identifies catalytic converters, electronic emissions control units, and onboard emissions diagnostic devices as SMECC. Currently, BEV and PHEV battery and electric powertrain components are not so specified, which limits their coverage requirement to the 2 years or 24,000 miles of CAA section 207(i)(1), a period which EPA believes is not sufficient, given the importance of
Several environmental NGOs and supplier organizations indicated support of PEV durability and warranty requirements, and referenced statutory language supporting these measures. Tesla advocated for warranty thresholds more consistent with the industry standard, and adoption of a standard 8-year, 80,000 miles warranty with 70 percent UBE. Lucid requested that EPA consider CARB's current battery warranty under ACC II, which is 70 percent SoH for 8 years or 100,000 miles, and aligns with EPA's proposed end point durability standard. In response, the warranty standard is based on the statutory criterion of 8 years or 80,000 miles for SMECC components, which does not specify a failure criterion for batteries. This standard matches Tesla's recommendation but does not specify a UBE requirement as failure criterion, consistent with past EPA practice regarding SMECC component warranty. In the proposed regulatory text EPA had tied the battery warranty failure criterion to the MPR criterion of 70 percent SOCE to provide clarity on what constitutes the need for a warranty repair. However, in light of comments received, additional research and consideration of existing warranty-related provisions in the current regulations, EPA has reconsidered the appropriateness of doing so at this time. EPA is not tying the battery warranty failure criterion to the durability performance requirement but will require manufacturers to specify the warranted percentage SOCE and will require use of the SOCE monitor value in determining a warranty claim, subject to the warranty claim procedures in 40 CFR 85.2106. See the regulatory text and further discussion in section 15.1 of the Response to Comments document. EPA has not yet determined if it is appropriate to specify a warranty failure criterion in this context and will continue to study the matter for possible inclusion in a future rulemaking.
Some commenters raised the issue of whether or not virtual mileage would be included in the mileage applicable to the warranty provisions, with some suggesting that it should be included. However, commenters did not clearly explain why virtual mileage should be extended to warranty mileage simply because it exists in the context of durability. EPA notes that the virtual mileage provision originates in EPA's adoption of GTR No. 22, which developed a concept of virtual mileage specifically for the context of battery durability. GTR No. 22 does not consider or establish warranty provisions. EPA retained the virtual mileage provision in the context of durability for the purpose of maintaining consistency with the GTR design and structure, and not for the purpose of potentially extending a virtual mileage concept to other mileage-related aspects of our regulations.
As an alternative to the inclusion of virtual warranty mileage, some commenters suggested that EPA should exclude vehicles that were used for V2G or V2B from warranty coverage. EPA continues to assess that these provisions are not necessary. We note that the warranty mileage, which does not include virtual mileage, is only 80,000 miles compared to the durability mileage of 100,000 miles. This reduced stringency largely addresses commenters' concerns regarding warranty mileage and likely levels of V2G or V2B usage. EPA also notes that V2G usage may not necessarily imply a shorter battery life as is commonly assumed. Recently, NREL found that a vehicle-to-grid control strategy which lowered the battery's average state of charge (SOC) when parked—while ensuring it was fully recharged in anticipation of the driver's next need—could extend the life of the battery if continued over time.
In the proposed regulatory text, EPA explicitly tied the warranty performance criteria to the durability requirement,
CARB recommended that EPA adopt the CARB warranty provisions, and that EPA explicitly tie battery warranty requirements to the durability performance requirement. However, CARB pointed out that the “proposal appears to mistakenly tie all non-battery powertrain components to this same battery durability performance requirement when defining failures that merit warranty replacement. Such a connection renders the warranty requirements meaningless for those components.” CARB went on to recommend that EPA adopt “an appropriate failure metric(s) for warranty coverage for non-battery components.”
In response to comments that EPA should not specify warranty performance criteria, EPA continues to find that the proposed warranty requirements are equivalent to those that EPA has the authority to require and has historically applied to other specified major emission control-related components for ICE vehicles under EPA's light-duty vehicle regulations,
In response to CARB's observation that the 70 percent SOCE stipulation is technically not applicable to associated powertrain components that are not batteries, the removal of the explicit connection addresses this comment. For these components EPA is specifying only the years and mileage terms and not specific failure criteria.
In response to comments that we should clarify what is meant by “associated powertrain components,” EPA has revised 40 CFR 85.2103(d)(1)(v) of the regulatory text, which now clarifies that the provision applies to “all components needed to charge the system, store energy, and transmit power to move the vehicle.”
Other comments are addressed in the RTC.
EPA is revising the durability group definition for vehicles with an IC engine, and adding two new grouping definitions, monitor family and battery durability family, for BEVs and PHEVs.
EPA anticipates the adoption and use of gasoline particulate filters (GPFs) to reduce PM emissions to the levels required with the revised PM standard. Particulate filters are currently utilized on diesel-powered vehicles to meet the existing Tier 3 p.m. standard. EPA's durability group definition in 40 CFR 86.1820-01 includes a catalyst grouping statistic based on the engine displacement and catalyst volume and loading to define the acceptable range of designs that may be combined into a single durability group. Previously, EPA has not required manufacturers to consider PM filters in the determination of the durability group.
PM filters can also be coated with precious metals resulting in the particulate filter performing the functions of a three-way catalyst in addition to reducing particulates. The Agency expects that manufacturers may choose to adopt PM filters with three-way catalyst coatings on some applications to reduce aftertreatment system cost by not increasing the number of substrates. We are accordingly clarifying that manufacturers need to include the volume and precious metal loading of the PM filter along with the corresponding catalyst values when calculating the catalyst grouping statistic. The volume of the PM filter will not be included in the catalyst grouping statistic if the PM filter does not include precious metals.
The durability group is used to specify groups of vehicles which are expected to have similar emission deterioration and emission component durability characteristics throughout their useful life. The inclusion of a particulate filter on a gasoline-fueled vehicle aftertreatment system can have an impact on the durability characteristics of the aftertreatment system and as such the Agency is finalizing its proposal that this device, or the lack of a PM filter in the aftertreatment system, needs to be included in the durability group determination for internal combustion engine aftertreatment systems. Specifically, we are finalizing that vehicles may be included in the same durability group only if all the vehicles have no particulate filter, or if all the vehicles have non-catalyzed particulate filters, or if all the vehicles have catalyzed particulate filters.
We are applying these updates to durability groups equally for both gasoline and diesel applications. However, diesel vehicles certified under 40 CFR part 86, subpart S, generally use a consistent configuration with particulate filters, so the changes are not likely to lead to changes in certification practices for those vehicles. The Agency did not receive any comments on these proposed changes to the durability group definition.
As described in section III.G.2.i of the preamble, EPA is establishing battery durability requirements for BEVs and PHEVs. As part of this durability standard, as proposed, the Agency is finalizing two new groupings for BEVs and PHEVs, the battery monitor family and the battery durability family.
As described in section III.G.2.i of the preamble, based on comments received to the NPRM, EPA will accept manufacturer compliance with the CARB ACC II durability program in lieu of the EPA durability program. Allowing BEV manufacturers to comply with the ACC II durability requirements has resulted in the need to revise the required groupings for BEVs.
In the NPRM it was proposed that BEVs would have battery monitor and battery durability families and would no longer require test group or exhaust emission durability groups. As the California ACC II program groups BEVs by test groups, EPA has concluded that BEVs will still require the definition of an exhaust emission durability group and test group for all BEVs.
In the NPRM it was proposed that PHEVs would have battery monitor and battery durability families in addition to test group and exhaust emission durability groups. PHEVs required keeping the test group and exhaust emission durability groups as these definitions were created to group vehicles based on their exhaust emission characteristics.
As finalized in this rulemaking BEVs and PHEVs which will comply with the California ACC II requirements and will not comply with the EPA requirements will only need to specify a durability family and a test group for these vehicles. BEVs and PHEVs which comply with the EPA requirements will need to specify a durability family, test group, battery monitor family, and battery durability family for these families.
To support the monitor accuracy evaluation requirements described in section III.G.2 of the preamble, manufacturers must install a battery SOH monitor which accurately estimates, monitors, and communicates the SOCE of the high-voltage battery (as defined in GTR No. 22 and described in section III.G.2 of the preamble) at the current point in the vehicle's lifetime. To evaluate the accuracy of the monitor during the life of the vehicle, manufacturers must procure and test consumer vehicles in-use. The SOCE
Through the introduction of monitor families for BEVs and PHEVs, EPA seeks to reduce test burden by recognizing that monitor accuracy may be similar for vehicles with sufficiently similar design characteristics that use the same monitor design. As described in GTR No. 22, vehicles that are sufficiently similar in their characteristics such that the monitor can be expected to perform with the same accuracy may be assigned to the same monitor family. The criteria for inclusion in the same monitor family includes characteristics such as the algorithm used for SOCE monitoring, electrified vehicle type (BEV or PHEV), sensor characteristics and sensor configuration, and battery cell characteristics that would not be expected to influence SOCE monitor accuracy.
In the NPRM, EPA proposed that for vehicles to be in the same monitor family, the following conditions must be met: the SOCE monitoring algorithm needs to utilize the same logic and have the same value for all calibration variables used in the algorithm; the algorithm used to determine UBE needs to utilize the same sampling and integration periods and the same integration technique; the locations of the sensor(s) (
If a manufacturer determines that additional vehicle characteristics affect the accuracy of SOCE estimation, the manufacturer can request the Administrator to allow the creation of additional monitor families. To request additional monitor families, the manufacturer may seek Agency approval and describe in their application the factors which produce SOCE estimation errors and how the monitor family will be divided to reduce the estimation errors.
Manufacturers can request that the Administrator include in the same monitor family vehicles for which these characteristics would not otherwise allow them to be in the same monitor family (except for including BEVs and PHEVs in the same monitor family). When seeking Agency approval, the manufacturer will need to include data demonstrating that these differences do not cause errors in the estimation of SOCE.
In introducing battery durability families for BEVs and PHEVs, EPA seeks to reduce test burden by recognizing that the degradation of UBE (as indicated by SOCE) may be similar for vehicles with sufficiently similar design characteristics. As described in GTR No. 22, vehicles that are sufficiently similar in their characteristics such that the UBE may be expected to degrade in the same way may be assigned to the same battery durability family. EPA is establishing provisions requiring use of the following powertrain characteristics and design features to determine battery durability families: maximum specified charging power, method of battery thermal management, battery capacity, battery (cathode) chemistry, and the net power of the electrical machines. In addition, BEVs and PHEVs cannot be placed in the same battery durability family.
EPA received comments from the Alliance requesting a number of changes to the criteria used to determine battery durability families for BEVs and PHEVs. The Alliance recommended removing the cathode chemistry criteria and including all unique cathode chemistries in a single Li-Ion family. Another commenter expressed uncertainty as to whether variants within specific Li-Ion sub-chemistries, such as NMC or LFP, would be considered the same or different chemistries. The Alliance also suggested removing the maximum charging power criteria. In addition, the Alliance recommended allowing batteries with capacities within 20 percent to be included in the same battery durability family. At this time, the Agency does not have sufficient information to conclude that the revisions the Alliance is suggesting will ensure that all vehicles within a durability family would be expected to degrade in the same manner. For example, it is well known that different lithium-ion chemistries, even within specific sub-chemistries such as NMC or LFP, can exhibit significantly different durability properties. As noted in this section and in the EPA regulations, EPA is providing manufacturers with the option to include in the same durability family vehicles for which these characteristics would not otherwise allow them to be in the same battery durability family. In order to make this inclusion, the manufacturer needs to provide data demonstrating the vehicle differences being included will age similarly and will degrade in an equivalent manner. The option to provide data applies to all of the powertrain characteristics and design features used to determine a battery durability family. Therefore, the Agency is finalizing the requirement to specify battery durability families based on the characteristics and design features described in GTR No. 22 with the provision to allow variations based on the submission of appropriate data demonstrating equivalent degradation. With regard to specific sub-chemistries, EPA clarifies that placement in the same battery durability family is not indicated when chemistry differences exist that would be expected to influence durability. Chemistry differences may include differences such as proportional metal composition of the cathode (for example, NMC811, NMC622, NMC333, etc.), composition of the anode (for example, graphite, graphite with silicon, other forms of carbon), or differences in particle size or morphology of cathode or anode active materials, unless data is provided otherwise as described above.
Manufacturers can request that the Administrator include in the same battery durability family vehicles for which the characteristics and design features described in the above paragraphs would not otherwise allow them to be in the same battery durability family (except for including BEVs and PHEVs in the same battery durability family). The manufacturer will need to include data with their request that demonstrates that these differences do not impact the durability of the vehicles with respect to maintaining UBE throughout the life of the BEV or PHEV.
If a manufacturer determines that additional vehicle characteristics result in durability differences which impact UBE, the manufacturer can request the Administrator to allow the creation of additional battery durability families. To request additional battery durability families the manufacturer will need to seek Agency approval. In their request for approval, the manufacturer must describe the factors which produce differences in vehicle aging and how the
EPA also received comments from the California Air Resources Board and the State of Colorado addressing EPA's proposed BEV durability program. Both Colorado and the California Air Resources Board were supportive of EPA's proposal and in both instances also asked EPA to implement a BEV durability program based on California's durability program adopted in their Advanced Clean Cars II regulation. The final rule accordingly includes an option for manufacturers to demonstrate compliance with battery durability requirements based on certification to CARB's ACC II program. Detailed responses to these comments can be found in the Response to Comments Document.
EPA is finalizing its proposal to clarify the certification compliance and enforcement requirements for GHG exhaust emission standards found in 40 CFR 86.1865-12 to more accurately reflect the intention of the 2010 light-duty vehicle GHG rule (75 FR 25324, May 7, 2010). In the 2010 rule, EPA set full useful life greenhouse gas emissions standards with which each vehicle is required to comply. Each vehicle has an individual full useful life greenhouse emission standard which is based on the measured GHG emissions used for fuel economy labeling purposes. Manufacturers determine compliance with the fleet average greenhouse gas standard by combining the individual vehicle's GHG emissions useful life values and comparing this result to the manufacturers fleet average standard. The preamble to the 2010 rule clearly explained that the CAA requires a vehicle to comply with emission standards over its regulatory useful life and affords EPA broad authority for the implementation of this requirement and that EPA has authority to require a manufacturer to remedy any noncompliance issues. EPA also explained that there may be cases where a repairable defect could cause the non-compliance and in those cases a recall could be the appropriate remedy. Alternatively, there may be scenarios in which a GHG non-compliance exists with no repairable cause of the exceedance. Therefore, the remedy can range from adjusting a manufacturer's credit balance to the voluntary or mandatory recall of noncompliant vehicles.
In the 2010 rule, EPA clearly intended to use its existing recall authority to remedy greenhouse gas non-compliances through traditional recalls when appropriate and to use the authority to correct the greenhouse gas credit balance as a remedy when no practical repair for in-use vehicles could be identified. See 75 FR 25474. However, the regulations did not describe these in-use compliance provisions with as much clarity as the preambular statements. Therefore, as proposed, EPA is finalizing clarifications to 40 CFR 86.1865-12(j) to make clear that EPA may use its existing recall authority to remedy greenhouse gas non-compliances when appropriate and specifically may use such authority to correct a manufacturer's greenhouse gas credit balance as a remedy when no practical repair can be identified.
The Alliance for Automotive Innovation commented that they believe such an approach is sensible. However, they stated that EPA does not have authority under section 207 of the CAA to require it. EPA disagrees; section 207 of the CAA clearly gives EPA the authority to require recall of non-compliant vehicles, but does not specify a precise form for such a recall. EPA responds to this comment in full in the Response to Comments.
In the 2010 rule, EPA set vehicle in-use emissions standards for carbon-related exhaust emission (CREE) to be 10 percent above the vehicle-level emission test results or model-type value if no subconfiguration test data are available. This 10 percent factor was intended to account for test-to-test variability or production variability within a subconfiguration or model type. EPA clearly did not intend for this factor to be used as an allowance for manufacturers to design and produce vehicles that generate CO
For the reasons that EPA articulated in the 2010 rulemaking, EPA expects that some in-use vehicles may generate slightly more CO
The first option was to clarify the regulatory language to make it clear that if a manufacturer's in-use data demonstrates that a manufacturer's CO
The second option was to set the in-use standards at the vehicle-level emission test results or model-type average value if no subconfiguration test data are available in the GHG report. Under this approach, manufacturers will have the option to voluntarily raise the GHG values submitted in the GHG report if they wish to create an in-use compliance margin. The proposed change in this second option would make the GHG ABT program consistent with all other ABT programs used in the light-duty program. In all other ABT programs (
The Alliance for Automotive Innovation commented that they opposed the second option, stating that even with perfect in-use performance, they would expect 50 percent of vehicles to exceed the original certification test simply due to test-to-test variation. They acknowledged that most test groups would avoid IUCP given the threshold of 10 percent exceedance for 50 percent of the tested vehicles. They commented that, it is not productive to have 50 percent of all initial tests be identified as failures.
Kia commented that keeping the 10-percent in-use standard is critical as EPA increases the stringency of criteria pollutants and GHG emissions 10-fold. The Alliance for Automotive Innovation commented that they support the first of the two options that maintains the 10 percent allowance.
BMW NA commented that they understand and support EPA in its proposal to align with the intent of the 2010 light-duty GHG rule and are in favor of the “Option 1.” However, they requested that EPA updates the proposal to clarify what is meant by “consistently higher” results with respect to GHG balance correction.
EPA is finalizing language in 40 CFR 86.1865-12 to make it clear that if a manufacturer's in-use data demonstrates a substantial number of vehicles fail to comply with the in-use GHG standards for any class or category of vehicle, EPA may use its recall authority to remedy a GHG noncompliance. In some cases, this remedy could be a repair of the affected vehicles, and in other cases it could be an adjustment to the GHG credit balance. In either case, the remedy must be adequate to ensure the manufacturer's GHG fleet average is representative of the actual vehicles it produced. This means that, in the case of a credit adjustment, the credit balance post-correction will reflect the actual in-use performance of the vehicles. In other words, if the manufacturer reports a value of X g/mile in calculating its fleet average, but its vehicles emit X+A g/mile in-use, the manufacturer's balance must be adjusted by the entire discrepancy (A). In the case of a repair to the affected vehicles, the remedy would also need to be sufficient such that the repaired vehicles emit the same X g/mile.
The overarching principle of compliance to the fleet average standards is that the calculated fleet average in the GHG report must accurately represent the actual fleet of vehicles a manufacture produced. If a manufacturer knowingly provides false or inaccurate data as part of their GHG report, the manufacturer may be subject to enforcement and EPA may void ab initio the certificates of conformity which relied on that data. Vehicles are covered by a certificate of conformity only if they are in all material respects as described in the manufacturer's application for certification (Part I and Part II) including the GHG report. If vehicles generate substantially more CO
EPA also proposed changes to 40 CFR 86.1850-01 to allow the Agency to void ab initio a previously issued certificate of conformity in the list of possible actions the agency may take if a manufacturer commits any of the infractions listed in 40 CFR 86.1850-01(b), namely: if a manufacturer submits false or incomplete information, renders inaccurate any test data which it submits, or fails to make a good engineering judgment. Specifically, EPA proposed removing the word “knowingly” from 40 CFR 86.1850-01(d). The Alliance for Automotive Innovation commented that EPA failed to set forth a plausible rationale for the proposed changes. Without taking a position on the substance of the comment, EPA has decided not to finalize the changes to 40 CFR 86.1850-01 as proposed.
EPA's existing regulations require manufacturers to conduct in-use testing as a condition of certification. Specifically, manufacturers must commit to later procure and test privately-owned vehicles that have been normally used and maintained. The vehicles are tested to determine the in-use levels of criteria pollutants when they are in their first and fourth years of service. This testing is referred to as the In-Use Verification Program (IUVP) testing, which was first implemented as part of EPA's Compliance Assurance Program (CAP) 2000 certification program.
Another component of the CAP 2000 certification program is the In-Use Confirmatory Program (IUCP). This is a manufacturer-conducted in-use test program that can be used as the basis for EPA to order an emission recall (although it is not the only potential basis for recall). For vehicles tested in the IUVP to qualify for IUCP, there is a threshold of 1.30 times the certification emission standard for criteria emissions (
Since measuring PM below 0.5 mg/mile may require measurement procedure adjustments in some laboratories, EPA is providing a temporary increase in the criteria that trigger an IUCP (in-use confirmatory testing program). The temporary criteria only apply to test groups certifying to the Tier 4 PM standard (0.5 mg/mi) and only extends through 2030 for LDV, LDT, MDPV, and through 2031 for MDV. The temporary criteria consist of a mean test group PM equal to or greater than 1.30 times the standard and the failure rate among vehicles in that test group of 80 percent or higher. The criteria revert to 1.30 times the standard and a failure rate among vehicles in that test group of 50 percent or higher starting in 2031 for LDV, LDT, MDPV, and starting in 2032 for MDV.
The 2010 light-duty GHG rule set full useful life greenhouse gas emissions standards for which each vehicle is required to comply and required in-use testing under the In-Use Verification Program (IUVP) testing provisions.
Since the 2010 light-duty GHG rule, EPA has received in-use greenhouse gas emissions test results from over 9,500 vehicles. EPA believes there is now sufficient data to establish IUCP threshold criteria based on greenhouse gas emissions and that doing so is warranted.
The 2010 light-duty GHG rule established an in-use CO
The Alliance for Automotive Innovation commented that EPA did not adequately justify the decision to exclude a threshold such as the 1.3 factor used for criteria pollutants in combination with the 50 percent trigger for IUCP testing. EPA disagrees with the comment. In the proposal, EPA explained that EPA did not propose a threshold for the average emissions of the test group (which is 1.3 times for criteria emissions) for a number of reasons. First, unlike criteria pollutants where the in-use standards are generally the same as the certification standards, EPA setting a margin of 10 percent above the reported GHG result for the in-use standard. Adding an additional multiplier on top of that would be unnecessary, and EPA believes a 10 percent exceedance threshold (either as a part of the in-use standard or as a threshold criteria) is appropriate given the Agency's experience with GHG compliance over the past decade. Second, unlike for criteria pollutants, the CO
Therefore, consistent with our proposal, EPA is not establishing additional criteria based on the average emissions of the test group.
As proposed, EPA is finalizing changes to 40 CFR 86.1844-01(e) “Part 2 Application” to make it clearer that the Part 2 application must include the part numbers and descriptions of the GHG emissions related parts, components, systems, software or elements of design, and Auxiliary Emission Control Devices (AECDs) including those used to qualify for GHG credits (
Also as proposed, EPA is finalizing changes to 40 CFR 85.2110 and 40 CFR 86.1844-01(e) “Part 2 Application” to no longer accept paper copies of service manuals, Technical Service Bulletins (TSB), owner's manuals, or warranty booklets. In response to the National Archives and Records Administration (NARA) mandate and OMB's Memorandum for Heads of Executive Departments and Agencies, M-19-21, Transition to Electronic Records, EPA will no longer accept paper copies of these documents.
The “Federal Test Procedure” (FTP) defines the process for measuring vehicle exhaust emissions, evaporative emissions, and fuel economy and is outlined in 40 CFR 1066.801(e). The process includes preconditioning steps to ensure the repeatability of the test results, as described in 40 CFR 86.132-96. EPA is finalizing two changes, consistent with our proposal, to the preconditioning process used for testing of only fuel economy data vehicles (FEDVs) (not emission data vehicles) in order reduce the testing burden while maintaining the repeatability and improving the accuracy of the test results.
Currently, all Fuel Economy Data Vehicles (FEDVs) must follow the regulations for preconditioning before conducting the cold-start portion of the test. Included in this preconditioning is the requirement to drain and refuel the fuel tank twice. We are finalizing our proposal to remove the second fuel drain step, which occurs after running the Urban Dynamometer Driving Schedule (UDDS) preconditioning cycle, but before the cold start test. The fuel drain and refuel step was originally included in the test procedure because fresh fuel was important for carbureted engines and could impact the test results. However, with today's fuel injection systems, EPA's assessment is that the refueling of the vehicle with fresh fuel does not impact the measured fuel economy of the vehicle.
EPA is also finalizing its proposal to remove the canister loading and purging steps from the preconditioning for FEDVs. This will provide the following benefits to manufacturers and EPA: the time to run the test will be reduced, less butane will be consumed by the laboratories which reduces the cost of running a test, and the fuel economy measurement accuracy will improve. EPA conservatively estimates that at least 88 kg of butane was consumed by manufacturers in the 2021 calendar year for the purposes of fuel economy testing, based on 909 fuel economy test submissions to EPA and assuming 97 grams of butane per canister. The measurement accuracy will improve because the calculations for fuel economy assume that 100 percent of the fuel consumed during the testing has the carbon balance of the liquid fuel in the tank. The butane vapor that is added
Finally, the regulations at 40 CFR 86.132-96(a) currently state that fuel caps must be removed during any period when the vehicle is parked outside awaiting testing but fuel caps may be in place while in the test area. As proposed, EPA is amending the regulations to simply require that vehicles be stored in a way that prevents fuel contamination and preserves the integrity of the fuel system. At this time EPA considers the possibility of contaminants getting into the fuel system while the fuel cap is off to be more significant than any possible canister loading. Modern vehicles purge the canister sufficiently during the preconditioning cycles to ensure that tests completed on vehicles that have been parked will not significantly affect test results. Custodians of test vehicles should avoid parking test vehicles outdoors during hot conditions.
EPA did not receive any adverse comments related to the proposed test streamlining described in this section. Ingevity commented that the streamlining steps seem acceptable as long as the full test procedure specified in 40 CFR part 86, subpart B, remains primary for EPA testing. The Agency notes that the appropriate test procedure steps will be followed when testing vehicles to determine compliance with the evaporative emission standards.
We are clarifying the pre-certification exemption in 40 CFR 85.1706 by amending the definition of “pre-certification vehicle” in 40 CFR 85.1702. The amended regulation limits the exemption to companies that already hold a certificate showing that they meet EPA emission standards. This has been a longstanding practice for highway and nonroad engines and vehicles. Companies that are not certificate holders may continue to request a testing exemption under 40 CFR 85.1705.
Also as proposed, we are updating the test procedures in 40 CFR 86.113-15 to reference test fuel specifications in 40 CFR part 1065 for diesel fuel, natural gas, and LPG. We do not expect this change to cause manufacturers to change the test fuels they use for certification, or to prevent any manufacturer from using carryover data to continue certifying vehicles in later model years. In the case of diesel fuel, the two sets of specifications are very similar except that 40 CFR 1065.703 takes a different approach for aromatic content of the fuel by specifying a minimum aromatic content of 100 g/kg. We expect current diesel test fuels to meet this specification. In the case of natural gas, 40 CFR 1065.715 decreases the minimum methane content from 89 to 87 percent, with corresponding adjustments in allowable levels of nonmethane compounds. In this case too, manufacturers will be able to continue meeting test fuel specifications without changing their current practice. In the case of LPG, 40 CFR 86.113-94 directs manufacturers to ask EPA to approve a test fuel. The final rule specifies, as proposed, that the fuel specifications already published in 40 CFR 1065.720 are appropriate for testing vehicles certified und 40 CFR part 86, subpart S.
The regulation currently requires manufacturers to include information in the application for certification for fuel-fired heaters (40 CFR 86.1844-01(d)(15)). The regulation also requires manufacturers to account for fuel-fired heater emissions in credit calculations for Tier 2 vehicles (40 CFR 86.1860-04(f)(4)). The Tier 3 regulation inadvertently omitted the requirement related to credit calculations in 40 CFR 86.1860-17. As proposed, we are restoring the requirement to account for emissions from fuel-fired heaters in credit calculations in 40 CFR 86.1844-01(d)(15).
This rule includes several structural changes that lead to a need to make the following changes to the regulations for correct terminology and appropriate organization:
• We are replacing cold temperature NMHC standards with cold temperature NMOG+NO
• We are setting separate emission standards for US06 and SC03 driving schedules rather than setting standards based on a composite calculation for the driving schedules that make up the Supplemental FTP. As a result, we are generally adjusting terminology for Tier 4 vehicles to refer to the specific cycles rather than the Supplemental FTP.
• The existing regulation includes several references to Tier 3 standards (or Tier 3 emission credits, etc.). Those references were generally written to say when regulatory provisions started to apply. Some of those provisions need to continue into Tier 4, but not all. The final rule includes new language in several places to clarify whether or how those provisions apply for Tier 4 vehicles.
• The Tier 4 standards apply nearly uniformly for both light-duty and medium-duty vehicles. This contrasts with earlier standards where many requirements and compliance provisions applied differently for light-duty and medium-duty vehicles. For Tier 3, that led us to adopt the light-duty standards in 40 CFR 86.1811-17 and the medium-duty standards in 40 CFR 86.1816-18. As a result, because of the extensive commonality for Tier 4 standards, we are finalizing the new criteria exhaust emission standards for all these vehicles in 40 CFR 86.1811-27 rather than continuing to rely on 40 CFR 86.1816 for medium-duty vehicles.
The rule includes several instances of removing regulatory text that has been obsolete for several years. Removing obsolete text is important to prevent people from making errors from thinking that obsolete text continues to apply. The final rule includes additional housekeeping amendments to remove obsolete text and to remove or update cross references to obsolete or removed regulatory text.
The proposed rule identified labeling information that included obsolete content for incomplete vehicles. We proposed to remove 40 CFR 86.1807-01(d), but are instead amending that paragraph for the final rule to preserve the labeling information, but exclude the references to obsolete regulatory provisions.
One case of obsolete text is related to special test procedures as specified in 40 CFR 86.1840-01. Vehicle manufacturers have completed a transition to following the exhaust test procedures specified in 40 CFR part 1066, such that those new test procedures apply instead of the test procedures in 40 CFR part 86, subpart B, starting with model year 2022. Since we address special test procedures in 40 CFR 1066.10(c), which in turn relies on 40 CFR 1065.10(c)(2), we no longer need to rely on 40 CFR 86.1840-01 for special test procedures. We note the following aspects of the transition for special test
• We are applying the provisions for special procedures equally to all vehicles certified under 40 CFR part 86, subpart S. The special test procedures were written in a way that did not apply for incomplete vehicles certified under 40 CFR part 86, subpart S. This is very likely an artifact of the changing scope of the regulation since 2001.
• We are keeping the reference to infrequently regenerating aftertreatment devices in 40 CFR 86.1840-01 as an example of special test procedures to clarify that we are not changing the way manufacturers demonstrate compliance for vehicles with infrequently regenerating aftertreatment devices. Specifically, we are not adopting the measurement and reporting requirements that apply for heavy-duty engines under 40 CFR 1065.680.
• We are applying the provisions related to infrequently regenerating aftertreatment devices equally to all vehicles certified under 40 CFR part 86, subpart S. The provisions in 40 CFR 86.1840-01 were written in a way that they did not apply for medium-duty passenger vehicles. This is very likely an artifact of the changing scope of the regulation since 2001.
We are finalizing the following additional amendments, as proposed:
• Section 85.1510(d): Waiving the requirement for Independent Commercial Importers (ICI) to apply fuel economy labels to electric vehicles. Performing the necessary measurements to determine label values would generally require accessing high-voltage portions of the vehicle's electrical system. Manufacturers can appropriately and safely make these measurements as part of product development and testing. These measurements can pose an unreasonable safety risk when making these measurements on production vehicles. The benefit of labeling information for these vehicles is not enough to outweigh the safety risks of generating that information.
• Section 86.1816-18: The published final rule to adopt the Tier 3 exhaust emission standards for Class 2b and Class 3 vehicles inadvertently increased the numerical value of those standards a trillion-fold by identifying the units as Tg/mile. We are reverting to g/mile as we intended by adopting the Tier 3 standards.
This rule includes expanded provisions for in-use testing under 40 CFR 86.1845-04 as described in sections III.D.5.iii. and III.G.2.i of this preamble. In addition to those new testing requirements, we are taking the opportunity for this final rule to clarify that the provisions allowing manufacturers to request approval to test fewer vehicles also includes an alternative of testing the required number of vehicles by waiving the detailed specifications for test vehicles. For example, if manufacturers are unable to procure the required number of test vehicles meeting specifications for mileage, geographic distribution, and altitude, they may ask for EPA approval to substitute test vehicles that fall short of meeting all those specifications. As always, EPA approval would depend on manufacturers taking all reasonable steps to meet those requirements. We are also allowing for EPA to approve extended deadlines for completing testing to recognize that practical limitations sometimes prevent manufacturers from finishing a test program within the specified time frame.
In reviewing material for the final rule, we realized that the proposed rule did not describe clearly enough how ICIs would need to manage per-vehicle compliance to certify vehicles relative to emission standards that allow or require manufacturers to comply with an averaging standard using emission credits. We are making the following amendments to 40 CFR 85.1515 in the final rule, largely to apply provisions that are consistent with certification practices for manufacturers where appropriate, and that are consistent with the practice of implementing standards for ICIs in recent years:
• The Tier 4 standards apply for ICIs starting in 2032, which is the first model year that small-volume manufacturers must comply with all the Tier 4 standards for light-duty vehicles. ICIs continue to be subject to Tier 3 standards through 2031.
• For both Tier 3 and Tier 4, we are clarifying that each imported vehicle is subject to the fleet average standard where manufacturers are allowed or required to demonstrate compliance based on emission credits. This applies for NMOG+NO
• For both Tier 3 and Tier 4, we are clarifying that ICIs may purchase emission credits to certify vehicles with emissions higher than the specified standards for any of the averaging-based standards. ICIs would need to purchase credits to enable importation of each vehicle individually. Aside from applying emission credits to those individual vehicles, ICIs would not be allowed to average, bank, or trade emission credits. Using this per-vehicle approach, ICIs would have no need to maintain an account with a balance of credits, and would never be in a situation where deficit credit provisions would apply.
• Where manufacturers certify using emission credits, we specify that the highest allowable emission level is the highest available NMOG+NO
• We are further clarifying that ICIs may not participate in the averaging, banking, and trading program for GHG emission credits.
• We are removing references to “motor vehicle engines” in some places since the ICI provisions no longer apply for heavy-duty engines.
• We are adding OBD to the list of standards and requirements for ICIs to certify vehicles. This is consistent with longstanding guidance.
As proposed, EPA is designating several emission control components of light-duty ICE vehicles as specified major emission control components. These include components of the diesel Selective Reductant Catalysts (SRC) system, components of the diesel Exhaust Gas Recirculation (EGR) system, and diesel and gasoline particulate filters (DPFs and GPFs). As the result of this designation, these components have the same warranty requirements as other components that have been established as specified major emission control components.
As described in section III.G.3 of the preamble, CAA section 207(i) specifies that the warranty period for light-duty vehicles is 2 years or 24,000 miles of use (whichever first occurs), except the warranty period for specified major emission control components is 8 years or 80,000 miles of use (whichever first occurs). The Act defines the term “specified major emission control component” to mean only a catalytic converter, an electronic emissions control unit, and an onboard emissions diagnostic device, except that the Administrator may designate any other pollution control device or component as a specified major emission control component if—
(A) the device or component was not in general use on vehicles and engines manufactured prior to the model year 1990; and
(B) the Administrator determines that the retail cost (exclusive of installation costs) of such device or component exceeds $200 (in 1989 dollars),
EPA believes that GPFs meet the requirements set forth in CAA section 207(i) and should be designated as specified major emission control components. GPFs were not in general use prior to model year 1990 and their cost exceeds the threshold specified in the CAA. EPA anticipates that manufacturers will choose to comply with the PM standards in this rule through application of a GPF for certain vehicles. In the event of a GPF failure, PM emissions will most likely exceed the standards. It is imperative that a properly functioning GPF be installed on a vehicle in order to achieve the environmental benefits projected by this rulemaking.
In order to meet the current emissions standards, diesel vehicles utilize Selective Reductant Catalysts (SRC) as the primary catalytic converter for NO
More specifically, the SCR catalytic converter relies on a system of components needed to inject a liquid reductant called Diesel Exhaust Fluid (DEF) into the catalytic converter. This system includes pumps, injectors, NO
Vehicles with diesel engines do not rely solely on aftertreatment to control emissions. Diesel engines utilize Exhaust Gas Recirculation (EGR) to control engine out emissions as a critical element of the emissions control system. Components of the EGR system such as electronic EGR valves and EGR coolers meet the criteria for designation as specified major emission control components.
The emission-related warranty period for heavy-duty engines and vehicles under CAA section 207(i) is “the period established by the Administrator by regulation (promulgated prior to November 15, 1990) for such purposes unless the Administrator subsequently modifies such regulation.” The regulations specify that the warranty period for light heavy-duty vehicles under 40 CFR 1037.120 is 5 years or 50,000 miles of use (whichever first occurs). EPA is clarifying, as proposed, that this same warranty period applies for medium-duty vehicles certified under 40 CFR part 86, subpart S, except that a longer warranty period of 8 years or 80,000 miles applies for engine-related components described in this section as specified major emission control components.
The warranty provisions in CAA section 207(i)(2) do not explicitly apply to medium-duty passenger vehicles. However, as with the new standards in this rule, we are applying, as proposed, warranty requirements to medium-duty passenger vehicles in the same way that they apply to light-duty vehicles. We did not receive substantive comments regarding the proposed changes and clarifications for warranty provisions described in this section.
EPA has had separate regulatory definitions for light truck for GHG standards and light-duty truck for criteria pollutant standards. The “light truck” definition used for determining compliance with the light-duty GHG emission standards (40 CFR 600.002) matches the definition that NHTSA uses in determining compliance with their fuel economy standards (49 CFR 523.5). This definition contains specific vehicle design characteristics that must be met to qualify a vehicle as a truck. The broader “light-duty truck” definition used for certifying vehicles to the criteria pollutant standards (40 CFR 86.1803-01) has allowed for some SUVs to qualify as trucks even if the specific vehicle does not contain the truck-like design attributes. The definition also includes some ambiguity that requires the manufacturers and EPA to apply judgment to determine the appropriate classification.
Historically this was not an issue because the car versus truck distinction was clear. Nearly all vehicles were passenger cars or pickup trucks with open cargo beds. The earliest sport utility vehicles (SUVs) were primarily derived from pickup truck platforms and were therefore considered light trucks. However, current versions of some of these SUVs now have car-based platforms with car-like features. Current differences between the two light-truck definitions leads to some SUVs being certified to GHG standards as a truck and to criteria pollutant standards as a car. To address this concern, as proposed, we are transitioning to a single definition of light-duty truck with the implementation of the Tier 4 criteria pollutant emission standards starting in model year 2027.
We are revising the definition of light-duty truck used in the criteria pollutant standards to match the definition of light-truck used in the GHG standards. This change will eliminate any confusion and simplify reporting for manufacturers because each vehicle will be treated consistently as either a car or a truck for all standards and reporting requirements.
Commenters pointed out that the revised definition would cause some vehicle models to become subject to the more stringent evaporative emission standards that apply for light-duty vehicles. We did not intend for the revised definition to cause a change in evaporative emission standards. At the same time, we are aware that the less stringent standards for light-duty trucks were originally intended to reflect differences in fuel tank volumes and other vehicle characteristics related to controlling evaporative emissions. It is apparent that vehicles affected by the changing definition of “light-duty truck” are not differentiated from light-duty vehicles based on such vehicle parameters related to evaporative emission control. From that perspective, the revised definition is likely to have the effect of accomplishing the original intent of applying standards corresponding to vehicles with expected evaporative-related characteristics for light-duty vehicles.
To address the concern expressed in the comments, we are therefore adding a provision for the final rule to allow manufacturers to continue to meet the standard for light-duty trucks even if their vehicles are recategorized as light-duty vehicles based on the change in the definition, provided that those vehicle models continue to qualify for carryover certification. With this approach, manufacturers would do new testing to meet the more stringent standard only if they already need to do new testing to certify to the evaporative emission standards. To avoid extending this provision indefinitely, we are including a requirement for manufacturers to meet the more stringent evaporative emission standards for such vehicles starting in model year 2032, even if they would otherwise qualify for carryover certification. Meeting the more stringent standards will likely involve modestly increasing canister volume and upgrading various design features and parameters in line with the technology solutions used for other light-duty vehicles. The several years of lead time will allow manufacturers to plan for making those changes.
EPA regulations state that onboard diagnostics (OBD) systems must generally detect malfunctions in the emission control system, store trouble codes corresponding to detected malfunctions, and alert operators appropriately. EPA adopted at 40 CFR 86.1806-17 a requirement for manufacturers to meet the 2013 California Air Resources Board (CARB) OBD regulation as a requirement for an EPA certificate, with certain additional provisions, clarifications and exceptions, in the Tier 3 Motor Vehicle Emission and Fuel Standards final rulemaking (79 FR 23414, April 28, 2014). Since that time, CARB has made several updates to their OBD regulations and continues to consider changes periodically. In this rule, EPA is updating to the latest version of the CARB OBD regulation (California's 2022 OBD-II requirements that are part of title 13, section 1968.2 of the California Code of Regulations, approved on November 30, 2022). This is accomplished by adding a new 40 CFR 86.1806-27 for model year 2027 and later vehicles. EPA had proposed adding a new monitoring requirement for gasoline particulate filters (GPFs) because the CARB regulation didn't include a specific requirement for them. In follow-up meetings, manufacturers explained they had already certified GPF diagnostics, and comments on the proposed rule recommended relying on CARB regulation as being sufficient for proper diagnostics to be created. Commenters also suggested that adding a separate requirement from EPA would be confusing. EPA has therefore decided to not finalize the proposed GPF monitoring requirements and instead rely on the GPF-related requirements already included in the CARB regulation.
See RTC section 5 for a more detailed discussion of comments related to OBD.
Executive Order 14037 directs EPA and the Department of Transportation (DOT) to coordinate, as appropriate and consistent with applicable law, during consideration of this rulemaking. EPA has coordinated and consulted with DOT/National Highway Traffic Safety Administration (NHTSA), both on a bilateral level during the development of this rule as well as through the interagency review of the EPA rule led by the Office of Management and Budget. EPA has set some previous light-duty vehicle GHG emission standards in joint rulemakings where NHTSA also established CAFE standards. Most recently, in establishing standards for model year 2023-2026, EPA and NHTSA concluded that it was appropriate to coordinate and consult but not to engage in joint rulemaking. EPA has similarly concluded that it is not necessary for this EPA rule to be issued in a joint action with NHTSA. In reaching this conclusion, EPA notes there is no statutory requirement for joint rulemaking and that the agencies have different statutory mandates and their respective programs have always reflected those differences. As the Supreme Court has noted “EPA has been charged with protecting the public's 'health' and 'welfare,' a statutory obligation wholly independent of DOT's mandate to promote energy efficiency.”
EPA also has consulted with analysts from other Federal agencies in developing this rule and the heavy-duty vehicles Phase 3 rulemaking, including the Federal Energy Regulatory Commission (FERC), the Joint Office for Energy and Transportation (which helps coordinate and leverage expertise between the U.S. Department of Energy and the U.S. Department of Transportation to further progress on zero-emission transportation infrastructure), the Department of State, the Department of Labor, the Department of Energy and several National Laboratories. EPA consulted with FERC on this rulemaking regarding potential impacts of these rulemakings on bulk power system reliability and related issues.
E.O. 14037 also directs EPA to coordinate with California and other states that are leading the way in reducing vehicle emissions. EPA has engaged with the California Air Resources Board on technical issues in developing this rule. EPA has considered certain aspects of the CARB Advanced Clean Cars II program, adopted in August 2022, as discussed elsewhere in this notice. We also have engaged with other states, including members of the National Association of Clean Air Agencies, Northeast States for Coordinated Air Use Management, and the Ozone Transport Commission. In addition, EPA received public comments from numerous states and state agencies, including the organizations noted above, various coalitions of state and local government Attorneys General, as well as several individual states and state/local environmental protection agencies. These comments and EPA's responses to them are found in the Response to Comments document.
EPA has conducted extensive engagement with a diverse range of interested stakeholders in developing this rule. We have engaged with those
EPA has conducted an updated technical assessment that extends and improves upon the analysis conducted for the proposal. Where applicable, we have incorporated the most recent and best available data, and revised and updated our inputs, assumptions, and methods in consideration of comments received during the public comment period. In addition to an analysis of the final standards, the updated analysis also includes an assessment of two alternatives that were considered, as well as a revised set of sensitivity cases.
The overall approach used for this final rule is consistent with that of the proposal, as well as our prior rulemakings for GHG and criteria pollutants for light- and medium-duty vehicles. We continue to refer to the extensive body of prior technical work that has underpinned those rules, and incorporated updated tools, models and data, subjected to peer review where appropriate, in conducting this assessment, based on the best available information and the public record. EPA conducted peer review
As in the proposal, some of the areas of particular focus are related to the significant developments in vehicle electrification that have continued to occur since the 2021 rule. Vehicle manufacturers have continued to introduce PEV products in increased volumes and new market segments, improving the ability to characterize the cost and performance of best-practice designs. Key legislation such as the IRA and the BIL continues to provide significant incentives for both the manufacture and purchase of PEVs, and for the expansion of charging infrastructure. Additionally, in light of public comments received, as well as the levels of electrification that continue to be anticipated under the final standards, EPA's new technical assessment contains additional discussion and updated assessments of battery costs, critical minerals, supply chain development, battery manufacturing capacity, impact of the IRA incentives, PEV charging infrastructure, and impacts on the electric grid.
Our modeling can be broadly divided into two categories. The first category is compliance modeling for the vehicle manufacturers, which includes the potential design and technology application decisions to achieve compliance under the modeled standard. The second category is effects modeling, which is intended to capture how changes in vehicle design and use will impact emissions, fuel consumption, public health and welfare, and other factors that are relevant to a societal benefits-costs analysis.
As in the proposal, EPA is using a significantly updated and peer-reviewed version of the Optimization Model for reducing Emissions of Greenhouse gases from Automobiles (OMEGA) to model vehicle manufacturer compliance with GHG standards. The updates include several provisions which the agency feels improve our overall fleet projection capabilities. In particular, the updated version of OMEGA extends the prior version's projections of cost-effective manufacturer compliance decisions by also accounting for the relationship between manufacturer compliance decisions and consumer demand and including important constraints on technology adoption. As discussed in the proposal, OMEGA is designed specifically around EPA's regulatory program under the Clean Air Act. In addition to modeling of the influence EPA's GHG standards, the updated OMEGA also allows for evaluation of other policies, such as state-level ZEV policies. These features make this updated version of OMEGA well-suited for analyzing standards in a market where PEVs may account for a steadily increasing share of new vehicle sales. EPA has utilized the OMEGA model in evaluating the effects of not only the GHG program but the criteria pollutant emissions program as well.
OMEGA takes as inputs detailed information about existing vehicles, technologies, costs, and definitions of the policies under consideration. From these inputs, the model projects the stock of vehicles and vehicle attributes, and their use over the analysis period. The updated version of the OMEGA model better accounts for the significant evolution over the past decade in vehicle markets, technologies, and mobility services. In particular, recent advancements in PEVs and their introduction into the full range of market segments provides strong evidence that increased vehicle electrification can play an important role in achieving greater levels of emissions reduction in the future. Among the key new features of OMEGA is the representation of consumer-producer interactions when modeling compliance pathways and the associated technology penetration into the vehicle fleet. This capability allows us to project the impacts of the producer and consumer incentives contained in the IRA and BIL legislation. It also allows us to model the rate of consumer acceptance of novel technologies.
EPA received a large number of public comments and recommendations for how to revise the NPRM's OMEGA modeling for this final rulemaking. The vast majority of comments were related to EPA's specific modeling inputs and assumptions and were not, for example, recommending a different modeling approach overall. A summary of updates made to our technical assessment since the NPRM is provided in section IV.A.2 of this preamble. One especially notable update for this final rule is the added capability for OMEGA to consider PHEVs as a compliance technology. OMEGA is described in detail in RIA Chapter 2.2.
EPA also uses its ALPHA vehicle simulation model to estimate emissions, energy rates, and other relevant vehicle performance estimates. The ALPHA model is described in more detail in Chapter 2 of the RIA. ALPHA simulation results create the inputs to the OMEGA model for the range of technologies considered in this rulemaking. To support both the proposal and the final rule analyses, we built upon our existing library of benchmarked engines and transmissions used in previous rulemakings by adding several new technologies for ICE-based powertrains, and newly refined models of BEV powertrains. For the final rule analysis we added PHEVs to ALPHA, which include both charge-depleting and charge-sustaining models. We also adopted an updated approach for representing the ALPHA simulation results in OMEGA, using `response surfaces' of emissions and energy rates. These continuous technology representations can be applied across vehicles of different size, weight, and performance characteristics without requiring that vehicles be binned into discrete vehicle classes. The response surface approach also simplifies the model validation process, since the absolute values of absolute emissions and energy rates that are produced can be readily checked against actual vehicle test data. This is in contrast to the validation process needed for the incremental effectiveness values that were estimated in previous rulemakings using either a `lumped parameter model' or direct table lookup of effectiveness. The modeling in ALPHA and generation of response surfaces is described in RIA Chapter 2.4.
As in the proposal, the technology cost estimates used in this final rule assessment are from both new and previously referenced sources, including some values used in recent rulemakings where those remain the best available estimates. For this final rule assessment, EPA has incorporated findings from several ongoing research efforts that were previously described in the proposal.
We have updated many of our PEV non-battery and ICE technology costs based on a detailed study from FEV, a large engineering firm with considerable experience in the analysis of vehicle technologies which the agency has cited regularly in previous rulemakings. As EPA has historically considered vehicle teardown studies as an important source of detailed cost estimates, this new study included a teardown of two comparable ICE and BEV vehicles, and a review of ICE and PEV component costs from similar teardowns previously conducted by the same firm. The latter work in particular improved on our estimates of technology costs and how they should be scaled depending on engine size, vehicle type, electric motor power, etc.
Battery costs are an important component of PEV costs. Consistent with prior rulemakings, our battery cost inputs are derived from costs modeled by Argonne National Laboratory's (ANL) BatPaC model. As also indicated in the proposal, and as requested by commenters, we updated our battery cost inputs, by working with ANL to conduct a more detailed analysis of battery costs in which ANL utilized the current version of BatPaC to estimate future battery pack costs by taking into account mineral price forecasts from leading analyst firms, and a technology roadmap of production and chemistry improvements likely to occur over the time frame of the rule.
The main function of the OMEGA compliance modeling is to show how a manufacturer can meet future GHG standards through the application of technologies. Among the many potential pathways that exist for achieving compliance, OMEGA aims to find a pathway that minimizes costs for the manufacturer given a set of inputs that includes technology costs and emissions rates. For any single run with its associated inputs, OMEGA produces merely one possible compliance path to provide information about the feasibility and potential costs of a set of standards. However, manufacturers remain free to adopt very different compliance paths, depending on their assessment of technologies and the vehicle market.
The compliance modeling for this rulemaking also includes constraints on new vehicle production and sales informed by our assessment of manufacturer and consumer decisions, and in some cases account for factors that were not included in the technical assessments in our prior rulemakings. EPA consulted and considered data and forecasts from government agencies, analyst firms, and industry in order to assess capacity for battery production and to thereby establish appropriate constraints on PEV battery production (in terms of gigawatt-hours (GWh) in a given year) during the time frame of the rule.
Consistent with compliance modeling for past rulemakings, the OMEGA model also limits the rate at which new vehicle designs can be introduced by applying redesign cycle constraints (RIA Chapter 2.6). EPA has evaluated historic vehicle data (
As in prior rulemakings, this assessment is a projection of the future, and is subject to a range of uncertainties. We have assessed a number of sensitivity cases for key assumptions in order to evaluate how they would impact the results.
EPA received numerous public comments addressing our technical record. In response to these comments, and consistent with our general approach to update data when practicable, EPA has reassessed all aspects of our technical analysis based on the public record and the best available data and information. In Table 66, we summarize the major updates made to our technical analyses between the proposal and this final rule. These updates have resulted in a more robust technical analysis that is responsive to numerous public comments.
EPA has assessed the effects of this rule with respect to a No Action case for the final standards and the two alternatives considered. The Office of Management and Budget (OMB) provides guidance for regulatory analysis through Circular A-4.
EPA recognizes that, even prior to this rule, the industry and market have already developed considerable momentum toward continuing increases in PEV uptake (as discussed at length throughout this preamble). This dynamic raises an important question about what the projected market penetration for PEVs would be in the absence of these final standards and thus reflected in the No Action case. EPA also recognizes there are many projections from third parties and various stakeholders, all showing increased PEV penetration in the future. There are a range of assumptions that vary across such projections such as consumer adoption, state level policies, financial incentives, manufacturing capacity and vehicle price. Vehicle price is also impacted by range and efficiency assumptions (more efficient EVs require smaller batteries to travel the same distance and smaller batteries cost less). Depending on what specific assumptions regarding the future are made, there can be significant variation in future PEV projections. Increasingly favorable consumer sentiment towards PEVs, decreasing costs (either through a reduction in manufacturing costs or through financial incentives), and a broadening number of PEV product offerings all support a projected higher number of new PEV sales in the future, independent of additional regulatory action. As described in section I.A.2.ii of this preamble, EPA reviewed several recent reports and studies containing PEV projections all of which include the IRA. Altogether, these studies project PEVs spanning a range from 42 to 68 percent of new vehicle sales in 2030. The mid-range projections of PEV sales from these studies, to which we compare our No Action case, range from 48 to 58 percent in 2030.
EPA notes that in our compliance modeling of the No Action case in OMEGA, the same technical, economic, and consumer inputs and assumptions are used as for the associated Action case. The only difference between the No Action and Action cases for a given central or sensitivity analysis is in the policy definition itself. The concept of an `analysis context', within which policies are evaluated, is discussed further in RIA Chapter 2. EPA has considered a similar set of factors in our analysis context as those studies conducted by other stakeholders. This includes detailed vehicle and battery cost analyses, impacts of consumer and manufacturing financial incentives (such as those provided by the Inflation Reduction Act), consumer acceptance studies, vehicle performance modeling and technology applications, and battery manufacturing assessments.
The No Action case in our central analysis reaches 39 percent PEVs in 2030, shown in Table 76. We note that the PEV share of new vehicle sales was 7.5 percent in MY 2022, and will likely reach about 12 percent for MY 2023.
While we consider manufacturer announcements as additional evidence that high levels of PEV penetration are feasible, for purposes of this analysis we have not integrated manufacturer announcements directly into our modeling of the No Action baseline. Although PEV penetrations in our No Action case may appear conservative, we provide two key reasons why our central No Action case projections of PEV penetration for this rulemaking are lower than announcements from some manufacturers and the mid-range third party projections. First, our analysis is based on the assumption that manufacturers follow a purely cost-minimizing compliance strategy. We do not account for strategic business decisions or corporate policies that might cause a manufacturer to pursue a higher-PEV strategy such as the numerous manufacturer announcements and published corporate goals that suggest this approach may underestimate the rate of PEV adoption in a No Action scenario. Second, our analysis does not include the effect of state-level policies whereas projections from other sources may include those policies. We did not include these policies because many are still not in effect; however, we do anticipate that in the next decade, state-level policies may play an important role in driving PEV penetration. For this reason, we have included a sensitivity No Action case, which includes the ZEV requirements of the California Advanced Clean Car (ACC) II program for California and other participating states.
As a way to explore the impact that alternative assumptions would have on the future PEV penetrations under the No Action case, the agency has also conducted a range of sensitivities in addition to a central No Action case. As described further in section IV.F of this preamble, the sensitivity cases include states' adoption of the California Advanced Clean Cars II (ACC II) program,
We acknowledge the range of possible assumptions, and that EPA's central No Action case is more conservative than other projections that include state-level policies and/or manufacturer announced plans. We believe that our approach of assessing multiple potential No Action cases provides a technically robust method of determining the feasibility and costs associated with the emissions reductions required by the standards.
The standards established by this rule continue EPA's longstanding approach of setting performance-based emissions standards that result in an appropriate and achievable trajectory of emissions reductions. EPA sets emission standards based on consideration of available and projected technologies, consistent with the factors EPA must consider when establishing standards under the Clean Air Act. As with prior rules, as part of the development of this rulemaking EPA has assessed the feasibility of the standards in light of current and anticipated progress by automakers in developing and deploying emissions-reducing technologies.
Compliance with EPA GHG and criteria pollutant standards over the past decade has been achieved predominantly through the application of advanced technologies and improved aftertreatment systems to internal combustion engine (ICE) vehicles. For example, in the development of the 2012 GHG rule, a significant portion of EPA's analysis included an assessment of technologies available to manufacturers for achieving compliance with the standards, and ICE technologies were identified as playing a major role in manufacturer compliance with the emission reductions required by that rule.
In that same time frame, as EPA standards have increased in stringency, automakers have relied to an increasing degree on a range of electrification technologies, including hybrid electric vehicles (HEVs) and, in recent years, plug-in hybrid electric vehicles (PHEVs) and battery-electric vehicles (BEVs). This trend in technology application is evidence of a continuing recognition of electrification as an effective technology for both criteria pollutant and GHG compliance. As many ICE technologies have now reached high penetrations across the breadth of manufacturers' product lines, electrification technology has become increasingly attractive as a cost-effective pathway to further emission reductions.
The advantages of powertrain electrification are evident along a continuum of technologies, starting with HEV vehicle architectures, which have provided vehicle manufacturers with a powerful technology path for reducing both GHG and criteria pollutant emissions. For example, the blending of ICE and electric power allows manufacturers to control the engine for optimal efficiency and operating conditions to reduce criteria pollutants, and the higher voltage battery provides the opportunity to preheat the catalyst to reduce cold start emissions. HEVs continue to play an important and potentially increasing role in reducing emissions. In addition to Toyota's Prius line which has sold millions of units in the U.S. since its introduction to the U.S. in MY 2001, Toyota and other OEMs have brought HEV architectures to other sedans as well as crossovers, SUVs and pickups. For example, Ford has said that 10 percent of its F-150 pickup buyers and 56 percent its Maverick pickup buyers choose the hybrid powertrain option over the ICE version, and that hybrid options will soon be added across its model
As ICE and HEV technologies have progressed over the past two decades, and as battery costs continued to decline, automakers also began including PHEVs and BEVs (together referred to as PEVs or plug-in electric vehicles) in their product lines, and today there is a rapidly increasing diversity of these vehicles already on the market and planned for production. In EPA's 2021 rule that set GHG emission standards for MYs 2023 through 2026, we projected (as one example pathway) that manufacturers could comply with the 2026 standards with about 17 percent PEVs at the industry-wide level, reflecting the increased cost-effectiveness of PEV technologies in achieving compliance with increasingly stringent emissions standards. In light of subsequent developments including the BIL and IRA, we now project that manufacturers will sell 27 percent PEVs in 2026 under the standards that are currently in place.
These developments are also driven by the need to compete in a diverse market, as transportation policies to control pollution continue to be implemented across the U.S. and across the world. An increasing number of U.S. states have taken actions to shift the light-duty fleet toward zero-emissions technology. In 2022, California finalized the Advanced Clean Cars II (ACC II) rule
In addition to the U.S., auto manufacturers also compete in a global market that is becoming increasingly electrified. Globally, at least 20 countries, as well as numerous local jurisdictions, have announced targets for shifting all new passenger car sales to zero-emission vehicles in the coming years, including Norway (2025); Austria, the Netherlands, Denmark, Iceland, India, Ireland, Israel, Scotland, Singapore, Sweden, and Slovenia (2030); Canada, Chile, Germany, Thailand, and the United Kingdom (2035); and France, Spain, and Sri Lanka (2040).
These trends echo an ongoing global shift toward electrification. Global light-duty passenger PEV sales surpassed 10 million in 2022, up from 6.6 million in 2021, bringing the total number of PEVs on the road to more than 26 million globally.
While ICE vehicles and HEVs together retain the largest share of the market, the year-over-year growth in U.S. PEV sales suggests that an increasing share of new vehicle buyers are concluding that a PEV is the best vehicle to meet their needs. Many PEVs already on the market today cost less to operate than ICE vehicles, offer improved performance and handling, have a driving range similar to that of ICE vehicles, and can be charged at a growing network of public chargers as well as at home.
In addition to the light-duty vehicle sector, the medium-duty sector is also experiencing a shift toward electrification in several important market segments. As described in section I.A.2 of this preamble, numerous commitments to produce all-electric medium-duty delivery vans have been announced by large fleet-operating businesses in partnerships with various OEMs. This rapid shift to BEVs in a fleet that is currently predominantly gasoline- and diesel-fueled suggests that the operators of these fleets consider BEV delivery vans the best available and most cost-effective technology for meeting their needs. Owing to the large size of these vehicle fleets, this segment alone is likely to represent a significant portion of the future electrification of the medium-duty vehicle fleet.
EPA believes the PHEV architecture may also lend itself well to future pickup truck and large SUV applications, which may also include some MDV pickup truck applications. A PHEV pickup or large SUV architecture would provide several benefits: some amount of zero-emission electric range (depending on battery size); increased total vehicle range during heavy towing and hauling operations using both charge depleting and charge sustaining modes (depending on ICE-powertrain sizing); job-site utility with auxiliary power capabilities similar to portable worksite generators, and the efficiency improvements normally associated with strong hybrids that provide regenerative braking, extended engine idle-off, and launch assist for high torque demand applications. Depending on the vehicle architecture, PHEVs used in pickup truck applications may also offer additional capabilities, similar to BEV pickups, with respect to torque control and/or torque vectoring to reduce wheel slip during launch in very heavy trailer towing applications. In addition, PHEVs may help provide a bridge for consumers that may not be ready to adopt a fully electric vehicle.
One major manufacturer, Stellantis, recently announced a new PHEV pickup truck, the 2025 Ram 1500 Ramcharger.
The MY 2023 Jeep Grand Cherokee 4xe PHEV with the Trailhawk package is a current-production example of a large SUV with significant tow capability. The vehicle has a 6,125-pound GVWR and a 12,125-pound GCWR using a combination of a 270-bhp turbocharged GDI engine with P2 and P0 electric machines of 100kW and 33kW, respectively. The vehicle also uses a 17.3 kWh battery pack that provides 25 miles of all-electric range. The MY 2023 Jeep Wrangler 4xe uses a similar powertrain and battery pack. The Wrangler 4xe equipped with the “Rubicon” package has a 6,400-pound GVWR and a 9,200-pound GCWR.
PHEV light-duty and MDV pickup trucks also show considerable promise for reducing CO
These trends in light- and medium-duty vehicle technology suggest that electrification is already poised to play a rapidly increasing role in the on-road fleet and provides further evidence that BEV and PHEV technologies are increasingly seen as an effective and feasible set of vehicle technologies that are available to manufacturers to achieve further emissions reductions.
Recent literature indicates that consumer affinity for PEVs is strong. A recent study utilizing data from all new light-duty vehicles sold in the U.S. between 2014 and 2020 focused on comparisons of BEVs with their closest ICE counterparts, and found that BEVs are preferred to the ICE counterpart in some vehicle segments.
According to the U.S. Bureau of Labor Statistics, growing consumer demand and growing automaker commitments to electrification are important factors in the growth of PEV sales and that growth will be further supported by policy measures including the BIL and the IRA.
While PEVs are typically offered at a higher price than comparable ICE vehicles at this time, the price difference for BEVs, which have only an electric powertrain, is widely expected to narrow or disappear as the cost of batteries and other components fall in the coming years.
Figure 22, taken from work by the Environmental Defense Fund, shows how the number of PHEV and BEV models available in the U.S. has steadily grown, and many public model announcements by manufacturers indicate further growth will occur in the years to come.
Globally and domestically, these ongoing announcements indicate a strong industry momentum toward electrification that is common to every major manufacturer. Given the breadth of these announcements, it is informative to consider the penetrations of PEVs that they imply when taken collectively.
Table 67 compiles public announcements of U.S. and global electrification targets to date by major manufacturers. Assuming that the MY 2022 U.S. sales shares for each manufacturer were to persist in 2030, these targets would collectively imply a U.S. PEV sales share of nearly 50 percent in 2030, consisting primarily of BEVs. A version of this table with supporting citations for each automaker announcement, and the raw data with additional tabulations, are available in the Docket.
EPA understands that manufacturer announcements such as these are not binding, and often are conditioned as forward-looking projections that are subject to uncertainty. However, the breadth and scale of these announcements across the entire industry signals that manufacturers are confident in the suitability and attractiveness of PEV technology to serve the needs of a large portion of light-duty vehicle buyers.
As seen in Figure 23, an analysis by the International Energy Agency (IEA) similarly concludes that the 2030 U.S. zero-emission vehicle sales share collectively implied by such announcements (“range of OEM declarations”) would amount to nearly 50 percent if not more, far exceeding the 20 percent that IEA considers sufficient to meet pre-IRA U.S. policies and regulations (“Stated Policies” scenario).
These announcements and others like them continue a pattern over the past several years in which most major manufacturers have taken steps to significantly invest in zero-emission technologies and reduce their reliance on the internal-combustion engine in various markets around the globe,
A 2021 analysis by the Center for Automotive Research showed that a significant shift in North American investment was already occurring toward electrification technologies, with $36 billion of about $38 billion in total automaker manufacturing facility investments announced in 2021 being slated for electrification-related manufacturing in North America, with a similar proportion and amount expected for 2022.
In the proposal for this rulemaking, EPA did not specifically model the adoption of PHEV architectures, although the agency acknowledged that PHEVs could provide significant reductions in GHG emissions, and that some vehicle manufacturers may choose to utilize this technology as part of their technology offering portfolio. For example, PHEVs may be effective at meeting specific types of customer needs and may provide manufacturers with an additional technology option with which to meet emissions standards (as some firms are already doing today). We also indicated that we were considering adding PHEVs as a technology option in the analysis for the final rule, and asked for comment on this possibility, and on technology costs and configurations we presented at the time.
Several commenters criticized the lack of PHEVs as a technology option in the analysis of the proposed standards. Commenters on this topic universally supported the addition of PHEVs in the compliance modeling for the final rulemaking analysis. As indicated in the proposal, and in response to comments received during the public comment period, EPA has updated its analysis to include PHEVs as a technology option for both light-duty and medium-duty vehicles.
Many commenters suggested that due to their smaller battery packs, PHEVs could reduce the demand for critical minerals and provide a viable pathway to GHG compliance should critical mineral supplies be less than projected. In response to commenters' concerns about potential limits on availability of critical minerals, EPA shows technologically feasible paths to compliance that rely more on PHEVs, resulting in much lower battery demand than in the central case.
In its comments, Auto Innovators requested that EPA include PHEVs such that they comprise at least 20 percent of PEVs in the compliance results. While that could be a potential outcome, the OMEGA model is designed to identify lowest-cost compliance pathways to performance-based standards, based on all technology options available in the model. EPA did not find any rationale for setting a minimum PHEV to BEV ratio (for example, as an input constraint). However, in modeling results for the 2030-2032 timeframe, PHEVs do account for over 10 percent of the total PEVs in the final standards analysis.
ICCT suggested that adding more technologies, including PHEVs, could reduce costs of compliance. EPA agrees that the inclusion of more technology choices should generally offer more cost-effective pathways to compliance. While we did not evaluate the impact of each update in data and assumptions for this final rulemaking analysis individually, it is likely that an analysis that excluded PHEVs would have higher costs.
EPA also requested comment on the types of PHEV architectures that EPA should consider in this final rulemaking analysis, including whether or not EPA should explicitly model PHEVs in light-duty and MDV pickup applications. In the proposal, EPA described ongoing contract work with Southwest Research Institute (SwRI) to investigate likely technology architectures of both PHEV and internal combustion engine range-extended electric light-duty and MDV pickup trucks to support analysis for the final rule. EPA also requested any relevant performance or utility data that may help inform our modeling and analyses.
In their comments, Auto Innovators and Toyota both recommended that EPA include the more capable strong-PHEV designs that meet US06 high power cold starts, as well as the range-extending architecture that EPA has modeled through its contract with SwRI. Toyota commented that PHEVs could apply to all light-duty vehicles; accordingly, EPA has included PHEVs as a technology option across all body styles. Stellantis highlighted the high-capability pickup truck segment as a key area where PHEVs would be beneficial. In this analysis, EPA has made the simplifying technical assumption that PHEVs will meet basic all-electric range requirements to qualify as ZEVs under ACC II
As stated in the proposal, EPA conducted contract work with SwRI to investigate likely technology architectures of both PHEV and ICE range-extended electric light-duty and MDV pickup trucks that we anticipated would provide data informative to the final rule. We have included modeling of PHEV architectures comparable to those included in SwRI's final report within our analysis. For more information, please refer to RIA Chapter 3.5. In addition, within the proposal's DRIA Chapter 2.6.1.4 “PHEV Powertrain Costs,” EPA provided component technology descriptions and cost
In the proposal, we noted that many light- and medium-duty PHEVs purchased for commercial use would be eligible for the Commercial Clean Vehicle Credit (45W), which provides a credit of up to $7,500 for qualified vehicles with gross vehicle weight ratings (GVWRs) of under 14,000 pounds.
In addition to the inclusion of PHEVs as a technology option, EPA also updated its characterization of other ICE and HEV vehicle technologies in its ALPHA modeling (see RIA Chapter 2.4). These updates included new hybrid architectures such as a series-parallel P4 hybrid for light-duty trucks, a range-extending PHEV configuration for medium-duty trucks, and new engines for medium-duty diesels, including a large bore gasoline PFI engine and an updated map for its diesel engine. ALPHA engine maps and motor maps for HEV, PHEV and BEV technologies are presented in RIA Chapter 3.5.
In RIA Chapter 3.1, we provide discussion of recent trends and feasibility of light-duty and medium-duty vehicle technologies that manufacturers have available to meet the standards. Other aspects of PEV feasibility, such as technology costs, consumer acceptance, charging infrastructure accessibility, supply chain security, manufacturing capacity, critical mineral availability, and effects of BEV penetration on upstream emissions are discussed in the respective chapters of the RIA.
EPA received comments from automotive suppliers and some environmental NGOs that suggested we should model continued advances in ICE technology in both light-duty and medium-duty vehicles. Some commenters (
EPA agrees that there is a potential for continued GHG reductions in ICE engine designs and manufacturers may choose to improve the efficiency of their ICE powertrains as part of their pathway for compliance. EPA's experience with modeling ICE powertrain technologies is that improvements are often targeting common loss mechanisms: reductions in pumping losses, reduction of friction and parasitics, improved combustion, broader and higher thermal efficiency, and on-cycle optimization of engine operation. In our modeling, one technology can often be used as a surrogate to reflect a range of technologies that address similar levels of improvements. For example, EPA has observed that an “advanced gasoline engine” could represent technologies ranging from Atkinson cycle engines to turbo downsized engines with the overall reduction in GHG emissions and costs of similar magnitude. While we do not model every unique technology combination that could potentially be implemented by manufacturers, our modeling of ICE powertrains should generally represent the emissions reduction potential and costs of advanced engine technologies. Nevertheless, we acknowledge that there are a wide range of possible ICE powertrain combinations available to manufacturers, beyond those included in EPA modeling, and that some of these technology implementations may outperform EPA's assessment of potential GHG reductions.
As evidenced by their public announcements, manufacturers have signaled a clear shift to focus on the development of electrified powertrains. Through conversations with OEMs, several companies have indicated that they are diverting their R&D budgets towards development of electric vehicles, and others have publicly indicated that the upcoming generation of internal combustion engines will be the last new designs.
This shift towards significantly greater adoption and deployment of electrification technologies makes it possible for manufacturers to achieve significantly greater emissions reductions than would be feasible relying solely on improved efficiencies of internal combustion engines. Accordingly, EPA focused its modeling efforts on those technologies which we anticipate OEMs will likely choose to adopt in support of these standards. EPA's analysis projects that manufacturers will use electrification as their primary compliance pathway, given the significantly more favorable cost effectiveness of electrified powertrains in achieving more stringent GHG standards.
Our assessment of technology generally represents the potential for cost-effective improvements and parallels the increased manufacturer focus on electrification. For these reasons, EPA has prioritized its modeling updates towards electrified technologies, rather than continued ICE advances. However, by maintaining performance-based GHG standards, the agency keeps in place a compliance architecture which fully recognizes all available technologies that result in reduced GHG emissions. Table 4 of the executive summary highlights three potential pathways which show a range of technology penetrations, and the sensitivities described in section IV.F of this preamble illustrate additional pathways to compliance.
Costs for electrification technologies, such as batteries and other electrified vehicle components, are an important input to the feasibility analysis. This section provides a general review of how battery and other electrification component costs were updated for this final rule analysis. A more detailed discussion of the electrification cost estimates and the sources we considered may be found in RIA Chapter 2. EPA responses to all of the comments on this topic may be found in RTC section 12.2.
Our battery costs for the final rule analysis are higher than in the proposal, due to a number of factors that we took into consideration, both from the public comments and from the completion of ongoing and additional research that we described in the proposal.
For the proposal, EPA used Argonne National Laboratory's (ANL) BatPaC model version 5.0 (then current) to generate base year (2022) direct manufacturing cost estimates for battery packs at an annual production volume of 250,000 packs. To estimate battery cost in future years, the proposal applied an annual cost reduction by
Forecasting of future battery costs is a very active research area, particularly at this time of rapidly increasing demand in an actively evolving industry. In the proposal, we noted that the battery costs we were using in the proposal analysis were nominally lower than the average pack cost that was reported in a late-breaking Bloomberg New Energy Finance (BNEF) report released on December 6, 2022. This annual battery price survey by BNEF indicated that after years of steady decline, the global average price for lithium-ion battery packs (volume-weighted across the passenger, commercial, bus, and stationary markets) had climbed by about 7 percent in 2022.
In light of the 2022 BNEF report, we noted that we would consider this and any other new forecasts of battery cost or similar information, as they became available and to the extent possible, for the final rule analysis. We also noted that we would be working with ANL to continue updating our estimates of battery cost by considering adjustments to key inputs to the BatPaC model to represent expected improvements to production processes, forecasts of future mineral costs, and design improvements.
In the proposal, EPA requested comment on all aspects of the battery and non-battery costs used in the NPRM analysis, including base year battery costs, future battery costs, electric vehicle driving range, and similar issues that would affect how battery and non-battery costs should be modeled. We received a variety of comments relating to current and future battery pack costs, and partly in response to these comments we have made significant updates to our battery cost assumptions.
Some commenters, primarily from environmental NGOs, electric vehicle manufacturers, and the electrification industry, stated that the battery costs in the proposal were either appropriate or too high. Other commenters, primarily representing major automakers, the fuels industry, and various advocacy groups, stated that the costs were too low. Many of those who felt that the costs were too low referred to uncertainty surrounding near-term and long-term mineral costs and cited (among other references) the aforementioned December 2022 BNEF survey as evidence that our base year battery costs were too low. These commenters also referred to volatility of mineral and component prices that might be expected during a time of rapid increase in demand and suggested that we should consider scenarios in which battery costs decline at a slower rate than we had assumed, or do not decline at all. Some specifically suggested that we consider a paper by Mauler et al.
Other commenters stated that our use of nickel-based cathode chemistry (NMC) did not recognize the potentially lower cost of lithium-iron phosphate (LFP) cathode chemistry, and that this chemistry has less exposure to uncertainties related to critical minerals.
Regarding PHEVs, we also received comment advocating for inclusion of longer-range PHEVs in the analysis, and that these vehicles could use the same batteries as BEVs, owing to the relatively large size of the battery.
To update our estimate of current and future battery pack costs, and as mentioned in the proposal, we worked with the Department of Energy and Argonne National Laboratory to develop a year-by-year projection of battery costs from 2023 to 2035, using specific inputs that represent ANL's expert view of the current state-of-the-art and of the path of future battery chemistries and the battery manufacturing industry.
A major element of the approach was to select BatPaC input parameters to reflect current and future technology advances and calculate the cost of batteries for different classes of vehicles at their anticipated production volumes. Material cost inputs to the BatPaC simulations were based on forecasted material prices by Benchmark Mineral Intelligence. That is, pack costs were estimated from current and anticipated future battery materials, cell and pack design parameters, and market prices and vehicle penetration. Pack cost improvements in future years were represented at three levels: manufacturing (increasing cell yield and plant capacity), pack (reducing cell and module numbers and increasing cell capacity), and cell (changing active material compositions and increasing electrode thickness). The simulations yielded battery pack cost estimates that can be represented by correlations for model years 2023 to 2035.
As with the pack designs modeled by EPA for the proposal, the pack designs modeled by ANL follow recent trends in PEV battery design and configuration in high-production PEV models. Pack
The ANL analysis provided EPA with several equations for battery pack direct manufacturing costs as a function of model year and battery capacity (kWh), for both nickel-based (NMC) chemistry and iron-phosphate based (LFP) chemistry. We have incorporated these costs into the analysis in place of the costs that were used for the proposal.
As a result of this updated work, and as seen in Figure 24, our updated battery direct manufacturing costs for the final rule are significantly higher than in the proposal. Using an example of a 100-kWh battery, Figure 24 compares the updated FRM battery costs (central case and sensitivities) to the costs and sensitivities used in the proposal.
As seen in Table 68, our battery cost inputs (example shown for a 100 kWh battery) have increased by an average of 26 percent compared to the proposal, ranging from about 21 percent higher in the early years to about 36 percent higher in the later years.
The increase in cost is largely a product of the most recent trends and forecasts of future mineral costs being now explicitly represented via the ANL work,
Accordingly, these updated battery costs are responsive to many of the comments. First, the ANL work accounts more explicitly for the potential effect of critical mineral prices on the cost of batteries over time. We worked with ANL to make available medium- and long-term mineral price forecasts from Benchmark Mineral Intelligence, a leading minerals analysis firm. These were then used to estimate electrode material prices over the years of the ANL analysis. This is one factor contributing to the higher battery costs used in our updated analysis. Second, as one outcome of this update, in the early years of the program, our battery cost inputs are now in closer agreement with the 2022 BNEF battery price survey, which commenters widely mentioned. Finally, the generally higher costs are responsive to general comments stating the position that our assumptions for current and future battery costs were too low. Because it allowed us to account for the most recent trends and developments, in particular by more fully considering the potential impact of mineral demand and the specific impact of anticipated advancements in lithium-ion technology and manufacturing, our use of the costs forecast by ANL is responsive to these comments.
As another way to account for commenter concerns about uncertainty in near-term battery costs, we have retained a plateau in costs between 2023 and 2025, in which our battery cost assumptions do not decline as would be indicated by the ANL equations for 2024 and 2025, but instead stay at the cost indicated by the ANL equations for 2023. Because the ANL cost equations account for the effect of projected mineral prices and do not indicate that battery costs will remain elevated at 2023 levels for 2024 and 2025, our retention of the plateau is a conservative assumption.
Some commenters raised the possibility that batteries manufactured in the U.S. (in order to capture the various IRA incentives) would experience higher labor rates. We also recognized the fact that, during the comment period and afterward, several major U.S. automakers were negotiating new labor contracts, with an emphasis on electrification. To represent higher labor costs, the ANL equations that EPA used are based on a $50 per hour labor cost ($70 per hour including variable overhead/benefits), which represents the assumption that U.S. battery plants will largely operate under the same labor agreements as major automotive plants. In comparison to the battery costs used in the NPRM analysis, which were based on the default value in BatPaC of $25 per hour ($35 including variable overhead/benefits), the higher labor cost resulted in an increase in pack cost per kWh of about two to three percent. It is well understood in the industry, and confirmed by BatPaC modeling, that labor is a relatively small portion of battery cost in comparison to material costs. The two to three percent increase is also generally consistent with recent remarks by General Motors that their new contract with the United Auto Workers would increase battery cell prices by about $3 per kWh.
In response to comments regarding the ability of longer-range PHEVs to use BEV batteries, we note that the ANL battery cost equations were developed with consideration of higher power-to-energy ratios at the lower end of their kWh capacity range, making those battery sizes applicable to either BEVs or PHEVs. In the updated analysis, only longer-range PHEVs
Our consideration of the public comments led to another update to our method of accounting for future learning. In the proposal, EPA introduced a method of accounting for learning-by-doing by considering cumulative production of batteries (in GWh) resulting from various policy scenarios modeled by OMEGA. When the OMEGA model generated a compliant fleet in a given future year of the analysis, battery costs for BEVs in that year were determined dynamically, by applying a learning cost reduction factor to the base year cost. The learning factor was calculated in part based on the cumulative GWh of battery production necessary to supply the number of BEVs that OMEGA had thus far placed in the analysis fleet, up to that analysis year. This approach was consistent with “learning by doing,” a standard basis for representing cost reductions due to learning in which a specific percentage cost reduction occurs with each doubling of cumulative production over time. This dynamic method of assigning a cost reduction due to learning meant that different OMEGA runs that result in different cumulative battery production levels would project somewhat different battery costs. In the proposal, EPA requested comment on our use of cumulative GWh as a determinant of learning effects, and evidence and data related to the potential use of global battery production volumes instead of domestic volumes in that context, and/or the use of battery production volumes in related sectors.
For several reasons, in the current analysis we chose to return to our previous practice of representing future battery cost reductions as a function of time rather than a function of cumulative GWh produced. Some commenters stated that the proposal's method was new with respect to previous analyses and lacked sufficient documentation; that it failed to establish a baseline that included global production; and that it should have been based on cumulative global production rather than only cumulative domestic production.
In light of these comments, we make several observations here. Because OMEGA does not model global demand for batteries, considering global demand is difficult in the context of this analysis. Also, the establishment of a baseline would require data on historical production of batteries both domestic and globally, which itself would be subject to uncertainty. We also note that some commenters stated the importance of alignment of EPA standards with those of the NHTSA CAFE proposal, which is consistent with the use of similar battery costs. Unlike the EPA compliance model, NHTSA's compliance model does not support the use of the cumulative GWh production approach, meaning that alignment on battery costs would be difficult if EPA were to continue using the proposal approach. Another relevant factor is both agencies' use of the ANL battery cost study, which promotes such alignment. The future battery cost equations provided by ANL incorporate fixed assumptions for battery cost
For 2023 to 2035, we use the battery cost equations developed by ANL for our battery cost assumptions, and because these are based on application of specific technology pathways, we no longer develop costs for those years by means of a time-based cost reduction factor. For years after 2035, where the ANL equations no longer apply, a cost reduction factor remains necessary, and for those years we implemented a 1.5 percent year-over-year cost reduction. Our use of 1.5 percent results in a rate of cost reduction within the range of long-term reductions commonly encountered in the literature. Moreover, we selected this specific figure because it is consistent with preventing projected battery costs in the far future from declining to levels that have not commonly found support in the literature. A 1.5 percent year over year cost reduction would limit battery cost from declining lower than about $60 per kWh in 2055, a figure that is similar to or conservative with respect to a number of long-range forecasts found in the literature. For example, this is generally consistent with projections found in a review of battery cost forecasting methods by Mauler et al.,
In response to comments and updated work from ANL, EPA also updated the OMEGA inputs for specific energy of HEV, PHEV and BEV battery packs. The ANL battery cost study included projections of the future specific energy of NMC and LFP battery packs, as provided by the BatPaC model that also determined their cost. This has resulted in somewhat lighter batteries over time than assumed in the NPRM analysis, where improvements in specific energy were not modeled.
In response to comments recommending inclusion of LFP chemistries, our updated battery costs are now a weighted average of ANL's cost equations for LFP and NMC batteries, with a weighting derived from forecasts of LFP cathode or battery production likely to be present in the U.S. PEV market. LFP is already present in a small portion of light-duty PEVs and its share is expected to increase in the future, due to its lower cost and absence of the critical minerals such as cobalt, manganese, and nickel. LFP chemistry is also potentially applicable to some medium-duty vehicles such as delivery vans, whose larger size may better accommodate the lower energy density of this chemistry. The weighting ranges from 8 percent LFP in 2023, 16 percent in 2025 and leveling off at 19 percent in 2028. For more discussion of the LFP weighting, see RIA Chapter 2.
We also received comment on the upper and lower battery cost sensitivities that we considered in the proposal, where we included sensitivities for battery pack costs that were 25 percent higher and 15 percent lower (on a $/kWh basis) than the battery pack costs in the central case. Some commenters who felt that our battery costs were too low and/or our learning rates were too high disagreed with the basis of the upper and lower sensitivity percentages as being arbitrary and/or insufficient, particularly on the high side. Some commenters specifically felt that EPA should have used an upper sensitivity of greater than 25 percent, or not limited to a fixed percentage over time, in order to capture what they believe is a more appropriate range of uncertainty. In particular, some commenters indicated that we should have considered Mauler et al. (2022) in setting the high sensitivity.
EPA continues to believe that a fixed percentage above and below the central case can be an appropriate way to establish upper and lower bounds for a sensitivity, if the resulting band can be shown to adequately cover a range of reasonably plausible outcomes for future battery costs. For the updated analysis, we examined the appropriateness of the plus 25 percent and minus 15 percent range as applied to the updated central case battery costs which are significantly higher than in the proposal. We also examined the Mauler et al. paper and compared the range of scenarios expressed there to the band of costs that would be defined by this range.
Figure 25 shows, for an example 100 kWh battery pack, how this band of sensitivities compares to the Mauler scenarios (which extend only to the year 2030). It shows that retaining the 25 and 15 percent sensitivities around the updated central case costs establishes a band that largely includes the Mauler scenarios, including almost all of the highest Mauler scenario, in which costs do not decline at all. The highest Mauler scenario, although not defined by the authors past 2030, presumably would continue its elevated price scenario indefinitely if it were so extended. However, such a scenario of perpetually elevated cost does not appear to be widely supported among analysts and is not consistent with the most recent forecasts of mineral prices through the same time frame, which indicate generally declining or flat costs for virtually every battery critical mineral.
Regarding the lower case sensitivity, we note that the most recent annual BNEF battery price survey, which was released in November 2023, indicates that battery prices fell by 14 percent since the 2022 survey was published, and forecasts costs of $113 per kWh in 2025 and $80 per kWh in 2030.
Because the range of sensitivities largely includes the extremes represented by the Mauler et al. paper (which was specifically cited by commenters), as well as the latest BNEF forecast for 2026 and 2030, EPA considers the plus 25 percent and minus 15 percent sensitivities in the updated analysis to be responsive to commenters' concerns. Specifically for 2023 to 2025, we truncated the high sensitivity at $150 per kWh,
In light of the updates described above and consideration of public comment, EPA considers the updated battery direct manufacturing cost estimates and the sensitivities to be reasonable and conservative, based on the record and best available information at this time. In particular, considering recent forecasts for falling mineral prices during the next several years, and the trend of falling battery prices recently indicated by the 2023 BNEF battery price survey, we consider it more likely that the central case may prove to be an overestimate than an underestimate. We also note that the battery costs in the lower sensitivity case are similar to the trajectory of the BNEF forecast, suggesting that the program costs may be more similar to that indicated by the lower battery cost sensitivity if the BNEF forecast proves accurate. A more detailed discussion of the development of the battery cost estimates used in this final rule and the sources we considered may be found in RIA Chapter 2.
The battery cost estimates discussed thus far do not include the effect of tax credits available to battery manufacturers under the Inflation Reduction Act. These include the cell and module production tax credit of up to $45 per kWh available to manufacturers under IRC 45X, and the additional tax credit for 10 percent of the production cost of (a) critical minerals and (b) electrode active materials available to manufacturers under 45X.
In the proposal, EPA estimated potential future uptake of the IRA credits and how they would impact manufacturing costs for batteries over the time frame of the rule. We requested comment on all aspects of our accounting for the IRA credits, including not only the values used for the credits but also whether or not we should also account for the additional 10 percent provisions for electrode active materials and critical mineral production, which we did not estimate for the proposal.
The 45X cell and module credit provides a $35 per kWh tax credit for U.S. manufacture of battery cells, and an additional $10 per kWh for U.S. manufacture of battery modules. 45X also provides a credit equal to 10 percent of the manufacturing cost of electrode active materials and another 10 percent for the manufacturing cost of critical minerals if produced in the U.S. The credits phase out from 2030 to 2032 (with the exception of the 10 percent for critical minerals, which continues indefinitely).
In the proposal, we assumed that manufacturer ability to take advantage of the $35 cell credit and the $10 module credit would ramp up linearly from 60 percent of total cells and modules in 2023 (based on the approximate percentage of U.S.-based battery and cell manufacturing likely to be eligible today for the credit)
We received comment on a variety of aspects of our modeling of 45X. Common themes included: questioning the ability of U.S. battery manufacturing facilities currently planned or under construction to ramp up quickly enough; the lack of accounting for the 10 percent electrode active material and critical mineral credit; the ability for imported vehicles to benefit from the credit in accounting for their battery cost; and the assumption that all of the value of the 45X credit would be realized as a cost reduction by OEMs when purchasing cells or packs from suppliers.
Comments received on our modeling of the 45X cell and module credit led us to further investigate our inputs for the phase-in schedule and average amount realized. This included working with the Department of Energy and Argonne National Lab (ANL) to update our assessment of U.S. battery manufacturing facilities and to account for gradual ramp-up of these facilities over time. As discussed in section IV.C.7 of this preamble, the updated analysis largely confirmed the previous assessment that currently planned U.S. battery cell manufacturing capacity is poised to meet projected U.S. demand during the time frame of the rule, even after explicitly accounting for a typical ramp-up period as assessed by DOE and ANL.
Regarding the ability of imported PEVs to benefit from 45X, some commenters stated that imported PEVs are likely to continue to comprise some portion of the market in the future, and because they arrive fully assembled including the battery, this portion of the PEV market is unlikely to benefit from the 45X cell and module credit. EPA agrees that imported vehicles are likely to continue to comprise some portion of the future PEV market. We also note, however, that even foreign manufacturers might in some cases be able to benefit from a reduced battery cost by purchasing cells or battery packs from U.S. suppliers that are able to claim the credit. Even if this possibility is not widely utilized, imported PEVs must compete with the presence of domestic PEVs that do benefit from the credit and may become a smaller part of the fleet over time due to this factor. For example, European battery maker Northvolt's CEO Peter Carlsson has said that with the IRA incentives available in the U.S., “it is basically impossible to operate in the North American market from anywhere else,” and has been actively pursuing opportunities to build plants in the U.S. as a result.
Regarding the passing of 45X credit savings realized by cell and module suppliers to OEMs via the selling price of the cells or modules, we continue to expect that many suppliers and OEMs will work closely together as they currently do through contractual agreements and partnerships and that these close connections will promote fair pricing arrangements. The large U.S. production capacity that is projected for the time frame of the rule also suggests that the market will be competitive and that suppliers will be motivated to pass credit savings along to customers in order to compete on price. OEMs that vertically integrate will not be subject to these variables and should be able to realize the full amount of the credit through their integrated operations.
Although EPA believes that these factors are likely to counteract commenters' concerns about these issues, EPA also acknowledges that at this early stage of the IRA credit availability, some uncertainty remains about the average amount of the available 45X cell and module credit that will in fact be realized across the U.S. PEV fleet. For example, if cells or modules are exported from the U.S. for use in vehicles that are then imported to the U.S., the value of the 45X credit, even if passed along to the purchaser of the cells or modules, would be offset to some degree by logistics and transportation costs. While local subsidies may exist in many jurisdictions to rival the 45X credit, there is no assurance that they will have the same value. We also note that ANL projections of U.S. battery cell manufacturing capacity prior to the time frame of the rule through 2025 (see section IV.C.7 of this preamble, at Figure 36) is roughly 50 percent of projected demand under the compliance scenarios, suggesting that only about half of PEV batteries may be claiming the 45X cell and module credit in those years preceding the rule. Accordingly to help account for uncertainties including (a) imported vehicles not necessarily having access to the credit, (b) the possibility that U.S. cell manufacturing facilities will not ramp up as quickly as announced, and (c) ANL's reduced projection of U.S. cell plant capacity from 2023 through 2025, we have conservatively reduced our estimates for the average value of the 45X cell and module credits from 2023. Specifically we have modified the yearly average amount as shown in Table 69. In general, we reduced the 2023 value to 50 percent of the available $45 (from 60 percent in the NPRM), and ramped up the value more slowly, to 75 percent in 2030. By 2030, we expect that enough lead time will have occurred (primarily, for manufacturers to secure 45X-qualifying battery supply and increase share of PEVs assembled in North America rather than imported), to gradually rejoin our original estimate of 100 percent of the available credit (now phased down by statute to $11.25) by 2032.
EPA considers these updated values to be responsive to the comments and to be a reasonable and conservative estimate of the 45X cell and module credit across the industry, reflecting current uncertainties. Over time, we expect that the impact of 45X on OEM battery manufacturing cost will become more evident and could turn out to be higher. For our low battery cost sensitivity case, we have retained the NPRM assumptions for 45X. We note
We also received comment that the 10 percent credit for electrode active materials and critical minerals under 45X could be significant, and therefore should be included in the analysis. To investigate this possibility, we consulted with the Department of Energy and Argonne National Laboratory to characterize the potential value of the 10 percent provisions of 45X on a dollar per kWh basis. ANL determined that the maximum value of the credits would change over time, as critical minerals become a larger share of battery manufacturing cost due to efficiencies in other material and manufacturing costs. As shown in Table 70, the maximum value for the electrode active materials (EAM) credit, or both the EAM credit and the critical minerals (CM) credit, would range from $5.60 to $10.70 per kWh in 2026 and decline to $3.50 to $7.60 per kWh in 2030, depending on chemistry. The decline is a result of ANL's projection that the amount (and hence manufacturing cost) of critical mineral content will decline over time due to improved cell chemistries for which minerals comprise a diminishing portion of total cost.
While these tax credits will be significant to manufacturers that produce EAM and CM in the U.S., their effect on average battery manufacturing cost across the fleet depends on the degree to which the average battery uses U.S.-produced EAM and CM. Because qualifying production of CM and EAM is unlikely to be sufficient to supply all U.S. PEV batteries based on announcements quantified at the time of ANL's analysis, the average value of the credit on a per kWh basis will be less than the figures above. Because of the uncertainty in predicting the degree of utilization across the industry, and the relatively small average value of the resulting credit, we have chosen to not include an estimate of the 10 percent credits in this analysis. Because some manufacturers will likely be in a position to qualify for some portion of the credit, this is a conservative assumption.
As we did in the proposal, we applied the 45X credits after the RPE markup. Because RPE is meant to be a multiplier against the direct manufacturing cost, and the 45X credit does not reduce the actual direct manufacturing cost at the factory but only compensates the cost after the fact, it was most appropriate to apply the 45X credit to the marked-up cost. The 45X cell and module credits per kWh were applied by first marking up the direct manufacturing cost by the 1.5 RPE factor to determine the indirect cost (
The IRA also includes consumer purchase incentives, which do not affect battery manufacturing cost, but reduce vehicle purchase cost to consumers. A substantial Clean Vehicle Credit (IRC 30D) of up to $7,500 is available to eligible buyers of eligible PEVs, subject to a number of requirements such as location of final assembly (in North America), critical minerals and battery component origin, vehicle retail price, and buyer income. Similarly, a Commercial Clean Vehicle Credit (IRC 45W) of up to $7,500 is available for light-duty vehicles purchased for commercial use. Consistent with the statutory text of the IRA and longstanding tax rules regarding leasing, vehicles leased to consumers (rather than sold) are commercial vehicles and can qualify for the credit to be paid to the lessor, equal to the excess of the purchase price for such vehicle over the price of a comparable internal
Because of the sourcing and eligibility requirements of the 30D credit and the uncertainties regarding relative utilization of the 45W credit, EPA did not assume in the proposal that all BEV sales would qualify for the full $7,500 30D or 45W credit. However, we did acknowledge that some portion of the market that is unable to capture the 30D credit may be capable of utilizing the 45W credit. For these reasons, in the analysis for the proposal, we applied only a portion of the $7,500 maximum from either incentive. For 2023, in the proposal, we estimated that an average credit amount (across all PEV purchases) of $3,750 per vehicle could reasonably be expected to be realized through a combination of the 30D and 45W tax credits. For later years, we recognized that the attractiveness of the credits to manufacturers and consumers would likely increase eligibility over time. To reflect this, we ramped the value linearly to $6,000 by 2032, the last year of the credits. The proposal analysis did not ramp to the full theoretical value of $7,500, in expectation that not all purchases will qualify for 30D due to MSRP or income requirements, and that not all PEVs are likely to enter the market through leasing.
We received a number of comments regarding our estimation of the 30D and 45W credits in the proposal. Commenters that emphasized the potential for IRA consumer incentives such as 30D and 45W to reduce vehicle cost to the consumer expressed broad support for EPA's inclusion of the credits in the analysis and did not disagree with EPA's year by year estimates of the average realized value of 30D and 45W credits. A variety of other commenters expressed the view that our estimates may have been too optimistic for various reasons. These reasons centered around their views regarding: the ability of U.S. battery manufacturing facilities and mineral mining and processing to ramp up rapidly enough to provide the critical minerals and battery components necessary to claim the credit; the ability of the domestic battery supply chain to grow fast enough to fulfill the increasing requirements for domestic sourcing for 30D eligibility; that the basis for the chosen values was unclear; that the impact of critical mineral and component sourcing requirements, and income and MSRP limits, was not quantified; and uncertainty surrounding the then-unreleased Treasury guidance regarding specific requirements for sourcing, particularly the Foreign Entity of Concern (FEOC) requirement. Some commenters also expressed skepticism that leasing rates under the 45W provision would increase sufficiently to achieve the modeled assumptions for 30D and 45W combined.
These comments led us to revisit our assumptions for the combined effect of the 30D and 45W credits over the time frame of the rule. We requested the Department of Energy to perform an independent assessment
DOE projected that the market-weighted average PEV can receive around $3,900 per vehicle in 2023 between the 30D and 45W credits, increasing to $6,000 in 2032. The figures are very close to the those that EPA used in the proposal.
Data sources underlying these projections include: PEV penetration rates based on EPA's projections from its 2021 rule for MYs 2023-2026 standards and the proposed standards for MYs 2027-2032; OEM production shares as of MY 2021 from the EPA Automotive Trends Database; share of cars and light trucks from the U.S. Energy Information Administration's Annual Energy Outlook 2023; shares of U.S. PEV sales and MSRPs derived from the Argonne National Laboratory E-Drive Sales Database, shares of North American final assembly compiled from
We also received comment that there is no guarantee that the full value of the 30D/45W credits will be passed on to the vehicle buyer but instead could be captured as profit by the vehicle manufacturer. However, we project that manufacturers will choose to produce PEVs as a means to comply with the standards. In this situation, we believe that manufacturers will be incentivized to compete with one another on a pricing basis. If a vehicle OEM were to capture a large portion of the credit as additional profit, this would conflict with the manufacturer's ability to sell the vehicles, which manufacturers are motivated to do as one of the lowest cost pathways to meeting the standards. In this final rule analysis, EPA continues to apply the full estimated average value of the 30D/45W credit toward the purchase price seen by the consumer. The 30D/45W credit amount is modeled in OMEGA as a direct reduction to the consumer purchase costs,
However, EPA also acknowledges that the relative newness of the 30D and 45W credits, as well as the content requirements for 30D and outstanding Treasury guidance that has not been finalized at the time of this writing, contribute to uncertainty at the present time regarding the average combined credit value that will ultimately be realized across the fleet and across the diversity of future PEV models. For example, specific guidance has not been finalized on the transition rule for non-traceable battery materials and excluded entity provision under 30D.
EPA considers the DOE analysis to represent the best accounting of potential future 30D/45W credits that is possible at this time. However, to further respond to uncertainties raised by commenters, EPA has revised the DOE figures downward for use in the OMEGA compliance analysis in order to remain conservative with respect to these uncertainties. As shown in Table 72, for 2023 through 2030, EPA has discounted the DOE estimates by 25 percent, and then ramped up to the DOE estimate between 2030 and 2032.
EPA considers this to be a reasonable accounting for the possible effect of these uncertainties which are not precisely quantifiable at this time but are not likely to have a large effect. DOE states that the impacts of the 30D MAGI limit “are likely to be limited,” stating further that “IRS tax statistics indicate that 9% of the 2022 tax filers would be MAGI-limited.” Further, DOE expects that the buyers excluded on an income basis would largely coincide with lessees (who remain eligible to benefit from 45W) and with the modeled 20 percent of vehicles that receive no credit in the DOE analysis.
After 2030, we gradually phase down the 25 percent discounting of the DOE figures, and rejoin the DOE-determined estimate of a combined $6,000 in 2032. This reflects likely trends in 30D and 45W over time, namely, decreasing uncertainty about material supply and diminished influence of 45W compared to 30D. Specifically, as time passes, uncertainty about mineral supply decreases; that is, vehicle eligibility for
After furthering considering the DOE analysis in light of comments on this topic, EPA concludes these updated values are responsive to the comments and represent a conservative but reasonable estimate of the average effective impact of 30D and 45W on PEV acquisition cost by consumers across the PEV fleet, reflecting current uncertainties. Over time, we expect that the impact of 30D and 45W will become more evident as additional data is collected by industry observers and may well turn out to be higher. Because our discounted estimates are conservative, we did not discount the DOE estimates in our low battery cost sensitivity case. Although 30D/45W does not directly factor into battery manufacturing cost, it does impact PEV cost as seen by the consumer and this sensitivity is intended to show a case in which PEV cost is generally more optimistic than in the central case. We note that many commenters supported our NPRM assumptions for 30D/45W, which were very close to the DOE estimates, and we continue to consider those values to represent another reasonable possibility for a future outcome although we have chosen to use lower and more conservative values in the central case. In addition, we conducted additional sensitivity analysis regarding the IRA tax credit assumptions in a memo to the docket.
EPA also considered potential impacts on battery manufacturing cost that might result from the battery durability and warranty requirements described in sections III.G.2 and III.G.3 of this preamble. We received comments stating the position that the existence of durability and warranty requirements would increase the cost of PEV batteries, and that we should account for this increased cost. However, commenters did not provide supporting data regarding cost increases that might result from these requirements. Because the durability minimum performance requirement and the minimum battery warranty are similar to currently observed industry practices regarding durability performance and warranty terms, EPA continues to expect that these requirements will not result in a significant increase in battery manufacturing costs.
In the proposal, EPA also updated the non-battery powertrain costs that were used to determine the direct manufacturing cost of electrified powertrains. We referred to a variety of industry and academic sources, focusing primarily on teardowns of components and vehicles conducted by leading engineering firms. These included the 2017 teardown of the Chevy Bolt conducted by Munro and Associates for UBS;
In the proposal, we described a new full-vehicle teardown study comparing a gasoline-fueled VW Tiguan to the battery-electric VW ID.4, conducted for
We also indicated in the proposal that we may rely on the information from this work for the final rule. For example, we indicated that component costs for the BEV and ICE vehicle might be used to support or update our battery or non-battery costs for electrified vehicles, or our costs for ICE vehicles; assembly labor data might be used to further inform the employment analysis; and any other qualitative or quantitative information that could be drawn from the report might be used in the analysis.
The project report was delivered to EPA in February 2023 and underwent a contractor-managed peer review process that has now been completed.
Concurrently with this contracted teardown project, EPA also contracted FEV to conduct a scaling exercise to develop up-to-date powertrain cost curves that could be used as inputs to OMEGA, using not only the teardown results of this project but also teardown results from FEV's extensive database of previous teardowns it has conducted for a wide variety of vehicles and components. As a result of that effort, we have updated our powertrain costs, including the non-battery technologies used in BEV, PHEV, and HEV powertrains. Chapter 2.6.1 of the RIA presents all of those updated powertrain cost curves. In general, the updated cost curves result in lower powertrain costs for nearly all powertrain technologies, with ICE powertrain costs being reduced somewhat more than those for electrified powertrains. As a result, the incremental costs when moving from ICE-only to any electrified powertrain have increased somewhat since the NPRM. Importantly, the scaling effort provided ICE, HEV, PHEV, and BEV powertrain costs that were generated using the same methodology. We consider the updated costs to represent the strongest and most up to date data available.
Some commenters encouraged EPA to conduct a teardown analysis of a relatively long-range PHEV, or to conduct a comparative analysis on PHEV and BEV costs with involvement of stakeholders such as car and truck makers. It was also noted that a PHEV may not need as strong a chassis as a BEV due to the lighter weight of the battery, and that this savings should be accounted for in PHEV cost. Given the time frame of the analysis, it was not possible to conduct a new teardown analysis of a long-range PHEV. Given the scope of the FEV teardown and the similarity of electrical components between the BEV that was analyzed and a long-range PHEV, it is unlikely that the results of a teardown of a long-range PHEV would provide significantly different costs estimates. While it may be possible that a PHEV could have less structural content owing to the smaller size and weight of the battery, it is unlikely that such cost savings could be generalized across the entire class of vehicles from the analysis of a single vehicle. For these reasons we did not conduct these additional analyses.
More discussion of the technical basis for the non-battery electrified vehicle cost estimates used in the final rule analysis may be found in RIA Chapter 2.
As PEVs are anticipated to represent a significant share of the future U.S. light- and medium-duty vehicle fleet, EPA has continued to develop approaches to estimate the upstream emissions (
As with the analysis for the proposal, charge demand from scenarios modeled within the OMEGA compliance model were regionalized into the 67 IPM regions using the EVI-X modeling suite of electric vehicle charging infrastructure analysis tools developed by the National Renewable Energy Laboratory (NREL) combined with a PEV likely adopter model. Chapter 5 of the RIA contains a detailed description of the analysis of PEV charging demand, electric generation and the resulting emissions and cost for different projected vehicle electrification scenarios. One update made within the power sector analysis for the final rule was the inclusion of heavy-duty charge demand based on an interim scenario developed from the Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 Proposed Rule.
Power sector modeling results of generation and grid mix from 2030 to 2050 and CO
Power sector modeling results showed that the increased use of renewables will largely displace coal and (to a lesser extent) natural gas EGUs and will primarily be driven by provisions of the IRA. By 2035, power sector modeling results also showed that non-hydroelectric renewables (primarily wind and solar) will be the largest source of electric generation (approximately 45 percent of total generation), and would account for more than 75 percent of generation by 2050. This displacement of coal EGUs by renewables was also the primary factor in the year-over-year reductions in CO
Power sector modeling also showed a significant increase in the use of batteries for grid storage, which is expected to be increasingly important for generation, transmission and distribution of electricity. When modeling PEV charge demand for both the final rule and for a No Action case, grid battery storage capacity increased from approximately zero capacity in 2020 to approximately 53 GW in 2030 and 150 GW in 2050, representing the equivalent of approximately 105 GWh and 326 GWh of annual generation, respectively. The increase in grid battery storage was primarily due to modeling of incentives under the IRA.
We received many comments regarding future charging infrastructure needs. Vehicle manufacturers, dealers, and representatives of the fuels industry, among others, raised concerns stating that charging infrastructure is inadequate today and that the pace of deployment is not on track to meet levels needed if the proposed standards are finalized. Commenters noted particular challenges for those who can't charge at home, as well as for rural areas. Manufacturers and others said customers won't buy PEVs if reliable charging infrastructure is not available. While they recognized the importance of the BIL and the IRA in supporting buildout of charging infrastructure, commenters expressed concerns that far more funding would be needed with some commenters characterizing BIL funds as a ‘good downpayment’. We also received comments from states, non-governmental organizations, electrification groups, electric vehicle manufacturers, and utilities highlighting the many public and private investments in charging infrastructure that have been announced or are already underway, along with a new analysis submitted by EDF.
As an initial matter, EPA notes that it anticipates automakers will employ a wide variety of control technologies, applied to ICE, hybrid, and electric powertrains, to meet the final standards and will continue to offer a diverse variety of vehicles for the duration of these standards and beyond. For example, under our central case modeling (which is only one estimate of a possible compliance path for the industry), in MY 2032, 29 percent of new vehicle sales would be non-hybrid ICE vehicles (with an additional 3 percent hybrid vehicles).
Public charging has been growing rapidly in the past few years. There are over 60,000 charging stations in the U.S. today with more than 160,000 electric vehicle supply equipment (EVSE) ports.
We agree with commenters that keeping up with charging needs as PEV adoption grows will require continued investments in charging infrastructure. The NREL study discussed above estimated that between $31 billion and $55 billion would be needed by 2030 for public charging infrastructure, noting that $24 billion in investments from public and private sources had already been announced as of March 2023.
The Bipartisan Infrastructure Law (BIL) provides up to $7.5 billion over five years to build out a national PEV charging network.
Ensuring equitable access to charging is one of the stated goals of these infrastructure funds. Accordingly, FHWA instructed states to incorporate public engagement in their planning process for the NEVI Formula Program, including reaching out to Tribes and rural, underserved, and disadvantaged communities.
The Inflation Reduction Act (IRA), signed into law on August 16, 2022, will also help reduce the costs for deploying infrastructure.
States, utilities, charging network providers, and others are also investing in and supporting PEV charging infrastructure deployment. California announced plans to invest $1.9 billion in state funds through 2027 for charging and hydrogen refueling infrastructure serving light-, medium-, and heavy-duty vehicles (and related activities), which it estimates could support 40,000 new EVSE ports.
In July 2023, seven automakers—BMW, GM, Honda, Hyundai, Kia, Mercedes-Benz, and Stellantis—announced that they would jointly deploy 30,000 EVSE ports in North
Other charging networks are also expanding. Francis Energy, which has fewer than 1,000 EVSE ports today,
We assess the infrastructure needs and the associated costs for this final
We estimate the costs to deploy the number of EVSE ports needed each year (2027-2055) to achieve the modeled network sizes for the Final rule and No Action case.
See RIA Chapter 5 for a more complete discussion of this analysis including low and high sensitivities not shown here. The final PEV charging infrastructure costs are presented in section VIII of this preamble.
EPA acknowledges that there may be additional infrastructure needs and costs beyond those associated with charging equipment itself. As vehicle electrification load increases, alongside other new loads from data centers, industry, and building electrification, the grid will accommodate higher loads, which may require generation, transmission, and distribution system upgrades and additions. Our examination of the record, informed by our consultations with DOE, FERC, and other power sector stakeholders, is that the final standards of this rule, whether considered separately or in combination with the Phase 3 HD vehicle standards and upcoming power sector rules, are unlikely to adversely affect the reliability of the electric grid, and widespread adoption of PEVs could have significant benefits for the electric power system.
In the balance of this section, we first provide an overview of the electric power system and grid reliability. We then discuss the impacts of this rule on generation. We find that the final rule, together with the Heavy-Duty Phase 3 GHG Proposed Rule, are associated with modest increases in electricity demand. We also conducted an analysis of resource adequacy, which is an important metric in North American Electric Reliability Corporation's (NERC) long-term reliability assessments. We find that the final rule, together with the HD Phase 3 Rule as well as other EPA rules that regulate the EGU sector, are unlikely to adversely affect resource adequacy. We then discuss transmission and find that the need for new transmission lines
The National Academy of Engineering ranks electrification as “the greatest engineering achievement of the 20th century.”
Operating on a “just in time” basis, it is comprised of three basic components: generation, transmission, and distribution systems. While the forms of generation have varied—primarily from coal-fired sources in the mid-2000s to renewable sources supplemented with natural gas-fired generation, at present—the components of the system which deliver electricity remain the same. These components are the transmission and distribution systems, which have over time increased in size and reliability to accommodate the overall economic growth of the U.S. as well as the electricity demand associated with air conditioning, data centers, building electrification, cryptocurrency mining, and now vehicle electrification.
The electric power system in the U.S. has historically been a very reliable system,
Power interruptions caused by extreme weather are the most-commonly reported, naturally- occurring factors affecting grid reliability, with the frequency of these severe weather events increasing significantly over the past twenty years due to climate change.
The average duration of annual electric power interruptions in the U.S., approximately two hours, decreased slightly from 2013 to 2021, when extreme weather events associated with climate change are excluded from reliability statistics. When extreme weather events associated with climate change are not excluded from reliability statistics, the national average length of annual electric power interruptions increased to about seven hours.
Around 93 percent of all power interruptions in the U.S. occur at the distribution-level, with the remaining fraction of interruptions occurring at the transmission- and generation-levels.
According to FERC, grid reliability is based on two key elements;
• Reliable operation—A reliable power grid has the ability to withstand sudden electric system disturbances that can lead to blackouts.
• Resource adequacy—Generally speaking, resource adequacy is the ability of the electric system to meet the energy needs of electricity consumers. This means having sufficient generation to meet projected electric demand.
We now turn to the impacts of this rule on generation and resource adequacy. As discussed in section IV.C.3 of the preamble and as part of our upstream analysis, we modeled changes to power generation due to the increased electricity demand anticipated under the final standards. Bulk generation and transmission system impacts are felt on a larger scale, and thus tend to reflect smoother load growth and be more predictable in nature. For a no action case, we project that generation will increase by 4.2% between 2028 and 2030 and by 36% between 2030 and 2050. Further, we project the additional generation needed to meet the projected demand of the light- and medium-duty PEVs under the final standards combined with our estimate of PEV demand from the Heavy-duty Phase 3 GHG proposed rule, to be relatively modest compared to a no action case, ranging from 0.93 percent in 2030 to approximately 12 percent in 2050 for both actions combined. Of that increased generation, approximately 84 percent in 2030 and approximately 66 percent in 2050 is due to light- and medium-duty PEVs, which are projected to represent approximately 0.78 percent and 7.6 percent of total U.S. generation in 2030 and 2050, respectively. Electric vehicle charging associated with the Action case (light- and medium-duty combined with heavy-duty) is expected to require 4 percent of the total electricity generated in 2030, which is slightly more than the increase in total U.S. electricity end-use consumption between 2021 and 2022.
Given the additional electricity demand associated with increasing adoption of electric vehicles, some commenters raised concerns that the additional demand associated with the rule could impact the reliability of the power grid.
Specifically, we considered whether the Vehicles Rules alone and combined with the Power Sector Rules would result in anticipated power grid changes such that they (1) respect and remain within the confines of key National Electric Reliability Corporation (NERC) assumptions,
Beginning with EPA's modeling of the Vehicle Rules, we used EPA's Integrated Planning Model (IPM), a model with built-in NERC resource adequacy constraints, to explicitly model the expected electric power sector impacts associated with the two vehicle rules. IPM is a state-of-the-art, peer-reviewed, multi-regional, dynamic, deterministic linear programming model of the contiguous U.S. electric power sector. It provides forecasts of least cost capacity expansion, electricity dispatch, and emissions control strategies while meeting energy demand and environmental, transmission, dispatch, and resource adequacy constraints. IPM modeling we conducted for the Vehicle Rules includes in the baseline all final rules that may directly impact the power sector, including the final Good Neighbor Plan for the 2015 Ozone National Ambient Air Quality Standards (NAAQS), 88 FR 36654.
EPA has used IPM for over two decades, including for prior successfully implemented rulemakings, to better understand power sector behavior under future business-as-usual conditions and to evaluate the economic and emissions impacts of prospective environmental policies. The model is designed to reflect electricity markets as accurately as possible. EPA uses the best available information from utilities, industry experts, gas and coal market experts, financial institutions, and government statistics as the basis for the detailed power sector modeling in IPM. The model documentation provides additional information on the assumptions discussed here as well as all other model assumptions and inputs. EPA relied on the same model platform at final as it did at proposal, but made substantial updates to reflect public comments. Of particular relevance, the model framework relies on resource adequacy-related constraints that come directly from NERC. This includes NERC target reserve margins for each region, NERC Electricity Supply & Demand load factors, and the availability of each generator to serve load across a given year as reported by the NERC Generating Availability Data System. Note that unit-level availability constraints in IPM are informed by the average planned/unplanned outage hours for NERC Generating Availability Data System. Therefore, the model projections for the Vehicle Rules are showing compliance pathways respecting these NERC resource adequacy criteria. These NERC resource adequacy criteria are standards by which FERC, NERC and the power sector industry judge that the grid is capable of meeting demand. Thus, we find that modeling results demonstrating that the grid will continue to operate within those resource adequacy criteria supports the conclusion that the rules will not have an adverse impact on resource adequacy, which is an essential element of grid reliability.
EPA also considered the cumulative impacts of the Vehicle Rules together with the Power Sector Rules, which as noted above are several recent proposed rules regulating the EGU sector. In a given rulemaking, EPA does not generally analyze the impacts of other proposed rulemakings, because those rules are, by definition, not final and do not bind any regulated entities, and because the agency does not want to prejudge separate and ongoing rulemaking processes. However, some commenters on this rule expressed concern regarding the cumulative impacts of these rules when finalized, claiming that the agency's failure to analyze the cumulative impacts of the Vehicle Rules and its EGU-sector related rules rendered this rule arbitrary and capricious. In particular, commenters argued that renewable energy could not come online quickly enough to make up for generation lost due to fossil sources that may retire, and that this together the increasing demand associated with the Vehicle Rules would adversely affect resource adequacy and grid reliability. EPA conducted additional analysis of these cumulative impacts in response to these comments. Our analysis finds that the cumulative impacts of the Vehicle Rules and Power Sector Rules is associated with changes to the electric grid that are well within the range of fleet conditions that respect resource adequacy, as projected by multiple, highly respected peer-reviewed models. In other words, taking into consideration a wide range of potential impacts on the power sector as a result of the IRA and Power Sector Rules (including the potential for much higher variable renewable generation), as well the potential for increased demand for electricity from both this rule and the Phase 3 Heavy Duty GHG rule, EPA found that the Vehicle Rules and proposed Power Sector Rules are not expected to adversely affect resource adequacy and that EPA's rules will not inhibit the industry from its responsibility to maintain a grid capable of meeting demand without disruption.
Finally, we note the numerous are existing and well-established institutional guardrails at the federal- and state-level, as well as non-governmental organizations, which we expect to continue to maintain resource adequacy and grid reliability. These well-established institutions—including the Federal Energy Regulatory Commission (FERC), state Public Service Commissions (PSC), Public Utility Commissions (PUC), and state energy offices, as well as NERC and Regional Transmission Organization (RTO) and Independent System Operator (ISO)—have been in place for decades, during which time they have ensured the resource adequacy and reliability of the electric power sector. As such, we expect these institutions will continue to ensure that the electric power sector is safe and reliable, and that utilities will proactively plan for electric load growth associated with all future electricity demand, including those increases due to our final rule. We also expect that utilities will continue to collaborate with EGU owners to ensure that any EGU retirements will occur in an orderly and coordinated manner. We also note that EPA's proposed Power Sector rules include built-in flexibilities that accommodate a variety of compliance pathways and timing pathways, all of which helps to ensure the resource adequacy and grid reliability of the electric power system.
The transmission system is another component of the electric power system with unique grid reliability attributes. The need for new transmission lines associated with the final rule and the HD Phase 3 Rule between now and 2050 is projected to be very small, approximately one percent or less of transmission. Nearly all of the projected new transmission builds appear to overlap with pre-existing transmission
We also find that, the federal government has a role in improving transmission system planning,
For example, two 230-kV transmission lines used by PPL Electric Utilities, in Pennsylvania, were found to be approaching their maximum transmission capacity in 2020. As a result, the utility paid more than $60 million in congestion fees in the winters of 2021-2022 and 2022-2023. Rather than rebuilding or reconductoring the two transmission lines, which would have cost tens of millions of dollars, the utility spent under $300 thousand installing dynamic line rating (DLR) sensors, which helped the utility to rebalance each of the two transmission lines and allowed them to reliably carry an additional 18 percent of power.
DOE recently announced several programs and projects aimed at helping to alleviate the interconnection queue backlog, including the Grid Resilience and Innovation Partnerships (GRIP) program, with $10.5 billion in Bipartisan Infrastructure Law funding to develop and deploy Grid Enhancing Technologies (GET); and the Interconnection Innovation e-Xchange (i2X), which aims to increase data access and transparency, improve process and timing, promote economic efficiency, and maintain grid reliability.
The capacity of existing electric power transmission lines can be increased by a process known as reconductoring, in which existing transmission lines, typically with steel cores, are replaced with higher capacity composite conductors. Since the process makes use of existing transmission towers, it typically does not require additional rights of way. As such, new generation capacity can be rapidly added, which serves to improve resource adequacy. For example, American Electric Power, a Texas-based transmission utility, replaced the aging conventional conductors of a 240 miles transmission line with advanced composite core conductors from 2012-2015.
Energy storage projects can also be used to help to reduce transmission line congestion and are seen as alternatives to transmission line construction in some cases.
Through such efforts, the interconnection queues can be reduced in length, transmission capacity on existing transmission lines can be increased, additional generation assets
We next discuss distribution infrastructure. We acknowledge that increases in electric vehicle charging associated with the final rule are likely to require additional distribution infrastructure. We first review the literature regarding and tools to support distribution needs associated with PEV charging, and then we discuss the TEIS, which specifically analyzes the distribution needs associated with this rule and the HD Phase 3 Rule.
Numerous tools are available to address and mitigate anticipated distribution needs, including managed charging, time-of-use (TOU) electric rates, distributed energy resources (DERs), Power Control Systems (PCS), and others, which are discussed in greater detail below. New technologies and solutions exist and are emerging to ensure that new charging stations can be connected to the grid as quickly as possible, without adversely affecting grid reliability. Utility hosting capacity maps are one tool available that developers can use to identify faster and lower cost locations to connect new EV chargers. These maps can help charging station developers identify locations where there is excess available grid capacity. Hosting capacity maps provide greater transparency into the ability of the distribution grid to host additional distributed energy resources (DERs) such as BEV charging. In addition, hosting capacity maps can identify where DERs can alleviate or aggravate grid constraints. Hosting capacity is commonly defined as the additional injection or withdrawal of electric power up to the limits where individual grid assets exceed their power ratings or where a voltage violation would occur. Hosting capacity maps, analyzed and created by the utility that owns the distribution system, are usually color-coded lines or surface diagrams overlayed on geographic maps, representing the conditions on the grid at the time when the map is published or updated. The analysis is based on power flow simulations of the distribution circuits given specific customers' load profiles supplied by the electric circuit and the grid asset data as managed by the utility. The hosting capacity is highly location specific. A DOE review found that utilities have published 39 hosting capacity maps in 24 states and the District of Columbia.
Hosting capacity maps can help direct new EV charger deployment to less constrained portions of the grid, giving utilities more lead time to make distribution system upgrades. In tandem, new technologies and power control protocols are helping connect new EV loads faster even where there are grid capacity constraints. One approach is for utilities to make non-firm capacity available immediately as they construct distribution system upgrades. Southern California Edison, a large electric utility in California, proposed a pilot to allow faster connection of new EV loads in constrained areas by deploying Power Control Systems (PCS).
Plans like Southern California Edison's (SCE) to use load constraint management systems (LCMS),
In addition to the flexible interconnection enabled by PCS, technologies including battery or generation backed charging and mobile charging can facilitate rapid charging deployment, even before utility connections can be upgraded. Mobile chargers can be deployed immediately because they do not require an on-site grid connection. They can be used as a temporary solution to bring additional charging infrastructure to locations before a stationary, grid-connected charger can be deployed. Mobile chargers can also help bring charging infrastructure to locations where traditional charger deployments can be more difficult, such as at multi-unit dwellings.
Battery-integrated charging is a promising solution to deploy DCFC quickly and inexpensively in relatively constrained areas of the grid. These chargers draw power from the grid slowly throughout the day and use a battery to store that power and then use it to charge EVs at much faster rates. A recent Argonne National Laboratory analysis found that battery-integrated DCFC results in either lower or similar levelized costs relative to non-battery-integrated DCFC in regions across the
Additional innovative charging solutions will further accelerate charging deployment by optimizing the use of chargers that have already been installed. Technologies are emerging to make the most of existing charging infrastructure. Other companies are working on facilitating the sharing of chargers between more drivers. One company, EVMatch, developed a software platform for sharing, reserving, and renting EV charging stations, which can allow owners of charging stations to earn additional revenue while making their chargers available to more EV drivers to maximize the benefit of each deployed charger. EVMatch is also rolling out a new product called the EVMatch adapter in partnership with Argonne National Laboratory. The EVMatch adapter is a smart charging adapter that can turn any Level 1 or 2 EVSE into a smart charger that can remotely monitor and control charging to enable even more efficient utilization of existing chargers.
It is not uncommon for the electric power system to have additional, unutilized generation capacity at various times throughout a given day. In a manner akin to load constraint management systems (discussed above), grid operators can utilize this previously untapped generation capacity by shifting the charging of electric vehicles to times where excess underutilized generation capacity exists and/or shift electric vehicle charging away from times where generation capacity is less prevalent, without affecting the utility of electric vehicles. This allows the grid operators to more effectively use existing electric power system resources, which decreases overall operative costs for all ratepayers. Prior research efforts
Integration of electric vehicle charging into the power grid, by means of vehicle-to-grid software and systems that allow management of vehicle charging time and rate, has been found to create value for electric vehicle drivers, electric grid operators, and ratepayers.
Managed EV charging provides several benefits to vehicle owners, rate payers that do not operate electric vehicles, and the operators of the electric power system, including lower costs and longer lifespans for electric power system assets. Managed electric vehicle charging, when coupled with time-of-use (TOU) electric rates, can help to further reduce already low refueling costs of EVs by allowing vehicle operators to charge when electric rates are most advantageous. Since low electricity costs coincide with surpluses of electricity, such charging reduces the overall costs of electricity generation and delivery to all electricity rate payers, not just those charging electric vehicles. Researchers at the Lawrence Berkeley National Laboratory (LBNL) identified 136 active or approved EV-specific TOU electric utility rates for U.S. investor-owned utilities in 37 states and the District of Columbia.
To better understand the potential impacts of the final rule on the distribution system, EPA commissioned a study as part of an interagency agreement with the U.S. Department of Energy entitled the “Transportation Electrification Impact Study” (TEIS) to estimate the potential costs and benefits associated with electrical distribution system upgrades that may be incurred as a result of this final rule in addition to those of the Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 Proposed Rule.
In the TEIS study, aggregate distribution system-level costs and benefits were estimated for five states using parcel-level
Load profiles were analyzed using output from two analytical cases:
1. A no-action case that included modeling of electric vehicle provisions from the IRA within the OMEGA compliance model and compliance with 2023 and later GHG standards (86 FR 74434) with the addition of heavy-duty vehicle (Class 4-8) charge demand estimated for the California Advanced Clean Trucks (ACT) Program.
2. A final rule policy case based upon Alternative 3 from the light- and medium-duty proposed rule with the addition of heavy-duty vehicle charge demand based on an interim scenario developed from the Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 Proposed Rule (HDP3).
Of the scenarios modeled in IPM after the proposal, Alternative 3 is the closest scenario with respect to PEV charging demand to the final rule and represents the final rule within the power sector analysis. Alternative 3 differs from the finalized program by forecasting higher PEV sales in 2027-2031 than finalized, and thus higher PEV charging demand in earlier years and comparable PEV charging demand after 2032. Thus, power sector impacts on emissions and cost within the final rule analysis should be considered conservatively high estimates. The load profiles from light-, medium- and heavy-duty are distributed into IPM regions using NREL's EVI-X suite of models for light-duty, LDVs, MDVs, and heavy-duty buses; and using LBNL's HEVI-LOAD model for all other heavy-duty applications. The resulting premise-level load profiles were aggregated up to electric utility service territories. The system-level grid impacts and costs of electricity service were determined based upon the profiles. Additional scenarios were modeled to evaluate the impact of both unmanaged charging and managed charging. In the unmanaged case, the study assumes that EVs are charged immediately when the vehicle returns to a charger. In contrast, managed charging spreads the charging out more evenly over the period when the vehicle is parked at the charger; we note that the managed charging scenario evaluated only the most basic and readily available managed charging methods, a small subset of the numerous tools to address distribution needs that we reviewed in our earlier discussion. As a result, this study provides detailed modeling of potential impacts of these vehicles rules at the neighborhood level of electricity distribution.
This methodology is first applied to five states, which were selected based upon their diversity in urban/rural population, utility distribution grid composition, freight travel demands, and state EV policies. The selected states are California, Oklahoma, Illinois, Pennsylvania, and New York. The results from these five states are then extrapolated to the 67 IPM regions that we use to represent the remaining 48 contiguous states within our power sector analysis.
The TEIS national-level results found that the Action case, with managed charging, provides significant distribution system benefits relative to unmanaged charging both financially and in terms of the ability to defer necessary distribution system upgrades. The TEIS also found that the incremental grid upgrades needed in the Action cases relative to the No Action cases are manageable and that benefits outweigh costs.
The study also found that the distribution costs associated with increasing demand from the Vehicle Rules were quite small relative to total distribution costs. Based on utility reports to the Federal Energy Regulatory Commission, data from electric co-ops, and extrapolation for the remaining utilities, the TEIS estimated that the national investment in distribution systems exceeded $60 billion annually as of 2021. A high-level approach for scaling the national distribution system investment to the five states under study was applied to estimate that $15 billion of distribution system investment occurred in 2021. Through 2032, the TEIS estimated that the incremental investment in distribution networks (to accommodate PEV growth due to EPA's rulemaking) as an additional $1.6 billion of grid investment for PEVs relative to a no action case when charging is managed and $2.3 billion when charging is unmanaged. Annualizing the latter number (reflecting unmanaged charging) between 2027 and 2032 results in an annual cost from the EPA light- and medium duty rule combined with the heavy-duty phase 3 proposed rule of $0.4 billion across the five states. Within the five states and extrapolated across the nation, this amounts to approximately 3% of existing annual distribution investments. We think this increase in distribution investment is modest and reasonable. Moreover, this value is conservative as it is inclusive of effects for both the light- and medium-duty vehicle standards and the heavy-duty Phase 3 proposed rule standards and so overstate the amount of grid investment associated with the final rule, and as it does not reflect managed charging. Given the very significant economic benefits of managed charging, we expect the market to adopt managed charging particularly under the influence of additional PEV adoption associated with the central case of the final rule, and that would further decrease the investment, to roughly $0.3 billion per year, or approximately 2% of annual distribution investments.
We also estimated the impact on retail electricity prices based on the TEIS. The TEIS results were extrapolated to all IPM regions in order to estimate impacts on electricity rates using the Retail Price Model (see RIA Chapter 5). We modeled retail electricity rates in the no action case with unmanaged charging compared to the action case with managed charging. We think this is a reasonable approach for the reason noted above: given the considerable economic benefits of managed charging, particularly in light of the increased PEV adoption associated with the central case of the final rule, there is an extremely strong economic incentive for market actors to adopt managed charging practices. Our analysis projects
A 2-3 percent increase in distribution system build out correlates to a small increase in manufacturing output so concerns regarding supply chain timing and cost are minimal. The total costs are modest both in and of themselves, as a percentage of grid investment even without considering mitigation strategies, and in terms of effect on electricity rates for users. EPA thus believes that the costs associated with distributive grid buildout attributable to the rule are reasonable.
Further discussion of the results of the TEIS study are included in the RIA Chapter 5.4.2., and additional details can be found in the TEIS report included in the docket for this final rule. Based on our review of the record, including the TEIS and other studies and public comments,
EPA carefully considered acceptance of light-duty vehicle technologies, qualitatively and quantitatively, because we recognize that consumer acceptance is an important factor for any innovation and therefore relevant factor to the feasibility of PEVs as a significant emissions control strategy.
EPA recognized that an evidence-based definition and understanding of consumer acceptance of PEVs was an important consideration for this rulemaking. Thus, EPA in coordination with the Lawrence Berkeley National Laboratory (LBNL), conducted a comprehensive review of the scientific literature regarding consumer acceptance of PEVs. That effort culminated in a peer-reviewed report on PEV acceptance in which EPA and LBNL organize and summarize the enablers and obstacles of PEV acceptance evident from the scientific literature.
Consumer Reports (CR) describes trends in PEV acceptance as a virtuous cycle in which consumer demand for PEVs will continue to grow. “As automakers deliver more volume, economies of scale and intensified competition for customers will further feed cost declines, which will feed back into the cycle, and lead to increased EV demand.”
In other words, PEV acceptance enablers (and diminishing obstacles) are part of a positive and robust feedback loop. Growth in PEV adoption has already grown based on technology advancement alone,
EPA further substantiates these and other findings with additional observations of key enablers of PEV acceptance, namely increasing market presence, more model choices, expanding infrastructure, and decreasing costs to consumers.
Recent research also further substantiates the conclusion that PEVs acceptance and adoption will continue to grow and expand. Foremost among those studies are the recent third-party projections of PEV market shares. EPA reviewed several recent reports and studies containing PEV projections, all of which include the impact of the IRA; none consider the impact of this rule. Altogether, these studies project PEV market share in a range from 42 to 68 percent of new vehicle sales in 2030. The mid-range projections of PEV sales from these studies, to which we compare our No Action case, range from 48 to 58 percent in 2030.
Lastly, many individuals and institutions provided diverse comments on our proposed rule regarding consumer acceptance. Commenters expressed views about both access to and demand for PEVs, some noting individual/household characteristics, vehicle attributes, and/or system conditions affecting consumer acceptance of PEVs. For example, Consumer Reports identified substantial unmet demand among U.S. consumers, calculating that “there are now approximately 45 EV-ready buyers for every EV being manufactured.”
Taking into account all of the above—EPA and LBNL's report on PEV acceptance, recent acceptance research, recent third party projections of PEV adoption, public comments, market trends, and analyses presented throughout this preamble and the RIA—we conclude that PEV acceptance is growing and will continue to grow rapidly for all body styles, particularly for vehicles likely to be used largely as passenger vehicles such as sedans, wagons, CUVs, and SUVs. Observed and expected PEV adoption and acceptance aligns well with patterns of adoption of innovations observed through history. Typically, sales of a new technology are low and increase slowly and unpredictably in what is called the innovator and early adopter stage. After the early adopter stage, adoption increases very quickly, with rapidly accelerating demand as the technology becomes mainstream. We expect PEV adoption and acceptance to follow the S-shaped behavior. See RIA Chapter 4.1.
We also conclude that our expectations for continued rapid growth in PEV acceptance are reasonable. The system of PEV growing acceptance enablers and diminishing obstacles is robust. PEV acceptance is responding to the evolution of the environment in which people make decisions (
While we have emphasized PEVs and the relative growth in PEV acceptance here, we note that the acceptance and purchase of ICE vehicles, HEVs, PHEVs, and BEVs will persist throughout the timeframe of this rule. Therefore, in relative terms, we represent acceptance of all vehicle technologies. All of these technologies are well-represented in EPA's modeling and in demonstrated compliance pathways, as they are in third-party projections. For more information on LD vehicle consumer modeling and considerations, see RIA Chapter 4.
All new motor vehicles, including ICE vehicles and PEVs, require manufacturing inputs in the form of materials such as structural metals, plastics, electrical conductors, electronics and computer chips, and many other materials, minerals, and components that are produced both domestically and globally. These inputs rely to varying degrees on a highly interconnected global supply chain that includes mining and recycling operations, processing of mined or
Although the market share of PEVs in the U.S. is already rapidly growing, EPA recognizes that many manufacturers will likely produce additional PEVs as part of their chosen strategy to achieve the performance-based emissions standards, particularly after 2030. Compared to ICE vehicles, the electrified powertrain of PEVs commonly contains a greater proportion of conductive metals such as copper as well as certain minerals and mineral products that are used in the high-voltage battery. Accordingly, many of the public comments we received were related to the need to secure sources of these inputs to support increased manufacture of PEVs for the U.S. market.
First, it is important to view this issue from a holistic perspective that also considers the inputs currently required by ICE vehicles. Compared to PEVs, ICE vehicles rely to a greater degree on certain inputs, most notably refined crude oil products such as gasoline or diesel. Historically, supply and price fluctuations of crude oil products have periodically created significant risks, costs, and uncertainties for the U.S. economy and for national security, and continue to pose them today. Manufacture of ICE vehicles also relies on critical minerals (for example, platinum group metals) used in emission control catalysts. EPA thus has many years of experience in assessing the availability of critical minerals as part of our assessment of feasibility of standards taking into consideration available technologies, cost, and lead time. The critical minerals used in emission control catalysts of ICE products, such as cerium, palladium, platinum, and rhodium,
The PEV supply chain consists of several activity stages including upstream, midstream, and downstream, which includes end of life. In this discussion, upstream refers to extraction of raw materials from mining activities. Midstream refers to additional processing of raw materials into battery-grade materials, production of electrode active materials (EAM), production of other battery components (
The value of developing a robust and secure supply chain that includes these activities and the products they create has accordingly received broad attention in the industry and is a key theme of comments we have received. The primary considerations here are (a) the capability of global and domestic supply chains to support U.S. manufacturing of batteries and other PEV components, (b) the availability of critical minerals as manufacturing inputs, and (c) the possibility that sourcing of these items from other countries, to the extent it occurs, might pose a threat to national security. In this section, EPA considers how these factors relate to the feasibility of producing the PEVs that manufacturers may choose to produce to comply with the standards.
As in the proposal, we continue to note several key themes that contribute to our conclusion that the proposed standards are appropriate with respect to these issues. First, we note that, to the extent that minerals, battery components, and battery cells are sourced from outside of the U.S., it is not because the products cannot be produced in the U.S., but because other countries have already invested in developing a supply chain for their production, while the U.S. has begun doing so more recently. The rapid growth in domestic demand for automotive lithium-ion batteries that is already taking place is driving the development of a supply chain for these products that includes development of domestic sources as well as a rapid buildout of production capacity in countries with which the U.S. has good relations, including countries with free-trade agreements (FTAs), long-established trade allies and other economic allies.
We received a large number of comments on our analysis of critical minerals, battery and mineral production capacity, and mineral security. Some common themes were: that the proposal did not adequately address critical minerals or battery manufacturing; that we should account for all critical minerals rather than lithium only; that the proposal did not adequately address the risk associated with uncertain availability of critical minerals in the future; and that the timeline and/or degree of BEV penetration anticipated by the proposal cannot be supported by available minerals and/or growth in domestic supplies or battery manufacturing. It was also suggested that the rapid growth in demand stemming from the rule would result in undue reliance on nations with which the U.S. does not have good trade relations, increased reliance on imports in general, and/or encourage environmentally or socially unsound sourcing practices. Some commenters felt that the discussion of national security in the proposal was not sufficient, pointing again to concerns about vulnerabilities resulting from a dependence on imported minerals and materials in order to manufacture vehicles or support the infrastructure they require.
Another frequent theme of the comments was a perception of uncertainty and risk, in reference to the question of whether or not critical mineral prices and availability will stabilize in the near term or even the long term. Some commenters also suggested that this uncertainty might be addressed by a stringency adjustment mechanism, in which progress in domestic sourcing of critical minerals, battery components, and other inputs to the supply chain would be monitored and the stringency of the standards adjusted if progress underperforms expectations. Commenters also cited the need for permitting reform and streamlining, as permitting is a major factor in the lead time necessary to develop new mineral sources. It was also suggested that the desire to source from responsible vendors that support Environmental, Social, and Governance (ESG) goals could increase the cost of purchased minerals by encouraging use of higher-cost domestic supplies. It was also suggested that BEVs are not an efficient use of these limited resources, and the goals of the standards could be more effectively met with HEVs and PHEVs, which require less critical mineral content and impose less demand on infrastructure, reducing the level of risk associated with all of these issues.
For this final rule we considered the public comments carefully. We have provided detailed responses to comments relating to critical minerals, the supply chain, and mineral security in section 15 of the RTC. We also continued our ongoing consultation with industry and government agency sources (including the Department of Energy (DOE) and National Labs, the Department of State, the U.S. Geological Survey (USGS), and several analysis firms) to collect information on production capacity forecasts, price forecasts, global mineral markets, and related topics. Importantly, we also coordinated with DOE and NHTSA in their assessment of the outlook for supply chain development and critical mineral availability. The Department of Energy is well qualified for such research, as it routinely studies issues related to electric vehicles, development of the supply chain, and broad-scale issues relating to energy use and infrastructure, through its network of National Laboratories. DOE worked together with Argonne National Laboratory (ANL) beginning in 2022 to assess global critical minerals availability and North American battery components manufacturing, and coordinated with EPA to share the results of these analyses during much of 2023 and early 2024. In sections IV.C.7.i through IV.C.7.iv of this preamble, below, we review the main findings of this work, along with the additional information we have collected since the proposal. As in the proposal, we have considered the totality of information in the public record in reaching our conclusions regarding the influence of future manufacturing capacity, critical minerals, and mineral security on the feasibility of the final standards.
In EPA's view, many of the concerns stated by commenters about the supply chain, critical minerals, and mineral security were stated as part of a broader argument that the proposed standards were too stringent; that is, that the commenter believed that the standards should be weakened (or withdrawn entirely) because the supply chain or the availability of critical minerals could not support the amount of vehicle electrification that would result from the standards, or it would create a reliance on imported products that would threaten national security. As will be discussed in the following sections, our updated assessment of the evidence continues to support the conclusion that the standards are appropriate from the perspective of critical minerals availability, the battery supply chain, and mineral security. Further, given the economic and other factors that are contributing to continued development of a robust and secure supply chain, we find no persuasive evidence that the need to establish supply chains for critical minerals or components will adversely impact national security by creating a long-term dependence on imports of critical minerals or components from covered nations or associated suppliers. The current and projected availability of critical minerals and components from domestic production or trade with friendly countries, including countries with FTAs, countries participating in the Mineral Security Partnership (MSP),
Regarding the adequacy of the supply chain in supporting the standards, EPA notes that it is a misconception to assume that the U.S. must establish a fully independent domestic supply chain for critical minerals or other inputs to PEV production in order to contemplate standards that may result in increased manufacture of PEVs. The supply chain that supports production of consumer products, including ICE vehicles, is highly interconnected across the world, and it has long been the norm that global supply chains are involved in providing many of the products that are commonly available in the U.S. market and that are used on a daily basis. As with almost any other product, the relevant standard is not complete domestic self-sufficiency, but rather a diversified supply chain that includes not only domestic production where possible and appropriate but also includes trade with FTA countries and other economic allies with whom the U.S. has good trade relations. As discussed later and further illustrated in Figure 38 of section IV.C.7.ii of this preamble, bilateral and multilateral trade agreements and other arrangements (such as defense agreements and various development and investment partnerships), either long-standing or more recently established, already exist with many countries, which greatly expands opportunities to develop a secure supply chain that reaches well beyond the borders of U.S.
EPA also notes that no analysis of future outcomes with regard to the supply chain, critical minerals, or mineral security can be absolutely certain. In general, in establishing appropriateness of standards, the Clean Air Act does not require that EPA must prove that every potential uncertainty associated with compliance with the standards must be eliminated a priori. It is well-established in case law that “[i]n the absence of theoretical objections to the technology, the agency need only identify the major steps necessary for development of the device, and give plausible reasons for its belief that the industry will be able to solve those problems in the time remaining. Thus, EPA is not required to rebut all speculation that unspecified factors may hinder `real world' emission control.”
Accordingly, our analysis of the supply chain and critical minerals is oriented toward recognizing the steps that are needed to support the increased penetrations of PEVs we project in the compliance analysis, and showing that these needs are capable of being addressed in a manner consistent with meeting the standards during the time frame of the rule.
EPA has considered the public comments in total, and as described throughout these rulemaking documents, is finalizing standards that are less stringent than in the proposal, particularly in the early years of the program. In the public comments relating to supply chain, critical minerals, and mineral security, EPA finds no evidence that would lead it to conclude that a further reduction in the stringency of the standards is appropriate or necessary.
While commenters have presented information to further demonstrate the well-understood concept that currently operating supply capacity must grow in order to meet projected future demand, and have recited many of the uncertainties commonly associated with predicting this or any future response of supply to future demand, they have failed to provide specific evidence to support the implication that the demand resulting from the standards will not or cannot be met by industry in the time available. Commenters question whether market forces and government initiatives and incentives that are already underway will lead to sufficient supply to meet the standards, but do not show specifically why these activities should reasonably be expected to fail. Indeed, EPA has shown that the industry is working actively and effectively to increase supply and secure supply chains for needed materials; that government incentives and initiatives have been defined and are moving forward with intended effect; and that current price forecasts and investment outlooks for the time frame of the rule do not suggest that industry at large foresees a looming inability to meet the proposed standards, especially given that they have been publicly known for nearly a year and were more stringent than the final standards.
Although commenters imply that current circumstances or future unknowns amount to a constraint that will prevent industry from meeting the standards or would cause harm by doing so, they have not identified any specific alleged constraint or set of constraints with sufficient specificity that it would lead EPA to reasonably conclude that a reduction in stringency is necessary to address their concerns. Nor have commenters detailed and quantified any such constraint sufficiently that it could be translated into any specific degree of stringency reduction that commenters believe would address their concerns.
The presence of uncertainty is a common element in any forward-looking analysis, and is typically approached as a matter of risk assessment, including sensitivity analysis conducted around costs, compliance paths, or other key factors. Taken as a whole, our examination of the status and outlook for development of the supply chain, combined with the
Section IV.C.7.i of the preamble provides a general review of how we considered supply chain and manufacturing considerations in this analysis, the sources we considered, and how we used this information in the analysis. Section IV.C.7.ii examines the issues surrounding availability of critical mineral inputs. Section IV.C.7.iii provides a high-level discussion of the security implications of increased demand for critical minerals and other materials used to manufacture electrified vehicles. Section IV.C.7.iv describes the role of battery and mineral recycling. Additional details on these aspects of the analysis may be found in RIA Chapter 3.1, including 3.1.5 where we describe how we used this information to develop modeling constraints on PEV penetration for the compliance analysis.
Major steps in manufacturing a PEV battery pack include manufacturing of battery cells and assembly of cells into modules that can be assembled into a battery pack. Inputs to cell manufacturing include electrode active materials (EAM), such as cathode and anode powders, as well as specialized products such as electrolytes, separators, binders, and similar materials. Depending on the level of vertical integration, a plant making cells might produce some of these inputs in-house or purchase them from a supplier. While other battery chemistries exist or are under development, this section focuses on supply chains for lithium-ion batteries given their wide use and likely predominance during the time frame of the rule.
In the proposal, we examined the outlook for U.S. and global battery manufacturing capacity for automotive lithium-ion batteries and compared it to our projection of U.S. battery demand under the proposed standards. We collected and reviewed a number of independent studies and forecasts, including numerous studies by analyst firms and various stakeholders, as well as a study of announced North American cell and battery manufacturing facilities compiled by Argonne National Laboratory. Our review of these studies included consideration of uncertainties of the sort that are common to any forward-looking analysis but did not identify any hard constraint that indicated that global or domestic battery manufacturing capacity would be insufficient to support battery demand under the proposed standards. The review indicated that the industry was already showing a rapidly growing and robust response to meet current and anticipated demand, that this activity was widely expected to continue, and that the level of North American manufacturing capacity that had been announced to date would be sufficient to meet the demand projected under the proposed standards. We assessed that battery manufacturing capacity was not likely to pose a limitation on the ability of auto manufacturers to meet the standards as proposed.
We received a variety of comments, some of which disagreed with our assessment and others which supported it. Among those that disagreed, some primary themes included: that we looked only at light-duty battery demand and not at other transportation or product sectors that use lithium-ion batteries, such as heavy-duty vehicles, stationary storage, and portable devices; that the projections of North American manufacturing capacity did not include sufficient ramp-up time; and that we should consider active material manufacturing in addition to cell manufacturing. The Alliance for Automotive Innovation included in its comments a BMI forecast that indicated a somewhat lower battery manufacturing capacity than that documented by ANL.
EPA appreciates and has carefully considered the substantive and detailed comments offered by the commenters. The additional information EPA has collected since the proposal, through these public comments and our continued research, informs many of the points raised by the commenters. Taken together, EPA does not find evidence that would change our previous assessment in the proposal that the outlook for U.S. battery production indicates that it is likely to be sufficient to support the standards.
One important factor in our assessment is a study of North American battery and cell manufacturing capacity performed by ANL, which updates an earlier version of the study that we cited in the proposal.
Some public commenters stated that we should include consideration of active material manufacturing. In response, EPA notes that the outlook for global cathode active material manufacturing capacity was considered in the proposal; later in this section we consider additional information regarding manufacturing for electrode active materials and other cell components.
In addition, our updated compliance analysis projects a substantially lower demand for battery production than in the proposal. This is largely due to the effect of our higher battery cost inputs, which reduce the penetration of BEVs, the inclusion of PHEVs which use smaller batteries than BEVs, and updated BEV efficiency inputs. After including all of these updates, projected North American automotive battery production capacity continues to surpass projected demand (see the later discussion at Figure 36). Even if a shortfall were to occur, our higher battery cost sensitivity accounts for higher battery costs that might result, and as previously noted, alternative compliance pathways that place less demand on battery production would continue to exist.
Since the proposal, we have not found evidence to change our observation that U.S. PEV production to date has not been particularly reliant on foreign manufacture of batteries and cells, nor that increased PEV penetration must imply such a reliance. In the proposal we noted that about 57 percent of cells and 84 percent of assembled packs sold in the U.S. from 2010 to 2021 were manufactured in the U.S.
We also continue to see evidence that global lithium-ion battery and cell production is growing rapidly and is likely to keep pace with increasing global demand. In the proposal we noted a 2021 report from Argonne National Laboratory (ANL)
Since the proposal, we have not seen evidence that the general conclusion conveyed by Figure 32 has changed. More recent projections have become available that indicate that projections of future capacity have grown dramatically in only a short time. For example, in May 2023 the International Energy Agency (IEA) projected a global capacity of 3.97 TWh in 2025,
As described in section I.A.2 of this preamble, manufacturers are continuing to project high levels of electrification in their future fleets and are continuing to make very large investments toward making this possible, by increasing manufacturing capacity and securing sources and suppliers for critical minerals, materials, and components. Although some manufacturers, such as Toyota and Stellantis, have most recently signaled a potential interest in including a significant percentage of HEVs and PHEVs in their fleets, this remains consistent with our modeling as it represents a potential compliance path that may be attractive to manufacturers with substantial expertise or customer base that supports these products. Indeed, as we show below, manufacturers' choosing to produce more HEVs and PHEVs would decrease the need for batteries, battery components, and critical minerals, providing even further support for our conclusion that related supply issues are unlikely to constrain compliance with the final rule.
One analysis we cited in the proposal indicated that 37 of the world's automakers are planning to invest a total of almost $1.2 trillion by 2030 toward electrification,
Since the proposal, ongoing work conducted by ANL examines the most recent developments in the growth of the supply chain and confirms continuation of this trend. As noted previously, ANL has continued tracking investments in battery and electric vehicle manufacturing to estimate growth of battery production in North America, based on press releases, financial disclosures, and news articles.
The majority of the battery investments are for lithium-ion batteries, linked to the development and deployment of electric vehicles. Historically, many of these investments have been in traditional auto manufacturing locations in eastern North America, with many found in a band from Ontario through Michigan and other Great Lakes states, and then to newer vehicle assembly plants in the south, especially in Alabama, Tennessee, and South Carolina. The most prominent battery cell manufacturing investments have roughly followed this pattern.
We also noted in the proposal that the Department of Energy had in 2021 accounted for at least 13 new battery plants, most of which will include cell manufacturing, that were expected to become operational in the U.S. in the next few years.
As noted in the proposal, manufacturers continue to approach construction of new battery manufacturing plants as part of joint ventures with established cell suppliers, by which the OEM may secure a supply of cells, modules, or battery packs for its products and develop a chain of supply that will support their production needs.
Overall, these investments are part of a pattern of rapidly increasing investment over the last three years that continues today. Figure 33 shows that cumulative announcements of investments in the battery supply chain have increased by a factor of six from about $25 billion three years ago to about $156 billion today.
Even as these investment trends have continued, in the second half of 2023 some automakers announced changes to previously announced battery production plans. For example, in mid-2023, Ford paused construction of their recently announced battery plant in Marshall, Michigan
The updated ANL analysis accounts not only for new announcements since the proposal, but also for recent reductions in scope, such as the reduction of the Ford plant's announced capacity. As seen in Figure 34, ANL indicates that overall projections for North American battery production capacity by 2030 have increased by a factor of about 10 over the last three years. The vertical axis shows the estimated North American production capacity for 2030, and the horizontal axis shows the date of company announcements. Expected capacity for 2030 increased from 300 GWh/year in December 2021 to 800 GWh/year by December 2022, and now stands at more than 1,300 GWh/year.
As shown in Figure 35, this updated study illustrates the rapid recent growth in new plant announcements. Light-duty vehicle applications are the largest portion of announced and operating plants. These production estimates are based on new plant announcements and construction and include an estimate of time between announcement and initial production based on historical data, as described previously.
Looking at cells dedicated specifically to light-duty vehicles, Figure 36 shows that in all years of the rule from 2027 to 2032, North American light-duty vehicle cell manufacturing is expected to be meet demand under all compliance scenarios EPA modeled.
The annual battery production required for the compliant fleet generated by OMEGA under our central case is 671 GWh in 2030, far less than the projected operating North American light-duty vehicle battery production capacity of 935 GWh projected for the same year in Figure 36 above. Demand reaches a maximum of 839 GWh in 2032, still less than projected capacity. These amounts compare to a maximum of about 540 GWh under the No Action case. Pathway B is a pathway with moderate penetration of HEVs and PHEVs (collectively called P/HEVs) in place of BEVs. Pathway C is a pathway in which no new BEV models are introduced beyond the No Action case, in which ICE, HEV and PHEV are more prevalent. Pathway C results in the lowest peak battery demand of 612 GWh in 2032. These latter cases show that compliance with the standards would continue to be possible even if critical mineral availability or manufacturing capacity were more constrained than current projections indicate.
Moving beyond battery and cell manufacturing, we now consider the outlook for North American manufacturing of electrode active materials and other cell components. Active materials include cathode and anode powders and electrolyte, for which critical minerals and precursor chemicals are important manufacturing inputs. Cell components include specialty products such as aluminum and copper current collector foils, electrode separators, and solvents and binders. In order to meet their projected operating capacities, the North American battery plants represented in Figure 36 above will either manufacture these materials on site or at another location, or purchase them from a supplier, or a combination of the two.
Significant production of many of these items is occurring in the U.S. For example, several large suppliers of batteries and cells, as well as major OEMs, are increasingly taking steps to secure domestically sourced raw minerals, active materials and cell components to supply their battery and cell manufacturing plants. Auto manufacturers are also moving to secure supplies of these items to support their production needs and partnerships. For example, Ford has moved to secure sources of raw materials for its battery needs;
In the 2024 ANL study of battery manufacturing,
Unlike with battery cell manufacturing, ANL found that a gap currently exists between anticipated future domestic demand and currently operating and announced future U.S. manufacturing capacity for many of the constituent materials and cell
Again, as stated previously, the relevant standard is not complete domestic self-sufficiency but rather a diversified supply chain that includes not only domestic production where possible and appropriate but also includes trade with FTA countries as well as our many other economic allies with whom the U.S. has good trade relations. While it is likely that some of domestic demand for the battery components listed above will be satisfied through imports, allies and partners outside of North America are likely to be key suppliers.
ANL observes that manufacturing announcements for battery components often significantly lag those for battery cell manufacturing, and without growth in battery cell manufacturing creating demand for their products in the U.S., battery component manufacturers would have little reason to increase their manufacturing capacity in North America. Indeed, with any product, the mere identification of a gap between projected supply and projected demand does not by itself constitute a future shortage, and often represents the very signal that motivates new supply to be developed or expanded.
ANL also notes that past history suggests that the market often rapidly adapts in response to demand and industrial policies.
Further, domestic production for any of these materials and components could be significantly underestimated to the degree that any of the announced cell production facilities discussed previously are also planning to manufacture these components onsite. Announcements of cell manufacturing plants typically lack sufficient detail to determine the degree of vertical integration that might be planned, and these details often are not separately announced. EPA also notes that the overall scale of investment in cell and component manufacturing capacity across the industry suggests that the industry at large has confidence in being able to secure sufficient supplies of materials and components to operate these plants in a manner that returns their investment.
Importantly, as noted above, allies and partners outside of North America are likely to be integral to meeting domestic battery component demand. Some of the world leaders in production of cell materials and components are close allies of the U.S. and are likely to have a prominent role in filling the gap, as they do today. For example, Japan and South Korea are the second and third largest producers of electrode active materials,
For these and similar reasons EPA does not consider the apparent gap between projected domestic demand and projected North American supply of cells, components, and material inputs identified by ANL to be indicative of a constraint that would prevent announced U.S. battery cell manufacturing from operating as planned, with a combination of domestically produced materials and components and those acquired through trade with economic allies.
To the extent that content is imported from partner nations, it is important to note that this carries significance primarily for qualification of a vehicle for the IRC 30D clean vehicle credit or for concerns about U.S. reliance on imports, and does not constrain U.S. cell production for U.S. PEVs per se. The presence of imported content does not exclude any PEV from being sold in the U.S. market, nor does it prevent access to the similarly significant 45X cell and module production credit to manufacturers.
We now consider the outlook for global production of cell materials and components.
In the figure, the labels T1 and T2 represent supplies that BMI considers as having a track record of supplying these materials outside of China and within China, respectively. The label T3 represents supplies that BMI assessed as not having an established track record of production, and thus represent earlier stage efforts, such as for example, new entrants to the market that intend to supply anticipated demand but which may not have established offtake agreements.
To the degree that the Li-Bridge assessment of global demand begins to enter T3 supply in 2029, the same observation cited above applies, regarding the shorter notice typically provided by announcements that react to demonstration of demand. That is, in the period between now and 2029 it is likely that increases in demand will motivate increases in supply that would not be announced until much closer to 2029. The ability of production capacity for many cell materials and components to adjust relatively quickly to changes in anticipated demand suggests that these materials do not represent a constraint to PEV production in the global context any more than in the domestic context. Also, new cell component or active material plants tend to have shorter construction and permitting time than cell manufacturing plants.
As another factor promoting domestic capacity, the IRA offers sizeable incentives and other support for further development of domestic and North American manufacture of electrified vehicles and components. These incentives represent a significant dollar investment. At the time of passage of the IRA, the Joint Committee on Taxation estimated that $30.6 billion would be realized by manufacturers through the 45X Advanced Manufacturing Production Credit alone.
In addition, funds continue to be awarded under the BIL, which provides for $7.9 billion to support development of the domestic supply chain for battery manufacturing, recycling, and critical minerals.
Further, the DOE Loan Programs Office continues to disburse substantial amounts of assistance through the Advanced Technology Vehicles Manufacturing (ATVM) Loan Program and Title 17 Innovative Energy Loan Guarantee Program, which include midstream activities such as manufacturing of active materials, battery components and cells among their focus.
Analyst sentiment largely agrees that the U.S. is taking the appropriate steps to secure its supply chain. According to BNEF, Canada and the United States rank first and third, respectively, in their Global Lithium-Ion Battery Supply Chain Ranking. This annual ranking rates 30 countries on their relative “potential to build a secure, reliable, and sustainable lithium-ion battery supply chain”. BNEF credits “clear policy commitment and implementation” for North America's high position, including the effect of the IRA.
In consideration of this updated information on battery cell and cell component manufacturing, EPA has continued to identify the steps necessary to secure the supply of battery cells and cell materials and components needed to comply with the standards. EPA also notes rapidly growing evidence that the federal investments and initiatives under the IRA and BIL are continuing to build the domestic supply chain as intended, and indicate that the federal government is taking appropriate actions to support its development. It continues to be our assessment that the development of this supply chain is proceeding in a manner capable of supporting the future levels of PEV technology indicated in the scenarios of the compliance analysis, and is therefore unlikely to constrain manufacturers' ability to comply.
Critical minerals include a large diversity of minerals and metals that are deemed to be essential to economic or national security of the U.S. and whose supply chain is potentially vulnerable to disruption.
As discussed in the opening paragraphs of section IV.C.7 of the preamble, certain critical minerals have long been essential to manufacturing both ICE vehicles and PEVs. Emission control catalysts for ICE vehicles utilize critical minerals including cerium, palladium, platinum, and rhodium, which (as described previously) were understood to be costly and potentially scarce in advance of emission control standards of the 1970s that were premised on use of those minerals for catalyst control of pollutants. These minerals are also required by PHEVs due to the presence of the ICE. Nickel-metal hydride batteries that have been used in many HEVs for over twenty years require significant amounts of nickel and rare-earth metals such as lanthanum. Critical minerals most important to lithium-ion battery production include lithium and graphite, and the cathode chemistries that are used in the majority of cells produced today also call for nickel, cobalt, and manganese. Aluminum is also used for cathode foils and in some cathode chemistries. Rare-earth metals are used in permanent-magnet electric machines, and include several elements such as dysprosium, neodymium, and samarium.
The battery cell manufacturing capacity discussed in the previous section will depend on the ability of manufacturers to secure the inputs necessary for battery components, which include battery minerals. This is one of the reasons why extraction, processing, and recycling of critical minerals such as lithium, cobalt, nickel, manganese, and graphite are gaining a large amount of attention as important parts of the supply chain. They are produced in upstream activities which include extraction and refining of raw materials and are inputs to midstream activities such as manufacturing of precursor substances and electrode active materials and production of electrolytes.
In addition to growing demand from the transportation industry, these minerals are also experiencing increasing demand across many other sectors of the global economy as the world seeks to reduce carbon emissions. As with any technology that is experiencing rapid demand growth, a robust supply chain to support increasing production of these products is continuing to develop. At the present time in the U.S., some of these minerals are not produced domestically in large quantities and are often sourced to varying degrees from global suppliers with whom manufacturers have developed supply relationships.
Here it is important to reiterate that it is erroneous to assume that the U.S. must establish a fully independent domestic supply chain in order to contemplate increased manufacture of products that use these minerals. Such a position is without any credible analogy in other products, including ICE vehicles, that are used widely in the U.S. on a daily basis. As discussed previously, it has long been the norm that global supply chains are involved in providing many products that are commonly available in the U.S. market. In the context of critical minerals needed for PEV production, the relevant concern is to develop and secure a supply chain that includes not only domestic production where possible and appropriate but also includes sourcing from FTA countries as well as our many economic allies with whom the U.S. has good trade relations.
In the proposal, we examined the outlook for U.S. and global critical mineral supply and demand in light of our projections of U.S. PEV demand under the proposed standards. We collected and reviewed a number of independent studies and forecasts, including numerous studies by analyst firms and various stakeholders. We also considered a compilation of lithium mining projects compiled by the Department of Energy and Argonne National Laboratory. Through this work it was our assessment that, among the critical minerals that were most likely to pose a potential constraint on PEV production, lithium availability was the most important consideration. We proceeded to examine detailed forecasts of supply and demand for lithium chemical products used in battery cell production, and reports of rapidly growing activity in securing sourcing agreements and lithium resource exploration in the U.S. Our review of this information indicated that the industry was responding rapidly to meet current and anticipated demand, and that this activity was likely to continue. Our analysis examined many uncertainties of the sort that are common to any forward-looking analysis but did not identify any hard constraint that indicated that global and domestic lithium supply would not be sufficient to support battery demand under the proposed standards. Our assessment found that availability of lithium chemical product was not likely to pose a limitation on the ability of auto manufacturers to meet the standards.
We received a variety of comments on our analysis of critical minerals, some of which disagreed with our findings and others which supported them. Supportive comments often included detailed analysis and discussion that built upon EPA's analysis by providing additional examples of domestic and global activity in critical mineral development, examples of how the BIL and IRA have been promoting this activity, and other information about the outlook for critical mineral supply and demand. Commenters who disagreed with our findings largely expressed the position that EPA did not adequately address the issue of critical minerals, particularly for minerals other than lithium such as nickel, cobalt, and graphite, that we had not adequately considered the risks associated with potential instability of the global critical minerals market, and that the pace of domestic critical mineral development and/or domestic mineral processing would be insufficient to meet demand under the proposed standards.
