This Final Rule codifies statutory requirements included in section 4102 of the Agriculture Improvement Act of 2018 (Pub. L. 115-334, the 2018 Farm Bill). Section 4102 established a statutory definition for the term “certification period” and established that certification periods for CSFP participants must be not less than one year and not more than three years. This final rule revises 7 CFR 247.16 to include this provision.

This rule also revises 7 CFR 247 per section 4102 of the Agriculture Act of 2014 (Pub. L. 113-79, the 2014 Farm Bill), which amended CSFP eligibility requirements and phased out individuals who do not meet the new requirements. This provision was implemented through a previous final rule, Commodity Supplemental Food Program (CSFP): Implementation of the Agricultural Act of 2014 (79 FR 38748), published on July 9, 2014. As of February 2020, the phase out of individuals who are not eligible for CSFP was completed. Thus this rule amends program regulations at 7 CFR part 247 to remove all remaining references to women, infants, and children.

Lastly, this rule amends citations that were revised during the previous final rule, Requirements for the Distribution and Control of Donated Foods—The Emergency Food Assistance Program: Implementation of the Agricultural Act of 2014 (81 FR 23085), published on April 19, 2016, which amended Food Distribution regulations at 7 CFR part 250. Accordingly, 7 CFR part 247 will be amended to reflect any updated references to 7 CFR part 250.

The Administrative Procedures Act (APA) at 5 U.S.C. 553(a)(2) specifically exempts rules involving grants and benefits from notice-and-comment requirements, giving the Department the authority to issue final rules in grants and benefits programs, like CSFP. Therefore, the Department is issuing this rule as a final rule without a comment period.

Section 4102 of the 2018 Farm Bill establishes a statutory definition for the term “certification period” as “the period during which a participant in the commodity supplemental food program in a State may continue to receive benefits under the commodity supplemental food program without a formal review of the eligibility of the participant.” The “certification period” definition will be amended in 7 CFR 247.1 to reflect the statutory definition.

Additionally, Section 4102 of the 2018 Farm Bill codifies new statutory requirements for CSFP certification periods. Accordingly, FNS is amending CSFP program regulations at 7 CFR 247.16 to reflect the new requirements that certification periods for CSFP participants must be not less than one year and not more than three years. Prior to the enactment of the 2018 Farm Bill, program regulations stipulated that the State agency must establish certification periods that may not exceed six months in length. However, the State agency could authorize local agencies to extend the certification period without a formal review of eligibility for additional six-month periods, as long as the conditions outlined in 7 CFR 247.16(a)(2)(i) and (ii) were met.

This final rule makes the following conforming changes to 7 CFR 247.16(a): (1) Establishes minimum certification periods to be no less than one year but no more than three years for program participants; (2) establishes that if the State agency chooses to establish a certification period that exceeds one year, the State agency must first receive approval from FNS by submitting an updated State Plan. Additionally, 7 CFR 247 is amended by removing all references to women, infants, and children, thus 7 CFR 247.16 is being reorganized.

Under the 2018 Farm Bill and updated program regulations, FNS shall approve a certification period exceeding one year on the condition that on an annual basis, local agencies administering CSFP do two things. Firstly, the local agency must verify the address and continued interest of the participant. Secondly, the local agency must have sufficient reason to determine that the participant still meets the income eligibility standards.

Furthermore, this final rule adds two sub-paragraphs to 7 CFR 247.16(a), in order to clarify 2018 Farm Bill statutory requirements. The first sub-paragraph, 7 CFR 247.16(a)(2), allows eligible CSFP applicants, including individuals on waiting lists, to be provided with a temporary monthly certification to fill any caseload slots resulting from nonparticipation by certified participants. The second sub-paragraph, 7 CFR 247.16(a)(3), establishes that should a State agency want to allow local agencies to continue providing benefits to individuals once their certification period expires, then individuals must be formally recertified following the application procedures outlined at 7 CFR 247.8.

The 2018 Farm Bill was signed into law on December 20, 2018. The Department determined that prolonging the implementation of this provision would negatively impact State agencies that administer CSFP by delaying their ability to utilize the new flexibility in certification periods. The Department also determined that this provision was self-executing and, therefore, implemented the provision immediately in FY 2019.

On March 8, 2019, FNS released a memorandum titled, CSFP—Implementation of the Agriculture Improvement Act of 2018 (Pub. L. 115-334), which set forth the changes to the certification period for CSFP participants. The memorandum defined the term “certification period” and directed CSFP States agencies to establish new certification periods that are not less than one year but not more than three years. The memorandum instructed CSFP State agencies and ITOs to amend their State Plans and submit them to FNS for review and approval by May 1, 2019. The memorandum required the State Plan amendments to outline the length of the State agency's new certification periods for participants and the procedures for implementation among CSFP local agencies. Lastly, the memorandum notified State agencies that they may permit their local agencies to certify individuals for one-month periods to maximize caseload use and provide temporary CSFP benefits to participants on waiting lists when a regular program participant misses a scheduled distribution.

Section 4102 of the 2014 Farm Bill amended CSFP eligibility requirements to transition it to a seniors-only program and phase out ineligible participants. Women, infants, and children who were certified and receiving CSFP benefits as of February 2014 under existing program rules, received assistance until they were no longer eligible under the program rules that went into effect on February 6, 2014. On July 9, 2014, FNS published a final rule implementing this provision. All ineligible participants have since phased out of CSFP. This rule amends program regulations at 7 CFR 247 to remove all references to women, infants, and children and to make conforming organizational changes within 7 CFR part 247.

This rule amends citations that were revised during previous rulemaking. On April 19, 2016, the Food Distribution Division published a final rule, Requirements for the Distribution and Control of Donated Foods—The Emergency Food Assistance Program: Implementation of the Agricultural Act of 2014 (81 FR 23085), which amended Food Distribution regulations at 7 CFR part 250. Accordingly, this rule amends 7 CFR 247 to reflect any updated references to 7 CFR part 250 as a result of previous rulemaking.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

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.

This final rule has been determined to be not significant and was reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.

This rule has been designated as not significant by the Office of Management and Budget, therefore, no Regulatory Impact Analysis is required.

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 would not have a significant impact on a substantial number of small entities. This final rule would not have an impact on small entities because the revised requirement provides more flexibility on the certification period at the local agency level. This lessens the administrative burden previously required by allowing State agencies to extend their certification periods from six months to one to three years.

Executive Order 13771 directs agencies to reduce regulation and control regulatory costs and provides that the cost of planned regulations be prudently managed and controlled through a budgeting process. This final rule is an E.O. 13771 deregulatory action. This rulemaking provides a reduction in the State agency/ITO requirements to certify CSFP participants on an annual basis. This rule lessens the administrative burden previously required by allowing State agencies to extend their certification periods from six months to one to three years.

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; GDP deflator source: Table 1.1.9 at http://www.bea.gov/iTable ) in any one year. When such a Statement is needed for a rule, Section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives and adopt the most cost effective or least burdensome alternative that achieves the objectives of the rule.

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 program is listed in the Catalog of Federal Domestic Assistance under Number 10.558 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

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 determined that this rule does not have Federalism implications. This rule does not impose substantial or direct compliance costs on State and local governments. Therefore, under Section 6(b) of the Executive Order, a Federalism summary impact Statement 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.

FNS has reviewed this final rule in accordance with USDA Regulation 4300-4, “Civil Rights Impact Analysis,” to identify any major civil rights impacts the rule might have on program participants on the basis of age, race, color, national origin, sex or disability. After a careful review of the rule's intent and provisions, FNS has determined that this rule is not expected to have any civil rights impacts or affect the overall level of participation in CSFP.

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. USDA is unaware of any current Tribal laws that could be in conflict with this rule.

The Paperwork Reduction Act of 1995 (44 U.S.C. chap. 35; 5 CFR part 1320) requires 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 contains information collections that are subject to review and approval by the Office of Management and Budget. The provisions discussed in this Final Rule are non-discretionary statutory requirements provided in the 2018 Farm Bill, therefore the Department did not publish a proposed rule with a public comment period for these provisions. However, since some of the provisions contained in this Final Rule have Paperwork Reduction Act (PRA) implications, the Food and Nutrition Service (FNS) is embedding a 60-Day Notice in this Final Rule to request public comments on these provisions. FNS is only requesting comments on the specific PRA implications resulting from this rule; the agency is not requesting comments on the rule itself. The Final Rule will be effective upon publication. The PRA requirements discussed in this rule, with their associated burden, will not be effective until OMB has reviewed and approved the Information Collection Request (ICR) associated with this Final Rule. FNS plans to prepare and submit the ICR after the due date for public comments has passed and FNS has analyzed the comments.

When the information collection requirements have been approved, the Department will publish a separate action in the Federal Register announcing OMB approval.

Title: Food Distribution Programs.

OMB Number: 0584-0293.

Expiration Date: July 31, 2023.

Type of Request: Revision of a Currently Approved Collection.

Abstract: This Final Rule codifies statutory requirements included in section 4102 of the Agriculture Improvement Act of 2018 (Pub. L. 115-334, the 2018 Farm Bill). Section 4102 of the 2018 Farm Bill established a statutory definition for the term “certification period” and established that certification periods for the Commodity Supplemental Food Program (CSFP) participants must be not less than one year and not more than three years.

Additionally, this rule also revises 7 CFR part 247 per section 4102 of the Agriculture Act of 2014 (Pub. L. 113-79, the 2014 Farm Bill), which amended CSFP eligibility requirements to phase out the participation of pregnant, breastfeeding and postpartum women, infants, and children (referred generally throughout this section as women, infants, and children), transitioning the CSFP to a seniors-only program. This provision was implemented through a previous final rule, Commodity Supplemental Food Program (CSFP): Implementation of the Agricultural Act of 2014 (79 FR 38748), published on July 9, 2014. The 2014 Farm Bill language was clear and mandatory, leaving no room for discretion. This action was finalized without prior notice or public comment under the authority of 5 U.S.C. 553(a)(2). As of February 2020, the phase out of all women, infants, and children was completed.

This final rule requires some State agencies to amend their State Plans to include the new certification period. Only those State agencies extending their current certification period longer than one year need to make an amendment. The Department believes that an additional fifteen minutes (0.25 hours) should be added to the current 5-hour burden estimate in the currently approved OMB Control Number 0584-0293 Food Distribution Programs, Expiration Date: 7/31/2023, to support State Plan amendments resulting from this change. Going forward, only those State agencies extending their certification period longer than one year will need to make amendments to their State Plans. The initial amendment to the State Plan is a one-time change and State agencies will not have to submit additional information going forward, if they choose to continue in subsequent years with their current certification period. State agencies will only have to submit a State Plan amendment in future years if they decide to change their certification period. The Department estimates that it will take fifteen minutes of a State agency staff person's time to prepare and send this information to FNS if making a change to their certification period. Per current estimates under State Plan Amendments at 7 CFR 247.6(d), under State Agency reporting in OMB Control Number 0584-0293 Food Distribution Programs, Expiration Date: July 31, 2023, approximately 40 State agencies typically make amendments to their State Plans on an annual basis. FNS believes that this change may result in approximately five additional State agencies submitting State Plan amendments to change their certification periods each year going forward. Accordingly, we are adding an additional 36.25 burden hours to cover future years in the event a State agency decides to adjust their certification period.

Currently FNS has approval under OMB Control Number 0584-0293 for individuals applying and certifying for CSFP. The individuals are broken into two groups, the elderly and women, infants, and children. CSFP certification periods for all CSFP participants are under 7 CFR 247.16. The currently approved collection includes 7,500 total burden hours for the application and recertification of women, infants, and children. The 2014 Farm Bill allowed women, infants, and children who were participating in the program on the date the law was enacted to continue on the program until their eligibility expired under the program rules in effect on that date. As of February 2020, all women, infants, and children have been phased out of the program, thus the burden for the application and recertification for these individuals needs to be removed from the collection.

As a result of the phase out of this population from CSFP, these 7,500 caseload slots have been reallocated to the population of elderly CSFP participants. Additionally, CSFP participation has increased in recent fiscal years (FY) due to the additional availability of program resources. In FY 2019 CSFP average annual participation was approximately 702,500. Therefore, FNS finds it reasonable to adjust the estimated number of elderly individuals to 702,500 for the application (7 CFR 247.8) and recertification (7 CFR 247.16) of elderly individuals. Per the final rule at 7 CFR 247.16, CSFP participants must provide verification to their local agency on an annual basis, regardless of the certification period that the State agencies impose on the local agencies. Therefore, elderly participants will provide information once per year, reducing the estimated responses from two to one. FNS estimates that this yearly contact will continue to take 15 minutes. The updated estimated burden for CSFP individuals is 175,625, which is a decrease of 110,875 from the previously approved burden of 286,500.

The following table reflects the burden associated with this rule in the existing burden collection in accordance with the Paperwork Reduction Act.

Affected public: State agencies.

Estimated number of respondents: 45.

Estimated total annual response per respondent: 1.

Estimated total annual responses: 45.

Estimated time per respondent: 5.25.

Estimated Total Annual Burden on Respondents: 236.25.

Affected public: CSFP Participants.

Estimated number of respondents: 702,500.

Estimated total annual response per respondent: 1.

Estimated total annual responses: 702,500.

Estimated time per respondent: 0.25.

Estimated Total Annual Burden on Respondents: 175,625.

Total Reporting Hours Resulting from Proposed Rule: 175,861.

Currently Approved Burden Hours in OMB #0584-0293: 1,161,377.

Estimated Burden Hours Including Hours from Final Rule: 1,043,038.

Burden Hour Difference: −118,339.

The Department is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Accordingly, 7 CFR part 247 is amended as follows:

A request for comments on Draft NUREG/BR-0006, Rev. 9 (ADAMS Accession No. ML20240A155) and Draft NUREG/BR-0007, Rev 8 (ADAMS Accession No. ML20240A181) was published in the Federal Register on August 15, 2019 (84 FR 41644), with a 90-day comment period ending on November 13, 2019. Comments received on NUREG/BR-0006, Rev. 9 and NUREG/BR-0007, Rev. 8 can be found on the Federal Rulemaking website ( https://www.regulations.gov ) under Docket ID NRC-2019-0108.

NUREG/BR-0006 and NUREG/BR-0007 provide instructions for reporting information to the Nuclear Materials Management and Safeguards System, as required by NRC regulations. The NRC has revised these documents to provide additional clarification and examples of nuclear material transaction reports and nuclear material status reports, to aid the licensee community in preparing clear and accurate submittals.

DOE incorporates by reference the following industry standard into 10 CFR part 430: ANSI/AHAM DW-1-2010, Household Electric Dishwashers, (ANSI approved September 18, 2010).

A copy of ANSI/AHAM DW-2010 is available at: Association of Home Appliance Manufacturers, 1111 19th Street NW, Suite 402, Washington, DC 20036, 202-872-5955, or go to http://www.aham.org.

For a further discussion of this standard, see section V.N.

In this final rule, DOE establishes a product class for standard residential dishwashers with a cycle time for the normal cycle of one hour or less from washing through drying. DOE believes that the new product class will offer greater consumer choice within DOE's existing energy and water conservation standards for residential dishwashers and will spur innovation in the design of dishwashers.

Since receipt of the petition, DOE conducted additional testing of dishwasher cycle times, as described in section II.B. of this final rule. As explained in Section II.B., the data show that a dishwasher with a “Normal” cycle time of 60 minutes or less is achievable, and that establishing a product class where the “Normal” cycle is 60 minutes or less could spur manufacturer innovation to generate additional product offerings to fill the market gap that exists for these products.

In establishing a product class with a “Normal” cycle of 60 minutes or less, DOE is creating an opportunity to introduce additional consumer choice in the dishwasher market. Specifically, DOE would be providing consumers the added option to purchase a standard residential dishwasher with a “Normal” cycle of one hour or less for the dishwasher to complete its operation from washing through drying. Consumers would still be able to purchase a dishwasher from the original dishwasher product class that is characterized by a longer “Normal” cycle, which often offers a “Quick” cycle (often recommended by the manufacturer for washing lightly soiled dishes) that may wash dishes even more quickly but potentially uses more energy or water than the “Normal” cycle. The distinction DOE has created through the introduction of this shorter one-hour “Normal” cycle product class and the original product class for standard dishwashers rests on the length of the cycle that manufacturers identify as the “Normal” cycle.

DOE's decision to establish the one hour “Normal” cycle product class is supported by the Department's test data, which indicate that the mean and median energy and water use values of the tested “Quick” cycles could meet the current DOE standards and had a mean and median duration of 1.3 hours (80 minutes). Further, ten of those quick cycles had a cycle time of less than one hour. The units selected for testing represent over 95 percent of dishwasher manufacturers and were a representative sample of the current dishwasher market. Based on these results, DOE is confident that, given the opportunity to do so, industry could feasibly develop and produce a standard dishwasher with the capabilities to meet the criteria of this new one hour product class. DOE intends to determine the specific energy and water conservation standards for the new product class, with a “Normal” cycle of one hour or less, in a separate rulemaking.

The Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., provides among other things, that “[e]ach agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.” (5 U.S.C. 553(e)) Pursuant to this provision of the APA, CEI petitioned DOE for the issuance of rule establishing a new product class under 42 U.S.C. 6295(q) that would cover dishwashers with a cycle time of less than one hour from washing through drying. (CEI Petition, No. 0006 at p. 1)  1 CEI stated that dishwasher cycle times have become dramatically longer under existing DOE energy conservation standards, and that consumer satisfaction and utility have dropped as a result of these longer cycle times. CEI also provided data regarding the increase in dishwasher cycle time, including data that, according to CEI, correlated increased cycle time with DOE's adoption of amended efficiency standards for dishwashers. ( Id., at pp. 2-3)

CEI requested that dishwasher product classes be further divided based on cycle time. CEI asserted that given the significant amount of consumer dissatisfaction with increased dishwasher cycle time, cycle time is a “performance-related feature” that provides substantial consumer utility, as required by EPCA for the establishment of a product class with a higher or lower energy use or efficiency standard than the standards applicable to other dishwasher product classes. (CEI Petition, No. 0006 at p. 5) CEI did not specify whether it requested the additional distinction apply to either the standard and compact classes or just the standard class.

CEI also cited 42 U.S.C. 6295(o)(4), which prohibits DOE from prescribing a standard that interested persons have established by a preponderance of the evidence would likely result in the unavailability in the United States in any covered product type (or class) of performance characteristics, features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States at the time of DOE's finding. ( Id., at p. 4) CEI stated that despite this prohibition, it appears that dishwasher cycle times have been impaired by the DOE standards and that many machines that offered shorter cycle times are no longer available. ( Id. )

In its petition, CEI suggested a cycle time of one hour or less as the defining characteristic for the new product class for standard dishwashers, because one hour is substantially below the cycle times for all current products on the market. ( Id., at p. 5) CEI stated that energy efficiency standards for current products would remain unchanged by the addition of the new product class, and that no backsliding would occur for the energy standards already in place. ( Id. ) Specifically, 42 U.S.C. 6295(o)(1) (“anti-backsliding provision”) prohibits DOE from prescribing a standard that increases the maximum allowable energy use, or in the case of showerheads, faucets, water closets or urinals, water use, or decreases the minimum required energy efficiency, of a covered product. CEI's petition did not suggest specific energy and water use requirements for the new product class, stating that the standards could be determined during the course of the rulemaking. (CEI Petition, No. 0006 at p. 1)

On April 24, 2018, DOE published a notice of receipt of CEI's petition for rulemaking. 83 FR 17768 (April 2018 Notification of Petition for Rulemaking). DOE requested comments on the petition, as well as any data or information that could be used to assist DOE's determination whether to proceed with the petition to create a new product class for standard residential dishwashers. In response to that request, the Department received a wide range of comments in favor of and opposing the creation of a new product class. Upon consideration of those comments, DOE granted CEI's petition and proposed to create a new product class for standard residential dishwashers with a cycle time of one hour or less for the normal cycle. 84 FR 33869 (July 16, 2019) (July 2019 NOPR). DOE addressed the comments received in response to publication of the petition in its July 2019 NOPR. DOE assumed that CEI's request, which did not specify whether it was requesting the additional product class distinction be applied to both standard and compact classes, would apply only to the standard dishwasher class because that class represents the vast majority of dishwasher shipments. Id. at 84 FR 33870. In response to the July 2019 NOPR, DOE received comments from industry and dishwasher manufacturers, state agencies and state officials, consumer organizations, utilities, energy efficiency advocates, and individuals. DOE discusses and responds to these comments in section III of this final rule.

In consideration of the comments received during this rulemaking, and supported by its own testing and evaluation, DOE establishes a new product class for standard residential dishwashers with a “Normal” cycle of one hour or less for washing through drying. DOE has determined that a cycle duration of this length provides for additional consumer choice in the dishwasher market. Specifically, in this final rule, DOE concludes that a product class of standard residential dishwasher with a “Normal” cycle of one hour or less would allow manufacturers to provide consumers with the option to purchase a dishwasher that maximizes the consumer utility of a short cycle time to wash and dry dishes. While the short cycle product class will enable the development of products that can provide consumers with dishwashers that offer a shorter “Normal” cycle, creation of this product class will in no way limit or prevent consumers that prioritize energy efficiency from continuing to purchase dishwasher models that offer more energy efficient cycles that exceed the current standard or meet ENERGY STAR ratings. Introduction of this product class expands the options available to consumers, particularly those who prioritize cycle time for the “Normal” cycle, when considering the purchase of a new dishwasher.

DOE testing and analysis included a review of normal and quick cycles available for a range of standard dishwashers currently available on the market. In conducting the testing, DOE analyzed the water and energy use, cycle duration, and cleaning performance of the “Normal” cycle and the shortest available cycle(s), as specified in the dishwasher's user manual. 2 The testing enabled DOE to determine whether it was feasible to manufacture a dishwasher with a cycle time of 60 minutes or less that could clean a full load of normally-soiled dishes, or whether a new product class for dishwashers with a “Normal” cycle of 60 minutes or less could be created to incentivize manufacturers to fill that gap in the market.

DOE tested 31 standard dishwasher models that encompassed various brands, features, and cycle options for different soil loads and durations. Test units were selected on the basis of different water and energy use, cycle durations, and features ( e.g., capacity, inlet water temperature requirement, soil sensors) with an emphasis on including a wide range of short-cycle options. The testing primarily examined short cycles with a duration of one hour or less. However, because many dishwasher units did not have cycles with such a short duration, cycles shorter in duration than the “Normal” cycle” for the given test unit but longer than one hour were also considered.

Each unit was tested according to the DOE dishwasher test procedure at 10 CFR, part 430, subpart B, appendix C1 (appendix C1) for the “Normal” cycle, and then the appendix C1 methodology was repeated for the short cycle(s) to compare water and energy use among the cycles. The duration of each test cycle from washing through drying was also measured and recorded. Additionally, though DOE does not regulate cleaning performance under EPCA, for purposes of this analysis, DOE used the ENERGY STAR Test Method for Determining Residential Dishwasher Cleaning Performance (Cleaning Performance Test Method) to determine the cleaning scores, expressed in terms of a per-cycle Cleaning Index, of the tested units on each of the three soiled cycles (heavy, medium, and light soil loads) that are run for appendix C1 for soil-sensing dishwashers. 3

The data summarizing the results of the testing, including 31 “Normal” cycles and 34 “Quick” cycles conducted on the 31 test units, may be reviewed in the docket for this rulemaking. 4 Parameters outlined include the per-cycle machine energy consumption, water consumption and associated water heating energy consumption, power dry energy consumption (if any), total energy consumption, duration, and Cleaning Index for each of the three soil load test cycles required under appendix C1. To determine the overall per-cycle values of energy and water consumption and cycle duration, for each “Normal” and “Quick” cycle, DOE applied the same weighting factors to the results from each soil load as specified in appendix C1. From these, along with the combined low-power mode energy consumption for each unit, an Estimated Annual Energy se (EAEU) for each “Normal” and “Quick” cycle was calculated, using the equations provided in 10 CFR 430.23(c)(2).

The results of DOE's analysis for “Quick” cycles are specified in Table II-1. While all of DOE's test results are included in the docket for this rulemaking, DOE presents the values for only the “Quick” cycle in Table II-1 because none of the “Normal” cycles on the units tested had a duration of less than 60 minutes.

As noted previously, each unit was tested according to the DOE dishwasher test procedure at 10 CFR, part 430, subpart B, appendix C1 (appendix C1) for the “Normal” cycle, and then the appendix C1 methodology was repeated for the short cycle(s) to compare water and energy use among the cycles. The results of this testing demonstrated that ten of the units tested already complete a “Quick” cycle in 60 minutes or less. Of these ten “Quick” cycles tested with a time of less than one hour using the same soil loads specified by the DOE test procedure for testing the “Normal” cycle, 90% of those cycles would meet the DOE standard for energy consumption that is based on the normal cycle of a standard-size dishwasher, 90% would meet the DOE standard for water consumption that is based on the normal cycle of a standard-size dishwasher, and 80% would meet both. DOE notes, however, that while five of these units had a weighted-average cleaning score greater than or equal to 70  5 , only one of these units had a cleaning score of greater than or equal to 70 for all three soil loads tested, and only one of the units is recommended by the manufacturer for a full load of normally soiled dishware—that single unit had a weighted-average cleaning score of only 63. Based on these results, DOE finds that a dishwasher with a “Normal” cycle time of 60 minutes or less is achievable and that establishing a product class where the “Normal” cycle is 60 minutes or less could spur manufacturer innovation to generate additional product offerings to fill the market gap that exists for these products ( i.e., ability to clean a load of normally-soiled dishes in under 60 minutes). Building upon existing dishwasher capabilities and the results of this testing as a foundation for future development of dishwasher models, and recognizing the potential for innovation within the industry for this specific product, this final rule establishes a product class where a one hour or less cycle from washing through drying represents the “Normal” cycle.

Based on the evaluation of the petition and careful consideration of comments submitted during both comment periods provided for this rulemaking action, the Department of Energy establishes a new dishwasher product class for standard residential dishwashers with a “Normal” wash cycle that would completely wash and dry a full load of normally soiled dishes in one hour (60 minutes) or less. DOE intends to conduct a separate rulemaking to determine the applicable test procedure and energy conservation standards  6 for the new product class that provide the maximum energy efficiency that is technologically feasible and economically justified, and will result in a significant conservation of energy, 42 U.S.C. 6295(o)(2)(A). 84 FR 33869, 33873 (July 16, 2019).

In evaluating CEI's petition and establishing a separate product class for dishwashers that wash and dry dishes in less than an hour during the “Normal” cycle, DOE has determined that under 42 U.S.C. 6295(q), dishwashers with a “Normal” cycle time of one hour or less have a performance-related feature that other dishwashers lack that justifies a separate product class subject to a higher or lower standard than the standards currently applicable to the existing product classes of dishwashers. Testing conducted by DOE demonstrates that because many dishwashers currently offer a 60 to 90 minute “Quick” cycle wash that, on average, could meet the current DOE energy and water conservation standards, and a number of the units tested completed a “Quick” cycle in less than 60 minutes, that the potential exists for industry to develop a dishwasher that can complete a “Normal” cycle within one hour or less. Based on the test results described in Section II.B. of this final rule, the development of such a product will require effort on the part of industry product designers, and DOE establishes a product class to facilitate the development of a standard dishwasher where such values represent the “Normal” cycle through finalizing this rule.

CEI petitioned DOE to establish a separate product class for dishwashers that have a cycle time of less than one hour from washing through drying. (CEI Petition, No. 0006 at p. 1) Under the current test procedure and energy conservation standards, dishwashers are tested and evaluated for compliance when operated on the “normal cycle.” Appendix C1, sections 2.6.1, 2.6.2, 2.6.3. “Normal cycle” is the cycle, including washing and drying temperature options, recommended in the manufacturer's instructions for daily, regular, or typical use to completely wash a full load of normally soiled dishes, including the power-dry setting. Appendix C1, section 1.12. Manufacturers may add additional cycles to dishwashers, but those additional cycles are not tested nor considered the “Normal cycle”. Although CEI's initial petition did not specify the cycle that would be limited to one hour under the separate product class, CEI provided information supplemental to its petition clarifying the request for a new product class for dishwashers for which the normal cycle is less than one hour. 7 In this final rule, based on evaluation of comments and the test data and analysis described in section II.B. DOE establishes a separate product class for dishwashers that have a normal cycle time of one hour or less from washing through drying.

EPCA directs that when prescribing an energy conservation standard for a type (or class) of a covered product DOE must specify a level of energy use or efficiency higher or lower than that which applies (or would apply) for such type (or class) for any group of covered products which have the same function or intended use, if DOE determines that covered products within such a group:

• Consume a different kind of energy from that consumed by other covered products within such type (or class); or

• have a capacity or other such performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard from that which applies (or will apply) to other products within such type.

DOE has concluded that it has the legal authority to establish a separate short cycle product class for standard residential dishwashers with the manufacturer recommended “Normal” cycle of one hour or less, pursuant to the Department's authority under 42 U.S.C. 6295(q). Dishwashers with a short “Normal” cycle have a performance-related feature that other dishwashers currently on the market lack, which justifies the establishment of a separate product class subject to a higher or lower standard than that currently applicable to dishwashers. 84 FR 33869, 33871 (July 16, 2019). Consumers that prioritize energy efficiency will still be able to purchase models characterized by a longer “Normal Cycle” while consumers who place a greater value on cycle time will now have the opportunity to select a model with a shorter “Normal cycle”. Creation of a new product class will allow the development of new offerings that will expand the market for standard residential dishwashers and provide consumers additional options when selecting the product that best meets their needs and differing preferences. As described in Section II.B., while many dishwashers on the market currently offer a “Quick cycle” option, these cycles are often not intended for normal loads, and the creation of a new product class will enable manufacturers to optimize their offerings to meet demand for short cycle products intended to clean a full load of normally soiled dishes.

DOE received comments from the Attorneys General of California, Connecticut, Illinois, Maine, Maryland, Massachusetts, Minnesota, New Jersey, New York, Oregon, Vermont, Washington, the District of Columbia, and the City of New York (State AGs and NYC); Sierra Club, Natural Resources Defense Council, and Earthjustice (the Joint Commenters); the Association of Home Appliance Manufacturers (AHAM); Appliance Standards Awareness Project (ASAP), along with the Consumer Federation of America (CFA), National Consumer Law Center on (NCLC), and Natural Resources Defense Council (collectively referred to as ASAP); and others challenging the Department's proposal that a one hour or less normal cycle was a performance-related feature that justifies the establishment of a new product class for standard residential dishwashers.

Comments submitted by the State AGs and NYC argued that the proposal does not qualify as “a performance-related feature” under 42 U.S.C. 6295(q) and that the consumer utility of a dishwasher is to clean dishes and other cookware. According to the commenters, while shorter cycles may provide clean dishes in less time, they do not provide an additional distinct dishwasher utility beyond the purpose of washing and drying dishes. The fundamental utility of a dishwasher, regardless of cycle length, is to clean dishes. A reduced cycle time is not a “performance-related feature” that would justify the creation of its own separate product class. (State AGs and NYC, No. 3136, pp. 5-8) Commenters cite DOE's prior rulemakings to conclude that the Department was acting inconsistently in proposing to establish a new product class for short cycle dishwashers under 42 U.S.C. 6295(q)(1). These commenters relied on the Department's cooking products rulemaking, where DOE determined that self-cleaning ovens justified a separate product class because the self-cleaning function was a distinct feature that standard ovens did not provide, as an example for when a separate product class was justified based on the existence of a performance-related feature. ( Id., pp. 7-8; 73 FR 62034, 62047 (Oct. 17, 2008)) Commenters distinguished self-cleaning ovens from DOE's water heaters rulemaking, where DOE determined water heaters that utilized heat pumps or electric resistance technology were still of the same utility ( i.e., providing hot water), and did not justify the creation of a new product class. Commenters argued that this dishwasher rulemaking was similar to the Department's water heaters rulemaking because dishwashers with a normal cycle exceeding one hour provided the same utility as a dishwasher with a normal cycle of one hour or less—both cycles provide clean dishes. Commenters' claim DOE provided insufficient justification as to why shorter cycle time deserves its own product class while a wide variety of other consumer options from speed to efficiency remain consumer preferences. (California Investor Owned Utilities (CA IOUs), No. 3142, p. 3)

Related comments also argued that if DOE were to establish “a separate standard for every appliance having a detectable difference in feature, no matter how slight . . . then hundreds of standards might result,” and that such actions would be contrary to the intent of Congress. (State AGs and NYC, No. 3136, p. 6 referencing H. Conf. Rep. No. 95-1751, at 115 (1978); Joint Commenters, No. 3145, p. 4 referencing H. Conf. Rep. No. 95-1751, at 115-116 (1978))

In response, DOE disagrees with the assertion that it is acting inconsistently with prior rulemakings by establishing a product class for dishwashers with a “Normal” cycle of one hour or less. DOE has previously determined that refrigerator-freezer configurations, oven door windows, and top loading clothes washer configurations all offer performance-related features that justified the creation of new product classes, including relying on cycle time as a feature with respect to commercial clothes washers. 84 FR 33869, 33872 (July 16, 2019). DOE maintains that a short cycle product class, the feature at issue in this rulemaking, is no different. In these prior rulemakings DOE recognized that the value consumers received from the feature, i.e., refrigerator-freezer configurations, oven door window and time, justified the establishment of the product class under 42 U.S.C. 6295(q)(1).

DOE has taken the view that utility is an aspect of the product that is accessible to the layperson and based on user operation, rather than performing a theoretical function. DOE's discussion of its prior rulemakings and what it has determined is a “utility” pursuant to this principle is described at length in the July 2019 NOPR. 84 FR 33869, 33872 (July 16, 2019). These commenters appear to be suggesting a very different principle—that DOE can determine that a product attribute is a feature only if it adds a performance characteristic or utility beyond the primary purpose of the product (here a performance characteristic or utility beyond a dishwasher's primary purpose of cleaning dishes). Following the logic of this comment would mean a refrigerator-freezer's primary utility is to store and preserve fresh food, and that the configuration of the refrigerator-freezer does not provide a consumer with the utility of different ways to access its contents. The principle described in the comment would also mean that an oven's primary utility is to cook food, which would not allow for DOE to accommodate the utility provided by the ability to see the food cooking through a window. An oven door with a window uses more energy than an oven door without a window, but it allows the user to see the oven's contents without opening the oven door. DOE recognized that the oven door window offered a distinct consumer utility even though an oven door window did not go beyond the oven's primary function of cooking food. The commenter's argument does not explain why an oven door window justifies a product class when it does not add to the oven's primary purpose of cooking food. The food would come out cooked from an oven without a door window just as the dishes would come out clean from a dishwasher without a shorter “Normal” cycle. DOE has determined that in both cases, however, the oven door window and a shorter “Normal” cycle on a dishwasher are “features” that provide consumer utility and justify a separate product class.