EPA appreciates and has carefully considered the substantive and detailed comments offered by the various commenters. Much of the information provided by commenters who disagreed with our findings expands upon the evidence that EPA already presented in the proposal concerning the risks and uncertainties associated with the development of the critical mineral supply chain. Much of the information provided by supportive commenters also expands on the evidence EPA presented in the proposal about the pace of activity and overall outlook for buildout of the critical mineral supply chain. While contributing to the record, the information provided by the commenters largely parallels the considerations and trends that were already identified and considered by EPA. In particular, the comments relating to risk and uncertainty largely present information of a similar nature to that which EPA identified and considered in the proposal, and do not identify new, specific constraints that would change the conclusions we reached in the proposal. Taken together,
The additional information EPA has collected, and other aspects of the updated analysis, largely respond to the concerns raised by the commenters. In particular, the Department of Energy through ANL has conducted an updated assessment
The study collects and examines potential domestic sources as well as sources outside the U.S., including Free Trade Agreement (FTA) partners, members of the Mineral Security Partnership (MSP), economic allies without FTAs (referred to as “Non-FTA countries” in the ANL study), and FEOC sources associated with covered nations. The study also highlights current activities that are intended to expand a secure supply chain for critical minerals both domestically and among U.S. allies and partner nations, and considers the potential to meet U.S. demand with domestic and other secure sources. EPA considers the assessment by DOE/ANL to be thorough and up to date.
In response to comments that we should consider availability of critical minerals other than lithium, we have included in this section additional analysis and discussion of graphite, cobalt, nickel, and lithium based on ANL's assessment.
As is already true for many of the materials used to produce ICE vehicles, the ANL analysis confirms that imports will be needed to supplement domestic supplies for many of the key minerals used in PEV production. However, there is ample evidence to indicate that the U.S. is fully capable of securing these minerals in the time frame needed for this rulemaking without harm to economic or national security. The ANL analysis shows that many of the minerals needed to support worldwide decarbonization goals are abundant outside of China and other covered nations, and those needed by the U.S. to meet the final standards can ultimately be supplied in the time frame needed for this rulemaking by relying primarily if not exclusively on a combination of domestic sources and sources accessed through FTA partners, MSP partners, and other economic allies. Hence the ensuing discussion, and in general the issue of future adequacy of the supply chain for critical minerals and PEV production to support the standards, is focused on the outlook for securing a mineral supply chain that includes domestic supply as well as supply accessible through our global trading partners.
In contrast to the concerns stated by some commenters, the evidence does not indicate that the status of mineral availability to comply with the standards is dire, nor that the U.S. must rely heavily in the long-term on covered nations or FEOCs. Rather, the U.S. and U.S. firms can secure sufficient minerals by executing strategies that have already been identified and are underway. While completing the development of a secure supply chain will require a deliberate effort between the U.S., allies, and partner countries, the work is already underway and is being further supported by strong government initiatives. The U.S. automotive industry is already engaging actively and successfully in efforts to secure these sources for their own production needs (motivated in part by IRA incentives that promote U.S. battery and battery component production, North American final assembly, and U.S./FTA mineral sourcing), and the U.S. government is also engaged in numerous activities that are further enabling U.S. industry to expand a secure supply chain for critical minerals among U.S. allies and partner nations. These include substantial efforts to scale mining supply domestically and in partner countries, strong financial support and technical guidance supporting investment in U.S. production facilities and technology research and development, building international partnerships that directly act to establish and secure mineral trade with friendly nations, and scaling battery recycling.
To illustrate the diversity of America's trade allies, and the many ways in which the U.S. already has or is actively developing relationships relevant to securing battery minerals and materials through these partners, Argonne National Laboratory has compiled an accounting of international initiatives (Figure 38). This figure identifies 85 countries that together comprise our FTA partners, MSP partners, Trade and Investment Framework Agreement partners, and parties to other bilateral investment treaties, multilateral initiatives or defense agreements.
ANL concludes that a diversified sourcing strategy that includes these international sources coupled with strategic investments at home and abroad represent a viable pathway to sustainable and secure critical mineral supplies for the U.S. This strategy includes the formation of “economic partnerships and trade with non-FTA countries that have significant capacity; strengthening processing, refining, and recycling in the U.S. and allied nations; and fostering collaborative efforts with FTA and MSP partners to ensure the success of mining projects.”
Internationally, the U.S. industry and federal government are actively working to facilitate the securing of minerals. These efforts include diversification of sourcing strategies by strengthening currently existing trade agreements and building new economic, technology, and regional security alliances. IRA incentives are also key to promoting onshoring and friendshoring of production. Manufacturers within the U.S. and globally are already beginning to alter their trading patterns in response, with U.S. manufacturers beginning to substitute supplies formerly obtained from FEOC sources with those from domestic sources or from FTA countries and other economic allies. Moves such as these are likely to reduce the potential for volatility in international supply chains. The U.S. government is facilitating this substitution through a range of initiatives that directly and indirectly enhance the resilience of the domestic battery components industry while also supporting that of its partners and allies.
We now examine the outlook for U.S. battery cell and electrode active material manufacturers to access sufficient critical minerals from domestic sources and global trade partners and allies.
As seen in Figure 39, ANL assessed potential upstream mined mineral supply based on the location of mine production.
The white horizontal line and the “+” represent low and high domestic demand scenarios, respectively. While ANL could not specifically assess domestic demand under the final standards (which were not yet public at the time of the study), ANL's description of BEV penetrations in each scenario indicates that the final standards would align closely to the “ANL-Low” scenario,
These results indicate that from 2025 to 2035, the currently identified capacity for lithium and nickel in the U.S. and FTA and MSP countries is significantly greater than U.S. demand under both the low and high domestic demand scenarios, and greater for cobalt under at least the low scenario. In particular, the U.S. is poised to become a key global producer of lithium, and supplemented by supply from FTA countries, the U.S. is positioned well for lithium through 2035. Of course, U.S. demand will be in competition with the demand for minerals created by other countries' decarbonization goals, particularly those outside of China. As a practical matter, this means that some portion of U.S. demand for these minerals might be secured to some degree from sources in partner countries that are not currently free trade partners or MSP members (but also are not covered nations or FEOCs). As previously shown in Figure 38, many of these non-FTA, non-MSP countries are economic allies that share other cooperative relationships or partnerships with the U.S. FTA, MSP, and the latter group of countries possess significant reserves. For example, an accounting of known mineral reserves in democratic countries across the world indicates that they surpass projected global needs through 2030 for the five minerals assessed by ANL, under a demand scenario that limits global temperature rise to 1.5 °C.
Figure 39 suggests that, among the minerals profiled, graphite is most exposed to potential need for supply from non-FTA, non-MSP countries. However, alternatives to imported graphite exist and are poised to become increasingly important during the time frame of the rule. ANL notes that synthetic graphite is already being produced and that scaling domestic synthetic graphite production holds significant promise for closing the gap. Unlike natural graphite, synthetic graphite does not depend on the existence of natural mineral deposits nor does it require the long permitting and approval time associated with mine development. Synthetic graphite can be manufactured from organic materials
In addition to these trends, supply sources of natural graphite are expected to become more diverse over time with new planned capacity in FTA countries (Canada and Australia) and in other economic allies (Tanzania and Mozambique), and others supported by the MSP.
The DOE grant to Novonix is just one example of how the DOE's Office of Manufacturing and Energy Supply Chains (MESC) program, enabled by the BIL, is targeting key elements of the U.S. battery supply chain for accelerated development. As previously described in section IV.C.7.i, the BIL provides for $7.9 billion to support development of the domestic supply chain for battery manufacturing, recycling, and critical minerals.
EPA notes that the categorization of mineral origins in Figure 39 refers to mine location and not where the extracted material is processed into inputs to cell manufacturing such as precursors or electrode powders. As noted in the study, a large portion of processing capacity for mined battery minerals is located in China. However, unlike mining of mineral resources, refining and processing can take place in any country where capacity is built. Just as with other elements of the supply chain, mineral processing is also receiving attention from the domestic battery industry and the federal government. For example, mineral processing facilities are eligible for the Qualifying Advanced Energy Project Credit (48C), and are among the projects in a first round of $4 billion in tax credits that have been announced.
In addition to EPA's assessment of the supply chain for critical minerals, several specific aspects of our updated compliance analysis act to address commenters' concerns about supply chain risk and uncertainty. Our updated central case projects a substantially lower demand for battery production than in the proposal, which would reduce resultant demand for critical minerals compared to the proposal. We
Regarding U.S. automaker access to critical minerals, EPA notes that U.S. automakers are actively addressing their need to secure a supply of critical minerals. In addition to continuing to reduce cobalt and rare earth magnet content in batteries and electric machines, manufacturers are also directly securing supplies of critical battery and rare-earth minerals necessary for increasing the scale of BEV production, often with a focus on U.S. sources.
As demand for these materials increases, we expect that mining and processing capacity across the world will continue to expand. Globally and in the U.S., interest and motivation toward developing new resources and expanding existing ones has become very high and is expected to remain so, as the demand outlook for lithium and other battery minerals continues to be robust. In the U.S. specifically, the process of establishing new mining capacity can be subject to greater uncertainty stemming from issues such as permitting; investor expectations of demand and future prices also make it difficult to predict with precision the rate at which new mines will be developed and brought online. For example, new lithium mining sources are sometimes described as taking from five to ten years or longer to develop. Comments from Toyota, for example, cite “exploration and feasibility studies, approval and permitting processes, potential for project abandonment and delays, learning rates for new companies, and production ramp up” as primary factors. These factors are well known in the industry and are typically considered by industry analysts when assessing production potential in future years, by assigning a percentage of potential production to each project based on their knowledge of the specific circumstances of each, including the level of development that has already taken place. Potential expansion of production at already-operating projects or resumption of halted or mothballed projects are typically weighted higher than entirely new operations. The 2024 ANL critical minerals analysis has identified numerous examples of mining development efforts in the U.S. that are currently in various stages of development, and has projected significant output in the future, particularly for lithium.
Additionally, the U.S. government is taking steps to promote the production of critical minerals through both mining and recycling. This includes developing recommendations for improving the process of mining on public lands including modernization of the U.S. Mining Law of 1872,
Complementing select mining investments through the Defense Production Act (DPA), midstream and downstream investments are expected to incentivize upstream operations. Companies are competing to secure materials to feed domestic mid-stream operations, such as processing, cathode, and anode production. As of January 2024, more than 600 facilities across the battery supply chain, including 79
The federal government is also taking many other steps to assist with domestic critical mineral development. For example, the U.S. Geological Survey (USGS) is leading numerous projects under the Earth Mapping Resources Initiative (Earth MRI) to improve mapping and exploration of domestic resources, including already-announced or in-progress projects in Alabama, Florida, New York, Montana, Kentucky, Tennessee, Georgia, and across the U.S. including projects focused on Arizona and Nevada.
With regard to lithium, rapid growth in demand has driven new development of global resources and robust growth in supply, which is likely a factor in recently observed reductions in lithium price.
In the proposal we cited expectations that the price of lithium and other critical minerals was likely to stabilize in the mid-2020s,
EPA considers this projected stability and moderate projected trends in pricing as further evidence of future mineral availability and a “healthy” mineral market. That is, the market has been anticipating large increases in mineral and active material demand during the time frame of the forecasts (2023-2028 and 2023-2032), and has also been aware of EPA's projected PEV penetrations through 2032 as published in the proposed rule in April 2023. These demand drivers have had significant time to be “priced in” by the market and nonetheless have not resulted in dramatically higher price expectations, which continue to be characterized by moderate upward trends in some minerals and little effect in others, suggesting that an irreconcilable shortfall is not anticipated. This suggests that like EPA, the industry at large has not identified hard constraints on the ability of the supply chain to react to growing demand without causing critical shortages.
Some analysts as well as public commenters have pointed out that lower mineral prices, if they remain low enough for long enough, may begin to discourage continued investments in new supply. For example, in describing the growth rate of lithium production, IEA also stated that the “recent decline in lithium prices could pose challenges to junior miners and early-stage projects.” Others have remained positive; for example, strong profit margins have often remained afterward,
Some commenters cited specific examples of mines that had received permitting and investment but which were later put on hold, or had production reduced or stopped, due to declining mineral prices. However, EPA notes that these operations can be restarted more quickly in the event of higher prices than new mining operations or new factories. Mineral analysis firms (
Regarding global lithium production, we have also supplemented our lithium analysis from the proposal with newly available research and information. The outlook for lithium production has evolved rapidly, with new projects regularly identified and contributing to higher projections of resource availability and production.
Benchmark Minerals Intelligence (BMI) conducted a comprehensive analysis of global and domestic lithium supply and demand in June 2023
EPA notes that BMI based its estimate of U.S. demand on PEV penetrations under the proposed standards, which projected higher PEV penetrations than in the final standards. This means that the top segment of each bar would be shorter under the final standards, making the depicted results more conservative.
EPA also notes that although BMI states that it is aware of 330 lithium mining projects ranging from announced projects to fully operating projects and stages in between, the supply projections shown here are limited to only 153 projects that are already in production or have publicly identified production estimates as of December 2022 (more than one year ago). Excluded from both the weighted and unweighted supply projections are 177 projects for which no information on likely production level was available. It is standard practice to weight projects that have production estimates according to their stage of development, and BMI has followed this practice with the 153 projects. However, complete exclusion of the potential production of 177 projects (more than half of the total) suggests that the projections shown may be extremely conservative. If even a very conservative estimate of ultimate production from these 177 projects by 2030 were to be added to the chart, projected supply would increase and perhaps meet or surpass demand. At this time of rising mineral demand coupled with active private investment and U.S. government activities to promote mineral resource development, exclusion of potential production from these resources is not likely to reflect their future contribution to U.S. supply.
In Figure 41 we show projections performed by ANL in February 2024 for U.S. lithium supply and demand alone.
In mid-2023, some analysts began speaking of the possibility of a future tightness in global lithium supply. Opinions varied, however, about its potential development and timing, with the most bearish opinions suggesting as early as 2025 with others suggesting 2028 or 2030.
We also continue to note developments indicating that the lithium supply continues to respond robustly to demand. Since the proposal, in which we described ongoing work by DOE to characterize lithium mining developments in the U.S.,
DOE's lithium resource assessment work has continued via the February 2024 ANL critical minerals study.
As shown in Figure 42, ANL anticipates that projects such as these will increase U.S. lithium production by almost an order of magnitude from about 50,000 metric tons of lithium carbonate equivalent in 2025 to over 450,000 metric tons by 2030.
We also note that the example provided by the critical mineral content requirements for $3,750 of the 30D Clean Vehicle Credit has spurred other countries to consider action that would further expand global lithium supply. For example, the European Union is seeking to promote rapid development of Europe's battery supply chains by considering targeted measures such as accelerating permitting processes and encouraging private investment. To these ends the European Parliament proposed a Critical Raw Materials Act on March 16, 2023, which includes these and other measures to encourage the development of new supplies of critical minerals not currently
We also note, as in the proposal, that supply and demand of some critical minerals is subject to the potential substitution of some minerals for others. We noted as an example that some PEV battery applications already employ a lithium-iron phosphate (LFP) cathode which does not require cobalt, nickel, or manganese. Since the proposal, we continue to see evidence that LFP batteries are increasingly specified for PEV use. Globally, LFP already has about 30 percent market share in PEV applications.
Similarly, we continue to assess that rare earth metals used in permanent-magnet electric machines have alternatives in the form of ferrite or other advanced magnets, or the use of induction machines or advanced externally excited motors, which do not use permanent magnets. EPA does not anticipate shortages or high prices in rare earth metals that would prevent compliance with the standards, as indicated by evidence of a gradually increasing but apparently stable price outlook for rare earths used in magnets, and a generally declining outlook for other rare earths, during the time frame of the rule.
In RIA Chapter 3.1.5, we describe our reasoning behind the selection of lithium supply as the primary mineral-based limiting factor in constraining the potential rate of PEV penetration for modeling purposes. In addition, with respect to other cathode and anode minerals, we note that there is some flexibility in choice of these minerals, as in many cases, opportunity will exist to reduce cobalt and manganese content or to substitute with iron-phosphate chemistries that do not utilize nickel, cobalt or manganese, or use other forms of carbon in the anode, or in conjunction with silicon. However, all chemistries currently used in PEV batteries require lithium in the electrolyte and the cathode, and these have no viable substitute that is expected to be commercially available in the near term.
Finally, EPA notes that manganese is listed as being “not critical” by a 2023 DOE Critical Minerals Assessment in both the near and medium terms, due both to a lack of supply risk and overall level of importance to clean energy technologies.
Taken together these outlooks support the perspective that critical minerals are not likely to encounter a critical shortage as supply responds to meet growing demand. It continues to be EPA's assessment that future availability of critical minerals will not pose a constraint on automakers' ability to meet the standards.
For additional details on the mineral supply outlook for the time frame of this rule, see Chapter 3.1.4 of the RIA.
Mineral security refers to the ability for the U.S. to meet its needs for critical minerals, and the potential economic or national security risks posed by their sourcing.
In the context of vehicle manufacturing, concern for U.S. mineral security relates to the global distribution of established supply chains for critical minerals that are important to vehicle production, and the fact that, at present, not all domestic demand for these materials is satisfied through domestic sources or from secure sources such as FTA countries, MSP countries or other economic allies.
Currently, despite a wide distribution of mineral resources globally, mineral production is not evenly distributed across the world. At present, production is concentrated in a relatively small number of countries due to several factors, including where the resources are found in nature, the level of investment that has occurred to develop the resources, economic factors such as infrastructure, and the presence or absence of government policy relating to their production. For example, investment in mineral refinement and processing has received strong emphasis in China, while Japan and South Korea have become leaders in cell and cell component manufacturing, and countries with abundant mineral resources have become leading producers, for example Indonesia for nickel, Australia for lithium, and Democratic Republic of Congo for cobalt.
While the U.S. is not currently a leading producer of minerals used in PEV production, substantial investment has already gone towards and continues to be deployed toward expanding domestic mineral supply and building a more secure supply chain among FTA partners, MSP partners, and economic allies.
To examine U.S. mineral security in the context of the rule, first it is important to understand how mineral security compares to the similar but distinct topic of energy security. As EPA defines them, energy security relates primarily to the securing of energy sources, while mineral security relates to mineral sources that are not a source of energy. Supply disruptions and fluctuating prices are relevant to critical minerals as well as to energy markets, but the impacts of such disruptions to the mineral market are felt differently and by different parties. Disruptions in the price or availability of oil or gasoline has an immediate impact on consumers through higher fuel prices, and thus has an immediate effect on the cost or ability to travel. The same disruptions in critical minerals do not impact the immediate ability to travel but affect only the production and cost of new vehicles. In practice, short-term price fluctuations do not always translate to higher production cost as most manufacturers purchase minerals via long-term contracts that insulate them to a degree from volatility in spot prices. Moreover, critical minerals are not concentrated among a small group of commodities such as crude oil or natural gas, but comprise a larger number of distinct commodities, each having its own supply and demand dynamics, and some being capable of substitution by other minerals. Importantly, while oil is consumed as a fuel and thus requires continuous supply, minerals become a constituent part of the vehicle and have the potential to be recovered and recycled. Thus, even when minerals are imported from other countries, their acquisition adds to the domestic mineral stock that is available for domestic recycling in the future.
In the proposal, EPA analyzed the primary issues surrounding mineral security. We collected and reviewed information relating to the present geographical distribution of developed and known critical mineral resources and products, including information from the U.S. Geological Survey, analyst firms and various stakeholders. In considering these sources we highlighted and examined the potential for the U.S. to secure its sources for critical minerals. Our assessment of the available evidence indicated that the increase in PEV production projected to result from the proposed standards could be accommodated without causing harm to national security.
We received a variety of comments on our analysis, some of which disagreed with our findings and others which supported them. Supportive comments often pointed to examples of rapidly increasing attention to development of mineral resources in the U.S. and in nations with which the U.S. has good trade relations, and also pointed to the current and ongoing influence of support from the BIL and IRA in advancing such projects. Commenters who disagreed with our findings largely expressed the position that EPA did not adequately address the issue, or did not adequately consider the risks posed by increased demand for critical minerals or products that use them. Because mineral security is closely related to development of the domestic supply chain, comments often included references to the state of the domestic supply chain and the commenter's views on how it either is or is not advancing at a sufficient pace to allay mineral security concerns.
EPA appreciates and has carefully considered the substantive and detailed comments offered by the various commenters. Much of the information provided by commenters who disagreed with our assessment tends to expand upon the evidence that EPA already presented in the proposal concerning the risks and uncertainties associated with the future impact of mineral demand on mineral security. Much of the information provided by supportive commenters also expands on the evidence EPA presented in the proposal about the pace of activity and overall outlook for buildout of the critical mineral supply chain. While contributing to the record, the information provided by the commenters largely serves to further inform the trends that were already identified and considered by EPA in the proposal, and do not identify new, specific aspects of mineral security that were not acknowledged in the proposal. Taken together, the totality of information in the public record continues to indicate that development of the critical mineral supply chain is proceeding both domestically and globally in a manner that supports the industry's compliance with the final standards. In light of this information provided in the public comments and additional information that EPA has collected through continued research, it continues to be our assessment that the increase in PEV production projected under the standards will not adversely impact national security.
The findings discussed in section IV.C.7 of this preamble inform our basis for this assessment. In fact, rather than harming national security, EPA finds that the final rule will promote the
In the proposal, we also acknowledged the well-known fact that critical minerals are distributed widely across the world and are traded via a highly globalized supply chain that includes numerous stages of their production. A description of worldwide sources of critical minerals as they exist today, and key takeaways from the ANL study which explores these issues,
The development of critical mineral mining, processing, and related manufacturing capacity in the U.S. is a primary focus of efforts on the part of both industry and the federal government toward building a secure supply chain that reduces or eliminates exposure to security risks. These efforts are being greatly facilitated by the provisions of the BIL and the IRA as well as large private-sector investments that are already underway and continuing. The Inflation Reduction Act and the Bipartisan Infrastructure Law are in fact continuing to be a highly effective means by which Congress and the Administration are supporting the building of a robust supply chain, and accelerating this activity to ensure that it forms as rapidly as possible.
The U.S. is also taking advantage of a significant and growing portfolio of international engagements to secure mineral supplies, including FTAs, the Minerals Security Partnership (MSP), Trade Investment Framework Agreements (TIFAs), and other bilateral and multilateral agreements such as the Partnership for Global Infrastructure and Investment (PGI). In the words of Assistant Secretary of State for Energy Resources Geoffrey R. Pyatt in June 2023, the administration is “using all the tools at its disposal, such as investments, loan programs, public-private partnerships, and technical assistance for energy infrastructure and supply chain development.”
For example, in 2023, the State Department launched the Minerals Investment Network for Vital Energy Security and Transition (MINVEST), a public-private partnership between the U.S. Department of State and SAFE Center for Critical Minerals Strategy to spur investment in mining, processing, and recycling opportunities.
Recent policy recommendations from Congress have also expressed the goal of expanding and strengthening trade relationships with allies. In December 2023 the House Select Committee on US-China Competition released a series
Since the proposal, EPA has observed a general trend of continued activity to build the domestic and allied supply chain for critical minerals. EPA believes that this continued progress indicates that automakers, suppliers, and investors are taking advantage of the business opportunities that this need presents, and that the U.S. manufacturing industry is taking the necessary steps to create a secure supply chain for these products. Our assessment of the available evidence indicates that the increase in PEV production projected to result from the proposed standards can be accommodated without causing harm to national security.
EPA received comment on the potential role of recycling as a means of reducing future reliance on newly mined or acquired critical minerals over the long term. Some commenters supported EPA's view that battery recycling will contribute to mineral security and sustainability, gradually becoming more important as a domestically produced mineral source that will reduce reliance on foreign-sourced minerals. Other commenters expressed the view that recycling would not be a significant factor or would not develop quickly enough.
In the proposal, EPA reviewed the potential for recycling to become an important source of future mineral supply but did not specifically rely on projections of growth in recycling activity or recycled content to justify the feasibility of the standards. Similarly, the compliance analysis for the final standards does not specifically consider recycled content nor rely on specific assumptions regarding the growth of recycling in the future. As such, our analysis is conservative: we find that critical minerals and the battery supply chain will not constrain manufacturers who choose to produce PEVs to comply with the final standards, assuming no recycling activities, even though we believe that recycling has the potential to provide a significant source of critical minerals and other materials for battery production, particularly in later years of the program.
As in the proposal, EPA continues to recognize that recycling will take time to become a strong contributor to ongoing domestic mineral supply. For example, we noted that growth in the return of end-of-life PEV batteries will lag the market penetration of PEVs, and that it is important to consider the development of a battery recycling supply chain during the time frame of the rule and beyond. We also noted evidence that suggest by 2050, battery recycling could be capable of meeting 25 to 50 percent of total lithium demand for battery production.
EPA continues to note that battery recycling has been and remains a very active area of research. The Department of Energy coordinates much research in this area through the ReCell Center, described as “a national collaboration of industry, academia and national laboratories working together to advance recycling technologies along the entire battery life-cycle for current and future battery chemistries.”
Recycling infrastructure is the subject of several provisions of the BIL. It includes a Battery Processing and Manufacturing program, which grants significant funds to promote U.S. processing and manufacturing of batteries for automotive and electric grid use, by awarding grants for demonstration projects, new construction, retooling and retrofitting, and facility expansion. It will provide a total of $3 billion for battery material processing, $3 billion for battery manufacturing and recycling, $10 million for a lithium-ion battery
The efforts to fund and build a mid-chain processing supply chain for active materials and related products will also be important to reclaiming minerals through domestic recycling. While domestic recycling can recover minerals and other materials needed for battery cell production, these materials commonly are recovered in elemental forms that require further midstream processing into precursor substances and active material powders that can be used in cell production. The DOE ReCell Center coordinates extensive research on development of a domestic lithium-ion recycling supply chain, including direct recycling, in which materials can be recycled for direct use in cell production without destroying their chemical structure, and advanced resource recovery, which uses chemical conversion to recover raw minerals for processing into new constituents.
Currently, pilot-scale battery recycling research projects and private recycling startups have access to only limited amounts of recycling stock that originate from sources such as manufacturer waste, crashed vehicles, and occasional manufacturer recall/repair events. As PEVs are currently only a small portion of the U.S. vehicle stock, some time will pass before vehicle scrappage can provide a steady supply of end-of-life batteries to support large-scale battery recycling. During this time, we expect that the mid-chain processing portion of the supply chain will continue to develop and will be able to capture much of the resources made available by the recycling of used batteries coming in from the fleet.
In this section, we discuss the projected new vehicles sales technology penetration rates from EPA's analysis for the final standards. EPA has incorporated PHEVs into our analysis for the final rule, as requested by commenters and as we had indicated in the proposal was our plan. Table 75 and Table 76 reflect the projected penetration rates of PEVs (which include BEVs and PHEVs
We note that we have also analyzed several sensitivities (refer to section IV.F of this preamble), including one looking at the impact of adoption of ACC II policies in various states and other sensitivities considering the possibility of higher or lower battery costs.
For both the final standards as well as the No Action case, BEVs make up the majority of PEVs. From 2027 MY to 2032 MY for the final standards, PHEV projections grow from 4 percent to 8 percent in sedans, 7 percent to 14 percent in pickups and 6 percent up to 13 percent in crossovers. The remainder of the projected PEV shares are BEVs. Table 77 and Table 78 show projected PHEV penetrations rates for the final standards and the No Action case.
Table 79 and Table 80 show the projected market penetrations for strong HEVs under the final standards and the No Action case. For MY 2027-2032, penetrations are less than 5 percent, and under the final standards are projected to decrease over time. However, these results do not imply that strong HEVs are ineffective as a compliance option. Instead, under the cost-minimizing compliance strategy used in our analysis, strong HEVs are being displaced by PEVs that provide emissions reductions at a relatively lower cost per Mg CO
Consistent with past rulemakings, EPA has evaluated a range of advanced technologies for ICE vehicles (“advanced ICE”) which include advanced turbocharged downsized engines (TURB12), advanced Atkinson (ATK) engines, and Miller (MIL) cycle engines.
In this section we discuss the projected MDV
The projected PHEV penetrations (which are a subset of total PEVs) are provided for the final standards in Table 87. Similar to what was seen in light-duty vehicles, for the van segment and the MDV fleet overall, most of the PEVs in the medium-duty compliance modeling are projected to be BEVs. However, for MDV pickups PHEV penetrations make up over half of the PEVs for that segment by MY 2032.
No strong HEVs were projected for the medium-duty fleet. However, there remain a significant penetration of advanced ICE vehicles (although their sales shares are projected to decline as the standards become more stringent). Table 88 and Table 89 show the penetration rates for advanced ICE vehicles for the final standards and the No Action case. For reference, Table 90 shows the advanced ICE percentage of all ICE vehicles for the final standards.
To meet the final criteria pollutant standards, vehicle manufacturers are anticipated to apply better emissions control technologies to ICE, hybrid and PHEV vehicles. While BEVs are anticipated to provide some contribution to a manufacturer's compliance, we expect that manufacturers will also choose to improve the emissions control of their ICE vehicles. ICE vehicles, hybrids and PHEVs can continue their downward trend in NMOG+NO
The final footprint CO
The modeled achieved CO
Comparing the target and achieved values (
The modeling predicts that the industry will over comply against the MY 2027-2032 standards in the No Action scenario, driven by the projected significant increase in PEVs. This is in part due to the economic opportunities provided for PEVs to both manufacturers and consumers by the IRA. Figure 43 shows a plot of industry average achieved g/mile compared to the projected targets for both the No Action case and the final standards. In
Based on the work-factor based standards curve coefficients described in section III.C.3 of the preamble, we present the projected industry average medium-duty vehicle fleet targets for both the final standards and the No Action case in Table 101 and Table 102. These average targets are shown for two different modeled body styles: vans and pickup trucks. The projected targets for each case are based on the industry sales weighted average of vehicle models (and their respective work factors) within each body style.
The modeled achieved CO
Similar to light-duty vehicles, within a given year it can be seen that the achieved values might be over target (higher emissions) or under target (lower emissions). This is another example of the unlimited credit transfer provision, which results in a compliance determination that is based on the overall fleet credits for each manufacturer, rather than a separate compliance determination for individual vehicles or groups of vehicles. The application of technologies is influenced by the relative cost-effectiveness of technologies among each manufacturer's vehicles. For the combined fleet, the achieved values are typically close to or slightly under the target values, which would represent the banking of credits that can be carried over into other model years. This indicates that overall, the modeled fleet tracks the standards very closely from year-to-year. Note that an achieved value for a manufacturer's combined fleet that is above the target in a given model year does not indicate a likely failure to comply with the standards, since the model includes the GHG program credit banking provisions that allow credits from one year to be carried into another year.
EPA has performed an assessment of the estimated per-vehicle costs for manufacturers to meet the MY 2027-2032 GHG and criteria air pollutant standards. The fleet average costs per vehicle, again grouped by both regulatory class and body style, are shown in Table 105 and Table 106. As shown, the combined cost for cars and trucks are about $200 for MY 2027 and then increase gradually through MY 2032.
Overall, EPA estimates the average costs of this final rule at approximately $2,100 per vehicle in MY 2032 relative to meeting the No Action case in MY 2032. However, these estimates represent the incremental technology costs to manufacturers; for consumers, these costs are offset by savings in the reduced fuel costs, and, for PEVs, maintenance and repair costs, as discussed in section VIII of the preamble. Additionally, consumers may also benefit from IRA purchase incentives for PEVs.
These light-duty compliance costs are somewhat different from the values presented in the NPRM, and now show lower costs in earlier years and higher costs in 2031 and 2032. These changes are the result of the additional credit flexibilities in the final standards that were not included in the proposed standards, as well as a number of modeling updates made in response to public comments and consideration of the latest and most appropriate data. As described in section IV.A.1 of the preamble, noteworthy updates to projected battery costs and revised ICE powertrain costs both contribute to the increased compliance costs in later years.
EPA's assessment of the estimated per-vehicle costs for manufacturers to meet the final MY 2027-2032 GHG and criteria air pollutant standards for medium-duty vehicles is presented here. The fleet average costs per vehicle, grouped by body style, are shown in Table 107. As shown, the combined cost for vans and pickups generally increases from MY 2027 through MY 2032.
Overall, EPA estimates the average costs of this rule at approximately $3,300 per medium-duty vehicle in MY 2032 relative to meeting the No Action case in MY 2032. Similar to our light-duty costs, these estimates represent the incremental costs to manufacturers; for consumers, these costs are offset by savings in reduced fuel costs, and for PEVs, maintenance and repair costs, as discussed in section VIII of the preamble. Additionally, consumers may also benefit from IRA purchase incentives for PEVs.
In section III.F of this preamble, we described alternatives that we considered in addition to the final light-duty vehicle GHG standards. See Figure 5 and Table 18 in section II.C of this preamble. The alternatives analyzed for the final rule, in addition to the standards we are finalizing, are Alternative A (the proposed standards) and Alternative B (less stringent standards). The analyses of the technology penetrations, targets and achieved levels, and compliance cost are summarized below. Additional details for each alternative are presented in the RIA Chapters 4, 8 and 12.
In comparing the per-vehicle costs of the final standards and the two alternatives, costs of Alternative A (the proposed standards) have increased compared to the projections of costs for the proposed standards as estimated in the NPRM. This cost increase is due to updates in technical inputs, as discussed in section IV.D.3 of this preamble and detailed in RIA Chapter 2.1.3. The final standards, which include a slower phase-out of flexibilities and a more gradual year-over-year stringency increase in the standards curves for MY 2027 through 2030, have reduced compliance costs compared to Alternative A.
The 6-year average of the final standards is about $1,200 per vehicle, which is about half of the 6-year average costs for Alternative A ($2,400). The lower costs of the final standards are largely attributed to the reduced compliance costs for MY 2027 through MY 2029 which are projected at or less than $1000 per vehicle.
While Alternative A achieves slightly greater cumulative CO
EPA's updated analysis shows that the final standards and Alternative A achieve similar levels of technology penetration in MY 2032. The important difference between the final standards and Alternative A is in the per-vehicle costs during the earlier years (MYs 2027 through 2030), where we believe the lower costs of the final standards are important considering the shorter lead time for manufacturers. EPA discusses further in section V of this preamble the reasons we believe the final standards represent the appropriate standards under the CAA.
Table 108 compares the projected PEV penetration rates for the final standards, the alternatives and the No Action case.
Table 109 compares the projected targets for the alternatives and the final standards, while Table 110 compares the achieved levels for each.
Table 111 presents a comparison of average incremental per-vehicle costs for the final standards and the alternatives, as well as the average annual cost over the rulemaking period.
EPA often conducts sensitivity analyses to help assess key areas of uncertainty in both underlying data and modeling assumptions, consistent with OMB Circular No. A-4 which establishes guidelines for conducting regulatory impact analyses, including benefit-cost analysis.
We have provided an analysis that accounts for state-level zero-emission vehicle (ZEV) policies as described by California's ACC II program and other participating states under CAA section 177. California has submitted to EPA a request for a waiver for its ACC II program, which is currently under review; EPA is not prejudging the outcome of any waiver process or whether or not certain states are able to adopt California's regulations under the criteria of section 177. Nevertheless, it is an important question to analyze what the potential effect of state adoption of ZEV policies might be in the context of the No Action case, particularly since manufacturers may be adjusting product plans to account for ACC II, and thus we are providing this sensitivity analysis to explore this question. As shown in Table 112, state adoption of ACC II is projected to amount to about 30 percent of total U.S. light-duty sales in 2027 and beyond. Within the states adopting ACC II, manufacturers are required to sell a certain portion of vehicles that meet the ZEV definition, which includes BEVs, FCEVs, and a limited number of PHEVs that satisfy a minimum requirement for charge depleting range. The required ZEV shares increase by model year, reaching 100 percent in 2035 as shown in Table 113.
EPA's analysis of state-level ZEV mandates was conducted by separating the base year fleet into two regions. We applied a minimum PEV sales share constraint to the portion of new vehicles in the ACC II-adopting states, using the values in Table 113. For the remainder of new vehicles, a minimum PEV sales share value of zero was specified. In both ZEV and non-ZEV regions, the OMEGA modeling allowed manufacturers to exceed the minimum PEV shares if it resulted in lower producer generalized cost, while still meeting other modeling constraints including compliance with the National GHG standards for the particular policy case and satisfying the consumer demand for PEVs. The results of the analysis for this state-level ZEV mandate sensitivity are summarized in Table 114 through Table 120.
The following section presents key OMEGA results for the low and high battery cost sensitivities, which are described in more detail in section IV.C.2 of the preamble.
The low battery cost assumes a 15 percent reduction in battery pack costs
The high battery cost assumes a 25 percent increase in battery pack costs (on a $/kWh basis) from the central case compliance analysis. The corresponding GHG targets and achieved g/mile levels are provided in Table 128 and Table 129. Technology penetrations of PEVs, PHEVs, strong HEVs, and advanced ICE vehicles are summarized in Table 130, Table 131, Table 132, and Table 133. The resulting incremental compliance costs (against the corresponding No Action case) are given in Table 134.
We have included sensitivities on the rate of BEV and PHEV acceptance. Given uncertainties in vehicle markets, we estimate results assuming both faster and slower rates of BEV acceptance for all body styles. We also acknowledge that PHEV acceptance could be more prevalent than we estimate in our central case. For information on what these BEV and PHEV acceptance rates are, refer to RIA Chapter 4.1.3.
Results assuming a faster rate of BEV acceptance are provided here. The corresponding GHG targets and achieved g/mile levels are provided in Table 135 and Table 136. Technology penetrations of PEVs, PHEVs, strong HEVs, and advanced ICE vehicles are summarized in Table 137, Table 138, Table 139, and Table 140. The resulting incremental compliance costs (against the corresponding No Action case) are given in Table 141.
Results assuming a slower rate of BEV acceptance are provided here. The corresponding GHG targets and achieved g/mile levels are provided in Table 142 and Table 143. Technology penetrations of PEVs, PHEVs, strong HEVs, and advanced ICE vehicles are summarized in Table 144, Table 145, Table 146, and Table 147. The resulting incremental compliance costs (against the corresponding No Action case) are given in Table 148.
As described in section III.C.4 of this preamble, averaging, banking and trading are some of the key compliance flexibilities that EPA has included in its emissions standards dating back to 1983. EPA expects manufacturers to leverage each of these flexibilities to some extent, including the trading of credits between companies. The OMEGA model is set up to allow trading between companies and can be configured so that all of the credits generated are traded to manufacturers that need them (perfect trading), or that only a percentage of credits are traded (imperfect trading), down to a hypothetical “no trading” case where each manufacturer must comply on its own using only averaging and banking without the ability to purchase credits earned by another manufacturer.
As we did for the proposal,
Table 149 and Table 150 present the targets and achieved levels for the No Trading case and the No Action No Trading case. Table 151 through Table 154 show the respective technology penetrations for PEVs, PHEVs, strong HEVs and advanced ICE vehicles, while Table 155 shows the incremental compliance costs for the No Trading case.
This sensitivity was developed to illustrate a hypothetical scenario where manufacturers choose to limit BEV production and focus on PHEVs as a more significant part of their compliance strategy than in the Central case. Note that this is the scenario referred to as “Pathway B” in section I.B.1 of this preamble. To characterize this scenario, we assume that consumers eventually consider PHEVs and ICE vehicles equally acceptable, all else equal. We also apply a production restriction to BEVs increasing over time in a trajectory similar to the No Action central case.
Results assuming Lower BEV Production are provided below. Table 156 and Table 157 give the targets and achieved levels for the Lower BEV Production case and the No Action case. Table 158 through Table 161 show the respective technology penetrations for PEVs, PHEVs, strong HEVs and advanced ICE vehicles, while Table 162 shows the incremental compliance costs for this pathway compared to its No Action case.
This sensitivity was developed to illustrate a hypothetical scenario where manufacturers choose to limit BEV production to the trajectory observed in the Central No Action case. Again, we assume that manufacturers use an increasing number of PHEVs to comply with the final standards. This scenario is also referred to as “Pathway C” in section I.B.1 of this preamble. To characterize this scenario, we assume that consumers eventually consider PHEVs and ICE vehicles equally acceptable, all else equal. We also apply a production restriction to BEVs increasing over time in a trajectory similar to the No Action central case.
Results for this sensitivity are provided below. Table 163 and Table 164 give the targets and achieved levels for the No Additional BEVs case and the No Action case. Table 165 through Table 168 show the respective technology penetrations for PEVs, PHEVs, strong HEVs and advanced ICE vehicles, while Table 169 shows the incremental compliance costs for this pathway compared to its No Action case.
The following is a summary of the sensitivities conducted and a comparison of resulting PEV penetrations and incremental technology costs for the standards compared to the respective No Action case.
As can be seen, the projected targets for the final standards are not significantly different across the range of sensitivities discussed in this section.
Table 170 and Table 171 present a comparison for the projected targets and achieved levels for the final standards, based on the various identified sensitivities (the central No Action case is provided for reference). While total PEV penetrations projected to meet the standards (shown in Table 174) do not vary much across the sensitivity cases, the mix of PHEVs and BEVs does vary across sensitivities (refer to Table 175 and Table 176). PEV penetrations in the No Action case vary significantly: projected MY 2032 PEV penetrations range from 39 percent to 65 percent based on different input assumptions which affect consumer demand for electric vehicles and in the case of the State-level ZEV Policies scenario also reflect state required BEV shares. The range of PEV penetrations in the No Action case is provided in Table 177.
Of the metrics considered, the range of sensitivities have the greatest impact on incremental vehicle cost compared to their respective No Action case. We have also provided industry average absolute vehicle costs in Table 178, with the incremental costs of compliance for each sensitivity in Table 179. Compared to a 6-year average incremental cost of about $1,200 for the central case, these sensitivities result in a range of 6-year average incremental costs from $100 (the Faster BEV Acceptance case) per vehicle to about $2,600 (the High Battery Costs case). The two sensitivity cases that result in less BEV penetrations in the No Action case—High Battery Costs and the No Additional BEVs cases—result in the highest incremental costs. Three
For medium-duty vehicles, we have conducted high and low battery pack cost sensitivities, similar to those done for the light-duty GHG analysis (for more information refer to section IV.F.2 of this preamble). The low and high battery pack cost sensitivities have been combined into the summary tables in this section.
Table 181 and Table 182 present a comparison for the targets and the projected achieved levels for the final standards, based on battery costs assumed for the central case and the low and high cost sensitivity cases. The range of PEV penetrations and PHEV penetrations for the final MD standards are provided in Table 183 and Table 184. These tables show generally consistent results between the central case and the battery cost sensitivities because consumer behavior was not reflected in the medium-duty compliance analysis.
Battery costs have the greatest impact on incremental vehicle cost compared to the No Action case. Compared to a 6-year average incremental costs of about $1,400 for the central case, these sensitivities result in a range of incremental costs from $1,100 per vehicle to about $1,900. Incremental vehicle costs for the final standards for the two sensitivities are provided in Table 185.
Similar to the approach we used for the light-duty GHG modeling sensitivity (section IV.F.4 of the preamble), we conducted a No Trading sensitivity for medium-duty vehicles. Refer to section IV.F.4 of this preamble for modeling details that we applied for this No Trading case.
Table 186 and Table 187 present the CO
For this analysis, EPA has also assessed the ability for manufacturers to comply with the final standards in an illustrative scenario where No New BEV models are sold beyond those that were already present in the MY 2022 fleet (5 percent of the new vehicle market). In this “No New BEVs Above Base Year Fleet” scenario, we restricted OMEGA so that ICE vehicles, HEVs and PHEVs cannot be redesigned as a new BEV. EPA also applied this restriction to the No Action case associated with this scenario. It is important to note that MY 2023 BEV sales for the U.S. are expected to approach 10 percent market share, so this analysis assumes a 50 percent reduction in BEV sales even from current levels. Although EPA recognizes that this scenario is highly unlikely to occur given the ongoing investment and growth in consumer acceptance of BEVs, it is illustrative of the potential range of compliance options available to manufacturers to meet these standards.
EPA developed this scenario to evaluate concerns raised by some commenters that the standards imposed a BEV “mandate” that would dramatically transform the U.S. economy. All regulated entities indicated their intention to produce BEVs as an increasing share of their fleet to achieve GHG emissions reductions—including in the absence of this rule due to their market strategies, the IRA, and other factors. As already explained, the final standards do not impose any BEV mandate, either legally or practically, and we expect manufacturers to choose to produce a range of BEV, PHEV, HEV and ICE vehicles during the timeframe for this rule. Nothing in the Clean Air Act requires EPA to identify multiple technology pathways to achieve compliance or to show that manufacturers can achieve the standards solely by relying on alternatives to what is currently the most effective technology for controlling emissions. Nonetheless, EPA performed this illustrative scenario to evaluate certain commenters' claims that this rule would force increased BEV adoption. EPA's modeling demonstrates that this is not the case. Rather, the final standards are feasible even with no new BEV adoption, albeit at a greater cost. As the modeling results show, the industry can comply with the final standards by producing the base year percentage of BEVs and a significant percentage of PHEVs. However, as PHEVs are not as cost-effective for compliance as BEVs, the cost of compliance increases. The corresponding GHG targets and achieved g/mile levels are provided in Table 191 and Table 192. Technology penetrations of PEVs, PHEVs, strong HEVs, and advanced ICE vehicles are summarized in Table 193 through Table 196. Incremental costs are relative to the alternative No Action case which also restricts additional production of new BEVs. Costs are provided in Table 197.
As we did for light-duty vehicles, EPA has also assessed the ability for manufacturers to comply with the final medium-duty GHG standards in a scenario where No New BEV models are sold beyond those already present in the base year fleet used for this analysis.
As the modeling results show, the industry can still comply with the final medium-duty GHG standards by producing a significant percentage of PHEVs. However, as PHEVs are not as cost-effective for compliance as pure battery electric vehicles, the costs of compliance increase. The corresponding GHG targets and achieved g/mile levels are provided in Table 198 and Table 199. Technology penetrations of PEVs, PHEVs, and advanced ICE vehicles
The Clean Air Act authorizes EPA to establish emissions standards for motor vehicles to regulate emissions of air pollutants that contribute to air pollution which, in the Administrator's judgment, may reasonably be anticipated to endanger public health or welfare. See also Coalition for Responsible Regulation v. EPA, 684 F. 3d at 122 (“the job Congress gave [EPA] in CAA section 202(a)” is “utilizing emission standards to prevent reasonably anticipated endangerment from maturing into concrete harm”). As discussed in section II of this preamble, emissions from motor vehicles contribute to ambient levels of pollutants for which EPA has established health-based NAAQS. These pollutants are linked with respiratory and/or cardiovascular problems and other adverse health impacts leading to increased medication use, hospital admissions, emergency department visits, and premature mortality. In addition, light and medium-duty vehicles are significant contributors to the U.S. GHG emissions inventories. As discussed in section II of this preamble, there is a critical need for further criteria pollutant and GHG reductions to address the adverse impacts of air pollution from light- and medium-duty vehicles on public health and welfare.
To this end, as in EPA's past light and medium duty rulemakings, in this final rule we considered the following factors in setting final standards: technology effectiveness, its cost (including per vehicle, per manufacturer, and per purchaser), the lead time necessary to implement the technology, and, based on this, the feasibility of potential standards; the impacts of potential standards on emissions reductions; the impacts of standards on oil conservation and energy security; the impacts of standards on fuel savings by vehicle operators; the impacts of standards on the vehicle manufacturing industry; as well as other relevant factors such as impacts on safety. To evaluate and balance these statutory factors and other relevant considerations, EPA must necessarily estimate a means of compliance: what technologies are projected to be available to be used, what do they cost, and what is appropriate lead time for their deployment. Thus, to support the feasibility of the final standards, EPA identified a potential compliance pathway. Having identified one means of compliance, EPA's task is to “answe[r] any theoretical objections” to that means of compliance, “identif[y] the major steps necessary,” and to “offe[r] plausible reasons for believing that each of those steps can be completed in the time available.” NRDC v. EPA, 655 F. 2d at 332. That is what EPA has done here in this final rule, and indeed what it has done in all of the motor vehicle emission standard rules implementing section 202(a) of the Act for half a century.
In assessing the means of compliance, EPA considers updated data available at the time of this rulemaking, including real-world technological and corresponding costs developments related to emissions-reducing technologies for light and medium duty vehicles. The statute directs EPA to assess the “development and application of the requisite technology, giving appropriate consideration to the cost of compliance within” the relevant timeframe, and specifically compels EPA to consider relevant emissions-reduction technologies on vehicles and engines regardless of “whether such vehicles and engines are designed as complete systems or incorporate devices to prevent or control such pollution.” CAA section 202(a)(1), (2). The statute does not prescribe particular technologies, but rather entrusts to the EPA Administrator the authority and obligation to identify a range of available technologies that have the potential to significantly control or prevent emissions of the relevant pollutants and establish standards based on his consideration of the lead-time and costs for such technologies, along with other factors. Pursuant to the statutory mandate and as explained throughout this preamble, EPA has considered the full range of vehicle technologies that meet these criteria and that we anticipate will be available in the MY 2027-32 timeframe, including numerous ICE and advanced ICE vehicle, HEV, PHEV, and BEV technologies.
With continued advances in internal combustion emissions controls and a range of vehicle electrification technologies being more widely deployed, EPA believes substantial further emissions reductions are feasible and appropriate under the Clean Air Act. It has been a decade since EPA updated light-duty vehicle criteria pollutant standards. While light-duty GHG standards have been updated more recently, various developments since the most recent light-duty standards are supportive of even greater levels of production and adoption of PEV technology, which is highly effective for controlling tailpipe emissions of criteria pollutants and GHGs.
The balance of this section summarizes the key factors found in the administrative record (including the entire preamble, RIA, and RTC) that form the basis for the Administrator's determination that the final standards are feasible and appropriate under our Clean Air Act authority. Section V.B of the preamble discusses the statutory factors of technological feasibility, compliance costs, and lead time, and it explains that the final standards are predicated upon technologies that are feasible and of moderate cost during the timeframe for this rule. Section V.C of the preamble evaluates emissions of GHGs and criteria pollutants, and it finds that the final standards would achieve significant GHG and criteria pollutant reductions that make an important contribution to mitigating air pollution, including climate change.
The technological readiness of the auto industry to meet the final standards for model years 2027-2032 is best understood in the context of over a decade of light-duty vehicle emissions reduction programs in which the auto industry has introduced emissions-reducing technologies in a wide lineup of ever more cost-effective, efficient, and high-volume vehicle applications. Among the range of technologies that have been demonstrated over the past decade, electrification technologies have seen particularly rapid development and lower costs. Since EPA first started assessing technologies for reducing GHG emissions, we have recognized that “electrification” represents a full spectrum of technologies, from reducing demand on a gasoline powertrain for certain accessories or circumstances (such as regenerative braking or engine stop-start), to hybrid gasoline-electric powertrains to pure electric powertrains. In light of increased automaker investment and reduced costs, the level of electrification across all the No Action scenarios, as well as the policy alternatives considered in this rule, is higher than in any of EPA's prior rulemakings. In particular, the advancements across the spectrum of electrification technologies, including those with tailpipe emissions rates much lower than ICE-only vehicles, are supportive of EPA setting standards with much lower GHG, NMOG+NO
In this rulemaking, unlike some prior vehicle emissions standards (including those adopted in the Clean Air Act of 1970), the technology necessary to achieve significantly more stringent standards has already been developed and demonstrated in production vehicles. For example, vehicles equipped with gasoline particulate filters are already in widespread use in Europe and China; manufacturers have been building gasoline particulate filter equipped cars and trucks in the U.S. for export to countries with more stringent PM standards; and at least one manufacturer has been selling vehicles with gasoline particulate filters in the U.S.
In response to these diminished constraints and the increased stringency of the standards, we expect that automakers will continue to adopt advanced technologies at an increasing pace across more of their vehicle fleets. EPA has carefully considered potential remaining constraints on further deployment of these advanced technologies. For example, in addition to considering the breadth of current product offerings, EPA has also considered vehicle redesign cycles. Based on previous public comments and industry trends, manufacturers generally require about five years to design, develop, and produce a new vehicle model.
Our analysis projects that for the industry overall, one potential compliance strategy manufacturers could choose to meet the standards is by using 68 percent PEVs in MY 2032, of which 56 percent are BEVs and 13 percent are PHEVs. EPA believes that this is an achievable level based on our technical assessment for this rule that includes consideration of the feasibility and required lead time, including acceptance of PEVs in the market. Our assessment of the appropriateness of the level of PEVs in our analysis is also informed by public announcements by manufacturers about their plans to transition fleets to electrified vehicles, as described in section I.A.2 of this preamble and further discussed in RIA Chapter 3.1.3. We also note that our “No Action” scenario, which models the effect of the IRA but does not attempt to account for manufacturers' announced strategies, shows that PEV penetration in the absence of revised standards is expected to grow from 31 percent in MY 2027 to 39 percent in MY 2030. We have good reason to believe that our No Action PEV estimates are conservative, and that they could be higher given that mid-range third party estimates range from 48 percent to 58 percent in 2030.
At the same time, we note that the GHG and criteria pollutant standards are performance-based, phase-in over six years, and do not mandate any specific technology for any manufacturer or any vehicle. Moreover, the overall industry does not necessarily need to reach this level of PEVs, or this particular percentage of BEVs and PHEVs, in order to comply—the projection in our analysis is one of many possible compliance pathways that manufacturers could choose to take under the performance-based standards. For example, for the GHG standards, our analysis indicates that it would be technologically feasible for PHEVs to meet the CO
Moreover, while all the standards can be met by an array of different technologies, the array of available technologies for meeting each standard varies. For example, in addition to the above possibilities, a manufacturer could meet the PM standard solely through adding gasoline particulate filters to ICE vehicles. Similarly, manufacturers could meet the NMOG+NO
In our technical assessment, we present various sensitivities in which the industry overall is projected to apply technologies in different proportions, with each scenario representing a different feasible compliance pathway. We do not expect, and the standards do not require, that all manufacturers follow a similar pathway. Instead, individual manufacturers can choose to apply a mix of technologies—including various levels of base ICE, advanced ICE, strong HEV, PHEV, and BEV technologies—that best suits the company's particular product mix and market position as well as its strategies for investment and technology development. Considering the range of potential paths for designing compliant vehicles and the diversity of consumer demand for vehicles, EPA anticipates that manufacturers will employ a wide range of technologies, applied to ICE, hybrid, plug-in hybrid and fully electric vehicles to meet their fleetwide average standards.
In considering the feasibility of the standards, EPA also considers the impact of available compliance flexibilities on automakers' compliance options.
At the same time, automakers typically have widely utilized the program's established ABT provisions which provide a variety of flexible paths to plan compliance. We have discussed this dynamic at length in past rules, and we anticipate that this same dynamic will support compliance with this rulemaking. Although the ABT program for GHG and criteria pollutants have some differences (as discussed in detail in sections III.C.4 and III.D.9 of the preamble), they fundamentally operate in a similar fashion. The GHG credit program was designed to recognize that automakers typically have compliance opportunities and strategies that differ across their fleet, as well as a multi-year redesign cycle, so not every vehicle will be redesigned every year to add emissions-reducing technology. Moreover, when technology is added, a given vehicle will generally not achieve emissions reductions corresponding exactly to a single year-over-year change in stringency of the standards. Instead, in any given model year, some vehicles will be “credit generators,” over-performing compared to their footprint-based CO
Moreover, the trading provisions of the program allow each manufacturer to design a compliance strategy relying not only on overcompliance and undercompliance by different vehicles or in different years within its own fleet, but also between different manufacturers. Credit trading is a compliance flexibility provision that allows one vehicle manufacturer to purchase credits from another, accommodating the ability of manufacturers to make strategic choices in planning for and reacting to normal fluctuations in an automotive business cycle. When credits are available for less than the marginal cost of compliance, EPA would anticipate that an automaker might choose to adopt a compliance strategy relying at least in part on purchasing credits.
The final performance-based standards with ABT provisions give manufacturers a degree of flexibility in the design of specific vehicles and their fleet offerings, while allowing industry
While the potential value of credit trading as a means of reducing costs to automakers was always clear, there is increasing evidence that automakers have successfully adopted credit trading as an important compliance strategy that reduces costs. The market for trading credits is now well established. As shown in the most recent EPA Trends Report, 21 vehicle firms collectively have participated in over 100 credit trading transactions totaling 194 Tg of credits since the inception of the EPA program through Model Year 2022. These firms include many of the largest automotive firms.
In light of the evidence of increased adoption of trading as a compliance strategy and the increased vehicle sales from EV-only manufacturers (who are likely to view credit sales as a potential revenue stream), EPA has included the ability of manufacturers to trade credits as part of our central case compliance modeling for this rule, rather than as a sensitivity analysis as we did in the modeling for the 2021 rule. We anticipate that the economic efficiencies of credit trading will generally be attractive to automakers, and thus we consider it appropriate to take trading into account in estimating the costs of the standards. However, trading is an optional compliance flexibility, and we recognize that automakers may choose to use it in their compliance strategies to varying degrees. For this final rule, EPA has analyzed a sensitivity case in which we assume that no manufacturers take advantage of the credit trading flexibility. As noted above, the active and widespread participation in credit trading (including by EV-only manufacturers) to date indicates that such an assumption is unlikely to apply across the entire industry. However, it is an illustrative bounding case since we find that all manufacturers can comply by only the application of technology without any reliance on purchased credits, at a cost that is similar to our central case analysis. In other words, we conclude that the standards are feasible and appropriate even in the absence of trading.
As part of its assessment of technological feasibility and lead time, EPA has considered the cost for the auto industry to comply with the revised standards. See section IV.D of the preamble and Chapter 12 of the RIA for our analysis of compliance costs. The estimated average cost to manufacturers to meet the light-duty standards (both criteria and GHG) is approximately $2,100 (2022 dollars) per vehicle in MY 2032, which is within the range of costs projected in prior rules, which EPA estimated at about $1,800 (2010 dollars, equivalent to approximately $2,400 in 2022 dollars), and $1,000 (2018 dollars, equivalent to approximately $1,200 in 2022 dollars) per vehicle for the 2012 and 2021 LD GHG rules respectively. The estimated average cost to comply for medium-duty manufacturers is projected to be $3,300 (2022 dollars) in 2032, compared to $1,400 (2013 dollars, equivalent to $1,700 in 2022 dollars) in the HD Phase 2 rulemaking.
EPA also carefully evaluated a range of sensitivities for both the light-duty and medium-duty standards, as described in detail in section IV of the preamble and RIA Chapter 12.1.4 and 12.2.4. Taken together these sensitivities, encompass a wide array of potential uncertainties and future scenarios, including higher and lower battery cost, greater and lesser consumer acceptance for different vehicle technologies, different assumptions about the availability of IRA tax credits, and a diversity of manufacturer compliance strategies. Specifically, for the light-duty vehicle sensitivity assessments presented in sections IV.F and IV.H.1 of the preamble and RIA Chapter 12.1.4, for the majority of scenarios we estimate six-year average cost increases that represent between 0.3 percent and 3.9 percent increase in the projected total costs of a new vehicle (six-year average costs of $130 to $1,700), with two of the sensitivities showing a projected 5.8 percent increase (six-year average costs of $2,500-$2,600).
EPA also performed cost assessments for the medium-duty vehicle CO
EPA recognizes that, although the costs of the final standards in the first year of the program are lower than those of the proposed standards, updates to our technology cost estimates, for example our battery cost estimates, have resulted in the estimated costs per vehicle of the final standards being higher than the costs of the proposed standards in the later years of the program. Over the 6-year rulemaking period of MYs 2027-2032, average new light-duty vehicle manufacturing costs are increased by $1,200 due to the final standards, compared to the increase of $680 for the proposed standards over the same period. Costs of the final standards in the earlier years are lower and remain in the $200-$1,000 range for MYs 2027-2029. Light-duty vehicle costs increase in the latter three years (MYs 2030-2032) range from $1,500 to the above mentioned $2,100 for MY 2032, which is within the proposal's cost range of $500 to $2,800 (in 2022 dollars) for that year across the sensitivity cases. The general increase in costs is a result of EPA's updated analysis of the inputs and assumptions for the modeling used in projecting costs, informed by public comments, and in consultation with DOE and NHTSA. The final rule uses the same OMEGA2 modeling approach as was used for the proposal, but as discussed in section IV of this preamble and Chapters 2, 3, 4, and 8 of the RIA, various inputs and assumptions have been improved to address certain issues EPA identified in the proposal and in response to public comments. For example, EPA and NHTSA have engaged in extended consultation with DOE and the National Labs to better estimate future availability and cost of batteries used in PEVs and to assess the impacts of the tax credits established in the IRA on manufacturer costs. As a result of this and other work, EPA has updated its inputs for both ICE technology costs and batteries. EPA has also explicitly modeled PHEVs as a compliance option for the final rulemaking analysis. In addition, EPA has revised its car/truck sales share forecast according to the 2023 version of EIA's Annual Energy Outlook, which now projects an increased share of truck sales for future years. This shift to a higher share of truck sales also tends to increase the cost of the fleetwide standards. Overall, these incremental refinements to the inputs have improved the robustness of the
As also discussed in section I.A.2.ii of this preamble, EPA has observed a shift toward increased use of electrification technologies both in vehicle sales and across the automotive industry at large, and that these changes are being driven to a large degree by the technological innovation of the automotive industry and the significant funds, estimated at $1.2 trillion by at least one analysis,
For this rule, EPA finds that standards are feasible in the lead time available, and that the expected compliance costs for automakers are reasonable, in light of the emissions reductions in air pollutants and the resulting benefits for public health and welfare. In making this finding we have considered our central case projection, as well as the full range of sensitivity analyses, considering the range of the projected costs, their respective likelihoods, the factors underlying them (
An essential factor that EPA considered in determining the appropriate level of the standards is the reductions in air pollutant emissions that will result from the program, including emissions of GHGs, criteria pollutants and air toxics, and associated public health and welfare impacts.
Although EPA has to date coordinated its light-duty GHG and criteria pollutants standards, this is the first time EPA has established both GHG and criteria pollutant standards in a single rulemaking for light-duty, as well as medium-duty, vehicles. The final standards will achieve very significant reductions of both GHG and criteria pollutants. The cumulative GHG emissions reductions through 2055 are projected to be 7,200 MMT of CO
As discussed in section VIII of the preamble, we monetize benefits of the standards and evaluate other costs in part to enable a comparison of costs and benefits pursuant to E.O. 12866, but we recognize there are benefits that we are currently unable to fully quantify. EPA's practice has been to set standards to achieve improved air quality consistent with CAA section 202, and not to rely on cost-benefit calculations, with their uncertainties and limitations, as identifying the appropriate standards. Nonetheless, our conclusion that the estimated benefits exceed the estimated costs of the program reinforces our view that the standards are appropriate under section 202(a).
The annualized value of climate benefits attributable to the standards are estimated at $72 billion using a 2 percent discount rate through 2055. See section VIII of the preamble and Chapter 9 of the RIA for a full discussion of the SC-GHG estimates used to monetize climate benefits and the data and modeling limitations that constrain the ability of SC-GHG estimates to include all the important physical, ecological, and economic impacts of climate change, such that the estimates are a partial accounting of climate change impacts and will therefore tend to be
The annualized value of PM
EPA also considered the impact of the final light- and medium-duty standards on consumers as well as on energy and safety. EPA concludes that the standards would be beneficial for consumers because the lower operating costs would offset increases in vehicle technology costs, even without consideration of PEV purchase incentives in the IRA. For example, in 2055, when the standards have been fully implemented and the in-use vehicle fleet has largely turned over to the new standards, EPA estimates the rule would provide $57 billion in consumer savings associated with reduced fuel consumption despite the increased consumption of electricity of $18 billion (both values on an annualized basis through 2055 at a 2 percent discount rate, see section VIII.C.1 of this preamble). Vehicle technology cost increases for light-and medium-duty vehicles through 2055 are estimated at $40 billion on an annualized basis at a 2 percent discount rate. Annualized maintenance and repair costs at a 2 percent discount rate through 2055 are estimated to be $16 billion lower due to the final standards (See sections VIII.C and VIII.G of the preamble and Chapter 9 of the RIA). Thus, considering fuel savings and the lower maintenance and repair costs the final rule will result in significant savings for consumers.
In addition to the above, EPA also carefully considered the distribution of consumer impacts of these standards, specifically the impacts of low-income consumers. We recognize that increases in upfront purchase costs are likely to be of particular concern to low-income households, but we anticipate that automakers will continue to offer a variety of models at different price points (see Chapter 4 of the RIA). Moreover, because lower-income households spend more of their income on fuel than other households, the effects of reduced fuel costs may be especially important for these households. Similarly, low-income households are more likely to buy used vehicles and own older vehicles, and thus would benefit from significant savings in repair and maintenance costs if they purchase electric vehicles. Furthermore, for used BEVs, there is evidence that the original purchase incentive is passed on to the next buyer (
EPA has also considered the impact of this rule on consumers through the need for sufficient charging infrastructure and potential impacts on the electricity grid. We expect that through 2055 the majority of light and medium duty PEV charging will occur at home, but we recognize the need for additional public charging infrastructure to support anticipated levels of PEV adoption. As discussed in section IV.C.5 of the preamble and RIA Chapter 5.3, charging infrastructure has grown rapidly over the last decade, and investments in charging infrastructure continue to grow. Based on our evaluation of the record, EPA finds the market for charging is already responding to increased demand through investments from a wide range of public and private entities, and it is reasonable to expect the market will continue to keep up with demand. We further anticipate these final standards will encourage additional investments in charging infrastructure. EPA does not find that the increase in electricity consumption associated with modeled increases in PEV sales will adversely affect reliability of the electric grid, and, as explained in section IV of this preamble and Chapter 5 of the RIA, more widespread adoption of PEVs could have significant benefits for the electric power system.
EPA also evaluated the impacts of the light- and medium-duty standards on energy, in terms of fuel consumption and energy security. This rule is projected to result in a reduction of U.S. gasoline consumption by 780 billion gallons through 2055 and an increase of 6,700 Terawatt hours (TWh) of electricity consumption (see RIA Chapter 8). EPA considered the impacts of these projected changes in fuel consumption on energy security, specifically the avoided costs of macroeconomic disruption (See section VIII.H of the preamble). Promoting energy independence and security through reducing demand for refined petroleum use by motor vehicles has long been a goal of both Congress and the Executive Branch because of both the economic and national security benefits of reduced dependence on imported oil, and was an important reason for amendments to the Clean Air Act in 1990, 2005, and 2007.
Section 202(a)(4)(A) of the CAA specifically prohibits the use of an emission control device, system or element of design that will cause or contribute to an unreasonable risk to public health, welfare, or safety. EPA has a long history of considering the safety implications of its emission standards from 1980 regulations establishing criteria pollutant standards
As with the 2021 rule, EPA considers safety impacts in the context of all projected health impacts from the rule including public health benefits from the projected reductions in air pollution. In considering these estimates in the context of anticipated public health benefits, EPA notes that the air quality modeling, as discussed further in Chapter 7 of the RIA, estimates that in 2055 such a scenario would prevent between 1,000 and 2,000 premature deaths associated with exposure to PM
Finally, EPA notes that the estimated benefits of the standards exceed the estimated costs, and estimates of the present values of net benefits of this rule through 2055 range from $1.7 trillion to $2.1 trillion (7 percent and 2 percent discount rates, with 2 percent near-term Ramsey discount rate for SC-GHG) (see section VIII of the preamble and Chapter 9 of the RIA). We recognize the uncertainties and limitations in these estimates (including unquantified benefits), and the Administrator has not relied on these estimates in identifying the appropriate standards under section 202. Nonetheless, we take note of the fact that estimated benefits exceed the estimated costs of these standards.
Under section 202(a)(1) EPA has a statutory obligation to set standards to reduce air pollution from classes of motor vehicles that the Administrator has found contribute to air pollution that may be expected to endanger public health and welfare. Consistent with our longstanding approach to setting motor vehicle standards, the Administrator has considered a number of factors in setting these vehicles standards. In setting such standards, the Administrator must, pursuant to section 202(a)(2), provide adequate lead time for the development and application of technology to meet the standards, taking into consideration the cost of compliance. Furthermore, in setting standards for NMOG+NO
Moreover, the provisions for credit carry-forward and deficit carry-forward under the existing GHG program, as well as carry forward of Tier 3 NMOG+NO
As noted above, section 202(a)(3) is explicit that, for certain pollutants for certain vehicles, the Administrator shall establish standards that achieve the greatest degree of emissions reduction achievable, although the provision identifies other factors to consider and requires the Administrator to exercise judgment in weighing those factors. Section 202(a)(1)-(2) provides greater discretion to the Administrator to weigh various factors but, as with the 2021 rule, the Administrator notes that the purpose of adopting standards under that provision of the Clean Air Act is to address air pollution that may reasonably be anticipated to endanger public health and welfare and that reducing air pollution has traditionally been the focus of such standards. Thus, for this rulemaking the agency's focus in identifying final standards is on
There have been very significant developments in the feasibility of further control of pollution from motor vehicles since EPA promulgated the 2021 rule. While at the time of the 2021 rule, estimates of financial commitments to electric vehicle technologies by the automotive industry were in the range of $500-600 billion, more recent estimates are $1.2 trillion, approximately twice that of only two years ago.
One of the most significant developments for U.S. automakers and consumers is Congressional passage of the IRA, which takes a comprehensive approach to addressing many of the potential barriers to wider adoption of PEVs in the United States. The IRA provides tens of billions of dollars in tax credits and direct Federal funding to reduce the upfront cost to consumers of purchasing PEVs, to increase the number of charging stations across the country, to reduce the cost of manufacturing batteries, and to promote domestic sources of critical minerals and other important elements of the PEV supply chain. By addressing all of these potential obstacles to wider PEV adoption in a coordinated, well-financed, strategy, Congress significantly advanced the potential for PEV adoption, and associated emissions reductions, in the near term. In fact, EPA anticipates that the increased PEV penetration for the initial years of these standards will be driven by automakers and consumers making use of IRA incentives, and would occur even in the absence of the revised standards.
In developing this rule, EPA has recognized that these significant developments in automaker investment, PEV market growth, and Congressional support through the BIL and IRA represent a significant opportunity to ensure that the emissions reductions these developments make possible will be realized as fully as possible and at a reasonable cost over the time frame of the rule. It is clear that these ongoing developments have already led to PEVs being increasingly employed across the fleet in both light-duty and medium-duty applications, largely independent of EPA's prior standards. Although the 2021 rule projected a PEV penetration rate of 17 percent for 2026, our updated modeling of the No Action case for this rule suggests a PEV penetration rate for 2026 of 27 percent, even with no change in the standards. As noted above. this projection is consistent with, if not more conservative than, the projections of third-party analysts.
In developing our PEV penetration estimates, EPA considered a variety of constraints which have, to date, limited PEV adoption and/or could limit it in the future, including: cost to manufacturers and consumers; refresh and redesign cycles for manufacturers; availability of raw materials, batteries, and other necessary supply chain elements; adequate electricity supply and distribution; and barriers to consumer acceptance such as adequate charging infrastructure and a wide range of vehicle model choices that meet a diverse set of consumer needs.
We also developed further analyses, recognizing that there are uncertainties in our projections. For example, battery costs may turn out to be higher or lower than we project, and consumers may adopt PEVs faster or slower than we anticipate. Overall, we identified a range of potential costs and PEV penetrations which we view as representing a wider range of possible, and still feasible and reasonable, compliance pathways under the standards.
Taking both the significant developments in the automotive market and all of these potential constraints and uncertainties into account, EPA's analyses found that it would be feasible to reduce net emissions (compared to the No Action case) by 37 percent for CO
In particular, EPA carefully considered comments in response to the range of alternatives for GHG standards presented in the proposal. Specifically, EPA considered standards somewhat more stringent (Alternative A, the proposed standards) and somewhat less stringent (Alternative B) than the final standards, as described in section III.F of the preamble. EPA's comparison of costs, technology penetrations and CO
Based on our review of the entire record, including public comments and extensive consultation with other agencies such as the Federal Energy Regulatory Commission, DOE and the National Labs, DOT, and the Joint Office for Energy and Transportation, EPA concludes it is reasonable, for the reasons discussed in section IV of the preamble and the RIA, to anticipate these complementary actions will all occur. EPA also concludes that it is appropriate to provide more lead time to achieve reductions to allow for the possibility that additional flexibility is required for automakers to implement their compliance strategies. EPA takes note of the very significant investments in shifting to cleaner technologies that automakers are anticipated to make before 2030. These standards align with those investments and are not based on significant additional technology costs in those initial years. The final standards established in this rule still achieve the same projected fleet average CO
EPA finds that the final standards achieve an appropriate level of emission reduction, but the more gradual phase-in of the standards between MYs 2027 and 2032 gives more appropriate consideration to costs and lead-time, particularly in light of the shifts to cleaner technologies occurring in the automotive industry.
EPA also considered adopting less stringent standards (
We acknowledge that both those stakeholders pressing for more and less rapid increases in stringency have submitted considerable technical studies in support of their positions, including analyses purportedly demonstrating that a more or less rapid adoption of emissions reduction technologies, including zero-emissions technologies, is feasible. These studies account for the vast range of economic, technology, regulatory, and other factors described throughout this preamble; draw different assumptions about key variables; and reach very different conclusions. We have carefully reviewed all these studies and further discuss them in the RIA and the RTC. The agency's final standards are premised upon our own extensive technical assessment, which in turn is based on a wide review of the literature and test data, extensive expertise with the industry and with implementation of past standards, peer review, and our modeling analyses. The data and resulting modeling demonstrate a relatively moderate rate of adoption of emission reduction technologies, at rates bounded between the higher and lower rates in studies provided by commenters.
On balance, we think the various comments and studies pressing for faster or slower increases in stringency than the final rule each have their strengths and weaknesses, and we recognize the inherent uncertainties associated with predicting the future of the highly dynamic vehicle and related industries up to eight years from today through MY 2032. This uncertainty pervades both scenarios with lesser and greater increases in stringency than the final standards. For example, slower increases in stringency would be more certainly feasible and less costly for manufacturers, but they would also risk giving up emissions reductions and consequent benefits to public health and welfare that are actually achievable. By contrast, faster increases in stringency would aim to achieve greater emissions reductions and consequent benefits for public health and welfare, but they would also run the risk of incurring greater costs of compliance and potentially being infeasible in light of the lead time provided. The final standards reflect our technical expertise in discerning a reasoned path among the varying sources of data, analyses, and other evidence we have considered, as well as the Administrator's policy judgment as to the appropriate level of emissions reductions that can be achieved at a reasonable cost in the available lead time.
While the final standards are more stringent than the prior standards, EPA applied numerous conservative approaches throughout our analysis (as identified throughout this section IV of the preamble and in the RIA) and the final standards additionally are less stringent than those proposed during the first several years of implementation leading to MY 2032. As explained above and throughout this notice, EPA has assessed the appropriateness and feasibility of these standards taking into consideration the potential benefits to public health and welfare, existing market trends and financial incentives
EPA also takes into consideration that this rule is setting coordinated but separate standards for both GHG and criteria pollutants. The widespread adoption of electrification technologies provides an important opportunity for EPA to achieve reductions of these different pollutants which each pose a continuing threat to public health and welfare. In other words, electrification technologies are extremely effective technologies at controlling emissions not only because they can reduce emissions to zero, but because they simultaneously reduce the emissions of multiple harmful pollutants.
Thus, as we have noted in section III of the preamble, the potential compliance strategies we model for the GHG standards would also be sufficient to achieve compliance with the final NMOG+NO
Likewise, although BEVs are one compliance path to meeting the PM standards, EPA judges that GPF technology is an alternative compliance path which is available at a reasonable cost in the relevant lead time for vehicles that have an internal combustion engine.
Moreover, EPA not only judges the NMOG+NO
Although EPA finds it appropriate to continue to coordinate GHG and criteria pollutant standards, taking into consideration that some of the available control technologies for these pollutants overlap, EPA has evaluated the feasibility and appropriateness of further GHG and criteria pollutant reductions separately. Each standard that we have set is justified in and of itself. As discussed above, for example, the GHG, NMOG+NO
Taking into consideration the importance of reducing criteria pollutant and GHG emissions and the primary purpose of CAA section 202 to reduce the threat posed to human health and the environment by air pollution, the Administrator finds it is appropriate and consistent with the text and purpose of section 202 to adopt standards that, when implemented, would result in significant reductions of light- and medium-duty vehicle emissions both in the near term and over the longer term, taking into consideration the cost of compliance within the available lead time. Likewise, the Administrator concludes that these standards are consistent with the text and purpose of section 202 for heavy-duty vehicles by achieving significant reductions of GHGs, taking into consideration the cost of compliance within the available lead time, and by achieving the greatest degree of emissions reduction achievable for certain other pollutants, taking into consideration cost, lead-time, energy and safety factors as specified in section 202(a)(3)(B).
In summary, after consideration of the very significant reductions in criteria pollutant and GHG emissions, given the technical feasibility of the final standards and the costs per vehicle in the available lead time, and taking into account a number of other factors such as the savings to consumers in operating costs over the lifetime of the vehicle, safety, the benefits for energy security, and the greater quantified benefits compared to quantified costs, EPA believes that the final standards are appropriate under EPA's section 202(a) authority.
To estimate emission inventory effects due to a potential policy, OMEGA uses as inputs a set of vehicle emission rates generated using MOVES vehicle inventories and the associated MOVES VMT and fuel consumption. For refinery emissions, OMEGA uses as inputs the refinery emission inventories generated in support of our air quality modeling along with estimates of the liquid fuel refined to calculate refinery emission rates. Those refinery emissions rates, along with estimates of how changes in domestic liquid fuel demand impact domestic refining, then allow OMEGA to estimate refinery emissions for a given policy. For electricity generating unit (EGU) emissions, OMEGA similarly uses as inputs a set of EGU inventories generated using EPA's Power Sector Modeling Platform, v.6.21,
Using OMEGA as described in section VI.A of this preamble and in Chapter 8 of the RIA, we estimated annual GHG emissions impacts associated with the final standards for the calendar years 2027 through 2055, as shown in Table 204. CO
The estimated emission impacts include refinery emissions and the consideration of the impact of reduced liquid fuel demand on domestic refining. In the NPRM, the central analysis estimated that 93 percent of the reduced liquid fuel demand resulted in reduced domestic refining. EPA noted the possibility, through a sensitivity
Considering the comments and an updated analysis of the domestic refining industry (see RIA Chapter 8.6), the final analysis estimates that 50 percent of reduced domestic liquid fuel demand will result in reduced domestic refining. That estimate is reflected in the results presented in Table 204. As a sensitivity, EPA also estimated that 20 percent of reduced domestic liquid fuel demand would result in reduced domestic refining. We chose this sensitivity as an estimate that falls between our central case where 50 percent of reduced demand would result in reduced domestic refining and a possible case in which this final rule would have no impact on domestic refining. EPA presents these results as a sensitivity given the uncertainty surrounding how changes in domestic demand for liquid fuel may or may not impact domestic refining of liquid fuel. The GHG impacts under that sensitivity are shown in Table 205.
The transportation sector is the largest U.S. source of GHG emissions, representing 29 percent of total GHG emissions.
As described in section VI.A of this preamble (and in more detail in Chapter 8 of the RIA), EPA used OMEGA to estimate criteria air pollutant and air toxic emission inventories associated with the final standards. These estimates are presented in section VII.A of this preamble, and additional estimates for the two alternatives are presented in RIA Chapter 8.6. OMEGA's emissions estimates include emissions from vehicles (using MOVES), electricity generation (using IPM, as described in section IV.B.3 of the preamble), and refineries.
Section VII.B of this preamble discusses the air quality impacts of the rule, section VII.C of the preamble describes how the rule will affect human health, and section VII.D of the preamble presents a summary of a demographic analysis on air quality.
Table 206 presents changes in criteria air pollutant emissions from vehicles resulting from the final standards.
Table 207 presents changes in criteria air pollutant emissions from EGUs and refineries resulting from the final standards. Note that we were not able to estimate EGU CO emissions.
Table 208 presents net changes in criteria air pollutant emissions from vehicles, EGUs and refineries resulting from the final standards.
Table 209 presents net changes in criteria air pollutant emissions from vehicles, EGUs, and refineries resulting from the final standards using our sensitivity case regarding the changes in U.S. refining in response to the projected lowered demand for liquid fuel (this sensitivity case is described in section VI.B of the preamble). EPA presents these results as a sensitivity given the uncertainty surrounding how changes in domestic demand for liquid fuel may impact domestic refining of liquid fuel.
Table 210 presents changes in emissions of air toxic pollutants from vehicles resulting from the final standards. Note that we were not able to estimate EGU or refinery toxic emissions.
The vehicle reductions in PM
Table 207 shows the “upstream” emissions impacts from EGUs and refineries. As explained in section IV.C.3 of the preamble, our power sector modeling predicts that EGU emissions will decrease between 2028 and 2055 due to increasing use of clean electricity primarily driven by provisions of the Inflation Reduction Act (IRA). As a
Table 208 shows the net impact of the final standards on emissions of criteria pollutants, accounting for vehicle, EGU, and refinery emissions. In 2055, when the fleet will be largely comprised of vehicles that meet the standards, there will be a net decrease in emissions of PM
The estimated refinery emission impacts include consideration of the impact of reduced liquid fuel demand on domestic refining. In the NPRM, the central analysis estimated that impact at 93 percent. In other words, 93 percent of the reduced liquid fuel demand results in reduced domestic refining. EPA noted the possibility that reduced domestic demand for liquid fuel would have no impact on domestic refining. In other words, domestic refiners would continue refining liquid fuel at the same levels and any excess would be exported for use elsewhere. In that event, there would be no decrease in domestic refinery emissions. In the proposal, EPA requested comment on the correct portion of reduced liquid fuel demand that would result in reduced domestic refining. EPA summarized those comments and provided responses in section VI.B of the preamble.
As discussed in RIA Chapter 8.6, the final analysis estimates that 50 percent of reduced domestic liquid fuel demand will result in reduced domestic refining. That estimate is reflected in the results presented in Table 208. As a sensitivity, EPA also estimated that just 20 percent of reduced domestic liquid fuel demand would result in reduced domestic refining. We chose this sensitivity as an estimate that falls between our central case where 50 percent of reduced demand would result in reduced domestic refining and a possible case in which this final rule would have no impact on domestic refining. The criteria pollutant impacts under that sensitivity case are shown in Table 209.
Table 210 shows reductions in vehicle emissions of air toxics. EPA expects this rule will reduce emissions of air toxics from light- and medium-duty vehicles. The GPF technology that EPA projects manufacturers will choose to use in meeting the final PM standards will decrease particle-phase pollutants, and the NMOG+NO
For most air toxic emissions, EPA relies on estimates from EPA's MOVES emissions model. In MOVES, emissions of most gaseous toxic compounds are estimated as fractions of the emissions of VOC. Toxic species in the particulate phase (
As discussed in section VII.A of the preamble, we project that the standards in the final rule will result in meaningful reductions in emissions of criteria and toxic pollutants from light- and medium-duty vehicles. We also project that the final standards will impact corresponding “upstream”
On the basis of the air quality modeling for this final rule, which uses projected emission impacts from the proposed standards,
We project that the rule will decrease annual average PM
When only the onroad emissions impacts of the rule are considered, annual average PM
We received a few comments about the impacts on ambient PM
We project that the rule will decrease ozone concentrations by an average of 0.09 ppb in 2055, with a maximum decrease of 0.71 ppb and a maximum increase of 0.36 ppb. The population-weighted average change in ozone concentrations will be a decrease of 0.16 ppb in 2055. In a few isolated areas, this rule is expected to result in increases in annual average ozone, likely due mainly to increases in EGU emissions. However, we project that more than 99 percent of the population will experience reductions in annual average ozone concentrations as a result of this rule.
When only the onroad emissions impacts of the rule are considered, ozone concentrations will decrease by an average of 0.09 ppb in 2055, with a maximum decrease of 0.70 ppb. The population-weighted average change in ozone concentrations attributable to the onroad emissions reductions will be a decrease of 0.16 ppb in 2055.
Chapter 7.4 of the RIA contains more detail on the impacts of the rule on ozone concentrations, as well as its impacts on county-level ozone design value concentrations in 2055.
We project that the rule will decrease annual NO
When only the onroad emissions impacts of the rule are considered, NO
Chapter 7.4 of the RIA contains more detail on the impacts of the rule on NO
We project that the rule will decrease annual SO
When only the onroad emissions impacts of the rule are considered, SO
Chapter 7.4 of the RIA contains more detail on the impacts of the rule on SO
In general, the air quality modeling results indicate that the rule will have relatively little impact on national average ambient concentrations of the modeled air toxics in 2055. Specifically, in 2055, our modeling projects that ambient 1,3-butadiene, benzene, and naphthalene concentrations will decrease by an average of less than 0.001 ug/m3 across the country. Acetaldehyde and formaldehyde will generally have small decreases in most areas with average annual reductions of 0.0021 ug/m3 and 0.0023 ppb for acetaldehyde and formaldehyde, respectively. We do project slight increases in benzene and formaldehyde concentrations in a few isolated areas of the country. Chapter 7.4 of the RIA contains more detail on the impacts of the modeled scenario on air toxics concentrations.
As described in section VII.B of this preamble and RIA Chapter 7, EPA conducted an air quality modeling analysis of a light- and medium-duty vehicle policy scenario in 2055. The results of that analysis found that in 2055, consistent with the OMEGA-based analysis, the standards will result in widespread decreases in criteria pollutant emissions that will lead to substantial improvements in public health and welfare. We estimate that in 2055, 1,000 to 2,000 PM
As noted in section VIII.J of the preamble, EPA received several comments related to the environmental justice (EJ) impacts of light- and medium-duty vehicles in general and the impacts of the proposal specifically. After consideration of comments, we conducted an EJ analysis using the 2055 air quality modeling data to evaluate how human exposure to future air quality varies with population characteristics relevant to potential environmental justice concerns in scenarios with and without the rule in place. The analysis is described in detail in RIA Chapter 7.6.
This rule applies nationally and will be implemented consistently throughout the nation. Specifically, because this final rule affects both onroad and upstream emissions, and because PM emission precursors and ozone can undergo long-range transport, we believe it is appropriate to conduct a national-scale EJ assessment of the contiguous U.S. As described in section VII.B of the preamble, and as depicted in the maps presented in RIA Chapter 7.4, these reductions will be geographically widespread. However, the spatial resolution of the air quality modeling data (12km by 12km grid cells) is not sufficient to capture the very local heterogeneity of human exposures, particularly the pollution concentration gradients near roads. Taking these factors into consideration, this analysis evaluates both national population-weighted average exposures and the distribution of exposure outcomes that will result from the final rule.
On average, all population groups included in the analysis will benefit from reductions in exposure to ambient PM
While national average results can provide some insight when comparing within and across population groups, they do not provide information on the full distribution of concentration impacts. This is because both population groups and ambient concentrations can be unevenly distributed across the spectrum of exposures, meaning that average exposures may mask important regional disparities. We therefore conducted a distributional analysis and found that for most of the population groups, the small differences in the distribution of pollution exposure reductions suggest that the rule is not likely to exacerbate nor mitigate PM
See RIA Chapter 7.6 for a detailed description of the methods and results of these analyses, including tables of national population-weighted average PM
This section summarizes our analyses of the rule's estimated costs, savings, and benefits. Overall, these analyses further support the reasonableness of the final standards.
Section VIII.A of the preamble summarizes the monetized costs, benefits, and net benefits of the final standards. Component costs and benefits, as well as transfers, are further discussed in sections VIII.B (vehicle technology and other costs), VIII.C (fueling impacts), V.D (non-emissions benefits), V.E (GHG benefits), V.F (criteria benefits), and V.G (transfers) of the preamble. Overall, EPA finds that the final rule creates significant positive net benefits for society. In addition, even when considering costs alone, this rule creates large cost savings due to cost increases (principally associated with higher vehicle technology and EVSE costs) being offset by significantly larger cost savings (principally associated with repair, maintenance,
EPA notes that, consistent with CAA section 202, in evaluating potential standards we carefully weighed the statutory factors, including the emissions impacts of the standards and the feasibility of the standards (including cost of compliance in light of available lead time). We monetize benefits of the standards and evaluate other costs in part to enable a comparison of costs and benefits pursuant to E.O. 12866, but we recognize there are benefits that we are currently unable to fully quantify. EPA's practice has been to set standards to achieve improved air quality consistent with CAA section 202, and not to rely on cost-benefit calculations, with their uncertainties and limitations, in identifying the appropriate standards. Nonetheless, our conclusion that the estimated benefits exceed the estimated costs of the final program reinforces our view that the standards are appropriate under section 202(a).
In sections VIII.H-K of this preamble, we consider additional non-monetized factors. As with the cost-benefit analysis, we did not rely on these factors in identifying the appropriate standards, but we find that these factors further support the reasonableness of this rule. In section VIII.H of this preamble, we find that this rule would have very small impacts (less than 0.8 percent) on light-duty vehicle sales, with increases in some years and decreases in other years. Though we do not expect this rule to impact new vehicle sales in a large way, as explained in section VIII.D.1 of this preamble we do expect the final standards will lead to increases in vehicle efficiency, making it possible for people to drive more without spending more and thus benefit from increased access to mobility. In section VIII.I of this preamble, we assess potential employment impacts, noting that the final standards are expected to increase employment in some sectors (
EPA estimates that the total benefits of this action far exceed the total costs with the annualized value of monetized net benefits to society estimated at $99 billion through the year 2055, assuming a 2 percent discount rate, as shown in Table 211.
The annualized value of vehicle technology costs is estimated at $40 billion. Notably, this rule will result in significant savings in vehicle maintenance and repair for consumers, which we estimate at an annualized value of $16 billion (note that these values are presented as negative costs, or savings, in the table). EPA projects generally lower maintenance and repair costs for electric vehicles and those societal maintenance and repair savings grow significantly over time. We also estimate various impacts associated with our assumption that consumers choose to drive more due to the lower cost of driving under the standards, called the rebound effect (as discussed further in section VIII of this preamble and in Chapters 8 and 9 of the RIA). Increased traffic noise and congestion costs are two such effects due to the rebound effect, which we estimate at an annualized value of $1.2 billion.
EPA also estimates impacts associated with fueling the vehicles under our standards. The rule will provide significant savings to society through reduced fuel expenditures with annualized pre-tax fuel savings of $46 billion. Somewhat offsetting those fuel savings is the expected cost of EV chargers, or electric vehicle supply equipment (EVSE), of $9 billion.
This rule includes other benefits not associated with emission reductions. Energy security benefits are estimated at an annualized value of $2.1 billion. The drive value benefit, which is the value of consumers' choice to drive more under the rebound effect, has an estimated annualized value of $2.1 billion. The refueling time impact includes two effects: time saved refueling for ICE vehicles with lower fuel consumption under our standards, and mid-trip recharging events for electric vehicles. Our past GHG rules have estimated that refueling time would be reduced due to the lower fuel consumption of new vehicles; hence, a benefit. However, in this analysis, we are estimating that refueling time will increase somewhat overall for the fleet due to our additional assumption for mid-trip recharging events for electric vehicles. Therefore, the refueling time impact represents a disbenefit (a negative benefit) as shown, with an annualized value at negative $0.8 billion. As noted in section VIII of this preamble and in RIA Chapter 4, we have updated our refueling time estimates but still consider them to be conservatively high for electric vehicles considering the rapid changes taking place in electric vehicle charging infrastructure driven largely by the Bipartisan Infrastructure Law and the Inflation Reduction Act.
Note that some costs are shown as negative values in Table 211. Those entries represent savings but are included under the “costs” category because, in past rules, categories such as repair and maintenance have been viewed as costs of vehicle operation; as discussed above, under this rule we project significant savings in repair and maintenance costs for consumers. Where negative values are shown, we
EPA received several comments related to the benefit-cost analysis. We summarize and respond to those comments in the Response to Comments document that accompanies this rulemaking. We have updated our analysis in light of comments and new data although we have not changed our general framework for conducting our benefit cost analysis. Consideration of comments also did not affect our conclusion that the benefits of the proposed and final rules significantly outweigh the costs. EPA follows applicable guidance and best practices when conducting its benefit-cost analyses.
Here we summarize results for the final standards. We present results for the two alternatives in Chapter 9 of the RIA.
Table 212 shows the estimated annual costs of the program for the indicated calendar years (CY). The table also shows the present-values (PV) of those costs and the annualized values (AV) for the calendar years 2027-2055 using 2, 3 and 7 percent discount rates.
We expect the technology costs of the program will result in a rise in the average purchase price for consumers, for both new and used vehicles. While we expect that vehicle manufacturers may choose to strategically price vehicles (
Our estimated incremental vehicle technology costs have increased since the NPRM, which we discuss at length throughout this preamble. The technology cost updates resulted in generally lower cost inputs but the magnitude of the changes were larger for ICE technologies than for HEV, PHEV and BEV technologies. As a result, the incremental costs of our Action scenarios compared to the No Action case have increased.
Associated with the changing cost of vehicles will be a change in insurance paid by owners and drivers of those vehicles. We received comment that we should have included insurance costs in our analysis, and we agree that it is appropriate to do so. To estimate insurance costs, we made use of an analysis done by ANL which focused on insurance costs associated with comprehensive and collision coverage.
To estimate the vehicle value in calculating insurance costs, we used a 14.9 percent annual depreciation rate (see Chapter 4.3.6 of the RIA). That depreciation rate is applied to the estimated price of the vehicle when new, which we take to be the purchase price calculated within OMEGA taking into consideration cross-subsidies and any applicable battery tax credits or, in other words, the estimated price paid by the consumer prior to receiving a vehicle purchase tax credit.
We did not estimate insurance costs in the NPRM, so these costs are new and represent increased costs relative to the proposal. As discussed, our estimated insurance rates differ slightly by body-style, but not by powertrain type. Note that insurance costs are calculated for all years of a vehicle's lifetime.
Maintenance and repair (M&R) are significant components of the cost of ownership for any vehicle. According to Edmunds, maintenance costs consist of two types of maintenance: scheduled and unscheduled. Scheduled maintenance is the performance of factory-recommended items at periodic mileage or calendar intervals. Unscheduled maintenance includes wheel alignment and the replacement of items subject to wear and usage such as the low-voltage battery, brakes, headlights, hoses, exhaust system parts,
We received comment that replacement of the high-voltage battery in PEVs should be considered as a maintenance and repair cost. EPA disagrees that high-voltage batteries will routinely need to be replaced in this way during the useful life of the vehicle. Based on current experience with vehicles in use in the field, and consultations on this topic that EPA has conducted with experts, stakeholders, and manufacturers, EPA finds no evidence that battery replacements out of warranty will typically be necessary for PEVs during their useful life, and therefore we do not include the cost of battery replacement in the cost of PEV maintenance and repair. We also note that the battery durability and warranty standards established in this rule provide greater assurance and transparency regarding battery performance and the conditions under which a warranty repair or replacement must be honored.
To estimate maintenance and repair costs, we have used the data gathered and summarized by Argonne National Laboratory (ANL) in their evaluation of the total cost of ownership for vehicles of various sizes and powertrains.
Maintenance costs are an important consideration in the full accounting of social benefits and costs and in a consumer's purchase decision process. In their study, ANL developed a generic maintenance service schedule for various powertrain types using owner's manuals from various vehicle makes and models, assuming that drivers would follow the recommended service intervals. After developing the maintenance schedules, the authors collected national average costs for each of the preventative and unscheduled services, noting several instances where differences in consumer characteristics and in vehicle attributes were likely important but not quantified/quantifiable.
Using the schedules and costs developed by the ANL authors and presented in the RIA, OMEGA calculates the cumulative maintenance costs from mile zero through mile 225,000. Because maintenance costs typically increase over the life of the vehicle, we estimate maintenance and repair costs per mile at a constant slope with an intercept set to $0 per mile such that the cumulative costs per the maintenance schedule are reached at 225,000 miles. Following this approach, the maintenance cost per mile curves calculated within OMEGA are as shown in Figure 44.
Using these maintenance cost per mile curves, OMEGA then calculates the estimated maintenance costs in any given year of a vehicle's life based on the miles traveled in that year. Table 212 presents the maintenance costs (savings) associated with the final rule. For a more detailed discussion of maintenance costs, including costs associated with the alternative scenarios analyzed in support of this final rule, see RIA Chapter 4.
Our maintenance savings are lower in the final analysis than in the NPRM. Because maintenance costs are estimated to depend on both powertrain type and miles driven, our incremental
Repairs are done to fix malfunctioning parts that inhibit the use of the vehicle and are generally considered to address problems associated with parts or systems that are covered under typical manufacturer bumper-to-bumper type warranties. In the ANL study, the authors were able to develop a repair cost curve for a gasoline car and a series of scalers that could be applied to that curve to estimate repair costs for other powertrains and vehicle types.
OMEGA makes use of ANL's cost curve and multipliers to estimate repair costs per mile at any age in a vehicle's life. Figure 45 provides repair cost per mile for a $35,000 car, van/SUV, and pickup, and Figure 46 provides the same information for medium-duty vans and pickups.
Table 212 presents the repair costs associated with the final rule. A more detailed discussion of repair costs appears in RIA Chapter 4.
Similar to maintenance savings, our incremental repair savings are lower in the final analysis compared to the NPRM but for slightly different reasons. Our estimated repair costs depend on body style, powertrain type and, importantly, estimated vehicle cost when new. While our final analysis has more pickups and SUVs than our proposal, which serves to reduce repair costs, our final analysis also has slightly fewer BEVs and more HEVs and PHEVs than in our NPRM which serves to increase costs. More importantly, our incremental vehicle costs are higher in the final analysis due in part to the updated technology costs as discussed in Chapters 2.5 and 2.6 of the RIA and because of inflationary effects on manufacturer suggested retail prices in our base year analysis fleet.
Costs associated with congestion and noise can increase in the event that drivers with more efficient vehicles drive more than they otherwise would have. This can occur because more efficient vehicles have lower fuel costs per mile of driving which allows drivers to drive more miles while spending the same amount of money they spent while driving their old, less efficient vehicle. This is known as the “rebound effect.” Delays associated with congestion impose higher costs on road users in the form of increased travel time and operating expenses. Likewise, vehicles driving more miles on roadways leads to more road noise from tires, wind, engines, and motors.
As in past rulemakings (
Both incremental congestion and noise costs are higher in our final analysis than our NPRM due to the additional rebound miles estimated in the final analysis which uses the same rebound rates as in the NPRM but with an updated methodology to more appropriately account for PHEVs (See Chapter 8.3 of the RIA).
The final standards are projected to reduce liquid fuel consumption (gasoline and diesel) while simultaneously increasing electricity consumption. The net effect of these changes in consumption for consumers is decreased fuel expenditures or fuel savings. For more information regarding fuel consumption, including other considerations like rebound driving, see RIA Chapter 4.
Fuel savings arise from reduced expenditures on liquid fuel due to reduced consumption of those fuels. Electricity consumption is expected to increase, with a corresponding increase in expenditures on electricity, due to electric vehicles replacing liquid-fueled vehicles. We describe how we calculate reduced fuel consumption and increased electricity consumption in Chapter 8 of the RIA. Table 215 presents liquid-fuel and electricity consumption impacts.
Table 216 presents the retail fuel savings, net of savings in liquid fuel expenditures and increases in electricity expenditures. These represent savings that consumers would realize. The table also presents the pretax fuel savings, net of savings in liquid fuel expenditures and increases in electricity expenditures. These represent the savings included in the net benefit calculation since fuel taxes do not contribute to the value of the fuel. We present fuel tax impacts along with other transfers in section VIII.G of this preamble.
Our incremental retail fuel savings in the final analysis are lower than those estimated in the NPRM due to the lower share of BEVs in the vehicle stock (roughly 42 percent in 2055 versus nearly 50 percent in the NPRM).
Another fueling impact included in the net benefits calculation is the EVSE costs discussed in section IV.C of this preamble and in Chapter 5 of the RIA. We present our estimated EVSE costs in Table 217. Note that the costs shown in Table 217 represent costs associated with the EVSE ports themselves and not the electricity delivered by them. Those electricity costs are included in Table 216.
Table 218 presents the estimated benefits that are not a direct result of emission inventory changes. Those benefits include the drive value, reductions in refueling time, and energy security. As shown in the table, the refueling time benefits are negative, meaning they are disbenefits. This benefit category in past rules has primarily represented reduced time spent on refueling due to improved vehicle efficiency. However, in this rule we're also including an estimate of mid-trip charging for BEVs, which includes increased time for refueling compared to ICE vehicles, resulting in more refueling time overall under the final standards and, therefore, a disbenefit.
Mentioned briefly above and discussed in greater detail in Chapter 4 of the RIA, the rebound effect might occur when an increase in vehicle efficiency makes it possible for people to choose to drive more without spending more because of the lower cost per mile of driving. Additional driving can lead to costs and benefits that can be monetized. See RIA Chapter 4 for a discussion of our estimates of the rebound effect. In this section, we take the size of the rebound effect, as discussed in the RIA, and highlight the costs and benefits associated with additional driving.
The increase in travel associated with the rebound effect produces social and economic opportunities that become accessible with additional travel. We estimate the economic benefits from increased rebound-effect driving as the sum of the fuel costs paid to drive those miles and the owner/operator surplus from the additional accessibility that driving provides. These benefits are known as the drive value and appear in Table 218.
The economic value of the increased owner/operator surplus provided by additional driving is estimated as one half of the product of the fuel savings per mile and rebound miles.
Our incremental drive value benefits are higher in the final analysis than the NPRM due entirely to revised estimation of rebound miles used for the final analysis and as discussed in Chapter 8.3 of the RIA. As noted in section VIII.B.4 of the preamble the change in rebound miles between the final analysis and the NPRM is the result of our improved calculation approach within OMEGA and not the result of any changes to the elasticity parameter used in calculating rebound.
In our analyses, we take into account refueling differences among liquid fuel vehicles, BEVs, and PHEVs. Provided fuel tanks on liquid fueled vehicles retain their capacity, lower fuel consumption is expected to reduce the frequency of refueling events and therefore reduce the time spent refueling resulting from less time spent seeking a refueling opportunity. OEMs may also elect to package smaller fuel tanks, leveraging lower fuel consumption to meet vehicle range, which would maintain fueling frequency but decrease the time spent refueling since it takes less time to fill a smaller fuel tank. Consistent with past analyses, we have estimated the former of these possibilities with respect to liquid fueled vehicles.
Electric vehicles are fueled via charging events. Many charging events are expected to occur at an owner's residence via a personally owned charge point or during work hours using an employer owned charge point, both of which impose very little time burden on the driver. However, charging events will also occur in public places where the burden on the driver's time may be relatively long (
The estimated incremental refueling time disbenefits are lower in the final analysis than the NPRM due largely to the updated number of miles per hour of mid-trip charging where the NPRM used a value of 100 miles per hour of charging and the final analysis uses a value of 400 miles per hour of charging. We discuss this change in more detail in Chapter 4.3 of the RIA.
In this section, we evaluate the energy security impacts of the final standards. Energy security is broadly defined as the uninterrupted availability of energy sources at affordable prices.
The U.S.'s oil consumption had been gradually increasing in recent years (2015-2019) before the COVID-19 pandemic in 2020 dramatically decreased U.S. and global oil consumption.
Oil is a commodity that is globally traded and, as a result, an oil price shock is transmitted globally. Given that the U.S. is projected to be a net exporter of crude oil and refined petroleum products for the time frame of this analysis (2027-2055), one could reason that the U.S. no longer has a significant energy security problem. However, U.S. refineries still rely on significant imports of heavy crude oil which could be subject to supply disruptions. Also, oil exporters with a large share of global production have the ability to raise or lower the price of oil by exerting the market power associated with the
We anticipate that U.S. consumption and net imports of petroleum will be reduced as a result of this final rule, both from an increase in fuel efficiency of light- and medium-duty vehicles using petroleum-based fuels and from the greater use of PEVs which are fueled with electricity. A reduction of U.S. net petroleum imports reduces both the financial and strategic risks caused by potential sudden disruptions in the supply of petroleum to the U.S. and global market, thus increasing U.S. energy security. Table 219 presents the impacts on U.S. imports of oil for selected years for the final rule. For EPA's assessment of the U.S. oil impacts of a more stringent and a less stringent alternative standard, see the Chapter 8 of the RIA.
It is anticipated that vehicle manufacturers will choose to comply with the final standards in part with an increased penetration of PEVs. Compared to the use of petroleum-based fuels to power vehicles, electricity used in PEVs is anticipated to be generally more affordable and more stable in its price,
Several commenters claimed that the proposal would improve the U.S.'s energy security and independence position by increasing the wider use of electric vehicles. We agree with these commenters that the wider use of electricity in light- and medium-duty PEVs will improve the U.S.'s energy security and energy independence position. We respond to these comments in more detail in section 21 of the RTC document.
In order to understand the energy security implications of reducing U.S. oil imports, EPA has worked with Oak Ridge National Laboratory (ORNL), which has developed approaches for evaluating the social costs and energy security implications of oil use. When conducting this analysis, ORNL estimates the risk of reductions in U.S. economic output and disruption to the U.S. economy caused by sudden disruptions in world oil supply and associated price shocks (
One commenter supported the use of the ORNL energy security methodology being used by EPA to estimate the oil security premiums in the proposed LMDV rule. Another commenter raised concerns that the ORNL oil security premium estimates that EPA is using in this proposed LMDV GHG rule are too high. This commenter claimed that the energy security methodology developed by ORNL is outdated and is no longer applicable to the current structure of global oil markets. In response, EPA notes that the ORNL model is continually updated to the current structure of global oil markets. Also, EPA and ORNL have worked together to revise the macroeconomic oil security premiums based upon the recent energy security literature. Based on the above, EPA concludes that the macroeconomic oil security premiums used in this final rulemaking are reasonable. We respond to these comments in more detail in the RTC document (see RTC section 21).
For this final rule, EPA is using macroeconomic oil security premiums estimated using ORNL's methodology, which incorporates updated oil price projections and energy market and economic trends from the U.S. Department of Energy's Energy Information Administration's (EIA) Annual Energy Outlook (AEO) 2023. To calculate the macroeconomic oil security benefits of this final rule, EPA is using the ORNL macroeconomic oil security premium methodology with: (1) estimated oil savings calculated by EPA and (2) an oil import reduction factor of 94.8 percent, which reflects our estimate of how much changes in U.S. oil consumption anticipated under the final standards will be reflected in changes in U.S. net oil imports. Based upon comments EPA received on this proposal and in consultation with DOE and NHTSA, the oil import reduction factor is being updated for this final rule to be consistent with revised estimates that U.S. refineries will operate at higher production levels than EPA estimated in the proposed rule. See Chapter 8 of the RIA and section 12 of the RTC document for more discussion of how EPA is updating its refinery throughput assumptions and, in turn, air quality impacts from refinery emissions, as a result of this rule. See Chapter 10 of the RIA and section 21 of the RTC document for EPA's discussion of how EPA is updating the oil import reduction factor to be consistent with new estimates of refinery throughput for this final rule. Below EPA presents macroeconomic oil security premiums for selected years being used for the final standards in Table 220. The energy security benefits for selected years for this final rule are presented in Table 218 and Table 9-7 in Chapter 9 of the RIA. For EPA's assessment of the energy security benefits of a more and a less
Some commenters suggested that the proposal would reduce the demand for renewable fuels since the proposal focused on the promotion of the wider use of PEVs. These commenters asserted that EPA should instead focus upon achieving U.S. energy security and energy independence objectives by increasing the use of flexible-fueled vehicles/higher ethanol blends and the greater use of renewable fuels (
Many commenters asserted that while EPA focuses on the energy security benefits of reduced dependence on U.S. oil imports, EPA fails to address the energy security threats of the U.S.'s increasing dependence on imports of minerals and PEV battery supply chains as a result of this rule. For this rule, EPA distinguishes between energy security, mineral/metal security and security issues associated with the importation of PEV batteries and component parts. Since energy security, metal/mineral security and issues associated with the importation of PEV batteries and various components are distinct issues in terms of their characteristics and potential impacts, EPA separates these types of security issues in this rulemaking. We address energy security issues associated with this final rule in section 21 of the RTC document. Comments associated with wider use of PEVs impacts on the U.S.'s mineral/metal security and security issues associated with the importation of PEV batteries and their component parts are addressed in separate EPA responses in this rule's RTC document (see RTC section 15).
In light of the public comments and consideration of the information in the public record, it continues to be our assessment that the energy security benefits of the final standards are substantial and, as discussed in section IV.C.7.iii of this preamble, we do not find that compliance with the standards will lead to a long-term dependence on foreign imports of critical minerals or components that would adversely impact national security.
EPA estimates the climate benefits of GHG emissions reductions expected from the final rule using estimates of the social cost of greenhouse gases (SC-GHG) that reflect recent advances in the scientific literature on climate change and its economic impacts and incorporate recommendations made by the National Academies of Science, Engineering, and Medicine.
The SC-GHG is the monetary value of the net harm to society associated with a marginal increase in GHG emissions in a given year, or the benefit of avoiding that increase. In principle, SC-GHG includes the value of all climate change impacts (both negative and positive), including (but not limited to) changes in net agricultural productivity, human health effects, property damage from increased flood risk and natural disasters, disruption of energy systems, risk of conflict, environmental migration, and the value of ecosystem
Since 2008, EPA has used estimates of the social cost of various greenhouse gases (
EPA is a member of the IWG and is participating in the IWG's work under E.O. 13990. As noted in previous EPA RIAs—including in the proposal RIA for this rulemaking-, while that process continues, EPA is continuously reviewing developments in the scientific literature on the SC-GHG, including more robust methodologies for estimating damages from emissions, and looking for opportunities to further improve SC-GHG estimation. In the December 2022 Oil and Gas Supplemental Proposal RIA,
EPA solicited public comment on the sensitivity analysis and the accompanying draft technical report, External Review Draft of Report on the Social Cost of Greenhouse Gases: Estimates Incorporating Recent Scientific Advances, which explains the methodology underlying the new set of estimates and was included as supplementary material to the RIA for the December 2022 Supplemental Oil and Gas Proposal.
As we noted in the light- and medium-duty vehicle NPRM, to ensure that the methodological updates adopted in the technical report are consistent with economic theory and reflect the latest science, EPA also initiated an external peer review panel to conduct a high-quality review of the technical report (see 88 FR 29372, noting this peer review process was ongoing at the time of our proposal); this peer review was completed in May 2023. The peer reviewers commended the agency on its development of the draft update, calling it a much-needed improvement in estimating the SC-GHG and a significant step towards addressing the National Academies' recommendations with defensible modeling choices based on current science. The peer reviewers provided numerous recommendations for refining the presentation and for future modeling improvements, especially with respect to climate change impacts and associated damages that are not currently included in the analysis. Additional discussion of omitted impacts and other updates were incorporated in the technical report to address peer reviewer recommendations. Complete information about the external peer review, including the peer reviewer selection process, the final report with individual recommendations from peer reviewers, and EPA's response to each recommendation is available on EPA's website.
Chapter 6.1 of the RIA provides an overview of the methodological updates incorporated into the SC-GHG estimates used in this final rule. A more detailed explanation of each input and the modeling process is provided in the final technical report, EPA Report on the Social Cost of Greenhouse Gases: Estimates Incorporating Recent Scientific Advances (U.S. EPA, 2023e).
Commenters on our LMDV NPRM brought up issues regarding baseline scenarios, climate modeling (
Table 221 through Table 224 present the estimated annual, undiscounted climate benefits of the net GHG emissions reductions associated with the final rule, and consequently the annual quantified benefits (
The light-duty passenger cars and light trucks and medium-duty vehicles subject to the standards are significant sources of mobile source air pollution, including directly-emitted PM
This section discusses the economic benefits from reductions in adverse health and environmental impacts resulting from criteria pollutant emission reductions that can be expected to occur as a result of the final emission standards. When feasible, EPA conducts full-scale photochemical air quality modeling to demonstrate how its national mobile source regulatory actions affect ambient concentrations of regional pollutants throughout the United States. The estimation of the human health impacts of a regulatory action requires national-scale photochemical air quality modeling to conduct a full-scale assessment of PM
EPA conducted an air quality modeling analysis of a regulatory scenario in 2055 involving light- and medium-duty vehicle emission reductions and corresponding changes in “upstream” emission sources like EGU (electric generating unit) emissions and refinery emissions. The results of this analysis are summarized in section VII of this preamble and discussed in more detail in RIA Chapter 7. Year 2055 was selected as a year that best represents the fleet turning over to nearly full implementation of the final standards. Decisions about the emissions and other elements used in the air quality modeling were made early in the analytical process for the final rulemaking. Accordingly, the air quality analysis does not fully represent the final regulatory scenario; however, we consider the modeling results to be a fair reflection of the impact the standards will have on PM
The BPT approach estimates the monetized economic value of PM
For the analysis of the final standards, we use the same mobile sector BPT estimates that were used in the proposal, except the constant dollar year they represent has been updated from year 2020 dollars to year 2022 dollars. The mobile sector BPTs were first published in 2019 and then updated to be consistent with the suite of premature mortality and morbidity studies used by EPA for the 2023 PM NAAQS Reconsideration Proposal.
A chief limitation to using PM
Table 225 presents the annual, undiscounted PM
We use a constant 3-percent and 7-pecent discount rate to calculate present and annualized values in Table 225, consistent with current applicable OMB Circular A-4 guidance. For the purposes of presenting total net benefits (see section VIII.A of this preamble), we also use a constant 2-percent discount rate to calculate present and annualized values. We note that we do not currently have BPT estimates that use a 2-percent discount rate to account for the value of those avoided health outcomes that are expected to accrue over more than a single year. If we discount the stream of annual benefits in Table 225 based on the 3-percent cessation lag BPT using a constant 2-percent discount rate, the present value of total PM
We believe the PM
There are four types of transfers included in our analysis. Two of these transfers come in the form of tax credits arising from the Inflation Reduction Act to encourage investment in battery technology and the purchase of electrified vehicles. These are transfers from the government to producers of vehicles (the 45X battery production tax credits), or to purchasers of vehicles (the 30D tax credit) or to lessors or commercial purchasers (the 45W tax credit). There are also transfers from the government to individuals and businesses who install EVSE (the 30C tax credit)
As discussed in section IV.A of this preamble, EPA used the OMEGA model to analyze projected impacts of this rule, including impacts on vehicle sales. The OMEGA model accounts for interactions in producer and consumer decisions in total sales and in the share of ICE and PEV vehicles in the market. As in the proposal, the sales impacts are based on a set of assumptions and inputs, including assumptions about the role of fuel consumption in vehicle purchase decisions, and assumptions on consumers' demand elasticity.
As in the proposal, for this final rule EPA separately represents the producer's perception of the purchase decision and the consumer's purchase decision. Focusing on producers, EPA assumes that automakers believe that LD vehicle buyers account for about 2.5 years of fuel consumption in their purchase decision.
In OMEGA, we use an estimate of demand elasticity to model the change in vehicle demand due to this rule. The demand elasticity is the percent change in quantity of vehicles demanded associated with a one percent change in vehicle price. This is explained further in Chapter 4.4.1 of the RIA. We received comment on the use of a demand elasticity of −0.4 in the proposal, with one commenter stating that it was too small. The commenter urged us to use an elasticity of at least −1.0, similar to what was used for previous rules and what NHTSA has used for previous rules. Continuing the approach in the proposal, however, EPA is using a demand elasticity for new LD vehicles of −0.4. The choice of elasticity is based on a 2021 EPA peer reviewed report, which included a literature review on and estimates of the effects of new vehicle price changes on the new vehicle market,
Under the final standards, there is a small change projected in total new LD vehicle sales compared to sales under the No Action scenario for each year under from MY 2027 through MY 2032.
Similar to the sales impacts of the final rule, total new vehicle sales impacts under the alternative scenarios analyzed show a very small change in sales compared to the No Action scenario. For more information on the estimates of sales impacts under the more and less stringent alternatives analyzed for this final rule, see Chapter 4.4 of the RIA.
In contrast to the light-duty market, the medium-duty vehicle market largely serves commercial applications. Thus, the assumptions in our analysis of the MD sales response are specific to that market, and do not arise from studies focused on the LD vehicle market.
A possible, though unlikely, sales effect on commercial medium-duty vehicles is pre-buy and low-buy. Pre-buy occurs when a purchaser makes a planned purchase sooner than originally intended in anticipation of EPA regulation that may make a future vehicle, under new regulations, have a higher upfront or operational cost, or have reduced reliability. Low-buy occurs when a vehicle that would have been purchased after the implementation of a regulation is either not purchased at all, or the purchase is delayed. Low-buy may occur directly as a function of pre-buy (where a vehicle was instead purchased prior to implementation of the new regulation), or due to a vehicle purchaser delaying the purchase of a vehicle due to cost or uncertainty. Pre- and low-buy are short-term effects, with research indicating that effects are seen for one year or less before and after a regulation is implemented.
In the NPRM, we asked for comment on our assumptions for MD vehicle sales impacts. One commenter stated that the assumption of an elasticity of 0 for MD vehicle sales impacts was not appropriate, suggesting that we use an elasticity of at least −1.0. The commenter did not provide research or data to support a change in our assumption for this rule, especially not to increase the price sensitivity of medium-duty vehicle buyers to be greater than that of light-duty vehicle purchasers. Though there may be impacts in the short term that are not captured by our demand assumptions, in the long term, we assume that commercial vehicle buyers will purchase the vehicle that fits their
In this section, we assess the employment impacts associated with this rule. As we explain in sections I and IV of this preamble, manufacturers are already rapidly shifting production away from ICE vehicles and toward PEVs, a trend that is occuring independent of this rulemaking and strongly supported by the Inflation Reduction Act. This shift is associated with decreased employment in some sectors (
First, given the rapid surge in PEVs expected over the next decade, there is a tremendous opportunity for increases in domestic manufacturing and employment associated with PEVs and their components, such as batteries. Congress strongly supported these increases in domestic manufacturing through the BIL, CHIPS Act, and IRA as described further in section VIII.I.1 of this preamble, below. Consistent with Congressional policy, this rulemaking further signals strong demand for PEVs domestically to meet GHG emissions reduction targets and contributes to a favorable regulatory environment for the United States to capture the increased manufacturing and employment associated with PEVs and their components. This positive impact is consistent with the history of EPA's Clean Air Act programs, where strong emission standards have historically contributed to the U.S. being a global leader in the supply of air pollution control equipment, with corresponding benefits for U.S. global competitiveness and domestic employment. In addition, there are extensive opportunities related to PEV charging infrastructure build-out and maintenance. These opportunities are enhanced by many projects and efforts put forth by Federal and State agencies and other public and private groups, as described throughout this section, as well as in Chapter 4.5 of the RIA and section 20 of the RTC.
Second, while EPA has not been able to comprehensively quantify the net changes in employment associated with this rule, we do estimate a partial quantitative analysis of employment impacts associated with this rule. The partial analysis finds that there is greater potential for overall job growth in the sectors included in the analysis for this rule than potential job losses, and that the potential for positive employment impacts increases over time.
If the U.S. economy is at full employment, even a large-scale environmental regulation is unlikely to have a noticeable impact on aggregate net employment. Instead, labor would primarily be reallocated from one productive use to another, and net national employment effects from environmental regulation would be small and transitory (
Economic theory of labor demand indicates that employers affected by environmental regulation may change their demand for different types of labor in different ways. They may increase their demand for some types, decrease demand for other types, or maintain demand for still other types. The uncertain direction of labor impacts is due to the different channels by which regulations affect labor demand. A variety of conditions can affect employment impacts of environmental regulation, including baseline labor market conditions, employer and worker characteristics, industry, and region. In general, the employment effects of environmental regulation are difficult to disentangle from other economic changes (especially the state of the macroeconomy) and business decisions that affect employment, both over time and across regions and industries. In light of these difficulties, we look to economic theory to provide a constructive framework for approaching these assessments and for better understanding the inherent complexities in such assessments.
In the proposal and previous rules (for example the 2021 rule), we estimated a partial employment effect on LD ICE vehicle manufacturing due to the increase in technology costs of the rule. In addition, the increasing penetration of electric vehicles in the market is likely to affect both the number and the nature of employment in the auto and parts sectors and related sectors, such as providers of charging infrastructure. Over time, as PEVs become a greater portion of the new vehicle fleet, the kinds of jobs in auto manufacturing are expected to change. For instance, there is no need for engine and exhaust system assembly for BEVs, while many assembly tasks for BEVs involve electrical rather than mechanical fitting. In addition, batteries represent a significant portion of the manufacturing content of an electrified vehicle, both BEVs and PHEVs, and some automakers are likely to purchase the cells, if not
In comments on the proposed rule, California Air Resources Board (CARB) stated that the proposed standards present opportunities for growth in many sectors across the U.S., including auto manufacturing, electricity in general and ZEV supply chains. A report by the Economic Policy Institute suggests that U.S. employment in the auto sector could increase if the share of vehicles, or powertrains, sold in the United States that are produced in the United States increases.
The UAW states that re-training programs will be needed to support auto workers in a market with an increasing share of electric vehicles in order to prepare workers that might be displaced by the shift to the new technology.
This expected private investment is also supported by recent Federal investment which will encourage increased investment along the vehicle supply chain, including domestic critical minerals, materials processing, battery manufacturing, charging infrastructure, and vehicle assembly and vehicle component manufacturing. This investment includes the BIL, the CHIPS Act, and the IRA. The BIL was signed in November 2021 and provides over $24 billion in investment in electric vehicle chargers, critical minerals, and battery components needed by domestic manufacturers of EV batteries and for
In addition, the IRA is expected to lead to increased demand for PEVs through tax credits for purchasers of PEVs. The BlueGreen Alliance and the Political Economy Research Institute estimate that IRA will create over 9 million jobs over the next decade, with about 400,000 of those jobs being attributed directly to the battery and fuel cell vehicle provisions in the act.
It is important to note that investments from the IRA have, so far, been focused in more economically disadvantages counties. The U.S. Department of Treasury states that as of November 2023, 70 percent of post-IRA investments in clean energy have happened in counties with a smaller share of the population employed than the U.S. average; almost 80 percent have happened in counties with below-average medium household incomes; more than 80 percent of have happened in counties with below-average wages; and more than 85 percent have gone to counties with below-average college graduation rates.
It is also important to note that though the majority of this discussion focuses on possible direct impacts these Federal Acts may have on jobs along the vehicle supply chain (including domestic critical minerals, materials processing, battery manufacturing, charging infrastructure, and vehicle assembly and vehicle component manufacturing), there may also be indirect job creation and support, for example, in constructing the new manufacturing facilities.
In the proposal, we asked for comment on our employment analysis. Some commenters, including the UAW, BlueGreen Alliance and the United Steelworkers Union, provided comments on possible impacts on both job quality and geographic impacts of the rule making the point that not all jobs should be treated as equal. The commenters stated that the rule will lead to a reduction in job quality, citing current differences in job quality for those working in plants manufacturing ICE vehicles, and those working in plants manufacturing BEVs or vehicle batteries. Commenters stated that the BEV and battery plant workers receive lower pay, fewer benefits, and are not unionized in comparison to those working at ICE manufacturing plants. In addition, commenters state that even if the number of jobs at the national level does not change, there will be local community level impacts due to the location of those jobs changing. For example, employment at an ICE plant in one community might be reduced while employment at a BEV or battery plant in another community might increase. Though the number of jobs might not change, employment in the “losing” community will decrease, or workers from that community might have to relocate if they are able. The UAW, in comments on the proposed rule stated support for emission reductions, though they also indicate a slower phase in of ZEVs into the market than that projected in the proposal would better support employees in auto manufacturing and supporting industries.
Even with expected increases in employment in component production and new domestic jobs related to ZEVs, these shifts in production may negatively affect workers currently employed in production of ICE vehicles. We acknowledge the possibility of geographically localized effects, and that there may be job quality impacts associated with this rule, especially in the short term. We note that there are Federal programs to assist workers in the transition to low or zero emitting vehicles, including a DOE funding package which makes $2 billion in grants, and up to $10 billion in loans available to support projects converting existing automotive manufacturing facilities to support electric vehicle production.
We do not have data to estimate current or future job quality. Nor are we able to determine the future location of vehicle manufacturing and supporting industries beyond the public announcements made as of the publication of this rule. We note that, compared to the proposal, we are finalizing standards that extend flexibilities and provide a slower increase in the stringency of the standards in the early years of the program. The more gradual shift allows for a more moderate pace in the industry's scale up to the battery supply chain and manufacturing, which in turn should help to reduce any potential impacts in employment across all sectors impacted by this rule. In addition, as illustrated by the range of sensitivity analyses which demonstrate alternative technology pathways manufacturers might choose to comply with the standards, as shown in sections IV.E and F of the preamble, there are multiple ways OEMs can choose to meet the standards, including through a wide range of BEV and PHEV technologies. These pathways continue to provide ICE technologies including base ICE, advanced ICE and HEVs in addition to PHEVs and BEVs.
Consistent with the proposal, in RIA Chapter 4.5 we describe three ways employment at the firm level might be affected by changes in a firm's production costs due to environmental regulation: A factor-shift effect, in which post-regulation production technologies may have different labor intensities than their pre-regulation counterparts; a demand effect, caused by higher production costs increasing market prices and decreasing demand; and a cost effect, caused by additional environmental protection costs leading regulated firms to increase their use of inputs.
Factor-shift effects are due to changes in labor intensity of production due to the standards. We do not have data on how the regulation might affect labor intensity of production within ICE vehicle production. There is ongoing research on the different labor intensity of production between BEV and ICE vehicle production, with inconsistent results. Some research indicates that the labor hours needed to produce a BEV are fewer than those needed to produce an ICE vehicle, while other research indicates there are no real differences. EPA worked with a research group to produce a peer-reviewed tear-down study of a BEV (Volkswagen ID.4) to its comparable ICE vehicle counterpart (Volkswagen Tiguan).
Data on the labor intensity of PHEV production compared to ICE vehicle production is also very sparse. PHEVs share features with both ICE vehicles, including engines and exhaust assemblies, and BEVs, including motors and batteries. If labor is a function of the number of components, PHEVs might have a higher labor intensity of production compared to both BEV and ICE vehicles, and if they are produced in the U.S. may provide labor demand. The labor needs of battery production are also a factor of the total labor needs to build a PHEV.
Given the current lack of data and inconsistency in the existing literature, we are unable to estimate a quantitative factor-shift effect of increasing relative PEV production as a function of this rule. However, we can say, generally, that research indicates that if production of PEVs and their power supplies are done in the U.S. at the same rates as ICE vehicles, we do not expect employment to fall, and it may likely increase. Electric vehicle manufacturing plants and battery plants are being built and announced in the U.S., as discussed in section IV of this preamble. In addition, states are making efforts to support increasing domestic production of electric vehicles and batteries, including support for the workforce. An Executive Order issued in South Carolina prioritized implementing a strategic initiative to explore opportunities related to ongoing economic development, business support and recruitment efforts with electric vehicle and automotive manufacturers.
Factor shift effects do not account for a change in the total number of vehicles sold. Demand effects on employment are due to changes in labor due to changes in demand. In general, if the regulation causes total sales of new vehicles to increase, more workers will be needed to assemble vehicles and manufacture their components. However, if BEVs, PHEVs and ICE vehicles have different labor intensities of production, the relative change in BEV, PHEV, and ICE vehicles sales will impact the demand effect on employment. As a simple example, assume that sales of BEV, PHEV and ICE vehicles increase. This would mean that the change in employment due to an increase demand will depend on the labor intensity of BEV, PHEV and ICE vehicle production and the increase in their respective sales. Now assume that PEV sales increased while ICE vehicle sales decreased. If total sales increase, that would indicate that PEVs replaced ICE vehicles, but there was new sales demand as well. For ease of illustration, ignore PHEVs for now, and assume that all PEV vehicles in this scenario are BEVs. The change in employment under this scenario would depend on the factor shift effect (the relative BEV and ICE vehicle labor intensity) for the replaced ICE vehicles, and the demand effect (labor intensity of BEVs) for the new sales demand. Under this same scenario (PEV sales are increasing while ICE sales are decreasing, with increased total sales) where PEVs are both replacing ICE vehicles, and there is new sales demand for PEVs, there is additional complexity when those PEVs are broken up unto BEVs and PHEVs. The factor shift effect for the replaced ICE vehicles would depend on whether PHEVs or BEVs are replacing them. In addition, there may be situations where BEVs are being replaced by PHEVs, or vice versa, and that effect would depend on the relative labor intensities of BEV and PHEV production. The demand effect for the new sales will depend on the labor intensity of the new BEVs and the new PHEVs, as well as the share of each that are being introduced into the market each model year.
For the same reason we cannot estimate a factor-shift effect, namely that we do not know the labor intensity of BEV or PHEV vs ICE vehicle production, we are not currently able to estimate a demand-shift effect on employment.
The cost effects on employment are due to changes in labor associated with increases in costs of production. BEVs, PHEVs and ICE vehicles require different inputs and have different costs of production, though there are interchangeable, common, parts as well. In previous LD and HD rules, we have estimated a partial employment effect due to the change in costs of production. We estimated the cost effect using the historic share of labor in the cost of production to extrapolate future estimates of impacts on labor due to new compliance activities in response to the regulations. Specifically, we multiplied the share of labor in
As described in Chapter 4.6 of the RIA, we used historical data on the number of employees per $1 million in expenditures from the Employment Requirements Matrix (ERM) provided by the U.S. Bureau of Labor Statistics (BLS) to examine labor needs of six manufacturing sectors related to ICE and BEV vehicle production to determine trends over time. Three of these sectors (Electrical equipment and manufacturing, Other electrical equipment and component manufacturing and Semiconductor and other electronic component manufacturing) are more closely related to battery electric production, while the other three (Motor vehicle manufacturing, Motor vehicle body and trailer manufacturing, and Motor vehicle parts manufacturing) are sectors that are more generally related to both battery electric and ICE vehicle production.
Over time, the amount of labor needed in the motor vehicle industry has changed: Automation and improved methods have led to significant productivity increases, which is reflected in the estimates from the BLS ERM. For example, in 1997 about 1.2 workers in the Motor vehicle manufacturing sector were needed per $1 million, but only 0.7 workers by 2022 (in 2022$).
We attempt to estimate partial employment effects of this rule by separating out costs mainly associated with electrified portions of vehicle production (for example, batteries) and the ICE vehicle portion of production (for example, engines), as well as the costs that are common between them (for example, gliders.
In previous rules, we have estimated the cost effect, which is done while keeping sales constant. However, OMEGA estimates costs and changes in sales concurrently. Therefore, as we did in the proposal, the partial employment effect we estimate here is a combined cost and demand effect, and is meant to give a sense of possible partial employment effects, including directionality and relative magnitude. The estimate includes effects due to both LD and MD cost changes, as the costs used in the analysis were the combined estimated costs for the light- and medium-duty sectors, as well as the change in new vehicle sales in the LD market.
Table 228 shows our estimates of partial employment results for the final rule for each year for the three sector groups. See Chapter 4.5.4 of the RIA for more information on the employment analysis.
These results show negative employment effects in the ICE focused sectors (except for 2027) and the sectors common to the ICE and electrified portions of production. There are positive employment effects in the sectors focused on the electrified portions of production.
Table 229 shows the range from the smallest estimated employment gain across the combination of sector groups to the largest estimated potential employment gain across the combination of sector groups. This is not a straight sum of the smallest and largest effects as seen in Table 228 above, which are based on absolute value (closest to and furthest from zero) and are not affected by the direction of the effect, but a sum of the minimum and maximum estimated effects, which include direction of the effect. The estimated range shows an expected increase in employment from 2027 through 2032. In addition, these estimates indicate that possible job growth over time in PEV related sectors will be greater than possible job loss in ICE or common sectors, and those gains are increasing over time.
These results are consistent with the results of the FEV tear-down study, discussed in section VIII.I.2 of this preamble, and indicate that even if fewer labor hours are needed at the assembly plant, increased labor hours will be needed elsewhere in the supply chain for the electrified portions of production, for example in building and assembling battery packs.
With respect to possible employment effects in other sectors, economy-wide impacts on employment are generally driven by broad macroeconomic effects. However, employment impacts, both positive and negative, in sectors upstream and downstream from the regulated sector, or in sectors producing substitute or complementary products, may also occur as a result of this rule. For example, changes in electricity generation may have consequences for labor demand in those upstream industries. Lower per-mile fuel costs could lead to labor effects in ride-sharing or ride-hailing services through an increase in demand for those services. Increased mobility related to the lower cost per mile of driving, as discussed in section VIII.D.1 of this preamble may also benefit drivers or owner/operators in other ways, including through MD fleets being able to service a greater range of customers, or consumers having access to a larger geographic area for employment opportunities. Reduced demand for gasoline may lead to impacts on demand for labor in the gas station sector, although the fact that many gas stations provide other goods, such as food and car washes, will moderate possible losses in this sector. There may also be an increase in demand for labor in sectors that manufacture, build and maintain charging stations. To that end, the BIL is investing in the build out of EV chargers along America's major roads, freeways and interstates, focusing on domestically produced iron and steel, and domestically manufactured chargers.
Electrification of the vehicle fleet is likely to affect both the number and the nature of employment in the auto and parts sectors and related sectors, such as providers of charging infrastructure and utilities supporting grid enhancements. ICCT estimated that charging infrastructure growth in the U.S. could create about 160,000 jobs by 2032, in sectors ranging from electrical installation, maintenance and repair, charger assembly, general construction, software maintenance and repair, planning and design, and administration and legal.
Reduced consumption of petroleum fuel represents fuel savings for purchasers of fuel, as well as a potential loss in value of output for the petroleum refining industry, fuel distributors, and gasoline stations, which may result in reduced employment in these sectors. These impacts may also pass up the supply chain to, for example, pipeline construction, operation and maintenance, and domestic oil production. However, because the fuel production sector is material-intensive, and we estimate that only part of the reduction in liquid fuel consumption will be met by reduced refinery production in the U.S. (see RIA Chapter 10), the employment effect is not expected to be large. In addition, it may be difficult to distinguish these effects from other trends, such as increases in petroleum sector labor productivity that may also lower labor demand.
As discussed in section I of this preamble, there have been several legislative and administrative efforts enacted since 2021 aimed at improving the domestic supply chain for electric vehicles, including electric vehicle chargers, critical minerals, and components needed by domestic manufacturers of EV batteries. These actions are also expected to provide opportunities for domestic employment in these associated sectors.
The standards may affect employment for auto dealers through a change in vehicles sold, with increasing sales being associated with an increase in labor demand. However, vehicle sales are also affected by macroeconomic effects, and it is difficult to separate out the effects of the standards on sales from effects due to macroeconomic conditions. In addition, auto dealers may also be affected by changes in maintenance and service costs, as well as through changes in the maintenance needs of the vehicles sold. For example, reduced maintenance needs of BEVs would lead to reduced demand for maintenance labor.
Commenters on the proposal stated concerns about a lack of available technicians qualified to service electric vehicles and charging infrastructure. We do not agree that there will be a significant lack of technicians in the timeframe of this rule given investments and programs focused on training for EV sector positions (including those
Commenters discussed possible transitory effects on impacted industries, noting that there will not be a one-to-one job replacement, in part because battery processing operations are largely conducted overseas and workers trained in one field may not necessarily be able to move into another field, stating that the U.S. labor pool supporting the automotive industry will be redefined. As noted earlier in this section, and in section VIII.I.1 of this preamble, there are many programs and targeted investments through federal, state and private programs to support and enhance employment opportunities in the U.S. related to the automotive industry, battery manufacturing, and charging infrastructure and support across the supply chains.
Some commenters appear to ignore that the market share of new PEVs sold is increasing over time, while other commenters point out that the IRA has already led to new jobs in the automotive industry, including in battery manufacturing, and additional research shows job creation in charging infrastructure industry. We agree that a shift in the automotive industry is already underway and, as reflected in our No Action scenario modeling, this shift is occurring independent of this rule.
Communities with environmental justice concerns, which can include a range of communities and populations, face relatively greater cumulative impacts associated with environmental exposures of multiple types, as well as impacts from non-chemical stressors. Numerous studies have found that environmental hazards such as air pollution are more prevalent in areas where people of color and low-income populations represent a higher fraction of the population compared with the general population.
EPA's 2016 “Technical Guidance for Assessing Environmental Justice in Regulatory Analysis” provides recommendations on conducting the highest quality analysis feasible of environmental justice (EJ) issues associated with a given regulatory decision, though it is not prescriptive, recognizing that data limitations, time and resource constraints, and analytic challenges will vary by media and regulatory context. Where applicable and practicable, the Agency endeavors to conduct such an EJ analysis. There is evidence that communities with EJ concerns are disproportionately and adversely impacted by vehicle emissions.
In section VIII.J.2 of the preamble, we discuss the EJ impacts of this final rule's GHG emission standards from the anticipated reduction of GHGs. We also discuss in section VIII.J.3 of the preamble the potential additional EJ impacts from the non-GHG (criteria pollutant and air toxic) emissions changes we estimate would result from compliance with the emission standards, including impacts near roadways and from upstream sources. EPA did not consider potential adverse disproportionate impacts of vehicle emissions in selecting the emission standards, but we provide information about adverse impacts of vehicle emissions for the public's understanding of this rulemaking, which addresses the need to protect public health consistent with CAA section 202(a)(1)-(2). When assessing the potential for disproportionate and adverse health or environmental impacts of regulatory actions on populations with potential EJ concerns, EPA strives to answer the following three broad questions, for purposes of the EJ analysis. (1) Is there evidence of potential EJ concerns in the baseline (the state of the world absent the regulatory action)? Assessing the baseline will allow EPA to determine whether pre-existing disparities are associated with the pollutant(s) under consideration (
EPA received several comments related to the environmental justice impacts of light- and medium-duty vehicles in general and the impacts of the proposal specifically. We summarize and respond to those comments in section 9 of the RTC document that accompanies this rulemaking. After consideration of comments, EPA updated our review of the literature, while maintaining our general approach to the environmental justice analysis. We note that the analyses in this section are based on data that was the most appropriate recent data at the time we undertook the analyses. We intend to continue analyzing data concerning disproportionate impacts of pollution in the future, using the latest available data. We also note that after consideration of comments, we conducted an analysis of how human exposure to future air quality varies with sociodemographic characteristics relevant to potential environmental justice concerns in scenarios with and without the rule in place. The results of this analysis are presented in section VII.D of this preamble and in RIA Chapter 7.6
In the 2009 Endangerment Finding, the Administrator considered how climate change threatens the health and welfare of the U.S. population. As part of that consideration, she also considered risks to various populations and communities, finding that certain parts of the U.S. population may be especially vulnerable based on their characteristics or circumstances. These groups include economically and socially disadvantaged communities; individuals at vulnerable life stages, such as the elderly, the very young, and pregnant or nursing women; those already in poor health or with comorbidities; the disabled; those experiencing homelessness, mental illness, or substance abuse; and Indigenous or other populations dependent on limited resources for subsistence due to factors including but not limited to geography, access, and mobility.
Scientific assessment reports produced over the past decade by the USGCRP,
Per the Fourth National Climate Assessment (NCA4), “Climate change affects human health by altering exposures to heat waves, floods, droughts, and other extreme events; vector-, food- and waterborne infectious diseases; changes in the quality and safety of air, food, and water; and stresses to mental health and well-being.”
The scientific assessment literature, including the aforementioned reports, demonstrates that there are myriad ways in which these particular communities and populations may be affected at the individual and community levels. Individuals face differential exposure to criteria pollutants, in part due to the proximities of highways, trains, factories, and other major sources of pollutant-emitting sources to less-affluent residential areas. Outdoor workers, such as construction or utility crews and agricultural laborers, who frequently are comprised of already at-risk groups, are exposed to poor air quality and extreme temperatures without relief. Furthermore, people in communities with EJ concerns face greater housing, clean water, and food insecurity and bear disproportionate and adverse economic impacts and health burdens associated with climate change effects. They have less or limited access to healthcare and affordable, adequate health or homeowner insurance.
The assessment literature cited in EPA's 2009 and 2016 Endangerment and Cause or Contribute Findings, as well as Impacts of Climate Change on Human Health, also concluded that certain populations and life stages, including children, are most vulnerable to climate-related health effects.
The Impacts of Climate Change on Human Health
The recent EPA report on climate change and social vulnerability
In a more recent 2023 report, Climate Change Impacts on Children's Health and Well-Being in the U.S., EPA considered the degree to which children's health and well-being may be impacted by five climate-related environmental hazards—extreme heat, poor air quality, changes in seasonality, flooding, and different types of infectious diseases.
Tribes and Indigenous communities face disproportionate and adverse risks from the impacts of climate change, particularly those communities impacted by degradation of natural and cultural resources within established reservation boundaries and threats to traditional subsistence lifestyles. Indigenous communities whose health, economic well-being, and cultural traditions depend upon the natural environment will likely be affected by the degradation of ecosystem goods and services associated with climate change. The IPCC indicates that losses of customs and historical knowledge may cause communities to be less resilient or adaptable.
For example, Indigenous agriculture in the Southwest is already being adversely affected by changing patterns of flooding, drought, dust storms, and rising temperatures leading to increased soil erosion, irrigation water demand, and decreased crop quality and herd sizes. The Confederated Tribes of the Umatilla Indian Reservation in the Northwest have identified climate risks to salmon, elk, deer, roots, and huckleberry habitat. Housing and sanitary water supply infrastructure are vulnerable to disruption from extreme precipitation events. Additionally, NCA4 noted that Tribes and Indigenous Peoples generally experience poor infrastructure, diminished access to quality healthcare, and greater risk of exposure to pollutants. Consequently, Native Americans often have disproportionately higher rates of asthma, cardiovascular disease, Alzheimer's disease, diabetes, and obesity. These health conditions and related effects (disorientation, heightened exposure to PM
NCA4 and IPCC's Fifth Assessment Report
In section VII of this preamble, in addition to GHG emissions impacts, we also discuss potential additional emission changes of non-GHGs (
As described in section II.C.8 of this preamble, concentrations of many air pollutants are elevated near high-traffic roadways. We recently conducted an analysis of the populations within the continental U.S. living in close proximity to truck freight routes as identified in USDOT's FAF4.
We additionally analyzed other national databases that allowed us to evaluate whether homes and schools were located near a major road and whether disparities in exposure may be occurring in these environments. Until 2009, the U.S. Census Bureau's American Housing Survey (AHS) included descriptive statistics of over 70,000 housing units across the nation and asked about transportation infrastructure near respondents' homes every two years.
In analyzing the 2009 AHS, we focused on whether a housing unit was located within 300 feet of a “4-or-more lane highway, railroad, or airport” (this distance was used in the AHS analysis).
In examining schools near major roadways, we used the Common Core of Data from the U.S. Department of Education, which includes information on all public elementary and secondary schools and school districts nationwide.
We also reviewed existing scholarly literature examining the potential for disproportionately high exposure to these pollutants among people of color and people with low socioeconomic status (SES). Numerous studies evaluating the demographics and socioeconomic status of populations or schools near roadways have found that they include a greater percentage of residents of color, as well as lower SES populations (as indicated by variables such as median household income). Locations in these studies include Los Angeles, CA; Seattle, WA; Wayne County, MI; Orange County, FL; Tampa, FL; the State of California; the State of Texas; and nationally.
Several publications report nationwide analyses that compare the demographic patterns of people who do or do not live near major roadways.
Overall, there is substantial evidence that people who live or attend school near major roadways are more likely to be of a non-White race, Hispanic, and/or have a low SES. As described in section II.C.8 of the preamble, traffic-related air pollution may have disproportionate and adverse impacts on health across racial and sociodemographic groups. We expect communities near roads will benefit from the reduced vehicle emissions of PM, NO
As described in Chapter 4.5 of the RIA, we expect some non-GHG emissions reductions from sources related to refining petroleum fuels and increases in emissions from EGUs, both of which would lead to changes in exposure for people living in communities near these facilities. The EGU emissions increases become smaller over time because of changes in the projected power generation mix as electricity generation uses less fossil fuels.
Analyses of communities in close proximity to EGUs have found that a higher percentage of communities of color and low-income communities live near these sources when compared to national averages.
The topic of the “energy paradox” or “energy efficiency gap” has been extensively discussed in many previous vehicle GHG standards' analyses.
While evidence exists to substantiate agreement upon the existence of the efficiency gap, there is less agreement on the reasons for its existence and its magnitude. There are a number of hypotheses in the literature that attempt to explain the existence of the energy efficiency gap, including both consumer and producer side reasons.
Part of the uncertainty surrounding reasons behind the energy efficiency gap is that most of the technologies applied to existing ICE vehicles were “invisible” to the consumer, both literally and also possibly in effect. For example, the technology itself was not something the mainstream consumer would know about, or the technology was applied to a vehicle at the same time as multiple other changes, making it unclear to the consumer what changes in vehicle attributes, if any, could be attributed to a specific technology. At the first purchase of a PEV, the energy efficiency technology is clearly apparent to the consumer (
Though the energy paradox is likely to persist for the reasons discussed above, including future fuel and electricity prices, uncertainty about charging infrastructure and availability, perceptions of comparisons of quality and durability of different powertrains, and other factors discussed in this section and in RIA Chapter 4.4, there are factors that may mitigate it. Uncertainties will be resolved over time (
EPA has long considered the safety implications of its emission standards. Section 202(a)(4) of the CAA specifically prohibits the use of an emission control device, system or element of design that will cause or contribute to an unreasonable risk to public health, welfare, or safety. With respect to its light-duty greenhouse gas emission regulations, EPA has historically considered the potential impacts of GHG standards on safety in its light-duty GHG rulemakings.
The potential relationship between GHG emissions standards and safety is multi-faceted, and can be influenced not only by control technologies, but also by consumer decisions about vehicle ownership and use. EPA has estimated the impacts of this rule on safety by accounting for changes in new vehicle purchase, fleet turnover and VMT, and changes in vehicle weight that occur either as an emissions control strategy or as a result of the adoption of emissions control technologies such as vehicle electrification. Safety impacts related to changes in the use of vehicles in the fleet, relative mass changes, and the turnover of fleet to newer and safer vehicles have been estimated and analyzed as part of the standard setting process.
The GHG emissions standards are attribute-based standards, using vehicle footprint as the attribute. Footprint is defined as a vehicle's wheelbase multiplied by its average track width—in other words, the area enclosed by the points at which the wheels meet the ground. The standards are therefore generally based on a vehicle's size: larger vehicles have numerically higher GHG emissions targets and smaller vehicles have numerically lower GHG emissions targets. Footprint-based standards help to distribute the burden of compliance across all vehicle footprints and across all manufacturers. Manufacturers are not compelled to build vehicles of any particular size or type, and each manufacturer has its own fleetwide standard for its car and truck fleets in each year that reflects the light-duty vehicles it chooses to produce. EPA has evaluated the relationship between vehicle footprint and GHG emissions targets and is finalizing GHG standards that are intended to minimize incentives to change footprint as a compliance strategy. EPA is not projecting any changes in vehicle safety due to changes in footprint as a result of this rule.
While EPA has not conducted new studies on the safety implications of electrified vehicles, we have consulted with NHTSA on potential safety issues and they have provided a number of studies to us. NHTSA's Office of Crashworthiness Standards has also informed us that NHTSA is not aware of differences in crash outcomes between electric and non-electric vehicles, although NHTSA is closely monitoring and conducting extensive research on this topic closely. EPA notes there is strong reason to believe that PEVs are at least as safe as ICE vehicles,
Consistent with previous light-duty GHG analyses, EPA conducted a quantitative assessment of the potential of the standards to affect vehicle safety. EPA applied the same historical relationships between mass, size, and fatality risk that were established and documented in NHTSA's 2023 proposed rulemaking. These relationships are based on the statistical analysis of historical crash data, which included an analysis performed by using the most recently available crash studies based on data for model years 2007 to 2011. EPA used these findings to estimate safety impacts of the modeled adoption of mass reduction as technology to reduce emissions, and the adoption of PEVs that result in some vehicle weights that are higher than comparable ICE vehicles due to the addition of the battery. Based on the findings of our safety analysis, we concluded there are no changes to the vehicles themselves, nor the combined effects of fleet composition and vehicle design, that will have a statistically significant impact on safety.
EPA has also estimated, over the same 27-year period, that total fatalities will increase by 2,602, with all of those attributed to increased driving. Our analysis projects that there will be an increase in vehicle miles traveled (VMT) under the standards of 567 billion miles compared to the No Action case in 2027 through 2055 (an increase of under 0.6 percent). As noted, the only statistically significant changes in the fatalities projected are the result from the projected increased driving—
On the whole, EPA considers safety impacts in the context of all projected health impacts from the rule including public health benefits from the projected reductions in air pollution. Considering these estimates in the context of public health benefits anticipated from the final standards, EPA notes that the estimated annualized value of monetized health benefits of reduced PM
In addition to the energy paradox, safety, and the effects that we monetize, we also look more closely into, but do not monetize, the effects of the standards on low-income households, on consumers of low-priced new vehicles and used vehicles, and on PEV consumers without access to home or work charging. These effects depend, in large part, on three elements of vehicle ownership, namely (a) the purchase prices of vehicles, (b) fueling expenditures, and (c) maintenance and repair. Typically, the introduction of more stringent standards leads to higher purchase prices and lower fuel expenditures, on average. These standards also yield reductions on average in vehicle maintenance and repair costs, especially among buyers of PEVs. The net effect varies across households. Regarding purchase price, the IRA provides tax credits for both new and used PEVs. The reduction in fuel expenditures may be especially beneficial for low-income households and consumers in the used and low-priced new vehicle markets. First, fuel expenditures are a larger portion of expenses for low-income households compared to higher income households. Second, lower-priced new vehicles have historically been more fuel efficient. Third, fuel economy and therefore fuel savings do not decline as vehicles age even though the price paid for vehicles typically declines as vehicles age and are resold. Fourth, low-income households are more likely to purchase lower-priced new vehicles and used vehicles, capturing their associated fuel savings.
Furthermore, for many vehicle consumers, access to credit for vehicle purchases is essential and may be of particular concern for low-income households. The effects of the standards on access to credit is influenced by the potentially countervailing forces of vehicle purchase costs and fuel costs. However, the degree of influence and the net effect is not clear (see RIA Chapter 8.4.3 of the 2021 rule). Increased purchase prices and presumably higher loan principal may, in some cases, discourage lending, while reduced fuel expenditures may, in some cases, improve lenders' perceptions of borrowers' repayment reliability.
Finally, while access to gasoline and diesel can be assumed for the most part, the number and density of charging stations varies considerably.
This action is a “significant regulatory action,” as defined under section 3(f)(1) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis is in the Regulatory Impact Analysis, which can be found in the docket for this rule and is briefly summarized in section VIII of this preamble.
The information collection activities in this rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR number 2750.02. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.
The Agency is adopting requirements for manufacturers to submit information to ensure compliance with the provisions in this rule. This includes a variety of requirements for vehicle manufacturers. Section 208(a) of the CAA requires that vehicle manufacturers provide information the Administrator may reasonably require to determine compliance with the regulations; submission of the information is therefore mandatory. We will consider confidential all information meeting the requirements of section 208(c) of the CAA for confidentiality.
Many of the information activities associated with the rule are covered by existing emission certification and reporting requirements for EPA's light-duty and medium-duty vehicle emission control program. Therefore, this ICR only covers the incremental burden associated with the updated regulatory requirements as described in this rule.
The total annual reporting burden associated with this rule is about 40,136 hours and $(6,213) million, based on a projection of 35 respondents. The estimated burden for vehicle manufacturers is a total estimate for new reporting requirements incremental to the current program. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; modify existing technology and systems for the purposes of collecting, validating, and verifying newly required information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the
I certify that this action will not have a significant economic impact on a substantial number of small entities (SISNOSE) under the Regulatory Flexibility Act (RFA).
EPA has focused its assessment of potential small business impacts on three key aspects of the standards, including GHG emissions standards, criteria pollutant standards (including NMOG+NO
There are three types of small entities under the RFA that could potentially be impacted by the GHG standards: (1) small entity vehicle manufacturers; (2) alternative fuel converters, which are companies that take a vehicle for which an OEM has already accounted for GHG compliance and convert it to operate on a cleaner fuel such as natural gas or propane; and (3) independent commercial importers (ICIs), which are firms that import vehicles from other countries for individual vehicle purchasers.
Under the current light-duty GHG program, small entities are exempt from the GHG standards. EPA is continuing the current exemption for all three types of small entities, including small entity manufacturers, alternate fuel converters, and ICIs. In contrast, current regulations require small entities making new medium-duty vehicles to meet the same GHG emission standards that apply for other companies. In this rule, we are not adopting new or revised GHG emission standards for medium-duty vehicles for small entities. As a result, medium-duty vehicles produced by small entities will continue to be subject to the MY 2026 standards indefinitely, instead of being subject to the new GHG emission standards for MY 2027 and later vehicles that we are adopting in this rule. However, EPA is finalizing its proposal to add some environmental protections for imported vehicles, as described below in this paragraph. EPA is continuing the current provision allowing small entity manufacturers to opt into the GHG program to earn credits, which they can then choose to sell in the credit market. The small entity vehicle manufacturers in the market at this time produce only electric vehicles. EPA received comments that there were small entity manufacturers that made internal combustion engine vehicles. EPA had previously reviewed those entities and determined that they did not qualify for consideration under the RFA (for further details see the Response to Comments document.) EPA requested comment on the potential need for small entity light-duty and medium-duty manufacturers to have an annual production cap (
Under existing EPA regulations, each ICI is currently limited to importing 50 vehicles per year. EPA is finalizing, as proposed, a reduced limit of 25 vehicles per year, which is well above historical sales, as a means of limiting the potential environmental impact of importing vehicles with potentially high GHG emissions. Importing of BEVs and fuel cell vehicles would not count against the 25 vehicles limit. EPA believes this lower vehicle limit is important for capping the potential for high-emitting imported vehicles, because unlike with criteria pollutant emissions, there are very limited add-on emissions control options for reducing the GHG emissions of an imported vehicle. To ease the burden required for ICIs to certify electric vehicles, EPA is finalizing its proposal to remove the requirement that the vehicle have a fuel economy label. Production electric vehicles do not normally have high voltage wiring accessible, so it is not practical for ICIs to measure the energy in and out of the battery, which is necessary when measuring energy for the fuel economy label.
EPA also has evaluated the potential impacts on small businesses for criteria pollutant emissions standards, including both the NMOG+NO
The final aspect of the final rule that could have potential impacts on small entities is battery durability (section III.G.2 of the preamble). EPA finds it appropriate to exempt small entities from battery durability requirements at this time while we implement the requirement for larger manufacturers. Based on our experience with larger manufacturers we will be in a better position to judge whether the requirements are appropriate to extend to smaller manufacturers in a future rulemaking.
This action contains Federal mandates under UMRA, 2 U.S.C. 1531-1538, that may result in expenditures of $100 million or more for state, local, and Tribal governments, in the aggregate, or the private sector in any one year. Accordingly, EPA has prepared a written statement of the costs and benefits associated with this action as required under section 202 of UMRA. This is discussed in section VIII of this preamble and Chapter 10 of the RIA. This action is not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action. However, EPA has engaged with our Tribal stakeholders in the development of this rulemaking by offering a Tribal workshop and offering government-to-government consultation upon request.
This action is subject to Executive Order 13045 because it is a significant regulatory action under section 3(f)(1) of Executive Order 12866, and EPA believes that the environmental health or safety risks of the pollutants addressed by this action may have a disproportionate effect on children. The 2021 Policy on Children's Health also applies to this action.
Children make up a substantial fraction of the U.S. population, and often have unique factors that contribute to their increased risk of experiencing a health effect from exposures to ambient air pollutants because of their continuous growth and development. Children are more susceptible than adults to many air pollutants because they have (1) a developing respiratory system, (2) increased ventilation rates relative to body mass compared with adults, (3) an increased proportion of oral breathing, particularly in boys, relative to adults, and (4) behaviors that increase chances for exposure. Even before birth, the developing fetus may be exposed to air pollutants through the mother that affect development and permanently harm the individual when the mother is exposed.
GHG emissions contribute to climate change and the GHG emissions reductions described in section VI of this preamble resulting from this rule will contribute to mitigation of climate change. The assessment literature cited in EPA's 2009 and 2016 Endangerment Findings concluded that certain populations and life stages, including children, the elderly, and the poor, are most vulnerable to climate-related health effects. The assessment literature since 2016 strengthens these conclusions by providing more detailed findings regarding these groups' vulnerabilities and the projected impacts they may experience. These assessments describe how children's unique physiological and developmental factors contribute to making them particularly vulnerable to climate change. Impacts to children are expected from heat waves, air pollution, infectious and waterborne illnesses, and mental health effects resulting from extreme weather events. In addition, children are among those especially susceptible to most allergic diseases, as well as health effects associated with heat waves, storms, and floods. Additional health concerns may arise in low-income households, especially those with children, if climate change reduces food availability and increases prices, leading to food insecurity within households. More detailed information on the impacts of climate change to human health and welfare is provided in section II of this preamble.
In addition to reducing GHGs, this final rule will also reduce onroad emissions of criteria pollutants and air toxics. section VII of this preamble presents the estimated onroad emissions reductions from the rule. Certain motor vehicle emissions present greater risks to children. Early lifestages (
In addition to reduced onroad emissions of criteria pollutants and air toxics, we expect the rule will also lead to reductions in petroleum-sector emissions and increases in pollutant emissions from EGUs (see section VII of the preamble). As described in section II of this preamble, the Integrated Science Assessments for a number of pollutants affected by this rule, including those for SO
There is substantial evidence that people who live or attend school near major roadways are more likely to be people of color, Hispanic ethnicity, and/or low socioeconomic status. Analyses of communities in close proximity to sources such as EGUs and refineries have also found that a higher percentage of communities of color and low-income communities live near these sources when compared to national averages. Within these highly exposed groups, children's exposure and susceptibility to health effects is greater than adults due to school-related and seasonal activities, behavior, and physiological factors.
Children are not expected to experience greater ambient concentrations of air pollutants compared to the general population. However, because of their greater susceptibility to air pollution, including the impacts of a changing climate, and their increased time spent outdoors, it is likely that these standards will have particular benefits for children's health.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. EPA has outlined the energy effects in Table 8-8 in Chapter 8 of the RIA, which is available in the docket for this action and is briefly summarized here.
This action reduces CO
This rulemaking involves technical standards. Except for the standards discussed in this section, the standards included in the regulatory text as incorporated by reference were all previously approved for incorporation by reference (IBR) and no change is included in this action.
In accordance with the requirements of 1 CFR 51.5, we are incorporating by reference the use of standards and test methods from the California Air Resources Board (CARB). The referenced standards and test methods may be obtained through the CARB website (
In accordance with the requirements of 1 CFR 51.5, we are incorporating by reference the use of standards and test methods from the United Nations. The referenced standards and test methods may be obtained from the UN Economic Commission for Europe, Information Service at Palais des Nations, CH-1211 Geneva 10, Switzerland;
In accordance with the requirements of 1 CFR 51.5, we are incorporating by reference the use of standards and test methods from SAE International. The referenced standards and test methods may be obtained from SAE International, 400 Commonwealth Dr., Warrendale, PA 15096-0001, (877) 606-7323 (U.S. and Canada) or (724) 776-4970 (outside the U.S. and Canada), or
In accordance with the requirements of 1 CFR 51.5, we are incorporating by reference the use of standards and test methods from ASTM International. The referenced standards and test methods may be obtained from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959, (610) 832-9585, or
EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice concerns.
EPA provides a summary of the evidence for potentially disproportionate and adverse effects among various populations analyzed prior to implementation of the action in sections II.C.8, VII.D, and VIII.J of the preamble for this rule.
EPA believes that this action is likely to reduce existing disproportionate and adverse effects on many communities with environmental justice concerns. The air pollutant emission reductions that will be achieved by this rule will improve air quality for the people who reside in close proximity to major roadways and who are disproportionately represented by people of color and people with low income, as described in section II.C.8 and section VIII.J of this preamble. We expect that localized increases in criteria and toxic pollutant emissions from EGUs and reductions in petroleum-sector emissions could lead to changes in exposure to these pollutants for people living in the communities near these facilities. Analyses of communities in close proximity to these sources (such as EGUs and refineries) have found that a higher percentage of communities of color and low-income communities live near these sources when compared to national averages.
Section VIII.J.2 of this preamble discusses the environmental justice issues associated with climate change. People of color, low-income populations and/or indigenous peoples may be especially vulnerable to the impacts of climate change. The GHG emission reductions from this action will contribute to efforts to reduce the probability of severe impacts related to climate change.
EPA is additionally identifying and addressing environmental justice concerns by providing just treatment and meaningful involvement with Environment Justice groups in developing this action and soliciting input for this rulemaking.
The information supporting this impacts review is contained in sections II.C.8, VII.D, and VIII.J of the preamble for this rule, and all supporting documents have been placed in the public docket for this action.
This action is subject to the CRA, and EPA will submit a rule report to each House of Congress and to the Comptroller General of the United States. This action meets the criteria set forth in 5 U.S.C. 804(2).
This final action is “nationally applicable” within the meaning of CAA section 307(b)(1) because it is expressly listed in the section (
This final rule includes new and revised requirements for numerous provisions under various aspects of the highway on-road emission control program, including revised standards for both criteria pollutants and GHG, test procedures, emission-related warranty, and other requirements. Therefore, this final rule is a multifaceted rule that addresses many separate things for independent reasons, as detailed in each respective portion of this preamble. We intend each portion of this rule to be severable from each other, though we took the approach of including all the parts in one rulemaking rather than promulgating multiple rules to ensure the changes are properly coordinated, even though the changes are not inter-dependent. We have noted the independence of various pieces of this package both in the proposal and in earlier sections of the preamble but we reiterate it here for clarity.
For example, as EPA noted in the proposal, although we are coordinating the GHG and criteria pollutant
Finally, EPA notes that there are a host of issues which are significant for implementation of any standards. For example, EPA is making changes to compliance testing (including requirements for fuels) and other certification procedures, as well as establishing battery durability and battery warranty provisions. Each of these issues has been considered and adopted independently of the level of the standards, and indeed of each other.
Thus, EPA has independently considered and adopted each of these portions of the final rule (including but not limited to the standards for LD GHG, LD NMOG+NO
Statutory authority for this final rule is found at 42 U.S.C. 7401-7675 and 49 U.S.C. 32901-32919q.
Environmental protection, Confidential business information, Greenhouse gases, Imports, Labeling, Motor vehicle pollution, Reporting and recordkeeping requirements, Research, Warranties.
Environmental protection, Administrative practice and procedure, Confidential business information, Incorporation by reference, Labeling, Motor vehicle pollution, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Electric power, Fuel economy, Incorporation by reference, Labeling, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Confidential business information, Greenhouse gases, Labeling, Motor vehicle pollution, Reporting and recordkeeping requirements, Warranties.
Environmental protection, Administrative practice and procedure, Air pollution control, Confidential business information, Labeling, Motor vehicle pollution, Reporting and recordkeeping requirements, Warranties.
Environmental protection, Air pollution control, Incorporation by reference, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Confidential business information, Imports, Motor vehicle pollution, Penalties, Reporting and recordkeeping requirements, Warranties.
For the reasons set out in the preamble, EPA is amending title 40, chapter I of the Code of Federal Regulations as set forth below.
42 U.S.C. 7401-7671q.
(f) If you have previously used small volume conversion manufacturer or qualified small volume test group/engine family procedures and you may exceed the volume thresholds using the sum described in § 85.535(f) to determine small volume status in 40 CFR 86.1838-01 or 1036.150(d), as appropriate, you must satisfy the requirements for conversion manufacturers who do not qualify for small volume exemptions or your exemption from tampering is no longer valid.
(a) You are exempted from the tampering prohibition with respect to new and relatively new vehicles/engines if you certify the conversion system to the emission standards specified in § 85.525 as described in paragraph (b) in this section; you meet the labeling and packaging requirements in § 85.530 before you sell, import or otherwise facilitate the use of a clean alternative fuel conversion system; and you meet the liability, recordkeeping, and end of year reporting requirements in § 85.535.
(b) Certification under this section must be based on the certification
(1) Test groups and evaporative/refueling families for light-duty and heavy-duty chassis certified vehicles.
(i) Small volume conversion manufacturers and qualified small volume test groups.
(A) If criteria for small volume manufacturer or qualified small volume test groups are met as defined in 40 CFR 86.1838-01, you may combine light-duty vehicles or heavy-duty vehicles which can be chassis certified under 40 CFR part 86, subpart S using good engineering judgment into conversion test groups if the following criteria are satisfied instead of those specified in 40 CFR 86.1827-01.
(
(
(
(
(
(
(
(
(
(
(
(
(B) EPA-established scaled assigned deterioration factors for both exhaust and evaporative emissions may be used for vehicles with over 10,000 miles if the criteria for small volume manufacturer or qualified small volume test groups are met as defined in 40 CFR 86.1838-01. This deterioration factor will be adjusted according to vehicle or engine miles of operation. The deterioration factor is intended to predict the vehicle's emission levels at the end of the useful life. EPA may adjust these scaled assigned deterioration factors if we find the rate of deterioration non-constant or if the rate differs by fuel type.
(C) As part of the conversion system description provided in the application for certification, conversion manufacturers using EPA assigned deterioration factors must present detailed information to confirm the durability of all relevant new and existing components and to explain why the conversion system will not harm the emission control system or degrade the emissions.
(ii) Conversion evaporative/refueling families are identical to the OEM evaporative/refueling families unless the OEM evaporative emission system is no longer functionally necessary. You must create any new evaporative families according to 40 CFR 86.1821-01.
(2) Engine families and evaporative/refueling families for heavy-duty engines.
(i) Small volume conversion manufacturers and qualified small volume heavy-duty engine families.
(A) If criteria for small volume manufacturer or qualified small volume engine families are met as defined in 40 CFR 1036.150(d), you may combine heavy-duty engines using good engineering judgment into conversion engine families if the following criteria are satisfied instead of those specified in 40 CFR 1036.230.
(
(
(
(
(
(
(
(
(
(
(
(
(
(B) EPA-established scaled assigned deterioration factors for both exhaust and evaporative emissions may be used for engines with over 10,000 miles if the criteria for small volume manufacturer or qualified small volume engine families are met as defined in 40 CFR 1036.150(d). This deterioration factor will be adjusted according to vehicle or engine miles of operation. The deterioration factor is intended to predict the engine's emission levels at the end of the useful life. EPA may adjust these scaled assigned deterioration factors if we find the rate of deterioration non-constant or if the rate differs by fuel type.
(C) As part of the conversion system description provided in the application for certification, conversion manufacturers using EPA assigned deterioration factors must present detailed information to confirm the durability of all relevant new and existing components and to explain why the conversion system will not harm the emission control system or degrade the emissions.
(ii) Conversion evaporative/refueling families are identical to the OEM evaporative/refueling families unless the OEM evaporative emission system is no longer functionally necessary. You must create any new evaporative families according to 40 CFR 86.1821.
(3) Conversion test groups/engine families for small volume conversion manufacturers and qualified small volume test groups/engine families may include vehicles/engines that are subject to different OEM emission standards; however, all the vehicles/engines certified under this subpart in a single conversion test group/engine family are subject to the most stringent standards that apply for vehicles/engines included in the conversion test group/engine family. For example, if OEM vehicle test groups originally certified to Tier 2, Bin 4 and Bin 5 standards are in the same conversion test group for purposes of fuel conversion, all the vehicles certified in the conversion test group under this subpart are subject to the Tier 2, Bin 4 standards. Conversion manufacturers may choose to certify a conversion test group/engine family to a more stringent standard than the OEM did. The optional, more stringent standard would then apply to all OEM test groups/engine families within the conversion test group/engine family. This paragraph (b)(3) does not apply to conversions to dual-fuel/mixed-fuel vehicles/engines, as provided in paragraph (b)(7) of this section.
(4)-(5) [Reserved]
(6) Durability testing is required unless the criteria for small volume manufacturer or qualified small volume test groups/engine families are met as defined in 40 CFR 86.1838-01 or 1036.150(d), as applicable.
(7) Conversion test groups/engine families for conversions to dual-fuel or
(8) The vehicle/engine selected for testing must qualify as a worst-case vehicle/engine under 40 CFR 86.1828-01 or 1036.235(a)(2), as applicable.
(9) The following requirements apply for OBD systems:
(i) The OBD system must properly detect and identify malfunctions in all monitored emission-related powertrain systems or components including any new monitoring capability necessary to identify potential emission problems associated with the new fuel.
(ii) Conduct OBD testing as needed to demonstrate that the vehicle/engine continues to comply with emission thresholds and other requirements that apply based on the original certification.
(iii) Submit the applicable OBD reporting information for vehicles as set forth in 40 CFR 86.1806-17. Submit the applicable OBD reporting information for engines as set forth in 40 CFR 86.010-18 or 1036.110, as appropriate. Submit the following statement of compliance if the OEM vehicles/engines were required to be OBD-equipped:
The test group/engine family converted to an alternative fuel has fully functional OBD systems and therefore meets the OBD requirements specified in [40 CFR part 86 or part 1036, as applicable] when operating on the alternative fuel.
(10) In lieu of specific certification test data, you may submit the following attestations for the appropriate statements of compliance, if you have sufficient basis to prove the statement is valid.
(i) The test group/engine family converted to an alternative fuel has properly exercised the optional and applicable statements of compliance or waivers in the certification regulations. Attest to each statement or waiver in your application for certification.
(ii) The test group/engine family converted to dual-fuel or mixed-fuel operation retains all the OEM fuel system, engine calibration, and emission control system functionality when operating on the fuel with which the vehicle/engine was originally certified.
(iii) The test group/engine family converted to dual fuel or mixed-fuel operation retains all the functionality of the OEM OBD system (if so equipped) when operating on the fuel with which the vehicle/engine was originally certified.
(iv) The test group/engine family converted to dual-fuel or mixed-fuel operation properly purges hydrocarbon vapor from the evaporative emission canister when the vehicle/engine is operating on the alternative fuel.
(11) Certification fees apply as described in 40 CFR part 1027.
(12) A certificate issued under this section is valid starting with the indicated effective date and expires on December 31 of the conversion model year for which it is issued. You may apply for a certificate of conformity for the next conversion model year using the applicable provisions for carryover certification. Even after the certificate expires, your exemption from the prohibition on tampering remains valid for the applicable conversion test group/engine family and/or evaporative/refueling family, as long as the conditions under which the certificate was issued remain unchanged, such as small volume manufacturer or qualified small volume test group/engine family status. Your exemption from tampering is valid only if the conversion is installed on the OEM test groups/engine families and/or evaporative emissions/refueling families listed on the certificate. For example, if you have received a clean alternative fuel conversion certificate of conformity in conversion model year 2011 for converting a 2010 model year OEM test group/evaporative/refueling family, your exemption from tampering continues to apply for the conversion of the same 2010 model year OEM test group/evaporative/refueling family as long as the conditions under which the certificate was issued remain unchanged, such as small volume manufacturer status.
(13) Conversion systems must be properly installed and adjusted such that the vehicle/engine operates consistent with the principles of good engineering judgment and in accordance with all applicable regulations.
(a) You are exempted from the tampering prohibition with respect to intermediate age vehicles/engines if you properly test, document and notify EPA that the conversion system complies with the emission standards specified in § 85.525 as described in paragraph (b) of this section; you meet the labeling requirements in § 85.530 before you sell, import or otherwise facilitate the use of a clean alternative fuel conversion system; and you meet the liability, recordkeeping, and end of year reporting requirements in § 85.535. You may also meet the requirements under this section by complying with the requirements in § 85.510.
(b) Documenting and notifying EPA under this section includes demonstrating compliance with all the provisions in this section and providing all notification information to EPA. You may notify us as described in this section instead of certifying the clean alternative fuel conversion system. You must demonstrate compliance with all exhaust and evaporative emissions standards by conducting all exhaust and evaporative emissions and durability testing as required for OEM certification subject to the exceptions and special provisions permitted in § 85.510. This paragraph (b) provides additional special provisions applicable to intermediate age vehicles/engines. Paragraph (b) is applicable to all conversion manufacturers unless otherwise specified.
(1) Conversion test groups for light-duty and heavy-duty chassis certified vehicles may be grouped together into an exhaust conversion test group using the criteria described in § 85.510(b)(1)(i)(A), except that the same OBD group is not a criterion. Evaporative/refueling families may be grouped together using the criteria described in § 85.510(b)(1)(ii).
(2) Conversion engine families for heavy-duty engines may be grouped together into an exhaust conversion engine family using the criteria described in § 85.510(b)(2)(i)(A), except that the same OBD group is not a criterion. Evaporative/refueling families may be grouped together using the criteria described in § 85.510(b)(2)(ii).
(3) Conversion test groups/engine families may include vehicles/engines that are subject to different OEM emission standards; however, all vehicles/engines in a single conversion test group/engine family are subject to the most stringent standards that apply for vehicles/engines included in the conversion test group/engine family. For example, if OEM vehicle test groups originally certified to Tier 2, Bin 4 and Bin 5 standards are in the same conversion test group for purposes of fuel conversion, all the vehicles in the conversion test group under this subpart are subject to the Tier 2, Bin 4 standards. This paragraph (b)(3) does not apply to conversions to dual-fuel/mixed-fuel vehicles/engines, as provided in paragraph (b)(7).
(4) EPA-established scaled assigned deterioration factors for both exhaust and evaporative emissions may be used for vehicles/engines with over 10,000 miles if the criteria for small volume manufacturer or qualified small volume test groups/engine families are met as defined in 40 CFR 86.1838-01 or 40 CFR 1036.150(d), as appropriate. This deterioration factor will be adjusted according to vehicle/engine miles or hours of operation. The deterioration factor is intended to predict the vehicle/engine's emission level at the end of the useful life. EPA may adjust these scaled assigned deterioration factors if we find the rate of deterioration non-constant or if the rate differs by fuel type.
(5) As part of the conversion system description required by paragraph (b)(10)(i) of this section, small volume conversion manufacturers and qualified small volume test groups/engine families using EPA assigned deterioration factors must present detailed information to confirm the durability of all relevant new and existing components and explain why the conversion system will not harm the emission control system or degrade the emissions.
(6) Durability testing is required unless the criteria for small volume manufacturer or qualified small volume test groups/engine families are met as defined in 40 CFR 86.1838-01 or 40 CFR 1036.150(d), as applicable. Durability procedures for large volume conversion manufacturers of intermediate age light-duty and heavy-duty chassis certified vehicles that follow provisions in 40 CFR 86.1820-01 may eliminate precious metal composition and catalyst grouping statistic when creating clean alternative fuel conversion durability groupings.
(7) Conversion test groups/engine families for conversions to dual-fuel or mixed-fuel vehicles/engines may not include vehicles/engines subject to different emissions standards unless applicable exhaust and OBD demonstrations are also conducted for the original fuel(s) demonstrating compliance with the most stringent standard represented in the test group/engine family. However, the data generated from testing on the new fuel for dual-fuel or mixed/fuel test vehicles/engines may be carried over to vehicles/engines that otherwise meet the conversion test group/engine family criteria and for which the test vehicle/engine data demonstrate compliance with the applicable vehicle/engine standards. Clean alternative fuel conversion evaporative families for dual-fuel or mixed-fuel vehicles/engines cannot include vehicles/engines that were originally certified to different evaporative emissions standards unless evaporative/refueling demonstrations are also conducted for the original fuel(s) demonstrating compliance with the most stringent standard represented in the evaporative/refueling family.
(8) You must conduct all exhaust and all evaporative and refueling emissions testing with a worst-case vehicle/engine to show that the conversion test group/engine family complies with exhaust and evaporative/refueling emission standards, based on the certification procedures.
(9)(i) The OBD system must properly detect and identify malfunctions in all monitored emission-related powertrain systems or components including any new monitoring capability necessary to identify potential emission problems associated with the new fuel. These include but are not limited to: Fuel trim lean and rich monitors, catalyst deterioration monitors, engine misfire monitors, oxygen sensor deterioration monitors, EGR system monitors, if applicable, and vapor leak monitors, if applicable. No original OBD system monitor that is still applicable to the vehicle/engine may be aliased, removed, bypassed, or turned-off. No MILs shall be illuminated after the conversion. Readiness flags must be properly set for all monitors that identify any malfunction for all monitored components.
(ii) Subsequent to the vehicle/engine fuel conversion, you must clear all OBD codes and reset all OBD monitors to not-ready status using an OBD scan tool appropriate for the OBD system in the vehicle/engine in question. You must operate the vehicle/engine with the new fuel on representative road operation or chassis dynamometer/engine dynamometer testing cycles to satisfy the monitors' enabling criteria. When all monitors have reset to a ready status, you must submit an OBD scan tool report showing that with the vehicle/engine operating in the key-on/engine-on mode, all supported monitors have reset to a ready status and no emission related “pending” (or potential) or “confirmed” (or MIL-on) diagnostic trouble codes (DTCs) have been set. The MIL must not be commanded “On” or be illuminated. A MIL check must also be conducted in a key-on/engine-off mode to verify that the MIL is functioning properly. You must include the VIN/EIN number of the test vehicle/engine. If necessary, the OEM evaporative emission readiness monitor may remain unset for dedicated gaseous fuel conversion systems.
(iii) In addition to conducting OBD testing described in this paragraph (b)(9), you must submit to EPA the following statement of compliance if the OEM vehicles/engines were required to be OBD-equipped:
The test group/engine family converted to an alternative fuel has fully functional OBD systems and therefore meets the OBD requirements specified in [40 CFR part 86 or part 1036, as applicable] when operating on the alternative fuel.
(10) You must notify us by electronic submission in a format specified by the Administrator with all required documentation. The following must be submitted:
(i) You must describe how your conversion system qualifies as a clean alternative fuel conversion. You must include emission test results from the required exhaust, evaporative emissions, and OBD testing, applicable exhaust and evaporative emissions standards and deterioration factors. You must also include a description of how the test vehicle/engine selected qualifies as a worst-case vehicle/engine under 40 CFR 86.1828-01 or 1036.235(a)(2), as applicable.
(ii) You must describe the group of vehicles/engines (conversion test group/conversion engine family) that are covered by your notification based on the criteria specified in paragraph (b)(1) or (b)(2) of this section.
(iii) In lieu of specific test data, you may submit the following attestations for the appropriate statements of compliance, if you have sufficient basis to prove the statement is valid.
(A) The test group/engine family converted to an alternative fuel has properly exercised the optional and applicable statements of compliance or waivers in the certification regulations. Attest to each statement or waiver in your notification.
(B) The test group/engine family converted to dual-fuel or mixed-fuel
(C) The test group/engine family converted to dual-fuel or mixed-fuel operation retains all the functionality of the OEM OBD system (if the OEM vehicles/engines were required to be OBD equipped) when operating on the fuel for which the vehicle/engine was originally certified.
(D) The test group/engine family converted to dual-fuel or mixed-fuel operation properly purges hydrocarbon vapor from the evaporative emission canister when the vehicle/engine is operating on the alternative fuel.
(iv) Include any other information as the Administrator may deem appropriate to establish that the conversion system is for the purpose of conversion to a clean alternative fuel and meets applicable emission standards.
(11) [Reserved]
(12) Your exemption from the prohibition on tampering remains valid for the applicable conversion test group/engine family and/or evaporative/refueling family, as long as the conditions under which you previously complied remain unchanged, such as small volume manufacturer or qualified small volume test group/engine family status. Your exemption from tampering is valid only if the conversion is installed on the OEM test groups/engine families and/or evaporative emissions/refueling families listed on the notification. For example, if you have complied properly with the provisions in this section in calendar year 2011 for converting a model year 2006 OEM test group/evaporative/refueling family, your exemption from tampering continues to apply for the conversion of the same model year 2006 OEM test group/evaporative/refueling family as long as the conditions under which the notification was submitted remain unchanged.
(13) Conversion systems must be properly installed and adjusted such that the vehicle/engine operates consistent with the principles of good engineering judgment and in accordance with all applicable regulations.
(b) * * *
(4) The following requirements apply for OBD systems:
(i) The OBD system must properly detect and identify malfunctions in all monitored emission-related powertrain systems or components, including any new monitoring capability necessary to identify potential emission problems associated with the new fuel. These include but are not limited to: Fuel trim lean and rich monitors, catalyst deterioration monitors, engine misfire monitors, oxygen sensor deterioration monitors, EGR system monitors, if applicable, and evaporative system leak monitors, if applicable. No original OBD system monitor that is still applicable to the vehicle/engine may be aliased, removed, bypassed, or turned-off. No MILs shall be illuminated after the conversion. Readiness flags must be properly set for all monitors that identify any malfunction for all monitored components.
(ii) Subsequent to the vehicle/engine fuel conversion, you must clear all OBD codes and reset all OBD monitors to not-ready status using an OBD scan tool appropriate for the OBD system in the vehicle/engine in question. You must operate the vehicle/engine with the new fuel on representative road operation or chassis dynamometer/engine dynamometer testing cycles to satisfy the monitors' enabling criteria. When all monitors have reset to a ready status, you must submit an OBD scan tool report showing that with the vehicle/engine operating in the key-on/engine-on mode, all supported monitors have reset to a ready status and no emission related “pending” (or potential) or “confirmed” (or MIL-on) diagnostic trouble codes (DTCs) have been stored. The MIL must not be commanded “On” or be illuminated. A MIL check must also be conducted in a key-on/engine-off mode to verify that the MIL is functioning properly. You must include the VIN/EIN of the test vehicle/engine. If necessary, the OEM evaporative emission readiness monitor may remain unset for dedicated gaseous fuel conversion systems.
(iii) In addition to conducting OBD testing described in this paragraph (b)(4), you must submit to EPA the following statement of compliance if the OEM vehicles/engines were required to be OBD-equipped:
The test group/engine family converted to an alternative fuel has fully functional OBD systems and therefore meets the OBD requirements specified in [40 CFR part 86 or 40 CFR part 1036, as applicable] when operating on the alternative fuel.
(6) You must notify us by electronic submission in a format specified by the Administrator with all required documentation. The following must be submitted.
(i) You must describe how your conversion system complies with the good engineering judgment criteria in paragraph (b)(3) of this section and/or other requirements under this subpart or other applicable subparts such that the conversion system qualifies as a clean alternative fuel conversion. The submission must provide a level of technical detail sufficient for EPA to confirm the conversion system's ability to maintain or improve on emission levels in a worst-case vehicle/engine. The submission of technical information must include a complete characterization of exhaust and evaporative emissions control strategies, the fuel delivery system, durability, and specifications related to OBD system functionality. You must present detailed information to confirm the durability of all relevant new and existing components and to explain why the conversion system will not harm the emission control system or degrade the emissions. EPA may ask you to supply additional information, including test data, to support the claim that the conversion system does not increase emissions and involves good engineering judgment that is being applied for purposes of conversion to a clean alternative fuel.
(ii) You must describe the group of vehicles/engines (conversion test group/conversion engine family) that is covered by your notification based on the criteria specified in paragraph (b)(2) of this section.
(iii) In lieu of specific test data, you may submit the following attestations for the appropriate statements of compliance, if you have sufficient basis to prove the statement is valid.
(A) The test group/engine family converted to an alternative fuel has properly exercised the optional and applicable statements of compliance or waivers in the certification regulations. Attest to each statement or waiver in your notification.
(B) The test group/engine family converted to dual-fuel or mixed-fuel operation retains all the OEM fuel system, engine calibration, and emission control system functionality when operating on the fuel with which the vehicle/engine was originally certified.
(C) The test group/engine family converted to dual-fuel or mixed-fuel operation retains all the functionality of the OEM OBD system (if the OEM vehicles/engines were required to be OBD equipped) when operating on the fuel with which the vehicle/engine was originally certified.
(D) The test group/engine family converted to dual-fuel or mixed-fuel operation properly purges hydrocarbon vapor from the evaporative emission canister when the vehicle/engine is operating on the alternative fuel.
(E) The test group/engine family converted to an alternative fuel uses fueling systems, evaporative emission control systems, and engine powertrain components that are compatible with the alternative fuel and designed with the principles of good engineering judgment.
(iv) You must include any other information as the Administrator may deem appropriate, which may include test data, to establish the conversion system is for the purpose of conversion to a clean alternative fuel.
(b) * * *
(3) Subject to the following exceptions and special provisions, compliance with greenhouse gas emission standards for medium-duty vehicles and heavy-duty vehicles subject to 40 CFR 86.1819-14 is demonstrated by complying with the N
(f) Clean alternative fuel conversion manufacturers must submit an end of the year sales report to EPA describing the number of clean alternative fuel conversions by fuel type(s) and vehicle test group/engine family by January 31 of the following year. The number of conversions is the sum of the calendar year intermediate age conversions, outside useful life conversions, and the same conversion model year certified clean alternative fuel conversions. The number of conversions will be added to any other vehicle and engine sales accounted for using 40 CFR 86.1838-01 or 1036.150(d), as appropriate to determine small volume manufacturer or qualified small volume test group/engine family status.
(a) A nonconforming vehicle or engine offered for importation into the United States must be imported by an ICI who is a current holder of a valid certificate of conformity unless an exemption or exclusion is granted by the Administrator under § 85.1511 or the vehicle is eligible for entry under § 85.1512.
(c) In any one certificate year (
(1) [Reserved]
(2) A total of 25 light-duty vehicles, light-duty trucks, and medium-duty passenger vehicles. This limit applies for vehicles with engines, including plug-in hybrid electric vehicles. This limit does not apply for electric vehicles.
(3) 50 highway motorcycles.
The revision reads as follows:
(a) A motor vehicle or motor vehicle engine may be imported under this section by a certificate holder possessing a currently valid certificate of conformity only if—
(d) * * *
(1) The certificate holder shall affix a fuel economy label that complies with the requirements of 40 CFR part 600, subpart D. The requirement for fuel economy labels does not apply for electric vehicles.
(f)
(a) Notwithstanding any other requirements of this subpart, any motor vehicle or motor vehicle engine conditionally imported pursuant to § 85.1505 or § 85.1509 and required to be emission tested shall be tested using the FCT at 40 CFR part 86 applicable to current model year motor vehicles and motor vehicle engines at the time of testing or reduced testing requirements as follows:
(1) ICIs are eligible for reduced testing under this paragraph (a) subject to the following conditions:
(i) The OEM must have a valid certificate of conformity covering the vehicle.
(ii) The vehicle must be in its original configuration as certified by the OEM. This applies for all emission-related components, including the electronic control module, engine calibrations, and all evaporative/refueling control hardware. It also applies for OBD software and hardware, including all sensors and actuators.
(iii) The vehicle modified as described in paragraph (a)(1)(ii) of this section must fully comply with all applicable emission standards and requirements.
(iv) Vehicles must have the proper OBD systems installed and operating. When faults are present, the ICI must test and verify the system's ability to find the faults (such as disconnected components), set codes, and illuminate the light, and set readiness codes as appropriate for each vehicle. When no fault is present, the ICI must verify that after sufficient prep driving (typically one FTP test cycle), all OBD readiness codes are set and the OBD system does not indicate a malfunction (
(v) The ICI may not modify more than 300 vehicles in any given model year using reduced testing provisions in this paragraph (a).
(vi) The ICI must state in the application for certification that it will
(2) The following provisions allow for ICIs to certify vehicles with reduced testing:
(i) In addition to the test waivers specified in 40 CFR 86.1829, you may provide a statement in the application for certification, supported by engineering analysis, that vehicles comply with any of the following standards that apply instead of submitting test data:
(A) Cold temperature CO, NMHC, NMOG+NO
(B) SFTP emission standards specified in 40 CFR 86.1811 and 86.1816 for all pollutants, and separate emission standards that apply for US06 and SC03 duty cycles.
(C) For anything other than diesel-fueled vehicles, PM emission standards specified in 40 CFR 86.1811 and 86.1816.
(D) Any running loss, refueling, spitback, bleed emissions, and leak standards specified in 40 CFR part 86, subparts A and S.
(ii) You must perform testing and submit test data as follows to demonstrate compliance with emission standards:
(A)
(B)
(b) [Reserved]
(c) Nonconforming motor vehicles conditionally imported pursuant to § 85.1505 or § 85.1509 must meet all the emission standards specified in 40 CFR part 86 for the OP year of the vehicle, with the following exceptions and clarifications:
(1) The useful life specified in 40 CFR part 86 for the OP year of the motor vehicle is applicable where useful life is not designated in this subpart.
(2)(i) Nonconforming light-duty vehicles and light light-duty trucks (LDV/LLDTs) originally manufactured in OP years 2004, 2005 or 2006 must meet the FTP exhaust emission standards of bin 9 in Tables S04-1 and S04-2 in 40 CFR 86.1811-04 and the evaporative emission standards for light-duty vehicles and light light-duty trucks specified in 40 CFR 86.1811-01(e)(5).
(ii) Nonconforming LDT3s and LDT4s (HLDTs) and medium-duty passenger vehicles (MDPVs) originally manufactured in OP years 2004 through 2006 must meet the FTP exhaust emission standards of bin 10 in Tables S04-1 and S04-2 in 40 CFR 86.1811-04 and the applicable evaporative emission standards specified in 40 CFR 86.1811-04(e)(5). For 2004 OP year HLDTs and MDPVs where modifications commence on the first vehicle of a test group before December 21, 2003, this requirement does not apply to the 2004 OP year. ICIs opting to bring all their 2004 OP year HLDTs and MDPVs into compliance with the exhaust emission standards of bin 10 in Tables S04-1 and S04-2 in 40 CFR 86.1811-04, may use the optional higher NMOG values for their 2004-2006 OP year LDT2s and 2004-2008 LDT4s.
(iii) Nonconforming LDT3s and LDT4s (HLDTs) and medium-duty passenger vehicles (MDPVs) originally manufactured in OP years 2007 and 2008 must meet the FTP exhaust emission standards of bin 8 in Tables S04-1 and S04-2 in 40 CFR 86.1811-04 and the applicable evaporative standards specified in 40 CFR 86.1811-04(e)(5).
(iv) Nonconforming LDV/LLDTs originally manufactured in OP years 2007 through 2021 and nonconforming HLDTs and MDPVs originally manufactured in OP year 2009 through 2021 must meet the FTP exhaust emission standards of bin 5 in Tables S04-1 and S04-2 in 40 CFR 86.1811-04, and the evaporative standards specified in 40 CFR 86.1811-04(e)(1) through (4).
(v) ICIs are exempt from the Tier 2 and the interim non-Tier 2 phase-in intermediate percentage requirements for exhaust, evaporative, and refueling emissions described in 40 CFR 86.1811-04.
(vi) In cases where multiple standards exist in a given model year in 40 CFR part 86 due to phase-in requirements of new standards, the applicable standards for motor vehicle engines required to be certified to engine-based standards are the least stringent standards applicable to the engine type for the OP year.
(vii) Nonconforming LDV/LLDTs originally manufactured in OP years 2009 through 2021 must meet the evaporative emission standards in Table S09-1 in 40 CFR 86.1811-09(e). However, LDV/LLDTs originally manufactured in OP years 2009 and 2010 and imported by ICIs who qualify as small-volume manufacturers as defined in 40 CFR 86.1838-01 are exempt from the LDV/LLDT evaporative emission standards in Table S09-1 in 40 CFR 86.1811-09(e), but must comply with the Tier 2 evaporative emission standards in Table S04-3 in 40 CFR 86.1811-04(e).
(viii) Nonconforming HLDTs and MDPVs originally manufactured in OP years 2010 through 2021 must meet the evaporative emission standards in Table S09-1 in 40 CFR 86.1811-09(e). However, HLDTs and MDPVs originally manufactured in OP years 2010 and 2011 and imported by ICIs, who qualify as small-volume manufacturers as defined in 40 CFR 86.1838-01, are exempt from the HLDTs and MDPVs evaporative emission standards in Table S09-1 in 40 CFR 86.1811-09(e), but must comply with the Tier 2
(ix) Nonconforming LDV/LLDTs originally manufactured in OP years 2013 through 2021 must meet the cold temperature NMHC emission standards in Table S10-1 in 40 CFR 86.1811-10(g). Nonconforming HLDTs and MDPVs originally manufactured in OP years 2015 through 2021 must meet the cold temperature NMHC emission standards in Table S10-1 in 40 CFR 86.1811-10(g).
(x) Nonconforming vehicles subject to the provisions of 40 CFR part 86, subpart S, originally manufactured in OP years 2022 through 2031 must meet the Tier 3 and related exhaust emission standards in 40 CFR 86.1811-17 and 86.1816-18, the Tier 3 evaporative emission standards in 40 CFR 86.1813-17, and the refueling emission standards in 40 CFR 86.1813-17(b) and have an OBD system meeting the requirements of 40 CFR 86.1806-17. In cases where the standard allows or requires demonstrating compliance using emission credits, each vehicle imported under this paragraph (c) is subject to the specified fleet average standard.
(xi) Nonconforming vehicles subject to the provisions of 40 CFR part 86, subpart S, originally manufactured in OP years 2032 and later must meet the Tier 4 exhaust emission standards in 40 CFR 86.1811-27, the Tier 3 evaporative emission standards in 86.1813-17, and the refueling emission standards in 40 CFR 86.1813-17(b) and have an OBD system meeting the requirements of 40 CFR 86.1806-27. In cases where the standard allows or requires demonstrating compliance using emission credits, each vehicle imported under this paragraph (c) is subject to the specified fleet average standard.
(3) The following provisions apply for demonstrating compliance with the Tier 2 fleet average NO
(i) As an option to the requirements of paragraph (c)(2)(i) through (viii) of this section, independent commercial importers may elect to meet lower bins in Tables S04-1 and S04-2 of 40 CFR 86.1811-04 than specified in paragraph (c)(2) of this section and bank or sell NO
(ii) Where an ICI desires to obtain a certificate of conformity using a bin higher than specified in paragraph (c)(2) of this section, but does not have sufficient credits to cover vehicles produced under such certificate, the Administrator may issue such certificate if the ICI has also obtained a certificate of conformity for vehicles certified using a bin lower than that required under paragraph (c)(2) of this section. The ICI may then produce vehicles to the higher bin only to the extent that it has generated sufficient credits from vehicles certified to the lower bin during the same model year.
(iii) Except for the situation where an ICI desires to bank, sell or use NO
(iv) ICIs using bins higher than those specified in paragraph (c)(2) of this section must monitor their production so that they do not produce more vehicles certified to the standards of such bins than their available credits can cover. ICIs must not have a credit deficit at the end of a model year and are not permitted to use the deficit carryforward provisions provided in 40 CFR 86.1860-04(e).
(v) The Administrator may condition the certificates of conformity issued to ICIs as necessary to ensure that vehicles subject to this paragraph (c) comply with the appropriate average NO
(4) The following provisions apply for demonstrating compliance with the cold temperature NMHC fleet average standards in 40 CFR 86.1811-10 through 2021:
(i) As an alternative to the requirements of paragraphs (c)(2)(ix) of this section, ICIs may elect to meet a cold temperature NMHC family emission level below the cold temperature NMHC fleet average standards specified in Table S10-1 of 40 CFR 86.1811-10 and bank or sell credits as permitted in 40 CFR 86.1864-10. An ICI may not meet a higher cold temperature NMHC family emission level than the fleet average standards in Table S10-1 of 40 CFR 86.1811-10, unless it demonstrates to the Administrator at the time of certification that it has obtained appropriate and sufficient NMHC credits from another manufacturer, or has generated them in a previous model year or in the current model year and not traded them to another manufacturer or used them to address other vehicles as permitted in 40 CFR 86.1864-10.
(ii) Where an ICI desires to obtain a certificate of conformity using a higher cold temperature NMHC family emission level than specified in paragraph (c)(2)(ix) of this section, but does not have sufficient credits to cover vehicles imported under such certificate, the Administrator may issue such certificate if the ICI has also obtained a certificate of conformity for vehicles certified using a cold temperature NMHC family emission level lower than that required under paragraph (c)(2)(ix) of this section. The ICI may then import vehicles to the higher cold temperature NMHC family emission level only to the extent that it has generated sufficient credits from vehicles certified to a family emission level lower than the cold temperature NMHC fleet average standard during the same model year.
(iii) ICIs using cold temperature NMHC family emission levels higher than the cold temperature NMHC fleet average standards specified in paragraph (c)(2)(ix) of this section must monitor their imports so that they do not import more vehicles certified to such family emission levels than their available credits can cover. ICIs must not have a credit deficit at the end of a model year and are not permitted to use the deficit carryforward provisions provided in 40 CFR 86.1864-10.
(iv) The Administrator may condition the certificates of conformity issued to ICIs as necessary to ensure that vehicles subject to this paragraph (c)(8) comply with the applicable cold temperature NMHC fleet average standard for each model year.
(5) In cases where a vehicle is subject to a Tier 3 or Tier 4 credit-based standard as described in paragraphs (c)(2)(x) and (xi) of this section, an ICI may import a vehicle with emissions higher than the applicable standard if it first arranges to purchase appropriate and sufficient emission credits from a manufacturer that has generated the emission credits as specified in 40 CFR part 86, subpart S. A vehicle's emissions may not exceed the specified values for the highest available NMOG + NO
(6) An ICI may comply with the cold temperature PM standard in 40 CFR 86.1811-27(c) based on an engineering evaluation.
(d) An ICI may not certify using nonconformance penalties and may not
As used in this subpart, all terms not defined herein shall have the meaning given them in the Act:
This section describes how you may implement design changes for an emergency vehicle that has already been placed into service to ensure that the vehicle will perform properly in emergency situations. This applies for any light-duty vehicle, light-duty truck, or heavy-duty vehicle meeting the definition of emergency vehicle in 40 CFR 86.1803-01 or 1036.801. In this section, “you” refers to the certifying manufacturer and “we” refers to the EPA Administrator and any authorized representatives.
(e) A remedial plan for an alternative remedy under 40 CFR 86.1865-12(j)(3) that does not involve vehicle repairs may omit items from this section that do not apply. For example, such a remedial plan will generally omit information related to proper maintenance, vehicle repairs, and vehicle labeling.
The revision and addition read as follows:
(a) Except as specified in paragraph (b) of this section, the notification of vehicle or engine owners shall contain the following:
(b) In the case of manufacturers submitting an alternative remedy under 40 CFR 86.1865-12(j)(3) that does not involve vehicle repairs, the proposed remedy must also include a proposal for notifying owners of the nonconformity. The notification must contain the following:
(1) The statement: “The Administrator of the U.S. Environmental Protection Agency has determined that your vehicle or engine may be emitting pollutants in excess of the Federal emission standards as defined in 40 CFR part 86. These emission standards were established to protect the public health or welfare from the dangers of air pollution.”
(2) A clear description of the measures to be taken to correct the nonconformity.
(a) Sections 85.2101 through 85.2111 are applicable to all 1981 and later model year vehicles subject to standards under 40 CFR part 86, subpart S.
(b) References in this subpart to engine families and emission control systems shall be deemed to apply to durability groups and test groups as applicable.
(a) As used in §§ 85.2101 through 85.2111 all terms not defined herein shall have the meaning given them in the Act. All terms additionally not defined in the Act shall have the meaning given in 40 CFR 86.1803-01, 1065.1001, or 1068.30:
(4)
(10)
(11)
(a) The manufacturer of each vehicle to which this subpart applies must provide a written commitment to meet warranty requirements as described in this section.
(b) The warranty periods under this section apply based on the vehicle's age in years and on the vehicle's odometer reading. The warranty period expires based on the specified age or mileage, whichever comes first. The warranty period for a particular vehicle begins on the date the vehicle is delivered to its ultimate purchaser or, if the vehicle is first placed in service as a “demonstrator” or “company” car prior to delivery, on the date it is first placed in service.
(c) Under the emission performance warranty, in the case of a vehicle failing to conform at any time during its useful life to the applicable emission standards or family emission limits as determined by an EPA-approved emission test, the manufacturer must remedy that nonconformity at no cost to the owner if such nonconformity results or will result in the vehicle owner having to bear any penalty or other sanction (including the denial of the right to use the vehicle) under local, State, or Federal law. The following warranty periods apply:
(1) For light-duty vehicles, light-duty trucks, and medium-duty passenger vehicles, the warranty period for the emission performance warranty is 24 months or 24,000 miles, except that the warranty period is 8 years or 80,000 miles for any nonconformity resulting from a failed specified major emission control component identified in paragraph (d) and (e) of this section.
(2) For medium-duty vehicles, the warranty period for the emission performance warranty is 5 years or 50,000 miles, except that the warranty period is 8 years or 80,000 miles for any
(d) An emission defect warranty applies as follows:
(1) An emission defect warranty applies for light-duty vehicles, light-duty trucks, and medium-duty passenger vehicles for a warranty period of two years or 24,000 miles, except that the following specified major emission control components have a warranty period of eight years or 80,000 miles:
(i) Catalytic converters and SCR catalysts, and related components.
(ii) Particulate filters and particulate traps, used with both spark-ignition and compression-ignition engines.
(iii) Components related to exhaust gas recirculation with compression-ignition engines.
(iv) Emission control module.
(v) Batteries serving as a Renewable Energy Storage System for electric vehicles and plug-in hybrid electric vehicles, along with all components needed to charge the system, store energy, and transmit power to move the vehicle. This paragraph (d)(1)(v) is optional for vehicles not yet subject to battery monitoring requirements under 40 CFR 86.1815-27.
(2) An emission defect warranty applies for medium-duty vehicles for a warranty period of five years or 50,000 miles, except that the specific major emission control components identified in paragraph (d)(1) of this section have a warranty period of eight years or 80,000 miles.
(3) An electric vehicle or plug-in hybrid electric vehicle fails to meet the manufacturer-defined value for percentage usable battery energy for the specified period as determined by the State of Certified Energy monitor required under 40 CFR 86.1815-27, subject to the warranty claim procedures in § 85.2106.
(d) The time/mileage interval for scheduled maintenance services shall be the service interval specified for the part in the written instructions for proper maintenance and use. However, in the case of certified parts having a maintenance or replacement interval different from that specified in the written instructions for proper maintenance and use, the time/mileage interval shall be the service interval for which the part was certified.
(e) The owner may perform maintenance or have maintenance performed more frequently than required in the maintenance instructions.
(f) Written instruction for proper use of battery electric vehicles and plug-in hybrid electric vehicles may identify certain behaviors or vehicle operating modes expected to unreasonably or artificially shorten battery durability. For example, exceeding a vehicle's towing capacity might be considered improper use. However, the manufacturer should not consider actions to be improper use if the vehicle can be designed to prevent the targeted behaviors or operating modes. Evidence of compliance with the requirement to properly use vehicles under this paragraph (f) is generally limited to onboard data logging, though manufacturers may also request vehicle owners to make a statement regarding specific behaviors or vehicle operating modes.
(g) Except as provided in paragraph (h) of this section, a manufacturer may deny an emission warranty claim on the basis of noncompliance with the written instructions for proper maintenance and use if and only if:
(1) An owner is not able to comply with a request by a manufacturer for evidence pursuant to paragraph (c) or (f) of this section; or
(2) Notwithstanding the evidence presented pursuant to paragraph (c) of this section, the manufacturer can prove that the vehicle failed because of any of the following conditions:
(i) The vehicle was abused.
(ii) An instruction for the proper maintenance and use was performed in a manner resulting in a component's being improperly installed or a component or related parameter's being adjusted substantially outside of the manufacturer's specifications.
(iii) Unscheduled maintenance was performed on a vehicle which resulted in the removing or rendering inoperative of any component affecting the vehicle's emissions.
(b) * * *
(3) List all objective evidence as defined in § 85.2102 that was used in the determination to deny warranty. This evidence must be made available to the vehicle owner or EPA upon request.
(a) A manufacturer shall furnish with each new motor vehicle, a full explanation of the emission warranties required by 42 U.S.C. 7541(a) and (b), including at a minimum the following information:
(1) A basic statement of the coverage of the emissions performance warranty as set out in § 85.2103. This shall be separated from any other warranty given by the manufacturer and shall be prefaced by the title “Emissions Performance Warranty” set in bold face type.
(2) A list of all items which are covered by the emission performance warranty for the full useful life of the vehicle. This list shall contain all specified major emission control components. All items listed pursuant to this subsection shall be described in the same manner as they are likely to be described on a service facility work receipt for that vehicle.
(3) A list or a reference to the location of the instructions for proper maintenance and use, together with the time and/or mileage interval at which such instructions are to be performed.
(4) An explanation of the effect that the use of certified parts will have on the emission performance warranty. This explanation shall comport with the provisions of § 85.2105 (b) and (c), including a statement in boldface type that maintenance, replacement, or repair of the emission control devices and systems may be performed by any automotive repair establishment or individual using any certified part.
(5) Complete instructions as to when and how an owner may bring a claim under the emissions performance warranty, as governed by §§ 85.2104 and 85.2106. These instructions shall include all the following:
(i) An explanation of the point in time at which a claim may be raised.
(ii) Complete procedures as to the manner in which a claim may be raised.
(iii) The provisions for manufacturer liability contained in § 85.2106(f) if the manufacturer fails to respond within the time period set in accordance with § 85.2106(d).
(iv) For battery electric vehicles and plug-in hybrid electric vehicles, the manufacturer-defined value for percentage usable battery energy specified in § 85.2103(d)(3).
(6) An explanation that an owner may obtain further information concerning the emission warranties or that an owner may report violations of the
(a) The manufacturer of each vehicle to which this subpart applies must send to EPA an owner's manual and warranty booklet (if applicable) in electronic format for each model vehicle that completely and accurately represent the warranty terms for that vehicle.
(1) The owner's manuals and warranty booklets should be received by EPA 60 days prior to the introduction of the vehicle for sale.
(2) If the manuals and warranty booklets are not in their final format 60 days prior to the introduction of the vehicle for sale, a manufacturer may submit the most recent draft at that time, provided that the manufacturer promptly submits final versions when they are complete.
(b) All materials described in paragraph (a) of this section shall be sent to the Designated Compliance Officer as specified at 40 CFR 1068.30 (Attention: Warranty Booklet).
42 U.S.C. 7401-7671q.
Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, EPA must publish a document in the
(a)
(1) ASTM C1549-09, Standard Test Method for Determination of Solar Reflectance Near Ambient Temperature Using a Portable Solar Reflectometer, approved August 1, 2009 (“ASTM C1549”); IBR approved for § 86.1869-12(b).
(2) ASTM D86-12, Standard Test Method for Distillation of Petroleum Products at Atmospheric Pressure, approved December 1, 2012 (“ASTM D86”); IBR approved for §§ 86.113-04(a); 86.113-94(b); 86.213(a); 86.513(a).
(3) ASTM D93-13, Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester, approved July 15, 2013 (“ASTM D93”); IBR approved for § 86.113-94(b).
(4) ASTM D445-12, Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (and Calculation of Dynamic Viscosity), approved April 15, 2012 (“ASTM D445”); IBR approved for § 86.113-94(b).
(5) ASTM D613-13, Standard Test Method for Cetane Number of Diesel Fuel Oil, approved December 1, 2013 (“ASTM D613”); IBR approved for § 86.113-94(b).
(6) ASTM D975-13a, Standard Specification for Diesel Fuel Oils, approved December 1, 2013 (“ASTM D975”); IBR approved for § 86.1910(c).
(7) ASTM D976-06 (Reapproved 2011), Standard Test Method for Calculated Cetane Index of Distillate Fuels, approved October 1, 2011 (“ASTM D976”); IBR approved for § 86.113-94(b).
(8) ASTM D1319-13, Standard Test Method for Hydrocarbon Types in Liquid Petroleum Products by Fluorescent Indicator Adsorption, approved May 1, 2013 (“ASTM D1319”); IBR approved for §§ 86.113-04(a); 86.213(a); 86.513(a).
(9) ASTM D1945-03 (reapproved 2010), Standard Test Method for Analysis of Natural Gas by Gas Chromatography, approved January 1, 2010 (“ASTM D1945”); IBR approved for §§ 86.113-94(e); 86.513(d).
(10) ASTM D2163-07, Standard Test Method for Determination of Hydrocarbons in Liquefied Petroleum (LP) Gases and Propane/Propene Mixtures by Gas Chromatography, approved December 1, 2007 (“ASTM D2163”); IBR approved for §§ 86.113-94(f).
(11) ASTM D2622-10, Standard Test Method for Sulfur in Petroleum Products by Wavelength Dispersive X-ray Fluorescence Spectrometry, approved February 15, 2010 (“ASTM D2622”); IBR approved for §§ 86.113-04(a); 86.113-94(b); 86.213(a); 86.513(a).
(12) ASTM D2699-13b, Standard Test Method for Research Octane Number of Spark-Ignition Engine Fuel, approved October 1, 2013 (“ASTM D2699”); IBR approved for §§ 86.113-04(a); 86.213(a).
(13) ASTM D2700-13b, Standard Test Method for Motor Octane Number of Spark-Ignition Engine Fuel, approved October 1, 2013 (“ASTM D2700”); IBR approved for §§ 86.113-04(a); 86.213(a).
(14) ASTM D3231-13, Standard Test Method for Phosphorus in Gasoline, approved June 15, 2013 (“ASTM D3231”); IBR approved for §§ 86.113-04(a); 86.213(a); 86.513(a).
(15) ASTM D3237-12, Standard Test Method for Lead in Gasoline by Atomic Absorption Spectroscopy, approved June 1, 2012 (“ASTM D3237”); IBR approved for §§ 86.113-04(a); 86.213(a); 86.513(a).
(16) ASTM D4052-11, Standard Test Method for Density, Relative Density, and API Gravity of Liquids by Digital Density Meter, approved October 15, 2011 (“ASTM D4052”); IBR approved for § 86.113-94(b).
(17) ASTM D5186-03 (Reapproved 2009), Standard Test Method for Determination of the Aromatic Content and Polynuclear Aromatic Content of Diesel Fuels and Aviation Turbine Fuels by Supercritical Fluid Chromatography, approved April 15, 2009 (“ASTM D5186”); IBR approved for § 86.113-94(b).
(18) ASTM D5191-13, Standard Test Method for Vapor Pressure of Petroleum Products (Mini Method), approved December 1, 2013 (“ASTM D5191”); IBR approved for §§ 86.113-04(a); 86.213(a); 86.513(a).
(19) ASTM D5769-20, Standard Test Method for Determination of Benzene, Toluene, and Total Aromatics in Finished Gasolines by Gas Chromatography/Mass Spectrometry, approved June 1, 2020 (“ASTM5769”); IBR approved for §§ 86.113-04(a); 86.213(a); 86.513(a).
(20) ASTM D6550-20, Standard Test Method for Determination of Olefin Content of Gasolines by Supercritical-Fluid Chromatography, approved July 1, 2020 (“ASTM D6550”); IBR approved for §§ 86.113-04(a); 86.213(a); 86.513(a).
(21) ASTM E29-93a, Standard Practice for Using Significant Digits in
(22) ASTM E903-96, Standard Test Method for Solar Absorptance, Reflectance, and Transmittance of Materials Using Integrating Spheres, approved April 10, 1996 (“ASTM E903”); IBR approved for § 86.1869-12(b).
(23) ASTM E1918-06, Standard Test Method for Measuring Solar Reflectance of Horizontal and Low-Sloped Surfaces in the Field, approved August 15, 2006 (“ASTM E1918”); IBR approved for § 86.1869-12(b).
(b)
(1) ANSI NGV1-2006, Standard for Compressed Natural Gas Vehicle (NGV) Fueling Connection Devices, 2nd edition, reaffirmed and consolidated March 2, 2006; IBR approved for § 86.1813-17(f).
(2) CSA IR-1-15, Compressed Natural Gas Vehicle (NGV) High Flow Fueling Connection Devices—Supplement to NGV 1-2006, ANSI approved August 26, 2015; IBR approved for § 86.1813-17(f).
(c)
(1) California Requirements Applicable to the LEV III Program, including the following documents:
(i) LEV III exhaust emission standards are in Title 13 Motor Vehicles, Division 3 Air Resources Board, Chapter 1 Motor Vehicle Pollution Control Devices, Article 2 Approval of Motor Vehicle Pollution Control Devices (New Vehicles), § 1961.2 Exhaust Emission Standards and Test Procedures—2015 and Subsequent Model Passenger Cars, Light-Duty Trucks, and Medium-Duty Vehicles, effective as of December 31, 2012; IBR approved for § 86.1803-01.
(ii) LEV III evaporative emission standards for model year 2015 and later vehicles are in Title 13 Motor Vehicles, Division 3 Air Resources Board, Chapter 1 Motor Vehicle Pollution Control Devices, Article 2 Approval of Motor Vehicle Pollution Control Devices (New Vehicles) § 1976 Standards and Test Procedures for Motor Vehicle Fuel Evaporative Emissions, effective as of December 31, 2012; IBR approved for § 86.1803-01.
(2) 13 CCR 1962.5, Title 13, Motor Vehicles, Division 3, Air Resources Board, Chapter 1, Motor Vehicle Pollution Control Devices, Article 2, Approval of Motor Vehicle Pollution Control Devices (New Vehicles), § 1962.5 Data Standardization Requirements for 2026 and Subsequent Model Year Light-Duty Zero Emission Vehicles and Plug-in Hybrid Electric Vehicles; Operative November 30, 2022; IBR approved for § 86.1815-27(h).
(3) 13 CCR 1962.7, Title 13, Motor Vehicles, Division 3, Air Resources Board, Chapter 1, Motor Vehicle Pollution Control Devices, Article 2, Approval of Motor Vehicle Pollution Control Devices (New Vehicles), § 1962.7 In-Use Compliance, Corrective Action and Recall Protocols for 2026 and Subsequent Model Year Zero-Emission and Plug-in Hybrid Electric Passenger Cars and Light-Duty Trucks; Operative November 30, 2022; IBR approved for § 86.1815-27(h).
(4) 13 CCR 1968.2 (known as Onboard Diagnostics II (OBD-II)), Title 13, Motor Vehicles, Division 3, Air Resources Board, Chapter 1, Motor Vehicle Pollution Control Devices, Article 2, Approval of Motor Vehicle Pollution Control Devices (New Vehicles), § 1968.2 Malfunction and Diagnostic System Requirements—2004 and Subsequent Model-Year Passenger Cars, Light-Duty Trucks, and Medium-Duty Vehicles and Engines, effective as of July 31, 2013; IBR approved for § 86.1806-17(a).
(5) 13 CCR 1968.2 (known as Onboard Diagnostics II (OBD-II)), Title 13, Motor Vehicles, Division 3, Air Resources Board, Chapter 1, Motor Vehicle Pollution Control Devices, Article 2, Approval of Motor Vehicle Pollution Control Devices (New Vehicles), § 1968.2 Malfunction and Diagnostic System Requirements—2004 and Subsequent Model-Year Passenger Cars, Light-Duty Trucks, and Medium-Duty Vehicles and Engines; Operative November 30, 2022; IBR approved for § 86.1806-27(a).
(d)
(1) ISO 13837:2008(E), Road Vehicles—Safety glazing materials—Method for the determination of solar transmittance, First edition, April 15, 2008; IBR approved for § 86.1869-12(b).
(2) ISO 15765-4:2005(E), Road Vehicles—Diagnostics on Controller Area Networks (CAN)—Part 4: Requirements for emissions-related systems, January 15, 2005; IBR approved for § 86.010-18(k).
(e)
(1) NIST Special Publication 811, 2008 Edition, Guide for the Use of the International System of Units (SI), March 2008; IBR approved for § 86.1901(d).
(2) [Reserved]
(f)
(1) SAE J1151, Methane Measurement Using Gas Chromatography, stabilized September 2011; IBR approved for § 86.111-94(b).
(2) SAE J1349, Engine Power Test Code—Spark Ignition and Compression Ignition—As Installed Net Power Rating, revised September 2011; IBR approved for § 86.1803-01.
(3) SAE J1711 FEB2023, Recommended Practice for Measuring the Exhaust Emissions and Fuel Economy of Hybrid-Electric Vehicles, Including Plug-In Hybrid Vehicles; Revised February 2023; IBR approved for § 86.1866-12(b).
(4) SAE J1877, Recommended Practice for Bar-Coded Vehicle Identification Number Label, July 1994; IBR approved for § 86.1807-01(f).
(5) SAE J1930, Electrical/Electronic Systems Diagnostic Terms, Definitions, Abbreviations, and Acronyms, Revised May 1998; IBR approved for §§ 86.1808-01(f); 86.1808-07(f).
(6) SAE J1930, Electrical/Electronic Systems Diagnostic Terms, Definitions, Abbreviations, and Acronyms—Equivalent to ISO/TR 15031-2, April 30, 2002, Revised April 2002; IBR approved for § 86.010-18(k).
(7) SAE J1939, Recommended Practice for a Serial Control and Communications Vehicle Network, Revised October 2007; IBR approved for § 86.010-18(k).
(8) SAE J1939-13, Off-Board Diagnostic Connector, Revised March 2004; IBR approved for § 86.010-18(k).
(9) SAE J1939-71, Vehicle Application Layer (Through February 2007), Revised January 2008; IBR approved for § 86.010-38(j).
(10) SAE J1939-73, Application Layer—Diagnostics, Revised September 2006; IBR approved for §§ 86.010-18(k); 86.010-38(j).
(11) SAE J1939-81, Network Management, Revised May 2003; IBR approved for § 86.010-38(j).
(12) SAE J1962, Diagnostic Connector Equivalent to ISO/DIS 15031-3, December 14, 2001, Revised April 2002; IBR approved for § 86.010-18(k).
(13) SAE J1978, OBD II Scan Tool—Equivalent to ISO/DIS 15031-4, December 14, 2001, Revised April 2002; IBR approved for § 86.010-18(k).
(14) SAE J1979, E/E Diagnostic Test Modes, Revised September 1997; IBR approved for §§ 86.1808-01(f) and 86.1808-07(f).
(15) SAE J1979, (R) E/E Diagnostic Test Modes, Revised May 2007; IBR approved for § 86.010-18(k).
(16) SAE J2012, (R) Diagnostic Trouble Code Definitions Equivalent to ISO/DIS 15031-6, April 30, 2002, Revised April 2002; IBR approved for § 86.010-18(k).
(17) SAE J2064 FEB2011, R134a Refrigerant Automotive Air-Conditioned Hose, Revised February 2011; IBR approved for § 86.1867-12(a).
(18) SAE J2284-3, High Speed CAN (HSC) for Vehicle Applications at 500 KBPS, May 2001; IBR approved for §§ 86.1808-01(f); 86.1808-07(f).
(19) SAE J2403, Medium/Heavy-Duty E/E Systems Diagnosis Nomenclature—Truck and Bus; Revised August 2007; IBR approved for §§ 86.010-18(k); 86.010-38(j).
(20) SAE J2534, Recommended Practice for Pass-Thru Vehicle Programming, February 2002; IBR approved for §§ 86.1808-01(f); 86.1808-07(f).
(21) SAE J2727 FEB2012, Mobile Air Conditioning System Refrigerant Emission Charts for R-134a and R-1234yf, Revised February 2012; IBR approved for § 86.1867-12(a).
(22) SAE J2727 SEP2023, Mobile Air Conditioning System Refrigerant Emissions Estimate for Mobile Air Conditioning Refrigerants, Revised September 2023; IBR approved for §§ 86.1819-14(h); 86.1867-12(a); 86.1867-31(a).
(23) SAE J2765 OCT2008, Procedure for Measuring System COP [Coefficient of Performance] of a Mobile Air Conditioning System on a Test Bench, Issued October 2008; IBR approved for § 86.1868-12(h).
(24) SAE J2807 FEB2020, Performance Requirements for Determining Tow-Vehicle Gross Combination Weight Rating and Trailer Weight Rating, Revised February 2020; IBR approved for § 86.1845-04(h).
(g)
(1) TMC RP 1210B, Revised June 2007, WINDOWSTMCOMMUNICATION API; IBR approved for § 86.010-38(j).
(2) [Reserved]
(h)
(1) ECE/TRANS/180/Add.22, Addendum 22: United Nations Global Technical Regulation, No. 22, United Nations Global Technical Regulation on In-vehicle Battery Durability for Electrified Vehicles; Adopted April 14, 2022, (“GTR No. 22”); IBR approved for § 86.1815-27.
(2) [Reserved]
The revisions read as follows:
(b) Diesel fuel. For diesel-fueled engines, use the ultra low-sulfur diesel fuel specified in 40 CFR 1065.703.
(c) Other fuels. For fuels other than gasoline or diesel fuel, use the appropriate test fuel as specified in 40 CFR part 1065, subpart H.
Use the fuels specified in 40 CFR part 1065 to perform valid tests, as follows:
(a) For service accumulation, use the test fuel or any commercially available fuel that is representative of the fuel that in-use vehicles will use.
(b) For diesel-fueled engines, use the ultra low-sulfur diesel fuel specified in 40 CFR part 1065.703 for emission testing.
(c) The following fuel requirements apply for gasoline-fueled engines:
(1) Use the appropriate E10 fuel specified in 40 CFR part 1065.710(b) to demonstrate compliance with all exhaust, evaporative, and refueling emission standards under subpart S of this part.
(2) For vehicles certified for 50-state sale, you may instead use California Phase 3 gasoline (E10) as adopted in California's LEV III program as follows:
(i) You may use California Phase 3 gasoline (E10) as adopted in California's LEV III program for exhaust emission testing.
(ii) If you certify vehicles to LEV III evaporative emission standards with California Phase 3 gasoline (E10), you may use that collection of data to certify to evaporative emission standards. For evaporative emission testing with California test fuels, perform tests based on the test temperatures specified by the California Air Resources Board. Note that this paragraph (c)(2)(ii) does not apply for refueling, spitback, high-altitude, or leak testing.
(iii) If you certify using fuel meeting California's specifications, we may perform testing with E10 test fuel meeting either California or EPA specifications.
(d) Interim test fuel specifications apply for model years 2027 through 2029 as described in 40 CFR 600.117.
(e) Additional test fuel specifications apply as specified in subpart S of this part.
(a) Prepare the vehicle for testing as described in this section. Store the vehicle before testing in a way that prevents fuel contamination and preserves the integrity of the fuel system. The vehicle shall be moved into the test area and the following operations performed.
(b)(1)
(2)
(f) Drain and then fill the vehicle's fuel tank(s) with test fuel, as specified in § 86.113, to the “tank fuel volume” defined in § 86.082-2. Refuel the vehicle within 1 hour after completing the preconditioning drive. Install fuel cap(s) within 1 minute after refueling.
(1) Diesel-fueled vehicles.
(2) Gaseous-fueled vehicles.
(3) Fuel economy data vehicles.
(4) In-use vehicles subject to testing under § 86.1845.
(g) The vehicle shall be soaked for not less than 12 hours nor more than 36 hours before the cold start exhaust emission test. The soak period starts at the end of the refueling event, or at the end of the previous drive if there is no refueling.
(h) During the soak period for the three-diurnal test sequence described in § 86.130-96, precondition any evaporative canisters as described in this paragraph (h); however, canister preconditioning is not required for fuel economy data vehicles. For vehicles with multiple canisters in a series configuration, the set of canisters must be preconditioned as a unit. For vehicles with multiple canisters in a parallel configuration, each canister must be preconditioned separately. If production evaporative canisters are equipped with a functional service port designed for vapor load or purge steps, the service port shall be used during testing to precondition the canister. In addition, for model year 1998 and later vehicles equipped with refueling canisters, these canisters shall be preconditioned for the three-diurnal test sequence according to the procedure in paragraph (j)(1) of this section. If a vehicle is designed to actively control evaporative or refueling emissions without a canister, the manufacturer shall devise an appropriate preconditioning procedure, subject to the approval of the Administrator.
(j) During the soak period for the supplemental two-diurnal test sequence described in § 86.130-96, precondition any evaporative canisters using one of the methods described in this paragraph (j); however, canister preconditioning is not required for fuel economy data vehicles. For vehicles with multiple canisters in a series configuration, the set of canisters must be preconditioned as a unit. For vehicles with multiple canisters in a parallel configuration, each canister must be preconditioned separately. In addition, for model year 1998 and later vehicles equipped with refueling canisters, these canisters shall be preconditioned for the supplemental two-diurnal test sequence according to the procedure in paragraph (j)(1) of this section. Canister emissions are measured to determine breakthrough. Breakthrough is here defined as the point at which the cumulative quantity of hydrocarbons emitted is equal to 2 grams.
(g) * * *
(1) * * *
(xvi) Fuel tank pressure may exceed 10 inches of water during the running loss test only if the manufacturer demonstrates that vapor would not be vented to the atmosphere upon fuel cap removal. Note that this allows for temporary pressure exceedances for vehicles whose tank pressure otherwise remains below 10 inches of water.
(a)
(1) The provisions of this subpart apply for light-duty vehicles and light-duty trucks.
(2) The provisions of this subpart apply for medium-duty passenger vehicles. The provisions of this subpart also apply for medium-duty vehicles at or below 14,000 pounds GVWR, except as follows:
(i) The provisions of this subpart are optional for diesel-cycle vehicles through model year 2017; however, if you are using the provisions of § 86.1811-17(b)(9) or § 86.1816-18(b)(8) to transition to the Tier 3 exhaust emission standards, the provisions of this subpart are optional for those diesel-cycle vehicles until the start of the Tier 3 phase-in for those vehicles.
(ii) The exhaust emission standards of this part are optional for vehicles above 22,000 pounds GCWR and for all incomplete medium-duty vehicles. Certain requirements in this subpart apply for such vehicles even if they are not certified to the exhaust emission standards of this subpart as follows:
(A) Such vehicles remain subject to the evaporative and refueling emission standards of this subpart.
(B) Such vehicles may remain subject to the greenhouse gas standards in § 86.1819-14 as specified in 40 CFR 1036.635.
(C) Such vehicles may remain subject to onboard diagnostic requirements a specified in 40 CFR 1036.110.
(iii) The provisions of this subpart are optional for diesel-fueled Class 3 heavy-duty vehicles in a given model year if those vehicles are equipped with engines certified to the appropriate standards in § 86.007-11 or 40 CFR 1036.104 for which less than half of the engine family's sales for the model year in the United States are for complete Class 3 heavy-duty vehicles. This includes engines sold to all vehicle manufacturers. If you are the original manufacturer of the engine and the vehicle, base this showing on your sales information. If you manufacture the vehicle but are not the original manufacturer of the engine, you must use your best estimate of the original manufacturer's sales information.
(3) The provisions of this subpart do not apply to heavy-duty vehicles above 14,000 pounds GVWR (see § 86.016-1 and 40 CFR parts 1036 and 1037), except as follows:
(i) Heavy-duty vehicles above 14,000 pounds GVWR may be optionally certified to the exhaust emission standards in this subpart, including the greenhouse gas emission standards, if they are properly included in a test group with similar vehicles at or below 14,000 pounds GVWR. Emission standards apply to these vehicles as if they were Class 3 medium-duty vehicles. The work factor for these vehicles may not be greater than the largest work factor that applies for vehicles in the test group that are at or below 14,000 pounds GVWR (see § 86.1819-14).
(ii) The greenhouse gas standards apply for certain vehicles above 14,000 pounds GVWR as specified in § 86.1819-14.
(iii) Evaporative and refueling emission standards apply for heavy-duty vehicles above 14,000 pounds GVWR as specified in 40 CFR 1037.103.
(4) If you optionally certify vehicles to standards under this subpart, those vehicles are subject to all the regulatory requirements as if the standards were mandatory.
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(1)
(2)
(3)
(j)
(1) Vehicle manufacturers (NAICS code 336111).
(2) Independent commercial importers (NAICS codes 811111, 811112, 811198, 423110, 424990, and 441120).
(3) Alternate fuel vehicle converters (NAICS codes 335312, 336312, 336322, 336399, 454312, 485310, and 811198).
(k)
(1) [Reserved]
(2) Maintaining eligibility for exemption from greenhouse gas emission standards. To remain eligible for exemption under this paragraph (k) the manufacturer's average sales for the three most recent consecutive model years must remain below 5,000. If a manufacturer's average sales for the three most recent consecutive model years exceeds 4999, the manufacturer will no longer be eligible for exemption and must meet applicable emission standards according to the provisions in this paragraph (k)(2).
(i) If a manufacturer's average sales for three consecutive model years exceeds 4999, and if the increase in sales is the result of corporate acquisitions, mergers, or purchase by another manufacturer, the manufacturer shall comply with the emission standards described in § 86.1818-12(c) through (e), as applicable, beginning with the first model year after the last year of the three consecutive model years.
(ii) If a manufacturer's average sales for three consecutive model years exceeds 4999 and is less than 50,000, and if the increase in sales is solely the result of the manufacturer's expansion in vehicle production, the manufacturer shall comply with the emission standards described in § 86.1818-12(c) through (e), as applicable, beginning with the second model year after the last year of the three consecutive model years.
(iii) If a manufacturer's average sales for three consecutive model years exceeds 49,999, the manufacturer shall comply with the emission standards described in § 86.1818-12(c) through (e), as applicable, beginning with the first model year after the last year of the three consecutive model years.
The revisions and additions read as follows:
(1) Such conditions are substantially included in driving cycles specified in this subpart, the fuel economy test procedures in 40 CFR part 600, and the air conditioning efficiency test in 40 CFR 1066.845;
(2) The need for the AECD is justified in terms of protecting the vehicle against damage or accident;
(3) The AECD does not go beyond the requirements of engine starting; or
(4) The AECD applies only for emergency vehicles and the need is justified in terms of preventing the vehicle from losing speed, torque, or power due to abnormal conditions of the emission control system, or in terms of preventing such abnormal conditions from occurring, during operation related to emergency response. Examples of such abnormal conditions may include excessive exhaust backpressure from an overloaded particulate trap, and running out of diesel exhaust fluid for engines that rely on urea-based selective catalytic reduction.
(1) The vehicle is capable of drawing recharge energy from a source off the vehicle, such as residential electric service; and
(2) The vehicle must be certified to Bin 0 emission standards.
(3) The vehicle does not have an onboard combustion engine/generator system as a means of providing electrical energy.
(1) Except as specified in paragraph (2) of this definition, light-duty truck means any motor vehicle that is not a heavy-duty vehicle, but is:
(i) Designed primarily for purposes of transportation of property or is a derivation of such a vehicle; or
(ii) Designed primarily for transportation of persons and has a capacity of more than 12 persons; or
(iii) Available with special features enabling off-street or off-highway operation and use.
(2) Starting in model year 2027, light-duty truck has the meaning given for “Light truck” in 40 CFR 600.002. Vehicles that qualify as emergency vehicles for any reason under § 86.1803-01 are light-duty trucks if they are derived from light-duty trucks.
(1) Except as specified in paragraph (2) of this definition, Medium-duty passenger vehicle means any heavy-duty vehicle (as defined in this subpart) with a gross vehicle weight rating (GVWR) of less than 10,000 pounds that is designed primarily for the transportation of persons. The MDPV definition does not include any vehicle which:
(i) Is an “incomplete vehicle” as defined in this subpart; or
(ii) Has a seating capacity of more than 12 persons; or
(iii) Is designed for more than 9 persons in seating rearward of the driver's seat; or
(iv) Is equipped with an open cargo area (for example, a pick-up truck box or bed) of 72.0 inches in interior length or more. A covered box not readily accessible from the passenger compartment will be considered an open cargo area for purposes of this definition.
(2) Starting with model year 2027, or earlier at the manufacturer's discretion, Medium-duty passenger vehicle means any heavy-duty vehicle subject to standards under this subpart that is designed primarily for the transportation of persons, with seating rearward of the driver, except that the MDPV definition does not include any vehicle that has any of the following characteristics:
(i) Is an “incomplete vehicle” as defined in this subpart.
(ii) Has a seating capacity of more than 12 persons.
(iii) Is designed for more than 9 persons in seating rearward of the driver's seat.
(iv) Is equipped with an open cargo area (for example, a pick-up truck box or bed) with an interior length of 72.0 inches or more for vehicles above 9,500 pounds GVWR with a work factor above 4,500 pounds. A covered box not readily accessible from the passenger compartment will be considered an open cargo area for purposes of this definition. For purposes of this definition, measure the cargo area's interior length from front to back at floor level with all gates and doors closed.
(v) Is equipped with an open cargo area with an interior length of 94.0 inches or more for vehicles at or below 9,500 pounds GVWR and for all vehicles with a work factor at or below 4,500 pounds.
(vi) Is a van in a configuration with greater cargo-carrying volume than passenger-carrying volume at the point of first retail sale. Determine cargo-carrying volume accounting for any installed second-row seating, even if the manufacturer has not described that as an available feature.
The revisions read as follows:
(c)
(d)
(b) * * *
(4) For vehicles with installed compression-ignition engines that are subject to standards and related requirements under 40 CFR 1036.104 and 1036.111, you must comply with the following additional requirements:
(i) Make parameters related to engine derating and other inducements available for reading with a generic scan tool as specified in 40 CFR 1036.110(b)(9)(vi).
(ii) Design your vehicles to display information related to engine derating and other inducements in the cab as specified in 40 CFR 1036.110(c)(1) and 1036.601(c).
(e) Onboard diagnostic requirements apply for alternative-fuel conversions as described in 40 CFR part 85, subpart F.
Model year 2027 and later vehicles must have onboard diagnostic (OBD) systems as described in this section. OBD systems must generally detect malfunctions in the emission control system, store trouble codes corresponding to detected malfunctions, and alert operators appropriately. Vehicles may optionally comply with the requirements of this section instead of the requirements of § 86.1806-17 before model year 2027.
(a) Vehicles must comply with the 2022 OBD requirements adopted for California as described in this paragraph (a). California's 2022 OBD-II requirements are part of Title 13, section 1968.2 of the California Code of Regulations, operative November 30, 2022 (incorporated by reference, see § 86.1). We may approve your request to certify an OBD system meeting a later version of California's OBD requirements if you demonstrate that it complies with the intent of this section. The following clarifications and exceptions apply for vehicles certified under this subpart:
(1) For vehicles not certified in California, references to vehicles meeting certain California Air Resources Board emission standards are understood to refer to the corresponding EPA emission standards for a given family, where applicable. Use good engineering judgment to correlate the specified standards with the bin standards that apply under this subpart.
(2) Vehicles must comply with OBD requirements throughout the useful life as specified in § 86.1805. If the specified useful life is different for evaporative and exhaust emissions, the useful life specified for evaporative emissions applies for monitoring related to fuel-system leaks and the useful life specified for exhaust emissions applies for all other parameters.
(3) The purpose and applicability statements in 13 CCR 1968.2(a) and (b) do not apply.
(4) The anti-tampering provisions in 13 CCR 1968.2(d)(1.4) do not apply.
(5) The requirement to verify proper alignment between the camshaft and crankshaft described in 13 CCR 1968.2(e)(15.2.1)(C) applies only for vehicles equipped with variable valve timing.
(6) The deficiency provisions described in paragraph (c) of this section apply instead of 13 CCR 1968.2(k).
(7) Apply thresholds for exhaust emission malfunctions from Tier 4 vehicles based on the thresholds calculated for the corresponding bin standards in the California LEV III program as prescribed for the latest model year in 13 CCR 1968.2(d). For example, for Tier 4 Bin 10 standards, apply the threshold that applies for the LEV standards. For cases involving Tier 4 standards that have no corresponding bin standards from the California LEV III program, use the monitor threshold for the next highest LEV III bin. For example, for Tier 4 Bin 5 and Bin 10 standards, apply a threshold of 50 mg/mile (15 mg/mile × 3.33). You may apply thresholds that are more stringent than we require under this paragraph (a)(7).
(8) Apply thresholds and testing requirements as specified in 40 CFR 1036.110(b)(5), (6) and (11) for engines certified to emission standards under 40 CFR part 1036.
(b) For vehicles with installed compression-ignition engines that are subject to standards and related requirements under 40 CFR 1036.104 and 1036.111, you must comply with the following additional requirements:
(1) Make parameters related to engine derating and other inducements available for reading with a generic scan tool as specified in 40 CFR 1036.110(b)(9)(vi).
(2) Design your vehicles to display information related to engine derating and other inducements in the cab as
(c) You may ask us to accept as compliant a vehicle that does not fully meet specific requirements under this section. Such deficiencies are intended to allow for minor deviations from OBD standards under limited conditions. We expect vehicles to have functioning OBD systems that meet the objectives stated in this section. The following provisions apply regarding OBD system deficiencies:
(1) Except as specified in paragraph (d) of this section, we will not approve a deficiency that involves the complete lack of a major diagnostic monitor, such as monitors related to exhaust aftertreatment devices, oxygen sensors, air-fuel ratio sensors, NO
(2) We will approve a deficiency only if you show us that full compliance is infeasible or unreasonable considering any relevant factors, such as the technical feasibility of a given monitor, or the lead time and production cycles of vehicle designs and programmed computing upgrades.
(3) Our approval for a given deficiency applies only for a single model year, though you may continue to ask us to extend a deficiency approval in renewable one-year increments. We may approve an extension if you demonstrate an acceptable level of effort toward compliance and show that the necessary hardware or software modifications would pose an unreasonable burden.
(d) For alternative-fuel vehicles, manufacturers may request a waiver from specific requirements for which monitoring may not be reliable for operation with the alternative fuel. However, we will not waive requirements that we judge to be feasible for a particular manufacturer or vehicle model.
(e) OBD-related requirements for alternative-fuel conversions apply as described in 40 CFR part 85, subpart F.
(f) You may ask us to waive certain requirements in this section for emergency vehicles. We will approve your request for an appropriate duration if we determine that the OBD requirement in question could harm system performance in a way that would impair a vehicle's ability to perform its emergency functions.
(g) The following interim provisions describe an alternate implementation schedule for the requirements of this section in certain circumstances:
(1) Manufacturers may delay complying with all the requirements of this section, and instead meet all the requirements that apply under § 86.1806-17 for any vehicles above 6,000 pounds GVWR that are not yet subject to all the Tier 4 standards in § 86.1811.
(2) Except as specified in this paragraph (g)(2), small-volume manufacturers may delay complying with all the requirements of this section until model year 2030, and instead meet all the requirements that apply under § 86.1806-17 during those years.
(a) * * *
(3) * * *
(iv) Monitor family and battery durability family as specified in § 86.1815-27, if applicable;
(d) The following provisions apply for incomplete vehicles certified under this subpart:
(1) Incomplete light-duty trucks must have the following prominent statement printed on the label required by paragraph (a)(3)(v) of this section: “This vehicle conforms to U.S. EPA regulations applicable to 20xx Model year Light-Duty Trucks when it does not exceed XXX pounds in curb weight, XXX pounds in gross vehicle weight rating, and XXX square feet in frontal area.”
(2) Incomplete heavy-duty vehicles must have the following prominent statement printed on the label required by paragraph (a)(3)(v) of this section: “This vehicle conforms to U.S. EPA regulations applicable to 20xx Model year Heavy-Duty Vehicles when it does not exceed XXX pounds in curb weight, XXX pounds in gross vehicle weight rating, and XXX square feet in frontal area.”
(a) No new vehicle shall be equipped with a defeat device.
(b) EPA may test or require testing on any vehicle at a designated location, using driving cycles and conditions that may reasonably be expected to be encountered in normal operation and use, for the purposes of investigating a potential defeat device.
(c) For cold temperature CO, NMHC, and NMOG+NO
(1) If the CO emission level is greater than the 20 °F emission standard, the vehicle will automatically be considered to be equipped with a defeat device without further investigation. If the intermediate temperature NMHC or NMOG+NO
(2) If the conditions in paragraph (c)(1) of this section do not apply, EPA may investigate the vehicle design for the presence of a defeat device under paragraph (d) of this section.
(d) The following provisions apply for vehicle designs EPA designates for investigation as possible defeat devices:
(1) The manufacturer must show to EPA's satisfaction that the vehicle design does not incorporate strategies that unnecessarily reduce emission control effectiveness exhibited over the driving cycles specified in this subpart, the fuel economy test procedures in 40 CFR part 600, or the air conditioning efficiency test in 40 CFR 1066.845, when the vehicle is operated under conditions that may reasonably be
(2) [Reserved]
(3) The following information requirements apply:
(i) Upon request by EPA, the manufacturer must provide an explanation containing detailed information regarding test programs, engineering evaluations, design specifications, calibrations, on-board computer algorithms, and design strategies incorporated for operation both during and outside of the Federal emission test procedures.
(ii) For purposes of investigation of possible cold temperature CO, NMHC, or NMOG+NO
(e) For each test group the manufacturer must submit an engineering evaluation with the Part II certification application demonstrating to EPA's satisfaction that a discontinuity in emissions of non-methane organic gases, particulate matter, carbon monoxide, carbon dioxide, oxides of nitrogen, nitrous oxide, methane, and formaldehyde measured on the Federal Test Procedure (40 CFR 1066.801(c)(1)) and on the Highway Fuel Economy Test Procedure (40 CFR 1066.801(c)(5)) does not occur in the temperature range of 20 to 86 °F.
(g) The cold temperature standards in this subpart refer to test procedures set forth in subpart C of this part and 40 CFR part 1066, subpart H. All other emission standards in this subpart rely on test procedures set forth in subpart B of this part and 40 CFR part 1066, subpart H. These procedures rely on the test specifications in 40 CFR parts 1065 and 1066 as described in subparts B and C of this part.
(h) Multi-fueled vehicles (including dual-fueled and flexible-fueled vehicles) must comply with all the requirements established for each consumed fuel (and blend of fuels for flexible-fueled vehicles). The following specific provisions apply for flexible-fueled vehicles that operate on ethanol and gasoline:
(1) For criteria exhaust emissions, we may identify the worst-case fuel blend for testing in addition to what is required for gasoline-fueled vehicles. The worst-case fuel blend may be the fuel specified in 40 CFR 1065.725, or it may consist of a combination of the fuels specified in 40 CFR 1065.710(b) and 1065.725. We may waive testing with the worst-case blended fuel for US06 and/or SC03 duty cycles; if we waive only SC03 testing for Tier 3 vehicles, substitute the SC03 emission result using the standard test fuel for gasoline-fueled vehicles to calculate composite SFTP emissions.
(2) For evaporative and refueling emissions, test using the fuel specified in 40 CFR 1065.710(b).
(3) No additional spitback or evaporative emission testing is required beyond the emission measurements with the gasoline test fuel specified in 40 CFR 1065.710.
(b) * * *
(8) * * *
(iii) * * *
(B) You may continue to use the E0 test fuel specified in § 86.113 as described in 40 CFR 600.117.
(d)
(g) * * *
(2) * * *
(ii) The manufacturer must calculate its fleet average cold temperature NMHC emission level(s) as described in § 86.1864-10(b).
(a)
(1) A vehicle meeting all the requirements of this section is considered a Tier 4 vehicle meeting the Tier 4 standards. Vehicles meeting some but not all requirements are considered interim Tier 4 vehicles as described in paragraph (b)(6)(iv) of this section.
(2) The Tier 4 standards include testing over a range of driving schedules and ambient temperatures. The standards for 25 °C or 35 °C testing in paragraph (b) of this section apply separate from the −7 °C testing in paragraph (c) of this section. We may identify these standards based on nominal ambient test temperatures. Note that −7 °C testing is also identified as cold temperature testing elsewhere in this subpart.
(3) See § 86.1813 for evaporative and refueling emission standards.
(4) See § 86.1818 for greenhouse gas emission standards.
(b)
(1) Measure emissions using the chassis dynamometer procedures of 40 CFR part 1066, as follows:
(i) Establish appropriate load settings based on loaded vehicle weight for light-duty program vehicles and adjusted loaded vehicle weight for medium-duty vehicles (see § 86.1803).
(ii) Emission standards under this paragraph (b) apply for all the following driving cycles unless otherwise specified:
(iii) Testing occurs at (20-30) °C ambient temperatures, except that a nominal ambient temperature of 35.0 °C applies for testing over the SC03 driving cycle. See paragraph (c) of this section for emission standards and measurement procedures that apply for cold temperature testing.
(iv) Hydrocarbon emission standards are expressed as NMOG; however, for certain vehicles you may measure exhaust emissions based on nonmethane hydrocarbon instead of NMOG as described in 40 CFR 1066.635.
(v) Measure emissions from hybrid electric vehicles (including plug-in hybrid electric vehicles) as described in 40 CFR part 1066, subpart F, except that these procedures do not apply for plug-in hybrid electric vehicles during charge-depleting operation.
(2) Fully phased-in standards apply as specified in the following table:
(3) The FTP standards specified in this paragraph (b) apply equally for testing at low-altitude conditions and high-altitude conditions. The US06, SC03, and HFET standards apply only for testing at low-altitude conditions.
(4) The NMOG+NO
(i) You must specify a family emission limit (FEL) for each test group based on the FTP emission standard corresponding to each named bin. The FEL serves as the emission standard for the test group with respect to all specified driving cycles. Calculate your fleet average emission level as described in § 86.1860 to show that you meet the specified fleet average standard. For multi-fueled vehicles, calculate fleet average emission levels based only on emission levels for testing with gasoline or diesel fuel. You may generate emission credits for banking and trading, and you may use banked or traded credits as described in § 86.1861 for demonstrating compliance with the fleet average NMOG+NO
(ii) Select one of the identified values from table 2 of this section for demonstrating that your fleet average emission level for light-duty program vehicles complies with the fleet average NMOG+NO
(iii) You may select one of the identified values from table 2 to paragraph (b)(4)(ii) of this section for demonstrating that your fleet average emission level for medium-duty vehicles complies with the fleet average NMOG+NO
(5) Qualifying vehicles are exempt from certain ACC II bin standards as follows:
(i) Vehicles are exempt from the ACC II bin standards for early driveaway if the vehicle prevents engine starting during the first 20 seconds of a cold-start FTP test interval and the vehicle does not use an electrically heated catalyst or other technology to precondition the engine or emission controls such that NMOG+NO
(ii) Vehicles are exempt from the ACC II bin standards for high-power PHEV engine starts if their all-electric range on the cold-start US06 driving cycles is at or above 10 miles for model years 2027 through 2029, and at or above 40 miles for model year 2030 and later.
(6) The Tier 4 standards phase in over several years, as follows:
(i)
(ii)
(iii)
(A) If you select the alternative early phase-in for light-duty program vehicles above 6,000 pounds GVWR, you must demonstrate that you meet the phase-in requirements in paragraph (b)(6)(i) of this section based on all your light-duty program vehicles.
(B) If you select the alternative early phase-in for medium-duty vehicles, include all medium-duty vehicles in the calculation to comply with the Tier 4 fleet average NMOG+NO
(C) If you select the alternative early phase-in but are unable to meet all the requirements that apply in any model year before model year 2030 for light-duty program vehicles and model year 2031 for medium-duty vehicles, you may switch to the default phase-in. Switching to the default phase-in does not affect certification or compliance obligations for model years before you switch to the default phase-in.
(iv)
(v)
(vi)
(vii) Keep records as needed to show that you meet the requirements specified in this paragraph (b) for phasing in standards and for complying with declining fleet average average standards.
(c)
(1) Measure emissions as described in 40 CFR 1066.801(c)(1) and (6).
(2) The standards apply to gasoline-fueled and diesel-fueled vehicles, except as specified. Multi-fuel, bi-fuel or dual-fuel vehicles must comply with requirements using only gasoline and diesel fuel, as applicable. Testing with other fuels such as electricity or a high-level ethanol-gasoline blend is not required.
(3) The following standards apply equally for light-duty program vehicles and medium-duty vehicles:
(i) Gasoline-fueled vehicles must meet a fleet average NMOG+NO
(ii) The PM standard is 0.5 mg/mile.
(iii) The CO standard is 10.0 g/mile.
(4) The CO standard applies at both low-altitude and high-altitude conditions. The NMOG+NO
(5) Phase-in requirements for standards under this paragraph (c) apply as described in paragraphs (b)(6) and (f) of this section.
(d)
(1) A/C-on specific calibrations (
(2) For AECDs involving commanded enrichment, these AECDs must not operate differently for A/C-on operation than for A/C-off operation. This includes both the sensor inputs for triggering enrichment and the degree of enrichment employed.
(e)
(1) The engine-based off-cycle emission standards in 40 CFR 1036.104(a)(3) apply for vehicles with compression-ignition engines based on measurement procedures with 2-bin moving average windows. Manufacturers may instead meet the following alternative standards for measurement procedures with 3-bin moving average windows:
(2) The following emission standards apply for spark-ignition engines:
(3) In-use testing requirements and measurement procedures apply as described in § 86.1845-04(h).
(f)
(1) Instead of the 25 °C fleet average NMOG+NO
(2) Instead of the phase-in specified in paragraph (b)(6)(i) of this section, small-volume manufacturers may comply with all the requirements of this section other than the NMOG+NO
The revisions and additions read as follows:
(a) * * *
(2) * * *
(i) The emission standard for the sum of diurnal and hot soak measurements from the two-diurnal test sequence and the three-diurnal test sequence is based on a fleet average in a given model year. You must specify a family emission limit (FEL) for each evaporative family. The FEL serves as the emission standard for the evaporative family with respect to all required diurnal and hot soak testing. Calculate your fleet average emission level as described in § 86.1860 based on the FEL that applies for low-altitude testing to show that you meet the specified standard. For multi-fueled vehicles, calculate fleet average emission levels based only on emission levels for testing with gasoline. You may generate emission credits for banking and trading, and you may use banked or traded credits for demonstrating compliance with the diurnal plus hot soak emission standard for vehicles required to meet the Tier 3 standards, other than gaseous-fueled or electric vehicles, as described in § 86.1861 starting in model year 2017. You comply with the emission standard for a given model year if you have enough credits to show that your fleet average emission level is at or below the applicable standard. You may exchange credits between or among evaporative families within an averaging set as described in § 86.1861. Separate diurnal plus hot soak emission standards apply for each evaporative/refueling emission family as shown for high-altitude conditions. The sum of diurnal and hot soak measurements may not exceed the following Tier 3 standards:
(iv) Vehicles that become light-duty vehicles based on the change in the definition for “light-duty truck” for Tier 4 vehicles may continue to meet the same evaporative emission standards under this paragraph (a) through model year 2031 as long as they qualify for carryover certification as described in § 86.1839.
(v) Vehicles that are no longer medium-duty vehicles based on the change in the definition for “medium-duty passenger vehicles” for Tier 4 vehicles may continue to meet the same evaporative emission standards under this paragraph (a) through model year 2031 as long as they qualify for carryover certification as described in § 86.1839.
(b) * * *
(1) The following implementation dates apply for incomplete heavy-duty vehicles:
(i) Refueling standards apply starting with model year 2027 for incomplete heavy-duty vehicles certified under 40 CFR part 1037 and in model year 2030 for incomplete heavy-duty vehicles certified under this subpart, unless the manufacturer complies with the alternate phase-in specified in paragraph (b)(1)(iii) of this section. If you do not meet the alternative phase-in requirement for model year 2026, you must certify all your incomplete heavy-duty vehicles above 14,000 pounds GVWR to the refueling standard in model year 2027.
(ii) Refueling standards are optional for incomplete heavy-duty vehicles at or below 14,000 pounds GVWR through model year 2029, unless the manufacturer uses the alternate phase-in specified in paragraph (b)(1)(iii) of this section to meet standards together for heavy-duty vehicles above and below 14,000 pounds GVWR.
(iii) Manufacturers may comply with an alternate phase-in of the refueling standard for incomplete heavy-duty vehicles as described in this paragraph (b)(1)(iii). Manufacturers must meet the refueling standard during the phase-in based on their projected nationwide production volume of all incomplete heavy-duty vehicles subject to standards under this subpart and under 40 CFR part 1037 as described in Table 4 of this section. Keep records as needed to show that you meet phase-in requirements.
(g) * * *
(2) * * *
(ii) * * *
(B) All the vehicles meeting the leak standard must also meet the Tier 3 evaporative emission standards. Through model year 2026, all vehicles meeting the leak standard must also meet the OBD requirements in § 86.1806-17(b)(1).
Except as specified in paragraph (h) of this section, battery electric vehicles and plug-in hybrid electric vehicles must meet requirements related to batteries serving as a Rechargeable Energy Storage System from GTR No. 22 (incorporated by reference, see § 86.1). The requirements of this section apply starting in model year 2027 for vehicles at or below 6,000 pounds GVWR. The requirements of this section start to apply for vehicles above 6,000 pounds GVWR when they are first certified to Tier 4 NMOG+NO
(a) Manufacturers must install an operator-accessible display that monitors, estimates, and communicates the vehicle's State of Certified Energy (SOCE) and include information in the application for certification as described in § 86.1844. Display SOCE as a percentage expressed at least to the nearest whole number. Manufacturers that qualify as small businesses under § 86.1801-12(j)(1) must meet the requirements of this paragraph (a) but are not subject to the requirements in paragraphs (c) through (g) of this section; however, small businesses may trade credits they generate from battery electric vehicles and plug-in hybrid electric vehicles for a given model year only if they meet requirements in paragraphs (c) through (g) of this section.
(b) Requirements in GTR No. 22 related to State of Certified Range do not apply.
(c) Evaluate SOCE based on measured Usable Battery Energy (UBE) values. Use the Multi-Cycle Range and Energy Consumption Test described in 40 CFR 600.116-12(a) for battery electric vehicles and either the UDDS Full Charge Test (FCT) or the HFET FCT as described in 40 CFR 600.116-12(c)(11) for plug-in hybrid electric vehicles. For medium-duty vehicles, perform testing with test weight set to Adjusted Loaded Vehicle Weight.
(d) In-use vehicles must display SOCE values that are accurate within 5 percent of measured values as calculated in GTR No. 22.
(e) Batteries installed in light-duty program vehicles must meet a Minimum Performance Requirement such that measured usable battery energy is at least 80 percent of the vehicle's certified usable battery energy after 5 years or 62,000 miles, and at least 70 percent of certified usable battery energy at 8 years or 100,000 miles.
(f) Manufacturers must divide test groups into families and perform testing and submit reports as follows:
(1) Identify battery durability families and monitor families as specified in Section 6.1 of GTR No. 22. Include vehicles in the same battery durability family only if there are no chemistry differences that would be expected to influence durability, such as proportional metal composition of the cathode, composition of the anode, or differences in particle size or morphology of cathode or anode active materials.
(2) Perform Part A testing to verify that SOCE monitors meet accuracy requirements as described in § 86.1845-04. Test the number of vehicles and determine a pass or fail result as specified in Section 6.3 of GTR No. 22.
(3) For light-duty program vehicles, perform Part B verification for each battery durability family included in a monitor family subject to Part A testing to verify that batteries have SOCE meeting the Minimum Performance Requirement. Determine performance by reading SOCE monitors with a physical inspection, remote inspection using wireless technology, or any other appropriate means.
(i) Randomly select test vehicles from at least 10 different U.S. states or territories, with no more than 50 percent of selected vehicles coming from any one state or territory. Select vehicles to represent a wide range of climate conditions and operating characteristics.
(ii) Select at least 500 test vehicles per year from each from each battery durability family, except that we may approve your request to select fewer vehicles for a given battery durability family based on limited production volumes. If you test fewer than 500 vehicles, you may exclude up to 5 percent of the tested vehicles to account for the limited sample size. Test vehicles may be included from year to year, or test vehicles may change over the course of testing for the battery durability family.
(iii) A battery durability family passes if 90 percent or more of sampled vehicles have reported values at or above the Minimum Performance Requirement.
(iv) Continue testing for eight years after the end of production for vehicles included in the battery durability family. Note that testing will typically require separate testing from multiple model years in a given calendar year.
(4) You may request our approval to group monitors and batteries differently, or to adjust testing specifications. Submit your request with your proposed alternative specifications, along with technical justification. In the case of broadening the scope of a monitor family, include data demonstrating that differences within the proposed monitor family do not cause error in estimating SOCE.
(5) Submit electronic reports to document the results of testing as described in § 86.1847.
(g) If vehicles do not comply with monitor accuracy requirements under this section, the recall provisions in 40 CFR part 85, subpart S, apply for each affected monitor family. If battery electric and plug-in hybrid electric vehicles do not comply with battery durability requirements under this section, the manufacturer must account for the nonconformity by forfeiting GHG credits calculated for all the vehicles within the battery durability group (see § 86.1865-12(j)(3)). Manufacturers must similarly adjust NMOG+NO
(h) Manufacturers may meet the requirements of this section for battery electric vehicles by instead complying with monitor accuracy and battery durability requirements based on the procedures specified in 13 CCR 1962.7 (incorporated by reference, see § 86.1), subject to the following exceptions and clarifications:
(1) References to the California ARB Executive Officer are deemed to mean the EPA Administrator. References to California are deemed to mean the United States. Test vehicles may be registered in any U.S. state or territory.
(2) Model year 2027 through 2029 vehicles must be designed to maintain 70 percent or more of the certification range value for at least 70 percent of the vehicles in a test group. Model year 2030 and later vehicles must be designed to maintain 80 percent or more of the certification range value as an average value for all vehicles in a test group. These requirements apply for a useful life of 10 years or 150,000 miles, whichever occurs first. If vehicles do not comply with these battery durability requirements, the manufacturer must adjust all credit balances to account for the nonconformity by forfeiting GHG credits calculated for all the vehicles within the test group (see § 86.1865-12(j)(3)). Manufacturers must similarly adjust NMOG+NO
(3) EPA may perform compliance and enforcement testing to support a finding of nonconformity as described in 13 CCR 1962.7(e).
(4) A minimum nationwide sampling rate of 500 in-use vehicles applies under
(5) Manufacturers must meet the data standardization requirements in 13 CCR 1962.5 (incorporated by reference, see § 86.1).
(6) Vehicles continue to be subject to warranty requirements as specified in 40 CFR part 85, subpart V.
(7) Meeting requirements under this paragraph (h) does not depend on creating battery durability families and monitor families. The Part A testing requirements for monitor accuracy also do not apply.
(8) Include the following information in the application for certification for each test group instead of the information specified in § 86.1844-01(d)(19):
(i) The worst-case certified range value to represent the test group, instead of certified usable battery energy.
(ii) A statement attesting that the SOCE monitor meets the accuracy requirement appropriate for the model year.
(iii) A statement that each test group meets the design targets in paragraph (h)(2) of this section.
(a)
(b) * * *
(14) Starting in model year 2027, you may certify vehicles using the following transitional Tier 4 bins as part of the compliance demonstration for meeting the Tier 4 declining fleet average NMOG+NO
The revisions read as follows:
(a)
(2) The standards specified in this section apply for testing at both low-altitude conditions and high-altitude conditions. However, manufacturers must submit an engineering evaluation indicating that common calibration approaches are utilized at high altitude instead of performing testing for certification, consistent with § 86.1829. Any deviation from low altitude emission control practices must be included in the auxiliary emission control device (AECD) descriptions submitted at certification. Any AECD
(3) A manufacturer that qualifies as a small business according to § 86.1801-12(j) is exempt from the emission standards in this section and the associated provisions in 40 CFR part 600; however, manufacturers may trade emission credits generated in a given model year only by certifying to emission standards that apply for that model year. Starting in model year 2027, manufacturers may produce no more than 500 exempt vehicles in any model year under this paragraph (a)(3). This limit applies for vehicles with engines, including plug-in hybrid electric vehicles; this limit does not apply for electric vehicles. Vehicles that are not exempt under this paragraph (a)(3) must meet emission standards as specified in this section.
(b)
(c)
(1) Each manufacturer must comply with separate fleet average CO
(2) A CO
(f)
(g)
(1)
(i) If a manufacturer's average sales for three consecutive model years exceeds 4999, and if the increase in sales is the result of corporate acquisitions, mergers, or purchase by another manufacturer, the manufacturer shall comply with the emission standards described in paragraph (c) of this section, as applicable, beginning with the first model year after the last year of the three consecutive model years.
(ii) If a manufacturer's average sales for three consecutive model years exceeds 4999 and is less than 50,000, and if the increase in sales is solely the result of the manufacturer's expansion in vehicle production (not the result of corporate acquisitions, mergers, or purchase by another manufacturer), the manufacturer shall comply with the emission standards described in paragraph (c), of this section, as applicable, beginning with the second model year after the last year of the three consecutive model years.
(2)
(i) In addition to the information required under paragraph (g)(4) of this section, new entrants must provide documentation that shows a clear intent by the company to actually enter the U.S. market in the years for which alternative standards are requested. Demonstrating such intent could include providing documentation that shows the establishment of a U.S. dealer network, documentation of work underway to meet other U.S. requirements (
(ii) Sales of vehicles in the U.S. by new entrants must remain below 5,000 vehicles for the first three model years in the U.S. market, and in subsequent years the average sales for any three consecutive years must remain below 5,000 vehicles. Vehicles sold in violation of these limits within the first five model years will be considered not covered by the certificate of conformity and the manufacturer will be subject to penalties on an individual-vehicle basis for sale of vehicles not covered by a certificate. In addition, violation of these limits will result in loss of eligibility for alternative standards until such point as the manufacturer demonstrates two consecutive model years of sales below 5,000 automobiles. After the first five model years, the eligibility provisions in paragraph (g)(1) of this section apply, where violating the sales thresholds is no longer a violation of the condition on the certificate, but is instead grounds for losing eligibility for alternative standards.
(iii) A manufacturer with sales in the most recent model year of less than 5,000 automobiles, but where prior model year sales were not less than 5,000 automobiles, is eligible to request alternative standards under this paragraph (g). However, such a manufacturer will be considered a new entrant and subject to the provisions regarding new entrants in this paragraph (g), except that the requirement to demonstrate an intent to enter the U.S. market in paragraph (g)(2)(i) of this section shall not apply.
(3) How to request alternative fleet average standards. Eligible manufacturers may petition for alternative standards for up to five consecutive model years if sufficient information is available on which to base such standards.
(i) To request alternative standards starting with the 2017 model year, eligible manufacturers must submit a completed application no later than July 30, 2013.
(ii) To request alternative standards starting with a model year after 2017, eligible manufacturers must submit a completed request no later than 36 months prior to the start of the first model year to which the alternative standards would apply.
(iii) The request must contain all the information required in paragraph (g)(4) of this section, and must be signed by a chief officer of the company. If the Administrator determines that the content of the request is incomplete or insufficient, the manufacturer will be notified and given an additional 30 days to amend the request.
(4)
(i)
(B) Vehicle models and projections of sales volumes for each model year.
(C) Detailed description of each model, including the vehicle type, vehicle mass, power, footprint, powertrain, and expected pricing.
(D) The expected production cycle for each model, including new model introductions and redesign or refresh cycles.
(ii)
(B) An evaluation of comparable models from other manufacturers, including CO
(C) A discussion of the CO
(D) An evaluation, at a minimum, of the technologies projected by the Environmental Protection Agency in a final rulemaking as those technologies likely to be used to meet greenhouse gas emission standards and the extent to which those technologies are employed or projected to be employed by the manufacturer. For any technology that is not projected to be fully employed, explain why this is the case.
(iii)
(B) For each model year, a projection of the lowest feasible sales-weighted fleet average CO
(C) A copy of any application, data, and related information submitted to NHTSA in support of a request for alternative Corporate Average Fuel Economy standards filed under 49 CFR part 525.
(iv)
(B) Information regarding ownership relationships with other manufacturers, including details regarding the application of the provisions of § 86.1838-01(b)(3) regarding the aggregation of sales of related companies.
(5)
(i) Where EPA has exercised its regulatory authority to administratively specify alternative standards, those alternative standards approved for model year 2021 continue to apply through model year 2026. Starting in model year 2027, manufacturers must certify to the standards in paragraph (h)
(ii) EPA may approve a request from other manufacturers for alternative fleet average CO
(6)
(7) Starting in model year 2032, all manufacturers must certify to the standards in paragraph (c) of this section.
(h)
(1) CO
(2) CO
The revisions and republications read as follows:
This section describes exhaust emission standards for CO
(a) * * *
(2) CO
(i) For vehicles with work factor at or below 5,500 pounds, use the appropriate work factor in the following equation to calculate a target value for each vehicle subconfiguration (or group of subconfigurations as allowed under paragraph (a)(4) of this section), rounding to the nearest whole g/mile:
(ii) For vehicles with work factor above 5,500 pounds, the CO
(d) * * *
(10) For dual-fuel, multi-fuel, and flexible-fuel vehicles, perform exhaust testing on each fuel type (for example, gasoline and E85).
(i) Use either the conventional-fueled CO
(ii) If you certify to an alternate standard for N
(13) This paragraph (d)(13) applies for CO
(15) You must submit a final report within 90 days after the end of the model year. Unless we specify otherwise, include applicable information identified in § 86.1865-12(l), 40 CFR 600.512, and 49 CFR 535.8(e). The final report must include at least the following information:
(i) Model year.
(ii) Applicable fleet average CO
(iii) Calculated fleet average CO
(iv) Number of credits or debits incurred and all values required to calculate those values.
(v) Resulting balance of credits or debits.
(vi) N
(vii) CH
(viii) Total and percent leakage rates under paragraph (h) of this section (through model year 2026 only).
(17) You may calculate emission rates for weight increments less than the 500-pound increment specified for test weight. This does not change the applicable test weights.
(i) Use the ADC equation in paragraph (g) of this section to adjust your emission rates for vehicles in increments of 50, 100, or 250 pounds instead of the 500 pound test-weight increments. Adjust emissions to the midpoint of each increment. This is the equivalent emission weight. For example, vehicles with a test weight basis of 11,751 to 12,250 pounds (which have an equivalent test weight of 12,000 pounds) could be regrouped into 100-pound increments as follows:
(ii) You must use the same increment for all equivalent test weight classes across your whole product line in a given model year. You must also specify curb weight for calculating the work factor in a way that is consistent with your approach for determining test weight for calculating ADCs under this paragraph (d)(17).
(h)
(j)
(1) For GHG compliance, you may certify any complete or cab-complete spark-ignition vehicles above 14,000 pounds GVWR and at or below 26,000 pounds GVWR to the GHG standards of this section even though this section otherwise specifies that you may certify vehicles to the GHG standards of this section only if they are chassis-certified for criteria pollutants. This paragraph (j)(1) also applies for vehicles at or below 14,000 pounds GVWR with GCWR above 22,000 pounds with installed engines that have been certified under 40 CFR part 1036 as described in 40 CFR 1036.635.
(2) You may apply the provisions of this section to cab-complete vehicles based on a complete sister vehicle. In unusual circumstances, you may ask us to apply these provisions to Class 2b or Class 3 incomplete vehicles that do not meet the definition of cab-complete.
(i) Except as specified in paragraph (j)(3) of this section, for purposes of this section, a complete sister vehicle is a complete vehicle of the same vehicle configuration as the cab-complete vehicle. You may not apply the provisions of this paragraph (j) to any vehicle configuration that has a four-wheel rear axle if the complete sister vehicle has a two-wheel rear axle.
(ii) Calculate the target value for fleet average CO
(iii) Test these cab-complete vehicles using the same equivalent test weight and other dynamometer settings that apply for the complete vehicle from which you used the work factor value (the complete sister vehicle). For GHG certification, you may submit the test data from that complete sister vehicle instead of performing the test on the cab-complete vehicle.
(iv) You are not required to produce the complete sister vehicle for sale to use the provisions of this paragraph (j)(2). This means the complete sister vehicle may be a carryover vehicle from a prior model year or a vehicle created solely for the purpose of testing.
(3) For GHG purposes, if a cab-complete vehicle is not of the same vehicle configuration as a complete sister vehicle due only to certain factors unrelated to coastdown performance, you may use the road-load coefficients from the complete sister vehicle for certification testing of the cab-complete vehicle, but you may not use emission data from the complete sister vehicle for certifying the cab-complete vehicle.
(4) The GHG standards of this section and related provisions apply for vehicles above 22,000 pounds GCWR as described in 40 CFR 1036.635.
(k)
(1)
(2)
(3)
(4)
(i) CO
(ii) The following optional alternative CO
(iii) CO
(5)
(i) Qualifying small manufacturers remain subject to the model year 2026 greenhouse gas standards; however, small manufacturers may trade emission credits generated in a given model year only by certifying to standards that apply for that model year.
(ii) Small manufacturers may produce no more than 500 exempt vehicles in any model year under paragraph (k)(5)(i) of this section. This limit applies for vehicles with engines, including plug-in hybrid electric vehicles; this limit does not apply for electric vehicles. Vehicles that are not exempt under this paragraph (k)(5) must meet emission standards as specified in this section.
(6)
(7)
(8)
(i) Engines certified under this paragraph (k)(8) are deemed to be certified to the standards of 40 CFR 1036.108 as specified in 40 CFR 1036.150(j).
(ii) For 2020 and earlier model years, the maximum allowable U.S.-directed production volume of engines you sell under this paragraph (k)(8) in any given model year is ten percent of the total U.S-directed production volume of engines of that design that you produce for heavy-duty applications for that model year, including engines you produce for complete vehicles, cab-complete vehicles, and other incomplete vehicles. The total number of engines you may certify under this paragraph (k)(8), of all engine designs, may not exceed 15,000 in any model year. Engines produced in excess of either of these limits are not covered by your certificate. For example, if you produce 80,000 complete model year 2017 Class 2b pickup trucks with a certain engine and 10,000 incomplete model year 2017 Class 3 vehicles with that same engine, and you do not apply the provisions of this paragraph (k)(8) to any other engine designs, you may produce up to 10,000 engines of that design for sale as loose engines under this paragraph (k)(8). If you produced 11,000 engines of that design for sale as loose engines, the last 1,000 of them that you produced in that model year 2017 would be considered uncertified.
(iii) For model years 2021 through 2023, the U.S.-directed production volume of engines you sell under this paragraph (k)(8) in any given model year may not exceed 10,000 units.
(iv) This paragraph (k)(8) does not apply for engines certified to the standards of 40 CFR 1036.108.
(v) Label the engines as specified in 40 CFR 1036.135 including the following compliance statement: “THIS ENGINE WAS CERTIFIED TO THE ALTERNATE GREENHOUSE GAS EMISSION STANDARDS OF 40 CFR 1036.150(j).” List the test group name instead of an engine family name.
(vi) Vehicles using engines certified under this paragraph (k)(8) are subject to the emission standards of 40 CFR 1037.105.
(vii) For certification purposes, your engines are deemed to have a CO
(A) If one or more of the CO
(B) If none of the CO
(viii) Production and in-use CO
(ix) N
(x) State in your applications for certification that your test group and engine family will include engines certified under this paragraph (k)(8). This applies for your greenhouse gas vehicle test group and your criteria pollutant engine family. List in each application the name of the corresponding test group/engine family.
(9)
(10)
(b) To be included in the same durability group, vehicles must be identical in all the respects listed in paragraphs (b)(1) through (7) of this section and meet one of the criteria specified in paragraph (b)(8) of this section:
(7) Type of particulate filter (none, catalyzed, noncatalyzed).
(8) The manufacturer must choose one of the following two criteria:
(i) Grouping statistic:
(A) Vehicles are grouped based upon the value of the grouping statistic determined using the following equation:
(B) Engine-emission control system combinations which have a grouping statistic which is either less than 25 percent of the largest grouping statistic value, or less than 0.2 g/liter (whichever allows the greater coverage of the durability group) shall be grouped into the same durability group.
(ii) The manufacturer may elect to use another procedure which results in at least as many durability groups as required using criteria in paragraph (b)(8)(i) of this section providing that only vehicles with similar emission deterioration or durability are combined into a single durability group.
(b) * * *
(10) Evaporative emission standard or family emission limit (FEL) for testing at low-altitude conditions.
(f)
(1)
(A) Multiple tests at a given mileage point are averaged together unless the same number of tests are conducted at each mileage point.
(B) Before and after maintenance test results are averaged together.
(C) Zero-mile test results are excluded from the calculation.
(D) Total hydrocarbon (THC) test points beyond the 50,000-mile (useful life) test point are excluded from the intermediate useful life deterioration factor calculation.
(E) A procedure may be employed to identify and remove from the DF calculation those test results determined to be statistical outliers providing that the outlier procedure is consistently applied to all vehicles and data points and is approved in advance by the Administrator.
(ii) The deterioration factor must be based on a linear regression, or another regression technique approved in advance by the Administrator. The deterioration must be a multiplicative or additive factor. Separate factors will be calculated for each regulated emission constituent and for the full and intermediate useful life periods as applicable. Separate DF's are calculated for each durability group except as provided in § 86.1839.
(A) A multiplicative DF will be calculated by taking the ratio of the full or intermediate useful life mileage level, as appropriate (rounded to four decimal places), divided by the stabilized mileage (reference § 86.1831-01(c),
(B) An additive DF will be calculated to be the difference between the full or intermediate useful life mileage level (as appropriate) minus the stabilized mileage (reference § 86.1831-01(c),
(iii) For Tier 3 vehicles, the DF calculated by these procedures will be used for determining full and intermediate useful life compliance with FTP exhaust emission standards, SFTP exhaust emission standards, and cold CO emission standards. At the manufacturer's option and using procedures approved by the Administrator, a separate DF may be calculated exclusively using cold CO test data to determine compliance with cold CO emission standards. Also, at the manufacturer's option and using procedures approved by the Administrator, a separate DF may be calculated exclusively using US06 and/or air conditioning (SC03) test data to determine compliance with the SFTP emission standards.
(iv) For Tier 4 vehicles, the DF calculated by these procedures may be used for determining compliance with all the standards identified in § 86.1811-27. At the manufacturer's option and using procedures approved by the Administrator, manufacturers may calculate a separate DF for the following standards and driving schedules:
(A) Testing to determine compliance with cold temperature emission standards.
(B) US06 testing.
(C) SC03 testing.
(D) HFET.
(E) Mid-temperature intermediate soak testing.
(F) Early driveaway testing.
(G) High-power PHEV engine starts.
(2)
(n)
(c) * * *
(1) Mileage accumulation must be conducted using the SRC or any road cycle approved under the provisions of § 86.1823-08(e)(1).
(k)
The durability-related requirements of this section apply for vehicles subject to refueling standards under this subpart. Refer to the provisions of §§ 86.1801 and 86.1813 to determine applicability of the refueling standards to different classes of vehicles. Diesel-fueled vehicles may be exempt from the requirements of this section under § 86.1829.
(c) * * *
(1) Mileage accumulation must be conducted using the SRC or a road cycle approved under the provisions of § 86.1823-08(e)(1).
(h)
(a) * * *
(5) Subject to the same emission standards (except for CO
(a)
(b)
(1) The vehicle configuration expected to exhibit the highest evaporative and/or refueling emission on candidate in-use vehicles shall be selected for each evaporative/refueling family and evaporative refueling emission system combination from among the corresponding vehicles selected for testing under paragraph (a) of this section. Separate vehicles may be selected to be tested for evaporative and refueling testing.
(2) Each test group must be represented by both evaporative and refueling testing (provided that the refueling standards are applicable) before it may be certified. That required testing may have been conducted on a vehicle in another test group provided the tested vehicle is a member of the same evaporative/refueling family and evaporative/refueling emission system combination and it was selected for testing in accordance with the provisions of paragraph (b)(1) of this section.
(3) For evaporative/refueling emission testing, the vehicle(s) selected shall be equipped with the worst-case evaporative/refueling emission hardware available on that vehicle considering such items as canister size and material, fuel tank size and material, purge strategy and flow rates, refueling characteristics, and amount of vapor generation.
(c)
(1) For cold temperature CO exhaust emission compliance for each durability group, the vehicle expected to emit the highest CO emissions at 20 degrees F on candidate in-use vehicles shall be selected from the test vehicles selected in accordance with paragraph (a) of this section.
(2) For cold temperature NMHC exhaust emission compliance for each durability group, the manufacturer must select the vehicle expected to emit the highest NMHC emissions at 20 °F on candidate in-use vehicles from the test vehicles specified in paragraph (a) of this section. When the expected worst-case cold temperature NMHC vehicle is also the expected worst-case cold temperature CO vehicle as selected in paragraph (c)(1) of this section, then cold temperature testing is required only for that vehicle; otherwise, testing is required for both the worst-case cold temperature CO vehicle and the worst-case cold temperature NMHC vehicle.
(d) [Reserved]
(e)
(f)
(a) Durability requirements apply as follows:
(1) One durability demonstration is required for each durability group. The
(2) Manufacturers may provide a statement in the application for certification that vehicles comply with the monitor accuracy and battery durability requirements of § 86.1815-27 instead of submitting test data for certification. The following durability testing requirements apply for battery electric vehicles and plug-in hybrid electric vehicles after certification:
(i) Manufacturers must perform monitor accuracy testing on in-use vehicles as described in § 86.1845-04(g) for each monitor family. Carryover provisions apply as described in § 86.1839-01(c).
(ii) Manufacturers must perform battery durability testing as described in § 86.1815-27(f)(2).
(b) The manufacturer must test EDVs as follows to demonstrate compliance with emission standards:
(1) Except as specified in this section, test one EDV in each test group using the test procedures specified in this subpart to demonstrate compliance with other exhaust emission standards.
(2) Test one EDV in each test group using the test procedures in 40 CFR part 1066 to demonstrate compliance with cold temperature exhaust emission standards.
(3) Test one EDV in each test group to each of the three discrete mid-temperature intermediate soak standards identified in § 86.1811-27.
(4) Test one EDV in each evaporative/refueling family and evaporative/refueling emission control system combination using the test procedures in subpart B of this part to demonstrate compliance with evaporative and refueling emission standards.
(d) Manufacturers may omit exhaust testing for certification in certain circumstances as follows:
(1) For vehicles subject to the Tier 3 PM standards in § 86.1811-17 (not the Tier 4 PM standards in § 86.1811-27), a manufacturer may provide a statement in the application for certification that vehicles comply with applicable PM standards instead of submitting PM test data for a certain number of vehicles. However, each manufacturer must test vehicles from a minimum number of durability groups as follows:
(i) Manufacturers with a single durability group subject to the Tier 3 PM standards in § 86.1811 must submit PM test data for that group.
(ii) Manufacturers with two to eight durability groups subject to the Tier 3 PM standards in § 86.1811 must submit PM test data for at least two durability groups each model year. EPA will work with the manufacturer to select durability groups for testing, with the general expectation that testing will rotate to cover a manufacturer's whole product line over time. If a durability group has been certified in an earlier model year based on submitted PM data, and that durability group is eligible for certification using carryover test data, that carryover data may count toward meeting the requirements of this paragraph (d)(1), subject to the selection of durability groups.
(iii) Manufacturers with nine or more durability groups subject to the Tier 3 PM standards in § 86.1811 must submit PM test data for at least 25 percent of those durability groups each model year. We will work with the manufacturer to select durability groups for testing as described in paragraph (d)(1)(ii) of this section.
(2) Small-volume manufacturers may provide a statement in the application for certification that vehicles comply with the applicable Tier 3 PM standard instead of submitting test data. Small-volume manufacturers must submit PM test data for vehicles that are subject to Tier 4 PM standards.
(3) Manufacturers may omit PM measurements for fuel economy and GHG testing conducted in addition to the testing needed to demonstrate compliance with the PM emission standards.
(4) Manufacturers may provide a statement in the application for certification that vehicles comply with the applicable formaldehyde standard instead of submitting test data.
(5) When conducting Selective Enforcement Audit testing, a manufacturer may petition the Administrator to waive the requirement to measure PM emissions and formaldehyde emissions.
(6) For model years 2012 through 2016, a manufacturer may provide a statement in its application for certification that vehicles comply with the applicable standards instead of measuring N
(7) Manufacturers may provide a statement in the application for certification that vehicles comply with the mid-temperature intermediate soak standards for soak times not covered by testing.
(8) Manufacturers may provide a statement in the application for certification that medium-duty vehicles above 22,000 pounds GCWR comply with the off-cycle emission standards in § 86.1811-27(e) for all normal operation and use when tested as specified. Describe in the application for certification under § 86.1844-01(d)(8) any relevant testing, engineering analysis, or other information in sufficient detail to support the statement. We may direct you to include emission measurements representing typical engine in-use operation at a range of ambient conditions. For example, we may specify certain transient and steady-state engine operation that is typical for your vehicles. Also describe the procedure you used to determine a reference CO
(9) For model year 2027 and 2028 vehicles subject to the Tier 4 PM standards in § 86.1811-27, a manufacturer may provide a statement in the application for certification that vehicles comply with the PM standard for −7 °C temperature testing instead of submitting PM test data.
(f) For electric vehicles and fuel cell vehicles, manufacturers may provide a statement in the application for certification that vehicles comply with all the emission standards and related requirements of this subpart instead of submitting test data. Tailpipe emissions of regulated pollutants from vehicles powered solely by electricity are deemed to be zero.
(g) Manufacturers must measure NMOG+NO
(h) When air conditioning exhaust emission tests are required, the manufacturer must document that the vehicle's air conditioning system is operating properly and in a representative condition. Required air conditioning system maintenance is performed as unscheduled maintenance and does not require the Administrator's approval.
(a) * * *
(1) * * *
(i) The Administrator may adjust or cause to be adjusted any adjustable parameter of an emission-data vehicle which the Administrator has determined to be subject to adjustment for certification testing in accordance with § 86.1833-01(a)(1), to any setting within the physically adjustable range of that parameter, as determined by the Administrator in accordance with § 86.1833-01(a)(3), prior to the performance of any tests to determine whether such vehicle or engine conforms to applicable emission standards, including tests performed by the manufacturer. However, if the idle speed parameter is one which the Administrator has determined to be subject to adjustment, the Administrator shall not adjust it to a setting which causes a higher engine idle speed than would have been possible within the physically adjustable range of the idle speed parameter on the engine before it accumulated any dynamometer service, all other parameters being identically adjusted for the purpose of the comparison. The Administrator, in making or specifying such adjustments, will consider the effect of the deviation from the manufacturer's recommended setting on emissions performance characteristics as well as the likelihood that similar settings will occur on in-use light-duty vehicles, light-duty trucks, or complete heavy-duty vehicles. In determining likelihood, the Administrator will consider factors such as, but not limited to, the effect of the adjustment on vehicle performance characteristics and surveillance information from similar in-use vehicles.
(4) Retesting for fuel economy reasons or for compliance with greenhouse gas exhaust emission standards in § 86.1818-12 may be conducted under the provisions of 40 CFR 600.008-08.
(b) * * *
(1) If the Administrator determines not to conduct a confirmatory test under the provisions of paragraph (a) of this section, manufacturers will conduct a confirmatory test at their facility after submitting the original test data to the Administrator under either of the following circumstances:
(i) The vehicle configuration has previously failed an emission standard.
(ii) The test exhibits high emission levels determined by exceeding a percentage of the standards specified by the Administrator for that model year.
(d)
(b)
(A) At or below 5,000 units for the Tier 3 standards described in §§ 86.1811-17, 86.1813-17, and 86.1816-18 and the Tier 4 standards described in § 86.1811-27. This volume threshold applies for phasing in the Tier 3 and Tier 4 standards and for determining the corresponding deterioration factors.
(B) No small-volume sales threshold applies for the heavy-duty greenhouse gas standards; alternative small-volume criteria apply as described in § 86.1819-14(k)(5).
(C) At or below 15,000 units for all other requirements. See § 86.1845 for separate provisions that apply for in-use testing.
(ii) If a manufacturer's aggregated sales in the United States, as determined in paragraph (b)(3) of this section are fewer than the number of units specified in paragraph (b)(1)(i) of this section, the manufacturer (or each manufacturer in the case of manufacturers in an aggregated relationship) may certify under the provisions of paragraph (c) of this section.
(iii) A manufacturer that qualifies as a small business under the Small Business Administration regulations in 13 CFR part 121 is eligible for all the provisions that apply for small-volume manufacturers under this subpart. See § 86.1801-12(j) to determine whether companies qualify as small businesses.
(iv) The sales volumes specified in this section are based on actual sales, unless otherwise specified.
(v) Except for delayed implementation of new emission standards, an eligible manufacturer must transition out of the special provisions that apply for small-volume manufacturers as described in § 86.1801-12(k)(2)(i) through (iii) if sales volumes increase above the applicable threshold.
(2)
(ii) If there are no additional manufacturers in an aggregated relationship meeting the provisions of paragraph (b)(3) of this section, then the manufacturer may certify whole test groups whose total aggregated sales (including heavy-duty engines) are less than 15,000 units using the small-volume provisions of paragraph (c) of this section.
(iii) If there is an aggregated relationship with another manufacturer which satisfies the provisions of paragraph (b)(3) of this section, then the following provisions shall apply:
(A) If none of the manufacturers own 50 percent or more of another manufacturer in the aggregated relationship, then each manufacturer
(B) If any of the manufacturers own 50 percent or more of another manufacturer in the aggregated relationship, then the limit of 14,999 units must be shared among the manufacturers in such a relationship. In total for all the manufacturers involved in such a relationship, aggregated sales (including heavy-duty engines) of up to 14,999 units may be certified using the small-volume provisions of paragraph (c) of this section. Only whole test groups shall be eligible for small-volume status under paragraph (c) of this section.
(iv) In the case of a joint venture arrangement (50/50 ownership) between two manufacturers, each manufacturer retains its eligibility for 14,999 units under the small-volume test group certification procedures, but the joint venture must draw its maximum 14,999 units from the units allocated to its parent manufacturers. Only whole test groups shall be eligible for small-volume status under paragraph (c) of this section.
(3)
(i) Vehicles and/or engines produced by two or more firms, one of which is 10 percent or greater part owned by another.
(ii) Vehicles and/or engines produced by any two or more firms if a third party has equity ownership of 10 percent or more in each of the firms.
(iii) Vehicles and/or engines produced by two or more firms having a common corporate officer(s) who is (are) responsible for the overall direction of the companies.
(iv) Vehicles and/or engines imported or distributed by all firms where the vehicles and/or engines are manufactured by the same entity and the importer or distributor is an authorized agent of the entity.
(a) In lieu of testing an emission-data or durability vehicle selected under § 86.1822, § 86.1828, or § 86.1829, and submitting data therefrom, a manufacturer may submit exhaust emission data, evaporative emission data and/or refueling emission data, as applicable, on a similar vehicle for which certification has been obtained or for which all applicable data required under § 86.1845 has previously been submitted. To be eligible for this provision, the manufacturer must use good engineering judgment and meet the following criteria:
(1) In the case of durability data, the manufacturer must determine that the previously generated durability data represent a worst case or equivalent rate of deterioration for all applicable emission constituents compared to the configuration selected for durability demonstration. Prior to certification, the Administrator may require the manufacturer to provide data showing that the distribution of catalyst temperatures of the selected durability configuration is effectively equivalent or lower than the distribution of catalyst temperatures of the vehicle configuration which is the source of the previously generated data.
(2) In the case of emission data, the manufacturer must determine that the previously generated emissions data represent a worst case or equivalent level of emissions for all applicable emission constituents compared to the configuration selected for emission compliance demonstration.
(b) In lieu of using newly aged hardware on an EDV as allowed under the provisions of § 86.1823-08(f)(2), a manufacturer may use similar hardware aged for an EDV previously submitted, provided that the manufacturer determines that the previously aged hardware represents a worst case or equivalent rate of deterioration for all applicable emission constituents for durability demonstration.
(c) In lieu of testing battery electric vehicles or plug-in hybrid electric vehicles for monitor accuracy under § 86.1822-01(a) and submitting the test data, a manufacturer may rely on previously conducted testing on a similar vehicle for which such test data have previously been submitted to demonstrate compliance with monitor accuracy requirements. For vehicles to be eligible for this provision, they must have designs for battery monitoring that are identical in all material respects to the vehicles tested under § 86.1845-04(g). If a monitor family fails to meet accuracy requirements, repeat the testing under § 86.1845-04(g) as soon as practicable.
Provisions for special test procedures apply as described in 40 CFR 1065.10 and 1066.10. For example, manufacturers must propose a procedure for EPA's review and advance approval for testing and certifying vehicles equipped with periodically regenerating aftertreatment devices, including sufficient documentation and data for EPA to fully evaluate the request.
(a) Certification levels of a test vehicle will be calculated for each emission constituent applicable to the test group for both full and intermediate useful life as appropriate.
(1) If the durability demonstration procedure used by the manufacturer under the provisions of § 86.1823, § 86.1824, or § 86.1825 requires a DF to be calculated, the DF shall be applied to the official test results determined in § 86.1835-01(c) for each regulated emission constituent and for full and intermediate useful life, as appropriate, using the following procedures:
(i) For additive DF's, the DF will be added to the emission result. The sum will be rounded to the same level of precision as the standard for the constituent at full and/or intermediate useful life, as appropriate. This rounded sum is the certification level for that emission constituent and for that useful life mileage.
(ii) For multiplicative DFs, the DF will be multiplied by the emission result for each regulated constituent. The product will be rounded to the same level of precision as the standard for the constituent at full and intermediate useful life, as appropriate. This rounded product is the certification level for that emission constituent and for that useful life mileage.
(iii) For a composite standard of NMHC+NO
(2) If the durability demonstration procedure used by the manufacturer under the provisions of § 86.1823, § 86.1824, or § 86.1825, as applicable, requires testing of the EDV with aged emission components, the official results of that testing determined under
(3) Compliance with full useful life CO
(4) The rounding required in paragraph (a) of this section shall be conducted in accordance with the provisions of § 86.1837-01.
(e) Unless otherwise approved by the Administrator, manufacturers must not use Reactivity Adjustment Factors (RAFs) in their calculation of the certification level of any pollutant for any vehicle.
The revisions and republication read as follows:
(d)
(1) Correspondence and communication information, such as names, mailing addresses, phone and fax numbers, and email addresses of all manufacturer representatives authorized to be in contact with EPA compliance staff. The address where official documents, such as certificates of conformity, are to be mailed must be clearly identified. At least one U.S. contact must be provided.
(2) A description of the durability group in accordance with the criteria listed in § 86.1820-01, or as otherwise used to group a product line.
(3) A description of applicable evaporative/refueling families and leak families in accordance with the criteria listed in § 86.1821-01, or as otherwise used to group a product line.
(4) Include the following durability information:
(i) A description of the durability method used to establish useful life durability, including exhaust and evaporative/refueling emission deterioration factors as required in §§ 86.1823, 86.1824 and 86.1825 when applicable.
(ii) The equivalency factor required to be calculated in § 86.1823-08(e)(1)(iii)(B), when applicable.
(5) A description of each test group in accordance with the criteria listed in § 86.1827-01 or as otherwise used to group a product line.
(6) Identification and description of all vehicles for which testing is required by §§ 86.1822-01 and 86.1828-01 to obtain a certificate of conformity.
(7) A comprehensive list of all test results, including official certification levels, and the applicable intermediate and full useful life emission standards to which the test group is to be certified as required in § 86.1829. Include the following additional information related to testing:
(i) For vehicles certified to any Tier 3 or Tier 4 emission standards, include a comparison of drive-cycle metrics as specified in 40 CFR 1066.425(j) for each drive cycle or test phase, as appropriate.
(ii) For gasoline-fueled vehicles subject to Tier 3 evaporative emission standards, identify the method of accounting for ethanol in determining evaporative emissions, as described in § 86.1813.
(iii) Identify any aspects of testing for which the regulations obligate EPA testing to conform to your selection of test methods.
(iv) For heavy-duty vehicles subject to air conditioning standards under § 86.1819, include the refrigerant leakage rates (leak scores), describe the type of refrigerant, and identify the refrigerant capacity of the air conditioning systems. If another company will install the air conditioning system, also identify the corporate name of the final installer.
(v) For vehicles with pressurized fuel tanks, attest that vehicles subject to EPA testing with the partial refueling test will meet the refueling emission standard for that testing. Include engineering analysis showing that canister capacity is adequate to account for the increased vapor load from venting the pressurized fuel tank upon fuel cap removal.
(8) A statement that all applicable vehicles will conform to the emission standards for which emission data is not being provided, as allowed under § 86.1806 or § 86.1829. The statement shall clearly identify the standards for which emission testing was not completed and include supporting information as specified in § 86.1806 or § 86.1829.
(9) Information describing each emission control diagnostic system required by § 86.1806, including all of the following:
(i) A description of the functional operation characteristics of the diagnostic system, with additional information demonstrating that the system meets the requirements specified in § 86.1806. Include all testing and demonstration data submitted to the California Air Resources Board for certification.
(ii) The general method of detecting malfunctions for each emission-related powertrain component.
(iii) Any deficiencies, including resolution plans and schedules.
(iv) A statement that the diagnostic system is adequate for the performance warranty test described in 40 CFR part 85, subpart W.
(v) For vehicles certified to meet the leak standard in § 86.1813, a description of the anticipated test procedure. The description must include, at a minimum, a method for accessing the fuel system for measurements and a method for pressurizing the fuel system to perform the procedure specified in 40 CFR 1066.985. The recommended test method must include at least two separate points for accessing the fuel system, with additional access points as appropriate for multiple fuel tanks and multiple evaporative or refueling canisters.
(10) A description of all flexible or dedicated alternate fuel vehicles including, but not limited to, the fuel and/or percentage of alternate fuel for all such vehicles.
(11) A list of all auxiliary emission control devices (AECD) installed on any applicable vehicles, including a justification for each AECD, the parameters they sense and control, a detailed justification of each AECD that results in a reduction in effectiveness of the emission control system, and rationale for why it is not a defeat device as defined under § 86.1809. The following specific provisions apply for AECDs:
(i) For any AECD uniquely used at high altitudes, EPA may request engineering emission data to quantify any emission impact and validity of the AECD.
(ii) For any AECD uniquely used on multi-fuel vehicles when operated on fuels other than gasoline, EPA may request engineering emission data to quantify any emission impact and validity of the AECD.
(iii) For Tier 3 vehicles with spark-ignition engines, describe how AECDs are designed to comply with the requirements of § 86.1811-17(d). Identify which components need protection through enrichment
(iv) For Tier 4 vehicles with spark-ignition engines, describe how AECDs comply with the requirements of §§ 86.1809-12(d)(2) and 86.1811-27(d).
(12) Identification and description of all vehicles covered by each certificate of conformity to be produced and sold within the U.S. The description must be sufficient to identify whether any given in-use vehicle is, or is not, covered by a given certificate of conformity, the test group and the evaporative/refueling family to which it belongs and the standards that are applicable to it, by matching readily observable vehicle characteristics and information given in the emission control information label (and other permanently attached labels) to indicators in the Part 1 Application. In addition, the description must be sufficient to determine for each vehicle covered by the certificate, all appropriate test parameters and any special test procedures necessary to conduct an official certification exhaust or evaporative emission test as was required by this subpart to demonstrate compliance with applicable emission standards. The description shall include, but is not limited to, information such as model name, vehicle classification (light-duty vehicle, light-duty truck, or complete heavy-duty vehicle), sales area, engine displacement, engine code, transmission type, tire size and parameters necessary to conduct exhaust emission tests such as equivalent test weight, curb and gross vehicle weight, test horsepower (with and without air conditioning adjustment), coast down time, shift schedules, cooling fan configuration, etc. and evaporative tests such as canister working capacity, canister bed volume and fuel temperature profile. The Part 1 may include ranges for test parameters in lieu of actual values.
(13) Projected U.S. vehicle sales volumes for each test group and evaporative/refueling family combination organized in such a way to determine projected compliance with any applicable implementation schedules or minimum sales requirements as specified in § 86.1810 or as otherwise required by this chapter.
(14) A request for a certificate of conformity for each test group after all required testing has been completed. The request must be signed by an authorized manufacturer representative and include a statement that the test group complies with all applicable regulations contained within this chapter.
(15) For vehicles with fuel-fired heaters, describe the control system logic of the fuel-fired heater, including an evaluation of the conditions under which it can be operated and an evaluation of the possible operational modes and conditions under which evaporative emissions can exist. Use good engineering judgment to establish an estimated exhaust emission rate from the fuel-fired heater in grams per mile for each pollutant subject to a fleet average standard. Adjust fleet average compliance calculations in §§ 86.1861, 86.1864, and 86.1865 as appropriate to account for emissions from fuel-fired heaters. Describe the testing used to establish the exhaust emission rate.
(16) A statement indicating that the manufacturer has conducted an engineering analysis of the complete exhaust system.
(i) The engineering analysis must ensure that the exhaust system has been designed—
(A) To facilitate leak-free assembly, installation and operation for the full useful life of the vehicle; and
(B) To facilitate that such repairs as might be necessary on a properly maintained and used vehicle can be performed in such a manner as to maintain leak-free operation, using tools commonly available in a motor vehicle dealership or independent repair shop for the full useful life of the vehicle.
(ii) The analysis must cover the exhaust system and all related and attached components including the air injection system, if present, from the engine block manifold gasket surface to a point sufficiently past the last catalyst and oxygen sensor in the system to assure that leaks beyond that point will not permit air to reach the oxygen sensor or catalyst under normal operating conditions.
(iii) A “leak-free” system is one in which leakage is controlled so that it will not lead to a failure of the certification exhaust emission standards in-use.
(17) The name of an agent for service located in the United States. Service on this agent constitutes service on you or any of your officers or employees for any action by EPA or otherwise by the United States related to the requirements of this part.
(18) For vehicles equipped with RESS, the recharging procedures and methods for determining battery performance, such as state of charge and charging capacity.
(19) For battery electric vehicles and plug-in hybrid electric vehicles, a description of each monitor family and battery durability family as described in § 86.1815-27(f)(1). Note that a single test group may include multiple monitor families and battery durability families, and conversely that individual monitor families and battery durability families may be associated with multiple test groups. Note also that provisions related to monitor families and battery durability families do not apply for certain vehicles as specified in § 86.1815-27(h)(8). Include the following information for each monitor family:
(i) The monitor, battery, and other specifications that are relevant to establishing monitor families and battery durability families to comply with the requirements of this section.
(ii) The certified usable battery energy for each battery durability family. For plug-in hybrid electric vehicles, identify whether the UDDS Full Charge Test or HFET Full Charge Test was used for battery measurements.
(iii) A statement attesting that the SOCE monitor meets the 5 percent accuracy requirement.
(iv) For light-duty program vehicles, a statement that each battery durability family meets the Minimum Performance Requirement.
(20) Acknowledgement, if applicable, that you are including vehicles with engines certified under 40 CFR part 1036 in your calculation to demonstrate compliance with the fleet average CO
(21) Measured NMOG+NO
(e)
(1) Identify all emission-related components, including those that can affect GHG emissions. Also identify software, AECDs, and other elements of design that are used to control criteria, GHG, or evaporative/refueling emissions. Identify the emission-related components by part number. Identify software by part number or other convention, as appropriate. Organize part numbers by engine code or other similar classification scheme.
(2) Basic calibration information, organized by engine code (or other similar classification scheme), for the major components of the fuel system, EGR system, ignition system, oxygen sensor(s) and thermostat. Examples of major components and associated calibration information include, but are not limited to; fuel pump and fuel pump
(3) Identification and description of all vehicles covered by each certificate of conformity to be produced and sold within the U.S. The description must be sufficient to identify whether any given in-use vehicle is, or is not, covered by a given certificate of conformity, the test group and the evaporative/refueling family to which it belongs and the standards that are applicable to it, by matching readily observable vehicle characteristics and information given in the emission control information label (and other permanently attached labels) to indicators in the Part 1 Application. For example, the description must include any components or features that contribute to measured or demonstrated control of emissions for meeting criteria, GHG, or evaporative/refueling standards under this subpart. In addition, the description must be sufficient to determine for each vehicle covered by the certificate, all appropriate test parameters and any special test procedures necessary to conduct an official certification exhaust or evaporative emission test as was required by this subpart to demonstrate compliance with applicable emission standards. The description shall include, but is not limited to, information such as model name, vehicle classification (light-duty vehicle, light-duty truck, or complete heavy-duty vehicle), sales area, engine displacement, engine code, transmission type, tire size and parameters necessary to conduct exhaust emission tests such as equivalent test weight, curb and gross vehicle weight, test horsepower (with and without air conditioning adjustment), coast down time, shift schedules, cooling fan configuration, etc. and evaporative tests such as canister working capacity, canister bed volume, and fuel temperature profile. Actual values must be provided for all parameters.
(4) Final U.S. vehicle sales volumes for each test group and evaporative/refueling family combination organized in such a way to verify compliance with any applicable implementation schedules. Final sales are not required until the final update to the Part 2 Application at the end of the model year.
(i) The manufacturer may petition the Administrator to allow actual volume produced for U.S. sale to be used in lieu of actual U.S. sales. The petition must establish that production volume is functionally equivalent to sales volume.
(ii) The U.S. sales volume shall be based on the location of the point of sale to a dealer, distributor, fleet operator, broker, or any other entity which comprises the point of first sale.
(5) Copies of all service manuals, service bulletins and instructions regarding the use, repair, adjustment, maintenance, or testing of such vehicles relevant to the control of crankcase, exhaust or evaporative emissions, as applicable, issued by the manufacturer for use by other manufacturers, assembly plants, distributors, dealers, and ultimate purchasers. These shall be submitted in electronic form to the Agency when they are made available to the public and must be updated as appropriate throughout the useful life of the corresponding vehicles.
(6) The NMOG-to-NMHC and HCHO-to-NMHC ratios established according to § 86.1845-04.
(7) The results of any production vehicle evaluation testing required for OBD systems under § 86.1806.
(g) * * *
(11) A description of all procedures, including any special procedures, used to comply with applicable test requirements of this subpart. Any special procedures used to establish durability data or emission deterioration factors required to be determined under §§ 86.1823, 86.1824 and 86.1825 and to conduct emission tests required to be performed on applicable emission data vehicles under § 86.1829 according to test procedures contained within this Title must also be included.
(h) Manufacturers must submit the in-use testing information required in § 86.1847.
(a)
(2) Unless otherwise approved by the Administrator, no emission measurements made under the requirements of this section may be adjusted by Reactivity Adjustment Factors (RAFs).
(3) The following provisions apply regarding the possibility of residual effects from varying fuel sulfur levels:
(i) Vehicles certified under § 86.1811 must always measure emissions over the FTP, then over the HFET (if applicable), then over the US06. If a vehicle meets all the applicable emission standards except the FTP or HFET emission standard for NMOG+NO
(ii) Upon a manufacturer's written request, prior to in-use testing, that presents information to EPA regarding pre-conditioning procedures designed solely to remove the effects of high sulfur in gasoline from vehicles produced through the 2007 model year, EPA will consider allowing such procedures on a case-by-case basis. EPA's decision will apply to manufacturer in-use testing conducted under this section and to any in-use testing conducted by EPA. Such procedures are not available for complete HDV. For model year 2007 and later Tier 2 vehicles, this provision can be used only in American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands, and then only if low sulfur gasoline is determined by the Administrator to be unavailable in that specific location.
(4) Battery-related in-use testing requirements apply for battery electric vehicles and plug-in hybrid electric vehicles as described in paragraph (g) of this section.
(5) Certain medium-duty vehicles are also subject to in-use testing requirements to demonstrate compliance with off-cycle emission
(b)
(2)
(3)
(4)
(5)
(ii) For vehicles subject to Tier 3 p.m. standards, manufacturers must measure PM emissions over the FTP and US06 driving schedules for at least 50 percent of the vehicles tested under paragraph (b)(5)(i) of this section. For vehicles subject to Tier 4 p.m. standards, this test rate increases to 100 percent.
(iii) Starting with model year 2018 vehicles, manufacturers must demonstrate compliance with the Tier 3 leak standard specified in § 86.1813, if applicable, as described in this paragraph (b)(5)(iii). Manufacturers must evaluate each vehicle tested under paragraph (b)(5)(i) of this section, except that leak testing is not required for vehicles tested under paragraph (b)(5)(iv) of this section for diurnal emissions. In addition, manufacturers must evaluate at least one vehicle from each leak family for a given model year. Manufacturers may rely on OBD monitoring instead of testing as follows:
(A) A vehicle is considered to pass the leak test if the OBD system completed a leak check within the previous 750 miles of driving without showing a leak fault code.
(B) Whether or not a vehicle's OBD system has completed a leak check within the previous 750 miles of driving, the manufacturer may operate the vehicle as needed to force the OBD system to perform a leak check. If the OBD leak check does not show a leak fault, the vehicle is considered to pass the leak test.
(C) If the most recent OBD leak check from paragraph (b)(5)(iii)(A) or (B) of this section shows a leak-related fault code, the vehicle is presumed to have failed the leak test. Manufacturers may perform the leak measurement procedure described in 40 CFR 1066.985 for an official result to replace the finding from the OBD leak check.
(D) Manufacturers may not perform repeat OBD checks or leak measurements to over-ride a failure under paragraph (b)(5)(iii)(C) of this section.
(iv) For vehicles other than gaseous-fueled vehicles and electric vehicles, one test vehicle of each evaporative/refueling family shall be tested in accordance with the supplemental 2-diurnal-plus-hot-soak evaporative emission and refueling emission procedures described in subpart B of this part, when such test vehicle is tested for compliance with applicable evaporative emission and refueling standards under this subpart. For gaseous-fueled vehicles, one test vehicle of each evaporative/refueling family shall be tested in accordance with the 3-
(6)
(7)
(c)
(2)
(3)
(4)
(5)
(ii) For vehicles subject to Tier 3 p.m. standards, manufacturers must measure PM emissions over the FTP and US06 driving schedules for at least 50 percent of the vehicles tested under paragraph (c)(5)(i) of this section. For vehicles subject to Tier 4 p.m. standards, this test rate increases to 100 percent.
(iii) Starting with model year 2018 vehicles, manufacturers must evaluate each vehicle tested under paragraph (c)(5)(i) of this section to demonstrate compliance with the Tier 3 leak standard specified in § 86.1813, except that leak testing is not required for vehicles tested under paragraph (c)(5)(iv) of this section for diurnal emissions. In addition, manufacturers must evaluate at least one vehicle from each leak family for a given model year. Manufacturers may rely on OBD monitoring instead of testing as described in paragraph (b)(5)(iii) of this section.
(iv) For vehicles other than gaseous-fueled vehicles and electric vehicles, one test vehicle of each evaporative/refueling family shall be tested in accordance with the supplemental 2-diurnal-plus-hot-soak evaporative emission procedures described in subpart B of this part, when such test vehicle is tested for compliance with applicable evaporative emission and refueling standards under this subpart. For gaseous-fueled vehicles, one test vehicle of each evaporative/refueling family shall be tested in accordance with the 3-diurnal-plus-hot-soak evaporative emission procedures described in subpart B of this part, when such test vehicle is tested for compliance with applicable evaporative emission and refueling standards under this subpart. The vehicles tested to fulfill the evaporative/refueling testing requirement of this paragraph (c)(5)(iv) will be counted when determining compliance with the minimum number of vehicles as specified in Tables S04-06 and S04-07 (tables 1 and 2 to paragraph (b)(3) of this section) for testing under paragraph (c)(5)(i) of this section only if the vehicle is also tested for exhaust emissions under the requirements of paragraph (c)(5)(i) of this section .
(6)
(7)
(d)
(1)
(2)
(ii) Test groups certified to 49-state standards: The test vehicles procured from the 49-state area must be procured from a location with a heating degree day 30-year annual average equal to or greater than 4,000.
(iii) Vehicles procured for high altitude testing may be procured from any area located above 4,000 feet.
(3)
(e)
(2)
(3)
(f)
(1) A manufacturer must conduct in-use testing on a test group by determining NMOG exhaust emissions using the same methodology used for certification, as described in 40 CFR 1066.635.
(2) For flexible-fueled vehicles certified to NMOG (or NMOG+NO
(3) If the manufacturer measures NMOG as described in 40 CFR 1066.635(a), it must also measure and report HCHO emissions. As an alternative to measuring the HCHO content, if the manufacturer measures NMOG as permitted in 40 CFR 1066.635(c), the Administrator may approve, upon submission of supporting data by a manufacturer, the use of HCHO to NMHC ratios. To request the use of HCHO to NMHC ratios, the manufacturer must establish during certification testing the ratio of measured HCHO exhaust emissions to measured NMHC exhaust emissions for each emission-data vehicle for the applicable test group. The results must be submitted to the Administrator with the Part II application for certification. Following approval of the application for certification, the manufacturer may conduct in-use testing on the test group by measuring NMHC exhaust emissions rather than HCHO exhaust emissions. The measured NMHC exhaust emissions must be multiplied by the HCHO to NMHC ratio submitted in the application for certification for the test group to determine the equivalent HCHO exhaust emission values for the test vehicle. The equivalent HCHO exhaust emission values must be compared to the HCHO exhaust emission standard applicable to the test group.
(g)
(1) Determine accuracy by measuring SOCE from in-use vehicles using the procedures specified in § 86.1815-27(c) and comparing the measured values to the SOCE value displayed on the monitor at the start of testing.
(2) Perform low-mileage testing of the vehicles in a monitor family within 24 months of the end of production of that monitor family for that model year. All test vehicles must have a minimum odometer mileage of 20,000 miles.
(3) Perform high-mileage testing of the vehicles in a monitor family by starting the test program within 4 years of the end of production of the monitor family and completing the test program within 5 years of the end of production of the monitor family. All test vehicles must have a minimum odometer mileage of 40,000 miles.
(4) Select test vehicles as described in paragraphs (b)(6), (c)(6), and (d)(1) and (3) of this section from the United States. Send notification regarding test location as described in paragraph (e)(2) of this section.
(5) You may perform diagnostic maintenance as specified in paragraph (b)(7) and (c)(7) of this section.
(6) See § 86.1838-01(b)(2) for a testing exemption that applies for small-volume monitor families.
(h)
(1) In-use testing requirements apply for both vehicles with spark-ignition engines and vehicles with compression-ignition engines.
(2) References to “engine family” should be understood to mean “test group”.
(3) In our test order we may include the following requirements and specifications:
(i) We may select any vehicle configuration for testing. We may also specify that the selected vehicle have certain optional features.
(ii) We may allow the vehicle manufacturer to arrange for the driver of a test vehicle to be an employee or a hired contractor, rather than the vehicle owner.
(iii) We may specify certain routes or types of driving.
(4) Within 45 days after we direct you to perform testing under this paragraph (h), send us a proposed test plan that meets the provisions in this paragraph
(i) Describe how you will select vehicles, including consideration of available options and features, to properly represent in-use performance for the selected vehicle configuration.
(ii) Describe any planned inspection or maintenance before testing the vehicle, along with any criteria for rejecting a candidate vehicle.
(iii) Describe test routes planned for testing. The test route must target a specific total duration or distance, including at least three hours of driving with non-idle engine operation. The test route must represent normal driving, including a broad range of vehicle speeds and accelerations and a reasonable amount of operation at varying grades. If the completed test route does not include enough windows for any bin as specified in paragraph (h)(8) of this section, repeat the drive over the approved test route.
(iv) Describe your plan for vehicle operation to include at least 50 percent of non-idle operation with gross combined weight at least 70 percent of GCWR. Trailers used for testing must meet certain specifications as follows:
(A) Trailers must comply with requirements in Row D through Row L of Table 1 of SAE J2807 (incorporated by reference, see § 86.1); however, the frontal area of the trailer may not exceed the vehicle manufacturer's specified maximum frontal area for towing. Trailers over 24,000 pounds must have a frontal area between 60 and 75 ft
(B) You may ask us to approve the use of a trailer not meeting SAE J2807 specifications. This may apply, for example, if the trailer has tires that are different than but equivalent to the specified tires. In your request, describe the alternative trailer's specifications, why you are using it, and how it is more representative of in-use operation than a trailer meeting the specifications in paragraph (h)(4)(iv)(A) of this section. Rather than demonstrating representativeness, you may instead describe why it is infeasible to use a trailer meeting the specifications in paragraph (h)(4)(iv)(A) of this section. We will consider whether your request is consistent with good engineering judgment.
(5) The accuracy margins in 40 CFR 1036.420(a) do not apply for vehicles with spark-ignition engines, or for vehicles with compression-ignition engines for demonstrating compliance with standards based on measurement procedures with 3-bin moving average windows.
(6) Determine a reference CO
(7) For testing based on the 3-bin moving average windows, identify the appropriate bin for each of the 300 second test intervals based on its normalized CO
(8) For testing based on 3-bin moving average windows, calculate the off-cycle emissions quantity for Bin 2a and Bin 2b using the method described in 40 CFR 1036.530 for Bin 2. Each bin is valid for evaluating test results only if it has at least 2,400 windows.
(a)
(2) The provisions of § 86.1845-04(a)(3) regarding fuel sulfur effects apply equally to testing under this section.
(b)
(2) A manufacturer shall test a test group, or a subset of a test group, as described in paragraph (j) of this section when the results from testing conducted under § 86.1845 show mean exhaust
(3) Additional testing is not required under this paragraph (b) based on evaporative/refueling testing or based on low-mileage US06 testing conducted under § 86.1845-04(b)(5)(i). Testing conducted at high altitude under the requirements of § 86.1845-04(c) will be included in determining if a test group meets the criteria triggering the testing required under this section.
(4) The vehicle designated for testing under the requirements of § 86.1845-04(c)(2) with a minimum odometer reading of 105,000 miles or 75% of useful life, whichever is less, will not be included in determining if a test group meets the triggering criteria.
(5) The SFTP composite emission levels for Tier 3 vehicles shall include the IUVP FTP emissions, the IUVP US06 emissions, and the values from the SC03 Air Conditioning EDV certification test (without DFs applied). The calculations shall be made using the equations prescribed in § 86.164. If more than one set of certification SC03 data exists (due to running change testing or other reasons), the manufacturer shall choose the SC03 result to use in the calculation from among those data sets using good engineering judgment.
(6) If fewer than 50 percent of the vehicles from a leak family pass either the leak test or the diurnal test under § 86.1845, EPA may require further leak testing under this paragraph (b)(6). Testing under this section must include five vehicles from the family. If all five of these vehicles fail the test, the manufacturer must test five additional vehicles.
EPA will determine whether to require further leak testing under this section after providing the manufacturer an opportunity to discuss the results, including consideration of any of the following information, or other items that may be relevant:
(i) Detailed system design, calibration, and operating information, technical explanations as to why the individual vehicles tested failed the leak standard.
(ii) Comparison of the subject vehicles to other similar models from the same manufacturer.
(iii) Data or other information on owner complaints, technical service bulletins, service campaigns, special policy warranty programs, warranty repair data, state I/M data, and data available from other manufacturer-specific programs or initiatives.
(iv) Evaporative emission test data on any individual vehicles that did not pass leak testing during IUVP.
(e)
(j)
(g) Manufacturers of battery electric vehicles and plug-in hybrid electric vehicles certified under this subpart must meet the following reporting and recordkeeping requirements related to testing performed under §§ 86.1815-27(f)(2) and (3):
(1) Submit the following records organized by monitor family and battery durability family related to Part A testing to verify accuracy of SOCE monitors within 30 days after completing low-mileage, intermediate-mileage, or high-mileage testing:
(i) A complete record of all tests performed, the dates and location of testing, measured SOCE values for each vehicle, along with the corresponding displayed SOCE values at the start of testing.
(ii) Test vehicle information, including model year, make, model, and odometer reading.
(iii) A summary of statistical information showing whether the testing shows a pass or fail result.
(2) Keep the following records related to testing under paragraph (g)(1) of this section:
(i) Test reports submitted under paragraph (g)(1) of this section.
(ii) Test facility information.
(iii) Routine testing records, such as dynamometer trace, and temperature and humidity during testing.
(3) Submit an annual report related to Part B testing to verify compliance with the Minimum Performance Requirement for SOCE, as applicable. Submit the report by October 1 for testing you perform over the preceding year or ask us to approve a different annual reporting period based on your practice for starting a new model year. Include the following information in your annual reports, organized by monitor family and battery durability family:
(i) Displayed values of SOCE for each sampled vehicle, along with a description of each vehicle to identify its model year, make, model, odometer reading, and state of registration. Also include the date for assessing each selected vehicle.
(ii) A summary of results to show whether 90 percent of sampled vehicles from each battery durability family meet the Minimum Performance Requirement.
(iii) A description of how you randomly selected vehicles for testing, including a demonstration that you meet the requirement to select test vehicles from different U.S. states or territories. Provide a more detailed description of your random selection if you test more than 500 vehicles.
(iv) A description of any selected vehicles excluded from the test results and the justification for excluding them.
(v) Information regarding warranty claims and statistics on repairs for batteries and for other components or systems for each battery durability family that might influence a vehicle's electric energy consumption.
(4) Keep the following records related to testing under paragraph (g)(3) of this section:
(i) Test reports submitted under paragraph (g)(3) of this section.
(ii) Documentation related to the method of selecting vehicles.
(5) Keep records required under this paragraph (g) for eight years after submitting reports to EPA.
(h) Manufacturers of high-GCWR vehicles subject to in-use testing under § 86.1845-04(j) must meet the reporting and recordkeeping requirements of 40 CFR 1036.430 and 1036.435 and include the following additional information:
(1) Describe the trailer used for testing.
(2) Identify the driving route, including total time and distance, and explain any departure from the planned driving route.
(3) Demonstrate that you met the specification for loaded operation.
(a)(1) If, after a review of the manufacturer's submitted Part I application, information obtained from any inspection, such other information as the Administrator may require, and any other pertinent data or information, the Administrator determines that the application is complete and that all vehicles within a test group and evaporative/refueling family as described in the application meet the requirements of this part and the Clean Air Act, the Administrator shall issue a certificate of conformity.
(2) If, after review of the manufacturer's application, request for certification, information obtained from any inspection, such other information as the Administrator may require, and any other pertinent data or information, the Administrator determines that the application is not complete or the vehicles within a test group or evaporative/refueling family as described in the application, do not meet applicable requirements or standards of the Act or of this part, the Administrator may deny the issuance of, suspend, or revoke a previously issued certificate of conformity. The Administrator will notify the manufacturer in writing, setting forth the basis for the determination. The manufacturer may request a hearing on the Administrator's determination.
(b) A certificate of conformity will be issued by the Administrator for a period not to exceed one model year and upon such terms as deemed necessary or appropriate to assure that any new motor vehicle covered by the certificate will meet the requirements of the Act and of this part.
(c) Failure to meet any of the following conditions will be considered a failure to satisfy a condition upon which a certificate was issued, and any affected vehicles are not covered by the certificate:
(1) The manufacturer must supply all required information according to the provisions of §§ 86.1843 and 86.1844.
(2) The manufacturer must comply with all certification and in-use emission standards contained in subpart S of this part both during and after model year production. This includes monitor accuracy and battery durability requirements for battery electric vehicles and plug-in hybrid electric vehicles as described in § 86.1815.
(3) The manufacturer must comply with all implementation schedules sales percentages as required in this subpart.
(4) New incomplete vehicles must, when completed by having the primary load-carrying device or container attached, conform to the maximum curb weight and frontal area limitations described in the application for certification as required in § 86.1844.
(5) The manufacturer must meet the in-use testing and reporting requirements contained in §§ 86.1815, 86.1845, 86.1846, and 86.1847, as applicable.
(6) Vehicles must in all material respects be as described in the manufacturer's application for certification (Part I and Part II).
(7) Manufacturers must meet all the provisions of §§ 86.1811, 86.1813, 86.1816, and 86.1860 through 86.1862 both during and after model year production, including compliance with the applicable fleet average standard and phase-in requirements. The manufacturer bears the burden of establishing to the satisfaction of the Administrator that the terms and conditions upon which each certificate was issued were satisfied. For recall and warranty purposes, vehicles not covered by a certificate of conformity will continue to be held to the standards stated or referenced in the certificate that otherwise would have applied to the vehicles. A manufacturer may not sell credits it has not generated.
(8) Manufacturers must meet all provisions related to cold temperature standards in §§ 86.1811 and 86.1864 both during and after model year production, including compliance with the applicable fleet average standard and phase-in requirements. The manufacturer bears the burden of establishing to the satisfaction of the Administrator that the terms and conditions upon which each certificate was issued were satisfied. For recall and warranty purposes, vehicles not covered by a certificate of conformity will continue to be held to the standards stated or referenced in the certificate that otherwise would have applied to the vehicles. A manufacturer may not sell credits it has not generated.
(9) Manufacturers must meet all the provisions of §§ 86.1818, 86.1819, and 86.1865 both during and after model year production, including compliance with the applicable fleet average standard. The manufacturer bears the burden of establishing to the satisfaction of the Administrator that the terms and conditions upon which the certificate(s) was (were) issued were satisfied. For recall and warranty purposes, vehicles not covered by a certificate of conformity will continue to be held to the standards stated or referenced in the certificate that otherwise would have applied to the vehicles. A manufacturer may not sell credits it has not generated.
(i) Manufacturers that are determined to be operationally independent under § 86.1838-01(d) must report a material change in their status within 60 days as required by § 86.1838-01(d)(2).
(ii) Manufacturers subject to an alternative fleet average greenhouse gas emission standard approved under § 86.1818-12(g) must comply with the annual sales thresholds that are required to maintain use of those standards, including the thresholds required for new entrants into the U.S. market.
(10) Manufacturers must meet all the provisions of § 86.1815 both during and after model year production. The manufacturer bears the burden of establishing to the satisfaction of the Administrator that the terms and conditions related to issued certificates were satisfied.
(d) One certificate will be issued for each test group and evaporative/refueling family combination. For diesel fueled vehicles and electric vehicles, one certificate will be issued for each test group. A certificate of conformity is deemed to cover the vehicles named in such certificate and produced during the model year.
(e) A manufacturer of new light-duty vehicles, light-duty trucks, and complete heavy-duty vehicles must obtain a certificate of conformity covering such vehicles from the Administrator prior to selling, offering for sale, introducing into commerce, delivering for introduction into commerce, or importing into the United States the new vehicle. Vehicles produced prior to the effective date of a certificate of conformity may also be covered by the certificate, once it is effective, if the following conditions are met:
(1) The vehicles conform in all respects to the vehicles described in the application for the certificate of conformity.
(2) The vehicles are not sold, offered for sale, introduced into commerce, or delivered for introduction into commerce prior to the effective date of the certificate of conformity.
(3) EPA is notified prior to the beginning of production when such production will start, and EPA is provided a full opportunity to inspect and/or test the vehicles during and after their production. EPA must have the opportunity to conduct SEA production line testing as if the vehicles had been produced after the effective date of the certificate.
(f) Vehicles imported by an original equipment manufacturer after December 31 of the calendar year for which the model year is named are still covered by the certificate of conformity as long as
(g) For test groups required to have an emission control diagnostic system, certification will not be granted if, for any emission data vehicle or other test vehicle approved by the Administrator in consultation with the manufacturer, the malfunction indicator light does not illuminate as required under § 86.1806.
(h) Vehicles equipped with aftertreatment technologies such as catalysts, otherwise covered by a certificate, which are driven outside the United States, Canada, and Mexico will be presumed to have been operated on leaded gasoline resulting in deactivation of such components as catalysts and oxygen sensors. If these vehicles are imported or offered for importation without retrofit of the catalyst or other aftertreatment technology, they will be considered not to be within the coverage of the certificate unless included in a catalyst or other aftertreatment technology control program operated by a manufacturer or a United States Government agency and approved by the Administrator.
The revisions read as follows:
(a) You must show that you meet the applicable Tier 3 fleet average NMOG+NO
(b) Calculate your fleet average value for each model year for all vehicle models subject to a separate fleet average standard using the following equation, rounded to the nearest 0.001 g/mile for NMOG+NO
You may use emission credits for purposes of certification to show compliance with the applicable fleet average NMOG+NO
(a) Calculate emission credits as described in this paragraph (a) instead of using the provisions of 40 CFR 1037.705. Calculate positive or negative emission credits relative to the applicable fleet average standard. Calculate positive emission credits if your fleet average level is below the standard. Calculate negative emission credits if your fleet average value is above the standard. Calculate credits separately for each applicable fleet average standard and calculate total credits for each averaging set as specified in paragraph (b) of this section. Convert units from mg/mile to g/mile as needed for performing calculations. Calculate emission credits using the following equation, rounded to the nearest whole number:
(b) The following restrictions apply instead of those specified in 40 CFR 1037.740:
(1) Except as specified in paragraph (b)(2) of this section, emission credits may be exchanged only within an averaging set, as follows:
(i) HDV represent a separate averaging set with respect to all emission standards.
(ii) Except as specified in paragraph (b)(1)(iii) of this section, light-duty program vehicles represent a single averaging set with respect to all emission standards. Note that FTP and SFTP credits for Tier 3 vehicles are not interchangeable.
(iii) LDV and LDT1 certified to standards based on a useful life of 120,000 miles and 10 years together represent a single averaging set with respect to NMOG+NO
(iv) The following separate averaging sets apply for evaporative emission standards:
(A) LDV and LDT1 together represent a single averaging set.
(B) LDT2 represents a single averaging set.
(C) HLDT represents a single averaging set.
(D) HDV represents a single averaging set.
(2) You may exchange evaporative emission credits across averaging sets as follows if you need additional credits to offset a deficit after the final year of maintaining deficit credits as allowed under paragraph (c) of this section:
(i) You may exchange LDV/LDT1 and LDT2 emission credits.
(ii) You may exchange HLDT and HDV emission credits.
(3) Except as specified in paragraph (b)(4) of this section, credits expire after five years.
For example, credits you generate in model year 2018 may be used only through model year 2023.
(4) For the Tier 3 declining fleet average FTP and SFTP emission standards for NMOG+NO
(5) Tier 3 credits for NMOG+NO
(6) A manufacturer may generate NMOG+NO
(i) Calculate generated credits separately for qualifying vehicles. Calculate generated credits by multiplying the applicable standard for light-duty program vehicles by the sales volume of qualifying vehicles in a given model year.
(ii) Apply generated credits to eliminate any deficit for light-duty program vehicles before using them to certify medium-duty vehicles.
(iii) Apply the credit provisions of this section as specified, except that you may not buy or sell credits generated under this paragraph (b)(6).
(iv) Describe in annual credit reports how you are generating certain credit quantities under this paragraph (b)(6). Also describe in your end of year credit report how you will use those credits for certifying light-duty program vehicles or medium-duty vehicles in a given model year.
(c) The credit-deficit provisions 40 CFR 1037.745 apply to the NMOG+NO
(d) The reporting and recordkeeping provisions of § 86.1862 apply instead of those specified in 40 CFR 1037.730 and 1037.735.
(e) The provisions of 40 CFR 1037.645 do not apply.
(f) The enforcement provisions described in § 86.1865-12(j)(3) apply with respect to NMOG+NO
(a)
(1) Tier 4 criteria exhaust emission standards, including cold temperature NMOG+NO
(2) Tier 3 evaporative emission standards in § 86.1813-17.
(3) Tier 3 FTP emission standard for NMOG+NO
(4) Tier 3 SFTP emission standard for NMOG+NO
(5) Tier 3 FTP emission standard for NMOG+NO
(6) Cold temperature NMHC standards in § 86.1811-17 for vehicles subject to Tier 3 NMOG+NO
(c) * * *
(2) When a manufacturer calculates compliance with the fleet average standard using the provisions in § 86.1860-17(f), the annual report must state that the manufacturer has elected to use such provision and must contain the fleet average standard as the fleet average value for that model year.
(d)
(a)
(b)
(c)
(1) Manufacturers must report in their annual reports to the Agency that they met the relevant fleet average standard by showing that their sales-weighted cold temperature fleet average emissions are at or below the applicable fleet average standard for each averaging set.
(2) If the sales-weighted average is above the applicable fleet average standard, manufacturers must obtain and apply sufficient credits as permitted under paragraph (d)(8) of this section. A manufacturer must show via the use of credits that they have offset any exceedance of the cold temperature fleet average standard. Manufacturers must also include their credit balances or deficits.
(3) If a manufacturer fails to meet the cold temperature fleet average standard for two consecutive years, the vehicles causing the exceedance will be considered not covered by the certificate of conformity (see paragraph (d)(8) of this section). A manufacturer will be subject to penalties on an individual-vehicle basis for sale of vehicles not covered by a certificate.
(4) EPA will review each manufacturer's sales to designate the vehicles that caused the exceedance of the fleet average standard. EPA will designate as nonconforming those vehicles in test groups with the highest certification emission values first, continuing until reaching a number of vehicles equal to the calculated number of noncomplying vehicles as determined above. In a group where only a portion of vehicles would be deemed nonconforming, EPA will determine the actual nonconforming vehicles by counting backwards from the last vehicle produced in that test group. Manufacturers will be liable for penalties for each vehicle sold that is not covered by a certificate.