The approach commenters suggest is contrary to the approach that DOE has taken in prior rulemakings, in which DOE recognized that the features for which consumers express a preference indicate that the feature provides some utility to the consumer, even if it is not the primary purpose of the product. For example, in a rulemaking to amend standards applicable to commercial clothes washers, DOE determined that the “axis of loading” constituted a feature that justified separate product classes for top-loading and front-loading clothes washers. DOE also determined that “the longer average cycle time of front-loading machines warrants consideration of separate [product] classes.” 79 FR 74492, 74498 (Sept. 15, 2014). DOE stated that a split in preference between top-loaders and front-loaders would not indicate consumer indifference to the axis of loading, but rather that a certain percentage of the market expresses a preference for ( i.e., derives utility from) the top-loading configuration. Similarly, the location of the freezer compartment for residential refrigerator-freezers ( e.g., top mounted, side-mounted, and bottom-mounted) on these products provides no additional performance-related utility other than consumer preference. In other words, the location of access itself provides distinct consumer utility that does not add to the food storage purpose of the refrigerator-freezer. Id., at 79 FR 74499.

Additionally, DOE maintains that the approach taken in this final rule and prior rulemakings is consistent with the rulemaking history that the commenters reference. In DOE's view, establishing a product class based on a top mounted freezer and bottom mounted freezer, for example, is no different than identifying a one hour or less “Normal” cycle for dishwashers as a performance-related feature that justifies a separate product class. In both cases, DOE has identified a feature that provides utility to the consumer and established a product class on the basis of that utility. It would be unreasonable to adopt the position these commenters assert, that features offering a distinct utility to consumers would not merit a separate product class, because they are a preference that is unrelated to the primary purpose of the product.

DOE's prior rulemakings also illustrate the value DOE has recognized in evaluating consumer preferences. As noted above, DOE determined the consumer value in seeing inside the oven, as opposed to opening the door and releasing the heat, was a feature that justified a separate product class. 63 FR 48038, 48041 (Sept. 8, 1998). Applying the same logic, DOE determined that the configuration of a refrigerator-freezer, which provided consumers with a value based on access to the bottom-mounted freezer compartment, was also a feature. 75 FR 59469, 59488 (Sept. 27, 2010). Under the commenters' proposed approach, neither feature would have justified the creation of a separate product class. DOE remains committed to recognizing the features that provide a utility for which consumers express a preference and that expand consumer choice.

Similarly, in the 2012 clothes washers' rulemaking, the Department received comments stating that consumer preference supported maintaining clothes washer product class distinction by method of access. 77 FR 32307, 32318 (May 31, 2012). In addition to noting that consumers preferred not to stoop or bend while loading clothes (something not required for top-loading washers), one manufacture estimated that top loading washers accounted for about 65 percent of the market. Consumer preference noticeably impacted the market and established the method of loading as a utility that ultimately supported the retention of the top-loader product class. DOE also specifically recognized cycle time as a feature pursuant to 42 U.S.C. 6295(q). Id., at 77 FR 32319. In this final rule, DOE concludes that EPCA authorizes the Department to establish a product class for dishwashers with a “Normal” cycle of one hour or less. See 42 U.S.C. 6295(q).

If DOE were to follow these contrary comments to their logical conclusion, DOE would then lack the ability to establish product classes for features that, in the commenters' view, do not add to or go beyond the primary purpose of a product even if consumers received a recognized utility from those features as specified in 42 U.S.C. 6295(q). The Department's authority to establish product classes based on capacity and fuel type cast doubt on the appropriateness of the commenters' suggested guiding principle. Congress included other criteria in EPCA for DOE to consider when using its discretion to identify the utility of a feature that justified the creation of a new product class—criteria that do not “add to” the primary purpose of the product—specifically, capacity and fuel use. Protecting consumer utility, at the cost of potential increased energy use, clearly has a role to play while supporting consumer choice. Therefore, DOE has determined that it would be unreasonable to limit the authority granted in EPCA in 42 U.S.C. 6295(q) to prohibit the creation of product classes if the “feature” at issue does not somehow go beyond the primary purpose of a product. Like its prior rulemakings, DOE also finds here that consumers would receive a utility from a dishwasher cycle that can completely wash and dry normally soiled dishes in one hour or less, which justifies the creation of a product class on that basis.

Additionally, 42 U.S.C. 6295(q) cannot be read to prevent DOE from recognizing features that provide energy savings or other technological innovations that could yield consumer utility. When DOE determined that the window in an oven door was a “feature” justifying a different standard, DOE recognized that if the window were removed from the oven door that it may cause users to open the door more frequently. Such activity has the potential to result in an increase in energy usage even though some heat escapes through the window itself. While retaining the oven door window caused some loss of heat and therefore energy efficiency, DOE determined that the elimination of the oven door window would reduce the utility consumers received from being able to see inside and cause a greater increase of energy use. 63 FR 48038, 48041 (Sept. 8, 1998).

Also, as mentioned in the July 2019 NOPR, DOE is exploring the energy use of network connectivity for covered products, a relatively new technology that is becoming a feature offered in updated models of covered products and is already considered a utility to consumers. 84 FR 33869, 33873 (July 16, 2019). While this feature requires some attendant energy use, consumers are interested in the benefits provided through the connectivity of appliances that allow for remote control access, automatic supply replenishment, and intelligent energy consumption. 83 FR 46886, 46887 (Sept. 17, 2018). The innovation that network connectivity provides is certainly a feature of increasingly great utility that many consumers may come to prefer.

The Joint Commenters also argued that DOE cannot justify this final rule by referencing the history of dishwasher standards. First, Joint Commenters stated that because Congress established tighter dishwasher standards in 2007 in the Energy Independence and Security Act (EISA), section 311(a)(2), DOE cannot now establish this product class because the Congress amended the statute to further increase the standards after most of the alleged increases in cycle length occurred. Joint Commenters contended that because Congress chose not to relax dishwasher standards then, DOE cannot use the product class provision to establish a feature that would lessen standards now. In response, DOE notes that this rulemaking does not alter any existing energy or water conservation standards for dishwashers; rather, this final rule creates a new product class for dishwashers with a short “Normal” cycle time of one hour or less. In addition, DOE emphasizes that Congressional action to establish new standards for dishwashers does not negate the authority Congress granted to DOE in 42 U.S.C. 6295(q) to establish product classes based on size, capacity, fuel use or other features after considering the utility of the feature to the consumer. The Joint Commenters also stated that DOE found that if it adopted stronger standards it would have required substantially longer cycle times to maintain cleaning performance and relied on this determination as a factor when rejecting stronger standards in 2012. (Joint Commenters, No. 3145, p. 5 referencing 77 FR 31918, 31956-31957 (May 30, 2012)) DOE notes that in issuing its “no new standard” determination for dishwashers in 2016 (81 FR 90072 (Dec. 13, 2016)), DOE determined that a substantially longer cycle time would be needed to maintain the cleaning performance of standards more stringent than those in place. 81 FR 90072, 90073 and 90116 (Dec. 13, 2016). There, DOE determined the existing standards were sufficient and rejected more stringent requirements that would have required longer cycle times. In addition, DOE clarifies that this final rule addresses an issue not addressed in that rulemaking, i.e., whether a one hour or less “Normal” cycle provides a consumer performance-related feature or utility.

The Joint Commenters also sought support for their position by arguing that when DOE surveyed the utility or performance-related features of dishwashers in 1991 that affect energy efficiency and determined that establishing capacity-based product classes was the only action needed to minimize the impact on consumer utility. (No. 3145 at p. 5 referencing 56 FR 22250, 22254, 22275 (May 14, 1991)). Their reliance on this rulemaking is misplaced. The standards and product offerings today are significantly different from what was considered available and offered nearly three decades ago in 1991, and such comparison of performance related features is not relevant for this final rule.

Some commenters expressed a concern that if DOE relies only on consumer preference there would be a plethora of product classes created. ( Id., at p. 4) However, in the product types DOE describes herein ( e.g., ovens, refrigerator-freezers, clothes washers, etc.), in which the Department developed a product class based on consumer preference, DOE has not seen the concern manifested. CEI's petition and the comments DOE received in response to the petition and its July 2019 proposed rule indicate that a significant number of consumers expressed various levels of dissatisfaction with the amount of time and energy necessary to run their dishwasher to clean a load of normally soiled dishes. The Committee for a Constructive Tomorrow (CFACT) cited a General Electric Appliances (GEA) survey of roughly 11,000 dishwasher owners that reported the long wait times for clean dishes as a major consumer annoyance. (CFACT, No. 2941 at p. 1) These comments express the utility consumers would receive from owning a dishwasher that could clean normally soiled dishes using a “short-cycle” dishwasher. (Attorneys General of Arizona, Indiana, Louisiana, Oklahoma, and South Carolina, and the then-Governor of Mississippi, Phil Bryant (Attorneys General and Governor Bryant), No. 3131, pp. 1-2) CEI's 2019 survey determined a majority of surveyed consumers would choose to own a faster dishwasher even if it cost more to operate. (No. 3137, p. 4)

Relying on their 2019 survey, CEI also considered the utility customers would receive from shorter cycle durations and faster dishwashers. ( Id., at pp. 2-3) The survey determined that 81% of participants believed a dishwasher that could clean and dry dishes in an hour or less would be useful and 92% of participants favored cycles with a duration of one hour or less. The survey polled consumers' thoughts regarding washing dishes by hand and nearly half of those surveyed considered washing their dishes by hand because the cycle was too long with about 50% stating that they often or always wash dishes by hand due to the long cycle time. ( Id., at pp. 3-4) Because handwashing is often times more water intensive than using the dishwasher, the survey results indicated that faster cycles could substantially reduce energy and water consumption by reducing the amount of handwashing. ( Id. ) Targeting respondents who mostly run their dishwashers when they go to bed, CEI's survey also asked respondents if they would run their dishwasher at some other time if the dishwasher was faster. The survey showed 77.7% of respondents said yes, indicating that even if all dishwashing was conducted overnight, there is evidence that households may do so as a result of long cycle times. ( Id., at 4)

The Joint Commenters remarked that if there are no dishwashers currently capable of meeting the proposal's cycle duration limit and cleaning performance goals while operating in the normal cycle, EPCA's product class provision does not provide DOE the authority to facilitate that capability. The Joint Commenters challenged DOE's interpretation of the product class provision as providing the Department the discretion to determine that some covered products should have a capacity or other performance-related feature they presently do not have. (No. 3145, p. 4; 84 FR 33869, 33872-33873 (July 16, 2019)) The Joint Commenters contend that the provision was written in the present tense, meaning that a performance-related feature may trigger an action only when there are covered products with that feature already part of an existing product class. Joint Commenters referenced certain provisions in EPCA ( e.g., 42 U.S.C. 6295(bb) (establishing performance specifications for compact fluorescent lamps and authorizing DOE updates), 42 U.S.C. 6295(i)(1), (3)-(5) (prescribing minimum color rendering index values for general service fluorescent lamps and authorizing DOE updates) to support their position. They argue that if there is no dishwasher currently capable of operating in the normal cycle in one hour or less, then the product class provision does not provide DOE the authority to make such a product available. Only in situations where the feature is already available does the product class provision provide DOE the authority to act. (Joint Commenters, pp. 4-5)

The Joint Commenters misunderstand the effect of DOE's product class rule. DOE is not requiring manufacturers to make dishwashers with a normal cycle one hour or less; rather, this rule is establishing a product class based on that criterion. Manufacturers can choose to develop such products if they want to do so, but they are not forced to take such action. As a result, the provisions cited in EPCA that establish performance specifications for fluorescent lamps and color rendering index values and authorize DOE to update those requirements cited by the commenter are inapplicable to this final rule establishing a new product class for dishwashers.

Additionally, while the commenter is correct that DOE does not regulate in a vacuum, the testing described by DOE in section II.B. of this final rule indicates that dishwashers already exist on the market that can wash dishes in a designated “Quick” cycle in 60 to 90 minute time periods. In this final rule, DOE is establishing a product class for dishwashers where the one hour or less time period denotes the “Normal” cycle. EPCA does not specify how prevalent a specific feature must be on the market ( i.e., the commenter specifies that DOE can act only when there are covered products with that feature already part of an existing product class). For example, as noted in the July 2019 NOPR and DOE's 2018 RFI on “smart products” (83 FR 46886 (Sept. 18, 2018)), DOE is just beginning to explore the energy use of the network connectivity of covered products. Network connectivity is a technology that has only recently begun to appear on the market. Moreover, it clearly has a desirable consumer utility and is a fast growing feature of new models of covered products. Network connectivity, however, comes with attendant energy use. EPCA's product class provision cannot be read to prohibit DOE from establishing product classes for products that have network mode connectivity simply because that feature is not currently common on the market. 8 Similarly, for dishwashers, 42 U.S.C. 6295(q) authorizes DOE to establish standards for product features that provide consumer utility, such as shorter cycle times.

DOE acknowledges that it has previously established product classes based on features that have been in the market for a significant period of time. For example, ventless clothes dryers had been on the market for at least 25 years when the Department established separate energy conservation standards for ventless clothes dryers. 9 In that rulemaking, DOE reasoned that ventless clothes dryers provided a unique utility to consumers because these products could be installed in areas where vents were otherwise impossible to install. 76 FR 22454, 22485 (Apr. 21, 2011). In that situation, however, manufacturers of those products had been operating for many years under a waiver from DOE's test procedure. It is important to note that a test procedure waiver is not a waiver from the standard. Those manufacturers were potentially at risk because their product met the definition of a clothes dryer but could not meet the standards applicable to clothes dryers even when using a modified test procedure. DOE established a test procedure and standards for ventless clothes dryers—standards that were lower than the standards currently applicable to other clothes dryers on the market—in 2011 (76 FR 22454, 22469-22471 (Apr. 21, 2011)), but early DOE action would provide manufacturers with certainty earlier in the process of product development as to the test procedure and standards applicable to their products. As noted in the previous paragraph, DOE is applying this reasoning to new technology and is exploring the energy use of network connectivity of covered products as the technology becomes more available. Similarly, the development of a new product class for dishwashers with a “Normal” cycle of one hour or less would initiate the development of innovative technologies that could achieve normal wash performance within a shorter cycle time.

DOE also received comments asserting that the proposal was unnecessary given that dishwashers on the market already offered a quick cycle and that there was no consumer utility to a short cycle to justify a new product class. ASAP and other commenters argued that because such quick cycles were already widely available, the utility of a short cycle already existed, making the creation of a separate product class unwarranted. (No. 3139. p. 2; Alliance to Save Energy (ASE), No. 3185, p. 2) Similarly, the Joint Commenters stated that because there are products currently capable of a quick wash, EPCA does not provide DOE the authority to mandate that the normal cycle should be one hour or less. (No. 3145, p. 4) The California Energy Commission (CEC) explained that EPCA's product class provision requires DOE to show that the new product class has a feature that other products in the class lack, not that the feature exists but is not offered as the normal cycle. CEC continued that with such quick cycle dishwashers already on the market, this situation fails to justify creating a new product category that would operate with a higher or lower standard under 42 U.S.C. 6295(q)(1)(B). (CEC, No. 3132, p. 6) Similarly, ASE commented that a new product class is not necessary, as demonstrated by AHAM's data, because dishwashers with cycle durations of about an hour are available. (No. 3185, p. 2) Arguing further that the proposal was unnecessary, the State AGs and NYC contended that cycle times have limited importance to consumers and that DOE's position does not meet the burden for explanation for the new product class. (No. 3136, p. 11) Electrolux Home Products (EHP) also noted that a specific short cycle dishwasher product was not a high priority for consumers and that short cycles consistently ranked low as the feature most wanted by consumers. (No. 3134, p. 1) Relying on the data provided from its members surveyed, AHAM similarly noted that, when selecting a dishwasher, cycle time was ranked lowest in importance among the features available to consumers whereas cleaning performance, loading, and dish rack features were considered much more important to consumers. AHAM indicated that this meant there was limited demand for such products. (No. 3188, pp. 4-5)

In contrast, other commenters noted in support of DOE's rule that the public will ultimately receive a significant benefit from the creation of such products. The Attorneys General and Governor Bryant commented that the new product class would provide a product that will clean and dry dishes within the hour that meet consumers' needs while reducing the total energy used and saving money as consumers will no longer need to run their dishwashers multiple times. (No. 3131, p. 3) Further, a new product class would increase the number of available dishwashers on the market and provide consumers with more freedom to select a product that best meets their needs. ( Id., pp. 4-5)

DOE maintains that while there may be dishwashers that offer a ”Quick” wash cycle in 60 to 90 minute intervals, these cycles are not tested nor considered the “Normal” wash cycle for purposes of demonstrating compliance with existing energy and water conservation standards. The existence of these products in the market does not prevent the establishment of the product class DOE is creating with this rulemaking. Manufacturers' compliance with existing dishwasher standards requires testing be conducted on the “Normal cycle”, which is defined as the “the cycle type recommended by the manufacturer for completely washing a full load of normally soiled dishes including the power dry feature.” See 10 CFR part 430, subpart B, appendix C1. Commenters note that current dishwasher models offer a variety of cycle options or settings such as normal, heavy, light, eco, quick, pots, and pans, china, and so on that include a quick wash cycle. These cycles do not meet DOE's regulatory definition of the “Normal cycle” and are not subject to the Department's established dishwasher test procedure that is used when determining compliance with energy conservation standards. DOE intends to conduct a rulemaking to establish standards for the new product class for standard residential dishwashers based on the one hour or less “Normal” cycle. This would provide consumers with a means to compare products across the product class and make an informed decision when deciding to purchase a product that emphasizes cycle time or a different product attribute subject to the applicable minimum standards. Contrary to the commenters' assertions, a new product class does not inevitably mean a loss of existing energy savings. DOE will consider the appropriate standards for the new product class in a separate rulemaking, where it will complete its rulemaking analysis pursuant to the seven factors specified in 42 U.S.C. 6295(o) for the establishment of standards.

AHAM and others commenters argued that most dishwashers available today already offer consumers cycle options that clean dishes in less time than the normal cycle, i.e., quick cycle. AHAM based this statement on a recent survey that claimed 86.7% of reported 2017 dishwasher shipments provided consumers a cycle option that could wash and dry a load in just over an hour. (AHAM, No. 3188, p. 2; ASE, No. 3185, pp. 2-3; and ASAP, No. 3139, p. 1) Ceres BICEP, relying on Consumer Reports' 2017 Spring Dishwashers Survey, also remarked that nearly every dishwasher today offers a quick cycle mode and that the majority of consumers surveyed either did not view the cycle length as an issue, or used a quick cycle to address concerns about cycle length. (No. 2746, pp. 2-3)

In response to these comments, DOE acknowledges that quick or fast cycles are available. CEI provided evidence that these quick cycles do not satisfy consumers' needs as these cycles are not designed and intended for normal use. (No. 3137, pp. 4-5) CEI identified various models that offered a quick wash cycle for lightly soiled recently used dishes or lightly soiled dishes with no dried-on food. 10 These cycles are not considered for testing purposes to determine compliance with DOE's energy conservation standards. DOE recognizes ASE's comment that, for a substantial percentage (just under half) of dishwashers with short cycles, manufacturers do not discourage consumers from using these cycles to wash normally soiled loads. Some even recommend using short cycles for normally soiled dishes. (No. 3185, p. 3) The fact that dishwashers have separate “Normal” and “Quick” cycles, however, indicates that these cycles provide a separate utility and that the consumer recognize that there is a difference between using the “Normal” versus the “Quick” cycle. The fact that manufacturers “do not discourage” use of the “Quick” cycle for a full load of normally soiled dishes also does not equate to the manufacturer-recommended cycle for doing so.

Based on the manufacturer descriptions of the intended use of these quick cycles, DOE reiterates that the “Quick” cycles available on current dishwasher models do not provide the same utility as the Department's new one hour or less short cycle product class. The new product class would be suited for cleaning normally soiled dishes and be subject to applicable energy and water conservation standards and testing like product classes for all covered products, pursuant to the outcome of separate rulemaking(s) to address these requirements.

Furthermore, while AHAM argued that existing quick wash cycles satisfy consumer needs, CEI's 2019 survey provided different consumer feedback. Consumer responses determined that 46.1% of consumers did not have a quick or express cycle available and only 13.5% of those surveyed said they used such a cycle more often than the manufacturer recommended normal cycle. Additionally, 84.6% of those consumers with a quick or express cycle stated that they would find a one-hour normal cycle useful. Of those consumers with a quick or express cycle, 87.6% said they would use such a cycle more if it cleaned their dishes better. (CEI, No. 3137, p. 5) Additionally, commenters supporting the new product class explained that the quick cycles identified by AHAM tend to include disclaimers with time additions that ultimately result in cycle durations that are comparable to the normal wash cycle. There is clearly a demand for such a product based on these results and the comments DOE received in response to its publication of the petition and the July 2019 NOPR. DOE reiterates that consumers, by expressing a preference, have identified a consumer utility that provides the basis for creating a product class based on cycle duration.

The CA IOUs commented that while manufactures do not always recommend quick cycles for daily use, DOE offered no evidence demonstrating that these cycles were less effective at cleaning. The CA IOUs called for DOE to conduct its own analysis regarding the cleaning adequacy for these quick cycles. (No. 3142 p. 2) The CEC called the proposed one hour cycle time arbitrary based on the fact that the cycle proposed is less time than current normal cycles. CEC argued that the rule relied on limited data that did not reach the conclusion that there is a consumer preference for this short cycle duration or that the cycle time would result in cleaner dishes. CEC concluded that DOE and CEI failed to demonstrate that a one-hour cycle time could not meet the existing standard, and that DOE made this presumption with no evidence provided as needed to justify the creation of a new product class. (No. 3132 p. 4)

In response, DOE emphasizes that EPCA does not authorize DOE to establish test procedures and standards that require manufacturers to evaluate or meet a certain level of cleaning performance. DOE test methods and standards pertain to the measurement of and establishment of minimum levels of energy use (and, for some products, water use) or maximum levels of energy efficiency. See 42 U.S.C. 6293 and 42 U.S.C. 6295. DOE has also previously addressed the argument concerning the consumer utility provided by a dishwasher with a faster manufacturer identified normal cycle in the preceding paragraphs of this section.

In establishing this product class, the Department conducted a comprehensive review assessing a range of dishwashers with additional cycles shorter than the manufacturers' recommended normal cycle, i.e., the cycle subject to DOE testing and compliance with efficiency standards. Based on this review, DOE determined that it was feasible to manufacture a dishwasher with a “Normal” cycle time of 60 minutes or less and that establishing a product class where the “Normal” cycle is 60 minutes or less could spur manufacturer innovation to generate additional product offerings to fill the market gap that exists for these products ( i.e., ability to clean a load of normally-soiled dishes in under 60 minutes).

DOE determined that ten of the 34 cycles tested offered a “Quick” cycle of less than one hour. Of those models with a “Quick” cycle of less than one hour using the same soil loads specified by the DOE test procedure for testing the “Normal” cycle, 90% could meet the current DOE energy consumption standard that is based on the normal cycle of a standard-size dishwasher, 90% would meet the water consumption standard that is based on the “Normal” cycle of a standard-size dishwasher, and 80% could meet both standards. 11 The “Quick” cycles of less than one hour were identified as offering lesser mean and median per-cycle cleaning indices ( i.e., the mean and median Cleaning Index for the heavy, medium, and light soil loads) than those for the “Normal” cycle and all “Quick” cycles including other slightly longer “Quick” cycles.

This indicates that the currently available 60 minute or less “Quick” cycles, on average, are less effective at cleaning dishes when compared to the “Normal” and other slightly longer “Quick” cycle options. As described in Section II.B., while DOE realizes that these “Quick” cycles are not necessarily intended to clean normally soiled dishes, at least some of these cycles appear to be capable of cleaning dishes at this soil level. DOE sees this as an opportunity for industry to develop a dishwasher that is characterized by a “Normal” cycle of one hour or less that manufacturers would recommend to clean normally soiled dishes. Based on this assessment and in consideration of comments received, DOE maintains the position taken in the July 2019 NOPR and characterizes the new short cycle product class for standard dishwashers on the one hour or less cycle for the manufacturer tested “Normal” wash.

Commenters also identified the prevalence of ENERGY STAR rated models, many offering “Quick” cycle models, as indicating that “Quick” cycles operate within in the existing standards. These commenters argued that a new class of dishwashers and accompanying different standards were not necessary to establish quicker cycles. This was because existing models already had the capability to provide “Quick” cycles while operating within the existing standard, therefore, the record failed to support the creation of a new product class. (State AGs and NYC, No. 3136, p. 10)

DOE cannot conclude that the existence of dishwashers with an ENERGY STAR rating that also offer “Quick” cycles is an indication that “Quick” cycles operate within the confines of current energy and water consumption standards. As stated previously, dishwasher energy and water efficiency is tested during the “Normal” wash cycle, not the “Quick” setting. The manufacturer's identified “Normal” wash is the cycle subject to energy and water consumption use testing and standards. While DOE test data indicated that the ten “Quick” cycles of less than 60 minutes duration met the current DOE standards, and five of the units had a weighted-average cleaning score of greater than 70, only one of these units had a cleaning score of greater than or equal to 70 for all three soil loads tested, and only one of the units is recommended by the manufacturer for a full load of normally soiled dishware—that single unit had a weighted-average cleaning score of only 63. This demonstrates that manufacturer innovation within the new product class could lead to dishwashers with a “Normal” cycle of 60 minutes or less and cleaning performance acceptable to consumers.

To excuse some dissatisfaction customers expressed with cycle time, AHAM noted many consumers were unaware that other options, such as a “Quick” cycle wash, were available on their dishwasher models. AHAM suggested such consumers should educate themselves about their dishwashers as opposed to having DOE issue new regulations. (AHAM, p. 5) DOE acknowledges AHAM's position that some consumers may not be aware of these cycle options, but DOE cannot rely on such a presumption in determining whether to establish the one hour or less “Normal” cycle product class in this final rule. This rulemaking is premised on consumers expressing their comments and views on cycle time and the appropriateness of a product class for “Normal” cycle dishwashers with a cycle time of one hour or less, rather than a discounting of consumer understanding of product user manuals.

Commenters supporting the new product class noted that the existing regulations were counterproductive to the goal of increasing energy efficiency of dishwashers as many consumers end up running their dishwasher multiple times to get dishes clean. (CEI, No. 3137, pp. 3-4; CFAST, No. 2941, p. 2) This was because the current standards do not take into account pre-washing or multiple wash cycles of the same load, which can increase the water and energy use associated with washing dishes. (Attorneys General and Governor Bryant, No. 3131, p. 3; CFACT, No. 2941, p. 1) These commenters acknowledged that DOE's rulemaking would remedy the problems of redundant or prewashing and the unaccounted energy and water use by establishing a new product class specifically for residential dishwashers that allow “a `normal' wash to accomplish” the task of cleaning dishes in an amount of time that meets consumer needs. (Attorneys General and Governor Bryant, No. 3131, p. 3)

DOE reiterates that the creation of a new product class would provide a utility to consumers based on consumers expressing their interest in a shorter cycle duration for the “Normal” cycle. Similar to the product class for oven doors with windows, a product class for dishwashers with a shorter “Normal” cycle could save energy and water by preventing the handwashing of dishes or the running of a dishwasher multiple times for the same load. CEI also responded directly to commenters who argued that cycle length was unimportant because consumers mostly run their dishwashers at bedtime or at night. Relying on data collected during a 2019 survey, CEI determined that 50% of Americans do not run their dishwasher at night. And, when consumers were asked whether they would run their dishwasher at some other time if the dishwasher cycle was faster, 77.7% of respondents said they would. From this information, CEI determined that “even if all dishwashing was done at bedtime, this would just be evidence that it is long dishwasher cycles that lead to much of the bedtime dishwasher use.” (No. 3137, p. 4) DOE concludes that even if the majority of consumers ran their dishwasher at night, this still indicates that consumers consider cycle time important. 84 FR 33869, 33874 (July 16, 2019).

CEI also responded to AHAM's arguments that there was no demand for a faster dishwasher, but that consumers were more interested in features such as quieter machines. (No. 3137, p. 4) CEI's survey asked consumers “[i]f you could choose between today's dishwasher models, or a model that is faster but costs slightly more to run, which would you choose?” The results found 59.4% would choose the faster model even if it cost slightly more to run. (CEI, p. 4) The survey provided evidence that consumer demand for faster dishwashers does exist even in light of increased expenses. DOE also notes that even if attributes such as noise level or detergent formulation lead to increases in cycle time, these factors do not undercut DOE's establishment of a shorter product class for the “Normal” cycle. Manufacturers can continue to determine desired trade-offs for cycle time, noise level, and other factors in developing their product offerings.

DOE received comments arguing that the Department's proposal violated EPCA's product class provision because the 2019 NOPR failed to include accompanying efficiency standards for the newly created product class for short cycle dishwashers. These commenters specified that when exercising its authority under 42 U.S.C. 6295(q), DOE is required to promulgate energy efficiency standards for any class created thereunder, in accordance with the other requirements of 42 U.S.C. 6295, including EPCA's anti-backsliding provision, and the economic justification and technological feasibility analyses. Commenters contend that DOE improperly bifurcated the product class rulemaking by separating the creation of the product class from the promulgation of applicable standards. (State AG and NYC, No. 3136, pp. 8-9; Joint Commenters, No. 3145, p. 7)

The Joint Commenters and ASAP continued to argue that DOE cannot avoid complying with an existing standard through the creation of a product class that lacks an accompanying standard. The establishment of a new product class is to accompany the establishment of a standard. DOE cannot delay evaluating whether a new standard would meet the anti-backsliding provision in a separate rulemaking because such actions must be considered together. (Joint Commenters, No. 3145 pp. 7-8; ASAP, No. 3139, p. 3)

DOE addresses commenters' concerns regarding anti-backsliding in section III.B. of this final rule. In response to the comments arguing a purported EPCA requirement to establish standards whenever a product class is established exists, DOE emphasizes that EPCA does not contain such requirement. Section 325(q) of EPCA states that, “[a] rule prescribing an energy conservation standard for a type (or class) of covered products shall specify a level of energy use or efficiency higher or lower than that which applies (or would apply) for such type (or class) for any group of covered products which have the same function or intended use[.]” This provision does not specify any requirements for the timing of product class designation in regards to a parallel establishment of a standard. The language of the statute accommodates pre-designation of a product class prior to the designation and establishment of applicable standards, as well as the simultaneous designation envisioned by commenters.

DOE's 2009 beverage vending machines (BVM) energy conservation standard rulemaking offers an example of a rulemaking where DOE designated a product class prior to the designation and establishment of an applicable standard for that product or equipment. When DOE initially considered energy conservation standards for BVMs, DOE did not consider combination vending machines as a separate equipment class, but considered that equipment with all other Class A and Class B BVMs. Based in part on the comments received concerning the proposed rule, DOE recognized that combination vending machines had a distinct utility, and concluded that combination vending machines were a class of BVMs. However, DOE was unable to determine whether energy conservation standards for combination vending machines were economically justified and would result in significant energy savings and subsequently decided to not set standards for the equipment class at that time. Instead, DOE reserved standards for combination vending machines and modified the definition of Class A and Class B BVMs to accommodate a definition for combination vending machines. 74 FR 44914, 44920 (Aug. 31, 2009). This action thereby reserved a place for the development of future standards for combination vending machines that DOE then established in 2016. 81 FR 1028, 1035 (Jan. 08, 2016). 12

The energy conservation standards rulemaking for distribution transformers in 2007 offers another example of this type of activity by the Department. There, DOE clarified that although it believed that underground mining distribution transformers were within the scope of coverage, it recognized that mining transformers were subject to unique and extreme dimensional constraints that impacted their efficiency and performance capabilities and decided to not establish energy conservation standards for underground mining transformers. In the final rule DOE established a separate equipment class for mining transformers and reserved a section with the intent to develop the analysis needed to establish an appropriate energy conservation standard in the future. 72 FR 58190, 58197 (Oct. 12, 2007). DOE later reached a similar conclusion in 2013 when it decided to again not set standards for mining distribution transformers. 78 FR 23336, 23353 (Apr. 18, 2013).

Both of these examples highlight prior instances where the Department established a new product class without simultaneously ascribing an associated energy conservation standard. DOE is simply doing the same by finalizing this rulemaking for a new product class for dishwashers with a one hour or less normal cycle.

In the July 2019 NOPR, DOE granted CEI's petition for a new product class for standard residential dishwashers with a short “Normal” cycle of one hour or less and finalizes the creation of such a product class through this final rule. This rulemaking considers the parameters of the new class of dishwashers through the identification of a performance-related feature pursuant to EPCA, 42 U.S.C. 6295(q)(1)(B). EPCA does not require DOE to simultaneously establish energy conservation standards in the same rulemaking as the determination of a new product. In fact, this action is similar to situations where DOE has finalized a determination and a covered product exists without an applicable standard until the Department completes a test procedure rulemaking and a standards rulemaking for that product. See 42 U.S.C. 6292(b).

Following issuance of this final rule, DOE intends to conduct the necessary rulemaking to consider and evaluate the energy and water consumption limits for the new product class to determine the standards that provide the maximum energy efficiency that is technologically feasible and economically justified, and will result in a significant conservation of energy, 42 U.S.C. 6295(o)(2)(A). DOE will provide interested members of the public an opportunity to comment on any preliminary rulemaking documents and proposed energy conservation standards for this product class during that rulemaking proceeding. 84 FR 33869, 33874 (July 16, 2019).

In response to CEI's claim that longer cycles are the product of Federal regulation, some commenters countered that longer cycles are actually a product of growing consumer preference for quieter dishwashers and mandated environmentally friendly detergents. (State AGs and NYC, No. 3136, p. 10; CA IOUs, No. 3142, p. 1; CEC, No. 3132, p. 4) ASE noted that changes in detergent over the past decade have lengthened dishwasher cycle times because of the change in using phosphates to enzyme-based detergents, which has also increased consumer interests in owning quieter dishwashers. This commenter argued that the creation of a new product class for dishwashers with a normal cycle time of less than one hour will not solve the residual problems of noise or associated heat damage—one or both of which will have to increase to insure adequate performance without phosphate detergents. (ASE, No. 3185, pp. 4-5)

DOE recognizes that consumers' interest in dishwasher attributes may extend beyond cycle duration. Consumers may be interested in environmentally friendly and energy efficient products, as well as products that produce less noise. DOE maintains that these interests are not mutually exclusive. The Department's creation of a new product class provides manufacturers the opportunity to invest in innovation to address the many aspects of product performance valued by consumers.

When establishing a new product class, DOE must consider EPCA's general prohibition against prescribing “any amended standard which increases the maximum allowable energy use, or, in the case of showerheads, faucets, water closets, or urinals, water use, or decreases the minimum required energy efficiency, of a covered product” in any rulemaking to establish standards for a separate product class. 42 U.S.C. 6295(o)(1). DOE recognizes that this provision must be read in conjunction with the authority provided to DOE in 42 U.S.C. 6295(q) to specify “ a level of energy use or efficiency higher or lower than that which applies (or would apply) for such type or class . . .” if the Secretary determines that covered products within such group consume a different type of energy or have a capacity or other performance-related feature that justifies “ a higher or lower standard from that which applies (or will apply) to other products within such type (or class). ” 42 U.S.C. 6295(q) (emphasis added). Therefore, EPCA explicitly acknowledges that product features may arise that require the designation of a product class with a standard lower than that applicable to other product classes for that covered product. 84 FR 33869, 33872 (July 16, 2019).

Opponents of the new product class argued that the finalization of the class would result in a weakening of efficiency standards for residential dishwashers and challenged that DOE cannot use the establishment of performance-related feature as a workaround for complying with EPCA's anti-backsliding provision, 42 U.S.C. 6295(o)(1).

Specifically, the State AGs and NYC commented that the proposal aimed to add a third product class without an applicable efficiency standard, thereby establishing a dishwasher subclass that could consume unlimited amounts of energy and water, violating the anti-backsliding provision. (No. 3136, p. 3, referencing 84 FR 33869, 33873 and 33880 (July 16, 2019)) These commenters disagreed with DOE's argument in the 2019 NOPR that the anti-backsliding prohibition of 42 U.S.C. 6295(o)(1) was conditioned by 42 U.S.C. 6295(q) because the latter subsection uses the present and future tense: DOE “shall specify a level of energy use or efficiency higher or lower than that which applies (or will apply) for such type (or class) for any group of covered products which have the same function or intended use.” 42 U.S.C. 6295(q) (emphasis added); (State AGs and NYC, No. 3136, p. 4 referencing 84 FR 33869, 33872-73 (July 16, 2019)). Commenters continued that DOE misconstrued the meaning of section 6295(q)'s reference to a standard not yet applicable as intending to account for situations where a basic product class and standards have not been established or yet to go into effect. The Department's reading, the commenters conclude, effectively repeals the anti-backsliding provision in product class designations. These commenters argue that while 42 U.S.C. 6295(q) acknowledges that differences in energy consumption, capacity or other performance-related features among products within a product group may justify the application of different standards, the provision cannot be construed to allow DOE to prospectively establish product classes as a means of evading EPCA's prohibition against backsliding. (State AGs and NYC, No. 3136, p. 4)

DOE received similar comments arguing that even if it had the authority to create a new product class based on a shorter cycle time qualifying as a performance-related feature, the anti-backsliding provision prevents the standard that applies to that class from being less stringent than the current standard applicable to all dishwashers regardless of cycle duration. (Joint Commenters, No. 3145, p. 1-2; CEC, No. 3132, pp. 6-7)) EPCA's anti-backsliding provision prohibits DOE from prescribing “any amended standard which increases the maximum allowable energy use, or, in the case of showerheads, faucets, water closets, or urinals, water use, or decreases the minimum required energy efficiency, of a covered product.” Therefore, even if DOE could lawfully create a new product class for dishwashers based on cycle duration, these commenters assert that any new standard established cannot “decrease the minimum required energy efficiency” of the dishwashers in that new class. 42 U.S.C. 6295(o)(1); (Joint Commenters, No. 3145, p. 1-2; Ceres BICEP, No. 2746, p. 1).

As an initial matter, DOE has yet to determine the standards that would be applicable to this new product class. Such standards will be established through DOE's standards-setting rulemaking process that includes opportunities for public comment. In the absence of such a rulemaking, neither DOE nor commenters can conclude that the potentially applicable standards for this new product class will be lower than the standards currently applicable to dishwashers. Data developed by DOE through the testing described in section II.B. of this final rule offer suggestions for what may be possible based on the existing dishwasher models evaluated against the current dishwasher standards as part of the Department's assessment of CEI's petition for a new product class of short cycle dishwashers. The current standards require standard residential dishwashers to not exceed 307 kWh/year and 5.0 gallons per cycle. 10 CFR 430.32(f)(1)(i). DOE's test data indicate that a short cycle product class characterized by a one hour or less cycle could, in theory, operate within the scope of the existing standards. Even with these considerations, DOE emphasizes that EPCA does not prohibit the establishment of a standard for dishwashers in the new product class that is ultimately lower than the standards currently applicable to residential dishwashers.

While some commenters expressed their disagreement with the overall application of the anti-backsliding provision to DOE's activities, DOE maintains that these concerns are too broad and ignore the limitations that EPCA itself places on the scope of the anti-backsliding provision, 42 U.S.C. 6295(o)(1). As stated in the NOPR, “EPCA's anti-backsliding provision is limited in its applicability with regard to water use to four specified products, i.e., showerheads, faucets, water closets, or urinals. DOE's existing energy conservation standard for dishwashers is comprised of both energy and water use components. As dishwashers are not one of the products listed in anti-backsliding provision with respect to water use, there is no prohibition on DOE specifying a maximum amount of water use for dishwashers that is greater than the existing standard without regard to whether DOE were to establish a separate product class for dishwashers as proposed in this proposed rule.” 84 FR 33869, 33873 (July 16, 2019); see 42 U.S.C. 6295(o)(1).

DOE also found the comments challenging the Department's reading of 42 U.S.C 6295(q) as avoiding 42 U.S.C. 6295(o)(1)'s anti-backsliding provision and evading EPCA's prohibition against backsliding unpersuasive because the statute does not contain such limitations. As DOE explained in the July 2019 NOPR, the term “which applies” included in the text of the product class provision undercuts the argument that DOE may only use this provision when there is no standard yet established. By using the present tense, “a higher or lower standard than that which applies,” EPCA authorizes DOE to reduce the stringency of the standard currently applicable to the products covered under the newly established separate product class. The applicability of this provision to current standards is further evidenced by the additional reference to standards that are not yet applicable ( i.e., standards that “would apply”). If 42 U.S.C. 6295(q)(1) were only to operate in instances in which standards have not yet been established, there would be no need to separately indicate the applicability to future standards. Nor would there be any purpose to calling out the potential for higher or lower standards since there would not be any standards against which to measure that potential. In this manner, 42 U.S.C. 6295(q) authorizes DOE to reduce the stringency of a currently applicable standard upon making the determinations required by 42 U.S.C. 6295(q).

Additionally, the term “will apply” is not by its term limited to the interim period between when the Department establishes a standard for a covered product and when compliance with that standard is required. This time limitation is nowhere expressly stated or implied in EPCA and is nonsensical because the Department would not be taking any further action with regard to the establishment of standards between the time it “applies” the standard through rulemaking and when compliance with that standard is required. As noted in the July 2019 NOPR, 42 U.S.C. 6295(q) of EPCA cannot be read to prohibit DOE from establishing standards that allow for technological advances or product features that could yield significant consumer benefits while providing additional functionality ( i.e., consumer utility) to the consumer. DOE relied on this concept when, in 2011, DOE established separate energy conservation standards for ventless clothes dryers, reasoning that the “unique utility” presented by the ability to have a clothes dryer in a living area where vents are impossible to install ( i.e., a high-rise apartment) merited the establishment of a separate product class. 76 FR 22454, 22485 (Apr. 21, 2011). Another example of this that DOE is just beginning to explore, as explained further in the July 2019 NOPR, is network connectivity of covered products. See also DOE's Smart Products RFI at 83 FR 46886 (Sept. 18, 2018).

In contrast, DOE's interpretation of 42 U.S.C. 6295(q) recognizes the potential for technological innovation and the development of product features like network mode (which was not contemplated at the time dishwasher standards were initially established) that result in the short term increase in energy consumption but have the potential in the long term to significantly improve energy efficiency overall. 84 FR 33869, 33872 (July 16, 2019). DOE does not think a reasonable reading of the statute would conclude that technology must be held constant to a single point in time.

DOE also stated in the July 2019 NOPR that this interpretation is consistent with DOE's previous recognition of the importance of technological advances that could yield significant consumer benefits in the form of lower energy costs while providing the same functionality to the consumer. In the proposed and supplemental proposed rule to establish standards for residential furnaces, 80 FR 13120, 13138 (Mar. 12, 2015); 81 FR 65720, 65752 (Sept. 23, 2016), DOE stated that tying the concept of a feature to a specific technology would effectively “lock-in” the currently existing technology as the ceiling for product efficiency and eliminate DOE's ability to address such technological advances. 81 FR 65720, 65752 (Sept. 23, 2016). The Department finds it unrealistic to set limitations that would ultimately prevent the manufacturing of innovative products sought by consumers.

The State AGs and NYC additionally argued that EPCA allows the exercise of 42 U.S.C. 6295(q)'s authority within the bounds of 42 U.S.C. 6295(o)(1), which means DOE may designate separate product classes when justified under subsection 6295(q) but must do so within the limits of 42 U.S.C.6295(o)(1) by not weakening existing standards. (State AGs and NYC, No. 3136, p. 4) State AGs and NYC explained that if the two sections are in conflict, the newer provision would control. Here the anti-backsliding provision was enacted after the product class provision; therefore, 42 U.S.C. 6295(o)(1)'s prohibition against retreating to less stringent standards limits the exercise of 42 U.S.C. 6295(q)'s product class provision. ( Id., pp. 5-6, referencing Watt, 451 U.S. at 267; Hines, Inc. v. United States, 551 F.2d 717, 725 (6th Cir. 1977)) This in turn means DOE must accommodate technological innovation within the same limitations. The commenters cite the creation of the ventless clothes dryer product class as, in their view, an example of DOE working within the limits of EPCA's anti-backsliding prohibition. Commenters asserted that DOE did not establish less stringent standards for this product class because no energy efficiency standards were “lowered in the creation of that product class as ventless clothes dryers were not previously subject to standards.” (State AGs and NYC, No. 3136, pp. 5-6 referencing 76 FR 22454, 22485 (Apr. 21, 2011))

DOE does not read these provisions in conflict as these comments suggest. In 2011 DOE determined that ventless clothes dryers offered a unique utility because they provided a means of including a dryer into a living area where traditional vents were impossible to install due to the configuration of high rise apartments. The Department recognized this feature as a unique utility that justified the creation of a separate product class and associated standard for ventless clothes dryers. 76 FR 22454, 22485 (Apr. 21, 2011). What commenters overlook when referencing this rulemaking is that prior to the establishment of the ventless clothes dryers product class, ventless clothes dryers were subject to the standards set for the product class as a whole. However, as these dryers could not at the time be tested using the applicable test procedure, ventless clothes dryers subsequently sought and received waivers from test procedure requirements from the Department. 76 FR 33271 (June 8, 2011).

The very fact that DOE issued waivers to the DOE test procedure for these products means that these products were subject to DOE testing and standards compliance requirements. As DOE noted in a waiver granted to LG in 2008 (73 FR 66641 (Nov. 10, 2008)), commenting stakeholders (AHAM, Miele, and Whirlpool) all stated that ventless clothes dryers cannot meet the DOE efficiency standard and recommended a separate product class and efficiency standard for ventless clothes dryers. DOE responded by acknowledging the commenters' experience in working with this type of product, but noted DOE had not been able to find data as to whether ventless clothes dryers can meet the existing DOE clothes dryer energy conservation standard. DOE further stated that if this type of clothes dryer is indeed unable to meet the standard, DOE cannot, in a waiver, establish a separate product class and associated efficiency level. These actions must be taken in the context of a standards rulemaking. DOE did indeed issue a final rule that included standards for ventless clothes dryers in 2011. 76 FR 22454 (Apr. 21, 2011).

DOE stated in the LG waiver that although it would be feasible to provide LG with an alternative test procedure, that the problem is likely more fundamental than one limited to a needed test procedure change; instead, in spite of technological developments, it was expected (though not definitively known at the time the waiver was issued) that ventless clothes dryers would not meet the DOE energy conservation standard, and that a separate clothes dryer class (with a separate efficiency standard) would have to be established for ventless clothes dryers. Otherwise, a type of product with unique consumer utility could be driven from the market. However, the establishment of product classes cannot be done in a waiver, but only in a standards rulemaking.

DOE therefore, consistent with the long-standing waiver granted to Miele, granted a similar waiver to LG from testing of its ventless clothes dryers. 73 FR 66641, 66642 (Nov. 10, 2008). 13

Commenters are incorrect that ventless clothes dryers were not subject to any standard. As in the case of ventless clothes dryers, which were subject to standards prior to the creation of a separate product class and separate (less-stringent) standard, DOE continues to read EPCA's provisions together to authorize the establishment of future standards for short cycle dishwasher product class at a level different from the existing standard if necessary.

Moreover, the current standard requires standard residential dishwashers to not exceed 307 kWh/year and 5.0 gallons per cycle for the “Normal” cycle. 10 CFR 430.32(f)(1)(i). Consistent with the results of the Department's evaluation of dishwashers offering a 60 to 90 minute “Quick” cycle, DOE's has identified an innovative opportunity for the further development of a dishwasher model offering a “Normal” cycle of one hour or less. In this final rule, DOE establishes a product class characterized by a cycle of one hour or less for the manufacturer-identified “Normal” cycle. Because DOE has not yet considered the appropriate standards for the new product class, the commenters are assuming an outcome of an action DOE has yet to take. As stated above, DOE will consider the appropriate energy use standards for the short cycle product class in a separate rulemaking.

Some commenters turned to case law to support the notion that EPCA's anti-backsliding provision prevents DOE from establishing a new product class. Citing to NRDC v. Abraham, 355 F.3d 179, 197 (2d Cir. 2004), these commenters claimed that the anti-backsliding provision must be interpreted in light of “the appliance program's goal of steadily increasing the energy efficiency of covered products” and Congress's intent to provide a “sense of certainty on the part of manufacturers as to the required energy efficiency standards.” (Joint Commenters, No. 3145, p. 2) The State AGs and NYC also argue, based on existing case law, that amendments to EPCA's anti-backsliding provision have steadily increased energy efficiency standards over time. Therefore, DOE may not render the anti-backsliding provision inoperative as it would counter case law and thwart the intent of Congress to maintain stability for future standards. (State AGs and NYC, No. 3136, p. 5; Joint Commenters, No. 3145, p. 2)

Congress crafted EPCA using both present and future-tense language to provide for the creation of new product classes with a level of energy use higher or lower than the product class as a whole that would be justified where the facts supported a differing standard. 42 U.S.C. 6295(q)(1)(B). The product class provision itself demonstrates that other factors such as capacity can be considered when setting a different standard for a new product and that energy efficiency at all cost was not the intent of EPCA. The Attorneys General and Governor Bryant suggest that the one hour or less dishwasher cycle is “plainly an essential performance characteristic of great utility to consumers.” (No. 3131, pp. 5-6) Looking to the facts surrounding CEI's petition, as referenced above, and the consumer utility evidenced by a short cycle product class, EPCA authorizes the Secretary to create such a product class, notwithstanding EPCA's anti-backsliding provision.

The State AGs and NYC also contend that EPCA's prohibition against backsliding bars DOE from retroactively asserting that cycle time is a performance feature under 42 U.S.C. 6295(o)(4). (No. 3136, p. 5) Under 42 U.S.C. 6295(o)(4) commenters assert that DOE may not prescribe standards that result in the elimination of “performance characteristics” or “features” and may designate and prescribe different standards for classes of a covered product if necessary to maintain a “performance-related feature” under section 6295(q). These commenters assert that because DOE never previously determined that cycle time was a distinct performance characteristic, the Department cannot make such a determination now that a dishwasher with a cycle of one hour or less is no longer available. ( Id., at p. 4) CEC also argued that even if cycle time was a utility and the one hour cycle was not arbitrary, the record does not demonstrate that the existing standards have prevented manufactures from offering consumers a dishwasher with a one-hour cycle, thereby causing the unavailability of such products, 42 U.S.C. 6295(o)(4). This means, according to the commenters, that DOE lacks the statutory authority to create new product features and classes in order to retroactively establish features that CEI speculates may have become unavailable due to decades of lawful standard setting. (CEC, No. 3132, p. 5)

In this final rule, the Department is establishing a product class based on the utility consumers would receive from having a dishwasher characterized by having a “Normal” cycle of one hour or less. The Department is not establishing a standard that would result in the unavailability of a feature, which 42 U.S.C. 6295(o)(4) prohibits. Instead, DOE is creating a product class that incentivizes manufacturers to develop a product that can meet consumers' interests by manufacturing a dishwasher defined by a one hour or less “Normal” cycle that would be subject to energy conservation standards. Whether DOE has previously defined cycle time as a feature for residential dishwashers is irrelevant. DOE has recognized the loss of the short cycle time feature as a result of the increased length of the manufacturer's identified “Normal” cycle.

In its initial petition, CEI voiced concern that Federal standards impaired dishwasher cycle times and that dishwashers with shorter “Normal” cycle times were no longer available on the market. (CEI Petition, No. 0006 at p. 4) EPCA prohibits DOE from prescribing efficiency standards that would result in the unavailability of any covered product (or class) of performance characteristics (including reliability), features, sizes, capacities and volumes that are substantially the same as those generally available at the time of the Secretary's finding. 42 U.S.C. 6295(o)(4).

Commenters contend that DOE cannot claim that the 42 U.S.C. 6295(o)(4) unavailability provision authorizes DOE to establish the new product class. These commenters assert that the 42 U.S.C. 6295(o)(4) unavailability provision does not authorize DOE to reanimate a feature not currently on the market. (Joint Commenters, No. 3145, p. 8 referencing 84 FR 33869, 33873 (July 16, 2019)) Commenters argue that using this as a justification for creation of a new product class is contrary to the anti-backsliding provision and lacks support in the text of the product class provision. ( Id. )

DOE is not relying on 42 U.S.C. 6295(o)(4) of EPCA to authorize the creation of a new product class of dishwashers or to establish weaker conservation standards through this rulemaking. EPCA provides that DOE may set standards for different product classes based on features that provide a consumer utility. 42 U.S.C. 6295(q). As stated previously, DOE has determined that the facts supporting a performance-related feature justifying a different standard may change depending on the technology and the utility provided to the consumer, and that consumer demand may cause certain products to disappear from or reappear in the market. DOE has also previously determined that the value consumers receive from a feature is to be determined based on a case-by-case assessment of its own research and information provided through public comment. 80 FR 13120, 13138 (Mar. 12, 2015). Lastly, DOE confirms that once the Department recognizes an attribute of a product as a feature, DOE cannot reasonably set standards that would cause the elimination of that feature. DOE notes that its test data also indicate that some dishwashers are available with a quick cycle that meets these performance characteristics. Establishing the product class characterized by a “Normal” cycle of one hour or less will provide manufacturers an opportunity for innovation. By finalizing this rulemaking, DOE will have responded to a gap in the market by establishing a new product class for a short cycle dishwashers. 84 FR 33869, 33873 (July 16, 2019).

Some commenters contend that DOE has failed to conduct a proper analysis of the data provided by commenters that justifies the creation of a new product class of dishwashers with a short cycle time. These commenters looked to the data provided by energy efficiency advocates and manufactures to claim that CEI's petition was based on insufficient analyses and relied on anecdotal information, and DOE's reliance on such information could compromise the integrity of the appliance standard and rulemaking process. (CA IOUs, No. 3142, p. 1) DOE also received comments asserting that the proposal failed to consider alternative cycle durations such as 50 or 70 minutes. (State AGs and NYC, No. 3136, p. 11) Throughout this rulemaking, DOE has requested comments from members of the public and has considered the comments received and conducted its own testing and analysis in determining how to proceed in this final rule. Based on its testing data, DOE has recognized that a dishwasher with a short cycle of one hour or less for the “Normal” cycle would provide a consumer utility not currently available. While DOE has identified some dishwashers offering “Quick” cycles that can accomplish a full cycle of cleaning and drying dishes in 60 to 90 minutes with energy and water use comparable to the existing conservation standards, DOE believes industry can develop a dishwasher with a “Normal” cycle to meet the criteria of the new product class.

Other commenters argued that by categorically excluding this proposed action from environmental review, the Department has also violated the National Environmental Policy Act (NEPA), 42 U.S.C. 4321, et seq., first by failing to follow the applicable regulations and second for applying an inapplicable categorical exclusion. (State AGs and NYC, No. 3136, p. 12) Commenters argue that DOE misplaces its reliance on the proposed categorical exclusion because finalizing the product class would in fact result in a significant impact to the environment and qualify as a major federal action. (Joint Commenters, No. 3145, p. 9; State AGs and NYC, No. 3136 p. 13) Commenters assert that DOE's decision to apply the A5 categorical exclusion, rather than conduct the environmental review required for major federal actions, is arbitrary and capricious for three reasons: (1) There is no standard for the new class of dishwashers, (2) DOE failed to consider circumstances related to the rulemaking that may affect the significance of the environmental effects of the action, and (3) DOE failed to account for the reasonably foreseeable connected and cumulative actions between the creation of a new product class and future rulemakings setting standards for the product class. (State AGs and NYC, No. 3136, pp. 14-16)

DOE maintains that this rulemaking, once finalized, will only establish a new product class for dishwashers with a ”Normal” cycle of one hour or less from washing through drying. Finalization of the rule will not result in adverse environmental impacts and is covered by Categorical Exclusion A5 under 10 CFR part 1021, subpart D. This categorical exclusion applies to any rulemaking that interprets or amends an existing rule without changing the environmental effect of that rule. DOE maintains that establishing a new product class for covered products will not result in a change to the environmental effect of the existing dishwasher product classes.

DOE will determine a standard for the product class established in this final rule that provides for the maximum improvement in energy efficiency that is technologically feasible and economically justified, and will result in a significant conservation of energy. 42 U.S.C. 6295(o)(2)(A). That standard will be developed in a separate rulemaking. This action, which only establishes a product class for dishwashers with a “Normal” cycle of one hour or less, therefore falls within the scope of the A5 Categorical Exclusion.

Additionally, commenters stated that DOE also violated the Administrative Procedure Act (APA), 5 U.S.C. 551, et seq., by failing to provide a satisfactory explanation and articulate a rational connection between the facts found and decision made in the NOPR. (State AGs and NYC, No. 3136, p. 9) Commenters argued that the proposal departs from DOE's previous determinations that only standard and compact dishwasher classes were appropriate, meaning DOE must explain why a quick cycle function is a performance-related feature to meet the burden of such a change. Commenters explain that changing a policy position, which they contend DOE is doing here, also requires good reasons for the reversal and that the new policy is permissible under the statute ( Fox, 556 U.S. at 515), and an unexplained inconsistency between agency actions is a reason for holding an interpretation to be an arbitrary and capricious change. Nat'l Cable & Telecomms. Ass'n v. Brand X internet Servs., 545 U.S. 967, 981 (2005). Commenters conclude that based on the limited explanation provided in the record that DOE has failed to meet this burden. (State AGs and NYC, No. 3136, pp. 10-11)

The Department maintains that it has met the APA's requirements for issuing a final rule and explained its reasoning for establishing a new product class for the one hour or less “Normal” cycle dishwasher sufficiently in the notice of proposed rulemaking and this final rule. DOE has responded to the information submitted through the public comment process and concluded that the public would derive a utility from the introduction of dishwasher that can clean normally soiled dishes in a shorter period of time than is presently available. The comments submitted identify a recognizable gap in the market for such a product and many consumers expressed a preference for such a product. (CEI, No. 3137, pp. 2-3)

Some commenters argued that if DOE created a new, less efficient product class for residential dishwashers that such actions would result in significant uncertainty on the part of manufactures, businesses, and consumers. (Ceres BICEP, No. 2746, pp. 3-4) Commenters continued that a new product class would likely result in stranded investments, because manufacturers have already invested heavily in meeting existing conservation standards and responding to consumers' energy and water efficiency interests, and manufactures would essentially be required to abandon these innovations. (AHAM, No. 3188, pp. 1-2, 6; GEA, No. 3189, p. 2; Public Interest Advocacy Collaborative (PIAC), No. 3132, p. 1) Some commenters argued that the new product class would also require manufactures to operate two research and development cycles at significant expense while providing no real benefit to consumers. (ASE, No. 3185, p. 5) These commenters conclude that the costs of such activity also remain unknown as DOE has not proposed any accompanying efficiency standards to the new product class and that this deregulation will increase the market uncertainty for manufactures. (AHAM, No. 3188, p. 6; PIAC, No. 3132, p. 3; Whirlpool, No. 3180, p. 1)

DOE emphasizes that manufactures seeking to push innovation in efficiency will not be forced to abandon their efforts as some commenters claim. This is because no current product would be prohibited as a result of the new product class characterized by the one hour or less “Normal” cycle. (CEI, No. 3137, p. 5) Additionally, if consumers do place a higher value on efficiency over cycle duration as some manufacturers claim, manufacturers will continue to have a viable market as those consumers will continue to purchase existing efficient products. Investments only become stranded if consumers value faster products over current models. ( Id., pp. 5-6) Understandably, manufacturers that choose to enter this new market will incur expenses in order to satisfy the potential demand created as a result of finalizing the creation of this new product class, but that is a business decision manufacturers will make based on an evaluation of whether doing so would be a worthwhile investment. No company will be forced to enter this market as a result of the new product class. ( Id., p. 6)

DOE has concluded that it has the legal authority to establish a separate product class as suggested by CEI pursuant to 42 U.S.C. 6295(q). DOE has created a separate product class for dishwashers characterized by a “Normal” cycle of one hour or less as identified by the dishwasher manufacturer for daily, regular, or typical use to completely wash and dry a full load of normally soiled dishes. DOE will consider energy conservation standards and test procedures for this product class in a separate rulemaking.

DOE also proposed to update the table specifying currently applicable dishwasher standards in 10 CFR 430.32(f) in the 2019 NOPR. The current requirement includes a table that specifies the obsolete energy factor requirements for standard and compact dishwashers. This table was intended to be removed in a final rule for dishwasher energy conservation standards published on December 13, 2016, but was inadvertently retained by the amendatory instructions for paragraph (f). 81 FR 90072, 90120. DOE will now remove this table and add a new paragraph (f)(1)(iii) that specifies standard dishwashers with a normal cycle of 60 minutes or less are not currently subject to energy or water conservation standards. Additionally, DOE amends paragraphs (f)(1)(i) through (iii) to clarify the terms “standard” and “compact” and to include reference to the ANSI/AHAM DW-1-2010 standard, which is the current industry standard referenced in the dishwasher test procedure at 10 CFR part 430, subpart B, appendix C1.

This regulatory action is a “significant regulatory action” under the criteria set out in section 3(f) of Executive Order 12866, “Regulatory Planning and Review.” (58 FR 51735 (Oct. 4, 1993)). Accordingly, this regulatory action was subject to review under the Executive order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB). As previously discussed in this preamble, DOE does not anticipate that the creation of a new product class will, in and of itself, result in any quantifiable costs or benefits. Rather, those costs or benefits would derive from the applicable test procedures and energy conservation standards, which the Department will prescribe in separate rulemakings.

On January 30, 2017, the President issued Executive Order (E.O.) 13771, “Reducing Regulation and Controlling Regulatory Costs.” (82 FR 9339 (Jan. 30, 2017)). More specifically, the order provides that it is essential to manage the costs associated with the governmental imposition of requirements necessitating private expenditures of funds required to comply with Federal regulations. In addition, on February 24, 2017, the President issued Executive Order 13777, “Enforcing the Regulatory Reform Agenda.” (82 FR 12285 (March 1, 2017)). The order requires the head of each agency to designate an agency official as its Regulatory Reform Officer (RRO). Each RRO is tasked with overseeing the implementation of regulatory reform initiatives and policies to ensure that individual agencies effectively carry out regulatory reforms, consistent with applicable law. Further, E.O. 13777 requires the establishment of a regulatory task force at each agency. The regulatory task force is required to make recommendations to the agency head regarding the repeal, replacement, or modification of existing regulations, consistent with applicable law.

DOE has determined that this final rule is consistent with these Executive orders. The proposed rule granted a petition submitted to DOE by the Competitive Enterprise Institute requesting that DOE establish a product class for dishwashers with “normal cycle” times of one hour or less from washing through drying. In this final rule, DOE has established a product class for dishwashers with “Normal” cycle time of one hour or less from washing through drying. DOE has designated this rulemaking as “deregulatory” under E.O 13771 because it is an enabling regulation pursuant to OMB memo M-17-21. DOE will make a determination of the appropriate standard levels for the product class in a subsequent rulemaking.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act of 1996) requires preparation of an initial regulatory flexibility analysis (IRFA) for any rule that by law must be proposed for public comment and a final regulatory flexibility analysis (FRFA) for any such rule that an agency adopts as a final rule, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. A regulatory flexibility analysis examines the impact of the rule on small entities and considers alternative ways of reducing negative effects. Also, as required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the DOE rulemaking process. (68 FR 7990). DOE has made its procedures and policies available on the Office of the General Counsel's website at: http://energy.gov/gc/office-general-counsel.

DOE reviewed this rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. DOE has concluded that this rule will not have a significant impact on a substantial number of small entities. The factual basis for this determination is as follows:

The Small Business Administration (SBA) considers a business entity to be a small business, if, together with its affiliates, it employs less than a threshold number of workers or earns less than the average annual receipts specified in 13 CFR part 121. The threshold values set forth in these regulations use size standards and codes established by the North American Industry Classification System (NAICS) that are available at: https://www.sba.gov/document/support--table-size-standards. The threshold number for NAICS classification code 335220, “Major Household Appliance Manufacturing,” which includes dishwasher manufacturers, is 1,500 employees.

Most of the companies that manufacture dishwashers are large multinational corporations. DOE collected data from DOE's compliance certification database  14 and surveyed the AHAM member directory to identify potential manufacturers of dishwashers. DOE then consulted publicly-available data, such as Dun and Bradstreet, to determine if those manufacturers meet the SBA's definition of a “small business.” Based on this analysis, DOE identified two potential small businesses, but determined that this rule does not impose any compliance or other requirements on any manufacturers, including small businesses. This rulemaking establishes a product class for dishwashers with a “Normal” cycle of one hour or less from washing through drying as described in the preamble. The rulemaking does not establish or impose energy conservation standards for the new product class of residential dishwashers that manufacturers will now be required to follow. Such requirements will be established in separate rulemakings where DOE will determine the appropriate standard levels and associated testing procedures. This rule will not result in any subsequent costs to any dishwasher manufacturer. Therefore, DOE concludes that the impacts of this final rule would not have a “significant economic impact on a substantial number of small entities,” and that the preparation of a FRFA is not warranted. DOE will transmit the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration pursuant to 5 U.S.C. 605(b).

Manufacturers of covered products/equipment generally must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for such products/equipment, including any amendments adopted for those test procedures, on the date that compliance is required. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment. 76 FR 12422 (March 7, 2011); 80 FR 5099 (Jan. 30, 2015). The collection-of-information requirement for certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB control number 1910-1400. Public reporting burden for the certification is estimated to average 30 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

This rule establishes a product class for dishwashers with a “Normal” cycle of one hour or less from washing through drying but does not set conservation standards or establish testing requirements for such dishwashers, and thereby imposes no new information or record keeping requirements. Accordingly, Office of Management and Budget clearance is not required under the Paperwork Reduction Act. (44 U.S.C. 3501 et seq. )

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

Pursuant to the National Environmental Policy Act (NEPA) of 1996, DOE has analyzed this action in accordance with NEPA and DOE's NEPA implementing regulations (10 CFR part 1021). DOE has determined that this rule qualifies for categorical exclusion under 10 CFR part 1021, subpart D, appendix A5 because it is an interpretive rulemaking that does not change the environmental effect of the rule and meets the requirements for application of a categorical exclusion. See 10 CFR 1021.410. Therefore, DOE has determined that promulgation of this rule is not a major Federal action significantly affecting the quality of the human environment within the meaning of NEPA, and does not require an environmental assessment or environmental impact statement.

Executive Order 13132, “Federalism,” 64 FR 43255 (Aug. 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. The Executive order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. (65 FR 13735). EPCA governs and prescribes Federal preemption of State regulations that are the subject of DOE's regulations adopted pursuant to the statute. In such cases, States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) Therefore, Executive Order 13132 requires no further action.

Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Regarding the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that each Executive agency make every reasonable effort to ensure that when it issues a regulation, the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and has determined that, to the extent permitted by law, the rule meets the relevant standards of Executive Order 12988.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. (Pub. L. 104-4, sec. 201 (codified at 2 U.S.C. 1531)) For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. (62 FR 12820) (This policy is also available at http://www.energy.gov/gc/office-general-counsel under “Guidance & Opinions” (Rulemaking)) DOE examined the rule according to UMRA and its statement of policy and has determined that the rule contains neither an intergovernmental mandate, nor a 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 in any year. Accordingly, no further assessment or analysis is required under UMRA.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule will not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

Pursuant to Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 18, 1988), DOE has determined that this rule will not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for Federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this rule under the OMB and DOE guidelines and has concluded that it is consistent with the applicable policies in those guidelines.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

DOE has concluded that the regulatory action in this document, the establishment of a new product class for dishwashers with a “Normal” cycle of one hour or less from washing through drying, is not a significant energy action because it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects for this rule.

On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (OSTP), issued its Final Information Quality Bulletin for Peer Review (the Bulletin). 70 FR 2664 (Jan. 14, 2005). The Bulletin establishes that certain scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal Government, including influential scientific information related to agency regulatory actions. The purpose of the bulletin is to enhance the quality and credibility of the Government's scientific information. Under the Bulletin, the energy conservation standards rulemaking analyses are “influential scientific information,” which the Bulletin defines as “scientific information the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions.” Id. at 70 FR 2667 (Jan. 14, 2005).

In response to OMB's Bulletin, DOE conducted formal in-progress peer reviews of the energy conservation standards development process and analyses and has prepared a Peer Review Report pertaining to the energy conservation standards rulemaking analyses. Generation of this report involved a rigorous, formal, and documented evaluation using objective criteria and qualified and independent reviewers to make a judgment as to the technical/scientific/business merit, the actual or anticipated results, and the productivity and management effectiveness of programs and/or projects. The “Energy Conservation Standards Rulemaking Peer Review Report,” dated February 2007, has been disseminated and is available at the following website: http://www1.eere.energy.gov/buildings/appliance_standards/peer_review.html. Because available data, models, and technological understanding have changed since 2007, DOE has engaged in a new peer review of its analytical methodologies.

In this document, DOE incorporates by reference the industry standard published by ANSI/AHAM, titled “Household Electric Dishwashers,” ANSI/AHAM DW-1-2010. ANSI/AHAM DW-1-2010 is an industry-accepted standard to measure the energy and water consumption of residential dishwashers and is already incorporated by reference for the current dishwasher test procedure at 10 CFR part 430, subpart B, appendix C1. DOE incorporates by reference this industry consensus standard at 10 CFR 430.32(f), which specifies the energy conservation standards for compact and standard dishwashers, for the purpose of distinguishing the standard and compact product classes pursuant to the industry standard.

Copies of ANSI/AHAM DW-1-2010 may be purchased from AHAM at 1111 19th Street NW, Suite 402, Washington, DC 20036, 202-872-5955, or by going to http://www.aham.org.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule before its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The Secretary of Energy has approved publication of this final rule.

This document of the Department of Energy was signed on October 19, 2020, by Daniel R. Simmons, Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set forth in the preamble, DOE amends part 430 of title 10 of the Code of Federal Regulations as set forth below:

Lending partnerships between national banks or Federal savings associations (banks) and third parties play a critical role in our financial system. 1 These partnerships expand access to credit and provide an avenue for banks to remain competitive as the financial sector evolves. Through these partnerships, banks often leverage technology developed by innovative third parties that helps to reach a wider array of customers. However, there is often uncertainty about how to determine which entity is making the loans and, therefore, the laws that apply to these loans. 2 This uncertainty may discourage banks from entering into lending partnerships, which, in turn, may limit competition, restrict access to affordable credit, and chill the innovation that can result from these relationships. Through this rulemaking, the Office of the Comptroller of the Currency (OCC) is providing the legal certainty necessary for banks to partner confidently with other market participants and meet the credit needs of their customers.