(d)
(2) There are no property rights associated with cold temperature credits generated under this subpart. Credits are a limited authorization to emit the designated amount of emissions. Nothing in this part or any other provision of law should be construed to limit EPA's authority to terminate or limit this authorization through rulemaking.
(3) The following transition provisions apply:
(i) Cold temperature NMHC credits may be used to demonstrate compliance with the cold temperature NMOG+NO
(ii) Credits earned from any light-duty vehicles, light-duty trucks, and medium-duty passenger vehicles may be used for any light-duty program vehicles, even if they were originally generated for a narrower averaging set.
(4) Credits are earned on the last day of the model year. Manufacturers must calculate, for a given model year, the number of credits or debits it has generated according to the following equation, rounded to the nearest 0.1 vehicle-grams/mile:
(5) NMHC and NMOG+NO
(6) Credits may be used as follows:
(i) Credits generated and calculated according to the method in paragraph (d)(4) of this section may be used only to offset deficits accrued with respect to the standard in § 86.1811-10(g)(2). Credits may be banked and used in a future model year in which a manufacturer's average cold temperature fleet average level exceeds the applicable standard. Credits may be exchanged only within averaging sets. Credits may also be traded to another manufacturer according to the provisions in paragraph (d)(9) of this section. Before trading or carrying over credits to the next model year, a manufacturer must apply available credits to offset any credit deficit, where the deadline to offset that credit deficit has not yet passed.
(ii) The use of credits shall not be permitted to address Selective Enforcement Auditing or in-use testing failures. The enforcement of the averaging standard occurs through the vehicle's certificate of conformity. A manufacturer's certificate of conformity is conditioned upon compliance with the averaging provisions. The certificate will be void ab initio if a manufacturer fails to meet the corporate average standard and does not obtain appropriate credits to cover its shortfalls in that model year or in the subsequent model year (see deficit carryforward provision in paragraph (d)(8) of this section). Manufacturers must track their certification levels and sales unless they produce only vehicles certified with FELs at or below the applicable to cold temperature fleet average levels below the standard and have chosen to forgo credit banking.
(7) The following provisions apply if debits are accrued:
(i) If a manufacturer calculates that it has negative credits (also called “debits” or a “credit deficit”) for a given model year, it may carry that deficit forward into the next model year. Such a carry-forward may only occur after the manufacturer exhausts any supply of banked credits. At the end of that next model year, the deficit must be covered with an appropriate number of credits that the manufacturer generates or purchases. Any remaining deficit is subject to an enforcement action, as described in this paragraph (d)(8). Manufacturers are not permitted to have a credit deficit for two consecutive years.
(ii) If debits are not offset within the specified time period, the number of vehicles not meeting the cold temperature fleet average standards (and therefore not covered by the certificate) must be calculated by dividing the total amount of debits for the model year by the cold temperature fleet average standard applicable for the model year in which the debits were first incurred.
(iii) EPA will determine the number of vehicles for which the condition on the certificate was not satisfied by designating vehicles in those test groups with the highest certification cold temperature NMHC or NMOG+NO
(iv)(A) If a manufacturer ceases production of vehicles affected by a debit balance, the manufacturer continues to be responsible for offsetting any debits outstanding within the required time period. Any failure to offset the debits will be considered a violation of paragraph (d)(8)(i) of this section and may subject the manufacturer to an enforcement action for sale of vehicles not covered by a certificate, pursuant to paragraphs (d)(8)(ii) and (iii) of this section.
(B) If a manufacturer is purchased by, merges with, or otherwise combines with another manufacturer, the controlling entity is responsible for offsetting any debits outstanding within the required time period. Any failure to offset the debits will be considered a violation of paragraph (d)(8)(i) of this section and may subject the manufacturer to an enforcement action for sale of vehicles not covered by a certificate, pursuant to paragraphs (d)(8)(ii) and (iii) of this section.
(v) For purposes of calculating the statute of limitations, a violation of the requirements of paragraph (d)(8)(i) of this section, a failure to satisfy the conditions upon which a certificate(s) was issued and hence a sale of vehicles not covered by the certificate, all occur upon the expiration of the deadline for offsetting debits specified in paragraph (d)(8)(i) of this section.
(8) The following provisions apply for trading cold temperature credits:
(i) EPA may reject credit trades if the involved manufacturers fail to submit the credit trade notification in the annual report. A manufacturer may not sell credits that are not available for sale pursuant to the provisions in paragraphs (d)(7)(i) of this section.
(ii) In the event of a negative credit balance resulting from a transaction that a manufacturer could not cover by the reporting deadline for the model year in which the trade occurred, both the buyer and seller are liable, except in cases involving fraud by either the buyer or seller. EPA may void ab initio the certificates of conformity of all engine families participating in such a trade.
(iii) A manufacturer may only trade credits that it has generated pursuant to paragraph (d)(4) of this section or acquired from another party.
The revisions and addition read as follows:
(h) * * *
(1) The test procedures for demonstrating compliance with CO
(j)
(2) The certificate issued for each test group requires all model types within that test group to meet the in-use emission standards to which each model type is certified. The in-use standards for passenger automobiles and light trucks (including MDPV) are described in § 86.1818-12(d). The in-use standards for medium-duty vehicles are described in § 86.1819-14(b).
(3) EPA will issue a notice of nonconformity as described in 40 CFR part 85, subpart S, if EPA or the manufacturer determines that a substantial number of a class or category of vehicles produced by that manufacturer, although properly maintained and used, do not conform to in-use CO
(4) Any remedial plan under paragraph (j)(3) of this section, whether voluntary or in response to a notice of nonconformity, must fully correct the difference between the measured in-use CREE of the affected class or category of vehicles and the reported CREE used to calculate the manufacturer's fleet average and credit balances.
(5) The manufacturer may request a hearing under 40 CFR part 1068, subpart G, regarding any voiding of credits or adjustment of debits under paragraph (j)(3) of this section. Manufacturers must submit such a request in writing describing the objection and any supporting data within 30 days after we make a decision.
(6) Each manufacturer must comply with the applicable CO
(7) Each manufacturer must comply on an annual basis with the fleet average standards as follows:
(i) Manufacturers must report in their annual reports to the Agency that they met the relevant corporate average standard by showing that the applicable production-weighted average CO
(ii) If the production-weighted average is above the applicable fleet average standard, manufacturers must obtain and apply sufficient CO
(iii) If a manufacturer fails to meet the corporate average CO
(iv) EPA will review each manufacturer's production to designate the vehicles that caused the exceedance of the corporate average standard. EPA will designate as nonconforming those vehicles in test groups with the highest certification emission values first, continuing until reaching a number of vehicles equal to the calculated number of noncomplying vehicles as determined in paragraph (k)(8) of this section. In a group where only a portion of vehicles would be deemed nonconforming, EPA will determine the actual nonconforming vehicles by counting backwards from the last vehicle produced in that test group. Manufacturers will be liable for penalties for each vehicle sold that is not covered by a certificate.
(k) * * *
(10) A manufacturer may generate CO
(i) Determine the emission standards from § 86.1818-12 for qualifying vehicles based on the CO
(ii) Calculate generated credits separately for qualifying vehicles as described in paragraph (k)(4) of this section based on the emission standards from paragraph (k)(10)(i) of this section, the mileage values for light trucks, and the total number of qualifying vehicles produced, with fleet average CO
(iii) Apply generated credits to eliminate any deficit for light trucks before using them to certify medium-duty vehicles.
(iv) Apply the credit provisions of this section as specified, except that you may not buy or sell credits generated under this paragraph (k)(10).
(v) Describe in the annual credit reports how you are generating certain credit quantities under this paragraph (k)(10). Also describe in your end of year credit report how you will use those credits for certifying light trucks or medium-duty vehicles in a given model year.
(a) Battery electric vehicles, plug-in hybrid electric vehicles, and fuel cell vehicles that are certified and produced for sale in the states and territories of the United States may use a value of zero grams CO
(c) * * *
(3) Multiplier-based credits for model years 2022 through 2024 may not exceed credit caps, as follows:
(i) Calculate a nominal annual credit cap in Mg using the following equation, rounded to the nearest whole number:
(ii) Calculate an annual g/mile equivalent value for the multiplier-based credits using the following equation, rounded to the nearest 0.1 g/mile:
(iii) Calculate a cumulative g/mile equivalent value for the multiplier-based credits in each year by adding the annual g/mile equivalent values calculated under paragraph (c)(3)(ii) of this section.
(iv) The cumulative g/mile equivalent value may not exceed 10.0 in any year.
(v) For every year of certifying with multiplier-based credits, the annual credit report must include the calculated values for the nominal annual credit cap in Mg and the cumulative g/mile equivalent value.
Manufacturers may generate credits applicable to the CO
(a) Calculate an annual rate of refrigerant leakage from an air conditioning system as follows, expressed to the nearest 0.1 grams per year:
(1) Through model year 2026, calculate leakage rates according to the procedures specified in SAE J2727 FEB2012 (incorporated by reference, see § 86.1). In doing so, the refrigerant permeation rates for hoses shall be determined using the procedures specified in SAE J2064 (incorporated by reference, § 86.1). The procedures of SAE J2727 may be used to determine leakage rates for HFC-134a and HFO-1234yf; manufacturers should contact EPA regarding procedures for other refrigerants.
(2) For model years 2027 through 2030, calculate leakage rates according to the procedures specified in SAE J2727 SEP2023 (incorporated by reference, § 86.1).
(b) The CO
(1) Passenger automobile leakage credit for an air conditioning system:
(2) Light truck leakage credit for an air conditioning system:
(c) Calculate the total leakage credits generated by the air conditioning system as follows:
(1) Calculate a total leakage credit in megagrams separately for passenger automobiles and light trucks using the following equation:
(2) Total leakage credits may not exceed the following maximum per-vehicle values in model years 2027 through 2030:
(d) The results of paragraph (c) of this section, rounded to the nearest whole number, shall be included in the manufacturer's credit/debit totals calculated in § 86.1865-12(k)(5).
(e) The following values for refrigerant global warming potential (
(1) For HFC-134a,
(2) For HFC-152a,
(3) For HFO-1234yf,
(4) For CO
Manufacturers may generate credits applicable to the CO
(a) Calculate an annual rate of refrigerant leakage from an air conditioning system in grams per year for refrigerants with GWP at or below 150 according to the procedures specified in SAE J2727 SEP2023 (incorporated by reference, see § 86.1).
(b) Determine the CO
(1) Calculate the leakage credit to the nearest 0.1 g/mile using the following equation:
(2) Calculate the high leak disincentive,
(c) Calculate the total leakage reduction credits generated by the air conditioning system separately for passenger automobiles and light trucks to the nearest whole megagram using the following equation:
(d) Include the results of paragraph (c) of this section in your credit totals calculated in § 86.1865-12(k)(5).
(e) Calculate leakage credits using values for refrigerant global warming potential (
(1) Use the following values for the specific refrigerants:
(i) For HFC-152a,
(ii) For HFO-1234yf,
(iii) For CO
(2) EPA will assign values for
Manufacturers may generate credits applicable to the CO
(a) Air conditioning efficiency credits are available for the following technologies in the gram per mile amounts indicated for each vehicle category in the following table:
(b) Air conditioning efficiency credits are determined on an air conditioning system basis. For each air conditioning system that is eligible for a credit based on the use of one or more of the items listed in paragraph (a) of this section, the total credit value is the sum of the gram per mile values for the appropriate model year listed in paragraph (a) for each item that applies to the air conditioning system. The total credit value for an air conditioning system may not be greater than 5.0 grams per mile for any passenger automobile or 7.2 grams per mile for any light truck.
(c) The total efficiency credits generated by an air conditioning system shall be calculated in megagrams separately for passenger automobiles and light trucks according to the following formula:
(d) The results of paragraph (c) of this section, rounded to the nearest whole number, shall be included in the manufacturer's credit/debit totals calculated in § 86.1865-12(k)(5).
(e)-(f) [Reserved]
(g) For AC17 validation testing and reporting requirements, manufacturers must validate air conditioning credits by
(1) For each air conditioning system (as defined in § 86.1803) selected by the manufacturer to generate air conditioning efficiency credits, the manufacturer shall perform the AC17 Air Conditioning Efficiency Test Procedure specified in 40 CFR 1066.845, according to the requirements of this paragraph (g).
(2) Complete the following testing and calculations:
(i) Perform the AC17 test on a vehicle that incorporates the air conditioning system with the credit-generating technologies.
(ii) Perform the AC17 test on a vehicle which does not incorporate the credit-generating technologies. The tested vehicle must be similar to the vehicle tested under paragraph (g)(2)(i) of this section and selected using good engineering judgment. The tested vehicle may be from an earlier design generation. If the manufacturer cannot identify an appropriate vehicle to test under this paragraph (g)(2)(ii), they may submit an engineering analysis that describes why an appropriate vehicle is not available or not appropriate, and includes data and information supporting specific credit values, using good engineering judgment.
(iii) Subtract the CO
(3) For the first model year for which an air conditioning system is expected to generate credits, the manufacturer must select for testing the projected highest-selling configuration within each combination of vehicle platform and air conditioning system (as those terms are defined in § 86.1803). The manufacturer must test at least one unique air conditioning system within each vehicle platform in a model year, unless all unique air conditioning systems within a vehicle platform have been previously tested. A unique air conditioning system design is a system with unique or substantially different component designs or types and/or system control strategies (
(i) The air conditioning system components and/or control strategies do not change in any way that could be expected to cause a change in its efficiency;
(ii) The vehicle platform does not change in design such that the changes could be expected to cause a change in the efficiency of the air conditioning system; and
(iii) The manufacturer continues to test at least one unique air conditioning system within each platform using the air conditioning system, in each model year, until all unique air conditioning systems within each platform have been tested.
(4) Each air conditioning system must be tested and must meet the testing criteria in order to be allowed to generate credits. Credits may continue to be generated by an air conditioning system in subsequent model years if the manufacturer continues to test at least one unique air conditioning system within each platform on an annual basis, unless all systems have been previously tested, as long as the air conditioning system and vehicle platform do not change substantially.
(5) AC17 testing requirements apply as follows for electric vehicles and plug-in hybrid electric vehicles:
(i) Manufacturers may omit AC17 testing for electric vehicles. Electric vehicles may qualify for air conditioning efficiency credits based on identified technologies, without testing. The application for certification must include a detailed description of the vehicle's air conditioning system and identify any technology items eligible for air conditioning efficiency credits. Include additional supporting information to justify the air conditioning credit for each technology.
(ii) The provisions of paragraph (g)(5)(i) of this section also apply for plug-in hybrid electric vehicles if they have an all electric range of at least 60 miles (combined city and highway) after adjustment to reflect actual in-use driving conditions (see 40 CFR 600.311(j)), and they do not rely on the engine to cool the vehicle's cabin for the ambient and driving conditions represented by the AC17 test.
(iii) If AC17 testing is required for plug-in hybrid electric vehicles, perform this testing in charge-sustaining mode.
(h) The following definitions apply to this section:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
This section describes how manufacturers may generate credits for off-cycle CO
(b) * * *
(2) The maximum allowable decrease in the manufacturer's combined passenger automobile and light truck fleet average CO
(i) Determine the gram per mile decrease for the combined passenger automobile and light truck fleet using the following formula:
(ii) If the value determined in paragraph (b)(2)(i) of this section is greater than the off-cycle credit cap specified in paragraph (b)(2)(v) of this section, the total credits, in Megagrams, that may be accrued by a manufacturer using the default gram per mile values in paragraph (b)(1) of this section shall be determined using the following formula:
(iii) If the value determined in paragraph (b)(2)(i) of this section is not greater than the off-cycle credit cap specified in paragraph (b)(2)(v) of this section, then the credits that may be accrued by a manufacturer using the
(iv) If the value determined in paragraph (b)(2)(i) of this section is greater than the off-cycle credit cap specified in paragraph (b)(2)(v) of this section, then the combined passenger automobile and light truck credits, in Megagrams, that may be accrued using the calculations in paragraph (f) of this section must not exceed the value determined in paragraph (b)(2)(ii) of this section. This limitation should generally be done by reducing the amount of credits attributable to the vehicle category that caused the limit to be exceeded such that the total value does not exceed the value determined in paragraph (b)(2)(ii) of this section.
(v) The manufacturer's combined passenger automobile and light truck fleet average CO
(f)
49 U.S.C. 32901-23919q, Pub. L. 109-58.
(a) The provisions of this part apply to 2008 and later model year automobiles that are not medium duty passenger vehicles (MDPV
(1) For LDV, LDT, and MDPV
(2) For HDV, engine code has the meaning given in § 86.1819-14(d)(12) of this chapter.
(1) Is an “incomplete truck” as defined in 40 CFR 86.1803-01; or
(2) Has a seating capacity of more than 12 persons; or
(3) Is designed for more than 9 persons in seating rearward of the driver's seat; or
(4) Is equipped with an open cargo area (for example, a pick-up truck box or bed) of 72.0 inches in interior length or more. A covered box not readily accessible from the passenger compartment will be considered an open cargo area for purposes of this definition.
(1) For LDV, LDT, and MDPV
(2) For HDV, subconfiguration has the meaning given in § 86.1819-14(d)(12) of this chapter.
(1) For LDV, LDT, and MDPV
(2) For HDV, vehicle configuration has the meaning given for “configuration” in § 86.1819-14(d)(12) of this chapter.
(b) * * *
(4) Each fuel economy data vehicle must meet the same exhaust emission standards as certification vehicles of the respective engine-system combination during the test in which the fuel economy test results are generated. This may be demonstrated using one of the following methods:
Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, EPA must publish a document in the
(a)
(1) ASTM D86-23, Standard Test Method for Distillation of Petroleum Products and Liquid Fuels at Atmospheric Pressure; Approved March 1, 2023; IBR approved for § 600.113-12(f).
(2) ASTM D975-13a, Standard Specification for Diesel Fuel Oils, Approved December 1, 2013; IBR approved for § 600.107-08(b).
(3) ASTM D1298-12b, Standard Test Method for Density, Relative Density, or API Gravity of Crude Petroleum and Liquid Petroleum Products by Hydrometer Method, Approved June 1, 2012; IBR approved for §§ 600.113-12(f); 600.510-12(g).
(4) ASTM D1319-20a, Standard Test Method for Hydrocarbon Types in Liquid Petroleum Products by Fluorescent Indicator Adsorption, Approved August 1, 2020; IBR approved for § 600.113-12(f).
(5) ASTM D1945-03 (Reapproved 2010), Standard Test Method for Analysis of Natural Gas By Gas Chromatography, Approved January 1, 2010; IBR approved for § 600.113-12(f) and (k).
(6) ASTM D3338/D3338M-20a, Standard Test Method for Estimation of Net Heat of Combustion of Aviation Fuels, Approved December 1, 2020; IBR approved for § 600.113-12(f).
(7) ASTM D3343-22, Standard Test Method for Estimation of Hydrogen Content of Aviation Fuels, Approved November 1, 2022; IBR approved for § 600.113-12(f).
(8) ASTM D4052-22, Standard Test Method for Density, Relative Density, and API Gravity of Liquids by Digital Density Meter, Approved May 1, 2022; IBR approved for § 600.113-12(f).
(9) ASTM D4815-22, Standard Test Method for Determination of MTBE, ETBE, TAME, DIPE, tertiary-Amyl Alcohol and C
(10) ASTM D5599-22, Standard Test Method for Determination of Oxygenates in Gasoline by Gas Chromatography and Oxygen Selective Flame Ionization Detection, Approved April 1, 2022; IBR approved for § 600.113-12(f).
(11) ASTM D5769-22, Standard Test Method for Determination of Benzene, Toluene, and Total Aromatics in Finished Gasolines by Gas Chromatography/Mass Spectrometry, Approved July 1, 2022; IBR approved for § 600.113-12(f).
(b)
(1) ISO/IEC 18004:2006(E), Information technology—Automatic identification and data capture techniques—QR Code 2005 bar code symbology specification, Second Edition, September 1, 2006; IBR approved for § 600.302-12(b).
(2) [Reserved]
(c)
(1) Motor Vehicle Dimensions—Recommended Practice SAE 1100a (Report of Human Factors Engineering Committee, Society of Automotive Engineers, approved September 1973 as revised September 1975); IBR approved for § 600.315-08(c).
(2) SAE J1634 JUL2017, Battery Electric Vehicle Energy Consumption and Range Test Procedure, Revised July 2017; IBR approved for §§ 600.116-12(a); 600.210-12(d); 600.311-12(j) and (k).
(3) SAE J1711 FEB2023, Recommended Practice for Measuring the Exhaust Emissions and Fuel Economy of Hybrid-Electric Vehicles, Including Plug-In Hybrid Vehicles; Revised February 2023; IBR approved for §§ 600.114-12(c) and (f); 600.116-12(b) and (c); 600.311-12(c), (j), and (k).
Perform testing under this part as described in § 600.111. This involves the following specific requirements:
(a) Perform the following tests and calculations for LDV, LDT, and MDPV
(1) Testing to demonstrate compliance with Corporate Average Fuel Economy standards and greenhouse gas emission standards generally involves a combination of two cycles—the Federal Test Procedure and the Highway Fuel Economy Test (see 40 CFR 1066.801). Testing to determine values for fuel economy labeling under subpart D of this part generally involves testing with three additional test cycles; § 600.210 describes circumstances in which testing with these additional test cycles does not apply for labeling purposes.
(2) Calculate fuel economy and CREE values for vehicle subconfigurations, configurations, base levels, and model types as described in §§ 600.206 and 600.208. Calculate fleet average values for fuel economy and CREE as described in § 600.510.
(3) Determine fuel economy values for labeling as described in § 600.210 using either the vehicle-specific 5-cycle method or the derived 5-cycle method as described in § 600.115.
(i) For vehicle-specific 5-cycle labels, the test vehicle (subconfiguration) data are adjusted to better represent in-use fuel economy and CO
(ii) For derived 5-cycle labels, calculate “unadjusted” fuel economy and CO
(4) Diesel-fueled Tier 3 vehicles are not subject to cold temperature emission standards; however, you must test at least one vehicle in each test group over the cold temperature FTP to comply with requirements of this part. This paragraph (a)(4) does not apply for Tier 4 vehicles.
(b) Perform the following tests and calculations for all chassis-tested vehicles other than LDV, LDT, and MDPV
(1) Test vehicles as described in 40 CFR 86.1811, 86.1816, and 86.1819. Testing to demonstrate compliance with CO
(2) Determine fleet average CO
(c) Manufacturers must use E10 gasoline test fuel as specified in 40 CFR 1065.710(b) for new testing to demonstrate compliance with all emission standards and to determine fuel economy values. This requirement starts in model year 2027. Interim provisions related to test fuel apply as described in § 600.117.
The revisions and addition read as follows:
The Administrator will use the calculation procedure set forth in this section for all official EPA testing of vehicles fueled with gasoline, diesel, alcohol-based or natural gas fuel. The calculations of the weighted fuel economy and carbon-related exhaust emission values require input of the weighted grams/mile values for total hydrocarbons (HC), carbon monoxide (CO), and carbon dioxide (CO
(f) * * *
(1) Gasoline test fuel properties shall be determined by analysis of a fuel sample taken from the fuel supply. A sample shall be taken after each addition of fresh fuel to the fuel supply. Additionally, the fuel shall be resampled once a month to account for any fuel property changes during storage. Less frequent resampling may be permitted if EPA concludes, on the basis of manufacturer-supplied data, that the properties of test fuel in the manufacturer's storage facility will remain stable for a period longer than one month. The fuel samples shall be analyzed to determine fuel properties as follows for neat gasoline (E0) and for a low-level ethanol-gasoline blend (E10):
(i)
(ii)
(B) For E10, determine carbon mass fraction of test fuel,
(iii)
(B) For E10, determine net heat of combustion,
(n) Manufacturers may use a value of 0 grams CO
(o)(1) For testing with E10, calculate fuel economy using the following equation, rounded to the nearest 0.1 miles per gallon:
(2) Use one of the following methods to calculate the carbon-related exhaust emissions for testing model year 2027 and later vehicles with the E10 test fuel specified in 40 CFR 1065.710(b):
(i) For manufacturers not complying with the fleet averaging option for N
(ii) For manufacturers complying with the fleet averaging option for N
(d) * * *
(2) To determine City CO
(e) * * *
(3) To determine Highway CO
(f) * * *
(1) If the 4-bag sampling method is used, manufacturers may use the equations in paragraphs (a) and (b) of this section to determine city and highway CO
(2) If the 2-bag sampling method is used for the 75 °F FTP test, it must be used to determine both city and highway CO
(4) To determine City and Highway CO
This section provides the criteria to determine if the derived 5-cycle method for determining fuel economy label values, as specified in § 600.210-08(a)(2) or (b)(2) or § 600.210-12(a)(2) or (b)(2), as applicable, may be used to determine label values. Separate criteria apply to city and highway fuel economy for each test group. The provisions of this section are optional. If this option is not chosen, or if the criteria provided in this section are not met, fuel economy label values must be determined according to the vehicle-specific 5-cycle method specified in § 600.210-08(a)(1) or (b)(1) or § 600.210-12(a)(1) or (b)(1), as applicable. However, dedicated alternative-fuel vehicles (other than battery electric vehicles and fuel cell vehicles), dual fuel vehicles when operating on the alternative fuel, MDPV
(b) Determine performance values for hybrid electric vehicles that have no plug-in capability as specified in §§ 600.210 and 600.311 using the procedures for charge-sustaining operation from SAE J1711 (incorporated by reference in § 600.011). We may approve alternate measurement procedures with respect to these vehicles if that is necessary or appropriate for meeting the objectives of this part. For example, we may approve alternate Net Energy Change/Fuel Ratio tolerances for charge-sustaining operation as described in paragraph (c)(5) of this section.
(c) * * *
(1) To determine CREE values to demonstrate compliance with GHG standards, calculate composite values representing combined operation during charge-depleting and charge-sustaining operation using the following utility factors, except as otherwise specified in this paragraph (c):
(2) Determine fuel economy values to demonstrate compliance with CAFE standards as follows:
(i) For vehicles that are not dual fueled automobiles, determine fuel economy using the utility factors specified in paragraph (c)(1) of this section for model year 2030 and earlier vehicles. Do not use the petroleum-equivalence factors described in 10 CFR 474.3.
(ii) Except as described in paragraph (c)(2)(iii) of this section, determine fuel economy for dual fueled automobiles from the following equation, separately for city and highway driving:
(iii) For 2016 and later model year dual fueled automobiles, you may determine fuel economy based on the following equation, separately for city and highway driving:
(5) Instead of the utility factors specified in paragraphs (c)(1) through (3) of this section, calculate utility factors using the following equation for vehicles whose maximum speed is less than the maximum speed specified in the driving schedule, where the vehicle's maximum speed is determined, to the nearest 0.1 mph, from observing the highest speed over the first duty cycle (FTP, HFET, etc.):
(6) Determine End-of-Test as follows:
(i) Base End-of-Test on a 2 percent State of Charge as specified in Section 3.5.1 of SAE J1711.
(ii) Base End-of-Test on a 1 percent Net Energy Change/Fuel Ratio as specified in Section 3.5.2 of SAE J1711.
(iii) For charge-sustaining tests, we may approve alternate Net Energy Change/Fuel Ratio tolerances as specified in Appendix C of SAE J1711 to correct final fuel economy values, CO
(7) Use the vehicle's Actual Charge-Depleting Range, Rcda, as specified in Section 7.1.4 of SAE J1711 for evaluating the end-of-test criterion.
(10) The utility factors described in this paragraph (c) and in § 600.510 are derived from equations in SAE J2841. You may alternatively calculate utility factors from the corresponding equations in SAE J2841 as follows:
(i) Calculate utility factors for labeling directly from the equation in SAE J2841 Section 6.2 using the Table 2 MDIUF Fit Coefficients (C1 through C10) and a normalized distance (norm_dist) of 399 miles.
(ii) Calculate utility factors for fuel economy standards from the equation in SAE J2841 Section 6.2 using the Table 5 Fit Coefficients for city/Hwy Specific FUF curves weighted 55 percent city, 45 percent highway and a normalized distance (norm_dist) of 399 miles.
(iii) Starting in model year 2031, calculate utility factors for GHG compliance with emission standards from the equation in SAE J2841 Section 6.2 using the Table 2 FUF Fit Coefficients (C1 through C6) and a normalized distance (norm_dist) of 583 miles. For model year 2026 and earlier, calculate utility factors for compliance with GHG emission standards as described in paragraph (c)(10)(ii) of this section.
(11) The following methodology is used to determine the usable battery energy (UBE) for a PHEV using data obtained during either the UDDS Full Charge Test (FCT) or the HFET FCT as described in SAE J1711:
(i) Perform the measurements described in SAE J1711 Section 5.1.3.d. Record initial and final SOC of the RESS for each cycle in the FCT.
(ii) Perform the measurements described in SAE J1711 Section 5.1.3.c. Continuously measure the voltage of the RESS throughout the entire cycle, or record initial and final voltage measurements of the RESS for each test cycle.
(iii) Determine average voltage of the RESS during each FCT cycle by averaging the results of the continuous voltage measurement or by determining the average of the initial and final voltage measurement.
(iv) Determine the DC discharge energy for each cycle of the FCT by multiplying the change in SOC of each cycle by the average voltage for the cycle.
(v) Instead of independently measuring current and voltage and calculating the resulting DC discharge energy, you may use a DC wideband Watt-hour meter (power analyzer) to directly measure the DC discharge energy of the RESS during each cycle of the FCT. The meter used for this measurement must meet the requirements in SAE J1711 Section 4.4.
(vi) After completing the FCT, determine the cycles comprising the Charge-Depleting Cycle Range (Rcdc) as described in SAE J1711 Section 3.1.14. Charge-sustaining cycles are not included in the Rcdc. Rcdc includes any number of transitional cycles where the vehicle may have operated in both charge-depleting and charge-sustaining modes.
(vii) Determine the UBE of the PHEV by summing the measured DC discharge energy for each cycle comprising Rcdc. Following the charge-depleting cycles and during the transition to charge-sustaining operation, one or more of the transition cycles may result in negative DC discharge energy measurements that result from the vehicle charging and not discharging the RESS. Include these negative discharge results in the summation.
(a) The following provisions apply instead of other provisions specified in this part through model year 2026:
(1) Except as specified in paragraphs (a)(5) and (6) of this section, manufacturers must demonstrate compliance with greenhouse gas emission standards and determine fuel economy values using E0 gasoline test fuel as specified in 40 CFR 86.113-04(a)(1), regardless of any testing with E10 test fuel specified in 40 CFR 1065.710(b) under paragraph (a)(2) of this section.
(2) Manufacturers may demonstrate that vehicles comply with emission standards for criteria pollutants as specified in 40 CFR part 86, subpart S, during fuel economy measurements using the E0 gasoline test fuel specified in 40 CFR 86.113-04(a)(1), as long as this test fuel is used in fuel economy testing for all applicable duty cycles specified in 40 CFR part 86, subpart S. If a vehicle fails to meet an emission standard for a criteria pollutant using the E0 gasoline test fuel specified in 40 CFR 86.113-04(a)(1), the manufacturer must retest the vehicle using the E10 test fuel specified in 40 CFR 1065.710(b) (or the equivalent LEV III test fuel for California) to demonstrate compliance with all applicable emission standards over that test cycle.
(3) If a manufacturer demonstrates compliance with emission standards for criteria pollutants over all five test cycles using the E10 test fuel specified in 40 CFR 1065.710(b) (or the equivalent LEV III test fuel for California), the manufacturer may use test data with the same test fuel to determine whether a test group meets the criteria described in § 600.115 for derived 5-cycle testing for fuel economy labeling. Such vehicles may be tested over the FTP and HFET cycles with the E0 gasoline test fuel specified in 40 CFR 86.113-04(a)(1) under this paragraph (a)(3); the vehicles must meet the emission standards for criteria pollutants over those test cycles as described in paragraph (a)(2) of this section.
(4) Manufacturers may perform testing with the appropriate gasoline test fuels specified in 40 CFR 86.113-04(a)(1), 40 CFR 86.213(a)(2), and in 40 CFR 1065.710(b) to evaluate whether their vehicles meet the criteria for derived 5-cycle testing under § 600.115. All five tests must use test fuel with the same nominal ethanol concentration.
(5) For IUVP testing under 40 CFR 86.1845, manufacturers may demonstrate compliance with greenhouse gas emission standards using a test fuel meeting specifications for demonstrating compliance with emission standards for criteria pollutants.
(6) Manufacturers may alternatively demonstrate compliance with greenhouse gas emission standards and determine fuel economy values using E10 gasoline test fuel as specified in 40 CFR 1065.710(b). However, manufacturers must then multiply measured CO
(7) If a vehicle uses an E10 test fuel for evaporative emission testing and E0 is the applicable test fuel for exhaust emission testing, exhaust measurement and reporting requirements apply over the course of the evaporative emission test, but the vehicle need not meet the exhaust emission standards during the evaporative emission test run.
(b) Manufacturers may certify model year 2027 through 2029 vehicles to greenhouse gas emission standards using data with E0 test fuel from testing for earlier model years, subject to the carryover provisions of 40 CFR 86.1839. In the case of the fleet average CO
(c) Manufacturers may perform testing under § 600.115-11 using E0 gasoline test fuel as specified in 40 CFR 86.113-04(a)(1) or E10 test fuel as specified in 40 CFR 1065.710(b) until EPA publishes guidance under § 600.210-12(a)(2)(iv) describing when and how to apply 5-cycle adjustment factors based on testing with the E10 test fuel.
(a) Fuel economy, CO
(1) If only one set of FTP-based city and HFET-based highway fuel economy values is accepted for a subconfiguration at which a vehicle configuration was tested, these values, rounded to the nearest tenth of a mile per gallon, comprise the city and highway fuel economy values for that subconfiguration. If only one set of FTP-based city and HFET-based highway CO
(2) If more than one set of FTP-based city and HFET-based highway fuel economy and/or carbon-related exhaust emission values are accepted for a vehicle configuration:
(i) All data shall be grouped according to the subconfiguration for which the data were generated using sales projections supplied in accordance with § 600.208-12(a)(3).
(ii) Within each group of data, all fuel economy values are harmonically averaged and rounded to the nearest 0.0001 of a mile per gallon and all CO
(iii) All FTP-based city fuel economy, CO
(3)(i) For the purpose of determining average fuel economy under § 600.510, the combined fuel economy value for a vehicle configuration is calculated by harmonically averaging the FTP-based city and HFET-based highway fuel economy values, as determined in paragraph (a)(1) or (2) of this section, weighted 0.55 and 0.45 respectively, and rounded to the nearest 0.0001 mile per gallon. A sample of this calculation appears in appendix II to this part.
(ii) For the purpose of determining average carbon-related exhaust emissions under § 600.510, the combined carbon-related exhaust emission value for a vehicle configuration is calculated by arithmetically averaging the FTP-based city and HFET-based highway carbon-related exhaust emission values, as determined in paragraph (a)(1) or (2) of this section, weighted 0.55 and 0.45 respectively, and rounded to the nearest tenth of gram per mile.
(4) For alcohol dual fuel automobiles and natural gas dual fuel automobiles the procedures of paragraphs (a)(1) or (2) of this section, as applicable, shall be used to calculate two separate sets of FTP-based city, HFET-based highway, and combined values for fuel economy, CO
(i) Calculate the city, highway, and combined fuel economy, CO
(ii) Calculate the city, highway, and combined fuel economy, CO
(a) Fuel economy and CO
(1) If only one set of 5-cycle city and highway fuel economy and CO
(2) If more than one set of 5-cycle city and highway fuel economy and CO
(i) All data shall be grouped according to the subconfiguration for which the data were generated using sales projections supplied in accordance with § 600.209-12(a)(3).
(ii) Within each subconfiguration of data, all fuel economy values are harmonically averaged and rounded to the nearest 0.0001 of a mile per gallon in order to determine 5-cycle city and highway fuel economy values for each subconfiguration at which the vehicle configuration was tested, and all CO
(iii) All 5-cycle city fuel economy values and all 5-cycle highway fuel economy values calculated in paragraph (a)(2)(ii) of this section are (separately for city and highway) averaged in proportion to the sales fraction (rounded to the nearest 0.0001) within the vehicle configuration (as provided to the Administrator by the manufacturer) of vehicles of each tested subconfiguration. The resultant values, rounded to the nearest 0.0001 mile per gallon, are the 5-cycle city and 5-cycle highway fuel economy values for the vehicle configuration.
(iv) All 5-cycle city CO
(3) [Reserved]
(4) For alcohol dual fuel automobiles and natural gas dual fuel automobiles, the procedures of paragraphs (a)(1) and (2) of this section shall be used to calculate two separate sets of 5-cycle city and highway fuel economy and CO
(i) Calculate the 5-cycle city and highway fuel economy and CO
(ii) Calculate the 5-cycle city and highway fuel economy and CO
(a) * * *
(4) Vehicle configuration fuel economy, CO
(i) If only one vehicle configuration within a base level has been tested, the fuel economy, CO
(ii) If more than one vehicle configuration within a base level has been tested, the vehicle configuration fuel economy values are harmonically averaged in proportion to the respective sales fraction (rounded to the nearest 0.0001) of each vehicle configuration and the resultant fuel economy value rounded to the nearest 0.0001 mile per gallon; and the vehicle configuration CO
(b) * * *
(3) * * *
(iii) * * *
(C) Note that the appropriate base level CO
(a)
(b)
(a) * * *
(2) * * *
(i) * * *
(B) For each model type, determine the derived five-cycle city CO
(ii) * * *
(B) For each model type, determine the derived five-cycle highway CO
(b) * * *
(2) * * *
(i) * * *
(B) Determine the derived five-cycle city CO
(ii) * * *
(B) Determine the derived five-cycle highway CO
(g)
42 U.S.C. 7401-7671q.
(a) The requirements of this section apply for engines certified under this part, except in the following circumstances:
(1) Heavy-duty engines intended to be installed in heavy-duty vehicles at or below 14,000 pounds GVWR must meet the OBD requirements in 40 CFR 86.1806-27. Note that 40 CFR 86.1806-27 allows for using later versions of specified OBD requirements from the California Air Resources Board, which includes meeting the 2019 heavy-duty OBD requirements adopted for California and updated emission thresholds as described in this section.
(2) Heavy-duty spark-ignition engines intended to be installed in heavy-duty vehicles above 14,000 pounds GVWR may instead meet the OBD requirements in 40 CFR 86.1806-27 if the same engines are also installed in vehicles
Engines that will be installed in Vehicles at or below 14,000 pounds GVWR that have GCWR above 22,000 pounds may be optionally certified under this part instead of vehicle certification under 40 CFR part 86, subpart S.
(a) Affected engines must meet the criteria pollutant standards specified in § 1036.104. The following specific provisions apply if engines are exempt from greenhouse gas standards under paragraph (b) or (c) of this section:
(1) Determine brake-specific CO
(2) For plug-in hybrid electric vehicles, meet battery monitor requirements under 40 CFR 1037.115(f) instead of the battery-related requirements under 40 CFR 86.1815-27.
(b) Affected engines that will be installed in complete vehicles are exempt from the greenhouse gas emission standards in § 1036.108, but engine certification under this part 1036 depends on the following conditions:
(1) The vehicles in which the engines are installed must meet the following vehicle-based standards under 40 CFR part 86, subpart S:
(i) Evaporative and refueling emission standards as specified in 40 CFR 86.1813-17.
(ii) Greenhouse gas emission standards as specified in 40 CFR 86.1819-14.
(2) Additional provisions related to relevant requirements from 40 CFR part 86, subpart S, apply for certifying engines under this part, as illustrated in the following examples:
(i) The engine's emission control information label must state that the vehicle meets evaporative and refueling emission standards under 40 CFR 86.1813-17 and greenhouse gas emission standards under 40 CFR 86.1819-14.
(ii) The application for certification must include the information related to complying with evaporative, refueling, and greenhouse gas emission standards.
(iii) We may require you to perform testing on in-use vehicles and report test results as specified in 40 CFR 86.1845-04, 86.1846-01, and 86.1847-01.
(iv) Demonstrate compliance with the fleet average CO
(3) State in the application for certification that you are using the provisions of this section to meet the fleet average CO
(c) The provisions in paragraph (b) of this section are optional for affected engines that will be installed in incomplete vehicles. If vehicles do not meet all the requirements described in paragraph (b) of this section, the engines must meet the greenhouse gas emission standards of § 1036.108 and the vehicles must be certified under 40 CFR part 1037.
42 U.S.C. 7401-7671q.
(l)
(1) Complete or cab-complete vehicles may optionally meet alternative standards as described in 40 CFR 86.1819-14(j).
(2) Complete high-GCWR vehicles must meet the greenhouse gas standards of 40 CFR part 86, subpart S, as described in 40 CFR 1036.635.
(3) Incomplete high-GCWR vehicles may meet the greenhouse gas standards of 40 CFR part 86, subpart S, as described in 40 CFR 1036.635.
42 U.S.C. 7401-7671q.
(b) The general procedure for determining road-load force is performing coastdown tests and calculating road-load coefficients. This procedure is described in SAE J1263 and SAE J2263 (incorporated by reference, see § 1066.1010). Continued testing based on the 2008 version of SAE J2263 is optional, except that it is no longer available for testing starting with model year 2026. This subpart specifies certain deviations from those procedures for certain applications.
(a) For motor vehicles at or below 14,000 pounds GVWR, develop representative road-load coefficients to characterize each vehicle covered by a certificate of conformity. Calculate road-load coefficients by performing coastdown tests using the provisions of SAE J1263 and SAE J2263 (incorporated by reference, see § 1066.1010). This protocol establishes a procedure for determination of vehicle road load force for speeds between 115 and 15 km/hr (71.5 and 9.3 mi/hr); the final result is a model of road-load force (as a function of speed) during operation on a dry, level road under reference conditions of 20 °C, 98.21 kPa, no wind, no precipitation, and the transmission in neutral. You may use other methods that are equivalent to SAE J2263, such as equivalent test procedures or analytical modeling, to characterize road load using good engineering judgment. Determine dynamometer settings to simulate the road-load profile represented by these road-load target coefficients as described in § 1066.315. Supply representative road-load forces for each vehicle at speeds above 15 km/hr (9.3 mi/hr), and up to 115 km/hr (71.5 mi/hr), or the highest speed from the range of applicable duty cycles.
(b) Follow the provisions of Sections 1 through 9 of SAE J1263 and SAE J2263 (incorporated by reference, see § 1066.1010), except as described in this paragraph (b). The terms and variables identified in this paragraph (b) have the meaning given in SAE J1263 or J2263 unless specified otherwise.
Determine dynamometer road-load settings for chassis testing by following SAE J2264 (incorporated by reference, see § 1066.1010).
(j) * * *
(1) Compare the following drive-cycle metrics, based on measured vehicle speeds, to a reference value based on the target cycle that would have been generated by driving exactly to the target trace as described in SAE J2951 (incorporated by reference, see § 1066.1010):
(a) Correct the results for Net Energy Change of the RESS as follows:
(1) For all sizes of EV, follow SAE J1634 (incorporated by reference, see § 1066.1010).
(2) For HEV at or below 14,000 pounds GVWR, follow SAE J1711 (incorporated by reference, see § 1066.1010) except as described in this paragraph (a). Disregard provisions of SAE J1711 that differ from this part or the standard-setting part if they are not specific to HEV. Apply the following adjustments and clarifications to SAE J1711:
(i) If the procedure calls for charge-sustaining operation, start the drive with a State of Charge that is appropriate to ensure charge-sustaining operation for the duration of the drive. Take steps other than emission measurements to confirm that vehicles are in charge-sustaining mode for the duration of the drive.
(ii) You may use Appendix C of SAE J1711 for charge-sustaining tests to correct final fuel economy values, CO
(iii) You may test subject to a measurement accuracy of ±0.3% of full scale in place of the measurement accuracy specified in Section 4.4 of SAE J1711.
(3) For HEV above 14,000 pounds GVWR, follow SAE J2711 (incorporated by reference, see § 1066.1010) for requirements related to charge-sustaining operation.
(a) * * *
(2) Calculate
For vehicles subject to an NMOG standard, determine NMOG as described in paragraph (a) of this section. Except as specified in the standard-setting part, you may alternatively calculate NMOG results based on measured NMHC emissions as described in paragraphs (c) through (f) of this section. Note that references to the FTP in this section apply for testing over the FTP test cycle at any ambient temperature.
This section describes procedures for measuring emissions of nonmethane organic gas (NMOG), oxides of nitrogen (NO
(a) * * *
(6) Analyze samples for NMOG, NO
(b) * * *
(2)
(d) * * *
(2) Fill the fuel tank to approximately 40% of the manufacturer's nominal fuel tank capacity. Use the appropriate gasoline test fuel for low-temperature testing as specified 40 CFR 1065.710 or use ultra low-sulfur diesel fuel as specified in 40 CFR 1065.703. However, you may ask us to approve an alternative formulation of diesel fuel under 40 CFR 1065.10(c)(1) if that better represents in-use diesel fuel in winter conditions. The temperature of the dispensed test fuel must be at or below 15.5 °C. If the leftover fuel in the fuel tank before the refueling event does not meet these specifications, drain the fuel tank before refueling. You may operate the vehicle prior to the preconditioning drive to eliminate fuel effects on adaptive memory systems.
This subpart I specifies how to apply the test procedures of this part for light-duty vehicles, light-duty trucks, and heavy-duty vehicles at or below 14,000 pounds GVWR that are subject to chassis testing for exhaust emissions under 40 CFR part 86, subpart S. For these vehicles, references in this part 1066 to the standard-setting part include subpart H of this part and this subpart I.
(a) Use the procedures detailed in this subpart to measure vehicle emissions over a specified drive schedule in conjunction with subpart E of this part. Where the procedures of subpart E of this part differ from this subpart I, the provisions in this subpart I take precedence.
(b) Collect samples of every pollutant for which an emission standard applies, unless specified otherwise.
(c) This subpart covers the following test procedures:
(1) The Federal Test Procedure (FTP), which includes the general driving cycle. This procedure is also used for measuring evaporative emissions. This may be called the conventional test since it was adopted with the earliest emission standards.
(i) The FTP consists of one Urban Dynamometer Driving Schedule (UDDS) as specified in paragraph (a) of appendix I to 40 CFR part 86, followed by a 10-minute soak with the engine off and repeat driving through the first 505 seconds of the UDDS. Note that the UDDS represents about 7.5 miles of driving in an urban area. Engine startup (with all accessories turned off), operation over the initial UDDS, and engine shutdown make a complete cold-start test. The hot-start test consists of the first 505 seconds of the UDDS following the 10-minute soak and a hot-running portion of the UDDS after the first 505 seconds. The first 505 seconds of the UDDS is considered the transient portion; the remainder of the UDDS is considered the stabilized (or hot-stabilized) portion. The hot-stabilized portion for the hot-start test is generally measured during the cold-start test; however, in certain cases, the hot-start test may involve a second full UDDS following the 10-minute soak, rather than repeating only the first 505 seconds. See §§ 1066.815 and 1066.820.
(ii) Evaporative emission testing includes a preconditioning drive with the UDDS and a full FTP cycle, including exhaust measurement, followed by evaporative emission measurements. In the three-day diurnal test sequence, the exhaust test is followed by a running loss test consisting of a UDDS, then two New York City Cycles as specified in paragraph (e) of appendix I to 40 CFR part 86, followed by another UDDS; see 40 CFR 86.134. Note that the New York City Cycle represents about 1.18 miles of driving in a city center. The running loss test is followed by a high-temperature hot soak test as described in 40 CFR 86.138 and a three-day diurnal emission test as described in 40 CFR 86.133. In the two-day diurnal test sequence, the exhaust test is followed by a low-temperature hot soak test as described in 40 CFR 86.138-96(k) and a two-day diurnal emission test as described in 40 CFR 86.133-96(p).
(iii) Refueling emission tests for vehicles that rely on integrated control of diurnal and refueling emissions includes vehicle operation over the full FTP test cycle corresponding to the three-day diurnal test sequence to precondition and purge the evaporative canister. For non-integrated systems, there is a preconditioning drive over the UDDS and a refueling event, followed by repeated UDDS driving to purge the evaporative canister. The refueling emission test procedures are described in 40 CFR 86.150 through 86.157.
(2) The US06 driving cycle is specified in paragraph (g) of appendix I to 40 CFR part 86. Note that the US06 driving cycle represents about 8.0 miles of relatively aggressive driving.
(3) The SC03 driving cycle is specified in paragraph (h) of appendix I to 40 CFR part 86. Note that the SC03 driving schedule represents about 3.6 miles of urban driving with the air conditioner operating.
(4) The hot portion of the LA-92 driving cycle is specified in paragraph (c) of appendix I to 40 CFR part 86. Note that the hot portion of the LA-92 driving cycle represents about 9.8 miles of relatively aggressive driving for commercial trucks. This driving cycle applies for heavy-duty vehicles above 10,000 pounds GVWR and at or below 14,000 pounds GVWR only for vehicles subject to Tier 3 standards.
(5) The Highway Fuel Economy Test (HFET) is specified in appendix I to 40 CFR part 600. Note that the HFET represents about 10.2 miles of rural and freeway driving with an average speed of 48.6 mi/hr and a maximum speed of 60.0 mi/hr. See § 1066.840.
(6) Cold temperature standards apply for NMOG+NO
(7) Emission measurement to determine air conditioning credits for greenhouse gas standards. In this optional procedure, manufacturers operate vehicles over repeat runs of the AC17 test sequence to allow for calculating credits as part of demonstrating compliance with CO
(8) The mid-temperature intermediate soak FTP is specified as the procedure for Partial Soak Emission Testing in Section E4.4 of California ARB's PHEV Test Procedures for plug-in hybrid electric vehicles, in Part II Section I.7 of California ARB's LMDV Test Procedures for other hybrid electric vehicles, and in Part II, Section B.9.1 and B.9.3 of California ARB's LMDV Test Procedures
(9) The early driveaway FTP is specified as the procedure for Quick Drive-Away Emission Testing in Section E4.5 of California ARB's PHEV Test Procedures for plug-in hybrid electric vehicles, in Part II Section I.8 of California ARB's LMDV Test Procedures for other hybrid electric vehicles, and in Part II, Section B.9.2 and B.9.4 of California ARB's LMDV Test Procedures for other vehicles (both incorporated by reference, see § 1066.1010). Additionally, vehicle speed may not exceed 0.0 mi/hr until 7.0 seconds into the driving schedule and vehicle speed may not exceed 2.0 mi/hr from 7.1 through 7.9 seconds.
(10) The high-load PHEV engine starts US06 is specified in Section E7.2 of California ARB's PHEV Test Procedures using the cold-start US06 Charge-Depleting Emission Test (incorporated by reference, see § 1066.1010).
(d) The following provisions apply for all testing:
(1) Ambient temperatures encountered by the test vehicle must be (20 to 30) °C, unless otherwise specified. Where ambient temperature specifications apply before or between test measurements, the vehicle may be exposed to temperatures outside of the specified range for up to 10 minutes to account for vehicle transport or other actions to prepare for testing. The temperatures monitored during testing must be representative of those experienced by the test vehicle. For example, do not measure ambient temperatures near a heat source.
(2) Do not operate or store the vehicle at an incline if good engineering judgment indicates that it would affect emissions.
(3) If a test is void after collecting emission data from previous test segments, the test may be repeated to collect only those data points needed to complete emission measurements. You may combine emission measurements from different test runs to demonstrate compliance with emission standards.
(4) Prepare vehicles for testing as described in § 1066.810.
(e) The following figure illustrates the FTP test sequence for measuring exhaust and evaporative emissions:
(c) For FTP, US06, SC03, New York City Cycle, HFET, and LA-92 testing, determine road-load forces for each test vehicle at speeds between 9.3 and 71.5 miles per hour. The road-load force must represent vehicle operation on a smooth, level road with no wind or calm winds, no precipitation, an ambient temperature of approximately 20 °C, and atmospheric pressure of
Sections 1066.831 and 1066.835 describe the detailed procedures for the Supplemental Federal Test Procedure (SFTP). This testing applies for Tier 3 vehicles subject to the SFTP standards in 40 CFR 86.1811-17 or 86.1816-18. The SFTP test procedure consists of FTP testing and two additional test elements—a sequence of vehicle operation with more aggressive driving and a sequence of vehicle operation that accounts for the impact of the vehicle's air conditioner. Tier 4 vehicles subject to 40 CFR 86.1811-27 must meet standards for each individual driving cycle.
(a) The SFTP standard applies as a composite representing the three test elements. The emission results from the aggressive driving test element (§ 1066.831), the air conditioning test element (§ 1066.835), and the FTP test element (§ 1066.820) are analyzed according to the calculation methodology and compared to the applicable SFTP emission standards as described in 40 CFR part 86, subpart S.
(b) The test elements of the SFTP may be run in any sequence that includes the specified preconditioning steps.
(e) * * *
(2) Operate the vehicle over the full US06 driving schedule, with the following exceptions that apply only for Tier 3 vehicles:
(i) For heavy-duty vehicles above 10,000 pounds GVWR, operate the vehicle over the Hot LA-92 driving schedule.
(ii) Heavy-duty vehicles at or below 10,000 pounds GVWR with a power-to-weight ratio at or below 0.024 hp/pound may be certified using only the highway portion of the US06 driving schedule as described in 40 CFR 86.1816.
The revision and addition read as follows:
(b) * * *
(3) SAE J1711 FEB2023, Recommended Practice for Measuring the Exhaust Emissions and Fuel Economy of Hybrid-Electric Vehicles, Including Plug-In Hybrid Vehicles; Revised February 2023, (“SAE J1711”); IBR approved for §§ 1066.501(a); 1066.1001.
(c)
(1) California 2026 and Subsequent Model Year Criteria Pollutant Exhaust Emission Standards and Test Procedures for Passenger Cars, Light-Duty Trucks, And Medium-Duty Vehicles (“California ARB's LMDV Test Procedures”); Adopted August 25, 2022; IBR approved for § 1066.801(c).
(2) California Test Procedures for 2026 and Subsequent Model Year Zero-Emission Vehicles and Plug-In Hybrid Electric Vehicles, in the Passenger Car, Light-Duty Truck and Medium-Duty Vehicle Classes (“California ARB's PHEV Test Procedures”); Adopted August 25, 2022; IBR approved for § 1066.801(c).
42 U.S.C. 7401-7671q.
Mine Safety and Health Administration (MSHA), Department of Labor.
Final rule.
The Mine Safety and Health Administration (MSHA) is amending its existing standards to better protect miners against occupational exposure to respirable crystalline silica, a significant health hazard, and to improve respiratory protection for miners from exposure to airborne contaminants. MSHA's final rule also includes other requirements to protect miner health, such as exposure sampling, corrective actions to be taken when a miner's exposure exceeds the permissible exposure limit, and medical surveillance for metal and nonmetal mines.
S. Aromie Noe, Director, Office of Standards, Regulations, and Variances, MSHA, at:
The preamble to the final standard follows this outline:
The purpose of this final rule is to reduce occupational disease in miners and to improve respiratory protection against airborne contaminants. The rule sets the permissible exposure limit (PEL) of respirable crystalline silica at 50 micrograms per cubic meter of air (µg/m
The statutory authority for this rule is provided by the Mine Act under sections 101(a), 103(h), and 508. 30 U.S.C. 811(a), 813(h), and 957. A full discussion of Mine Act legal requirements can be found in
Respirable crystalline silica is classified by the International Agency for Research on Cancer (IARC) as a human carcinogen. Occupational exposure to respirable crystalline silica results in adverse health effects and increases risk of death. The adverse health effects include silicosis (
Existing standards pertaining to respirable crystalline silica for both MNM and coal mines have been in place since the early 1970s. For MNM mines, the existing standards, established by the Department of Interior, Bureau of Mines, in 1974, helped protect miners from the most dangerous levels of exposure to respirable crystalline silica. The existing MNM PELs for the three polymorphs of respirable crystalline silica are: 0.1 mg/m
However, since the promulgation of these existing standards, the National Institute for Occupational Safety and Health (NIOSH) has recommended a
To better protect miners' health, therefore, with this final rule MSHA is lowering its existing exposure limits for quartz or respirable crystalline silica to 50 µg/m
MSHA amends its existing standards on respirable crystalline silica or quartz, after considering all the testimonies and written comments the Agency received from a variety of stakeholders, including miners, mine operators, labor unions, industry trade associations, government officials, and public health professionals, in response to its notice of proposed rulemaking. Below is a summary of major provisions in the final rule.
This final rule:
1.
2.
3.
4.
5.
6.
7.
8.
The requirements in the new part 60 will take effect on June 17, 2024. For coal mine operators, compliance with part 60 is required by 12 months after the publication date; for MNM operators, compliance is required by 24 months after the publication date. The delayed compliance is to strike a balance between meeting the urgent need to protect miners from this health hazard and giving mining operators adequate preparation time to allow them to comply effectively with the new requirements.
In addition, conforming amendments to parts 56, 57, 70, 71, 72, 75, and 90 will take effect on June 17, 2024. Compliance with conforming amendments to parts 56 and 57 is required by 24 months after the publication date; and compliance with conforming amendments to parts 70, 71, 72, 75, and 90 is required by 12 months after the publication date.
MSHA's economic analysis estimates that the final rule would cost approximately an average of $89 million per year in 2022 dollars at an undiscounted rate, $90 million at a 3 percent discount rate, and $92 million at a 7 percent discount rate. Based on the results of the Final Regulatory Impact Analysis (FRIA), MSHA estimates that this final rule's monetized benefits would exceed its costs, with or without discount rates. Monetized benefits are estimated from avoidance of 531 deaths related to NMRD, silicosis, ESRD, and lung cancer and 1,836 cases of silicosis associated with silica exposure over the first 60-year period after the promulgation of the final rule. The estimated annualized net benefit is approximately $294 million at an undiscounted rate, $157 million at a 3 percent discount rate, and $40 million at a 7 percent discount rate.
A rule is significant under Executive Order 12866 Section 3(f)(1), as amended by E.O. 14094, if it is likely to result in “an annual effect on the economy of $200 million or more.” The Office of Management and Budget has determined that the final rule is significant under E.O. 12866 Section 3(f)(1).
In summary, this final rule will strengthen MSHA's existing regulatory framework and improve health protections for the nation's miners. It establishes a uniform PEL that aligns respirable crystalline silica exposure limits for MNM and coal miners with workers in other industries. Moreover, the final rule updates the existing respiratory protection standard to require mine operators to provide miners with NIOSH-approved respiratory equipment that has been fitted, selected, maintained, and used in accordance with recent consensus standards. It also requires all MNM operators to provide medical surveillance in the form of a medical examination regime similar to the one that already covers coal miners. Cumulatively, the final rule will lower miners' risks of developing chronic, irreversible, disabling, and potentially fatal health conditions, consistent with MSHA's mission and statutory mandate to prevent occupational diseases and protect U.S. miners from suffering material health impairments.
The statutory authority for this final rule is provided by the Mine Act under sections 101(a), 103(h), and 508. 30 U.S.C. 811(a), 813(h), and 957. MSHA implements the provisions of the Mine Act to prevent death, illness, and injury from mining and promote safe and healthful workplaces for miners. The Mine Act requires the Secretary of Labor (Secretary) to develop and promulgate improved mandatory health or safety standards to prevent hazardous and unhealthy conditions and protect the health and safety of the nation's miners. 30 U.S.C. 811(a).
Congress passed the Mine Act to address these dangers, finding “an urgent need to provide more effective means and measures for improving the working conditions and practices in the Nation's coal or other mines in order to prevent death and serious physical harm, and in order to prevent occupational diseases originating in such mines.” 30 U.S.C. 801(c). Congress concluded that “the existence of unsafe and unhealthful conditions and practices in the Nation's coal or other mines is a serious impediment to the future growth of the coal or other mining industry and cannot be tolerated.” 30 U.S.C. 801(d). Accordingly, “the Mine Act evinces a clear bias in favor of miner health and safety.”
Section 101(a) of the Mine Act gives the Secretary the authority to develop, promulgate, and revise mandatory health standards to address toxic materials or harmful physical agents. Under Section 101(a), a standard must protect lives and prevent injuries in mines and be “improved” over any standard that it replaces or revises.
The Secretary must set standards to assure, based on the best available evidence, that no miner will suffer material impairment of health or functional capacity from exposure to toxic materials or harmful physical agents over their working lives. 30 U.S.C. 811(a)(6)(A). In developing standards that attain the “highest degree of health and safety protection for the miner,” the Mine Act requires that the Secretary consider the latest available scientific data in the field, the feasibility of the standards, and experience gained under the Mine Act and other health and safety laws.
Section 103(h) of the Mine Act gives the Secretary the authority to promulgate standards involving recordkeeping and reporting. 30 U.S.C. 813(h). Additionally, section 103(h) requires that every mine operator establish and maintain records, make reports, and provide this information as required by the Secretary.
MSHA's final rule to lower the exposure limits for respirable crystalline silica adopts an integrated monitoring approach across all mining sectors and updates the existing respiratory protection requirements. The final rule fulfills Congress' direction to protect miners from material impairments of health or functional capacity caused by exposure to respirable crystalline silica and other airborne contaminants.
On August 29, 2019, MSHA published a Request for Information (RFI) in the
Specifically, MSHA requested input from industry, labor, and other interested parties on the following four topics: (1) new or developing technologies and best practices that can be used to protect miners from exposure to quartz dust; (2) how engineering controls, administrative controls, and personal protective equipment can be used, either alone or concurrently, to protect miners from exposure to quartz dust; (3) additional feasible dust-control methods that could be used by mining operations to reduce miners' exposures to respirable quartz during high-silica cutting situations, such as on development sections, shaft and slope work, and cutting overcasts; and (4) any other experience, data, or information that may be useful to MSHA in evaluating miners' exposures to quartz (84 FR 45456).
The Agency received 57 comments from citizens, labor, industry, and public health stakeholders in response to the RFI. Stakeholders expressed various and differing opinions on how and to what extent MSHA should address the protection of miners' health from exposure to silica. Many of these stakeholders also commented on MSHA's proposed rulemaking, summarized below.
On June 30, 2023, MSHA made an informal copy of the proposed rule available on the Agency's website, prior to publication in the
On July 13, 2023, MSHA published the proposed rule,
On July 26, 2023, MSHA published a notice in the
On August 14, 2023, in response to requests from the public, MSHA published a notice in the
During the comment period, MSHA received 157 written comments on the proposed rule from miners, mine operators, individuals, government officials, labor organizations, advocacy groups, industry groups, trade associations, and health organizations. Some commenters supported various aspects of the proposal. Other commenters opposed aspects of the proposal and offered recommendations for suggested changes to the proposed rule. All public comments and supporting documentation are available at
Silica is a common component of rock composed of silicon and oxygen (chemical formula SiO
Cristobalite and tridymite are formed at very high temperatures and are associated with volcanic activity. Naturally occurring cristobalite and tridymite are rare, but they can be found in volcanic ash and in a relatively small number of rock types limited to specific geographic regions. Although rare, exposure to cristobalite can occur when volcanic deposits are mined. In addition, when other materials are mined, miners can potentially be exposed to cristobalite during certain processing steps (
Most mining activities generate silica dust because silica is often contained in the ore being mined or in the overburden (
Inhaled small particles of silica dust can be deposited throughout the lungs. Because of their small size, many of these particles can reach and remain in the deep lung (
In the U.S. in 2021, a total of 12,162 mines produced a variety of commodities. As shown in Table IV-1, of those 12,162 total mines, 11,231 mines were MNM mines and 931 mines were coal mines. MNM mines can be broadly divided into five commodity groups: metal, nonmetal, stone, crushed limestone, and sand and gravel. These broad categories encompass approximately 98 different commodities.
The 931 coal mines—underground and surface—produce bituminous, subbituminous, anthracite, and lignite coal. Coal mining activities generate mixed coal mine dust that contains respirable silicates such as kaolinite, oxides such as quartz, and other components (IARC, 1997). These activities include the general mining activities previously mentioned (
Since the early 1970s, MSHA has maintained health standards to protect MNM and coal miners from excessive exposure to airborne contaminants, including respirable crystalline silica. These standards require mine operators to use engineering controls as the primary means of suppressing, diluting, or diverting dust generated by mining activities. They also require mine operators to provide miners with respiratory protection in limited situations for a short period. The existing standards for MNM and coal mines differ in some respects, including exposure limits and monitoring requirements. This section describes MSHA's existing standards for respirable crystalline silica and presents respirable crystalline silica sampling data to show how MNM and coal mine operators have complied with the standards in recent years.
MSHA's existing standards for exposure to airborne contaminants in MNM mines, including respirable crystalline silica, are found in 30 CFR 56 subpart D (Air Quality and Physical Agents) and 30 CFR 57 subpart D (Air Quality, Radiation, Physical Agents, and Diesel Particulate Matter). These standards include PELs for airborne contaminants (§§ 56.5001 and 57.5001), exposure monitoring (§§ 56.5002 and 57.5002), and control of exposure to airborne contaminants (§§ 56.5005 and 57.5005).
MSHA encourages MNM mine operators to conduct sampling for airborne contaminants to ensure a healthy and safe work environment for miners, because sampling provides more accurate information about miners' exposures and the effectiveness of existing controls in reducing exposures. When a mine operator's respirable dust survey indicates that miners have been overexposed to any airborne contaminant, including respirable crystalline silica, the operator is expected to adjust its control measures (
The use of respiratory protective equipment is also allowed under specified circumstances, such as where engineering controls are not yet developed or when it is necessary due to the nature of the work—for example, while establishing controls or during occasional entry into hazardous atmospheres to perform maintenance or investigation. Respirators approved by NIOSH and suitable for their intended purpose must be provided by mine operators at no cost to the miner and must be used by miners to protect themselves against the health and safety hazards of respirable crystalline silica and other airborne contaminants. When respiratory protective equipment is used, MNM mine operators must implement a respiratory protection program consistent with the requirements of
Under the existing coal mine standards, there is no separate standard for respirable crystalline silica. MSHA's existing standards for exposure to respirable quartz in coal mines, found in 30 CFR 70.101 and 71.101, establish a respirable dust standard when quartz is present for underground and surface coal mines, respectively. Under 30 CFR part 90 (Mandatory Health Standards—Coal Miners Who Have Evidence of the Development of Pneumoconiosis), § 90.101 also sets the respirable dust standard when quartz is present for Part 90 miners.
Under its existing respirable coal mine dust standards, MSHA defines quartz as crystalline silicon dioxide (SiO
When a respirable dust sample exceeds the exposure limit of 100 µg/m
When taking corrective actions to reduce the exposure to respirable dust, coal mine operators must make approved respiratory equipment available to miners under §§ 70.208, 70.209, and 71.206. Whenever respiratory protection is used, § 72.700 requires coal mine operators to comply with requirements specified in ANSI Z88.2-1969.
Under the existing standards, MSHA collects respirable dust samples at mines and analyzes them for respirable crystalline silica to determine whether the respirable crystalline silica exposure limits are exceeded and whether exposure controls are adequate. MSHA's inspection and respirable dust sampling were discussed in detail in the proposal (88 FR 44862). This section, for ease of reference, briefly summarizes the process for MSHA's inspection and respirable dust sampling.
Under the existing standards, MSHA inspectors arrive at mines, determine which miners and which areas of the mine to select for respirable dust sampling, and place gravimetric samplers on the selected miners and at the selected locations. The gravimetric samplers capture air from the breathing zone of each selected miner and from each selected work area for the entire duration of the work shift. Full-shift sampling is used to minimize errors associated with fluctuations in airborne contaminant concentrations during the miners' work shifts and to avoid any speculation about the miners' exposures during unsampled periods of the work shift. Once sampling is completed, MSHA inspectors send cassettes containing the full-shift respirable dust samples to the MSHA Laboratory for analysis.
The MSHA Laboratory analyzes respirable dust samples following the standard operating procedures summarized below.
• MNM mine respirable dust samples: greater than or equal to 0.100 mg;
• Underground coal mine respirable dust samples: greater than or equal to 0.100 mg; and
• Surface coal mine respirable dust samples: greater than or equal to 0.200 mg.
If cristobalite analysis is requested for MNM mine respirable dust samples, filters having a mass gain of 0.05 mg or more are analyzed. In the rare instance when tridymite analysis is requested, a qualitative analysis for the presence of the polymorph is conducted concurrently with the cristobalite analysis.
The MSHA Laboratory uses two analytical methods to determine the concentration of quartz (and cristobalite and tridymite, if requested) in respirable dust samples: X-ray diffraction (XRD) for samples from MNM mines and Fourier transform infrared spectroscopy (FTIR) for samples from coal mines.
Department of Labor, Mine Safety and Health Administration, Pittsburgh Safety and Health Technology Center, X-Ray Diffraction Determination of Quartz and Cristobalite in Respirable Metal/Nonmetal Mine Dust.
MSHA calculates full-shift exposures to respirable crystalline silica (and other airborne contaminants) in the same way for MNM and coal miners when the miner works an 8-hour shift, but the calculated exposures differ for longer shifts. For work shifts that last longer than 8 hours, a coal miner's full-shift exposure is calculated using the entire duration of the coal miner's shift. For the MNM miner, by contrast, MSHA calculates extended full-shift exposure for respirable dust samples using 480 minutes (8 hours) as the sampling time, meaning that contaminants collected over extended shifts (
MSHA's respirable crystalline silica sampling results for MNM mines were discussed in detail in the proposal (88 FR 44863). This section, for ease of reference, summarizes the results of respirable dust samples that were collected by MSHA inspectors at MNM mines from 2005 to 2019. From January 1, 2005, to December 31, 2019, a total of 104,354 valid samples were collected. Of this total, 57,769 samples met the minimum mass gain criteria and were analyzed for respirable crystalline silica. The vast majority of the 46,585 valid samples that were excluded from the analysis did not meet the mass gain criteria. Further information on the valid respirable dust samples that were excluded from the analysis can be found in Appendix A of the preamble.
Table IV-2 below shows the variation between 2005 and 2019 in: (1) the number of MNM respirable dust samples analyzed for respirable crystalline silica; and (2) the number and percentage of samples that had concentrations of respirable crystalline silica greater than 100 µg/m
Because the MNM mining industry produces commodities that contain varying degrees of respirable crystalline silica, it is important to examine each commodity separately. MNM mines can be grouped by five commodities: metal, sand and gravel, stone, crushed limestone, and nonmetal (where nonmetal includes all other materials that are not metals, besides sand, gravel, stone, and limestone). This grouping is based on the mine operator-reported mining products and the North American Industry Classification System (NAICS) codes. (Appendix B of the preamble provides a list of the NAICS codes relevant for MNM mining and how each code is assigned to one of the five commodities.)
Table IV-3 shows the distribution of the respirable dust samples analyzed for respirable crystalline silica by mine commodity. The percentage of samples with respirable crystalline silica concentrations greater than the existing exposure limit of 100 µg/m
To examine how miners who perform different tasks differ in occupational exposure to respirable crystalline silica, MSHA grouped MNM mining jobs into 11 occupational categories. These categories include jobs that are similar in terms of tasks performed, equipment used, and engineering or administrative controls used to control miners' exposure. For example, backhoe operators, bulldozer operators, and tractor operators were grouped into “operators of large powered haulage equipment,” whereas belt crew, belt cleaners, and belt vulcanizers were grouped into “conveyer operators.” The 121 MNM job codes used by MSHA inspectors were grouped into the following occupational categories:
(1) Drillers (
(2) Stone Cutting Operators (
(3) Kiln, Mill, and Concentrator Workers (
(4) Crushing Equipment and Plant Operators (
(5) Packaging Equipment Operators (
(6) Conveyor Operators (
(7) Truck Loading Station Tenders (
(8) Operators of Large Powered Haulage Equipment (
(9) Operators of Small Powered Haulage Equipment (
(10) Mobile Workers (
(11) Miners in Other Occupations (
Table IV-4 shows sample numbers and overexposure rates by MNM occupation. Operators of large powered haulage equipment accounted for the largest number of samples analyzed for silica (17,016 samples), whereas conveyor operators accounted for the fewest (215 samples). Table IV-4 also shows the number and percentage of the samples exceeding the existing respirable crystalline silica PEL of 100 µg/m
This analysis of MSHA inspector sampling data shows that MNM operators have generally met the existing standard. Of the 57,769 respirable dust samples from MNM mines, approximately 6 percent exceeded the existing respirable crystalline silica PEL of 100 µg/m
In summary, the analysis of MSHA inspector sampling data indicates that the controls that MNM mine operators are using, together with MSHA's enforcement, have generally been effective in keeping miners' exposures at or below the existing limit of 100 µg/m
MSHA's respirable crystalline silica sampling results for coal mines were discussed in detail in the proposal (88 FR 44866). This section, for ease of reference, summarizes the results of RCMD samples collected by MSHA inspectors from 2016 to 2021. (The data analyses for this rulemaking do not include any respirable dust samples collected by coal mine operators.) The analysis below is based on the samples collected by MSHA inspectors starting on August 1, 2016, when Phase III of MSHA's 2014
Of the 63,127 valid samples analyzed for respirable crystalline silica and used for this analysis, about 1 percent (777 samples) were over the existing quartz exposure limit of 100 µg/m
In examining trends from one year to the next, the discussion below focuses on the samples collected in the 6 calendar years from 2016 to 2021. The number of samples per year was stable from 2017 to 2019 before decreasing in 2020.
Coal mining activities differ depending on the characteristics and locations of coal seams. When coal seams are several hundred feet below the surface, miners tunnel into the earth and use underground mining equipment to extract coal, whereas miners at surface coal mines remove topsoil and layers of rock to expose coal seams. Due to these differences, it is important to examine the respirable crystalline silica data by location to determine how underground and surface coal miners differ in occupational exposure to respirable crystalline silica.
Table IV-6, which presents the overexposure rate by type of mine where respirable coal mine dust samples were collected, shows that samples from surface coal mines reflected higher rates of overexposure than samples from underground mines. Out of the 53,095 respirable coal mine dust samples from underground mines, 1 percent (537 samples) were over the existing exposure limit. By contrast, there were 10,032 samples from surface coal mines, and approximately 2.4 percent (240 samples) of those samples were over the existing exposure limit.
To assess the exposure to respirable crystalline silica of miners in different occupations, MSHA has consolidated the 220 job codes for coal mines into 9 occupational categories (using a similar process to the one it used for the MNM mines, but with different job codes and categories). For the coal mine occupational categories,
Of the nine occupational categories used for coal miners, the five underground categories are:
(1) Continuous Mining Machine Operators (
(2) Longwall Workers (
(3) Roof Bolters (
(4) Operators of Large Powered Haulage Equipment (
(5) All Other Underground Miners (
The four surface occupational categories are:
(1) Drillers (
(2) Crusher Operators (
(3) Operators of Large Powered Haulage Equipment (
(4) Mobile Workers (
The most sampled occupational category was operators of large powered haulage equipment (underground), representing approximately 34 percent of the samples taken. The least sampled occupational category was crusher operators (surface), consisting of 1 percent of the samples taken. Table IV-7 displays the number and percent of respirable coal mine dust samples with quartz greater than the existing exposure limit for each occupational category.
Looking at trends, every occupational category shows a decrease in overexposure rates over time. See Figure IV-1. Most of the nine categories had lower rates of overexposure in the 2019-2021 period than in the 2016-2018 period.
* For Crusher Operators (Surface), only one sample with a quartz concentration greater than 100 µg/m
In all occupational categories, coal miners were sometimes exposed to respirable crystalline silica levels above the existing exposure limit. But the sampling data showed that coal mine operators can generally comply with the existing exposure limit. For example, although mining tasks performed by the occupational category of roof bolters (underground) historically resulted in high levels of overexposure to quartz, the low levels of overexposure for that occupation in 2016-2021 (
This analysis of MSHA inspector sampling data shows that coal mine operators generally comply with the existing standards related to quartz. Of the 63,127 valid respirable dust samples from coal mines over the most recent 5-year period, 1.2 percent had respirable quartz over the existing exposure limit of 100 µg/m
This section summarizes the health effects from occupational exposure to respirable crystalline silica. MSHA's full analysis of the health effects literature is contained in the standalone document, entitled “
1. Miners in MNM and coal mines exposed to respirable crystalline silica at MSHA's existing exposure limits are subject to material impairment of health or functional capacity. The illnesses associated with exposure to respirable crystalline silica develop independent of other exposures.
2. Occupational exposure to respirable crystalline silica (as quartz and/or cristobalite) causes silicosis,
3. Exposure to respirable crystalline silica contributes to the development of autoimmune disorders through inflammatory pathways.
4. The development of silicosis, NMRD, lung cancer, renal disease, and autoimmune disorders is largely dependent upon cumulative respirable crystalline silica exposure.
These conclusions are the basis of MSHA's Final Risk Analysis (FRA) on miners' exposure to respirable crystalline silica. In the FRA, MSHA quantifies risks associated with the five specific health outcomes mentioned above. The FRA summary is presented in
From its health effects literature review and FRA, MSHA determines that miners exposed to respirable crystalline silica continue to face a risk of material impairment of health or functional capacity under MSHA's existing exposure limits. Thus, MSHA also makes the following conclusions:
(1) The rate of silicosis and other diseases caused by respirable crystalline silica exposure would decrease with reduction in occupational exposures, which is the most effective way to prevent these types of diseases.
(2) Regulatory action is necessary to reduce these occupational exposures and protect miners' health. Section 101(a)(6)(A) of the Federal Mine Safety and Health Act of 1977, as amended (Mine Act), requires MSHA to “set standards which most adequately assure on the basis of the best available evidence that no miner will suffer material impairment of health or functional capacity even if such miner has regular exposure to the hazards dealt with by such standard for the period of his working life.” 30 U.S.C. 811(a)(6)(A).
Regulatory action to protect miners' health is required by section 101(a)(6)(A) of the Mine Act, and MSHA's statutory authority and mission has been recognized and upheld by reviewing courts. “[T]he Mine Act evinces a clear bias in favor of miner health and safety.”
On July 13, 2023, MSHA published a notice of proposed rulemaking, entitled “
This section will describe how MSHA conducted its review of the health effects literature on respirable crystalline silica and what the Agency has found about the toxicity of respirable crystalline silica. This section will also present the findings on the following health effects: (1) Silicosis; (2) Non-malignant respiratory disease (NMRD), excluding silicosis; (3) Lung cancer and cancer at other sites; (4) Renal disease; and (5) Autoimmune diseases. Public comments received are reflected throughout this section.
MSHA reviewed a wide range of health effects literature totaling over 600 studies that explore the relationship between respirable crystalline silica exposure and resultant adverse health effects in miners and other workers across various industries. The health effects literature reviewed by MSHA included both studies reviewed by OSHA for its 2016 respirable crystalline silica standard and many other newer studies and studies that focused specifically on the mining industry.
OSHA's “Health Effects Analysis and Preliminary Quantitative Risk Assessment” (2013b) included studies that were identified from previously published scientific reviews, such as the IARC (1997) and NIOSH (2002), and from newer evaluations of scientific literature, literature searches, and contact with experts and stakeholders. That document underwent extensive peer review by a panel of nationally recognized experts in occupational epidemiology, biostatistics and risk assessment, animal and cellular toxicology, and occupational medicine who had no conflict of interest (COI) or apparent bias in performing the review. These experts were asked to consider the strengths, weaknesses, interpretations, and inclusion of studies used to support the findings, and OSHA revised the document based on their feedback.
To ensure that its literature review was thorough and up to date, MSHA reviewed a large body of additional evidence beyond the studies considered by OSHA. It added many studies focused on miners' exposures to respirable crystalline silica, as well as newer studies published over the past decade. MSHA drew upon numerous studies conducted by NIOSH, the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), and other researchers. These studies provided epidemiological data, analyses of morbidity (having a disease or a symptom of disease) and mortality (disease resulting in death), progression and pathology evaluations, death certificate and autopsy reviews, medical surveillance data, health hazard assessments, in vivo (animal) and in vitro (cell-based) toxicity data, and other toxicological reviews. These studies are cited throughout this summary and are listed in the References section of MSHA's standalone Health Effects
MSHA received some comments from industry stakeholders who disagreed with MSHA's selection of studies for its literature review and therefore with its findings. The Nevada Mining Association (NVMA) and the Sorptive Minerals Institute (SMI) stated that not all relevant studies were discussed in the Health Effects literature review (Document ID 1441; 1446). NVMA also stated that the studies referenced are outdated. The National Stone, Sand, & Gravel Association (NSSGA) stated that MSHA's review is overly reliant on OSHA's review (2013b) (Document ID 1448, Attachment 3). The state mining association stated that the studies MSHA considered do not recognize that the likelihood of prolonged exposure to respirable crystalline silica has been dramatically reduced over the years, noting improvements to respirators, equipment, and engineering controls (Document ID 1441).
However, commenters from health and labor organizations stated that MSHA's review was thorough, was consistent with the scientific consensus, and addressed the primary health effects of concern. These commenters agreed with MSHA's findings and conclusions related to health risks from exposure to respirable crystalline silica (Document ID 1398; 1405; 1410; 1416). The American Public Health Association (APHA) also noted the inclusion of several recent peer-reviewed publications included in MSHA's review (Document ID 1416). The American College of Occupational and Environmental Medicine (ACOEM) commented that there has been an explosion of new information about the molecular basis for silica's adverse effects since OSHA's comprehensive summary of the medical literature in its preamble to the 2016 revisions to the silica standard (Document ID 1405). This commenter stressed that this new information only adds to the urgency of establishing and enforcing MSHA's proposed standard and applauded the Agency's review of the medical and epidemiologic literature on the health effects of silica exposure.
MSHA has taken several steps to ensure that its review of health effects literature represents the current understanding of health risks related to exposures to respirable crystalline silica. In its initial standalone Health Effects document, which was published alongside the proposed rule, MSHA included several recent publications (published as late as 2022), and since then, it has added more recent publications (through 2023) in its final standalone Health Effects document. Examples of recent literature included in the standalone Health Effects document are: Carrington and Hershberger (2022), Cohen
Two commenters (an industry trade association and a training consulting company) stated that MSHA presented a significant amount of data showing the consequences of the various chronic health effects that silica can and does have on the human body but no viable data on mortality and morbidity among MNM miners (Document ID 1442; 1392).
As discussed elsewhere, MSHA is not required to prove a risk of death due to silica exposure to justify regulating to reduce a silica health risk. But the evidence shows that respirable silica exposure causes death as well as chronic disease. MSHA reviewed and discussed multiple studies that reported an increase in mortality rates throughout the standalone Health Effects document (
Commenters from health and labor organizations suggested additional studies for MSHA to include in the final standalone Health Effects document (Document ID 1405; 1373; 1449). These studies included topics such as new information regarding the molecular basis for silica's adverse health effects or related to engineered stone workers. One commenter stated that MSHA should include studies from outside of the mining industry (Document ID 1448, Attachment 3).
MSHA thoroughly reviewed these studies and did not find sufficient evidence to alter MSHA's overall conclusions of health risk, as discussed in detail in the sections that follow. However, MSHA did add many of the recommended studies to its final standalone Health Effects document (
To analyze the extensive literature that it considered, MSHA used the widely accepted weight-of-evidence (WoE) approach. Under this approach, studies with varied methodologies and conclusions are evaluated for their overall quality. Causal inferences are drawn based on a determination of whether there is substantial evidence that exposure increases the risk of a particular adverse health effect. This approach is a well-accepted method of conducting health hazard assessments (NRC, 2009; NIOSH, 2019a). Additionally, it was used by OSHA in its review of health effects literature (2013b) for its 2016 respirable crystalline silica standard. Factors that MSHA considered in its WoE analysis include: (1) size of the cohort studied and power of the study to detect a
MSHA received one comment from the NSSGA challenging the validity of MSHA's literature review methodology (Document ID 1448, Attachment 3). This commenter submitted a report analyzing MSHA's health effects literature review, arguing that MSHA's review cannot be replicated or fully evaluated for its scientific validity and claiming that it is unclear whether MSHA's interpretations are sufficiently reliable as a basis for decision-making. The commenter asserted the need for literature reviews to be done pursuant to Lynch
On the other hand, the APHA provided a different perspective on the methodology (Document ID 1416). This commenter stated that MSHA thoroughly describes the health risks, which include developing chronic silicosis, accelerated silicosis, progressive massive fibrosis, chronic obstructive pulmonary disease, lung cancer and kidney disease. Further, the commenter noted that MSHA's review of the health effects literature included more than three dozen peer-reviewed papers published in just the last few years. This commenter concurred with MSHA's determination that miners' exposure to respirable crystalline silica presents a risk of material impairment of health or functional capacity.
MSHA disagrees with the comment challenging MSHA's methodology. Although the “systematic review” framework outlined in Lynch
The term, “weight-of-evidence” was coined as early as 40 years ago by the NRC (1983) in their seminal publication “
In summary, MSHA's weight-of-evidence analysis is based on OSHA's extensive literature review and peer review process; includes a substantial number of studies and data published after the OSHA rulemaking; and has received support from NIOSH experts.
As described in greater detail in MSHA's standalone Health Effects document, the scientific understanding of how respirable crystalline silica causes adverse health effects has evolved greatly in the more than 45 years since the Mine Act was passed in 1977. MSHA's review of the literature indicates that under the existing standards found in 30 CFR parts 56, 57, 70, 71, and 90, miners are still developing preventable diseases that are material impairments of health or functional capacity. Regulatory action to reduce occupational exposures that cause these diseases is necessary to ensure no miner suffers material impairment of health or functional capacity, as required by section 101(a)(6)(A) of the Mine Act.
Based on an extensive review of health effects literature, MSHA determines that occupational exposure to respirable crystalline silica causes silicosis (acute silicosis, accelerated silicosis, chronic silicosis, and progressive massive fibrosis (PMF)), NMRD (including COPD), lung cancer, and end-stage renal disease (ESRD). Each of these effects is exposure-dependent, potentially chronic, irreversible, potentially disabling, and can be fatal. In addition, MSHA's review of the health effects literature has shown that respirable crystalline silica exposure is causally related to the development of some autoimmune disorders through inflammatory pathways. Current health information cited in the final standalone Health Effects document indicates that miners are suffering material impairment of health or functional capacity due to their occupational exposures to respirable crystalline silica. MSHA's review of respirable crystalline silica health effects concludes that the final rule, which lowers the exposure limits in MNM and coal mining to 50 µg/m
Respirable crystalline silica is released into the environment during mining or milling processes, thus creating an airborne hazard. The particles may be freshly generated or re-suspended from surfaces on which they are deposited in mines or mills. Respirable crystalline silica particles may be irregularly shaped and variable in size. These particles may be inhaled by miners and can be deposited throughout the lungs. Some pulmonary clearance of particles deposited in the alveolar region (deep lung) may occur, but many particles can be retained and initiate or advance the disease process. The toxicity of these retained particles is amplified because the particles are not water-soluble and are not metabolized into less toxic compounds. This is important because insoluble dusts may remain in the lungs for prolonged periods, resulting in a variety of cellular responses that can lead to pulmonary disease (ATSDR, 2019). Respirable crystalline silica particles that are cleared from the lungs by the lymphatic system are distributed to the lymph nodes, blood, liver, spleen, and kidneys, potentially accumulating in these other organ systems and causing renal disease and other adverse health effects (ATSDR, 2019).
Physical characteristics relevant to the toxicity of respirable crystalline silica primarily relate to its size and surface characteristics, both of which play important roles in how respirable crystalline silica causes tissue damage. Any factor that influences or modifies these physical characteristics may alter the toxicity of respirable crystalline silica by affecting the mechanistic processes (ATSDR, 2019).
Inflammatory pathways affect disease development in various systems and tissues in the human body. For instance, it has been proposed that lung fibrosis caused by exposure to respirable crystalline silica results from a cycle of cell damage, oxidant generation, inflammation, scarring, and ultimately fibrosis. This has been reported by: Nolan
Respirable crystalline silica entering the lungs could cause damage by a variety of mechanisms, including direct damage to lung cells. In addition, activation or stimulation by respirable crystalline silica of alveolar macrophages (after phagocytosis) and/or alveolar epithelial cells may lead to: (1) release of cytotoxic enzymes, reactive oxygen species (ROS), reactive nitrogen species (RNS), inflammatory cytokines and chemokines; (2) eventual cell death with the release of respirable crystalline silica; and (3) recruitment and activation of polymorphonuclear leukocytes (PMNs) and additional alveolar macrophages (Castranova and Vallyathan, 2000; Castranova, 2004; Hamilton
The strong immune response in the lung following exposure to respirable crystalline silica may also be linked to a variety of extra-pulmonary adverse effects such as hypergammaglobulinemia (overproduction of more than one class of immunoglobulins by plasma cells), production of rheumatoid factor, anti-nuclear antibodies, and release of other immune complexes (Haustein and Anderegg, 1998; Green and Vallyathan, 1996; Parks
Proposed mechanisms involved in respirable crystalline silica-induced carcinogenesis have included: direct DNA damage, inhibition of the p53 tumor suppressor gene, loss of cell cycle regulation; stimulation of growth factors, and production on oncogenes (Nolan
Three commenters expressed concerns about the findings of the health effects literature review and their relevance to the sorptive minerals industry (Document ID 1446, Attachment 1; 1442; 1419). The SMI and Essential Minerals Association (EMA) stated that MSHA has an incomplete understanding of the latest available scientific research (Document ID 1446, Attachment 1; 1442). Asserting that occluded quartz in sorptive clays is not fractured (either in the clay formation in which it exists or during the mining and processing of the material to form sorptive mineral-based products), the SMI concluded that occluded quartz in sorptive clays does not pose the health risk posed by fractured quartz (Document ID 1446, Attachment 1). Discussing at length studies it recommended MSHA include in its health effects literature review, SMI and EMA said that much of this research was previously considered by OSHA (2013b) and that it had led to OSHA's decision to exempt sorptive clays from coverage under OSHA's silica standard. SMI also noted that additional research since OSHA's revised silica standard was promulgated has advanced the question of how quartz causes disease and the difference in risk potential between fractured and unfractured and occluded quartz. Asserting that, without consideration of the additional research provided, the proposed standard would not be based on the best available evidence and would not reflect the latest available scientific data in the field, this commenter discussed Mine Act statutory provisions and case law that it asserted demonstrate the high level of scientific evidence and scrutiny required of MSHA when setting health and safety standards.
A more detailed response to SMI's overall comment can be found in
Others appeared to be irrelevant to the scope of the rule, such as those focused on amorphous silica, microscopy techniques, or workshop discussions (
After reviewing the available literature, MSHA concludes that miners working in the sorptive minerals industry are exposed to respirable crystalline silica. OSHA (2013b) concluded that while there was considerable evidence that several environmental influences can modify surface activity to either enhance or diminish the toxicity of silica, the available information was insufficient to determine in any quantitative way how these influences may affect disease risk to workers in any particular workplace setting (81 FR at 16311). MSHA agrees with OSHA (2013b) that there is evidence to support that surface activity of respirable crystalline silica may play a role in producing disease. However, mining is significantly different from other industries regulated by OSHA, for instance, in that it involves milling, grinding and removal of overburden. While the available information is insufficient to determine how these influences may affect disease risk to miners in any quantitative way and in any mining sector. MSHA is permitted “ `to err on the side of overprotection by setting a fully adequate margin of safety.' ”
Silicosis is a material impairment of health or functional capacity, as defined by the Mine Act, and refers to a group of lung diseases caused by the inhalation of respirable crystalline silica. See 30 U.S.C. 811(a)(6)(A). Silicosis is a progressive, occupational disease, in which accumulation of respirable crystalline silica particles causes an inflammatory reaction in the lung. This reaction leads to lung damage and scarring and, in some cases, progresses to disability and death. Respirable crystalline silica has long been identified as a cause of lung diseases in miners, and adverse health effects were noted and described as early as 1550 by Georgius Agricola (Agricola, as translated by Banner in 1950). Based on the review of the literature, MSHA has determined that exposure to respirable crystalline silica causes silicosis in MNM and coal miners and that it is a significant cause of premature morbidity and mortality (Mazurek and Attfield, 2008; Mazurek and Wood, 2008a,b; Mazurek
When respirable crystalline silica accumulates in the lungs, it causes an inflammatory reaction, leading to lung damage and scarring. Silicosis can continue to develop even after silica exposure has ceased (Hughes
Acute silicosis is an aggressive inflammatory process following intense exposure to respirable crystalline silica for “periods measured in months rather than years” (Cowie and Becklake, 2016). It causes alveolar proteinosis, an accumulation of lipoproteins in the alveoli of the lungs. This restructuring of the lungs leads to symptoms such as coughing and difficult or labored breathing, and often progresses to profound disability and death due to respiratory failure or infectious complications. In addition, symptoms often advance even after exposure has stopped, primarily due to the massive amount of protein debris and fluid that collects in the alveoli, which leads to the impairment of gas exchange (oxygen) in the lungs and respiratory distress of the patient. The X-ray appearance and results of microscopic examination of acute silicosis are like those of idiopathic (having an unknown cause) pulmonary alveolar proteinosis.
Accelerated silicosis includes both inflammation and fibrosis and is associated with intense respirable crystalline silica exposure. Accelerated silicosis usually manifests over a period of three to ten years (Cowie and Becklake, 2016), but it can develop in as little as two to five years if exposure is sufficiently intense (Davis, 1996). Accelerated silicosis may have features of both chronic and acute silicosis, with alveolar proteinosis in addition to X-ray evidence of fibrosis, seen as small opacities or the large opacities of PMF. Although the symptoms are like those of chronic silicosis, the clinical and radiographic progression of accelerated silicosis evolves more rapidly, and often leads to PMF, severe respiratory impairment, and respiratory failure. Accelerated silicosis can progress with associated morbidity and mortality, even if exposure ceases. Accelerated silicosis is frequently fatal.
Chronic silicosis is the most frequently observed form of silicosis in the United States today (Banks, 2005; OSHA, 2013b; Cowie and Becklake,
Among coal miners, silicosis is usually found in conjunction with simple coal workers' pneumoconiosis (CWP) because of the miners' exposures to RCMD that also contains respirable crystalline silica (Castranova and Vallyathan, 2000). Coal miners also face an added risk of developing mixed-dust pneumoconiosis (MDP) (includes the presence of coal dust macules), mixed-dust fibrosis (MDF), and/or silicotic nodules (Honma
PMF or “complicated silicosis” has been diagnosed in both coal and MNM miners exposed to dusts containing respirable crystalline silica. Recent literature on the pathophysiology of PMF supports the importance of crystalline silica as a cause of PMF in silica-exposed workers such as coal miners (Cohen
The studies reviewed by MSHA used one of two established methods for identifying findings of pneumoconiosis: the International Labour Office (ILO) Classification System or the Chinese categorization system, each of which is described below. In addition, the NIOSH case definition of silicosis used in surveillance systems relies on the ILO system.
The ILO developed a standardized system to classify the radiographic appearances of pneumoconiosis identified in chest X-rays films or digital chest radiographic images (ILO, 1980, 2002, 2011, 2022). One aspect of the ILO system involves grading the size, shape, and profusion (density) of opacities in the lungs. The density of opacities is classified on a four-point major category scale (category 0, 1, 2, or 3), with each major category divided into three subcategories, giving a 12-point scale between 0/− and 3/+. Differences between ILO categories are subtle. For each subcategory, the top number indicates the major category that the profusion most closely resembles, and the bottom number indicates the major category that was given secondary consideration. For example, film readers may assign classifications such as 1/0, which means the reader classified it as category 1, but category 0 (normal) was also considered (ILO, 2022). Major category 0 indicates the absence of visible opacities consistent with pneumoconiosis and categories 1 to 3 reflect increasing profusion of opacities and a concomitant increase in severity of disease.
However, some studies in MSHA's literature review used the Chinese system of X-ray classification based on the “Radiological Diagnostic Criteria of Pneumoconiosis and Principles for Management of Pneumoconiosis” (GB5906-86). This includes four categories of pneumoconiosis findings: a suspected case (0+), stage I, stage II, or stage III. Under this scheme, a panel of three radiologists determines the presence and severity of radiographic changes consistent with pneumoconiosis. The four categories correspond to ILO profusion category 0/1, category 1, category 2, and category 3, respectively. A suspected case of silicosis (0+) in a dust-exposed worker refers to a dust response in the lung and its corresponding lymph nodes, or a scale and severity of small opacities that fall short of the level observed in a stage I case of silicosis (Chen
MSHA's analysis of silicosis studies uses NIOSH's surveillance case definition to determine the presence of silicosis. As described further in the final standalone Health Effects document, NIOSH defines the presence of silicosis in terms of the ILO system and considers a small opacity profusion score of 1/0 or greater to indicate pneumoconiosis (NIOSH, 2014b). This definition originated from testimony before Congress regarding the 1969 Coal Act in which the Public Health Service recommended that miners be removed from dusty environments as soon as they showed “minimal effects” of dust exposure on a chest X-ray (
MSHA reviewed studies referenced by OSHA (2013b) that examined the relationship between exposure and progression, as well as between X-ray findings and pulmonary function. Additionally, MSHA considered literature not previously reviewed by OSHA (2013b) (Mohebbi and Zubeyri, 2007; Wade
Progression of silicosis is recognized when there are changes or worsening of the opacities in the lungs, and sequential chest radiographs are
Overall, the studies indicate that progression is more likely with continued exposure, especially high average levels of exposure. Progression is also more likely for miners with higher ILO profusion classifications. As discussed previously, progression of disease may continue after miners are no longer exposed to respirable crystalline silica (Cochrane
Of the studies in which silicosis progression was documented in populations of workers, four included quantitative exposure data that were based on either existing exposure levels or historical measurements of respirable crystalline silica (Ng
Miller
Buchanan
The risks of increased rate of progression predicted by Buchanan
The results of many surveillance studies conducted by NIOSH as part of the Coal Workers' Health Surveillance Program indicate that the pathology of pneumoconiosis in coal miners has changed over time, in part due to increased exposure to respirable crystalline silica. The studies of Cohen
Many studies found an association between pulmonary function decrements and ILO profusion category 2 or 3. Additionally, the review of the literature indicated a decreased lung function among workers who were exposed to respirable crystalline silica. MSHA therefore concludes that respirable crystalline silica exposure may impair lung function in some instances before silicosis can be detected by chest X-rays.
MSHA reviewed the occupation-based epidemiological literature, which examines health outcomes among workers and their potential association with conditions in the workplace. In addition, MSHA reviewed additional occupation-based literature specific to respirable crystalline silica exposure in MNM and coal miners and concludes that respirable crystalline silica exposure increases the risk of silicosis morbidity and early mortality.
One study examined the acute and accelerated silicosis outbreak that occurred during and after construction of Hawk's Nest Tunnel in West Virginia from 1930 to 1931. There, an estimated 2,500 men worked in a tunnel drilling rock consisting of 90 percent silica or more. The study later estimated that at least 764 of the 2,500 workers (30.6 percent) died from acute or accelerated silicosis (Cherniack, 1986). There was also high turnover among the tunnel workers, with an average length of employment underground of only about two months.
MSHA's review included the occupation-based literature cited by OSHA (2013b) in developing its respirable crystalline silica standard (OSHA, 2016a). Overall, MSHA found substantial evidence suggesting that occupational exposure to respirable crystalline silica increases the risk of silicosis. This conclusion is consistent with OSHA's conclusion.
In a population of granite quarry workers (mean length of employment:
The risk of silicosis, and particularly its progression, carries with it an increased risk of reduced lung function. Strong evidence has shown that lung function deteriorates more rapidly in miners exposed to respirable crystalline silica, especially in those with silicosis (Hughes
Blackley
Accordingly, MSHA concludes that respirable crystalline silica exposure increases the risk of silicosis morbidity and mortality among miners. This conclusion is consistent with OSHA's conclusion that there is substantial evidence that occupational exposure to respirable crystalline silica increases the risk of silicosis.
In addition to occupation-based epidemiological studies, MSHA reviewed surveillance studies, including those submitted by commenters, which provide and interpret data to facilitate the prevention and control of disease, and ultimately MSHA finds that the prevalence of silicosis generally increases with duration of exposure (work tenure). This is evident from the statistically significant proportional mortality ratios (PMRs) reported in the National Occupational Mortality System (NORMS) data previously reviewed by OSHA and reported by MSHA in its standalone Health Effects document. Several small and
However, the available statistics may underestimate silicosis-related morbidity and mortality in miners. It has been widely reported that statistics underestimate silicosis cases due to: (1) misclassification of causes of death (as TB, chronic bronchitis, emphysema, or
In addition to the relationship between silica exposure and silicosis, studies indicate a relationship between silica exposure, silicosis, and pulmonary TB. MSHA reviewed these studies and concluded that silica exposure and silicosis increase the risk of pulmonary TB (Cowie, 1994; Hnizdo and Murray, 1998; teWaterNaude
Although early descriptions of dust diseases of the lung did not distinguish between TB and silicosis and most fatal cases described in the first half of the 20th century were likely a combination of silicosis and TB (Castranova
Ng and Chan (1991) hypothesized that silicosis and TB “act synergistically” (are more than additive) to increase fibrotic scar tissue (leading to massive fibrosis) or to enhance susceptibility to active mycobacterial infection. The authors found that lung fibrosis is common to both diseases, and that both diseases decrease the ability of alveolar macrophages to aid in the clearance of dust or infectious particles.
These findings are also supported by studies published since OSHA's (2013b) review (Oni and Ehrlich, 2015; Ndlovu
Overall, MSHA finds, consistent with OSHA's conclusion, that silica exposure increases the risk of pulmonary TB, and that pulmonary TB can be a complication of chronic silicosis.
In addition to causing silicosis, exposure to respirable crystalline silica causes other NMRD. NMRD is an umbrella term that includes chronic obstructive pulmonary disease (COPD). Emphysema and chronic bronchitis are two lung diseases included within COPD. In patients with COPD, either chronic bronchitis or emphysema may be present or both conditions may be present together (ATS, 2010a).
Based on its review of the literature, MSHA concludes that exposure to respirable crystalline silica increases the risk for mortality from NMRD. The following summarizes MSHA's review of the literature.
Emphysema results in the destruction of lung architecture in the alveolar region, causing airway obstruction and impaired gas exchange. Based on its health effects literature review, MSHA concludes that exposure to respirable crystalline silica can increase the risk of emphysema, regardless of whether silicosis is present. In addition, MSHA concludes that this is the case for
Becklake
The findings of several cross-sectional and case-control studies were more mixed. For example, de Beer
Several of the studies found that emphysema might occur in respirable crystalline silica-exposed workers who did not have silicosis and suggested a causal relationship between respirable crystalline silica exposure and emphysema (Becklake
OSHA (2013b) and others have concluded that there is a relationship between respirable crystalline silica exposure and emphysema. Green and Vallyathan (1996) reviewed several studies of emphysema in workers exposed to silica and found an association between cumulative dust exposure and death from emphysema. The IARC (1997) also reviewed several studies and concluded that exposure to respirable crystalline silica increases the risk of emphysema. Additionally, NIOSH (2002b) concluded in its Hazard Review that occupational exposure to respirable crystalline silica is associated with emphysema; however, it noted some epidemiological studies that suggested that this effect might be less frequent or absent in non-smokers.
Overall, MSHA concludes that exposure to respirable crystalline silica causes emphysema even in the absence of silicosis. Thus, MSHA concurs with the conclusions previously reached by OSHA (2013b).
MSHA considered many studies that examined the association between respirable crystalline silica exposure and chronic bronchitis and concluded the following: (1) exposure to respirable crystalline silica causes chronic bronchitis regardless of whether silicosis is present; (2) an exposure-response relationship may exist; and (3) smokers may be at an increased risk of chronic bronchitis compared to non-smokers. Chronic bronchitis is long-term inflammation of the bronchi, increasing the risk of lung infections. This condition develops slowly by small increments and “exists” when it reaches a certain stage, specifically the presence of a productive cough with sputum production for at least three months of the year for at least two consecutive years (ATS, 2010b). MSHA's conclusions are supported by OSHA's review of the literature.
Miller
Cowie and Mabena (1991) found that chronic bronchitis was present in 742 of 1,197 (62 percent) South African gold miners, and Ng
Sluis-Cremer
Studies examining the effect of years of mining on chronic bronchitis risk were mixed. Samet
Some reviews concluded that respirable crystalline silica exposure causes the development of bronchitis. The American Thoracic Society (ATS) (1997) published a review that found chronic bronchitis to be common among worker groups exposed to dusty environments contaminated with respirable crystalline silica. NIOSH (2002b) also published a review demonstrating that occupational exposure to respirable crystalline silica has been associated with bronchitis; however, some epidemiological studies suggested this effect might be less frequent or absent in non-smokers.
Additionally, Hnizdo
Overall, MSHA concludes that exposure to respirable crystalline silica causes chronic bronchitis, regardless of whether silicosis is present, and that an exposure-response relationship may exist. This conclusion is consistent with the findings of OSHA's Health Effects document (2013b).
Pulmonary function impairment is a common feature of NMRD and may be assessed via spirometry (lung volumes, flows) and gas diffusion tests. MSHA has reviewed the studies cited by OSHA and agrees with their conclusions. Based on its review of the evidence in numerous longitudinal and cross-sectional studies and reviews, OSHA concluded that there is an exposure-response relationship between respirable crystalline silica and the development of impaired lung function. OSHA also concluded that the effect of tobacco smoking on this relationship may be additive or synergistic, and workers who were exposed to respirable crystalline silica, but did not show signs of silicosis, may also have pulmonary function impairment.
OSHA reviewed several longitudinal studies regarding the relationship between respirable crystalline silica exposure and pulmonary function impairment. To evaluate whether exposure to silica affects pulmonary function in the absence of silicosis, the studies focused on workers who did not exhibit progressive silicosis.
Among both active and retired Vermont granite workers exposed to an average quartz dust exposure level of 60 µg/m
Each of these studies reported its findings in terms of rates of decline in any of several pulmonary function measures (
OSHA reviewed cross-sectional studies that described relationships between lung function loss and respirable crystalline silica exposure (or exposure measurement surrogates such as tenure). The results of these studies were like those of the longitudinal studies previously discussed. In several studies, respirable crystalline silica exposure was found to reduce lung function of:
(1) White South African gold miners (Hnizdo
(2) Black South African gold miners (Irwig and Rocks, 1978; Cowie and Mabena, 1991),
(3) Respirable crystalline silica-exposed workers in Quebec (Bégin
(4) Rock drilling and crushing workers in Singapore (Ng
(5) Granite shed workers in Vermont (Theriault
(6) Aggregate quarry workers and coal miners in Spain (Montes
(7) Concrete workers in the Netherlands (Meijers
(8) Chinese refractory brick manufacturing workers in an iron-steel plant (Wang
(9) Chinese gemstone workers (Ng
(10) Hard-rock miners in Manitoba, Canada (Manfreda
(11) Pottery workers in France (Neukirch
(12) Potato sorters in the Netherlands (Jorna
(13) Slate workers in Norway (Suhr
(14) Men in a Norwegian community with years of occupational exposure to respirable crystalline silica (quartz) (Humerfelt
OSHA (2013b) recognized that many of these studies found that pulmonary function impairment: (1) can occur in respirable crystalline silica-exposed workers without silicosis, (2) was still observable when controlling for silicosis in the analysis, and (3) was related to the magnitude and duration of respirable crystalline silica exposure, rather than to the presence or severity of silicosis. Many other studies described by OSHA (2013b) have also
MSHA reviewed the studies and concludes that there is an exposure-response relationship between respirable crystalline silica and the impairment of lung function. MSHA also concludes that that the effect of tobacco smoking on this relationship may be additive or synergistic, and that workers who were exposed to respirable crystalline silica, but did not show signs of silicosis, may also have pulmonary function impairment. MSHA's conclusions are consistent with OSHA's findings from its literature review.
Commenters from United Steelworkers (USW), American Industrial Hygiene Association (AIHA), and Vanderbilt Minerals, agreed with MSHA's conclusion that miners exposed to respirable crystalline silica have an increased risk of lung cancer (Document ID 1447; 1351; 1419). The AIHA also cited research by the International Agency for Research on Cancer (IARC) as documenting the health risks from inhalation of respirable crystalline silica, specifically cancers of the lung, stomach, and esophagus (Document ID 1351). MSHA agrees with this comment for the reasons discussed below.
Lung cancer, an irreversible and usually fatal disease, is a type of cancer that forms in lung tissue. MSHA has found that the scientific literature supports that respirable crystalline silica exposure significantly increases the risk of lung cancer mortality among miners. This determination is consistent with the conclusions of other government and public health organizations, including the ATS (1997), the IARC (1997, 2012), the NTP (2000, 2016), NIOSH (2002b), and the ACGIH (2010), which have classified respirable crystalline silica as a “known human carcinogen.” The Agency's determination also is supported by epidemiological literature, encompassing more than 85 studies of occupational cohorts from more than a dozen industrial sectors including: granite/stone quarrying and processing (Guénel
One commenter stated that the work of Steenland and Sanderson should not be “discounted” and that Miller and MacCalman “did not report on occupational exposure monitoring concentrations” reported by Steenland and Sanderson (Document ID 1351).
MSHA chose Miller and MacCalman (2010) rather than the Steenland
The strongest evidence comes from the worldwide cohort and case-control studies reporting excess lung cancer mortality among workers exposed to respirable crystalline silica in various industrial sectors. This evidence is confirmed by the ten-cohort pooled case-control analysis by Steenland
Recent studies examined lung cancer mortality among coal and non-coal miners (Meijers
In addition, based on its review of the health effects literature, MSHA has determined that radiographic silicosis is a marker for lung cancer risk. Reducing exposure to levels that lower the silicosis risk would reduce the lung cancer risk to exposed miners (Finkelstein, 1995, 2000; Brown, 2009). MSHA has also found that, based on the available epidemiological and animal data, respirable crystalline silica causes lung cancer (IARC, 2012; RTECS, 2016; ATSDR, 2019). Miners who inhale respirable crystalline silica over time are at increased risk of developing silicosis and lung cancer (Greaves, 2000; Erren
Other toxicity studies (non-animal) provide additional evidence of the carcinogenic potential of respirable crystalline silica. Studies using DNA exposed directly to freshly fractured respirable crystalline silica demonstrate that respirable crystalline silica directly increases DNA breakage. Cell culture research has investigated the processes by which respirable crystalline silica disrupts normal gene expression and replication. Studies have demonstrated that chronic inflammatory and fibrotic processes resulting in oxidative and cellular damage may lead to neoplastic changes in the lung (Goldsmith, 1997). In addition, the biologically damaging physical characteristics of respirable crystalline silica and its direct and indirect genotoxicity support MSHA's determination that respirable crystalline silica is an occupational carcinogen (Borm and Driscoll, 1996; Schins
In addition to examining studies on lung cancer, MSHA has reviewed studies examining the relationship between respirable crystalline silica exposure and cancers at other sites. MSHA has reviewed the studies
MSHA reviewed three lung cancer studies also discussed by OSHA (2013b) which suggested an association between respirable crystalline silica exposure and increased mortality from laryngeal cancer (Davis
MSHA reviewed the literature discussed by OSHA (2013b) to assess a potential relationship between respirable crystalline silica exposures and stomach cancers. OSHA concurred with observations made previously by Cocco
MSHA has reviewed studies that focused on miners and concludes that the literature does not support attributing increased esophageal cancer mortality with exposure to respirable crystalline silica. The studies by Meijers
MSHA reviewed the studies presented by OSHA (2013b) and agrees with OSHA's conclusion that the literature does not support attributing increased esophageal cancer mortality to exposure to respirable crystalline silica. OSHA considered several studies that examined the relationship between respirable crystalline silica exposures and esophageal cancer and found that the studies were limited in terms of size, study design, or potential for confounding variables. Three nested case-control studies of Chinese workers demonstrated a dose-response association between increased risk of esophageal cancer mortality and respirable crystalline silica exposure (Pan
MSHA's review of additional studies specific to miners further establishes that respirable crystalline silica exposure increases the risk of lung cancer, although there is insufficient evidence to demonstrate a causal relationship between respirable crystalline silica exposure and other (non-lung) cancer mortalities. Specifically, MSHA concludes that the epidemiological literature is not sufficient to conclude that there is an association between respirable crystalline silica exposures and increased cancer of the larynx, gastric cancer mortality, or esophageal cancer mortality.
MSHA's conclusion is consistent with OSHA's conclusion. Overall, OSHA concluded that there was insufficient evidence of an association between silica exposure and cancer at sites other than the lungs. OSHA included a health literature review by NIOSH (2002b) that examined effects potentially associated with respirable crystalline silica exposure; that review identified only infrequent reports of statistically significant excesses of deaths for other cancers. Cancer studies have been reported on the following organs/systems: salivary gland, liver, bone, pancreas, skin, lymphopoietic or hematopoietic, brain, and bladder (see NIOSH, 2002b for full bibliographic references). However, the findings were not observed consistently among epidemiological studies, and NIOSH (2002b) concluded that no association has been established between these cancers and respirable crystalline silica exposure. OSHA concurred with NIOSH that these isolated reports of excess cancer mortality were insufficient to determine the role of respirable crystalline silica exposure.
MSHA has reviewed the studies cited by OSHA and agrees with OSHA's conclusion. MSHA's review of additional studies specific to miners further establishes that respirable crystalline silica exposure increases the risk of lung cancer, though there is insufficient evidence to demonstrate a causal relationship between respirable crystalline silica exposure and other (non-lung) cancer mortalities.
MSHA received two comments related to MSHA's conclusions related to renal disease. The AIHA agreed that silica probably causes renal disease, quoting a paper by Steenland (2005b) (Document ID 1351). In contrast, the NSSGA stated that it was unclear whether renal disease is causally related to occupational crystalline silica exposure, citing a 2017 German Federal Institute for Occupational Safety and Health systematic review that conducted a meta-analysis on respirable crystalline silica and non-malignant renal disease (Möhner
MSHA acknowledges that some studies have not found associations between respirable crystalline silica exposures and renal disease; however, those studies are generally statistically underpowered, meaning that their sample sizes are too small to detect even some substantial health effects. In contrast, as discussed below, studies with large cohort sizes and well-documented, validated job-exposure matrices found statistically significant effects on renal disease. MSHA reviewed the study by Möhner
Renal disease is characterized by the loss of kidney function and, in the case of ESRD, a permanent loss of kidney function leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life. MSHA reviewed a wide variety of longitudinal and mortality epidemiological studies, including case series, case-control, and cohort studies, as well as case reports, and concludes that there is substantial evidence in the literature suggesting that occupational exposures to respirable crystalline silica exposure increases the risk of morbidity and mortality related to ESRD. However, MSHA notes that the available literature on respirable crystalline silica exposures and renal disease in coal miners is less conclusive than the literature related to MNM miners.
Epidemiological studies have found statistically significant associations between occupational exposure to respirable crystalline silica and chronic renal disease (
Possible mechanisms suggested for respirable crystalline silica-induced renal disease include: (1) a direct toxic effect on the kidney, (2) a deposition in the kidney of immune complexes (
Overall, MSHA determines that respirable crystalline silica exposure in mining increases the risk of renal disease.
Two commenters—AIHA and National Coalition of Black Lung and Respiratory Disease Clinics (hereafter referred to as “Black Lung Clinics”)—agreed with MSHA's finding that there is evidence of a relationship between respirable crystalline silica exposure and autoimmune diseases (Document ID 1351; 1410). The Black Lung Clinics also qualified that there is insufficient data to model the risk of disease (Document ID 1410). This is consistent with MSHA's conclusion that there is a casual association between occupational exposure to respirable crystalline silica and the development of systematic autoimmune diseases in miners; however, there are no studies available to date that can be used to model respirable crystalline silica-exposure risk of autoimmune diseases in the Agency's risk analysis.
Autoimmune diseases occur when the immune system mistakenly attacks healthy tissues within the body, causing inflammation, swelling, pain, and tissue damage. Examples of autoimmune diseases include autoimmune rheumatic diseases, sarcoidosis and seropositive rheumatoid arthritis (RA), Crohn's disease (CD), ulcerative colitis (UC), systemic lupus erythematosus (SLE), scleroderma, and systemic sclerosis (SSc). Some studies reviewed by MSHA suggest a casual association between occupational exposure to respirable crystalline silica and the development of systematic autoimmune diseases, particularly RA.
Wallden
Based on its literature review, MSHA concludes that there is a causal association between occupational exposure to respirable crystalline silica and the development of systemic autoimmune diseases in miners, but that no studies are available to date that can be used to model respirable crystalline silica-exposure risk in a risk analysis.
MSHA concludes that exposure to respirable crystalline silica causes silicosis (acute, accelerated, chronic, and PMF), NMRD (including COPD), lung cancer, and renal disease. Each of these effects is exposure-dependent, potentially chronic, irreversible, potentially disabling, and can be fatal.
The health effects literature, including peer-reviewed medical, toxicological, public health, and other related disciplinary publications, is robust and compelling. It shows that miners exposed to the existing respirable crystalline silica exposure limits of 100 µg/m
MSHA is entrusted with ensuring that “no miner will suffer material impairment of health or functional capacity even if such miner has regular exposure to the hazards dealt with by such standard for the period of his working life” (30 U.S.C. 811(a)(6)(A)). The Agency believes that when the final rule is implemented and enforced effectively, it will reduce the rate of silicosis and other diseases caused by respirable crystalline silica exposure and will substantially improve miners' lives.
MSHA's FRA quantifies risks associated with five specific health outcomes identified in the standalone Health Effects document: silicosis morbidity and mortality, and mortality from NMRD, lung cancer, and ESRD. This section serves as a summary of the standalone FRA document, which is placed into the rulemaking docket for the MSHA respirable crystalline silica rulemaking (RIN 1219-AB36, Docket No. MSHA-2023-0001) and is available at
MSHA developed an FRA to support its risk determinations and to quantify the health risk to miners exposed to respirable crystalline silica under the existing exposure limits for MNM and coal miners, at the new PEL of 50 µg/m
This analysis addresses three questions related to the final rule:
(1) whether potential health effects associated with existing exposure conditions constitute material impairment to any miner's health or functional capacity;
(2) whether existing exposure conditions place miners at risk of incurring any material impairment if regularly exposed for the period of their working life; and
(3) whether the final rule will reduce those risks.
To answer these questions, MSHA relied on the large body of research on the health effects of respirable crystalline silica and published, peer-reviewed, quantitative risk assessments that describe the risk of exposed workers to silicosis mortality and morbidity, NMRD mortality, lung cancer mortality, and ESRD mortality. These quantitative risk assessments are based on several studies of occupational cohorts in a variety of industrial sectors. The underlying studies are described in the standalone Health Effects document and are summarized in
Based on its analysis, MSHA found that, once the current mining workforce is replaced with new entrants to the mining industry so that all working miners and retired miners have been exposed only under the new PEL, the final rule will decrease lifetime excess deaths by at least 1,067 and will decrease lifetime excess cases of non-fatal silicosis by at least 3,746 among the working and future retired miner population. In the FRA, MSHA also increases its estimate of the number of miners who will benefit from this rule to include future retired miners. While the Preliminary Risk Analysis (PRA) did consider reductions in excess risk during years of retirement, the PRA did not account for the fact that future retired miners are among the population that will benefit from the rule. Once the entire mining workforce, including future retired miners, has worked only under the new PEL (
This summary highlights the main findings from the FRA, briefly describes how they were derived, and directs readers interested in more detailed information to corresponding sections of the standalone FRA document.
MSHA evaluated the literature and selected an exposure-response model for each of the five health endpoints—silicosis morbidity, silicosis mortality, NMRD mortality, lung cancer mortality, and ESRD mortality. The selected exposure-response models were used to estimate lifetime excess risks and lifetime excess cases among the current population of working and the future population of retired MNM and coal miners based on real exposure conditions, as indicated by the samples in the compliance sampling datasets.
MSHA's FRA is largely based on the methodology and findings from OSHA's 2013 preliminary quantitative risk assessment (PQRA), OSHA's 2016 final quantitative risk assessment (QRA), and the associated analysis of health effects in connection with OSHA's promulgation of a rule setting PELs for workplace exposure to respirable crystalline silica. OSHA's PQRA presented quantitative relationships between respirable crystalline silica exposure and multiple health endpoints. Following multiple legal challenges, the U.S. Court of Appeals for the D.C. Circuit rejected challenges to OSHA's risk assessment methodology and its findings on different health risks.
MSHA's FRA presents detailed quantitative analyses of health risks over a range of exposure concentrations that have been observed in MNM and coal mines. MSHA applied exposure-response models to estimate the respirable crystalline silica-related risk of material impairment of health or functional capacity of miners exposed to respirable crystalline silica at three levels—(1) the existing standards, (2) the new PEL, and (3) the action level. As in past MSHA rulemakings, MSHA estimated and compared lifetime excess risks associated with exposures at the existing and new PEL (and at the action level) over a miner's full working life of 45 years and 15 years of retirement.
MSHA's FRA is also based on a compilation of miner exposure data to respirable crystalline silica. For the MNM sector, MSHA evaluated 57,769 valid respirable dust samples collected between January 2005 and December 2019; and for the coal sector, MSHA evaluated 63,127 valid respirable dust samples collected between August 2016 and July 2021. The compiled data set characterizes miners' exposures to respirable crystalline silica in various locations (
Exposures at TWA 100 µg/m
When quartz is the only respirable crystalline silica polymorph in the sample, the existing MNM standard limits respirable crystalline silica exposures to 100 µg/m
One commenter (a safety compliance consultant) stated that the
In addition, commenters from the United Mine Workers of America (UMWA), the Black Lung Clinics, and the Appalachian Citizens' Law Center (ACLC) expressed concern that MSHA used coal mine dust data from 2016-2021, a historically low period for quartz levels in coal mining, according to the commenters (Document ID 1398; 1410; 1445). The ACLC asserted that, as a result, the estimate of avoided illnesses and deaths in MSHA's PRA is low and urged the Agency to include a longer history of coal dust sampling data when estimating miners' future exposures (Document ID 1445). As discussed below, MSHA chose this time period to account for the 2014 RCMD Standard, which came into full effect in 2016. The ACLC also stated that, because the 2014 RCMD Standard does not directly regulate respirable crystalline silica, there is no justification for excluding prior sampling data (Document ID 1445).
MSHA believes the 2014 RCMD Standard impacted respirable crystalline silica exposures, in part because (a) the coal dust exposure limit is based on a formula that reduces the limit when the respirable crystalline silica content exceeds 100 µg/m
The primary results of the FRA are the calculated number of deaths and illnesses avoided assuming full compliance after implementation of MSHA's final rule. These calculations were performed for non-fatal silicosis illnesses (morbidity) and for deaths (mortality) due to silicosis, lung cancer, NMRD, and ESRD. For each health outcome, the reduced number of illnesses or deaths is calculated as the difference between (a) the number of excess illnesses and deaths currently occurring in the industry, assuming mines fully comply with the previous standards (100 µg/m
Excess risks and cases were estimated under two scenarios: (a) a Baseline scenario where all exposures were capped at 100 μg/m
To calculate excess risks, MSHA grouped MNM miners into the following exposure intervals: ≤25, >25 to ≤50, >50 to ≤100, >100 to ≤250, >250 to ≤500, and >500 μg/m
MSHA uses weighted average FTE ratios to account for the fact that contract miners may experience lower exposures per year from mining. However, this underestimates the cumulative exposures that miners (excluding contract miners) experience. The average coal miner (excluding contract miners), for example, works approximately 2,280 hours per year, which equates to an average shift of over 9.1 hours when assuming 250 working days per year.
MSHA calculated
For a given scenario (either Baseline or New PEL 50 μg/m
In the PRA, MSHA underestimated the number of miners who will benefit from the proposed rule. Based on the 2019 Quarterly Employment Production Industry Profile (MSHA, 2019a) and the 2019 Quarterly Contractor Employment Production Report (MSHA, 2019b), the current number of working miner FTEs is estimated to be 184,615 for MNM and 72,768 for coal. In the PRA, MSHA assumed excess cases of disease would be reduced only among these working miners. However, once the current mining workforce is replaced with new entrants to the mining industry so that the entire workforce has worked only under the new PEL for their 45 years of working life, the future mining workforce will experience fewer excess deaths and illnesses from exposure to respirable crystalline silica. The PRA's methodology did not include the number of future retired miners who will experience lower exposure for their working lives under the final rule and will continue to benefit during retirement, and therefore, the PRA underestimated the number of avoided lifetime excess cases attributable to the rule. In the FRA, the estimates are updated to account for all excess cases that will be avoided among not only working miners but also future retired miners. As discussed in greater detail in the FRA, the number of future retired miners who are expected to benefit from the rule can be calculated from the survival rates (which are computed in the life tables) and from the assumption that the mining workforces in MNM and coal will remain the same size as they are today.
On the related question raised by the ACLC about whether new clinical data suggests that the PRA underestimated benefits of the lower PEL, MSHA
MSHA reviewed extensive research on the health effects of respirable crystalline silica and quantitative risk assessments published in the peer-reviewed scientific literature regarding occupational exposure risks of illness and death from silicosis, NMRD, lung cancer, and ESRD. The standalone Health Effects document describes the specific studies reviewed by MSHA. Of the many studies evaluated, MSHA believes that the 13 studies used by OSHA (2013b) to estimate risks provide reliable estimates of the disease risk posed by miners' exposure to respirable crystalline silica. These studies are summarized in Table VI-1.
Of these 13 studies, OSHA selected one per health endpoint for final modeling and estimation of lifetime excess risk and cases. Combining the five selected studies with the observed exposure data yields estimates of actual lifetime excess risks and lifetime excess cases among working and future retired miner populations based on real exposure conditions. Table VI-2 summarizes key characteristics of the models presented in the 13 studies from OSHA's PQRA, including the cohort that was investigated, the specific health endpoint (
As explained in detail in the standalone FRA document, MSHA developed its risk estimates based on recent mortality data and certain assumptions that differed from those used by OSHA. Examples of these MSHA assumptions include a lifetime that ends at age 80, updated background mortality data and all-cause mortality, miner population sizes, and miner-specific full-time equivalents (FTEs).
MSHA's modeling has been done using life tables, in a manner consistent with OSHA's PQRA. In general, the life table is a technique that allows estimation of excess risk of disease-specific mortality while factoring in the probability of surviving to a particular age, assuming no exposure to respirable crystalline silica. This analysis accounts for competing causes of death, background mortality rates of disease, and the effect of the accumulation of risk due to elevated mortality rates in each year of a working life. For each cause of mortality, the selected study was used in the life table analysis to compute the increase in miners' disease-specific mortality rates attributable to respirable crystalline silica exposure.
MSHA uses cumulative exposure (
Two commenters (SMI and NVMA) expressed concern that not all relevant studies were considered in MSHA's analysis of the health effects literature on occupational exposure to respirable crystalline silica (Document ID 1446; 1441). For example, the NVMA commented that the studies referenced in the health effects literature review are
MSHA reviewed the relevant literature, including recent publications. Additionally, in response to comments on the PRA, MSHA read and reviewed studies suggested by commenters. MSHA selected the studies which provide the best available epidemiological models to develop the estimates of lifetime excess risks and lifetime excess cases. These models contain information regarding how the cumulative level of exposure relates to the risk of adverse health outcomes. The selected studies were based on analyses of miners with a range of exposure histories. Further, MSHA's modeling of the avoided cases in the FRA directly accounts for any relevant changes in exposure conditions because it includes exposure data from as recently as 2019 for MNM miners and 2021 for coal miners. The exposure data captures actual concentrations of respirable crystalline silica that miners were exposed to during their shifts. To the extent that changing conditions, technological advancements, or the 2014 RCMD Standard have impacted miners' exposures to respirable crystalline silica, these effects are accounted for in MSHA's models, which use recent exposure data. The final provisions of the 2014 RCMD Standard went into effect in 2016, which is the first year of coal exposure data MSHA used when modeling coal miners' exposures to respirable crystalline silica dust.
For each health endpoint, MSHA generated two sets of risk estimates—one representing a scenario of full compliance with the existing standards (herein referred to as the “Baseline” scenario) and another representing a scenario wherein no samples exceed the new PEL (herein referred to as the “New PEL 50 μg/m
For purposes of calculating risk in the FRA, both for MNM and coal miners, MSHA estimated excess risks by using the concentration of respirable crystalline silica collected over the full shift and calculating it as a full-shift, 8-hour TWA expressed in ISO standards. This metric of exposure intensity—the 8-hour TWA concentration of respirable crystalline silica in ISO standards—was used consistently across all sets of estimates (both MNM and coal sectors, and both the Baseline and New PEL 50 μg/m
Commenters, including MSHA Safety Services Inc.; Silica Safety Coalition (SSC); the NSSGA; Jervois Idaho Cobalt Operations; and the EMA, suggested that disease data show respirable crystalline silica exposure and associated adverse health effects are not a problem or crisis in MNM mining or that there is only negligible exposure to respirable crystalline silica for certain MNM miners (Document ID 1392; 1432; 1448; 1453; 1442). Similarly, the Portland Cement Association stated that silicosis is unknown in the cement industry (Document ID 1407). One miner-related business further stated that silicosis cases are on the rise in coal and are decreasing in MNM and, therefore, MSHA's standard should focus only on coal mining, specifically underground coal mining (Document ID 1392). In addition, MNM mine operators such as K & E Excavating Inc. and K & E Alaska, Inc., also commented that there is little to no evidence of silicosis or other similar symptoms in MNM mining, especially in comparison to coal mining (Document ID 1435; 1436). Finally, the president of N-Compliance Safety Services expressed concern regarding the origin of the mortality reduction data included in the FRA and stated that they could not find deaths reported by MSHA for MNM miners or the associated 7000-1 forms (Document ID 1383).
On the other hand, several commenters from labor unions and health organizations agreed with MSHA's finding that MNM miners are at risk of respirable crystalline silica-related disease from occupational exposures (Document ID 1447; 1449; 1418; 1373). USW asserted that rock crushing in iron and other surface mines can release silica-laden dust and that silica is also a hazard in cement plants (Document ID 1447). The same commenter stated that silica control in MNM mines is becoming increasingly important because of new technologies that are likely to lead to higher dust exposures (Document ID 1447). Further, Miners Clinic of Colorado commented that its data support the need for better control of exposure to respirable crystalline silica in MNM mines, and said that, of the 400 MNM miners the clinic provided medical surveillance for in the past 20 years, 62 percent reported having spent over half of their mining tenure in MNM or at least 10 years as a MNM miner and, of those 62 percent, 26 percent had pneumoconiosis (based on a positive chest radiograph B reading) (Document ID 1418). This commenter concluded that MNM miners are at risk for progressive and potentially disabling work-related lung disease, although information on silicosis disease rates among MNM miners are less readily available than those for coal miners (Document ID 1418). Finally, citing several studies (Kramer
MSHA disagree with the assertion that silicosis or other diseases linked to respirable crystalline silica are not risks for MNM miners. MSHA reviewed a wide range of studies that demonstrated disease risks amongst miners occupationally exposed to respirable crystalline silica. These studies were not limited to underground coal miners and show that respirable crystalline exposure produces excess risk for coal and MNM miners as well as underground and surface miners. The studies MSHA evaluated covered occupations relevant to MNM mining such as sandblasters (Abraham and Wiesenfeld, 1997; Hughes
Further, the ACOEM commented that new information about the molecular basis for silica's adverse health effects since OSHA's 2016 summary of the medical literature highlights the need for establishing and enforcing the 50 μg/m
Regarding the comment about reported deaths, selected surveillance data for both silicosis cases and silicosis deaths are reported in the standalone Health Effects document. Nonetheless, MSHA's estimated risk and case reductions are based on samples MSHA collected from MNM mines and peer-reviewed models of the relationship between exposure to respirable crystalline silica and related diseases. The FRA does not rely on reported mortality data. MSHA previously has not required operators to conduct medical surveillance for MNM miners and becomes aware of cases only when miners inform their employer of their illness. Thus, these case data are not complete enough to serve as a basis for estimating applicable exposure-response models needed for a comprehensive risk analysis. However, MSHA believes that the final rule's MNM medical surveillance provisions, which are discussed in further detail in the FRIA and in the final rule text, will likely help to improve this gap in the data.
Commenters from the SMI, EMA, and Vanderbilt Minerals, argued that the aged and occluded crystalline silica (quartz) encountered in sorptive minerals, does not pose the same health risk of other forms of crystalline silica (Document ID 1446; 1442; 1419). The SMI commented that their mining and processing operations do not pose a risk to miners' health (Document ID 1446). A more comprehensive discussion of these commenters' concerns is addressed in the preamble under
The Agency notes that, unlike OSHA, MSHA has no requirement to identify a “significant risk” before regulating to protect miners' health and safety.
MSHA examined evidence and references from the commenters and conducted its own review of the scientific literature. MSHA agrees that there is some evidence to suggest that occluded silica is less toxic than unoccluded silica (Wallace
There have been few epidemiological studies focused on workers exposed to dust generated from sorptive minerals. Examples include Phibbs
MSHA finds that the limited epidemiological data involving sorptive minerals do not refute the conclusions drawn from other epidemiological and toxicological studies included in MSHA's standalone Health Effects document. MSHA concludes, from the best available evidence, that exposure to the crystalline silica present in sorptive minerals poses a risk of material impairment of health or functional capacity to miners. In the Posthearing Brief to OSHA, NIOSH (2014) concluded that “currently available information is not adequate to inform differential quantitative risk management approaches for crystalline silica that are based on surface property measurements.” MSHA concurs with NIOSH's recommendation for a single PEL for respirable crystalline silica without consideration of surface properties.
After reviewing the available studies that support quantitative modeling, MSHA selected one exposure-response model from literature for each of the five health outcomes that are modeled in the FRA. These selections and the exposure-response models are discussed below.
Due to the long latency periods associated with chronic silicosis, OSHA's respirable crystalline silica standard relied on the subset of studies that were able to contact and evaluate many workers through retirement. Studies that included retired workers provides the best available evidence of lifetime risk of silicosis morbidity.
The health endpoint of interest in these studies was the appearance of opacities on chest radiographs indicative of pulmonary pneumoconiosis (a group of lung diseases caused by the lung's reaction to inhaled dusts). The most reliable estimates of silicosis morbidity, as detected by chest X-rays, come from the studies that evaluated those X-rays over time, included radiographic evaluation of workers after they left employment, and derived cumulative or lifetime estimates of silicosis disease risk.
To describe the presence and severity of pneumoconiosis, including silicosis, the International Labour Organization (ILO) developed a standardized system to classify lung opacities identified on chest radiographs (X-rays) (ILO, 1980, 2002, 2011, 2022). The ILO system grades the size, shape, and profusion of opacities. Although silicosis is defined and categorized based on chest X-ray, the X-ray is an imprecise tool for detecting pulmonary pneumoconiosis (Craighead and Vallyathan, 1980; Hnizdo
OSHA summarized the Miller
The 1,416 men had previous chest X-rays dating from before, during, or just after this high respirable crystalline silica exposure period. Of these 1,416 men, 384 were identified as having died by 1990/1991. Of the 1,032 remaining men, 156 were untraced, and, of the 876 who were traced and replied, 711 agreed to participate in the study. Of these, the total number of miners who were surveyed was 551. Four of these were omitted, two because of a lack of an available chest X-ray. The 547 surviving miners (age range: 29-85 years, average=59 years) were interviewed and received their follow-up chest X-rays between November 1990 and April 1991. The interviews consisted of questions on current and past smoking habits and occupational history since leaving the coal mine, which closed in 1981. They were also asked about respiratory symptoms and were given a spirometry test (OSHA, 2013b, pages 333-334).
Exposure characterization was based on extensive respirable dust sampling; samples were analyzed for quartz content by IR spectroscopy. Between 1969 and 1977, two coal seams were mined. One had produced quarterly average concentrations of respirable crystalline silica much less than 1,000 μg/m
Three physicians read each chest film taken during the current survey as well as films from the surveys conducted in 1974 and 1978. Films from an earlier 1970 survey were read only if no films were available from the subsequent two surveys. Silicosis cases were identified if the median classification of the three readers indicated an ILO category of 1/1 or greater (Miller
MSHA modeled the exposure-response relationship by using cumulative exposure expressed as gram/m
Both Miller
OSHA had a high degree of confidence in the estimates of silicosis morbidity risk from this Scotland coal mine study. This was mainly because of highly detailed and extensive exposure measurements, radiographic records, and detailed analyses of high exposure-rate effects. MSHA has reviewed and agrees with OSHA's conclusion.
Buchanan
MSHA estimated silicosis risk by using the Buchanan
OSHA concluded in their risk assessment, and MSHA agrees, that there is little evidence of a dose-rate effect at respirable crystalline silica concentrations in the exposure range of 25 μg/m
NIOSH stated in its post-hearing brief to OSHA that a “detailed examination of dose rate would require extensive and real time exposure history which does not exist for silica (or almost any other agent)” (81 FR 16285, 16375). Similarly, Dr. Kenneth Crump, a researcher from Louisiana Tech University Foundation who served on OSHA's peer review panel for the Review of Health Effects Literature and Preliminary Quantitative Risk Assessment, wrote to OSHA that, “[h]aving noted that there is evidence for a dose rate effect for silicosis, it may be difficult to account for it quantitatively. The data are likely to be limited by uncertainty in exposures at earlier times, which were likely to be higher” (OSHA 2016a, 81 FR 16286, 16375). OSHA agreed with the conclusions of NIOSH and Dr. Crump. OSHA believed that it used the best available evidence to estimate risks of silicosis morbidity and sufficiently accounted for any dose rate effect at high silica average concentrations by using the Buchanan
MSHA is using the Buchanan
Analysis provided by Buchanan
The Buchanan
In this model, both the cumulative exposure concentration variables were “highly statistically significant in the presence of the other” (Buchanan
Buchanan
Buchanan
The results indicated miners exposed to exceedances above MSHA's existing standard could develop progression of silicosis at an exaggerated rate. The results of Buchanan
MSHA used a life table approach to estimate the lifetime excess silicosis morbidity from age 21 to age 80, assuming exposure from the start of age 21 through the end of age 65 (45 years of working life) and an additional 15 years of potential illness progress thereafter. MSHA used the Buchanan
Silicosis mortality was ascertained in the studies included in the pooled analysis by Mannetje
OSHA found that the estimates from Mannetje
Mannetje
(1) U.S. diatomaceous earth workers (Checkoway
(2) Finnish granite workers (Koskela
(3) U.S. granite workers (Costello and Graham, 1988),
(4) U.S. industrial sand workers (Steenland and Sanderson, 2001),
(5) U.S. gold miners (Steenland and Brown, 1995b), and
(6) Australian gold miners (de Klerk and Musk, 1998).
These six cohorts contained 18,364 workers and 170 silicosis deaths, where silicosis mortality was defined as death from silicosis (ICD-9 502, n=150) or from unspecified pneumoconiosis (ICD-9 505, n=20). Table VI-3 provides information on each cohort, including size, time period studied, overall number of deaths, and number of deaths identified as silicosis for the pooled analysis conducted by Mannetje
Mannetje
To evaluate the reasonableness of the exposure assessment for the lung cancer pooled study, Mannetje
(1) 4,450 µg/m
(2) 9,080 µg/m
(3) 16,260 µg/m
(4) 42,330 µg/m
In addition, in seven of the cohorts, there was a statistically significant trend between silicosis mortality and cumulative exposure. For two of the cohorts (U.S. granite workers and U.S. gold miners), the trend test was not statistically significant (p=0.10). An analysis could not be performed on the South African gold miner cohort because silicosis was never coded as an underlying cause of death, apparently due to coding practices in that country.
Based on this analysis, Mannetje
Furthermore, in their pooled analysis of silicosis mortality for six of the cohorts, Mannetje
As part of an uncertainty analysis conducted for OSHA, Drs. Steenland and Bartell (ToxaChemica International, Inc., 2004) examined the quality of the original data set and analysis to identify and correct any data entry, programming, or reporting errors (ToxaChemica International, Inc., 2004). This quality assurance process revealed a small number of errors in exposure calculations for the originally reported results. Primarily, these errors resulted from rounding of job class exposures when converting the original data file for use with a different statistical program. Although the corrections affected some of the exposure-response models for individual cohorts, ToxaChemica International, Inc. (2004) reported that models based on the pooled dataset were not impacted by the correction of these errors (OSHA, 2013b, pages 271-272).
Silicosis mortality was evaluated using standard life table analysis in Mannetje
The categorical analysis found a nearly monotonic increase in silicosis rates with cumulative exposure, from 4.7 per 100,000 person-years in the lowest exposure category (0-990 µg/m
Mannetje
In summary, OSHA's estimates of silicosis morbidity risks were based on studies of active and retired workers for which exposure histories could be constructed and chest X-ray films could be evaluated for signs of silicosis. MSHA agrees with OSHA's estimate of silicosis morbidity risks.
There is evidence in the record that chest X-ray films are relatively insensitive to detecting lung fibrosis (OSHA 2016a, 81 FR 16286, 16397). Hnizdo
To estimate the risk of silicosis mortality at the then existing and then proposed exposure limits, OSHA used the categorical model described by Mannetje
In view of the aforementioned discussion, MSHA agrees with OSHA's analysis, and MSHA also selected the Mannetje
In response to MSHA's question about the PRA in the proposed rule, the NVMA cited a 2021 study examining silica exposure in artificial stone workers, which this commenter asserted found higher prevalence of silicosis amongst those who did not use personal protective equipment (PPE) and amongst tobacco users (Requena-Mullor
MSHA acknowledges that the relationship between exposure to respirable crystalline silica and silicosis may be confounded by several variables, including smoking. However, confounders are discussed in the FRA and were considered by the original authors of the studies MSHA selected for modeling. Park
In addition to causing silicosis, exposure to respirable crystalline silica causes increased risks of other NMRD. These include chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis, emphysema, and combinations of the two, and is a cause of chronic airways obstruction. COPD is characterized by airflow limitation that is usually progressive and not fully reversible. OSHA reviewed several studies of NMRD morbidity and used a study by Park
The California diatomaceous earth cohort consisted of 2,570 diatomaceous earth workers employed for 12 months or more from 1942 to 1994. As noted above, Park
Park
Using Poisson regression models and Cox proportional hazards models, the authors fit the same series of relative rate exposure-response models that were evaluated by Rice
Relative or excess rates were modeled using internal controls and adjusting for age, calendar time, ethnicity, and time since first entry into the cohort. In addition, relative rate models were evaluated using age- and calendar time-adjusted external standardization to U.S. population mortality rates for 1940 to 1994 (OSHA, 2013b, page 296).
There were no LDOC deaths recorded among workers having cumulative exposures above 32,000 µg/m
Therefore, Park
Model fit was assessed by evaluating the decrease in deviance resulting from addition of the exposure term, and cubic-spline models were used to test for smooth departures from each of the model forms described. Park
Among the models based on the restricted dataset [excluding observations with cumulative exposures greater than 10,000 µg/m
Based on its superior fit to the cohort data, Park
The estimates of Park
Less than 25 percent of the LDOC deaths in the Park
It is also possible that some of the difference between Mannetje
Based on the available risk assessments for silicosis mortality, OSHA believed that the estimates from the pooled study by Mannetje
Following its own independent review, MSHA agrees with and has followed the rationale presented by OSHA in its selection of the Park
MSHA used a life table analysis to estimate the lifetime excess NMRD mortality through age 80. MSHA used the Park
A state mining association cited CDC data to state that the largest decrease in pneumoconiosis deaths over the 1999-2018 time period was in the coal mining industry, with a decrease of 69.6 percent, and the largest increase was in the OSHA construction sector (Bell and Mazurek, 2020) (Document ID 1368). This commenter also stated that, beyond the CDC data, there is little understanding of pneumoconiosis case attribution, such as what percentage of cases were specifically due to mining-related employment compared to non-mining activities that might lead to harmful exposure. The commenter's point that it is difficult to correctly attribute pneumoconiosis is precisely why MSHA's FRA has relied on peer-reviewed epidemiological studies, which control for confounders where necessary and quantify the precise exposure-response relationship. Regarding pneumoconiosis, the cited article was about declining pneumoconiosis
Since the publication of OSHA's final rule in 2016, NIOSH has published two documents concerning occupational carcinogens,
MSHA used the Miller
Miller
This cohort mortality study used Cox proportional hazards regression methods which controlled for a variety of external and internal factors. The external controls included British administrative regional age-, time-, and cause-specific mortality rates from which to calculate SMRs. The internal controls included each miner's age, smoking status, and detailed dust and respirable crystalline silica (quartz) time-dependent exposure measurements. Cox regression analyses were done in stages, with the initial analyses used to establish what factors were required for baseline adjustment (OSHA, 2013b, page 287).
For the analysis using external mortality rates, the all-cause mortality SMR from 1959 through 2005 was 100.9 (95% CI: 99.0-102.8), based on all 10,698 deaths. However, these SMRs were not uniform over time. For the period from 1990-2005, the SMR was 109.6 (95% CI:106.5-112.8), while the ratios for previous periods were less than 100. This pattern of increasing SMRs in the recent past was also seen for cause-specific deaths from chronic bronchitis, SMR = 330.0 (95% CI:268.1-406.2); tuberculosis, SMR = 193.4 (95% CI: 86.9-430.5); cardiovascular disease, SMR = 106.6 (95% CI: 102.0-111.5); all cancers, SMR = 107.1 (95% CI:101.3-113.2); and lung cancer, SMR = 115.7 (95% CI: 104.8-127.7). The SMR for NMRD was 142.1 (95% CI: 132.9-152.0) in this recent period and remained highly statistically significant. In their previous analysis on mortality from lung cancer, reflecting follow-up through 1995, Miller
OSHA reported that Miller and MacCalman (2010) used these analyses to estimate relative risks for a lifetime exposure of 5 gram-hours/m
For the models using only quartz exposures with a 15-year lag, pneumoconiosis, RR = 1.21 (95% CI: 1.12-1.31); COPD, RR = 1.11 (95% CI: 1.05-1.16); and lung cancer, RR = 1.07 (95% CI: 1.01-1.13) showed statistically significant increased risks.
For lung cancer, analyses based on these Cox regression methods provided strong evidence that, for these coal miners, quartz exposures were associated with increased lung cancer risk, but simultaneous exposures to coal dust were not associated with increased lung cancer risk. The relative risk (RR) estimate for lung cancer deaths using coal dust with a 15-year lag in the single exposure model was 1.03 (95% CI: 0.96 to 1.10). In the model using both quartz and coal mine dust exposures, the RR based on coal dust decreased to 0.91, while that for quartz exposure remained statistically significant, increasing to a RR = 1.14 (95% CI: 1.04 to 1.25). According to Miller and MacCalman (2010), other analyses have shown that exposure to radon or diesel fumes was not associated with an increased cancer risk among British coal miners (OSHA, 2013b, page 288).
The RRs in the Miller and MacCalman (2010) report were used to estimate excess lung cancer risk for OSHA's purposes. Life table analyses were done as in the other studies above. Based on the RR of 1.14 (95% CI: 1.04-1.25) for a cumulative exposure of 5 ghm
However, three factors might explain these differences. First, these estimates were adjusted for individual smoking histories so any smoking-related lung cancer risk (or smoking-respirable crystalline silica interaction) that might possibly be attributed to respirable crystalline silica exposure in the other studies was not reflected in the risk estimates derived from the study of these coal miners. Second, these coal miners had significantly increased risks of death from other lung diseases, which may have decreased the lung cancer-susceptible population. Of note, for example, were the higher increased SMRs for NMRD during the years 1959-2005 for this cohort (Miller and MacCalman, 2010, Table 2, Page 7). Third, the difference in risk seen in these coal miners may have been the result of differences in the toxicity of quartz present in the coal mines as compared to the work environments of the other cohorts. One Scottish mine (Miller
All these factors in this mortality analysis for the British coal miner cohort could have combined to yield an underestimation of lung cancer risk estimates. However, OSHA believed that these coal miner-derived estimates were credible because of the quality of several study factors relating to both study design and conduct. In terms of design, the cohort was based on union rolls with very good participation rates and good reporting. The study group also included over 17,000 miners, with an average of nearly 30 years of follow-up, and about 60 percent of the cohort had died. Just as important was the high quality and detail of the exposure measurements, both of total dust and quartz. However, one exposure factor that may have biased the estimates upward was the lack of exposure information available for the cohort after the mines closed in the mid-1980s. Since the mortality ratio for lung cancer was higher during the last study period, 1990-2005, this period contributed to the increased lung cancer risk. It is possible that any quartz exposure experienced by the cohort after the mines had closed could have accelerated either death or malignant tumor (lung cancer) growth. By not accounting for this exposure, if there was any, the risk estimates would have been biased upwards. Although the 15-year lag period for quartz exposure used in the analyses provided slightly higher risk estimates than use of no lag period, the better fit seen with the lag may have been artificial. This may have occurred because there appeared to have been no exposures during the recent period when risks were seen to have increased (OSHA, 2013b, page 289).
MSHA believes, as OSHA did, that this study of a large British coal mining cohort provides convincing evidence of the carcinogenicity of respirable crystalline silica. This large cohort study, with almost 30 years of follow-up, demonstrated a positive exposure-response after adjusting for smoking histories. Additionally, the authors state that there was no evidence that exposure to potential confounders such as radon and diesel exhaust were associated with excess lung cancer risk (Miller and MacCalman (2010, page 270). MSHA is relying on the British studies conducted by Miller
MSHA found these two studies suitable for use in the quantitative characterization of health risks to exposed miners for several reasons. First, their study populations were of sufficient size to provide adequate statistical power to detect low levels of risk. Second, sufficient quantitative exposure data were available over a sufficient span of time to characterize cumulative respirable crystalline silica exposures of cohort members. Third, the studies either adjusted for or otherwise adequately addressed confounders such as smoking and exposure to other carcinogens. Finally, these researchers developed quantitative assessments of exposure-response relationships using appropriate statistical models or otherwise provided sufficient information that permits MSHA to do so.
MSHA implemented the risk model in its life table analysis so that the use of background rates of lung cancer and assumptions regarding length of exposure and lifetime were consistent across models. Thus, MSHA was able to estimate lung cancer risks associated with exposure to specific levels of respirable crystalline silica of interest to the Agency. MSHA used the Miller
MSHA's FRA uses risk estimates derived from 10 coal mines in the U.K. (Miller
MSHA's use of Miller and MacCalman (2010) to estimate lung-cancer mortality risk is in contrast to OSHA's use of Steenland
NVMA criticized MSHA's reliance on the Miller and MacCalman (2010) study because, according to the commenter, it primarily focused on coal miners, does not consider technological advancements in the mining sector, and is “insufficient for justifying the implementation of a rule of this magnitude on MNM mines” (Document ID1441). Commenters from the Black Lung Clinics and UMWA were in support of MSHA's use of Miller and MacCalman (2010) in assessing lung cancer mortality (Document ID 1410; 1398).
MSHA does not agree that reliance on Miller and MacCalman (2010) refutes the risk of material impairment of health to MNM miners. MSHA considered several other studies on lung cancer mortality, which covered a variety of populations aside from coal miners, including gold miners, diatomaceous earth workers, granite workers, industrial sand employees, pottery workers, tin miners, and tungsten miners. As OSHA showed in its QRA, the estimates from Miller and MacCalman (2010) were lower by roughly two- to four-fold than the estimates from other cohort studies. In selecting Miller and MacCalman (2010), MSHA chose a study that found smaller risks than the other studies. The Miller and MacCalman (2010) study has many strengths, including the fact that it had very high participation rates, with over 17,000 miners and nearly 30 years of follow up. In addition to detailed exposure information, the study also used individual smoking histories to adjust its estimates for the effect of smoking. Further, exposure changes owing to technological advancements are accounted for by MSHA's models which use recent exposure data.
Urging MSHA to lower the PEL to 25 µg/m
MSHA clarifies that, although it departed from OSHA's risk assessment by using the exposure-response model from Miller and MacCalman (2010) to assess lung cancer mortality, Steenland and Sanderson's work was not discounted. MSHA relied on Steenland and Sanderson in the standalone Health Effects document and the FRA. Further, MSHA acknowledges that there remains a risk of material impairment of health at the revised PEL; however, a further reduction in the PEL is not achievable at all mines (see MSHA's Technological Feasibility analysis). MSHA concludes that the final PEL will provide a substantial reduction in the risk of material impairment of health to miners.
Several epidemiological studies have found statistically significant associations between occupational exposure to respirable crystalline silica and renal disease, although others have failed to find a statistically significant association. These studies are discussed in the standalone Health Effects document (Section 14). Possible mechanisms suggested for respirable crystalline silica-induced renal disease included a direct toxic effect on the kidney, deposition of immune complexes (IgA) in the kidney following respirable crystalline silica-related pulmonary inflammation, and an autoimmune mechanism (Gregorini
MSHA, like OSHA, chose the Steenland
The average duration of exposure, cumulative exposure, and concentration of respirable crystalline silica for the pooled cohort were 13.6 years, 1,200 µg/m
A nested case-control analysis was also performed which allowed for more detailed examination of exposure-response. This analysis included 95 percent of the cohort for which there were adequate work history and quartz exposure data. This analysis included 50 cases for underlying cause mortality and 194 cases for multiple-cause mortality. Each case was matched by race, sex, and age within 5 years to 100 controls from the cohort. Exposure-response trends were examined in a categorical analysis where renal disease mortality of the cohort divided by exposure quartile was compared to U.S. rates (OSHA, 2013b, page 315).
In this analysis, statistically significant exposure-response trends for SMRs were observed for multiple-cause (p<0.000001) and underlying cause (p=0.0007) mortality (Steenland
With the lowest exposure quartile group serving as a referent, the case-control analysis showed monotonic trends in mortality with increasing cumulative exposure. Conditional regression models using log-cumulative exposure fit the data better than cumulative exposure (with or without a 15-year lag) or average exposure. Odds ratios by quartile of cumulative exposure were 1.00, 1.24, 1.77, and 2.86 (p=0.0002) for multiple cause analyses and 1.00, 1.99, 1.96, and 3.93 for underlying cause analyses (p=0.03) (Steenland
Based on the exposure-response coefficient for the model with the log of cumulative exposure, Steenland (2005b) estimated lifetime excess risks of death (age 75) over a working life (age 20 to 65). At 100 µg/m
MSHA notes that these studies added to the evidence that renal disease is associated with respirable crystalline silica exposure. Statistically significant increases in odds ratios and SMRs were seen primarily for cumulative exposures of >500 µg/m
OSHA had a large body of evidence, particularly from the three-cohort pooled analysis (Steenland
To estimate renal disease mortality risk from the pooled cohort analysis, OSHA implemented the same life table approach as was done for the assessments on lung cancer and NMRD. However, for this life table analysis, OSHA used 1998 all-cause and background renal mortality rates for U.S. males, rather than the 2006 rates used for lung cancer and NMRD. The 1998 rates were based on the ICD-9 classification of diseases, which was the same as used by Steenland
MSHA acknowledges the uncertainty associated with the divergent findings in the renal disease literature; however, MSHA concludes that the evidence supporting causality regarding renal risk outweighs the evidence casting doubt on that conclusion.
Upon reviewing the PRA, the NSSGA commented that it is unclear whether renal disease is causally related to occupational respirable crystalline silica exposure (Document ID 1448, Attachment 3). The commenter cited a 2017 German Federal Institute for Occupational Safety and Health systematic review and meta-analysis on respirable crystalline silica and non-malignant renal disease, which concluded that “while the studies of cohorts exposed to silica found elevated SMRs for renal disease, no clear evidence of a dose-response relationship emerged.” As detailed above in
To estimate renal disease mortality risk from the pooled cohort analysis, MSHA implemented the same life table approach as OSHA. However, MSHA's life table analysis used 2018 all-cause and 1998 background renal mortality rates for U.S. males. The 1998 renal death rates were based on the ICD-9 classification of diseases, 580-589. This is the same classification used by Steenland
Exposure to respirable coal mine dust causes lung diseases including CWP, emphysema, silicosis, and chronic bronchitis, known collectively as “black lung.” These diseases are debilitating, incurable, and can result in disability and premature death. There are no specific treatments to cure CWP or COPD. These chronic effects may progress even after miners are no longer exposed to coal dust.
MSHA's 2014 Coal Dust Rule quantified benefits among coal miners related to reduced cases of CWP due to lower exposure limits for respirable coal mine dust. In the FRA, MSHA has not quantified the reduction in morbidity risk associated with CWP among coal miners. Nonetheless, MSHA believes that the final rule would reduce the excess risk of morbidity from this disease. Many coal miners work extended shifts, increasing their potential exposure to respirable crystalline silica; therefore, calculating exposures based on a full-shift 8-hour TWA would be more protective. Thus, the final rule is expected to provide additional reductions in CWP risk beyond those ascribed in the 2014 Coal Dust Rule. However, exposure-response relationships based on respirable crystalline silica exposure are not available for CWP, so the reductions in this disease due to reductions in silica exposure cannot be quantified.
In the FRA, PMF deaths are captured in part by silicosis mortality as defined by Mannetje
Finally, the Appalachian Voices expressed concern that the modeling conducted for the rule does not incorporate data that medical clinics in Appalachia have reported since 2010 (Document ID 1425). This commenter stated that, while not all cases can be attributed directly to silica exposure, reporting over the last 15 years has led medical experts to believe that silica is a significant driver of the increased prevalence of severe black lung disease
MSHA notes that comprehensive longitudinal clinical outcome data, paired with exposure histories, are not available for U.S. miners. MSHA acknowledges that these data would be useful for the purpose of estimating risk reductions and acknowledges that the exposure-response models used in this FRA are not based on current disease incidence among U.S. miners. While clinic data help document pneumoconiosis as an important problem, these data alone are not sufficient to estimate the reduction in excess morbidity and mortality that are specifically attributable to the new PEL. Calculating future miners' reduction in excess cases from the current disease incidence reported by clinics would also require those clinic patients' exposure and work histories, which are not available. Moreover, the data from medical clinics in Appalachia represent only a portion of miners whose respirable crystalline silica exposures may have exceeded the existing standard and who may have worked during a time when the coal mining industry was larger. The methodology of the FRA is to use peer-reviewed exposure-response models to estimate avoided excess deaths and illnesses that are specifically attributable to reducing respirable crystalline silica exposure from, at most, the existing standard to the new PEL of 50 μg/m
Table VI-4 summarizes the FRA's main results: once all miners and retirees have only been exposed under the new PEL, the final rule is expected to result in at least 1,067 avoided deaths and 3,746 avoided cases of silicosis morbidity among the working and future retired miner population. This is a change from the PRA, which predicted at least 799 avoided deaths and 2,809 avoided cases of silicosis morbidity in the working miner population. The increased avoided deaths and cases in the FRA are the result of changes to MSHA's risk analysis methodology; specifically, the inclusion of future retired miners. This methodological change is discussed in detail in the standalone FRA. The expected reductions in death and illness in the FRA are based on actual exposure conditions, peer-reviewed exposure-response models, and the assumption that miners have 45 years of employment under the new PEL (from the beginning of age 21 through the end of age 65) and 15 years of retirement (up through the end of age 80). These estimates of the avoided lifetime excess mortality and morbidity represent the final calculations based on the five selected models and the observed exposure data. The first group of miners that will experience the avoided lifetime deaths and illnesses shown in Table VI-4 is the population living 60 years after the start of implementation of the final rule. In other words, this group will only contain miners exclusively exposed under the final rule for the duration of their working lives. To calculate benefits associated with the rulemaking, the economic analysis monetizes avoided deaths and illnesses while accounting for the fact that, during the first 60 years following the start of implementation of the final rule, miners will have fewer avoided lifetime deaths and illnesses because they will have been exposed under both the existing standards and the new PEL.
Table VI-5 summarizes miners' expected percentage reductions in lifetime excess risk of developing or dying from certain diseases due to their reduced respirable crystalline silica exposure expected to result from implementation of the final rule. The lifetime excess risk reflects the probability of developing or dying from diseases over a maximum lifetime of 45 years of exposure during employment and 15 years of retirement.
Table VI-6 presents MSHA's estimates of lifetime excess risk per 1,000 miners at exposure levels equal to the existing standards, the new PEL, and the action level. These estimates are adjusted for FTE ratios and thus utilize cumulative exposures that more closely reflect the average hours worked per year.
For a coal miner who is currently exposed at the existing standard of 85.7 μg/m
Supporting the need for the proposed rule overall, the National Black Lung Association (NBLA) cited a 2023 investigation (Berkes and Hicks, 2023), which the commenter said reported 21,000 excessive respirable crystalline silica dust exposures from 1986 to 2016 (Document ID 1402). In its above review of exposure data, MSHA also found exposures that exceeded the new PEL. On the other hand, questioning the necessity of the proposed rule for the coal industry, the Pennsylvania Coal Alliance asserted that only 1.2 percent of the samples MSHA relied on for its analysis showed an exceedance of 100 μg/m
While coal exposure data since 2016 may indicate a recent trend of less frequent noncompliance, 6.9 percent of samples for coal miners showed an exceedance of the new PEL. As Table VI-6 demonstrates, reducing a coal miner's exposure from 85.7 μg/m
MSHA accounted for “healthy worker survivor bias” in estimating the risks for coal and MNM miners. The healthy worker survivor bias causes epidemiological studies to underestimate excess risks associated with occupational exposures. As with most worker populations, miners are composed of heterogeneous groups that possess varying levels of background health. Over the course of miners' careers, illness tends to remove the most at-risk workers from the workforce prematurely, thus causing the highest cumulative exposures to be experienced by the healthiest workers who are most resistant to developing disease. Failing
Given that MSHA has calculated risks using the same underlying epidemiological studies OSHA used in 2016, the healthy worker survivor bias is likely impacting the estimates in Table V-6 of lifetime excess risk and lifetime excess cases avoided. Accordingly, as part of a sensitivity analysis, MSHA re-estimated risks for MNM and coal miners to account for the healthy worker survivor bias. MSHA adjusted for this effect by increasing the risk estimates of lung cancer risk by 28 percent and increasing the risk of each other disease by 50 percent. This produced larger estimates of lifetime excess risk reductions and lifetime excess cases avoided, which are presented in FRA Table 23 through FRA Table 26 of the FRA document. As these tables show, when adjusting for the healthy worker survivor bias, the new PEL will decrease lifetime silicosis morbidity risk by 23.9 cases per 1,000 MNM miners (compared to the unadjusted estimate of 15.9 cases per 1,000 MNM miners, see FRA Table 15 of the FRA document) and 5.8 cases per 1,000 coal miners (compared to 3.8 cases per 1,000 coal miners, see FRA Table 16 of the FRA document). Still accounting for the healthy worker survivor bias, the new PEL will decrease total morbidity by 5,131 lifetime cases among MNM miners (compared to 3,421 cases, see FRA Table 17 of the FRA document) and by 487 lifetime cases among coal miners (compared to 325 cases, see FRA Table 18 of the FRA document). Among the current MNM and coal mining populations, implementation of the new PEL during their full lives will have avoided 1,457 deaths and 126 deaths, respectively, over their lifetimes (compared to unadjusted estimates of 982 deaths and 85 deaths, respectively).
MSHA believes adjusted estimates for the healthy worker survivor bias are more reliable than unadjusted estimates. However, given that the literature does not support specific scaling factors for each of the health endpoints analyzed, these adjustments for the healthy worker survivor bias have not been incorporated into the final lifetime excess risk estimates that served as the basis for monetizing benefits. Because the monetized benefits do not account for the healthy worker bias, MSHA believes the reductions in lifetime excess risks and lifetime excess cases, as well as the monetized benefits, likely underestimate the true reductions and benefits attributable to the final rule.