However, the OCC understands that there is concern that its rulemaking facilitates inappropriate `rent-a-charter' lending schemes—arrangements in which a bank receives a fee to `rent' its charter and unique legal status to a third party. These schemes are designed to enable the third party to evade state and local laws, including some state consumer protection laws, and to allow the bank to disclaim any compliance responsibility for the loans. These arrangements have absolutely no place in the federal banking system and are addressed by this rulemaking, which holds banks accountable for all loans they make, including those made in the context of marketplace lending partnerships or other loan sale arrangements.

On July 22, 2020, the OCC published a notice of proposed rulemaking (proposal or NPR) to determine when a bank makes a loan. 3 Under the proposal, a bank made a loan if, as of the date of origination, it (1) was named as the lender in the loan agreement or (2) funded the loan.

As the proposal explained, federal law authorizes banks to enter into contracts, to make loans, and to subsequently transfer these loans and assign the loan contracts. 4 The statutory framework, however, does not specifically address which entity makes a loan when the loan is originated as part of a lending partnership involving a bank and a third party, nor has the OCC taken regulatory action to resolve this ambiguity. In the absence of regulatory action, a growing body of case law has introduced divergent standards for resolving this issue, as discussed below. As a result of this legal uncertainty, stakeholders cannot reliably determine the applicability of key laws, including the law governing the permissible interest that may be charged on the loan.

This final rule establishes a clear test for determining when a bank makes a loan, by interpreting the statutes that grant banks their authority to lend. Specifically, the final rule provides that a bank makes a loan when it, as of the date of origination, (1) is named as the lender in the loan agreement or (2) funds the loan.

The OCC received approximately 4,000 comments on the proposal, the vast majority of which were from individuals using a version of one of three short form letters to express opposition to the proposal. Other commenters included banks, nonbank lenders, industry trade associations, community groups, academics, state government representatives, and members of Congress.

Commenters supporting the proposal stated that the judicial true lender doctrine has led to divergent standards and uncertainty concerning the legitimacy of lending partnerships between banks and third parties. They also stated that, by removing the uncertainty, the OCC would help ensure that banks have the confidence to enter into these lending relationships, which provide affordable credit to consumers on more favorable terms than the alternatives, such as pawn shops or payday lenders, to which underserved communities often turn. Supporting commenters also observed that the proposal would enhance a bank's safety and soundness by facilitating its ability to sell loans. These commenters also noted that the proposal (1) makes clear that the OCC will hold banks accountable for products with unfair, deceptive, abusive, or misleading features that are offered as part of a relationship and (2) is consistent with the OCC's statutory mission to ensure that banks provide fair access to financial services.

Commenters opposing the proposal stated that it would facilitate so-called rent-a-charter schemes, which would result in increased predatory lending and disproportionately impact marginalized communities. Other opposing commenters stated that the proposal is an attempt by the OCC to improperly regulate nonbank lenders, a role they consider to be reserved exclusively to the states. Opposing commenters also asserted that the OCC did not have sufficient legal authority to issue the proposal and that the proposal violated the Administrative Procedure Act (APA) and 12 U.S.C. 25b.

Both supporting and opposing commenters recommended changes. These recommendations included (1) adopting a test that requires the true lender to have a predominant economic interest in the loan; (2) providing additional “safe harbor” requirements to enhance consumer protections ( e.g., interest rate caps); (3) clarifying that certain traditional bank lending activities do not fall under the funding prong of the rule ( e.g., indirect auto lending and mortgage warehouse lending); (4) providing additional details on how the OCC would supervise these relationships; and (5) stating that the rule will not displace certain federal consumer protection laws and regulations.

The comments are addressed in greater detail below.

As noted in the prior section, commenters raised a variety of issues for the OCC's consideration. These are discussed below.

Some commenters argued the OCC lacks the legal authority to issue the rule because it would contravene the unambiguous meaning of 12 U.S.C. 85. These commenters believe that section 85 incorporates the common law of usury as of 1864, which they view as requiring courts to look to the substance rather than the form of a transaction. In a similar vein, commenters argued that section 85 incorporates all usury laws of a state, including its true lender jurisprudence. One commenter also argued that the proposal contradicts judicial and administrative precedent interpreting sections 85 and 86.

The OCC disagrees. The rule interprets statutes that authorize banks to lend—12 U.S.C. 24, 371, and 1464(c)—and clarifies how to determine when a bank exercises this lending authority. The OCC has clear authority to reasonably interpret these statutes, which do not specifically address when a bank makes a loan. 5

Banks do not obtain their lending authority from section 85 or 12 U.S.C. 1463(g). Nor are these statutes the authority the OCC is relying on to issue this rule. The proposal referenced sections 85 and 1463(g) in the regulatory text to ensure that interested parties understand the consequences of its interpretation of sections 24, 371, and 1464(c), 6 including that this rulemaking operates together with the OCC's recently finalized ` Madden -fix' rulemaking. 7 When a bank makes a loan pursuant to the test established in this regulation, the bank may subsequently sell, assign, or otherwise transfer the loan without affecting the permissible interest term, which is determined by reference to state law. 8

Other commenters questioned the OCC's authority on different grounds. Some asserted the OCC lacks authority to (1) exempt nonbanks from compliance with state law or (2) preempt state laws that determine whether a loan is made by a nonbank lender. One commenter also asserted that the proposal is an attempt by the OCC to interpret state law. A commenter further argued that the OCC's statutory interpretation is not reasonable, including because the proposal (1) would allow nonbanks to enjoy the benefits of federal preemption without submitting to any regulatory oversight and (2) violates the presumption against preemption, especially in an area of historical state police powers like consumer protection.

This rulemaking does not assert authority over nonbanks, preempt state laws applicable to nonbank lenders, or interpret state law. It interprets federal banking law and has no direct applicability to any nonbank entity or activity. Rather, in identifying the true lender, the rule pinpoints key elements of the statutory, regulatory, and supervisory framework applicable to the loan in question. As noted in the proposal, if a nonbank partner is the true lender, the relevant state (and not OCC) would regulate the lending activity, and the OCC would assess the bank's third-party risk management in connection with the relationship itself.

Furthermore, because commenters expressed concern that this rule would undermine state usury caps, it is also important to emphasize that sections 85 and 1463(g) provide a choice of law framework for determining which state's law applies to bank loans and, in this way, incorporate, rather than eliminate, state law. These statutes require that a bank refer to, and comply with, the usury cap established by the laws of the state where the bank is located. Thus, disparities between the usury caps applicable to particular bank loans result primarily from differences in the state laws that impose these caps, not from an interpretation that section 85 or 1463(g) preempt state law.

A commenter also asserted that the OCC's interpretation is not reasonable because it (1) does not solve the problem it claims to remedy, arguing that the proposal itself is unclear and requires banks to undertake a fact-specific analysis and (2) departs from federal cases holding that state true lender law applies to lending relationships between banks and nonbanks.

The OCC believes that this rule provides a simple, bright-line test to determine when a bank has made a loan and, therefore, is the true lender in a lending relationship. The only required factual analysis is whether the bank is named as the lender or funds the loan. The OCC has evaluated various standards established by courts and has determined that a clear, predictable, and easily administrable test is preferable. This test will provide legal certainty, and the OCC's robust supervisory framework effectively targets predatory lending, achieving the same goal as a more complex true lender test.

Several commenters also asserted that the proposal contravenes 12 U.S.C. 1, which charges the OCC with ensuring that banks treat customers fairly. One commenter also argued that the proposal is inconsistent with the Community Reinvestment Act (CRA) because it encourages predatory lending. As the OCC explained in the proposal, the rule's purpose is to provide legal certainty to expand access to credit, a goal that is entirely consistent with the agency's statutory charge to ensure fair treatment of customers and banks' statutory obligation to serve the convenience and needs of their communities.

Several commenters asserted that the agency should have complied with 12 U.S.C. 25b, which applies when the OCC issues a regulation or order that preempts a state consumer financial law. Some of these commenters argued that the proposal fails to meet the preemption standard articulated in Barnett Bank of Marion County, N.A. v. Nelson, Florida Insurance Commissioner, et al. ( Barnett ), 9 as incorporated into section 25b. Commenters also argued that (1) section 25b(f) does not exempt the OCC's proposal from the requirements of section 25b because the rule is not limited to banks charging interest and (2) the proposal undermines or contravenes section 25b(h) because it extends preemptive treatment to subsidiaries, affiliates, and agents of banks.

The OCC disagrees: The requirements of section 25b are inapplicable to this rulemaking. Section 25b applies when the Comptroller determines, on a case-by-case basis, that a state consumer financial law is preempted pursuant to the standard for conflict preemption established by the Supreme Court in Barnett, i.e., when the Comptroller makes a preemption determination. 10 This rulemaking does not preempt a state consumer financial law but rather interprets a bank's federal authority to lend. Furthermore, commenters arguing that section 25b(f) (which addresses section 85) does not exempt this rulemaking from the procedures in section 25b and that sections 25b(b)(2), (e), and (h)(2) (which address bank subsidiaries, affiliates, and agents) preclude the agency from issuing this rule are mistaken; this rulemaking is not an interpretation of section 85, nor does it address the applicability of state law to bank subsidiaries, affiliates, or agents.

Several commenters asserted that, for various reasons, the proposal is arbitrary and capricious and, therefore, in violation of the APA. Some commenters argued that the proposal lacks an evidentiary basis, either entirely or with respect to certain assertions, such as the existence of legal uncertainty. The OCC disagrees. The APA's arbitrary and capricious standard requires an agency to make rational and informed decisions based on the information before it. 11 Furthermore, the standard does not require the OCC to develop or cite empirical or other data to support its rule or wait for problems to materialize before acting. 12 Instead, the OCC may rely on its expertise to address the problems that may arise. 13

The OCC has decided to issue this rule to resolve the effects of legal uncertainty on banks and their third-party relationships. In this case, the OCC's views are informed by courts' divergent true lender tests and the resulting lack of predictability faced by stakeholders. 14 While the OCC understands its rule may not resolve all legal uncertainty for every loan, this is not a prerequisite for the agency to take this narrowly tailored action. 15 Taking these considerations into account, the OCC has made a rational and informed decision to issue this rule.

Commenters also argued that the OCC's actions violate the APA because the agency has not given notice of its intention to reverse an existing policy or provided the factual, legal, and policy reasons for doing so. Specifically, these commenters referenced the OCC's longstanding policy prohibiting banks from entering into rent-a-charter schemes. This rulemaking does not reverse the OCC's position. The OCC's longstanding and unwavering opposition to predatory lending, including but not limited to predatory lending as part of a third-party relationship, remains intact and strong. 16 In fact, this rulemaking would solve the rent-a-charter issues raised and ensure that banks do not participate in those arrangements. As noted in the proposal, the OCC's statutes and regulations, enforceable guidelines, guidance, and enforcement authority provide robust and effective safeguards against predatory lending when a bank exercises its lending authority. This rule does not alter this framework but rather reinforces its importance by clarifying that it applies to every loan a bank makes and by providing a simple test to identify precisely when a bank has made a loan. If a bank fails to satisfy its compliance obligations, the OCC will not hesitate to use its enforcement authority consistent with its longstanding policy and practice.

Furthermore, the final rule does not change the OCC's expectation that all banks establish and maintain prudent credit underwriting practices and comply with applicable law, even when they partner with third parties. These expectations were in place before the OCC issued its proposal and will remain in place after the final rule takes effect. For these reasons, the final rule does not represent a change in OCC policy.

As noted previously, the OCC's proposed regulatory text set out a test for determining when a bank has made a loan for purposes of 12 U.S.C. 24, 85, 371, 1463(g), and 1464(c). Under this test, a bank made a loan if, as of the date of origination, it was named as the lender in the loan agreement or funded the loan.

Some commenters supported the rule without change, stating that the proposal provided the clarity needed to determine which entity is the true lender in a lending relationship. Other commenters supported the proposal as a general matter but suggested specific changes, including clarifying that the funding prong does not include certain lending or financing arrangements such as warehouse lending, indirect auto lending (through bank purchases of retail installment contracts (RICs)), loan syndication, and other structured finance.

These commenters are correct that the funding prong of the proposal generally does not include these types of arrangements: They do not involve a bank funding a loan at the time of origination. For example, when a bank purchases a RIC from an auto dealer, as is often the case with indirect auto lending, the bank does not “fund” the loan. 17 When a bank provides a warehouse loan to a third party that subsequently draws on that warehouse loan to lend to other borrowers, the bank is not funding the loans to these other borrowers. In contrast, and as noted in the proposal, the bank is the true lender in a table funding arrangement when the bank funds the loan at origination. 18

Another commenter recommended that the OCC consider the “safe harbor” established in the recent settlement between the Colorado Attorney General and several financial institutions and fintech lenders. 19 While we are aware of this settlement, the OCC believes that our approach achieves the goal of legal certainty while providing the necessary safeguards.

One commenter requested that the OCC expressly state in the final rule that the rulemaking is not intended to displace or alter other regulatory regimes, including those that address consumer protection. Another commenter requested that the OCC clarify how account information in true lender arrangements should be reported to consumer reporting agencies under the Fair Credit Reporting Act. As the preamble to the proposal noted, the OCC's rule does not affect the application of any federal consumer financial laws, including, but not limited to, the meaning of the terms (1) “creditor” in the Truth in Lending Act (15 U.S.C. 1601 et seq. ) and Regulation Z (12 CFR part 1026) and (2) “lender” in Regulation X (12 CFR part 1024), which implements the Real Estate Settlement Procedures Act of 1974 (12 U.S.C. 2601 et seq. ). Similarly, the OCC's rule does not affect the applicability of the Home Mortgage Disclosure Act (12 U.S.C. 2801 et seq. ), the Equal Credit Opportunity Act (15 U.S.C. 1691 et seq. ), the Fair Credit Reporting Act (15 U.S.C. 1681 et seq. ), or their implementing regulations (Regulation C (12 CFR part 1003), Regulation B (12 CFR part 1002), and Regulation V (12 CFR part 1022)), respectively. The OCC recommends that commenters direct questions regarding these statutes and regulations to the Consumer Financial Protection Bureau.

Some commenters stated that the two prongs in the proposal's test would produce contradictory and absurd results. For example, several commenters noted that, under the proposal, two banks could be the true lender ( e.g., at origination, one bank is named as the lender on the loan agreement and another bank funds the loan). In response to this comment, we have amended the regulatory text to provide that where one bank is named as the lender in the loan agreement and another bank funds the loan, the bank named as the lender in the loan agreement makes the loan. This approach will provide additional clarity and allow stakeholders, including borrowers, to easily identify the bank that makes the loan. Otherwise, the OCC adopts the regulatory text as proposed.

The OCC received multiple comments expressing concern that the proposal would facilitate rent-a-charter relationships and thereby enable nonbank lenders to engage in predatory or otherwise abusive lending practices. These commenters noted that nonbanks are generally not subject to the type of prudential supervision that applies to banks and that usury caps are the most effective method to curb predatory lending by nonbanks. They argued that the OCC's rule would effectively nullify these caps and facilitate the expansion of predatory lending.

As explained above, in a rent-a-charter arrangement, a lender receives a fee to rent out its charter and unique legal status to originate loans on behalf of a third party, enabling the third party to evade state and local laws, such as usury caps and other consumer protection laws. At the same time, the lender disclaims any responsibility for these loans. As a result of these arrangements, consumers can find themselves in debt to an unscrupulous nonbank lender that is subject to very little or no prudential supervision on a loan at an interest rate grossly in excess of the state usury cap.

The OCC agrees that rent-a-charter schemes have no place in the federal financial system but disagrees that this rule facilitates such schemes. As noted above, instead, this proposal would help solve the problem by (1) providing a clear and simple test for determining when a bank makes a loan and (2) emphasizing the robust supervisory framework that applies to any loan made by a bank and to all third-party relationships to which banks are a party. As noted above, if a bank fails to satisfy its obligations under this supervisory framework, the OCC will use all the tools at its disposal, including its enforcement authority. 20

Although the proposal discussed this supervisory framework in detail, it bears repeating because of its importance to this rulemaking. Every bank is responsible for establishing and maintaining prudent credit underwriting practices that: (1) Are commensurate with the types of loans the bank will make and consider the terms and conditions under which they will be made; (2) consider the nature of the markets in which the loans will be made; (3) provide for consideration, prior to credit commitment, of the borrower's overall financial condition and resources, the financial responsibility of any guarantor, the nature and value of any underlying collateral, and the borrower's character and willingness to repay as agreed; (4) establish a system of independent, ongoing credit review and appropriate communication to management and to the board of directors; (5) take adequate account of concentration of credit risk; and (6) are appropriate to the size of the institution and the nature and scope of its activities. 21 Moreover, every bank is expected to have loan documentation practices that: (1) Enable the institution to make an informed lending decision and assess risk, as necessary, on an ongoing basis; (2) identify the purpose of a loan and the source of repayment and assess the ability of the borrower to repay the indebtedness in a timely manner; (3) ensure that any claim against a borrower is legally enforceable; (4) demonstrate appropriate administration and monitoring of a loan; and (5) take account of the size and complexity of a loan. 22 Every bank should also have appropriate internal controls and information systems to assess and manage the risks associated with its lending activities, including those that provide for monitoring adherence to established policies and compliance with applicable laws and regulations, as well as internal audit systems. 23

In addition, a bank's lending must comply with all applicable laws and regulations, including federal consumer protection laws. For example, section 5 of the Federal Trade Commission Act (FTC Act) provides that “unfair or deceptive acts or practices in or affecting commerce” are unlawful. 24 The Dodd-Frank Wall Street Reform and Consumer Protection Act also prohibits unfair, deceptive, or “abusive” acts or practices. 25 The OCC has taken a number of public enforcement actions against banks for violating section 5 of the FTC Act and will continue to exercise its enforcement authority to address unlawful actions. 26

Banks also are subject to federal fair lending laws and may not engage in unlawful discrimination, such as “steering” a borrower to a higher cost loan on the basis of the borrower's race, national origin, age, or gender. If a bank engages in any unlawful discriminatory practices, the OCC will take appropriate action under the federal fair lending laws. 27 Further, under the CRA regulations, CRA-related lending practices that violate federal fair lending laws, the FTC Act, or Home Ownership and Equity Protection Act, or that evidence other discriminatory or illegal credit practices, can adversely affect a bank's CRA performance rating. 28

The OCC has also taken significant steps to eliminate predatory, unfair, or deceptive practices in the federal banking system, recognizing that “[s]uch practices are inconsistent with important national objectives, including the goals of fair access to credit, community development, and stable homeownership by the broadest spectrum of America.”  29 To address these concerns, the OCC requires banks engaged in lending to take into account the borrower's ability to repay the loan according to its terms. 30 In the OCC's experience, “a departure from fundamental principles of loan underwriting generally forms the basis of abusive lending: Lending without a determination that a borrower can reasonably be expected to repay the loan from resources other than the collateral securing the loan, and relying instead on the foreclosure value of the borrower's collateral to recover principal, interest, and fees.”  31

Additionally, the OCC has cautioned banks about lending activities that may be considered predatory, unfair, or deceptive, noting that many such lending practices are unlawful under existing federal laws and regulations or otherwise present significant safety, soundness, or other risks. These practices include those that target prospective borrowers who cannot afford credit on the terms being offered, provide inadequate disclosures of the true costs and risks of transactions, involve loans with high fees and frequent renewals, or constitute loan “flipping” (frequent re-financings that result in little or no economic benefit to the borrower that are undertaken with the primary or sole objective of generating additional fees). 32 Policies and procedures should also be designed to ensure clear and transparent disclosure of the terms of the loan, including relative costs, risks, and benefits of the loan transaction, which helps to mitigate the risk that a transaction could be unfair or deceptive. The NPR also highlighted specific questions that the OCC evaluates as part of its robust supervision of banks' lending relationships. 33

In addition to this framework targeted at banks' lending activities, the OCC has issued comprehensive guidance on third-party risk management. 34 These standards apply to any relationship between a bank and a third party, including lending relationships, regardless of which entity is the true lender. Pursuant to this guidance, the OCC expects banks to institute appropriate safeguards to manage the risks associated with their third-party relationships.

Under the final rule, this robust supervisory framework will continue to apply to banks that are the true lender in a lending relationship with a third party. Rather than allowing banks to enter into rent-a-charter schemes, the final rule will ensure that banks understand that the OCC will continue to hold banks accountable for their lending activities.

Paperwork Reduction Act. In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., the OCC may not conduct or sponsor, and respondents are not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC has reviewed the final rule and determined that it will not introduce any new or revise any existing collection of information pursuant to the PRA. Therefore, no submission will be made to OMB for review.

Regulatory Flexibility Act. The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires an agency, in connection with a final rule, to prepare a Final Regulatory Flexibility Analysis describing the impact of the rule on small entities (defined by the Small Business Administration (SBA) for purposes of the RFA to include commercial banks and savings institutions with total assets of $600 million or less and trust companies with total assets of $41.5 million or less) or to certify that the final rule would not have a significant economic impact on a substantial number of small entities.

The OCC currently supervises approximately 745 small entities. The OCC expects that all of these small entities would be impacted by the rule. While this final rule could affect how banks structure their current or future third-party relationships as well as the amount of loans originated by banks, the OCC believes the costs associated with any administrative changes in bank lending policies and procedures would be de minimis. Banks already have systems, policies, and procedures in place for issuing loans when third parties are involved. It takes significantly less time to amend existing policies than to create them, and the OCC does not expect any needed adjustments will involve an extraordinary demand on a bank's human resources. In addition, any costs would likely be absorbed as ongoing administrative expenses. Therefore, the OCC certifies that this rule will not have a significant economic impact on a substantial number of small entities. Accordingly, a Final Regulatory Flexibility Analysis is not required.

Unfunded Mandates Reform Act. Consistent with the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1532, the OCC considers whether a final rule includes 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 adjusted for inflation (currently $157 million) in any one year. The final rule does not impose new mandates. Therefore, the OCC concludes that implementation of the final rule would not result in an expenditure of $157 million or more annually by state, local, and tribal governments, or by the private sector.

Riegle Community Development and Regulatory Improvement Act. Pursuant to section 302(a) of the Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA), 12 U.S.C. 4802(a), in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions, the OCC must consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations. In addition, section 302(b) of RCDRIA, 12 U.S.C. 4802(b), requires new regulations and amendments to regulations that impose additional reporting, disclosures, or other new requirements on insured depository institutions generally to take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form. This final rule imposes no additional reporting, disclosure, or other requirements on insured depository institutions, and therefore, section 302 is not applicable to this rule.

Congressional Review Act. For purposes of the Congressional Review Act (CRA), 5 U.S.C. 801 et seq., the Office of Information and Regulatory Affairs (OIRA) of the OMB determines whether a final rule is a “major rule,” as that term is defined at 5 U.S.C. 804(2). OIRA has determined that this final rule is not a major rule. As required by the CRA, the OCC will submit the final rule and other appropriate reports to Congress and the Government Accountability Office for review.

Administrative Procedure Act. The APA, 5 U.S.C. 551 et seq., generally requires that a final rule be published in the Federal Register not less than 30 days before its effective date. This final rule will be effective 60 days after publication in the Federal Register , which meets the APA's effective date requirement.

For the reasons set out in the preamble, the OCC amends 12 CFR part 7 as follows.

This notice announces that the FAA has given its overall approval to the Burlington International Airport noise compatibility program, effective October 30, 2020.

Under Section 104(a) of the Aviation Safety and Noise Abatement Act of 1979 (hereinafter the Act), an airport operator who has previously submitted a noise exposure map may submit to the FAA a noise compatibility program which sets forth the measures taken or proposed by the airport operator for the reduction of existing non-compatible land uses and prevention of additional non-compatible land uses within the area covered by the noise exposure maps.

The Act requires such programs to be developed in consultation with interested and affected parties including local communities, government agencies, airport users, and FAA personnel.

Each airport noise compatibility program developed in accordance with 14 CFR part 150 is a local program, not a federal program. The FAA does not substitute its judgment for that of the airport proprietor with respect to which measures should be recommended for action. The FAA's approval or disapproval of the part 150 program recommendations is measured according to the standards expressed in part 150 and the Act, and is limited to the following determinations:

(a) The noise compatibility program was developed in accordance with the provisions and procedures of FAR part 150;

(b) Program measures are reasonably consistent with achieving the goals of reducing existing non-compatible land uses around the airport and preventing the introduction of additional non-compatible land uses;

(c) Program measures would not create an undue burden on interstate or foreign commerce, unjustly discriminate against types or classes of aeronautical uses, violate the terms of airport grant agreements, or intrude into areas preempted by the federal government; and

(d) Program measures relating to the use of flight procedures can be implemented within the period covered by the program without derogating safety, adversely affecting the efficient use and management of the navigable airspace and air traffic control systems, or adversely affecting other powers and responsibilities of the Administrator as prescribed by law.

Specific limitations with respect to FAA's approval of an airport noise compatibility program are delineated in part 150, § 150.5. Approval is not a determination concerning the acceptability of land uses under Federal, state, or local law. Approval does not by itself constitute a FAA implementing action. A request for Federal action or approval to implement specific noise compatibility measures may be required, and an FAA decision on the request may require an environmental assessment of the proposed action.

Approval does not constitute a commitment by the FAA to financially assist in the implementation of the program nor a determination that all measures covered by the program are eligible for grant-in-aid funding from the FAA under the Airport and Airway Improvement Act of 1982. Where Federal funding is sought, requests for project grants must be submitted to the FAA Regional Office in Burlington, Massachusetts.

The Burlington International Airport study contains a proposed noise compatibility program comprised of actions designed for implementation by airport management and adjacent jurisdictions. The Burlington International Airport, South Burlington, Vermont requested that the FAA evaluate and approve this material as a noise compatibility program as described in Section 104(b) of the Act. The FAA began its review of the program on April 15, 2020, and was required by a provision of the Act to approve or disapprove the program within 180 days (other than the use of new flight procedures for noise control). Failure to approve or disapprove such a program within the 180-day period shall be deemed to be an approval of such a program.

The submitted program contained 9 noise mitigation measures, including 2 to be removed. The FAA completed its review and determined that the procedural and substantive requirements of the Act and Part 150 have been satisfied. All 7 recommended measures were approved, and 2 recommended for removal were approved for removal. The new program will de-emphasize land acquisition in lieu of sound insulation, as the primary noise mitigation measure.

The Airports Division originally approved the program on August 27, 2020. After issuance of the Record of Approval, the FAA discussed its implementation with the City of Burlington. Based on this discussion, the FAA made two small revisions to the Record of Approval and issued a revised approval on October 14, 2020. These revisions clarify FAA funding of the Purchase Assurance and Sales Assistance programs (measures #6 and #7). That prior approval is superseded by issuance of a new Record of Approval on October 14, 2020.

FAA's determinations are set forth in detail in a Record of Approval approved on October 14, 2020. The Record of Approval, as well as other evaluation materials and the documents comprising the submittal, are available for review at the FAA office listed above and at the administrative offices of Burlington International Airport, South Burlington, Vermont.

Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document and supplemental information, including the complete Department of Health and Human Services (HHS) and DEA eight-factor analyses, to this interim final rule (IFR) are available at http://www.regulations.gov for easy reference.

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. Interested persons may file requests for a hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44 (a) or (b), and include a statement of interest in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing together with a written statement regarding the interested person's position on the matters of fact and law involved in any hearing as set forth in 21 CFR 1308.44(c).

All requests for a hearing and waivers of participation must be sent to DEA using the address information provided above.

Under the Improving Regulatory Transparency for New Medical Therapies Act, Public Law 114-89, 2(b), 129 Stat. 698, 700 (2015), DEA is required to commence an expedited scheduling action with respect to certain new drugs approved by the U.S. Food and Drug Administration (FDA). As provided in 21 U.S.C. 811(j), this expedited scheduling is required where both of the following conditions apply: (1) The Secretary of the Department of Health and Human Services (the Secretary) has advised DEA that an application for a new drug has been submitted for a drug that has a stimulant, depressant, or hallucinogenic effect on the central nervous system, and that it appears that such drug has an abuse potential; and, (2) the Secretary recommends that DEA control the drug in schedule II, III, IV, or V pursuant to 21 U.S.C. 811(a) and (b). In these circumstances, DEA is required to issue an IFR controlling the drug within 90 days.

The law further states that the 90-day timeframe starts the later of (1) the date DEA receives the HHS scientific and medical evaluation/scheduling recommendation, or (2) the date DEA receives notice of the application approval by HHS. In addition, the law specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause therefor. Thus, the purpose of subsection (j) is to speed the process by which DEA schedules newly approved drugs that are currently either in schedule I or not controlled (but which have sufficient abuse potential to warrant control) so that such drugs may be marketed without undue delay following FDA approval. 1

Subsection (j) further provides that the IFR shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, DEA must issue a final rule in accordance with the scheduling criteria of subsections 21 U.S.C. 811(b), (c), and (d) and 21 U.S.C. 812(b).

On November 2, 2017, Trevena, Inc. (Sponsor) submitted an initial New Drug Application (NDA) to FDA for oliceridine that was subsequently resubmitted on February 7, 2020. FDA determined that oliceridine is a new molecular entity, and HHS determined that oliceridine has a depressant effect on the central nervous system. On August 7, 2020, FDA approved the NDA for oliceridine for medical use as an intravenous drug for the management of acute pain severe enough to require an intravenous opioid analgesic and for patients for whom alternative treatments are inadequate.

On July 27, 2020, DEA received a scientific and medical evaluation document from HHS prepared by FDA related to oliceridine, titled: “Basis for the Recommendation to Control Oliceridine and its Salts in Schedule II of the Controlled Substances Act.” Pursuant to 21 U.S.C. 811(b), this document contained an eight-factor analysis of the abuse potential of oliceridine, along with HHS's recommendation to control oliceridine under schedule II of the CSA. Subsequently, on August 7, 2020, DEA received notification from HHS that FDA had approved an NDA for oliceridine (OLINVYK).

In response, DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS, along with all other relevant data, and completed its own eight-factor review document pursuant to 21 U.S.C. 811(c). DEA concluded that oliceridine met the 21 U.S.C. 812(b)(2) criteria for placement in schedule II of the CSA.

Pursuant to subsection 811(j), and based on HHS's recommendation, the NDA approval by HHS/FDA, and DEA's determination, DEA is issuing this IFR to schedule oliceridine as a schedule II controlled substance under the CSA.

Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its scheduling action. Please note that both the DEA and HHS analyses are available in their entirety under “Supporting Documents” in the public docket for this IFR at http://www.regulations.gov, under Docket Number “DEA-715.” Full analysis of, and citations to, the information referenced in the summary may also be found in the supporting and related material.

1. Its Actual or Relative Potential for Abuse: Oliceridine is a new molecular entity that has not been marketed in the United States or any other country. Thus, information about the diversion and actual abuse of oliceridine is limited. Oliceridine is currently not available for medical treatment, has not been diverted from legitimate sources, and individuals have not taken this substance in amounts sufficient to create a hazard to public health and safety. DEA notes that there are no reports for oliceridine in the National Forensic Laboratory Information System (NFLIS), 2 which collects drug identification results from drug cases submitted to and analyzed by Federal, State, and local forensic laboratories. There were also no reports in DEA's laboratory drug evidence data system of record, STARLiMS. 3

According to the legislative history of the CSA, one of the criteria by which DEA should assess actual or relative potential for abuse is whether the substance in question “is so related in its action to a substance already listed as having a potential for abuse to make it likely that it will have the same potential for abuse as such substance, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.”  4 As stated by HHS, oliceridine is a high-affinity mu opioid agonist that produces behavioral effects similar to other mu opioid agonists, such as the schedule II opioid morphine. Moreover, in a rat drug discrimination study, oliceridine generalized to morphine, showing that oliceridine has opioid-like properties. In a clinical study investigating the abuse potential of oliceridine, HHS concluded that oliceridine produced subjective responses that were similar to those for morphine. Specifically, like morphine, oliceridine produced positive subjective responses and euphoria-related adverse events in clinical studies. Together, this evidence demonstrates that oliceridine is related in action and effect to the schedule II substance morphine, and can therefore be expected to have a similar potential for abuse.

2. Scientific Evidence of Its Pharmacological Effects, if Known: Oliceridine has high affinity for the mu-opioid receptor and does not bind to any other receptors that are typically associated with abuse, such as kappa and delta opioid receptors, cannabinoid receptors, GABAergic receptors, or other ion channels. According to HHS, general behavioral studies in animals indicate that oliceridine produces behavioral and motor effects similar to those of morphine, a schedule II substance. Additionally, oliceridine produces self-administration in rats. Furthermore, in a drug discrimination study used to predict subjective effects in humans, oliceridine mimicked the stimulus effects of morphine. In a human abuse potential (HAP) study, therapeutic and supratherapeutic doses of oliceridine produced euphoria, somnolence, and paresthesia. These adverse events are consistent with those of other schedule II opioids such as morphine. In other clinical studies, adverse events such as somnolence, sedation, anxiety, restlessness, and paresthesia were seen in subjects treated with oliceridine. As concluded by HHS, results from preclinical and clinical studies indicate that oliceridine has abuse potential similar to morphine.

3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: Oliceridine is a new molecular entity, chemically known as N -[(3-methoxythiophen-2-yl)methyl] ({2-[(9 R )-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl})amine fumarate. It has a molecular formula of C 22 H 30 N 2 O 2 S.C 4 H 4 O 4. Oliceridine is a white to lightly-colored solid that is sparingly soluble in water. On August 7, 2020, FDA approved an NDA for oliceridine for medical use to manage acute pain severe enough to require an intravenous opioid analgesic and for which alternative treatments are inadequate. Thus, oliceridine has an accepted medical use in the United States. Oliceridine will be marketed as an intravenous medication formulated in vials containing 1, 2, or 30 mg of oliceridine.

4. Its History and Current Pattern of Abuse: There is no information available relating to the history and current pattern of abuse of oliceridine, since this drug is not currently marketed in any country. HHS notes that oliceridine produces abuse-related signals, such as euphoria and somnolence, and abuse potential similar to that of schedule II controlled substance morphine. DEA searched NFLIS and STARLiMS databases for oliceridine encounters. Consistent with the fact that oliceridine is a new molecular entity, these databases had no records of encounters of oliceridine by law enforcement.

5. The Scope, Duration, and Significance of Abuse: Oliceridine is currently not marketed in any country. Thus, information on the scope, duration, and significance of abuse for oliceridine is lacking. However, as stated by HHS, data from animal and human studies indicate that oliceridine has abuse potential similar to morphine. Therefore, upon marketing, oliceridine scope of abuse is expected to be similar to morphine.

6. What, if any, Risk There is to the Public Health: The extent of abuse potential of a drug is an indication of its public health risk. Data from the preclinical and clinical studies suggest that the abuse potential and physical or psychological dependence potential of oliceridine are similar to the schedule II substance morphine. Thus, oliceridine upon its availability for marketing would be expected to create a public health risk.

7. Its Psychic or Physiological Dependence Liability: Physical dependence for oliceridine was tested in an animal toxicity study. According to HHS, the animal toxicity study using rats demonstrated dose-dependent decreases in food consumption and body weight as well as classic opioid withdrawal signs from discontinuation of oliceridine. In a rat self-administration study as well as in clinical studies, oliceridine produced rewarding effects similar to morphine. Based on these studies, HHS stated that oliceridine may produce physical and psychological dependence.