The ACLC provided comments that the agency's proposed rule would do little to alter the status quo (Document ID 1445). Specifically, this commenter cited the findings of the PRA that thousands of miners would continue to get sick and die from overexposure to silica dust under the new proposed rule (Document ID 1445). Recommending that the Agency should focus on entirely preventing any disability or disease from inhaling silica dust, the commenter urged MSHA to strengthen the proposed rule such that the vast majority of miner lives will be saved over the coming decades (Document ID 1445). MSHA acknowledges that reducing respirable crystalline silica concentrations to 25 μg/m
Also, upon reviewing these results, many commenters, including the ACLC, the American Thoracic Society, the American Lung Association, and the American College of Chest Physicians (hereafter referred to as “The American Thoracic Society
There are a number of reasons why current incidence of disease would be higher than estimates in the FRA:
• For all diseases except silicosis, the FRA does not present the total number of cases that are expected in the future. The FRA only presents the number of
• There is a lag between the time when exposure occurred and new diagnoses. Many of the new cases of silicosis and PMF that are currently being diagnosed in coal miners are for individuals who likely worked during a time when the coal mining industry was substantially larger than (
• Additionally, as the FRA explains, the Baseline scenario involves reducing all noncompliant exposures to the existing standard (100 μg/m
• For PMF morbidity, not all cases of this disease are quantified in the FRA. The term “PMF” is used to refer to complicated CWP (caused by coal dust exposure) and to refer to complicated silicosis (caused by respirable crystalline silica exposure). The FRA only captures silicosis profusion 2/1+ morbidity (which may overlap partially with some definitions of PMF) but does not quantify benefits associated with reducing CWP morbidity.
MSHA conducted extensive uncertainty analyses to assess the impact on risk estimates of factors including treatment of data in excess of the new PEL, sampling error, and use of average rather than median point estimates for risk. The impact of excluding insufficient mass (weight) samples was also examined. As discussed below, some sources of uncertainty suggest that miners' risks may be lower than what MSHA modeled, and other sources suggest that risks may be higher. MSHA's estimates represent central values, which are based on the most reliable data and assumptions. Moreover, the overall weight-of-evidence indicates that increased exposures to respirable crystalline silica cause increased risk of mortality and morbidity, from which it follows that reduced exposures would lead to reduced risks.
To quantify the impact of sampling uncertainty on the risk estimates, 1,000 bootstrap resamples of the original exposure data were generated (sampling with replacement). The resamples were stratified by commodity to preserve the relative sampling frequencies of coal, metal, non-metal, sand and gravel, crushed limestone, and stone observations in the original dataset. Risk calculations were repeated on each of the 1,000 bootstrap samples, thereby generating empirical distributions for all risk estimates. From these empirical distributions, 95 percent confidence intervals were calculated. These confidence intervals characterize the uncertainty in the risk estimates arising from sampling error in the exposure data. All lifetime excess risk estimates had narrow confidence intervals, indicating that the estimates of lifetime excess morbidity and mortality risks have a high degree of precision.
In regard to use of average, rather than median, point estimates of risk, the estimates acquired from average exposures are similar to the estimates from median exposures, with 95 percent confidence intervals having similar widths. However, the 95 percent confidence intervals are not always overlapping, and average exposures tended to yield higher estimates of reduced morbidity and mortality. Among MNM miners, MSHA expects the new PEL to reduce lifetime excess cases of silicosis morbidity by 3,394-3,703 when using average exposures to model risks (see FRA Table 41 of the FRA document), compared to 3,271-3,576 fewer cases when using median exposures to model risks (see FRA Table 37 of the FRA document). Among coal miners, this reduction in excess cases of silicosis morbidity is expected to be 328-372 when using average exposures (see FRA Table 42 of the FRA document), compared to 305-354 when using median exposures (see FRA Table 38 of the FRA document). The new PEL is estimated to prevent 981-1,056 MNM miner deaths and 87-97 coal miner deaths when using average exposures to model risks (see FRA Tables 41 and 42 of the FRA document), compared to 945-1,020 fewer MNM miner deaths and 80-92 fewer coal miner deaths using median exposures to model risks (see FRA Tables 37 and 38 of the FRA document).
To estimate excess risks and excess cases under the new PEL, MSHA assumed that no exposures will exceed the new limit, which effectively reduced any exposures exceeding 50 μg/m
As with lifetime excess risks, the highball method also yields larger reductions in lifetime excess cases. Using the highball method, MNM miners are expected to experience 4,148 fewer cases of non-fatal silicosis and coal miners are expected to experience 446 fewer cases of non-fatal silicosis over their lifetimes. MNM miners would experience 1,519 fewer deaths and coal miners would experience 164 fewer deaths over their lifetimes. Compared to the lowball method—which estimates that the new PEL would avoid a total of 3,746 lifetime cases of non-fatal silicosis and 1,067 lifetime excess deaths (among both MNM and coal miners)—the highball method estimates totals of 4,594 avoided lifetime cases of non-fatal silicosis and 1,683 avoided lifetime excess deaths.
The MSHA Laboratory does not analyze samples for respirable crystalline silica that do not meet a minimum threshold for total respirable dust mass. The MNM exposure data gathered by enforcement from January 1, 2005, through December 31, 2019, contain samples that were analyzed using the P-2 method. As discussed, the P-2 method specifies that filters are only analyzed for quartz if they achieve a net mass (weight) gain of 0.100 mg or more. If cristobalite is requested, a mass gain of 0.050 mg or more is required for a filter to be analyzed (MSHA, 2022c). During the 15-year sample period for MNM exposure data, 40,618 MNM
Similarly, the coal exposure data gathered by enforcement from August 1, 2016, through July 31, 2021, contains samples that were analyzed using the P-7 method. For samples taken in underground mines, the P-7 method requires a minimum sample mass of 0.100 mg
MNM and Coal samples that did not meet the MSHA Laboratory's minimum mass criteria were excluded from the risk analysis because their concentrations of respirable crystalline silica are not known. The unanalyzed samples all had very low total respirable dust mass, making it unlikely that many would have exceeded the existing standards or the new PEL. Nonetheless, excluding these unanalyzed samples from the exposure datasets may introduce bias, potentially causing the Agency to overestimate the proportion of high-intensity exposure values.
As a sensitivity analysis, MSHA used imputation techniques to estimate the respirable crystalline silica mass for each sample based on the sample weight and the median percent silica content for each commodity and occupation. All the unanalyzed samples with imputed concentrations were estimated to be <25 µg/m
When including the imputed values for the unanalyzed samples, the new PEL would result in 2,327 fewer cases of non-fatal silicosis among MNM miners and 171 fewer cases among coal miners, over their lifetimes. The new PEL would also result in 666 fewer deaths (due to all 4 diseases) among MNM miners and 46 fewer deaths among coal miners, over their lifetimes. This yields a total reduction in lifetime excess morbidity of 2,498 miner deaths and a total reduction in lifetime excess mortality of 712 miner deaths. While these estimates are lower than those presented in Table VI-4 (of 3,746 avoided lifetime cases of non-fatal silicosis and 1,067 avoided lifetime excess deaths), MSHA nonetheless believes that—even including these unanalyzed samples—the new PEL would still reduce the risk of material impairment of health or functional capacity in miners exposed to respirable crystalline silica. Moreover, the possible positive bias that may arise when excluding these samples would be offset by other negative biases discussed herein (
It should be noted that the imputation method has some limitations. For example, the method assumes that, if the insufficient mass samples had been analyzed, every sample would have possessed a percentage of quartz, by mass, equal to the median percentage for that sample's associated commodity and occupation. (See Section 17.1 of the standalone FRA document for a full discussion of the imputation method.) However, within a given occupation, this percentage varies substantially and is positively correlated with exposure concentration. Suppressing the variation in this percentage quartz, by mass, produces less variation in the resulting imputed concentrations. Consequently, the imputation method may underestimate the number of unanalyzed samples that would truly exceed 50 μg/m
This section, technological feasibility, presents MSHA's conclusions on the technological feasibility of the final rule for mine operators. The section considers whether currently available technologies, used alone or in combination with each other, can be used by mine operators to comply with the final rule and notes and responds to public comments received regarding technological feasibility. In the proposed rule, MSHA preliminarily determined that it is technologically feasible for mine operators to achieve the proposed requirements. In the proposal, MSHA requested public comments on these preliminary conclusions and any other aspects of the proposed rule. After receiving public comments, the Agency has reviewed them and has determined that it is technologically feasible for mine operators to conduct air sampling and analysis and to achieve the final rule's PEL using commercially available samplers. MSHA has also determined that these technologically feasible samplers are widely available, and a number of commercial laboratories provide the service of analyzing dust containing respirable crystalline silica. In addition, MSHA has determined that technologically feasible engineering controls are readily available, can control crystalline silica-containing dust particles at the source, provide reliable and consistent protection to all miners who would otherwise be exposed to respirable dust, can be monitored, and are achievable. MSHA has also determined that administrative controls, used to supplement engineering controls, can further reduce and maintain exposures at or below the final rule's PEL. Moreover, MSHA has determined the final rule's respiratory protection practices for respirator use are technologically feasible for mine operators to implement. For MNM operators, MSHA has determined that the final rule's medical surveillance requirements are technologically feasible. This section focuses on technological feasibility; public comments specifically related to technological feasibility are addressed here, other comments are addressed in
MSHA is required to set standards to assure, based on the best available evidence, that no miner will suffer material impairment of health or functional capacity from exposure to toxic materials or harmful physical agents over his working life. 30 U.S.C. 811(a)(6)(A). The Mine Act also instructs MSHA to set health standards to attain “the highest degree of health and safety protection for the miner” while considering “the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws.” 30 U.S.C. 811(a)(6)(A). But the health and safety of the miner is always the paramount consideration: “[T]he Mine Act evinces a clear bias in favor of miner health and safety,” and “[t]he duty to use the best evidence and to consider feasibility are appropriately viewed through this lens and cannot be wielded as counterweight to MSHA's overarching role to protect the life and health of workers in the mining industry.”
The D.C. Circuit clarified the Agency's obligation to demonstrate the technological feasibility of reducing occupational exposure to a hazardous substance. MSHA “must only
This section presents technological feasibility findings that guided MSHA's selection of the final rule's requirements, including the PEL. MSHA's technological feasibility findings are organized into two main sections covering: (1) the technological feasibility of part 60: PEL and action level; engineering and administrative controls; sampling provisions, including methods of sampling, and sampler and sample analysis requirements; and medical surveillance requirements for MNM mines; and (2) the technological feasibility of the revision to previous respiratory protection standards. Based on the analyses presented in the two sections, MSHA concludes that the Agency's final rule is technologically feasible. MSHA's feasibility determinations in this rulemaking are supported by its findings that the majority of the industry is already using technology that will allow it to effectively comply with the final rule.
As noted above, MSHA has determined that part 60 is technologically feasible. Many mine operators already maintain respirable crystalline silica exposures at or below the final rule's PEL of 50 µg/m
Second, the analysis shows that the final rule's update to MSHA's prior respiratory protection requirements is also technologically feasible. The mining industry's existing respiratory protection practices for selecting, fitting, using, and maintaining respiratory protection include program elements that are similar to those of
The technological feasibility analysis for the PEL relies primarily on information from three key sources:
• MSHA's Standardized Information System (MSIS) respirable crystalline silica exposure data, which includes 57,769 MNM and 63,127 coal mine compliance samples collected by MSHA inspectors; these samples were of sufficient mass gain to be analyzed for respirable crystalline silica by MSHA's analytical laboratory.
• The NIOSH series on reducing respirable dust in mines, including: “Dust Control Handbook for Industrial Minerals Mining and Processing, Second Edition” (NIOSH, 2019b) and “Best Practices for Dust Control in Coal Mining, Second Edition” (NIOSH, 2021a).
• MSHA's knowledge of the mining industry. MSHA has over four decades of experience inspecting surface mines at least twice per year and underground mines at least four times per year and in assisting mine operators and miners with technological issues, such as control of respirable dust (including respirable crystalline silica) exposure. MSHA provides compliance assistance, including informational programs, training, publications, onsite evaluations, and investigations that document conditions in mines and help mines operate in a safe and healthy manner.
Additionally, MSHA consulted other published reports, scientific journal articles, and information from equipment manufacturers and mining industry suppliers.
MSHA did not identify any comments specific to the technological feasibility analysis methodology. This final rule retains the methodology supporting the technological feasibility analysis of the PEL in the proposed rule.
As described in the Preliminary Regulatory Impact Analysis (PRIA), MSHA categorized mine types into six MNM “commodity categories” (using the method of Watts
Within each commodity, MSHA further separated mining operations into the four activity groups widely used by the industry: (1) development and production miners (drillers, stone cutters); (2) ore/mineral processing miners (crushing/screening equipment operators and kiln, mill, and concentrator workers in mine facilities); (3) miners engaged in load/haul/dump activities (conveyor, loader, and large haulage vehicle operators, such as dump truck drivers); and (4) miners in all other occupations (mobile and utility workers, such as surveyors, mechanics, cleanup crews, laborers, and operators of compact tractors and utility trucks).
Before determining the feasibility of reducing miners' exposure to respirable crystalline silica, MSHA gathered and analyzed information to understand current miner exposures by creating an “exposure profile,” identified the existing (
MSHA classified all valid respirable crystalline silica samples in the Agency's MSIS data,
In Table VII-1, the respirable crystalline silica exposure data for MNM miners are summarized by commodity and for the MNM industry as a whole, while Table VII-2 presents the exposure profile as the percentage of samples in each exposure range. Overall, approximately 82 percent of the 57,769 MNM compliance samples were at or below the PEL (50 µg/m
Table VII-3 and Table VII-4 present the corresponding respirable crystalline silica exposure information for coal miners by location (underground or surface). Overall, approximately 93 percent of the 63,127 samples obtained by MSHA inspectors for coal miners were at or below the PEL (50 µg/m
MNM and coal mines are controlling dust containing respirable crystalline silica in various ways. As shown in Tables VII-1 through VII-4, respirable crystalline silica exposures exceeded the PEL of 50 µg/m
Despite the extensive dust control methods available, dust control measures have been implemented in some commodity categories to a greater degree than in others. This is partly because some commodity categories tend to have larger mines. MSHA has found that the larger the amount (tonnage) of material a mine moves (including overburden and other waste rock), the faster the mine tends to operate its equipment (
MSHA has also found that metal mines, which are typically large operations with higher numbers of miners, tend to have available engineering controls for dust management. On the other hand, sand and gravel mines, which generally employ fewer miners and handle modest amounts of material, have very limited, if any, dust control measures. This is because most of the mined material is a commodity that only requires washing and screening into various sizes of product stockpiles, generating little waste material. Nonmetal, stone, and crushed limestone mines occupy the middle range in terms of employment, existing engineering controls, and maintenance practices.
Over the years, staff from multiple MSHA program areas have worked alongside miners and mine operators to improve safety and health by inspecting, evaluating, and researching mine conditions, equipment, and operations. These key programs, each of which has an onsite presence, include (but are not limited to) Mine Safety and Health Enforcement; Directorate of Educational Policy and Development, which includes the National Mine Health and Safety Academy and the Educational Field and Small Mine Services; and the Directorate of Technical Support, which comprises the Approval and Certification Center and the Pittsburgh Safety and Health Technology Center (including its Health Field Division, Analytical and Laboratory Services Division, National Air and Dust Laboratory, Ventilation Division, and other specialized divisions). Table VII-5 reflects the collective observations of these MSHA programs, presented in terms of existing dust control (baseline conditions) and the classes of additional control measures that will provide those mines with the greatest benefit to reduce exposures below the PEL and action level.
Table VII-5 shows MSHA's assessment of existing dust controls in mines (baseline conditions) and additional controls needed to meet the PEL for each commodity category, including the need for frequent scheduled maintenance. By conducting frequent scheduled maintenance, mine operators can reduce the concentration of respirable crystalline silica. Table VII-5 shows that metal mines have adopted extensive dust controls, while sand and gravel mines tend to have minimal engineering controls, if any.
Based on MSHA's experience, NIOSH research, and effective respirable dust controls currently available and in use in the mining industry, MSHA finds that the baseline conditions include various combinations of existing engineering controls selected and installed by individual mines to address respirable crystalline silica generated during mining operations.
Under the final rule, the mine operator must install, use, and maintain engineering controls, supplemented by administrative controls, when necessary, to keep each miner's exposure at or below the PEL. Engineering controls reduce or prevent miners' exposure to hazards.
MSHA data and experience show that mine operators already have numerous engineering and administrative control options to control miners' exposures to respirable crystalline silica. These control options are widely recognized and used throughout the mining industry. NIOSH has extensively researched and documented engineering and administrative controls for respirable crystalline silica in mines. As noted previously, NIOSH has published a series on reducing respirable dust in mines (NIOSH, 2019b, 2021a).
Examples of existing engineering controls used at mines and commercially available engineering controls that MSHA considered include:
• Wetting or water sprays that prevent, capture, or redirect dust;
• Ventilation systems that capture dust at its source and transport it to a dust collection device (
• Process enclosures that restrict dust from migrating outside of the enclosed area, sometimes used with an attached ventilation system to improve effectiveness (
• Operator enclosures, such as mobile equipment cabs or control booths, which provide an environment with clean air for an equipment operator to work safely;
• Protective features on mining process equipment to help prevent process failures and associated dust releases (
• Preventive maintenance conducted on engineering controls and mining equipment that can influence dust levels at a mine, to keep them functioning optimally; and
• Instrumentation and other equipment to assist mine operators and miners in evaluating engineering control effectiveness and recognizing control failures or other conditions that need corrective action.
Administrative controls include practices that change the way tasks are performed to reduce a miner's exposure. Administrative controls can be very effective and can even prevent exposure entirely. MSHA has determined that various administrative controls are readily available to provide supplementary support to engineering controls. Examples of administrative controls include housekeeping procedures; proper work positions of miners; walking around the outside of a dusty process area rather than walking through it; cleaning of spills; and measures to prevent or minimize contamination of clothing to help decrease miners' exposure to respirable crystalline silica. However, these control methods depend on human behavior and intervention and are less reliable than properly designed, installed, and maintained engineering controls. Therefore, administrative controls will be permitted only as supplementary measures, with engineering controls required as the primary means of protection. Nevertheless, administrative controls play an important role in reducing miners' exposure to respirable crystalline silica.
Various control options can also be used in combinations. NIOSH has documented in detail most control methods and has confirmed that they are currently used in mines, both individually and in combination with each other (2019b, 2021a).
MSHA finds that a strong preventive maintenance program plays an important role in achieving consistently lower respirable crystalline silica exposure levels. MSHA has observed that when engineering controls are installed and maintained in working condition, respirable dust exposures tend to be below the existing exposure limits. When engineering controls are not maintained, dust control efficiency declines and exposure levels rise. When engineering controls fail due to a lack of proper maintenance, a marked rise in exposures can occur, resulting in noncompliance with MSHA's existing exposure limits. Some examples of the impact that proper maintenance can have on respirable dust levels include:
• Water spray maintenance: An experiment using water spray bars that could be turned on or off showed that dust reduction was less effective each time additional spray nozzles were deactivated. A 10 percent decrease occurred when three of 21 sprays were shut off, but a 50 percent decrease occurred when 12 out of the 21 sprays were shut off. Decreased total water spray volume and gaps in the spray pattern (due to deactivated nozzles) were both partially responsible for the decreased dust control (Seaman
• Water added to drill bailing air: When introduced into the drill hole (with the bailing air through a hollow drill bit), water mixes with and moistens the drill dust ejected from the hole and can reduce respirable dust by more than 90% (NIOSH, 2019b, 2021a). NIOSH reports that this same control measure, and others, are similarly effective for MNM and surface coal mine drills preparing the blasting holes used to expose the material below (whether ore or coal).
• Ventilation system maintenance: The amount of air cleaned by an air scrubber is decreased by up to one-third (33 percent) after one continuous mining machine cut. Cleaning the scrubber screens restores scrubber efficacy, but this maintenance must be performed after every cut. Spare scrubber screens make frequent cleaning practical without slowing production (NIOSH, 2021a).
• Operator enclosure maintenance: Tests with mining equipment showed that maintenance activities such as repairing weather stripping and replacing clogged and missing cab ventilation system filters (intake, recirculation, final filters) increased miner protection by up to 95 percent (NIOSH, 2019b, 2021a).
• Filter selection during maintenance: Airflow is as important as filtration and pressurization in operator enclosures; during maintenance, filter selection can influence all three factors. Performing serial end-shift testing of enclosed cabs (on a face drill and a roof/rock bolter) at an underground crushed limestone mine, NIOSH compared installed HEPA filters and an alternative (MERV 16 filters). The latter provided an equal level of filtration and better overall miner protection by allowing greater airflow and cab pressurization. As an added advantage, NIOSH showed that these filters cost less and required less-frequent replacement, reducing maintenance expenses in this mining environment (Cecala
• Proper design and installation—foundation for effective maintenance: A new replacement equipment operator enclosure (control booth) installed adjacent to the primary crusher at a granite stone quarry initially provided 50 to 96 percent respirable dust reduction, even with inadequate pressurization. The protection it offered miners tripled after the booth's second pressurization/filtration unit was activated (Organiscak
MSHA has observed that when engineering controls are properly maintained, exposure levels decrease or stay low. Metal mines, which typically have substantial controls already installed, primarily need reliable preventive maintenance programs to achieve the PEL. It is also important to repair equipment damage that contributes to dust exposure (for example, damage to conveyor skirtboards that protect the conveyor system from damage and prevent spillage which generates airborne dust). Maintenance and repair programs must
Some commenters described conditions where they found engineering controls were not feasible. The NSSGA, the NVMA, and US Silica (a MNM mine operator) cited examples such as water sprays that freeze in winter or are not practical where the product must be kept dry so mine workers can bag it; and enclosures and ventilation systems that are sometimes impractical for portable operations at some locations and limited (so made less effective) by the physical constraints of others (Document ID 1448; 1441;1455). The MNM mine operator commenter indicated that at their worksite, these physical conditions cause engineering controls to be ineffective more than does lack of effort (Document ID 1455).
In MSHA's considerable experience providing technical support to mines, there is always a way to eliminate overexposures to respirable dust (including respirable crystalline silica) by using the information contained in NIOSH best practice guides for mines. MSHA has found that the number of control options and level of detail in the guides make compliance achievable through engineering controls alone. By adding administrative controls (or procedural practices) mines routinely achieve consistent compliance. MSHA agrees with commenters that exposed water sprays are not effective in freezing weather, however, the Agency has found that one or more other options is available for every circumstance. For example, enclosing the process equipment is one alternative to using water sprays for dust control. Rather than suppressing dust, as water spray does, enclosing the dusty process equipment limits the amount of dust that escapes from the process enclosure, in turn limiting the amount of dust in the equipment operator's breathing zone. A process equipment enclosure can be constructed with baffles to help calm the air inside the enclosure, so dust settles more quickly inside the enclosure. As another option, a ventilation dust collection system can be paired with a process equipment enclosure to make both even more effective. Yet another example is to enclose the equipment operators (
The Brick Industry Association (BIA) noted that their industry usually operates with the minimum number of personnel even under optimal staffing conditions and explained that it can be difficult to avoid rotating workers to achieve efficient workflow (Document ID 1422). This commenter also stated that it could be difficult to maintain productive operations if management is not able to either rotate workers to minimize exposure levels or allow personnel to wear respirators for day-to-day tasks.
As MSHA stated in the proposed rule and, and included in this final rule, miner rotation is not considered an acceptable administrative control for minimizing miner exposure levels or complying with any provision of part 60. MSHA understands that mine operators may assign a variety of work tasks for business reasons unrelated to compliance with the PEL. However, MSHA will not consider as compliance a mine operator's implementation of a varied task schedule for particular miners for purposes of avoiding conflict with the PEL, as engineering and administrative controls can feasibly reduce exposure levels below the PEL.
This final rule prioritizes engineering controls for reducing miner exposures, because they (1) control crystalline silica-containing dust particles at the source; (2) provide reliable, predictable, effective, and consistent protection to miners who would otherwise be exposed to dust from that source; and (3) can be monitored. MSHA maintains that as described earlier in this section, a combination of engineering controls and administrative controls can reduce miner exposures to levels below the PEL and that equipment maintenance will help minimize exposures. Some examples of engineering controls include wet dust suppression methods; enclosure; ventilation—permanent or portable trunks; pre-cleaning—by washing or HEPA vacuuming; and controlling dust sources. Examples of administrative controls include proper miner positioning and improved housekeeping. For a detailed discussion on rotation of miners, see
MSHA finds that the technological feasibility analysis process was effective and controlling exposure levels to the PEL or lower using engineering controls is both feasible and practical. The final rule, as did the proposed rule, emphasizes engineering controls, supplemented with administrative controls, to control miner exposure.
MSHA's final PEL is 50 μg/m
Effective maintenance will also help mine operators comply with the final rule. MSHA finds that maintaining (including adjusting) or repairing existing equipment will help achieve exposures at or below 50 μg/m
Other engineering controls (
A similar hypothetical example is a coal miner helper who spends 90 minutes (1.5 hours) per 8-hour shift assisting a drilling rig operator (in a protective operator's cab) drilling blast holes. The combination of controls used to control drilling dust (including water added to the bailing air, which can reduce airborne respirable dust emissions by up to 96 percent) can keep the helper's respirable crystalline silica exposure in the range of 35 μg/m
Based on these examples and the wide range of effective exposure control options available to the mining industry, MSHA finds that control technologies capable of reducing miners' respirable crystalline silica exposures are available, proven, effective, and transferable between mining commodities; however, they must be well-designed and consistently used and maintained. MSHA also finds that methods of maintaining engineering controls are known, available, and effective.
Based on the exposure profiles in Table VII-1 and Table VII-2 for MNM mines, and in Table VII-3 and Table VII-4 for coal mines, and the examples in the previous section that demonstrate the beneficial effect of combined controls, MSHA finds that the PEL of 50 μg/m
Table VII-6 summarizes the technological feasibility of control technologies available to the mining industry, by commodity. MSHA finds that control technologies are technologically feasible for all six commodities and their respective activity groups. Under baseline conditions, mines in each commodity category have already achieved respirable crystalline silica exposures at or below 50 μg/m
MSHA finds that mine operators can achieve exposure levels below the action level of 25 μg/m
One control option is increased automation, such as expanding the use of existing autonomous or remote-controlled drilling rigs, roof bolters, stone cutting equipment, and packaging/bagging equipment. This type of automation can reduce exposures by increasing the distance between the equipment operator and the dust source. Other options include completely enclosing most processes and ventilating the enclosures with dust extraction equipment or controlling the speed of mining equipment (
Mines that only occasionally work with higher-silica-content materials may not be equipped with the controls required to achieve the action level of 25 μg/m
MSHA finds that the action level of 25 μg/m
MSHA received numerous comments related to exposure control methods. Several commenters recommended that the standard incorporate by reference certain materials to assist mine operators with compliance. The International Society of Environmental Enclosure Engineers (ISEEE) discussed ISO 23875 (Document ID 1377).
MSHA has reviewed the comments and suggested material. The Agency agrees that ISO 23875 is a useful tool that promotes feasible dust control equipment manufacture and maintenance practices. Although MSHA has not incorporated it into the final rule, the Agency will keep this standard in mind during future initiatives. MSHA acknowledges that many other organizations and agencies, including NIOSH with its detailed and carefully illustrated best practice guides for the mining industries, have published extensive information that may be helpful to mine operators seeking methods to protect miners. The Agency encourages mine operators to use these tools to identify proper and adequate engineering controls, choose those that will be useful in their mines, and ensure that the controls are correctly installed, implemented, and maintained.
MSHA received several comments regarding the description and use of feasible engineering controls. The NVMA requested that MSHA supply a definition for what is “feasible” (Document ID 1441).
Within MSHA's standard development process, the term “feasible” generally means “capable of being done.” In the case of respirable crystalline silica exposure controls, these controls exist already and are not technology-forcing. Based on its extensive experience inspecting and providing compliance assistance and technical support in mines, MSHA has observed that U.S. mines are already using an extensive array of engineering controls. As documented by NIOSH in its best practices guides and other resources for the mining industry, the numerous readily available engineering controls provide evidence that it is technologically feasible for mine operators to reduce miner respirable crystalline silica exposure to levels at or below the PEL and, in some cases, below the action level (NIOSH, 2019b, 2021a).
These engineering controls, including examples and data, were discussed in more detail previously in this Technological Feasibility section (see
Some commenters, including the UMWA, American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), Black Lung Clinics, and AIHA echoed the availability of effective engineering controls in the mining industry
MSHA concurs with these comments. MSHA's experience is consistent with these comments. Based on MSHA's experience, consideration of the OSHA silica rule (2016), and documentation from NIOSH as discussed in this section of the preamble, MSHA determines that engineering controls exist for mining operations to reduce miners' exposure to the level of the PEL (50 µg/m
MSHA received several comments on the technological feasibility of the action level (25 µg/m
After careful consideration of the comments, MSHA has determined a full-shift 8-hour TWA action level of 25 µg/m
Comments on the analytical limit of detection and reliability relative to the action level relate to analytical methodology and are addressed in
The action level is an important provision of this final rule, necessary to protect miners' health. According to NIOSH research, wherever exposure measurements are above one-half the PEL, the employer cannot be reasonably confident that the employee is not exposed to levels above the PEL on days when no measurements are taken (NIOSH, 1975). Thus, an action level (in this case set at one-half of the PEL) allows mine operators to take action before overexposures occur. The action level of 25 µg/m
MSHA finds that the PEL of 50 µg/m
MSHA's final rule requires mine operators in both MNM and coal mines to conduct sampling for respirable crystalline silica using respirable particle size-selective samplers that conform to the “
MSHA received supportive comments from Badger Mining Corporation (BMC), National Mining Association (NMA), and SKC Inc., regarding the requirement for samplers to conform to ISO 7708:1995 (Document ID 1417; 1428; 1366). BMC reported having no objection to MSHA's sampling device provisions proposed here (Document ID 1417). NMA encouraged MSHA to clarify that any sampling technology that meets the characteristics for respirable-particle-size-selective samplers that conform to the ISO 7708:1995 standard is acceptable for air sampling under the rule (Document ID 1428). NMA, BMC, and SKC, Inc. each mentioned currently available sampling equipment that meets the ISO criteria (Document ID 1428; 1417; 1366), and the manufacturer SKC, Inc. pointed out that, for respirable crystalline silica sampling, mine operators can use any respirable dust sampling device that conforms to ISO 7708:1995 (and where appropriate, meets MSHA permissibility requirements) (Document ID 1366). In the Section-by-Section analysis of this preamble, MSHA clarifies that mine operators are allowed to use any type of sampling device for respirable crystalline silica sampling, as long as the device is designed to meet the characteristics for respirable-particle-size-selective samplers that conform to the ISO 7708:1995 standard and, where appropriate, meet MSHA permissibility requirements.
The American Exploration & Mining Association (AEMA), NMA, and Portland Cement Association expressed concern that sufficient samplers (and sampling pumps) might not be available by the proposed compliance date (Document ID 1424; 1428; 1407).
As discussed in more detail in
MSHA received comments both for and against the proposed requirement of sampling within 180 days after the effective date of the final rule to complete the baseline sampling requirements, with most commenters stating, for a variety of reasons, that it was not enough time and recommending a longer period ranging from 1 year to 3 years. The Metallurgical Coal Producers Association (MCPA) and MSHA Safety Services, Inc. stated that providing only 180 days to complete baseline sampling is not sufficient because of the limitation of available resources for conducting sampling (Document ID 1406; 1392). The Portland Cement Association, SSC, and the NMA stated that this requirement may not be feasible for many operators because of competition for outsourced resources such as rental equipment, media, professional services, and laboratory sample analysis (Document ID 1407; 1432;1428). Concerned that mine operators will be competing to obtain these resources, the Portland Cement Association and National Lime Association (NLA) stated that small mines are likely to have the greatest difficulty in finding these resources in a short period of time (Document ID 1407; 1408). The NSSGA, NLA, BMC, and the Arizona Mining Association each expressed concerns about performing other tasks within the proposed timeframe for compliance, including establishing contracts with accredited laboratories and other service providers necessary for sampling, performing sampling for all miners who may reasonably be expected to be exposed to respirable crystalline silica, and designing and implementing new engineering controls (Document ID 1448; 1408; 1417; 1368). The NSSGA also urged MSHA to factor in the increased demand that might result from the state of California's effort to promulgate an Emergency Temporary Standard on silica (Document ID 1448). The MCPA and the Portland Cement Association recommended a phased timeline similar to the OSHA silica rule (which gave employers one year before the commencement of most requirements and two years before the commencement of sample analysis methods) and the MSHA 2014 RCMD Standard (which gave operators 18 months after the rule became effective) for completing sampling (Document ID 1406; 1407).
Other commenters considered the rule feasible and practical. The AFL-CIO stated that technologically feasible air sampling and analysis exist to achieve the proposed PEL using commercially available samplers (Document ID 1449). This commenter noted that these technologically feasible samplers are widely available, and a number of commercial laboratories provide the service of analyzing dust containing respirable crystalline silica. One individual supported the proposed requirement that baseline sampling be conducted within 180 days of the rule's effective date (Document ID 1367).
Samplers used in both MNM and coal mines can be used to perform the sampling, and because other commercially available (already on the market) samplers also conform to the ISO standard, MSHA finds that sampling in accordance with the ISO standard is technologically feasible and the technological feasibility analysis supporting the sampling methods provisions in the proposed rule remain in effect for this final rule.
After a respirable dust sample is collected and submitted to a laboratory, it must be analyzed to quantify the mass of respirable crystalline silica present. The laboratory method must be sensitive enough to detect and quantify respirable crystalline silica at levels below the applicable concentration. The analytical limit of detection (LOD) and/or limit of quantification (LOQ), together with the sample volume, determine the airborne concentration LOD and/or LOQ for a given air sample. MSHA's final PEL for respirable crystalline silica is 50 μg/m
MSHA uses two main analytical methods (1)
For an analytical method to have acceptable sensitivity for determining exposures at the PEL of 50 μg/m
Two commenters mentioned the need for sampling devices with real-time or near real-time sample analysis capabilities for respirable crystalline silica (Document ID 1428; 1449). One of these commenters, the NMA, noted that personal dust monitoring devices with real-time analysis did not appear in the proposed respirable crystalline silica rule, noting that this equipment was included in MSHA's 2014 Coal Dust Rule (Document ID 1428). The commenter recommended that MSHA adopt new technology from the domestic or international mining community to better protect miners. Also interested in new technology, the AFL-CIO stated that, to more appropriately characterize exposures, MSHA should incorporate continuous and rapid quartz monitoring systems into the rule (Document ID 1449).
MSHA agrees with these commenters that new technology, such as real-time dust monitors and NIOSH's rapid field-based quartz monitoring (RQM) system with end-of-shift reporting
A commenter, AISI, expressed concern that the action level was too close to the limit of accurate detection of respirable crystalline silica (Document ID 1426) and one commenter, SSC, stated that there is little confidence in the reliability of sampling results below 50 μg/m
MSHA agrees that limits of detection and reliability are important considerations, and, in this context, the agency carefully reviewed currently available sampling equipment and analytical methods as part of the final rule and in Table VII-7. In Table VII-7, MSHA demonstrates how exposure levels well below the PEL and action level can be reliably quantified using particle size-selective samplers under various sampling parameters and established analytical method reporting limits. The minimum quantifiable quartz concentrations shown in Table VII-7 are all less than 25 μg/m
MSHA finds that current analytical methods are sufficiently sensitive to meet the PEL and action level in the final rule. This finding is based on information presented in this section showing the availability and sensitivity of MSHA, NIOSH, and OSHA analytical methods capable of measuring respirable crystalline silica concentrations below 50 μg/m
MSHA's final rule requires, for sample analysis, that mine operators use laboratories that meet
MSHA received comments in support of the requirement for sample analysis by the AIHA and the American Association for Laboratory Accreditation (A2LA) (Document ID 1351; 1388). Both commenters agreed that MSHA should rely on laboratories accredited to the ISO 17025 standards. The A2LA explained that relying on accredited laboratories' impartiality, expertise, and accuracy will permit MSHA to focus time and resources on policy, enforcement actions and other Agency responsibilities (Document ID 1388).
MSHA interviewed three AIHA LAP accredited laboratories (one small-capacity laboratory,
MSHA's final rule requires mine operators to commence sampling, by the compliance date in the final rule, for each miner who is or may reasonably be expected to be exposed to respirable crystalline silica.
All mine operators covered by the rule must initiate sampling by the compliance dates, potentially creating a peak demand for analysis around those dates. MSHA finds, however, that the final rule is feasible for mine operators to secure the services of analytical laboratories. First, the extended MNM compliance date permits more time to accommodate and prepare for any increase in demand. MSHA expects many mine operators will avoid last-minute sampling and begin the sampling process earlier than required; thus, the sampling and associated analysis will be spread over many months, meaning that any eventual peak period for laboratory analysis will be longer and less intense (
Under § 60.12(a), (b), and (d), mine operators may be required to conduct additional sampling. First, when the most recent sampling indicates that miner exposures are at or above the action level (25 µg/m
In its standalone Final Regulatory Impact Analysis (FRIA) document (referred to as the standalone FRIA document throughout the preamble), Table 4-5 “Estimated Number of Samples Taken by Type and Year,” MSHA estimates that, starting in the first 12-month period after the rule's effective date, coal mine operators will secure laboratory services for analysis of 5,423 above-action-level samples (those samples required when the previous sample is at or above the action level, but at or below the PEL), 1,991 corrective actions samples, and 4,390 post-evaluation samples, in addition to the 29,796 first-time and second-time samples mentioned in the previous subsection. MSHA assumes that coal industry analytical needs will be reduced in subsequent years as mine operators reduce miner exposures to levels below the PEL or action level. In the second 12-month period, in addition to 596 first-time and second time samples, coal mine operators will secure laboratory services for analysis for 10,556 above-action-level, 3,934 corrective actions, and 4,390 post-evaluation samples.
Similarly, starting in the second 12-month period (due to the extended MNM compliance date), MSHA estimates that MNM mine operators will secure laboratory analysis for 36,442 above-action-level, 23,414 corrective actions, and 12,564 post-evaluation samples (plus the 124,288 first-time and second-time samples discussed previously). MSHA estimates that the MNM industry's need for analysis will be lower in the following years as mine operators reduce miner exposures to levels below the PEL or action level. In the third 12-month period after the rule goes into effect, MNM mines are projected to need analysis for 2,486 first-time and second-time, 66,764 above-action-level, 43,041 corrective actions, and 12,564 post-evaluation samples.
MSHA estimated that the total number of analyses (699,800) that laboratories will be able to perform per year is nearly three times the maximum total estimated number of samples analyses required (216,183).
The AEMA and NMA expressed concern that laboratory capacity might not be available by the proposed compliance date (Document ID 1424; 1428). As discussed in more detail in
As part of the proposed rule, MSHA examined the capacity of laboratories that meet the ISO 17025 standard to conduct respirable crystalline sample analyses. MSHA made the preliminary determination that there would be sufficient processing capacity to meet the sampling analysis schedule envisioned by the proposed rule, and that the proposed rule is technologically feasible for laboratories to conduct baseline sampling analyses (88 FR 44923). MSHA also preliminarily determined that the availability of samplers needed to conduct the required baseline sampling is technologically feasible (88 FR 44921). This preliminary determination, however, only examined whether sampler technology exists to conduct the respirable crystalline silica sampling as required under the proposal, not the availability of that technology to meet the demands that the final rule will impose.
MSHA agrees with commenters that the sampling requirements of the final rule will create an initial rush for sampling devices and related equipment and services. MSHA understands that there are more sampling devices (as well as related services and supplies) currently available in the market now than prior to OSHA's proposed silica rule. Nevertheless, based on OSHA's successful promulgation of that Agency's 2016 respirable crystalline silica final rule that included new silica sampling requirements (with similar
Resource limitations may be an issue for MNM mine operators since there are far more MNM mines in the U.S. compared to coal mines (in 2021, there were 11,231 MNM mines compared to 931 coal mines). As such, the expected demand for sampling devices, supplies, and services to meet the sampling requirements of this final rule is expected to be greater for MNM mines compared to coal mines.
MSHA carefully considered the above information about availability of laboratory capacity and sampling devices, including the likely increase in demand for such services and devices. MSHA acknowledges commenters' concerns about the need for more time to conduct sampling and implement necessary engineering controls. Accordingly, MSHA has adjusted the requirements in the final rule to allow MNM mine operators a total of 24 months after the publication date of the final rule to comply. This will provide sufficient time for MNM mine operators to comply with the requirements of part 60. Actions the operator may take in preparation for compliance with part 60 may include, for example, purchasing sampling equipment, securing sampling services, making arrangements with laboratories, and performing sampling. MSHA has changed the requirements in the final rule to allow coal mine operators a total of 12 months after publication of the final rule to come into compliance. MSHA expects that the extended time for compliance will provide coal mine operators with time to purchase additional sampling equipment and acquire necessary laboratory services. MSHA also notes that the AIHA, an accrediting body for commercial laboratories that analyze respirable crystalline silica, concurred with MSHA's findings that technologically feasible samplers are widely available, and a number of commercial laboratories provide the service of analyzing dust containing respirable crystalline silica (Document ID 1351). Additional discussion of the compliance dates can be found in
Under MSHA's final rule, respiratory protection will not be allowed for compliance. As discussed elsewhere, MSHA has determined that the PEL is feasible for all mines and all mines must comply with it. However, when exposures are above the PEL, mine operators must take immediate corrective actions, provide miners with respirators, and ensure that they are worn until exposures are below the PEL. There is a sufficient supply of respirators for mine operators to obtain and maintain for temporary use. Therefore, MSHA has determined that the requirements in the final rule for respirator use are technologically feasible. This finding is supported by the Agency's knowledge of and experience with the mining industry, evidence presented by NIOSH (2019b, 2021a), and Tables VII-1 through VII-4 (exposure profiles for MNM and coal mines). These tables indicate that the PEL (50 μg/m
Section 60.14(b) requires that any miner unable to wear a respirator must receive a temporary job transfer to an area or to an occupation at the same mine where respiratory protection is not required. The paragraph also requires that a miner transferred under this requirement continue to receive compensation at no less than the regular rate of pay in the occupation held by that miner immediately prior to the transfer. MNM mine operators must already comply with the job transfer provisions under the existing standard in § 57.5060(d)(7) that requires mine operators to transfer miners unable to wear a respirator to work in an existing position in an area of the mine where respiratory protection is not required. Section 60.14(b) is similar to these existing requirements. MSHA finds that mine operators will have a similar experience implementing the job transfer provisions of § 60.14(b). As discussed in
For miners who need to wear respiratory protection on a temporary basis, section 60.14(c)(1) requires the mine operator to provide NIOSH-approved atmosphere-supplying respirators or NIOSH-approved air-purifying respirators equipped with high-efficiency particulate filters in one of the following NIOSH classifications under 42 CFR part 84: 100 series or High Efficiency (HE). As discussed below in the Section-by-Section analysis, MSHA finds that particulate respirators meeting these criteria will offer the best filtration efficiency (99.97 percent) and protection for miners exposed to respirable crystalline silica and are widely available and used by most industries. This finding is based on the characteristics of the 100 series as compared to the other two most common series (95 and 99). The 95- and 99-series particulate respirators do not offer as high a degree of protection as the 100-series (95 percent and 99 percent efficiency, respectively), and are less likely to provide the expected level of protection due to concerns about poor fit and vulnerability to mishandling such as folding or crushing. The NIOSH-approved 100-series particulate respirators also have broad commercial availability.
Section 60.14(c)(2) incorporates the
This section discusses the update to MSHA's existing respiratory protection standards in 30 CFR 56.5005, 57.5005, and 72.710 which deal with other airborne contaminants and do not include respirable crystalline silica. Respiratory protection requirements for respirable crystalline silica are in final § 60.14 and are substantially similar to MSHA existing standards. Respirators are used by mine operators to protect miners against respiratory hazards, including particulates, gases, and vapors. Under existing standards, for MNM and coal mine operators, respirators must not be used in place of engineering controls to control airborne contaminants. If respirable coal mine dust samples exceed the standard, coal mine operators must make approved respiratory equipment available to affected miners while taking immediate corrective actions to lower the concentration of respirable dust to at or below the respirable dust standard. Metal and nonmetal mine operators must provide miners with respirators and miners must use respirators while engineering control measures are being developed or when necessary by the nature of work involved (for example, while establishing controls or occasional entry into hazardous atmospheres to perform maintenance or investigation).
Where respirators are used, they must seal and isolate the miner's respiratory system from the contaminated environment. The risk that a miner will experience an adverse health effect from a contaminant when relying on respiratory protection is a function of the toxicity or hazardous nature of the air contaminants present, the concentrations of the contaminants in the air, the duration of exposure, and the degree of protection provided by the respirator. When respirators fail to provide the expected protection, there is an increased risk of adverse health effects. Therefore, it is critical that respirators perform as they are designed.
Accordingly, MSHA is incorporating by reference ASTM F3387-19 by amending §§ 56.5005, 57.5005, and 72.710 to replace the Agency's existing respiratory protection standard in those sections. Final §§ 56.5005, 57.5005, and 72.710 requires mine operators to develop a written respiratory protection program meeting the requirements in accordance with ASTM F3387-19. These requirements allow for achieving expected protection levels from respirator use. This revision to MSHA's existing standards will better protect miners who temporarily wear respiratory protection.
The
The updated respiratory protection standard reflects current practice at many mines that use respiratory protection and does not require the use of new technology. Thus, MSHA finds that the update is technologically feasible for affected mines of all sizes.
By amending existing standards to incorporate the updated respiratory protection consensus standard (ASTM F3387-19), MSHA intends that mine operators will develop effective respiratory protection practices that meet the updated consensus standard and that will better protect miners from respiratory hazards.
MSHA presumes that most mines with respiratory protection programs, and particularly those MNM mines that have operations under both MSHA and OSHA jurisdiction, are already following either the ANSI/ASSE Z88.2—2015 standard, the ASTM F3387-19 standard, or OSHA 29 CFR 1910.134. As several commenters noted, consistency between OSHA and MSHA requirements is beneficial for organizations regulated by both agencies, as it permits them to more easily comply with a single, consistent set of requirements. Mine operators with operations under OSHA jurisdiction would, by this logic, choose to comply with 29 CFR 1910.134 across all operations rather than develop separate programs for MSHA-regulated facilities. The respiratory protection program elements under ASTM F3387-19 are largely similar to those in the previous standard.
MSHA expects that some operators may need to adjust their current respiratory protection practices and standard operating procedures to reflect ASTM F3387-19 standard practices. Examples of adjustments include formalizing annual respirator training and fit testing; updating the training qualifications of respirator trainers, managers, supervisors, and others responsible for the respiratory protection program; reviewing the information exchanged with the physician or other licensed health care professional (PLHCP) conducting medical evaluations; and formalizing internal and external respiratory protection program reviews or audits.
Overall, MSHA finds that the amendments to parts 56, 57, and 72 are technologically feasible because the requirements of ASTM F3378-19 have already been implemented at many mines.
MSHA received several comments on the Agency's decision to limit respirator
The Construction Industry Safety Coalition (CISC) suggested that coal miners should be prohibited from working in overexposures while using respirators, stating that the working conditions, especially in underground coal mines, make it very difficult for miners to communicate and work safely while wearing respirators (Document ID 1430). Many commenters suggested that MSHA utilize the full hierarchy of controls to recognize respirators as an acceptable solution when combined with other efforts to lower exposure levels, including Arizona Mining Association, AEMA, NMA, NVMA, NSSGA, US Silica, SSC, BMC, Illinois Association of Aggregate Producers (IAAP) (Document ID 1368; 1424; 1428; 1441; 1448; 1455; 1432; 1417; 1456). Advocating expanded use of respiratory protection, but differing in their approach, a few commenters, including SSC, NSSGA, US Silica, and IAAP, wrote that respirators are the only feasible means of protection for certain tasks, including housekeeping, dust collector maintenance and repair, and bagging operations (Document ID 1432; 1448; 1455; 1456). The AEMA stated that MSHA should allow the use of respirators, including PAPRs, whenever miners are working in exposures above the PEL (Document 1424). Another commenter stated that miners should always use respirators, to ensure complete protection from respirable crystalline silica exposures. MSHA finds that engineering controls, supplemented by administrative controls, are technologically feasible and provide reliable, consistent protection for miners engaged in the identified tasks; MSHA declines to expand the allowable use of respiratory protection. MSHA emphasizes that both in the existing standards for MNM mines and in § 60.14, respiratory protection use is required to be temporary. The Agency emphasizes that it will continue to enforce “temporary” use of respirators as meaning that respirators are used for only a short period of time.
MSHA clarifies that the final rule does not permit the use of respirators in lieu of feasible engineering and administrative controls. If anything, MSHA has provided greater protection for miners by requiring (as opposed to making available) usage of respirators for all miners when exposed to respirable crystalline silica above the PEL.
Under the final rule, MNM mine operators will be required to provide periodic medical examinations performed by a physician or other licensed health care professional (PLHCP) or specialist, at no cost to the miner. 30 CFR 60.15. The medical surveillance standards extend to MNM miners similar protections to those available to coal miners under existing standards in 30 CFR 72.100. The requirements in § 60.15 are consistent with the Mine Act's mandate to provide maximum health protection for miners, which includes making medical examinations and other tests available to miners at no cost. 30 U.S.C. 811(a)(7).
Under the final rule, all MNM miners who are employed or have already worked in the mining industry must be provided the opportunity for an initial voluntary examination starting during an initial 12-month period that begins no later than the compliance date or during a 12-month period that begins whenever a new mine commences operations. Subsequent medical examinations must be available at least every 5 years during a 6-month period that begins no less than 3.5 years and not more than 4.5 years from the end of the previous 6-month period. MNM miners who begin work in the mining industry for the first time must receive an initial examination within 60 days of beginning employment. After their initial examination, these new miners must be provided a follow-up examination within 3 years. If the 3-year follow-up examination indicates any medical concerns associated with chest X-ray findings or decreased lung function, these miners must have another follow-up examination in 2 years. After this 2-year follow-up examination, or if the 3-year follow-up examination indicates no medical concerns associated with chest X-ray findings or decreased lung function, these miners will be eligible for voluntary periodic 5-year examinations, transferring them into the larger cohort of miners already employed in the mining industry.
The final rule requires that medical examinations include a review of the miner's medical and work history, a physical examination with special emphasis on the respiratory system, a chest X-ray, and a pulmonary function test. The medical and work history covers a miner's present and past work exposures, illnesses, and any symptoms indicating respirable crystalline silica-related diseases and compromised lung function. The required chest X-ray must be classified by a NIOSH-certified B Reader, in accordance with the Guidelines for the Use of the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses. The ILO recently made additional standard digital radiographic images available and has published guidelines on the classification of digital radiographic images (ILO, 2022). These guidelines provide standard practices for detecting changes of pneumoconiosis, including silicosis, in chest X-rays. The required pulmonary function test must be conducted by either a spirometry technician with a current certificate from a NIOSH-approved Spirometry Program Sponsor, or, as discussed in
MSHA has determined that it is technologically feasible for MNM mine operators to provide periodic examinations as described in the previous paragraph. Under the rule, a PLHCP, as defined, does not have to be an occupational medicine physician or a physician to conduct the initial and periodic examinations required by the rule, but can be any health care professional who is state-licensed to provide or be delegated the responsibility to provide those services. The procedures required (
Overall, MSHA finds that the medical surveillance provisions are technologically feasible and in the final rule maintains the proposed medical surveillance provisions, with some modifications.
MSHA received several comments on the feasibility of proposed § 60.15(a). The AIHA, the American Association of Nurse Practitioners (AANP), and CertainTeed, LLC supported MSHA's proposal to require MNM mine operators to provide MNM miners with medical examinations performed by a PLHCP or specialist (Document ID 1351; 1400; 1423). The Arizona Mining Association and the BIA expressed concerns with this requirement and asserted that many MNM mines may experience issues with access to a PLHCP or specialist qualified to perform the examinations (Document ID 1368; 1422). The APHA, the AOEC, and the ACOEM advocated for medical surveillance to be performed by physicians who are board-certified in occupational medicine or pulmonary medicine (Document ID 1416; 1373; 1405). The Hon. Rep. Robert C. “Bobby” Scott and an individual recommended that MNM miners should be able to choose their own health care provider (Document ID 1439; 1412). The AIHA and Black Lung Clinics stated that MSHA should require MNM miners to use NIOSH-approved facilities (Document ID 1351; 1410) while the AEMA and the NMA (Document ID 1424; 1428) expressed concerns about the limited availability of these facilities. The NMA, the Portland Cement Association, and the AEMA noted that there are only a limited number of B Readers available (Document ID 1428; 1407; 1424).
MSHA reviewed these comments and made one change to § 60.15(a) in the final rule. Under the proposed rule, a pulmonary function test must be administered by a spirometry technician with a current certificate from a NIOSH-approved Spirometry Program Sponsor. In the final rule, paragraph 60.15(a)(2)(iv) retains that language but adds pulmonary function technologists with current credentials from the National Board for Respiratory Care as individuals who may administer pulmonary function tests. This addition to the final rule text should further expand the pool of individuals eligible to administer pulmonary function tests.
MSHA determined that MNM mine operators should not experience any significant issues identifying a PLHCP or specialist to conduct medical examinations and emphasizes the final rule allows flexibility by not mandating that the medical examinations be conducted by full-time health care professionals employed by mine operators. As stated in the proposal, a PLHCP is an individual whose legally permitted scope of practice (
The Agency has reviewed the comments related to availability of B Readers. MSHA has determined that, based on technological improvements that remove the need for geographic proximity between patients and technicians such as B Readers, as well as widespread availability of tests such as X-rays, getting X-ray tests and the results classified by B Readers is technologically feasible. With respect to chest X-ray classification, the availability of digital X-ray technology permits electronic submission to remotely located B Readers for interpretation. After consulting NIOSH, MSHA determined there are B Readers with remote reading capabilities available to meet the demands of the final rule. Therefore, MSHA finds that the limited number of B Readers in certain geographic locations will not be an obstacle for MNM operators. MSHA further concludes that any increase in demand for these services can be addressed by providers. Further discussion regarding NIOSH-approved facilities and B Readers can be found in
MSHA's experience with the coal mine medical surveillance program has shown the Agency that PLHCPs who have the required NIOSH or other certifications have the training to effectively examine miners and identify the occurrence or progression of silica-related diseases, even if they may not operate within NIOSH-approved facilities. MSHA's updated research continues to support OSHA's conclusion in its 2016 silica final rule that the number of B Readers in the United States is adequate to classify chest X-rays (OSHA 2016a, 81 FR 16286, 16821). Further, an increased demand for B Readers as a result of this final rule will lead to additional training for many health care providers. In addition, digital X-rays can be easily transmitted electronically to B Readers anywhere in the United States. The final rule ensures that medical examinations are comprehensive and tailored to discern and mitigate potential health risks associated with miners' occupational exposures to respirable crystalline silica. The final rule will ensure that the medical examinations are both robust and flexible enough to accommodate advancements and variations in medical evaluation techniques. Further discussion regarding NIOSH-approved facilities and B Readers can be found in
The final rule does not require that examinations conducted under this section occur in NIOSH-approved facilities. There are only 168 NIOSH-approved health clinics nationwide. NIOSH manages the Coal Workers' Health Surveillance Program and the program's facilities are concentrated in geographies where coal mining is prevalent (
Based on MSHA's technological feasibility analysis, MSHA has determined that all elements of the rule on
MSHA considers economic feasibility in terms of industry-wide revenue and overall costs incurred by the mining industry (inclusive of MNM and coal) under a given rule. To establish economic feasibility, MSHA uses a revenue screening test—whether the estimated yearly costs of a rule are less than 1 percent of estimated revenues or are negative (
Based on its analysis of the Agency's sampling database, MSHA believes roughly 90 percent of mines will be able to meet the PEL without incurring additional costs, and only 580 mines will need to install engineering control to meet the new PEL (see standalone FRIA document Section 4). In response to public comments that MSHA underestimated the cost of implementing necessary exposure controls, MSHA increased its estimate of the number of mine operators that will have to implement additional exposure controls to meet the requirements of the final rule.
One commenter pointed out that engineering controls need to factor in site-specific conditions (Document ID 1441). MSHA acknowledges that the exposure control costs will differ depending on the size of the mine, the current level of exposure to respirable crystalline silica, existing engineering and administrative controls, the mine layout, work practices, and other variables. MSHA's price and cost estimations are based on a variety of sources including market research and MSHA's experience and sample data. Some of the cost estimates from commenters—such as those from very large mines or those representing many mines controlled by one operator—are impossible to meaningfully compare to MSHA's estimates. Nonetheless, these and other public comments about the costs of the final rule are addressed in more detail below in
For the MNM and coal mining sectors, MSHA estimates the projected impacts of the rule by calculating the annualized compliance costs for each sector as a percentage of total estimated revenues for that sector. To be consistent with costs that are calculated in 2022 dollars, MSHA first inflated estimated mine revenues in 2019 to their 2022 equivalent using the GDP Implicit Price Deflator. See Table VII-9.
Table VII-10 compares aggregate annualized compliance costs for the MNM and coal sectors at a 0 percent, 3 percent, and 7 percent discount rates to each sector's total annual revenues. At a 3 percent discount rate, total aggregate annualized compliance costs for the entire mining industry are projected to be $90.3 million (including both 30 CFR part 60 and 2019 ASTM costs), while aggregate revenues are estimated to be $124.2 billion in 2022 dollars. MSHA estimates that the mining industry is expected to incur compliance costs that comprise 0.07 percent of total revenues.
For the MNM sector, MSHA estimated that the annualized compliance costs of the final rule (including both 30 CFR part 60 and 2019 ASTM update costs) would be $82.1 million at a 3 percent discount rate, which is approximately 0.09 percent of the total estimated annual revenue of $95.1 billion for MNM mine operators. For the coal sector, MSHA estimated that the annualized cost of the final rule (including both 30 CFR part 60 and 2019 ASTM costs) will be $8.2 million at a 3 percent discount rate, which is approximately 0.03 percent of the total estimated annual revenue of $29.1 billion for coal mine operators.
The ratios of screening analysis are well below the 1.0 percent of total revenues threshold. Therefore, MSHA concludes that the requirements of the final rule are economically feasible, and no sector will likely incur a significant cost.
As previously mentioned, under the final rule, MSHA amends its existing standards on respirable crystalline silica or quartz, after considering all the testimonies and written comments the Agency received from a variety of stakeholders, including manufacturers, medical professionals, miners, mining associations, mining companies, labor organizations that represent mine workers, health associations, and safety associations in response to its notice of proposed rulemaking. The final rule establishes a PEL of respirable crystalline silica at 50 µg/m
The sections that follow address testimonies and written comments received on general issues and specific provisions in the proposal and MSHA provides its responses and final conclusions.
In this section, MSHA addresses comments that relate to the rulemaking as a whole and that are not specific to a single section of the final rule. MSHA identified six general issues for discussion below: Existing Respirable Dust Standards for Coal Mines; Training for Miners—Respirable Crystalline Silica; Sorptive Minerals; OSHA Table 1 Approach for Compliance; Medical Removal/Transfer; and Compliance Assistance.
MSHA will enforce the final rule's requirements for respirable crystalline silica in coal mines within the context of the Agency's existing standards for miners' exposure to respirable coal mine dust in 30 CFR parts 70, 71, and 90.
Some commenters, including the Wyoming County WV Black Lung Association, AFL-CIO, and two individuals, were concerned that controls implemented as immediate corrective actions for respirable crystalline silica at coal mines would not be incorporated into an underground coal mine's approved ventilation plan required under 30 CFR part 75 (Document ID 1393; 1449; 1399; 1412).
Under the final rule, mine operators are required to install, use, and maintain feasible engineering and administrative controls to keep each miner's exposure to respirable crystalline silica at or below the PEL. Mine operators must use feasible engineering controls as the primary means of controlling respirable crystalline silica; administrative controls can only be used, when necessary, as a supplementary control. Rotation of miners—that is, assigning more than one miner to a high-exposure task or location, and rotating them to keep each miner's exposure below the PEL—is prohibited as a means of complying with the rule.
For underground coal mines, the necessary controls to maintain compliance with existing respirable coal mine dust and respirable crystalline silica standards are contained in the ventilation plan that is approved by the appropriate District Manager. Under 30 CFR 75.370(a)(1), the approved ventilation plan shall control methane and dust and contains the detailed engineering controls that the operator will use to comply with the existing dust standards.
Under the existing respirable dust standards for coal mines, MSHA evaluates the approved ventilation plan to ensure that it is suitable to current conditions and mining systems at the mine. During each shift, the plan must be followed to protect miners from overexposure to respirable coal mine dust, which includes respirable crystalline silica. Currently, only MSHA sampling is used to evaluate miners' exposure to respirable crystalline silica. When respirable coal mine dust or respirable crystalline silica overexposures are documented, MSHA may consider the relevant portion of the ventilation plan deficient and require that the plan be revised to include additional ventilation controls, or the plan can be revoked by the Agency, as appropriate. MSHA evaluates the approved ventilation plan at least every 6 months, or more often if there are changes in the mine, mining processes, dust controls, or conditions at the mine affecting miners' exposure to respirable coal mine dust or respirable crystalline silica dust. MSHA typically samples all mechanized mining units and Part 90 miners (coal miners with evidence of pneumoconiosis) during each quarterly regular inspection of underground coal mines. MSHA typically samples the Designated Areas (DA)—outby areas of the mine—at least annually. This sampling represents an evaluation of dust exposure compliance and dust controls that are in the approved ventilation plan to ensure that they are effective. MSHA intends to continue conducting this sampling.
Under the existing respirable dust standards for coal mines, as in the final silica rule, when miners are overexposed, the operator must take immediate corrective actions to lower the miner's exposure to at or below the standard and sample to verify that the corrective actions are effective. The mine operator determines necessary engineering controls but must address the underlying conditions and practices which caused the overexposure. Corrective action sampling will be conducted with the control measures in place. Under the final silica rule, mine operators must report overexposures to the District Manager and corrective actions must be described in the record mandated in § 60.16. If a silica overexposure occurs, operators remain responsible for adjusting ventilation plans to account for additional controls needed to prevent future overexposures.
The existing respirable dust standards for coal mines will also maintain silica controls through mine operators' pre-shift and on-shift examinations. These examinations must ensure the ventilation controls that have been evaluated and found effective are maintained. The examinations protect miners from health and safety hazards between and on sampling shifts.
The UMWA, AFL-CIO, Wyoming County WV Black Lung Association, and an individual requested that additional sampling be conducted at coal mines (Document ID 1398; 1449; 1393; 1382). UMWA and an individual supported the standalone silica PEL but urged MSHA to retain the reduced dust standard concept due to the large number of quarterly dust samples operators must take that indirectly monitor silica exposure (Document ID 1398; 1382).
MSHA's enforcement of respirable coal mine dust under the existing respirable coal mine dust standards will continue. The final rule establishes a standalone silica PEL and adds operator silica sampling that may result in additional operator silica sampling (every three months) in many underground coal mines. It also requires immediate corrective actions and resampling if exposures exceed the PEL. The final rule also requires periodic evaluations at least every 6 months, or whenever there is a change in production; processes; installation and maintenance of engineering controls; installation and maintenance of equipment; administrative controls; or geologic conditions. Dependent on the results of the periodic evaluation in this final rule, coal mine operators may have to perform additional sampling. MSHA expects the final rule's requirements will result in sufficient sampling to accurately detect miners' exposures to silica at coal mines.
The final rule requires that mine operators sample miners exposed or reasonably expected to be exposed to respirable crystalline silica. If samples are above the action level and below the PEL, mine operators must continue to sample within three months. Operators must conduct representative sampling (at least two samples) of the occupations at highest risk of respirable crystalline silica exposure. The existing standards for respirable coal mine dust sampling require 15 valid representative consecutive shift samples for certain high-dust occupations, followed by more samples in other identified occupations and areas the District Manager designates based on anticipated or actual exposures.
The final rule decouples silica sampling and enforcement from the existing respirable dust standard requirements that reduce the total
MSHA received several comments both in favor of and against including respirable crystalline silica training for miners in 30 CFR part 46 (Training and Retraining of Miners Engaged in Shell Dredging or Employed at Sand, Gravel, Surface Stone, Surface Clay, Colloidal Phosphate, or Surface Limestone Mines) (part 46) and 30 CFR part 48 (Training and Retraining of Miners) (part 48). Two mining trade associations suggested that existing training requirements under parts 46 and 48 for new miner training, experienced miner training, annual refresher training, and task training remain sufficient and that an additional training requirement would be unnecessary (Document ID 1424, 1441). Other commenters, including a mining labor union and several professional associations, stated that the final rule should include new training requirements separate from parts 46 and 48 (Document ID 1398; 1351; 1377; 1373).
MSHA believes existing training standards in parts 46 and 48 require appropriate training regarding health hazards, including exposure to respirable crystalline silica dust.
Part 46 requires new miners and newly hired experienced miners to receive training on the health and safety aspects of the tasks to be assigned, including the safe work procedures of such tasks, the mandatory health and safety standards pertinent to such tasks, information about the physical and health hazards of chemicals in the miner's work area, the protective measures a miner can take against these hazards, and the contents of the mine's HazCom program. They must also receive instruction and demonstration on the use, care, and maintenance of self-rescue and respiratory devices, if used at the mine.
Annual refresher training conducted under part 46 must include instruction on changes at the mine that could adversely affect the miner's health or safety and other health and safety subjects relevant to mining operations at the mine, including mandatory health and safety standards, health, and respiratory devices.
For new task training, part 46 requires miners to receive training in the health and safety aspects of the task to be assigned, including the safe work procedures of such tasks, information about the physical and health hazards of chemicals in the miner's work area, the protective measures a miner can take against these hazards, and the contents of the mine's HazCom program. Section 46.9 requires records of training and includes specific provisions for the record requirements.
Part 48 requires new miners to receive training on health including instruction on the purpose of taking dust, noise, and other health measurements, and any health control plan in effect at the mine shall be explained. New miners must also receive training in the health and safety aspects of the tasks to be assigned, including the safe work procedures of such tasks, the mandatory health and safety standards pertinent to such tasks, information about the physical and health hazards of chemicals in the miner's work area, the protective measures a miner can take against these hazards, and the contents of the mine's HazCom program.
Experienced miner training under Part 48 must include instruction in health, including the purpose of taking dust, noise, and other health measurements, where applicable, and review of the health provisions of the Mine Act. Experienced miners must also receive training in the health and safety aspects of the tasks to be assigned, including the safe work procedures of such task, information about the physical and health hazards of chemicals in the miner's work area, the protective measures a miner can take against these hazards, and the contents of the mine's HazCom program.
For new task training, part 48 requires miners to receive training on the health and safety aspects and safe operating procedures for work tasks, equipment, and machinery, including information about the physical and health hazards of chemicals in the miner's work area, the protective measures a miner can take against these hazards, and the contents of the mine's HazCom program.
Annual refresher training conducted under part 48 must include instruction on mandatory health and safety standard requirements which are related to the miner's tasks and on the purpose of taking dust, noise, and other health measurements, as well as an explanation of any health control plan in effect at the mine. The health provisions of the Mine Act and warning labels must also be explained. Sections 48.9 (Underground Miners) and 48.29 (Surface Miners) require records of training.
Training is also a required element of the mine operator's respiratory protection program. Miners required to wear a respirator must be trained in accordance with the provisions of ASTM F3387-19 and records must be retrained in accordance with the provisions of section 9.
MSHA expects mine operators to include information in their existing training plans about respirable crystalline silica hazards and protections, including: the PEL and action level; sampling requirements; miners who are reasonably expected to be exposed to respirable crystalline silica; engineering and administrative controls used at the mine; the importance of maintaining controls; and, for MNM mines, medical surveillance requirements, including the importance of early disease detection. MSHA remains available to assist mine operators with their training plans.
The SMI, EMA, and Vanderbilt Minerals, LLC requested that MSHA follow OSHA's approach to sorptive minerals and exclude them from the scope of the final rule (Document ID 1446; 1442; 1419). These commenters asserted that lower toxicity of occluded and aged crystalline silica indicates a lack of health risks stemming from inhaling sorptive mineral dust containing respirable crystalline silica.
After considering the commenters' statements and evidence, as well as OSHA's approach to the issue, MSHA has determined that sorptive minerals should not be excluded from the scope of this rulemaking.
MSHA evaluated all the evidence submitted by commenters during the rulemaking process, including the hearings, and concludes that the balance of the best available evidence supports that there is increased risk of material impairment of health or functional capacity over the course of a miner's working life associated with regular exposure to respirable crystalline silica present at sorptive mineral mines. MSHA's approach is consistent with NIOSH's recommendation for a single PEL for respirable crystalline silica without consideration of surface properties. MSHA is unable to substantiate one commenter's statement that, in every instance, the silica in sorptive minerals is either amorphous (
MSHA's method for analyzing respirable dust samples cannot differentiate between “freshly fractured” and occluded crystalline silica. Respirable dust enforcement samples in MNM mines are prepared for crystalline silica analysis using the MSHA P-2 method for X-ray diffraction (XRD). Crystalline materials each have their own unique diffraction patterns and are quantitatively discriminated between other crystalline and non-crystalline materials through XRD analysis. Potential interferences from other minerals are removed from the result by scanning the sample at multiple diffraction angles specific to crystalline silica and using profile fitting software to separate adjacent diffraction peaks. MSHA cannot determine if crystalline silica particles in the sample are “freshly fractured” or occluded with a layer of clay, only that the diffraction pattern matches that of the pure crystalline silica standard reference material.
MSHA's enforcement data in Table VIII-1 below show that miners working in this industry are exposed to respirable quartz at concentrations above both the former PEL (100 µg/m
The results in the table indicate that 5.1 percent of miners working at these operations during the relevant period were exposed to levels of respirable crystalline silica over the former PEL of 100 µg/m
MSHA disagrees with commenters' statements that the silica contained in sorptive minerals does not pose health risks. MSHA does not equate “lower toxicity” with other toxicological terms such as “non-hazardous”, “non-toxic”, or “safe.” “Lower toxicity” does not mean the absence of adverse health effects, disease, or risk of material impairment of health or functional capacity. For example, the bioactivity of respirable crystalline silica (quartz) originating from bentonite deposits is well-recognized and documented on sorptive mineral-based pet litter safety data sheets (SDSs). MSHA concludes from its own sampling data and analyses that the mining of sorptive minerals creates an inhalation hazard. As confirmed by MSHA's review of epidemiological and toxicological studies, these mineral dusts are toxic and can lead to serious adverse health effects in miners such as silicosis or lung cancer. Accordingly, MSHA concludes that there is a risk of material impairment of health or functional capacity in mining, whether or not that risk is equal to unoccluded quartz encountered in other workplaces.
In its 2016 final rule, OSHA concluded that quartz originating from bentonite deposits had some biological activity but “lower toxicity” than quartz encountered in most workplaces (81 FR 16377). OSHA also found that the record provided no sound basis for determining significance of risk for exposure to sorptive minerals containing quartz, and thus decided to exclude sorptive minerals from the
MSHA has examined research references from commenters and has conducted its own review of the scientific literature. These studies do not disprove the health-based risks associated with exposure to respirable crystalline silica or support a conclusion that sorptive minerals present no risk.
As presented by SMI, there have been few epidemiological studies of workers exposed to dust generated from sorptive minerals (Document ID 1446, Attachment 2). Two examples include Phibbs
MSHA disagrees with the comment that the occluded surface of the silica that may be found in sorptive minerals protects miners from material impairment of health, including silicosis and lung cancer. Furthermore, there is no evidence to suggest that the occluded layer of the quartz particles that are inhaled remains unchanged over time following deposition throughout the respiratory tract. It is not understood how conditions and physiological responses may alter the characteristics of occluded quartz particles deposited in the respiratory tract. Likewise, while animal studies involving respirable crystalline silica suggest that the aged form has lower toxicity than the freshly fractured form, the aged form still retains significant toxicity (Shoemaker
MSHA considered commenters' statements and evidence regarding the toxicity of quartz in sorptive minerals. MSHA's conclusions are consistent with those that NIOSH provided to OSHA (NIOSH Posthearing Brief to OSHA, 2014d). NIOSH corrected various erroneous statements that referenced published papers (
NIOSH addressed a commenter's presumption that further study was needed on occluded quartz before regulation was warranted. NIOSH explained that further study on occluded quartz was less pertinent for OSHA's rulemaking than the fact that the OSHA PEL was consistent with the NIOSH REL in not distinguishing respirable crystalline silica exposures based on relative age or degree of occlusion of particle surfaces. MSHA concurs with NIOSH's conclusion that “currently available information is not adequate to inform differential quantitative risk management approaches for crystalline silica that are based on surface property measurements.” For these reasons, MSHA does not exempt the sorptive minerals sector from the requirements of this final rule.
OSHA's “Table 1—Specified Exposure Control Methods When Working With Materials Containing Crystalline Silica” (Table 1) (29 CFR 1926.1153(c)(1)) identifies common construction equipment and tasks that, when properly controlled, are expected to generate levels of respirable crystalline silica below the PEL. Construction employers who follow these engineering and work practice control methods and provide the required respiratory protection outlined in Table 1 are generally not required to sample their workers' exposures to silica and are presumed to be in compliance with OSHA's standard.
MSHA did not propose adopting specified exposure control methods for task-based work practices, similar to OSHA's Table 1. However, in the proposal, MSHA sought comments on specific tasks and exposure control methods appropriate for a Table 1 approach for the mining industry that would also adequately protect miners from risk of exposure to respirable crystalline silica.
MSHA has decided not to include a Table 1 approach for the mining industry in the final rule. After considering input from stakeholders on specific tasks and exposure control methods suitable for a Table 1 approach, MSHA determined that such an approach would not provide the necessary protection for miners against overexposure to respirable crystalline silica under all mining conditions. The Agency has concluded that because of the changing nature of the mining environment, exposure monitoring is essential to ensure that controls are functioning effectively, properly maintained, and adjusted as necessary to ensure compliance.
Under the final rule, mine operators are required to implement feasible engineering controls, and administrative controls, when necessary, to maintain each miner's exposure below the PEL.
Commenters from an industrial hygiene association and labor organizations, supported MSHA's decision not to include a Table 1 approach for mining activities (Document ID 1351; 1398; 1449). The UMWA stated that this approach is not necessary since mine operators already have access to proper dust control systems and MSHA-approved ventilation plans (Document ID 1398). This commenter also noted that, because mining conditions are constantly changing, it would be incorrect to assume that operators using a Table 1 approach to control respirable crystalline silica exposure would always be in compliance. Two commenters (a professional association and a labor union) stated that the Table 1 approach would be neither protective nor feasible in the mining context, while one of those commenters stated that delaying the final rule to develop a Table 1 approach will create more harm for workers (Document ID 1351; 1398).
MSHA agrees that due to constantly changing mining conditions, OSHA's Table 1 is not the most effective approach for protecting miners' health. A fundamental aspect of mining is that the mine environment is dynamic, resulting in varying exposures to respirable crystalline silica for miners. Silica exposures can fluctuate based on the amount of silica present in rock, which depends on the geological composition of the rock. Miners engaged in tasks that generate dust from this rock material may face elevated exposure levels. For example, activities that involve cutting, grinding, drilling, or crushing rock with higher-silica levels can generate dust with high silica content. In addition, mining operations are diverse, involving different types of mining, each with various mining processes. Each process involves specific equipment and methods tailored to the unique characteristics of the material being mined.
Many commenters, including trade associations, mining related businesses, a labor union, and a MNM operator urged MSHA to include a provision like Table 1 in the final rule, with Portland Cement Association, NSSGA, and CertainTeed, LLC submitting example tables for MSHA to consider (Document ID 1407; 1408; 1424; 1441; 1448; 1404; 1409; 1429; 1442; 1417; 1431; 1423). SSC noted that certain tasks, processes, and environments are at least somewhat similar or common across many MNM mines and may be characterized by the extent to which they may release respirable crystalline silica, mechanisms for doing so, and effective exposure controls (Document ID 1432). This commenter also stated that a Table 1 approach would provide mine operators with a choice between using their own controls and sampling to evaluate effectiveness (and compliance with the standard) or using the controls listed in the table. SSC noted that a clear list of controls required for each type of task, exposure, or process would simplify compliance and enforcement. SSC further noted that if a mine operator relied on the table and implemented or used all the engineering and administrative controls in the table, they would know that, in so doing, they would achieve compliance.
MSHA has determined that reliance on a task-based approach would not address all mining tasks and situations that could result in respirable crystalline silica exposures, leaving miners without adequate protection. In addition, a task-based approach may not address cumulative exposures over a shift for miners who perform multiple tasks that generate respirable silica during a single shift. MSHA has determined that because mining involves a wide range of activities, each with its own potential for different dust generating sources and potential silica exposure, a task-based approach does not protect miners, especially those miners who perform multiple tasks involving silica exposures during a single shift.
MSHA agrees with commenters that there are many job positions in the mining industry that have similar exposure risks. However, as one commenter testified, miners may work at multiple job positions or tasks throughout the shift or a workweek. This commenter noted that a miner may work as a laborer, crusher operator, or a loader operator in a single shift. Another commenter acknowledged that it would be difficult for a Table 1 approach to work because of the various tasks a miner performs (this commenter referenced a discussion on this topic between a mine operator and the Agency at the Denver, Colorado public hearing). MSHA's data indicates that a significant number of miners are classified as laborers, mobile workers, and utility workers. Approximately 31 percent of the MNM miners are mobile workers and approximately 39 percent of coal miners are laborers, utility workers and other workers who do not have specific job categories. These are job positions that perform different work activities during a shift. MSHA has determined that OSHA's Table 1 would be difficult to implement for most mines, especially mines that employ laborers, mobile workers, and utility workers.
The Portland Cement Association and NSSGA stated that OSHA's 2019 RFI, which assessed the effectiveness of Table 1, demonstrated that it was effective in lowering exposures and encouraged the adoption of engineering controls (Document ID 1407; 1448). However, AIHA explained that research indicates that worker exposure in the construction industry can exceed the OSHA PEL of 50 μg/m
Portland Cement Association recommended that MSHA should adopt an OSHA Table 1 approach that encourages mine operators to install engineering controls and remove the operator's obligation to assess exposures in work environments where individual miner's respirable crystalline silica exposures are controlled by engineered devices to ensure compliance with the action level and the PEL (Document ID 1407). Under OSHA's approach, prescribed engineering controls and work practice methods, along with respiratory protection, are assumed to be sufficiently effective in reducing miners' exposures; exposure monitoring to ensure compliance with the PEL is not required. MSHA, however, has determined that exposure monitoring is critical in safeguarding miners' health. It provides the quantitative data needed to assess the effectiveness of engineering controls and is essential to ensuring that controls remain effective at all times. This is consistent with NIOSH's recommendation to OSHA during its rulemaking that Table 1 should not replace sampling requirements for the construction industry because even fully implementing the control methods and respiratory protection described in OSHA's Table 1 would not ensure compliance with the PEL. In addition, MSHA, in this final rule, does not allow respiratory protection as a means to achieve compliance.
OSHA's Table 1 approach relies on respiratory protection when engineering and administrative controls are not sufficient to limit exposures. Respiratory protection is used for compliance when control methods cannot reduce exposures below the PEL. MSHA has determined that existing engineering controls are the most
The mining industry encompasses a wide range of processes and equipment due to the diversity of mined commodities. However, as commenters noted, processes and equipment are tailored to the type of material mined. SSC noted that certain tasks, processes, and environments are at least somewhat similar or common across many MNM mines and may be characterized by the extent to which they may release respirable crystalline silica, mechanisms for doing so, and effective exposure controls (Document ID 1432). IME recommended that MSHA adopt a Table 1 approach for rock drilling operations that use a dust collection system around the drill bit and the use of low-flow water spray to wet the dust discharged from the dust collector (Document ID 1404). This commenter also noted that all drill rigs used by the explosives industry have fully enclosed cabs to isolate operators from dusty conditions. EMA suggested that a Table 1 approach could include processes with consistent/predicable dust generation characteristics, such as mobile equipment cabs, control rooms with proper ventilation and seals on doors and windows, utility vehicles, handheld power tools such as jackhammers, and tasks performed in potentially high exposure areas, such as crushing or bagging (Document ID 1442). This commenter submitted that many engineering and administrative controls or work practices can be gleaned from NIOSH's updated Dust Control Handbook for Industrial Minerals Mining and Processing, Second Edition. The commenter further noted that the NIOSH Dust Control Handbook is an excellent resource and could reduce the amount of research necessary to create a usable Table 1.
MSHA has determined that these controls cannot be relied on without independent assessment (exposure monitoring) to ensure that they are effective and continue to protect miners. For example, MSHA has found that equipment operators who are working in enclosed cabs report some of the highest exposures. These miners are exposed to high silica exposures because the enclosures are not properly maintained. Under a Table 1 approach, equipment operators would be presumed to be protected by enclosed cabs and not exposed to silica above the PEL.
A fundamental feature of mining is that the mine environment constantly changes. MSHA has concluded that miners' exposures to respirable crystalline silica vary with much greater frequency than in general industry, construction, or maritime settings. A feasible engineering control implemented in a mine (including a mill) cutting into or processing lower-quartz-containing rock might not be appropriate for a mine cutting into rock with a higher percentage of quartz or using a different mining process or modified equipment.
In addition, certain mining environments must take into account bystander exposure. For example, in underground mining environments, the ventilation is often in a series configuration, where the exhaust of one miner's controls could be the intake for other miners downwind. This results in the upwind engineering controls having an effect on all of the miners that are downwind. In contrast, OSHA's construction and general industry worksites have controls that can be exhausted to the outside atmosphere and will not affect other workers nearby.
MSHA has determined that, in the context of mining, Table 1 controls cannot be relied on without independent assessment (exposure monitoring) to ensure that they are effective, maintained, and continue to protect miners. MSHA's enforcement experience and data show that some of the highest respirable crystalline exposures result from mine operators not maintaining engineering controls. Poor maintenance of engineering controls, without exposure monitoring, can result in miners working above the PEL for extended periods, jeopardizing their health. For example, a miner working at a surface MNM mine was exposed to 192 μg/m
In addition, geological formations and quantities of quartz are not always predictable and the Agency believes that controlling exposures to respirable crystalline silica to below the PEL through sampling is the best way to protect miners' health. Accordingly, MSHA has concluded that because of the dynamic, constantly changing nature of the mining environment, exposure monitoring is essential to ensure that controls are functioning effectively, properly maintained, and adjusted as necessary to ensure compliance.
In response to MSHA's solicitation for stakeholder input on a Table 1 approach, commenters representing the stone, sand, and gravel industries provided information and data on an alternative Table 1 for MSHA's consideration. The NSSGA provided a proposed Table 1 that grouped various equipment operator positions by equipment and tasks (including a description of operation and tasks performed) and identified engineering and work practice control methods for the equipment and tasks (Document ID 1448). The commenter noted that this Table 1 is protective of workers and does not give operators an “out” when a worker performs a task that is listed on the table. The commenter further noted that under their proposed Table 1, the operator must ensure all engineering and work practice control methods are done to comply with the table and not engage in exposure monitoring. The commenter stated their Table 1 approach works because sampling has been done that demonstrates these
The Portland Cement Association provided respirable crystalline silica exposure data by job classification and an alternative Table 1 that identified equipment/tasks, engineering and work practice controls, and required respiratory protection and assigned protection factor (Document ID 1407). As the commenter noted, the table shows control measures in widespread use in the cement manufacturing industry, which the commenter believes some MNM mine operators use at their operations.
MSHA considered commenters' Table 1 approaches. Like OSHA, the commenters' alternative approaches provide specific guidance on how to control work exposures to respirable crystalline silica for specific tasks. The suggested Table 1 approaches list the equipment/task and identify the similarly exposed positions and appropriate engineering and work practice control methods.
MSHA has determined that because mining involves a wide range of activities, from drilling and blasting to crushing and processing materials, each with its own potential for different dust generating sources and potential silica exposure, as well as differing silica-bearing strata, a task-based approach does not protect miners, especially those miners who perform multiple tasks involving silica exposures during a single shift. A Table 1 approach can be effective for construction activities. However, Table 1's applicability to mining and milling operations is limited due to the complexity, variability, and unique challenges inherent in mining and milling operations. Activities in these operations are highly variable, due to the types of ores, minerals, and materials processed. Mining and milling operations run continuously, unlike some construction activities which may not be continuous or steady. Continuous operations require different control measures and monitoring strategies to address sustained miner exposures over an extended period. In addition, MSHA has determined that specified control methods may not provide a continued and verifiable level of protection to miners. Exposure monitoring is essential to ensure that the controls remain effective at all times. Further, as stated earlier, this final rule does not allow respiratory protection as a means to achieve compliance.
MSHA also received comments stating that a Table 1 approach would benefit intermittent and seasonal mining operations. The NSSGA stated that these mine operators do not have as much time to conduct sampling and would benefit from a Table 1 approach (Document ID 1448). Similarly, North America's Building Trades Unions (NABTU) noted that being able to implement controls according to job function, without having to take air samples, would help portable mines and construction contractors to achieve compliance in dynamic work environments (Document ID 1414). CISC explicitly requested that MSHA conduct a final review and produce a report for comment analyzing silica exposure from all jobs associated with quarrying operations, and either exclude them from the proposed rule or create a Table 1 approach, indicating that most jobs in surface quarrying operations are incapable of exceeding the proposed PEL (Document ID 1430). As noted above, MSHA has determined that, due to the diverse range of activities involved in mining, and constantly changing mining conditions—including drilling, blasting, crushing, and material processing, each with its unique potential for silica exposure—a Table 1 approach does not adequately protect miners. This is particularly true for miners who are engaged in multiple tasks involving silica exposure within a single shift. MSHA has also concluded that control methods must be assessed to ensure they provide sufficient protection; therefore, exposure monitoring is essential to verify the ongoing effectiveness of implemented controls.
The Agency also received comments about alternative approaches to Table 1-type guidance. NSSGA stated that jobs where workers are in enclosed cabs, booths, and buildings have consensus standards and should be in Table 1 (Document ID 1448). Some commenters, including AIHA and IEEE, suggested that MSHA incorporate or recommend relevant control standards designed to protect workers performing certain tasks, such as ISO 23875: 2021, to provide operators with more tools to protect workers while continuing mandated exposure monitoring (Document ID 1351; 1377). Draeger, Inc. stated that MSHA should consider incorporating Table 1 content into a silica guidance document (Document ID 1409). NVMA suggested that MSHA should allow operators to develop their own Table 1 as part of their dust protection plan but cautioned that MSHA should not be permitted to cite the development of an internal tool unless the PEL is exceeded, and a respirator is not used (Document ID 1441). Draeger, Inc. also acknowledged that creating a Table 1 approach would be a significant effort and suggested that MSHA initially consider high-risk tasks in developing the control methods (Document ID 1409). EMA recommended that MSHA should consult the Dust Control Handbook for Industrial Minerals Mining and Processing, Second Edition, to reduce the amount of research necessary to create a Table 1 approach (Document ID 1442).
MSHA acknowledges that consensus standards can assist mine operators in the development and selection of proper engineering controls for their mine sites and supports the use of consensus standards in the design of operator enclosures for hazardous environments. MSHA also recognizes the value of providing guidance on engineering and work practice control methods for similar exposure groups to ensure compliance with the final rule. The Agency supports and encourages the use of NIOSH's Dust Handbook by mine operators to determine feasible and appropriate engineering controls for their mine sites. MSHA will work with operators and miners to develop and implement effective controls, including necessary exposure monitoring. MSHA encourages mine operators to be proactive in their approach to protecting miners from silica exposures. MSHA encourages operators to develop dust control plans or other engineering tools in their operations. MSHA also commits to developing guidance that includes information on consensus standards related to control methods. MSHA will collaborate with stakeholders, including industry and labor, as well as NIOSH, to help mine operators and miners in implementing appropriate control methods. MSHA will also provide education and training to mine operators and miners covering all aspects of the final rule.
MSHA does not include a medical removal/transfer option for MNM miners with evidence of silica-related disease in the final rule. MSHA intends to consider this issue in a future rulemaking.
In the proposed rule, MSHA solicited comments on whether the final rule should include a medical removal/transfer option for MNM miners who have developed evidence of silica-related disease that is equivalent to the transfer rights and exposure monitoring provided to coal miners in 30 CFR part 90 (part 90). Under part 90, any coal miner who has evidence of the development of pneumoconiosis based on a chest X-ray or other medical examination has the option to work in
MSHA received comments from labor organizations, mining trade associations, black lung clinics, a federal elected official, an industrial hygiene professional association, an advocacy organization, a medical professional association, and an individual generally supporting medical removal/transfer rights. These commenters urged MSHA to include the provisions of part 90 in the rule and stated these protections should apply for a medically confirmed diagnosis of silicosis for any miner (Document ID 1351; 1398; 1416; 1418; 1421; 1424; 1439; 1441; 1449). Many of these commenters, as well as the Black Lung Clinics, the USW, and an individual stated that MNM miners should be provided similar medical removal/transfer rights as coal miners (Document ID 1410; 1447; 1437). The UMWA, Black Lung Clinics, and AFL-CIO noted that a medical removal/transfer program helps address the barriers related to fear of retaliation and income loss workers face when choosing to participate in medical surveillance (Document ID 1398; 1410; 1449).
After reviewing the comments and based on its experience with part 90 for coal miners, MSHA agrees that medical removal/transfer would enhance health protections for MNM miners who choose to exercise their rights; however, the Agency has determined that this would be more appropriately addressed in a future rulemaking. MSHA believes that the NIOSH-established reporting system referenced in the final rule needs to be developed and implemented before implementing medical removal/transfer requirements. For example, under part 90, NIOSH administers medical surveillance and notifies mine operators when a miner exercises their part 90 rights. Under this final rule, MNM medical surveillance is administered independent of NIOSH, and there are many more MNM miners than coal miners. Because of these differences, the Agency concluded that medical removal/transfer would benefit from additional notice and comment on a number of decision points, including protecting miners' privacy, adequacy of forms for notification, timing of benefits, what area of the mine the miner would be transferred to, whether NIOSH must make the determination, and consistent ILO classification. Further, MSHA agrees with the many commenters that urged the Agency to issue this final rule without delay.
MSHA also clarifies that, under final § 60.14(b), a mine operator must, upon receiving written notification from a PLHCP, facilitate the temporary transfer of an affected miner who cannot wear a respirator to a different area or occupation within the same mine where respiratory protection is not necessary. The final rule requires that transferred miners continue to receive compensation at no less than the regular rate of pay in the occupation that they held immediately prior to the transfer.
MSHA will provide compliance assistance to the mining community (including industry and labor) after publication of the final rule. This assistance will include guidance to assist mine operators in developing and implementing appropriate controls; outreach seminars (onsite and virtual, dates and locations will be posted on MSHA's website); dust control workshops held at the National Mine Health and Safety Academy; support from the Educational Field and Small Mine Services staff; support from MSHA's Technical Support staff; silica training and best practice materials; and information on MSHA's enforcement efforts.
Additionally, MSHA will continue its Silica Enforcement Initiative by evaluating all sampling data and enforcement actions and providing compliance assistance on specific engineering controls. MSHA will continue to maintain a team of experts in regulatory compliance and respirable dust control to conduct compliance assistance visits. These visits will evaluate the conditions, mining practices, and controls that lead to silica dust overexposures. MSHA will discuss its results with mine operators and miners and make recommendations as a part of the Agency's compliance assistance activities.
As a part of its ongoing alliance agreements, MSHA will discuss issues and questions in regular alliance safety and health meetings. MSHA will continue to work with NIOSH in the development and delivery of compliance assistance materials. Compliance assistance materials will be posted on MSHA's and NIOSH's website, some of which may be reposted to the MSHA app. NIOSH's Dust Control Handbook is a useful tool for mine operators to determine feasible and appropriate engineering controls for their mine sites. MSHA encourages mine operators to use this resource. MSHA will work with mine operators and miners to develop and implement effective controls, including evaluating exposure monitoring results. MSHA encourages mine operators to be proactive in their approach to protecting miners from silica exposures and to develop dust control plans or other engineering tools in their operations. MSHA also commits to developing guidance that includes information on consensus standards related to control methods. MSHA will also provide education and training to mine operators and miners covering all aspects of the final rule.
Part 60 of the final rule establishes uniform mandatory health standards for exposure to respirable crystalline silica in MNM and coal mines. Part 60 includes 10 sections: Scope and compliance dates; Definitions; Permissible exposure limit (PEL); Methods of compliance; Exposure monitoring; Corrective actions; Respiratory protection; Medical surveillance for metal and nonmetal mines; Recordkeeping requirements; and Severability. For each section below, MSHA discusses the requirements of the final rule and addresses the public comments received in response to the July 2023 proposed rule.
The final rule establishes requirements for the scope of the rule and the compliance dates in § 60.1. Section 60.1 paragraph (a) identifies the scope of the final rule, and the language is unchanged from the proposal. In a change from the proposal, paragraph (b) identifies the separate compliance dates for coal mine operators in paragraph (b)(1) and for metal and nonmetal mine operators in paragraph (b)(2). Paragraph (b)(1) establishes a compliance date for coal mine operators of 12 months after publication of the final rule. Paragraph (b)(2) establishes a compliance date for metal and nonmetal mine operators of 24 months after publication of the final rule. Below is a detailed discussion of the comments received on this section and modifications made in response to the comments.
MSHA received many comments regarding the scope of the rule. Some commenters, including the AIHA, ACOEM, APHA, expressed support for
MSHA continues to believe that a unified approach to controlling respirable crystalline silica provides the greatest level of health protection for MNM and coal miners. The purpose of this final rule is to reduce respirable crystalline silica-related occupational diseases in miners and to improve respiratory protection against airborne contaminants. Based on MSHA's review of the adverse health effects related to respirable crystalline silica—a known carcinogen—MSHA concludes that the health risks threaten all miners exposed to respirable crystalline silica. It is important that the mandatory health standards for MNM and coal miners be consistent to ensure that all miners are equally protected from exposure. Selected surveillance data for both silicosis cases and deaths are reported in the standalone Health Effects document and in the preamble in
While MSHA acknowledges that MNM and coal mines have been regulated separately in the past, there is precedent for a unified approach. For example, MSHA's health standard for occupational noise covers both MNM and coal mines, as discussed in “Evaluating hearing loss risks in the mining industry through MSHA citations” (Sun and Azman, 2018). Like respirable crystalline silica, occupational noise is a hazard for all miners. MSHA's survey and enforcement data indicate that since the occupational noise rule became effective in September of 2000, there has been a drastic decrease in the rate of overexposures at both MNM and coal mines. Because the hazards and control methods of respirable crystalline silica are common to both coal and MNM, MSHA believes a unified standard will offer miners consistent improvement of working conditions in both sectors.
As addressed in the standalone Health Effects document, MSHA has reviewed studies supporting increased risk of adverse health effects for miners working in both coal and MNM mines. After decades of declining prevalence of pneumoconiosis among underground coal miners in the U.S., prevalence, including more advanced forms of disease, has increased since the late 1990s (Laney and Weissman, 2012; Blackley
MSHA does not agree with the assertion that silicosis or other diseases linked to respirable crystalline silica are not risks for MNM miners. MSHA reviewed a wide range of studies that demonstrated disease risks among miners occupationally exposed to respirable crystalline silica. These studies were not limited to coal miners and covered occupations relevant to MNM mining such as sandblasters (Hughes
This rule will strengthen miners' health protections by reducing exposures to respirable crystalline silica, which is the root cause of silica-related disease. MSHA believes that this uniform approach provides a more protective, coherent, logical, and predictable standard for miners and mine operators. Unlike the existing standards, this final rule establishes a single, uniform PEL and action level, and eliminates any need for conversion based on percent respirable crystalline silica and any variations in calculation for different silica polymorphs. The final uniform PEL will provide all miners with a consistent level of protection that is similar to the protection provided to workers in industries covered by OSHA's silica standards, and consistent with the recommendations of NIOSH.
Several commenters requested clarification of applicability or exemptions to specific sectors of the mining industry: mining contractors, portable mines, and the sorptive minerals sector.
Some commenters from industry trade associations and mining trade associations requested that MSHA clarify the rule's applicability to mining contractors in the final rule (Document ID 1422; 1433; 1424; 1428; 1378). Consistent with the Mine Act, MSHA's existing standards, and the Agency's longstanding policy, independent contractors engaging in mining activities, including construction, maintenance, and drilling, are required to comply with the requirements in this final rule.
Some commenters (MNM operators and a mining-related business) requested that MSHA exempt portable mine operations from exposure monitoring (Document ID 1392; 1415; 1427; 1435; 1436). The mining-related business commented that an exemption should be granted for portable mines that are shut down for more than 3 months out of the year or operate in a pit for less than 30 days before moving (Document ID 1392). Several portable mine operators, including B & B Roads, Inc., stated that rock crushing jobs are typically completed within 4 to 10 days, at which point the portable mine moves to another job location, which could be between 30 to 200 miles away (Document ID 1427; 1436). These commenters specifically requested exemptions for sites that they do not own, stating that sampling data would not be applicable if done at pits where they do not conduct operations regularly. However, these commenters expressed that they were not asking for exemptions to pits where they regularly conduct operations or to locations they control.
MSHA reviewed the comments and determined that because of MSHA's clear mandate to protect the health of all miners, the final rule does not exempt portable mines. Under existing MNM standards for airborne contaminants, portable operations are not exempt from any regulatory requirements or any other health standards. This final rule, like existing standards, requires portable mine operators to protect their miners from overexposure to respirable crystalline silica and other airborne contaminants, and to monitor miners' exposures to airborne contaminants, including silica. Portable mine operations often involve crushing, which can generate substantial amounts of dust, and they handle a variety of commodities generating varying amounts of respirable crystalline silica depending on the geological features of the pit.
The final rule requires that all mine operators, including portable mine operators, conduct exposure monitoring in accordance with § 60.12, including first-time sampling. With respect to portable mine operators, MSHA has taken into consideration that these mines are unique and may move frequently. However, the final rule does not exempt portable mine operators because miners must be protected at all times, and the methods of compliance, sampling and evaluation provisions are necessary to protect miners.
Sampling ensures engineering controls put in place by mine operators are effective in protecting miners. If the portable mine operator anticipates being at the site for at least three months, MSHA expects the portable mine operator to conduct the second-time sampling at that site within the three-month timeframe under § 60.12(a)(2). If the portable mine operator moves to a different site before conducting its second-time sampling within three-months, the operator is required to conduct the second-time sample at the next site. If either operator or MSHA samples are at or above the action level and at or below the PEL, portable operators must sample every three months under § 60.12(a)(3). Similarly, if the most recent sampling was above the PEL, the portable mine operator must take immediate corrective actions, immediately report the overexposure to MSHA, ensure provided respirators are worn appropriately by affected miners before the start of the next work shift, and resample, regardless of whether the portable mine has moved to a different site by the time the sampling results are received. Under the final rule, at least every 6 months or if there are any changes in processes, production, equipment, or geological conditions, mine operators are required to conduct a qualitative evaluation. Protecting miners' health requires monitoring and controlling levels of respirable crystalline silica, and, consistent with the Mine Act, miners at portable mines must be afforded the same health protections and informational awareness of their exposures as all other miners.
If the results of the evaluation reveal that their miners may be reasonably exposed to respirable crystalline silica at or above the action level but at or below the PEL, the sampling provisions of the final rule apply. Also, if sampling indicates levels above the PEL, under the final rule, portable mine operators must take immediate corrective actions, resample, and record these actions.
MSHA provides two examples that illustrate how and why the final rule will affect portable mine operators. In example 1, the portable mine operator conducts first-time sampling on mine site A and the sample result is below 25 μg/m
In example 2, the portable mine operator is located on mine site X. The portable mine operator conducts a qualitative evaluation and determines that miners' exposures may reasonably be at or above the action level, triggering sampling. The portable mine operator conducts sampling, and the results are above the PEL. The mine operator takes immediate corrective actions, immediately reports the overexposure to MSHA, ensures provided respirators are worn appropriately by affected miners before the start of the next work shift, and resamples. The operator then moves to mine site Y before corrective actions sampling results are received. Depending on the results of the corrective actions sampling from mine site X, the portable mine operator must conduct either above-action-level sampling or corrective actions sampling
These examples illustrate that when sampling is required at one portable mine site, the requirement continues when the portable mine moves to a new mine site. Sampling across different portable mine sites is needed to determine whether the engineering controls applied to the portable mine (for example, dust collection or water spray) are effective to keep miners healthy. Periodic evaluations will also be critical for mines that move frequently and encounter different conditions that expose miners to respirable crystalline silica. These evaluations and any related samplings will allow operators to verify that adequate engineering controls are effective and are maintained properly to protect miners as they move to different worksites, regardless of mining location or commodity mined or milled.
MSHA encourages portable mine operators to work with their District Managers to develop an appropriate compliance approach that protects miners' health. MSHA will provide compliance assistance to portable mine operators.
The applicability of the rule to one specific industry within MNM—the sorptive minerals industry—was the subject of several comments from SMI, EMA, and Vanderbilt Minerals, LLC (Document ID 1446; 1442; 1419). These commenters requested that the sorptive minerals industry be exempted from the rule. The commenters stated that this industry exposes workers only to aged quartz, and that aged quartz is less toxic than freshly fractured quartz in other industries. After careful consideration, MSHA has decided not to exempt sorptive minerals mines. The Agency's rationale for this decision is discussed in detail above in
This final rule will take effect 60 days after publication in the
MSHA received comments both in support of and against having compliance commence immediately when the final rule takes effect. Some commenters, including labor organizations, an industrial hygiene professional association, and an advocacy organization, supported the proposed effective date, citing the need for the new rule to be implemented as soon as possible to protect miners' health (Document ID 1398; 1425; 1351; 1449). Appalachian Voices and the AFL-CIO stated that the technologies and practices necessary to reduce dust and silica exposure are well-known and that mine operators have had ample notice that this rule was forthcoming (Document ID 1425; 1449). In contrast, several commenters, including multiple mining trade associations and a mining industry organization, expressed the need for a longer preparation period prior to compliance (Document ID 1428; 1407; 1408; 1442; 1441; 1448). Some commenters, including a state mining association, a MNM operator, and an industry trade association, suggested that MSHA allow more time, ranging from one to three years, to comply with the final rule (Document ID 1441; 1432; 1442; 1448; 1392). Some cited reasons for allowing more time include: the two-year preparation period that OSHA provided for compliance with its 2016 silica rule; the time needed for operators to plan, purchase, and implement engineering controls; and the challenges that the rule could present for MNM mine operators new to sampling and medical surveillance (Document ID 1407; 1419; 1424; 1428). Other commenters, including a professional association, industry trade associations, mining trade associations, and MNM operators, suggested a phased approach to implementation, with different compliance dates for the different requirements in the rule (Document ID 1377; 1407; 1413; 1428; 1424; 1456; 1417; 1453). Examples given of past rules that had used this approach included: OSHA's silica rule (which became effective 90 days after publication, but, for example, for construction, allowed one year after the effective date for compliance with most of the rule requirements, and two years for compliance with certain laboratory requirements); MSHA's diesel particulate matter rule (which included incremental reductions in the PEL over two years); and MSHA's 2014 RCMD Standard (which allowed operators 18 months after the effective date to comply with sampling requirements and 24 months to implement the standards) (Document ID 1407; 1424; 1441; 1442).
Several commenters, including three industry trade associations, a mining trade association, and a MNM operator, expressed concern that the rule would lead to excessive demand and backlogs for sampling devices, industrial hygienists, labs, medical facilities, and B Readers (Document ID 1407; 1404; 1413; 1428; 1419). The NSSGA stated that over 80 percent of aggregate companies have fewer than 25 employees and therefore will likely rely on their insurance companies or industrial hygiene consultants for sampling, and that scheduling of sampling will be based on priorities outside the control of the mine operator (Document ID 1448). A mining trade association, industry trade associations, and a MNM operator also asserted that because post-pandemic supply chain delays are continuing, and in some cases escalating, operators are facing long lead times for procurement of critical infrastructure items, including those essential for mandatory health and safety requirements (Document ID 1428; 1404; 1407; 1419). Finally, these commenters expressed concern that requiring mine operators to comply with the final rule 120 days after publication would not provide enough time for MSHA to issue guidance and for mine operators to digest relevant implementation and compliance guidance documents (Document ID 1428; 1404; 1407; 1419).
After careful consideration, MSHA has decided to provide additional time for mine operators to prepare for compliance with the final rule. MNM mine operators must comply with the final rule by 24 months after publication of the final rule, while coal mine operators will have 12 months to come into compliance with the rule (except for medical surveillance, which applies only to MNM mines). MSHA believes that this final compliance date gives coal mine operators sufficient time to plan and prepare for effective compliance with the new standards, while also ensuring that improved protections for miners from the hazards of respirable crystalline silica take effect as soon as practically possible. Unlike MNM mines, underground and surface coal mine operators have considerable experience with frequent sampling, and they can more quickly integrate the sampling requirements in this final rule into their existing underground mine ventilation plans and surface mine respirable dust control plans. In addition, coal mines already have
In the case of MNM mines, MSHA has adjusted the requirements in the final rule to allow operators a total of 24 months after the publication of the final rule to comply. MSHA is allowing this longer period for compliance because MNM operators, particularly small mines, may have less experience with sampling and may also need time to prepare for compliance with medical surveillance. The longer period for compliance is generally responsive to some commenters. The Agency believes the longer period for compliance will provide operators adequate time to meet their compliance obligations under the final rule. MSHA believes that mine operators will use the compliance period to familiarize themselves with the new standard; evaluate, update, and enhance existing engineering controls; research, purchase, and install new or additional engineering controls, if necessary; arrange for sampling; and commence sampling. MSHA notes that the 24 months provided for MNM operators is the same as that provided in the OSHA rule and the same as MSHA provided in the 2014 RCMD Standard. MSHA believes that there are enough laboratories, sampling equipment, medical service providers, respiratory equipment, and contractor service providers for sampling to meet any increase in demand for equipment or services required by this final rule. The additional 24 months will provide MNM operators additional time to procure equipment and services. For a detailed discussion of the availability of respirators and laboratory and medical services necessary for compliance with the rule, see
MSHA believes that these compliance periods in the final rule provide operators adequate time to prepare for successful implementation, balanced against the Agency's priority goal and statutory mandate to move quickly to protect miners against respirable crystalline silica hazards. Mine operators in both MNM and coal have had many years of experience with monitoring and controlling airborne contaminants, including respirable crystalline silica, and this experience should facilitate implementation of the final rule. MSHA data show that many mines are already meeting the respirable crystalline silica PEL of 50 μg/m
The final rule, like the proposal, includes definitions for the following terms in § 60.2: “action level,” “respirable crystalline silica,” and “specialist.” In a change from the proposal, MSHA removes the definition of “objective data” from the final rule. MSHA received multiple comments on the proposed definitions of action level and objective data, as discussed in more detail below. The Agency did not receive any comments on the proposed definitions of respirable crystalline silica or specialist.
The final rule, like the proposal, defines “action level” as “an airborne concentration of respirable silica of 25 micrograms per cubic meter of air (μg/m
MSHA received several comments in support of and against the proposed adoption of an action level. Several commenters including labor unions, medical professional associations, and advocacy organizations supported the proposal to institute an action level of 25 μg/m
After careful consideration of the comments, MSHA has determined an action level of 25 μg/m
Commenters stated that MSHA should not have an action level. The AEMA and NVMA said the Agency does not use an action level in other air contaminant exposure rules (Document ID 1424; 1441).
At exposures of 25 μg/m
Some commenters, including trade associations, MNM operators, a state mining association, and a mining-related business, stated that the action level would increase costs for mine operators (Document ID 1408; 1442; 1419; 1440; 1441; 1392). MSHA recognizes that costs may increase as a result of the sampling requirements in the final rule. Mine operators are encouraged to reduce exposures below the action level to avoid additional costs associated with the sampling requirements triggered when exposures are at or above the action level. The Agency emphasizes that the requirements of the final rule are established to protect miners from the adverse health effects resulting from exposure to respirable crystalline silica.
Several commenters, including industry trade associations, MNM operators, and a mining trade association, cautioned that the action level was too close to the limit of accurate detection of respirable crystalline silica (Document ID 1426; 1413; 1432; 1440; 1448). SSC stated that there is little confidence in the reliability of sampling results below 50 μg/m
MSHA's analytical methods for air samples can reliably detect respirable crystalline silica at or below the action level. The MSHA P-2 and P-7 analytical methods have a reporting limit of 12 μg for quartz in mine dust. Both methods are sufficiently sensitive to quantify levels of quartz collected on air samples from concentrations at the action level. Most accredited laboratories that offer crystalline silica analysis by X-ray diffraction use either the OSHA ID-142 or NIOSH 7500 methods. The OSHA method specifies a reliable quantification limit of 12 μg/m
The AEMA and NVMA disagreed with MSHA's calculation of the action level as an 8-hour TWA (Document ID 1424; 1441). These commenters said NIOSH recommends calculating exposure levels for a 10-hour shift.
The final rule includes an 8-hour TWA because it provides more protection to miners who work extended shifts. Further discussion of the 8-hour TWA is discussed below under
The Arizona Mining Association stated the proposed action level is not achievable with current available technology (Document ID 1368). The commenter provided testimonial information about a mine that conducted a baseline test with a continuous dust monitor in an office setting and was close to the proposed action level.
MSHA clarifies that the action level applies only to respirable crystalline silica, which is a component of respirable dust. If an office or other setting contains levels of respirable crystalline silica that meet or exceed the action level, sampling is required under the final rule.
After careful consideration of the rulemaking record, MSHA has determined the action level is appropriate. The Agency's experience with existing standards indicates that an action level of one-half the PEL provides necessary information to mine operators on actions they need to take to reduce miners' exposures below the action level, where feasible. Operator sampling at or above the action level but at or below the PEL also provides critical information to miners on their exposures. Under § 60.12(g), operators must share sampling records and laboratory reports with miners so that they have an awareness and understanding of the important role that engineering and administrative controls play in protecting their health. Mine operators who keep their exposures below the action level avoid the costs of required compliance with provisions triggered by the action level, provide improved health protection for miners, and may experience better miner health and less turnover. MSHA concludes that an action level is needed at one-half the PEL based on residual risk at the PEL of 50 μg/m
Under the proposal, operators could use “objective data” to confirm sampling results below the action level and discontinue sampling.
MSHA removes the definition of “objective data” in the final rule. The term “objective data” was defined in the proposed rule as “information such as air monitoring data from industry-wide surveys or calculations based on the composition of a substance that indicates the level of miner exposure to respirable crystalline silica associated with a particular product or material or a specific process, task, or activity.”
MSHA received several comments on the proposed definition of objective data, with numerous commenters stating that the definition was vague and overly broad. Some commenters, including labor organizations, a Federal elected official, and an industry trade association, requested clarification on how to determine the validity and acceptability of objective data and who should make the determinations (Document ID 1398; 1449; 1439; 1442). Others, such as AIHA, Black Lung Clinics, and AFL-CIO, commented that objective data is not an accurate or reliable measure of exposure to respirable crystalline silica and that objective data should not be used to exempt operators from sampling. (Document ID 1351; 1410; 1449; 1412).
The Agency agrees with commenters who asserted sampling is more accurate than using objective data as defined in the proposed rule. Additional discussion on the comments received on objective data and MSHA's response regarding the proposal are discussed in
The final rule, like the proposal, defines “respirable crystalline silica” as “quartz, cristobalite, and/or tridymite contained in airborne particles that are determined to be respirable by a sampling device designed to meet the characteristics for respirable-particle-size-selective samplers that conform to the International Organization for Standardization (ISO) 7708:1995: Air Quality—Particle Size Fraction Definitions for Health-Related Sampling.”
MSHA did not receive any comments on the definition of respirable crystalline silica. The final rule's definition has two main advantages. First, the ISO 7708:1995 definition of respirable particulate mass represents an international consensus, and by adopting the ISO 7708:1995 criterion, MSHA is able to harmonize its standards with the standards used by other occupational health and safety organizations in the U.S. and internationally, including ACGIH, OSHA (29 CFR 1910.1053 and 29 CFR 1926.1153), NIOSH (2003b, Manual of Analytical Methods), and the European Committee for Standardization (CEN) (ISO 7708:1995). Second, the definition eliminates inconsistencies in the existing standards for MNM and coal mines. Defining respirable crystalline silica to include quartz, cristobalite, and/or tridymite and establishing a PEL for exposure to respirable particles of any combination of these three polymorphs provides consistency across different mining sectors.
The final rule, like the proposal, defines “specialist” as “an American Board-Certified Specialist in Pulmonary Disease or an American Board-Certified Specialist in Occupational Medicine.” The definition is applicable to § 60.15, which addresses medical surveillance for MNM mines. Under the medical surveillance requirements, MNM mine operators are required to provide miners with medical examinations performed by a specialist in pulmonary disease or occupational medicine or a PLHCP.
MSHA did not receive any comments on the definition of specialist. The medical surveillance provisions for MNM mines require a specialist to conduct a follow-up medical examination no later than 2 years after the follow-up examination for new miners if the chest X-ray shows evidence of pneumoconiosis or the spirometry examination indicates evidence of decreased lung function (§ 60.15(c)(3)). The provision is intended to ensure that any miner who shows evidence of pneumoconiosis or decreased lung function is seen by a professional with expertise in respiratory disease. The definition is important because it ensures miners benefit from expert medical judgment and receive advice regarding how work practices and personal habits could affect their health.
The final rule, like the proposal, requires the mine operator to ensure that no miner is exposed to respirable crystalline silica in excess of 50 μg/m
MSHA analyzed and considered the comments received in response to the proposed PEL of 50 μg/m
AIHA and MSHA Safety Services did not believe the proposed PEL was appropriate, with the AIHA stating that the proposed PEL of 50 μg/m
After considering the data and evidence in the rulemaking record, the final rule establishes a PEL of 50 μg/m
As some commenters noted, the PEL is consistent with NIOSH's respirable crystalline silica recommended exposure limit of 50 μg/m
As discussed in the standalone Health Effects document, occupational exposure to respirable crystalline silica is detrimental to an individual's health. Silicosis and other diseases caused by respirable crystalline silica exposure are irreversible, disabling, and potentially fatal. At the same time, these diseases are exposure-dependent and are therefore preventable. The lower a miner's exposure to respirable crystalline silica, the less likely that miner is to suffer from adverse health effects.
Regarding the comments recommending MSHA adopt a PEL of 25 μg/m
An individual urged MSHA to adopt, in addition to the proposed PEL of 50 μg/m
In conclusion, MSHA has determined, as presented in the standalone FRA document accompanying this final rule, that: (1) under previous respirable crystalline silica or quartz standards, miners were exposed to respirable crystalline silica at concentrations that result in a risk of material impairment of health or functional capacity and (2) lowering the PEL to 50 μg/m
In the case of coal mines, the final rule establishes a PEL for respirable crystalline silica independent from the respirable coal mine dust (RCMD) standard. The 2014 RCMD Standard does not directly limit coal miners' exposure to respirable crystalline silica; under the existing coal mine respirable dust standard, MSHA cannot issue a separate citation for silica or quartz.
Separating the respirable crystalline silica PEL from the respirable coal mine dust standard allows for coal miners' exposure to respirable crystalline silica to be controlled directly, rather than only indirectly through the respirable
MSHA solicited comments on whether to eliminate the reduced standard for total respirable dust when quartz is present at coal mines and received feedback from stakeholders generally agreeing with the Agency's proposal to establish a standard for respirable crystalline silica that is independent from the respirable coal mine dust standard, including other mine industry organizations, a labor union, mining trade associations, and Black Lung Clinics (Document ID 1378; 1398; 1406; 1428; 1410). The ACLC expressed support for a standalone and separately enforceable PEL, but recommended maintaining a reduced standard for respirable dust when silica is present in coal mines, which would ensure that standalone effects of silica and coal dust are accounted for and allow for better monitoring overall (Document ID 1445). The NMA, the MCPA, and the Pennsylvania Coal Alliance supported the removal of the respirable dust standards when quartz is present (
MSHA has concluded that establishing an independent and lower PEL for respirable crystalline silica for coal mines allows more effective control of respirable crystalline silica than the existing reduced standards because the separate standard is less complicated and more protective. MSHA believes that the adoption of a separate improved standard that carries risk of a citation and monetary penalty when overexposures of the respirable crystalline silica PEL occur is thus more protective than the indirect method under the existing reduced standards. MSHA clarifies that mine operators will continue to sample for respirable coal mine dust under existing §§ 70.100, 71.100, and 90.100. MSHA agrees with the commenters supporting the removal of §§ 70.101, 71.101, and 90.101. With the PEL and action level (both calculated as a full-shift 8-hour TWA), sampling, recordkeeping, and reporting requirements in this final rule, MSHA does not believe that retaining the reduced standard is necessary. MSHA believes that the implementation of the separate silica standard will ensure that operators are correctly evaluating and implementing controls to protect miners from respirable crystalline silica. Further, MSHA will continue its sampling. Under the final rule, MSHA is removing these sections in their entirety since they are no longer needed. See
Under the final rule, the PEL and the action level apply to a miner's full-shift exposure, calculated as an 8-hour TWA. This limit means that over the course of any work shift, exposures can fluctuate but the average exposure to respirable crystalline silica cannot exceed 50 μg/m
Regardless of a miner's actual working hours (full shift), 480 minutes is used in the denominator. This means that the respirable crystalline silica collected over an extended period (
This calculation method (
MSHA received comments both in agreement with the proposed calculation method and against it. Some commenters, including the AFL-CIO and USW, stated that they support the proposed calculation method of full-shift monitoring and calculating exposures over an 8-hour period (
Under the final rule, the PEL and action level applies to a miner's full-shift exposure, calculated as an 8-hour TWA. MSHA agrees with commenters who stated that the full shift, 8-hour TWA captures cumulative exposure to silica dust accurately. The goal of the respirable crystalline silica final rule is to prevent miners at all times from suffering a body burden high enough to cause adverse health effects.
“Body burden” refers to the total amount of a substance that has accumulated in the body at any given time (ATSDR, 2009). This reflects the interplay between cumulative exposure, pulmonary deposition, and lung clearance, in the case of respirable crystalline silica.
MSHA has determined that it is important to specify that exposures be normalized to 8-hour TWAs.
Because the full shift, 8-hour TWA calculation takes this additional factor into account, sampling using this calculation method likely results in more sampling results that show overexposures, which leads to exposure monitoring, corrective actions, and/or respiratory protection for miners that may not have otherwise been provided using the full shift TWA calculation. The concept of adjusting occupational exposure limits for “extended shifts” has been addressed by researchers (Brief and Scala, 1986; Elias and Reineke, 2013). Their research is based on the industrial hygiene concept that longer workdays lead to more time for the workplace chemical to accumulate in the body and less time for it to be eliminated. To account for this, the research establishes models that adjust (
This final rule establishes a lower PEL and applies it to all miners using a consistent method for calculating exposures. These changes improve the health and safety of miners while making compliance more straightforward and transparent. NIOSH has also supported the use of the TWA and has discussed this term since the publication of the NIOSH Pocket Guide to Chemical Hazards (First Edition, 1978) (the “White Book”).
MSHA's PEL for a miner's full-shift exposure calculated as an 8-hour TWA differs from OSHA standards for extended work shifts. In the OSHA standards, sampling for extended work shifts is conducted using the worst (
The NMA and AEMA disagreed with how MSHA calculates the full shift 8-hour TWA and stated that if MSHA does not use the entire duration worked, the Agency should instead use OSHA's method of sampling for the worst 8-hour
MSHA has not included the commenter's suggestion in the final rule. MSHA's requirement in the final rule to sample miners for the entire duration of their work shift will provide an accurate representation of their exposures. Calculating the full shift 8-hour TWA will better protect the health of miners who work extended shifts because it considers the heightened risks posed by increased cumulative exposure and shorter recovery time. The final rule full shift 8-hour TWA calculation is consistent with MSHA's longstanding MNM calculation method, which is based on the guidance provided by the ACGIH in 1973 (TLVs® Threshold Limit Values for Chemical Substances in Workroom Air Adopted by ACGIH for 1973). This calculation method is supported by NIOSH and continues to be supported in the current guidance provided by the ACGIH.
Some commenters, including NSSGA and SSC, expressed concerns about whether silica can be accurately and consistently measured at the action level and PEL (Document ID 1448; 1432). The AIHA suggested that statistics of sampling and sample analysis should be considered to identify upper and lower confidence limits (Document ID 1351). Several commenters, including NMA and West Virginia Coal Association (WVCA), recommended that the PEL and action level should have a margin of error, or error factor, to account for sampling and analysis errors (Document ID 1428; 1443). WVCA recommended that, as in the 2014 RCMD Standard, MSHA should apply an error factor to the PEL to normalize results to account for errors in sampling and weighing that cause deviations in individual concentration measurements (Document ID1443). The NMA cited sources to assist with determining the error factor (Document ID 1428).
In
MSHA is confident that current sampling and analytical methods for respirable crystalline silica provide accurate estimates of measured exposures. Because there are multiple sampling methods that comply with the ISO 7708:1995 standard and variations in laboratory analysis methods, this final rule does not include a specific error factor. Mine operators can rely on sampling results from ISO-accredited laboratories to meet the sampling requirements of § 60.12(f) to determine their compliance with the PEL and action level under the final rule. Miners should be confident that those exposure results provide them with reasonable estimates of their exposures to respirable crystalline silica.
The final rule identifies the methods for compliance in § 60.11. Section 60.11 paragraph (a), unchanged from the proposal, requires mine operators to install, use, and maintain feasible engineering controls, supplemented by administrative controls when necessary, to keep each miner's exposure to respirable crystalline silica at or below the PEL. Paragraph (b), unchanged from the proposal, states that rotation of miners shall not be considered an acceptable administrative control used for compliance with the PEL. Below is a detailed discussion of the comments received on this section and modifications made in response to the comments.
Paragraph (a) requires mine operators to use feasible engineering controls as the primary means of controlling respirable crystalline silica; administrative controls can be used, when necessary, as supplementary controls.
Examples of engineering controls include, but are not limited to, ventilation systems, dust suppression devices, enclosed cabs or control booths with filtered breathing air, and changes in materials handling or equipment used. Engineering controls generally suppress (
Examples of administrative controls include, but are not limited to, work practices that change the way tasks are performed to reduce a miner's exposure. These practices could include work process training; housekeeping procedures; proper work positions of miners; cleaning of spills; and measures to prevent or minimize contamination of clothing to help decrease miners' exposure to respirable crystalline silica.
MSHA requested comments on the proposed requirement that mine operators install, use, and maintain feasible engineering and administrative controls to keep miners' exposures to respirable crystalline silica at or below the proposed PEL. The Agency received comments both supporting and opposing the proposal.
Several commenters, including an industrial hygiene professional association, a labor union, and black lung clinics, expressed support for the use of feasible engineering controls and administrative controls to keep miners' exposures to respirable crystalline silica below the proposed PEL (Document ID 1351; 1398; 1410; 1353). AFL-CIO, UMWA, and NMA stated that mine operators should already be utilizing feasible engineering and administrative controls to comply with law and with their existing ventilation plans (Document ID 1449; 1398; 1428). Black Lung Clinics urged MSHA to require that mine operators rely primarily on engineering controls to limit dust exposure, with administrative controls serving as supplemental measures (Document ID 1410).
Other commenters identified limitations with engineering controls. NSSGA, US Silica, and a presenter at one of the hearings provided the following examples where engineering controls will not suffice due to the nature of the work: non-routine maintenance tasks; periodic maintenance tasks; tasks of limited duration; and seasonal tasks (Document ID 1448; 1455; 1353). US Silica also stated that MSHA must offer more flexible options for control methods and give more consideration to the challenges of implementing certain controls at certain mines (Document ID 1455).
After carefully considering the comments, MSHA has concluded that the requirement for installation, use, and maintenance of feasible engineering
Engineering controls, which address the generation of dust at its source, minimize respirable crystalline silica exposures of all miners, including those in surrounding work areas, who may not be working at the dust generating source. In contrast to other controls and other interventions, engineering controls can be regularly evaluated and monitored, which increase their effectiveness.
NIOSH has long promoted the use of engineering controls to control miners' exposures to respirable crystalline silica. This final rule aligns with the 1995 NIOSH recommendation that “the mine operator shall use engineering controls and work practices [administrative controls] to keep worker exposures at or below the REL [recommended exposure limit]” (NIOSH, 1995, page 5). Specifically, NIOSH recommends the use of engineering controls to keep free silica dust exposures below the REL of 50 μg/m
Requiring engineering controls as the primary method of compliance is consistent with generally accepted industrial hygiene principles, existing Agency standards, and the Mine Act.
Some commenters provided specific examples when discussing engineering control limitations. The IME stated that MSHA should allow the use of equivalent dust suppression methods, where an alternative exists, and its effectiveness can be demonstrated (Document ID 1404). USW explained that engineering controls must be capable of dealing with all belt speeds for collection and suppression and be protected from freezing in cold weather which can increase their exposure (Document ID 1447). Conspec Controls questioned whether MSHA will explain how to reduce dust particulate during operations and how different systems will be prioritized in instances where an action improves the dust conditions but exacerbates gas readings (Document ID 1324).
After reviewing these comments, the Agency agrees that differences in mine size, job duties, commodity mined, equipment, and environmental conditions across the mining industry necessitate different types of engineering controls. However, in MSHA's experience, the mine operator has the information and experience at their mine to determine which engineering controls are feasible and effective at reducing respirable crystalline silica exposures for their mining conditions. For example, MSHA agrees with commenters that exposed water sprays are not effective in freezing weather; however, the Agency has found that at least one, or more, option is available for every circumstance. For example, enclosing the process equipment or using water sprays are two options for controlling dust. Water sprays suppress dust, and enclosures limit the amount of dust in the equipment operator's breathing zone. Equipment enclosures can be constructed with baffles to slow the airflow inside the enclosure, so dust settles more quickly inside the enclosure. As another option, a ventilation dust collection system can be paired with an equipment enclosure to make both more effective for controlling dust. MSHA intends to work with stakeholders, mine operators, and the mining community to develop compliance assistance materials and share best practices on engineering controls during and after the implementation of the final rule.
MSHA received several comments on the use of administrative controls. AIHA emphasized that administrative controls, when used to supplement engineering controls, can further reduce exposures, and maintain them at or below the PEL (Document ID 1351). Several commenters, including mining trade associations, state mining associations, and MNM operators, stated that OSHA's 2016 silica rule treats engineering and administrative controls as equally effective in reducing silica dust exposures and urged MSHA to consider broader use of administrative controls and personal protective equipment to achieve compliance (Document ID 1428; 1424; 1432; 1455; 1441; 1443).
MSHA has reviewed the comments and concludes that administrative controls are effective in protecting miners from respirable crystalline silica exposures when they are used as a supplement to engineering controls. For example, NIOSH has co-developed a clothes cleaning system that can clean dusty work clothes throughout the workday. This is an example of an administrative control that is a safe and effective method to remove silica dust from a miner's clothing, reducing exposures to respirable crystalline silica. In the final rule, administrative controls are secondary to engineering controls because administrative controls require significant oversight by mine operators to ensure miners understand and follow the prescribed work processes. If not properly implemented, understood, or followed, administrative controls may not be effective in preventing miners' overexposure to respirable crystalline silica.
MSHA clarifies that administrative controls, except for rotation of miners, can be used as a method of compliance if engineering controls are not feasible. However, as MSHA discussed in the RFI and in its previous 2014 RCMD Standard, engineering controls remain the primary means to control all forms of respirable dust, including respirable crystalline silica, in the mine atmosphere (84 FR 45454; 65 FR 4214; 68 FR 10798-10799, 10818).
For these reasons, final paragraph § 60.11(a) is the same as the proposal.
Paragraph (b) prohibits mine operators from using miner rotation as an administrative control.
As noted above, prioritizing engineering controls is consistent with accepted industrial hygiene principles, MSHA's existing standards, and the Mine Act. In particular, the prohibition against rotation of miners to achieve compliance with the PEL is consistent with MSHA's June 6, 2005, diesel particulate matter (DPM) final rule (70 FR 32867) and its 2014 Coal Dust Rule (79 FR 24813). Under the existing standards in the 2014 Coal Dust Rule, MSHA does not permit rotation of miners to reduce exposures to coal mine dust if feasible engineering controls are in use (79 FR 24909). In the DPM final rule, MSHA prohibited rotation of miners to reduce miners' exposure to diesel particulate matter, an airborne contaminant that is also a carcinogen. 71 FR 28926; 30 CFR 57.5060(e).
MSHA received several comments on the feasibility of prohibiting miner rotation. AISI and SSC requested that MSHA permit the use of rotation of miners when engineering controls are not feasible (Document ID 1426; 1432). Some commenters, including Portland Cement Association, NSSGA, Pennsylvania Coal Alliance, Pennsylvania Aggregates & Concrete (PACA), BMC, CISC, and Tata Chemicals Soda Ash Partners, LLC, added that, because miner rotation historically has been used to lower miners' exposures, it should continue to be a part of the hierarchy of controls (Document ID 1407; 1448; 1378; 1413; 1417; 1430; 1452; 1364). BIA stated that, in their operations, which are already understaffed, worker rotation is necessary to ensure miners are not exposed to levels above the PEL, particularly if MSHA also discontinues the use of respirators as a method of control (Document ID 1422). Other commenters, including MSHA Safety Services, Inc., and BIA, stated that some mine operators will be substantially impacted by prohibiting miner rotation (Document ID 1392; 1422), while a few commenters, including NSSGA and IAAP stated that worker rotation is sometimes the only feasible control to limit overexposure, such as when miners perform periodic or non-routine tasks that do not allow for engineering controls (Document ID 1448; 1456).
UMWA, AFL-CIO, and Black Lung Clinics stated that worker rotation could be acceptable to minimize musculoskeletal stress, but not for work involving respirable dust or carcinogens, since the practice would expose more miners to the hazards (Document ID 1398; 1449; 1410). Black Lung Clinics further stated that, because the risk of silica-related disease appears to be continuous, rather than associated with a threshold exposure, worker rotation does not reduce the risk of disease (Document ID 1410).
However, some commenters disagreed. NVMA stated that miner rotation is standard practice when dealing with non-carcinogens and since there is not enough data on whether silica exposure alone, as opposed to in combination with tobacco use, is the carcinogen causing respiratory issues, worker rotation should not be prohibited (Document ID 1441). NSSGA provided literature expressing a well-established threshold for silicosis and lung cancer and stated that the use of miner rotation to reach that limit of exposure should be allowed (Document ID 1448).
After considering the comments, the final rule prohibits rotation of miners. MSHA does not consider it to be an effective control because it does not address the root cause of the hazard, requires continuous attention and actions on the part of miners and management, and increases risks to additional miners. MSHA considers that worker rotation, which may be an appropriate control to minimize musculoskeletal stress or heat stress, is not an acceptable control for silica, which is classified as a Group 1 human carcinogen (IARC, 1997). For example, MSHA's existing standards for diesel particulate matter prohibit rotation of miners as an acceptable administrative control because diesel particulate matter is a probable human carcinogen. 30 CFR 57.5060. MSHA's risk assessment for the diesel particulate matter rule noted the majority of scientific data for regulating exposures to carcinogens supports that job rotation is an unacceptable method for controlling exposure to both known and probable human carcinogens because it increases the number of persons exposed. The Agency concludes that the rotation of miners would increase the number of miners exposed to the hazard of respirable crystalline silica.
MSHA considered these comments in light of the Agency's longstanding prohibition against rotation of miners as a means of compliance for exposures to carcinogens. Commenters did not provide specific data in support of their position that mine operators will be substantially impacted by the prohibition of miner rotation for reducing silica exposure. The intent of this final rule is to provide health protection to as many miners as possible from the adverse health effects of respirable crystalline silica exposure. The Agency has found that a combination of engineering and administrative controls can reduce miner exposures to levels at or below the PEL and is feasible for mine operators.
MSHA also received comments requesting clarification on the implementation of the prohibition of rotation of miners under the final rule. NLA and NSSGA stated that MSHA has not adequately explained the proposed prohibition of miner rotation, which creates confusion as to whether worker rotation can be used for other purposes and how the provision will be enforced (Document ID 1408; 1448). NSSGA further stated that, if MSHA does not remove the prohibition in the final rule, it should at a minimum, confirm that it will not prohibit miner rotation for purposes other than compliance with the PEL, or rotating employees to maintain exposure below the action level (Document ID 1448). Similarly, some commenters, including NLA, AEMA, NMA, and NSSGA suggested that MSHA should clarify that miner rotation can still occur for legitimate reasons, including avoidance of heat stress or musculoskeletal stress (Document ID 1408; 1424; 1428; 1448). SSC asked MSHA to explain whether an operator who rotates workers to comply with part 62 will be cited if part 60 prohibits the rotation of that miner (Document ID 1432).
MSHA clarifies that this provision is not a general prohibition of worker rotation wherever workers are exposed to respirable crystalline silica and is intended only to prohibit its use as a compliance method for the PEL. It is not intended to bar the use of miner rotation as deemed appropriate by the mine operator in activities such as cross-training or to allow workers to alternate physically demanding tasks with less strenuous activities.
MSHA received comments on the proposed rule's alignment with industry standards. MSHA Safety Services, Inc. stated that the rotation of miners is accepted by everyone except MSHA (Document ID 1392). California Construction and Industrial Materials Association (CalCIMA) stated that miner rotation is recommended by NIOSH, and under the OSHA respirable crystalline standard, the rotation of employees as an administrative control is not prohibited (Document ID 1433). A couple commenters, including NSSGA, an individual, and Vanderbilt Minerals, LLC, stated that MSHA had mischaracterized the NIOSH recommendations on worker rotation
Respirable crystalline silica has long been recognized as a carcinogen (IARC, 1997). The Agency considers it more protective of miner safety and health to limit the number of miners exposed to respirable crystalline silica. MSHA does not consider rotation of miners to be an effective control because it does not address the source of the hazard. NIOSH's publication entitled “Current Intelligence Bulletin 68: NIOSH Chemical Carcinogen Policy,” recommends that occupational exposures to carcinogens should be reduced as much as possible through the hierarchy of controls, most importantly, the elimination or substitution of other chemicals that are known to be less hazardous and engineering controls (NIOSH, 2017b). According to Stewart (2011), “rotation of workers may reduce overall average exposure for the workday but it provides periods of high short-term exposure for a larger number of workers. As more becomes known about toxicants and their modes of action, short-term peak exposures may represent a greater risk than would be calculated based on their contribution to average exposure.” Miner rotation is not allowed in assessing coal miners' exposure to respirable coal mine dust; coal operators must sample occupations or areas, not individual miners, to ensure that the environment is controlled. The Agency has determined it more protective of miner safety and health to limit the number of miners exposed to respirable crystalline silica and require engineering controls, supplemented by administrative controls, excluding rotation of miners.
For these reasons, final paragraph § 60.11(b) is the same as the proposal.
MSHA received comments regarding the definition of the term “feasible” and the use of feasible engineering controls. NVMA requested that MSHA supply a definition for what is “feasible” (Document ID 1441). Arizona Mining Association stated that the cost-benefit analysis of the proposed standard is flawed and that many mines will face more financial hardship and require far longer implementation times than MSHA has anticipated (Document ID 1368). NMA stated that engineering controls are not always economically feasible, particularly for small businesses (Document ID 1428).
MSHA clarifies that the courts have interpreted the term “feasible” as meaning “ `capable of being done, executed, or effected,' both technologically and economically.”
Based on MSHA's experience and enforcement and sampling data, consideration of the OSHA silica rule, and documentation from NIOSH as discussed in
MSHA received comments about how the proposed rule related to the hierarchy of controls. Several commenters, including NMA, SSC, US Silica, AEMA, WVCA, and American Road and Transportation Builders Association, stated MSHA should allow mine operators to effectively utilize the hierarchy of controls to comply with the proposed silica standard (Document ID 1428; 1432; 1455; 1424; 1443; 1353). These commenters defined the most effective controls according to the hierarchy as: elimination, substitution, engineering, administrative, and personal protective equipment (
Other commenters stated that respirators should be permitted to be used as a method of compliance. WVCA stated that the differences between mining environments across the industry mean that while engineering controls may be the most effective controls in some mines, other controls, like respirators, might protect miners more effectively in others (Document ID 1443). US Silica asked MSHA to treat respirators as engineering controls (Document ID 1455). IME stated that although engineering controls are preferred, it does not make sense to require the use of engineering and work practice controls the operator believes or knows would be inadequate to meet the PEL, knowing that respirators may be more effective for a given task (Document ID 1404). Some commenters, including the Arizona Mining Association, NVMA, and US Silica, stated that the OSHA standard recognizes the priority of engineering controls but allows respiratory protection programs as substitutes when engineering controls are not feasible (Document ID 1368; 1441; 1455; 1353; 1424; 1428).
Some commenters provided specific situations or conditions in which they believe respirators should be used as a method of compliance. NSSGA suggested that to prevent mine operators from relying on respirators for compliance, MSHA could require operators to outline their process for determining when respirators will be used in their respiratory protection plans (Document ID 1448). A few commenters, including SSC, WVCA, Vanderbilt Minerals, LLC, and IME,
MSHA also received comments that supported this provision of the proposed rule, stating that respirators are an ineffective method of compliance. Black Lung Clinics discussed the limitations of respirators, stating that facial hair can interfere with the use of respirators, respirators do not provide real-time feedback on their effectiveness, miners' communication abilities may be impeded, and there is uncertainty about whether respirators are actually effective in the working environment in coal mines (Document ID 1410). USW stated that respiratory protection must never be defined as an engineering control because its effectiveness depends on too many variables (Document ID 1447). BlueGreen Alliance also supported the prohibition on respirators as a method of compliance and suggested that MSHA should strengthen the penalties for noncompliance (Document ID 1438).
MSHA understands that employers across many industries follow the NIOSH Hierarchy of Controls in structuring and applying their industrial hygiene programs and practices. This reflects a generally accepted industrial hygiene principle that recommends the use of engineering and administrative controls to implement effective control solutions, in the following order (1) elimination; (2) engineering controls; (3) administrative controls; and finally, (4) personal protective equipment. MSHA recognizes that while elimination of all respirable crystalline silica from a mine environment would be the most effective means of risk reduction, it is generally not feasible. Under the final rule, mine operators are required to use engineering or environmental controls as the primary means of maintaining compliance. MSHA acknowledges that administrative controls may be necessary to further lower exposure levels and encourages mine operators to use such controls (with the exclusion of miner rotation).
MSHA does not agree that respirators are an engineering control. Engineering controls provide consistent and reliable protection to miners; these controls work independently and verifiably. Engineering controls do not depend on individual performance, supervision, or intervention, to function as intended, and they can be continually evaluated and monitored relatively easily. Unlike PAPRs or supplied-air helmets, engineering controls operate at the hazard generation source, providing protection against both primary (miners directly involved in the task or immediate area) and secondary (miners not directly in the task or working in surrounding areas) exposures to the hazard.
MSHA's enforcement and compliance assistance experience substantiate that respirators are not as reliable as engineering controls in reducing miners' exposure to toxic substances such as respirable crystalline silica. Respirator effectiveness depends on a number of factors, including a properly developed and fully implemented respiratory protection program; individual performance in donning, wearing, and doffing the respirator; and proper supervision to ensure that the protection factor is fully achieved.
In response to comments regarding the use of respirators, MSHA amended the final rule, paragraph 60.14(a), to require MNM operators to provide respiratory protection for temporary use when miners' exposures are above the PEL. For MNM operators, temporary use of respirators is required while engineering control measures are being developed and implemented, which includes taking corrective actions to ensure miner exposures are at or below the PEL. Under the final rule, MNM mine operators are also required to use respirators, on a temporary basis, when exposures are above the PEL, and it is necessary by the nature of work involved (for example, occasional entry into hazardous atmospheres to perform maintenance or investigation). The Agency believes this will provide MNM miners additional protection during these specific circumstances. However, respiratory use under this provision does not constitute compliance with the PEL; all exposures above the PEL violate the standard. Further discussion on respiratory use in the final rule is located in
MSHA received one comment from ISEEE suggesting that the Agency incorporate by reference ISO 23875, Cab Air Quality Standard, to assist mine operators with compliance for installing and using filtration systems to maintain exposures at or below the PEL in operator cabs (Document ID 1377). ISO 23875 is an international standard that unifies the design, testing, operation, and maintenance of air quality control systems for heavy machinery cabs and other operator enclosures. ISEEE stated that the standard provides practical and cost-effective requirements and testing methods for engineering controls that would meet the proposed rule's requirements, given that the desired outcome in all cabs that meet the standard's requirements is compliance with air quality regulations at the 25 μg/m
MSHA has reviewed the comment and has determined that an evaluation of the costs and benefits for economic and technological feasibility would need to be conducted, along with an examination of the costs to implement the standard for mine operators. Therefore, the Agency does not include the requirements of ISO 23875 in this final rule; however, the Agency will evaluate the standard and encourages the use of new technologies and consensus standards to improve miner safety and health.
APHA stated that guides prepared by NIOSH for MNM mines and coal mines contain helpful illustrations of feasible engineering controls that reduce exposure to respirable dust (Document ID 1416). MSHA acknowledges that NIOSH and other organizations and agencies have published information that may be helpful to mine operators. MSHA has worked in partnership with NIOSH in developing this final rule and will continue to do so and use information from NIOSH to facilitate implementation of the final rule. The Agency encourages mine operators to use NIOSH information to ensure that feasible and effective engineering controls are installed, used, and maintained.
The final rule establishes requirements for exposure monitoring in § 60.12. Section 60.12 paragraph (a) establishes the requirements for sampling. Paragraph (a)(1) requires mine operators to commence sampling by the compliance date to assess the full shift, 8-hour TWA exposure of respirable crystalline silica for each miner who is or may reasonably be expected to be exposed to respirable crystalline silica.
The exposure monitoring requirements help facilitate operator compliance with the PEL and harmonize MSHA's approach to monitoring and evaluating respirable crystalline silica exposures to better protect all miners' health. Below is a discussion of the comments received on this section and modifications made in response to the comments.
Under the final rule, mine operators are required to commence sampling by the compliance date to assess miners' exposures to respirable crystalline silica. Samples will be compared to the action level and the PEL to determine the effectiveness of existing controls and the need for additional controls.
Under the final rule, MSHA removes references to “baseline sampling” and “periodic sampling” and only uses the term “sampling”. MSHA also removes proposed § 60.12(a)(2)(i), which allowed mine operators to discontinue sampling based on objective data or historical sample data,
MSHA determined that the terms “baseline sampling” and “periodic sampling” are no longer needed to describe the sampling requirements under the final rule. With the removal of objective data and historical sample data, under the final rule, discontinuing sampling is contingent upon the results of two consecutive samplings indicating that miner exposures are below the action level.
Under the final rule, MSHA removes the use of “objective data” as a method of discontinuing sampling. Proposed paragraph (a)(2) allowed operators to discontinue sampling when, among other things, objective data indicated that miner exposures were below the action level. As discussed earlier, in the proposal, MSHA defined objective data as information such as air monitoring data from industry-wide surveys or calculations based on the composition of a substance, demonstrating miner exposure to respirable crystalline silica associated with a particular product or material or a specific process, task, or activity. The data must reflect mining conditions closely resembling or with a higher exposure potential than the processes, types of material, control methods, work practices, and environmental conditions in the operator's current operations.
MSHA received several comments on its proposed use of objective data as a means for operators to discontinue periodic sampling, with some commenters in support of using objective data and some commenters against it. Several commenters, including mining and industry trade associations and a state mining association, expressed support for the use of objective data, with some commenters noting that it would reduce the sampling burden on mine operators (Document ID 1442; 1406; 1408; 1441; 1424; 1428). Some commenters, including the AEMA, NMA, and Vanderbilt Minerals, LLC, stated that objective data more than 12 months old should be permitted because exposures may not change, or the data may still be valid in certain circumstances (Document ID 1424; 1428; 1419). Several other commenters, including AIHA, UMWA, USW, and Appalachian Voices, opposed the use of objective data, with most arguing that sampling is more accurate than objective data and that such data should not be used to exempt operators from sampling (Document ID 1351; 1398; 1447; 1425; 1412). AFL-CIO, NVMA, and Rep. Robert C. “Bobby” Scott, stated that the term “objective data” is unclear, too subjective, and capable of being manipulated; that various mining aspects could invalidate or skew objective data results; and that the proposal's use of objective data is at odds with the Mine Act's requirement that newly promulgated health and
While the Agency acknowledges that the use of objective data would ease operators' sampling burden, MSHA has determined that objective data cannot be used to discontinue sampling because it is not likely to represent mining conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions in the mine operator's current operations. The Agency agrees with commenters who stated that sampling is more accurate than using objective data and that the use of objective data as a means for operators to discontinue sampling, may be too subjective to confirm that sample results are below the action level. Furthermore, objective data, as defined in the proposal, utilized a historical approach, while the collection of samples will more accurately reflect respirable crystalline silica concentrations under current mining conditions.
MSHA also removes the provisions in proposed paragraph (a)(2) allowing operators to discontinue sampling when sampling conducted by the Secretary or the mine operator within the preceding 12 months confirmed that miner exposures were below the action level.
Some commenters, including SSC, NVMA, Vanderbilt Minerals, LLC, and Portland Cement Association, supported the use of past sampling to discontinue sampling, noting that many operators already use such data to implement their current monitoring programs (Document ID 1432; 1441; 1419; 1407). However, the UMWA opposed allowing past sampling to be used to discontinue sampling (Document ID 1398). The UMWA stated that exempting mine operators from sampling based on past sampling fails to protect miners from unhealthy levels of respirable crystalline silica or ensure that operators are complying with the standard. The UMWA recommended that MSHA, not mine operators, regularly sample all miners.
MSHA agrees that operators cannot rely on samples taken within the preceding 12 months prior to the first sampling under the final rule to discontinue sampling. This is because past samples may not accurately represent miners' current exposures. However, operators still have pathways to discontinue sampling; the final rule requires two consecutive sample results below the action level that may come from operator or MSHA sampling. MSHA will continue to perform its own dust samplings as part of its regular health inspections and take necessary enforcement actions.
In a change from the proposal, the final rule requires MNM mine operators to comply with the requirements and commence sampling within 24 months of the publication date and requires coal mine operators to comply with the requirements and commence sampling within 12 months after the publication date.
Under the proposal, both MNM and coal mine operators would have been required to perform the first sampling under this standard within the first 180 days (6 months) after the effective date of the final rule. MSHA received comments both for and against the proposed 180-day compliance period, with many commenters from the MNM mining industry stating that it was not enough time and recommending a longer period ranging from 1 year to 3 years (Document ID 1408; 1432; 1433; 1417; 1392). Some commenters, including Portland Cement, SSC, CalCIMA, and NLA, stated that providing only 180 days to commence sampling was not sufficient because of the limitation of available resources for conducting sampling (Document ID 1407; 1432; 1433; 1408). Portland Cement, SSC, and AEMA stated that this requirement may not be feasible for many operators because of competition for outsourced resources such as rental equipment, media, professional services, and laboratory sample analysis (Document ID 1407; 1432; 1424). Commenters expressed concerns about performing other tasks within the proposed timeframe for compliance, including establishing contracts with accredited laboratories and other service providers necessary for sampling; performing sampling for all miners who may reasonably be expected to be exposed to respirable crystalline silica; and designing and implementing new engineering controls. These commenters recommended a phased timeline similar to OSHA's final requirement in its silica rule (which gave employers one year before the commencement of most requirements and two years before the commencement of sample analysis methods) and MSHA's final requirement in its 2014 RCMD Standard (which gave operators 18 months after the rule became effective). The NLA stated that small mines are likely to have the greatest difficulty competing for resources in a short period of time (Document ID 1408).
In contrast, some commenters, including AIHA and SKC Inc., stated that technologically feasible air sampling and analysis exists to allow mine operators to achieve compliance with the PEL using commercially available samplers (Document ID 1351; 1366). These commenters stated that technologically feasible samplers are widely available, and a number of commercial laboratories provide the service of analyzing dust containing respirable crystalline silica. Other commenters, including AFL-CIO and UMWA, supported requiring first-time sampling within 180 days of the rule's effective date (Document ID 1449; 1398). Some commenters, including Appalachian Voices, Rep. Robert C. “Bobby” Scott, and Robert Cohen, emphasized the need to implement the final rule quickly to protect miners (Document ID 1425; 1439; 1372). Appalachian Voices stated that the technologies and practices necessary to reduce dust and silica exposure are well-known and that mine operators have had ample warning that this rule was forthcoming (Document ID 1425).
Under the proposal, MSHA examined the capacity of laboratories that meet the ISO/IEC 17025 standard to conduct respirable crystalline sample analyses. MSHA made the preliminary determination that there would be sufficient processing capacity to meet the sampling analysis schedule and that it would be technologically feasible for laboratories to conduct the required sampling analyses (88 FR 44923). MSHA also preliminarily determined that the availability of samplers needed to conduct the required sampling is technologically feasible (88 FR 44921). This preliminary determination, however, only examined whether sampler technology exists to conduct the respirable crystalline silica sampling as required under the proposed rule, not the availability of that technology to meet the demands that the final rule would impose.
MSHA agrees with commenters that the sampling requirements of the final rule may create initial increased demand for sampling devices and related equipment and services. MSHA understands that there are more sampling devices (as well as related services and supplies) currently available based on the increased demand resulting from the promulgation of the OSHA silica rule in 2016, and MSHA expects that there may be another increase in demand because of this final rule. MSHA expects that the sampling device market will respond, as it did for OSHA, with an increase in the supply of sampling devices to meet the
MSHA carefully considered the above information about availability of laboratory capacity and sampling devices, including the likely increase in demand for such services and devices. MSHA acknowledges commenters' concerns about the need for more time to conduct sampling and implement necessary engineering controls. All mine operators covered by the rule must initiate sampling by the compliance dates, potentially creating a peak demand for sampling and analysis around those dates. The extended compliance dates permit more time to accommodate and prepare for any increase in demand. MSHA expects many mine operators will avoid last-minute sampling and begin the sampling process earlier than required; thus, the sampling and associated analysis will be spread over many months, meaning that any eventual peak period for laboratory analysis will be longer and less intense (
A few commenters, including Petsonk PLLC and Appalachian Voices, requested that MSHA clarify the sampling requirement for mines that begin operations after the rule goes into effect (Document ID 1399; 1425). Petsonk PLLC suggested amending proposed § 60.12(a)(1) to require sampling within 180 days after the rule becomes effective or 180 days after the mine commences production, whichever occurs later.
MSHA disagrees with the commenters regarding the need to specify a separate sampling schedule for new mines since mine operators would have knowledge of the sampling requirements before commencing operations. The Agency expects that new mines begin sampling immediately upon commencing operations in accordance with the exposure monitoring requirements in § 60.12. Coal mine operators are required to begin sampling within 12 months of the publication of the final rule. Operators of new coal mines that begin operation after the 12 months must begin sampling upon commencing operations. MNM mine operators are required to begin sampling within 24 months of the publication date of the final rule. Operators of new MNM mines that begin operation after the 24 months must begin sampling upon commencing operations.
Under the final rule, mine operators are required to assess the exposure of each miner “who is or may reasonably be expected to be exposed to respirable crystalline silica.”
In the proposal, MSHA requested comments on the Agency's assumption that most miners are exposed to at least some level of respirable crystalline silica, and on the proposed requirement that these miners should be subject to sampling. MSHA described its assumption that most occupations related to extraction and processing would meet the “reasonably be expected” threshold for sampling. Further, MSHA assumed that some miners may work in areas or perform tasks where exposure is not reasonably expected, if at all.
MSHA received many comments from advocacy organizations, mining and industry trade associations, MNM mine operators, labor organizations, and a state mining association on the “reasonably be expected” basis for sampling (Document ID 1398; 1407; 1417; 1419; 1424; 1425; 1428; 1441; 1445; 1448; 1449). Commenters were generally divided on whether most miners are exposed to at least some level of respirable crystalline silica. The UMWA agreed with MSHA's assumption and stated that most mining occupations would reasonably be expected to be exposed to silica and thus meet the threshold for sampling, while some miners may not be reasonably expected to be exposed to silica, depending on their occupation (Document ID 1398). In contrast, Vanderbilt Minerals, LLC stated that it is not reasonable to assume that most miners are exposed to at least some level of respirable crystalline silica (Document ID 1419). This commenter cited MSHA's Mine Data Retrieval System (MDRS) data that shows many mine locations do not have any detectable exposure to respirable crystalline silica. Appalachian Voices, questioning MSHA's assumption about occupations related to extraction and processing meeting the “reasonably be expected” threshold for sampling, described testimony from several miners who worked in non-production positions and were exposed to high levels of silica dust (Document ID 1425). This commenter requested expansion of the interpretation to include or consider non-production work above ground because of the placement of engineering controls, such as return air entries near mine offices. Further, other commenters, including NSSGA and BMC, requested clarification on what the “reasonably be expected” threshold means since it was not defined in the proposal (Document ID 1448; 1417).
MSHA has considered these comments. Based on the Agency's enforcement and compliance assistance experience and sampling data, the final rule retains the language in the proposal. This data considers MSHA and operator sampling experience, miners' job tasks and occupations, and mining conditions when overexposures are identified and need to be corrected. Operators already are expected to know whether their miners are exposed or reasonably are expected to be exposed to respirable crystalline silica, given coal operators' existing sampling regimen (that includes regular sampling) and MNM's requirements under §§ 56.5002 and 57.5002 to conduct surveys (sampling) “as frequently as necessary to determine the adequacy of control measures.” MSHA believes that most occupations related to extraction and processing which generate dust are likely to meet the “reasonably be expected” threshold. However, MSHA clarifies that sampling should not be limited to extraction and processing occupations; in every instance, the mine operator must determine whether exposure to respirable crystalline silica is or may reasonably be expected. In the example given by the commenter, miners performing above-ground non-production work who were exposed to high levels of silica dust would reasonably be expected to be exposed to respirable crystalline silica and thus would be required to be sampled. On the other hand, MSHA recognizes that some miners are not exposed to respirable crystalline silica in day-to-day mining operations, may work in areas or perform tasks where respirable crystalline silica exposures are not
Many commenters stated that MSHA should require an exposure “trigger” level to be used as a basis for conducting sampling. Several commenters, including NMA, BMC, NSSGA and AEMA, stated that the “reasonably be expected” threshold for sampling should be associated with the action level of 25 µg/m
Under the final rule, MSHA concludes that an action level trigger for initial sampling is not appropriate for mining conditions. The extraction and milling of minerals can reasonably be expected to expose most miners to some level of respirable crystalline silica. In MSHA's experience, dust generation is common in the mining process, and the approach in the final rule ensures that mine operators have the necessary data and information to understand which miners may be exposed to respirable crystalline silica, can make determinations regarding the adequacy of existing engineering and administrative controls, and can make necessary changes to ensure miners are not overexposed.
In the final rule, MSHA requires mine operators to sample within 3 months of the previous sampling when the most recent sampling indicates that miner exposures are at or above the action level but at or below the PEL. The most recent sampling could be a first sample under the standard, a corrective action sample, a post-evaluation sample, or a sample taken by MSHA during its inspections. Sampling must continue until two consecutive sample analyses show miners' exposures are below the action level. Once this happens, mine operators may discontinue sampling for miners whose exposures are represented by these samples, until such time that a subsequent MSHA sampling or post-evaluation sampling by the mine operator indicates that miners may be exposed at or above the action level. MSHA clarifies that during the compliance period, the two consecutive samplings needed to discontinue further sampling may not begin with an MSHA sampling followed by an operator sampling conducted within 3 months of that MSHA sampling; however, it may begin with an operator sampling (
MSHA received many comments on the proposed frequency of sampling, with some commenters stating that the 3-month sampling frequency is too frequent and other commenters stating that the sampling is not frequent enough. Some MNM mine operators, including SSC and NLA, stated that mines with sampling results consistently above the action level but below the PEL should not be required to sample every 3 months, and instead the frequency should be annual (Document ID 1432; 1408). The NVMA stated that the 3-month frequency should be associated with the PEL rather than the action level (Document ID 1441). The AISI stated that the frequency of sampling should be dictated by the history of miner exposures, noting that some miners should not be sampled as frequently as others and some miners should not be sampled at all (Document ID 1426). Portland Cement Association, NSSGA, BMC, and Vanderbilt Minerals, LLC, stated that MSHA should model its sampling requirements after OSHA's silica rule, where repeat monitoring is conducted within 6 months for exposures above the action level but below the PEL and within 3 months for exposures above the PEL (Document ID 1407; 1448; 1417; 1419). The AEMA and NMA, stated that follow-up sampling should occur no more frequently than every 6 months, as proposed in MSHA's Regulatory Alternative #1 (Document ID 1424; 1428). The commenters stated that sampling each miner whose exposure is at or above the action level but at or below the PEL every 3 months is excessive and causes undue burden on mine operators.
Other commenters, including advocacy organizations and labor unions, stated that MSHA's proposed sampling frequency was not enough (Document ID 1434; 1447; 1449; 1412; 1445; 1398; 1385). The USW and the AFL-CIO stated that the periodic sampling requirement in the proposal is not sufficient to assess silica concentrations in mining and prevent overexposures and noted the coal mining industry is already required to perform quarterly periodic sampling which they believe is not frequent enough (Document ID 1447; 1449). An individual stated that MSHA's proposed sampling frequency is not aligned with a 2014 NIOSH study cited by the Agency that referenced a 2020 report from DOL's Inspector General, which recommended more frequent monitoring where there is wide variability in silica levels (Document ID 1412). ACLC recommended that MSHA require weekly sampling (over multiple shifts) by operators and monthly sampling by MSHA inspectors (Document ID 1445). The USW, AFL-CIO, and Nicholas County Black Lung Association supported more frequent sampling by MSHA without suggesting a specific schedule and stated that mines should be constantly checking for silica dust, especially where continuous mining machine operators and roof bolters are working (Document ID 1447; 1449; 1385).
As commenters noted, OSHA requires a 6-month sampling interval for monitoring exposures between the action level and PEL and a 3-month interval for monitoring exposures above the PEL. 29 CFR 1910.1053(d)(3)(iii) and (iv). OSHA explained, “[i]n general, the more frequently periodic monitoring is performed, the more accurate the employee exposure profile.” 81 FR 16766. Accordingly, OSHA noted that “[s]electing an appropriate interval between measurements is a matter of judgment,” and determined that the 6-month and 3-month frequencies were both “practical for employers and protective of employees.”
MSHA's sampling provisions differentiate between miners based on their exposure levels. The sampling provisions require first-time sampling of miners exposed or reasonably expected to be exposed to respirable crystalline silica, and subsequent sampling of miners exposed at or above the action level. In MSHA's experience, ever-changing mining conditions require a shorter interval between samplings to ensure that miners are protected. MSHA's monitoring approach is consistent with NIOSH's recommendation to monitor miners' silica exposures frequently due to the variability of silica content in mining
Under the final rule, when exposures are above the PEL, mine operators must take immediate corrective actions and sample until exposures are at or below the PEL. Like the proposal, the final rule does not define a specific sampling frequency above the PEL but anticipates that operators will sample upon taking corrective actions and sample as frequently as needed until corrective actions have resolved the overexposure. Once at or below the PEL, mine operators will resume the 3-month schedule.
In the final rule, MSHA allows mine operators to discontinue sampling when two consecutive samplings indicate that miner exposures are below the action level. MSHA believes a short period of time—within three months—between samples is needed to verify current conditions and lack of exposure to respirable crystalline silica. In addition, MSHA sampling may indicate exposure levels that require mine operators to commence sampling. The Agency also requires operators to conduct periodic evaluations at least every 6 months or whenever there is a change in production, processes, installation or maintenance of engineering controls, installation or maintenance of equipment, administrative controls, or geological conditions, to evaluate whether the change may reasonably be expected to result in new or increased respirable crystalline silica exposures. This will ensure that mine operators continue to monitor changes in mining conditions and practices that may impact exposure levels and lead to further sampling.
MSHA received several comments on using two consecutive samples as a means of discontinuing sampling requirements. The AIHA and AFL-CIO expressed doubt that two samples can provide confidence that a task is safe from harmful exposures (Document ID 1351; 1449). A MNM operator noted that one or two sample results below the action level do not necessarily equate to overall lower exposures and it is likely that many two-samples below action level results will occur merely by chance (Document ID 1417). In contrast, the NMA agreed with using two consecutive samples and stated that OSHA has a similar requirement (Document ID 1428). The NMA stated that two samples should be enough to confirm lack of exposure in theory and in practice. Other comments from professional associations, labor organizations, and a miner health advocate questioned whether mine operators should be permanently exempted from sampling at all (Document ID 1372; 1377; 1398; 1449; 1405).
MSHA agrees with the commenter who stated that two consecutive samples should be enough to confirm lack of exposure to respirable crystalline silica. In response to the commenters' concern about discontinuing sampling, MSHA is confident that the results from two consecutive samplings will provide data to confirm that the operator's controls are working effectively and that miners' exposures are below the action level. MSHA also believes that two consecutive samplings below the action level indicate a low probability that, under the prevailing conditions, exposure levels exceed the PEL. As such, unchanged from the proposal, the final rule includes a requirement for two consecutive samples below the action level to discontinue sampling.
Mine operators may discontinue sampling once two consecutive sample analyses show the miners' exposures are below the action level. Specifically, in paragraph 60.12(a)(4), to discontinue sampling, the second sampling must be taken after the operator receives the results of the prior sampling but no sooner than 7 days after the prior sampling was conducted. However, MSHA clarifies that the final rule includes two scenarios where mine operators are required to resume sampling with actual or expected miner exposures at or above the action level but below the PEL. First, mine operators must conduct sampling within 3 months if sampling by the operator or MSHA indicates that miner exposures are at or above the action level but at or below the PEL (§ 60.12(a)(3)), and mine operators must continue to sample until two consecutive samplings indicate that miner exposures are below the action level. Second, mine operators must conduct post-evaluation sampling if they determine, as a result of their periodic evaluation, that miners may be exposed to respirable crystalline silica at or above the action level (§ (60.12(d)).
A miner health advocate stated that an inadequacy of the proposal was that it failed to address a situation in which a mine operator took multiple samples at the same time (Document ID 1372). The commenter was concerned that if one of these samples was under the action level and others were over, the operator would choose the sample under the action level as the basis for discontinuing sampling.
MSHA clarifies that, under the final rule, as in the proposal, mines that have any miners with silica exposures at or above the action level but at or below the PEL are required to continue conducting sampling for those miners at or above the action level but at or below the PEL in accordance with § 60.12(a).
Under final paragraph (a)(4), for the purposes of discontinuing sampling, MSHA clarifies that subsequent sampling must be taken after the operator receives the results of the prior sampling but no sooner than 7 days after the prior sampling was conducted. In response to comments, this is a change from the proposed rule.
In the proposal, MSHA requested comment on whether consecutive samples should be taken at least 7 days apart. MSHA received comments from AIHA, MCPA, and SSC in response to the minimum time period between consecutive samplings (Document ID 1351; 1406; 1432). The MCPA expressed concern that requiring 7 days between samplings, combined with the time it would take a laboratory to process the samples, could result in a miner having to wear a respirator for 3-4 weeks despite effective engineering controls being in place (Document ID 1406). This commenter also asked if MSHA considered the time it takes to obtain sample results from a laboratory. The AIHA stated that consecutive samples do not necessarily need to be at least 7 days apart, depending on workplace circumstances (Document ID 1351). The SSC stated that a time limit between consecutive samples is not needed and stated that MSHA has not offered any reason or justification for requiring 7 days (Document ID 1432). The ISEEE cautioned that, without a clear requirement in the rule, mine operators might take consecutive samples only during the most favorable times,
MSHA reviewed the comments and decided that a minimum time between samplings is necessary to ensure that controls are in place and are effective in reducing miners' exposures to respirable crystalline silica. The final rule requires that, to discontinue sampling, subsequent sampling must be taken after the operator receives the results of the
In the final rule, as in the proposal, where the most recent sampling indicates that miner exposures are above the PEL, MSHA requires the mine operator to conduct sampling after corrective actions are taken and until sampling indicates that miner exposures are at or below the PEL. In a change from the proposal, MSHA also requires mine operators to immediately report all exposures above the PEL from operator sampling to the District Manager or to any other MSHA office designated by the District Manager.
Portland Cement Association recommended that MSHA adopt OSHA's standard for corrective actions sampling and suggested that operators repeat sampling at 3-month intervals until exposures are at or below the PEL (Document ID 1407). An individual expressed concern that the proposal does not require a minimum number of full-shift samples to validate the effectiveness of corrective actions (Document ID 1412).
Section 60.13 requires mine operators to take corrective actions when sampling results show exposure levels above the PEL. Sampling after taking corrective actions provides operators with specific information regarding the effectiveness of the corrective actions for the mine environment and provides additional data for use in making decisions about updating or improving controls. Once sampling shows that exposures are at or below the PEL, the Agency requires mine operators to conduct repeat sampling within 3-month intervals as long as previous sampling results indicate miners' exposures are at or above the action level but at or below the PEL. Corrective action sampling is required for all samples over the PEL at all mines, including portable operations.
Some commenters, including a miner health advocate and an advocacy group, questioned whether citations will be issued if exposures are over the PEL, with Hon. Robert C. “Bobby” Scott suggesting that MSHA incorporate reporting requirements for dust samples (Document ID 1425; 1439; 1399). AMI Silica, LLC stated that requiring operators to report overexposures was a departure from MSHA's current practice and requires operators to “self-incriminate” (Document ID 1440). However, other commenters including labor organizations and a miner health advocate requested more MSHA oversight of operator sampling to ensure compliance (Document ID 1449; 1398; 1399).
Under the final rule, MSHA requires mine operators to immediately report all exposures above the PEL to the District Manager or to any other MSHA office designated by the District Manager. This is responsive to comments requesting that the Agency be more actively involved in operator sampling and consistent with the approach MSHA outlined at a public hearing. Requiring mine operators to report sampling results over the PEL will ensure that MSHA is aware of all overexposures and can take appropriate action, including compliance assistance and enforcement action. Samples indicating concentrations over the PEL should be reported immediately, without delay once the operator becomes aware of the information, and in accordance with guidance from the MSHA District Office. Once MSHA is aware that a sample indicates overexposure, the Agency can provide appropriate assistance and monitor progress toward abatement of the condition. Enforcement actions for samples that are over the PEL, where appropriate, will be handled on a case-by-case basis. Enforcement practices are discussed in
Under the final rule, mine operators are required to conduct periodic evaluations at least every 6 months or whenever there is a change in: production; processes; installation and maintenance of engineering controls; installation and maintenance of equipment; administrative controls; or geological conditions. Mine operators are required to make a record of the periodic evaluation and post it on the mine bulletin board and, if applicable, by electronic means, for the next 31 days. If the mine operator determines, as a result of the periodic evaluation, that miners may be exposed to respirable crystalline silica at or above the action level, the mine operator shall perform sampling for each of those miners who may be exposed at or above the action level.
The final rule is modified from the proposal, which would have only required operators to conduct periodic evaluations every 6 months. In addition to requiring mine operators to conduct periodic evaluations at least every 6 months, the final rule also requires mine operators to conduct an evaluation whenever there is a change in production, processes, installation and maintenance of engineering controls, installation and maintenance of equipment, administrative controls, or geological conditions.
MSHA received comments from mining trade associations, labor unions, miner health advocates, professional associations, an advocacy organization, a black lung clinic, and a federal elected official on the proposed semi-annual evaluation requirement. The UMWA, ACOEM, APHA, and AEMA stated that mine operators should be constantly conducting qualitative evaluations any time a change occurs that may reasonably be expected to result in new or increased respirable crystalline silica exposures (Document ID 1398; 1405; 1416; 1424). The ISEEE stated that it is crucial to regularly reevaluate and address any deficiencies across all aspects of the mine site to prevent unnecessary exposures and emphasized that conducting timely risk assessments is a standard practice in the mining industry (Document ID 1377). The UMWA and AFL-CIO stated the proposed evaluation requirement could create the possibility for miners to be exposed to dangerous levels of silica for up to six months (Document ID 1398; 1449). The AEMA believed the proposed evaluation requirement would be excessive given the lack of frequency with which changes occur (Document ID 1424). The AEMA and NMA recommended MSHA require an annual evaluation (Document ID 1424; 1428). The NSSGA stated that MSHA should adopt OSHA's requirement to reassess respirable crystalline silica exposures whenever there has been a change that may reasonably be expected to result in new or additional exposures at or above the action level, or when the employer has any reason to believe that new or
MSHA agrees with commenters who stated that mine operators should be required to conduct a qualitative evaluation when a change occurs to help minimize overexposures to respirable crystalline silica. The requirement to conduct a qualitative evaluation at least every 6 months or whenever a change occurs in production, processes, controls, or geological conditions ensures that mine operators are assessing changing processes, conditions, and practices that may impact miner exposure levels on a regular basis to determine if additional sampling is needed. The requirement to conduct an evaluation whenever a change occurs is consistent with the existing MNM requirement to conduct surveys as frequently as necessary to determine the adequacy of control measures (§§ 56.5002 and 57.5002), while the minimum 6-month requirement is consistent with the underground coal requirement to review the ventilation plan every 6 months to assure that it is suitable to current conditions (§ 75.370(g)). This requirement is also consistent with the existing MNM standard for controlling diesel particulate matter (DPM), which requires that mine operators monitor as often as necessary to effectively determine, under conditions that can be reasonably anticipated in the mine, whether the average personal full-shift airborne exposure to DPM exceeds the DPM limit (57.5071(a)). Under the final rule, mine operators are responsible for conducting periodic evaluations. The Agency emphasizes that it will not conduct periodic evaluations but may use its enforcement discretion to review a mine's records of periodic evaluations, when necessary.
In response to a comment from a miner health advocate, the final rule modifies proposed paragraph(c)(1), which required operators to “[m]ake a record of the evaluation and the date of the evaluation.” The commenter stated MSHA should require the record of the evaluation to specify all changes that could affect respirable crystalline silica exposures and the effect of the changes on exposure levels (Document ID 1372). MSHA agrees with the commenter who stated the record of the evaluation needs to be more informative and responds by requiring the record of the evaluation to also include the evaluated change and the impact the change has on respirable crystalline silica exposure. The additional required data will provide MSHA, mine operators, and miners with information on the specific changes that may reasonably be expected to result in new or increased respirable crystalline silica exposures.
Unchanged from the proposal, under the final rule, MSHA requires mine operators to post the record on the mine bulletin board and, if applicable, by electronic means, for 31 days. The NSSGA stated that MSHA's requirement to post results on a bulletin board is too prescriptive and may cause an issue for operators who do not have a bulletin board (Document ID 1448). The final rule includes this requirement because it is consistent with MSHA's existing standards and gives miners ready access to recent sampling results, providing additional accountability for mine operators, and necessary information for miners. Also, section 109(a) of the Mine Act requires mines to have a bulletin board where information can be posted and shared with miners and their representatives. 30 U.S.C. 819(a). For portable operations and other operators who prefer to communicate electronically, the final rule permits electronic notification in addition to posting the record on the bulletin board.
Under the final rule, like the proposal, mine operators are required to conduct post-evaluation sampling to assess the full shift, 8-hour TWA exposure of respirable crystalline silica when the results of the periodic evaluation show that miners may be exposed to respirable crystalline silica at or above the action level.
MSHA received some comments on the post-evaluation sampling proposal from an advocacy organization, a labor union, a federal elected official, a medical professional association, and a black lung clinic stating that MSHA should require sampling whenever there are any changes in mine conditions that could lead to an increased risk of respirable crystalline silica exposures (Document ID 1416; 1398; 1439; 1405; 1418). A miner health advocate stated that mine operators should not have the discretion to decide whether miners may be exposed to respirable crystalline silica at or above the action level or whether they should perform sampling to assess miners' exposure levels as a result (Document ID 1399). The same commenter suggested that MSHA should provide simple and straightforward triggers that mandate sampling, rather than just the requirement to conduct an evaluation that might lead to additional sampling.
Post-evaluation sampling is needed to ensure workers are protected from respirable crystalline silica when a change may increase their exposure. MSHA believes that mine operators have the most knowledge about their mine's operations and conditions. Mine operators are aware of the extent and degree of miners' exposures to respirable crystalline silica because they have been complying with respirable dust standards for over 40 years. Mine operators are also aware of the occupations, work areas, and work activities where overexposures to respirable crystalline silica are most likely to occur. Further, MSHA believes that mine operators will make good-faith efforts to comply with the post-evaluation sampling requirements to ensure healthy working conditions for miners. The final rule, in a change from the proposal, requires mine operators to conduct an evaluation whenever there are changes that may reasonably be expected to result in new or increased respirable crystalline silica exposures and to require operators to maintain more detailed records of the evaluation. These records will allow miners, their representatives, and MSHA to hold operators accountable for conducting timely and appropriate evaluations and required sampling.
The final rule includes sampling requirements to ensure mine operators' respirable crystalline silica monitoring is representative of miners' actual exposure levels. The sampling requirements in the final rule are the same sampling requirements from the proposal, with a few modifications. Each of the sampling requirements is discussed in more detail below.
In the final rule, MSHA includes shaft and slope sinking, construction, and removal of overburden to clarify that these mining activities are within the scope of the final rule.
Several commenters stated the proposal was vague and did not clearly specify what “typical mining activities” includes. Black Lung Clinics, Hon. Robert C. “Bobby” Scott, and a miner
MSHA agrees with commenters that construction and development activities are typical mining activities and clarifies this in the final rule. The Agency is aware that many construction and development activities generate silica dust, which can lead to respirable crystalline silica exposures well above the PEL. MSHA stated at the public hearings and clarifies in this final rule that typical mining activities include shaft and slope mining, construction, and removal of overburden. In June 2022, MSHA implemented its Silica Enforcement Initiative (SEI) for MNM and coal mines. The purpose of the SEI is to reduce silica exposures in MNM and coal mines, and to provide compliance assistance to mine operators, where appropriate. The SEI was posted on MSHA's website and discussed with the mining community at safety and health conferences and during frequent MSHA stakeholder calls.
MSHA also clarifies that the existing requirements for respirable coal mine dust sampling differ from this final rule's requirements for respirable crystalline silica sampling. Under the existing standards for respirable coal mine dust sampling, the operator is required to sample coal mine dust exposures for specific occupations and areas during consecutive normal production shifts where coal mine dust is generated from production activities. Under the final rule, MSHA interprets construction and development activities as typical mining activities subject to respirable crystalline silica sampling, even though they may not be considered production activities under the requirements for respirable coal mine dust sampling.
Under the final rule, MSHA does not specify any operating conditions or environmental conditions for the purposes of conducting respirable crystalline silica sampling.
In the proposal, MSHA requested comments on whether the Agency should specify environmental conditions for sampling. The AEMA, NMA, and NSSGA recommended that MSHA not specify typical operating conditions or environmental conditions (Document ID 1424; 1428; 1448). MSHA Safety Services Inc. stated that it is impossible to predict the weather (Document ID 1392). The AFL-CIO cautioned that sampling while it is raining—a natural dust suppressant—could skew results, while two commenters stated that some mines operate in areas where rain, snow, and wind are common and requiring sampling in their absence is not feasible (Document ID 1449; 1424; 1428). The NLA stated that sampling should be performed under normal or typical operating conditions while also emphasizing the need for mine operators to have flexibility to determine whether conditions for testing are appropriate on any day (Document ID 1408). Black Lung Clinics specified that sampling should be conducted at something approaching full production for typical tasks (Document ID 1410).
MSHA recognizes the existence of exposure variability due to changing mining operations and environmental conditions and agrees with commenters that operators should have the flexibility, within reason, to determine what constitutes typical operating conditions and normal production levels at their mine. MSHA also agrees with the commenters who stated it would be impossible to predict the weather, and thus determined that including specific environmental conditions would make conducting exposure sampling unduly complicated or at times difficult to achieve. MSHA believes that the consistent use of effective engineering controls and workplace practices will help reduce exposure variability and provide operators with greater confidence that they are complying with the PEL. However, MSHA acknowledges that an operator's conscientious application and maintenance of all feasible engineering controls and workplace practices cannot eliminate exposure variability.
Under the final rule, MSHA requires personal breathing-zone air samples for MNM operations and requires occupational environmental samples collected in accordance with § 70.201I (underground coal mines), § 71.201(b) (surface coal mines and surface work areas of underground coal mines), or § 90.201(b) (coal miners who have evidence of the development of pneumoconiosis) for coal operations.
MSHA received a few comments on the proposed sampling device placement requirements. The AIHA and NMA expressed support for taking samples from MNM miners' personal breathing-zones with the latter commenter stating that the approach makes sense because MNM miners perform various job functions over the course of a shift (Document ID 1351; 1428). NMA also reasoned that the personal breathing-zone method would be preferable for coal miners, rather than the proposed occupational environmental sampling, because occupational environmental samples may measure several miners performing the same job function over the course of a shift and make it more difficult to maintain compliance with the PEL. The NVMA stated that providing two different sampling methods under the same standard does not make sense and suggested MSHA have two separate rulemakings—one for coal mines and one for MNM mines (Document ID 1441).
The Agency reiterates that the final rule creates a uniform standard that establishes consistent, industry-wide requirements to address the adverse health effects of overexposure to respirable crystalline silica for all miners, while still recognizing the differences between MNM and coal operations. MSHA believes that the consistent use of effective engineering controls and workplace practices will help all mines—MNM and coal—maintain compliance with the PEL and ensure effective health protection of miners. MSHA established the requirements for personal breathing-zone air samples for MNM miners and occupational environmental samples for coal miners to mirror existing sampling requirements for both industries. These sampling methods are tools that, when used appropriately, achieve the purpose
A miner health advocate recommended that MSHA require coal mine operators to conduct both designated area sampling and designated occupation sampling, rather than allowing them the discretion to sample either (Document ID 1399). This is a misinterpretation of the rule. Final paragraph (e)(2)(ii), which was proposed as paragraph (f)(2)(ii), states that “[t]he full-shift, 8-hour TWA exposure for such miners shall be measured based on . . . Occupational environmental samples collected in accordance with § 70.201(c), § 71.201(b), or § 90.201(b) of this chapter for coal operations.” Sections 70.201(c) and 71.201(b) both prescribe processes for occupational samples, including conversion of designated areas to Other Designated Occupations and requirements for how sampling devices must be used and worn. Paragraph (e)(2)(ii) does not change operators' discretion under section 70.201(c) or 71.201(b).
As a general principle, mine operators must accurately characterize miners' exposure to respirable crystalline silica. In some cases, this requires sampling all exposed miners, while in other cases, sampling a “representative” fraction of miners is sufficient. When a mine operator elects to engage in representative sampling, the mine operator may take, and submit for analysis, fewer samples. Under this rule, mine operators must assess the typical circumstances of each shift and each employee to identify miners most at risk for overexposure (for example, miners working near where dust collector cleaning or bagging operations are taking place) and choose those miners to be “representative” for sampling purposes. This approach allows mine operators to assess the highest likely exposure levels and implement and adjust engineering controls to address the highest likely concentrations of respirable crystalline silica. MSHA finds that representative sampling is sufficient to measure the effectiveness of the engineering controls in place. This applies to miners who were not included in the sampling but who are represented by the representative samples.
Under the final rule, like the proposal, where several miners perform the same tasks on the same shift and in the same work area, mine operators may sample a representative fraction (at least two) of these miners. When sampling a representative fraction of miners, mine operators are required to select the miners expected to have the highest exposure to respirable crystalline silica. For example, sampling a representative fraction may involve monitoring the exposure of those miners who are closest to the dust source. The sampling results for these miners can then be attributed to the remaining miners in the group. When miners are performing different tasks, a representative sample of miners in the same working area is not sufficient to characterize actual exposures, and therefore individual samples are necessary.
MSHA received many comments on the proposed representative sampling requirements from MNM mine operators, mining and industry trade associations, labor unions, and an industrial hygiene professional association, with many commenters supporting the proposal (Document ID 1398; 1392; 1351; 1407; 1432; 1448; 1417; 1378; 1424; 1419; 1441; 1378; 1399). The AIHA, Portland Cement Association, SSC, and NSSGA suggested that “similar exposure groups,” or SEGs, be used as a method to determine which miners to sample for representative sampling and to reduce operator costs for complying with the exposure monitoring requirements in the rule (Document ID 1351; 1407; 1432; 1448). Arizona Mining Association stated that mine operators should be allowed to use SEGs because the alternative of viewing all miners' exposure as the same will result in large cost increases and wasted resources (Document ID 1368).
MSHA did not adopt an SEG approach in the final rule. The Agency agrees that mine operators do not always need to conduct sampling for every exposed miner. Sampling for a representative fraction of miners is similar to the SEG concept because both approaches group miners with similar exposure characteristics for the purpose of sampling a smaller subset of the group.
However, there is likely more room for error and misclassification using SEGs in mining, especially among smaller mines. SEGs rely on the principle of grouping workers into exposure profiles and assessing the health risks to those workers based on similar exposure conditions. Accordingly, SEGs are commonly established by experienced environmental health and safety (EHS) professionals using a combination of exposure characteristics, including location, job, task, and equipment used. Small mines may not have EHS professionals to correctly define SEGs and validate data using proper statistical analyses. There is also risk for SEG misclassification if, for example, sampling data is incorrectly grouped, not representative of all exposures on all shifts, or not collected for the full shift. MSHA is also concerned with variability in silica concentrations in the ore body in mining (especially in coal). Mines are constantly changing, which means that miners' exposures will also change. SEGs would need to be continuously reviewed by EHS professionals to ensure that they are correctly defined over time.
The NSSGA, BMC, Pennsylvania Coal Alliance, and AEMA stated that samples from miners performing the same task in the same area but on different shifts should qualify as representative, with the Pennsylvania Coal Alliance stating that MSHA's limitation of samples to a single shift is unduly restrictive (Document ID 1448; 1417; 1378; 1424).
The final rule requires representative sampling to be restricted to the same shift, rather than spanning across multiple shifts. MSHA believes that where miners are not performing the same tasks on the same shift and in the same work area, representative sampling will not adequately characterize actual exposures. In the Agency's experience, mine operators may schedule high hazard-generating activities during one shift and not others, which would create differences in the environment. Humidity, changes in geology, and other environmental conditions that might impact sampling results could change across shifts, as well; for example, a typically warm and sunny day shift versus a cooler shift where temperatures approach or move further from the dewpoint. MSHA finds that rather than trying to control for potentially significant and unanticipated variables across shifts, miner health and safety is better protected if representative sampling is confined to the same shift, where conditions are more likely to be consistent across miners represented by the sampling. MSHA notes that OSHA's requirements for representative sampling for general industry and construction are also applied to individual shifts.
ISO 7708:1995(E),
Under the final rule, MSHA requires mine operators to use respirable-particle-size-selective samplers that conform to the ISO 7708:1995 standard to determine compliance with the PEL. Mine operators are allowed to use any type of sampling device for respirable crystalline silica sampling, as long as the device is designed to meet the characteristics for respirable-particle-size-selective samplers that conform to the ISO 7708:1995 standard and, where appropriate, meet MSHA permissibility requirements.
Sampling devices, such as cyclones
A cyclone sampler calibrated to operate at the manufacturer's specified air flow rate that conforms to the ISO standard can be used to collect respirable crystalline silica samples under this final rule. MSHA reviewed OSHA's feasibility analysis for its 2016 silica final rule and agrees that there are commercially available cyclone samplers that conform to the ISO standard and allow for the accurate and precise measurement of respirable crystalline silica at concentrations below both the action level and PEL (OSHA, 2016a). Cyclone samplers include, but are not limited to, the Dorr-Oliver 10-mm nylon cyclone, as well as the Higgins-Dewell, GK2.69, SIMPEDS, and SKC aluminum cyclone. Each of these cyclones has different operating specifications, including flow rates, and performance criteria, but all are compliant with the ISO criteria for respirable dust with an acceptable level of measurement bias. MSHA's determination is that cyclone samplers, when used at the appropriate flow rates, can collect a sufficient mass of respirable crystalline silica to quantify atmospheric concentrations lower than the action level and meet MSHA's crystalline silica sample analysis specifications for samples collected at MNM and coal mines.
MNM mine operators who currently use a Dorr-Oliver 10 mm nylon cyclone can continue to use it at a flow rate of 1.7 L/min, which conforms to the ISO standard, to comply with the requirements. For coal mine operators, the gravimetric samplers previously used to sample RCMD (
The NMA, AEMA, and SKC Inc., noted that samplers other than cyclones and elutriators should be considered acceptable under the final rule (Document ID 1428; 1424; 1366). A miner health advocate stated that when conducting sampling under OSHA requirements, they currently use a type of sampler called a “parallel particle impactor,” or PPI sampler, that meets the ISO 7708:1995 standard (Document ID 1375). This commenter stated that there is a disconnect between the cyclone samplers mentioned in the proposed rule and the use of PPI samplers as an acceptable sampling device, implying that PPI samplers are not acceptable because they were not included in the list of example samplers that meet the ISO 7708:1995 standard in the Sampling Methods section of the proposed rule. This commenter also suggested that the PPI sampling device be considered acceptable under this final rule. Similarly, the NMA, AEMA and SKC stated that MSHA's proposal implies that only cyclone and elutriator type samplers meet the specifications for acceptable sampling devices.
MSHA clarifies that cyclone and elutriator type samplers are not the only acceptable sampling devices that can be used to conduct sampling for respirable crystalline silica under this rule. In the Sampling Methods section of the proposed rule, MSHA included a list of example samplers that conform to the ISO 7708:1995 standard. This list was not meant to be all-inclusive, but rather provide several examples of samplers currently available in the marketplace that conform to the ISO 7708:1995 standard (88 FR 44921). As stated above, mine operators can use any type of sampling device, as long as it is designed to meet the characteristics for respirable-particle-size-selective samplers that conform to the ISO 7708:1995 standard and, where appropriate, meet MSHA permissibility requirements. MSHA clarifies that under this final rule, any sampling device that meets the ISO 7708:1995 particle size selective criteria for respirable dust samplers are acceptable for respirable crystalline silica sampling, even if the sampler is not specifically mentioned in the list of examples. Under the final rule, the PPI sampler would be acceptable.
Several commenters, including labor organizations and a federal elected official, noted the need for sampling devices with real-time or near real-time sample analysis capabilities for respirable crystalline silica (Document ID 1449; 1447; 1398; 1412; 1399; 1439). The AFL-CIO stated that one of the most significant items not included in the proposal (that was included in the 2014 Coal Dust Rule) was personal dust monitoring devices with real-time analysis (Document ID 1449). The commenter recommended the adoption of new technology used by the domestic or international mining community to better protect miners. An individual stated that MSHA should consider and incorporate continuous and rapid quartz
MSHA is aware of NIOSH's rapid field-based quartz monitoring (RQM) approach as an emerging technology. It provides a field-based method for providing respirable crystalline silica exposure measurements at the end of a miner's shift. With such an end-of-shift analysis, mine operators can identify overexposures and mitigate hazards more quickly. NIOSH Information Circular 9533, “Direct-on-filter Analysis for Respirable Crystalline Silica Using a Portable FTIR Instrument” provides detailed guidance on how to implement a field-based end-of-shift respirable crystalline silica monitoring program.
While the current RQM cannot be used for compliance with the sampling requirements under this final rule, MSHA encourages mine operators to use the RQM as an engineering tool as the Agency believes it could assist operators in identifying areas of concern, including samples that would be most appropriate for further laboratory analysis. MSHA notes that samples taken by operators using the RQM with results above the PEL are not subject to the requirements of the final rule (
MSHA maintains that analysis of samples using accredited laboratories is an accurate and reliable method of determining respirable crystalline silica exposures. Accurate laboratory analysis is needed as a reference measurement at the beginning and again at the end of an initial exposure assessment as well as when completing follow-up assessments to validate compliance. However, end-of-shift monitoring can reduce the number of samples taken and provide quick results that can be used to reduce the expense of more frequent sampling and laboratory analysis, during implementation of corrective actions, to validate the effectiveness of corrective actions between collection of gravimetric samples, and to increase awareness of potential overexposures in a timely manner.
Seasonal and intermittent mines may have less time to conduct 3-month sampling. Under the rule, all operators, including seasonal and intermittent, must conduct initial sampling when commencing operations after the listed compliance dates. If that initial sampling is below the action level, MSHA believes that, although the operator may wait up to 3 months to conduct the next sample, most operators would have an incentive to take another sample as soon as practicable under § 60.12(a) in order to be relieved from the continuing 3-month sampling requirements if a second consecutive sample result is below the action level. In that situation, the operator would need only to conduct its periodic evaluation every six months or when circumstances change pursuant to § 60.12(c). If the initial sample is at or above the action level and at or below the PEL, all operators would need to take a second sample within 3 months, and within every three months after that unless they meet the criteria to discontinue sampling. Operators that are active during the 3-month period would need to meet these sampling deadlines, even if the operator is not active full-time during the 3-month period. Once operators have closed for the season, or for an extended period (more than 3 months), they would not be expected to continue sampling every 3 months. However, when they re-open, if they have not met the requirements for discontinuing sampling, they would need to start sampling immediately and every three months. MSHA encourages operators to work with their District Managers to develop a workable sampling schedule that protects miners as this rule intends.
The final rule, like the proposal, specifies the methods to be used for analysis of respirable crystalline silica samples, including details regarding the specific analytical methods to be used and the qualifications of the laboratories where the samples are to be analyzed.
Mine operators are required to use laboratories that are accredited to the International Organization for Standardization (ISO) or International Electrotechnical Commission (IEC) (ISO/IEC) 17025, “
The ISO/IEC 17025 standard is a consensus standard developed by ISO/IEC and approved by ASTM International (formerly the American Society for Testing and Materials). This standard establishes criteria by which laboratories can demonstrate proficiency in conducting laboratory analysis through the implementation of quality control measures. To demonstrate competence, laboratories must implement a quality control program that evaluates analytical uncertainty and provides estimates of sampling and analytical error when reporting samples. The ISO/IEC 17011 standard establishes criteria for organizations that accredit laboratories under the ISO/IEC 17025 standard. For example, the American Industrial Hygiene Association (AIHA) accredits laboratories for proficiency in the analysis of respirable crystalline silica using criteria based on the ISO/IEC 17025 and other criteria appropriate for the scope of the accreditation.
MSHA received a few comments regarding the proposed requirement for mine operators to use laboratories accredited to ISO/IEC 17025 where the accreditation has been issued by a body that is compliant with ISO/IEC 17011 from AIHA, NVMA, BMC, and A2LA (Document ID 1351; 1441; 1417; 1388). AIHA and A2LA stated that they agree
Under the final rule, all mine operators will have to use third-party laboratories accredited to ISO/IEC 17025 to have respirable dust samples analyzed for respirable crystalline silica. Many MNM mine operators already use third-party laboratories to perform respirable crystalline silica sample analyses. For most coal mine operators, using a third-party laboratory to analyze respirable crystalline silica samples is a new requirement because respirable coal mine quartz samples are currently analyzed by MSHA. Under the final rule, coal mine operators are responsible for directly monitoring crystalline silica (quartz) exposures in addition to coal dust. Requiring all mines to use third-party laboratories ensures that sample analysis requirements and MSHA enforcement efforts are consistent across all mines.
The final rule requires mine operators to ensure that laboratories evaluate all samples using analytical methods for respirable crystalline silica that are specified by MSHA, NIOSH, or OSHA. These are validated methods currently being used by third party accredited laboratories for measuring respirable crystalline silica in mine dust matrices. MSHA expects that samples collected in MNM mines will be analyzed by X-ray diffraction (XRD) and samples collected in coal mines will be analyzed by Fourier transform infrared spectroscopy (FTIR).
MNM samples are currently analyzed by XRD because the XRD method can distinguish and isolate respirable crystalline silica for measurement, thereby avoiding interference or confounding of respirable crystalline silica analysis results. For MNM samples, the methods used for respirable crystalline silica sample analysis using XRD include MSHA P-2, NIOSH 7500, and OSHA ID-142. All three methods can distinguish between the three silica polymorphs.
MSHA and NIOSH have specific FTIR methods for analyzing quartz in coal mine dust. The NIOSH 7603 method is based on the MSHA P-7 method which was collaboratively tested and specifically addresses the interference from kaolinite clay. Current FTIR methods, however, cannot quantify quartz if either of the other two forms of crystalline silica (cristobalite and tridymite) are present in the sample. Additional steps such as acid treatment can be taken to remove respirable crystalline silica interferences from other minerals that can be found in mine dust sample matrices. For coal samples, the methods used for respirable crystalline silica sample analysis using FTIR include MSHA P-7, NIOSH 7602, and NIOSH 7603.
MSHA received some comments from mining trade associations, a MNM mine operator, and a labor union regarding the proposed requirements for specified analytical methods (Document ID 1398; 1424; 1417; 1428; 1443). BMC stated that they have no objection to MSHA's proposed provisions and UMWA stated that they are supportive of MSHA's proposed requirements. The AEMA, NMA and WVCA cautioned that many minerals interfere with the laboratory's analysis of silica and cited a list produced by OSHA of 18 mineral types that might interfere. Some of these commenters expressed concern that interference could erroneously elevate silica sample levels and cause mine operators to spend resources on corrective actions that are not needed.
As discussed above, MSHA expects that samples collected in MNM mines will be analyzed by XRD and samples collected in coal mines will be analyzed by FTIR. In response to the commenters' concern about mineral types that could erroneously elevate silica sample levels, MSHA disagrees with the commenters and notes that the OSHA method cited by the commenters (
Under the final rule, the mine operator is required to create a record for each sample taken that includes the sample date, the occupations sampled, and the concentrations of respirable crystalline silica and respirable dust. The mine operator is also required to post the record and the laboratory report on the mine bulletin board and, if applicable, by electronic means, for the next 31 days, upon receipt.
MSHA received a few comments on the proposed sampling records provision. The APHA recommended that MSHA update § 60.12(h) to require mine operators to provide a description or data that shows the sample was taken during typical mining activities (Document ID 1416). The same commenter also recommended that MSHA require the person collecting the samples and recording the data to certify the accuracy of the records in writing. The Hon. Robert C. “Bobby” Scott, The American Thoracic Society
In MSHA's experience, commercial laboratories that produce reports for respirable crystalline silica exposures include information on sample locations and/or activities being performed. In some cases, the name of the person that was sampled is also included. The final rule only requires the sampling record to include the date, occupations sampled, and concentrations of respirable crystalline silica and respirable dust since the laboratory report may contain additional information. MSHA believes the elements it requires as part of the sampling record provide mine operators and miners with the most important pieces of information while balancing concerns about recordkeeping burden. As required in § 60.16(b), any sampling record that is created may be requested at any time by, and must promptly be made available to, miners, authorized representatives of miners, or an authorized representative of the Secretary.
The final rule establishes the requirements for corrective actions in § 60.13. Section 60.13 paragraph (a) requires mine operators to take certain actions when any sampling result indicates that a miner's exposure to respirable crystalline silica exceeds the PEL. Paragraph (a) has three subparagraphs—(1), (2), and (3). Paragraph (a)(1) requires mine operators to make NIOSH-approved respirators available to affected miners before the start of the next work shift. In a change from the proposal, paragraph (a)(1) specifies that this requirement must be made in accordance with § 60.14 (b) and (c). Paragraph (a)(2), unchanged from the proposal, requires mine operators to ensure that affected miners wear respirators properly for the full shift or during the period of overexposure until miner exposures are at or below the PEL. Paragraph (a)(3), unchanged from the proposal, requires mine operators to immediately take corrective actions to lower the concentration of respirable crystalline silica to at or below the PEL. Paragraph (b) mirrors language from the
MSHA received several comments including an individual who is a director at a pulmonary rehab center, advocacy organizations, and a miner health advocate, recommending that mine operators stop all production work and withdraw miners if samples are above the PEL (Document ID 1445; 1395; 1396; 1425; 1394; 1399). Some commenters (
MSHA's existing health standards do not require the withdrawal of miners when sampling is over the PEL and mine operators are taking corrective actions, except in certain circumstances based on the risk and exposure to the miner according to section 104(b) of the Mine Act. Accordingly, under § 60.13, mine operators must ensure that affected miners wear respirators properly for the full shift or during the period of overexposure while the mine operators are taking immediate corrective actions to lower miner exposures to at or below the PEL.
MSHA received several comments on the use of respirators while corrective actions are being taken by the operator. A law firm said respirators should be used permanently as a corrective action (Document ID 1353). UMWA and Rep. Robert “Bobby” Scott opposed the mandatory use of respirators and stated that mandating respirator use is inconsistent with the Mine Act; UMWA instead supported the voluntary usage of respirators as a supplement to engineering controls (Document ID 1353; 1398; 1439). USW cautioned that the provision could allow mine operators to justify respirator usage on more than a temporary basis (Document ID 1447). The UMWA was also concerned that using respirators as a mandatory temporary solution might lead to reduced use of engineering and environmental methods as the primary means of controlling exposures (Document ID 1398). ACLC stated that the language is vague and unclear on how long miners will be required to rely on respirators while corrective actions are being taken (Document ID 1445). Further, commenters including advocacy organizations, labor organizations, MNM operators, an industry trade association, and a medical professional association stated that the final rule needs to clarify how long miners are allowed to wear respirators when their exposure is over the PEL (Document ID 1404; 1421; 1425; 1432; 1439; 1440; 1445; 1447; 1449; 1393; 1395; 1396). AFL-CIO stated that corrective actions should be strengthened to include actions other than respirator use and if sampling shows that there is continued non-compliance with the PEL there needs to be more significant corrective actions taken to ensure that dust concentrations are reduced permanently (Document ID 1449; 1353).
As explained earlier, respirator use is not allowed for compliance. Under § 60.13, if sampling shows exposure above the PEL, mine operators are required to provide miners with approved respirators before the next shift begins, and affected miners must wear respirators properly for the full shift or during the period of overexposure until miner exposures are at or below the PEL. This provides miners with protection from respirable crystalline silica dust and thereby limits the serious health effects associated with respirable crystalline silica exposures until engineering controls are in place. Mine operators must also immediately take corrective actions to lower the concentration of respirable crystalline silica to at or below the PEL. This approach is consistent with the NIOSH 1995 Criteria Document in which NIOSH recommends the use of respirators as an interim measure when engineering controls and work practices are not effective in maintaining worker exposures at or below the PEL. Under this section, MSHA emphasizes that respirators are to be used only while mine operators take corrective actions to lower the concentration of respirable crystalline silica to at or below the PEL. MSHA clarifies that whenever exposures are over the PEL, corrective actions must be taken and MSHA must be notified immediately.
Further, MSHA emphasizes that section 202(h) of the Mine Act, an interim standard applicable to underground coal mine operators, specifically prohibits operators from using respirators as a substitute for engineering controls in the active workings. Section 202(h) of the Mine Act provides that “Respiratory equipment approved by the Secretary and the Secretary of Health and Human Services shall be made available to all persons whenever exposed to concentrations of respirable dust in excess of the levels required to be maintained under this chapter. Use of respirators shall not be substituted for environmental control measures in the active workings.” 30 U.S.C. 842(h). The final rule is consistent with the Mine Act, MSHA's existing standards, and case law.
MSHA believes the corrective actions provisions are appropriate and requires mine operators to make changes to reduce miners' exposures to respirable crystalline silica when exposures are above the PEL. MSHA clarifies that respirator use is not a corrective action; the corrective actions are those actions—such as watering roadways, repairing or installing new water sprays, or repairing or installing a new dust collection system—that reduce the respirable crystalline silica concentration to at or below the PEL. MSHA will determine, on a case-by-case basis, the adequacy of the corrective action that must be taken immediately and the appropriate timeframe within which it must occur. Although each engineering control employed as a corrective action is different, mine operators are expected to minimize the time spent performing corrective actions and, as a result, the time affected miners spend using respirators. Any exposures over the PEL are a violation of the standard. Additionally, when engineering controls are being developed and implemented as a part of corrective actions, mine operators are to continue corrective action sampling. Any operator samples over the PEL, including corrective action sampling,
Once corrective actions have been taken, the mine operator shall conduct sampling pursuant to paragraph 60.12(b). The operator will need to take additional or new corrective actions until sampling indicates miner exposures are at or below the PEL. Further corrective action sampling is discussed in
Section 60.14 expands on the requirements for the use of respiratory protection for respirable crystalline silica. Section 60.14 paragraph (a) addresses MNM mines only. This paragraph requires the temporary use of respirators at MNM mines when concentrations of respirable crystalline silica are above the PEL. In a change from the proposal, the final rule specifies that the requirements in paragraph (a) only apply to MNM mines; coal mines are not covered under this paragraph—coal mines are addressed under section 60.13 paragraph (a). The Agency also removed the term “non-routine” from proposed paragraph (a).
Paragraph (b), unchanged from the proposal, applies to all mines and addresses circumstances where miners are medically unable to wear respirators. Paragraph (c) also applies to all mines and addresses the respiratory protection requirements. Paragraph (c)(1), which requires mine operators to provide NIOSH-approved respirators to affected miners, is unchanged from the proposed rule. Paragraph (c)(2) is changed from the proposal and specifies that where approved respirators are used mine operators must have a written respiratory protection program in accordance with ASTM F3387-19 and lists the mandatory ASTM program elements.
MSHA received many comments regarding the respiratory protection provisions, with some commenters supporting the proposal and some opposing it. After reviewing all the comments, MSHA concludes that the proposed respiratory protection provisions should be retained, with some modifications.
Final 60.14(a) states that when MNM miners must work in concentrations of respirable crystalline silica above the PEL while engineering controls are being developed and implemented or it is necessary by nature of the work involved, the mine operator shall use respiratory protection as a temporary measure. In a change from the proposal, MSHA removed the term “non-routine” from the paragraph heading and clarified that the requirement for temporary use of respirators is applicable only to MNM mines.
MSHA received several comments on the proposed temporary non-routine use of respirators, with many commenters opposing the proposed mandatory use requirement for coal mines. Commenters identified difficulties in wearing respirators and stated that coal mine operators must comply with existing standards for ventilation and dust control plans, which have to be submitted to and approved by MSHA. Other commenters expressed concern that there was an absence of a time limit for which silica levels over the PEL are permitted.
Some advocacy organizations and a miner health advocate asked that MSHA require mine operators to withdraw miners when sampling indicated exposures above the PEL (Document ID 1445; 1395; 1367; 1396; 1425). A medical professional also requested that MSHA require operators to withdraw miners from hazardous conditions when sampling indicates they are exposed to respirable silica above the PEL (Document ID 1394).
An individual stated that mine construction and coal production, in particular, should be excluded from the circumstances in which temporary and non-routine use of respirators are allowed (Document ID 1412). Many commenters including advocacy organizations, black lung clinics, miner health advocates, and labor organizations suggested that coal miners should be prohibited from working in overexposures while using respirators, stating that the working conditions, especially in underground coal mines, make it very difficult for miners to communicate and work safely while wearing respirators (Document ID 1372; 1399; 1398; 1447; 1449; 1421; 1393; 1395; 1396; 1402; 1425; 1445; 1410; 1342; 1363; 1391; 1394). One of the labor organizations noted that respirators do nothing to address bystander exposures (Document ID 1449).
After considering the comments, MSHA agrees, and clarifies that paragraph (a) does not apply to coal mine operators. MSHA determined that coal mine operators control silica and coal mine dust through their approved ventilation and dust control plans. Underground coal mine operators are required to have ventilation plans, which include a respirable dust control plan, which must be submitted to and approved by MSHA.
In MSHA's experience, if there are overexposures to respirable crystalline silica or coal mine dust, coal mine operators will adjust their ventilation and dust controls to address these overexposures. MSHA's experience has shown that these adjustments have generally been successful in protecting miners from silica and dust exposures without the need for respirators and that most conditions can be corrected within a day. Additionally, as is currently the case when a respirable coal dust overexposure occurs, under the final rule, citations for respirable crystalline silica overexposures will require abatement through immediate corrective actions before the citation is terminated. MSHA sets any citation abatement deadline with the protection of the miners as the primary consideration.
Also, the proposal was a departure from existing standards for coal mine operators. Under the existing standards, coal mine operators have to provide respiratory protection, but miners did not have to wear respirators. Therefore, MSHA has changed this requirement in the final rule to apply to MNM mines only for paragraph (a). MSHA reiterates under § 60.13(a) that coal mine operators must use respirators when sampling indicates that a miner's respirable crystalline silica exposure exceeds the PEL.
Commenters including advocacy organizations, labor organizations, MNM operators, an industry trade association, and a medical professional association requested that MSHA clarify the meaning of “temporary non-routine”
MSHA agrees with the commenters who stated that the meaning of “temporary non-routine” needed to be clarified. MSHA removed “non-routine” from the paragraph heading for clarity and to be more consistent with the existing requirements for MNM mine operators in §§ 56.5005 and 57.5005. Final paragraph (a) applies only to MNM operators, is consistent with the existing requirements for controlling exposure to airborne contaminants in §§ 56.5005 and 57.5005 and is responsive to comments.
Final paragraph (a)(1) requires respirator use as a temporary measure while MNM miners must work in concentrations of respirable crystalline silica above the PEL while engineering control measures are being developed and implemented. Final paragraph (a)(2) includes a clarifying change from the proposal to include an example in the existing MNM standard that requires MNM mine operators to use respirators in temporary situations when it is necessary by the nature of work involved (for example, occasional entry into hazardous atmospheres to perform maintenance or investigation) when miners are working in concentrations of respirable crystalline silica above the PEL. Several existing MSHA standards use the term “temporary” although the Agency does not specify a time limit. The mining industry is familiar with these standards. MSHA expects “temporary” to have the same meaning as in existing standards—a short period of time.
Under existing standards, MNM miners can work for reasonable periods of time in concentrations of airborne contaminants exceeding permissible levels if they are protected by approved respirators when developing and implementing engineering control measures or when necessary by the nature of work involved. Under these existing MNM standards, mine operators who have overexposures and are required to provide respiratory protection to miners are issued a citation for the overexposure. Generally, if MNM mine operators have a written respiratory protection program in place, the citation would be non-Significant and Substantial.
MSHA has always intended for miners to work in these conditions temporarily and the agency has enforced it as such. The final rule thus does not make any substantive changes from the existing standard in MNM. The update in language from “reasonable periods of time” to “temporary” in the final rule is an update in line with MSHA's original intent and as previously noted, with other existing MSHA standards. Husch Blackwell (on behalf of the SSC), NSSGA, U.S. Silica, and IAAP stated that respirators are the only feasible means of protection for certain tasks in mining environments, such as housekeeping, working on dust collectors, and bagging operations (Document ID 1432; 1448; 1455; 1456). MSHA emphasizes that respiratory protection under § 60.14 (a) is required to be temporary. The Agency intends for temporary to mean that miners wear respiratory protection only for short periods of time; for example, the time necessary to conduct maintenance and repair of engineering controls. Similar to existing MNM standards, the Agency, under this final rule, does not intend that miners will wear respirators for extended periods of time. As an example, when a crusher needs maintenance or repair after an overexposure resulting from a defective water spray bar, miners must wear respiratory protection when performing maintenance or conducting repairs to the spray bar. Another example includes when miners change defective dust bags that can cause overexposures to respirable crystalline silica; when replacing the dust bags, miners must wear respiratory protection.
After reviewing these comments, MSHA revised paragraph (a)(2) to provide a clarifying example on when MNM mine operators would temporarily use respirators due to the nature of the work involved. Under the final rule, the Agency prohibits use of respirator to achieve compliance with the PEL. In response to the comment that respirators are the only means to achieve compliance for certain mining tasks, MSHA has reviewed its sample data and has determined that mine operators are generally able to achieve compliance with existing engineering controls, supplemented by administrative controls. MSHA is aware that certain mining tasks related to maintenance and repair of engineering controls will require respiratory protection. However, MSHA anticipates that respirator use will be temporary, until controls are repaired and effective, and respirator use will not be considered as a means to achieve compliance. This clarifying change on the use of respirators for certain tasks such as the occasional entry into hazardous atmospheres to perform maintenance or investigation, is consistent with the Agency's existing standards.
A joint comment by The American Thoracic Society
MSHA understands that respirator use under paragraphs (a)(1) and (a)(2) will be different depending on the facts and circumstances in the MNM mines and that the temporary nature of respirator use will depend on the time needed to correct an overexposure. MSHA will determine the time required for temporary respirator use on a case-by-case basis. MSHA emphasizes that the District Manager will be informed of all overexposures under 60.12(b). MSHA can take enforcement action, including issuing a withdrawal order under 104(b) of the Mine Act, if the facts and circumstances at the mine require it.
An individual stated that the proposed rule rejected respirator use as a method of compliance in the preamble to § 60.11 but proposed § 60.14 appeared to contradict the prohibition (Document ID 1412). The Black Lung Clinics stated there is no real-time feedback for determining whether a respirator is effectively reducing exposure levels (Document ID 1410) which may provide a false sense of security that the miner is protected from cumulative exposures to respirable crystalline silica.
In response, MSHA clarifies that there is not a contradiction between § 60.11 and § 60.14. Final rule § 60.11 requires engineering controls supplemented by administrative controls to reduce exposures. In MSHA's experience, miners who use respirators under a respiratory protection program that is in accordance with MSHA's standards are protected from cumulative exposures to airborne hazards. Final § 60.14(a) additionally requires the use of respirators in MNM mines in case of an overexposure; however, MNM mine operators will be cited for the overexposure. This is consistent with MSHA's existing standards and enforcement practice for MNM mines.
Comments from MNM mining operators, mining trade associations, and state mining associations suggested that, consistent with the OSHA rule, MSHA should allow operators to use respirators as a method of compliance where engineering and administrative controls are unable to reduce silica levels below the PEL (Document ID 1368; 1424; 1428; 1441; 1448; 1455). The NMA stated that respirators, including PAPRs, should be allowed to be used whenever miners are working in exposures above the PEL (Document ID 1428). The Pennsylvania Coal Alliance and Vanderbilt Minerals, LLC stated that PAPRs are comfortable to wear for long periods and do not restrict breathing (Document ID 1378; 1419). In contrast, three labor organizations opposed the use of respirators (Document ID 1398; 1447; 1449). These commenters stated that the Mine Act forbids respirator use as a mandatory administrative control or as a substitute for environmental controls and noted that the proposed rule allowed for continued production with respirators in hazardous silica dust levels. A medical professional stated that miners should always use respirators, to ensure complete protection from respirable crystalline silica exposures (Document ID 1375).
MSHA disagrees with these commenters that respirators should be used as a method of compliance or that miners should always use respirators. MSHA has determined that respirators cannot be used as a method of compliance. Respirators do not provide effective protection from overexposures for various reasons that include: (1) without a proper fit, dust particles enter the miner's breathing zone; (2) inconsistent or incorrect use can compromise the effectiveness of the respirator; and (3) respirators can hinder effective communication among miners. MSHA has decided that respirators must not be used for compliance because they do not address the dust generation at the source. Engineering controls are reliable, provide consistent levels of protection to many miners, allow for predictable performance levels, can be monitored continually, and can remove harmful levels of airborne contaminants, including respirable crystalline silica, from the miner's environment. However, MSHA recognizes that respirators must be used, on a temporary basis, for certain mining tasks.
MSHA has provided greater health protection for miners by requiring (as opposed to making available) use of respirators for coal miners when exposed to respirable crystalline silica above the PEL, while continuing necessary protection for MNM miners. Also, in
Engineering controls are reliable, provide consistent levels of protection to many miners, allow for predictable performance levels, can be monitored continually, and can remove harmful levels of airborne contaminants, including respirable crystalline silica, from the miner's environment.
The AFL-CIO stated that mine operators should be required to submit scenarios where respirators are necessary under limited circumstances and if MSHA does not have evidence respirators are needed for a particular task, they should not be permitted (Document ID 1449). After considering this comment, MSHA has decided not to require MNM mine operators to submit scenarios, or plans, for the temporary use of respirators because MSHA approval takes time and, in the Agency's experience, there are unforeseen circumstances in a mine that may require the immediate implementation of engineering controls. When overexposures to respirable crystalline silica occur, paragraph 60.13(a)(3) requires the mine operator to take immediate corrective actions to lower concentrations of respirable crystalline silica to at or below the PEL. Therefore, requiring mine operators to submit a plan and receive MSHA approval before implementing changes would allow respirable crystalline silica exposures above the PEL to remain uncorrected for longer than necessary, and put miners' health at risk.
The final rule is changed from proposed paragraph 60.14(b). MSHA has revised the heading for paragraph (b) to include “at all mines” so that it is clear that paragraph (b) is applicable to miners unable to wear respirators at MNM and coal mines. Paragraph (b)(2) is also changed from the proposal to remove “non-routine.” This change is made to be consistent with the change discussed in paragraph (a). The rest of paragraph (b) is unchanged from the proposal. Paragraph (b) requires that, upon written determination by a PLHCP that an affected miner is unable to wear a respirator, the miner be temporarily transferred to work in a separate area of the same mine or to an occupation at the same mine where respiratory protection is not required. Paragraph (b)(1) states that the affected miner shall continue to receive compensation at no less than the regular rate of pay in the occupation held by that miner immediately prior to the transfer. Paragraph (b)(2) states the affected miner may be transferred back to the miner's initial work area or occupation when temporary use of respirators is no longer required.
The USW supported the temporary transfer of miners unable to wear respirators (Document ID 1447) while the Arizona Mining Association stated that it would be challenging to transfer miners who cannot wear respirators to another location or occupation where respirators are not needed (Document ID 1368).
After reviewing the comments, MSHA has determined that no change to the proposal is necessary. MSHA believes that it should not be difficult for a mine operator to temporarily transfer miners to a separate area or occupation to ensure their health and safety. Under the rule, the concentration of respirable crystalline silica to which the miner is exposed must be controlled through feasible engineering and administrative controls; therefore, instances in which a miner is transferred because of an inability to wear a respirator should be infrequent. Miners may be able to work in other areas of the mine where respirable crystalline silica concentrations are under the PEL. Furthermore, under paragraph (b)(2) the miner may be transferred back to the initial work area or occupation when the limited use of respirators is no longer required.
The final rule is changed from proposed paragraph (c). MSHA has revised the heading for paragraph (c) to include “at all mines” so that it is clear that paragraph (c) is applicable to MNM and coal mines. Paragraph (c)(1) is adopted as proposed and requires mine operators to provide affected miners with a NIOSH-approved atmosphere-supplying respirator or NIOSH-approved air-purifying respirator equipped with particulate protection classified as 100 series under 42 CFR part 84 or particulate protection classified as High Efficiency “HE” under 42 CFR part 84.
Some commenters, including mining and industry trade associations, stated that the NIOSH Pocket Guide to Chemical Hazards recommends the use of N-, R-, or P-95 and 99 series respirators to lower miners' exposures to respirable crystalline silica and suggested MSHA revise the final rule to also allow for these respirators
After reviewing comments, MSHA has decided to maintain paragraph (c)(1) in the final rule, as proposed. N-, R-, or P-95 and 99 respirators may provide an appropriate level of filtration when properly fitted, worn, and maintained; however, MSHA has observed that the structural integrity of these respirators is very easily compromised in the harsh mining environment. N-, R-, or P-95 and 99 respirators are not as durable as other types of air-purifying respirators. N-, R-, or P-95 and 99 respirators are easily contaminated, damaged, and deformed and must be routinely replaced to maintain effectiveness. Also, the N-, R-, or P-95 and 99 respirators do not hold their shape or maintain an effective seal when they become wet. N-, R-, or P-95 and 99 respirators that are damaged or deformed provide little, if any, protection and may offer a false sense of security to miners. MSHA recognizes that PAPRs may be more comfortable to wear than full-face or half-face, tight-fitting air purifying respirators; however, PAPRs are still not as reliable or effective as engineering controls and are not a permanent solution. PAPRs add noise from the fan and the full-face covering making it difficult for the miner to hear or communicate effectively, which could subject the miner to hazards while working. They may also reduce the miner's peripheral vision and decrease the wearer's situational awareness around equipment or other mining hazards. PAPRs, like full-face or half-face, tight-fitting air purifying respirators, must be worn only as a temporary measure in accordance with paragraph 60.14(b).
MSHA believes that air-purifying respirators classified as 100 series or High Efficiency under the NIOSH classifications for particulate protection will provide the maximum level of protection when miners are wearing respirators and are most suitable in protecting the health and safety of miners from occupational exposure to respirable crystalline silica when exposures are above the PEL.
Paragraph (c)(2) is modified from the proposal and requires that when approved respirators are used, the mine operator must have a written respiratory protection program that meets the following requirements in accordance with ASTM F3387-19: program administration; written standard operating procedures; medical evaluation; respirator selection; training; fit testing; maintenance, inspection, and storage. The proposal did not specify the requirement for a written respiratory protection program or list the mandatory program elements. The language in the final rule is consistent with the requirements of ASTM F3387-19,
MSHA received comments on the incorporation by reference of ASTM F3387-19, with some commenters supporting the proposal and some commenters opposing it. An industrial hygiene professional association, labor organization and a mining related business supported the proposal to update the existing respirator protection standard (Document ID 1351; 1398; 1392). The AIHA and UMWA stated that the proposed incorporation by reference of ASTM F3387-19 to amend the Agency's respiratory protection program to current and comprehensive requirements was appropriate (Document ID 1351; 1398). The AEMA and NMA, who opposed the proposal, stated that MSHA should not reference the ASTM F3387-19 requirements if the Agency does not allow the use of respirators for compliance purposes (Document ID 1424; 1428). Vanderbilt Minerals, LLC asserted that incorporating ASTM F3387-19 is beyond MSHA's statutory authority and conflicts with the intent of the Mine Act (Document ID 1419).
As discussed in
The AIHA, NMA, and EMA stated that the proposed ASTM F3387-19 standard's requirements were too prescriptive and asked that MSHA give operators the flexibility to select the elements of that standard that are most applicable to their own needs and the hazards at their mines (Document ID 1451; 1441; 1442). The AFL-CIO expressed concern that mine operators would be allowed to determine which parts of the respiratory standard they will follow and urged MSHA to require certain components (Document ID 1449). The AEMA stated that the final rule should clarify whether a specific written respiratory protection program is required and under what standards (Document ID 1424). The AEMA also asked for more clarity from MSHA on what elements of ASTM F3387-19 will be required when respiratory protection for miners is needed.
The CISC, MSHA Safety Services, Inc., and Tata Chemicals Soda Ash Partners, LLC recommended that MSHA align the respiratory protection requirements with OSHA's requirements (Document ID 1430; 1392; 1452). Draeger Inc. asked that MSHA include in the rule additional specific provisions of ASTMF3387-19, such as the breathing gas requirements in section 13 of the ASTM F3387-19 standard and wearer seal checks, and also suggested that MSHA add requirements to the fit testing procedures to include physical movements that are more relevant to low-seam coal mines (Document ID 1409).
The Agency agrees with commenters who expressed that the requirements of the respiratory protection program are appropriate, and the Agency makes clarifying changes to the requirements in the final rule. The Agency has clarified paragraph (c)(2) to state the specific respiratory protection program requirements. In paragraph (c)(2), MSHA has deleted “as applicable” and added that, when respirators are used, a mine operator must have a written respiratory protection program that meets the following requirements in accordance with ASTM F3387-19: program administration; written standard operating procedures; medical evaluation; respirator selection; training; fit testing; maintenance, inspection, and storage. MSHA has the authority, both under the Mine Act and Federal regulatory guidelines, to include the incorporation by reference of consensus standards such as ASTM F3387-19. The Mine Act specifically requires MSHA to issue improved mandatory safety and
MSHA received a comment from the MCPA asserting that the medical evaluation and fit testing requirements for respirators in ASTM F3387-19 were too rigorous because there may be situations where a miner fails a medical evaluation or fit test simply due to personal desires, such as having a beard (Document ID 1406).
MSHA believes that the medical evaluation and fit testing requirements for use of respirators are appropriate because they are critical to ensuring proper protection and safe respirator use for respirator wearers who are exposed to airborne contaminants. In addition, medical evaluations and fit tests are required under MSHA's current respiratory protection standard (ANSI Z88.2-1969). Therefore, mine operators who have used respirators previously should be familiar with these requirements.
MSHA incorporates by reference this consensus standard for two reasons. ASTM F3387-19 reflects current respirator technology and accepted effective respiratory protection practices. For example, ASTM F3387-19 provides detailed information on respirator selection that is based on NIOSH's research and long-standing experience of testing and approving respirators for occupational use and OSHA's respiratory protection standards. The ASTM F3387-19 standard is prepared and maintained by subject matter experts, using a rigorous and well-defined process. The standard is reviewed by internationally recognized experts and is approved for use only if the appropriate procedures are followed. In addition, adopting voluntary consensus standards is consistent with OMB Circular A-119.
MSHA has observed that many operators, especially larger mine operators, have already implemented respiratory protection programs that meet many of the OSHA requirements, which are substantially similar to many requirements in ASTM F3387-19. In response to commenters who suggested that MSHA adopt the OSHA respiratory protection standards, ASTM F3387-19 references OSHA's respiratory standards that include assigned protection factors and maximum use concentrations, and fit testing. MSHA believes that the mining industry is familiar with many provisions in ASTM F3387-19. MSHA anticipates that for many large mine operators, few changes to their respiratory protection program may be warranted, whereas small mines may need to revise their respiratory protection programs in accordance with the requirements in ASTM F3387-19. The program requirements are discussed in more detail in
The AIHA stated that respirators should be used only under a comprehensive respiratory protection program and under the supervision of an industrial hygienist (Document ID 1351). AIHA suggested that MSHA should refer to the most recent edition of ASTM's respiratory protection standard and not the 2019 edition, which may become obsolete by the time the silica standard is adopted.
According to the Office of the Federal Register, MSHA is required to inform the public of the standard to be incorporated and the specific edition that the Agency intends to require. In the proposed rule, MSHA proposed to incorporate the 2019 edition of ASTM F3387, which is the most recent respiratory protection standard. MSHA is incorporating by refence ASTM F3387-19 in this final rule. MSHA is aware that larger mines may have an industrial hygienist or safety specialist administer their respiratory protection program; this practice is consistent with, but not required by, the ASTM F3387-19 standard's requirements for program administration. ASTM F3387-19 specifies that responsibility and authority for the respirator program should be assigned to a single qualified person with sufficient knowledge of respiratory protection. Qualifications could be gained through training or experience; however, the qualifications of a program administrator must be commensurate with the respiratory hazards at the mine site.
The program administrator should have access to and direct communication with the site manager about matters impacting worker safety and health. ASTM F3387-19 notes a preference that the administrator be in the company's industrial hygiene, environmental, health physics, or safety engineering department; however, a third-party entity that meets the standard's requirements may also provide this service. ASTM F3387-19 outlines the respiratory protection program administrator's responsibilities, specifying that they should include: measuring, estimating, or reviewing information on the concentration of airborne contaminants; ensuring that medical evaluations, training, and fit testing are performed; selecting the appropriate type or class of respirator that will provide adequate protection for each contaminant; maintaining records; evaluating the respirator program's effectiveness; and revising the program, as necessary.
The final rule establishes requirements for medical surveillance for MNM mines in § 60.15. Paragraph (a) requires MNM mine operators to provide each miner periodic medical examinations performed by a PLHCP or specialist, at no cost to the miner. In a change from the proposal, under paragraph (a)(2)(iv), MSHA adds that the pulmonary function test may also be administered by a pulmonary function technologist with a current credential from the National Board for Respiratory Care. The rest of paragraph (a) remains unchanged from the proposal.
Paragraph (b) establishes the requirements for each MNM mine operator to provide voluntary medical examinations every 5 years to all miners employed at the mine or who have already worked in the mining industry. In a change from the proposal, new paragraph (b)(1) specifies that the voluntary medical examinations must be offered during an initial 12-month period. New paragraph (b)(2), the same as proposed paragraph (b), requires mine operators to continue to offer voluntary medical examinations after the period in paragraph (b)(1) at least every 5 years during a 6-month period that begins no less than 3.5 years and not more than 4.5 years from the end of the last 6-month period.
Paragraph (c) specifies that each mine operator is required to provide the medical examinations specified in paragraph (a) to each miner who begins work in the mining industry for the first time. In a change from the proposal, paragraph (c)(1) requires the initial medical examination to take place no later than 60 days after beginning employment (instead of 30 days). Paragraphs (c)(2) and (c)(3) remain unchanged from the proposal.
Paragraph (d) specifies the requirements for medical examination results. In a change from the proposal, paragraph (d)(1) specifies that the medical examination results must be provided from the PLHCP or specialist within 30 days of the medical examination. Like the proposal, the medical examination results must be provided to the miner, and at the request of the miner, to the miner's designated physician. In a change from the proposal, the medical examination results may also be provided, at the request of the miner, to another
MSHA received several comments regarding the medical surveillance provisions for MNM mines, offering both support and opposition. The PACA, IAAP, and CalCIMA opposed the proposal, stated that the requirements were too prescriptive, and asked that MSHA give operators more flexibility in implementing medical surveillance programs (Document ID 1413; 1456; 1433). A mining-related business owner asserted that medical surveillance requirements are not needed, stating that there is a lack of silicosis cases in MNM miners (Document ID 1392).
Three commenters—an elected federal official, a miner health clinic, and a medical association—supported the proposal and asserted that the medical surveillance requirements would help MNM miners track their respiratory health and mitigate risks for silica-related chronic diseases (Document ID 1439; 1418; 1373). Two unions, the AFL-CIO and the USW, stated that both MNM and coal miners should be provided with the same level of protection and care through their medical surveillance programs (Document ID 1449; 1447).
After reviewing the comments, MSHA concludes that the proposed medical surveillance provisions for MNM mines should be retained, with some modifications. As discussed in
Some commenters requested that the Agency use a risk-based approach for medical surveillance. The NMA, NSSGA, AEMA, and SSC urged MSHA to adopt OSHA's risk-based medical surveillance framework, which requires medical monitoring only for those miners exposed to respirable silica above the action level for more than 30 days per year (Document ID 1428; 1448; 1424; 1432).
The Agency disagrees with this approach. Unlike OSHA's silica standard, the final rule does not include an exposure trigger provision because the Agency believes it is important to maintain consistency between the medical surveillance requirements for MNM and coal mines to ensure all miners have the information necessary for the early detection of silica-related disease. The purpose of medical surveillance is to provide MNM miners necessary information to determine if their health may be adversely affected by exposure to respirable crystalline silica and enable miners to take appropriate action to stop further disease progression.
Below is a detailed discussion of the comments received on this section and modifications made in response to the comments.
Paragraph § 60.15(a) requires that each MNM mine operator make medical examinations, performed by a PLHCP or specialist, available to each MNM miner, at no cost to the miner. Mine operators must ensure that medical examinations follow the requirements under § 60.15(a)(2)(i)-(iv). In a change from the proposed rule, under paragraph (a)(2)(iv), MSHA adds that the pulmonary function test may be administered by a pulmonary function technologist with a current credential from the National Board for Respiratory Care.
MSHA received several comments on proposed paragraph 60.15(a). The AIHA, AANP, and CertainTeed, LLC supported MSHA's proposal to require MNM mine operators to provide MNM miners with medical examinations performed by a PLHCP or specialist and agreed with MSHA's broad definition of PLHCP (Document ID 1351; 1400; 1423). The BIA and the Arizona Mining Association expressed concerns with this requirement and asserted that many MNM mines may experience issues with getting access to a PLHCP or specialist qualified to perform the examinations (Document ID 1422; 1368). The APHA and AOEC advocated for medical surveillance to be performed only by physicians who are board-certified in occupational medicine or pulmonary medicine, or who have experience in silica medical surveillance (Document ID 1416; 1373). Two commenters recommended that MNM miners should be able to choose their own health care provider (Document ID 1439; 1412). The Arizona Mining Association inquired about whether medical examinations may be incorporated within the mine operator's health care plans (Document ID 1368).
After reviewing the comments, MSHA adds under paragraph (a)(2)(iv) that the pulmonary function test may be administered by a pulmonary function technologist with a current credential from the National Board for Respiratory Care. This option will provide a larger pool of qualified respiratory care professionals who may administer pulmonary function tests.
MSHA believes that MNM mine operators should not encounter any significant issues with identifying and hiring a qualified PLHCP or specialist to conduct medical examinations. The final rule provides flexibility in the selection of health care professionals. As discussed in § 60.1, the final rule allows MNM mine operators more time to comply; MNM mine operators will have 24 months after the publication of the final rule, rather than 4 months after the publication of the final rule as specified in the proposed rule. This additional time addresses commenters' concerns about time needed for establishing a medical surveillance program.
The Agency also clarifies that mine operators may give miners the option to choose their own health care provider, if the provider meets the requirements of this section. As stated in the proposal, a qualified PLHCP is an individual whose legally permitted scope of practice (
MSHA does not require medical examinations in the final rule to be performed only by physicians who are board-certified in occupational medicine or pulmonary medicine, because PLHCPs may have the knowledge and skills to conduct these examinations independently or under
The Agency received comments regarding the use of NIOSH facilities and NIOSH B Readers. The American Industrial Hygiene Association and National Coalition of Black Lung and Respiratory Disease Clinics stated that MSHA should require MNM operators to use NIOSH-approved facilities (Document ID 1351; 1410). However, several commenters, including the ACOEM, NLA, NVMA, and NSSGA, expressed concerns about the limited availability and geographic distribution of these facilities (Document ID 1405; 1408; 1441; 1448). The NMA, Portland Cement Association, and AEMA noted that there are only a limited number of B Readers available (Document ID 1428; 1407; 1424). The Black Lung Clinics supported MSHA's assertion that the availability of digital radiography allows for the electronic transmission of chest radiographs to remotely located B Readers (Document ID 1410).
MSHA agrees with commenters who expressed concerns about the accessibility of NIOSH-approved facilities, and, like the proposal, the final rule does not include a requirement to use such facilities. MSHA believes that requiring a NIOSH-certified B Reader to classify chest X-rays and requiring either a spirometry technician with a current certificate from a NIOSH-approved Spirometry Program Sponsor or a pulmonary function technologist with a current credential from the National Board for Respiratory Care to perform pulmonary function tests, will ensure that miners receive the necessary standard of care to protect their health while providing broader access to PLHCPs. As did OSHA in its 2016 silica final rule (81 FR 16286, 16821), MSHA has determined that the number of B Readers in the United States is adequate to classify the additional chest X-rays that will be required under this rule. In addition, digital X-rays can be transmitted electronically to B Readers anywhere in the United States, so this requirement will provide operators greater access to B Readers. Further, as discussed more below, under § 60.15(d)(2), mine operators are required to ensure that, within 30 days of the medical examination, the PLHCP or specialist provides the results of chest X-ray classifications to NIOSH, once NIOSH establishes a reporting system.
In the proposed rule, MSHA solicited comment on whether other diagnostic technology, such as high-resolution computed technology (CT), should be included in the final rule. The AOEC, APHA, USW, and a medical professional urged MSHA to include a low-dose CT scan, either as a primary test or if recommended by the examining clinician, because such scans are more sensitive than conventional chest radiographs and would facilitate earlier detection of disease or dysfunction (Document ID 1373; 1416; 1447; 1437). The UMWA cautioned against requiring CT scans because they are not as readily available and are more costly (Document ID 1409). The American Thoracic Society
MSHA agrees with commenters regarding the cost concerns and limited availability of low-dose chest CT scans. MSHA is aware that there are increased health risks from higher radiation exposures from screening with low dose chest CT scans. MSHA is also aware that “ultra-low-dose” methods for CT scans are available that would subject the miner to lower radiation doses than other screening chest CT scans; however, this method is not widely available and is therefore not a practical resource for mine operators at this time. Also, as a medical professional association acknowledged, low-dose chest CT scans do not have a standard for the classification of the results, unlike classification standards for chest X-rays (Document ID 1421). For the reasons above, the final rule does not add CT scans to the medical examination requirements in § 60.15(a).
The Agency received some comments recommending adding testing requirements. The Miners Clinic of Colorado and the Black Lung Clinics suggested requiring diffusion capacity testing as a pulmonary function test (Document ID 1418; 1410). MSHA considered these comments and determined that diffusion capacity testing is not as widely available as forced vital capacity (FVC) and forced expiratory volume tests (
MSHA also received comments on tuberculosis testing requirements. Commenters—the AOEC, APHA, and the NSSGA—recommended that a test for latent tuberculosis be required as an initial test or if recommended by the examining PLHCP, noting that it is included in OSHA's silica standard (Document ID 1373; 1416; 1448). However, the Portland Cement Association argued that testing for tuberculosis is unnecessary (Document ID 1407). After considering these comments, MSHA has decided not to include a tuberculosis test requirement because it would be duplicative of the information provided in the medical and work history examination, which requires an assessment of the miner's history of tuberculosis under § 60.15(a). The Agency determined that the information gathered through the medical and work history examination will effectively screen for tuberculosis. In MSHA's experience, tuberculosis is not a significant health concern in the MNM mining industry.
Final 60.15(b) requires mine operators to provide the opportunity to all miners employed at the mine to have the medical examinations under 60.15(a). Based on its review of the comments, MSHA has modified the language to clarify the timing of medical examinations. Under final paragraph (b), MNM mine operators must provide the opportunity for miners to receive medical examinations as specified under (b)(1) and (b)(2). This applies to all MNM miners who are not new to the mining industry. Miners who are new to the industry are required to receive medical examinations as specified under paragraph (c).
Paragraph (b)(1) requires mine operators to provide medical examinations during an initial 12-month period. This change ensures that examinations are offered to miners during a 12-month period that begins by the compliance date or during a 12-month period that begins whenever a new mine commences operation.
Under paragraph (b)(2), mine operators must provide subsequent medical examinations to miners not new to the mining industry at least every 5 years after the period in paragraph (b)(1). The medical examinations must be available during a 6-month period that begins no less than 3.5 years and not more than 4.5 years from the end of the last 6-month period. As discussed in
MSHA received many comments about proposed § 60.15(b). Several commenters, including the AEMA, NVMA, NSSGA, SSC, and USW, urged that the medical examinations remain voluntary in the final rule (Document ID 1424; 1441; 1448; 1432; 1447; 1437;1412). The NSSGA asked MSHA to clarify that while operators are required to offer workers the option of participating in medical surveillance, workers can decline if they wish, unless employers require it as a condition of employment. (Document ID 1448).
In response to comments, MSHA emphasizes that while MNM mine operators are required to make the medical examinations available, miner participation is voluntary. However, MSHA believes mine operators should encourage miner participation because medical surveillance is crucial for early detection and prevention of silica-related diseases to ensure miners' well-being and safety. MSHA expects mine operators to include information on medical surveillance in their parts 46 and 48 training plans. MSHA will provide guidance to mine operators on how medical surveillance, as well as other silica requirements in this final rule, can best be integrated in their existing training plans.
MSHA also considered comments supporting different timelines for medical surveillance frequency for medical examinations. The American Thoracic Society
Some commenters referenced the OSHA standard as a rationale for more frequent medical examinations. The AOEC, a medical professional, NSSGA, and USW said that all miners should have the same medical examination frequency and should follow OSHA's standard of making medical examinations available every 3 years (Document ID 1373; 1437; 1448; 1447). The Portland Cement Association expressed support for using OSHA's exposure-based approach if medical surveillance is in the final rule, but with a frequency of every 5 years as in MSHA's proposal (Document ID 1407).
After considering the comments, MSHA has determined that the 5-year period for voluntary medical examinations is appropriate, after an initial examination within a 12-month period starting no later than the compliance date or within an initial 12-month period of a new mine commencing operations after the compliance date. The 5-year period along with the initial examination will provide miners with information needed for the timely detection of silica-related diseases. Miners should use the information obtained from medical surveillance to establish a baseline and make informed decisions regarding their health. MSHA does not believe a schedule requiring more frequent periodic examinations is necessary. . In the Agency's experience with the coal miners' medical surveillance program, 5-year periodic examinations are appropriate to provide miners with information needed for early detection of silica-related disease. MSHA intends to provide miners and mine operators with information and education to help them recognize the signs and symptoms of silica related diseases. MSHA expects miners will use this information to help inform their decisions regarding their medical care. The Agency believes the medical examinations under the final rule are comprehensive and will promote miners' health and safety.
The Agency received comments on the timeline in proposed paragraph 60.15(b). NSSGA and IAAP stated that that prescribing a 6-month period when examinations must be offered creates logistical challenges for scheduling resources and accounting for miners' work schedules, and they urged MSHA not to specify when examinations should be scheduled (Document ID 1448; 1456). However, BMC offered support for this language, stating that they supported MSHA's provision that mine operators must provide medical surveillance to miners no later than a specified number of years, but within a certain range (Document ID 1417).
MSHA agrees that operators must provide medical surveillance to miners employed at the mine on a consistent schedule. However, in response to comments, MSHA has modified the language in this paragraph to clarify the timing of the voluntary medical examinations. Paragraph (b)(1), changed from the proposed rule, requires mine operators to provide medical examinations during an initial 12-month period. Under paragraph (b)(2), the mine operators must provide medical examinations at least every 5 years after the period in paragraph (b)(1). The final rule specifies that medical examinations must be available during a 6-month period that begins no less than 3.5 years and not more than 4.5 years from the end of the last 6-month period. The Agency believes the change in paragraph (b)(1) will provide miners necessary health information earlier than under the proposed rule. The final rule will ensure miners have early detection of adverse health effects from silica exposure. MSHA believes the final rule safeguards miners' health, while fostering enhanced preventative and protective measures within the mining industry.
MSHA received comments asking the Agency to clarify how to verify whether miners have had previous medical evaluations. NVMA asked for clarification about how operators should verify whether a miner new to the operator but experienced in the industry has already completed a medical examination (Document ID 1441). Other commenters, including the USW, recommended that more efforts should be made to encourage participation and educate workers (Document ID 1447; 1437). The USW further stated that
In response to the commenter regarding verification of medical examinations of newly hired experienced miners, MSHA encourages mine operators to work together to determine the completion of prior medical examinations without compromising the confidentiality and privacy of the miners' health information. MSHA clarifies that, under the final rule, mine operators have no obligation to verify whether a newly-hired experienced miner had a medical examination.
MSHA believes that the rule is designed to prioritize the health and safety of miners by making medical examinations available to them. MSHA requires operators offer medical examinations, ensuring that miners are aware, through training, of their availability, purpose, and health benefits. MSHA agrees with commenters that fostering an informed environment where miners are made aware of the risk of silica exposure will encourage miners to take advantage of the availability of medical examinations. The final rule is designed to help miners become more aware of how medical surveillance can protect them against silica risks. In response to commenters' concern about discrimination and retaliation, MSHA investigates, in accordance with its responsibility under the Mine Act, discrimination complaints to encourage miners to exercise their rights under the Mine Act, including the right to medical evaluations. 30 U.S.C. 815(c).
Final paragraph (c) requires MNM mine operators to provide a mandatory initial medical examination for each MNM miner who is new to the mining industry. Under paragraph (c)(1), the mandatory initial medical examination must occur no later than 60 days after a miner new to the industry begins employment. This is a change from the proposed rule, which required the initial medical examination within 30 days. Final paragraphs (c)(2) and (3) are unchanged from the proposed rule. Under paragraph (c)(2), mine operators are required to provide a mandatory follow-up medical examination to the miner no later than 3 years after the miner's initial medical examination. Final paragraph (c)(3) requires that, if a miner's 3-year follow-up medical examination shows evidence of pneumoconiosis or decreased lung function, the operator provide the miner with another mandatory follow-up medical examination with a specialist, as defined in § 60.2, within 2 years.
MSHA determined that a 3-year follow-up is appropriate because there are some individuals who respond adversely to respirable coal mine dust exposure relatively quickly, and it is important to identify those individuals early. A 3-year interval at the start of a miner's career will provide necessary information for evaluating the results of subsequent spirometry tests and final paragraph (c)(1) requires a mandatory follow-up examination be given 3 years after the miner's initial examination. This is consistent with the 2014 RCMD Standard.
MSHA received comments on mandatory medical examinations. A couple of commenters, including BMC and AOEC, offered support for mandatory medical examinations, with some stating that medical examinations should be a mandatory requirement for both new and existing miners (Document ID 1417; 1373). MCPA opposed mandatory examinations even for new miners, stating that participation in medical surveillance is a personal choice that should be left up to each miner (Document ID 1406). NLA stated that making medical examinations mandatory for new miners would make it difficult to retain new hires (Document ID 1408).
NSSGA, IAAP, and BMC stated that MSHA should not prohibit operators from making participation in medical surveillance a mandatory condition of employment, if the mine operator believes mandatory participation is warranted (Document ID 1448; 1456; 1417). Some commenters, including USW, were opposed to mine operators mandating medical examinations as a condition of employment (Document ID 1447; 1437; 1412). One commenter emphasized that miners could be terminated for declining to visit an operator's selected PLHCP (Document ID 1412). The Brick Industry Association stated that if participation in a medical surveillance program is a condition of employment, companies will not be able to staff their operations (Document ID 1422).
Arizona Mining Association requested clarification on whether medical surveillance services are mandatory or are just required to be made available to the miners upon request. (Document ID 1368). PACA, IAAP, and NSSGA asked MSHA to clarify whether operators can make medical surveillance mandatory, and whether operators may conduct more extensive medical surveillance than required under the proposed rule (Document ID 1413; 1456; 1448). BMC asked if operators can make medical examinations mandatory as long as they meet MSHA's minimum medical surveillance requirements (Document ID 1417).
In response to these comments, MSHA notes that it is aware that some mine operators already have mandatory health screening as part of their employment policies. MSHA is also aware that some operators require periodic health examinations as part of their industrial hygiene practices. As a result, mandatory medical examinations may not be new for some mine operators. Many operators make participation in medical surveillance a mandatory condition of employment as a part of their overall safety and health program for their workforce. In response to comments, operators can conduct more extensive medical surveillance and can make medical examinations mandatory as long as they meet MSHA's minimum medical surveillance requirements. The Agency does not intend for the final rule's requirements to interfere with the operator's decision-making process with respect to managing its operation and miners.
The Agency has weighed USW and other commenters' concerns about the final rule making medical examinations mandatory and determined that it is critical to administer medical examinations when MNM miners first enter the profession. Mandatory examinations provided in close proximity to when miners are first hired and first exposed to respirable coal mine dust are necessary in order to establish an accurate baseline of each miner's health. Miners may not recognize early symptoms of silica-related disease; therefore, they might not be likely to seek medical assistance.
MSHA received comments requesting a longer period for initial medical examinations. The NSSGA, PACA, CalCIMA, and IAAP suggested that many miners new to the industry will not continue employment beyond an initial probation period due to the physical demands of the work (Document ID1448; 1413; 1433; 1456). During the Denver, Colorado public hearing, one commenter suggested making the period for medical examinations for new miners longer, so that mine operators would be providing medical examinations for those new miners who are more likely to remain employed (Document ID 1375). MSHA agrees with the commenter and has changed final paragraph (c)(1) to require an initial medical examination no later
The NSSGA and Vanderbilt Minerals, LLC suggested eliminating the mandate for a follow-up examination after an observed decrease in lung function, as that requirement is too broad, and the decrease could be due to non-occupational contaminants (Document ID 1448; 1419). In response to comments, the Agency has not included this change in the final rule. MSHA acknowledges the complex nature of lung function decrease; the final rule includes a medically sound approach that aligns examinations and subsequent actions with individual miner's health statuses and occupational exposure profiles. Evaluating lung function and changes in lung burden is a normal function of assessing the development of lung diseases. This provision will allow for a uniform approach to medical surveillance that is already implemented in the coal industry.
Some mining trade associations suggested that mandatory examinations be triggered by a specific level of exposure, instead of being required for all miners new to the industry (Document ID 1408; 1428; 1448; 1424). The final rule does not include a “trigger provisions because the Agency believes it is necessary to maintain consistency between the final rule's requirements for MNM mines and existing medical surveillance standards for coal mines. In MSHA's experience, medical surveillance requirements benefit coal miners, and the Agency has implemented outreach initiatives to expand coal miners' participation. MSHA believes that aligning the MNM medical surveillance requirements with the requirements for coal mines will effectively protect the health and safety of MNM miners.
Proposed paragraph (d) would have required that the results of any medical examination performed under this section be provided by the PLHCP or specialist only to the miner and, at the request of the miner, to the miner's designated physician. In response to comments, MSHA added language under paragraph (d)(1) to require the PLHCP or specialist to provide test results within 30 days of the medical examination and added a requirement that the PLHCP provide test results to another designee identified by the miner. Under paragraph (d)(2), the proposed provision was changed to require mine operators to ensure, within 30 days of the medical examination, that the PLHCP provide results of the chest x-ray classifications to NIOSH, once NIOSH establishes a reporting system.
MSHA received comments regarding the sharing of the medical examination results. Several commenters from MNM operators and mining industry organizations stated the medical examination results should be shared with the operator (Document ID 1424; 1417; 1456; 1441; 1448). The NSSGA suggested medical providers be required to send a written medical opinion to the operator if the operator requires the miner to sign a medical release form stating what information can be shared with the operator (Document ID 1448). This commenter also stated that examination results need to be shared with the operator as soon as possible, so that the operator can take actions to protect miners' health (Document ID 1448). Other commenters, including BMC, AEMA, and NVMA, suggested that medical examination results should be shared with mine operators (Document ID 1417; 1424; 1441). AEMA stated that the failure to communicate a confirmed diagnosis to the mine operator may inadvertently adversely hamper the miner's ability to receive compensation under workers' compensation program (Document ID 1424). However, commenters from labor organizations and medical professional associations stated that the proposed standard ensures that miners' medical confidentiality is protected when those miners undergo medical surveillance (Document ID 1398; 1447; 1449; 1410; 1373).
MSHA agrees with the commenters who expressed concerns regarding the confidentiality and timeliness of medical examination results. Under final paragraph (d)(1), MSHA modified the language of the proposal to clarify that the final rule requires the mine operator to ensure the PLHCP or specialist provide the medical examination results only to the miner, or to the miner's designated physician or another designee identified by the miner, and that this be done within 30 days of the examination. Paragraph (d)(1) ensures that the mine operator does not receive the miner's medical examination results. MSHA also added a provision to paragraph (d)(1) specifying that the miner can add a designee to receive the examination results in addition to the miner's physician, in case the miner needs to provide the examination results to other persons, such as family members or a health care professional who is not a physician. MSHA believes the timely receipt of medical examination results is important to allow the miner to make informed decisions regarding their health. Therefore, the Agency adds the requirement that the mine operator must ensure that the PLHCP or specialist provide the miner with their medical examination results within 30 days.
Under paragraph (e), the mine operator will obtain a written medical opinion from the PLHCP or specialist within 30 days of the medical examination. The written opinion must contain only the following: the date of the medical examination, a statement that the examination has met the requirements of this section, and any recommended limitations on the miner's use of respirators. No other information from the miner's medical examination may be obtained by the mine operator. Based on MSHA's experience with medical surveillance for coal miners, the Agency believes that confidentiality regarding medical conditions is essential, because it encourages miners to take advantage of the opportunity to detect early adverse health effects caused by respirable crystalline silica. (79 FR 24813, 24928).
The AIHA and the Black Lung Clinics expressed support for a requirement that operators submit medical surveillance plans to NIOSH for approval (Document ID 1351; 1410). ACOEM stated that if submitting for NIOSH approval creates administrative bottlenecks, employers should instead be allowed to contract with qualified physicians for these examinations, with the requirement that the supervising physician be board-certified in pulmonary disease or occupational medicine or another American Board of Medical Specialties (ABMS) (Document ID 1405). Two commenters, the NVMA and AEMA, stated that NIOSH is not a regulatory agency, and thus should not oversee medical surveillance plans (Document ID 1441; 1424).
The Black Lung Clinics suggested that medical examination results should be reported to NIOSH so that MSHA can monitor the effectiveness of dust controls (Document 1410). This commenter further suggested that MSHA create a repository for all screening results accessible to health care providers that can help detect early disease (Document ID 1410). The UMWA recommended that MSHA work with NIOSH to expand the Coal Workers Health Surveillance Program's mobile
After considering the comments, MSHA agrees with commenters that medical examination results should be submitted to NIOSH. MSHA has added a new final paragraph (d)(2) that requires the mine operator to ensure that, within 30 days of a miner's medical examination, the PLHCP or specialist provides the results of chest X-ray classifications to NIOSH, once NIOSH establishes a reporting system. The final rule does not require medical surveillance plans or NIOSH approval of them. MSHA agrees with commenters' concerns that having MNM mine operators develop and submit a medical surveillance plan for approval could cause administrative delays and adversely affect miners' health. The new requirement to submit chest X-ray classifications to NIOSH for occupational health research will provide the public important health information related to respirable crystalline silica disease and MSHA expects this information will provide a public health benefit.
This requirement is important because NIOSH intends to work with MSHA and the MNM mining community to create a reporting system to help mine operators ensure that PLHCPs or specialists may easily submit the required information. MSHA and NIOSH will inform mine operators and other stakeholders in a timely manner when the reporting system is available. When NIOSH establishes the system, NIOSH and MSHA will issue a joint notice to the mining community. In this notice, NIOSH and MSHA will include the logistics of the reporting system, information on how operators can ensure that the PLHCPs provide the required information to NIOSH, and information on how miners and medical professionals can effectively use the system. This information will be posted on both Agencies' websites. MSHA enforcement and Educational Field and Small Mine Services (EFSMS) staff will work with operators to facilitate compliance.
As discussed above, final paragraph (e), unchanged from the proposed rule, requires MNM mine operators to obtain a written medical opinion from a PLHCP or specialist within 30 days of the medical examination, and requires that this opinion include only the date of a miner's medical examination, a statement that the examination has met the requirements of this section, and any recommended limitations on the miner's use of respirators. The purpose of the opinion is to enable the mine operator to verify the examination has occurred and to provide the operator with information on miners' ability to use respirators.
The Agency received several comments regarding proposed paragraph (e). One commenter, the CalCIMA, was concerned about whether the medical opinion would be available in a timely manner (Document ID 1433). MSHA understands the commenter's concern. The Agency believes that the 30-day requirement to provide the medical opinion regarding the recommended limitation on the miner's use of respirators should provide the mine operator sufficient notice to address any issues.
The AOEC suggested that MSHA should follow OSHA in requiring clinicians to prepare a written report to the worker and provide a written medical opinion to the employer (Document ID 1373). That commenter stated that under OSHA's rule, the report remains confidential, the clinician discusses the examination results with the worker, and the worker signs a medical release form that clarifies what information the employer has received (Document ID 1373). MSHA notes that its final rule includes requirements similar to OSHA's reporting requirements in that the operator receives very limited information and will not be apprised of the results of the examination. Because the mine operator is receiving very limited information, MSHA determined that a medical release form signed by the miner is not necessary.
Final paragraph (f), unchanged from the proposed rule, requires the mine operator to maintain a record of the written medical opinion obtained from the PLHCP or specialist under paragraph (e). This requirement provides a record to ensure compliance with the standard. MSHA received comments on the record retention requirements for written medical opinion records that are discussed further in
The NSSGA highlighted the importance of compliance assistance for mines, especially small mines that do not have experience with medical surveillance programs (Document ID 1448). MSHA agrees with the commenter that compliance assistance is needed and will develop compliance materials to assist mine operators in implementing the final rule, including the medical surveillance requirements. MSHA will work with the mining community to ensure the final rule is implemented consistently and in a manner that adds to existing protections for miners. See the more complete discussion on MSHA's compliance assistance for this rulemaking under
Section 60.16 identifies recordkeeping retention requirements for records created in part 60. The final rule requires mine operators to retain evaluation, sampling, and corrective actions records for at least 5 years. The final rule requires mine operators to retain written determination records and written medical opinion records for the duration of a miner's employment plus 6 months. It also requires mine operators, upon request from an authorized representative of the Secretary, from an authorized representative of miners, or from miners, to promptly provide access to any record listed in § 60.16.
In the proposal, MSHA sought comment on the utility of the recordkeeping requirements in this section. MSHA received several comments on the proposed recordkeeping requirements, including from an industrial hygiene professional association and mining trade association, supporting the Agency's proposed recordkeeping provisions (Document ID 1351; 1424). A MNM operator and mining trade association opposed the recordkeeping requirements, stating that the requirements were duplicative and should be more flexible (Document ID 1419; 1448). Below is a detailed discussion of the comments received on this section.
MSHA received comments from labor unions, advocacy organizations, one MNM operator, and a federal elected official requesting an increase in the retention periods for sampling records (Document ID 1398; 1416; 1417; 1425; 1439; 1447; 1449). Records that were to be retained by the mine operator under this section include evaluation, sampling, and corrective actions records, as described in proposed paragraphs 60.16(a)(1) to (3).
USW and AFL-CIO stated that increased record retention is particularly important for MNM mines,
USW and AFL-CIO expressed concern that retaining records for 2 years would be insufficient to establish a pattern of exposure or provide other critical information such as the evaluation of corrective actions. Labor unions, advocacy organizations, a MNM operator, and an individual suggested that MSHA should align its recordkeeping requirements with the OSHA silica standard recordkeeping requirements (29 CFR 1910.1020) (Document ID 1398; 1412; 1416; 1417; 1425; 1447).
In response to comments requesting an increase in the record retention period, the final rule increases the record retention period for evaluation, sampling, and corrective actions records in paragraphs (a)(1) to (3) to at least 5 years. Increasing to the 5-year record retention period for evaluation, sampling, and corrective actions records will help mine operators, miners, and MSHA better evaluate and monitor changes in exposures, understand health hazards, and ensure the implementation and maintenance of proper controls to protect miners from health hazards associated with respirable crystalline silica.
Under final (a)(1) and (2), evaluation and sampling records confirm that sampling results accurately represent current exposure conditions. The 5-year recordkeeping requirement for evaluation and sampling records will provide mine operators with robust information to enable them to understand a history of occupational exposures at the mines and to take appropriate actions to protect miners, such as implementing engineering and administrative controls. Evaluation and sampling records can identify overexposures due to changes in production, processes, controls, or geological conditions. These records help mine operators develop, implement, and adjust controls and other measures that protect miners from overexposures. In addition, these expanded records will provide miners and their representatives with information about exposure patterns over time to understand health hazards at their mines and to make informed decisions about their health care. As some commenters noted, this information can be invaluable to miners who have already been diagnosed with an illness or experienced negative health effects and help them to make decisions about their health and future employment. The 5-year records of evaluation and sampling will also enable MSHA staff in Technical Support and Educational Field and Small Mine Services to provide needed compliance assistance.
The 5-year recordkeeping requirement for corrective actions records in final paragraph (a)(3) will help mine operators and MSHA enforcement staff determine if existing controls are effective, or if maintenance or additional controls are needed. In MSHA's experience, the cumulative record provides MSHA and mine operators with information to identify trends in exposures and operational changes. Mine operators can use trend information to determine the effectiveness of controls over time and to take proactive measures to prevent future overexposures, while miners and their representatives can use the trend information to determine health hazards and protection needs at their mines.
MSHA has determined that the 5-year retention period in final paragraphs (a)(1) to (3) balances the operator's burden to maintain records and the need for this information to take appropriate action to protect miners' health. The 5-year record retention is also consistent with MSHA's record retention period for operator samples collected for diesel particulate matter in underground metal and nonmetal mines (§ 57.5071(d)(2)) and other injury and illness reports required for all mines (§ 50.40). From MSHA's experience and observation, informed miners who are aware of occupational health hazards around them are more likely to follow safe work practices and to report these hazards to their operators or MSHA when necessary. When miners are aware of occupational health hazards and participate in the identification, remediation, and control of those hazards, the overall level of safety and health at the mine will be improved. In sum, informed miners are more likely and better able to play an active role in safety and health as the Mine Act envisions and better protect themselves and other miners.
MSHA notes that minor changes have been made to final paragraphs (a)(1) to (3) to change the citation for the records addressed and to reflect changes discussed in § 60.12 and 60.13. MSHA has similarly revised the citations in Table 1 to Paragraph (a)—Recordkeeping Requirements.
Like the proposal, final paragraphs (a)(4) and (5) require that the written determination by a PLHCP that a miner is unable to wear a respirator under § 60.14(b), as well as the medical surveillance records under§ 60.15(f), be retained for the duration of the miner's employment plus 6 months. MSHA received several comments regarding the retention period for medical surveillance records, with most commenters supporting a longer retention period.
UMWA recommended that medical surveillance records be kept for 30 years and provided to the miner on termination of employment; that operators be required to transfer records to a successor employer; and that when an employer is ceasing operations and there is no successor employers to receive the record, the employer be required to notify affected employees of their rights of access to records at least 3 months prior to the cessation of the employer's business Document ID 1398). AOEC, APHA, and USW suggested that MSHA should align its recordkeeping requirements for medical surveillance records with the OSHA silica standard recordkeeping requirements (29 CFR 1910.1020) (Document ID 1373; 1416; 1447). These same commenters and a black lung clinic and an individual suggested that, given the latency periods associated with health effects from silica exposure, medical surveillance records are invaluable for miners who are diagnosed with silica-related health conditions (Document ID 1373; 1416; 1447; 1418; 1412).
In response to these comments, MSHA reiterates that mine operators do not have access to a miner's medical information and therefore, do not maintain a record of such information. Only the PLHCP's written determination made under paragraph 60.14(b) on whether a miner is able to wear a respirator must be provided to mine operators. Under the final rule, as in the proposal, the mine operator will retain
Under final 60.15(d), medical examination results must be provided to the miner, at the request of the miner, to the miner's designated physician or another designee identified by the miner, and to NIOSH, once NIOSH establishes a reporting system. MSHA is not regulating the retention of medical examination results since they are not provided to the mine operator. The medical surveillance information (the written medical opinion records) that the mine operator will retain under final paragraph (a)(5) includes a record of the date of the medical examination, a statement that the examination has met the requirements of this section, and any recommended limitations on the miner's use of respirators. MSHA believes that retaining these medical surveillance records for the duration of the miner's employment plus 6 months is appropriate. The requirement to retain records for an additional 6 months beyond the miner's employment gives a miner more time to request records if the miner is employed at another mine. For example, a miner who was determined to be medically unable to wear a respirator may need this record for new mine operator. The final rule does not increase the retention period because, as described above, the written medical opinion that the operator receives contains only basic information compared to the medical examination records that are in the miner's possession and control.
NVMA asked for clarification on the medical surveillance recordkeeping requirements, remarking that the rule does not include provisions requiring tracking of miners' exposure throughout their careers and noting that miners often change companies over the course of their careers (Document ID 1441). This commenter asked whether it would be assumed that a miner's occupational illness stems from work with their current employer, even if all samples and medical surveillance show the miner was not exposed above the PEL during their current employment.
MSHA reiterates that each miner's medical examination results are provided to that miner, to the miner's physician or other designee at the request of the miner, and to NIOSH, once NIOSH establishes a reporting system. NIOSH's reporting system, once established, will provide public health information on rates of silica-related disease, tenure, and prevalence in the MNM industry.
Miners will have access to all medical examination results obtained under this part and will be able to track any impacts of exposure. The purpose of the medical surveillance examination requirements is to help miners seek help from medical professionals who can identify early symptoms of respirable crystalline silica-related diseases and inform them of their health status, so that they can take early and necessary steps to protect their health.
Vanderbilt Minerals, LLC stated that medical records are required to be collected under the Health Insurance Portability and Accountability Act and that an additional requirement by MSHA would be duplicative and unnecessary (Document ID 1419). MSHA clarifies that the mine operator is not responsible for obtaining and preserving the miner's medical examination results or records. Therefore, there is no duplication of collecting medical records.
Final paragraph 60.16(b), like the proposal, requires mine operators to make records in this section available promptly upon request to miners, authorized representatives of miners, and authorized representatives of the Secretary of Labor. A federal elected official stated that MSHA should require sampling records and any other information required to be posted on the mine bulletin board to be submitted to miner representatives (Document ID 1439). This commenter also urged MSHA to require operators to provide cumulative exposure records to the miner upon request, similar to 30 CFR 57.5040. A miner health advocate suggested that corrective actions records should be required to be submitted to MSHA and miner representatives (Document ID 1372).
After considering the comments, MSHA determined that no change to final paragraph (b) is necessary. The requirement to provide all the listed records promptly upon request to miners, authorized representatives of miners, and authorized representatives of the Secretary of Labor ensures that miners and MSHA will have access to records as needed which facilitates enforcement and transparency. Miners, miners' representatives, and MSHA can request the records in this section at any time; therefore, MSHA has determined that it is not necessary to require operators submit records to miners, miners' representatives, and MSHA without request.
The APHA suggested that all required records should be made available to NIOSH (Document ID 1416). As discussed in response to comments under paragraph 60.15(d)(2), MSHA is requiring that the results of chest X-ray classifications obtained under medical surveillance examinations be made available to NIOSH for its research. MSHA has determined that it is not necessary to provide other records required under part 60 to NIOSH.
The AIHA supported the proposed recordkeeping requirements and recommended that operators be required to develop and maintain exposure control plans that identify the tasks that involve miners' exposures above the PEL and the methods used to protect miners, including procedures to restrict access to work areas where high exposures may occur (Document ID 1351).
After considering the comment, MSHA has concluded that an exposure control plan record is not necessary, because of the sampling and control methods required. As required under part 60, mine operators must use engineering and administrative controls to prevent overexposures to respirable crystalline silica. Under § 60.12(c), mine operators are required to evaluate these controls at least every 6 months or whenever there is a change in production, processes, installation and maintenance of engineering controls, installation and maintenance of equipment, administrative controls, or geological conditions to determine if the change is reasonably expected to result in new or increased respirable crystalline silica exposures. The operator must make a record of the evaluation, including the evaluated change, the impact on respirable crystalline silica exposure, and the date of the evaluation and post the record on the mine bulletin board and, if applicable, by electronic means, for the next 31 days. Operators are expected to conduct these evaluations to assess changing conditions on a regular basis to ensure miners are not exposed at levels above the PEL. The evaluation records provide important information to mine operators to enable them to implement effective control methods to protect miners, to identify occupations and work areas where there is a risk of overexposure, and to make necessary adjustments. MSHA has determined requiring exposure control plan records is not necessary.
Under paragraph 60.12(g), when mine operators sample for respirable crystalline silica, operators must make a record of the sample date, the occupations sampled, and the concentrations of respirable crystalline silica and respirable dust, must obtain
The final rule includes a statement of severability that each section of this part, as well as sections in 30 CFR parts 56, 57, 70, 71, 72, 75, and 90 that address respirable crystalline silica or respiratory protection, is separate and severable from the other sections and provisions.
The severability clause under § 60.17 serves two purposes. First, it expresses MSHA's intent that if any section or provision of the
Under the principle of severability, a reviewing court will generally presume that an offending provision of a regulation is severable from the remainder of the regulation, so long as that outcome appears consistent with the issuing agency's intent, and the remainder of the regulation can function independently without the offending provision. See
MSHA did not receive any comments on this section. Final § 60.17 is the same as proposed.
The final rule makes conforming amendments in 30 CFR parts 56, 57, 70, 71, 72, 75, and 90 based on the new part 60. The compliance dates for the conforming amendments align with the compliance dates for part 60. Compliance with the conforming amendments to parts 56 and 57 is required by 24 months after publication, for MNM operators; and compliance with the conforming amendments to parts 70, 71, 72, 75, and 90 is required by 12 months after publication, for coal mine operators. The compliance dates for the conforming amendments assure that miners are protected under the existing standards until mine operators are required to comply with part 60.
In other words, existing sections in parts 56 and 57 will remain in place for 24 months following publication. For MNM operators, compliance with the conforming amendments in parts 56 and 57 is not required until 24 months after publication. Existing sections in parts 70,71, 72, 75, and 90 will remain in place for 12 months following publication. For coal operators, compliance with the conforming amendments in these parts is not required until 12 months after publication.
For the conforming amendments, a set of instructions involving the establishment of temporary sections and redesignation of those sections are required for the
The conforming amendment changes to respiratory protection standards are discussed in
The final rule, like the proposal, amends § 56.5001(a) to add respirable crystalline silica as an exception. Amended paragraph (a) governs exposure limits for airborne contaminants other than respirable crystalline silica and asbestos for surface MNM mines. MSHA did not receive any comments on the proposed change.
In a change from the proposal, MSHA makes a non-substantive change to paragraph (a) to update the terminology for the name of the MSHA District Office to the Mine Safety and Health Enforcement District Office. The Mine Safety and Health Enforcement District Office covers both MNM mines and coal mines since the Agency no longer maintains separate offices for both types of mines. The Agency no longer differentiates between MNM District Offices and Coal District Offices. This change was not discussed in the proposal.
As described above, 60 days after publication of the final rule, a new temporary section with the suffix “T” will be added for the conforming amendments in part 56. Then, 720 days after publication of the final rule, the existing section for the conforming amendments in part 56 will be removed and the temporary section will be redesignated without the “T” to replace the removed section. The result of these
The final rule, like the proposal, amends § 57.5001(a) to add respirable crystalline silica as an exception. Amended paragraph (a) governs exposure limits for airborne contaminants other than respirable crystalline silica and asbestos for underground MNM mines. MSHA did not receive any comments on the proposed change.
In a change from the proposal, MSHA makes a non-substantive change to paragraph (a) to update the terminology for the name of the MSHA district office to the Mine Safety and Health Enforcement District Office. The Mine Safety and Health Enforcement District Office covers both MNM mines and coal mines since the Agency no longer differentiates between MNM District Offices and Coal District Offices. This change was not discussed in the proposal.
As described above, 60 days after publication of the final rule, a new temporary section with the suffix “T” will be added for the conforming amendments in part 57. Then, 720 days after publication of the final rule, the existing section for the conforming amendments in part 57 will be removed and the temporary section will be redesignated without the “T” to replace the removed section. The result of these technical changes is that mine operators must comply with the existing standards until the compliance dates in part 60.
The final rule, like the proposal, removes the
The final rule, like the proposal, removes § 70.101 in its entirety and reserves the section number. Section 70.101,
As discussed in greater detail in
In response to commenters, MSHA has concluded that establishing an independent and lower PEL for respirable crystalline silica for coal mines allows more effective control of respirable crystalline silica than the existing reduced standards, because the separate standard is more transparent and protective. MSHA clarifies that the respirable coal mine dust standard is not eliminated, only the sampling requirements for when silica is present under § 70.101. MSHA agrees with the commenters supporting the removal of § 70.101.
The final rule, like the proposal, amends paragraph 70.205(c) to remove the reference to the reduced RCMD standard. References to the RCMD exposure limit specified in § 70.100 replace references to the applicable standard. The rest of the section remains unchanged.
The final rule, like the proposal, removes § 70.206 and reserves the section number. Section 70.206 included requirements for bimonthly sampling of mechanized mining units which were in effect until January 31, 2016, and are no longer applicable.
The final rule, like the proposal, removes § 70.207 and reserves the section number. Section 70.207 included requirements for bimonthly sampling of designated areas that were in effect until January 31, 2016, and are no longer applicable.
The final rule, like the proposal, amends § 70.208 to remove references to a reduced RCMD standard. Paragraph (c) in § 70.208 is removed and the paragraph designation reserved. References to the respirable dust standard specified in § 70.100 replace references to the applicable standard throughout the section.
A new table 1 is added to § 70.208. The new table contains the Excessive Concentration Values (ECV) for the section based on a single sample, 3 samples, or the average of 5 or 15 full-shift coal mine dust personal sampler unit (CMDPSU) or continuous personal dust monitor (CPDM) concentration measurements. The new table contains the remaining ECV after the removal of the reduced standard in § 70.101 and was generated from data previously contained in Tables 70-1 and 70-2 in Subpart C of part 70. Conforming changes are made to paragraphs (e) and (f)(1) and (2) to update the name of the table to table 1. MSHA did not receive any comments on the proposed changes.
The final rule, like the proposal, amends § 70.209 to remove references to a reduced RCMD standard. Paragraph (b) in § 70.209 is removed and the paragraph designation reserved. References to the RCMD exposure limit specified in § 70.100 replace references to the applicable standard.
A new table 1 is added to § 70.209. The new table contains the ECVs for the section based on a single sample, 2 or more samples, or the average of 5 or 15 full-shift CMDPSU/CPDM concentration measurements. This table contains the remaining ECV after the removal of the reduced RCMD standard in § 70.101 and was generated from data previously contained in Tables 70-1 and 70-2 in Subpart C of part 70. Conforming changes are made to paragraphs (c) and (d)(1) and (2) to update the name of the table to table 1. MSHA did not receive any comments on the proposed changes.
The final rule, like the proposal, removes Table 70-1 to Subpart C of Part 70,
As described above, 60 days after publication of the final rule, a new temporary section with the suffix “T” will be added for most of the conforming amendments in part 70. Then, 360 days after publication of the final rule, the existing section for these conforming amendments in part 70 will be removed and the temporary section will be redesignated without the “T” to replace the removed section. The result of these technical changes is that mine operators must comply with the existing standards until the compliance dates in part 60.
The final rule, like the proposal, removes the
MSHA is removing § 71.101 in its entirety and reserving the section number. The respirable coal mine dust standard when quartz is present in § 71.101 is no longer needed because MSHA is adopting an independent respirable crystalline silica standard in part 60.
As discussed in greater detail in
In response to commenters, MSHA has concluded that establishing an independent and lower PEL for respirable crystalline silica for coal mines allows more effective control of respirable crystalline silica than the existing reduced standards, because the separate standard is more transparent and protective. MSHA clarifies that the respirable coal mine dust standard is not eliminated, only the sampling requirements for when silica is present under § 71.101. MSHA agrees with the commenters supporting the removal of §§ 71.101.
The final rule, like the proposal, amends paragraph (c) to remove the reference to the reduced RCMD standard. References to the respirable dust standard specified in § 71.100 replace the reference to the applicable standard.
The final rule, like the proposal, amends § 71.206 to remove references to the reduced RCMD standard. Paragraph (b) in § 71.206 is removed and the paragraph designation reserved. Other conforming changes for § 71.206 remove references to the applicable standard and replace them, where needed, with references to the respirable dust standard specified in § 71.100.
MSHA is also amending paragraph (l) by removing Table 71-1
Final paragraph (m), like the proposal, removes the language, “in effect at the time the sample is taken, or a concentration of respirable dust exceeding 50 percent of the standard established in accordance with § 71.101,” because the reduced standard in § 71.101 is removed.
A new table 1 is added to § 71.206. This table contains the ECV for the section based on a single sample, two or more samples, or the average of five full-shift CMDPSU/CPDM concentration measurements. This table contains the remaining ECV after the removal of the reduced standard in § 71.101. It was generated from data contained in existing Tables 71-1 and 71-2 to Subpart C of part 71. Conforming changes are made to paragraphs (h) and (i)(1) and (2) to update the name of the table to table 1. MSHA did not receive any comments on the proposed changes.
Final § 71.300, like the proposal, removes references to the reduced RCMD standard. The respirable dust standard specified in § 71.100 replaces references to the applicable standard. MSHA did not receive any comments on the proposed change.
Final § 71.301, like the proposal, removes references to the reduced RCMD standard. The respirable dust standard specified in § 71.100 replaces references to the applicable standard. MSHA did not receive any comments on the proposed change.
As described above, 60 days after publication of the final rule, a new temporary section with the suffix “T” will be added for most of the conforming amendments in part 71. Then, 360 days after publication of the final rule, the existing section for these conforming amendments in part 71 will be removed and the temporary section will be redesignated without the “T” to replace the removed section. The result of these technical changes is that mine operators must comply with the existing standards until the compliance dates in part 60.
Final § 72.800, like the proposal, removes references to the reduced RCMD standard. The section also replaces references to Tables 70-1, 71-1, and 90-1 with references to the new tables in §§ 70.208, 70.209, 71.206, and 90.207. MSHA did not receive any comments on the proposed changes.
As described above, 60 days after publication of the final rule, a new temporary section with the suffix “T” will be added for the conforming amendments in part 72. Then, 360 days
The final rule, like the proposal, updates § 75.350 by revising paragraph (b)(3)(i) and removing paragraphs (b)(3)(i)(A) and (B) and (b)(3)(ii). Paragraph (b)(3)(i) is revised to “[T]he average concentration of respirable dust in the belt air course, when used as a section intake air course, shall be maintained at or below 0.5 mg/m
As described above, 60 days after publication of the final rule, a new temporary section with the suffix “T” will be added for the conforming amendments in part 75. Then, 360 days after publication of the final rule, the existing section for the conforming amendments in part 75 will be removed and the temporary section will be redesignated without the “T” to replace the removed section. The result of these technical changes is that mine operators must comply with the existing standards until the compliance dates in part 60.
The final rule, like the proposal, removes the
In addition, MSHA is revising the definition of
The final rule, like the proposal, revises paragraph (a) in § 90.3 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in § 90.100). MSHA did not receive any comments on the proposed change.
In a change from the proposal, MSHA updates § 90.100 by removing paragraphs (a) and (b) and revising the section to, “After the 20th calendar day following receipt of notification from MSHA that a part 90 miner is employed at the mine, the operator shall continuously maintain the average concentration of respirable dust in the mine atmosphere during each shift to which the part 90 miner in the active workings of the mine is exposed, as measured with an approved sampling device and expressed in terms of an equivalent concentration, at or below 0.5 mg/m
The final rule, like the proposal, removes § 90.101 in its entirety and reserves the section number. The respirable coal mine dust standard when quartz is present in § 90.101 is no longer needed because MSHA is adopting an independent respirable crystalline silica standard in part 60.
As discussed in greater detail in
In response to commenters, MSHA has concluded that establishing an independent PEL of 50 µg/m
The final rule, like the proposal, amends § 90.102 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in § 90.100). MSHA did not receive any comments on the proposed change.
The final rule, like the proposal, amends § 90.104 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in § 90.100). MSHA did not receive any comments on the proposed change.
The final rule, like the proposal, amends § 90.205 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in § 90.100). MSHA did not receive any comments on the proposed change.
The final rule, like the proposal, amends § 90.206 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in
The final rule, like the proposal, amends § 90.207 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in § 90.100).
Paragraph (b) in § 90.207 is removed and the paragraph designation reserved. Conforming changes are made to paragraphs (c) and (d)(1) and (2) to update the name of the table to table 1.
MSHA is amending paragraph (g) by removing Table 90-1
The final rule, like the proposal, amends § 90.300 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in § 90.100). MSHA did not receive any comments on the proposed change.
The final rule, like the proposal, amends § 90.301 to remove “the applicable standard” (which referred to the reduced RCMD standard) and just include “the standard” (which refers to the respirable dust standard specified in § 90.100). MSHA did not receive any comments on the proposed change.
As described above, 60 days after publication of the final rule, a new temporary section with the suffix “T” will be added for the conforming amendments in part 90. Then, 360 days after publication of the final rule, the existing section for the conforming amendments in part 90 will be removed and the temporary section will be redesignated without the “T” to replace the removed section. The result of these technical changes is that mine operators must comply with the existing standards until the compliance dates in part 60.
MSHA is updating the Agency's existing respiratory protection standard to help safeguard the life and health of all miners exposed to respirable airborne contaminants at MNM and coal mines. The final rule amends the Agency's existing respiratory protection standards to incorporate by reference ASTM F3387-19,
Incorporating this voluntary consensus standard complies with the Federal mandate—as set forth in the National Technology Transfer and Advancement Act of 1995 and OMB Circular A-119—that agencies use voluntary consensus standards in their regulatory activities unless doing so would be legally impermissible or impractical. This standard also improves clarity because it is a consensus standard developed by stakeholders.
Under existing standards, whenever respiratory protective equipment is used, mine operators are required to have a respiratory protection program that is consistent with the provisions of ANSI Z88.2-1969. At the time of its publication, ANSI Z88.2-1969 reflected a consensus of accepted practices for respiratory protection.
Respirator technology and knowledge on respiratory protection have since advanced, and as a result, changes in respiratory protection standards have occurred. For example, in 2006, OSHA revised its respiratory protection standard to add definitions and requirements for Assigned Protection Factors (APF) and Maximum Use Concentrations (MUCs) (71 FR 50122, 50123). In addition to this rulemaking, OSHA updated Appendix A to § 1910.134: Fit Testing Procedures (69 FR 46986, 46993, Aug. 4, 2004).
After withdrawing the 1992 version of Z-88.2 in 2002, ANSI published the American National Standard, ANSI/AIHA Z88.10-2010, “
The ASTM standard contains detailed guidance and provisions on respirator selection that are based on NIOSH's extensive experience with testing and approving respirators for occupational use and OSHA's research and rulemaking on respiratory protection. ASTM F3387-19 also addresses all aspects of establishing, implementing, and evaluating respiratory protection programs and establishes minimum acceptable respiratory protection program requirements in the areas of program administration, standard operating procedures, medical evaluation, respirator selection, training,
Under the final rule, MSHA requires that the respiratory protection program be in writing and be consistent with the requirements of ASTM 3387-19, including program administration, standard operating procedures, medical evaluation, respirator selection, training, fit testing; and maintenance, inspection, and storage. The following subsections discuss some of the requirements listed in ASTM F3387-19.
ASTM F3387-19 specifies several practices related to respiratory protection program administration, including the qualifications and responsibilities of a program administrator. For example, ASTM F3387-19 provides that responsibility and authority for the respirator program be assigned to a single qualified person with sufficient knowledge of respiratory protection. Qualifications may have been gained through training or experience; however, the qualifications of a program administrator must be commensurate with the respiratory hazards present at a worksite.
This individual administering the program should have access to and direct communication with the site manager about matters impacting worker safety and health. ASTM F3387-19 notes a preference that the administrator be in the company's industrial hygiene, environmental, health physics, or safety engineering department; however, a third-party entity meeting the provisions may also provide this service. ASTM F3387-19 outlines the respiratory protection program administrator's responsibilities, specifying that they should include: measuring, estimating, or reviewing information on the concentration of airborne contaminants; ensuring that medical evaluations, training, and fit testing are performed; selecting the appropriate type or class of respirator that will provide adequate protection for each contaminant; maintaining records; evaluating the respirator program's effectiveness; and revising the program, as necessary.
Written SOPs shall be established by the employer and shall cover a complete respirator program for routine and emergency. ASTM F3387-19 also states that written SOPs for respirator programs are necessary when respirators are used routinely or sporadically. Written SOPs should cover hazard assessment; respirator selection; medical evaluation; training; fit testing; issuance, maintenance, inspection, and storage of respirators; schedule of air-purifying elements; hazard re-evaluation; employer policies; and program evaluation and audit. ASTM F3387-19 also provides that wearers of respirators be provided with copies of the SOP and that written SOPs include special consideration for respirators used for emergency situations. The procedures are reviewed in conjunction with the annual respirator program audit and are revised by the program administrator, as necessary.
Medical evaluations determine whether an employee has any medical conditions that would preclude the use of respirators, limitation on use, or other restrictions. ASTM F3387-19 provides that a program administrator advise the PLHCP of the following conditions to aid in determining the need for a medical evaluation: type and weight of the respirator to be used; duration and frequency of respirator use (including use for rescue and escape); typical work activities; environmental conditions (
Proper respirator selection is an important component of an effective respiratory protection program. ASTM F3387-19 provides that proper respirator selection consider the following: the nature of the hazard, worker activity and workplace factors, respirator use duration, respirator limitations, and use of approved respirators. ASTM F3387-19 states that the respirator selection process for both routine and emergency use should include hazard assessment, selection of respirator type or class that can offer adequate protection, and maintenance of written records of hazard assessment and respirator selection.
ASTM F3387-19 provides specific steps to establish the nature of inhalation hazards, including determining the following: the types of contaminants present in the workplace; the physical state and chemical properties of airborne contaminants; the likely airborne concentration of the contaminants (by measurement or by estimation); potential for an oxygen-deficient environment; an occupational exposure limit for each contaminant; existence of an IDLH atmosphere; and compliance with applicable health standards for the contaminants.
ASTM F3387-19 includes other information to support the respirator selection process, including information on operational characteristics, capabilities, and performance limitations of various types of respirators. These limitations must be considered during the selection process. ASTM F3387-19 also describes types of respirators and considerations for their use, including service life, worker mobility, compatibility with other protective equipment, durability, comfort factors, compatibility with the environment, and compatibility with job and workforce performance. Finally, ASTM F3387-19 provides other information that is essential for respirator selection, including degree of oxygen deficiency, ambient noise, and need for communication.
Employee training is essential for correct respirator use. ASTM F3387-19 provides that all users be trained in their area of responsibility by a qualified person to ensure the proper use of respirators. A respirator trainer must be knowledgeable about the application and use of the respirators and must understand the site's work practices, respirator program, and applicable regulations. Employees who should receive training under ASTM F3387-19 include the workplace supervisor, the person issuing and maintaining respirators, respirator wearers, and emergency teams. To ensure the proper and safe use of a respirator, the standard also provides that the training for each respirator wearer should cover, at a minimum: the need for respiratory protection; the nature, extent, and effects of respiratory hazards in the workplace; reasons for particular respirator selections; reasons for engineering controls not being applied or reasons why they are not adequate; types of efforts made to reduce or eliminate the need for respirators; operation, capabilities, and limitations
A serious hazard may occur if a respirator, even though properly selected, is not properly fitted. For example, if a proper face seal is not achieved, the respirator will provide a lower level of protection than it is designed to provide because the respirator could allow contaminants to leak into the breathing area. Proper fit testing verifies that the selected make, model, and size of a respirator fits adequately and ensures that the expected level of protection is provided. ASTM F3387-19 includes provisions for qualitative and quantitative fit testing to determine the ability of a respirator wearer to obtain a satisfactory fit with a tight-fitting respirator and incorporates ANSI/AIHA Z88.10,
Proper maintenance and storage of respirators are important in a respiratory protection program. ASTM F3387-19 includes specific provisions for decontaminating, cleaning, and sanitizing respirators, inspecting respirators, replacing, and repairing parts, and storing and disposing of respirators. For example, the decontamination provisions state that respirators must be decontaminated after each use and cleaned and sanitized regularly per manufacturer instructions. Following cleaning and disinfection, reassembled respirators are inspected to verify proper working condition. ASTM F3387-19 states that employers consult manufacturer instructions to determine component expiration dates or end-of-service life, inspect the rubber or other elastomeric components of respirators for signs of deterioration that would affect respirator performance, and repair or replace respirators failing inspection. ASTM F3387-19 also provides that respirators are stored according to manufacturer recommendations and in a manner that will protect against hazards (
Final § 56.5005 is changed from the proposal. The final rule requires a written respiratory protection program consistent with the requirements of ASTM F3387-19. In the NPRM, MSHA proposed to revise paragraph (b) to remove the incorporation by reference to ANSI Z88.2—1969 and incorporate by reference ASTM F3387-19 to state that approved respirators must be selected, fitted, cleaned, used, and maintained in accordance with the requirements of ASTM F3387-19 “as applicable.” MSHA proposed to update the Agency's existing respiratory protection standard to help safeguard the life and health of all miners when exposed to respirable airborne contaminants at MNM mines while wearing respirators. The ASTM F3387-19 standard includes, for example, provisions for selection, fitting, use, and care of respirators used to remove airborne contaminants from the air using filters, cartridges, or canisters, as well as respirators that protect in oxygen-deficient or immediately dangerous to life or health (IDLH) atmospheres. MSHA proposed to incorporate by reference ASTM F3387-19 because it is the most recent consensus standard developed by experts in government and professional associations on the selection, use, and maintenance for respiratory equipment.
AEMA stated that the final rule should clarify whether a specific written respiratory protection program is required and under what standards (Document ID 1424. MSHA's response to these comments is discussed in detail in
In response to comments, MSHA has modified the language in paragraph (b) in the final rule compared to the proposal. The modifications include: the removal of “as applicable”; clarification that a respiratory protection program must be in writing, and one non-substantive edit in the introductory clause. These changes clarify what the requirements are for MNM mine operators' respiratory protection programs.
MNM mine operators do not have to create a separate written respiratory protection program under each of 30 CFR parts 56, 57, and 60 where ASTM F3387-19 is incorporated by reference. Operators may create one single program that is applicable to respirable crystalline silica hazards (part 60) and other airborne contaminants (parts 56 and 57). However, as required by ASTM F3387-19 and MSHA standards, the respiratory protection program must assess the potential respiratory hazard or hazards and the mine operator must then select approved respirators which are appropriate for the airborne hazard(s) encountered. MSHA believes the final rule provides MNM mine operators with additional time which should be sufficient to allow them to prepare and develop written respiratory protection programs, if necessary, that are based on the finalrule's requirements.
Consistent with the proposal, MSHA is changing paragraph (c) to require the presence of at least one other person with backup equipment and rescue capability when respiratory protection is used in atmospheres that are IDLH. This change is needed to conform to language in the incorporation by reference of ASTM F3387-19, which defines IDLH as “any atmosphere that poses an immediate hazard to life or immediate irreversible debilitating effects on health” (ASTM International, 2019).
As described above in
Final § 57.5005 is changed from the proposal for the same reasons discussed in § 56.5005. The final rule requires a written respiratory protection program consistent with the requirements of ASTM F3387-19. In the NPRM, MSHA proposed to revise paragraph (b) to remove the incorporation by reference to ANSI Z88.2—1969 and incorporate by reference ASTM F3387-19 to state that approved respirators must be selected, fitted, cleaned, used, and maintained in accordance with the requirements of ASTM F3387-19 “as applicable.” MSHA proposed to update the Agency's existing respiratory protection standard to help safeguard the life and health of all miners when exposed to respirable airborne contaminants at MNM mines while wearing respirators. The ASTM F3387-19 standard, for example, includes provisions for selection, fitting, use, and care of respirators used to remove airborne contaminants from the air using filters, cartridges, or canisters, as well as respirators that protect in oxygen-deficient or immediately dangerous to life or health (IDLH) atmospheres. MSHA proposed to incorporate by reference ASTM F3387-19 because it is the most recent consensus standard developed by experts in government and professional associations on the selection, use, and maintenance for respiratory equipment.
AEMA stated that the final rule should clarify whether a specific written respiratory protection program is required and under what standards (Document ID 1424). MSHA's response to these comments is discussed in detail in
In response to comments, MSHA has modified the language in paragraph (b) in the final rule compared to the proposal. The modifications include: the removal of “as applicable”; clarification that a respiratory protection program must be in writing, and one non-substantive edit in the introductory clause. These changes clarify what the requirements are for MNM mine operators' respiratory protection programs.
MNM mine operators do not have to create a written respiratory protection program under each of 30 CFR parts 56, 57, and 60 where ASTM F3387-19 is incorporated by reference. Operators may create one single program that is applicable to respirable crystalline silica hazards (part 60) and other airborne contaminants (parts 56 and 57). However, as required by ASTM F3387-19 and MSHA standards, the respiratory protection program must assess the potential respiratory hazard or hazards and the mine operator must then select approved respirators which are appropriate for the airborne hazard(s) encountered. The final rule provides MNM mine operators additional time for compliance, which MSHA believes should give them sufficient time to prepare and develop written respiratory protection programs, if necessary, that are based on the final rule's requirements.
Consistent with the proposal, MSHA is changing paragraph (c) to require the presence of at least one other person with backup equipment and rescue capability when respiratory protection is used in atmospheres that are IDLH. This change is needed to conform to language in the proposed incorporation by reference of ASTM F3387-19, which defines the term IDLH as “any atmosphere that poses an immediate hazard to life or immediate irreversible debilitating effects on health” (ASTM International, 2019).
As described above in
Final § 72.710 includes two changes from the proposal. The final rule requires that approved respirators be selected, fitted, used, and maintained in accordance with the provisions of a written respiratory protection program consistent with the requirements of ASTM F3387-19. In the NPRM, MSHA proposed an editorial change to the introductory statement to § 72.710 and that approved respirators must be selected, fitted, used, and maintained in accordance with the requirements of ASTM F3387-19 “as applicable.”
MSHA proposed to update the Agency's existing respiratory protection standard to help safeguard the life and health of coal miners when exposed to respirable airborne contaminants such as respirable coal dust while wearing respirators. The ASTM F3387-19 standard includes provisions for selection, fitting, use, and care of respirators used to remove airborne contaminants from the air using filters, cartridges, or canisters, as well as respirators that protect in oxygen-deficient or immediately dangerous to life or health (IDLH) atmospheres. MSHA proposed to incorporate by reference ASTM F3387-19 because it is the most recent consensus standard developed by experts in government and professional associations on the selection, use, and maintenance for respiratory equipment.
AEMA stated that the final rule should clarify whether a specific written respiratory protection program is required and under what standards (Document ID 1424).
MSHA's response to these comments is discussed in detail in
In response to comments, MSHA has modified the language to remove as “as applicable” and to clarify that the respiratory protection program must be in writing and must be consistent with ASTM F3387-19. This change clarifies what the requirements are for coal mine operators' respiratory protection programs.
Coal mine operators do not have to create a separate written respiratory protection program under 30 CFR parts 60 and 72 part where ASTM F3387-19 is incorporated by reference. Operators may create a single program that is applicable to respirable crystalline silica hazards (part 60) and other airborne contaminants (part 72). However, as required by ASTM F3387-19 and MSHA standards, the respiratory protection program must assess the potential respiratory hazard or hazards and the mine operator must select approved respirators which are
As described above in
Executive Order (E.O.) 12866, as amended by E.O. 14094, and E.O. 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).
Executive Order 14094 of April 6, 2023: Modernizing Regulatory Review. 88 FR 21879. April 11, 2023.
Executive Order 13563 of January 18, 2011: Improving Regulation and Regulatory Review. January 18, 2011.
Under E.O. 12866 (as amended by E.O. 14094), the Office of Management and Budget (OMB)'s Office of Information and Regulatory Affairs (OIRA) determines whether a regulatory action is significant and, therefore, subject to the requirements of the E.O. and review by OMB. 58 FR 51735, 51741 (1993). As amended by E.O. 14094, section 3(f) of E.O. 12866 defines a “significant regulatory action” as a regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more; or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, territorial, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the E.O. OIRA has determined that this final rule is a significant regulatory action under section 3(f)(1) of E.O. 12866, and accordingly it has been reviewed by OMB. Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, also known as the Congressional Review Act (5 U.S.C. 801
E.O. 13563 directs agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; the regulation is tailored to impose the least burden on society, consistent with achieving the regulatory objectives; and in choosing among alternative regulatory approaches, the agency has selected those approaches that maximize net benefits. E.O. 13563 recognizes that some benefits are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitative values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.
To comply with E.O.s 12866 and 13563, MSHA has prepared a final regulatory impact analysis (FRIA) for the final rule. The purpose of the FRIA is to:
• Profile the mining industry impacted by the final rule;
• Estimate the monetized societal benefits attributable to the new PEL resulting from reductions in fatal cases of lung cancer, non-malignant respiratory disease, end-stage renal disease, and both fatal and non-fatal cases of silicosis;
• Identify additional non-quantified benefits expected from the final rule;
• Estimate the costs that the mining industry will incur to achieve compliance with the final rule;
• Assess the economic feasibility of the final rule for the mining industry; and
• Evaluate the principal regulatory alternatives to the final rule that MSHA has considered.
MSHA estimates the final rule will have an annualized cost of $90.3 million in 2022 dollars at a discount rate of 3 percent. The breakdown of this total cost value by compliance cost for each provision is as follows: approximately 59 percent is attributable to exposure monitoring; 21 percent to medical surveillance; 15 percent to exposure controls (engineering, improved maintenance and repair, and administrative controls); 5 percent to respiratory protection and incorporating ASTM F3387-19. Of the annualized compliance cost of $90.3 million, the MNM sector will incur $82.1 million (approximately 91 percent) and the coal sector will incur $8.2 million (approximately 9 percent).
Under a discount rate of 3 percent, the total monetized benefits of the new respirable crystalline silica final rule from avoided deaths and morbidity cases, including the benefits of avoided morbidity preceding mortality, are $246.9 million per year in 2022 dollars. The net quantified benefits of the final rule are calculated as the difference between the estimated benefits and costs. MSHA estimates that the net annualized benefits of the final rule, using a discount rate of 3 percent, is $156.6 million.
In addition to these quantified benefits, there are unquantified benefits. MSHA believes that the medical surveillance program will help miners to detect silica-related diseases early. Early detection of illness often leads to early intervention and treatment, which may slow disease progression and/or improve health outcomes. However, MSHA lacks data to quantify these additional benefits. Furthermore, MSHA expects that there will be additional benefits from replacing ANSI Z88.2-1969 with ASTM F3387-19. The ASTM standard reflects developments in respiratory protection since the time in which MSHA issued its existing standards. The updated standard will play a critical role in safeguarding the health of miners, reducing their exposures to respirable crystalline silica and other airborne contaminants. Again, due to a lack of data, MSHA did not quantify the expected additional benefits that would be realized by requiring respiratory protection
The standalone FRIA contains detailed supporting data and discussions for the summary materials presented here, including the profile of the mining industry, estimated costs and benefits attributable to the final rule, the assessment of the economic feasibility of the final rule for the mining industry, and the evaluation of regulatory alternatives. The standalone FRIA is placed in the rulemaking docket at
The FRIA includes several revisions made since the PRIA. In response to public comments on the proposed rule and PRIA, MSHA revised its cost and benefit estimates. The revisions increased both the estimated costs and benefits.
Four types of changes were made to the cost and benefit estimates. First, the final rule includes several changes from the proposed rule, and these changes affected estimated costs. The changes include: additional time provided by MSHA for mine operator compliance; revisions to exposure monitoring requirements including removal of the use of objective data and historical sample data to discontinue sampling; the requirement for mine operators to immediately report all exposures above the PEL from operator sampling to the MSHA District Manager or other designated office; revisions to the requirement for periodic evaluations to include additional evaluations whenever changes are made; the requirement of respiratory protection for MNM mines when engineering controls are being developed and implemented, or it is necessary by the nature of the work performed; and changes to the medical surveillance requirements for MNM operators related to the compliance date and a new requirement for reporting miners' chest X-ray results to NIOSH.
Second, MSHA revised the FRIA methodology to annualize compliance costs over 60 years, which is the regulatory time horizon for this analysis. The 60-year analysis period starts with the first day of compliance for the coal sector (12 months after publication of the final rule). Coal mine operators incur compliance costs beginning 12 months after publication of the final rule. MNM mine operators incur compliance costs beginning 24 months after publication of the final rule. The analysis period ends 60 years after the first day of compliance for the coal sector, thus 60 years of compliance costs for coal mine operators and 59 years of compliance costs for MNM mine operators are included in the analysis. MSHA also updated both compliance costs and benefits to reflect 2022 dollars using the GDP implicit price deflator.
Third, MSHA made several changes to the PRIA cost estimation methodology; for example, the Agency modified its assumption about the proportion of the miner workforce that would be sampled in larger mines, as well as its assumption about the number of corrective actions, to account for circumstances in which multiple corrective actions may be necessary to reduce miners' exposure to below the PEL. MSHA also revised estimates of maintenance and repair and administrative control costs each year.
Lastly, MSHA made some changes to the PRIA benefit estimation methodology. Changes were also made to the benefit estimates. As discussed in
This section provides information on the characteristics of the MNM and coal mining sectors, including their estimated revenues, number of mines in each sector, commodities the industry produces, and employment sizes. In addition, this section provides the respirable crystalline silica exposure profiles for miners across different occupational categories in the MNM and coal sectors. These data come from the U.S. Department of the Interior (DOI), U.S. Geological Survey (USGS); U.S. Department of Labor (DOL), Mine Safety and Health Administration (MSHA), Educational Policy and Development and Program Evaluation and Information Resources; DOL, Bureau of Labor Statistics (BLS), Occupational Employment and Wage Statistics (OEWS); U.S. Census Bureau, Statistics of U.S. Businesses (SUSB); and the Energy Information Administration (EIA).
In general, economic profiles were developed using 2019 data because this was the most recent year available that was not impacted by temporary changes resulting from the COVID-19 pandemic. To estimate the current number of miners, MSHA used the 2019 Quarterly Employment Production Industry Profile (MSHA, 2019a) and the 2019 Quarterly Contractor Employment Production Report (MSHA, 2019b). MSHA estimated the number of and type of mines using 2019 data from the Mine Data Retrieval System, including the Mines database, (MSHA, 2022d) and the 2019 employment data (MSHA, 2019a,b).
The size of the mining industry is difficult to forecast given the uncertainties in future demand for various mined commodities, as well as uncertainties about technological changes. MSHA assumed the current mining workforce and the current number of mines would not change during the 60 years following implementation of the final rule. If the industry were to contract or expand in the future, the relative ratio of benefits to costs would remain roughly the same because both the benefits and costs of the final rule are in proportion to the size of the industry.
The mining industry can be divided into two major sectors: (1) MNM mines and (2) coal mines, with further distinction made regarding type of operation (
MSHA categorizes mines by size based on employment. For purposes of
MSHA tracks mine characteristics and maintains a database containing the number of mines by mine type and size, number of employees, and employee hours worked. MSHA also collects data on the number of independent contractor firms who provide miners to the industry, the number of contract miners they employ, and their employed contract miners' hours worked. Contract miners may work at any mine.
Table IX-1 presents an overview of the mining industry, including the number of MNM and coal mines, their employment (excluding contract miners), and their estimated revenues by commodity and size. As mentioned above, all data regarding the number of miners and mines are current in reference to the year 2019 and are assumed to remain constant during the 60 years following the implementation of the final rule. Estimated revenues are also based on 2019 data but have been inflated to 2022 dollars using the GDP implicit price deflator (U.S. Bureau of Economic Analysis, 2023).
The MNM mining sector is comprised of an estimated 11,525 mines which employ an estimated 169,070 individuals, of which 150,928 are miners (excluding contract miners) and 18,142 are office workers. In addition, contract miners work an estimated 71.3 million hours in MNM mines each year.
The coal mining sector is comprised of an estimated 1,106 mines that employ an estimated 52,966 individuals, of which 51,573 are miners (excluding contract miners) and 1,393 are office workers. In addition, contract miners work an estimated 28.0 million hours in coal mines each year.
A further breakdown of MNM mines and coal mines by mine commodity and mine size is provided below.
There are 24 groups of metal commodities mined in the U.S. Metal mines represent an estimated 2.4 percent (280/11,525) of all MNM mines and employ an estimated 24.5 percent of all MNM miners (excluding contract miners). Of these 280 estimated mines, 157 (56.1 percent) employ 20 or fewer miners and 22 (7.9 percent) employ greater than 500 miners. Additionally, MSHA data show that there is an estimated total of 13,792 contract miners in the metal mining industry with an estimated 18.9 million reported production hours in a year.
There are 35 non-metal commodities mined in the U.S., not including stone and sand and gravel. Non-metal mines represent an estimated 7.8 percent (897/
The stone mining subsector includes eight different stone commodities. Of these eight, seven are further classified as either dimension stone or crushed and broken stone. Stone mines make up an estimated 20.9 percent (2,409/11,525) of all MNM mines and employ an estimated 23.4 percent of all MNM miners (excluding contract miners). The majority of these mines (83.1 percent) employ fewer than 20 miners and one mine employs over 500 miners. According to MSHA data, there are an estimated 18,559 contract miners in the stone mining industry with an estimated total of 18.8 million reported production hours in a single year.
Crushed limestone mines make up an estimated 16.2 percent (1,862/11,525) of all MNM mines and are estimated to employ about the same percentage (16.0 percent) of all MNM miners (excluding contract miners). Of the 1,862 crushed limestone mines, the vast majority (83.5 percent) employ fewer than 20 miners; none employ over 500 miners. Additionally, MSHA data show that there are an estimated 9,065 contract miners in the crushed limestone mining industry with an estimated total of 10.2 million reported production hours in a single year.
Sand and gravel mines account for an estimated 52.7 percent (6,077/11,525) of all MNM mines and employ an estimated 21.1 percent of all MNM miners (excluding contract miners). Nearly all (96.7 percent) employ fewer than 20 employees; none employ over 500 miners. MSHA data show that there are an estimated 7,512 contract miners in the sand and gravel mining industry with an estimated 8.9 million production hours in a single year.
Of the estimated 1,106 total coal mines, an estimated 63.9 percent (707/1,106) employ fewer than 20 miners and 1.1 percent employ more than 500 miners. Overall coal mine employment is estimated to be 52,966, of which 51,573 are miners (excluding contract miners) and the remaining 1,393 are office workers. Additionally, there are an estimated total of 22,003 contract miners in the coal mining industry with an estimated 28.0 million reported production hours in a single year.
The value of all MNM mining output in 2022 dollars was estimated at $95.1 billion (U.S. Department of Interior, 2019). Metal mines, which include iron, gold, copper, silver, nickel, lead, zinc, uranium, radium, and vanadium mines, contributed $30.5 billion. In the USGS Mineral Commodity Summaries, production values for nonmetals, stone, sand and gravel, and crushed limestone are combined into one commodity group titled “industrial minerals.” Therefore, MSHA estimated the production value of each individual commodity by taking the proportion of revenues for the commodity in question among all commodities in the 2017 SUSB and applying that proportion to the 2019 production value for all industrial minerals reported by USGS. This approach yields the following estimates: non-metal production is valued at an estimated $22.3 billion, stone mining at $14.6 billion, crushed limestone at $14.4 billion, and sand and gravel at $10.2 billion.
The U.S. coal mining sector is made up of three major commodity groups: bituminous, anthracite, and lignite. According to MSHA data, bituminous operations represent approximately 92.1 percent of total coal production in short tons and employ 91.9 percent of all coal miners (excluding contract miners). Anthracite operations represent 0.4 percent of coal production and employ 1.9 percent of coal miners (excluding contract miners). Lignite operations represent roughly 7.5 percent of total coal production and employ 6.2 percent of coal miners (excluding contract miners).
To estimate coal revenues in 2019, MSHA combined production estimates with unit prices. Mine production data were taken from MSHA quarterly data and the coal unit prices per ton were taken from the 2019 EIA Annual Coal Report. Estimated revenues were then inflated to 2022 dollar values using the GDP implicit price deflator. As shown in Table IX-1, 2019 total coal revenues expressed in 2022 dollars totaled an estimated $29.1 billion.
Using the quarterly employment data submitted by mines and the Occupational Employment and Wage Statistics (OEWS) reported by the BLS, MSHA estimated the distribution of miners (excluding contract miners) across different occupational categories. For contract miners, MSHA lacked information on occupational categories. However, based on MSHA's program experience, MSHA assumed that the distribution of contract miners across the different occupational categories mirrors that of the miners (excluding contract miners) in each of the two sectors. For example, MSHA assumed that, because 1.9 percent of MNM production miners are drillers, 1.9 percent of contract miners working in MNM mines are also drillers.
As discussed in
MSHA's exposure data is described in
MSHA distributed the respirable dust samples in its MNM and coal exposure datasets by occupational category and exposure interval. Because exposure data associated with individual miners are not available, MSHA derived the imputed exposure profile of miners and miner FTEs stratified by occupational category and exposure interval. Based on this imputation, MSHA found that, in the MNM sector, an estimated 13,242 miners (6 percent), including contract miners, currently have respirable crystalline silica exposures above the existing PEL of 100 µg/m
In the coal sector, an estimated 1,406 miners (2 percent), including contract miners, currently have respirable crystalline silica exposures above the existing PEL of 85.7 µg/m
The FRIA assesses the costs in the MNM and coal sectors of reducing miners' exposures to silica to 50 μg/m
Under the final rule, mine operators are required to: implement exposure controls (§ 60.11); conduct exposure monitoring and report all samples over the PEL to MSHA (§ 60.12); take immediate corrective actions and provide miners with respirators when a sampling result indicates that miner exposure exceeds the PEL (§ 60.13); respiratory protection is required as a temporary measure for all MNM miners when MNM miner exposure exceeds the PEL while engineering controls are being developed and implemented or when it is necessary by the nature of work involved (for example, occasional entry to hazardous atmospheres to perform maintenance or investigation) (§ 60.14)(a); make periodic medical examinations available to MNM miners and ensure certain medical results are reported to NIOSH (§ 60.15); develop or revise existing respiratory protection programs and practices in accordance with the ASTM F3387-19 (§§ 56.5005, 57.5005, and 72.710); and retain records for the specified durations (§ 60.16).
MSHA estimates the annualized costs of the final rule range from $88.8 million to $92.4 million, depending on the discount rate used (Table IX-3). Of this total, about 91 percent will be incurred by mine operators in the MNM sector and 9 percent by mine operators in the Coal sector. The difference in cost between the MNM and coal sectors is driven by the much larger number of MNM mines, as well as differences in mine size and the extent to which current exposures are already below 50 μg/m
For the PRIA, MSHA estimated annualized costs would range from $56.2 million (0 percent discount rate) to $60.0 million (7 percent discount rate). However, the estimated compliance costs for the PRIA were calculated in 2021 dollars. To compare PRIA and FRIA costs on an equivalent basis, MSHA inflated estimated PRIA compliance costs from 2021 dollars to 2022 dollars, which increases PRIA costs by about 7 percent. In 2022 dollars, estimated PRIA costs range from $60.1 million (0 percent discount rate) to $64.2 million (7 percent discount rate). Annualized estimated FRIA compliance costs exceed PRIA costs by about $28.2 to $28.7 million per year.
After accounting for the inflation to 2022 dollars, the remaining difference in estimated compliance costs between the PRIA and FRIA are attributable to several changes to the proposed rule, including:
• A longer phase-in implementation is provided for both coal and MNM mines.
• Objective data and historical sample data may no longer be used to demonstrate compliance with exposure monitoring requirements.
• Sample results exceeding the PEL must be reported to the MSHA district manager or other designated office.
• Periodic evaluations must be conducted at least every 6 months or whenever there is a change in: production; processes; installation or maintenance of engineering controls; installation or maintenance of equipment; administrative controls; or geological conditions.
• Limited temporary use of respirators is permitted in MNM mines only.
• For medical surveillance, the first medical examination offered to all MNM miners must be within 12 months of the compliance date. Also, chest X-ray results must be reported to NIOSH.
Under the FRIA, annualized costs are attributable to the following provisions of the final rule:
• Exposure Monitoring ($53.2 million, 59 percent of total)
• Exposure Controls ($13.7 million, 15 percent of total)
• Respiratory Protection ($3.3 million, 4 percent of total)
• Medical Surveillance ($18.8 million, 21 percent of total), and
• ASTM Update ($1.2 million, 1 percent of total).
Nearly two-thirds of the increase in estimated compliance costs ($19.0 million) is attributable to the exposure monitoring requirements under the final rule. The remainder is largely attributable to increased estimates for exposure controls ($7.5 million) and respiratory protection ($2.2 million). MSHA expects that the amount of sampling performed by mine operators will increase because the final rule does not allow mine operators to use objective data and historical sample data (operator and MSHA sample data from prior 12 months) to demonstrate compliance with exposure monitoring requirements. Below the estimate of each cost component is discussed in more detail.
There are five types of exposure monitoring required under the final rule:
• First-time sampling and second-time sampling based on a representative fraction of miners (§ 60.12(a)). First-time sampling occurs starting by the rule's respective compliance dates for coal mines and MNM mines. Second-time sampling occurs within three months of first-time sampling.
• Above-action-level sampling of a representative fraction of miners. If the most recent sampling results are at or above the action level (§ 60.12(a)), above-action-level sampling starts three months after the most recent sampling and continues until two consecutive samples demonstrate that miners' exposures are below the action level.
• Corrective actions must be performed for samples over the PEL. The mine operator must take corrective actions to reduce exposure and conduct corrective actions sampling until sample results are at or below the PEL (§ 60.12(b)). All corrective actions sample results exceeding the PEL must be immediately reported to the MSHA District Manager or other office designated by the District Manager.
• Periodic evaluations (qualitative monitoring) must be performed at least every 6 months, or whenever there is a change in production, processes, engineering or administrative controls, or geological conditions that may reasonably be expected to result in new or increased respirable crystalline silica exposures to ensure that any change will not have increased miners' exposures (§ 60.12(c)).
• If the periodic evaluations conducted under § 60.12(c) determine that increased exposures are likely, post-evaluation sampling must be conducted to ensure exposures remain at or above the action level (§ 60.12(d)).
For quantitative monitoring, MSHA estimates total sampling costs as a function of several factors: the unit cost of sampling, made up of labor costs (miners' and external consultants' time and hourly wage), laboratory costs for analyzing the samples, and clerical costs for recording the results; the number of samples that constitutes the required representative fraction each time the operator conducts sampling; and the frequency with which operators are assumed to carry out different types of monitoring (samplings and evaluation). MSHA assumes that regardless of the type of sampling, the unit cost of sampling does not vary, since the process of collecting a dust sample and
The most important component of sampling and evaluation cost is the time required to conduct the activities. For sampling, this includes the time needed to prepare for sampling, take the samples, and perform recordkeeping tasks on the results. Sampling takes time, which is valued at the hourly wage of the person wearing the sampling equipment and the person conducting the sampling. To err on the side of overestimates, MSHA assumed that in MNM mines, sample preparation and collection is performed by an industrial hygienist (IH).
In addition, MSHA assumed the personnel conducting sampling can collect 2, 3, and 4 samples per day at small, medium, and large mines, respectively. This determines the number labor hours needed to complete sampling at a mine, and therefore directly affects labor costs.
MSHA estimates that laboratory analysis will cost the mine operator $150 per sample. This includes the cost of packing and shipping the sample to the lab, the laboratory analysis, and reporting sample results to the operator.
The labor time required for recording results of sampling is estimated at 17 minutes and is valued at the loaded hourly wage of an industrial hygienist. Thus, costs for recordkeeping time due to sampling range from $19 to $23 per sample.
While the cost of labor time and laboratory analysis are the primary components of cost per sample, a second major determinant of sampling cost at any mine is the number of samples required each time sampling occurs. Where several miners perform the same tasks on the same shift and in the same work area, the mine operator may sample a representative fraction (
The third component of sampling cost is the frequency with which it must be performed. Sampling frequency depends on sample results, as specified by MSHA's exposure monitoring requirements.
MSHA estimated the percent of samples exceeding the action level in Year 1 based on its exposure profile developed using the Agency's compliance sampling data. MSHA assumed that mine operators will reduce the percentage of samples exceeding the action level from their current level of 31 percent to about 15 percent of samples by Year 7.
However, because the rule requires periodic evaluation whenever factors change that may affect exposures, some mines, such as portable mines, will likely have to conduct evaluations more frequently than semi-annually. Therefore, MSHA increased its estimate of the number of periodic evaluations by 20 percent (
Table IX-4 summarizes how the costs of each type of monitoring measures are estimated.
Table IX-5 below presents the estimated number of samples by sampling type and by commodity sector in the first 7 years of the analysis because MSHA expects a long-run average to be reached in Year 7. MSHA projects that in the first 2 years (following the coal and MNM compliance dates), 259,059 samples will be taken compared to 92,663 per year in Years 7 through 60. This is a result of: (a) declines in first-time and second-time sampling after the first year of compliance, and (b) declines in above-action-level and corrective actions sampling as mine operators become more experienced in developing and implementing new controls.
Table IX-6 below presents estimated total annualized exposure monitoring costs by type of monitoring and mining sector. The five types of exposure monitoring (samplings and evaluation) are projected to cost mine operators an average of about $53.2 million (3 percent discount rate) per year over 60 years. The first-time and second-time sampling ($4.2 million per year) account for about 8 percent of exposure monitoring costs; above-action-level sampling ($23.5 million) accounts for 44 percent; corrective actions sampling ($14.9 million) accounts for 28 percent; and periodic evaluations and post-evaluation sampling ($10.7 million) together account for about 20 percent. Of the total exposure monitoring costs, about 89 percent are expected to be incurred by MNM mines and the remaining 11 percent by coal mines.
Several commenters disagreed with MSHA's estimates for sampling costs (Document ID 1419; 1441; 1442; 1448) in the PRIA. For example, a mining trade association NSSGA provided estimates from several mine operators that exposure monitoring costs would be substantially higher than those reported in MSHA's PRIA (Document ID 1448). This commenter provided sampling costs ranging from a low of $139 to a maximum of $1,800 per sample, with a median of $650 per sample, that would increase costs by $34 million to $162 million for 250,000 MNM miners. This commenter further stated that sampling costs vary according to the number of miners sampled: $2,866 for one miner, but $3,247 for 3 miners (approximately $1,082 per miner). A second commenter, a MNM mine operator/owner Vanderbilt Minerals, LLC, listed costs in excess of $11,000 for a single 3-day sampling event (Document ID 1419). A third commenter, an industry trade association EMA, stated that 400 of its 446 employees would require 1,200 individual samples over the course of one year to meet the sampling requirements (Document ID 1442). A fourth commenter, NVMA, stated that one of its members estimated sampling costs would increase by $1.2 million for its 7,000 employees (Document ID 1441).
MSHA acknowledges that the range of costs per sample provided by commenters likely exceeds MSHA's own estimates. As explained earlier, and in greater detail in Section 4 of the standalone FRIA document, MSHA's calculations of the average unit costs of sampling, sample analysis, and evaluation take into account the labor cost of time spent sampling, laboratory fees for sample analysis, lost work time due to sampling, recordkeeping time, plus the cost of performing periodic evaluations. MSHA assumes that the labor cost of sampling varies by commodity and mine size. MSHA estimates that mine operators will take 5.76 million samples at a cost of $3.09 billion over the 60-year analysis period. MSHA estimated the weighted average (mean) cost at $500 per sample, with costs ranging from $250 per sample (for coal mines with more than 500 employees) to $750 per sample (for metal mines with 20 or fewer employees). A direct comparison with the cost estimates provided by the above commenter (NSSGA) is not possible because NSSGA presents the median but not the mean cost per sample from the organization's members who provided data. Because the distribution of costs provided by this commenter is skewed towards higher values, the mean cost is likely to exceed the median value. Thus, these data suggest the sampling costs provided by the commenter are probably falling within the range of MSHA's estimates.
However, MSHA estimates sampling costs of a “typical” mine for the purpose of this analysis.
MSHA acknowledges that some mine operators will incur higher sampling costs than the operator of a “typical” mine. MSHA believes that some small mine operators may experience higher sampling costs than MSHA estimates due to operating in remote areas where it may be more difficult to procure sampling services, and to the size of the mine. MSHA estimates the labor cost per sample at a small MNM mine will be nearly twice the cost per sample at larger MNM mines. Under MSHA estimates, the percentage of miners needed to achieve representative sampling (50 percent) is twice as large as the percentage at larger mines (25 percent or less).
MSHA was unable to determine from the information provided by commenters, how they determined a representative sample and the frequency of samples taken. For example, the range of values provided by the NSSGA was based on “more than 20 companies.” However, there are more than 6,000 sand and gravel mines affected by the rule, and it is unclear whether this cost data represents the whole sector.
MSHA's estimated cost per sample is largely influenced by a mine's need to hire a sampling professional. Some mines might perform their own sampling, others may hire a sampling professional (
Estimated total sampling costs from some commenters are much higher than MSHA's estimates because they assume more miners would have to be sampled than MSHA estimated under the proposed rule. For example, NSSGA estimated that at a cost per sample of $139 per sample, industry costs will increase by $34 million, while its median cost of $650 per sample will increase industry cost by $162 million (Document ID 1448). This commenter appears to have multiplied the cost per sample by its estimated number of affected miners, 250,000. Similarly, EMA mentioned an operator who assumes that 400 of 446 employees would be sampled (Document ID 1442), while a member mentioned by the NVMA appears to assume that all, or at least the vast majority of its 7,000 employees would be sampled (Document ID 1441).
In response to public comments, MSHA increased its estimate of the number of samples operators would need to take to meet the sampling requirements of the final rule by increasing the number of samples that constitutes the required representative fraction (or sampling representativeness) and frequency of sampling and evaluation. For example, over the first six years starting from the start of implementation, MSHA now estimates 758,000 samples of all types will be taken (Table IX-5), compared to 499,000 under the proposed rule.
Based on exposure profiles for the MNM and coal mining industries and MSHA's experience and knowledge of the mining industry, MSHA expects that on average the ratio of samples to miners sampled will be smaller than estimated by commenters. The final rule allows mine operators to sample a representative fraction of miners to meet the rule requirement. That is, a mine operator would be required to sample a minimum of two miners where several miners perform the same tasks on the same shift and in the same work area, so not all miners working in the same mine need to be sampled. Additionally, this sampling will stop when sampling results demonstrate exposure at a mine is below the action level. In Section 8.2.2 of the standalone FRIA document, MSHA provides two examples of how representative sampling will reduce the number of samples required based on MSHA experience in exposure sampling at mines and occupation categories.
MSHA has determined that exposure monitoring requirements in the final rule are necessary to maintain exposure levels at a safe level to ensure miners' health. The exposure monitoring requirements are also consistent with the Mine Act's statutory purpose to provide improved health protection for miners. Section 8.2.2 of the standalone FRIA document outlines a number of steps mine operators can take to reduce their monitoring cost.
To estimate the installation cost and to determine which mines will likely incur exposure control costs to reach compliance with the new PEL, MSHA analyzed the most recent 5 years of data on silica exposure (2015-2019 for MNM and August 2016-July 2021 for coal). As a starting point, it assumed that a mine will incur costs to meet the new PEL if it had a single sample result that exceeded the new PEL from the most recent day for which sample results were available. Analysis of the data yielded an initial estimate that 9.7 percent of all mines would incur costs, as reported in the PRIA. In response to public comments, MSHA updated this estimate to reflect the likelihood that more mines would incur additional costs of exposure controls. Based on its analysis and experience, MSHA projects in this FRIA that each year, about 20 percent of mines will incur some type of exposure control costs under the final rule.
MSHA estimated three types of exposure control costs, as described in the following sections:
• Installation costs, consisting of the costs of purchasing new engineering control equipment and installing it or
• Maintenance and repair costs, to ensure proper use of existing engineering controls with increased frequency of dust control maintenance and repair.
• Costs of administrative controls to reduce dust exposure (for example, the costs of training or posting signage regarding new policies).
Breaking down the total by type of cost, each year 5 percent of mines are expected to incur additional amortized installation costs, while 20 percent (that 5 percent plus an additional 15 percent) are expected to incur additional maintenance and repair costs and costs for administrative controls.
Some affected mines will incur installation costs because they will need to implement additional engineering control measures to reduce exposure levels. Using historical data and institutional knowledge, MSHA estimates the number of mines, by size, that will require additional engineering controls to meet the new PEL and the estimated level of capital investment (
MSHA estimates an average cost for engineering controls based on NIOSH evaluation of the dust controls used in the mining industry. MSHA assumed operating and maintenance (O&M) costs to be 35 percent of initial capital expenditure and assumed that installation cost, when appropriate, will be equal to initial capital expenditure. MSHA assumed most controls will have a 10-year service life, with exceptions for some equipment. For example, heavy haulage and excavating machinery are assumed to have a 15-year service life, and new or substantially renovated structural ventilation systems are assumed to have a 30-year service life. Within each category of capital expenditures, MSHA takes an average of the engineering control costs, inclusive of installation, maintenance, capital, and replacements costs over the 60-year analysis period and annualized the costs. Each affected mine is assigned the average value for its capital expenditure category. At a 3 percent discount rate, annualized costs range from $556 per mine for the lowest cost tier of capital equipment to $24,345 per mine for the highest cost tier. The annualized cost is $2,573 per mine per year when averaged across all mines.
Table IX-8 presents total annualized engineering costs calculated at $1.43 million (0 percent) to $1.58 million (7 percent) over 60 years.
Beyond adopting more advanced engineering control infrastructure, an integral method of reducing respirable crystalline silica exposure is by increasing the frequency of maintenance and repairs for dust control systems. In MSHA experience, when there are overexposures, often engineering controls are in place but the operator has neglected maintenance and repair. MSHA has determined that, when the appropriate dust control systems are used, effective and regular maintenance and repair of such systems can help reduce respirable crystalline silica exposure below the new PEL. Maintenance and repair activities are usually conducted at the beginning of each shift (or as frequently as necessary) and can be a part of existing safety and operational checks performed on most equipment.
MSHA estimates, on average, that mine operators would spend 16 hours per quarter on additional inspection and maintenance (
MSHA anticipates that additional mines will incur increased maintenance and repair costs each year to reduce exposure below the action level to avoid exposure monitoring costs. MSHA assumes that in total, these maintenance and repair costs will be incurred by 19.7 percent of mines, or 2,489 mines (2,249 MNM mines and 241 coal mines). These mines include the 4.7 percent that will incur new installation costs, plus an additional 15 percent that will incur only maintenance and repair costs and costs of administrative controls. MSHA assumes that this is the share of mines industrywide that will incur costs in each year, even as the specific mines incurring those costs may vary from year to year. Multiplying the average maintenance and repair cost per mine by the estimated 2,489 mines that will incur costs ranging from $8.65 million (0 percent discount rate) to $8.27 million (7 percent discount rate) for increased maintenance and repair (Table IX-9).
Administrative controls comprise a variety of methods to reduce exposure to respirable crystalline silica dust. In general, mine operators evaluate situations in which exposure can be reduced through changes in policies and work practices, and implements those changes by informing miners through training, published announcements, procedures, instructions, and signage. Examples of administrative controls include enclosing cabs to work with doors and windows shut and setting speed limits and minimum distances for equipment operated on dusty haul roads.
While many of these examples are applications of common-sense policies, they can be circumvented either accidently or deliberately. Administrative controls are not always effective, or as effective as they could be, because unlike engineering controls, administrative controls depend on miners' adherence to the policies and work practices. Administrative controls rank lower than engineering controls in the hierarchy of effectiveness.
The cost of administrative controls is composed of labor hours. MSHA believes that 2,489 mines will spend, on average, 16 labor hours on administrative controls starting in Year 1 for coal and Year 2 for MNM of the 60-year analysis period. As with the estimates of additional maintenance and repair costs, this figure for number of affected mines is based on MSHA's assumption that, beyond those mines with exposures currently above the new PEL, an additional 10 percent of mines might incur increased administrative costs each year to reduce exposure to below the action level.
In addition to the time spent identifying administrative controls, mine staff need to prepare and publish training and instructional materials, and post signage and/or other informational materials to implement such controls; to account for this, MSHA increases the value of labor hours by a factor of 2.0. MSHA estimates that the additional labor costs spent on administrative controls as an average of the loaded hourly wage rate weighted by the relative employment of these occupations in the mining industry. The estimated average cost is $1,439 per affected MNM mine (Year 2—60) and $2,222 per coal mine (Year 1—60).
Table IX-10 shows the estimated number of mines and annual costs expected to be incurred in Year 1 and Years 2 through 60 for administrative controls. Additionally, Table IX-11 shows that total annualized costs range from $3.7 million (0 percent discount rate) to $3.6 million (7 percent discount rate) based on the discount rate used. The higher totals for the MNM sector are attributable to the much larger number of affected mines than the coal sector.
Several commenters did not agree with MSHA's exposure control estimates as applied to their mines, stating that MSHA underestimated the costs of implementing exposure controls (Document ID 1419; 1441; 1448; 1455), and/or asserted that most mine operators who meet the current PEL will need to install significant new engineering controls to meet the new PEL. For example, Nevada Mining Association, stated that estimated compliance costs for one of their members was $22.7 million for the first year and $13.6 million for each following year to retrofit mobile equipment with filtered pressurized air as well as medical surveillance and exposure sampling costs (Document ID 1441). NSSGA stated that “[b]ased on communications with 13 member companies, costs for exposure controls will vary widely, but on average are $920,000 annually, with a median of $225,000 (Document ID 1448).” Neither the types of controls nor the number of mines installing the controls was included with the commenter's estimate. One of NSSGA's members also stated that its 2023 budget for exposure controls is approximately equal to the MSHA annual estimate for all of MNM. Another commenter, US Silica, stated that in 2023 alone, it incurred $3.6 million in capital costs on two automated projects and multiple other projects exceeding MSHA's estimate for the industry (Document ID 1455). A fifth commenter, Vanderbilt Minerals, LLC provided expected costs of $7 million for a list of renovations to existing facilities and new equipment purchases (Document ID 1419).
Based on its analysis of the Agency's sampling database, MSHA believes roughly 90 percent of mines will be able to meet the PEL without incurring additional costs. In Section 4 of the standalone FRIA document, MSHA estimates that about 1,230 mines are expected to incur exposure control costs to meet the new PEL. Of these, a little more than 50 percent (650 mines) should be able to meet the new PEL using controls such as additional maintenance and repair, and administrative controls. The remaining 47 percent of mines (580 mines) expected to incur costs will also implement engineering controls—in addition to increased maintenance, repair, and administrative costs—to meet the new PEL.
MSHA assumes that all mines are currently in compliance with the existing PEL when estimating compliance costs. Costs incurred by operators are attributed to lowering exposures from the existing PEL to the new PEL. Some mine operators have found it difficult to consistently control exposures to meet the existing PEL; any additional costs incurred by them will be more appropriately attributed to maintaining compliance with the existing PEL.
The estimated costs presented in the standalone FRIA represent the average estimated compliance costs for a typical mine. MSHA acknowledges that the exposure control costs will differ depending on the size of the mine, the current level of exposure to respirable crystalline silica, existing engineering and administrative controls, the mine layout, work practices, and other variables. MSHA's price and cost estimations are based on a variety of sources including market research and MSHA's experience and sample data. The evidence provided by the commenters was collected from members of trade organizations. It appears that at least some of the cost estimates are from either very large mines—far larger than the “typical” mine used for MSHA cost estimates—or may reflect an estimate for all mines controlled by an operator. For example, the comment that the “total amount to retrofit all underground and surface mobile equipment with filtered pressurized air, medical surveys and increased sampling is $22.7 million for the first year, and $13.6 million each year after” is from an MNM operator with 7,000 employees. If this represents a single mine, only 26 MNM mines (0.2 percent) employed more than 500 miners in 2019 (Table IX-1), if this represents multiple mines, then the anticipated compliance costs per mine would be smaller. Because the number of mines is unknown, and because the commenter includes sampling costs (provided separately as $1.2 million per year) and medical surveillance costs in the total, it is impossible to meaningfully compare this estimate with MSHA's estimates.
Similarly, US Silica presented costs exceeding $3.6 million in capital expenditures on two automated projects; totaling all projects, US Silica states it exceeded MSHA's estimate for the entire industry (Document ID 1455). However, it is unclear how many mines owned by US Silica incurred the costs. In addition, US Silica installed two automated systems. Generally, an automated bagging operation is more costly to purchase and install than a manual bagging system. The higher capital cost of an automated system also likely results in offsetting cost savings (
Vanderbilt Minerals LLC provided expected costs of $7 million for renovations to existing facilities and new equipment purchases at a single site, including “the purchase/installation of such items as a new
A further difficulty in evaluating commenters' estimates of engineering costs is that MSHA presents annualized costs; that is, compliance costs with initial capital and one-time costs amortized over the service life of the control. Many commenters provided first-year costs (without identifying capital, one-time, or recurring (operation and maintenance) cost components) to show that MSHA underestimated exposure control costs. The comparison of commenters' first-year costs with MSHA's annualized cost estimates is inappropriate. For example, a MNM mine operator provided $3.6 million as the first-year cost estimate without offering information about the actual service lives of these automation projects (Document ID 1455). If those costs are amortized at a 3 percent discount rate using an assumed 10-year service life (implying the system will be replaced 6 times over the course of the 60-year analysis period), the annualized capital component of their cost is about $410,000; if the expected service life is 30 years (replaced twice over 60 years), the annualized cost is about $178,000. Similarly, when amortized using a 3 percent rate, a $7 million in initial capital cost is equivalent to less than $800,000 annualized cost per year if the system has a 10-year service life, and less than $400,000 if the service life is 30 years. Thus, it is difficult to directly compare MSHA's annualized costs with first-year costs provided by commenters without service life information.