8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled under the CSA: Oliceridine is not an immediate precursor of any controlled substance, as defined in 21 U.S.C. 802(23).

Conclusion: After considering the scientific and medical evaluation conducted by HHS, HHS's scheduling recommendation, and its own eight-factor analysis, DEA has determined that these facts and all relevant data constitute substantial evidence of a potential for abuse of oliceridine. As such, DEA hereby schedules oliceridine as a controlled substance under the CSA.

The CSA outlines the findings required to place a drug or other substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all available data, the Acting Administrator of DEA, pursuant to 21 U.S.C. 812(b)(2), finds that:

Oliceridine is a mu-opioid receptor agonist and produces behavioral effects that are similar to those of morphine (schedule II opioid substance) in animals and humans. A self-administration study in animals demonstrated that oliceridine produced self-administration that was comparable to morphine. Additionally, a drug-discrimination study in animals demonstrated that oliceridine generalized to morphine, indicating that it has mu-opioid receptor agonist properties. Results from a HAP study showed that oliceridine produces positive subjective effects as well as adverse events such as euphoria, similar to that of morphine, a schedule II substance with a high potential for abuse. Lastly, clinical studies in healthy individuals indicate that oliceridine produces abuse-related adverse events such as euphoria and sedation. These data collectively indicate that oliceridine has a high potential for abuse similar to the schedule II substance morphine.

FDA recently approved a NDA for oliceridine for the management of acute pain severe enough to require an intravenous opioid analgesic and for patients for whom alternative treatments are inadequate. Thus, oliceridine has a currently accepted medical use in treatment in the United States.

Chronic administration of oliceridine in rats followed by drug discontinuation produced classic opioid withdrawal signs, similar to that of schedule II drug morphine. This study would indicate oliceridine's potential to cause physical dependence similar to that of morphine. Oliceridine also produces self-administration in rats and positive subjective responses in a HAP study. These results parallel those produced by morphine and suggest that oliceridine can also produce psychological dependence. These data collectively suggest that oliceridine abuse may lead to psychological and physical dependence similar to that of schedule II opioids.

Based on these findings, the Acting Administrator of DEA concludes that oliceridine warrants control in schedule II of the CSA. 21 U.S.C. 812(b)(2).

Oliceridine is subject to the CSA's schedule II regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule II substances, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) oliceridine, or who desires to handle oliceridine, must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312. Any person who currently handles or intends to handle oliceridine, and is not registered with DEA, must submit an application for registration and may not continue to handle oliceridine, unless DEA has approved the application for registration, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

2. Quota. Only registered manufacturers are permitted to manufacture oliceridine in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

3. Disposal of stocks. Any person who does not desire or is not able to maintain a schedule II registration must surrender all quantities of currently held oliceridine, or may transfer all quantities of currently held oliceridine to a person registered with DEA in accordance with 21 CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.

4. Security. Oliceridine is subject to schedule II security requirements and must be handled and stored pursuant to 21 U.S.C. 821 and 823 and in accordance with 21 CFR 1301.71-1301.93.

5. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of oliceridine must comply with 21 U.S.C. 825 and 958(e) and be in accordance with 21 CFR part 1302.

6. Inventory. Every DEA registrant who possesses any quantity of oliceridine must take an inventory of oliceridine on hand, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

Any person who becomes registered with DEA to handle oliceridine must take an initial inventory of all stocks of controlled substances containing oliceridine on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including oliceridine) on hand every two years, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

7. Records and Reports. Every DEA registrant must maintain records and submit reports for oliceridine, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317.

8. Orders for oliceridine. Every DEA registrant who distributes oliceridine is required to comply with order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.

9. Prescriptions. All prescriptions for oliceridine or products containing oliceridine must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C.

10. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule II controlled substances, such registrants should be advised that (consistent with the foregoing considerations) any manufacturing or distribution of oliceridine may only be for the legitimate purposes consistent with the drug's labeling, or for research activities authorized by the Federal Food, Drug, and Cosmetic Act, as applicable, and the CSA.

11. Importation and Exportation. All importation and exportation of oliceridine must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

12. Liability. Any activity involving oliceridine not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Public Law 114-89 was signed into law, amending 21 U.S.C. 811. This amendment provides that in cases where a new drug is (1) approved by HHS, and (2) HHS recommends control in CSA schedule II-V, DEA shall issue an IFR scheduling the drug within 90 days. Additionally, the law specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause. Therefore, DEA has determined that the notice and comment requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to this scheduling action.

In accordance with 21 U.S.C. 811(a) and (j), this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.

This IFR is not an E.O. 13771 regulatory action pursuant to E.O. 12866 and OMB guidance. 5

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does 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 rule does not have tribal implications warranting the application of E.O. 13175. It does 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.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. Under 21 U.S.C. 811(j), DEA is not required to publish a general notice of proposed rulemaking. Consequently, the RFA does not apply to this IFR.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined that this action would not result in any 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 for inflation) in any one year.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action does not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This rule does not result in: An annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, DEA has submitted a copy of this IFR to both Houses of Congress and to the Comptroller General.

For the reasons set out above, DEA amends 21 CFR part 1308 as follows:

Expiration Date: Unless extended after consideration of submitted comments, this IFR will cease to be in effect upon termination of the President's declared national emergency regarding COVID-19, in accordance with applicable law (50 U.S.C.1622(a)).

If the ASD(HA) determines it would be appropriate to make these changes permanent, the ASD(HA) will follow-up with final rulemaking. The ASD(HA) will publish a document in the Federal Register announcing the expiration date.

A novel coronavirus (SARS-CoV-2), which causes COVID-19, was first detected in December 2019 and has spread rapidly throughout the world. On March 13, 2020, the President declared a national emergency due to the COVID-19 outbreak, retroactive to March 1, 2020 (Proclamation 9994, 85 FR 15337). According to data from the Centers for Disease Control and Prevention (CDC), on August 24, 2020, there were 5,682,491 confirmed COVID-19 cases in the United States (176,223 confirmed deaths), with the number of cases rapidly expanding each day. 1 Medical experts from NIAID anticipated more cases in the United States and overseas beginning in February 2020. 2

While stay-at-home orders and recommendations for social distancing have slowed the spread of COVID-19, there is currently no cure for COVID-19, nor are there vaccines capable of preventing transmission of the virus. Many potential COVID-19 treatments and vaccines are being tested in clinical trial settings designed to evaluate their safety and effectiveness. As of June 23, 2020, there were 27 clinical trials underway sponsored by NIAID.

A TRICARE COVID-19-related IFR published on May 12, 2020 (85 FR 27921), provided a temporary exception to the regulatory exclusion prohibiting audio-only telehealth services, temporarily eliminated copayments and cost-shares for TRICARE Prime and Select beneficiaries utilizing authorized telehealth services provided by network providers as a necessary incentive to prevent further spread of COVID-19, and temporarily authorized reimbursement of interstate practice by providers (both in-person and remotely) for care provided to TRICARE beneficiaries when such practice is permitted by federal or state law, even if the provider is not licensed in the state where practicing. That IFR was focused on temporary changes to the TRICARE program to aid in slowing community transmission of COVID-19. A second IFR, published on September 3, 2020 (85 FR 54914-54924), continued efforts by the ASD(HA) to implement temporary regulation changes in response to COVID-19 by focusing on temporary benefit and reimbursement changes that would support treatment of TRICARE beneficiaries. It also implemented two permanent regulation changes consistent with the statutory requirement that TRICARE reimburse like Medicare, to the extent practicable. This third COVID-19-related IFR builds on the efforts of the second IFR to provide beneficiaries access to emerging treatments (including vaccines) for COVID-19 by adding coverage for NIAID-sponsored COVID-19 clinical trials. This regulation implements an agreement entered into by the DoD with the National Institutes of Health (NIH) to cover such clinical trials, in accordance with statutory requirements.

Pursuant to the President's national emergency declaration regarding COVID-19 and as a result of the worldwide COVID-19 pandemic, the ASD(HA) hereby temporarily modifies the regulation to permit coverage of NIAID-sponsored COVID-19 phase I, II, III, and IV clinical trials. Details as follows:

a. 32 CFR 199.4(e)(26): Title 10, U.S.C. 1079(a)(12) authorizes, pursuant to an agreement with the Secretary of Health and Human Services (HHS) and under such regulations as the Secretary of Defense may prescribe, a waiver of the requirement that covered care be medically or psychologically necessary in connection with clinical trials sponsored by the NIH, provided the Secretary of Defense determines that such a waiver will promote access by covered beneficiaries to promising new treatments and contribute to the development of such treatments. On September 19, 2020, the DoD entered into an agreement with NIH to permit coverage of such trials.

Based on an agreement with the National Cancer Institute (NCI) and 32 CFR 199.4(e)(26), TRICARE currently covers NCI sponsored clinical trials related to cancer prevention, screening, and early detection. The intent of these statutory and regulatory provisions is to expand TRICARE beneficiary access to new treatments and to contribute to the development of such treatments.

This IFR will, pursuant to the agreement with the NIH, temporarily amend the regulation to authorize coverage of cost-sharing for medical care and testing of TRICARE-eligible patients who participate in Phase I, II, III, or IV clinical trials examining the treatment or prevention of COVID-19 that are sponsored by NIAID, enforcing the provisions within the agreement between DoD and NIH. Additionally, this change establishes requirements for TRICARE cost-sharing care related to NIAID-sponsored COVID-19 clinical trials; these new requirements mirror the existing requirements set forth in 32 CFR 199.4(e)(26)(ii)(B) for coverage of cancer clinical trials. This change supports statutory intent by encouraging participation of TRICARE beneficiaries in clinical trials studying the prevention or treatment of COVID-19 and contributing to the development of treatments, including vaccines, for COVID-19. This temporary modification will be effective for the duration of the President's national emergency regarding COVID-19; however, a patient who has been enrolled in an NIAID-sponsored clinical trial during the national emergency will continue to have his or her care cost-shared for the duration of that clinical trial, even if the national emergency has ended. Although this temporary provision is only effective for clinical trials for the treatment or prevention of COVID-19, and only for the duration of the national emergency, the DoD may consider expanding coverage to include other NIH clinical trials for the treatment of other diseases after evaluation of associated costs, benefits, risks, and other considerations; any such change would occur through future rulemaking. We invite comment on all benefit changes in this provision of the IFR, including comments on potential expansion of TRICARE's clinical trial benefit beyond cancer clinical trials and COVID-19 clinical trials.

b. Dates. This modification will become effective on October 30, 2020, and will cease to be in effect upon termination of the President's declared national emergency regarding COVID-19.

If the DoD determines it would be appropriate to continue coverage of COVID-19 clinical trials sponsored by NIAID or otherwise expand the clinical trial benefit beyond the duration of the national emergency, the DoD will issue a final rule to make permanent changes.

Agency rulemaking is governed by the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq. Section 553 of title 5, U.S.C., requires that, unless the rule falls within one of the enumerated exemptions, the DoD must publish a notice of proposed rulemaking in the Federal Register that provides interested persons an opportunity to submit written data, views, or arguments, prior to finalization of regulatory requirements. Section 553(b)(B) authorizes a department or agency to dispense with the prior notice and opportunity for public comment requirement when the agency, for “good cause,” finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest. Section 553(d)(3) requires that an agency must include an explanation of such good cause with the publication of the new rule.

As noted in this preamble, the United States, as well as numerous other countries, has taken unprecedented measures to try to contain or slow the spread of COVID-19. Although studies of potential treatments of COVID-19 are in progress, these studies are expected to take time. Unfortunately, TRICARE beneficiaries who have contracted COVID-19 may not have time to wait for these treatments, given the rapidity with which the disease overtakes individuals who develop the most severe responses to the illness.

Given the national emergency caused by COVID-19, it would be impracticable and contrary to the public health—and, by extension, the public interest—to delay these implementing regulations until a full public notice-and-comment process is completed.

Therefore, pursuant to 5 U.S.C. 553(b)(B), and for the reasons stated in this preamble, the ASD(HA) concludes that there is good cause to dispense with prior public notice and the opportunity to comment on this rule before finalizing this rule. For the same reasons, the ASD(HA) has determined, consistent with section 5 U.S.C. 553(d), that there is good cause to make this IFR effective immediately upon publication in the Federal Register , with applicability of its provisions to coincide with the duration of the President's national emergency regarding the COVID-19 outbreak.

This provision, 32 CFR 199.4(e)(26), temporarily waives the medical necessity requirements under 10 U.S.C. 1079(a)(12), as authorized by that statute, and establishes a clinical trial benefit for patients participating in NIAID-sponsored clinical trials for the prevention or treatment of COVID-19 during the President's national emergency regarding the COVID-19 outbreak. This provision also removes the reference to the NCI from the 32 CFR 199.4(e)(26) introductory text and authorizes coverage of clinical trials sponsored by any NIH Institute or Center, provided that the statutory requirements are also met ( i.e., the creation of an agreement with the Secretary of HHS and the creation of regulatory requirements implementing the agreement). This allows TRICARE coverage of clinical trials sponsored by the NIAID, one of the NIH Institutes and Centers responsible for sponsoring and approving clinical trials related to the treatment and prevention of COVID-19, among other diseases. In other words, this change temporarily removes the restriction that clinical trials under this paragraph be limited to NCI clinical trials.

The current regulatory language only includes waivers for NCI trials related to past or existing demonstrations, and it would be infeasible to create and implement a new COVID-19 demonstration due to the rapid spread of the pandemic, so this provision adds a third category of waiver for public health emergencies and specifically authorizes TRICARE coverage of beneficiary costs related to participation in NIAID-sponsored clinical trials for the treatment or prevention of COVID-19. This third category of waiver for public health emergencies is also a temporary provision; it merely provides an additional waiver type under which the NIAID clinical trials fall and criteria for that waiver type. This provision also establishes regulatory requirements for the coverage of NIAID-sponsored COVID-19 clinical trials to implement the agreement between DHA and NIH, as required by statute.

The DoD and NCI established a partnership in 1994 that allowed TRICARE beneficiaries to participate in cancer clinical trials for certain breast cancer treatments under a demonstration. The demonstration project expanded in 1996 to include all cancers and NCI-sponsored phase II and III cancer treatment clinical trials. The demonstration project partnership was ended by 71 FR 35390, which instead provided a continuous waiver of the medical necessity provision under 10 U.S.C. 1079(a)(12) when care was provided under NIH sponsored trials. That rule established the existing regulations under § 199.4(e)(26) for phase II and III cancer clinical trials. The DoD noted in the preamble for that rule that the demonstration had improved beneficiary access and resulted in contributions to the development of such treatments, justifying the formalization of the clinical trial benefit under TRICARE regulation. The regulation was modified again in 2011, with the addition of coverage for phase I cancer clinical trials (76 FR 2253).

Based on the success of the cancer clinical trial benefit and the urgent need for patients to have access to new treatments during the COVID-19 global pandemic, the ASD(HA) is temporarily waiving the medical necessity provision at 10 U.S.C. 1079(a)(12) for NIAID-sponsored clinical trials for the prevention or treatment of COVID-19 under a public health emergency waiver, as established in this regulation change, which implements the provisions of the agreement between DHA and NIH. TRICARE will cover cost-sharing for medical care and testing required for determining eligibility and participating in Phase I, Phase II, Phase III, and Phase IV clinical trials that meet the requirements set forth in this change. These requirements will implement the agreement between DHA and NIH and will be similar to the existing requirements for coverage of NCI cancer clinical trials, with the following differences: References to NCI and cancer will be changed to NIAID and COVID-19, respectively; Phase IV clinical trials will also be covered under the benefit; and there will be no prior authorization requirement for COVID-19 clinical trials, as the rapid progression of the disease necessitates a more rapid enrollment of beneficiaries and prior authorization would inhibit this enrollment. TRICARE will continue to deny coverage for care rendered in the NIH or costs associated with non-treatment research activities associated with the clinical trials, as well as for any items or services that are already covered under the investigational protocol, such as the drug and device being studied. For example, if the clinical trial were testing the efficacy of a COVID-19 vaccine, that vaccine would already be covered under the protocol ( i.e., neither TRICARE nor the patient would be liable for cost-sharing). Only those supplies and services that TRICARE otherwise would have covered during the normal course of treatment (including costs for screening tests to determine clinical trial eligibility) will be eligible for cost-sharing. This is consistent with the coverage policy which has been used for the cancer clinical trial benefit. Coverage will last for the duration of the President's national emergency regarding the COVID-19 outbreak, or, provided that the clinical trial begins and the beneficiary enrolls in the clinical trial before the termination of the national emergency, until the completion of the clinical trial, whichever occurs later. As required by 10 U.S.C. 1079(a)(12), DHA has entered into an agreement with NIH in order to cost-share eligible clinical trials; these regulatory provisions enforce this agreement.

Covering these trials will encourage participation by TRICARE beneficiaries in eligible clinical trials, contribute to the development of treatments and vaccines for COVID-19, and ensure that covered clinical trials meet similar requirements as those for NCI clinical trials for treatment of cancer. Due to the rapid progression of the COVID-19 pandemic, the severity of the disease in many individuals, and the absence of any existing treatments or vaccines, participation in clinical trials may also be the safest and most successful method of providing TRICARE beneficiaries with early access to care for prevention or treatment of COVID-19. There are already multiple ongoing NIAID-sponsored COVID-19 trials for treatments and vaccines, and we expect many more to be developed. The requirements in this provision, as well as NIAID protocols and institutional review board requirements, will protect participant safety.

Any NIAID-sponsored Phase I, II, III, or IV trial with the purpose of: (1) Preventing infection with COVID-19; (2) diagnosing infection (current or past infection); (3) treating the infection; (4) treating the symptoms of infection (to include associated symptoms such as neurological impairment, cardiovascular illness, or other symptoms as they arise, both acute and long-term); or (5) alleviating pain or other conditions associated with the infection; may be covered under this regulatory provision. Trials that are solely for the purpose of public health research and which do not affect the medical management of the individual patient, such as randomized serological testing to determine prevalence or lasting immunity, may be covered only to the extent that the health plans of other, non-DoD participants are also billed for such care, consistent with TRICARE's regulation at 32 CFR 199.9 regarding appropriate billing practices. Further, care reimbursed under this regulatory provision applies to NIH extramural care, such as NIAID-sponsored trials occurring at partner universities. Care provided at NIH facilities (termed “intramural” care) is excluded.

This temporary provision, including the creation of a public health emergency waiver category, is only effective for the period beginning the date this rule publishes in the Federal Register through the end of President's national emergency regarding the COVID-19 outbreak. However, we may consider creating additional waivers to cover NIH-sponsored clinical trials in the future, including establishing permanent coverage of NIAID trials, if appropriate, after a review of the costs, benefits, risks, and other considerations. Such waivers would fall under the agreement between DHA and NIH that is being implemented in this provision and would require further rulemaking. We invite public comment on the NIAID COVID-19 clinical trial benefit as implemented in this IFR, as well as the potential expansion of the clinical trial benefit as part of a final rule to cover other NIH Institutes or Centers trials or clinical trials for other diseases.

This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program.

Title 32 CFR 199.4 is revised every few years to ensure requirements continue to align with the evolving health care field. It was most recently permanently updated on September 29, 2017, with an IFR (82 FR 45438) that implemented the Congressionally-mandated TRICARE Select benefit plan. This revision to 32 CFR 199.4 included the addition of medically necessary foods as a benefit under the TRICARE Basic Program. Paragraph 199.4(e)(26) was last revised on January 13, 2011 (76 FR 2253), with the addition of coverage for NCI sponsored phase I clinical trials.

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. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB) under the requirements of these Executive Orders. This rule has been designated a “significant regulatory action,” although not determined to be economically significant, under section 3(f) of Executive Order 12866. This rule is not expected to have a significant impact on the economy.

Executive Order 13771 requires that for every significant regulation promulgated, an agency must identify two for elimination and offset its costs. Executive Order 13771 seeks to control costs associated with the government imposition of private expenditures required to comply with Federal regulations and to reduce regulations that impose such costs. Consistent with the analysis of transfer payments under OMB Circular A-4, this interim final rule does not involve regulatory costs subject to Executive Order 13771.

The modifications to paragraph 199.4(e)(26) in this IFR will temporarily permit TRICARE coverage of cost-sharing for NIAID-sponsored clinical trials for the treatment or prevention of COVID-19 for the duration of the President's national emergency for the COVID-19 outbreak. The modifications will also implement the agreement between NIH and DHA by establishing requirements for coverage of Phase I, II, III, and IV clinical trials. TRICARE will cover cost-sharing for medical care and testing required for determining eligibility and participating in clinical trials that meet these requirements.

This change affects all TRICARE beneficiaries who wish to participate in NIAID-sponsored clinical trials for the treatment or prevention of COVID-19. TRICARE-authorized providers will be affected by being able to treat TRICARE beneficiaries in NIAID clinical trials. The participation of TRICARE beneficiaries in NIAID-sponsored trials positively affects the general public through the development of treatments and vaccines, although it may negatively affect some individuals who desire to participate in such trials but are unable to do so because they were displaced from participation by TRICARE beneficiaries. TRICARE's health care contractors will be affected by being required to implement the provisions of this regulatory change. State, local, and tribal governments will not be affected.

We estimate the total cost for TRICARE participation in NIAID-sponsored COVID-19 clinical trials will be $3.2M for the duration of the national emergency, with an additional $4.0M for continued care for beneficiaries enrolled in clinical trials prior to termination of the national emergency. There were several assumptions we made in developing this estimate. The duration of the COVID-19 national emergency is uncertain; however, for the purposes of this estimate, we assumed the national emergency would expire on September 30, 2021 the end of fiscal year (FY) 2021, for ease of calculations. As of the drafting of this IFR, there were 27 NIAID-sponsored COVID-19 clinical trials begun since the start of the national emergency. We assumed 6.5 new trials every 30 days, for a total of 126 trials by September 2021, and that trials would last 17 months, on average, which is the average of the 27 NIAID-sponsored COVID-19 trials used in calculating this estimate. We assumed, based on average trial enrollment (1,770 participants per trial, on average) and that TRICARE beneficiaries would participate in trials at the same rate as the general population, that 4,549 TRICARE beneficiaries would participate through September 2021. Additionally, we assumed that costs for NIAID-sponsored trials will be similar to costs for NCI-sponsored trials, excluding chemotherapy, radiation, and surgery costs; the average government cost for NCI-sponsored trials less the excluded items was $93.00 per participant, per month in FY 2018 and FY 2019. Each of the assumptions in this estimate is highly uncertain, and our estimate could be higher or lower depending on real world events (more or fewer trials, a longer or shorter national emergency, and/or higher or lower participation in clinical trials by TRICARE beneficiaries).

This change expands the therapies available to TRICARE beneficiaries in settings that ensure informed consent of the beneficiary, and where the benefits of treatment outweigh the potential risks. Participation in clinical trials may provide beneficiaries with benefits such as reduced hospitalizations and/or use of a mechanical ventilator. Although we cannot estimate the value of this avoidance quantitatively, the potential long-term consequences of serious COVID-19 illness, including permanent cardiac or lung damage, are not insignificant. Beneficiary access to emerging therapies that reduce these long-term consequences or even death can be considered to be high-value for those able to participate.

Providers will be positively affected by being able to provide their patients with a broader range of treatment options. The general public will benefit from an increased pool of available participants for the development of treatments and vaccines for COVID-19, as well as the evidence (favorable or otherwise) that results from this participation.

The DoD considered several alternatives to this IFR. The first alternative involved taking no action. Although this alternative would be the most cost neutral for DHA, it was rejected as not addressing the urgent medical needs of the beneficiary population in response to the COVID-19 pandemic.

The second alternative the DoD considered was implementing a more limited benefit change for COVID-19 patients by not covering phase I clinical trials. While this would have the benefit of reimbursing only care that has more established evidence in its favor, this alternative is not preferred because early access to treatments is critical for TRICARE beneficiaries given the rapid progression of the disease and the lack of available approved treatments.

The Secretary certifies that this IFR is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending by State, local, and tribal governments, in the aggregate, or by the private sector, in any one year of $100 million in 1995 dollars, updated annually for inflation. This IFR will not impose any Federal mandate for State, local, or tribal governments, nor will it affect private sector costs.

32 CFR part 199 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates an IFR (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This IFR will not have a substantial effect on State and local governments.

Accordingly, 32 CFR part 199 is amended to read as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On July 22, 2020, EPA proposed to approve amendments and additions to the VOC rules located at OAC Chapter 3745-21, including an alternative monitoring, recordkeeping, and reporting program for the BP-Husky Refining LLC, Toledo Refinery at OAC 3745-21-09(T)(4), and alternate site-specific limitations for the Accel facility contained in its September 19, 2019, operating permit (85 FR 44255). An explanation of the applicable Clean Air Act requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in the notice of proposed rulemaking (NPRM) and will not be restated here. The public comment period for this proposed rule ended on August 21, 2020. EPA received one supportive comment (from BP-Husky) on the proposal. Therefore, we are finalizing our action as proposed.

EPA is approving the revisions to OAC Chapter 3745-21, specifically to the following rules: 3745-21-09, 3745-21-10, 3745-21-25, 3745-21-26, 3745-21-28, and 3745-21-29, as contained in Ohio's April 5, 2019 submittal. EPA is also approving into the SIP the addition of paragraphs B.4, B.6, B.8, B.9.c), C.1.b)(1)d, C.1.b)(2)a, C.1.d)(2), C.1.d)(3), C.1.e)(3), C.1.f)(1)c, C.2.b)(1)d, C.2.b)(2)a, C.2.d)(2), C.2.d)(3), C.2.e)(3), and C.2.f)(1)e as listed in the September 19, 2019 operating permit for the Accel facility.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Ohio Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the Clean Air Act as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

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 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because it is not a significant regulatory action under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• 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 et seq. );

• 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 an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• 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; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, 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. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 29, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, EPA amends title 40 CFR part 52 as follows:

You may be potentially affected by this action if you work in or employ persons working in crop production agriculture where pesticides are applied. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Agricultural Establishments (NAICS code 111000).

• Nursery and Tree Production (NAICS code 111421).

• Timber Tract Operations (NAICS code 113110).

• Forest Nurseries and Gathering of Forest Products (NAICS code 113210).

• Farm Workers (NAICS codes 11511, 115112, and 115114).

• Pesticide Handling on Farms (NAICS code 115112).

• Farm Labor Contractors and Crew Leaders (NAICS code 115115).

• Pesticide Handling in Forestry (NAICS code 115310).

• Pesticide Manufacturers (NAICS code 325320).

• Farm Worker Support Organizations (NAICS codes 813311, 813312, and 813319).

• Farm Worker Labor Organizations (NAICS code 813930).

• Crop Advisors (NAICS codes 115112, 541690, 541712).

If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

This action is issued under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y, particularly sections 136a(d), 136i, and 136w. Additionally, in accordance with the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) (Pub. L. 116-8; March 8, 2019), EPA is only revising the AEZ requirements in the WPS.

EPA is revising the AEZ requirements of the WPS (40 CFR part 170) adopted in 2015 (80 FR 67496, November 2, 2015) (FRL-9931-81) (Ref. 1) to clarify and simplify the requirements. Specifically, EPA is amending the AEZ requirements by:

• Modifying the AEZ so it is applicable and enforceable only on an agricultural employer's property, as proposed.

• Adding clarifying language indicating that pesticide applications which have been suspended due to individuals entering an AEZ on the establishment may be resumed after those individuals have left the AEZ.

• Excepting agricultural employers and handlers from the requirement to suspend applications owing to the presence within the AEZ of persons not employed by the establishment who are in an area subject to an easement that prevents the agricultural employer from temporarily excluding those persons from that area.

• Allowing the owners and their immediate family (as defined in 40 CFR 170.305) to shelter in place inside closed buildings, housing, or shelters within the AEZ, and allowing the application performed by handlers to proceed provided that the owner has instructed the handlers that only the owner's immediate family are inside the closed shelter and that the application should proceed despite their presence.

• Simplifying and clarifying criteria and factors for determining AEZ distances of either 100 or 25 feet by basing the AEZ on application method. EPA has removed the language and criteria pertaining to spray quality and droplet size, as proposed, so that all ground spray applications from a height greater than 12 inches are subject to the same 25-foot AEZ.

As discussed further in this document, these revisions take into consideration the comments received from the public in response to the AEZ proposed rule (84 FR 58666, November 1, 2019) (FRL-9995-47) (Ref. 2).

As further described in Unit II.B. of the proposed rule (Ref. 2), EPA initiated this rulemaking to clarify and simplify the WPS AEZ requirements in response to feedback about the AEZ requirements in the 2015 WPS rule from members of the agricultural community, including the U.S. Department of Agriculture (USDA), state pesticide regulatory agencies ( i.e., State Lead Agencies (SLAs)) and organizations, and several agricultural interest groups, as well as discussions with the Pesticide Program Dialogue Committee (PPDC) and public comments. This rulemaking is also responsive to the Agency's efforts to reduce burden on regulated entities, while providing the necessary protections for agricultural workers and the public. EPA remains committed to ensuring the protection of workers and persons in areas where pesticide applications are taking place. The AEZ and no contact provisions aim to ensure such protections. EPA also has a strong interest in promulgating regulations that are enforceable, clear, and effective.

EPA evaluated the potential incremental economic impacts and determined that these changes reduce existing burden. This analysis (Ref. 3), which is available in the docket, is summarized here.

The primary benefit of revising the AEZ requirements is a reduction in the complexity of applying a pesticide and improving the compliance and enforceability of the requirements. This deregulatory action is expected to reduce the burden for affected entities because the revised requirements are expected to substantially reduce the complexity of arranging and conducting a pesticide application. EPA has not, however, quantified the anticipated cost savings.

1. Statutory authority. Enacted in 1947, FIFRA established a framework for the pre-market registration and regulation of pesticide products; since 1972, FIFRA has prohibited the registration of pesticide products that cause unreasonable adverse effects. FIFRA makes it unlawful to use a pesticide in a manner inconsistent with the labeling and gives EPA's Administrator authority to develop regulations to carry out the Act. FIFRA's legislative history indicates that Congress specifically intended for FIFRA to protect workers and other persons from occupational exposure directly to pesticides or to their residues (Ref. 4).

Under FIFRA's authority, EPA has implemented measures to protect workers, handlers, other persons, and the environment from pesticide exposure in two primary ways. First, EPA includes product-specific use instructions and restrictions on individual pesticide product labeling. These instructions and restrictions are the result of EPA's stringent registration and reevaluation processes and are based on the risks of the particular product. Since users must comply with directions for use and restrictions on a product's labeling, EPA uses the labeling to convey mandatory requirements for how the pesticide must be used to protect people and the environment from unreasonable adverse effects of pesticide exposure. Second, EPA enacted the WPS to expand protections against the risks of agricultural pesticides without making individual product labeling longer and much more complex. The WPS is a uniform set of requirements for workers, handlers, and their employers that are generally applicable to all agricultural pesticides and are incorporated onto agricultural pesticide labels by reference. Its requirements complement the product-specific labeling restrictions and are intended to minimize occupational exposures generally.

2. EPA's regulation of pesticides. EPA uses a science-based approach to register and re-evaluate pesticides in order to protect human health and the environment from unreasonable adverse effects that might be caused by pesticides. The registration process begins when a manufacturer submits an application to register a pesticide. The application must contain required test data, including information on the pesticide's chemistry, environmental fate, toxicity to humans and wildlife, and potential for human exposure. EPA also requires a copy of the proposed labeling, including directions for use and appropriate warnings.

Once an application for a new pesticide product is received, EPA conducts an evaluation, which includes a detailed review of scientific data to determine the potential impact on human health and the environment. EPA considers the risk assessments and results of any peer review and evaluates potential risk management measures that could mitigate risks that exceed EPA's level of concern. In the registration process, EPA evaluates the proposed use(s) of the pesticide to determine whether it would cause adverse effects on human health, non-target species, and the environment. In evaluating the impact of a pesticide on occupational health and safety, EPA considers the risks associated with use of the pesticide (occupational, environmental) and the benefits associated with use of the pesticide (economic, public health, environmental). However, FIFRA does not require EPA to balance the risks and benefits for each exposed group individually. For example, a product may pose risks to workers, but those risks may nevertheless be reasonable in comparison to the economic benefit of continued use of the product to society at large.

If the application for registration does not contain sufficient evidence for EPA to determine that the pesticide meets the FIFRA registration criteria, EPA communicates to the applicant the need for more or better refined data, labeling modifications, or additional use restrictions. Once the applicant has demonstrated that a proposed product meets the FIFRA registration criteria and any applicable requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 321 et seq., EPA approves the registration subject to any risk mitigation measures necessary to meet the FIFRA registration criteria. EPA devotes significant resources to the regulation of pesticides to ensure that each pesticide product meets the FIFRA requirement that pesticides not cause unreasonable adverse effects to the public and the environment.

When EPA approves a pesticide, the labeling generally includes all risk mitigation measures required by EPA for the particular pesticide product and the uses specified on its label. The risk mitigation measures may include requiring certain engineering controls, such as the use of closed systems for mixing pesticides and loading them into application equipment to reduce potential exposure to those who handle pesticides; establishing conditions on the use of the pesticide by specifying certain use sites, maximum application rate or maximum number of applications; or establishing restricted entry intervals (REIs) during which entry into an area treated with the pesticide is generally prohibited until residue levels have declined to levels unlikely to cause unreasonable adverse effects. Because users must comply with the directions for use and use restrictions on a product's labeling, EPA uses the labeling to establish and convey mandatory requirements for how the pesticide must be used to protect the applicator, the public, and the environment from pesticide exposure.

Under FIFRA, EPA is required to review periodically the registration of pesticides currently registered in the United States. The 1988 FIFRA amendments required EPA to establish a pesticide reregistration program. Reregistration was a one-time comprehensive review of the human health and environmental effects of pesticides first registered before November 1, 1984 to ensure that these pesticides' registrations were consistent with contemporary standards. The 1996 amendments to FIFRA required that EPA establish, through rulemaking, an ongoing “registration review” process of all pesticides at least every 15 years. The final rule establishing the registration review program was signed in August 2006 (71 FR 45720, August 9, 2006) (FRL-8080-4), and is promulgated in 40 CFR part 155. The purpose of both re-evaluation programs is to review all pesticides registered in the United States to ensure that they continue to meet current safety standards based on up-to-date scientific approaches and relevant data.

Pesticides reviewed under the reregistration program that met current scientific and safety standards were declared “eligible” for reregistration. The results of EPA's reviews are summarized in Reregistration Eligibility Decision (RED) documents. Often before a pesticide could be determined “eligible,” additional risk reduction measures had to be put in place. For a number of pesticides, measures intended to reduce exposure to handlers and workers were needed and are now reflected on pesticide labeling. To address occupational risk concerns, REDs include mitigation measures such as: Voluntary cancellation of the product or specific use(s); limiting the amount, frequency, or timing of applications; imposing other application restrictions; classifying a product or specific use(s) for restricted use only by certified applicators; requiring the use of specific personal protective equipment (PPE); establishing specific REIs; and improving use directions. During this process, EPA also encouraged registrants to find replacements for the inert ingredients of greatest concern. As a result of EPA's reregistration efforts, current U.S. farm workers are not exposed to many of the previously used active and inert ingredients that were of the greatest toxicological concern. And for most of the older products that remain registered, reregistration resulted in the inclusion of additional risk mitigation measures on the label.

EPA's registration review program is a recurring assessment of products against current standards. EPA reviews each registered pesticide at least every 15 years to determine whether it continues to meet the FIFRA standard for registration. Pesticides registered before 1984 were reevaluated initially under the reregistration program. These and pesticides initially registered in 1984 or later are all subject to registration review.

In summary, EPA's pesticide reregistration and registration reviews assess the specific risks associated with particular chemicals and ensure that the public and environment do not suffer unreasonable adverse effects from those risks. EPA implements the risk reduction and mitigation measures identified in the pesticide reregistration and registration review programs through amendments to individual pesticide product labeling.

3. The Agricultural Worker Protection Standard (WPS). The Agricultural WPS regulation in 40 CFR part 170 is incorporated on certain pesticide product labeling through a statement in the agricultural use box. The WPS provides a comprehensive collection of pesticide management practices generally applicable to all agricultural pesticide use scenarios in crop production, complementing the product-specific requirements that appear on individual pesticide product labels.

The risk reduction measures of the WPS may be characterized as being one of three types: Information, protection, and mitigation. To ensure that employees will be informed about exposure to pesticides, the WPS requires that workers and handlers receive training on general pesticide safety, and that employers provide access to information about the pesticides with which workers and handlers may have contact. To protect workers and handlers from pesticide exposure, the WPS prohibits the application of pesticides in a manner that exposes workers or other persons, generally prohibits workers and other persons from being in areas being treated with pesticides, and generally prohibits workers from entering a treated area while an REI is in effect (with limited exceptions that require additional protections). In addition, the rule protects workers by requiring employers to notify them about areas on the establishment treated with pesticides through posted and/or oral warnings. The rule protects handlers by ensuring that they understand proper use of and have access to required PPE. Finally, the WPS has provisions to mitigate exposures if they do occur by requiring the employer to provide to workers and handlers with an ample supply of water, soap, and towels for routine washing and emergency decontamination. The employer must also make transportation available to a medical care facility if a worker or handler may have been poisoned or injured by a pesticide and provide health care providers with information about the pesticide(s) to which the person may have been exposed.

EPA manages the risks and benefits of each pesticide product primarily through the labeling requirements specific to each pesticide product. If pesticide products are used according to the labeling, EPA does not expect use to cause unreasonable adverse effects. However, data on incidents of adverse effects to human health and the environment from the use of agricultural pesticides show that users do not always comply with labeling requirements. Rigorous ongoing training, compliance assistance, and enforcement are needed to ensure that risk mitigation measures are appropriately implemented in the field. The framework provided by the WPS is critical for ensuring that the improvements brought about by reregistration and registration review are realized in the field. For example, the requirement for handlers to receive instruction on how to use the pesticide and the application equipment for each application is one way to educate handlers about updated requirements on product labeling to ensure they use pesticides in a manner that will not harm themselves, workers, the public, or the environment. In addition, REIs are established through individual pesticide product labeling, but action needs to be taken at the use site to ensure that workers are aware of areas on the establishment where REIs are in effect and given directions to be kept out of the treated area while the REI is in effect. The WPS has been designed to enhance the effectiveness of the existing structure of protections and to better realize labeling-based risk mitigation measures at the field level.

1. Background and intent of the AEZ requirements. In 2015, EPA finalized revisions to the WPS for the first time since 1992 (Ref. 1). As established in the 1992 WPS rule (57 FR 38101, August 21, 1992) (FRL-3374-6), the pesticide handler's employer and the pesticide handler are required to ensure that no pesticide is applied so as to contact, either directly or through drift, any agricultural worker or other person, other than appropriately trained and equipped pesticide handlers involved in the application. This requirement is commonly referred to as the “Do Not Contact” provision and has been one of the key protective and enforcement mechanisms on both pesticide labels and in the WPS. This requirement prohibits application in a way that contacts agricultural workers or other persons both on and off the agricultural establishment where the pesticide is being applied.

The 2015 WPS rule (Ref. 1) added requirements to supplement the existing requirements and to enhance compliance with safe application practices designed to protect agricultural workers and bystanders from pesticide exposure through drift. The 2015 WPS rule established the AEZ requirements for outdoor production, defined as “the area surrounding the application equipment that must be free of all persons other than appropriately trained and equipped handlers during pesticide applications.” The AEZ moves with the application equipment and is no longer in effect once the pesticide application stops. For aerial, air blast, and ground applications with fine or very fine droplet size, as well as fumigations, mists, and foggers, the area encompasses 100 feet from the application equipment in all directions. For ground applications with medium or larger droplet size and a spray height of more than 12 inches from the ground, the area encompasses 25 feet from the application equipment in all directions. For all other applications, there is no AEZ.

The 1992 WPS rule prohibited agricultural employers from allowing or directing any agricultural worker or other person other than trained and properly equipped pesticide handlers involved in the application to enter or remain in the treated area until after the pesticide application is complete. The 2015 WPS rule further prohibited the employer from allowing anyone in the part of the AEZ (which can extend beyond the treated area) that is within the boundaries of the establishment. For example, employers and handlers must ensure that workers in adjacent fields or buildings within their establishment move out of an AEZ as the pesticide application equipment passes; workers could return once the equipment has moved on (provided no REI is in effect in that area; the treated area does not map to the AEZ). The 2015 WPS rule also required handlers to “immediately suspend a pesticide application” if anyone other than a trained and properly equipped handler is within the AEZ, including any part of the AEZ beyond the boundaries of the agricultural establishment.

These restrictions were intended to reduce incidents, or the probability of incidents, in which people in areas adjacent to pesticide applications could be affected by drift. Additionally, the purpose of the AEZ was to supplement and establish written controls to guide employers and handlers on how to comply with the primary prohibition against applying pesticides in a manner that results in contact to others by establishing a well-defined area from which persons generally must be excluded during applications. The AEZ requirement was just one of the many worker and public health protection tools incorporated into the 2015 WPS rule to emphasize one of the key safety points in the WPS and on pesticide labels in general—do not spray people.

2. Stakeholder engagement after the 2015 WPS rule. Shortly after the publication of the 2015 WPS rule and during the Agency's extensive outreach and training efforts for State Lead Agencies (SLAs) after promulgating the rule, some SLAs and organizations that represent SLAs began raising concerns about the AEZ requirements (Ref. 5). Frequent comments about the AEZ included concerns about its complexity and enforceability. In an effort to address questions and concerns raised by SLAs early on during the initial outreach and training efforts, EPA issued an AEZ-specific guidance in April 2016 (Ref. 6). Despite this guidance, EPA continued to hear from key stakeholder groups, including those representing SLAs such as the Association of American Pesticide Control Officials (AAPCO) (Ref. 7) and the National Association of State Departments of Agriculture (NASDA) (Ref. 8), regarding their concerns around the AEZ requirements.

In accordance with Executive Order 13777, Enforcing the Regulatory Reform Agenda (82 FR 12285, March 1, 2017), and based on the feedback received up to that point, EPA solicited additional public comments on the AEZ and other provisions of the WPS in the spring of 2017 on regulations that may be appropriate for repeal, replacement, or modification as part of the Agency's Regulatory Reform Agenda efforts. EPA encouraged entities significantly affected by Federal regulations, including state, local, and tribal governments, small businesses, consumers, non-governmental organizations, and trade associations, to provide input and other assistance, as permitted by law. EPA received comments from stakeholders on the WPS regulations, as amended in 2015, as part of the public's response to the Executive Order 13777 request.

These revisions are also in the spirit of Executive Order 13790, Promoting Agriculture and Rural Prosperity in America (82 FR 20237, April 25, 2017), the intent of which was to help ensure that regulatory burdens do not unnecessarily encumber agricultural production or harm rural communities. The Executive Order required USDA to assemble an interagency taskforce, including EPA, to identify legislative, regulatory, and policy changes to promote in rural America agriculture, economic development, job growth, infrastructure improvements, technological innovation, energy security, and quality of life.

Information pertaining specifically to EPA's evaluation of existing regulations under Executive Order 13777, including the comments received, can be found at https://www.regulations.gov under docket ID number EPA-HQ-OA-2017-0190. Among the comments received, approximately 25 commenters provided input specific to the AEZ requirements in the 2015 WPS rule. Commenters on the AEZ requirements included SLAs, state organizations/associations, an agricultural coalition, farm bureau federations, grower and trade organizations, and a retailer organization (Ref. 9). Commenters discussed the need for changes to several WPS requirements, including the AEZ. Comments on the AEZ from organizations representing SLAs and agricultural interests raised concerns about the states' ability to enforce the AEZ requirements, expressed a need for clarity about how the requirement was intended to work, described problems with worker housing near treated areas, and the perception of increased burden on the regulated community. As noted in several of the SLA comments, including those submitted by AAPCO, EPA's efforts to address some of the concerns raised since 2015 through guidance have not been adequate. Commenters also indicated that EPA did not provide the necessary clarity to assist state regulatory agencies with compliance and enforcement activities.

In addition to comments received through the Regulatory Reform Agenda process, EPA solicited feedback on the WPS and AEZ requirements from the Pesticide Program Dialogue Committee (PPDC). The PPDC is a federal advisory committee that includes a diverse group of stakeholders from environmental and public interest groups, pesticide manufacturers, trade associations, commodity groups, public health and academic institutions, federal and state agencies, and the general public. In May 2017, the PPDC discussed the implementation of the WPS in general as part of the ongoing Executive Order 13777 efforts (Ref. 10). On November 2, 2017, PPDC members again discussed the WPS requirements for the application exclusion zone in a public meeting with EPA (Ref. 11). Feedback EPA received on the AEZ revolved around the need to develop additional training and enhanced guidance for certain scenarios to ensure the success of the provision. With this feedback in mind, EPA addressed the remaining AEZ issues with a second guidance document, issued in February 2018 (Ref. 12). Despite this additional guidance, feedback from SLAs indicated that this guidance was still unable to adequately address the issues identified during the Regulatory Reform process and the Agency's outreach efforts.

Requests from SLAs to clarify and simplify WPS AEZ requirements, together with comments received through 2018 from various stakeholders regarding the need for improved clarity and guidance on the AEZ requirements, and the Agency's inability to effectively address all AEZ issues through guidance, prompted EPA's decision to address these issues through rulemaking.

On November 1, 2019 (Ref. 2), EPA proposed narrow updates to the WPS regulation to improve the long-term success of the Agency's AEZ requirements. Specifically, EPA proposed to:

• Modify the AEZ so it is applicable and enforceable only on an agricultural employer's property, where an agricultural employer can lawfully exercise control over employees and bystanders who could fall within the AEZ. As currently written, the off-farm aspect of this provision has proven difficult for state regulators to enforce. These proposed changes would enhance both enforcement and implementation of the AEZ for state regulators and agricultural employers respectively. Off-farm bystanders would still be protected from pesticide applications by the existing “do not contact” requirement that prohibits use in a manner that would contact unprotected individuals.

• Add clarifying language indicating that pesticide applications which have been suspended due to individuals entering an AEZ may be resumed after those individuals have left the AEZ.

• Simplify the criteria for deciding whether pesticide applications are subject to the 25- or 100-foot AEZ.

• Exempt the owners of certain family-owned farms from the AEZ requirements in regard to immediate family members who remain inside closed buildings, housing, or shelters on the establishment. This would allow farm owners and their immediate family members to stay in their homes or other enclosed structures on their property during certain pesticide applications. EPA proposed these targeted updates to improve enforceability for state regulators and reduce regulatory burdens for farmers while maintaining public health protections for farm workers and other individuals near agricultural establishments that could be exposed to agricultural pesticide applications.

The public comment period for the proposed rule closed on January 30, 2020. EPA received 126 unique submissions to the docket, of which three were mass mail/signature campaigns that included over 28,000 written comments and/or signatures. Commenters included state pesticide regulatory agencies and associations, farmworker advocacy organizations, public health associations and professionals, growers and grower organizations, agricultural producer organizations, applicators and applicator organizations, farm bureaus, concerned citizens, and others. Comments and EPA's responses to these comments, including those that do not raise significant issues or substantially change the proposed requirements, are in a Response to Comments document (Ref. 13) that is available in the docket for this action. Those comments that have prompted changes to the proposed requirements for the final rule are discussed in Unit V, which describes the comments and the final requirements. In this unit, EPA is providing a summary of the substantive issues raised by comments and EPA's responses, which are discussed in detail in the Response to Comment document (Ref. 13).

1. Comments. Of the 126 unique submissions to the docket, approximately 16 commenters submitted comments in support of EPA's efforts to clarify and simplify the AEZ requirements of the WPS, noting that these changes would result in improved enforceability and compliance while maintaining other protections intended to ensure the safety of workers or other persons from contact during pesticide applications. In addition to general support, 10 of these commenters provided additional recommendations to further improve upon the proposed changes.

2. EPA Response. EPA appreciates the commenters' general support for the proposed revisions. EPA acknowledges that several commenters provided additional feedback or recommendations on ways to improve the AEZ provision, which will be discussed in more detail in the following sections of this document and in the Response to Comments document (Ref. 13).

1. Comments. Most of the comments submitted to the docket expressed opposition to EPA finalizing the proposed changes. Of the 126 unique submissions to the docket, EPA received 110 unique submissions in opposition to the proposed rule changes. This includes 3 mass mail/signature campaigns with 28,202 signatures or general comments of opposition and 89 individual comments submitted to the docket. Some of these comments speak to personal experiences with pesticide exposures, while others asked EPA in general to protect human health and the environment by maintaining the AEZ requirements. Other commenters stated that EPA should not allow humans to be sprayed, and that all people should receive adequate protections both on and off the establishment. In addition to the general comments received in opposition to the proposed rule, EPA received approximately 18 comments with more specific recommendations and concerns on the proposed rule, including feedback on EPA's analyses and rationale for the proposed changes.

2. EPA Response. EPA appreciates the many commenters who provided personal stories about experiences with pesticide exposures. These and many other experiences are some of the reasons EPA implements and supports the WPS requirements and makes every effort to ensure workers and bystanders are protected from pesticide risks.

EPA generally agrees with the commenters regarding protecting workers and bystanders from exposure during pesticide applications and believes that many of the comments result from deficiencies in the proposed rule's explanation of the proposed changes. Many of the commenters thought that by limiting the AEZ requirements to within the boundaries of the establishment where owners have the ability to control the movement of people, thereby excepting individuals off the establishment or on easements, and by exempting agricultural establishment owners and their immediate families from leaving their homes that are within the AEZ boundaries, EPA was permitting handlers to spray pesticides in a manner that would result in people being contacted by pesticides and being unnecessarily exposed. This is a misunderstanding of the proposed rule, which retained protections sufficient to protect workers, bystanders, and family members.

Consistent with both agricultural pesticide labels and the WPS since 1994, the handler employer and the handler must ensure that no pesticide is applied so as to contact, directly or through drift, any worker or other person, other than appropriately trained and equipped handlers involved in the application. This is a long-standing requirement, often referred to as the “Do Not Contact” provision, that was in place before (and after) EPA finalized its updates to the 2015 rule that introduced the concept of the AEZ. The AEZ, when considered by the agency, was initially framed as a set of guiding practices to support the “Do Not Contact” provision. Although EPA proposed that the AEZ would no longer apply to areas outside of the agricultural establishment's boundaries or to those outside of the agricultural employer's control ( e.g., those who are working on or in easements), EPA did not propose any change to the requirement that handlers must ensure that their application does not contact persons directly or through drift. If a handler has any reason to believe that workers or bystanders may be contacted by a pesticide during a pesticide application, the application should not take place until either those individuals leave the area or the handler can take measures to ensure that contact will not occur. Otherwise, the handler risks causing harm to others and violating the WPS and pesticide label.

EPA acknowledges it is critical to educate handlers and others on how to prevent pesticide exposure from occurring. The AEZ guidance documents issued by EPA since 2016 state that applications near establishment borders can continue provided that the applicator or handler follows certain measures or steps to ensure that applications will not result in individuals being contacted by spray or through drift off the establishment. As noted in these guidelines, this same information is incorporated into required WPS handler training programs (see 40 CFR 170.501 for handler training requirements) approved by EPA since June 2018. Most of these approved handler trainings are available through one of EPA's cooperative agreements at http://www.pesticideresources.org/wps/training/handlers.html. EPA-approved training programs will continue to provide this valuable information (including training related to the AEZ) to handlers regarding how to the comply with the “Do Not Contact” provision. EPA is open to working with the various stakeholder groups on other training or supplemental educational materials for handlers. Ultimately, EPA and stakeholders have a shared interest in providing handlers with information and tools needed to prevent pesticides contacting anyone on or off the establishment.

1. Comments. Several commenters, including some advocacy groups, individuals within the public health field, and a joint letter signed by seven State Attorneys General (AG) offices, expressed opposition and concern regarding EPA's justification of the proposed AEZ changes. The commenters argued that EPA's proposal reflected an unsupported change in the position EPA took when promulgating the 2015 Rule. These commenters argued that the proposed rule rests on new conclusions based substantially on the same evidence the agency considered when reaching the opposite conclusions in 2015. Several commenters argued that if finalized, this rulemaking would likely violate the Administrative Procedure Act (APA) because the revisions reflect an unjustified and unsupported departure from the agency's prior position. Furthermore, these commenters maintain that the agency's explanation that changes are necessary to facilitate state compliance efforts is contrary to the evidence.

Commenters frequently pointed to EPA's 2015 WPS rule where EPA concluded that creating the AEZ was a necessary supplemental protection because the “do not contact” requirement was not sufficiently protecting people against harmful pesticide exposure. They also noted that EPA further cited specific instances of pesticide exposure beyond the boundaries of the agricultural establishment that the AEZ as finalized in 2015 could have prevented, but that a more limited AEZ would not. They suggested that the AEZ proposal reverses course entirely from that position and that it would be arbitrary and capricious to limit the AEZ without new evidence just five years after establishing the AEZ, with no explanation of why EPA's assessment of those facts in 2015 was incorrect.

Commenters dispute the reasons EPA presented to demonstrate the AEZ as established in 2015 is unworkable or difficult to administer. As evidence, the commenters cited EPA's reliance on feedback solicited and received in 2016 and 2017 through three venues:

• Training and outreach to state pesticide regulatory agencies;

• as part of EPA's “Regulatory Reform Agenda” efforts in 2017; and

• two meetings of the PPDC in 2017.

The commenters suggest that EPA's reliance on these venues to support the proposed change is irrational and mischaracterized.

For example, commenters maintain that feedback from EPA's training and outreach to state agencies in 2016 cannot form a rational basis for the proposal because EPA's own Inspector General concluded that the agency's training efforts to prepare the regulated community for compliance with the 2015 WPS were woefully deficient. Commenters cited a 2018 evaluation by the EPA Office of Inspector General (OIG) that found that “essential” training and implementation materials—including the WPS Inspection Manual and How to Comply manual—were not available through 2016 (Ref. 14). As a result, they cite that “many state officials said they were not given the time, tools, or resources to successfully implement the revised WPS” by January 2, 2017, the compliance date for certain revisions.

Commenters also discussed information received in response to the agency's “Regulatory Reform” solicitations in the spring of 2017, the provisions of the AEZ that the agency now proposes to modify were not even in effect at the time. The “suspend application” provisions of the AEZ had a compliance date of January 1, 2018. Commenters argued it would be irrational to rely on comments submitted in 2017 to support the proposition that the AEZ requirements are too hard to work with, when key requirements had not even come into effect.

Several advocacy organizations and the letter from the State AGs also commented on EPA's reliance on feedback from the Pesticide Program Dialogue Committee (PPDC), a federal advisory committee under the Federal Advisory Committee Act, 5 U.S.C. App.2, that consists of representatives from user/grower groups, environmental, public interest, and animal welfare groups, farmworker representatives, public health representatives, chemical and biopesticides industry and trade associations, state, local, and tribal government, and federal agencies. The commenters stated that EPA's reliance on PPDC's feedback is flawed, and that EPA failed to disclose that the PPDC met and decided that there were no AEZ issues that necessitated revoking or curtailing it, and that they believed any potential issues could be addressed through guidance, education, and training (Ref. 13). Commenters cited that in the transcript, an EPA official summarized the discussion with respect to AEZ by noting that “what we largely talked about was the need to develop some additional and enhanced guidance around certain scenarios.”

2. EPA Response. The feedback EPA has received since finalizing the 2015 WPS, and the Agency's attempts at addressing these concerns, influenced EPA's approach to revising the AEZ requirements in the proposed rule. Based on the commenters' statements, EPA believes it is necessary to more fully describe the process and the record relied upon, provide more context on the steps taken to address issues raised between 2015 and the proposed AEZ rulemaking and why a departure from the 2015 WPS justification for the AEZ is both warranted and will not result in unreasonable adverse effects.

In late 2015 and early 2016, during the Agency's extensive outreach and training efforts for SLAs, some SLAs raised concerns about the AEZ requirements. Frequent comments about the AEZ included concerns about its complexity and enforceability, and that it would be difficult for states to provide compliance assistance in the absence of clear guidance from the Agency. In an effort to address some of the initial questions and concerns raised by SLAs during these efforts, EPA issued AEZ-specific guidance in April 2016 (Ref. 6). In the document, EPA interpreted the suspension requirement for people within the AEZ, but off the establishment, to mean that applications could resume if handlers take measures to ensure workers will not be contacted by sprays, such as:

• Assessing the wind and other weather conditions to confirm they will prevent workers or other persons from being contacted by the pesticide either directly or through drift;

• adjusting the application method or employing drift reduction measures in such a way to ensure that resuming the application will not result in workers or other persons off the establishment being contacted by the pesticide;

• asking the workers or other persons to move out of the AEZ until the application is complete; or,

• adjusting the treated area or the path of the application equipment away from the workers or other persons so they would not be in the AEZ.

While this guidance addressed some of the issues raised, EPA continued to hear from SLAs and state associations representing SLAs regarding their concerns around the AEZ and the need for additional and clearer guidance on the AEZ specifically and the WPS in general (Refs. 7, 8). In an effort to address the concerns, EPA assisted a cooperative agreement partner on a comprehensive “How-to-Comply” manual, released in late 2016 (Ref. 15).

Despite these efforts, SLAs continued to bring to EPA issues regarding the AEZ. Several SLAs, AAPCO, and NASDA submitted comments on these issues under Executive Order 13777 about their concerns (Ref. 9). These commenters continued to express concerns about a lack of clear AEZ guidance and the resulting confusion for both growers and state pesticide regulatory agencies. These concerns were grounded in the SLAs' preparations to enforce the AEZ requirement and could not reasonably be ignored solely on account of preceding the AEZ compliance date, as commenters propose. As a result of these and other comments, EPA decided to raise this issue for discussion during the 2017 PPDC meetings.

During a meeting on May 4, 2017, EPA and PPDC members briefly discussed and flagged for further discussion the challenges in understanding the AEZ requirement, and obstacles to enforcement, compliance assistance, and education. On November 2, 2017 (Ref. 11), EPA and PPDC members discussed the AEZ in more detail. To clarify EPA's record, EPA acknowledges that the commenters are correct that the PPDC did not recommend that rulemaking was required to achieve better compliance with the AEZ requirements. Rather, the feedback EPA received on the AEZ revolved around the need for additional training and enhanced guidance around certain scenarios to ensure the success of the AEZ provision.

Following the PPDC's feedback on needing enhanced guidance, EPA completed a second AEZ guidance document. In the February 2018 guidance document (Ref. 12), EPA attempted to clarify the remaining issues on implementing the AEZ both on and off the establishment. Building upon the April 2016 guidance, EPA addressed the off-establishment AEZ by explaining what steps to take when someone enters the AEZ that is located off the establishment, when and under what circumstances handlers can resume pesticide applications that have been suspended, as well as providing more detail about how to evaluate situations and what measures can be taken when people are within the AEZ but off the establishment. Similarly, EPA updated the WPS Inspection Manual (Ref. 16) in August 2018 with some of the same language and references to the 2016 and 2018 guidance documents and additional guidance for inspectors on compliance and enforcement when persons are in the AEZ but outside of the boundaries of the establishment or within easements. This detailed information is provided in both the February 2018 guidance document, the 2018 WPS Inspection Manual, and the response to comments document for this rulemaking.

The guidance documents issued between 2016 and now clarify that applications near establishment boundaries can occur when people are in the AEZ but outside of the boundaries of the establishment, provided that the applicator/handler follows all labeling requirements and takes the appropriate steps to prevent contact from occurring. While EPA believed this to be a workable and reasonable solution for implementing the AEZ requirements off the establishment, SLAs continued to inform EPA that guidance did not adequately address their issues. In particular, even though an applicator/handler ensures that conditions are favorable or takes measures to prevent drift off the establishment, the AEZ regulatory text could be read as prohibiting the application and risking of an enforcement action, even if a contact does not occur. As one SLA stated in their public comment to the AEZ proposal, guidance does not “carry the weight and authority” of codified regulations, and that their state AG had advised their office that they would be “on shaky ground were we to ignore the plain language of the Standard and regulate based on interpretative guidance.”

EPA agrees that guidance does not carry the weight of regulation, and that handlers and handler employers may be concerned about state or federal authorities taking a strict reading of the regulation. In addition, handlers unaware of the existing guidance may interpret the AEZ provision more strictly than necessary. For these reasons, EPA agrees it is best to revise the regulation itself to clarify that the AEZ does not extend beyond the boundaries of the establishment and does not apply on or in easements where agricultural employers do not have control.

Despite proposing to limit the AEZ to within the boundaries of the establishment, public comments submitted by SLAs, AAPCO, and NASDA on the proposal emphasized that workers and bystanders have many protections provided by:

• The whole suite of WPS requirements, including the AEZ on the establishment, the “Do No Contact” provision at 40 CFR 170.505(a), the REI, and others;

• the certification and training regulations governing applicators of RUPs; and,

• product-specific labeling requirements and the pesticide label statement which prohibits applications to be made in such a way that workers or other persons are contacted by pesticides, either directly or through drift. (Note: The “Do Not Contact” requirement is provided on labels as well as in the WPS.)

These requirements work together to protect people from exposure to pesticides during applications. The trained handler or applicator should understand the principles underlying the AEZ requirement and how it relates to the “Do Not Contact” requirement. Any applicator or handler with any reason to believe someone may be contacted during the application, should suspend the application until they can assure people would not be contacted by pesticides. Otherwise, the applicator or handler would be at risk of violating the WPS and FIFRA.

EPA's risk assessments and registration decisions presume that no workers or other persons are being sprayed directly. Before the WPS 2015 revision, details on how to comply with the “Do Not Contact” provision was limited. With the 2015 revision, EPA's intention with the AEZ requirement was to provide applicators and handlers with specific criteria for suspending applications and actions to prevent contact with pesticides during applications. When developing the 2015 WPS rule, EPA found that incidents of exposure to drift or direct spray and other misuse violations continued to occur.

Based on the comments in opposing the changes, EPA recognizes that the AEZ proposed rule lacked important details and information on several fronts. Specifically, how the Agency intends to equip handlers with knowledge and tools to prevent contacting persons off the establishment with pesticides during applications; why the Agency believes the “Do Not Contact” provision is the most appropriate mechanism to prevent contacting persons off the establishment with pesticides; and why the “Do Not Contact” provision is adequately protective for persons off-establishment, despite the Agency's 2015 assessment.

The Agency believes that the enhanced training requirements of the 2015 WPS should substantially increase compliance with the “Do Not Contact” requirement. The AEZ requirement provides an extra measure of assurance that applications will not result in worker or bystander exposure. This extra measure of assurance may be considered a redundant protection, but EPA considered it appropriate based on its 2015 understanding that the burdens of compliance with the AEZ would be minimal, inasmuch as the handler and handler employer were already required to take all steps necessary to prevent contact to workers or other persons. The changes to the AEZ (making it inapplicable off-establishment and to easements and the immediate family exemption) reflect EPA's current understanding that in certain circumstances, the AEZ imposes burdens that are disproportionate to the need for the extra measure of assurance the AEZ is intended to provide.

1. Comments. Several farmworker advocacy groups, former pesticide regulators, and the State AGs' letter argue that the “Do Not Contact” provision has a history of shortcomings and despite the clear prohibition against spraying pesticides so as to contact workers or bystanders, EPA updated the WPS precisely because contact was still occurring. The commenters acknowledge that the “Do Not Contact” provision is an important mechanism, but it alone is not enough to protect workers and bystanders. Furthermore, several commenters argue that the “Do Not Contact” provision lacks specific guidance to the handler or applicator on how to comply with the provision and protect bystanders. By contrast, they point out that the AEZ provision clearly explains what must be done to protect workers and bystanders; spraying must be suspended if anyone is in the AEZ. While the “Do Not Contact” provision provides an important protection against pesticide poisoning, commenters argue that the vagueness and lack of instruction for the owner/applicator is part of what lead to the inclusion of the AEZ in the 2015 WPS.

Commenters argue that the AEZ proactively protects against pesticide poisoning by requiring the suspension of application before anyone is sprayed while in contrast the “Do Not Contact” provision can be enforced only after contact with pesticides has occurred. The “Do Not Contact” provision prohibits action that once violated will have already resulted in harm to workers. Thus, they argue that enforcement of the “Do Not Contact” provision does not in itself prevent harm in the first place. They argue, however, that enforcement of the AEZ could help prevent a dangerous incident from occurring.

One commenter cites two situations where California enforced the AEZ provision of the WPS. In January 2017, California amended its existing worker safety regulations to align with the 2015 Rule, creating state AEZ provisions, Cal. Code Regs. tit. 3, 6762, that are equivalent to the 2015 AEZ provisions. The commenter states that California enforced the AEZ requirement in at least two instances. On August 16, 2017, fieldworkers pruning tomato plants were exposed to pesticides during an application to melons less than 100 feet from where they were working. The fieldworkers suffered adverse health effects and two of them were taken to the hospital by ambulance. Similarly, on June 5, 2019, employees working with kiwi vines sought medical treatment after exposure to pesticides during an application at a different site less than 100 feet away. In both cases, the county agricultural commissioners issued administrative civil penalties based on violations of the California AEZ provisions. The commenter states that California has not encountered the challenges implementing the AEZ requirement that EPA has invoked as the reason for the Proposed Rule. They argue that California's regulations—which mirrors the federal AEZ provisions—have not been difficult to enforce, are not confusing or unnecessary, and that it shows that the AEZ requirements are effective and can be implemented.

At least two other commenters explained that a situation in Texas that they felt showed it is easier to enforce violations of the AEZ requirement than the “Do Not Contact” provision. In April 2019, an employee for a nonprofit organization saw a pesticide being applied from a plane in a field immediately north of another field where more than 60 workers were working. The two fields belonged to different owners. The complaint was eventually denied because, regardless of the workers' proximity to the aerial spray, the inspector believed they would not have been physically contacted by the pesticides under those conditions. The commenters argue this demonstrates that the “Do Not Contact” provision can be difficult to enforce, and it would be easier to prove violations of the AEZ provision.

Overall, the comments argue that EPA's claims in the proposal are false. Specifically, commenters argue that EPA's claims that the AEZ offers no more protection than the “Do Not Contact” provision already provides, and that curtailing the AEZ would not reduce protections are false and are entirely inconsistent with the findings in 2015 that the AEZ was a necessary supplement to the “Do Not Contact” provision. Furthermore, they state that EPA does not dispute its findings in 2015 that without the AEZ in place, people are still being sprayed, creating an unreasonable risk.

2. EPA Response. EPA disagrees with commenters on the assertion that enforcing the “Do Not Contact” provision does not prevent harm in the first place. The “Do Not Contact” provision applies in all situations and application scenarios, regardless of whether the AEZ is required or has been followed. The primary safety goal of any application is to prevent pesticides from contacting people. Complying with the AEZ does not absolve handlers or handler employers from that primary responsibility. A handler could comply with the AEZ during an application and yet fail to follow all pesticide labeling requirements such that pesticide contacts people outside of the AEZ. The combination of following labeling requirements based on EPA's product-specific risk assessments and the WPS requirements together play a role in protecting human health. Reinforcing the need to not spray people is a key piece of that equation.

The requirement to suspend application if people other than trained and equipped handlers are in the AEZ was intended to act as a supplement or guide for applicators on the “Do Not Contact” requirement by giving the applicator specific criteria for suspending applications. It was EPA's intent that these specific criteria would be useful to applicators attempting to comply with the existing “Do Not Contact” requirement beyond the boundaries of the agricultural establishment.

Regardless of whether it is easier in a particular instance to prove a violation of the AEZ requirement or of the do not contact requirement, the goal of the WPS is not to create easily proven violations but to reduce adverse effects to human health and the environment. EPA believes that the combination of protections created by the 2015 WPS, notwithstanding the revisions in this final rule, appropriately achieves that goal. The comments suggest a misplaced emphasis on creating easily proven violations, irrespective of adverse effects. EPA is not aware of any AEZ violation having been enforced without pesticide without contact occurring first, such as the two cases in California. In the Texas incident cited by the commenters, the inspector did not find a WPS violation because there was no evidence to suggest that pesticide contact could have occurred given the workers' proximity to the application, the application method, and variables such as weather, wind speed and direction, and vegetation. This is likely due, in part, to EPA's guidance on how to implement the AEZ off the establishment, which has interpreted the requirements at 40 CFR 170.505(b) to mean that applications can resume after the handler has assessed the conditions or used various safety measures to prevent a situation where individuals could be sprayed accidentally.

Despite EPA's best efforts to offer clarity and a workable solution through guidance, incongruity remains between EPA's interpretation of the “suspend” requirement as a temporary measure until handlers take appropriate steps, and how others may interpret the language at 40 CFR 170.505(b) to mean something more strict or permanent. For example, even though a handler could follow the steps in guidance and EPA-approved training and apply the pesticide safely without it contacting a person off the establishment, a state regulator could take an enforcement action against them if they held a strict reading of the regulatory requirement to suspend the application. While changes in this final rule rectify this difficult situation, the goal to prevent pesticide from contacting others will continue to be met through required WPS training, including training on how to comply with the “Do Not Contact” requirement. Thus, EPA is open to working with the various stakeholder groups on other training or educational materials so that handlers have the information and tools so as not to spray pesticides in a manner that results in contact with anyone on or off the establishment.

1. Comments. Several commenters, including several advocacy groups and the joint State AGs letter, argue that EPA's cost analysis for the AEZ proposal fails to adequately justify the proposed revisions of the AEZ. Some of the commenters cite EPA's 2015 cost analysis indicating that the benefits of extending the AEZ beyond the agricultural establishment's boundaries could be substantial while the burden on applicators to temporarily suspending applications was minimal.

One commenter states that while the benefits of the proposal presumably correspond to reducing the “complexity” costs of the 2015 AEZ provisions, it is hard to see how a provision that requires the size (and shape) of the AEZ to change as the application equipment moves is less complex than a rule establishing an AEZ of a constant size and shape. Yet, EPA appears to be drawing a different conclusion now without any effort to explain why it has changed its view of the benefits and costs of maintaining the larger AEZ. In sum, they argue that EPA's characterization of the costs and benefits of applying the AEZ protections beyond the agricultural establishment's boundaries in the AEZ proposed rule is at odds with the rationale EPA presented in 2015 to justify the AEZ provision.