Small mine operators specifically questioned MSHA's estimates of the cost of controlling exposure to respirable silica crystalline silica dust (Document ID 1411; 1415; 1427; 1435; 1436). Water based dust suppression, especially if combined with magnesium chloride, is likely to be more expensive at some remote mines in arid regions due to the cost of obtaining and transporting water. However, these commenters did not discuss the applicability of other methods of reducing exposures presented in the FRIA and Technological Feasibility discussions. For example, operating vehicles with windows closed, reduced vehicle speed, and wider vehicle spacing have all been shown to decrease operator exposure to dust. These commenters provided the cost of cabin air filters and their preference to not use air conditioning, but it should be noted that there may be trade-offs in the choices mine operators make to reduce exposure to dust. For example, the use of air conditioning by vehicle operators will increase costs (filters, fuel use), but will decrease exposures. These increased operating costs should be offset by reduced sampling costs.
The new PEL may result in an increased use of respirators by miners when compared with usage under the existing PEL. This additional usage will result from provisions § 60.13: Corrective actions and § 60.14 (a): Respiratory protection. Under § 60.13, if sampling results indicate miners' exposure exceeds the new PEL, mine operators must make approved respirators available to affected miners; ensure that miners wear respirators properly during the period of overexposure; and take corrective actions to lower the concentration of respirable crystalline silica to at or below the PEL. Section 60.14 (a) requires the temporary use of respirators by MNM miners when engineering controls are developed and implement or when necessary due to the nature of work involved (
Under § 60.13 MSHA believes that miners who are most likely to need incremental respirator use to perform corrective actions work in the following occupations:
To estimate the number of miners who might be required to use respirators under § 60.13, MSHA first uses sample data to estimate the number of miners in these occupations with respirable crystalline silica exposures between the new PEL and the existing standards (50 μg/m
Under § 60.14, MSHA uses sample data to estimate the number of MNM miners that might need to increase their use of respirators due to the rule. MSHA assumes that MNM mine operators will need to provide additional respiratory protection for 20 percent of MNM miners in all occupations with exposures between the new PEL and the existing PEL. MSHA estimates MNM operators will need to provide respiratory protection to 4,945 MNM miners to meet the requirements of § 60.14.
Under sections 60.13 and 60.14 together, mine operators are expected to increase respirator protection for approximately 7,054 miners and contract miners (6,928 MNM miners and 125 coal miners).
MSHA estimates two types of respiratory protection costs: the purchase of new respirators to be issued and the incremental cost of additional temporary respirator use. MSHA believes that given the existing respiratory protection standards, most miners have already been issued respirators to deal with intermittent, temporary circumstances where exposures exceed the existing standards. However, some mine operators with miners at low risk of exceeding the existing standard may need to purchase respirators to account for possible temporary exposures in the range between the new PEL and existing standards. It is likely that some miners newly at risk for exposure in this range will not have respirators. In addition,
MSHA assumes that in Year 1, coal mine operators will incur costs for new respirators for 50 percent of their coal miners who are expected to increase respirator use (
MSHA assumed that mine operators will purchase tight-fitting, re-useable half-mask elastomeric respirators at a cost of $39.57 each plus $17.29 for filters.
Table IX-12 presents the estimated annual costs of purchasing new respirators for respiratory protection under the new PEL for miners who did not require respiratory protection under the existing PEL. In Year 1 of compliance for coal mines, 63 coal miners (including contract miners), who occasionally perform corrective actions where they would likely be exposed to respirable crystalline silica in the range between the new PEL and the existing standards are expected to be provided with new respirators by mine operators t a cost of $9,821. In Year 1 of compliance for MNM mines (Year 2 following publication of the final rule), 3,464 MNM miners will also be provided with new respirators for corrective actions and temporary use at a cost to mine operators of $502,282. New respirator purchase costs in Year 1 of compliance for coal and MNM mine operators are estimated to total $512,103 across both sectors. In subsequent years (Years 2 through 60 for coal mines; Years 3 through 60 for MNM mines), annual costs are expected to be about half of first year costs ($256,052).
Table IX-13 summarizes the total annualized cost of new respirator purchases by sector. Overall, the new PEL is expected to lead mine operators to purchase new respirators costing an average of $256,134 (at a 0 percent discount rate) to $255,285 (at a 7 percent discount rate) per year over the 60-year analysis period.
MSHA estimates the cost of additional respirator use under the new PEL for miners who did not need it under the existing standards. MSHA assumes the cost of additional respirator use starts in Year 1 (for coal mines) and Year 2 (for MNM mines) will remain constant over the 60-year analysis period. On average, MSHA believes additional respirator use will be necessary for 4 hours per week per miner, or an additional 208 hours per year (4 hours per week × 52 weeks per year). For estimating costs, if an elastomeric respirator uses two filters at a time, and the filters last eight hours before requiring replacement, then these miners will need an additional 26 pairs of filters per year (208 hours per year/8 hours per filter pair). At an average price of $17.29 per pair of filters, mine operators will spend an additional $450 per miner per year ($17.29 × 26 filter pairs) for respirator filters.
Table IX-14 and Table IX-15 present the estimated total annual and annualized cost of additional respirator usage by sector. The annual cost of additional temporary respirator use is expected to be $450 per miner per year over the 60-year analysis period (Table IX-14) and total annualized cost is expected to range from $3.12 million (0 percent discount rate) to $2.96 million (7 percent discount rate) per year (Table IX-15).
The estimate presented in Table IX-15 may be an overestimate of the cost of respirator use. MSHA assumed respiratory use would remain constant over the 60-year analysis period, it is likely that need for additional respirator use will decline as mines implement and improve engineering and administrative controls. However, with little data to support an assumption concerning how quickly the need for additional respirators might decline, MSHA chose to model it as constant. Second, while most mines operate year-round, some mines may operate for as little as 3 months per year. This will also decrease the need for respirators use.
Some commenters provided unit cost data for respirators and filters that were greater than the unit cost estimates that used in the PRIA (Document ID 1411; 1415; 1427; 1435; 1436). First, based on their data, the replacement filter cartridges last much longer than those costed by MSHA, so that the cost of one year's use will be lower than MSHA's cost estimate due to the long life span of replacement filters used by commenters. Second, the commenters assumed all employees would require new respirators and did not account for baseline use (or availability) of respirators at the mine. The final rule requires MNM mine operator to use respiratory protection as a temporary measure when miners must work in concentrations of respirable crystalline silica above the PEL when engineering control measures are being developed and implemented or necessitated by the nature of work involved. MSHA determined that its cost assumption is more comprehensive and likely overestimates respirator protection costs.
Under the final rule, MSHA will require each MNM mine operator to provide mandatory medical examinations to miners who are new to the mining industry and voluntary periodic examinations to all currently employed miners. These new medical surveillance standards extend to MNM miners the opportunity for medical surveillance that is already available to coal miners under the existing rules.
The medical examinations will be provided by a physician or other licensed health care professional (PLHCP), or by a specialist. The medical examination will include a miner's medical and work history, a physical examination, a chest X-ray, and a pulmonary function test. For those miners new to the mining industry, the first mandatory examination must take place within 60 days after beginning employment. This must be followed by a mandatory follow-up examination at 3 years. Should the follow-up examination indicate any medical issues related to lung disease, a second mandatory follow-up examination must take place in 2 years. In addition to these mandatory examinations, mine operators must also offer voluntary periodic medical examinations to all MNM miners at least every 5 years. The first periodic medical examination for existing MNM miners must be provided within 12 months of the final rule's MNM compliance date, or if a MNM mine commences operation after the compliance date, within 12 months of the mine beginning operations. All of the medical examinations must be provided at no cost to the miner.
Additionally, the MNM mine operator must ensure that, within 30 days of the medical examination, the PLHCP or specialist provides the results of chest X-ray classifications to NIOSH, once NIOSH establishes a reporting system. The cost of the x-ray includes the cost of preparing the report and transmitting those results to NIOSH.
To estimate the costs of compliance with the medical surveillance requirement, MSHA first estimated the “unit cost” of a single medical examination. MSHA then estimated how many examinations would occur in each year over the 60-year analysis period and multiplied the numbers of examinations by the unit cost to determine total costs in each year. MSHA summed the costs in each year to estimate a total cost over the full 60-year period.
MSHA assumed that all examinations entail the same cost elements (in decreasing order of cost): the physical examination, chest X-ray, spirometry test, lost work time while being examined, lost travel time, symptom assessment and occupational history, transportation cost, and recordkeeping of the mine operator. Table IX-16 displays estimated components in 2022 dollars, which sum to a unit cost of $628.58 per examination.
To estimate the number of examinations expected per year, MSHA used the estimated number of full-time equivalent (FTE) employees in MNM mining, which is 184,615 FTE workers. MSHA assumed that the MNM employment will remain constant over the 60-year analysis period following compliance of the medical surveillance requirement.
MSHA estimates total medical surveillance costs over the 60-year analysis period under two different scenarios due to the uncertainty of how many currently employed miners will participate in voluntary medical surveillance programs. Assuming a participation rate of 25 percent (Scenario 1), annualized costs range from $14.6 million (with a 0 percent discount) to $14.0 million (with a 7 percent discount rate) and the annualized cost per MNM miner ranges from $79 (with 0 percent discount rate) to $76 (with a 7 percent discount rate).
In scenario 2, MSHA assumed that the participation rate is 75 percent. Annualized costs range from $23.7 million (0 percent discount rate) to $23.1 million (7 percent discount rate). The annualized cost per MNM miner range from $128 (7 percent discount rate) to $125 (0 percent discount rate). A summary of estimated medical surveillance costs under the two scenarios is presented in Table IX-17.
Vanderbilt Minerals LLC stated that MSHA underestimated the cost of medical surveillance and stated its program cost approximately $9,400 per site per year, plus an additional $4,000 per site per year in employee time at 3 hours per employee (Document ID 1419). Assuming an average loaded wage of a nonmetal sector extraction worker at $40.47 per hour, $4,000 in employee time would cover 33 employees. This suggests that average medical surveillance costs would be about $406 per employee by dividing total costs of $13,400 (= $9,400 + $4,000) per site by 33 employees.
Another commenter, National Mining Association, stated that the proposed medical surveillance requirements would impose significant costs on its members, due to the expansion to cover potentially 200,000 MNM miners at more than 11,000 mines (Document ID 1428). As mentioned above, MSHA assumes that under the final rule, operators are required to conduct medical surveillance on currently employed miners and new miners (those who start to work on the mining industry for the first time). For currently employed miners, MSHA assumes two participation rates (25 percent and 75 percent) for medical surveillance and estimates the number of tests per year as 6,700 under 25 percent participation rate and 20,200 under 75 percent participation rate tests per year at an average cost of $4.24 million to $12.7 million each year (undiscounted). Average over the two participation rates, MSHA estimates that operators will conduct an average of 13,500 tests per year on the new miners at an average cost of $8.5 million each year (undiscounted).
Commenters also shared concerns on medical surveillance costs for small mine operators (Document ID 1408; 1411; 1415; 1427; 1435; 1436). The specific issue raised by these commenters concerned the cost of hourly wages and travel expenses from remote mine locations to obtain medical examinations. Thus, their costs will be larger than estimated by MSHA. MSHA acknowledges these concerns but notes that commenters provided no specific data in support of their position.
At least two commenters, NSSGA and Illinois Association of Aggregate Producers, stated that, under the proposed rule, companies would incur millions of dollars in costs that do not benefit miners' health and safety, using as examples requiring sampling every 3 months indefinitely for exposures between 25 μg/m
Under the final rule, mine operators are required to have a written respiratory protection program in accordance with the 2019 ASTM F3387-19 standard. A written respiratory protection program must include: program administration; written standard operating procedures; medical evaluations; respirator selection; training; fit testing; and maintenance, inspection, and storage. Mine operators will compare the ASTM standard to their existing respiratory protection program or practices and identify the elements of their existing respiratory protection program or practices that need to be revised. MSHA evaluated the components of the 2019 ASTM standard that have the potential to impose additional costs on mine operators.
MSHA assumes that 20 percent of MNM mines will incur costs to meet the 2019 ASTM standard each year. MSHA assumes that all coal mines are affected by the update to the 2019 ASTM standard because 30 CFR 72.700(a) requires coal mine operators to make respirators available to their miners. This should be an overestimate because it is likely that many coal mines already meet the 2019 ASTM standard. MSHA assumes that only a small subset of miners uses respirators each year. MSHA assumes about 10 percent of MNM miners and 3.7 percent of coal miners are expected to be required to use respirators each year.
Table X-18 presents the total number of mines compared to the total number of mines expected to incur compliance costs to update their respiratory protection program and practices. In Year 1, MSHA assumes that 1,106 coal mines will incur costs to update their respiratory protection program and practices to the 2019 ASTM standard, and 2,722 coal miners and contract miners are expected to wear respirators. Starting in Year 2, MSHA estimates that 3,411 mines (
MSHA evaluates the components of the 2019 ASTM standard that may impose additional costs on mine operators, and the assumptions in estimating those costs.
Table IX-19 presents average compliance costs per mine by sector. In Year 1, compliance costs average about $1,700 for coal mines. In Year 2, compliance costs average about $1,200 for MNM mines and $500 for coal mines. In Years 3 and following, average compliance costs per mine are smaller, ranging from $262 for MNM mines to $479 for coal mines, with an overall average of $332 per mine.
MSHA assumes that all mines are affected by the requirement to have a written respiratory protection program that meets the ASTM standard but not all mines are expected to incur costs for this requirement. MSHA estimates, in Year 1 (for coal mines) and Year 2 (for MNM mines), only 50 percent of affected mines are expected to incur costs under provision 2 (SOPs) because many mines already have SOPs that comply with the ASTM. In Years 2 through 60 (for coal) and Years 3 through 60 (for MNM), the number of affected mines that would incur costs is smaller than in Years 1 and 2 because following Year 1 (for coal) and Year 2 (for MNM), additional compliance costs are expected to be incurred primarily by new mines entering the industry. For example, provisions related to written SOPs, Training for the Respirator Trainer, and Training for the Mine Operator and Person Responsible for Issuing Respirators are initial costs incurred in the first year of compliance. In subsequent years, those costs would generally be incurred only by the 2 percent of new mines entering the industry.
Below in Table IX-20 are the annualized costs associated with the ASTM requirement. The total annualized cost to the mining industry ranges from $1.18 million (0 percent discount rate) to $1.32 million (7 percent discount rate), with 53 percent of those costs attributable to MNM mines and 47 percent attributable to coal mines.
MSHA estimates that the annualized cost of the final rule will range from $88.8 million to $92.4 million in 2022 dollars. At a discount rate of 3 percent,
Given the larger size of the MNM sector and the higher proportion of samples in the MNM sector that are above 50 μg/m
To estimate compliance costs, MSHA determined the expected measures necessary for mines to comply with each provision of the final rule then estimated the costs incurred by a typical mine to comply with each provision. These include one-time costs, such as those to purchase and install an engineering control, provide equipment expected to last multiple years (
MSHA annualizes all costs using 3 percent and 7 percent discount rates as recommended by OMB.
For both MNM and coal mines, the estimated costs to comply with the new PEL (50 μg/m
Two mining trade organizations, American Exploration and Mining Association and Nevada Mining Association, stated that MSHA's cost projections were inaccurate because they predicted fixed costs based on gross proceeds (instead of net proceeds) (Document ID 1424; 1441). These commenters also noted that, because the cost model for each commodity differs, compliance costs for each commodity will differ. MSHA did not estimate compliance costs based on either gross or net proceeds. MSHA has determined that its approach better identifies likely costs than the approach recommended by the commenters. The Agency estimated compliance costs based on a wide range of quantitative and qualitative data including: sampling data on miner exposure, MSHA program experience, and MSHA's knowledge of typical controls, maintenance, and work practices at mines of different types and size. MSHA estimates compliance costs using mine size, labor cost, and other factors at commodity level, which is more flexible and accurate than the estimation of proceeds.
One commenter, a mining-related business, stated that MSHA's cost estimates were based on flawed sampling data, that “used samples taken by MSHA inspectors and then weighted these based on the number of samples plus exposures to the current standard (Document ID 1392). The commenter stated that powered haulage operators account for the bulk of samples, while conveyor operators account for the fewest samples, resulting in a ratio of about 1 conveyor operator to 79 powered haulage operators. The commenter stated that in its experience, the ratio is about 1 conveyor operator to 4 haulage operators. Because conveyor operators are underrepresented in the analysis, this would affect MSHA's cost estimates.
As described in
The samples taken by MSHA inspectors were not weighted based on
One commenter, N-Compliance Safety Services, Inc., stated that large mining company costs under the proposed rule would be in the millions of dollars annually, a figure that does not include the cost of citations, downtime, and contesting violations (Document ID 1383). Stating that the proposed rule's costs would drive up the costs of commodities and impact transportation needs and expenses, the commenter said that the proposed 25 μg/m
In the FRIA, MSHA estimates that, during the 60 years following the compliance date for the coal sector (
In the FRIA, MSHA estimates and monetizes the excess morbidity and mortality cases avoided during the same 60-year analysis timeframe as considered by the cost analysis so that benefits can be directly compared with the costs of the final rule. The number of avoided cases presented in the FRIA during the 60-year analysis period is less than the number of lifetime cases avoided estimated in the FRA, since miners with exposure under the current limits are gradually replaced by miners with exposure under the new PEL during the 60 years following the start of implementation.
In the PRA, MSHA underestimated the number of miners who would benefit from this rule. Based on the 2019 Quarterly Employment Production Industry Profile (MSHA, 2019a) and the 2019 Quarterly Contractor Employment Production Report (MSHA, 2019b), the current number of working miners full-time equivalents (FTEs) is assumed to be 184,615 for MNM and 72,768 for coal.
Both the FRA and the FRIA are updated to account for benefits among both working miners and future retired miners. It is important to note that the FRIA only monetizes benefits to future retired miners—
MSHA estimates that:
• For a population of working and retired miners exposed only under the new PEL, the final respirable crystalline silica rule will result in a total of 1,067 lifetime avoided deaths (982 in MNM mines and 85 in coal mines) and 3,746 lifetime avoided morbidity cases (3,421 in MNM mines and 325 in coal mines). These avoided cases will be achieved once all miners, working and retired, have been exposed exclusively under the new PEL (see Table IX-23).
• Over the first 60 years immediately following the start of implementation, fewer cases will be avoided than are shown in Table IX-23. This is because the annual number of cases avoided will increase gradually to the long-run steady-state values, which ultimately will be achieved only when all miners have been exposed only under the new PEL. Table IX-24 shows that, in the first 60 years following the start of implementation, the final rule will result in a total of 531 avoided deaths (487 in MNM and 44 in coal) and 1,836 avoided morbidity cases (1,673 in MNM and 162 in coal), which are the benefits MSHA monetized in its FRIA. In general, the actual number of cases that will be avoided in the 60 years
• Under a discount rate of 3 percent, the total benefits of the new respirable crystalline silica rule from these avoided deaths and morbidity cases, including the benefits of avoided morbidity preceding mortality, are $246.9 million per year in 2022 dollars (see Table IX-25).
• Because a higher monetary value is placed on avoided death as compared to an avoided morbidity case, the majority (62.5 percent; $154.3 million) of these benefits is attributable to avoided mortality due to non-malignant respiratory disease (NMRD) ($75.4 million), silicosis ($40.3 million), and end-stage renal disease (ESRD) ($28.4 million), and lung cancer ($10.2 million) (see Table IX-25).
○ Benefits from avoided morbidity due to non-fatal silicosis are $72.8 million per year. Of this, $66.3 million are due to cases avoided in MNM mines and $6.5 million are due to cases avoided in coal mines (see Table IX-25).
○ Benefits from avoided morbidity that precedes fatal cases of NMRD, silicosis, renal disease, and lung cancer, are $19.8 million. Of this, $18.2 million are due to cases avoided in MNM mines and $1.6 million are due to cases avoided in coal mines (see Table IX-25).
MSHA acknowledges that its benefit estimates are influenced by underlying assumptions and that the long timeframe of this analysis (
• Employment is held constant over the 60 years (
• For analyses under the “Baseline” scenario, any exposures to respirable crystalline silica above the existing standards (
• For analyses under the “New PEL 50” scenario, any exposures to respirable crystalline above the new PEL are capped at the new PEL (
• Miners have identical employment and hence identical exposure tenures (
In addition to the above-mentioned quantified health benefits, MSHA expects that there will be additional benefits from requiring approved respirators be selected, fitted, used, and maintained in accordance with ASTM F3387-19. The ASTM standard reflects improved developments in respiratory protection since the time in which MSHA issued its existing standards. ASTM F3387-19 also includes respiratory protection program elements such as program administration; standard operating procedures (SOPs); medical evaluation; respirator selection; training; fit testing; and respirator maintenance, inspection, and storage.
This provision of the final rule will ensure that, in circumstances where respirator use is required, mine operators will provide miners with respiratory protection that incorporates advances in technology and changes in respiratory protection practices. This respiratory protection will play a critical role in safeguarding the health of miners and reducing their exposures to respirable crystalline silica and other airborne contaminants. As demonstrated in the FRA, reductions in occupational exposure to respirable crystalline silica are expected to reduce adverse health outcomes. However, given the uncertainty about the current state of mine operator respiratory protection practices, MSHA did not quantify the expected additional benefits that would be realized by requiring approved respirators to be selected, fitted, used, and maintained in accordance with the requirements of ASTM F3387-19.
MSHA believes that reductions in coal miners' exposure to respirable crystalline silica may also lead to lower levels of coal mine dust inhalation. MSHA expects that adverse health outcomes attributable to respirable coal mine dust exposure, such as simple and complex coal workers' pneumoconiosis (CWP), will also be reduced. MSHA has not estimated the reduction in risk associated with CWP among coal miners because the literature does not contain an exposure-response model that quantifies the impact of respirable crystalline silica on CWP mortality risk, and because MSHA is not making any assumptions about whether levels of coal mine dust will be reduced due to the final rule. MSHA anticipates that there will be additional unquantified benefits from the reduction in CWP provided by the final rule. Within the avoided silicosis and NMRD deaths, however, MSHA includes benefits from avoided mortality due to progressive massive fibrosis (PMF)—including mortality due to complicated CWP and complicated silicosis.
Finally, MSHA also expects that the final rule's medical surveillance provisions will reduce mortality and morbidity from respirable crystalline silica exposure among MNM miners. The initial mandatory examination that assesses a new miner's baseline pulmonary status, coupled with periodic examinations, will assist in the early detection of respirable crystalline silica-related illnesses. Early detection of illness often leads to early intervention and treatment, which may slow disease progression and/or improve health outcomes. This may also result in less miner time-off and less miner turnover. However, MSHA lacks data to quantify these additional benefits.
National Coalition of Black Lung and Respiratory Disease Clinics was concerned that the projected benefits of the proposed rule for coal miners were significantly lower than the projected benefits for MNM miners and suggested that MSHA correct for this by including dust samples from coal mines taken prior to August 1, 2016 (Document ID 1410). Similarly, the Appalachian Citizens' Law Center asserted that the benefits estimated in the PRA are low and urged MSHA to include a longer history of coal dust sampling data (Document ID 1445). MSHA believes that samples from before August 1, 2016, may not accurately reflect the current conditions in coal mines and therefore should not be used in analyzing the impact of this final rule. As discussed in Appendix A of the preamble, on August 1, 2016, Phase III of the 2014 RCMD Standard went into effect, and this lowered the PEL for RCMD in coal mines. The controls put in place to achieve that new PEL impacted both RCMD with and without respirable crystalline silica dust in coal mines, and as such, these controls likely lowered concentrations of respirable crystalline silica. Using data from after the coal mine dust rule went into effect helps to ensure that benefits attributable to that rule are not attributed to this rule incorrectly. More details about the respirable crystalline silica sample dataset, including the time coverage and brief statistics, are described in “Description of MSHA Respirable Crystalline Silica Samples” (Appendix A of the preamble of Proposed Rule). In addition to the prior effects of the 2014 RCMD Standard on respirable crystalline silica exposure in the coal sector, there will also be greater benefits to MNM miners owing to the medical surveillance requirements which are already existing for coal miners. However, these benefits are unquantified in the FRA and FRIA analyses and therefore, do not specifically contribute to the discrepancy mentioned by these commenters.
Further, the benefits quantified here may underestimate the true benefits to coal miners. MSHA believes this final rule will likely lower not only respirable crystalline silica concentrations, but also RCMD levels. As a result, MSHA believes this final rule will provide additional reductions in CWP, NMRD, and PMF beyond those conferred by the 2014 RCMD Standard. In the 2014 Coal Dust Rule, NIOSH emphasized the important role respirable crystalline silica plays in causing these diseases, stating that, “in concentrating on this particular exposure-response relationship with coal mine dust, we must not forget that [coal] miners today are being exposed to excess silica levels, particularly in thinner seam and small mines, and that this situation could well get worse as the thicker seams are mined out. Hence, since silica is more toxic than mixed coal dust, tomorrow's [coal] miners could well be at greater risk, despite a reduction in the mixed coal mine dust standard.” While additional reductions in total RCMD would be expected due to this final rule, these reductions cannot be quantified as the reductions depend on the particular control measures that mine operators implement. Additionally, exposure-response models for respirable crystalline silica exposure and resultant CWP are not available. Thus, the benefits quantified in this FRIA may underestimate the true benefits to coal miners, as MSHA does not account for expected reductions in CWP or in other diseases due to reduced RCMD.
The net benefits of the final rule are the differences between the estimated benefits and costs. Table IX-26 shows estimated net benefits using alternative discount rates of 0, 3, and 7 percent. The choice of discount rate has an effect on annualized costs, benefits, and net benefits. While the net benefits of the final respirable crystalline silica rule vary depending on the choice of discount rate used to annualize costs and benefits, total benefits exceed total costs under all discount rate considered. MSHA's estimate of the net annualized benefits of the final rule, using a discount rate of 3 percent, is $156.6 million a year, with the majority ($143.9 million; 91.9 percent) attributable to the MNM sector.
As mentioned in
Under the assumption that the same number of miners (257,383) are working at any given time the lower the tenure, the more turnover there would be among miners, the greater the number of new miners who would enter each year to replace those who are retiring or changing jobs. For example, when the scenario changes from a 45-year tenure (which was used in the benefit analysis) to a 15-year tenure, the analysis would require a single miner who would work for 45 years to be effectively replaced by three miners who would each be working for 15 years (one after another) during those same 45 years. This means that, in these lower-tenure scenarios, each miner would have accumulated less exposure by the time they retire, but there would be more miners retiring with that level of exposure.
From analyzing the alternative scenarios with different tenures, using its risk model, MSHA found that lower tenures tended to result in more avoided cases of mortality. This is because, while the risk of mortality increases for any miner who works more years, at lower tenure rates, many more miners are exposed and are put at risk of dying from the disease. According to the models, the increased number of exposed miners, when tenure is short, leads to a greater increase in overall mortality than does the increased likelihood of mortality occurring for each miner, when the tenure is long. As a result, this sensitivity analysis found that the rule would have greater benefits, in terms of reducing mortality, under scenarios with shorter tenure than under the 45-year tenure assumption used in the benefits analysis. The assumption of a 45-year tenure may be seen as effectively leading to an underestimate the benefits of the rule in terms of reduced mortality, relative to assumptions involving lower tenures.
From the way the risk model is designed, however, the opposite effect was observed with regard to morbidity cases, where there were more cases of morbidity under longer tenure rates. Under longer tenure rates, there are estimated to be more cases of morbidity overall, and therefore the rule has a greater estimated effect on reducing cases of morbidity under the assumption of a 45-year tenure than under the alternative scenarios. Nevertheless, because the benefits of reduced mortality cases count much more than the benefits of reduced morbidity cases, it may be concluded that under the shorter tenures of the alternative scenarios, the benefits of the rule would be greater. In other words, if the tenures of miners are, in fact, shorter than 45 years, the assumption of a 45-year tenure has the net effect of underestimating the benefits of the rule.
In developing the final rule, MSHA considered three regulatory alternatives. The first two alternatives contain less stringent exposure monitoring provisions than the final rule, which comparatively presents a comprehensive approach for lowering miners' exposure to respirable crystalline silica and improving respiratory protection for all airborne contaminants. The first alternative includes no change to the final rule's PEL and action level, whereas the second alternative includes a more stringent PEL. The second alternative combines less stringent exposure monitoring with a more stringent PEL. The third alternative examines a different methodology for calculating miners' exposures and assessing compliance. MSHA discusses the regulatory options in the sections below.
Under this alternative, the new PEL would remain unchanged at 50 μg/m
Mine operators would still be required to conduct sampling under this Regulatory Alternative and would thus incur compliance costs. However, exposure monitoring requirements under this alternative are less stringent than the requirements under the final rule because the frequency of above-action-level sampling and periodic evaluations are set at half the frequency of the final exposure monitoring requirements. Therefore, the cost of compliance would be lower under this alternative. MSHA estimates that annualized exposure monitoring costs would total $29.3 million for this alternative (at a 3 percent discount rate), compared to $53.2 million for the final exposure monitoring requirements, resulting in an estimated difference of $24.0 million in compliance costs per year (Table IX-27).
Although this alternative does not eliminate exposure monitoring, the requirements are minimal relative to the monitoring requirements under the final rule. However, MSHA believes it is necessary for mine operators to establish an initial baseline for any miner who may be reasonably expected to be exposed to respirable crystalline silica. In addition, above-action-level sampling helps mine operators correlate mine conditions to miner exposure levels and see exposure trends more rapidly than would result from semi-annual or annual sampling. This will enable mine operators to take necessary measures to ensure continued compliance with the new PEL. Further, more frequent monitoring will enable mine operators to ensure the adequacy of controls at their mines and better protect miners' health. These benefits cannot be quantified, but they are nevertheless material benefits that increase the likelihood of compliance.
MSHA also believes that requiring more frequent above-action-level sampling will provide mine operators with greater confidence that they are in compliance with the new PEL. Because of the variable nature of miner exposures to airborne concentrations of respirable crystalline silica, maintaining exposures below the action level
Two mining trade associations, American Exploration and Mining Association and National Mining Association, expressed support for Regulatory Alternative #1 (Changes in Sampling and Evaluation Requirements) as a more appropriate approach than the one in the proposed rule, with one clarifying that its support for Regulatory Alternative #1 is only secondary to its primary recommendation that MSHA adopt OSHA's risk-based approach to sampling and evaluation requirements (Document ID 1424; 1428). Specifically, these commenters supported the Regulatory Alternative #1 requirement for baseline sampling for miners whose exposure is at or above the proposed action level of 25 µg/m
MSHA believes it is necessary for mine operators to establish a solid baseline for any miner who is reasonably expected to be exposed to respirable crystalline silica. In addition, frequent, regular sampling and evaluation help mine operators correlate mine conditions to mine exposure levels and see exposure trends more rapidly than would result from semi-annual sampling and annual evaluation. This will enable mine operators to take measures necessary to ensure continued compliance with the PEL. Further, more frequent monitoring will enable mine operators to ensure the adequacy of controls at their miners and better protect miners' health. These benefits cannot be quantified, but they are nevertheless material benefits that increase the likelihood of compliance. MSHA believes that the benefits of the sampling and evaluation requirements justify the additional costs for the final rule relative to Regulatory Alternative 1. Therefore, MSHA did not select Regulatory Alternative 1.
Under this Regulatory Alternative, the PEL would be set at 25 μg/m
When estimating the cost of monitoring requirements under the final rule, MSHA assumed that the number of samples for post-evaluation sampling are relatively small (2.5 percent of miners) because mine operators are already collecting information which can be used for these purposes through the significant amount of above-action-level sampling. Since Regulatory Alternative 2 does not require above-action-level sampling given the lack of an action level under this alternative, MSHA increases the share of samples after each evaluation to 10 percent of miners to ensure the monitoring requirements can be met.
In addition, to meet the PEL of 25 μg/m
MSHA first estimated the number of mines expected to incur the cost of implementing engineering controls to reach the more stringent PEL. After excluding mines that are affected at the new PEL of 50 μg/m
In addition, MSHA also includes the 1,226 affected mines expected to incur costs to reach the new PEL of 50 μg/m
MSHA estimates a total of 4,703 mines will incur costs to purchase, install, and operate engineering controls to meet the more stringent PEL of 25 μg/m
MSHA identified potential engineering controls that would enable mines with respirable crystalline silica dust exposures at or above 25 μg/m
Where more precise information is unavailable, MSHA assumed operating and maintenance (O&M) costs to be 35 percent of initial capital expenditure
However, the difficulty of meeting a PEL of 25 μg/m
Table IX-29 presents the annualized engineering control costs per mine and total annualized engineering control costs by mine sector. At a 3 percent discount rate, the annualized engineering control costs are about $98,124 per mine, resulting in an additional cost of $461.5 million if the PEL were set at 25 μg/m
Table IX-30 summarizes the estimated annualized cost of this Regulatory Alternative under consideration. At a 3 percent discount rate, exposure monitoring costs less than it does for the final rule. However, this lower monitoring cost is more than offset by the increased control costs necessitated by the requirement that mines maintain respirable crystalline silica exposure levels below 25 μg/m
Regulatory Alternative 2 increases miner protection by establishing the PEL at 25 μg/m
Table IX-32 presents the monetized benefits associated with this avoided morbidity and mortality. The expected total benefits, discounted at 3 percent, are $516.3 million, which is more than twice the expected total benefits of $246.9 million under the new PEL (50 μg/m
Under this Regulatory Alternative, these benefits are made up of $369.0 million due to avoided mortality, $47.3 million due to avoided morbidity preceding mortality, and $100.0 million due to avoided morbidity not preceding mortality. However, when compared to the annualized costs of $520.7 million (3 percent) and $662.2 million (7 percent) for the Part 60 requirements, the net benefits of this alternative are negative at a 3 percent and 7 percent discount rate.
A professional association, American Industrial Hygiene Association, expressed support for Regulatory Alternative 2 (Changes in Sampling and Evaluation Requirements and the Proposed PEL) (Document ID 1351). However, the commenter recommended that mine operators be required to (1) conduct baseline sampling and periodic sampling, (2) conduct semi-annual or more frequent evaluations of changing conditions, and (3) sample as frequently as necessary to determine the adequacy of controls. In addition, the commenter stated that, under this alternative, mine operators should be required to perform post-evaluation sampling when the operators determine from the semi-annual evaluation that miners are exposed at the 95-percent confidence level to respirable crystalline silica above the PEL of 50 μg/m
Although the benefits associated with this avoided morbidity and mortality under Regulatory Alternative 2 (Table IX-31 and Table IX-32) are greater than those for the final rule, the net benefits of this alternative are negative at both a 3 percent and 7 percent real discount rate owing to the much higher compliance costs for this alternative as compared to those for the final rule (Table IX-31). Further, MSHA determines that meeting a PEL of 25 μg/m
Regulatory Alternative 3 calculates exposure concentrations as an entire-shift time-weighted average, called a “full shift TWA”. Under this Regulatory Alternative, a different methodology is used for calculating exposures and assessing compliance. Elsewhere in the final rule, the costs and benefits are based on calculating exposure for a full shift, calculated as an 8-hour TWA. In this Regulatory Alternative, MSHA calculates exposure as a full shift TWA and re-analyzes the costs and benefits of the rule. No other changes, such as changes to the rule requirements, are included under this Regulatory Alternative.
MSHA expects a change in the number of affected mines. MSHA has estimated the number of mines expected to incur costs when baseline exposure concentrations are re-calculated as full shift TWAs. Based on the use of a full shift TWA, MSHA finds that 1,053 mines operating in 2019 would incur costs to purchase, install, and operate exposure controls under the final rule. Of this total, 955 are MNM mines and 98 are coal mines. This total is 173 fewer mines than what would incur new compliance costs under an 8-hour TWA (1,226 affected mines).
Aside from the change to the calculation of exposure concentrations and the number of affected mines at those concentrations, MSHA does not make any additional changes in assumptions or calculations under this Regulatory Alternative. Therefore, the cost estimates of this Regulatory Alternative are calculated using the same methodology as described in Section 4 of the FRIA. The changes in cost estimates are completely attributable to changes in the estimated baseline exposure conditions and the total number of affected mines, as described in Section 7.3.1 of the FRIA.
Table IX-33 below presents the estimated annualized compliance costs of part 60 if exposure concentrations were calculated using a full shift TWA instead of a full shift, 8-hour TWA.
While the compliance costs decrease when a full shift TWA is used, the estimated benefits of the rule are also expected to decrease. When miners work shifts that are longer than 8 hours (which commonly occurs, as seen both in the exposure data and in the employment data), the full shift, 8-hour TWA will result in a higher calculated exposure level than the full shift TWA.
Table IX-34 presents the estimated number of avoided deaths and illnesses during the 60 years following the start of implementation of the new rule, under the Regulatory Alternative. The total number of avoided morbidity cases over the 60-year analysis period is 1,500, which is 18 percent lower under the Regulatory Alternative than the estimate of 1,836 avoided morbidity cases in the main analysis (see Table IX-24). The total number of avoided mortality cases over the 60-year analysis period is 434, which is 18 percent lower under the Regulatory Alternative than the estimate of 531 avoided mortality cases in the main analysis (see Table IX-24).
Table IX-35 presents the annualized benefits of the final rule under this Regulatory Alternative. The undiscounted annualized benefits under the Regulatory Alternative are estimated at $312.8 million, with $291.5 million attributable to MNM mines and $21.3 million attributable to coal mines. The discounted annualized benefits under the Regulatory Alternative are estimated at $201.9 million at a 3 percent discount rate and $107.9 million at a 7 percent discount rate. At a 3 percent discount rate, the annualized benefits are $45.0 million (18 percent) less under the Regulatory Alternative than when using an 8-hour TWA ($246.9 million). The annualized benefits under the Regulatory Alternative are also 18 percent lower both at the 0 percent discount and 7 percent discount rates.
The net annualized benefits under the Regulatory Alternative are $226.5 million (undiscounted), $114.3 million (3 percent discount rate), and $18.6 million (7 percent discount rate). The net benefits under the Regulatory Alternative are lower than those in the main analysis by 23 percent (0 percent discount rate), 27 percent (3 percent discount rate), and 53 percent (7 percent discount rate).
MSHA received comments both in agreement with the Agency's proposed “full-shift, 8-hour TWA” calculation method and against it. Commenters in favor stated that the proposed calculation method of collecting a sample for a full-shift and calculating the exposure level over an 8-hour period (
The Agency does not choose Regulatory Alternative 3, that uses full shift TWA as an alternate calculation of exposure concentration. Regulatory Alternative 3 yields much smaller net benefits than the final rule. Importantly, Regulatory Alternative 3 would provide miners less health protection. Cumulative exposure to respirable crystalline silica is an important risk factor in the development of silica-related disease, as discussed in the standalone FRA document and section VIII.B.3.c of this preamble. However, the full shift TWA methodology does not account for the increased health risks associated with the higher cumulative exposures that can occur during longer work shifts. The full shift TWA calculation does not differentiate between the impacts of working 8-hour shifts and working extended shifts. Regulatory Alternative 3 would provide less protection for miners working longer shifts.
The Regulatory Flexibility Act of 1980 as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, hereafter jointly referred to as the RFA, requires that an agency consider the economic impact that a final rulemaking will have on small entities. The RFA provides that, “[w]hen an agency promulgates a final rule under section 553 of this title, after being required by that section or any other law to publish a general notice of proposed rulemaking . . . the agency shall prepare a final regulatory flexibility analysis.” 5 U.S.C. 604(a). However, under section 605(b), in lieu of an initial regulatory flexibility analysis (IRFA) or final regulatory flexibility analysis (FRFA), the head of an agency may certify that the final rule “will not, if promulgated, have a significant economic impact on a substantial number of small entities.” 5 U.S.C. 605(b). That certification must be supported by a factual basis.
As part of its notice of proposed rulemaking, MSHA prepared an IRFA that analyzed the potential impact of the proposed rule on small entities.
(1) a statement of the need for, and objectives of, the rule;
(2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;
(3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments;
(4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available;
(5) a description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and
(6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected; and for a covered agency, as defined in section 609(d)(2), a description of the steps the agency has taken to minimize any additional cost of credit for small entities. 5 U.S.C. 604(a).
While a full understanding of MSHA's analysis and conclusions with respect to costs and economic impacts on small entities requires a reading of the standalone FRIA document, this FRFA summarizes the key aspects of MSHA's analysis as they affect small entities.
As part of the proposed rule, MSHA published an IRFA. MSHA's proposed rule would affect MNM and coal mining operations. The IRFA identified which mine controllers were small entities, estimated the direct compliance costs for those small entities, and compared the compliance costs to the revenues of the small entities. Results from the IRFA are summarized below.
In its IRFA analysis, MSHA relied on the Small Business Administration (SBA)'s 2017
MSHA estimated that in 2021, there were a total of 11,791 mines and a total of 5,879 controllers. Of the controllers, 5,007 were small-entity controllers; these small-entity controllers owned 8,240 mines. Many controllers owned one or two mines, while some controllers owned hundreds of mines nationwide (or worldwide).
MSHA estimated the regulatory compliance costs and revenues for each of the 5,007 small-entity controllers identified in 2021. In estimating compliance costs for small-entity controllers, MSHA factored in the types of commodities that controllers produced and their employment size, which were gathered from the MSHA Standardized Information System (MSIS). MSHA estimated the revenues of the small-entity controllers based on data from the Statistics of U.S. Businesses published by the U.S. Census Bureau, using NAICS codes and each controller's employment size.
From these two sets of estimates, MSHA generated estimates of the ratios of regulatory compliance cost to revenue for each controller. Table X-1 shows the number of controllers, average annual regulatory costs, average annual
On July 13, 2023, MSHA published its notice of proposed rulemaking in the
During the public comment period, MSHA held three public hearings (virtual and in-person)—in Arlington, Virginia (on August 3, 2023), Beckley, West Virginia (on August 10, 2023), and Denver, Colorado (on August 21, 2023)—to facilitate the participation of the public, small businesses and organizations that represent them, and all other stakeholders.
On August 30, 2023, MSHA attended a Small Business Labor Safety Roundtable organized by the SBA's Office of Advocacy to discuss the proposal. The Roundtable was also attended by the small business community and representatives from industry and labor. MSHA provided education about the NPRM's content at this roundtable.
Based on its review of the health effects literature, MSHA determined that occupational exposure to respirable crystalline silica causes silicosis and other diseases. In its FRA, MSHA also determined that, under existing standards, miners face a risk of material impairment of health or functional capacity from exposures to respirable crystalline silica.
Following these determinations, MSHA is issuing a final rule to better protect miners against occupational exposure to respirable crystalline silica, a carcinogen, and to improve respiratory protection for airborne contaminants. The final rule will affect both MNM and coal mining operations.
The final rule establishes, for mines of all sizes, a PEL of 50 µg/m
MSHA received written comments from trade associations representing small businesses or small mines (Document ID 1406; 1408; 1411; 1413; 1415; 1422; 1424; 1427; 1430; 1435; 1436; 1441; 1448; 1453; 1456; 1300; 1302; 1303; 1349; 1368; 1369; 1378; 1383; 1392; 1398). The Agency also received a letter from the Deputy Chief Counsel and Assistant Chief Counsel for Advocacy of the SBA requesting a 60-day extension of the public comment period to give small businesses more time to comment and provide small business representatives time to consult their membership about their operations and how the proposed rule would impact them.
On August 14, 2023, MSHA published a notice in the
Commenters raised concerns about MSHA's estimates of the proposed rule's costs and impacts. MNM operators, mining and industry trade associations, and a mining related business stated that MSHA had underestimated the costs of the proposal for small mines (Document ID 1427; 1430; 1435; 1436 1448; 1456; 1392). Commenters, including mining related businesses, MNM operators, and mining trade associations, also stated that, for some mines, there would be high costs of initial compliance or high costs of annual compliance thereafter (Document ID 1408; 1411; 1415; 1427; 1430; 1435; 1436; 1448; 1453; 1456; 1383; 1392). Commenters including mining trade associations and MNM operators cited the cost of obtaining equipment and services needed to establish sampling and medical surveillance programs, as well as the cost of implementing engineering controls (Document ID 1408; 1411; 1415; 1427; 1435; 1436; 1441; 1448; 1392). MNM operators, mining trade associations, and other mine organizations commented on the costs of lab fees, respirators, and travel to undergo medical examinations for medial surveillance (Document ID 1408; 1411; 1415; 1435; 1436; 1448; 1453; 1378; 1392). Several MNM operators and a mining-related business stated that compliance with the proposal would substantially increase their water costs (Document ID 1411; 1415; 1427; 1435; 1436; 1392). Some commenters including a mining-related business, mining trade associations, MNM operators, and other mine industry organizations noted that the costs of compliance would be higher for small mines operating in remote locations (Document ID 1408; 1411; 1415; 1422; 1424; 1453; 1378; 1392). A mining trade association and a mining-related business stated that MSHA failed to consider that some small mines might go out of business due to being unable to afford to comply with the new rule, which would result in losses to local economies (Document ID 1429; 1368; 1392).
Taking these comments into consideration, MSHA changed its compliance dates and other requirements, which resulted in revisions to some of previous cost estimates. MSHA's cost estimates are detailed in Section 4 of the standalone FRIA document. MSHA believes its cost estimates for sampling, exposure controls, laboratory fees, and medical surveillance are accurate for small-entity controllers. As explained in Section 8 of the standalone FRIA document, MSHA adjusted some compliance costs upwards in response to commenters; in particular, sampling and exposure control costs. MSHA incorporated these adjusted costs in the cost estimates for small entities. In the FRFA methodology, the compliance costs that were derived in the FRIA, per mine employee, were estimated for specific size categories of mines, and for the type of commodity produced in the mine.
MSHA understands that some small-entity controllers might have high initial capital investments for the installation of new engineering controls. However, high initial capital expenses, in general, are not uncommon in mining operations, especially with regard to the purchase of major units of equipment for engineering controls. Because these new engineering controls will last for many years, their purchase is comparable to any other type of investment in physical capital, for mining operations, that will be either paid directly or financed through periodic payments. If they are paid directly, this would be a one-time payment to cover several years, resulting in a lower cost per year. If the payment is financed, the annual (or monthly) costs will be much lower as well. Because these costs, on an annual basis, as determined by the useful life of the engineering controls, will be much lower than the initial investment, and these annual costs will be a small fraction of the revenues earned in those years, MSHA believes these new engineering controls will not, on average, be significantly burdensome to small-entity controllers. Moreover, MSHA expects that many of the mines that implement new engineering controls will be able to discontinue sampling once exposure levels are reduced below the action level. Thus, even mines with higher initial expenditures are unlikely to also have high annual costs thereafter.
MSHA acknowledges the concerns from small mine operators in rural and remote areas. Because of the nature of mining, many mine operators, including small-entity operators, operate in rural and remote areas. MSHA believes that this final rule will not present major logistical challenges for small mine operators. As MSHA has stated in
A mining-related business noted that the IRFA included no estimates of indirect costs of the rule (Document ID 1392). Examples of such costs cited by the commenter included lost
MSHA considered the comment that the rule might lead to lost production. MSHA is providing additional compliance time for mine operators, including small-entity controllers, to prepare for the final rule's requirements. The extended compliance period under the final rule (24 months after the publication date for MNM operators and 12 months after the publication date for coal operators) provides additional time for mine operators to comply with the requirements, such as implementing engineering controls and finding appropriate resources (industrial hygienists, medical facilities, laboratories, sampling devices, etc.). This extended compliance period is intended to provide industry additional time for planning. For example, a MNM small entity mine operator could use the increased time to identify and implement engineering controls to reduce miners' exposures.
As in the IRFA, the FRFA includes the travel expenses related to miners' time lost due to travelling to medical examinations and their transportation costs. Regarding the costs of travel time to medical examinations, MSHA believes its estimates of the average travel time spent to and from medical examinations and the related cost are reliable, though it should be recognized that these are averages and that travel times could be different for different mines.
MSHA considered the comment that the rule could incur “costs to communities” by making it harder for mine operators to make charitable donations to those communities. MSHA has not included charitable donations from operators in its analysis, as charitable donations are voluntary. MSHA believes that the final rule will benefit communities because the health and safety of miners is greatly improved. In this regard, MSHA's final rule is expected to have a net beneficial effect on mining communities through the improved health of miners, which should reduce the need for charitable support. Details on the revised estimates are provided in
The final rule, like the proposed rule, will affect MNM and coal mining operations. As in its IRFA, MSHA considered a controller (parent company) that owns and operates one or more mines as the appropriate unit of this FRFA.
To determine the number of small entities subject to the final rule, MSHA used SBA's 2023 Size Standards and other guidance from the Office of Advocacy such as how to determine if a government entity is a small entity, NAICS codes, and MSIS, which identifies mines and their numbers of employees working at mines.
MSHA estimated that the number of small-entity controllers in 2021 was 5,462 out of the total number of controllers (5,879). The 5,462 small-entity controllers owned a total of 9,395 mines out of a total of 12,529 mines owned by all controllers in 2021.
In analyzing controllers of mines, MSHA determined that mining operations subject to the final rule would fall under 19 NAICS codes. These industry categories and their accompanying six-digit NAICS codes are shown in Table X-2.
Table X-2 presents the distribution of controllers by the one NAICS code for which they have the most employees, because some controllers are in more than one mining NAICS code.
The final rule not only establishes a PEL of 50 µg/m
In addition, the final rule creates new information collection requirements for mine operators. As described in greater detail in
In response to commenters who expressed concerns that the rule would lead to excessive demand and backlogs for sampling devices, industrial hygienists, labs, medical facilities, and NIOSH B Readers, MSHA adjusted the requirements in the final rule to provide additional time for small-entity controllers and other controllers, to prepare for compliance (24 months after publication of the final rule for MNM mines and 12 months after publication of the final rule for coal mines). MSHA is allowing this longer period for compliance because MNM operators, particularly small-entity controllers, may have less experience with sampling and may also need time to prepare for compliance with medical surveillance. For coal mines, the delayed compliance period gives operators sufficient time to plan and prepare for effective compliance with the new standards, while also ensuring that improved protections for miners from the hazards of respirable crystalline silica take effect as soon as practically possible. For additional details on the compliance dates, see
MSHA will also provide compliance assistance to small-entity controllers and the mining community overall (including industry and labor) after publication of the final rule. This assistance will include guidance to assist mine operators in developing and implementing appropriate controls; outreach seminars (onsite and virtual, dates and locations will be posted on MSHA's website); dust control workshops at the National Mine Health and Safety Academy; support from the Educational Field and Small Mine Services staff; support from MSHA's Technical Support staff; silica training and best practice materials; and information on MSHA's enforcement efforts.
MSHA examined three possible regulatory alternatives to this final rule and considered how they could affect small-entity controllers.
Under Regulatory Alternative 1, the PEL would remain unchanged at 50 μg/m3 and the action level would remain unchanged at 25 μg/m3. Further, mine operators would conduct: (1) first-time and second-time sampling for miners who may be exposed to respirable crystalline silica at or above the action level of 25 μg/m3, (2) periodic sampling twice per year, and (3) an annual evaluation of changing mining processes or conditions that would reasonably be expected to result in new or increased respirable crystalline silica exposures. Under Regulatory Alternative 2, the PEL would be set at 25 μg/m3; mine operators would install whatever controls are necessary to meet the PEL; and there would not be an action level. Further, mine operators would (1) not be required to conduct any sampling, but they would be required to (2) conduct periodic evaluations of changing conditions and (3) sample as frequently as necessary to determine the adequacy of controls.
MSHA determined that the final rule will provide improved health protections for miners and will be achievable for all mines, including those that are owned and operated by small entities. MSHA has made the following determinations regarding the three alternatives considered:
• Regulatory Alternative 1, “Changes in Sampling and Evaluation Requirements,” would reduce overall costs to the mining industry by 26.9 percent for costs calculated at a 3 percent, and by 26.4 percent for costs calculated at a 7 percent discount rate. These reduced costs would be proportionally experienced by small entities. The average costs as a percent of revenues for small entities would then be reduced (relative to the final rule) from 0.318 percent to 0.232 percent based on a 3 percent discount rate, or to 0.234 percent based on a 7 percent discount rate.
• Regulatory Alternative 2, “Changes in Sampling and Evaluation Requirements and the Proposed PEL,” would increase overall costs to the mining industry by 484.8 percent for costs calculated at a 3 percent discount rate, and by 627.1 percent for costs calculated at a 7 percent discount rate. The average costs as a percent of revenues for small entities would then rise (relative to the final rule) from 0.318 percent to 1.859 percent based on a 3 percent discount rate, and from 0.318 percent to 2.31 percent based on a 7 percent discount rate.
• Regulatory Alternative 3, “Changes in the Calculation of Exposure Concentrations,” would change the methodology used for calculating exposures and assessing compliance to a full shift TWA, rather than a full-shift exposure, calculated as an 8-hour TWA. MSHA estimated that this alternative would decrease overall costs to the mining industry by 3.02 percent for costs calculated at a 3 percent discount rate, and by 3.41 percent for costs calculated at a 7 percent discount rate. The average costs as a percent of revenues for small entities would then fall from 0.318 percent to 0.308 percent based on a 3 percent discount rate, and to 0.307 percent based on a 7 percent discount rate.
Regulatory Alternative 1 would reduce the costs to small entities. However, the final rule will better protect miners from exposures to respirable crystalline silica. The final rule's exposure monitoring requirements are necessary to ensure that miners' health is adequately protected. MSHA determined that Regulatory Alternative 1 would not protect miners' health. The final rule's exposure monitoring requirements, including monitoring on a more frequent basis, will provide mine operators with greater confidence that they are in compliance with the final rule.
Regulatory Alternative 2 would increase costs to small entities, making it an unsuitable choice for small mines. Additionally, this alternative would not be achievable for all mines because a PEL of 25 µg/m
Regulatory Alternative 3 would reduce the costs to small entities. However, the final rule will better protect miners by using an exposure calculation method that recognizes the importance of cumulative exposure to respirable crystalline silica being an important risk factor in the development of silica-related disease. Regulatory Alternative 3 does not take into account the increased health risks associated
Because the controllers vary in the scale of their mining operations, MSHA first estimated regulatory costs on a per-miner basis. MSHA anticipated that the regulatory costs per miner would vary across the six major commodity categories: coal, metal, nonmetal, stone, crushed limestone, and sand and gravel.
MSHA examined employment data for each controller. By combining this information with per-mine compliance cost information, MSHA derived estimates of the regulatory costs for each of the 5,462 small-entity controllers identified in 2021. See the average annual regulatory cost per controller in Table X-3.
The compliance burden on the controllers, large and small, consists primarily of the costs of additional dust control measures, exposure monitoring, medical surveillance for MNM mines, and other program activities needed to comply with the rule. For costs estimates by component, by commodity, and by mine size, please see Section 4 of the standalone FRIA document.
MSHA estimated revenues for each small-entity controller. The Agency estimated revenues per employee, by mine, and by controller, using data published by the U.S. Bureau of Census in their report, “Statistics of U.S. Businesses” (SUSB).
Some of the small-entity controllers have operations in non-mining industries. Non-mining revenues are not accounted for in this analysis, as the data was not available. If non-mining revenues were accounted for, the ratio of regulatory costs to revenues shown in the summary table would be even smaller.
MSHA calculated the number of mining employees for each small-entity controller, and for each NAICS category (for mining NAICS) within each controller's activities. MSHA then combined these data with SUSB data on revenues by NAICS category and size category to generate estimated revenues for each small-entity controller. See the estimated average annual revenue per controller in Table X-3.
MSHA estimated the average annual regulatory cost per small-entity controller, as well as the average annual revenue per small-entity controller. MSHA estimated, for each controller, the annual compliance cost of the final rule as a proportion of that controller's annual revenue.
Based on the methodology described above, MSHA generated estimates of the ratios of regulatory compliance cost to revenue for each controller. Table X-3 shows the number of controllers, average annual regulatory costs, average annual revenues, and average cost as a percent of revenue.
MSHA estimated that the final rule would have an average cost, per small-entity controller, of $11,026 per year in 2022 dollars. The estimated costs for the final rule represent the costs necessary for small-entity mine operators to achieve full compliance with the final rule.
From the cost and revenue estimates described above, MSHA estimated the ratio of annual regulatory cost to annual revenue for each small-entity controller. As shown in Table X-3, the average of these proportions (weighting controllers equally) was 0.318 percent. In other words, for every $1 million in revenue earned by a small-entity controller, the average compliance cost was estimated to be approximately $3,000. This compliance cost-to-revenue ratio is slightly lower for controllers with five or fewer employees (0.299), implying that the low compliance cost-to-revenue ratios are generally applicable for the smallest of the small-entity controllers. The low cost-to-revenue ratio of these controllers with five or fewer employees is due largely to the estimated annual revenues of these controllers averaging above $1 million in 2022 dollars, in comparison to their estimated compliance costs averaging approximately $3,000 per year.
MSHA believes that the Agency could certify the economic impact of this final rule on small entities, however, in the interest of public disclosure and transparency, the Agency prepared a full analysis to inform the public of its decision-making process.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) provides for the Federal Government's collection, use, and dissemination of information. The goals of the Paperwork Reduction Act include minimizing paperwork and reporting burdens and ensuring the maximum possible utility from the information that is collected under 5 CFR part 1320. The Paperwork Reduction Act requires Federal agencies to obtain approval from the Office of Management and Budget (OMB) before requesting or requiring “
As part of the Paperwork Reduction Act process, agencies are generally required to provide a notice in the
MSHA has made several additions and changes to the proposed rule and methodology that have paperwork burden implications. Key additions include the immediate reporting of samples over the PEL to MSHA, reporting chest X-ray classification results to NIOSH, as well as a written respiratory protection program consistent with the requirements of ASTM F3387-19. Key changes include certain compliance dates, sampling requirements, medical examination dates for current miners, as well as the frequency of periodic evaluations and post-evaluation recordkeeping. Each addition and change and reasons for each are discussed in detail in
MSHA sought comment on the utility of the recordkeeping requirements in part 60. MSHA received multiple comments on the proposed recordkeeping requirements, with several commenters supporting MSHA's proposed recordkeeping provisions or recommending that records have a longer retention period than proposed. None of the comments addressed the methodology, assumptions, or calculations made in the Paperwork Reduction Act portion of the proposal.
This section presents a summary of the comments received and the Agency's responses.
The NSSGA stated that MSHA should adopt the same rule as the Occupational Safety and Health Administration's (OSHA) 2016 Silica Rule since some companies have OSHA and MSHA regulated facilities (Document ID 1448). This commenter stated that MSHA's silica rule with different requirements than OSHA creates excessive, unnecessary paperwork for these companies.
The Agency clarifies that the Mine Act gives MSHA jurisdiction over each MNM or coal mine and each operator of such mine. The mining industry is different from the industries that are subject to OSHA's standards. MSHA did consider and adopt, as appropriate, some of OSHA's regulatory approach to controlling workers' exposures to respirable crystalline silica in developing its final rule. This final rule will better protect miners against occupational exposure to respirable crystalline silica, a carcinogenic hazard, and improve respiratory protection for airborne contaminants miners encounter. Nonetheless, the Agency has developed the rule's paperwork requirements to minimize burden on mine operators.
For records retained under proposed paragraphs 60.16(a)(1) through (3)—evaluation records, sampling records, and corrective action records, respectively—many commenters, including labor organizations, advocacy organizations, and a MNM mine operator, recommended that record retention periods should be extended beyond the proposed requirements, especially for MNM mines (Document ID 1416; 1417; 1425; 1439; 1447; 1449). A miner health advocate recommended that sampling records under § 60.16(a)(2) be preserved for as long as the mine is in operation instead of the 2-year proposed requirement (Document ID 1372). Additionally, Appalachian Voices recommended that the records under § 60.16(a)(2) should be retained for longer than the life of the mine operation (Document ID 1425).
In response to comments requesting an increase in the record retention period, in the final rule, MSHA increases the record retention period for evaluation, sampling, and corrective actions records in paragraphs (a)(1) to (3) to at least 5 years. The 5-year record retention period for evaluation, sampling, and corrective actions records is consistent with the 5-year record retention period for operator samples collected while monitoring for airborne exposure to diesel particulate matter in underground metal and nonmetal mines (§ 57.5071(d)(2)) and other injury and illness reports required under section 50.40. MSHA concludes in this final rule that a 5-year retention period for the records retained under paragraphs § 60.16(a)(1) through (3) is effective in providing information for the protection of miners. This is because the evaluation, § 60.16(a)(1), and sampling, § 60.16(a)(2), records can identify a change in operation that might lead to increased exposures to respirable crystalline silica. Similarly, the 5-year recordkeeping requirement for corrective action records under § 60.16(a)(3) is intended to help the operator and MSHA identify the effectiveness of existing controls, or the need for maintenance or additional control measures. In MSHA's experience, recent records can more effectively assist MSHA and mine operators in achieving these goals. MSHA believes the 5-year retention period achieves the proper balance between the operator's burden to maintain records and the effective utility of older records to mine operators, miners, and MSHA.
For records retained under proposed paragraphs § 60.16(a)(4) and (5)—written determination and medical opinion records, respectively, received from a PLHCP or specialist—some commenters such as a medical professional organization, a public health advocacy organization, and labor unions also suggested an increased retention period to help miners diagnosed with silica-related health conditions request workers' compensation claims (Document ID 1416; 1425; 1373; 1437; 1412; 1398; 1447). A labor union recommended that medical surveillance data collected by mine operators should be kept for the duration of a miner's employment plus 20 or 30 years and for the records to be provided to the miner upon termination of employment (Document ID 1398). MSHA concludes in this final rule that it is appropriate to retain determination and medical opinion records, which have very limited medical information only relevant to the miner's ability to wear a respirator, for the duration of the miner's employment plus 6 months because the miner may need to wear a respirator at some point without notice. The requirement to retain records for an additional 6 months beyond the miner's employment gives miners more time to request records once they terminate their employment at the mine.
A commenter (NVMA) asked for clarification on the medical surveillance recordkeeping requirements, stating that the rule does not include provisions requiring tracking of miners' silica exposure throughout their careers and noting that miners often change companies over the course of their careers (Document ID 1441). MSHA clarifies that mine operators do not have access to a miner's medical information and, therefore, do not maintain a record of such information. Instead, the mine operator will retain a record of the date of the medical examination, a statement
Two commenters including a labor union also suggested that corrective action records and cumulative exposure records be submitted to MSHA, miner representatives, or miners (Document ID 1447; 1439). After considering the comments, MSHA determined that it is not necessary to change the requirement of providing all the listed records promptly upon request to miners, authorized representatives of miners, and authorized representatives of the Secretary of Labor. This is because the requirement to provide all the listed records promptly upon request ensures that miners and MSHA will have access to records as needed can facilitate enforcement and transparency. Because miners, miners' representatives, and MSHA can request the records at any time for their own recordkeeping purposes, MSHA does not believe it is necessary to have operators submit the records to miners and MSHA without request. However, in response to comments, the final rule requires mine operators to immediately report all exposures above the PEL from operator sampling to the MSHA District Manager or to any other MSHA office designated by the District Manager. This modification will allow the Agency to promptly address overexposures as appropriate. As discussed below, this change from the proposal presents a modest increase in the estimated paperwork burden.
The final rule requires a new information collection as well as modifications to existing collections. As required by the Paperwork Reduction Act, the Department has submitted information collections, including a new information collection and revisions of two existing collections, to OMB for review to reflect new burdens and changes to existing burdens. Once OMB completes its review, the Agency will publish a notice on the new information collection under OMB Control Number 1219-0156. (The regulated community is not required to respond to any collection of information unless it displays a current, valid, OMB Control Number.)
Under final part 60, certain new burdens apply to all mine operators, and other burdens apply to only some mine operators. Section 60.16 lists all the recordkeeping requirements related to part 60. Each of the requirements are discussed below:
Section 60.12 requires mine operators to make a record for each sampling and each periodic evaluation conducted pursuant to the section. The samplings identified in § 60.12(a) include: sampling by the compliance date (§ 60.12(a)(1)), an additional sampling (§ 60.12(a)(2)), above-action-level-sampling (§ 60.12(a)(3)), corrective actions sampling (§ 60.12(b)), and post-evaluation sampling (§ 60.12(d)). The sampling record consists of the sampling date, the occupations sampled, and the concentrations of respirable crystalline silica and respirable dust, and the mine operator must also retain laboratory reports on sampling results under § 60.12(g).
In a change from the proposal, under final § 60.12(c), the periodic evaluations must be conducted at least every 6 months or whenever there is a change in: production; processes; installation and maintenance of engineering controls; installation and maintenance of equipment; administrative controls; or geological conditions; mine operators shall evaluate whether the change may reasonably be expected to result in new or increased respirable crystalline silica exposures. The periodic evaluation record includes the evaluated change, the impact on respirable crystalline silica exposure, and the date of the evaluation under § 60.12(c)(1). In addition, the mine operator is required to post the sampling and evaluation records and the laboratory report on the mine bulletin board and, if applicable, by electronic means, for 31 days, upon receipt under § 60.12(c)(2).
The mine operator must immediately report all exposures above the PEL to the MSHA District Manager or to any other MSHA office designated by the District Manager under § 60.12(b). A corrective action must be taken immediately to lower the concentration of respirable crystalline silica to at or below the PEL, once a sample reporting exposure above the PEL is recorded. The corrective actions record must include the corrective actions taken, including any related respirator use by affected miners, and the dates of the corrective actions under § 60.13(c). All records must be retained for at least 5 years from the date of each sampling, evaluation, or corrective action.
Section 60.14(b) requires mine operators to temporarily transfer a miner either to work in a separate area of the same mine or to an occupation at the same mine where respiratory protection is not required if the miner has a written determination from the PLHCP that the miner is unable to wear a respirator. Section 60.16(a)(4) requires the written determination record to be retained for the duration of a miner's employment plus 6 months. In a change from the proposal, final § 60.14(c)(2) requires mine operators to have a written respiratory protection program that meets the following requirements in accordance with ASTM F3387-19: program administration; written standard operating procedures; medical evaluation; respirator selection; training; fit testing; maintenance, inspection, and storage.
Section 60.15 requires MNM mine operators to provide miners periodic medical examinations at no cost to the miner. Section 60.15(d)(1) requires the mine operator to ensure that the results of medical examinations or tests are provided from the PLHCP or specialist to the miner within 30 days of the medical examination, and, at the request of the miner, to the miner's designated physician or another designee identified by the miner. Section 60.15(d)(2) requires MNM mine operators to ensure that, within 30 days of the medical examination, the PLHCP or specialist provides the results of chest X-ray classifications to the National Institute for Occupational Safety and Health (NIOSH), once NIOSH establishes a reporting system. Mine operators are required to obtain a written medical opinion from the PLHCP or specialist within 30 days of a miner's medical examination. The written medical opinion must contain only the date of the medical examination, a statement that the examination has met the requirements of the section, and any recommended limitations on the miner's use of respirators under § 60.15(e). The written medical opinion record must be retained by MNM mine operators for the duration of a miner's employment plus 6 months under § 60.15(f).
The final rule results in changes to two existing information collection packages: a non-substantive change to information collection package under OMB Control Number 1219-0011, Respirable Coal Mine Dust Sampling; and a substantive change to information collection package under OMB Control Number 1219-0048, Respirator Program Records. This is a change from the proposal, which only contained non-substantive changes to existing information collections.
Non-substantive changes to OMB Control Number 1219-0011 involve references to respirable dust when
OMB Control Number 1219-0048 involves recordkeeping requirements under 30 CFR parts 56 and 57 for MNM mines when respiratory protection is used. Under the final rule, MSHA updates the existing respiratory protection standard and requires a written respiratory protection program that meets the following requirements in accordance with ASTM F3387-19: program administration; written standard operating procedures; medical evaluation; respirator selection; training; fit testing; maintenance, inspection, and storage. This substantive change will result in an increase in the paperwork burden and costs associated with respiratory protection in the existing information collection.
There are provisions of this rule that will take effect at different times after the date of publication of this rule, and there are information collection provisions that will have different respondents, responses, burden hours, and costs in each year. Therefore, this ICR estimates the first 3 years of compliance.
There were changes in this ICR between the proposed and final rule based on changes in methodology and the rule text. Based on changes to § 60.1 in the final rule, MNM mines are not expected to begin implementing the rule until year 2. This change decreases the recordkeeping burden for all cost items in the final rule. In the proposed rule, operators were allowed to use historical and objective data instead of a second-time sampling. In the final rule, every mine is required to conduct a first-time and second-time sampling, thereby increasing the related time burden. The methodology for calculating corrective actions samples and post-evaluation samples was also changed, leading to an increased time burden for both. Additionally, based on changes to § 60.12(b) in the final rule, operators are now required to notify MSHA after every overexposure.
The inclusion of ASTM F3387-19 costs in this ICR was a result of a change in the rule text between the proposed rule and final rule. In the proposed rule, operators could choose which ASTM F3387-19 elements to adopt. In the final rule, mine operators must have a written respiratory protection program that meets an explicit set of requirements in accordance with ASTM F3387-19. This change leads to a substantial increase in the recordkeeping burden for this ICR. Lastly, the addition of § 60.15(d)(2) in the final rule, which requires the mine operator to ensure that a miner's PLHCP or specialist provides the results of chest X-ray classifications to the National Institute for Occupational Safety and Health (NIOSH), created a new recordkeeper cost.
Highlighted below are the key assumptions, by provision, used in the burden estimates in Table XI-1:
First-time sampling and second-time sampling apply to every coal and MNM mine. However, a certain number of mines are predicted to be able to discontinue sampling if the results of these samples are below the action level. Furthermore, subsequent to Year 1 for Coal, and Year 2 for MNM, all first-time and second-time sampling will only be performed by new mines. MSHA projects that about 2 percent of mines in any given year will be new entrants to the mining industry. MSHA assumes that all active coal mines (1,106 mines) will conduct first-time and second-time sampling in year 1 of compliance (producing 29,796 samples). In years 2 and 3, an estimated 22 new coal mines will conduct first-time and second-time sampling (producing 596 samples each year). Similarly, MSHA assumes that all 11,525 MNM mines will conduct first-time and second-time sampling in year 2 of compliance (producing 124,288 samples). In year 3, 231 new MNM mines will conduct first-time and second-time sampling (producing 2,486 samples). MSHA estimates that an annual average of 52,587 first-time and second-time samples will be collected in the first 3 years of compliance.
The estimated number of above-action-level sampling is calculated based on the following factors: the number of miners with sampling results at or above the action level (25 μg/m
MSHA estimates that an annual average of 731 active mines (604 MNM and 127 coal) will carry out an annual average of 25,417 corrective actions (22,152 MNM and 3,265 coal) due to overexposure, and these mines will then conduct corrective actions sampling for each corrective action. Miner operators will have to immediately notify MSHA about each overexposure. MSHA estimates that an annual average of 25,417 corrective action notifications will be sent to MSHA.
Next, MSHA assumes that all 1,106 coal mines will record periodic evaluation results approximately 2.4 times, on average, per year, and then post those results on a mine bulletin board, or if applicable, by electronic means. In a change from the proposal, MSHA increased its estimate for the number of periodic evaluations from about 2 per year to about 2.4 per year, a 20 percent increase. This was done for two reasons. First, § 60.12(c) now requires periodic evaluations at least every 6 months after commencing sampling or whenever there is a change in production; processes; installation or maintenance of engineering controls; installation or maintenance of equipment; administrative controls; or geological conditions. Second, MSHA now accounts for portable mines, which move frequently and are therefore more likely to experience one of the changes noted in § 60.12(c). A more thorough explanation for this calculation can be found in Section 4.2 of the standalone FRIA document.
The number of records for periodic evaluation in coal mines is 2,449 each year. All 11,525 MNM mines will record periodic evaluation results approximately 2.4 times, on average, a year, and then post those results on a mine bulletin board, or if applicable, by electronic means, starting in year 2. The number of records for periodic evaluation in MNM mines is 0 for year 1, and 25,859 for years 2 and 3. Mine operators will also post results of each periodic evaluation on mine bulletin boards, creating an annual average of 19,688 records (2,449 in year 1, 28,308 in year 2, and 28,308 in year 3). Additionally, MSHA estimates mines will conduct post-evaluation sampling as a result of their periodic evaluations, resulting in an annual average of 12,766 sampling records (8,376 for MNM mines and 4,390 for coal mines). MSHA estimates an annual average of 39,377 periodic evaluation recordings and postings and 12,766 post-evaluation samples.
The assumption for calculating corrective actions samples and post-evaluation samples was changed from the proposal. In the proposed rule, the number of corrective actions samples was combined with the number of post-evaluation samples and their sum was assumed to be equivalent to a constant 2.5 percent of all miners per periodic evaluation. In the final rule, the number of corrective actions samples is based on the projected share of samples over the PEL, increased by 25 percent to account for some operators needing multiple samples before obtaining a sample below the PEL, while the number of post-evaluation samples alone is now equivalent to 2.5 percent of miners per periodic evaluation. The change in methodology is intended to made estimates more consistent with existing sampling data. In year 1 for coal mines and year 2 for MNM mines, they will sample for only half a year. See Section 4.2 of the standalone FRIA document for more details.
MSHA estimates that it takes 15 minutes to record the sampling results, 15 minutes to record the results of a periodic evaluation, 5 minutes to notify MSHA after an overexposure, and 3 minutes to post each of the evaluation results on the mine bulletin board, and, if applicable, by electronic means.
This is a change from the proposal, where MSHA assumed that
For the ASTM F3387-19 incorporation by reference under § 60.14(c)(2), MSHA assumes, to err on the side of overestimation, that a total of 3,411 mine respondents (2,305 MNM mines and 1,106 coal mines) would have respiratory protection programs. MSHA assumes that a half of the coal mines (553 mines) would write new standard operating procedures (SOPs) relating to the respiratory protection program and the remaining half (533 mines) would revise existing SOPs in year 1. New coal mines, estimated at 2 percent (22 mines), are assumed to write respiratory protection SOPs in years 2 and 3. Similarly, for MNM mines, MSHA assumes that: a half of them (1,153 mines) would write new SOPs relating to the respiratory protection program; the remaining half (1,152 mines) would revise existing SOPs in year 2; and approximately 46 new MNM mines to write respiratory protection SOPs in year 3.
The inclusion of ASTM F3387-19 costs in this ICR is a result of a change between the proposed rule and final rule. In the proposed rule, operators could choose which ASTM F3387-19 elements to adopt. In the final rule, mine operators must have a written respiratory protection program that meets the following requirements in accordance with ASTM F3387-19: program administration; written standard operating procedures; medical evaluation; respirator selection; training; fit testing; maintenance, inspection, and storage. MSHA estimates that 3,411 mines will be affected by respiratory protection requirements, an annual average of 599 existing mines will have to write new respiratory protection SOPs, and an annual average of 569 mines will have to revise existing SOPs each year.
Also, MNM mine operators must obtain a written medical opinion from a PLHCP or specialist regarding any recommended limitations on a miner's use of respirators under § 60.15(e). The written medical opinion must contain the date of the medical examination, a statement that the examination has met the requirements of the section, and any recommended limitations on the miner's use of respirators. The written medical opinion record must be retained by MNM mine operators for the duration of a miner's employment plus 6 months under § 60.16(a)(5).
As per § 60.1, the compliance date for MNM mines begins one year after the compliance date for coal mines.
MSHA further estimates that 8,392 miners each year, including contract workers, are new miners and contractors working in MNM mines and receive mandatory medical examinations. MSHA estimates that the turnover of MNM miners will be 8,392 miners per year, starting from year 2 (1/22 of the estimated total of 184,615 MNM workers, with an average number of 22 years on the job before leaving the mining industry). This results in an annual average of 5,595 MNM miners receiving mandatory medical examinations (0 in year 1, 8,392 in years 2 and 3). The estimated total respondents per year therefore will be 34,965 (= 29,371 current miners × 5,595 new miners).
Total recordkeeping burden for Part 60 is summarized in Table XI-1.
The total annual number of respondents is 47,596; the total annual number of responses will be 265,509; and the estimated annual burden will be 63,972 hours.
The following estimates of information collection burden are summarized in Table XI-2.
The number of responses and burden hours decreased from year 2 to year 3 mainly as a result of decreases in sampling in current MNM mines. In year 2, MNM mines will conduct first-time and second-time sampling, while only a small number of new mines starting operations in year 3 are required to conduct this type of sampling. The increase in capital costs in year 2 is a result of all medical examinations for current miners taking place in that year.
For a detailed summary of the burden hours and related costs by provision, see the FRIA accompanying the final rule. The FRIA includes the estimated costs and assumptions related to the paperwork requirements under this final rule.
In October 2022, MSHA received OMB approval for the reauthorization of Respirable Coal Mine Dust Sampling under OMB Control Number 1219-0011. This information collection request outlines the legal authority, procedures, burden, and costs associated with recordkeeping and reporting requirements for coal mine operators. MSHA's standards require that coal mine operators sample respirable coal mine dust quarterly and make records of such samples.
This non-substantive change request revises the supporting statement for this information collection request due to the establishment of a PEL for respirable crystalline silica separate from coal mine dust in this final rule. These revisions remove any reference in the information collection request to quartz or the reduction of the respirable coal mine dust standard due the presence of quartz. This change does not modify the authority, affected mine operators, or paperwork burden in this information collection request.
The calculated burden including respondents and responses remain the same.
Title 30 CFR parts 56 and 57 incorporate by reference requirements of ANSI Z88.2-1969, “
This substantive change request is to revise the supporting statement for this information collection request due to a modification of respiratory protection standard from ANSI Z88.2-1969 to ASTM F3387-19 in the final rule. These revisions require mine operators to update their respiratory protection standard and increase recordkeeping costs. The change does not modify the authority or affected mine operators but increases the paperwork burden and costs associated with respiratory protection in this information collection request.
The calculated burden including respondents and responses increases.
The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321
MSHA reviewed this rule according to the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
The statutory authority for the final rule is provided by the Mine Act under sections 101(a), 103(h), and 508. 30 U.S.C. 811(a), 813(h), and 957. MSHA implements the provisions of the Mine Act to prevent death, illness, and injury from mining and promote safe and healthful workplaces for miners. The Mine Act requires the Secretary of Labor (Secretary) to develop and promulgate improved mandatory health and safety standards to prevent hazardous and unhealthy conditions and protect the health and safety of the nation's miners. 30 U.S.C. 811(a).
MSHA concludes that the final rule would impose a federal mandate on the private sector in excess of $196 million in expenditures in one of the 60-year implementation years, as documented in the standalone FRIA document (see Table C-2, Appendix C). The expenditure burden on the private sector will be borne by mine operators. Such expenditures may include conducting exposure monitoring; selecting, improving, and implementing exposure controls; providing respiratory protection; updating respiratory protection practices in accordance with the 2019 ASTM standard; and, for MNM mine operators, making specified medical examinations available for all their miners. However, the rule will not require State, local, or tribal governments to expend, in the aggregate, $196 million or more in any one year for their commercial activities. Accordingly, the rule does not trigger the requirements of the UMRA based on its impact on State, local, or tribal governments.
Section 202(c) of the UMRA, 2 U.S.C. 1532(c), authorizes a Federal agency to prepare any written statement required under section 202(a) of the UMRA in conjunction with or as a part of any other statement or analysis that accompanies the final rule. The FRIA constitutes the written statement containing a qualitative and quantitative assessment of these anticipated costs and benefits required under Section 202(a) of the UMRA.
In addition, section 205(a) of UMRA, 2 U.S.C. 1535(a), requires MSHA to identify and consider a reasonable number of regulatory alternatives before promulgating a rule for which a written statement under section 202 is required. MSHA is required to select from those alternatives the most cost-effective and least burdensome alternative that achieves the objectives of the rule unless the Agency publishes an explanation for doing otherwise, or the selection of such an alternative is inconsistent with law. After considering three regulatory alternatives, this final rule presents a comprehensive approach for lowering miners' exposure to respirable crystalline silica and MSHA has determined the rule is both technologically feasible and economically justified as described in
Section 654 of the Treasury and General Government Appropriations Act of 1999 (5 U.S.C. 601 note) requires agencies to assess the impact of Agency action on family well-being. MSHA has determined that the final rule will have no effect on family stability or safety, marital commitment, parental rights and authority, or income or poverty of families and children, as defined in the Act. The final rule impacts the mining industry and does not impose requirements on states or families. Accordingly, MSHA certifies that this final rule will not impact family well-being, as defined in the Act.
Section 5 of E.O. 12630 requires Federal agencies to “identify the takings implications of proposed regulatory actions . . .” MSHA has determined that the final rule does not implement a taking of private property or otherwise have takings implications. Accordingly, E.O. 12630 requires no further Agency action or analysis.
The final rule was written to provide a clear legal standard for affected conduct and was carefully reviewed to eliminate drafting errors and ambiguities to minimize litigation and avoid undue burden on the Federal court system. Accordingly, the final rule meets the applicable standards provided in section 3 of E.O. 12988, Civil Justice Reform.
E.O. 13045 requires Federal agencies submitting covered regulatory actions to OMB's Office of Information and Regulatory Affairs (OIRA) for review, pursuant to E.O. 12866, to provide OIRA with (1) an evaluation of the environmental health or safety effects that the planned regulation may have on children, and (2) an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. In E.O. 13045,
MSHA has determined that, in accordance with E.O. 13045, while the final rule is considered significant under E.O. 12866 Section 3(f)(1), it does not concern an environmental health or safety risk that may have a disproportionate impact on children. MSHA's final rule would lower the occupational exposure limit to respirable crystalline silica for all miners, including pregnant miners, take other actions to protect miners from adverse health risks associated with exposure to respirable crystalline silica, and require updated respiratory standards to better protect miners from airborne contaminants.
MSHA is aware of studies which have characterized and assessed the risks posed by “take-home” exposure pathways for hazardous dust particles. However, the final rule's primary reliance on engineering and administrative controls to protect miners from respirable crystalline silica exposures helps minimize risks associated with “take-home” exposures by reducing or eliminating silica that is in the mine atmosphere or the miner's personal breathing zone. The risks of take-home exposures are further minimized by MSHA's existing standards, mine operators' policies and procedures, and mine operators' use of clothing cleaning systems.
MSHA's existing standards limit miners' exposures to respirable crystalline silica. MSHA also requires coal mine operators to provide miners with bathing facilities and change rooms. Miners have access to these facilities to shower and change their work clothes at the end of each shift. In addition, some mine operators provide miners with clean company clothing for each shift, have policies and procedures for cleaning or disposing of contaminated clothing, and provide a boot wash for miners to clean work boots during and after each shift. Moreover, some mine operators use clothing cleaning systems that can remove dust from a miner's clothing. Many of these systems include NIOSH-designed dust removal booths that use compressed air to remove dust, which is then vacuumed through a filter to remove airborne contaminants. Overall, the Agency's standards, mine operators' policies and procedures, and other safety and health practices including the use of clothing cleaning systems help to reduce or eliminate the amount of take-home exposure, therefore protecting other persons in a miner's household or persons who come into contact with the miner outside of the mine site.
MSHA identified one epidemiological study (Onyije
MSHA has no evidence that the environmental health or safety risks posed by respirable crystalline silica, including “take-home” exposure to respirable crystalline silica, disproportionately affect children. Therefore, MSHA concludes no further analysis or action is needed, in accordance with E.O. 13045.
MSHA has determined that the final rule does not have “federalism implications” because it will not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Accordingly, under E.O. 13132, no further Agency action or analysis is required.
MSHA has determined the final rule does not have “tribal implications” because it will not “have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” Accordingly, under E.O. 13175, no further Agency action or analysis is required.
E.O. 13211 requires agencies to publish a Statement of Energy Effects for “significant energy actions,” which are agency actions that are “likely to have a significant adverse effect on the supply, distribution, or use of energy” including a “shortfall in supply, price increases, and increased use of foreign supplies.” MSHA has reviewed the final rule for its impact on the supply, distribution, and use of energy because it applies to the mining industry. The final rule would result in annualized compliance costs of $8.2 million using a 3 percent discount rate and $8.6 million using a 7 percent discount rate for the coal industry relative to annual revenue of $29.1 billion. The final rule would also result in annualized compliance costs of $81.9 million using a 3 percent discount rate and $83.6 million using a 7 percent discount rate for the metal/nonmetal mine industry relative to annual revenue of $95.1 billion. Because it is not “likely to have a significant adverse effect on the supply, distribution, or use of energy” including a “shortfall in supply, price increases, and increased use of foreign supplies,” it is not a “significant energy action.” Accordingly, E.O. 13211 requires no further agency action or analysis.
MSHA has thoroughly reviewed the final rule to assess and take appropriate account of its potential impact on small businesses, small governmental jurisdictions, and small organizations. MSHA's analysis is presented in
E.O. 13985 provides “that the Federal Government should pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality.” E.O. 13985 defines “equity” as “consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such
In 2008, NIOSH conducted a survey of mines, which entailed sending a survey packet to 2,321 mining operations to collect a wide range of information, including demographic information on miners. NIOSH's 2012 report, entitled “National Survey of the Mining Population: Part I: Employees” reported the findings of this survey (NIOSH, 2012a). Race and ethnicity information about U.S. mine workers is presented in Table XII-1. Of all mine workers, including miners as well as administrative employees at mines, 93.4 percent of mine workers were white, compared to 80.6 percent of all U.S workers.
Table XII-2 shows that there are 22 mining communities, defined as counties where at least 2 percent of the population is working in the mining industry.
The final rule would lower exposure to respirable crystalline silica and improve respiratory protection for all mine workers. MSHA determined that the final rule is consistent with the goals of E.O. 13985 and would support the advancement of equity for all workers at mines, including those who are historically underserved and marginalized.
The Office of the Federal Register (OFR) has regulations concerning incorporation by reference. 5 U.S.C. 552(a); 1 CFR part 51. These regulations require that information that is incorporated by reference in a rule be “reasonably available” to the public. They also require discussion in the preamble to the rule of the ways in which materials are reasonably available to interested parties or how the Agency worked to make those materials reasonably available to interested parties. Additionally, the preamble to the rule must summarize the material. 1 CFR 51.5(b).
In accordance with the OFR's requirements, MSHA provides the following: (a) summaries of the materials to be incorporated by reference and (b) information on the public availability of the materials and on how interested parties can access the materials.
ASTM F3387-19 is a voluntary consensus standard that represents up-to-date advancements in respiratory protection technologies, practices, and techniques. The standard includes provisions for selection, fitting, use, and care of respirators designed to remove airborne contaminants from the air using filters, cartridges, or canisters, as well as respirators that protect miners in oxygen-deficient or immediately dangerous to life or health atmospheres. These provisions are based on NIOSH's long-standing experience of testing and approving respirators for occupational use and OSHA's respiratory protection standards on assigned protection factors and fit testing. This final rule incorporates by reference ASTM F3387-19 in §§ 56.5005T, 57.5005T, and 72.710T (which will become permanent §§ 56.5005 and 57.5005 720 days after publication and permanent § 72.710 360 days after publication) and in § 60.14(c)(2) to better protect all miners from airborne contaminants. MSHA believes that incorporating by reference ASTM F3387-19 provides mine operators with up-to-date requirements for respirator technology, reflecting an improved understanding of effective respiratory protection and therefore better protecting the health and safety of miners. For further details on MSHA's update to the Agency's existing respiratory protection standard, please see
A paper copy or printable version of ASTM F3387-19 may be purchased by mine operators or any member of the public at any time from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959;
In addition, upon finalization of this rule, ASTM F3387-19 will be available for review free of charge at MSHA headquarters at 201 12th Street South, Arlington, VA 22202-5450 (202-693-9440) and at Mine Safety Health Enforcement District and Field Offices.
ISO 7708:1995 is an international consensus standard that defines sampling conventions for particle size fractions used in assessing possible health effects of airborne particles in the workplace and ambient environment. It defines conventions for the inhalable, thoracic, and respirable fractions. The final rule incorporates by reference ISO 7708:1995 in § 60.12(e)(4) to ensure consistent sampling collection by mine operators through the utilization of samplers conforming to ISO 7708:1995. For further details on MSHA's incorporation by reference of ISO 7708:1995, please see
A paper copy or printable version of ISO 7708:1995 may be purchased by mine operators or any member of the public at any time from ISO, CP 56, CH-1211 Geneva 20, Switzerland; phone: + 41 22 749 01 11; fax: + 41 22 733 34 30; website:
In addition, upon finalization of this rule, ISO 7708:1995 will be available for review free of charge at MSHA headquarters at 201 12th Street South, Arlington, VA 22202-5450 (202-693-9440) and at Mine Safety Health Enforcement District and Field Offices.
ACGIH's publication entitled “
TLVs®, which appears the amendatory text of this rule, was previously approved for use in §§ 56.5001 and 57.5001.
Copies of the document may be purchased from the American Conference of Governmental Industrial Hygienists, 3640 Park 42 Drive, Cincinnati, OH 45241; 513-742-2020;
ANSI Z88.2-1969, which appears the amendatory text of this rule, was previously approved for use in § 72.710.
This document describes the respirable crystalline silica samples used in this rule. The Mine Safety and Health Administration (MSHA) collected these samples from metal/nonmetal (MNM) and coal mines, then analyzed the data to support this rulemaking. Technical details are discussed in the attachments that follow.
From January 1, 2005, to December 31, 2019, 104,354 valid MNM respirable dust samples were entered into the MSHA Technical Support Laboratory Information Management System (LIMS) database.
Respirable dust samples collected by MSHA inspectors are assigned a three-digit “contaminant code” based on the contaminant in the sample. MSHA's contaminant codes group contaminants based on their health effects
The MNM respirable crystalline silica dataset includes five contaminant codes.
• Contaminant code 521—MNM respirable dust samples that were not analyzed for respirable crystalline silica.
• Contaminant code 523—MNM respirable dust samples containing 1 percent or more quartz.
• Contaminant code 525—MNM respirable dust samples containing cristobalite.
• Contaminant code 121—MNM respirable dust samples containing less than 1 percent quartz where the commodity is listed as a “nuisance particulate” in Appendix E of the TLVs® Threshold Limit Values for Chemical Substances in Workroom Air Adopted by ACGIH for 1973 (reproduced in Table A-1).
• Contaminant code 131—MNM respirable dust samples containing less than 1 percent quartz where the commodity is not listed as a “nuisance particulate” in Appendix E of the 1973 ACGIH TLV® Handbook (reproduced below).
The 57,824 samples that contained at least 0.100 mg of respirable dust were analyzed to quantify their respirable crystalline silica content—mostly respirable quartz but also respirable cristobalite. The respirable crystalline silica concentrations were entered into the MSHA Standardized Information System (MSIS) database (internal facing) and Mine Data Retrieval System (MDRS) database (public facing). MSIS and MDRS differ from LIMS in that some of the fields associated with a sample can be modified or corrected by the inspector who conducted the sampling. These correctable fields include Mine ID, Location Code, and Job Code. Inspectors cannot access or modify the fields in the LIMS database.
Fifty-five samples
The LIMS database also included 46,530 MNM respirable dust samples that contained less than 0.100 mg of respirable dust. These samples did not meet the minimum dust mass criterion of 0.100 mg and were not analyzed for respirable crystalline silica by MSHA's Laboratory.
From these 46,530 samples, 167 samples
After removing the 222 samples mentioned above (55 sufficient-mass and 167 insufficient-mass), the dataset consisted of 104,132 MNM respirable dust samples: 57,769 sufficient-mass samples and 46,363 insufficient-mass samples. A breakdown of the MNM respirable dust samples is included in Table A-2.
From August 1, 2016, to July 31, 2021, 113,607 valid respirable dust samples from coal mines were collected by MSHA inspectors and entered in the LIMS database.
Of these samples collected by MSHA inspectors, 67,963 samples were analyzed for respirable crystalline silica; 45,644 samples were not. The record of a respirable dust sample from coal mines contains a record of the sample type and the occupation of the miner sampled. A coal sample's type is based on the location within the mine as well as the occupation of the miner sampled. Below is a list of coal sample types and descriptions, as well as the mass of respirable dust required for that type of sample to be analyzed for respirable crystalline silica.
• Type 1—Designated occupation (DO). The occupation on a mechanized mining unit (MMU) that has been determined by results of respirable dust samples to have the greatest respirable dust concentration. Designated occupation samples must contain at least 0.100 mg of respirable dust to be analyzed for respirable crystalline silica.
• Type 2—Other designated occupation (ODO). Occupations other than the DO on an MMU that are also designated for sampling, required by 30 CFR part 70. These samples must contain at least 0.100 mg of respirable dust to be analyzed for respirable crystalline silica.
• Type 3—Designated area (DA). Designated area samples are from specific locations in the mine identified by the operator in the mine ventilation plan under 30 CFR 75.371(t), where samples will be collected to measure respirable dust generation sources in the active workings. These samples must contain at least 0.100 mg of respirable dust to be analyzed for respirable crystalline silica.
• Type 4—Designated work position (DWP). A designated work position in a surface coal mine or surface work area of an underground coal mine that is designated for sampling in order to measure respirable dust generation sources in the active workings. Designated work position samples must contain at least 0.200 mg of respirable dust to be analyzed for respirable crystalline silica. There are exceptions for certain occupations: bulldozer operator (MSIS general occupation code 368), high wall drill operator (code 384), high wall drill helper (code 383), blaster/shotfirer (code 307), refuse/backfill truck driver (code 386), or high lift operator/front end loader (code 382). Samples from these occupations must have at least 0.100 mg of respirable dust to be analyzed for respirable crystalline silica.
• Type 5—Part 90 miner. A Part 90 miner is employed at a coal mine and has exercised the option under the old section 203(b) program (36 FR 20601, Oct. 27, 1971) or under 30 CFR 90.3 to work in an area of a mine where the average concentration of respirable dust in the mine atmosphere during each shift to which a miner is exposed is continuously maintained at or below the applicable standard and has not waived these rights. A sample from a Part 90 miner must contain at least 0.100 mg of respirable dust to be analyzed for respirable crystalline silica.
• Type 6—Non-designated area (NDA). Non-designated area samples are taken from locations in the mine that are not identified by the operator in the mine ventilation plan under 30 CFR 75.371(t) as areas where samples will be collected to measure respirable dust generation sources in the active workings. These samples are not analyzed for respirable crystalline silica.
• Type 7—Intake air samples are taken from air that has not yet ventilated the last working place on any split of any working section or any worked-out area, whether pillared or non-pillared, as per 30 CFR 75.301. These samples are not analyzed for respirable crystalline silica.
• Type 8—Non-designated work position (NDWP). A work position in a surface coal mine or a surface work area of an underground coal mine that is sampled during a regular health inspection to measure respirable dust generation sources in the active workings but has not been designated for mandatory sampling. For the analysis of respirable crystalline silica, these samples must have at least 0.200 mg of respirable dust. There are exceptions for certain occupations: bulldozer operator (MSIS general occupation code 368), high wall drill operator (code 384), high wall drill helper (code 383), blaster/shotfirer (code 307), refuse/backfill truck driver (code 386), or high lift operator/front end loader (code 382). Samples taken from these occupations must contain at least 0.100 mg respirable dust to be analyzed for respirable crystalline silica.
There were 67,963 samples from coal mines collected by MSHA inspectors from underground and surface coal mining operations that were analyzed for respirable crystalline silica. These results were entered first into LIMS, and then into MSIS and MDRS. Results from MSIS were used as they may be updated by the inspectors at later dates.
Similar to MNM respirable dust samples, the LIMS database includes 45,644 coal samples that did not meet the criteria for analysis and were thus not analyzed for respirable crystalline silica content.
In total, 18,079 respirable dust samples from coal mines were removed from the original datasets: 4,836 samples that were analyzed for respirable crystalline silica and 13,243 samples that were not. This created a final dataset of 95,528 samples: 63,127 analyzed samples and 32,401 samples that were not analyzed.
Cristobalite is one of the three polymorphs of respirable crystalline silica. At the request of the inspector, MNM
While the samples that were analyzed for cristobalite were assigned to all four contaminant codes seen in this dataset, the majority were assigned contaminant code 523.
The distribution of the 359 samples by cristobalite mass can be seen in Table A1-3.
The mass of each sample was then used to calculate a cristobalite concentration by dividing the mass of cristobalite by the volume of air sampled (0.816 m
In the proposed rule, respirable crystalline silica refers to three polymorphs: quartz, cristobalite, and tridymite. MSHA's Laboratory uses two methods to analyze respirable crystalline silica content in respirable dust samples. The first method, X-ray diffraction (XRD), separately analyzes quartz, cristobalite, and tridymite contents in respirable dust samples that mine inspectors obtain at MNM mine sites (MSHA Method P-2, 2018a). The second method, Fourier transform infrared spectroscopy (FTIR), is used to analyze quartz in respirable dust samples obtained at coal mines (MSHA Method P-7, 2018b and 2020b). Although the XRD method can be expanded from MNM to coal dust samples, MSHA chooses to use the FTIR method for coal dust samples because it is a faster and less expensive method. However, the current MSHA P-7 FTIR method cannot quantify quartz if cristobalite and/or tridymite are present in the sample. The method also corrects the quartz result for the presence of kaolinite, an interfering mineral for quartz analysis when found in coal dust.
The Limits of Detection (LOD) and Limits of Quantification (LOQ) are the two terms used to describe a method's capability. The LOD refers to the smallest amount of the target analyte (respirable crystalline silica) that can be detected in the sample and distinguished from zero with an acceptable confidence level that the analyte is actually present. It can also be described as the instrument signal that is needed to report with a specified confidence that the analyte is present. The LOQ refers to the smallest amount of the target analyte that can be repeatedly and accurately quantified in the sample with a specified precision. The LOQ is higher than the LOD. The values of the LOD and LOQ are specific to MSHA's Laboratory as well as the instrumentation and analytical method used to perform the analysis. These values do not change from one batch to another when samples are analyzed on the same equipment using the same method. However, their levels may change over time due to updated analytical methods and technological advances. The values of the LOD and LOQ for the methods (XRD and FTIR) used in analyzing respirable crystalline silica samples are explained in MSHA documents for MNM samples and coal samples (MSHA Method P-2, 2018a; MSHA Method P-7, 2018b and 2020b). MSHA periodically updates these values to reflect progress in its analytical methods. The values of LOD and LOQ were last updated in 2022 for MNM samples and in 2020 for coal samples.
The values of LODs and LOQs for respirable crystalline silica in samples from MSHA inspectors depend on several factors, including the analytical method used (XRD or FTIR) and the silica polymorph analyzed (quartz, cristobalite, or tridymite), as presented in Table A2-1.
For a sample with respirable crystalline silica content less than the method LOD, the maximum concentration is calculated as the respirable crystalline silica mass equivalent to LOD divided by the volume of air sampled. For example, the XRD analysis as performed for a MNM sample, as a method LOD of 5μg. If a such a sample is analyzed using that method and no quartz is detected and that sample is collected at 1.7 L/min air flow rate for 480 minutes (
The air volume is treated differently for MNM and coal samples under the existing standards. In the case of MNM samples, 8-hour equivalent time weighted averages (TWAs) are calculated using 480 minutes (8 hours) and a flow rate of 1.7 L/min, even if samples are collected for a longer duration. In contrast, coal TWAs are calculated using the full duration of the shift and a flow rate of 2.0 L/min and converted to an MRE equivalent concentration under existing standards.
Samples from MNM mines that contain at least 0.100 mg of dust mass are analyzed for the presence of quartz and/or cristobalite. For samples from coal mines, the minimum amount of respirable dust for a sample to be analyzed for respirable crystalline silica is determined by sample type and the occupation of the miner sampled. For Sample Types 1, 2, and 5, the sample must contain at least 0.100 mg of respirable dust. For Sample Types 4 and 8, the sample must contain at least 0.200 mg of respirable dust unless it comes from one of the following occupations: bulldozer operator (MSIS general occupation code 368), high wall drill operator (code 384), high wall drill helper (code 383), blaster/shotfirer (code 307), refuse/backfill truck driver (code 386), and high lift operator/front end loader (code 382). Samples taken from these occupations must contain at least 0.100 mg respirable dust to be analyzed for respirable crystalline silica.
MSHA makes separate assumptions based on the mass of respirable crystalline silica for a sample, whether it is above or below the method LOD. For all samples reporting a mass of respirable crystalline silica greater or equal to the method LOD, MSHA used the reported values to calculate the respirable crystalline silica concentration for the sample. For samples with values below the method LOD, including samples reported as containing 0 μg of silica, MSHA used
The reported value of respirable crystalline silica mass from an MNM or coal sample can fall under one of four groups: (1) at or above the method LOQ, (2) at or above the method LOD but below the LOQ, (3) greater than 0 μg but less than the method LOD, or (4) equal to 0 µg. MSHA treats these samples differently based on their respirable crystalline silica mass.
For MNM and coal samples reporting quartz mass at or above the method LOQs, MSHA uses the values reported by the MSHA's Laboratory.
For MNM and coal samples reporting quartz mass at or above the method LOD but below the LOQ, MSHA uses the values reported by the MSHA's Laboratory.
A review of respirable crystalline silica samples in LIMS reveals that some samples had a respirable crystalline silica mass below the LOD of the analytical methods but greater than 0 μg. Values in this range (
In these cases, MSHA used
A portion of the MNM and coal samples below the LOD are listed as having respirable crystalline silica (specifically quartz) mass levels of 0 μg. For these samples, instead of treating the mass of silica in the sample as a true zero, MSHA replaced the value with
Table A2-3 presents an example for quartz, one of the respirable crystalline silica polymorphs. This table shows the LOD of quartz mass and the possible range of quartz concentrations for samples reporting a quartz mass of 0 μg. These adjusted concentrations are expected to have a limited impact of the assessment of respirable crystalline silica concentration, as supported by MSHA's sensitivity analyses.
Respirable dust samples from MNM mines are rarely analyzed for cristobalite by MSHA, and respirable coal dust samples are not analyzed for the presence of cristobalite. MNM samples are analyzed for the presence of cristobalite only when requested by MSHA inspectors because the geological or work conditions indicate this specific polymorph may be present. The LIMS database includes samples for which cristobalite was analyzed, either with or without quartz analysis. MSHA uses similar assumptions for cristobalite and quartz.
The cristobalite LOD for these samples is 10 μg. The MSHA Laboratory-reported values are used for analyzed dust samples with cristobalite mass values equal to or above the method LODs. Samples that were analyzed for cristobalite and had a cristobalite mass value below the method LOD were assigned values of
When a sample is analyzed for two polymorphs (
There are also samples whose dust mass fell below their associated mass threshold, and as such, they were not analyzed for the presence of quartz and/or cristobalite. The respirable dust mass for a sample was considered to be 0 μg when the net mass gain of dust was 0 μg or less.
For this final rule, the mining industries are grouped into six commodities—Coal, Metal, Nonmetal, Stone, Crushed Limestone, and Sand and Gravel. The table below shows the six commodity groupings based on the Standard Industrial Classification (SIC) codes and the 2022 North American Industry Classification System (NAICS) codes. The SIC system is a predecessor of NAICS using industry titles to standardize industry classification. The NAICS is widely used by Federal statistical agencies, including the Small Business Administration (SBA), for classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy.
This Appendix explains how MSHA categorized MNM and coal samples in constructing respirable crystalline silica exposure profile tables for the final rule. MSHA developed respirable crystalline silica exposure profile tables using its inspectors' sampling results. One set of exposure profile tables displays the analysis of 15 years of respirable crystalline silica sampling data collected from MNM mines (Attachment 1), and the other set displays the analysis of 5 years of respirable crystalline silica samples collected from coal mines (Attachment 2).
MSHA inspectors use job codes to label samples of respirable dust when they conduct health inspections.
The three-digit job codes are taken from MSHA's Inspection Application System (IAS), which includes 220 job codes for coal mines and 121 job codes for MNM mines. Attachments 3 and 4 list the complete list of IAS job codes for coal and MNM operations, respectively.
Some of the original work to group the MNM job codes into occupational categories was completed in 2010 in support of earlier rulemaking efforts. The MNM occupational categories were developed first and were later updated with additional sampling data as it became available. The coal occupational categories were developed several years later and were generally modeled after the MNM tables; however, coal occupational categories are first divided based on surface and underground locations because occupational activities at different locations of a mine can have differing impacts on coal miners' exposures to respirable crystalline silica. Originally, MSHA used 9 coal and 14 MNM occupational categories for its respirable crystalline silica data analyses.
For the respirable crystalline silica exposure profile tables in the proposed
There are 220 job codes for coal miners in IAS.
• Job code 0 “Area,” because area samples are not specific to any one occupation.
• Job code 398 “Groundman,” because there were no sample data for this code in the respirable crystalline silica sampling dataset.
• Job codes 590 “Education Specialist,” 591 “Mineral Industrial Safety Officer,” 592 “Mine Safety Instructor,” and 594 “Training Specialist,” because there were no coal respirable crystalline silica (quartz) data for these codes for the timeframe selected.
• Job codes 602 “Electrician,” 604 “Mechanic,” 609 “Supply Person,” 632 “Ventilation Worker,” and 635 “Continuous Miner Operator Helper,” because there were no sample data for these codes in the respirable crystalline silica sampling dataset.
The remaining 209 coal job codes are first divided by the job location—underground or surface—because potential respirable crystalline silica exposures at coal mines can vary depending on where a miner works at a given mine. (Three job codes are used in both underground and surface locations: job codes 402 “Master Electrician,” 404 “Master Mechanic,” and 497 “Clerk/Timekeeper.”) The underground and surface job codes are further grouped on the basis of the types of tasks and typical engineering controls. For example, as shown in Figure C-1, the underground “Continuous Mining Machine Operators” occupational category includes 14 different occupations that involve drilling activities—occupations such as “Coal Drill Helper,” “Coal Drill Operator,” and “Rock Driller.” The underground “Operators of Large Powered Haulage Equipment” occupational category has 12 similar occupations including “Loading Machine Operator,” “Shuttle Car Operator,” and “Motorman.”
There are five categories of underground occupations and four categories of surface occupations.
The five underground occupational categories include:
(1) Continuous Mining Machine Operators (
(2) Operators of Large Powered Haulage Equipment (
(3) Longwall Workers (
(4) Roof Bolters (
(5) Underground Miners (
The four surface occupational categories include:
(1) Drillers (
(2) Operators of Large Powered Haulage Equipment (
(3) Crusher Operators (
(4) Mobile Workers (
Attachments 1 and 3 provide the full lists of occupational categories and coal job codes.
From the 121 MNM job codes in IAS, 120 job codes are included in the occupational categories and 1 job code is excluded. The code that has been excluded is:
• Job code 413 “Janitor,” because there were no sample data for this code in the respirable crystalline silica sampling dataset.
Of the 120 job codes included, 1 job code was listed in both the “Crushing Equipment and Plant Operators” occupational category and the “Kiln, Mill and Concentrator Workers” category. The code that was used twice is:
• Job Code 388 “Screen/Scalper Operators,” because MNM job codes do not indicate the location where the work is taking place and this work can be conducted either in a plant or on the surface of the mine.
The final 121 MNM job codes (with job code 388 included twice) were first grouped into 14 occupational categories based on the types of tasks and typical engineering controls used. For example, as seen in Figure C-2, the “Drillers” occupational category includes the 20 different occupations that involve drilling activities, such as “Diamond Drill Operator,” “Drill Operator Churn,” and “Continuous Miner Operator.” “Belt Cleaner,” “Belt Crew,” and “Belt Vulcanizer” are included in the occupational category, “Conveyor Operators.” Similar tasks were grouped together because the work activities and respirable crystalline silica exposures were anticipated to be comparable.
The 14 occupational categories were:
(1) Bagging Machines;
(2) Stone Saws;
(3) Stone Trimmers, Splitters;
(4) Truck Loading Stations;
(5) Mobile Workers (
(6) Conveyors;
(7) Crushers;
(8) Dry Screening Plants;
(9) Kilns/Dryers, Rotary Mills, Ball Mills, and Flotation/Concentrators;
(10) Large Powered Haulage Equipment (
(11) Small Powered Haulage Equipment (
(12) Jackhammers;
(13) Drills; and
(14) Other Occupations.
After additional consideration, it was determined that the original 14 categories could be further condensed into the final 11 categories since some of the occupational categories contained job codes where the types of tasks and engineering and administrative controls were similar enough to be combined.
The final 11 occupational categories include:
(1) Drillers (
(2) Stone Cutting Operators (
(3) Operators of Large Powered Haulage Equipment (
(4) Conveyor Operators (
(5) Crushing Equipment and Plant Operators (Crusher Operator/Worker, Scalper Screen Operator, and Dry Screen Plant Operator);
(6) Kiln, Mill, and Concentrator Workers (
(7) Operators of Small Powered Haulage Equipment (
(8) Packaging Equipment Operators (
(9) Truck Loading Station Tenders (
(10) Mobile Workers (Laborers, Electricians, Mechanics, and Supervisors, etc.); and
(11) Miners in Other Occupations (Welder, Dragline Operator, Shotcrete/Gunite Man, and Dredge/Barge Operator, etc.).
The sampling data for each of the 11 occupational categories were then summarized by commodity group (“Metal,” “Nonmetal,” “Stone,” “Crushed Limestone,” and “Sand and Gravel”) based on the material being extracted.
Chemicals, Electric power, Explosives, Fire prevention, Hazardous substances, Incorporation by reference, Metal and nonmetal mining, Mine safety and health, Noise control, Reporting and recordkeeping requirements, Surface mining.
Chemicals, Electric power, Explosives, Fire prevention, Gases, Hazardous substances, Incorporation by reference, Metal and nonmetal mining, Mine safety and health, Noise control, Radiation protection, Reporting and recordkeeping requirements, Underground mining.
Coal, Incorporation by reference, Metal and nonmetal mining, Medical surveillance, Mine safety and health, Respirable crystalline silica, Reporting and recordkeeping requirements, Surface mining, Underground mining.
Coal, Mine safety and health, Reporting and recordkeeping requirements, Respirable dust, Underground coal mines.
Coal, Mine safety and health, Reporting and recordkeeping requirements, Surface coal mines, Underground coal mines.
Coal, Health standards, Incorporation by reference, Mine safety and health, Training, Underground mining.
Coal, Mine safety and health, Reporting and recordkeeping requirements, Underground coal mines, Ventilation.
Coal, Mine safety and health, Reporting and recordkeeping requirements, Respirable dust.
For the reasons discussed in the preamble, the Mine Safety and Health Administration is amending 30 CFR subchapters K, M, and O as follows:
30 U.S.C. 811.
The following is required until April 7, 2026. Except as permitted by § 56.5005—
As of April 8, 2026 the following is required, except as permitted by § 56.5005—
(a)
(b)
(2)
(ii)
(3)
(c)
The following is required until April 7, 2026. Control of employee exposure to harmful airborne contaminants shall be, insofar as feasible, by prevention of contamination, removal by exhaust ventilation, or by dilution with uncontaminated air. However, where accepted, engineering control measures have not been developed or when necessary by the nature of work involved (for example, while establishing controls or occasional entry into hazardous atmospheres to perform maintenance or investigation), employees may work for reasonable periods of time in concentrations of airborne contaminants exceeding permissible levels if they are protected by appropriate respiratory protective equipment. Whenever respiratory protective equipment is used a program for selection, maintenance, training, fitting, supervision, cleaning, and use shall meet the following minimum requirements:
As of April 8, 2026, the following is required. Control of employee exposure to harmful airborne contaminants shall be, insofar as feasible, by prevention of contamination, removal by exhaust ventilation, or by dilution with uncontaminated air. However, where accepted engineering control measures have not been developed or when necessary by the nature of work involved (for example, while establishing controls or occasional entry into hazardous atmospheres to perform maintenance or investigation), employees may work for reasonable periods of time in concentrations of airborne contaminants exceeding permissible levels if they are protected by appropriate respiratory protective equipment. Whenever respiratory protective equipment is used, its selection, fitting, maintenance, cleaning, training, supervision, and use shall meet the following minimum requirements:
(a) Respirators approved by NIOSH under 42 CFR part 84 which are applicable and suitable for the purpose intended shall be furnished and miners shall use the protective equipment in accordance with training and instruction.
(b) A written respiratory protection program consistent with the requirements of ASTM F3387-19,
(c) When respiratory protection is used in atmospheres immediately dangerous to life or health (IDLH), the presence of at least one other person with backup equipment and rescue capability shall be required in the event of failure of the respiratory equipment.
30 U.S.C. 811.
The following is required until April 7, 2026. Except as permitted by § 57.5005—
As of April 8, 2026, except as permitted by § 57.5005—
(a)
(b)
(2)
(ii)
(3)
(c)
The following is required until April 7, 2026. Control of employee exposure to harmful airborne contaminants shall be, insofar as feasible, by prevention of contamination, removal by exhaust ventilation, or by dilution with uncontaminated air. However, where accepted engineering control measures have not been developed or when necessary by the nature of work involved (for example, while establishing controls or occasional entry into hazardous atmospheres to perform maintenance or investigation), employees may work for reasonable periods of time in concentrations of airborne contaminants exceeding permissible levels if they are protected by appropriate respiratory protective equipment. Whenever respiratory protective equipment is used a program for selection, maintenance, training, fitting, supervision, cleaning, and use shall meet the following minimum requirements:
As of April 8, 2026, the following is required. Control of employee exposure to harmful airborne contaminants shall be, insofar as feasible, by prevention of contamination, removal by exhaust ventilation, or by dilution with uncontaminated air. However, where accepted engineering control measures have not been developed or when necessary by the nature of work involved (for example, while establishing controls or occasional entry into hazardous atmospheres to perform maintenance or investigation), employees may work for reasonable periods of time in concentrations of airborne contaminants exceeding permissible levels if they are protected by appropriate respiratory protective equipment. Whenever respiratory protective equipment is used, its selection, fitting, maintenance, cleaning, training, supervision, and use shall meet the following minimum requirements:
(a) Respirators approved by NIOSH under 42 CFR part 84 which are applicable and suitable for the purpose intended shall be furnished and miners shall use the protective equipment in accordance with training and instruction.
(b) A written respiratory protection program consistent with the requirements of ASTM F3387-19,
(c) When respiratory protection is used in atmospheres immediately dangerous to life or health (IDLH), the presence of at least one other person with backup equipment and rescue capability shall be required in the event of failure of the respiratory equipment.
30 U.S.C. 811, 813(h) and 957.
(a) This part sets forth mandatory health standards for each surface and underground metal, nonmetal, and coal mine subject to the Federal Mine Safety and Health Act of 1977, as amended. Requirements regarding medical surveillance for metal and nonmetal mines are also included.
(b) The compliance dates for the provisions of this part are as follows:
(1) For coal mine operators, April 14, 2025.
(2) For metal and nonmetal mine operators, April 8, 2026.
The following definitions apply in this part:
The mine operator shall ensure that no miner is exposed to an airborne concentration of respirable crystalline silica in excess of 50 μg/m
(a) The mine operator shall install, use, and maintain feasible engineering controls, supplemented by administrative controls when necessary, to keep each miner's exposure at or below the PEL, except as specified in § 60.14.
(b) Rotation of miners shall not be considered an acceptable administrative control used for compliance with this part.
(a)
(2) If the sampling under paragraph (a)(1) of this section is:
(i) Below the action level, the mine operator shall take at least one additional sampling within 3 months.
(ii) At or above the action level but at or below the PEL, the mine operator shall take another sampling within 3 months.
(iii) Above the PEL, the mine operator shall take corrective actions and sample pursuant to § 60.12(b).
(3) Where the most recent sampling indicates that miner exposures are at or above the action level but at or below the PEL, the mine operator shall continue to sample within 3 months of the previous sampling.
(4) The mine operator may discontinue sampling when two consecutive samplings indicate that miner exposures are below the action level. The second of these samplings must be taken after the operator receives the results of the prior sampling but no sooner than 7 days after the prior sampling was conducted.
(b)
(c)
(1) Make a record of the evaluation, including the evaluated change, the impact on respirable crystalline silica exposure, and the date of the evaluation; and
(2) Post the record on the mine bulletin board and, if applicable, by electronic means, for the next 31 days.
(d)
(e)
(2) The full-shift, 8-hour TWA exposure for such miners shall be measured based on:
(i) Personal breathing-zone air samples for metal and nonmetal operations; or
(ii) Occupational environmental samples collected in accordance with § 70.201(c), § 71.201(b), or § 90.201(b) of this chapter for coal operations.
(3) Where several miners perform the same tasks on the same shift and in the same work area, the mine operator may sample a representative fraction (at least two) of these miners to meet the requirements in paragraphs (a) through (e) of this section. In sampling a representative fraction of miners, the mine operator shall select the miners who are expected to have the highest exposure to respirable crystalline silica.
(4) The mine operator shall use respirable-particle-size-selective samplers that conform to ISO 7708:1995(E) to determine compliance with the PEL. ISO 7708:1995(E),
(f)
(2) The mine operator shall ensure that the laboratory evaluates all samples using respirable crystalline silica analytical methods specified by MSHA, the National Institute for Occupational Safety and Health (NIOSH), or the Occupational Safety and Health Administration (OSHA).
(g)
(a) If any sampling indicates that a miner's exposure exceeds the PEL, the mine operator shall:
(1) Make approved respirators available to affected miners before the start of the next work shift in accordance with § 60.14(b) and (c);
(2) Ensure that affected miners wear respirators properly for the full shift or during the period of overexposure until miner exposures are at or below the PEL; and
(3) Immediately take corrective actions to lower the concentration of respirable crystalline silica to at or below the PEL.
(b) Once corrective actions have been taken, the mine operator shall:
(1) Conduct sampling pursuant to § 60.12(b); and
(2) Take additional or new corrective actions until sampling indicates miner exposures are at or below the PEL.
(c) The mine operator shall make a record of corrective actions and the dates of the corrective actions under paragraph (a) of this section.
(a)
(1) Engineering control measures are being developed and implemented; or
(2) It is necessary by the nature of work involved (for example, occasional entry into hazardous atmospheres to perform maintenance or investigation).
(b)
(1) The affected miner shall continue to receive compensation at no less than the regular rate of pay in the occupation held by that miner immediately prior to the transfer.
(2) The affected miner may be transferred back to the miner's initial work area or occupation when temporary use of respirators under paragraph (a) of this section or section 60.13 is no longer required.
(c)
(i) Particulate protection classified as 100 series under 42 CFR part 84; or
(ii) Particulate protection classified as High Efficiency “HE” under 42 CFR part 84.
(2) When approved respirators are used, the mine operator must have a written respiratory protection program that meets the following requirements in accordance with ASTM F3387-19: program administration; written standard operating procedures; medical evaluation; respirator selection; training; fit testing; maintenance, inspection, and storage. ASTM F3387-19,
(a)
(1) Medical examinations shall be provided at frequencies specified in this section.
(2) Medical examinations shall include:
(i) A medical and work history, with emphasis on: past and present exposure to respirable crystalline silica, dust, and other agents affecting the respiratory system; any history of respiratory system dysfunction, including diagnoses and symptoms of respiratory disease (
(ii) A physical examination with special emphasis on the respiratory system;
(iii) A chest X-ray (a single posteroanterior radiographic projection or radiograph of the chest at full inspiration recorded on either film (no less than 14 x 17 inches and no more than 16 x 17 inches) or digital radiography systems), classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified B Reader; and
(iv) A pulmonary function test to include forced vital capacity (FVC) and forced expiratory volume in one second (FEV
(b)
(1) During an initial 12-month period; and
(2) At least every 5 years after the end of the period in paragraph (b)(1). The medical examinations shall be available during a 6-month period that begins no less than 3.5 years and not more than 4.5 years from the end of the last 6-month period.
(c)
(1) An initial medical examination no later than 60 days after beginning employment;
(2) A follow-up medical examination no later than 3 years after the initial examination in paragraph (c)(1) of this section; and
(3) A follow-up medical examination conducted by a specialist no later than 2 years after the examinations in paragraph (c)(2) of this section if the chest X-ray shows evidence of pneumoconiosis or the spirometry examination indicates evidence of decreased lung function.
(d)
(2) The mine operator shall ensure that, within 30 days of the medical examination, the PLHCP or specialist provides the results of chest X-ray classifications to the National Institute for Occupational Safety and Health (NIOSH), once NIOSH establishes a reporting system.
(e)
(1) The date of the medical examination;
(2) A statement that the examination has met the requirements of this section; and
(3) Any recommended limitations on the miner's use of respirators.
(f)
(a) Table 1 to this paragraph (a) lists the records the mine operator shall retain and their retention period.
(1) Evaluation records made under § 60.12(c) shall be retained for at least 5 years from the date of each evaluation.
(2) Sampling records made under § 60.12(g) shall be retained for at least 5 years from the sample date.
(3) Corrective actions records made under § 60.13(c) shall be retained for at least 5 years from the date of each corrective action. These records must be stored with the records of related sampling under § 60.12(g).
(4) Written determination records received from a PLHCP under § 60.14(b) shall be retained for the duration of the miner's employment plus 6 months.
(5) Written medical opinion records received from a PLHCP or specialist under § 60.15(f) shall be retained for the duration of the miner's employment plus 6 months.
(b) Upon request from an authorized representative of the Secretary, from an authorized representative of miners, or from miners, mine operators shall promptly provide access to any record listed in this section.
Each section of this part, as well as sections in 30 CFR parts 56, 57, 70, 71, 72, 75, and 90 that address respirable crystalline silica or respiratory protection, is separate and severable from the other sections and provisions. If any provision of this subpart is held to be invalid or unenforceable by its terms, or as applied to any person, entity, or circumstance, or is stayed or enjoined, that provision shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from these sections and shall not affect the remainder thereof.
30 U.S.C. 811, 813(h), 957.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) Approved sampling devices shall be operated at the flowrate of 2.0 L/min if using a CMDPSU; at 2.2 L/min if
(b) If using a CMDPSU, each approved sampling device shall be examined each shift by a person certified in sampling during:
(1) The second hour after being put into operation to assure it is in the proper location, operating properly, and at the proper flowrate. If the proper flowrate is not maintained, necessary adjustments shall be made by the certified person. This examination is not required if the sampling device is being operated in an anthracite coal mine using the full box, open breast, or slant breast mining method.
(2) The last hour of operation to assure that the sampling device is operating properly and at the proper flowrate. If the proper flowrate is not maintained, the respirable dust sample shall be transmitted to MSHA with a notation by the certified person on the back of the dust data card stating that the proper flowrate was not maintained. Other events occurring during the collection of respirable dust samples that may affect the validity of the sample, such as dropping of the sampling head assembly onto the mine floor, shall be noted on the back of the dust data card.
(c) If using a CPDM, the person certified in sampling shall monitor the dust concentrations and the sampling status conditions being reported by the sampling device at mid-shift or more frequently as specified in the approved mine ventilation plan to assure: The sampling device is in the proper location and operating properly; and the work environment of the occupation or DA being sampled remains in compliance with the standard at the end of the shift. This monitoring is not required if the sampling device is being operated in an anthracite coal mine using the full box, open breast, or slant breast mining method.
The following is required from February 1, 2016, until April 14, 2025:
As of April 14, 2025:
(a) The operator shall sample each calendar quarter:
(1) The designated occupation (DO) in each MMU on consecutive normal production shifts until 15 valid representative samples are taken. The District Manager may require additional groups of 15 valid representative samples when information indicates the operator has not followed the approved ventilation plan for any MMU.
(2) Each other designated occupation (ODO) specified in paragraphs (b)(1) through (10) of this section in each MMU or specified by the District Manager and identified in the approved mine ventilation plan on consecutive normal production shifts until 15 valid representative samples are taken. Sampling of each ODO type shall begin after fulfilling the sampling requirements of paragraph (a)(1) of this section. When required to sample more than one ODO type, each ODO type must be sampled over separate time periods during the calendar quarter.
(3) The quarterly periods are:
(i) January 1-March 31
(ii) April 1-June 30
(iii) July 1-September 30
(iv) October 1-December 31.
(b) Unless otherwise directed by the District Manager, the approved sampling device shall be worn by the miner assigned to perform the duties of the DO or ODO specified in paragraphs (b)(1) through (10) of this section or by the District Manager for each type of MMU.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
I [Reserved]
(d) If a normal production shift is not achieved, the DO or ODO sample for that shift may be voided by MSHA. However, any sample, regardless of production, that exceeds the standard by at least 0.1 mg/m
(1) Make approved respiratory equipment available to affected miners in accordance with § 72.700 of this chapter;
(2) Immediately take corrective action to lower the concentration of respirable dust to at or below the respirable dust standard; and
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine f'reman's or equivalent of'icial's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the representative of miners.
(f) Noncompliance with the standard is demonstrated during the sampling period when:
(1) Three or more valid representative samples meet or exceed the ECV in table 1 to this section that corresponds to the particular sampling device used; or
(2) The average for all valid representative samples meets or exceeds the ECV in table 1 to this section that corresponds to the particular sampling device used.
(g)(1) Unless otherwise directed by the District Manager, upon issuance of a citation for a violation of the standard involving a DO in an MMU, paragraph (a)(1) of this section shall not apply to the DO in that MMU until the violation is abated and the citation is terminated in accordance with paragraphs (h) and (i) of this section.
(2) Unless otherwise directed by the District Manager, upon issuance of a citation for a violation of the standard involving a type of ODO in an MMU, paragraph (a)(2) of this section shall not apply to that ODO type in that MMU until the violation is abated and the citation is terminated in accordance with paragraphs (g) and (h) of this section.
(h) Upon issuance of a citation for violation of the standard, the operator shall take the following actions sequentially:
(1) Make approved respiratory equipment available to affected miners in accordance with § 72.700 of this chapter;
(2) Immediately take corrective action to lower the concentration of respirable coal mine dust to at or below the standard; and
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine f'reman's or equivalent of'icial's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the representative of miners.
(4) Begin sampling, within 8 calendar days after the date the citation is issued, the environment of the affected occupation in the MMU on consecutive normal production shifts until five valid representative samples are taken.
(i) A citation for a violation of the standard shall be terminated by MSHA when:
(1) Each of the five valid representative samples is at or below the standard; and
(2) The operator has submitted to the District Manager revised dust control parameters as part of the mine ventilation plan applicable to the MMU in the citation and the changes have been approved by the District Manager. The revised parameters shall reflect the control measures used by the operator to abate the violation.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) The operator shall sample quarterly each designated area (DA) on consecutive production shifts until five valid representative samples are taken. The quarterly periods are:
(1) January 1-March 31
(2) April 1-June 30
(3) July 1-September 30
(4) October 1-December 31.
(b) [Reserved].
(c) When a valid representative sample taken in accordance with this section meets or exceeds the ECV in table 1 to this section that corresponds to the particular sampling device used, the operator shall:
(1) Make approved respiratory equipment available to affected miners in accordance with § 72.700 of this chapter;
(2) Immediately take corrective action to lower the concentration of respirable dust to at or below the respirable dust standard; and
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine foreman's or equivalent official's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the representative of miners.
(d) Noncompliance with the standard is demonstrated during the sampling period when:
(1) Two or more valid representative samples meet or exceed the ECV in table 1 to this section that corresponds to the particular sampling device used; or
(2) The average for all valid representative samples meets or exceeds the ECV in table 1 to this section that corresponds to the particular sampling device used.
(e) Unless otherwise directed by the District Manager, upon issuance of a citation for a violation of the standard, paragraph (a) of this section shall not apply to that DA until the violation is abated and the citation is terminated in accordance with paragraphs (e) and (f) of this section.
(f) Upon issuance of a citation for a violation of the standard, the operator shall take the following actions sequentially:
(1) Make approved respiratory equipment available to affected miners in accordance with § 72.700 of this chapter;
(2) Immediately take corrective action to lower the concentration of respirable coal mine dust to at or below the standard; and
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine foreman's or equivalent official's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the representative of miners.
(4) Begin sampling, within 8 calendar days after the date the citation is issued, the environment of the affected DA on consecutive normal production shifts until five valid representative samples are taken.
(g) A citation for a violation of the standard shall be terminated by MSHA when:
(1) Each of the five valid representative samples is at or below the standard; and
(2) The operator has submitted to the District Manager revised dust control parameters as part of the mine ventilation plan applicable to the DA in the citation, and the changes have been approved by the District Manager. The revised parameters shall reflect the control measures used by the operator to abate the violation.
30 U.S.C. 811, 813(h), 957.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) Approved sampling devices shall be operated at the flowrate of 2.0 L/min, if using a CMDPSU; at 2.2 L/min, if using a CPDM; or at a different flowrate recommended by the manufacturer.
(b) If using a CMDPSU, each sampling device shall be examined each shift by a person certified in sampling during:
(1) The second hour after being put into operation to assure it is in the proper location, operating properly, and at the proper flowrate. If the proper flowrate is not maintained, necessary adjustments shall be made by the certified person.
(2) The last hour of operation to assure that it is operating properly and at the proper flowrate. If the proper flowrate is not maintained, the respirable dust sample shall be transmitted to MSHA with a notation by the certified person on the back of the dust data card stating that the proper flowrate was not maintained. Other events occurring during the collection of respirable dust samples that may affect the validity of the sample, such as
(c) If using a CPDM, the person certified in sampling shall monitor the dust concentrations and the sampling status conditions being reported by the sampling device at mid-shift or more frequently as specified in the approved respirable dust control plan, if applicable, to assure: The sampling device is in the proper location and operating properly; and the work environment of the occupation being sampled remains in compliance with the standard at the end of the shift.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) Each operator shall take one valid representative sample from the DWP during each quarterly period. The quarterly periods are:
(1) January 1-March 31
(2) April 1-June 30
(3) July 1-September 30
(4) October 1-December 31.
(b) [Reserved].
(c) Designated work position samples shall be collected at locations to measure respirable dust generation sources in the active workings. The specific work positions at each mine where DWP samples shall be collected include:
(1) Each highwall drill operator (MSHA occupation code 384);
(2) Bulldozer operators (MSHA occupation code 368); and
(3) Other work positions designated by the District Manager for sampling in accordance with § 71.206(m).
(d) Operators with multiple work positions specified in paragraphs (b)(2) and (3) of this section shall sample the DWP exposed to the greatest respirable dust concentration in each work position performing the same activity or task at the same location at the mine and exposed to the same dust generation source. Each operator shall provide the District Manager with a list identifying the specific work positions where DWP samples will be collected for:
(1) Active mines—by October 1, 2014.
(2) New mines—Within 30 calendar days of mine opening.
(3) DWPs with a change in operational status that increases or reduces the number of active DWPs—within 7 calendar days of the change in status.
(e) Each DWP sample shall be taken on a normal work shift. If a normal work shift is not achieved, the respirable dust sample shall be transmitted to MSHA with a notation by the person certified in sampling on the back of the dust data card stating that the sample was not taken on a normal work shift. When a normal work shift is not achieved, the sample for that shift may be voided by MSHA. However, any sample, regardless of whether a normal work shift was achieved, that exceeds the standard by at least 0.1 mg/m
(f) Unless otherwise directed by the District Manager, DWP samples shall be taken by placing the sampling device as follows:
(1)
(2)
(g) Upon notification from MSHA that any valid representative sample taken from a DWP to meet the requirements of paragraph (a) of this section exceeds the standard, the operator shall, within 15 calendar days of notification, sample that DWP each normal work shift until five valid representative samples are taken. The operator shall begin sampling on the first normal work shift following receipt of notification.
(h) When a valid representative sample taken in accordance with this section meets or exceeds the excessive concentration value (ECV) in table 1 to this section that corresponds to the particular sampling device used, the mine operator shall:
(1) Make approved respiratory equipment available to affected miners in accordance with § 72.700 of this chapter;
(2) Immediately take corrective action to lower the concentration of respirable coal mine dust to at or below the standard; and
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine foreman's or equivalent official's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the representative of miners.
(i) Noncompliance with the standard is demonstrated during the sampling period when:
(1) Two or more valid representative samples meet or exceed the ECV in table 1 to this section that corresponds to the particular sampling device used; or
(2) The average for all valid representative samples meets or exceeds the ECV in table 1 to this section that corresponds to the particular sampling device used.
(j) Unless otherwise directed by the District Manager, upon issuance of a citation for a violation of the standard, paragraph (a) of this section shall not apply to that DWP until the violation is abated and the citation is terminated in accordance with paragraphs (j) and (k) of this section.
(k) Upon issuance of a citation for violation of the standard, the operator shall take the following actions sequentially:
(1) Make approved respiratory equipment available to affected miners in accordance with § 72.700 of this chapter;
(2) Immediately take corrective action to lower the concentration of respirable coal mine dust to at or below the standard; and
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine foreman's or equivalent official's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the representative of miners.
(4) Begin sampling, within 8 calendar days after the date the citation is issued, the environment of the affected DWP on consecutive normal work shifts until five valid representative samples are taken.
(l) A citation for violation of the standard shall be terminated by MSHA when the equivalent concentration of each of the five valid representative samples is at or below the standard.
(m) The District Manager may designate for sampling under this section additional work positions at a surface coal mine and at a surface work area of an underground coal mine where a concentration of respirable dust exceeding 50 percent of the standard has been measured by one or more MSHA valid representative samples.
(n) The District Manager may withdraw from sampling any DWP designated for sampling under paragraph (m) of this section upon finding that the operator is able to maintain continuing compliance with the standard. This finding shall be based on the results of MSHA and operator valid representative samples taken during at least a 12-month period.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) Within 15 calendar days after the termination date of a citation for violation of the standard, the operator shall submit to the District Manager for approval a written respirable dust control plan applicable to the DWP identified in the citation. The respirable dust control plan and revisions thereof shall be suitable to the conditions and the mining system of the coal mine and shall be adequate to continuously maintain respirable dust to at or below the standard at the DWP identified in the citation.
(1) The mine operator shall notify the representative of miners at least 5 days prior to submission of a respirable dust control plan and any revision to a dust control plan. If requested, the mine operator shall provide a copy to the representative of miners at the time of notification;
(2) A copy of the proposed respirable dust control plan, and a copy of any proposed revision, submitted for approval shall be made available for inspection by the representative of miners; and
(3) A copy of the proposed respirable dust control plan, and a copy of any proposed revision, submitted for approval shall be posted on the mine bulletin board at the time of submittal. The proposed plan or proposed revision shall remain posted until it is approved, withdrawn, or denied.
(4) Following receipt of the proposed plan or proposed revision, the representative of miners may submit timely comments to the District Manager, in writing, for consideration during the review process. Upon request, a copy of these comments shall be provided to the operator by the District Manager.
(b) Each respirable dust control plan shall include at least the following:
(1) The mine identification number and DWP number assigned by MSHA, the operator's name, mine name, mine address, and mine telephone number and the name, address, and telephone number of the principal officer in charge of health and safety at the mine;
(2) The specific DWP at the mine to which the plan applies;
(3) A detailed description of the specific respirable dust control measures used to abate the violation of the respirable dust standard; and
(4) A detailed description of how each of the respirable dust control measures described in response to paragraph (b)(3) of this section will continue to be used by the operator, including at least the specific time, place and manner the control measures will be used.
The following is required until April 14, 2025:
As of April 8, 2026:
(a) The District Manager will approve respirable dust control plans on a mine-by-mine basis. When approving respirable dust control plans, the District Manager shall consider whether:
(1) The respirable dust control measures would be likely to maintain concentrations of respirable coal mine dust at or below the standard; and
(2) The operator's compliance with all provisions of the respirable dust control plan could be objectively ascertained by MSHA.
(b) MSHA may take respirable dust samples to determine whether the respirable dust control measures in the operator's plan effectively maintain concentrations of respirable coal mine dust at or below the applicable standard.
(c) The operator shall comply with all provisions of each respirable dust control plan upon notice from MSHA that the respirable dust control plan is approved.
(d) The approved respirable dust control plan and any revisions shall be:
(1) Provided upon request to the representative of miners by the operator following notification of approval;
(2) Made available for inspection by the representative of miners; and
(3) Posted on the mine bulletin board within 1 working day following notification of approval, and shall remain posted for the period that the plan is in effect.
(e) The operator may review respirable dust control plans and submit proposed revisions to such plans to the District Manager for approval.
30 U.S.C. 811, 813(h), 957.
The following is required until April 14, 2025. In order to ensure the maximum amount of respiratory protection, approved respirators shall be selected, fitted, used, and maintained in accordance with the provisions of the American National Standards Institute's (ANSI)
As of April 14, 2025: Approved respirators shall be selected, fitted, used, and maintained in accordance with the provisions of a written respiratory protection program consistent with the requirements of ASTM F3387-19. ASTM F3387-19,
The Secretary will use a single, full-shift measurement of respirable coal mine dust to determine the average concentration on a shift since that measurement accurately represents atmospheric conditions to which a miner is exposed during such shift. Until April 14, 2025, noncompliance with the respirable dust standard, in accordance with this subchapter, is demonstrated when a single, full-shift measurement taken by MSHA meets or exceeds the applicable ECV in table 1 to § 70.208, table 1 to § 70.209, table 1 to § 71.206, or table 1 to § 90.207 of this chapter that corresponds to the particular sampling device used. Upon issuance of a citation for a violation of the standard, and for MSHA to terminate the citation, the mine operator shall take the specified actions in this subchapter.
The Secretary will use a single, full-shift measurement of respirable coal mine dust to determine the average concentration on a shift since that measurement accurately represents atmospheric conditions to which a miner is exposed during such shift. As of April 14, 2025, noncompliance with the respirable dust standard, in accordance with this subchapter, is demonstrated when a single, full-shift measurement taken by MSHA meets or exceeds the applicable ECV in table 1 to § 70.208, table 1 to § 70.209, table 1 to § 71.206, or table 1 to § 90.207 of this chapter that corresponds to the particular sampling device used. Upon issuance of a citation for a violation of the standard, and for MSHA to terminate the citation, the mine operator shall take the specified actions in this subchapter.
30 U.S.C. 811, 813(h), 957.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) The belt air course must not be used as a return air course; and except as provided in paragraph (b) of this section, the belt air course must not be used to provide air to working sections or to areas where mechanized mining equipment is being installed or removed.
(1) The belt air course must be separated with permanent ventilation controls from return air courses and from other intake air courses except as provided in paragraph (c) of this section.
(2) Effective December 31, 2009, the air velocity in the belt entry must be at least 50 feet per minute. When requested by the mine operator, the district manager may approve lower velocities in the ventilation plan based on specific mine conditions. Air velocities must be compatible with all fire detection systems and fire suppression systems used in the belt entry.
(b) The use of air from a belt air course to ventilate a working section, or an area where mechanized mining equipment is being installed or removed, shall be permitted only when evaluated and approved by the district manager in the mine ventilation plan. The mine operator must provide justification in the plan that the use of air from a belt entry would afford at least the same measure of protection as where belt haulage entries are not used to ventilate working places. In addition, the following requirements must be met:
(1) The belt entry must be equipped with an AMS that is installed, operated, examined, and maintained as specified in § 75.351.
(2) All miners must be trained annually in the basic operating principles of the AMS, including the actions required in the event of activation of any AMS alert or alarm signal. This training must be conducted prior to working underground in a mine that uses belt air to ventilate working sections or areas where mechanized mining equipment is installed or removed. It must be conducted as part of a miner's 30 CFR part 48 new miner training (§ 48.5), experienced miner training (§ 48.6), or annual refresher training (§ 48.8).
(3)(i) The average concentration of respirable dust in the belt air course, when used as a section intake air course, shall be maintained at or below 0.5 milligrams per cubic meter of air (mg/m
(ii) A permanent designated area (DA) for dust measurements must be established at a point no greater than 50 feet upwind from the section loading point in the belt entry when the belt air flows over the loading point or no greater than 50 feet upwind from the point where belt air is mixed with air from another intake air course near the loading point. The DA must be specified and approved in the ventilation plan.
(4) The primary escapeway must be monitored for carbon monoxide or smoke as specified in § 75.351(f).
(5) The area of the mine with a belt air course must be developed with three or more entries.
(6) In areas of the mine developed after the effective date of this rule, unless approved by the district manager, no more than 50% of the total intake air, delivered to the working section or to areas where mechanized mining equipment is being installed or removed, can be supplied from the belt air course. The locations for measuring these air quantities must be approved in the mine ventilation plan.
(7) The air velocity in the belt entry must be at least 100 feet per minute. When requested by the mine operator, the district manager may approve lower velocities in the ventilation plan based on specific mine conditions.
(8) The air velocity in the belt entry must not exceed 1,000 feet per minute. When requested by the mine operator, the district manager may approve higher velocities in the ventilation plan based on specific mine conditions.
(c) Notwithstanding the provisions of § 75.380(g), additional intake air may be added to the belt air course through a point-feed regulator. The location and use of point feeds must be approved in the mine ventilation plan.
(d) If the air through the point-feed regulator enters a belt air course which is used to ventilate a working section or an area where mechanized mining equipment is being installed or removed, the following conditions must be met:
(1) The air current that will pass through the point-feed regulator must be monitored for carbon monoxide or smoke at a point within 50 feet upwind of the point-feed regulator. A second point must be monitored 1,000 feet upwind of the point-feed regulator unless the mine operator requests that a lesser distance be approved by the district manager in the mine ventilation plan based on mine specific conditions;
(2) The air in the belt air course must be monitored for carbon monoxide or smoke upwind of the point-feed regulator. This sensor must be in the belt air course within 50 feet of the mixing point where air flowing through the point-feed regulator mixes with the belt air;
(3) The point-feed regulator must be provided with a means to close the regulator from the intake air course without requiring a person to enter the crosscut where the point-feed regulator is located. The point-feed regulator must also be provided with a means to close the regulator from a location in the belt air course immediately upwind of the crosscut containing the point-feed regulator;
(4) A minimum air velocity of 300 feet per minute must be maintained through the point-feed regulator;
(5) The location(s) and use of a point-feed regulator(s) must be approved in the mine ventilation plan and shown on the mine ventilation map; and
(6) An AMS must be installed, operated, examined, and maintained as specified in § 75.351.
30 U.S.C. 811, 813(h), 957.
Until April 14, 2025, the following definitions apply in this part:
(1) The CMDPSU, the equivalent concentration is determined by multiplying the concentration of respirable coal mine dust by the constant factor prescribed by the Secretary.
(2) The CPDM, the device shall be programmed to automatically report end-of-shift concentration measurements as equivalent concentrations.
(1) Two sets of mining equipment are used in a series of working places within the same working section and only one production crew is employed at any given time on either set of mining equipment, the two sets of equipment shall be identified as a single MMU.
(2) Two or more sets of mining equipment are simultaneously engaged in cutting, mining, or loading coal or rock from working places within the same working section, each set of mining equipment shall be identified as a separate MMU.
(1) Any change in occupation code of a part 90 miner;
(2) any movement of a part 90 miner to or from an MMU; or
(3) any assignment of a part 90 miner to the same occupation in a different location at a mine.
As April 14, 2025, the following definitions apply in this part:
(1) The CMDPSU, the equivalent concentration is determined by multiplying the concentration of respirable coal mine dust by the constant factor prescribed by the Secretary.
(2) The CPDM, the device shall be programmed to automatically report end-of-shift concentration measurements as equivalent concentrations.
(1) Two sets of mining equipment are used in a series of working places within the same working section and only one production crew is employed at any given time on either set of mining equipment, the two sets of equipment shall be identified as a single MMU.
(2) Two or more sets of mining equipment are simultaneously engaged in cutting, mining, or loading coal or rock from working places within the same working section, each set of mining equipment shall be identified as a separate MMU.
(1) Any change in occupation code of a part 90 miner;
(2) any movement of a part 90 miner to or from an MMU; or
(3) any assignment of a part 90 miner to the same occupation in a different location at a mine.
The following is required until April 14, 2025:
Effective April 14, 2025:
(a) Any miner employed at a coal mine who, in the judgment of the Secretary of HHS, has evidence of the development of pneumoconiosis based on a chest X-ray, read and classified in the manner prescribed by the Secretary of HHS, or based on other medical examinations shall be afforded the option to work in an area of a mine where the average concentration of respirable dust in the mine atmosphere during each shift to which that miner is exposed is continuously maintained at or below the standard. Each of these miners shall be notified in writing of eligibility to exercise the option.
(b) Any miner who is a section 203(b) miner on January 31, 1981, shall be a part 90 miner on February 1, 1981, entitled to full rights under this part to retention of pay rate, future actual wage increases, and future work assignment, shift and respirable dust protection.
(c) Any part 90 miner who is transferred to a position at the same or another coal mine shall remain a part 90 miner entitled to full rights under this part at the new work assignment.
(d) The option to work in a low dust area of the mine may be exercised for the first time by any miner employed at a coal mine who was eligible for the option under the old section 203(b) program (
(e) The option to work in a low dust area of the mine may be re-exercised by any miner employed at a coal mine who exercised the option under the old section 203(b) program (
(f) No operator shall require from a miner a copy of the medical information received from the Secretary or Secretary of HHS.
The following is required until April 14, 2025. After the 20th calendar day following receipt of notification from MSHA that a part 90 miner is employed at the mine, the operator shall continuously maintain the average concentration of respirable dust in the mine atmosphere during each shift to which the part 90 miner in the active workings of the mine is exposed, as measured with an approved sampling device and expressed in terms of an equivalent concentration, at or below:
The following is required as of April 14, 2025. After the 20th calendar day following receipt of notification from MSHA that a part 90 miner is employed at the mine, the operator shall continuously maintain the average concentration of respirable dust in the mine atmosphere during each shift to which the part 90 miner in the active workings of the mine is exposed, as measured with an approved sampling device and expressed in terms of an equivalent concentration, at or below 0.5 mg/m
The following is required until April 14, 2025:
As of April 14, 2025:
(a) Whenever a part 90 miner is transferred in order to meet the standard, the operator shall transfer the miner to an existing position at the same coal mine on the same shift or shift rotation on which the miner was employed immediately before the transfer. The operator may transfer a part 90 miner to a different coal mine, a newly created position or a position on a different shift or shift rotation if the miner agrees in writing to the transfer. The requirements of this paragraph do not apply when the respirable dust concentration in a part 90 miner's work position complies with the standard but circumstances, such as reductions in workforce or changes in operational status, require a change in the miner's job or shift assignment.
(b) On or before the 20th calendar day following receipt of notification from MSHA that a part 90 miner is employed at the mine, the operator shall give the District Manager written notice of the occupation and, if applicable, the MMU unit to which the part 90 miner shall be assigned on the 21st calendar day following receipt of the notification from MSHA.
(c) After the 20th calendar day following receipt of notification from MSHA that a part 90 miner is employed at the mine, the operator shall give the District Manager written notice before any transfer of a part 90 miner. This notice shall include the scheduled date of the transfer.
The following is required until April 14, 2025:
(a) A part 90 miner may waive his or her rights and be removed from MSHA's active list of miners who have rights under part 90 by:
(1) Giving written notification to the Chief, Division of Health, Mine Safety and Health Enforcement, MSHA, that the miner waives all rights under this part;
(2) Applying for and accepting a position in an area of a mine which the miner knows has an average respirable dust concentration exceeding the applicable standard; or
(3) Refusing to accept another position offered by the operator at the same coal mine that meets the requirements of §§ 90.100, 90.101 and 90.102(a) after dust sampling shows that the present position exceeds the applicable standard.
(b) If rights under part 90 are waived, the miner gives up all rights under part 90 until the miner re-exercises the option in accordance with § 90.3(e) (Part 90 option; notice of eligibility; exercise of option).
(c) If rights under part 90 are waived, the miner may re-exercise the option under this part in accordance with § 90.3(e) (Part 90 option; notice of eligibility; exercise of option) at any time.
As of April 14, 2025:
(a) A part 90 miner may waive his or her rights and be removed from MSHA's active list of miners who have rights under part 90 by:
(1) Giving written notification to the Chief, Division of Health, Mine Safety and Health Enforcement, MSHA, that the miner waives all rights under this part;
(2) Applying for and accepting a position in an area of a mine which the miner knows has an average respirable dust concentration exceeding the standard; or
(3) Refusing to accept another position offered by the operator at the same coal mine that meets the requirements of §§ 90.100, 90.101 and 90.102(a) after dust sampling shows that the present position exceeds the applicable standard.
(b) If rights under part 90 are waived, the miner gives up all rights under part 90 until the miner re-exercises the option in accordance with § 90.3(e) (Part 90 option; notice of eligibility; exercise of option).
(c) If rights under part 90 are waived, the miner may re-exercise the option under this part in accordance with § 90.3(e) (Part 90 option; notice of eligibility; exercise of option) at any time.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) Approved sampling devices shall be operated at the flowrate of 2.0 L/min if using a CMDPSU; at 2.2 L/min if using a CPDM; or at a different flowrate recommended by the manufacturer.
(b) If using a CMDPSU, each approved sampling device shall be examined each shift, by a person certified in sampling during:
(1) The second hour after being put into operation to assure it is in the proper location, operating properly, and at the proper flowrate. If the proper flowrate is not maintained, necessary adjustments shall be made by the certified person. This examination is not required if the sampling device is being operated in an anthracite coal mine using the full box, open breast, or slant breast mining method.
(2) The last hour of operation to assure that the sampling device is operating properly and at the proper flowrate. If the proper flowrate is not maintained, the respirable dust sample shall be transmitted to MSHA with a notation by the certified person on the back of the dust data card stating that the proper flowrate was not maintained. Other events occurring during the collection of respirable dust samples that may affect the validity of the sample, such as dropping of the sampling head assembly onto the mine floor, shall be noted on the back of the dust data card.
(c) If using a CPDM, the person certified in sampling shall monitor the dust concentrations and the sampling status conditions being reported by the sampling device at mid-shift or more frequently as specified in the approved respirable dust control plan, if applicable, to assure: The sampling device is in the proper location and operating properly; and the work environment of the Part 90 miner being sampled remains in compliance with the standard at the end of the shift. This monitoring is not required if the sampling device is being operated in an anthracite coal mine using the full box, open breast, or slant breast mining method.
The following is required until April 14, 2025:
(a) The operator shall take five valid representative dust samples for each part 90 miner within 15 calendar days after:
(1) The 20-day period specified for each part 90 miner in § 90.100; and
(2) Implementing any transfer after the 20th calendar day following receipt of notification from MSHA that a part 90 miner is employed at the mine.
(b) Noncompliance with the standard shall be determined in accordance with § 90.207(d).
(c) Upon issuance of a citation for a violation of the standard, the operator shall comply with § 90.207(f).
The following is required until April 14, 2025:
As of April 14, 2025:
(a) Each operator shall take five valid representative samples every calendar quarter from the environment of each part 90 miner while performing normal work duties. Part 90 miner samples shall be collected on consecutive work days. The quarterly periods are:
(1) January 1-March 31
(2) April 1-June 30
(3) July 1-September 30
(4) October 1-December 31.
(b) [Reserved]
(c) When a valid representative sample taken in accordance with this section meets or exceeds the ECV in table 1 to this section corresponding to the particular sampling device used, the mine operator shall:
(1) Make approved respiratory equipment available to affected miners in accordance with § 72.700 of this chapter;
(2) Immediately take corrective action to lower the concentration of respirable coal mine dust to below the standard; and
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine foreman's or equivalent official's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the part 90 miner.
(d) Noncompliance with the standard is demonstrated during the sampling period when:
(1) Two or more valid representative samples meet or exceed the ECV in table 1 to this section that corresponds to the particular sampling device used; or
(2) The average for all valid representative samples meets or exceeds the ECV in table 1 to this section that corresponds to the particular sampling device used.
(e) Unless otherwise directed by the District Manager, upon issuance of a citation for a violation of the standard, paragraph (a) of this section shall not apply to that Part 90 miner until the violation is abated and the citation is terminated in accordance with paragraphs (e) and (f) of this section.
(f) Upon issuance of a citation for a violation of the standard, the operator shall take the following actions sequentially:
(1) Make approved respiratory equipment available to the affected part 90 miner in accordance with § 72.700 of this subchapter.
(2) Immediately take corrective action to lower the concentration of respirable dust to below the standard. If the corrective action involves:
(i) Reducing the respirable dust levels in the work position of the part 90 miner identified in the citation, the operator shall implement the proposed corrective actions and begin sampling the affected miner within 8 calendar days after the date the citation is issued, until five valid representative samples are taken.
(ii) Transferring the Part 90 miner to another work position at the mine to meet the standard, the operator shall comply with § 90.102 and then sample the affected miner in accordance with § 90.206(a).
(3) Make a record of the corrective actions taken. The record shall be certified by the mine foreman or equivalent mine official, no later than the end of the mine foreman's or equivalent official's next regularly scheduled working shift. The record shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. Such records shall be retained at a surface location at the mine for at least 1 year and shall be made available for inspection by authorized representatives of the Secretary and the part 90 miner.
(g) A citation for a violation of the standard shall be terminated by MSHA when the equivalent concentration of each of the five valid representative samples is below the standard.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) If an operator abates a violation of the standard by reducing the respirable dust level in the position of the Part 90 miner, the operator shall submit to the District Manager for approval a written respirable dust control plan for the Part 90 miner in the position identified in the citation within 15 calendar days after the citation is terminated. The respirable dust control plan and revisions thereof shall be suitable to the conditions and the mining system of the coal mine and shall be adequate to continuously maintain respirable dust below the standard for that Part 90 miner.
(b) Each respirable dust control plan shall include at least the following:
(1) The mine identification number assigned by MSHA, the operator's name, mine name, mine address, and mine telephone number and the name, address and telephone number of the principal officer in charge of health and safety at the mine;
(2) The name and MSHA Individual Identification Number of the part 90 miner and the position at the mine to which the plan applies;
(3) A detailed description of how each of the respirable dust control measures used to continuously maintain concentrations of respirable coal mine dust below the standard; and
(4) A detailed description of how each of the respirable dust control measures described in response to paragraph (b)(3) of this section will continue to be used by the operator, including at least the specific time, place, and manner the control measures will be used.
The following is required until April 14, 2025:
As of April 14, 2025:
(a) The District Manager will approve respirable dust control plans on a mine-by-mine basis. When approving respirable dust control plans, the District Manager shall consider whether:
(1) The respirable dust control measures would be likely to maintain concentrations of respirable coal mine dust below the standard; and
(2) The operator's compliance with all provisions of the respirable dust control plan could be objectively ascertained by MSHA.
(b) MSHA may take respirable dust samples to determine whether the respirable dust control measures in the operator's plan effectively maintain concentrations of respirable coal mine dust below the standard.
(c) The operator shall comply with all provisions of each respirable dust control plan upon notice from MSHA that the respirable dust control plan is approved.
(d) The operator shall provide a copy of the current respirable dust control plan required under this part to the part 90 miner. The operator shall not post the original or a copy of the plan on the mine bulletin board.
(e) The operator may review respirable dust control plans and submit proposed revisions to such plans to the District Manager for approval.
Food and Nutrition Service (FNS), Department of Agriculture (USDA).
Final rule.
This final rule considers public comments submitted in response to the proposed rule revising the WIC food packages published on November 21, 2022. It revises regulations to align the WIC food packages with the current
•
Allison Post, Chief, Administration, Benefits, and Certification Branch, Policy Division, Food and Nutrition Service, USDA, 1320 Braddock Place, Alexandria, Virginia, 22314, (703) 305-2746 OR
WIC is a powerful, evidence-based public health program, with a long history of improving health and developmental outcomes for children. Through the WIC food packages, nutrition and breastfeeding education, and referrals, WIC is uniquely positioned as an effective tool to help reduce disparities in maternal and child health outcomes.
• Encouraging fruit and vegetable consumption.
• Addressing key nutritional needs to support healthy dietary patterns.
• Providing greater flexibility, variety, and choice to accommodate personal and cultural food preferences and special dietary needs.
• Strengthening support for individual breastfeeding goals to help establish long-term breastfeeding.
The Department is committed to advancing nutrition security and health equity through this final rule, ensuring mothers, babies, and young children have equitable access to the key nutrition they need during crucial stages of growth and development.
The WIC food packages provide supplemental foods designed to address the specific nutritional needs of low-income pregnant, breastfeeding, and non-breastfeeding postpartum individuals, infants, and children up to five years of age who are at nutritional risk. Every WIC participant receives a monthly food benefit from one of seven science-based food packages, according to their participant category and nutritional needs.
The seven food packages available in the following participant categories are:
As part of the WIC certification process, a comprehensive nutrition (and
Food categories and quantities, as well as minimum nutritional requirements, are established at the Federal level and outlined in WIC regulations at 7 CFR 246.10. Depending on the food package, the authorized food categories include infant formula, cereal, and foods; exempt infant formulas; WIC-eligible nutritionals; milk; cheese; breakfast cereal; juice; fruits and vegetables; whole wheat/whole grain bread; eggs; legumes and/or peanut butter; and canned fish.
The WIC Program is administered by 89 WIC State agencies, including the 50 states, 33 Indian Tribal Organizations (ITOs), the District of Columbia, and five U.S. Territories (the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands). In accordance with Federal WIC regulations, each WIC State agency determines which eligible foods, including brands and package sizes, will be made available to their participants. When creating their APL, WIC State agencies consider a variety of factors including participant acceptance and choice, product availability, and price. WIC State agencies may establish criteria in addition to the Federal minimum requirements (
Participants redeem their food benefits (
This final rulemaking represents the third
The most recent comprehensive revision to the WIC food packages was based on the Institute of Medicine's (now NASEM) 2006 report “WIC Food Packages: Time for a Change,” which cited the health and nutrition risks WIC's target population faced, including overweight and obesity; diets lacking in whole grains, fruits, and vegetables; and short duration of breastfeeding. USDA contracted with the Institute of Medicine to complete this review and recommend cost-neutral changes to the WIC food packages based on the nutritional needs of the WIC population. The report provided the scientific basis for the proposed rule to revise the WIC food packages published in August 2006 (71 FR 44784), which garnered broad support from public commenters, the majority of whom were Program participants.
Reflecting the comments received, USDA published an interim rule in December 2007 (72 FR 68966) that implemented revised WIC food packages. Due to the extent and comprehensive nature of the revisions, the Department provided an extended public comment period on the interim rule to obtain comments on the impacts of implementing the new WIC food packages. On March 4, 2014, USDA published the final rule “Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages” (79 FR 12274), hereafter referred to as “the 2014 final rule.” The revisions in the 2014 final rule aligned the WIC food packages with nutritional science current at the time, aimed to promote and support the establishment of successful long-term breastfeeding, provided participants with a wider variety of foods, and provided WIC State agencies with greater flexibility in prescribing WIC food packages to accommodate participants' cultural food preferences. Key changes implemented through the 2014 final rule and preceding interim final rule included:
Introduction of the CVV for the purchase of fruits and vegetables.
• Addition of whole grains (
• Addition of soy-based beverage, yogurt, and tofu as milk alternatives.
• Reductions in some foods (
• Allowance for participants in Food Package III to receive all authorized WIC foods.
In 2014, USDA contracted with NASEM to conduct a second review of the WIC food packages, in accordance with the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296, HHFKA), which requires USDA to conduct a scientific review of the WIC food packages at least every ten years. The Department charged NASEM with developing recommendations for revising the WIC food packages to be consistent with the DGA and that considered the health and cultural needs of WIC participants while ensuring WIC remained cost-neutral, efficient for nationwide distribution, and straightforward to administer. NASEM's process included a comprehensive review and analysis of available scientific evidence, including relevant published literature, National Health and Nutrition Examination Survey (NHANES) 2005-2012 data, WIC food benefit redemption data, the 2015-2020 DGA, and, for children under age 2 years, recommendations from expert authorities in the health of the WIC population including the AAP, the Academy of Nutrition and Dietetics (AND), and the World Health Organization. In 2017, NASEM published its recommendations in the report, “Review of WIC Food Packages: Improving Balance and Choice: Final Report,” which informed many of the revisions in the 2022 proposed rule.
Using a systematic process, NASEM developed recommendations aimed to ensure the WIC food packages:
• Provide a balanced supplement to the diets of women and children.
• Contribute to reduced prevalence of inadequate and excessive nutrient intake.
• Contribute to a dietary pattern that is consistent with the 2015-2020 DGA for individuals 2 years of age and older.
• Contribute to a diet that is consistent with established recommendations for infants and children less than 2 years of age, including encouragement of and support for breastfeeding.
• Include foods that are available in forms and amounts suitable for low-income persons who may have limited transportation options, storage, and cooking facilities.
• Include foods that are readily acceptable, commonly consumed, widely available, consider cultural eating patterns and food preferences, and provide incentives for families to participate in the WIC Program.
• Include foods that do not create an undue burden on WIC State agencies or vendors.
NASEM's review emphasized the supplemental nature of the food packages—meaning foods are provided as part of a balanced diet that meets but does not exceed recommended amounts of foods and nutrients to prevent overweight/obesity and/or displace other healthy and important food groups and nutrients. Accordingly, NASEM designed food packages that provide moderate proportions of individuals' nutrient requirements and food group amounts recommended as part of a healthy dietary pattern, and that prioritize nutrients that are under consumed and associated with health outcomes relevant to the WIC-eligible population. Finding that the current food packages provide varying proportions of priority nutrients
Following the 2017 NASEM report, on December 29, 2020, the USDA and the U.S. Department of Health and Human Services published the 2020-2025 DGA, which provides science-based recommendations for healthy dietary patterns by life stage and, for the first time since the 1985 edition, recommendations for infants, children up to 2 years of age, and pregnant and breastfeeding individuals. To ensure the changes to the WIC food packages aligned with the current dietary guidelines, USDA conducted a thorough review of the 2020-2025 DGA and incorporated relevant updates into the 2022 proposed rule.
The revisions to the food packages support WIC participants' nutritional needs, achieve a better balance of nutrients, and align with the supplemental nature of the Program. Nutrition security—meaning consistent and equitable access to healthy, safe, and affordable food essential to optimal health and well-being—is prioritized over cost neutrality while the supplemental nature of the WIC food packages remains central to the final revisions. The changes to the WIC food packages are designed to:
• Provide additional flexibility, variety, and choice for individuals with special dietary needs due to medical conditions, limited cooking and/or storage facilities, and cultural and personal preferences (including, but not limited to, vegan and vegetarian diets), while ensuring the delivery of priority nutrients to WIC participants.
• Consider marketplace availability of supplemental foods.
• Increase the actual and perceived value of the WIC food packages to eligible populations.
• Improve equitable access to nutritious foods.
• Promote and support breastfeeding of all durations and intensities.
• Provide foods in amounts that are more consistent with the supplemental nature of the Program.
• Align with DGA guidance to follow a healthy dietary pattern and meet, but not exceed, recommended food group and subgroup amounts and nutrients appropriate for an individual's life stage.
• Build on the 2014 changes to the WIC food packages and the positive impact those had on participant diet quality and reduced prevalence of obesity among children.
The 2022 proposed rule to revise regulations governing the WIC food packages was published in the
USDA worked in collaboration with a data analysis company to code and analyze the public comments using a commercial web-based software product and obtained data showing support for or opposition to each proposed change. Over 12,000 commenters provided broad general support for revisions to the WIC food packages while approximately 20 commenters provided general comments in opposition to the 2022 proposed rule. The remaining
USDA appreciates the many comments expressing support for revisions to the WIC food packages and urging USDA to implement the science-based recommendations included in the 2022 proposed rule. USDA agrees the WIC food packages' benefits have an important role in supporting and improving the health of infants, children, and women who are at nutritional risk and, consequently, improving healthcare costs.
The following is a discussion of the provisions set forth in the 2022 proposed rule, a summary of the comments received that addressed these provisions, and the Department's rationale for changes in the final rule that either modify or retain the proposed revisions. Provisions not discussed in this preamble did not receive significant or substantial public comments and are retained in this final rule as proposed.
This preamble communicates the rationale for modifications to the 2022 proposed rule that are codified in this final rulemaking. The reasons for the proposed changes were carefully examined in consideration of comments received to determine their continued applicability, given the goals for this rulemaking and the foundation of current nutritional science. Unless otherwise stated in the preamble of this final rule, the rationales included in the preamble of the 2022 proposed rule are regarded as a basis for the final regulations. Therefore, a thorough understanding of the rationales for the final regulations may require reference to the preamble of the 2022 proposed rule (87 FR 71090).
The following chart provides a summary comparison of the proposed and final revisions to the WIC food packages.