Another commenter states that the Agency has arbitrarily failed to quantify the costs of the increased pesticide exposure that would result from the proposal. Specifically, the comment cites that EPA's acknowledgement in the proposal that farmworkers and others benefit from extending the AEZ boundary beyond the agricultural establishment, but without explanation or support, the proposal characterizes these benefits as “minimal.” Furthermore, the Cost Analysis includes no discussion—whether quantitative or qualitative—of the costs of foregoing these protections, or of the increased risks to farmworkers or others of limiting the AEZ to within the boundaries of the establishment. Instead, they argue that the Cost Analysis states that “EPA is unable to quantify any increased risk of pesticide exposure from revising the AEZ requirements” and that the Agency asserts without explanation or support that any increase in this risk “may be negligible.” The Agency cannot avoid its obligation to analyze the consequences that foreseeably arise merely by saying that the consequences are unclear. The EPA's refusal to quantify the costs of the proposal, including the costs of adverse impacts to human health, is striking given the agency's statutory mandate under FIFRA to protect humans and the environment from unreasonable adverse effects of pesticides. As a result, the commenter argues that the APA does not permit the agency to ignore so central an evidentiary question.

Another commenter argues that the agency failed to support its assessment of the benefits of weakening the AEZ. EPA first claims that the proposal is expected to reduce the burden of compliance and lead to cost savings, but then predicts that “[i]n general, revising the AEZ requirement is not expected to result in any quantifiable cost savings for farms covered by the WPS.” The commenter then states that an “analysis that predicts cost savings but refuses to quantify those savings—indeed, that claims any such savings cannot be quantified—is not a rational basis for revising the AEZ.”

The commenters argue that given these flaws, the AEZ revisions would be arbitrary and capricious if finalized.

2. EPA Response. The economic analysis (2015 EA) (Ref. 17) for the 2015 WPS rule was more comprehensive than the cost analysis for the AEZ proposal. However, the level of analysis specific to the AEZ provision in the 2015 EA was similar to what was contained in the cost analysis for the AEZ proposal. In the 2015 EA, the costs of the AEZ were qualitative, and assumed to be low as the AEZ was designed to supplement the “Do Not Contact” requirements of the WPS and the label that establish the responsibility of the applicator to prevent pesticides from contacting people. In both the 2015 EA and the cost analysis for the AEZ proposal, the discussion was qualitative and appropriate for a rule change that has impacts on application requirements and change in risks of exposure that cannot reasonably be quantified. A qualitative discussion of the potential effects of the rule is appropriate in the absence of information on which to base quantitative estimates. EPA's action for this rulemaking is consistent with the APA.

EPA's statement that changes to the AEZ in the proposed rule would reduce complexity was referring to restricting the AEZ to the establishment, removing the complex definition of droplet sizes based on the Volume Median Diameter (VMD), and making the size of the AEZ consistent across application methods. Although restricting the AEZ to the establishment does potentially change the size and shape of the AEZ near the edges of the establishment, it does reduce complexity because, in situations where the applicator is able to apply the pesticide without contacting any person, the applicator would not be required to suspend solely on account of the presence of persons who are outside the control of the agricultural employer. If the AEZ extends to persons outside the control of the agricultural employer (either off the farm or on farms through an easement), then the agricultural employer would be unable to fulfill his or her obligation to exclude those people. As a result, this could cause the application to halt for extended periods of time despite the applicator's ability to take other measures to prevent drift from contacting those people.

The commenters suggested that EPA did not consider the costs of changing the AEZ in the proposal, which they felt would increase the risks of pesticide exposure to people who would have been within the AEZ but off the establishment, within the AEZ and within an easement on the establishment, or in between the 25 and 100 feet area from application equipment, if the size of the AEZ were reduced on the establishment for some application methods. EPA evaluated the potential for increased risk, and concluded that the “Do Not Contact” requirement, the changes to the WPS-required training content in 2015, and the suite of requirements in the 2015 WPS rule provide effective protection from pesticide exposures during applications.

1. Comments. Several advocacy commenters, individuals with public health expertise, State AGs, and general public commenters argued that EPA failed to comply with its obligations under Executive Order 12898 to address environmental justice (EJ) in minority populations and low-income populations. Under Executive Order 12898, federal agencies are directed to identify and address disproportionately high and adverse human health or environmental effects of their policies on minority populations and low-income populations in the United States. Commenters argue that the proposal does not meaningfully address its EJ impacts. Commenters argue that EPA relies on an unsupported conclusion that the proposal “would not have disproportionately high and adverse human health or environmental effects on minority or low-income populations.” Commenters suggest that by EPA failing to take a “hard look” at EJ issues in its review and to identify any method or analysis, the agency's analysis in the proposal would likely fail to satisfy the APA's arbitrary-and-capricious standard.

Similarly, commenters argue that EPA failed to comply with Executive Order 13045, which requires agencies to identify and assess health and safety risks that may disproportionately affect children and ensure that activities address disproportionate risks to children. Commenters cite examples of exposures involving children as well as various studies and information cited within the 2015 WPS indicating risks toward children; they argue based on this information, EPA did not fully consider how eliminating the off-establishment AEZ would impact children near the boundaries of establishments.

2. EPA Response. EPA does not believe this rulemaking will have disproportionately high and adverse human health or environmental effects on minority or low-income populations, nor will it have a disproportionate effect on children. EPA does consider the environmental and health protections for risks of agricultural pesticides to all potentially affected populations and addresses them in two ways. First, EPA manages the risks and benefits of each pesticide product primarily through registration and labeling requirements specific to each pesticide product. Routine pesticide registration reviews, and subsequent labeling directives as a result of those reviews, take into account protecting all groups, including vulnerable groups ( e.g., children and EJ communities). Second, the framework provided by the 2015 WPS is critical for ensuring that the improvements brought about by reregistration and registration review are realized. Therefore, if agricultural pesticide products are used according to their labeling, EPA does not expect there to be unreasonable adverse effects to children, EJ communities, or anyone else. Compliance assistance and enforcement also play a role in ensuring that risk mitigation measures are appropriately implemented in the field.

As indicated by the commenters, the 2015 WPS went through an exhaustive public participation to incorporate a number of safety mechanisms into the regulation, and extensively engaged farmworker representatives, and when possible, worked directly with workers and handlers, to solicit their feedback and ideas for improvements. Some of these retained requirements and improvements to the WPS that promotes safety included enhanced and expanded training, and notifications; adding protection requirements such as the AEZ on the establishment; the “Do Not Contact” requirement and REIs; mitigating exposures by having decontamination supplies available and ensuring that workers receive emergency assistance if necessary; and establishing a minimum age of 18 for handler and early entry worker duties. EPA remains committed to ensuring the long-term success of the WPS and continues to support ongoing implementation efforts that arose from these interactions. This includes funding various cooperative agreements that support implementation and education and reviewing and approving all trainings to ensure appropriate information is provided to both workers and handlers on pesticide safety.

One of the areas that has seen a significant improvement as a result of that feedback involves that of enhanced training in place since the end of 2018. These enhanced trainings for workers and handlers include more steps on how to minimize worker and handler exposure and that of the families from pesticide residues carried from the treated areas to the home. In one cooperative agreement funded by EPA, early data provided to the Agency has shown worker knowledge gains as a result of these improved trainings, which have been provided in the field for over a year (Ref. 18). While EPA does not have similar information regarding knowledge gains for handlers, EPA expects that handler trainings have also increased the overall understanding of the requirements to ensure safer applications of pesticides. For example, the requirement for handlers to receive training and instruction on how to use the pesticide and the application equipment for each application is one way to inform handlers of updated product labeling requirements so as not to apply pesticides in a manner that will harm themselves, workers, the public, or the environment.

EPA-approved trainings since 2018 (83 FR 29013; June 22, 2018) have also incorporated EPA's 2016 guidance on how to apply pesticides near establishment borders and provide information on various measures applicators or handlers can take to prevent individuals from being contacted by spray or through drift. Those measures include:

• Assessing the wind and other weather conditions to confirm he/she will prevent workers or other persons from being contacted by the pesticide either directly or through drift;

• Adjusting the application method or employing drift reduction measures in such a way to ensure that resuming the application will not result in workers or other persons off the establishment being contacted by the pesticide;

• Asking the workers or other persons to move out of the area until the application is complete; or

• Adjusting the treated area or the path of the application equipment away from the workers or other persons so they will not be sprayed.

EPA believes that by having incorporated this information into EPA-approved training, handlers have the information they need to safely apply pesticides when the establishment's owner and handler lack control over people's movements off the establishment. Based on this information already existing on how to comply with the “Do Not Contact” requirement of the WPS, EPA does not believe the change to limit the AEZ to within the boundaries of the establishment will result in unreasonable adverse effects for any persons, including EJ communities or children, off the establishment. EPA remains committed to the goal of conveying this information accurately and consistently through training and supplemental education materials, and the Agency is open to working with its stakeholders to ensure the information is current and available.

In regard to the proposed changes to simplify the AEZ criteria for ground applications ( i.e., establish an AEZ of 25 feet when sprayed at a height greater than 12 inches) on the establishment, EPA determined that these changes would not result in unreasonable adverse effects on farmworker communities because the “Do Not Contact” requirement remains in effect. These changes would not result in unreasonable adverse effects on children because of the minimum age requirement prohibiting children under the age of 18 from participating in handler or early entry worker activities also remains in effect. Additionally, since the owner has control over the movement of people on his or her establishment, the owner can schedule applications and worker activities around each other to prevent potential conflicts with the AEZ and the “Do Not Contact” provision. With proper planning, EPA believes this to be of minimal impact on the establishment.

Commenters cited studies, such as those from Felsot et al. (Ref. 19) and Kasner et al. (Ref. 20), that show that pesticide applications using fine sprays are prone to drift greater than 25 feet. Some commenters instead recommended a simplified 100-foot AEZ to ensure that protections would be increased while meeting EPA's stated goal of simplifying the AEZ. Drift potential is based on a number of factors in addition to droplet size, and the AEZ is designed to work in tandem with other provisions to ensure no contact and other label requirements (to reduce drift) to protect workers. Simplifying the AEZ criteria can help handlers better understand and implement the AEZ requirements successfully and promotes awareness on how to comply with the “Do Not Contact” provision. Additionally, all handlers must take EPA-approved trainings addressing how the AEZ facilitates compliance with the “Do Not Contact” provision, and by simplifying the AEZ message, EPA expects that these annual trainings will better inform handlers' decision-making in regard to preventing contact even where the AEZ requirement does not apply. EPA believes that the potential costs and burdens for establishment owners to move workers who are within 100 feet of all ground spray applications would be disproportionate to the benefits, particularly when making applications using a medium or larger spray quality. Therefore, EPA has decided to finalize the AEZ distance requirements on the establishment as proposed. Specifically, EPA is establishing a 25-foot AEZ for all sprayed applications made from a height greater than 12 inches from the soil surface or planting medium, and no longer differentiating between sprayed applications based on the spray quality or other factors for setting different AEZ distances for outdoor production. EPA will maintain the existing AEZ distances of 100 feet for pesticide applications made by the following methods: Aerially; by air blast or air-propelled applications; or as a fumigant, smoke, mist or fog. This issue is discussed in more detail in Unit V.C.

1. Comment. One commenter argued that EPA violated FIFRA's procedural mandates. The commenter cites the requirement at Section 21(b) that before publishing regulations for “any public health pesticide,” the EPA Administrator “shall solicit the views of the Secretary of Health and Human Services in the same manner as the views of the Secretary of Agriculture are solicited under Section 25(a)(2).” The commenter further cites the definition of “public health pesticide,” which is defined at FIFRA Section 2(nn) as “any minor use pesticide product registered for use and used predominantly in public health programs for vector control or for other recognized health protection uses, including the prevention or mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or other living animal) that pose a threat to public health.” The commenter then states that for such pesticides, “[a]t least 60 days prior to signing any proposed regulation for publication in the Federal Register , the Administrator shall provide [the Secretary of Health and Human Services] a copy of such regulation.”

The commenter argues that the protections provided by the WPS applies to all agricultural pesticides, including public health pesticides, and that EPA was required to send a copy of the proposed rule to the Secretary of Health and Human Services (HHS) before it published the proposal in the Federal Register . By not doing so, the commenter claims EPA violated this procedural mandate in FIFRA.

2. EPA Response. EPA disagrees with this comment. The WPS only applies to agricultural establishments, where agricultural pesticides are used on agricultural plants (“any plant grown or maintained for commercial or research purposes and includes, but is not limited to, food, feed, and fiber plants; trees; turfgrass; flowers, shrubs; ornamentals; and seedlings”). See 40 CFR 170, Subpart D, for the scope, applicability, and definitions for “agricultural establishment” and “agricultural plant”. Conversely, Section 21(b) only applies to “public health pesticides” as defined in Section 2(nn) and quoted above.

Because this rulemaking applies only to agricultural pesticides used on agricultural plants on agricultural establishments, and not to “public health pesticides” as defined in FIFRA, the Agency is not required to solicit the views of the Secretary of HHS in regard to this rulemaking.

1. Proposal. EPA proposed to revise the AEZ provision at 40 CFR 170.505(b) that requires handlers to “suspend the application” if a worker or other person is in the AEZ, which as written in the 2015 WPS can extend beyond the boundaries of the agricultural establishment. EPA proposed to limit the AEZ to within the boundaries of the agricultural establishment. This change would make the requirement at 40 CFR 170.505(b) for pesticide handlers to suspend applications consistent with the requirement at 40 CFR 170.405(a)(2) for agricultural employers to exclude persons from the AEZ.

The AEZ is an area surrounding pesticide application equipment that exists only during outdoor pesticide applications. The 2015 WPS added the AEZ requirements to supplement the “Do Not Contact” requirements to reduce the number of incidents of exposure to pesticides during agricultural applications. The 2015 WPS requirement at 40 CFR 170.505(b) required pesticide handlers (applicators) making a pesticide application to temporarily suspend the application if any worker or other person (besides trained/equipped handlers assisting in the application) is in the AEZ. The handler must suspend an application if a worker or other person is in any portion of the AEZ—on or off the establishment. EPA proposed to revise 40 CFR 170.505(b) so the handler/applicator would not be responsible for areas of AEZ off the establishment, where he/she lacks control over persons in the AEZ. However, EPA did not propose any changes to the existing provision in the 2015 WPS that prohibits a handler/applicator and the handler employer from applying a pesticide in such a way that it contacts workers or other persons directly or through drift (other than appropriately trained and PPE equipped handlers involved in the application). This provision will remain the key mechanism for ensuring the protections of individuals off the establishment from the potential exposures to pesticides from nearby agricultural pesticide applications.

2. Final Rule. In the final rule, EPA has adopted the proposed changes to limit the AEZ to within the boundaries of the establishment in those areas where the agricultural employer has control over persons on the establishment.

3. Comments and Responses. a. Comments. Two SLAs, AAPCO, NASDA, several agricultural stakeholder associations, and farm bureaus expressed general support for EPA's proposal to limit the AEZ to within the boundaries of the establishment. These commenters cited some of the previously identified concerns associated with the AEZ off the establishment, where the establishment owner has no legal control or authority over anyone outside the establishment and could thereby impact applications long-term and potentially on a permanent basis depending on the presence of fixed structures. Additionally, commenters from SLAs, AAPCO, and NASDA expressed support for this revision because it creates more consistency between the owner and handlers' responsibilities under the WPS and clarifies the plain language of the requirement to be consistent with EPA's interpretive guidance. These commenters also expressed that minimizing and managing risks of pesticide exposure to all persons is central to their missions, and that extending such protections to individuals who are not agricultural workers or handlers is more properly accomplished by other means, such as the protections afforded under the “Do Not Contact” provision.

Several commenters from farmworker advocacy groups, public health professionals/associations, and commenters from the general public expressed opposition to the proposal to limit the AEZ requirements to within the boundaries of the establishment. Commenters argued that the proposed limitation of the AEZ to the boundaries of the farm would lessen protections for workers who might be exposed to drift from a neighboring farm, citing various example of cross-boundary drift situations. These commenters have argued that a robust implementation of the AEZ might have protected workers on adjacent fields from being sprayed. Frequently, commenters noted that drift does not stop at boundary lines, that the AEZ requirement is necessary and not confusing. Therefore, they argue it should be maintained both on and off the establishment and for those working on or in easements.

Commenters argued that limiting the AEZ to the boundaries of the farm would lessen protections, and that it is irrelevant whether the applicator (or the agricultural employer or the owner of an agricultural establishment) has control over a person who is outside of the boundaries of the agricultural establishment. One commenter stated that if such a person is in the AEZ, there is a very high risk that the person is close enough to be sprayed by the pesticide, and the applicator should (and the current AEZ provision would require him/her to) suspend the application to give such individuals a chance to move away. The commenter further argued that restricting the AEZ to land within the agricultural establishment would significantly diminish the protection of bystanders. Further, the commenter suggested that the notion to make the duty of the agricultural employer and the applicator “more consistent” ignores the fact that these distinct duties usually rest on different people, stating that applicator typically works for the agricultural employer, and each would need training on the different duties imposed.

Commenters also argued that it is necessary that the AEZ apply beyond the boundaries of the agricultural establishment because it protects people who might otherwise be sprayed with a pesticide, citing EPA's analysis in the 2015 WPS that including the area of the AEZ outside the boundaries of the agricultural establishment could potentially reduce unintended pesticide spray contact incidents four- to ten-fold. Commenters stated that EPA provided no rationale for why maintaining such a significant increase in protection is “unnecessary,” and stated that having an inconsistent shape ( i.e., the AEZ no longer being a consistent shape around the application equipment for off the establishment and for workers in easements) could actually be more confusing and complex to implement.

Similarly, commenters stated that removing AEZ protections for persons on or in easements should not be finalized, and that using the scenarios of “easements” and “utility workers” as a rationale for allowing pesticide applications to be resumed even when someone is still within the AEZ is potentially misleading. Commenters expressed concerns that, due to the use of conditional language (“persons not employed by the establishment are present on easements that may exist . . . . The owner or ag employer may be unable to control the movement of people”), this revised requirement could be used as rationale to resume application while anyone is present within the AEZ, including people willing to vacate the area during the application, as well as those who are not on an easement. They argue that even if the conditional language is removed, people in easements should continue to be protected by EPA regulations, and that the rationale that people on easements are not within an owner's control “in whole or in part” should not deprive them of their right to be protected. For those in easements, one commenter offered the solution to post a notice on the boundary of the easement about the date and time of pesticide application, so that individuals are empowered to leave the area so they can avoid being exposed to pesticides.

b. EPA Response. EPA disagrees with the commenters that the change to limit the AEZ within the boundaries of the establishment will result in protections being weakened. As stated in Unit IV.B above in previous responses to the overarching comments, handlers are still required to comply with the “Do Not Contact” requirements in the WPS and on pesticide labels. This requirement is applicable regardless of distance from the application equipment, and regardless of whether the persons are on or off the establishment or within easements.

Additionally, EPA believes that the enhanced training requirements of the 2015 WPS will significantly improve compliance with the “Do Not Contact” requirement. These annual trainings (versus every 5 years under the previous rule) include best practices to prevent exposure during applications and are consistent with how EPA has been interpreting and implementing the AEZ off the establishment. To reiterate these best application practices covered in the new training materials, these measures include:

• Assessing the wind and other weather conditions to confirm he/she will prevent workers or other persons from being contacted by the pesticide either directly or through drift;

• Adjusting the application method or employing drift reduction measures in such a way to ensure that resuming the application will not result in workers or other persons off the establishment being contacted by the pesticide;

• Asking the workers or other persons to move until the application is complete; or

• Adjusting the treated area or the path of the application equipment away from the workers or other persons so they will not be sprayed.

While the AEZ will no longer apply off the establishment or to persons on the establishment pursuant to easements as a regulatory requirement, agricultural employers and handler employers must still include the AEZ as one of the safety measures in their trainings. Trained handlers will understand the principles underlying the AEZ and how it facilitates compliance with the “Do Not Contact” requirement, and that training will help inform their decision-making in regard to preventing contact with persons outside the establishment or present under an easement. EPA is committed and open to working with stakeholders to ensure that this information is presented to handlers in a clear and effective manner to impress upon handlers their responsibility under the WPS to not spray pesticides in a manner that results in contact in any situation.

EPA also disagrees with the commenters that requiring the AEZ only on the establishment would be more complex or confusing. For example, owners already have the responsibility of not allowing or directing any worker or other person not involved in the application to enter or remain in an AEZ that is within the establishment's boundaries. As indicated in the public comments submitted by NASDA, this change brings the pesticide handlers' duty to suspend applications in 40 CFR 170.505(b) in line with the agricultural employers' duty to exclude persons from the AEZ in 40 CFR 170.405(a)(2), so the two requirements will be consistent and will be noted as such in handler trainings.

1. Proposal. EPA proposed to revise the AEZ provision at 40 CFR 170.505(b) to add a paragraph clarifying conditions under which a handler may resume an application that was suspended because of people present in the AEZ on the agricultural establishment. The proposed revision of 40 CFR 170.505(b) would also clarify how the AEZ applies to persons not employed by the agricultural establishment who may be in easements ( e.g., gas, mineral, utility, or wind/solar energy workers) that may be within the boundaries of the establishment. These people are generally not within the control of the owner or agricultural employer of the establishment, so their presence could disrupt and prevent pesticide applications. EPA did not propose any changes to the existing “Do Not Contact” provision in the WPS.

The 2015 WPS rule was silent on if and when a handler could resume an application that was suspended, because workers or other people were present in the AEZ. EPA never envisioned that the AEZ requirement would lead to an application being suspended permanently, and the proposed change makes EPA's expectations explicit. EPA therefore proposed to revise the WPS to clarify that handlers may resume a suspended application when no workers or other persons (other than appropriately trained and equipped handlers involved in the application) remain in an AEZ within the boundaries of the establishment.

EPA also proposed language to allow applications to be made or resume while persons not employed by the establishment in easements that may exist within the boundaries of agricultural establishments because, depending on the terms of the easement, the owner or agricultural employer may be unable to control the movement of people ( e.g., utility workers) within the easement. The 2015 AEZ requirement at 40 CFR 170.405(a)(2) precludes an application from being made on an agricultural establishment while workers or other people are in the AEZ within the boundaries of the establishment. In developing the original AEZ requirement, EPA presumed that all persons on an agricultural establishment would be subject to the control of the owner or agricultural employer, not recognizing the prevalence of easements which deprive the landowner of the ability, in whole or in part, to control the movement of persons within the easement. The proposed revisions at 40 CFR 170.505(b) address this situation by allowing handlers to make or resume an application despite the presence within the AEZ of persons not employed by the establishment who are working on or in an area subject to an easement. These individuals will still be protected by the “Do Not Contact” provision, so even though they could remain in an easement, the handler and the handler employer would be prohibited from allowing the pesticide application to result in any contact to these persons. The proposed revision to the regulatory text would be codified at 40 CFR 170.505(b).

2. Final Rule. In the final rule, EPA has adopted the proposed changes regarding when applications can resume after they have been suspended.

3. Comments and Responses. a. Comments. Several agricultural stakeholders, advocacy groups, and one SLA association expressed support for clarifying that applications can be resumed once all individuals within the AEZ have left the area, other than those permitted by the regulation. All commenters cited the importance of providing clarity and aiding applicators in making better decisions regarding how to abide by the AEZ requirements.

However, several advocacy groups disagreed with the proposed change to limit the AEZ to within the boundaries of the establishment. They were against allowing handlers to continue to spray while individuals on adjacent properties were within the 25 and 100-foot AEZ distances as required in the 2015 WPS Rule. Additionally, the commenters expressed opposition to EPA's proposed changes which would allow the following groups of people to remain within the AEZ during applications:

• People who are present within the boundaries of the agricultural establishment because their presence is allowed pursuant to an easement, and

• People who are in the immediate family of the owner of the agricultural establishment.

b. EPA Response. EPA agrees with the commenters that revisions to clearly explain when applications can resume after being suspended are important and provide clarity not afforded under the 2015 WPS regulatory language. While the notion of suspending applications was implicitly meant to apply only until individuals not participating in the application have left the AEZ, EPA plans to move forward with the proposal to ensure that it is explicitly stated that suspended applications may resume once people leave the AEZ.

Regarding the commenters who disagreed with EPA's other proposals, those issues have been addressed more specifically in Sections A, C, and D of this Unit.

1. Proposal: EPA proposed to revise the criteria and factors for determining AEZ distances at 40 CFR 170.405(a). EPA proposed the following revisions to simplify the AEZ requirements while maintaining the protections intended under the 2015 WPS:

• Eliminate the language and criteria pertaining to spray quality and droplet size and VMD for “sprayed applications”.

• Limit the criteria for 100-foot AEZ distances for outdoor production to pesticide applications made by any of the following methods: (1) Aerially; (2) by air blast or air-propelled applications; or (3) as a fumigant, smoke, mist, or fog.

• Establish a 25-foot AEZ for all sprayed applications made from a height greater than 12 inches from the soil surface or planting medium, and no longer differentiating between sprayed applications based on the spray quality or other factors for setting different AEZ distances for outdoor production.

Some pesticide labels will have restrictions for applications that are different than the criteria in the 2015 WPS or this AEZ rulemaking. For example, the restrictions on soil fumigant labels are more restrictive than the AEZ of 100 feet. In situations like this, pesticide users must follow the product-specific instructions on the labeling. As stated in 40 CFR 170.303(c) and 170.317(a), when 40 CFR part 170 is referenced on a pesticide label, pesticide users must comply with all the requirements in 40 CFR part 170, except those that are inconsistent with product-specific instructions on the pesticide product labeling.

2. Final Rule. EPA has finalized the AEZ distances of 25 and 100 feet as proposed. Also as proposed, EPA has removed the criteria of spray quality and droplet size for determining whether a ground spray is subject to a 25-foot or 100-foot AEZ, and has established a 25-foot AEZ for all ground spray applications made from a height greater than 12 inches from the soil surface or planting medium.

3. Comments and Responses. a. Comments. Farmworker advocacy group commenters, individuals within the public health field, former pesticide regulators and several general public commenters recommended that EPA keep the regulations for application method, height, and criteria as written in the 2015 WPS. While some acknowledge that problems with clarity and compliance exist, they state that the original criteria were a step in the right direction to protect workers and bystanders from direct spray and from drift. They claim that making the proposed changes would eliminate the AEZ entirely for applications of fine droplet size sprayed at 12 inches or lower and significantly reduces the AEZ for those that are sprayed higher than 12 inches in general. They argue that because pesticides sprayed with a fine droplet size are most prone to drift, the AEZ should be wider in those cases, not narrower. Commenters cited studies showing that pesticide applications using fine or smaller sprays are prone to drift greater than 25 feet. Finally, they maintain that EPA did not present any new or compelling evidence to support the changes in criteria.

A couple of commenters discussed that having a single distance requirement for the AEZ for each application method is a logical choice and doing so would moot any conflicts over terminology to describe spray droplet characteristics. However, they argue that a problem with EPA's proposals—to eliminate the AEZ for spray applications of fine droplets released less than one foot off the ground and to set a standard, 25-foot AEZ for all other ground spray applications—is that a pesticide spray composed of tiny droplets will easily move farther than 25 feet. They state that EPA has the capability, but failed to analyze, how much and how far a pesticide spray application could be expected to travel, and that such an analysis would show that a large percentage of the spray would drift outside a 25-foot AEZ under common weather conditions. One commenter argued that EPA's proposal also completely ignored the more protective (and equally straight-forward and enforceable) option of setting a standard AEZ of 100 feet for all ground spray applications. Finally, commenters stated reducing the AEZ distance from 100 to 25 feet significantly reduces the size of the AEZ for ground spray applications with fine droplet sizes from ~ 31,415 square feet to ~ 1,963 square feet, a reduction of ~ 93%.

b. EPA Response. In choosing a 25-foot AEZ for ground applications above 12 inches, EPA sought one simplified AEZ criterion for ground spray applications that would maintain protection while alleviating the complexity. During repeated outreach and training events during WPS implementation efforts after the 2015 rulemaking, it became clear to EPA that there was a great deal of confusion and misunderstanding regarding the AEZ requirements and the criteria for determining the appropriate AEZ distance. Comments on simplifying the AEZ, which are summarized below, included:

• It would be very difficult to enforce the AEZ requirements in many circumstances, because it would be challenging to determine what the AEZ should have been during an application in many situations, unless it is simplified or there were additional recordkeeping requirements.

• The current rule refers to factors and criteria for determining the AEZ ( i.e., droplet size and “volume median diameters” or VMDs) that are no longer appropriate based on new information from the American Society of Agricultural and Biological Engineers (ASABE). The ASABE standards regarding the criteria for the droplet size classification system have been revised multiple times, thereby resulting in the VMD of 294 microns established under the 2015 WPS being no longer appropriate. An AEZ distance based on this factor makes it difficult for some applicators to determine their required AEZ. This has resulted in confusion and difficulty in complying with the AEZ requirement.

• The AEZ distances are currently based on factors that make it difficult for some applicators to determine their required AEZ, making it difficult to comply with the requirement. The complexity has resulted in many calling for the elimination of the AEZ altogether.

• Although there is a good rationale and basis for the AEZ requirement, it needs to be simplified to make it more practical, understandable, and easier to implement.

The Agency considered maintaining the spray quality and spray droplet criteria from the 2015 WPS. EPA agrees that sprays may drift greater than 25 feet and smaller droplet sizes increase the drift potential. In addition to spray droplet size, numerous factors impact the potential for spray drift, including application method, wind speed and direction, temperature and humidity, nozzle release height, pesticide formulation, terrain and target crop. The Agency's efforts, however, are to develop a simplified approach that is easier to understand and implement while still providing necessary guidance on how to comply with the overarching “Do Not Contact” requirement.

EPA also considered the recommendation by several public commenters to simplify the AEZ by establishing a 100-foot AEZ for all ground spray applications above 12 inches. EPA agrees with the commenters that a 100-foot AEZ would simplify the criteria. However, EPA believes that the potential costs and burdens for establishment owners to move workers who are within 100 feet of all ground spray applications would be disproportionate to the benefits, particularly when making applications using a medium or larger spray quality.

The WPS “Do Not Contact” provision prohibits contacting persons with pesticides for all situations and without any distance limitation on the proximity of the application. The “Do Not Contact” provision is a performance standard that mandates an outcome but does not specify how it is to be achieved. The AEZ requirements are supplemental to the “Do Not Contact” requirements (and any label-specific requirements intended to protect against contact) in that they provide a small set of concrete benchmarks intended to help handlers accomplish the no-contact objective. The AEZ, when coupled with the provisions to ensure no contact and other label requirements (which may prescribe nozzle types, droplet sizes, and buffers based on product-specific assessments), is designed to be just one of several mechanisms to protect workers and other persons. EPA has concluded that the 2015 AEZ ground spray criteria are too complex, and in many cases too restrictive, and the “Do Not Contact” requirement would be better supplemented by the combination of a simplified AEZ and additional product-specific requirements where needed. Where EPA's product-specific risk assessments result in labeling language that is inconsistent with or exceeds the requirements of the 25-foot AEZ, the handler must comply with the pesticide product labeling. Therefore, EPA has decided to finalize the proposed 25-foot AEZ for all ground applications sprayed from a height greater than 12 inches to serve as the baseline for ground applications when product labels do not provide something more protective and to remove spray quality and spray droplets to make this baseline simple to determine. EPA is finalizing changes to simplify the criteria so applicators can better understand the AEZ requirements and need for the AEZ protections, and how to implement them.

1. Proposal. EPA proposed to revise § 170.601 so that owners and applicators would be exempt from the AEZ requirements of § 170.405(a)(2) in regard to members of their immediate families who are inside closed buildings, housing, or shelters on the establishment during pesticide applications. Immediate family, as defined at § 170.305, includes the owner's (or owners') spouse, parents, stepparents, foster parents, father-in-law, mother-in-law, children, stepchildren, foster children, sons-in-law, daughters-in-law, grandparents, grandchildren, brothers, sisters, brothers-in-law, sisters-in-law, aunts, uncles, nieces, nephews, and first cousins. “First cousin” is defined as the child of a parent's sibling, i.e., the child of an aunt or uncle.

EPA proposed this revision to address unforeseen impacts of the 2015 AEZ requirements in certain situations. Stakeholders raised concerns related to the AEZ requirement in 40 CFR 170.405(a)(2) (requiring that employers must not allow workers/people to remain in the AEZ on the establishment other than properly trained and equipped handlers involved in the application) applying to workers or other persons that are in buildings, housing, or shelters on the establishment. Even when workers or other people are in closed buildings, housing, or shelters that are within the boundaries of the establishment, the employer cannot legally apply the pesticide if those people are within the boundary area of the AEZ—it is a violation of the WPS. There is no choice under the current rule but to remove them from the AEZ before the application can take place, regardless of whether the buildings are enclosed, or the handler can ensure the pesticide will not contact the people. This raised specific concerns for owners of agricultural establishments and their immediate families.

In the case of owners of agricultural establishments and their immediate families, family members cannot stay in their own home within the AEZ during pesticide applications even if the owner and applicator take appropriate steps to ensure family members would not be contacted by pesticide spray or drift. This can be burdensome, for example, when owners are employing EPA-recommended best practices such as those prescribed under the pollinator protection strategy to apply pesticides in the evening and when temperatures are below 50 °F, when pollinators are not as active but immediate family members are more likely to be present. Although EPA acknowledged that there is an exposure risk for owners and immediate family members present within the AEZ during pesticide applications, EPA anticipates that family members would take appropriate steps to protect other family members to ensure they would not be contacted during pesticide applications, and that the AEZ requirement therefore subjects owners of agricultural establishments and their immediate families to unnecessary burdens. Accordingly, EPA proposed to revise 40 CFR 170.601(a) so that owners and applicators would be exempt from the provisions of 40 CFR 170.405(a)(2) regarding members of their immediate families who are inside closed buildings, housing, or shelters on the establishment. This would not impact WPS protections for workers and handlers, because owners and applicators would still have to observe AEZ requirements for non-family member employees on the establishment. Because the proposed exemption was limited to 40 CFR 170.405(a)(2), family members would still be subject to all other AEZ requirements.

2. Final Rule. In the final rule, EPA has adopted the proposed change to § 170.601(a)(1), but with several modifications. EPA has narrowed the proposed regulatory language to clarify that these exemptions only apply in regard to immediate family members who remain inside closed buildings, housing, or shelters on the establishment. In addition, EPA has added new regulatory language to §§ 170.601, 170.405(a)(2) and 170.505(b)(1) to make it clear that the immediate family exemption to the AEZ also applies when the handler performing the application is not an owner of the establishment, but only when the handler has been instructed by the owner to proceed with the application near family homes or closed buildings containing only the owner's immediate family inside.