The final rule increases the CVV amounts for child, pregnant, postpartum, and breastfeeding participants; requires the authorization of an additional form of fruits and vegetables beyond fresh, dependent on participant category; requires vendors to stock at least three varieties of vegetables; and expands what foods can be purchased with the CVV.
This final rule codifies the increase in the CVV amounts for child, pregnant, breastfeeding, and postpartum participants as summarized in the 2022 proposed rule. The increase to the CVV is consistent with the temporary increase in the CVV that has been in place since October 1, 2021, as a result of appropriations legislation (the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022, Pub. L. 117-103; the Consolidated Appropriations Act, 2023, Pub. L. 117-328; and the Consolidated Appropriations Act, 2024, Pub. L. 118-42).
Commenters expressed broad support for the increase to the CVV amounts of $24 for child participants, $43 for pregnant and postpartum participants, and $47 for partially (mostly) and fully breastfeeding participants adjusted annually for inflation. In expressions of support, commenters cited that the increased CVV amounts: (1) allow participants to buy and consume more fruits and vegetables to support improved health; (2) have led to greater participant satisfaction and retention; (3) support retailers in low-income and rural areas stocking more fruits and vegetables because of the increased buying power, improving choice and access; and (4) support the economy, particularly produce farmers.
No comments opposed the increase in CVV amounts. Some commenters requested adjusting the value of the CVV for WIC State agencies administering WIC in high-cost areas, citing reduced purchasing power because of the likelihood of relatively higher food prices. Given that NASEM recommended further study to evaluate the feasibility of making such adjustments to the CVV, the Department is not making this change in the final rule and instead seeks to pursue future cross-program research to obtain data necessary to better understand variations in cost of living to inform potential future changes.
Some commenters suggested increasing CVV amounts beyond those proposed, with several requests for USDA to increase the amount for pregnant participants to match that of breastfeeding participants at $47. The CVV amounts in the 2022 proposed rule provide approximately half of the recommended daily amounts of fruits and vegetables for adults and children, which aligns with the goal of providing supplemental amounts of foods and nutrients in the WIC food packages. These increased CVV amounts are consistent with the DGA recommendation to increase consumption of fruits and vegetables and afford participants greater choice to select fruits and vegetables that accommodate their cultural and personal food preferences. For these reasons, the Department maintains the amounts as proposed. The following are the CVV amounts (using 2022 as the base year)
This final rule codifies the requirement that WIC State agencies authorize fresh and at least one other form (frozen, canned, and/or dried) of both fruits and vegetables for the child, pregnant, postpartum, and breastfeeding food packages and requires fresh and at least one other form (frozen or canned) for the CVV substitution for infant (ages 6 through 11 months) food packages. Dried fruits and vegetables pose a choking hazard for infants and are not authorized.
Most commenters expressed support for requiring another form of fruits and vegetables in addition to fresh. Many WIC State agencies commented that they already allow for an additional form so there is no burden to implementing this provision. Commenters also highlighted that the provision would support the purchase of produce with a longer shelf life and expand participant choice, which could lead to increased redemption rates and mitigate food waste. The Department agrees with these comments and adds that in combination with the increase in the CVV, the provision will provide participants with greater flexibility to accommodate various storage or cooking conditions as well as special dietary needs (
Some WIC State agencies requested clarification regarding frozen, canned, and dried options as well as pickled or fermented products and sugar in additional forms of fruits and vegetables. Several commenters expressed support for additional forms of fruits and vegetables with concern about the sodium, sugar, and additives in canned and frozen products. The Department clarifies that with this provision, canned or frozen fruit may not contain added sugars, fats, oils, or salt and, that canned or frozen vegetables may not contain added sugars, fats, or oils (§ 246.10(e)(12), Table 4). Regarding sodium, the Department acknowledges the sodium content of canned vegetables may be higher than other forms (
The Department recognizes the potential for confusion among households with infant participants whose benefits are aggregated
This final rule codifies the provision to require vendors to stock at least three varieties of vegetables as summarized in the proposed rule.
Most commenters, including WIC State and local agencies, expressed support for this provision. Several suggested the requirement would not create additional burden as most retailers already stock more than two varieties of vegetables, noting this provision could reduce barriers and increase equitable access to vegetables. The Department agrees with these commenters and adds that increasing the minimum number of vegetables stocked will help reduce disparities in food access in communities where obtaining produce is difficult and provide participants with greater access to support establishing healthy dietary patterns during critical life stages.
Several commenters expressed concern that this provision could result in a potential loss of small vendors, and a few WIC State agencies cited the administrative burden of requiring additional varieties of vegetables. The Department recognizes that the requirement for vendors to stock at least three varieties of vegetables could potentially impact some small vendors. The ability to stock shelf stable forms of vegetables will ease this concern, as Federal regulations will not require small vendors to stock three forms of fresh vegetables. As suggested in several comments, the Department will develop resources and technical assistance for WIC State agencies to adapt and use in training WIC-authorized vendors on the new provisions and allowable flexibilities in this final rule.
This final rule expands what can be purchased with the CVV, including fresh cut herbs, white potatoes, and larger sizes of packaged fruits and vegetables.
This final rule codifies allowing participants to purchase fresh cut herbs with the CVV as summarized in the 2022 proposed rule.
Allowing fresh cut herbs to be purchased with the CVV increases participant choice, helps accommodate cultural eating patterns, and aligns with the DGA, which categorizes fresh herbs (
The few comments received specific to this proposal were supportive, with WIC State agencies noting that herbs can have health benefits by increasing flavor and decreasing the salt and sugar added during cooking. Commenters cited the potential of including fresh herbs to better meet recommended daily food group amounts for fruits and vegetables. The Department agrees with comments acknowledging that herbs can help enhance the flavor of foods as a strategy to reduce added sugars, saturated fat, and sodium in support of healthy dietary patterns.
Several commenters asked for clarification on this provision, specifically what is included as a fresh herb and whether dried herbs could also be considered in this provision. The Department agrees that clarification on the types of allowable herbs is important. The intent of this provision is to allow participants to purchase fresh herbs, cut at the root or with the root intact, that are in a consumable form. For consistency with the WIC Farmers' Market Nutrition Program and the DGA, the Department will not allow dried herbs to be purchased with the CVV. The Department will further address this through technical
This final rule permanently removes white potatoes as an excluded vegetable, as summarized in the 2022 proposed rule. Doing so codifies the provision in the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) that precludes the exclusion or restriction of any variety of fresh, whole, or cut vegetables (except vegetables with added sugars, fats, or oils) in WIC. FNS issued WIC Policy Memorandum #2015-3:
This final rule codifies allowing larger package sizes of fresh fruits and vegetables to be WIC-eligible as summarized in the 2022 proposed rule. Prior to this rulemaking, regulations prohibited larger package sizes of fresh cut produce, referred to as “party trays.” In accordance with current nutrient requirements, packages of fresh fruits and vegetables regardless of size may not contain added sugars, fats, or oils (which may appear in the form of dips, sauces, or glazes). The change will also allow participants with more than one family member participating in WIC to use aggregate benefits to purchase larger amounts of precut fruits and vegetables.
The Department received broad general support for this provision, with commenters noting the added flexibility of larger package sizes will better serve participants and support consumption of a variety of fruits and vegetables. WIC State agencies noted party trays commonly contain dips or sauces, which are not WIC-eligible and may cause confusion among participants, and that party trays are typically less cost effective and have a greater risk of food spoilage if not consumed quickly. The Department acknowledges these concerns, will continue to provide technical assistance to WIC State agencies to assist in implementing the provisions of this final rule, and encourages WIC State agencies to address package size considerations to minimize food spoilage through nutrition education.
This final rule codifies a reduction in juice from 128 to 64 ounces in the child food package and from 144 to 64 ounces in the pregnant and breastfeeding food package as proposed, and a reduction in juice from 96 ounces to 64 ounces in the postpartum food package, which modifies the proposed provision to eliminate juice. In addition, this rule allows substitution of a $3 CVV for the full juice amount across all food packages as originally proposed.
This final rule codifies the reduction of juice from:
• 128 ounces to 64 ounces in the child food package, as proposed,
• 144 ounces to 64 ounces in the pregnant and breastfeeding food packages, as proposed, and
• 96 ounces to 64 ounces in the postpartum food package. Based on public comment, the Department modified its proposal to eliminate juice in the postpartum food package.
Many commenters, including WIC State agencies, expressed support for the reduction in juice with several suggesting the Department eliminate juice from all WIC food packages. Commenters cited overconsumption, particularly among young children, as reason to reduce or eliminate juice, noting the lack of dietary fiber that may contribute to excess caloric intake. The Department agrees with the importance of limiting juice consumption as part of a healthy dietary pattern and notes the reduced quantities provide more appropriate supplemental amounts at approximately 27 to 53 percent of DGA-recommended limits for juice for most participants compared to 40 to 107 percent previous WIC food packages provided.
Comments in opposition cited juice as a convenient and cost-effective source of fruit, an under consumed food group among the WIC-eligible population. Some commenters expressed general concern with the reduced benefit level, believing this disincentivizes participation and may impede participant retention goals. Several commenters requested the Department reconsider eliminating juice from the postpartum food package, noting the benefits of juice are applicable to the entire WIC-eligible population and the elimination is not aligned with the Department's goal of improving equitable access to supplemental foods.
The Department agrees that juice, specifically 100 percent juice which the WIC food packages provide, is a convenient and cost-effective source of nutrients, particularly vitamin C. However, the Department also acknowledges that juice is lower in dietary fiber—a dietary component of public health concern—than whole fruits and vegetables, and that juice in the current WIC food packages provides a disproportionate amount of fruit and vegetable servings compared to servings from whole forms. The Department believes the overall improved variety, flexibility, and choice afforded through the WIC food packages will appeal to participants while also providing foods in appropriate supplemental amounts.
The Department appreciates comments citing the benefits of juice across life stages, including for postpartum individuals, and agrees with the importance of ensuring equitable access to nutrient-dense foods for all participant categories. Further, the Department acknowledges the recommended amounts of fruits and vegetables in the 2020-2025 DGA are equivalent across life stages; specifically, the DGA recommends 2 and 2.5 to 3 cup equivalents per day of fruits and vegetables, respectively, for pregnant, breastfeeding, and postpartum individuals. The provision of 64 fluid ounce provides approximately 27 percent of the upper limit of juice in the recommended fruit and vegetable category of the DGA for postpartum women, which aligns with the supplemental amounts provided for all pregnant and breastfeeding participant categories.
This final rule codifies the provision allowing participants to substitute a $3 CVV for the full juice amount (64 fluid ounces) through individual tailoring during benefits issuance, as summarized in the 2022 proposed rule. The dollar value of the CVV substitution for juice will be adjusted annually for inflation, consistent with fruit and vegetable CVV adjustments in § 246.16.
Most commenters expressed support for the CVV substitution option, citing the importance of participant choice and the benefits of whole fruits and vegetables in comparison to juice, namely dietary fiber. Commenters further suggested increasing the dollar amount of the CVV substitution to $4 or more, believing this higher amount to be reflective of the market value for juice, and that as a Federal requirement or WIC State agency option the CVV be the default with juice as the substitution upon participant request. The Department agrees with the importance of participant choice and clarifies that (a) WIC State agencies have the option to make the $3 CVV the default with juice substituted upon request and (b) the dollar value of the CVV substitution will be evaluated and adjusted annually for inflation to ensure it keeps pace with the market value of juice.
Comments in opposition noted substituting 64 ounces of juice with a $3 CVV results in fewer net servings of fruits and vegetables as whole forms of fruits and vegetables typically cost more than juice, with one suggestion to also allow substituting additional juice for the CVV. The Department notes that while juice in nutrient-dense forms can be included in healthy dietary patterns, the 2020-2025 DGA emphasizes fruits and vegetables in whole forms and sets limits on the amount of juice consumption. As noted above, juice in the current WIC food packages provides a disproportionate amount of fruit and vegetable servings compared to servings from whole forms. Further, the option to substitute a $3 CVV for the full juice amount (64 fluid ounces), supports the Department's goals of providing greater flexibility, variety, and choice to accommodate special dietary needs, cultural practices, and personal preferences.
This final rule revises milk and milk substitutions as proposed with some modifications based on public comments and in consideration of providing greater flexibility, variety, and choice to WIC State agencies and participants. The changes include:
Reduce milk amounts provided in child, pregnant, and breastfeeding food packages.
Permit only unflavored milk and establish an added sugar limit for yogurts and plant-based milk alternatives.
• Allow plant-based
• Add a calcium specification for tofu and a vitamin D specification for yogurts.
• Allow reduced-fat yogurts for 1 year-old children without restrictions.
• Remove cheese as a separate food category from the fully breastfeeding food package.
• Require authorization of unflavored lactose-free milk.
• Increase yogurt substitution amounts.
• Remove the limitation that no more than a total of 4 quarts of milk (for participants in Food Packages IV-VI) or 6 quarts of milk (for participants in Food Package VII) may be substituted for a combination of cheese, yogurt, or tofu.
• Create separate food packages for children 12 through 23 months and children 2 through 4 years.
• Update the FDA standards of identity citations for yogurt.
As NASEM recommended, this final rule codifies the proposed reduction in milk amounts from:
• 16 quarts to 12 quarts for children ages 12 to 23 months in the child food package
• 16 quarts to 14 quarts for children ages 2 through 4 years in the child food package,
• 22 quarts to 16 quarts in the pregnant and partially breastfeeding food packages, and
• 24 quarts to 16 quarts in the fully breastfeeding package.
These changes provide appropriate supplemental quantities and improve the balance of foods in the food packages.
The provision to reduce milk amounts received mixed support. Many commenters, including several WIC State and local agencies, expressed support for the reduced milk amounts, with the primary rationales that participants report receiving too much milk, the changes are consistent with the supplemental nature of WIC even after the reductions to the dairy amounts, and the WIC food packages still provide most of the recommended dairy amounts. Some commenters also suggested alternatives to the provision as proposed, including retaining current amounts or reducing amounts to a lesser degree for various participant categories. However, there were also many commenters, including a few WIC State agencies, who opposed the reduced amounts. Comments in opposition stated that dairy provides important nutrients and should not be reduced in a program that serves at-risk participants; dairy foods are some of the most highly redeemed products in the WIC food packages and a reduction would be noticeable and impact WIC participants and retailers; reducing milk amounts conflicts with the DGA and runs counter to WIC's nutrition focus; and that the change, which is not needed as a cost-savings measure, will lead to participants increasing their consumption of less nutritious beverages, and will reduce participation in WIC. The Department also acknowledges, while legally non-binding, the report language from the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act (Pub. L. 118-42) requests that the Secretary not reduce the maximum monthly allowance with respect to milk when submitting this final rule.
The Department agrees that milk provides important nutrients, and WIC continues to support access to dairy products while rebalancing the foods and beverages currently provided in quantities that exceed recommended amounts. The current DGA recommends consuming amounts of foods to meet nutrient needs while not exceeding calorie requirements. The recommended amounts of dairy range from 1.66 to 3.00 cups per day across life stages. At current levels, the WIC food packages provide up to 128 percent of these amounts from milk alone. Recognizing the inconsistency with WIC's supplemental intent, NASEM recommended reducing the milk amounts to provide a more balanced supplement to participants' diets. Ultimately, the reduced milk quantities reflect NASEM's recommendations and will provide 71 to 96 percent of the dairy amounts the DGA recommends; help to rebalance the food packages to better align with DGA dietary patterns; and are more consistent with the
Regarding the concern that reduced milk quantities will disincentivize program participation, the Department believes that through flexibilities and additions made in this final rule, such as increasing the CVV, adding canned fish to more WIC food packages, and adding additional juice, dairy, and whole grain substitution flexibilities and food options to accommodate special dietary needs, cultural practices, and personal preferences, participants will continue to see the WIC food packages as a valuable benefit.
This final rule permits only unflavored milk and establishes an added sugar limit for yogurts and plant-based milk alternatives.
This final rule codifies the provision to allow only unflavored milk as summarized in the 2022 proposed rule.
This provision received broad support, with commenters, including several WIC State agencies, stating that only a small number of WIC State agencies currently authorize flavored milk. The Department will provide targeted technical assistance to WIC State agencies currently authorizing flavored milk to support successful implementation of this change. Commenters in support of this provision also cited alignment with the DGA recommendation that nutrient-dense beverages include little to no added sugars. Commenters who opposed no longer allowing flavored milk, including a few WIC State agencies, stated that participants would not drink unflavored milk and that a healthy dietary pattern can include some added sugars, which would allow for added sugars in dairy. The Department clarifies the 2020-2025 DGA includes a limit on added sugars of less than 10 percent of calories per day and that nutrient-dense beverages include little, if any, sweeteners. The DGA further recommends that children 12 through 23 months of age avoid added sugars because their nutrient requirements are high relative to the amount of food consumed, providing virtually no room in their diets for added sugars. The Department clarifies that this provision also applies to lactose-free milk.
This final rule replaces the current total sugars limits with an added sugars limit and codifies the following provisions for reducing sugars in yogurts and plant-based milk alternatives based on public comment as requested in the 2022 proposed rule:
• Plain or flavored yogurts (dairy and plant-based) must contain ≤16 grams of added sugars per 8 ounces (see
• Plant-based milk alternatives must contain ≤10 grams of added sugars per 8 fluid ounces (see
To maintain consistency across food categories that currently have total sugar limits, this final rule also codifies an added sugars limit for breakfast cereal (see section F. Breakfast Cereals).
The Department acknowledges the 2022 proposed rule requested comment on an added sugars limit for yogurt and soy-based beverages. As discussed below (see
Commenters in support of using an added versus total sugars limit in yogurt and plant-based milk alternatives, including several WIC State agencies, highlighted that added sugars are not equivalent to natural sugars found in lactose or fruit, an added sugar limit is more consistent with DGA recommendations, and added sugars information is available on the Nutrition Facts label under FDA requirements. The Department agrees with the commenters and notes that using an added sugars limit instead of a total sugars limit increases consistency with proposed limits for Federally administered Child Nutrition Programs, which is of value to USDA and those who participate in such programs. At the time NASEM developed their WIC food packages recommendations, FDA's regulation to include added sugars on food labels was not yet implemented. Given the DGA recommendations on limiting added sugar, and that the FDA's labeling requirement for added sugars are in effect, this final rule includes an added sugar limit for yogurt and plant-based milk alternatives (as well as for breakfast cereal, see section F).
Comments in opposition stated that specific to yogurt, the varied fat levels of yogurts result in differing amounts of naturally occurring sugar from lactose. These commenters suggested the added sugars limits NASEM provided in Table 6.5 (page 303) of their 2017 report would be complex and create an administrative burden. Commenters further highlighted the lack of naturally occurring sugar in plant-based yogurts, noting these products require additional added sugars for palatability, and expressed concern regarding any proposed limit for total or added sugars. The Department agrees there would be substantial administrative burden associated with added sugars limits that differ based on the fat content of yogurt. The added sugars limit of ≤16 grams per 8 ounces of yogurt aligns with NASEM's suggested limits, which ranged from 11-18 grams of added sugars per 8 ounces depending on fat content, while easing administrative burden and aligning with proposed limits for Federally administered Child Nutrition Programs. The Department believes that a limit on the allowable added sugars content in plant-based yogurts is important for consistency with current dietary guidance and to support healthy dietary patterns.
This final rule adds plant-based milk alternatives, yogurts, and cheeses as milk substitution options.
This final rule codifies allowing plant-based milk alternatives that meet the nutrient specification for WIC-eligible soy beverages in current WIC regulations (§ 246.10(e)(12), Table 4) as summarized in the 2022 proposed rule, with the addition of an added sugar limit codified in this final rule (see
This final rule also codifies a technical correction to 7 CFR 246.10(e)(10) through (12) to reflect the
Most commenters, including WIC State agencies, supported offering other plant-based milk alternatives that meet nutrient specifications and discussed that many children who are allergic to milk are also allergic to soy, and so providing other plant-based milk alternatives provides a healthy beverage option for these participants. Commenters also discussed that providing additional plant-based milk alternatives provides more options for those with cultural preferences for non-dairy milks and urged the Department to allow a variety of plant-based milks beyond soy. Some commenters, including WIC State agencies, noted the limited availability of products that meet the current nutrient specifications and expressed concern for the relatively high cost of plant-based milks. The Department recognizes the limited availability of products that currently meet nutrient specifications and, given that dairy and soy are among the most common food allergens, is creating a pathway to allow WIC Stage agencies to authorize such products as they become available rather than waiting for a future rulemaking. Such a pathway provides WIC State agencies with greater flexibility to prescribe and tailor WIC food packages that accommodate participants' special dietary needs and personal and cultural food preferences, thus increasing equity. Additionally, USDA understands the cost concerns that some WIC State agencies expressed, and while the Department encourages WIC State agencies to offer as much flexibility, variety, and choice as possible for their participants, USDA also reminds WIC State agencies that they are not required to authorize all WIC-eligible foods. When deciding which types and brands of WIC foods to authorize, including when authorizing plant-based milk alternatives, WIC State agencies should consider factors such as package size, food prices, product availability across their jurisdiction, and program management costs along with participant preference and demand.
Some commenters also expressed a concern about the unit of measure since some products are available in 48-ounce containers. The current substitution ratio for soy-based beverages—an equal quart for quart substitution—will apply to plant-based milk alternatives, as will the ability for participants to substitute these products for the full milk allotment. Since milk and plant-based milk alternatives provide critical nutrients such as calcium and vitamin D, it is important that WIC participants have a way to redeem their full food benefit. For all foods authorized, WIC State agencies must authorize container sizes that equal or add up to the full MMA. However, this final rule also gives WIC State agencies the option to also authorize container sizes that may not equal or add up to the full MMA (see section J. Maximum Monthly Allowance (MMA)).
While the Department received broad support for this provision, several commenters expressed mixed views on the nutrient specifications for, or current nutrient content of, plant-based milk alternatives. One WIC State agency and one local WIC agency supported allowing plant-based milk alternatives but opposed the nutrient requirements, citing variety and flexibility as more important than matching the nutrient content of dairy milk. In contrast, some commenters expressed concern about the lack of equivalency in the nutrient content of plant-based milk alternatives relative to WIC-eligible dairy products, noting the important nutrients dairy-based products provide and citing the AAP, the AND, the American Academy of Pediatric Dentistry (AAPD), and the American Heart Association (AHA) as not recommending plant-based milk alternatives. A couple of commenters opposing this provision asserted the proposed authorization of lactose-free milk and flexibilities for substituting yogurt and cheese will ensure dairy's nutrients and health benefits are accessible to all WIC participants without a need to authorize plant-based milk alternatives.
USDA agrees cow's milk provides important nutrients, including calcium, vitamin D, and potassium—defined as nutrients of public health concern in the 2020-2025 DGA. As such, based on recommendations from NASEM, FNS proposed in 2006, implemented in 2007, and finalized in 2014 a provision to allow soy-based beverage that was fortified to contain nutrients in amounts similar to cow's milk. This was to ensure participants who substitute soy-based beverage for milk consume priority nutrients in similar amounts relative to dairy milk. Allowing other plant-based milk alternatives with the same nutrient specifications as soy-based beverage supports consumption of priority nutrients in similar amounts relative to dairy milk. It also creates consistency across eligible products and reduces administrative burden and the possibility of participant and vendor confusion.
USDA does not agree that lactose-free milk and dairy-based yogurt and cheese alone are sufficient alternatives for WIC participants. Individuals do not consume dairy for a variety of reasons, including special dietary needs such as an allergy, or cultural or personal preferences. While some individuals with lactose intolerance may tolerate dairy-based yogurt and cheese and soy-based beverages, dairy and soy are among the top food allergens, making these foods unavailable options as milk substitutions for WIC participants with these allergies.
The Department highlights the 2020-2025 DGA's recognition of beverages fortified with calcium, vitamin A, and vitamin D as included in the dairy group because of the similarity in nutrient composition when compared to cow's milk. While the nutritional content of many plant-based milk alternatives currently available in the retail marketplace is not similar to dairy
Based on public comment requested, this final rule codifies allowing plant-based yogurts and cheeses as substitution options for milk as summarized in the 2022 proposed rule with modification to the vitamin D specification and the use of an added versus a total sugar limit (see
• Plant-based yogurts must contain ≤16 grams of added sugars and at least 250 milligrams of calcium, 6.5 grams of protein, and 106 IU (2.67 micrograms) of vitamin D per 8 ounces.
• Plant-based cheeses must contain at least 250 milligrams of calcium and 6.5 grams of protein per 1.5 ounces.
Several commenters, including WIC State agencies, supported allowing additional plant-based yogurts and cheeses (
This final rule adds a calcium specification for tofu and a vitamin D specification for yogurt.
This final rule codifies a calcium requirement for tofu as summarized in the 2022 proposed rule with modification to 100 milligrams of calcium per 100 grams of tofu.
Commenters, including WIC State agencies, expressed general support for requiring calcium fortification of tofu, stating this would be especially beneficial for participants with milk allergies. Many commenters expressed concerns about current marketplace availability of tofu products that meet the proposed specification (200 milligrams of calcium per 100 grams of tofu), stating that this requirement would remove or eliminate all tofu products currently eligible and noting the effect that adding calcium has on the texture of tofu.
Based on comments, USDA conducted additional marketplace analyses. Using USDA Agricultural Research Service's (ARS) Food Data Central Database, 27 out of 40 tofu products randomly selected across a variety of brands and textures were found to provide 100 milligrams or more of calcium per 100 grams of tofu. For the three WIC State agencies that provided information about products in their state, this calcium amount is consistent with the lower end of what they reported as being available: 100-153 milligrams of calcium per 100 grams of tofu. Calcium is a priority nutrient for the WIC target population, so adding a calcium specification for WIC-eligible tofu ensures those who substitute tofu for milk still obtain calcium. Lowering the minimum requirement from 200, as proposed, to 100 milligrams of calcium per 100 grams of tofu increases access to this priority nutrient in a manner that reflects current marketplace availability.
This final rule codifies a vitamin D requirement for yogurts (dairy- and plant-based) as summarized in the 2022 proposed rule with modification to 106 IU (2.67 micrograms) of vitamin D per 8 ounces of yogurt. The Department is also extending the implementation date for this requirement to April 26, 2027, based on public comment. This date is a deadline, thus if products that meet the vitamin D specification are available sooner, WIC State agencies may and are encouraged to authorize these products in advance of this date.
Most commenters, including WIC State agencies, supported adding a vitamin D specification to yogurt to improve participant health, citing the underconsumption of this nutrient. The primary concern among commenters, including a couple of WIC State agencies, who supported and opposed this provision was marketplace availability and the potential for reducing or eliminating all currently authorized yogurts followed by a concern about manufacturers' willingness to modify products. However, through the public comment process, an industry advocacy group and several yogurt manufacturers expressed their support for a vitamin D specification for WIC-eligible yogurts. No manufacturers or industry representatives submitted comments in opposition to adding a vitamin D specification, and two of the manufacturers and an industry advocacy group recommended that USDA implement a specification to match the minimum optional vitamin D fortification amount outlined in the FDA's updated SOI for yogurt (21 CFR 131.200), which states that: “If added, vitamin D must be present in such quantity that the food contains not less than 10 percent Daily Value per Reference Amount Commonly Consumed (RACC) thereof, within limits of current good manufacturing practices.” With a RACC of 6 ounces and a Daily Value of 800 IU (20 micrograms), the minimum amount of
Industry commenters also requested USDA extend implementing this provision to 30 months to allow time for manufacturers to reformulate products. The Department finds this timeline to be reasonable based on the current marketplace requirements for vitamin D in yogurt and the Department's experience with review of reformulated and new products. To allow additional time for WIC State agencies' product review and APL and MIS updates, the Department is further extending the implementation date for the vitamin D requirement for yogurt by an additional 6 months, for a total of 36 months after publication of this final rule.
USDA received one comment stating that vitamin D is already present in several other fortified WIC-eligible foods and this nutrient should be obtained through active time outdoors. As noted in the proposed rule, the DGA identifies vitamin D as a nutrient of public health concern for people in all life stages and notes that vitamin D recommendations are hard to achieve through natural sources from diet alone and would require consuming foods and beverages fortified with this vitamin. The DGA also notes that some individuals may have difficulty producing sufficient vitamin D from sunlight exposure. Additionally, the Centers for Disease Control and Prevention (CDC)
This final rule codifies allowing reduced-fat yogurts for 1-year-old children without restriction as summarized in the 2022 proposed rule (
Commenters, including several WIC State agencies, largely supported this provision, citing that the DGA dietary pattern for children 12 through 23 months of age includes low-fat plain yogurts in the dairy food group for this age category to support consumption of a combination of foods to meet nutrient needs within limited calories. Commenters also stated that the change would expand yogurt variety and participant choice for children in this age group, improve participants' shopping experience because of the expanded options it affords, increase access to and consumption of dairy/yogurt, and reduce administrative, participant, and healthcare provider burden. The few commenters who opposed this provision, including WIC State agencies, stated that this change would create an administrative burden, requiring WIC State agencies to re-work the current category/subcategory structure on the MIS for the different fat levels of yogurt, and requesting to retain whole fat yogurt as the default standard issuance and allow the participant to determine which yogurt best suits their needs at the store.
The Department appreciates support for this provision and highlights the change to allow whole and low-fat yogurts as standard issuance to children 12 to 23 months of age aligns with the 2020-2025 DGA and expands yogurt variety and participant choice. While there are administrative efforts associated with the change, this one-time effort to update the MIS reduces the ongoing administrative burden of prescribing fat content at the time of food package prescription, as well as participant and healthcare provider burden associated with the current WIC State agency option to require (if necessary) a consultation with the child's health care provider to issue low-fat (0.5-2 percent) or nonfat yogurt.
The Department received one comment expressing concern the change may increase the amount of sugar young children consume, given the relatively higher added sugar content of low-fat yogurt. Through this rulemaking, USDA is reducing added sugars provided through the WIC food packages by no longer allowing flavored milk and placing limits on added sugars for WIC-eligible plant-based beverages and dairy and plant-based yogurts. The Department believes this change allows modest flexibility to participants within the DGA-recommended limits on sugars that supports a healthy dietary pattern over time and that through nutrition education WIC staff can work with parents and caretakers to identify the yogurt that works for them and encourage foods and beverages with little to no added sugars.
This final rule removes cheese as a separate food category for fully breastfeeding participants (Food Package VII) as NASEM recommended to provide a better balance of nutrients and align with the DGA recommendation for reducing saturated fat consumption. Participants receiving the fully breastfeeding food package will continue to be able to substitute cheese for milk like all other participants receiving milk in their food package.
The Department received several comments in support of this provision, including from several WIC State agencies, stating that reducing the cheese allotment would be consistent with NASEM and DGA recommendations regarding reducing saturated fat intake and provide a better balance of nutrients. Commenters also noted that retaining the ability to substitute cheese for milk allows participants continued access to this food. Some commenters opposed this provision, including several WIC State agencies, asserting that it is detrimental to nursing mothers who have increased caloric needs and particularly so for individuals who are lactose intolerant but may tolerate cheese. These comments also discussed the overall importance of dairy products to health and nutrition and that removing cheese could limit calcium and protein for breastfeeding participants and disincentivize fully breastfeeding.
The Department reiterates that cheese remains available to all participants (except for infants) as a partial milk substitution. While participants receiving the fully breastfeeding food package will no longer have cheese as a separate food item, they are still able
The following provisions did not receive significant or substantial public comment; this final rule codifies the following provisions as summarized in the 2022 proposed rule:
• Require all State agencies to authorize unflavored lactose-free milk.
• Increase yogurt substitution amounts from 1 quart of yogurt for 1 quart of milk to allow up to 2 quarts of yogurt for 2 quarts of milk.
• Expand substitution options by removing the limitation that no more than a total of 4 quarts of milk (for participants in Food Packages IV-VI) or 6 quarts of milk (for participants in Food Package VII) may be substituted for a combination of cheese, yogurt, or tofu.
• Create separate food packages for children 12 through 23 months (Food Package IV-A) providing 12 quarts of milk and children 2 through 4 years (Food Package IV-B) providing 14 quarts of milk.
• Update the FDA Standard of Identity (SOI) citations for yogurt.
As NASEM recommended, this final rule reduces the amount of infant cereal for all infants and reduces the amount of infant fruits and vegetables and infant meat for fully breastfed infants. This final rule also increases substitution amounts for infant fruits and vegetables; allows forms other than fresh; and lowers the minimum age for all infants to receive a CVV. These changes provide supplemental quantities and align with AAP's complementary feeding recommendations. This final rule does not exclude “added fats” from the ingredients authorized for infant foods as originally proposed.
This final rule does not address the early introduction of peanut butter to infants. While the Department appreciates comments on this topic in conjunction with comments on the proposed changes to infant foods, the topic is outside the scope of this final rule. Infants ages 6 through 11 months receive complementary foods in the categories of infant cereals, infant food fruits and vegetables, and infant food meat. Currently, a legumes and peanut butter category is not part of the infant food packages. In their 2017 report, NASEM did not recommend changes to include new infant foods, such as legumes and peanut butter, to the infant food packages or review the appropriate amount of peanut butter to include in the infant food package if such changes were made. The Department recognizes there is an evolving body of scientific data that supports the early introduction of peanut-containing foods to help prevent a food allergy to peanuts; however, the applicability to the WIC food packages still requires further exploration and this topic may be included as part of the next comprehensive scientific review of the WIC food packages.
This final rule codifies the reductions to infant foods as summarized in the 2022 proposed rule. The revisions do not change the types of infant foods offered, maintaining alignment with DGA recommendations to introduce foods from all food groups starting at about 6 months of age and to include foods rich in iron and zinc, particularly for infants fed human milk. The reduction to infant foods provides appropriate supplemental quantities, as NASEM recommended, and align with the AAP's complementary feeding recommendations. In the interest of clarity, reduction to infant cereal, infant fruits and vegetables, and infant meat are discussed separately in this section.
Based on NASEM recommendations, this final rule codifies the reduction in the amount of infant cereal from 24 ounces to 16 ounces for fully breastfed infants and from 24 ounces to 8 ounces for partially (mostly) breastfed and fully formula fed infants. NASEM's review identified the current infant food packages as providing 150 percent of the maximum amounts of infant cereal recommended by the AAP.
Many commenters, including multiple WIC State agencies, expressed support for the reduction in infant cereal noting alignment with NASEM and AAP recommendations. Multiple WIC State agencies reported low redemption rates of infant cereal, and another commenter stated that cereal is often used as a starter food for infants up to 9 months of age and not used much thereafter. Some commenters expressed concern about reducing cereal for breastfed infants as it is a reliable source of iron for infants past 6 months of age, especially for infants who do not receive iron-fortified formula and for the WIC population, which has higher nutritional risk.
One commenter stated that the 2017 NASEM report reflects an incorrectly calculated AAP recommendation for infant cereal. The Department does not agree with this comment. NASEM's recommendations are based on the AAP's 2014 Pediatric Nutrition, 7th Edition recommendations, which were unchanged in their 2020 update and remain current.
The Department agrees that providing iron and zinc rich foods to infants 6 months of age and older is important, especially for fully breastfed infants. This final rule provides infant cereal in amounts that align with the NASEM and current AAP recommendations and recognize that breastfed infants may require more iron and zinc fortified cereal than formula fed infants because human milk contains low levels of these nutrients. USDA may further assess adequate iron intake through infant cereal during the next comprehensive review of the WIC food packages.
In addition to comments on the amount of infant cereal in WIC food packages, the Department received a few comments encouraging the removal of infant rice cereal as a WIC-eligible food, citing high arsenic levels. Through comments, the Department is aware that several WIC State agencies have already removed refined infant rice cereals from APLs due to concerns of arsenic levels. One commenter suggested requiring infant cereals to be whole grain with the exclusion of brown rice as a method of reducing exposure to arsenic, while others acknowledged arsenic concerns
The Department is following the recommendations of the FDA's Closer to Zero
As NASEM recommended, this final rule codifies the reduction in jarred infant fruits and vegetables for fully breastfed infants from 256 ounces per month to 128 ounces per month. According to NASEM, the current fruit and vegetable amount in the fully breastfed food package provides more than a one cup-equivalent of fruits and vegetables per day, an amount difficult for 6 through 11-month-old infants to consume. The revised amount aligns with the amount currently provided to partially (mostly) breastfed and fully formula fed infants.
Many commenters, including WIC State agencies, expressed support for the proposed reductions in infant fruits and vegetables due to low redemption rates and the importance of introducing a variety of foods—in multiple forms—to infants beginning at about 6 months. The Department agrees. As noted in the 2022 proposed rule, the current food package provides fully breastfed infants with more than a one cup-equivalent of fruits and vegetables per day, an amount difficult for an infant 6 to 11 months of age to consume.
The few comments in opposition cited general concern for a reduction in the amount of food provided, noting this may disincentivize the fully breastfeeding food package. The Department appreciates this concern and believes that the numerous changes to this food package, designed to increase variety, choice, and flexibility will provide continued appeal for fully breastfeeding participants. In addition, the Department notes that the reduction aligns with the overarching rationale for this rulemaking to provide supplemental amounts of food and improve the balance of foods and nutrients in the food packages.
The Department also received one suggestion to codify the reduced amount but introduce this provision beginning at 4 months of age. While the Department recognizes some infants may show developmental signs of readiness for nutrient-dense complementary solid foods before 6 months of age, the AAP recommends complementary foods should be introduced to infants at about 6 months of age.
This final rule codifies the reduction in infant meats for fully breastfed infants from 77.5 to 40 ounces, as summarized in the 2022 proposed rule. This revised amount provides approximately 65 percent of the AAP-recommended maximum (previously 130 percent).
Many commenters, including WIC State and local agencies, expressed support for the reduction of infant meats in the fully breastfeeding package to align with the supplemental nature of the program and cited low redemption rates of infant meats. Several commenters stated that many of their WIC clients do not like the single ingredient jarred infant meats. Another commenter stated that pureed meats are one of the lowest redeemed foods and are not as culturally acceptable within their Tribe as other protein sources. There were few comments in opposition to this provision. Some commenters stated that meats are a good source of complete protein, heme iron, zinc, and other vitamins and minerals that support neurologic development and immune function, especially among breastfed infants that do not receive iron supplementation in formula. Another commenter stated that meat-based protein is considered optimal for infants as it is a high-quality protein and digested and absorbed more efficiently.
The Department agrees that infant meats provide a good source of iron and zinc that is important for fully breastfed infants. However, reducing infant meats to a supplemental quantity is consistent with the goals of this rulemaking and dietary guidance to consume a balanced diet that meets but does not exceed recommended amounts of foods and nutrients.
Due to the low redemption of infant meat and the importance of this food as an iron source for fully breastfed infants, the Department requested public comment on ways to support increased redemption of infant meats, and iron-rich foods in general, for fully breastfed infants. Several commenters requested USDA allow alternatives to infant jarred meats, such as infant combination foods containing meats and vegetables, or allowing meat alternatives such as eggs, legumes, and tofu. Other commenters recommended adding fresh meat and fish to infant food packages. The Department appreciates these suggestions but believes that before such changes can be incorporated, additional research is needed to identify and develop strategies to increase iron consumption among WIC infants, as well as identify good sources of heme iron that meet eligibility criteria for WIC. Although no changes were made in this final rule in response to these comments, the Department will consider these comments in the future development of nutrition education and resources.
The Department appreciates the suggestions to increase redemption and consumption of infant meat and alternate options for iron-rich foods. NASEM considered inclusion of infant meat dinners (which contain meat and vegetables) but determined the amount of iron per ounce is significantly lower compared to single ingredient products. NASEM also determined that the non-heme iron found in eggs, tofu, and legumes would not be nutritionally equivalent to the heme iron available in infant meats. Regarding seafood for infants, while the current EPA-FDA advice for eating fish
Commenters also highlighted the importance of nutrition education as a way to improve iron consumption. The Department agrees that nutrition education can be used to encourage consuming iron rich foods, including those containing meat, and this messaging should continue to be part of the nutrition education provided to WIC participants.
This final rule codifies the increase to the CVV substitution amount for infants; allows the CVV for infants to be used to purchase at least one other form of fruits and vegetables in addition to fresh (see section A. Fruits and Vegetables. Require One Other Form of Fruits and Vegetables in Addition to Fresh); and lowers the age (from 9 to 6 months) at which the CVV can be substituted for infant fruits and vegetables, as summarized in the 2022 proposed rule.
Many commenters expressed support for all three actions in this provision, stating they better meet the needs of and empower families to prepare more foods at home, accommodate varied food preferences, and are more consistent with the developmental progression of feeding complementary foods. One commenter suggested allowing the CVV substitution to begin at 4 months of age, which the Department will not implement as NASEM and the DGA recommend introducing complementary foods around 6 months of age (see b. Infant Fruits and Vegetables above).
One commenter opposed this provision, stating that allowing the CVV substitution would be inconsistent with NASEM recommendations and reduce the net fruit and vegetable servings obtained through WIC and expressed concern that substituting a CVV for infant fruit and vegetable purees may result in older family members consuming the food, instead of the infant as intended. The Department clarifies this provision mirrors NASEM's recommendation to provide either: 128 ounces of infant fruits and vegetables; 64 ounces of infant fruits and vegetables and a $10 CVV; or no infant fruits and vegetables and a $20 CVV, and that all three options support a supplemental amount of fruits and vegetables for infants. Substituting jarred infant fruits and vegetables with the CVV may allow participants to buy more servings of these foods and allow caregivers to prepare foods with developmentally appropriate textures for older infants. Regarding the potential of another family member using the infant CVV, the Department appreciates this concern and believes it is addressed through education at the time of food package issuance, which includes instructions that all foods issued—not just the CVV substitution—are intended for participant use only.
This final rule will not codify excluding “added fats” from the ingredients allowed in infant foods as summarized in the 2022 proposed rule. The Department proposed this change to align infant food packages with the healthy eating patterns of children as they grow. However, several commenters expressed general concern about this proposed provision, finding the recommendation vague and affirming that variables (such as those described below) would need to be considered to carry out the provision effectively. Other commenters discussed the benefits of fats, including omega-3 fatty acids needed for brain development. One commenter questioned the availability of infant meats without broth/gravy containing added fats, suggesting USDA consider excluding added fats from infant cereal, fruits, and vegetables only. The Department finds merit in the concerns commenters expressed pertaining to restricting all added fats from infant foods which would include polyunsaturated fats which play a role in brain development of infants as well as the operational feasibility of implementing this provision. USDA may consider additional research during the next comprehensive review of the food package to determine if restricting added fats is feasible in a way that supports infants' comprehensive nutrition needs and program administration.
This final rule increases formula amounts in the first month for partially (mostly) breastfed infants; allows all prescribed infant formula quantities to be considered “up to” amounts; and creates a separate and enhanced food package for partially (mostly) breastfeeding participants. These changes will be codified as proposed, with no modification, and will collectively add flexibilities to infant formula amounts and create a separate food package to strengthen support individual breastfeeding goals to help participants establish successful long-term breastfeeding.
This final rule codifies the increased maximum monthly infant formula amounts for partially (mostly) breastfed infants in the first month from 104 fluid ounces to up to 364 fluid ounces, as summarized in the proposed rule. Consistent with current requirements, the amount of formula issued will continue to be tailored based on an individual nutrition and breastfeeding assessment. [Note: The revised amount of 364 fluid ounces reflects the FNB and corresponds to the MMA of 388 fluid ounces of reconstituted liquid concentrate, 384 fluid ounces of ready-to-feed, or 435 fluid ounces of reconstituted powder formula for partially breastfed infants aged one through three months. Therefore, this provision eliminates the need for the birth to one month feeding category.]
This proposed change received support from many commenters, who cited that the change would assist participants in achieving their breastfeeding goals, ensure infants receive adequate nutrition, increase breastfeeding duration, and decrease premature categorization of fully formula-fed infants. A few commenters requested USDA focus on providing education and counseling resources to help WIC staff support participants in the early postpartum period. They also requested additional breastfeeding supports to address breastfeeding challenges as well as additional funding for training staff and incentivizing the breastfeeding packages. One commenter requested the Department consider making the “up to” 364 ounces in the first month a WIC State agency option. A few commenters mentioned that more
Increasing the amount of infant formula in the first month for partially (mostly) breastfed infants, as NASEM recommended, encourages participants in the early postpartum period to try to breastfeed or extend breastfeeding duration by providing flexibility to tailor formula amounts based on an individual nutrition and breastfeeding assessment. As NASEM noted, this change is intended to prevent the premature categorization of an infant as “fully formula fed” and a mother as “postpartum” and allow the mother to receive the partially (mostly) breastfeeding food package to support nutritional needs and breastfeeding goals. USDA agrees with commenters who stated that early postpartum anticipatory guidance and frequent contact with skilled breastfeeding staff are key ways to encourage and support WIC participants in reaching their individual breastfeeding goals. The Department finds merit with the comments requesting further examination of the impact of this provision on breastfeeding duration and will consider this for future research opportunities.
This final rule codifies that all prescribed infant formula quantities will be considered “up to” amounts as summarized in the 2022 proposed rule. This change is intended to reduce interference with the successful establishment of breastfeeding.
Many commenters expressed support for allowing all prescribed infant formula quantities to be considered “up to” amounts. Specifically, several commenters expressed support for tailoring formula benefits to meet individual needs. An individual commenter thanked the Department for removing the minimum nutrition requirement. One commenter stated the change aligns with recommendations among the healthcare/nutrition community on customized nutrition and another said the change would help establish long-term breastfeeding.
One commenter supported removing the FNB requirement stating that it, and MMAs, create a narrow window of formula amounts that WIC agencies must provide depending on the age of the client. While the Department appreciates this comment, the FNB is intended to provide close to 100 percent of the nutritional needs of a non-breastfed infant from birth to 6 months and is used as the basis for determining comparable MMAs of infant formula across the three physical forms of formula. The MMA is intended to provide infants the FNB with consideration of the reconstituted fluid ounce yields of the physical forms of formula products. However, formula amounts, even those in the fully formula-fed category, can still be individually tailored to meet, but not exceed, the formula needs of breastfeeding infants.
A few commenters had questions about the meaning of this provision as well as operational concerns. One commenter stated they would rather address overissuing/over feeding of formula via education at the time formula is issued. Another commenter requested clarity on what is meant by the phrase “up to” amounts for fully formula fed infants. The Department clarifies that across all infant food packages, formula amounts should be considered “up to” amounts to emphasize the importance of assessing the actual need for formula and reduce the possibility of interfering with the successful establishment of the participant's desired breastfeeding behavior. One commenter stated this change will be a burden for MIS changes because the FNB serves as a cutoff to determine whether participants are fully formula feeding or partially (mostly) breastfeeding and that WIC State agencies using the roundup method still need an FNB. The Department appreciates this concern and provides further clarification on implementation related comments in section V. Implementation.
Although the Department did not propose a revision to the iron standard for infant formula, it did seek comment on the current infant formula iron requirement of at least 10 milligrams of iron per liter (at least 1.5 milligrams per 100 kcal) of formula. Several commenters stated that the current requirement for iron-fortified formula should remain, noting iron-deficiency anemia continues to be a health concern for infants in the United States. A few commenters said they would support a change if backed by evidence. One commenter stated they support reducing the standard if this allows for a greater variety of formula to be available for WIC participants without compromising infant health. Another commenter noted that because infants normally have dietary iron sources other than formula (especially fortified infant cereal and meats), that 12 milligrams of iron per liter in formula appears to supply more iron than is necessary. In its comments, the AAP concluded that infant formula containing 12 milligrams of elemental iron per liter is safe for its intended use. One commenter requested that USDA consider revising the minimum iron requirements for infant formula to be consistent with the 1 milligram per 100 kcal requirement under § 246.10(e)(1)(iii) for iron-fortified infant formulas.
The Department appreciates the comments provided and agrees with most commenters that a regulatory change to the current iron specifications for infant formula is not warranted at this time due to inadequate evidence available to support a modification. The Department agrees with NASEM that updated data is needed to understand the optimal level of iron in infant formula, particularly in cases where the baseline iron status of infants is not optimal. The FDA announced on May 19, 2023, that NASEM will conduct a study to look at supply, market competition, and regulation of infant formula in the U.S. The study will explore the current state of the U.S. infant formula market. The study will also examine the differences in nutrition content, labeling, and regulatory requirements between infant formula sold in the U.S. and forms sold in foreign markets. Results of the study will be submitted to Congress and the FDA. New evidence from this study and other available sources regarding iron formula supplementation, including the FDA/NASEM study may be used to inform the next review of the WIC food packages.
This final rule codifies the creation of separate food packages for partially (mostly) breastfeeding participants, as summarized in the proposed rule. Pregnant participants will now receive Food Package V-A and partially (mostly) breastfeeding participants and pregnant participants with two or more fetuses will now receive Food Package V-B.
Many commenters expressed support for creating a separate and enhanced food package for partially (mostly) breastfeeding participants. Several commenters stated it better met the nutrient needs of participants in these categories, better aligned with NASEM recommendations on customized nutrition, supported breastfeeding, more accurately reflected breastfeeding rates,
A few commenters asked that breastfeeding benefits be expanded to two years instead of one year to incentivize breastfeeding. WIC legislation specifies that “breastfeeding women means women up to one year postpartum who are breastfeeding their infants.”
Some commenters specifically addressed the food package for participants who are pregnant with or breastfeeding multiples. One commenter stated that participants who are breastfeeding multiples should remain in the same category as pregnant with multiples participants so they can benefit from the extra calories this food package provides. Another commenter asked for a separate food package for breastfeeding multiples, since applying the 1.5 multiplier to the allowed food quantities for Food Package VII can be difficult to translate to actual WIC purchases. The commenter also requested the food package be updated to list specific MMAs in amounts that translate to whole containers. Per the DGA and NASEM's recommendations, participants who are fully breastfeeding multiple infants, pregnant with multiple fetuses, or both pregnant and breastfeeding have higher nutrient and caloric needs than participants with singletons. In the absence of any evidence on the additional energy needs for the participants fully breastfeeding multiple infants, NASEM estimated the additional energy need would be approximately 400 kcal per day for additional milk produced and assumed no further maternal fat mobilization. This represents approximately 50 percent more energy than the fully breastfeeding package supplies, indicating the current regulation to provide 1.5 times Food Package VII to these participants is appropriate. To eliminate concern about providing “half” of a food package, WIC State agencies have the option to issue foods in Food Package VII in amounts averaged over a 2-month timeframe where they issue double the “regular” fully breastfeeding package one month and the “regular” fully breastfeeding package the next month. NASEM did not study, nor did USDA propose a separate WIC food package for participants fully breastfeeding multiple infants.
Several commenters raised concerns that this change could have negative impacts on breastfeeding efforts. A few commenters stated the proposed revision would make the food packages for exclusively breastfeeding participants and partially (mostly) breastfeeding participants similar, minimizing the actual and perceived value of the exclusively breastfeeding package compared to the partially breastfeeding package. Some commenters reasoned the new food package, along with the reduction in benefits for fully breastfeeding participants, would disincentivize participants to fully breastfeed.
The Department appreciates comments highlighting the importance of nutrition education and other resources to support and encourage exclusive breastfeeding and will continue to evaluate and add to breastfeeding support services as needed. The Department clarifies that participants in the fully breastfeeding category will still receive more benefits than partially (mostly) breastfeeding participants due to their higher caloric needs.
This final rule requires that WIC-eligible whole grain breakfast cereals contain a whole grain as the first ingredient. This rule modifies the initial proposal and requires 75 percent of a WIC State agency's authorized breakfast cereals to meet the whole grain criteria of having whole grain as the first ingredient; and breakfast cereals contain no more than 6 grams of added sugars per dry ounce.
This final rule codifies the whole grain criteria for breakfast cereals as summarized in the 2022 proposed rule, requiring WIC-eligible whole grain cereals to contain a whole grain as the first ingredient.
Commenters expressed general support for this provision, with many WIC State agencies appreciating the reduced burden to operationalize the criteria for whole grain breakfast cereal, explaining the current criteria (having whole grain as the primary ingredient by weight and meeting the FDA labeling requirements for making a health claim as a
The few comments opposing this provision cited concern that breakfast cereals with a refined grain as the first ingredient but with more than 50 percent total whole grains would no longer be eligible. The Department understands and addresses this concern by requiring that at least 75 percent of breakfast cereals meet the criteria for whole grain cereal, as discussed below.
This final rule codifies the requirement that WIC-eligible breakfast cereals meet the whole grain criteria as summarized in the 2022 proposed rule with modification to require 75 percent of cereals rather than 100 percent of cereals meet the whole grain requirement as initially proposed.
USDA received numerous comments in support of the provision as proposed. In expressions of support, commenters stated that requiring all WIC-eligible breakfast cereals to be whole grain aligns with the DGA recommendation to consume at least half of total grains as whole grains and supports consumption of an under consumed food subgroup and the nutrients whole grains provide. Several commenters suggested the provision would have an added benefit of expanding marketplace availability of whole grain cereals. The Department agrees with the importance of consuming whole grains and clarifies that while the marketplace could expand further, there are numerous breakfast cereals currently available that meet the whole grain criteria, including gluten-free varieties suitable for individuals with allergies to wheat.
While commenters supported the goal of increasing whole grain consumption, the Department received many comments in opposition to requiring that all breakfast cereals meet the whole grain criteria. WIC State agencies cited the increased burden on small vendors and the reduction in participant choice as primary concerns. Some commentors noted that cereal consumption can help drive milk and fruit consumption as well as highlighted the overall nutrients cereals provide (
The Department appreciates the comments received on this provision and specific suggestions to modify the requirement so that 75 percent of WIC-eligible breakfast cereals meet the whole grain criteria. Breakfast cereal is included in the WIC food packages to deliver key nutrients—primarily iron—to WIC participants. Some highly redeemed WIC cereals deliver key nutrients (
This final rule codifies a limit of 6 grams of added sugars per dry ounce of breakfast cereal based on public comment as requested in the 2022 proposed rule.
In response to the request for comment on the use of an added sugars limit instead of a total sugars limit for breakfast cereal, the Department received broad general support. Commenters noted an added sugars limit aligns with current dietary guidance and Federal standards for Child Nutrition Programs. Commenters further highlighted that an added sugars limit allows for distinction between naturally occurring sugars and those added during product manufacturing, which is not possible with a total sugars limit. The Department agrees there is value in alignment across Federal nutrition programs and that an added sugars limit is consistent with the 2020-2025 DGA as well as feasible to operationalize following the addition of added sugars to the Nutrition Facts label.
Comments in opposition cited concern that an added sugars limit may reduce the number of WIC-eligible breakfast cereals. A small number of WIC State agencies noted the additional burden associated with identifying breakfast cereals meeting the added sugars limit. One commenter suggested an added sugars limit may increase the use of low- and no-calorie sweeteners to retain product palatability. The Department clarifies the added sugars limit maintains the same numeric limit (6 grams) as the current total sugars limit; however, the limit no longer applies to naturally occurring sugars, in effect creating a more permissive standard for products containing naturally occurring sugars. In practice this means that no currently eligible WIC breakfast cereals will be excluded under the added sugars limit. The Department appreciates the burden associated with identifying products that meet WIC specifications and the potential substitution of low- and no-calorie sweeteners for caloric alternatives; however, the Department recognizes these considerations exist regardless of whether the limit applies to total or added sugars.
This final rule reduces the amount of whole wheat bread, whole grain bread, and whole grain options in the child food packages and increases the amount in the pregnant, postpartum, and breastfeeding food packages as proposed. This rule also expands whole grain options as proposed with the modification to allow for additional whole grain options that meet regulation requirements.
This final rule codifies the reduction in bread and whole grain options in the child food packages (from 32 to 24 ounces), and the increase in bread and whole grain options in the pregnant, postpartum, and breastfeeding food packages (from 16 to 48 ounces) as summarized in the 2022 proposed rule.
Commenters, including several WIC State agencies, expressed mixed support for this provision, with many generally supporting the increase for pregnant, postpartum, and breastfeeding participants but with some concern cited over the reduced quantities for children. Commenters asserted the importance of consuming and ensuring equitable access to whole grains, highlighting the reduced quantity for children could lead to a reduction in whole grain intake. Consistent with comments received on other provisions reducing quantities of supplemental foods provided, including juice and milk, several WIC State agencies noted the reduced quantity of bread and whole grain options may disincentivize participation and impede participant retention goals. Commenters generally appreciated the Department aligning quantities with the common 24-ounce package size.
The Department agrees that providing whole wheat bread, whole grain bread, and other whole grain options through the WIC food packages is important to support whole grain consumption among WIC participants. The quantities of 24 ounces for children and 48 ounces for pregnant, postpartum, and breastfeeding participants provide up to 53 percent of the whole grain subgroup amount recommended in the DGA dietary patterns, which the Department believes is an appropriate supplemental
This final rule codifies the change in criteria for whole grain bread to require that such breads must contain at least 50 percent whole grains with the remaining grains being either enriched or whole grains as summarized in the 2022 proposed rule. The current requirement that whole grain bread conform to FDA standards of identity, as applicable, is maintained.
Most commenters, including many WIC State agencies, supported the change in criteria for whole grain bread, with several acknowledging the alignment with other Federal nutrition programs. Many commenters stipulated support for this provision as dependent on the Department providing guidance on the evaluation of grain products, noting that product labels often do not easily identify the whole grain composition placing the burden on WIC State agencies to identify allowable products under the revised criteria. Commenters further suggested USDA consider individuals with intolerances or allergies to wheat in finalizing the criteria for whole grain breads.
The Department agrees with the importance of guidance on the evaluation of grain products meeting the criteria for whole grain breads and will support WIC State agencies in the implementation of this provision. The Department understands the importance of providing whole grain foods that do not contain gluten to accommodate special dietary needs and clarifies that in addition to whole wheat bread, which contains gluten, whole grain breads, which may or may not contain gluten depending on the grain(s) included, continue to be WIC-eligible foods. The Department encourages WIC State agencies to authorize whole grain breads without gluten as necessary to meet the needs of their participants. Additionally, the Department is expanding whole grain options in this final rule, as discussed below.
This final rule codifies the expansion of whole grain options to include the following options as summarized in the 2022 proposed rule: quinoa; wild rice; millet; triticale; amaranth; kamut; sorghum; wheat berries; tortillas made with folic acid-fortified corn masa flour (once available in the marketplace); corn meal (including blue); teff; buckwheat; and whole wheat pita, English muffins, bagels, and naan. Further, based on public comments received, to increase participant choice, and maximize administrative flexibility, this final rule allows WIC State agencies to authorize additional whole grain options that meet nutrient requirements in WIC regulations (
Commenters, including numerous WIC State and local agencies, broadly supported this provision, noting the expanded options will allow participants to enjoy a greater range of nutrient-dense foods while accommodating special dietary needs (
The Department agrees with the importance of participant choice and accommodating cultural and personal dietary preferences and appreciates suggestions to further expand whole grain options. The Department recognizes that culturally preferred foods vary and are unique to individual cultural identity and that WIC State agencies are best positioned to determine the whole grain options to authorize to accommodate the needs of their participants. Therefore, through this final rulemaking, USDA provides the option for WIC State agencies to authorize additional whole grain options that do not include added fats or sugars, salt, or oil, including but not limited to the options suggested through public comments (
One commenter requested clarification on changes to the minimum stocking requirements for vendors, noting the potential for food waste and economic loss if vendors are required to stock whole grain options that are not popular locally. In response, the Department clarifies that with this provision, there will be no changes to the whole grain stocking requirement of at least one whole grain cereal set in WIC regulations § 246.12(g)(3)(i). The Department recognizes WIC State agencies may choose to establish additional minimum stocking requirements to ensure access to a greater variety of supplemental foods. However, establishing additional minimum stocking requirements cannot have the effect of limiting either the number or distribution of WIC authorized vendors in such a way that participants cannot reasonably redeem their benefits.
This final rule expands the categories of participants receiving canned fish as proposed, with the modification of including 1 year old children, to create more equitable access to this under consumed, nutrient-dense food.
This final rule codifies the addition of canned fish to the food packages for children with modification to provide:
• 6 ounces per month for children 2 through 4 years of age, versus 5 ounces as proposed, and
• 6 ounces per month for children 12 through 23 months of age.
In the 2022 proposed rule, out of an abundance of caution for the safety of young children and the concern for methylmercury exposure, USDA limited the addition of canned fish per month to 5 ounces for children 2 through 4 years and excluded canned light tuna as a canned fish option for children. At the time, the Department lacked information on marketplace availability of WIC-eligible canned varieties in sizes that would provide a supplemental amount for 1-year old children and meet
• * Serving size for 1-3 years old is 1 ounce. Serving size for 4-5 years old is 2 ounces.
• Children ages 1-4 years: Canned light tuna and chub mackerel should not be consumed if greater than 2 oz per week is consumed.
Commenters, including WIC State and local agencies, expressed broad support for providing fish in the child food packages, citing the benefits of fish in helping children meet their nutrient needs for optimum growth and development as well as reducing risk of developing chronic diseases. In addition to being supportive of adding fish, the food industry, many WIC State agencies, and professional organizations commented on the importance of providing light tuna as an option for all children 1 to 4 years of age.
To inform this final rule, USDA requested public comment on the availability of 3-ounce or smaller package sizes of canned salmon, Atlantic mackerel, and sardines in boneless varieties, and canned light tuna in package sizes safe for consumption by young children (
In alignment with NASEM and DGA recommendations and EPA-FDA joint advice about eating fish, and in consideration of the numerous comments and evidence received on marketplace availability of smaller container sizes of WIC-eligible varieties of canned fish in both boneless and bone-in options, this final rule adds 6 ounces of canned fish to the food packages for children 1 through 4 years of age in the same varieties as canned fish offered to pregnant, postpartum, and breastfeeding participants (
The Department appreciates and agrees with comments highlighting the important role WIC nutrition education will have in encouraging parents and caretakers to select boneless canned fish or remove bones prior to consumption to prevent choking, choose lower sodium varieties and amounts that limit methylmercury exposure, and preserve unused portions of canned fish safely.
This final rule codifies the monthly amounts of canned fish for pregnant, postpartum, and partially (mostly) and fully breastfeeding participants as summarized in the 2022 proposed rule:
Commenters expressed broad support for adding canned fish to the WIC food packages for pregnant, postpartum, and partially (mostly) breastfeeding participants and revising amounts for fully breastfeeding participants. In expressions of support, commenters asserted that omega-3 fish oils are essential for reducing risk for pre-term births and other such complications and that the changes would provide more equitable access to a nutrient-dense food choice, for which current intakes fall below DGA-recommended levels. A WIC State agency commented that the change will improve nutrient content and versatility of the WIC food packages. The Department appreciates comments expressing concern about the reduction of canned fish for the fully breastfeeding food package and requests to increase amounts of canned fish for partially (mostly) and fully breastfeeding participants. The revised monthly canned fish amounts for all pregnant, postpartum, and breastfeeding participants align with the supplemental nature of WIC and recommendations for DGA healthy dietary patterns.
This final rule codifies removing jack mackerel from the WIC-eligible canned fish varieties as summarized in the 2022 proposed rule.
Commenters expressed broad support for revising WIC-eligible fish varieties. One WIC state agency expressed opposition to the exclusion of jack mackerel, adding that the decision would increase its administrative burden. The FDA and EPA currently do not have methylmercury data on the commercial canned fish product “jack mackerel” and do not include this product in their joint advice about eating fish. Furthermore, the FDA guidance on defining jack mackerel species referenced in § 246.10(e)(12) is no longer available. Due to the lack of data on methylmercury levels in jack mackerel, this final rule retains the provision to remove jack mackerel as an allowable fish type for WIC. All other WIC-eligible varieties of canned fish (
In response to the request USDA received to remove “canned” from the name of the fish category to account for other package types, the Department clarifies that § 246.10(e)(12), table 4 outlines minimum requirements and specifications for canned fish and defines that “canned” fish refers to processed food items in cans or other shelf-stable containers such as jars or pouches, which serves to denote that fresh and frozen fish are not WIC-eligible items.
This final rule requires authorizing both dried and canned legumes; requires substituting legumes and peanut butter for eggs in certain situations; and provides the option to substitute tofu for eggs as proposed. This rule will also provide the option for State agencies to authorize nut and seed butters as a modification to the proposed rule. The changes allow participants (except infants) to substitute the following for one dozen eggs to accommodate special dietary needs, cultural practices, and personal preferences:
This final rule codifies the requirement for WIC State agencies to authorize both dried and canned legumes as summarized in the 2022 proposed rule. Prior to this rulemaking, regulations only required dried legumes
Commenters expressed broad support for this change to increase flexibility and choice for participants, specifically citing the time-saving benefits of canned legumes, flexibility for participants lacking knowledge or equipment to prepare dried legumes, and potential increases in redemption rates. The Department agrees that this change will reduce a potential barrier to preparing and consuming legumes for participants who are unable to prepare dried legumes.
Among comments were requests to allow frozen unflavored legumes and small amounts of added sugars in canned legumes, reasoning that some canning processes require sugar to maintain the quality and structure of the food. USDA currently allows small amounts of added sugar to canned legumes for processing. The Department clarifies that WIC State agencies will retain their current authority to elect to authorize only low/lower sodium canned varieties. Regarding adding frozen legumes to the list of authorized legumes, currently, frozen legumes can be purchased with the CVV. The Department will explore the feasibility of adding frozen legumes to the legumes category for consideration in future rulemaking.
USDA did not receive any comments in opposition, though a few commenters noted the potential need for MIS changes. The Department addresses this concern for all categories of food in section V. Implementation.
This final rule codifies the requirement for WIC State agencies to allow participants to substitute legumes and peanut butter for eggs and the option for WIC State agencies to authorize tofu as a substitute for eggs as summarized in the 2022 proposed rule.
Numerous commenters, including several WIC State agencies, expressed support for this provision citing a greater variety to accommodate special dietary needs, cultural practices, or personal preferences, as outlined in the 2022 proposed rule. In conjunction with this provision, the Department requested comment on the impact of requiring WIC State agencies to authorize tofu as an egg substitution. Some commenters expressed concern with the substitution of tofu for eggs, stating that eggs are high-protein, low-cost, and a better nutrition source than tofu. While the Department agrees that eggs are a high-protein, low-cost food, it believes the proposed substitutions are appropriate for those who cannot or choose not to eat eggs due to allergies or food preferences. As noted in the 2022 proposed rule, allowing tofu as a substitute for eggs provides participants with a source of iron and choline when eggs, legumes, and peanut butter are not acceptable food choices. However, the Department appreciates the comment from a WIC State agency expressing concern that tofu may not be readily accessible and clarifies that while legumes and peanut butter must be offered to participants as egg substitutions, authorizing tofu as a substitute for eggs is a WIC State agency option. A few commenters expressed concerns related to implementation in MIS and point of sale systems. The Department addresses MIS concerns for all categories of section V. Implementation.
This final rule codifies the WIC State agency option to authorize nut and seed butters as a substitute for peanut butter based on public comment as requested in the 2022 proposed rule. While NASEM did not recommend alternative nut and seed butter as substitutions, the Department recognizes nut and seed butters are included in a healthy dietary pattern as recommended by the DGA and requested public comment on allowing these products as a peanut butter or legume substitution option to further accommodate participants with food allergies. The Department specifically requested comments on the commercial availability of nut and seed butters that are nutritionally comparable to peanut butter/legumes in terms of specific nutrients (
Commenters overwhelmingly supported allowing nut and seed butters as substitute for peanut butter, stating that many nut and seed butters could be nutritionally equivalent to peanut butter for protein, iron, choline, and fiber. They also discussed the prevalence and severity of peanut allergies and the importance of WIC food packages providing foods nutritionally equivalent to peanut butter.
The Department recognizes allergies to peanuts and other tree nuts as being among the most common food allergies in children in the United States. In USDA's School Meal Programs, schools must provide meal modifications for participants with disabilities, which may include providing substitutions for students with peanut or tree nut allergies. This requirement for the School Meal Programs and allowing nut and seed butters as a substitute to peanut butter as a WIC State agency option, both support access for participants with food allergies. Since peanut butter serves as a source of iron—a priority nutrient NASEM identified for WIC participants and a DGA nutrient of public health concern for women who are pregnant—in the WIC food packages, this final rule allows WIC State agencies the option to authorize nut and seed butters that provide a comparable nutritive value to peanut butter (
As individuals who are allergic to peanuts may also be allergic to tree nuts, the Department encourages WIC State agencies to consider authorizing a suitable option (
This final rule codifies the option for WIC State agencies to authorize additional product package sizes that provide less than the full MMA as summarized in the 2022 proposed rule. WIC State agencies are still required to make available the full MMA amounts to participants (
Many commenters, including WIC State agencies, expressed general support, stating that providing greater package size flexibility reduces barriers to WIC shopping and increases options for participants; and more options save time and transportation costs for participants by reducing the need to shop at multiple stores and/or make return trips, particularly for those in rural and/or Tribal areas; reduce barriers to benefit redemption and WIC participation; and could ease burdens for small vendors who have expressed difficulty stocking the currently required package sizes. One commenter supported the change and noted participant education would be critical to show that redeeming a certain size may prevent the redemption of full benefits.
In requesting comments on this added WIC State agency flexibility, the Department also requested public comment on requiring State agencies to authorize both package sizes that equal or add up to the MMA (to ensure participants have a pathway to receiving the full food benefits to which program participation entitles them) and packages sizes that do not (to ensure greater variety and choice). Some commenters raised concerns with such a requirement, noting that implementation would require burdensome technical efforts or that the flexibility in approving package sizes could increase the APL size and potentially make it unmanageable. However, a few commenters requested that USDA require WIC State agencies to approve varying food package sizes to create distribution and retail efficiencies in addition to participant flexibility and choice.
The Department acknowledges the administrative burden of requiring WIC State agencies to authorize both package sizes that equal or add up to the MMA and packages sizes that do not for each food category, thus retained the latter as a WIC State agency option in this final rule. WIC State agencies wishing to exercise this option may do so at a rate reasonable to retain a manageable APL size and, as an option, are not required to do so by the implementation date for required provisions. To meet participants' needs, the Department encourages WIC State agencies to provide as much variety and choice as possible for as many food categories as possible, to the extent that is administratively and financially feasible given cost containment measures. Additionally, the Department agrees with commenters who noted the importance of education to ensure participants receive the greatest benefit from their WIC food package and reminds WIC State agencies of this requirement as outlined in § 246.10(b)(2)(ii)(A).
This final rule updates the definition of
This final rule codifies an update to the definition of disability as summarized in the 2022 proposed rule: the term disability means, with respect to an individual, a physical or mental impairment that substantially limits one or more of the major life activities of such individual, a record of such an impairment, or being regarded as having such an impairment as described in 28 CFR 35.108.
Commenters were in broad support of this provision and no commenters opposed.
This final rule codifies including breast pumps as a WIC benefit and adds reference to the sale or offer to sell breast pumps to the definition of
All comments on this provision generally supported the change. Several commenters, including WIC State agencies, expressed support for the dollar threshold, while some commenters requested adjustments to the threshold to a lower amount, such as $500, to allow WIC State agencies to act sooner to address violations. A WIC State agency added that the agency rarely encounters participants who are selling or offering breast pumps, but instead deals with many participants who fail to return the WIC-owned pump. The Department supports WIC State and local agencies in implementing policies and procedures to retrieve breast pumps, without the threat of disqualification, before the dollar threshold is reached.
This final rule codifies clarifying language to the definition of WIC-eligible nutritionals, which are enteral products specifically formulated to provide nutritional support for those with qualifying conditions (see § 246.2 for full definition), as summarized in the 2022 proposed rule, to convey the intent that homemade formulas and manufactured products in the marketplace that appear to be blenderized foods (
A few commenters, including WIC State agencies, supported the updated definition and added it would clarify which foods qualify and would better enable WIC State agencies to enforce which products can be categorized as WIC-eligible nutritionals. A few commenters, including WIC State agencies, urged USDA to continue to include commercially blenderized tube feedings in the definition, stating that commercially blenderized tube feedings meet the definition of a WIC-eligible nutritional, are nutritionally complete, intended for use under medical supervision, and are not equivalent to manufactured blenderized conventional foods. They also requested guidance regarding manufactured products that appear to be blenderized as they have seen an increase in requests. The Department clarifies that commercially blenderized medical foods that meet the requirements of the definition will continue to be eligible for WIC. No commenters opposed.
This final rule codifies adding clarifying language to nutrition tailoring that exists in current policy and language to convey that nutrition tailoring also involves making substitutions to the types and forms of foods to accommodate an individual participant's food allergy or intolerance, cultural preferences, and medical or special dietary needs, as well as situations where the participant refuses or cannot use the item, as summarized in the 2022 proposed rule. This final rule also codifies the clarification that offering a participant substitution in
Commenters, including WIC State and local agencies, were supportive of this provision, stating that the revisions will help accommodate participants with food allergies, cultural preferences, and dietary needs, and promote safety for participants with food allergies. Some commenters urged USDA to ensure product substitutions are determined in advance and not in retail settings and requested to exclude the required documentation needed when a participant requests a change to a food package based on preference.
The Department clarifies that Federal regulations at § 246.10(d)(1) do not require medical documentation to issue food substitutions outside of Food Package III (except for infant formula). The WIC competent professional authority provides nutrition education that addresses nutrition risks identified with diets that restrict certain foods and/or food groups, and WIC State agencies are encouraged to continue ongoing communication between WIC and healthcare providers as necessary. Regarding the request to determine product substitutions in advance and not in retail settings, WIC State agencies are responsible for determining the brands, types, and forms of foods authorized, including the substitution options they elect to authorize. In some situations, such as tailoring a food package for a participant with a peanut allergy, the determination to issue legumes instead of peanut butter is made at the time the food package is issued. In other instances, the WIC State agency may allow the participant to select from a range of allowable options at the time of purchase at the store for other foods, such as canned salmon or canned tuna, and selecting brown rice, corn or wheat tortillas, or whole-grain barley based on their preference and product availability.
This final rule codifies updating the base year (from 2008 to 2022) for the annual inflation adjustment to the CVV amounts as summarized in the 2022 proposed rule.
Most commenters expressed support for this provision, stating that it helps to offset increased food costs, ensures that participants obtain the recommended intake of fruits and vegetables, and allows for the continuity of the benefit. A few commenters stated that the rounding procedure as described in § 246.16(j)(5) should be revised so that the inflation adjustment is rounded up to the nearest multiple of $1 (not rounded down to the next multiple of $1 as is currently in regulation). The approach selected by FNS aligns with the one used in the Supplemental Nutrition Assistance Program (SNAP), which also rounds inflation adjustments down to the next multiple of $1 (7 CFR 273.10(e)(4)(ii)), as well as the National School Lunch Program's national average payment rates, which are rounded down to the nearest cent (7 CFR 210.4(b)). The 2022 proposed rule did not request public comment or make any changes to the current rounding procedures. Therefore, the Department is not making this change in this final rule.
One commenter opposed, stating that the CVV amounts should not be increased for inflation for at least five years since the 2023 amounts should be sufficient for now. The Department disagrees with this suggestion since unadjusted CVV amounts would over time decrease the amounts of fruits and vegetables participants could purchase, thereby conflicting with NASEM's recommendation to provide approximately half of the recommended daily amounts of fruits and vegetables for adults and children.
This final rule codifies conforming revisions and corrections to typographical and grammatical errors as well as improvements for conciseness and clarity of final provisions. The changes will have no substantive effect on the public.
The Department initially proposed WIC State agencies would have 18 months from publication of the final rule to implement the revisions to the food packages and all other provisions in the rule. Additionally, the Department proposed that once the WIC State agency began issuing each new food package, it be done on a State agency-wide basis. The Department requested comments on the administrative burden associated with both proposed implementation components.
Commenters generally highlighted time, limited resources, and extensive system changes needed to successfully implement the provisions in this final rule. These changes included MIS changes, administrative time associated with the identification and review of new products, changes to shopping applications, participant education, work with retailers, and food product development. While WIC State agencies need to ensure their MIS is flexible to adapt to this and other changes effected through this rulemaking, the Department acknowledges that at any given time WIC State agencies are at different stages of updating their systems. To allow for the MIS changes this final rule requires, the Department extended the implementation timeframe for this final rule.
After evaluating comments, the Department is providing a 24-month implementation timeline for all provisions, with two exceptions: a 60-day implementation timeline for the revised CVV amounts for all children and women participants, and a 36-month timeline for implementing the Vitamin D specification in yogurt. WIC State agencies are allowed and encouraged to implement the provisions earlier than the 24-month timeline; however, they must issue food benefits based on either the new food package in its entirety or maintain the current food package. For example, a WIC State agency may not add fish to the current foods and quantities available under the children's food package and make no other changes. A WIC State agency may, however, phase-in the new WIC food packages on a participant category basis. WIC State agencies may also implement any provisions expanding substitution options (
With near unanimous support of a CVV increase in public comments in response to the proposed rule, implementation of the final CVV amounts 60 days after publication of the final rule promotes timely access to the scientifically recommended amounts of fruits and vegetables. In addition, WIC State agencies need less time to update their MIS to issue the new amounts.
Among the commenters who opposed or expressed concern for the proposed vitamin D specification for yogurt, the primary concern was marketplace availability followed by a concern about manufacturers' willingness to modify products. Several commenters expressed their support for implementing a vitamin D specification for WIC-eligible yogurts but requested USDA provide a longer timeframe for this provision to allow for product reformulation. Based on information regarding the lifecycle for reformulated and new products, USDA agrees that
The implementation dates are as follows:
• WIC State agencies must implement the provision in tables 2 and 3 to 7 CFR 246.10(e)(10) and (11) increasing the cash value voucher, adjusted for inflation, for children to $26, pregnant and postpartum women to $47, and partial and fully breastfeeding women to $52 on June 17, 2024.
• WIC State agencies must implement the provision in table 4 to 7 CFR 246.10(e)(12) that establishes a minimum vitamin D requirement for yogurt no later than April 19, 2027.
• WIC State agencies must implement all other required provisions of this rule no later than April 20, 2026.
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 14094 of April 6, 2023, focuses on modernizing regulatory review and updates the definition of a significant regulation.
This final rule has been determined to be significant under section 3(f)(1) of Executive Order (E.O.) 12866, as amended by E.O. 14094, and was reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.
As required for all rules that have been designated as Significant by the Office of Management and Budget, a Regulatory Impact Analysis (RIA) was developed for this final rule. It follows this rule as appendix A. The following summarizes the conclusions of the regulatory impact analysis:
Section 17 of the Child Nutrition Act mandates that the United States Department of Agriculture (USDA) conduct a comprehensive scientific review of the WIC food packages at least every ten years and revise the foods available, as needed, to reflect nutritional science, public health concerns, and cultural eating patterns (42 U.S.C. 1786(f)(11)(C)). This rule makes changes that are intended to provide WIC participants with a wider variety of foods that align with the latest nutritional science; provide WIC State agencies with greater flexibility to prescribe food packages that accommodate participants' personal and cultural food preferences and special dietary needs; provide more equitable access to supplemental foods; and better promote and support individual breastfeeding goals of participants to help establish successful long-term breastfeeding.
The changes to the WIC food packages enacted under this rule are intended to provide WIC participants with a wider variety of foods that align with the latest nutritional science, provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participant personal and cultural food preferences and special dietary needs, and better promote and support the establishment of successful long-term breastfeeding.
The increases in the value of the cash-value voucher (CVV) for fruits and vegetables, increases in canned fish, and changes to whole grain requirements will better align the WIC food packages with the 2020-2025 DGA. The DGA identified average daily food group intakes of fruits, vegetables, seafood, and whole grains as falling below the recommended intake ranges for adults and children.
NASEM's analysis estimates that in order to meet half of the recommended intakes of fruits and vegetables, WIC participants would need to spend $24, $43, or $47 (adjusted for inflation to FY 2022), depending on participant category, to meet 50 percent of the recommended intakes for fruits and vegetables. This suggests that the current regulatory CVV levels (which would have been $9 for children and $11 for pregnant, postpartum, and breastfeeding individuals in FY 2022 had Congress not temporarily enacted higher levels through annual appropriations that aligned with the NASEM recommendations) only provide enough for around 19 percent and 12 percent of recommended fruit and vegetable intakes for these groups, respectively. By increasing the value of the CVV to the levels proposed by NASEM to meet 50 percent of the recommended fruit and vegetable intakes, the rule is expected to significantly increase fruit and vegetable purchases and consumption among WIC participants.
While it is difficult to quantify the full extent of projected benefits associated with the revisions to the WIC food packages, USDA's and NASEM's analyses find that the revisions better align the WIC food packages with the latest nutrition recommendations in the DGA and accordingly will support participants in achieving healthy dietary patterns. The 2020-2025 DGA highlights the importance of a healthy dietary pattern to help achieve a healthy body weight and reduce the risk of chronic disease. The DGA also emphasizes the importance of exposing young children to nutrient-dense foods at an early age to support the establishment of healthy dietary patterns. By supporting healthy dietary patterns among pregnant women, the changes to the WIC food packages will advance the Program's capacity to address nutrition-related causes of maternal and infant morbidity and mortality. The Department finds that this rule presents an effective approach to supporting pregnant participants and families with infants and young children in achieving balanced, healthy diets and broadly promoting public health.
The Department estimates that the rule to revise regulations governing the WIC food packages would result in a net
As described above, the increase in value of the CVV accounts for most of the increased Federal spending, adding around $5.6 billion in costs over five years. This estimate assumes that the redemption rate of the increased CVV will continue at 2020 redemption levels (71.6 percent) and accounts for annual inflation adjustments. The addition of canned fish to most food packages is estimated to add around $213 million in additional spending over five years. The increase to the amounts of jarred infant fruits and vegetables that can be substituted for CVV and the expansion of the allowable age range to substitute CVV for jarred fruits and vegetables are estimated to increase redemptions for these items, adding $119 million in additional spending over five years, despite the reduction in the quantity of jarred fruits and vegetables issued to fully breastfed infants. Requiring all State agencies to authorize both dry and canned legumes is estimated to increase costs by $16 million over five years as some participants shift from purchasing dry legumes to more costly canned legumes.
The remaining provisions will either result in net savings at the food category level or are not estimated to have a significant impact on costs. Although the expanded substitution options for milk and juice are expected to increase redemption rates for these food categories, the reductions to the maximum monthly allowances issued are still expected to result in a net savings of $118 million for milk and $640 million for juice over five years. The estimated savings associated with the reduction in the allowances for juice offset part of the costs of the increase to the CVV—encouraging greater consumption of whole fruits and vegetables as emphasized in the DGA. While the rule will increase the amount of infant formula allowed in the first month for partially breastfed infants, this change is intended to support continued breastfeeding and is estimated to result in a shift of 5 percent of infant mother dyads from fully formula feeding food packages to partially breastfeeding food packages, which would ultimately lead to a net savings of $34 million on infant formula over five years. The changes to infant meats, infant cereals, whole wheat/whole grains, breakfast cereal, and cheese are also expected to result in cost savings as summarized in Table 2d of the RIA in appendix A at the end of this document.
In addition to the above impact on Federal transfer payments, the Department also estimates that WIC State agencies and local agencies will incur an increase in administrative burden associated with administering and explaining the changes to participants. This additional administrative burden is expected to account for about $179 million in State agency and local agency labor costs over five years between FY 2025 and FY 2029. These administrative costs are considered allowable expenses for State agencies under their annually awarded Nutrition Services and Administration (NSA) grants. In general, the Department expects that State agencies will be able to absorb the costs associated with implementing the provisions under this rule with current NSA funds.
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to analyze the impact of rulemaking on small entities and consider alternatives that would minimize any significant impacts on a substantial number of small entities. Pursuant to that review, it has been certified that this rule will not have a significant impact on a substantial number of small entities. This final rule will not have a significant adverse impact on small entities in the Special Supplemental Nutrition Program for Women, Infants, and Children; the impact is not significant as it allows for greater options and flexibilities within approved food lists for State and local agencies to offer participants. State agencies are already required on an annual basis to review their approved foods lists.
As discussed in the Regulatory Impact Analysis (RIA), this rule is not expected to change the administrative burden on most vendors. There may be a small one-time burden on small vendors to stock three varieties of vegetables instead of two, but the overall burden on vendors will remain substantially unchanged. Requiring vendors to stock at least three vegetables serves to improve access and equity to nutritious foods for WIC participants by providing a greater variety of vegetables, particularly important for those living in locations where it is difficult to access vegetables.
The Department does not routinely track data necessary to determine how WIC benefit redemptions vary by most vendor characteristics, including indicators for whether the store is a small business or independent grocer. The Department estimates that due to the one-time stocking burden, approximately 150 vendors may decide to discontinue participation in the Program out of approximately 40,000 total vendors, or approximately one to two vendors per State agency, on average. This estimate assumes that, among vendors with WIC redemptions in the bottom 10 percent nationwide, those such as small convenience stores that offer limited grocery items may have the greatest difficulty stocking one additional vegetable. Comments from the public on this assumption were requested in the proposed RIA and none were received.
Due to the unavailability of data on vendor size, the Department does not have estimated costs for small vendors to offer a third variety of vegetables. However, based on the estimated number of small vendors that could be impacted, this rule will not have a significant economic impact on a substantial number of small entities. The updated stocking requirement will require vendors to carry one additional form of vegetable and will allow vendors to meet this requirement by stocking fresh, canned, or frozen vegetables, depending on their policies. Given the flexibility in this requirement, the Department anticipates minimum negative impact on vendors and, in the long-term, and expects that the administrative burden on vendors will remain substantially unchanged.
Pursuant to the Congressional Review Act (5 U.S.C. 801
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and Tribal governments, and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local or Tribal governments, in the aggregate, or the private sector, of $146 million or more (when adjusted for inflation; gross domestic product (GDP) deflator source: Table 1.1.9 at
This final rule does not contain Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, and Tribal governments, or the private sector of $146 million or more in any one year. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA.
The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) is listed in the Catalog of Federal Domestic Assistance under Number 10.557 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials (see 2 CFR chapter IV). Since WIC is State-administered, USDA's FNS Regional Offices have formal and informal discussions with State and local officials, including representatives of Indian Tribal Organizations, on an ongoing basis regarding program requirements and operations. This provides USDA with the opportunity to receive regular input from program administrators and contributes to the development of feasible program requirements.
Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of Executive Order 13132. The Department has considered the impact of this rule on State and local governments and has determined that this rule does not have federalism implications. Therefore, under section 6(b) of the Executive order, a federalism summary is not required.
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations, or policies which conflict with its provisions or which would otherwise impede its full and timely implementation. This rule is not intended to have retroactive effect. Prior to any judicial challenge to the provisions of this final rule, all applicable administrative procedures must be exhausted.
FNS has reviewed this final rule in accordance with USDA Regulation 4300-004, Civil Rights Impact Analysis, to identify and address any major civil rights impacts the final rule might have on minorities, women, and persons with disabilities. A comprehensive Civil Rights Impact Analysis (CRIA) was conducted on the final rule, including an analysis of participant data and provisions contained in the final rule. The CRIA outlines outreach, mitigation, and monitoring strategies to lessen any possible civil rights impacts. The CRIA concludes by stating FNS believes that the promulgation of this final rule will impact WIC State agencies including Indian Tribal Organizations (ITOs), WIC vendors, WIC local agencies and clinic sites, food producers and manufacturers, and WIC participants. Specifically, WIC participants will be impacted by the changes to the WIC food packages to align with the latest nutrition science, accommodate special dietary needs and personal and cultural food preferences, and promote breastfeeding. WIC vendors will be required to consistently stock three vegetable varieties. State agencies, including ITOs, will have to identify new foods and package sizes and update their WIC Approved Product Lists consistent with the changes outlined in the final rule. WIC local agency and clinic staff will have to review and update procedures to ensure they prescribe the revised food package correctly and accurately communicate the changes to participants. Additionally, although the final rule's changes to the food packages were selected to align with available products, there may be a minimal need for food manufacturers to reformulate products or create new products or package sizes. However, FNS finds that the implementation of the outreach, mitigation, and monitoring strategies by the FNS Civil Rights Division and FNS WIC may lessen these impacts. If deemed necessary, FNS Civil Rights Division will propose further mitigation and outreach strategies to alleviate impacts that may result from the implementation of the final rule.
Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. On November 30, 2021, FNS provided opportunity for consultation on the rule and received substantive feedback from several Tribal leaders which was taken into consideration during the development of this final rule, including support for more traditional foods, consideration of impacts on small or Tribal stores, and swift publication of the rulemaking. FNS will explore
The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; 5 CFR part 1320) requires that the Office of Management and Budget (OMB) approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number.
In accordance with the Paperwork Reduction Act of 1995, this final rule revises existing information collection requirements currently approved under OMB Control Number 0584-0043, “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program Regulations—Reporting and Recordkeeping Burden” (expiration date January 31, 2027), and contains new requirements for the same information collection. These information collection requirements are subject to review and approval by OMB.
The Department published the proposed rule, “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages,” in the
This final rule does not change the information collection requirements that were proposed in the proposed rule. However, the baseline number of hours currently approved under OMB Control Number 0584-0043 have been updated since the proposed rule was published, due to the regular revision of the WIC Program ICR. The revisions to the existing information collection requirements and the introduction of new information collection requirements that will take effect with the final rule will result in an overall increase in burden hours for State and local agencies, applicants for Program benefits, and businesses responding to these requirements. These changes are contingent upon OMB approval under the Paperwork Reduction Act of 1995. When the information collection requirements have been approved, the Department will publish a separate action in the
During the certification process, a program applicant or participant provides pertinent data, receives notification of their rights and responsibilities, receives information on other health-related and public assistance programs, is assigned a food package based on their nutrition risk assessment and categorical eligibility, and receives their initial nutrition education including breastfeeding promotion and support. Currently, the Department estimates that it takes 25 minutes per applicant or participant to complete this certification process. Due to the program (food package) changes in this rule, the Department estimates that the certification process will take an additional three minutes to complete per participant. These three minutes account for the time required for clinic staff to review updated procedures, correctly prescribe the food package with the changes, and communicate the changes to each participant. Therefore, the Department estimates that going forward, certification will require 28 minutes (0.4676 hours) per applicant or participant. This change will increase the reporting burden for State and local agencies and program applicants and participants as follows:
• For the 1,379,126 adult participants, the Department estimates an additional 69,094.21 hours (3 minutes or 0.0501 hours × 1,379,126 participants) of reporting burden for certification. This will add 48,365.95 hours to the annual reporting burden for the 1,267 government local agencies that perform certifications for 70 percent of adult participants (0.7 × 1,379,126 = 965,388.20 adult participants), and 20,728.26 hours to the annual reporting burden for the 543 non-profit local agencies that perform certifications for the remaining 30 percent of adult participants (0.3 × 1,379,126 = 413,737.80 adult participants).
• For the 3,400,090 child participants, the Department estimates an additional 170,344.51 hours (0.0501 hours × 3,400,090 participants) of reporting burden for certification. This will add 119,241.16 hours to the annual reporting burden for the 1,267 government local agencies that perform certifications for 70 percent of child participants (0.7 × 3,400,090 = 2,380,063 child participants), and 51,103.35 hours to the annual reporting burden for the 543 non-profit local agencies that
• For the 1,464,744 infant participants, the Department estimates an additional 73,383.67 hours (0.0501 hours × 1,464,744 participants) of reporting burden for certification. This will add 51,368.57 hours to the annual reporting burden for the 1,267 government local agencies that perform certifications for 70 percent of infant participants (0.7 × 1,464,744 = 1,025,320.80 infant participants), and 22,015.10 hours to the annual reporting burden for the remaining 543 non-profit local agencies that perform certifications for the remaining 30 percent of infant participants (0.3 × 1,464,744 = 439,423.20 infant participants).
Additionally, the Department estimates that communicating the food package changes in this rule to current participants will require a one-time, five-minute (0.0835 hours) explanation per participant. An estimated 521,370.66 burden hours will be required for all current WIC participants to receive this explanation (6,243,960 participants × 5 minutes or 0.0835 hours = 521,370.66 hours). Staff at the 1,267 government local agencies will require 364,959.46 hours to provide this explanation to the 70 percent of WIC participants they serve (0.7 × 6,243,960 = 4,370,772 participants × 0.0835 hours = 364,959.46 hours), and staff at the 543 non-profit local agencies will require 156,411.20 hours to provide this explanation to the remaining 30 percent of WIC participants they serve (0.3 × 6,243,960 = 1,873,188 participants × 0.0835 hours = 156,411.20 hours).
Each State agency is required to identify foods that are acceptable for use in the Program in their jurisdiction, in accordance with program regulations. This includes establishing criteria for and identifying foods, substitutions, brands and packaging the State agency will authorize for use in the Program. The rule includes additional requirements and options for WIC-authorized foods that will impact State agencies' identification of foods, substitutions, brands, and packaging acceptable for use in the Program to include:
• Requiring one other form of fruits and vegetables in addition to fresh.
• Allowing greater flexibility to authorize additional package sizes (
• Allowing plant-based yogurts and plant-based cheeses as substitution options for milk.
• Requiring the authorization of lactose-free milk.
• Allowing additional whole grain options as substitutes for bread.
• Requiring the authorization of canned legumes in addition to dry legumes.
• Allowing the authorization of nut and seed butters as an alternative to peanut butter.
Currently, the Department estimates that identifying foods for use in the Program takes an average of 40 hours per State agency each year. With the changes to acceptable foods in the rule, the Department estimates that, on average, it will take each State agency an additional three hours (based on an estimated range of 2 to 4 hours per State agency) to comply with this regulatory provision. This represents an average of a 5 to 10 percent increase in burden time. Therefore, the Department estimates 3,827 total annual burden hours for this provision (89 State agencies × 43 hours per State agency), which is an increase of 267 hours due to the rule.
Each State agency is required to provide local agencies with a list of foods that are acceptable for use in the Program in their jurisdiction. Due to the changes in the WIC food packages the food lists will be revised. State agencies will need to develop and deliver training for local agencies on the revised food lists. In addition, State agencies will attend an FNS-provided training about the food package changes. These training activities result in a one-time estimated burden of five hours for each State agency (one hour to attend the FNS training, three hours to develop State agency-specific trainings for local agencies, and one hour to provide training to local agencies). The Department estimates an additional one-time State agency reporting burden of 445 hours for these training activities (89 State agencies × 5 hours = 445 hours).
Local agencies will be required to attend the hour-long training on updated food lists provided by their State agency. Therefore, the Department estimates an additional one-time burden of 1,267 hours for the 1,267 government local agencies and 543 hours for the 543 non-profit local agencies to attend their State agency training.
The Department estimates that the new requirement for WIC-authorized retail vendors to stock three varieties of vegetables (currently vendors are required to stock two varieties) will result in 150 fewer vendors submitting applications and/or fewer vendors signing agreements. This estimate assumes that among vendors with WIC redemptions in the bottom 10 percent nationwide, those such as small convenience stores that offer limited grocery items may have the greatest difficulty stocking an additional vegetable, and therefore will be most impacted by the small increase in the minimum stock requirement in the final rule (37,417 retail vendors − 150 = 37,267 retail vendors).
State agencies are required to enter into a written agreement with retail vendors. State agencies must review completed application forms and sign a vendor agreement where the agreement period must not exceed three years. The Department estimates that one-third of all retail vendors will submit applications each year and that it requires the State agency 40 minutes (0.668 hours) to review each application and agreement. With the expected decrease in the number of retail vendors due to the rule, the Department estimates a decrease in the associated State agency reporting burden of 33.07 hours (0.33 × 150 retail vendors = 49.50 fewer applications and agreements to review × 0.668 hours = 30.07 fewer hours).
Additionally, retail vendors spend an estimated one hour every three years completing these applications or agreements. With the expected decrease in the number of retail vendors due to the rule, the Department estimates a decrease in the associated retail vendor reporting burden of 49.50 hours (0.33 × 150 retail vendors = 49.50 fewer vendors completing applications and agreements × 1 hour = 49.50 fewer hours).
The Department further estimates that each retail vendor application and agreement requires onehour to collect and record in the State agency's recordkeeping system; most State agencies use an electronic MIS for this purpose. With the expected decrease in the number of retail vendors due to the rule, the Department estimates a decrease in the State agency recordkeeping burden associated with collecting and recording vendor applications and agreements of 49.50 hours (0.33 × 150 retail vendors = 49.50 fewer vendors completing applications
This rule includes breast pumps as a Program benefit and adds reference to the sale or offer to sell breast pumps to the definition of
FNS is committed to complying with the E-Government Act of 2002 to promote the use of the internet and other information technologies to provide increased opportunities to provide for citizen access to government information and services, and for other purposes.
Administrative practice and procedure, Civil rights, Food assistance programs, Foods, Grants administration, Grant programs—health, Grant programs—social programs, Indians, Infants and children, Maternal and child health, Nutrition, Penalties, Public health, Reporting and recordkeeping requirements, Women.
Accordingly, Food and Nutrition Service amends 7 CFR part 246 as follows:
42 U.S.C. 1786.
The additions and revision read as follows:
(j) * * *
(10) During WIC certification, every Program applicant, parent, or caretaker shall be informed that selling or offering to sell WIC benefits, cash-value vouchers, paper food instruments, EBT cards, supplemental foods, or breast pumps in person, in print, or on-line is a participant violation.
(a)
(b)
(i) Establish criteria in addition to the minimum Federal requirements in table 4 to paragraph (e)(12) of this section for the supplemental foods in their States, except that the State agency may not selectively choose which eligible fruits and vegetables are available to participants. These State agency criteria could address, but not be limited to, other nutritional standards, competitive
(ii) Make food package adjustments to better accommodate participants who are homeless. At the State agency's option, these adjustments would include, but not be limited to, issuing authorized supplemental foods in individual serving-size containers to accommodate lack of food storage or preparation facilities.
(iii) Authorize package sizes, in addition to those authorized to fulfill paragraph (b)(2)(i) of this section, that increase participant variety and choice, except WIC formula, which must be authorized in sizes that correspond with the maximum monthly allowances per paragraphs (e)(9) and (11) of this section.
(2) State agencies must:
(i) Identify the brands of foods and package sizes that are acceptable for use in the Program in their States in accordance with the requirements of this section; all State agencies must authorize at least one package size (or combination of package sizes) that equal or add up to the maximum monthly allowances of all authorized supplemental foods in each of the food packages. State agencies must also provide to local agencies, and include in the State Plan, a list of acceptable foods and their maximum monthly allowances as specified in tables 1 through 4 to paragraphs (e)(9) through (12) of this section; and
(ii) Ensure that local agencies:
(A) Make available to participants the maximum monthly allowances of authorized supplemental foods, except as noted in paragraph (c) of this section, inform participants about the maximum monthly allowances of authorized supplemental foods to which they are entitled as a Program participant and any food substitution options as specified in tables 1 through 3 to paragraphs (e)(9) through (11) of this section that the State agency authorizes, and abide by the authorized substitution rates for WIC food substitutions as specified in tables 1 through 3 to paragraphs (e)(9) through (11);
(B) Make available to participants more than one food from each WIC food category except for the categories of peanut butter and eggs, and any of the WIC-eligible fruits and vegetables (fresh or processed) in each authorized food package as listed in paragraph (e) of this section;
(C) Authorize only a competent professional authority to prescribe the categories of authorized supplemental foods in quantities that do not exceed the regulatory maximum and are appropriate for the participant, taking into consideration the participant's nutritional and breastfeeding needs; and
(D) Advise participants or their caretaker, when appropriate, that the supplemental foods issued are only for their personal use. However, the supplemental foods are not authorized for participant use while hospitalized on an in-patient basis. In addition, consistent with § 246.7(m)(1)(i)(B), supplemental foods are not authorized for use in the preparation of meals served in a communal food service. This restriction does not preclude the provision or use of supplemental foods for individual participants in a nonresidential setting (
(c)
(1) Medically or nutritionally warranted (
(2) A participant refuses or cannot use the maximum monthly allowances, or chooses to take less than the maximum monthly allowance; or
(3) The quantities necessary to supplement another program's contribution to fill a medical prescription would be less than the maximum monthly allowances.
(d)
(i) Any non-contract brand infant formula;
(ii) Any infant formula prescribed to an infant, child, or adult who receives Food Package III (see paragraph (e)(3) of this section);
(iii) Any exempt infant formula;
(iv) Any WIC-eligible nutritional;
(v) Any authorized supplemental food issued to participants who receive Food Package III; and
(vi) Any contract brand infant formula that does not meet the requirements in table 4 to paragraph (e)(12) of this section.
(2)
(ii) The State agency has the discretion to require medical documentation for any contract brand infant formula other than the primary contract infant formula and may decide that some contract brand infant formula may not be issued under any circumstances.
(3)
(i) Made a medical determination that the participant has a qualifying condition as described in paragraphs (e)(1) through (7) of this section that dictates the use of the supplemental foods, as described in paragraph (d)(1) of this section; and
(ii) Provided the written documentation that meets the technical requirements described in paragraphs (d)(4)(ii) and (iii) of this section.
(4)
(ii)
(A) The name of the authorized WIC formula (infant formula, exempt infant formula, WIC-eligible nutritional) prescribed, including amount needed per day;
(B) The authorized supplemental food(s) appropriate for the qualifying condition(s) and their prescribed amounts;
(C) Length of time the prescribed WIC formula and/or supplemental food is required by the participant;
(D) The qualifying condition(s) for issuance of the authorized supplemental food(s) requiring medical documentation, as described in paragraphs (e)(1) through (7) of this section; and
(E) Signature, date, and contact information (or name, date, and contact information), if the initial medical documentation was received by telephone and the signed document is forthcoming, of the health care professional licensed by the State to write prescriptions in accordance with State laws.
(iii)
(B)
(5)
(e)
(1)
(ii)
(iii)
(iv)
(A) The participant's household has an unsanitary or restricted water supply or poor refrigeration;
(B) The person caring for the participant may have difficulty in correctly diluting concentrated or powder forms; or
(C) The WIC infant formula is only available in ready-to-feed.
(v)
(2)
(ii)
(iii)
(iv)
(3)
(ii)
(A) Infants whose only condition is:
(
(
(B) Women and children who have a food intolerance to lactose or milk protein that can be successfully managed with the use of one of the other WIC food packages (
(C) Any participant solely for the purpose of enhancing nutrient intake or managing body weight without an underlying qualifying condition.
(iii)
(A) If a ready-to-feed form better accommodates the participant's condition; or
(B) If it improves the participant's compliance in consuming the prescribed WIC formula.
(iv)
(v)
(vi)
(4)
(ii)
(5)
(ii)
(6)
(ii)
(7)
(ii)
(8)
(9)
(10)
(11)
(12)
(f)
(2) The State agency must:
(i) Distribute the commodity foods to its local agencies or participants; and
(ii) Ensure satisfactory storage facilities and conditions for the commodity foods, including documentation of proper insurance.
(g)
(h)
(1)
(i) For State agencies that use rounding up of infant formula, the FNB is determined over the timeframe (the number of months) that the participant receives the food package. In any given month of the timeframe, the monthly issuance of reconstituted fluid ounces of infant formula may exceed the maximum monthly allowance or fall below the FNB; however, the cumulative average over the timeframe may not fall below the FNB without individual tailoring to allow “up to” amounts to support breastfeeding. In addition, the State agency must:
(A) Use the methodology described in paragraph (h)(1)(ii) of this section for calculating and dispersing the rounding up option;
(B) Issue infant formula in whole containers that are all the same size; and
(C) Disperse the number of whole containers as evenly as possible over the timeframe with the largest monthly issuances given in the beginning of the timeframe.
(ii) The methodology to calculate rounding up and dispersing infant formula to the next whole container over the food package timeframe is as follows:
(A) Multiply the FNB amount for the appropriate food package and feeding option (
(B) Divide the total amount of infant formula to be provided by the yield of the container (in reconstituted fluid ounces) issued by the State agency to determine the total number of containers to be issued during the timeframe that the food package is prescribed.
(C) If the number of containers to be issued does not result in a whole number of containers, the State agency must round up to the next whole container in order to issue whole containers.
(2)
(ii) State agencies that use the rounding up option for infant foods must:
(A) Use the methodology described in paragraph (h)(2)(iii) of this section for calculating and dispersing the rounding up option;
(B) Issue infant foods in whole containers; and
(C) Disperse the number of whole containers as evenly as possible over the timeframe (the number of months the participant will receive the food package).
(iii) The methodology to round up and disperse infant food is as follows:
(A) Multiply the maximum monthly allowance for the infant food by the timeframe the participant will receive the food package to determine the total amount of food to be provided.
(B) Divide the total amount of food provided by the container size issued by the State agency (
(C) If the number of containers to be issued does not result in a whole number of containers, the State agency must round up to the next whole container in order to issue whole containers.
(i)
(2) FNS will evaluate a State agency's plan for substitution of foods for different cultural eating patterns based on the following criteria:
(i) Any proposed substitute food must be nutritionally equivalent or superior to the food it is intended to replace.
(ii) The proposed substitute food must be widely available to participants in the areas where the substitute is intended to be used.
(iii) The cost of the substitute food must be assessed and comparable to the cost of the food it is intended to replace.
(3) FNS will make a determination on the proposed plan based on the evaluation criteria specified in paragraph (i)(2) of this section, as appropriate. The State agency shall substitute foods only after receiving the written approval of FNS.
(a) * * *
(1) Nutrition education including breastfeeding promotion and support shall be considered a benefit of the Program and shall be made available at no cost to the participant. Nutrition education including breastfeeding promotion and support, shall be designed to be easily understood by participants, and it shall bear a practical relationship to participant nutritional needs, household situations, and cultural preferences including information on how to select food for themselves and their families as well as the maximum monthly allowances of authorized supplemental foods to which they are entitled as a Program participant.
(g) * * *
(3) * * *
(i)
(u) * * *
(2) * * *
(i)
(j)
(1)
(2)
(i) $24 for children;
(ii) $43 for pregnant and postpartum women; and
(iii) $47 for breastfeeding (fully and partially (mostly)) women.
(3)
(i) Multiplied by the inflation adjustment described in paragraph (j)(4) of this section; and
(ii) Subject to rounding as described in paragraph (j)(5) of this section.
(4)
The following appendix will not appear in the Code of Federal Regulations.
Section 17 of the Child Nutrition Act of 1966 (Pub. L. 89-642) mandates that the USDA conduct a comprehensive scientific review of the WIC food packages at least every ten years and revise the foods available, as needed, to reflect nutritional science, public health concerns, and cultural eating patterns (42 U.S.C. 1786(f)(11). This rule makes changes that are intended to provide WIC participants with a wider variety of foods that align with the latest nutritional science; provide WIC State agencies with greater flexibility to prescribe food packages that accommodate participants' personal and cultural food preferences and special dietary needs; and address key nutritional needs to support healthy dietary patterns. This rule provides foods in amounts that are more consistent with the supplemental nature of the Program; encourages fruit and vegetable consumption; and strengthens support for individual breastfeeding goals of participants to help establish successful long-term breastfeeding.
Established in 1974, the mission of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is to safeguard the health of low-income pregnant, postpartum, and breastfeeding individuals, infants, and children ages 1 through 4 years who are at nutritional risk by providing nutritious foods to supplement diets, nutrition education (to include breastfeeding promotion and support), and referrals to health and other social services. Participation in WIC is associated with improved pregnancy outcomes and lower infant mortality, and also associated with improved diet quality.
The monthly WIC food packages are prescribed to (1) address the prevalence of inadequate and excessive nutrient intakes for each WIC participant category, (2) contribute to an overall dietary pattern consistent with the Dietary Guidelines for Americans (DGA), and (3) deliver priority nutrients to participants to meet their supplemental nutrition needs. There are seven WIC food packages available for the following participant categories:
On December 13, 2010, Congress passed the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296), amending section 17(f)(11) of the Child Nutrition Act by mandating that the USDA conduct a scientific review of the WIC food packages at least every ten years. In response to the mandate, in 2014, FNS contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a comprehensive review of the current WIC food packages in relation to the current nutritional science, dietary guidance, and program administration considerations. In 2017, NASEM published its recommendations for WIC food package revisions in the report: “Review of WIC Food Packages: Improving Balance and Choice” (the “NASEM report”).
In its report, NASEM recommended modifications to the current WIC food
After NASEM released its 2017 report, on December 29, 2020, the USDA and the Department of Health and Human Services released the Dietary Guidelines for Americans (DGA), 2020-2025,
In FY 2022, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2022 (Pub. L. 117-103) directed USDA to temporarily increase the WIC cash-value voucher (CVV), which participants use to purchase fruits and vegetables, to amounts consistent with NASEM recommendations, adjusted for inflation, through September 30, 2022. As a result, the CVV was increased to the same amounts that are set in this rule, equal to $24 for child participants, $43 for pregnant and postpartum participants, and $47 for fully and partially breastfeeding participants in FY 2022. The Consolidated Appropriations Act of 2023 (Pub. L. 117-328) included the same CVV increase, setting CVV values at $25 for child participants, $44 for pregnant and postpartum participants, and $49 for fully and partially breastfeeding participants through September 30, 2023, after adjusting for inflation. To date, these legislative provisions have only increased the CVV on a time-limited basis. This final rule would make permanent the CVV increase initially enacted in FY 2022, by revising the regulations governing the WIC food packages. Due to the temporary nature of the CVV increases in FY 2022, FY 2023, and FY 2024, the following analysis presents both the total cost, in terms of increased Federal transfers, for the rule as a whole (
On November 21, 2022, USDA published the proposed rule, “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages.”
The revisions finalized in this rule align the WIC food packages with the 2020-2025 DGA and largely reflect the recommendations in the 2017 NASEM Report with modifications the Department deemed necessary for program administration considerations. This final rule maintains the supplemental nature of the WIC food package while prioritizing changes that support nutrition security.
In its 2017 report, NASEM included an impact analysis of its recommended revisions. The regulatory impact analysis published with the proposed rule built on NASEM's analysis to update cost estimates for the provisions outlined in the rule and calculated new or revised estimates for provisions that expand or modify those recommended by NASEM to align with the 2020-2025 DGA and/or accommodate program administration considerations.
This analysis of the final rule follows the methodology of the proposed rule analysis, using the most recent possible participation data, inflation data, and price data, as well as accounting for minor changes made between the proposed and final rules that affected the estimated cost (or savings) of the rule. Updating these input data resulted in changes in both the baseline cost estimate and the cost of the final rule relative to the estimates published with the proposed rule; the revised estimates are presented below in their entirety.
On November 21, 2022, the Department published a proposed rule to revise the WIC food packages (87 FR 71090). There were no comments addressing the regulatory impact analysis (RIA) or the validity of USDA's cost estimates of the proposed rule. The Department received 15,028 comments addressing the proposed increases to the CVV and 20 comments addressing the CVV annual inflation adjustment. Comments suggesting alternative implementations of the CVV are analyzed in the Alternatives section below. Other comments relating to the provisions of the rule are described in the preamble text accompanying the rule, and the impacts of those are described in the analysis that follows.
Table 1 summarizes the revisions to regulations governing the WIC food packages, alongside current requirements as described in Federal Regulations, absent the temporary CVV increase enacted in FY 2022 (Pub. L. 117-103) and FY 2023 (Pub. L. 117-328).
The following analysis describes the estimated impacts of the rule on the Federal WIC spending, accounted for in terms of Federal transfer payments projected between FY 2025 and FY 2029, as well as the key health and nutrition benefits for WIC participants expected as a result of the changes. An overview of the cost impacts on Federal transfers and on State and local administrative costs is followed by a detailed description of impacts on Federal transfers by food item and the concomitant participant health benefits by food item. The analysis concludes with an in-depth discussion of impacts on State agency administrative burden and costs, participation, and specific food markets.
The Department estimates that the rule to revise regulations governing the WIC food packages will result in a net increase in Federal WIC spending of $4.9 billion over five years from FY 2025 through FY 2029, which includes the CVV increase as enacted in FY 2022, FY 2023, and FY 2024. Excluding the CVV increases as currently implemented, the provisions of this rule result in a net decrease in Federal spending of $617 million over five years between FY 2025 and FY 2029. These cost changes only reflect changes in overall Federal transfers for WIC food expenditures. In addition to the change in food expenditures accounted for in terms of Federal transfers, the Department also estimates that WIC State agencies and local agencies will incur an increase in administrative burden of about $179 million in additional labor costs associated with the required State and local agency staff time over five years between FY 2025 and FY 2029.
Applying 3 percent and 7 percent discount rates to these nominal streams gives present values (in 2024 dollars):
As required by OMB Circular A-4, the Department has prepared an accounting statement showing the annualized estimates of benefits and transfers associated with the provisions of this rule, in Table 2c below. Table 2c takes the discounted streams from Table 2b and computes annualized values in FY 2024 dollars.
WIC food expenditures are a function of the number of participants receiving each food package, the cost of WIC-eligible food items, the quantity of WIC foods issued to each participant, and the percentage of WIC foods redeemed by participants (known as the “redemption rate”). These estimates are summarized at the food category level in Table 2d, where all changes under a given food category (
The Department is allowing for an extended implementation window for most of the provisions in this final rule; for the purposes of these estimates, the Department assumes that the CVV provision will be fully in effect in FY 2025 and that the other provisions will be fully in effect beginning in FY 2026. The exact implementation schedule of the various provisions (except the CVV increase) is somewhat left to the discretion of the State agencies; it is possible that some State agencies will implement some provisions prior to FY 2026 while other State agencies will not implement at least some provisions until later in FY 2026 or FY 2027, but the Department expects these assumptions to provide an accurate estimate of costs across the five-year estimation period. All dollar amounts in all tables and text are adjusted for annual inflation, except for the values in Tables 2b and 2c above.
This increase in Federal WIC food expenditures is driven by the increase in the CVV, which is estimated to increase WIC food expenditures by $5.6 billion over five years when compared to current CVV levels as outlined in 7 CFR 246.10. As explained above, however, the CVV levels proposed in this rule were recently enacted on a temporary basis for FY 2022, FY 2023, and FY 2024. As a result, when compared to the FY 2022—FY 2024 enacted food packages, the CVV increase made permanent in this rule would not impact Federal WIC expenditures. With the CVV impact zeroed out of the overall cost estimate for the rule, the remaining provisions are expected to result in a net
The overall change in total Federal spending on WIC is summarized in Table 3. The Department estimates the total five-year Federal spending on WIC under the current food packages to be $34.9 billion from FY 2025 through FY 2029; this estimate does not include the cost of the temporary increase in the CVV authorized in FY 2022, FY 2023, and FY 2024 (see Table 4 for comparisons to FY 2022 through FY 2024 enacted expenditures). The additional food costs of $4.9 billion estimated under this rule will bring total Federal WIC spending, in terms of Federal transfers, up to $39.9 billion in total from FY 2025 through FY 2029.
In addition to the above increase in food expenditures accounted for in terms of Federal transfers, USDA also estimates that WIC State agencies and local agencies will incur an increase in administrative burden associated with administering and explaining the changes to participants (including estimated burden for State and local agency staff training). This additional administrative burden is expected to account for about $179 million in additional labor costs associated with the required State and local agency staff time over five years between FY 2025 and FY 2029. These administrative costs are considered allowable expenses for State agencies under their annually awarded Nutrition Services and Administration (NSA) grants. In general, USDA expects that State agencies will be able to absorb the costs associated with implementing the provisions under this rule with current NSA funds.
The changes to the WIC food packages are expected to improve dietary quality by increasing intake of foods currently under-consumed by WIC participants, specifically fruits and vegetables, whole grains, and seafood.
The total projected baseline Federal cost of WIC under the current food package for FY 2025 through 2029 is shown in Table 4 below. At the Federal level, WIC expenditures are broadly split between grants to State agencies to fund food benefits (“food costs”) and Nutrition Service and Administration (NSA) grants to fund all approved non-food expenses (“NSA costs”). As described later in this analysis, the Department estimates that the changes under this rule will result in a net increase to WIC food costs but will not affect the NSA costs of the Program. Table 4 provides the total cost of the current WIC food packages both with and without the CVV increase enacted in FY 2022, FY 2023, and FY 2024.
WIC food costs are a function of the number of participants receiving each food package, the retail prices of WIC-eligible food items, the quantity of WIC foods issued to each participant, and the percentage of WIC foods issued that are redeemed by participants (known as the “redemption rate”). The following describes how each of these factors are estimated for FYs 2025 through 2029 in this analysis.
This analysis bases WIC participation projections on the latest trends observed through data available in November 2023. After over a decade of gradual declines, WIC participation increased slightly in FY 2022. Increases in participation have accelerated through FY 2023; average monthly WIC participation grew to 6.57 million by the end of FY 2023—a 5 percent increase over the prior year. While it is difficult to attribute this growth to any single factor, increased birth rates, alongside recent investments in outreach, modernization, and an improved, higher valued food package, may all be contributing to the rise in participation.
Baseline unit costs for WIC food categories are estimated using average national retail unit cost data calculated from the Information Resources, Inc. (IRI) Infoscan retail dataset.
The quantity of WIC foods purchased, or redeemed, by participants is estimated as the product of the Maximum Monthly Allowance (MMA) of each food item multiplied by the estimated redemption rate for that item. Baseline estimates use the MMAs under the current food packages while the projections for redemption under the food package revisions use the MMAs defined under the rule. Key changes to MMAs by food item under this rule are summarized above in Table 1. Baseline redemption rates are estimated by food category using 2020 redemption data that FNS collected from 48 State agencies (see the appendix to the RIA, Tables A-1 through A-12 for redemption rate estimates by food category).
The following section describes the benefits to WIC participants and the estimated impact on the cost of the food packages of the changes for each WIC food category. As described previously, all cost estimates are adjusted for annual inflation. Apart from the CVV, USDA applies NASEM's estimates of the relative impacts of the revisions under each food category on redemption rates and unit costs, where applicable. NASEM's estimates of the impacts on redemption rates are based on several factors, including changes to the amount of a food category prescribed, changes to the substitution options available, and changes to nutrient requirements that may affect participant preferences.
In general, the most consistent impact on redemption rates was driven by changes in the amount of a food item prescribed in the revised food packages. To consider this impact, NASEM first used EBT data from three State agencies (Kentucky, Michigan, and Nevada) from a 2014 report to understand three different types of WIC redemption patterns: (1) full redemption, (2) partial redemption, and (3) non-redemption.
NASEM's approach poses a few limitations. Without much of a precedent for
Although the food costs presented here are updated with the best available information and to reflect the food package revisions as defined in this rule, including where the Department's provisions differ from NASEM's recommendations, NASEM's impact analysis provides additional background information, analyses, and discussion of rationales (see Appendix U of the 2017 NASEM report, p. 869-988).
• Increase CVV maximum monthly allowances for child, pregnant, postpartum, and breastfeeding participants.
Consistent with the proposed rule and as supported by most public comments,
Fruits and vegetables are nutrient dense and associated with a reduced risk of chronic diseases,
The changes to regulations governing the CVV are expected to increase fruit and vegetable consumption among WIC participants by supporting the purchase of a greater amount and variety of fruits and vegetables that align with individual and cultural preferences.
NASEM estimated that WIC participants would need to spend $24, $43, or $47 (adjusted for inflation to FY 2022), depending on participant category, to meet 50 percent of the DGA-recommended intakes for vegetables and fruits.
Congress temporarily authorized a four month increase in CVV benefits under the American Rescue Plan Act (ARPA) of 2021 (Pub. L. 117-2).
The increase in value of the CVV accounts for most of the increased Federal spending under the rule, adding around $5.6 billion in costs over five years compared to the CVV levels as currently established in WIC regulations at 7 CFR 246.10. This estimate assumes that the redemption rate of the increased CVV will continue at the 2020 level (71.6 percent) and accounts for annual inflation adjustments.
The CVV cost estimates only include costs associated with the changes to the CVV for child, pregnant, postpartum, and breastfeeding participants described above. Any costs associated with the CVV substitution option for infants is accounted for under the infant fruit and vegetable estimates. Similarly, costs associated with the $3 CVV substitution option for juice are accounted for in the juice cost estimates.
To better understand how the increase to the CVV may impact CVV redemption rates, USDA collected CVV redemption data from nine large State agencies covering the period from April to August 2021, during the implementation of a temporary increase to CVV levels authorized under the American Rescue Plan Act (ARPA) of 2021 (Pub. L. 117-2).
• Add canned fish to food packages for children (ages 1 through 4 years).
• Add canned fish in food packages for pregnant, partially (mostly) breastfeeding and postpartum participants not currently receiving canned fish, revise amounts for fully breastfeeding participants, and revise WIC-eligible varieties.
The revisions add select varieties of canned fish (salmon, sardines, Atlantic mackerel, Chub mackerel, and light tuna) to food packages for children ages 1 through 4 years and for pregnant, postpartum and breastfeeding participants to better align the WIC food packages with the DGA and NASEM recommendations. The amount of fish offered in the revised food packages provides a supplemental quantity of between 17 to 69 percent of the DGA-recommended amounts, depending on participant category. This change represents an improvement over the current packages, which do not offer fish to child, pregnant, postpartum, or partially breastfeeding participants, and are consistent with the EPA-FDA advice about eating fish.
The changes to the quantities of canned fish are expected to increase WIC food spending by an estimated $218 million over five years compared to the cost of canned fish in the current food packages. This estimate is based on NASEM's assumption that the current redemption rate for fish in the food package for fully breastfeeding participants, just under 44 percent in 2020, will be slightly lower for all food packages receiving fish under the revised food package. The Department estimates the redemption rate for fish will be around 43 percent across all food packages under the revisions.
• Reduce infant jarred fruit and vegetable amounts for fully breastfed infants.
• Expand allowable age range to substitute CVV for infant fruits and vegetables and increase substitution amounts.
The amounts of jarred fruits and vegetables currently provided for fully breastfed infants far exceed what is nutritionally appropriate for infants. Further, fully breastfed infants do not have a greater need for fruits and vegetables compared to other infants. Thus, the reduced amounts of jarred fruits and vegetables for fully breastfed infants will be the same amounts currently provided to partially (mostly) breastfed or fully formula fed infants.
NASEM found that the current food package for fully breastfed infants provides an excessive amount of jarred fruits and vegetables per day—more than one cup-equivalent, which is an amount difficult for infants 6 through 11 months old to consume daily. Furthermore, the more generous amount for fully breastfed infants was not based on a nutritional rationale (the DGA and the American Academy of Pediatrics (AAP) do not have specific recommendations for the quantity of fruit and vegetable consumption for this age group) but was recommended by the 2006 Institute of Medicine (IOM, now known as the National Academies of Science, Engineering, and Medicine (NASEM)) committee to promote full breastfeeding.
Reducing the amount of jarred infant fruits and vegetables provided to fully breastfeeding infants better aligns this food package with the concept of supplemental, particularly since fully breastfed infants do not have a greater need for fruits and vegetables than infants fed infant formula or a combination of infant formula and human milk.
Expanding the age range at which infants are eligible to substitute CVV for infant fruits and vegetables (specifically, by lowering the eligible age from 9 months old to 6 months old) and increasing substitution amounts will provide additional choice to WIC participants to accommodate special dietary needs, cultural preferences, and personal preferences without compromising the nutritional integrity of the infant food packages. In addition, by permitting the purchase of more fruits and vegetables through the CVV, a parent or caretaker has the opportunity to introduce a wider variety and texture of fruits and vegetables (compared to the jarred variety) to the infant according to the infant's developmental readiness for textures.
Although this rule decreases the maximum monthly allowance of jarred infant fruits and vegetables issued to fully breastfed infants, the Department estimates that the changes to infant fruits and vegetables under this rule will result in a net increase of $119 million in Federal WIC spending over five years. These costs are the cumulative costs associated with both infant jarred fruit and vegetable redemptions and the infant CVV substitution option (
• Change whole grain criteria for breakfast cereals.
• Require that 75 percent of approved breakfast cereals in each State agency meet whole grain criteria.
• Modify existing breakfast cereal specifications to establish an added sugar limit rather than a total sugar limit.
This final rule will change the criteria for whole grain breakfast cereals and require that 75 percent of breakfast cereals on a State agency's authorized food list meet the criteria for whole grain. This is a change from the proposed rule recommendation that 100 percent of breakfast cereals meet the whole grain criteria. The provisions in this final rule are designed to promote whole grain consumption and to improve consistency with the Child Nutrition Programs (the Child and Adult Care Food Program (CACFP), the National School Lunch Program, and the National School Breakfast Program) while maintaining more flexibility than the proposed rule in response to concerns raised in public comments. Comments from WIC State agencies cited the increased burden on small vendors and the reduction in participant choice as primary concerns. This rule also finalizes a new provision based on comments regarding sugar specifications for breakfast cereals.
To address inadequate consumption of whole grains and excess consumption of refined grains among WIC participants, NASEM recommended that all WIC-eligible breakfast cereals meet the criteria for whole grain cereal. This is also consistent with the DGA recommendation to shift intake from refined to whole-grain versions of foods to
Many stakeholders (including many State agencies) supported the goal of increasing whole grain consumption but cited concerns with the requirement that all cereals be whole grain. Some commenters highlighted the overall nutrients cereals provide (
The Department is also switching the nutrient specifications for breakfast cereals in WIC food packages to be based on an
These provisions are expected to help address inadequate consumption of whole grains (and excess consumption of refined grains) among WIC participants. NASEM's analysis of NHANES data concluded that the consumption of whole grains by WIC participants was poor and that consumption of refined grains by WIC participants was excessive. An updated analysis of NHANES data for years 2011-2016 confirms low intakes of whole grains among young children participating in WIC. On a given day, 48 percent of WIC participants ages 1 through 4 years consumed whole grains, whereas 82 percent consumed refined grains. On average, less than half of grains consumed were whole grains.
The DGA recommend that at least half of grain intake consist of whole grains, as whole grains are nutrient-dense and contribute more fiber to a healthy diet than refined grains, but according to the DGA, 98 percent of Americans fail to eat enough whole grains, and 74 percent of Americans consume too many refined grains.
Although the final rule does not fully implement NASEM's recommendation that all breakfast cereals meet the whole grain criteria, the final provision is still expected to promote whole grain consumption, while continuing to provide access to other key nutrients (
While the maximum monthly allowances for breakfast cereal will not change under the rule, the Department estimates that the revisions to whole grain requirements for cereal will decrease costs by approximately $9 million over five years. The decrease in cost is driven by the estimated impact of these changes on redemption rates. NASEM estimated that the originally proposed changes (
• Increase infant formula amounts in the first month for partially breastfed infants.
• Allow all prescribed infant formula quantities to be considered “up to” amounts.
As recommended by NASEM, the rule increases maximum monthly infant formula amounts in the first month for partially (mostly) breasted infants from 104 fluid ounces to up to 364 fluid ounces. Consistent with current requirements, the amount of formula provided would be tailored based on an individual nutrition and breastfeeding assessment and would not exceed the maximum 364 fluid ounces per month. Tailored issuance of formula in the first month, and nutrition and breastfeeding education and support from WIC staff, not only maximizes the potential for women to achieve exclusive breastfeeding goals, but also to achieve successful partial breastfeeding when exclusive breastfeeding is not possible or desired.
This provision increases the maximum monthly infant formula amount in the first month of life for partially (mostly) breastfed infants, consistent with NASEM's recommendations. As NASEM notes, while current regulations intend to encourage participants who initiate breastfeeding to do so exclusively, the current approach may cause infants who need more than 104 fluid ounces of formula in the first month to be prematurely categorized as fully formula fed (and the mother as “postpartum”) in order to obtain additional formula from the Program.
Breastfeeding is associated with several improved health outcomes for both infants and breastfeeding mothers. Individuals who breastfeed have a reduced risk of breast and ovarian cancer, hypertension, and type 2 diabetes, and their infants have a lower risk of asthma, Type-1 diabetes, sudden infant death syndrome (SIDS), and gastrointestinal, ear, and lower respiratory infections.
The change will increase participant flexibility and provide better support for any amount of breastfeeding during the first month by providing partially (mostly) breastfeeding infants any amount of formula (up to the maximum 364 fluid ounces allowed) to support the participant's desired level of breastfeeding. It is possible that this provision may extend the duration of breastfeeding for some mothers who were previously categorized as “postpartum” prematurely and discontinued breastfeeding. NASEM specifically estimates that this increase to the infant formula amounts allowed during the first month of an infant's life will result in a 5 percent shift in infant-mother dyads moving from the fully formula feeding to partially (mostly) breastfeeding food packages after the first year of implementation. Public comments echoed this assessment, noting that this change would encourage breastfeeding and help participants achieve their breastfeeding goals.
The change to consider all formula quantities to be issued as “up to” amounts will encourage and enable WIC staff to assess the actual formula needs of participants and tailor the quantities of infant formula provided accordingly. This change, as recommended by NASEM, is intended to reduce interference with the successful establishment of the mother's desired breastfeeding behavior while appropriately issuing formula amounts that meet infants' nutritional needs.
By increasing the amount of infant formula allowed in the first month of life for partially breastfed infants, the Department assumes a shift of 5 percent of fully formula fed infants into the partially breastfed infant category after one full year of implementation, based on NASEM's analysis.
The revised amounts of infant formula prescribed under this rule are also estimated to impact spending in other food categories. As described above, NASEM estimates these changes will result in a 5 percent shift of fully formula fed infants into the partially breastfed infant category. This corresponds with a shift of 5 percent of participants from the postpartum food package (VI) category into the partially breastfeeding category (V-B). In this analysis, the Department estimates the impact of this shift in participant categories separately from the other food-specific cost estimates (
Revising the regulatory language to permit formula quantities prescribed as “up to” amounts rather than only setting a minimum amount for full nutrition benefit is not projected by NASEM to have a significant impact on the cost of the food packages. While the effect on cost is expected to be minimal, the impact of this provision will ultimately depend upon the extent to which it is used—both in terms of how frequently formula quantities are tailored and the extent to which tailoring formula amounts changes the quantities prescribed.
• Increase whole wheat/whole grain bread and other whole grain option amounts for pregnant, postpartum and breastfeeding individuals, reduce amounts for children, and revise specifications for package sizes.
• Require that whole grain breads contain at least 50 percent whole grains.
• Expand whole grain options.
The revisions largely reflect NASEM's recommendations and will provide whole wheat bread, whole grain bread, and whole grain options in supplemental amounts that better align with the DGA, particularly for women. The DGA recommend that at least half of grain intake consist of whole grains, as whole grains are nutrient-dense and contribute more fiber to a healthy diet than refined grains, but according to the DGA, 98 percent of Americans fail to eat enough whole grains, and 74 percent of Americans consume too many refined grains.
The reduced amount for children represents the upper end of NASEM's recommended range of 16 to 24 ounces and will provide 27 to 53 percent of DGA recommended amounts, better aligning the children's food packages with the supplemental nature of the food packages.
The increased amount for pregnant, postpartum, and breastfeeding participants exceeds NASEM's recommended amount (24 ounces). Specifically, the Department's amount will provide 40 to 53 percent of the DGA recommended whole grain amounts, while the amount recommended by NASEM would provide 13 to 27 percent. The increased amount will provide and encourage consumption of whole grains, consistent with the DGA and in quantities closer to NASEM's definition of a supplemental amount. The changes also better align the Program with common package sizes found in the marketplace.
Changing the allowable package sizes will increase the whole wheat/whole grain bread choices available for State agencies to authorize as WIC-eligible, thereby increasing choice for participants. When WIC adopted the 16-ounce bread size, very few products on the market adhered to this specification, which required manufacturers to produce a relatively limited number of products sized specifically for WIC; consequently, WIC participants had relatively few choices among different types of WIC-approved breads. Although this availability has become less of a problem since the implementation of the 2009 WIC food package revisions, far more whole wheat/whole grain breads available in the marketplace still come in either a 20-ounce or 24-ounce package size as compared to a 16-ounce package size.
Finally, the expansion of whole grain options is responsive to participant requests for more choices for bread substitutions, while still providing priority nutrients, and is intended to increase whole grain consumption by offering a greater variety of grains to WIC participants.
The revisions under the whole wheat bread, whole grain bread, and other whole grain options contribute to both costs and savings under the rule. Overall, these changes result in an estimated decrease of about $22 million in food costs over five years.
NASEM estimates that expanding the number of allowable substitution options and providing greater flexibility in package sizes would increase the overall redemption rate for whole grains by around 13 percent. The rule differs from NASEM's recommendation to allow a specific range of package sizes under this category and instead allows State agencies to authorize a greater variety of package sizes to increase variety and choice, while still providing participants with package sizes that ensure they can receive the full benefit amount. Despite this variation, the effect on redemption rates is expected to be consistent with NASEM's projections. By applying NASEM's projections to current rates, the Department estimates the rule will increase redemption rates for whole wheat bread, whole grain bread, and other whole grain options from 44 percent in 2020 to nearly 50 percent after implementation of the rule. The increase in the maximum monthly allowance for pregnant, postpartum, and breastfeeding participants from 16 ounces to 48 ounces is also expected to increase overall food costs associated with whole grains in the pregnant, postpartum, and breastfeeding food packages.
The increases in costs described above are more than offset by the estimated decrease in unit costs for whole grain products in all food packages and the decrease in the maximum monthly allowance of whole grains in the food packages for children from 32 ounces to 24 ounces. In its report, NASEM estimates the cost of 16 ounces of whole wheat bread to be $2.35 under the current food package. To account for allowing 24-ounce package sizes in the revised food package and the addition of alternative whole grain substitutions, NASEM computes a composite cost of $2.67 for 24 ounces of whole grain products under the revised food
• Remove cheese as a food category for fully breastfeeding participants to better align with the DGA.
As recommended by NASEM, this rule removes cheese as a separate food category for fully breastfeeding participants (Food Package VII). This change aligns with the DGA recommendation for reducing saturated fat consumption.
Removing cheese as a separate food category for fully breastfeeding participants aligns with the DGA recommendation for reducing saturated fat consumption. However, cheese remains a milk substitution option in the food packages for child, pregnant, postpartum, and breastfeeding participants, meaning that cheese can be substituted for a portion of the maximum monthly allowance of milk. Even with the removal of the standalone cheese category, fully breastfeeding participants would still be able to receive two pounds of cheese as a partial substitute for milk.
Removing cheese as a standalone food category is estimated to decrease WIC food costs by $37 million over five years.
• Reduce infant meats amounts to better align with AAP recommendations.
This provision reduces the maximum monthly allowance of infant meat for fully breastfed infants from 77.5 to 40.0 ounces. The NASEM committee found that the current food package II-BF provides fully breastfed infants with approximately 130 percent of the maximum amount of infant meat recommended by the AAP. The Committee also found that the redemption rate for infant meat, an important source of heme iron and zinc for fully breastfed infants, was only about 20 percent. The rule reduces the amount of infant meat provided to a level representing approximately 65 percent of the AAP recommended maximum amount. This revision better aligns with the concept of providing a supplemental amount of infant meat to fully breastfeeding infants.
Reducing the maximum monthly allowance of infant meats in the fully breastfed 6 through 11-month-old infant food package is estimated to reduce WIC food costs by $16 million over 5 years. NASEM estimates that reducing the quantity of infant meats prescribed to fully breastfed infants will increase the overall redemption rate—this is largely based on the assumption that when a smaller amount is prescribed, a larger proportion of that amount will be redeemed by partial redeemers. Applying NASEM's estimates, this cost savings assumes a 39 percent increase in the redemption rate of infant meats—increasing from around 23 percent in 2020 to 32 percent under the rule.
• Reduce infant cereal amounts for all infants to better align with AAP recommendations.
This provision reduces the maximum monthly allowance of infant cereal to fully breastfed infants from 24 to 16 ounces. For partially breastfed and fully formula fed infants, the amount is reduced from 24 to 8 ounces. The NASEM committee found that the current food packages provide approximately 150 percent of the maximum amount of infant cereal recommended by the AAP. The revisions better align with AAP recommendations for fully breastfed infants and with the Program's intent to provide supplemental amounts of food for all other infants. The revised infant cereal quantities will provide approximately 100 percent of the AAP-recommended amount for fully breastfeeding infants because fortified infant cereal is an important source of the iron and zinc that fully breastfed infants need from a commentary food source starting at age 6 months. The revised quantities will provide 50 percent of the AAP recommended amount for partially (mostly) breastfed and fully formula fed infants.
Reducing infant cereals in all infant food packages is estimated to reduce WIC food costs by around $99 million over five years. NASEM estimates the reduction in the maximum monthly allowance of infant cereals will result in a 21 percent increase in the redemption rate. Applying NASEM's projections, the Department estimates that the redemption rate for infant cereals across all infant food packages will increase from 43 percent in 2020 to 53 percent under the rule.
• Reduce the amount of milk provided in all child, pregnant, postpartum, and breastfeeding participant food packages to better align with the DGA.
• Require authorization of unflavored lactose-free milk.
• Permit only unflavored milk and reduce the added sugars allowed in yogurt and plant-based milk alternatives and substitutes.
• Add calcium specifications for tofu and vitamin D specifications for yogurt.
• Increase yogurt substitution amounts.
• Add plant-based substitution options for milk.
• Update the FDA standards of identity citations for yogurt.
• Allow reduced-fat yogurts for 1 year-old children without restrictions.
The revised quantities reflect NASEM recommendations, are more consistent with the supplemental nature of the Program and are consistent with nutrition education messages to consume a balanced diet that meets, but does not exceed, recommended amounts of foods and nutrients to prevent overweight/obesity and/or displace other healthy and important food groups and nutrients.
The revisions to reduce the amount of milk prescribed to WIC participants, as recommended by NASEM, will better align the food packages with the supplemental nature of the Program. The current food packages provide 85 to 128 percent of the DGA recommendations for dairy products. The revision recommended by NASEM and finalized in this rule will provide 71 to 96 percent of the amounts recommended by DGA. Furthermore, the revised quantities are more consistent with nutrition education messages to consume a balanced diet that meets, but does not exceed, recommended amounts of food to prevent excess weight gain and displacement of other foods that provide key nutrients.
The revisions to the substitution options improve participant choice and promote equity in accessing key WIC benefits for participants with dietary restrictions and allergies, while ensuring that substitution options meet key nutrient specifications. The option for substitution of 2 quarts of yogurt in place of 2 quarts of milk may improve intakes for participants who prefer dairy in this form.
The final rule will require that all State agencies authorize lactose-free milk as a substation available to participants.
The rule allows only unflavored milk and specifies limits on added sugar for yogurt and plant-based milk alternatives to better align the WIC food package with the DGA, which emphasize nutrient dense foods and beverages that provide vitamins, minerals, and other health-promoting components with little or no added sugars. As noted in the DGA, nutrient dense foods are particularly
Reducing the maximum monthly allowance of milk and making the other policy changes as described is estimated to reduce WIC food costs by $118 million over five years, representing a 2 percent decrease of the estimated $4.94 billion that would have been spent from FY 2025-2029 on milk products in the absence of this rule (milk spending is now estimated to be $4.82 billion from FY 2025-2029 under this rule).
The decrease in costs is driven by the decrease in the maximum monthly allowance for milk in most food packages under the rule. The savings associated with the reduction in milk quantities are expected to be partially offset by the changes to milk substitution options (including the increase in the amount of yogurt available for substitution), which are expected to increase both redemption rates and the composite unit cost of milk and milk alternatives. To estimate a composite unit cost for milk redemptions that considers the combined costs of redeeming milk amounts for fluid milk, cheese, and yogurt, this analysis derives a composite unit cost for milk redemptions using the same approach that NASEM applies in its report and updates NASEM's model with WIC unit cost data for whole and reduced-fat milk (accounting for lactose-free and plant-based substitutions, see Table 7 notes below), cheese, and yogurt from the WIC PC 2018 Food Costs Report. NASEM's composite milk cost model represents “high-cost” substitution scenarios, within allowable substitution limits for cheese and yogurt, across food packages for child, pregnant, postpartum, and breastfeeding participants. The Department applies current unit cost estimates to this model, maintaining NASEM's substitution scenarios, and finds that, consistent with NASEM, revisions under the rule are expected to increase the composite unit cost for the milk category across all food packages, as shown below in Table 7. The increase in this composite unit cost reflects an expected shift towards an increase in the proportion of milk that is substituted for yogurt. The increase in yogurt redemptions, relative to milk, is the combined result of three factors: (1) reduction in quantity of milk in most food packages, (2) an increase in the amount of yogurt that participants are allowed to substitute for milk, and (3) increased flexibility in allowable yogurt package sizes.
Cost estimates for milk also apply NASEM's assumptions about the impact of the revisions on redemption rates. NASEM estimates that the revisions under their proposal, particularly the additional amount of yogurt authorized for substitution, is expected to increase redemption rates across all food packages (see the appendix to the RIA, Table A-10 for detailed redemption rates).
As of FY 2015 (the most recent data available), flavored milk was only authorized by three States and 14 Indian Tribal Organizations—collectively covering only around 3 percent of total WIC participants. As a result, the provision to no longer allow flavored milk is not expected to have a significant impact on overall costs or redemptions because this only represents a policy change for a small proportion of participants.
While this final rule adds additional plant-based milk substitution options, these options are not expected to have a significant impact on costs. It is expected that the vast majority of participants opting for the newly added plant-based milk alternatives (such as oat and almond milk) would have otherwise elected for the existing, similarly priced soy-based beverage or lactose-free milk options under the current food packages. While these options do importantly provide a new pathway for participants with concurrent soy and dairy allergies to access their full WIC benefits in this category, the coexistence of soy and dairy allergies is relatively rare, and any additional redemption of benefits under this accommodation would not be significant from a cost perspective.
• Reduce juice amounts for child, pregnant, postpartum, and breastfeeding participants.
• Allow CVV juice substitution.
The reduction of juice in food packages for child, pregnant, postpartum, and breastfeeding participants better aligns the food packages with the latest dietary guidance and with the supplemental intent of the Program. The current food packages provide between 96 and 144 fluid ounces (depending on participant category), or 40 to 107 percent of DGA-recommended limits for juice. The reduced quantities will provide
The DGA emphasize the consumption of whole forms of fruits and vegetables over juice. While the DGA include 100 percent juice as part of the fruit and vegetable food category, it emphasizes whole fruit and a variety of vegetables from all subgroups, it places limits on juice amounts that should contribute towards an overall dietary pattern, and juice is not a recommended food. Also, juice is neither a separate food category nor a subgroup (like dark-green vegetables) in the dietary patterns that Americans should consume each day.
As noted by the NASEM committee, the AAP recommends that most fruit intake should be from whole fruit because whole fruit also contributes fiber and other important plant-based compounds that are removed during fruit juice processing.
The option for CVV substitution of juice aligns with both the AAP and DGA recommendations and provides additional flexibility to WIC participants by allowing them to select from options that may better meet their special dietary needs, cultural needs, and personal preferences. These changes will likely increase the consumption of whole fruits and vegetables among participants that prefer this substitution over juice.
All juice offered through the WIC food packages will be 64 fluid ounces, potentially decreasing vendor burden by streamlining options across food packages.
The reduction of juice in all food packages accounts for an estimated net decrease of $640 million in WIC food costs over five years. This estimate also accounts for an expected increase in the redemption rate of the juice benefit as a result of the added $3 CVV juice substitution option, which slightly offsets cost savings. Specifically, NASEM estimates that the CVV substitution, combined with the overall decrease in amounts of juice issued, will increase the redemption rate of juice by about 13 percent. Applying NASEM's estimate to current rates, the Department estimates that redemption rates for juice, including the $3 CVV juice substitution, will increase from 63 percent in 2020 to 71 percent under the rule. Like the estimates for infant jarred fruit and vegetable redemptions, the estimated redemption rate for juice in the revised food packages accounts for both redemption of juice and redemption of the $3 CVV substitution for juice.
• Require both dry and canned legumes be allowed.
• Add required and optional substitution options for eggs.
• Add optional substitution options for peanut butter.
As recommended by NASEM, this rule will require State agencies to authorize dried and canned legumes. Currently only dried legumes are required, and it is a State agency option to allow canned legumes. The NASEM committee noted that consumption of legumes, a source of fiber, protein, B vitamins, iron, zinc, and other nutrients, was below recommended amounts across WIC participant subgroups. To help address under-consumption of this nutrient-rich food, this provision will require State agencies to authorize both dried and canned legumes for WIC participants. State agencies are currently only required to authorize dried legumes, and allowing canned legumes is a State agency option.
Based on NASEM's recommendations, with modification, the final rule requires that State agencies allow the substitution of eggs with legumes or peanut butter when individually tailoring food packages. The rule also allows State agencies the option to authorize tofu as a substitute for eggs. Like eggs, legumes and peanut butter (to a lesser extent) are sources of choline, and both are sources of iron. Given iron's role in growth and development, the prevalence of inadequate intake among the WIC population, and the health consequences of inadequate intake, offering foods with iron is critical to WIC participants' health.
In addition, peanut butter and legumes are required foods in the food packages; therefore, the Department anticipates no additional administrative effort related to identifying and authorizing these foods as substitutes for eggs. Requiring peanut butter and legumes as substitutes for eggs is nutritionally appropriate, will not result in increased administrative burden, and increases equity in program delivery.
The rule also allows State agencies the option to authorize tofu as a substitute for eggs. Similar to eggs, tofu is a source of choline. Appropriate food package tailoring and nutrition education will need to address other food sources of iron, especially for participants determined to have low iron levels.
A new provision in the final rule allows State agencies the option to authorize nut and seed butters as an alternative to peanut butter when individually tailoring food packages for children and women for nutrition reasons (
Requiring all State agencies to authorize canned legumes is expected to increase food costs by around $16 million over five years. This increase in costs is the result of both an estimated increase in the composite unit cost of legumes and a slight increase in redemption rates. The Department estimates that requiring State agencies to authorize canned legumes will slightly increase redemption rates from 38 percent in 2020 up to 39 percent under the rule. This increase is less than the increase that NASEM projects because NASEM's estimate also considers the effect of reducing the amounts of legumes issued—which is not changed in this rule. The estimated increase in redemption rates for legumes is also small because this provision only represents a policy change for an estimated 15 percent of WIC participants.
Requiring that State agencies offer legumes or peanut butter as a substitution for eggs is not projected to have a significant impact on food costs. Currently, participants are prescribed legumes or peanut butter in amounts that exceed the DGA recommended amounts for the food subgroups these items are within, and redemption rates for legumes and peanut butter are some of the lowest redemption rates among WIC food categories. Substitutions are limited to participants with an egg allergy, vegan participants, or for other nutritional reasons determined by the State agency. In 2018, only 1 percent of WIC participants in a study sample representative of 12 State agencies reported having an egg allergy.
Allowing State agencies to offer other nut and seed butters as substitutions for peanut butter is also not projected to have a significant impact on food costs. In 2018, only 1 percent of WIC participants in a study sample representative of 12 State agencies reported having a peanut allergy.
• State agencies required to authorize an additional form of fruits and vegetables.
• Require vendors to stock at least 3 different vegetables.
• Expand what can be purchased with the CVV.
As recommended by NASEM, the rule requires State agencies to authorize fresh and at least one other form (frozen, canned, and/or dried) of both fruits and vegetables for the food packages for child, pregnant, postpartum, and breastfeeding participants and require fresh and at least one other form (frozen or canned) for the CVV substitution for infant (ages 6 through 11 months) food packages.
Currently, WIC State agencies are not required, but may choose, to authorize other forms of fruits and vegetables in addition to fresh for child, pregnant, postpartum, and breastfeeding participants. In 2021, only eight of 89 State agencies did not authorize a form other than fresh. Therefore, the Department anticipates that the change will have minimal impact on most State agencies, while ensuring greater participant choice in those State agencies currently not authorizing other forms of fruits and vegetables. Additionally, with the increase in the CVV, having the option to buy other forms that are not as perishable as fresh may encourage fuller redemption and consumption of the fruits and vegetables benefit.
As recommended by NASEM, the rule also requires vendors to stock at least three varieties of vegetables. Currently, vendors are required to stock two varieties of vegetables. NASEM recommended the requirement for stocking a greater variety of vegetables as opposed to fruits because its review noted higher redemption of fruits compared to vegetables in two State agencies.
Thus, the change is intended to increase the purchase and consumption of vegetables among WIC participants, particularly given the increase to the value of the CVV, by requiring vendors to offer more variety for participants to select from. If participants have more vegetables from which to select, they may redeem their CVV for more vegetables and increase their vegetable consumption. In addition, the change is intended to promote equity by ensuring all participants, regardless of where they redeem benefits, have access to a variety of vegetables, while incurring minimal additional burden on small vendors.
This revision could also have the spillover effect of increasing general availability of different types of vegetables in areas served by small WIC vendors, as those additional vegetable types will be available for retail purchase by the general public.
This rule also finalizes the provision to allow fresh herbs, to codify that State agencies cannot exclude white potatoes from purchase with the CVV, and to allow larger sizes of packaged fresh fruits and vegetables. The WIC CVV provides participants with flexibility to purchase fruits and vegetables that meet their dietary, taste, and cultural preferences. Expanding CVV-eligible items further to include fresh herbs and larger packages of fruits and vegetables is intended to encourage healthier dietary patterns and support increased convenience. Increased use of fresh herbs in diets can help enhance the flavor of foods in place of added sugar, fats, and sodium. Packaged fruits and vegetables provide a more convenient option for participants who see preparation time as a barrier to consumption.
The requirement for State agencies to authorize at least one additional form of fruits and vegetables other than fresh, the requirement that vendors stock at least three varieties of vegetables, and expanding what can be purchased with the CVV are not expected to increase food costs in WIC. Both provisions may incur some initial administrative burden on State agencies and vendors (as discussed in the Administrative Impacts section below); however, these administrative impacts are expected to be minimal and short-lived. Furthermore, because 81 out of 89 State agencies already authorize at least one form of fruits and vegetables other than fresh, the impact of this provision will only impact a small number of State agencies.
As described above, the changes to the WIC food packages will improve the balance of nutritious foods to align with recommendations from NASEM, the 2020-2025 DGA, and the AAP. The changes also better reflect the supplemental nature of the WIC food package. Table 8 and Table 9 below summarize the estimated proportions of DGA daily recommended intakes for child (ages 2 through 4 years) and for pregnant participants, respectively, to provide examples of the impacts of the rule on the food package contents.
The 2020-2025 DGA identified average daily food group intakes of vegetables, seafood, and whole grains as falling below the recommended intake ranges for women and children across the general population. The DGA and the AAP
To estimate the level of fruits relative to vegetables that should be accounted for when considering the proportion of DGA recommendations provided in the WIC food packages, NASEM based its estimates on the assumption that 67 percent of the CVV is typically spent on fruits while 33 percent is spent on vegetables—based on data collected from Wyoming and Texas at the time of NASEM's analysis. This ratio of CVV redemption for fruits relative to vegetables is consistent with more recent internal USDA data collected from Ohio, Wyoming, and Texas in 2018 as part of a forthcoming study on CVV redemption patterns. Therefore, USDA maintains NASEM's assumptions on
The rule will decrease the amount of total dairy and refined grains in the food packages for child, pregnant, postpartum, and breastfeeding participants. The decrease in the proportion of refined grains is the result of the revised whole grain breakfast cereal requirements described above. This change improves the balance between whole and refined grains and aligns with DGA guidelines that emphasize that at least half of total grain intake should be in the form of whole grains. The decrease in total dairy, as described in the previous section, will better align the food packages with the supplemental nature of WIC. Although the maximum monthly allowance for legumes exceeds the DGA daily recommended intakes for children and the allowance for peanut butter exceeds daily recommended intakes for children and women, USDA chose not to decrease the amounts provided for either food. This decision was made partly due to market availability, as it is more difficult to find package sizes for beans or peanut butter that fall below the current maximum allowances.
The rule is not expected to substantially change the administrative burden on participants. The general benefits and requirements of the Program are not changing. There will be a one-time burden on participants, estimated to account for an additional 5 minutes per participant, to become familiar with the new food packages and with new foods (
The rule is not expected to substantially change the long-term administrative burden on local WIC agencies. The general benefits and requirements of the Program are not changing. The Department estimates there will be a one-time 1-hour burden for local agencies to attend State Agency provided training on the food package changes. The food package changes are also expected to have both a short-term and ongoing impact on the length of WIC appointments. There will be a one-time burden on local WIC agencies for helping WIC participants become familiar with the new food package and with new foods, which is estimated to take local agencies about 5 minutes per participant in the first year the food package revisions are implemented (estimated to be FY 2026). In addition, the Department expects the revised food packages may take longer to explain than the current food packages on an ongoing basis because of the additional food package size flexibilities and additional substitution options—to account for this, USDA estimates local agencies will spend an additional 3 minutes explaining the food packages at each WIC certification appointment. The Department sought input from FNS Regional Office staff in making these estimates. The Department notes that comments on this assumption were requested in the proposed regulatory impact analysis, but no comments on the specifics of the burden assumptions or calculations were received.
The general benefits and requirements of the Program are not changing. However, the rule includes additional requirements and options for WIC-authorized foods that will impact State agencies' identification of foods, substitutions, brands, and packaging acceptable for use in the Program. The Department estimates a slight increase (5 to 10% increase, or about 3 hours per State agency) in the amount of time it takes annually for State agencies to identify foods that are acceptable for use in the Program in their State. In addition, the Department estimates 5 hours of training activities added to the burden in the first year related to the food package changes (this includes attending FNS training, developing guidance materials and providing other technical assistance to local agencies). Also, there may be a one-time burden on State WIC agencies for programming the new food packages into their MIS, but the Department expects that these activities can be absorbed into existing State WIC agency administrative processes for system maintenance and program administration, and the Department expects that the long-term administrative burden on State WIC agencies to be minimal. The Department notes that comments on this assumption were requested in the proposed regulatory impact analysis, and none were received.
The rule is not expected to change the administrative burden on most vendors. The general benefits and requirements of the Program are not changing. There may be a small one-time burden on small vendors if they currently only stock two varieties of vegetables, as the rule would require them to stock at least three varieties of vegetables, but the Department expects that the long-term administrative burden on vendors will remain substantially unchanged. The Department notes that other provisions of the rule may decrease burden, at least on some vendors—for example, allowing 20 or 24 ounce package sizes for whole grain breads may lessen the burden on small vendors that have difficulty stocking the less common 16 ounce package size currently required by WIC, or allowing canned legumes to be stocked instead of dry legumes. Therefore, the total burden change to the average vendor will likely be minimal, though the burden changes may vary from vendor to vendor. The Department estimates that, as a result of the one-time burden on vendors to stock three varieties of vegetables, approximately 150 vendors will decide to discontinue participation in the Program (out of approximately 40,000 total vendors). This estimate assumes that among vendors with WIC redemptions in the bottom 10 percent nationwide, those such as small convenience stores that offer limited grocery items may have the greatest difficulty stocking an additional vegetable, and therefore would be most likely to be impacted. The Department notes that comments on this assumption were requested in the proposed regulatory impact analysis, and none were received.
The changes to the food packages were selected to align with products currently available on the market, so the Department expects that the new food package implementation to have exceedingly minimal effects on food manufacturers' need to reformulate products or create new products or package sizes. The Department expects that most manufacturers will not have to reformulate any products to meet the requirements of this rule; in those rare cases where minor reformulation or repackaging may be necessary, USDA does not expect this burden to be more pronounced than the burden of regularly reviewing and reformulating products within a competitive marketplace, so USDA expects the long-term administrative burden on food manufacturers to remain substantially unchanged. The Department notes that comments on this assumption were requested in the proposed regulatory impact analysis, and none were received.
As described above, USDA expects most administrative burden and costs associated with this rule to be highly localized, most to be one-time and minimal, and/or to be absorbed within current programmatic overhead. Specifically, USDA only expects measurable administrative cost increases for State agencies and local agencies to account for the added time for the identification of
A detailed accounting of the State agency and local agency burden (OMB 0584-0043) is provided in the annual burden adjustment estimates published with this rule. Information provided by FNS Regional Office staff (with direct, routine contact with State agencies) was used to determine the burden estimates. In total, USDA estimates that each of the 89 State agencies will spend an additional 3 hours identifying acceptable foods in the first year the provisions are implemented, or about 267 total hours across all State agencies. This increase in burden is estimated to increase State agency administrative costs by around $16,000 in FY 2025. As described above, State and local WIC agencies are also expected to incur some burden for training activities related to the changes. The 5 hours estimated for State agency training activities is estimated to increase administrative costs by around $27,000 while the 1 hour of training for each of the 1,808 local agencies is estimated to increase administrative costs by around $99,000. USDA also estimates that in the first year following the food package changes, WIC staff at the local agency level will take an additional 5 minutes per participant to explain the food package changes to all participants. Multiplying this time by the over 6 million annual WIC participants, accounts for approximately 572,000 add burden hours at a cost of $31.4 million in FY 2025. As described above, the Department also expects local agency staff will take an additional 3 minutes to explain the options in the revised food packages at each WIC certification appointment on an ongoing basis. While this is a small change at the individual level, when applied to all approximately 10 million WIC certifications estimated per year, this additional staff time is estimated to account for an additional $147 million in administrative costs over five years. Taken together, the administrative burden for State and local agency staff is estimated to amount to 1,085,018 hours at a total cost of $179 million over five years from FY 2025 through FY 2029.
As noted in the above analysis, the Department's primary estimate includes a shift of 5 percent of fully formula-fed infant-mother dyads to partially breastfeeding dyads, similar to the assumptions made in the NASEM cost analysis. Other than the shift towards increased breastfeeding under the revised food packages (as described above), NASEM projects the rest of their cost neutral food package changes will not have a meaningful impact on participation. This final rule goes beyond NASEM's cost neutral recommendations for the CVV, so it is reasonable to consider an additional participation impact from this provision. The Department expects that much of the potential participation impact of the CVV on participation will have already been realized in FY 2022 through FY 2024, however, due to the implementation of the higher CVV amounts in those years. Nevertheless, it is possible that this rule could have a modest, conceptual participation impact by sustaining the levels of participation seen in FY 2022-FY 2023 and thus far in FY 2024 if compared to a hypothetical future in which CVV values return to pre-2021 CVV levels.
Beyond FY 2023, the baseline and revised costs presented in this analysis also both assume increases in WIC participation as a result of ongoing efforts supported by the $390 million in additional WIC funding made available in the American Rescue Plan Act of 2021 (ARPA, Pub. L. 117-2) to carry out outreach, innovation, and program modernization. Therefore, as described in the baseline section above, it is difficult to attempt to disentangle any single, potential participation impact from several concurrent factors that may be affecting WIC participation.
The Department acknowledges that, because the rule goes beyond NASEM's cost neutral recommendations (particularly in the increases to the CVV), the rule may be more likely to have an impact on participation. Given planned efforts to increase participation and retention under ARPA, as described above, however, as well as the fact that the CVV increases have already been implemented in FY 2022, FY 2023, and FY 2024, the Department is uncertain at this time how much of an increase in participation may be attributable solely to the rule. The Department presents additional cost estimates in the Uncertainties section below, which demonstrate how the cost of the rule would be affected if participation remains flat or increases compared to our primary estimate.
Generally, the changes made by this rule attempt to align with products widely available in the current marketplace and to provide WIC participants with additional choices to meet their cultural and personal preferences, and special dietary needs, while at the same time providing food packages that supply appropriate, supplemental amounts of key nutrient-dense foods. For example, the package size flexibilities, and the addition of canned legumes, milk substitutions, forms of fruit and vegetables, etc. are all designed to increase product choice in line with products currently available in the U.S. food marketplace and should not result in additional burden on food manufacturers. The Department anticipates that the general impact of this rule on the wider U.S. food market will be small and easily absorbed by the competitive marketplace. The Department notes that comments on this assumption were requested in the proposed regulatory impact analysis, and none were received.
The dollar impacts of the rule on the different food categories are presented in our
The two biggest cost provisions affect the juice market (the decrease in juice) and the fruit and vegetable market (the increase in CVV value). Even in these instances, the Department expects the competitive marketplaces to absorb these changes with minimal disruption. The U.S. juice market was estimated to be $24 billion in 2021, growing to $27 billion by 2026.
Similarly, the Department anticipates that the U.S. fruit and vegetable market is large and varied enough to absorb the increased purchasing power of the CVV with minimal disruption (in reality, the U.S. fruit and vegetable market has already absorbed the increased purchasing power of the CVV with minimal disruption, as the increase has been in effect since FY 2022). The total size of the U.S. fruit and vegetable market is more difficult to estimate with non-proprietary data sources (the Department did not have access to the necessary proprietary data sources on the U.S. fruit and vegetable market when preparing this analysis); however, ERS estimates that farm cash receipts for “vegetables and melons,” “fruits and nuts,” and “mushrooms” combined was approximately $47 billion in 2020.
The increase in economic activity attributable to the rule will also increase revenues to farmers, farmers' markets (to the extent that WIC participants choose to redeem their additional CVV benefits at farmers' markets), food processors, food distributors, and food retailers. The Department does not attempt to estimate separate direct or indirect effects for each of these economic sectors, such an estimate would be too complex and too uncertain to estimate with precision.
As stated above and outlined in Table 5, the primary analysis assumes WIC participation growth is consistent with current projections. These estimates assume an increase in participation through FY 2027 with slowing participation growth through FY 2028 and FY 2029. Table 11, below, compares the cost of the rule under current participation projections compared to a model that assumes flat WIC participation across all categories between FY 2025 to FY 2029 (remaining flat at projected FY 2024 average participation of 6.85 million). As shown below, the projected increase in participation accounts for $187 million of the food cost of the rule over five years. An additional 1 percent participation growth each year above our primary estimate would increase food costs by an additional $148 million over five years.
Compared to the current food packages outlined in 7 CFR 246.10, the increase to the CVV accounts for the largest share of the costs associated with the rule, and as such, even small variations in the model for the CVV cost estimates can result in large changes to the cost of the rule. Redemption rates for all WIC-eligible foods, including the CVV, vary by State agency and by month or season. Redemption rate data is also relatively new, as many States have only fully implemented electronic benefits transfer (EBT) in WIC over the past few years.
Some public comments requested that USDA further increase the CVV for pregnant participants to match the CVV for breastfeeding participants. The amounts in this rule reflect NASEM's evidence-based recommendations to provide approximately half of the recommended daily amounts of fruits and vegetables for each participant group and are consistent with supplemental amounts relative to the 2020-2025 DGA recommendations for the applicable life stages of WIC adult participants (postpartum, pregnant, and lactating) based on the average caloric needs of these various groups (2,000 kcal, 2,200 kcal, and 2,400 kcal, respectively). Therefore, the Department does not make the requested change in this final rule. If the CVV value for pregnant participants were increased to match the levels for breastfeeding participants, then the final rule would increase Federal spending by an additional $119 million over five years between FY 2025 and FY 2029.
USDA received public comments calling for a change to the rounding procedure used when adjusting the CVV for inflation as described in § 246.16(j)(5). The commenters suggested that the CVV be rounded up to the nearest multiple of $1 instead of rounded down as currently defined in regulations. In their report, NASEM made no recommendations regarding the rounding procedures. The proposed rule did not include any changes to the current rounding procedures or request public comment. The approach selected by FNS aligns with the one used in the Supplemental Nutrition Assistance Program (SNAP), which also rounds inflation adjustments down to the next multiple of $1 (7 CFR 273.10), as well as the National School Lunch Program's national average payment rates, which are rounded down to the nearest cent (7 CFR 210.4(b)). Therefore, the Department is not making this change in this rule. If the CVV were to be rounded up instead of rounded down, beginning in FY 2025, this change would increase the cost of the CVV changes in this rule by a total of $234 million over five years between FY 2025 and FY 2029.
NASEM recommended adding canned fish to the child, pregnant, postpartum, and partially breastfeeding participant food packages on a three-month rotation, alternating with peanut butter and legumes. The Department decided to reject this alternative in favor of providing canned fish to all pregnant, postpartum and breastfeeding participants and most child participants while keeping the existing peanut butter and legume benefits.
In evaluating the three-month rotation recommendation, the Department determined that this would be too confusing to participants and would be administratively challenging to implement. There are currently no WIC foods provided on a three-month rotation. In addition, the cost neutrality constraints that NASEM applied in making its recommendations are outweighed by the Department's goals of promoting nutrition security and equitable access to foods.