Upon review of the comments, EPA recognized that expanding the § 170.601(a) immediate family exemption to include § 170.405(a)(2) is not sufficient to accomplish the proposed goal of allowing immediate family members to remain in the home or other shelter within the AEZ during applications. As proposed, the regulatory text of the revised rule would exempt a farm owner of his or her responsibilities as an agricultural employer, but it is not clear that it would also exempt the farm owner from § 170.505(b) when acting as a handler; he or she could still be subject to § 170.505(b) and have to suspend the application until family members are evacuated from the home within the AEZ. Moreover, the proposed regulatory text made no exemption for applications made by handlers other than an establishment owner, so as drafted, there would effectively be no exemption at all. In order to accomplish the stated goals of the proposal, EPA is revising § 170.601(a) to expressly include the AEZ requirements in § 170.505(b) as well as those in § 170.405(a)(2) in the immediate family exemption, and to extend that exemption to include handlers in certain circumstances. The AEZ requirements would still apply when owners and immediate family members are in the AEZ and outside of closed buildings, housing, or shelters.

As revised in this final rule, § 170.601(a)(1) provides that the owner of the establishment may permit handlers to perform applications near closed buildings, housing, or shelters where the owners or their immediate family members are present, provided that the owner has expressly instructed the handlers that only the owners or their immediate family members remain inside the closed shelters, and that the application should proceed despite their presence in the closed shelters. Without these expressed instructions from the owner, handlers will be required to suspend the application if the owner or their immediate family members are inside closed structures within an AEZ.

EPA has also added references to this § 170.601(a)(1)(vi) exemption in §§ 170.405(a)(2) and 170.505(b)(1) for clarity.

3. Comments and Responses. a. Comments. SLAs, AAPCO, NASDA, and several agricultural stakeholder groups and farm bureaus expressed their general support for adding the AEZ requirements to the 40 CFR 170.601 immediate family exception. These commenters state that allowing immediate family members to remain inside closed buildings inside the AEZ boundaries during pesticide applications would reduce the burden to applicators who are on their own family farm. These commenters agreed with EPA's proposal that immediate family members, including children, would be as safe as they are now without the exemption because applicators would protect their own family members. Furthermore, the revision would reduce the considerable burden on farmers and their family members and create more flexibility while not compromising safety.

Conversely, several farmworker advocacy commenters and individuals in the general public expressed concerns over EPA's proposal to exempt farm owners and their immediate family members. Among the comments received, commenters stated that it is in everyone's best interest to leave the AEZ during a pesticide application, so requiring everyone to do so, including owners' family members, should not generate “undue burden,” and that the applicator would not be able to ensure that only the owners' family members are inside particular buildings. Commenters also suggested that the proposed revision of the AEZ would put a real burden on rural communities by reducing protection to family members who might not necessarily understand the risk of exposure to which they are subjecting themselves. Lastly, they maintain that the risk to public health outweighs any benefits.

In addition to these comments, one commenter stated that the Agency made no effort to explain why its rationale would justify exempting family members when the family members are outdoors but within an AEZ, and that, at best, it would justify an exemption only when family members are in a closed building. Second, the commenter suggested that the Agency did not explain how its rationale aligns with an earlier justification to exempt family members from certain WPS requirements. The commenter stated that when the Agency included provisions in the 1992 WPS to exempt family members from certain requirements, EPA explained that it was reasonable to expect owners of agricultural establishments to take all steps necessary to protect their own family members, and at the same time the exemption gave owners flexibility on how to provide those protections. So, for example, the WPS does not require owners to give family members formal pesticide safety training or to keep records documenting that the family members had been trained. The commenter indicated that the Agency reasoned that such training could and would happen informally (and perhaps better) over time. As the commenter notes, the protection provided by the AEZ provisions, however, is not like training; it cannot be provided informally, or even adequately, over time, and that the AEZ provision is only meaningful if the applicator suspends spraying at the moment when someone is too near the application equipment. They believe that exempting family members will only encourage applicators to be less careful in complying with the “Do Not Contact” provision.

One commenter suggested that while the proposed exemption for family members is unjustifiably overbroad, EPA's rationale does raise a valid concern. The commenter thought that it seemed reasonable that the WPS regulation should not require suspension of an application every time the application equipment passes near a closed, occupied building, but that there was a serious practical issue with the Agency's proposed exemption of family members. To the extent that it is designed to address circumstances in which an immediate family member could be inside of a building within an AEZ, it would be practically impossible for an applicator to know whether any people were present and whether the only people in the building were members of the immediate family. Under the proposal, in order to comply, the applicator would most likely need to suspend application in order to check the building. Thus, the commenter believes that the proposed change probably would not provide any real relief from the alleged burden. Moreover, another practical consideration is that an applicator who is not the owner of the agricultural establishment might well not know the relationship of the person in the AEZ (either within a building or not) to the owner.

b. EPA Response. The proposed rule regulatory text would exempt farm owners from providing the protections of 40 CFR 170.405(a)(2) to themselves or their immediate family members. The proposed language would exempt them from all requirements of the AEZ whether family members are inside or outside of enclosed structures as one of the commenters noted. EPA agrees with the commenter that the proposed language was overly broad and acknowledges that this was not the intention of the proposed exemption. As stated in the preamble to the proposal, EPA intended the exemption to apply only to family members inside closed buildings, housing, or shelters to reduce the burdens of having to leave their homes during a pesticide application.

EPA believes this approach is consistent with the 1992 WPS rationale cited by one of the commenters. EPA expects owners of agricultural establishments to take all steps necessary to protect their own immediate family members, and the final rule gives owners flexibility to provide those protections by sheltering immediate family members in enclosed structures within the AEZ.

Accordingly, EPA is changing the regulatory text at 40 CFR 170.601(a)(1)(vi) to state that the exemption only applies when immediate family members of farm owners remain inside closed buildings, housing, or shelters on the establishment. This change clarifies that the AEZ requirements fully apply to immediate family members when they are outdoors, and that the exemption only applies when they shelter-in-place.

While reviewing the comments, EPA identified an ambiguity in the proposed rule regarding whether the proposed family exemption is broad enough to allow handlers who are not an owner of the establishment to perform the application while owners and their immediate family members to remain inside closed buildings, houses, or structures. This is, in part, because the existing 40 CFR 170.601(a)(1) only applies to owners, and while it could be construed to apply to owners when performing the handler activities, it would not extend to other handlers who have been hired by the owner to perform those duties. However, EPA's intent was to allow the owner, who generally has awareness of, and control over, the movement of immediate family members on the establishment, to instruct an applicator or handler to perform an application while the owners or their immediate family members remained inside closed structures within the AEZ. The final rule reflects this intent and will relieve owners and their immediate families of the burden of vacating the building when the owner judges it unnecessary. Without the express instruction from the owner to proceed with an application despite his or her family's presence in the closed structure, the final rule requires handlers to comply with the suspension requirements at § 170.505 and not proceed with the application until the owner's immediate family vacates the AEZ.

Some of the commenters understood the proposal to mean that applicators or handlers who are not owners of the agricultural establishment would need to comply with the AEZ requirements and suspend the application in all situations until they could confirm the structure was clear as required under 40 CFR 170.505, while others viewed EPA's proposal to apply more broadly ( i.e., family members could stay inside while a hired handler performs the application). The Agency recognizes that as proposed, § 170.601(a)(1)(iv) might only apply to owners in their role as agricultural employers; it would not necessarily exempt the owner or any other person from the handler requirements of § 170.505(b), making the proposed exemption unusable. This would not be consistent with EPA's intent, or the understanding of at least some commenters.

Accordingly, EPA has revised the regulatory text at § 170.601 to make clear that applications conducted by other handlers can proceed when owners or their immediate family members remain inside closed buildings, housing, and structures, provided that the owner has expressly instructed the handler that only the owner and/or their immediate family members remain inside the closed building and that the application can proceed despite the owner and their immediate family members' presence inside the closed building. Handlers will have to receive this information from the owner of the establishment prior to application and cannot assume that only the owner's family are inside without that assurance. The rule does not require that the instruction be provided to the handler in writing, as that could be unnecessarily burdensome in many cases. However, insisting on a written instruction may provide a handler relief from an enforcement action if the owner's representation proves to be incorrect.

EPA assumes that owners will take into account the risks to their immediate family members before instructing a handler to proceed with an application. This approach gives owners flexibility on how to provide appropriate protections when their family remains in an enclosed structure within the AEZ while reducing burdens during applications. This revision to the regulatory text will not lessen protections for workers or other persons, as this exemption to the AEZ requirement does not apply if a person present in the AEZ is not a member of the owner's immediate family.

EPA, however, disagrees with the assertion that the exemption would result in applicators being less careful in complying with the “Do Not Contact” provision. The farm owner or applicator must still suspend application if anyone other than the owners or their immediate family members are within the AEZ, including inside enclosed structures within an AEZ. It is reasonable to believe that owners will warn their immediate family of a pesticide application in advance and instruct them that no one, other than their immediate family members, may be inside during the application. Moreover, the agricultural employer's responsibility under 40 CFR 170.405(a)(2) to not allow or direct any worker or other person within the AEZ other than appropriately trained and equipped handlers involved in the application requires the farm owner or agricultural employer to ensure that no one outside of the immediate family will be permitted in the house within an AEZ until after the application they are performing is complete or the application equipment has moved on.

1. Comments. One SLA, one state association representing SLAs, and one agricultural stakeholder association requested that EPA establish a mechanism to review and accept (when warranted) AEZ equivalency plans or provisions submitted by SLAs, territories, and tribes. The commenters all indicated that at least one state “shelter-in-place” provision has protections in addition to those specified in the federal AEZ. Commenters indicated that the state law was developed after a long, inclusive, and transparent rulemaking process with farm worker advocacy groups and grower groups. This state law provides clarifications and revisions to the federal requirements and provides protections in addition to those in the federal AEZ.

2. EPA Response. In the early development of the AEZ proposal, EPA had considered addressing state equivalency plans and a mechanism to review and accept those plans. EPA's preference at the time was to address state equivalency plans with the whole WPS in mind. However, under PRIA 4 (Pub. L. 116-8; March 8, 2019), EPA is required to carry out the 2015 WPS rule and is not permitted to propose or finalize revisions to the WPS other than to the AEZ prior to October 1, 2021. As a result of this statutory limitation, EPA has determined that EPA's preferred path to revising the state equivalency request language at 40 CFR 170.609 would be outside the scope of what is permitted under statute since the preferred approach would not be limited to the AEZ requirements. While EPA is currently limited by PRIA 4 to make this change, EPA may be able to reexamine this recommendation starting in October 2021.

1. Comments. In addition to the requests to establish mechanisms for state equivalency plans, two agricultural stakeholders and one SLA requested that EPA expand the exemption offered to agricultural owners and their immediate families to include workers and others who remain in an enclosed structure.

Another commenter argued that the EPA exemption allowing agricultural owners and their immediate families to remain inside a closed building within an AEZ would not need to be as complicated as suggested in the proposal. The commenter suggested that instead of naming different types of buildings, the criteria could be that application could continue as long as all visible openings by which the pesticide spray could enter the building— e.g., doors and windows—appear closed, and that unnamed “variables” are irrelevant. The commenter stated that what should matter from a safety perspective is whether the spray is likely to contact someone within the AEZ, not the relationship between the owner of the agricultural establishment and the person in the AEZ. They argue this suggestion would eliminate the arbitrary distinction in the proposal that affords different protections to people in the owner's immediate family and those who are not. Further, the commenter argues that an applicator could determine more quickly and easily whether he or she needed to suspend application simply by looking at the exterior of the building, rather than entering the building.

2. EPA Response. EPA disagrees with the commenters' recommendations to extend the exemption to remain in the AEZ to anyone provided they remain in an enclosed structure ( i.e., “shelter-in-place”). EPA had considered addressing this issue through development of an exception to the AEZ requirement that would consider and identify appropriate conditions that would allow people to remain in a building or structure in the AEZ. EPA believes that conditions vary too much for EPA to establish a generally applicable “shelter-in-place” provision, and would be better suited to narrowly-targeted “shelter-in-place” provisions developed by SLAs based upon the circumstances and need within their jurisdictions. However, as indicated previously, EPA's preferred path for developing state equivalency mechanisms and revising the language under 40 CFR 170.609 is currently limited by PRIA 4. EPA may reexamine this issue again if and when EPA has the authority to reconsider other aspects of the WPS.

1. Definitions. a. Application Exclusion Zone.

i. Current rule and proposal. Under 40 CFR 170.305, the application exclusion zone means “the area surrounding the application equipment that must be free of all persons other than appropriately trained and equipped handlers during pesticide applications.”

Under the proposed rule, EPA proposed to change the definition to mean “the area surrounding the application equipment from which persons generally must be excluded during pesticide applications.”

The proposed change was intended to reflect the various proposed revisions limiting the AEZ to within the boundaries of the establishment and addressing easements within establishment boundaries and allowing an owner's immediate family to remain in an enclosed building within an AEZ during an application.

ii. Comments and Responses.

Comments. One commenter recommended that EPA revise the definition of AEZ to mean “the area surrounding the point(s) of pesticide discharge from the application equipment that must be free of all persons during pesticide applications, other than those persons noted under 40 CFR 170.405(a)(2) and 170.601(a)(1).” The commenter stated that definition of the AEZ as proposed was unclear and even EPA's explanation of it was inconsistent, which will make compliance and enforcement difficult. For example, the April 2016 and February 2018 guidances both show graphics in which the AEZ is measured from the entirety of the pesticide application equipment for a ground sprayer. However, the February 2018 adds a graphic for an aerial spray in which the AEZ is measured from the points of pesticide discharge for an aerial sprayer. The two graphics are side by side in the February 2018 guidance.

In addition to this revised definition, the commenter recommended that to be consistent with this recommended definition, similar language should be added at 40 CFR 170.405(a)(1)(i) and 170.405(a)(1)(ii) to be clear that the AEZ distance is determined from the point(s) of pesticide discharge from the application equipment.

EPA Response. EPA agrees with the commenter and revised the final regulatory text when discussing measuring the AEZ from the points of pesticide discharge to “the area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications;” this recommended change is a commonsense revision to the definition and regulatory text that helps to improve the clarity of the rule and is consistent with EPA's past outreach on the AEZ requirements. EPA did not include as part of the definition “other than those persons noted under § 170.405(a)(2) and § 170.601(a)(1).” The limits to the AEZ boundaries, exceptions, and exemptions are addressed through the responsibilities of the agricultural employer or handler during applications within an AEZ, and regulatory text is found at §§ 170.405(a)(2), 170.505(b) and 170.601(a)(1), respectively. However, EPA has revised the definition to clarify that exclusion is the general rule, to which there are exceptions.

b. Easements. i. Current rule and proposal. Under the current rule, there is no definition or exception associated with easements. EPA proposed to allow applications to be made or resume while persons not employed by the establishment are present on easements that may exist within the boundaries of agricultural establishments, because, depending on the terms of the easement, the owner or agricultural employer may be unable to control the movement of people ( e.g., utility workers) within an easement. The proposal to address people not employed by the establishment who are in an area subject to an easement ( e.g., utility workers) provides regulatory relief to handlers and agricultural employers and may prevent disruptions to pesticide applications. Despite this proposed change, EPA did not define the meaning of an “easement.”

ii. Comment and Response.

Comment. One commenter stated that adding the exception to the AEZ beyond the boundary of the establishment where handlers do not have the ability to control the movement of people off the establishment or within easements allows a more reasonable approach on shared property. However, the commenter felt that without a definition of “easement”, the interpretation of such is left up to each state or historical elucidation. The commenter stated that “easement” is commonly defined as “a nonpossessory right to use and/or enter onto the real property of another without possessing it,” which allows some relief of the AEZ requirements along utility or roadway rights-of-ways that are clearly an “easement.” However, there is the challenge of unintentional consequences if the term is not defined on properties such as driveways, access roads, etc. A definition of “easement” should be added to clarify exactly how EPA is defining “easement” to ensure consistency in the interpretation of the rule.

EPA Response. EPA's intention for the easement exception was to recognize that some persons may have a legal right to be on parts of an agricultural establishment independent of the agricultural employer's control, and for their presence not to be an insurmountable obstacle to pesticide application provided the pesticide could be applied without contacting such persons. Whether a person has such a legal right is a matter of state law, so it seems inappropriate for EPA to try to impose a national definition of “easement” in the WPS. EPA agrees that the commenter's definition of “easement” is a common definition; however, EPA does not think that including it in the rule would substantially aid in interpretation or implementation.

2. Making the AEZ Based on Wind Direction. a. Current rule and proposal. Under the current rule, for aerial, air blast, fumigations, mists, and foggers, as well as ground applications with fine or smaller droplet sizes (less than 294 microns VMD), the AEZ area encompasses 100 feet from the application equipment in all directions. For ground applications with medium or larger droplet sizes (VMD greater than 294 microns) and a spray height of more than 12 inches from the ground, the area encompasses 25 feet from the application equipment in all directions. For all other applications, there is no AEZ.

In the proposed rule, EPA proposed to limit the criteria for 100-foot AEZ distances for outdoor production to pesticide applications made by any of the following methods: (1) Aerially; (2) by air blast or air-propelled applications; or (3) as a fumigant, smoke, mist, or fog. Additionally, the proposal set to establish a 25-foot AEZ for all sprayed applications made from a height greater than 12 inches from the soil surface or planting medium, and no longer differentiate between sprayed applications based on the droplet size of 294 microns or other factors for setting different AEZ distances for outdoor production.

b. Comments and Responses.

i. Comments. Three commenters recommended improving implementation of the AEZ without compromising the safety of workers by making the AEZ based on wind direction. These commenters suggest that the AEZ should only apply to the downwind side of the applicator as drift only moves downwind. They argued that, for example, aerial applicators have the tools necessary to provide immediate onsite wind direction measurement so if wind direction does change during the application they can respond immediately. The commenters indicated that the labels for some products are reflective of this concept and offer evidence supporting the concept of buffer zones based on wind direction and believe this same logic should also be applied to the AEZ.

ii. EPA Response. EPA disagrees with this recommendation, as it would make the requirements of the AEZ more complex rather than less. This recommendation could also lead to workers being placed too close to applications based on wind direction, resulting in potential pesticide exposures with sudden shifts in wind direction during application. By maintaining an omnidirectional AEZ ( i.e., an AEZ around the application equipment in all directions), the AEZ will provide a margin of security against changes in wind direction for those on the establishment who may be near the ongoing application but are not properly trained and equipped handlers participating in the application.

3. Recommendation to Reduce Redundancy. a. Comment. One commenter suggested the following change presented in the proposal to make the final rule text less redundant:

• In 40 CFR 170.505(b)(1), remove “, other than an appropriately trained and equipped handler involved in the application,” because this language was repeated in the proposed text at 40 CFR 170.505(b)(1)(i).

b. EPA Response. EPA agrees with the commenter and has removed, “other than an appropriately trained and equipped hander involved in the application” from the final regulatory text in 40 CFR 170.505(b)(1) since it is repeated in 40 CFR 170.505(b)(1)(i).

Additionally, while not explicitly mentioned in any public comment, EPA has made a similar edit from the proposed to final rule to remove the redundant text, “. . . within the boundaries of the agricultural establishment . . . ,” in 40 CFR 170.501(3)(xi) since that clarification is previously stated in the sentence.

The Agency intends that the provisions of this rule be severable. In the event that any individual provision or part of this rule is invalidated, the Agency intends that this would not render the entire rule invalid, and that any individual provisions that can continue to operate will be left in place.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

Under FIFRA section 25, EPA has submitted a draft of the final rule to the Secretary of the Department of Agriculture (USDA), the FIFRA Scientific Advisory Panel (SAP), and the appropriate Congressional Committees. USDA reviewed the draft final rule during the interagency review mentioned in Unit IX.A. and waived further review on October 7, 2020. Since there are no science issues warranting review, the FIFRA SAP waived a detailed review on October 12, 2020.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket. EPA prepared a cost analysis associated with this action, which is briefly summarized in Unit I.E. and is available in the docket (Ref. 3).

This action is a deregulatory action as specified in Executive Order 13771 (82 FR 9339, February 3, 2017). The EPA cost analysis associated with this action is briefly summarized in Unit I.E. and is available in the docket (Ref. 3).

This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2070-0190. This rule does not impose or modify any information collection burdens because the AEZ requirements are not associated with any information collection activities that require approval under the PRA.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves burden or has no net burden on the small entities subject to the rule. The changes to the AEZ requirements in this rule will reduce the impacts on all entities subject to the rule, so there are no significant impacts to any small entities. EPA has therefore concluded that this action will relieve regulatory burden for all directly regulated small entities.

This action does not contain an unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The rule requirements will primarily affect agricultural employers and commercial pesticide handler employers. This action is also expected to be a burden-reducing action because removing the requirements should reduce the complexity of arranging and conducting a pesticide application. The cost analysis associated with this action is briefly summarized in Unit I.E. and is available in the docket (Ref. 3). As such, the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

This action does not have federalism implications as defined in Executive Order 13132 (64 FR 43255, August 10, 1999), 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.

This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have any effect on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. There are no costs to Tribes associated with these changes because the WPS is implemented through the pesticide label, so changes to the regulation do not impose any new obligations on the part of Tribes. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This determination is discussed in more detail in Unit IV.F.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

This rulemaking does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). A more detailed discussion of this determination is provided in Unit IV.F.

This action is subject to the CRA, 5 U.S.C. 801-808, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons set forth in the preamble, 40 CFR chapter I, subchapter R is amended as follows:

The National Flood Insurance Act of 1968, as amended (NFIA), Title 42 of the United States Code (U.S.C.) 4001 et seq., authorizes the Administrator of FEMA to establish and carry out the National Flood Insurance Program (NFIP) to enable interested persons to purchase insurance against loss resulting from physical damage to or loss of property arising from floods in the United States. 1 Under the NFIA, FEMA may only grant flood insurance to properties within communities that have adopted and that enforce adequate land use and control measures that regulate floodplains. 2 The statute authorizes FEMA to develop land use criteria consistent with requirements laid out in the NFIA and to encourage the adoption and enforcement of State and local measures implementing those criteria. 3 FEMA floodplain management regulations governing community eligibility for participation in the NFIP are located at 44 CFR parts 59, 60, and 64.

FEMA regulations at 44 CFR 60.3, 60.4, and 60.5 contain land use measures for floodplain management. If a community fails to demonstrate to FEMA that it meets these requirements, or decided to withdraw from the NFIP, FEMA may initiate probation, suspension, or withdrawal procedures as described in 44 CFR 59.24. In the case of a loss of eligibility, for instance if a community is suspended for failing to enforce its floodplain regulations, FEMA notifies the community of the upcoming loss directly and gives the community an opportunity to correct the deficiency that triggered the procedures. In cases of loss of eligibility, FEMA publishes a notice of the upcoming loss of eligibility in the Federal Register as required by 44 CFR 59.24.

NFIP regulations at 44 CFR 64.6 provide a list of communities where the sale of flood insurance under the NFIP is authorized as set forth in Subpart B, “Eligibility Requirements,” to part 59 of the regulations. Due to the large number of communities eligible for flood insurance and the relative frequency to changes to community eligibility, maintaining a list of communities in FEMA's regulations is not feasible; however, FEMA meets this requirement by publishing the updated list of communities through periodic final rules in the Federal Register . FEMA last published an updated list in the Federal Register in August 2006.

On February 12, 2020, FEMA published a Notice of Proposed Rulemaking (NPRM) (85 FR 7902) proposing to make two changes to its regulations regarding publication requirements of community eligibility status information under the NFIP. The NPRM proposed to replace outdated regulations that require publication of community loss of eligibility notices in the Federal Register with a requirement that FEMA publish the information on the internet or other comparable method. The NPRM also proposed to replace the requirement that the agency maintain a list of communities eligible for flood insurance in the Code of Federal Regulations (CFR) with a requirement that FEMA publish this list on the internet or other comparable method. The NPRM explained FEMA would transition to the new form of publication by first publishing brief notices monthly in the Federal Register for six months after the effective date of the final rule.

The NPRM solicited public comment on these proposed changes. FEMA received six comments related to the rulemaking. In this final rule, FEMA adopts the changes it proposed in the NPRM, with clarifications in consideration of the related comments. FEMA describes these changes below.

Of the six comments FEMA received related to this rulemaking, five were generally in support of the proposed changes in the NPRM and one was neutral. Three members of the public [FEMA-2019-0016-0003, FEMA-2019-1660-0007, and FEMA-2019-0016-0002] expressed their support for the rule generally. One member of the public [FEMA-2019-0016-0003] stated she was supportive of the move to an online notification process and also of the proposed transition period in the NPRM while another member of the public [FEMA-2019-1660-0007] expressed support for the changes and noted that the NRPM aligned with OMB M-19-21 regarding a transition to electronic records and other such Federal Government initiatives. A third member of the public [FEMA-2019-0016-0002] expressed general support for the changes. The Association of State Floodplain Managers (ASFPM) [FEMA-2016-0016-0006] expressed support for the changes, as did the Massachusetts Department of Conservation and Recreation [FEMA-2019-1600-0004].

Three commenters provided feedback on the use of the CSB. One anonymous commenter [FEMA-2019-0016-0005] stated a need to include communities that are not mapped in a Special Flood Hazard Area (SFHA) and not participating in the NFIP in the CSB. The commenter opined that the absence of these communities from the list of communities not participating in the NFIP created confusion for everyday users and required them to reach out to additional resources which undermines the cost savings proposed in the rule. FEMA respectfully disagrees with the commenter. The statute requires FEMA to develop minimum floodplain management criteria to “(1) constrict the development of land which is exposed to flood damage where appropriate, (2) guide the development of proposed construction away from locations which are threatened by flood hazards, (3) assist in reducing damage caused by floods, and (4) otherwise improve the long-range land management and use of flood-prone areas.”  4 FEMA is required to focus NFIP floodplain management efforts on communities with flood-prone or special flood hazard areas. Consistent with the statutory requirement, the CSB provides a list of those communities participating in the NFIP and those communities not participating in the NFIP when those communities are in a currently mapped flood risk area. Some communities that do not have special flood hazard areas may still participate in the NFIP. The statutory language allows any state or area (or subdivision thereof) to participate if they have expressed an interest in participating and have adopted the required land use and control measures “consistent with the comprehensive criteria for land management and use” required by the statute and regulatory framework. 5 Such participation is voluntary and those communities are captured in the CSB as participating communities. It would be impractical and inappropriate for FEMA to include communities that are not in special flood hazard areas that are not participating in the NFIP program in the CSB. Including those communities in the CSB would not be consistent with its purpose—to provide the status of those communities participating in the NFIP. ASFPM [FEMA-2019-0016-0006] requested that FEMA develop a second tool to compare to the CSB to determine which communities are eligible, providing a mechanism for users to find communities not otherwise found in the CSB. As explained above, if a community is eligible and participating, the community is listed as a participating community in the CSB. If the community is suspended from participating in the NFIP, that community is also listed in the CSB as a community not participating in the NFIP along with other communities that contain identified flood hazard areas that have either withdrawn from or have not yet participated in the NFIP. The NFIP is a voluntary program. FEMA would not have knowledge of those communities that do not contain special flood hazard areas and would otherwise be eligible for the program, which requires that they have land use authority, unless those communities apply for the NFIP. Finally, a member of the public [FEMA-2019-0016-0002] suggested that FEMA make the CSB easy to search and access if the rule is to be finalized. FEMA appreciates the comment and will add instructions to the main CSB page on www.fema.gov on how to search the CSB.

ASFPM also requested that FEMA develop and implement an outreach plan to message changes to the publication process and improve awareness of the CSB. The commenter recommended FEMA coordinate with state and local partners on this outreach effort, to update printed and online materials regarding process, and to provide accommodations for those that cannot access information online. As explained in the NPRM, FEMA will continue to publish notices in the Federal Register for six months after the effective date of this rule to notify communities of their NFIP status to allow communities to adjust to the changed process as part of the ongoing outreach efforts. The notices will contain information on how to access community status information so that the public will become familiar with the new process. Additionally, FEMA will utilize www.fema.gov to provide notifications to communities of their status with information on how individuals can check their community status during and after the transition period. In the required notification letters FEMA sends to impacted communities notifying them of potential suspensions 90 days and 30 days prior to final suspension, FEMA will provide information on how the notification process will transition to the CSB and www.fema.gov respectively. The agency will also ensure outreach to notify other stakeholders of these changes through webinars, printed materials, and other information posted on www.fema.gov for flood insurance agents and the public. Individuals without internet access will be able to contact their local floodplain management official and/or State NFIP Coordinating Office directly for assistance.

Additionally, the Massachusetts Department of Conservation and Recreation [FEMA-2019-1600-0004] commented that FEMA must continue to notify state NFIP coordinating offices in a timely manner of communities which have become ineligible to participate in the program. FEMA intends to continue the current practice of notifying state coordinators of community suspensions and this final rule will not impact that practice.

One member of the public [FEMA-2019-1660-0003] suggested broadcasting community status information through TV commercials, social media, and/or billboards in the impacted community to raise awareness. FEMA appreciates the commenter's desire to ensure stakeholders are notified of community status changes and the agency's goal is to ensure the public continues to have the most current community status information available. Some of the suggestions would result in additional costs and would not necessarily result in sufficient or immediate access to the information that the final rule changes provide. Additionally, the commenter's suggestion to utilize social media strategies to educate the public on the new process and of suspensions, such as using Twitter and other social media platforms is not an appropriate use of FEMA's social media tools. Notices of NFIP community status are routine and not suited to social media platforms that are more focused on communicating materials regarding the Agency's mission, including disaster preparedness, mitigation, and response and recovery to stakeholders. FEMA will provide this notice to the public by publishing links to www.fema.gov information on community suspensions as proposed.

Finally, another member of the public [FEMA-2019-1660-0007] recommended a major revision to the agency's website. The comment noted that the current www.fema.gov had far too many topics in the navigation bar, which were not in any logical order and were overwhelming to the user. The commenter requested a more user-friendly experience when using FEMA's website and more search function versatility. FEMA appreciates the comment. FEMA recently completed updates to its website pursuant to the passage of the 21st Century Integrated Digital Experience Act. 6 The revamped website provides more user functionality, including a section of the website dedicated to floodplain management.

The final rule removes the requirements contained in 44 CFR 59.24(a), (c), (d), and (e) that community loss of eligibility notices be published in the Federal Register and adds a requirement that FEMA publish the notices on the internet or by another comparable method. FEMA will store these notices on its website for a minimum of one year after the notices are issued, so that they are easily available to all interested parties. These notices will be available in the CSB area of the website and the CSB will also be updated regularly to reflect current community status information. The standard URL link for the CSB is https://www.fema.gov/national-flood-insurance-program-community-status. After removal from FEMA's public-facing website, the agency will retain copies of the notices in accordance with all statutory and regulatory requirements. Note that changes to the community's status will be reflected in the updated CSB so that individuals can always find the current status of their community.

Second, 44 CFR 64.6 is revised to remove the requirement that FEMA maintain a list of communities eligible for flood insurance under the NFIA in the CFR. Instead, the final rule requires publication and maintenance of the list on the internet or through another comparable method. As explained in the NPRM, FEMA will continue to maintain an online CSB, providing a list of communities that are, and are not, eligible for flood insurance under the NFIP. These changes do not impact the other notification requirements found at 44 CFR 59.24. To aid in the transition to the new form of publication, FEMA will publish brief notices monthly in the Federal Register for six months, after the effective date of this rule, alerting stakeholders to the change, and letting them know where to go to access community status information. The agency will also complete various outreach activities, including notifications to impacted communities as part of the 90-day and 30-day letters they receive during the suspension process, updated process information to state and local partners, and webinars and other materials for flood insurance agents and the public.

Executive Orders 13563 (“Improving Regulation and Regulatory Review”) and 12866 (“Regulatory Planning and Review”) 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 (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 13771 (“Reducing Regulation and Controlling Regulatory Costs”) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

The Office of Management and Budget (OMB) has not designated this rule a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum “Guidance Implementing Executive Order 13771, Titled `Reducing Regulation and Controlling Regulatory Costs' ” (April 5, 2017).

Under the NFIA, FEMA may only grant flood insurance to properties within communities that have adopted adequate land use and control measures. 7 Pursuant to this statutory direction, FEMA has adopted regulations governing community eligibility for participation in the NFIP at 44 CFR parts 59, 60, and 64. These regulations include requirements that a community follow certain steps to retain eligibility for the NFIP. If a community fails to follow these requirements or decides to withdraw from the NFIP, FEMA initiates loss of eligibility procedures as described in 44 CFR 59.24 and publishes a notice of the upcoming loss of eligibility in the Federal Register . In addition, 44 CFR 64.6 states that flood insurance under the NFIP is authorized for communities set forth under Section 64.6 of the regulations, requiring FEMA to maintain a list of eligible communities in the CFR.

FEMA is making two changes to the current regulations.

First, FEMA will remove the requirement pursuant to § 59.24(a), (c), (d), and (e) to publish community loss of eligibility notices in the Federal Register . In lieu of publication in the Federal Register , the rule requires that these notices be published on the internet or by another comparable method. To aid in the transition, FEMA will publish brief notices in the Federal Register for 6 months after the effective date of the final rule, alerting stakeholders to the change.

Second, FEMA is removing the requirement pursuant to § 64.6 that FEMA maintain a list of eligible communities in the CFR. In lieu of this requirement, the final rule will require FEMA to publish and maintain a list of eligible communities on the internet or through another comparable method.

These two changes will result in reduced FEMA expenditures, largely by reducing costs associated with Federal Register publication. The changes to § 59.24 will also provide faster and more user-friendly access to community loss of eligibility information by requiring publication of the notices online instead of in the Federal Register . In addition, these changes direct FEMA to consolidate community status information into one location, allowing stakeholders to have more streamlined access to community status-related information.

Community loss of eligibility notices were published a total of 246 times in the Federal Register from 2010 to 2019. Based on data from these notices, FEMA calculates that on average, from 2007 to 2016, the notices were published about 25 times per year, rounded to the nearest whole number (246 ÷ 10 = 24.6. 24.6 rounded to the nearest whole number = 25).

With respect to the requirement for FEMA to maintain a list of eligible communities in the CFR, FEMA notes that it currently maintains this list online in the Community Status Book rather than in the CFR. 8 In addition, FEMA prepares quarterly reports in an attempt to comply with the publication requirement contained in § 64.6. The quarterly preparation burden is approximately 15 hours per quarter at a cost of $80 per hour, for a total of $4,800 each year (15 hours per quarter × $80 per hour × 4 quarters a year). 9 FEMA has not published the quarterly reports in the CFR since 2006 due to the recurring costs involved, and the ability to maintain a more up-to-date list, since the CFR is only updated annually.

As a substitute for publishing the required community loss of eligibility notices in the Federal Register , this final rule requires FEMA to publish community loss of eligibility notices online. FEMA currently maintains a public website ( www.fema.gov ) where similar notices, bulletins, and updates from across the agency are published for public consumption. While there is no direct cost to adding individual web pages or sections to the site, publishing community loss of eligibility notices online creates labor costs for staff that need to develop a template to format and process the notices for web publication.

FEMA recently completed a website re-design that included more versatile search functionality for the user, a more standardized look and feel, increased search engine optimization, and better capture of meta-data. FEMA anticipated the use of this re-design in the analysis of this final rule. Development of this publication process for online notices will be labor intensive at the beginning. Once a template is created, each update will be less labor intensive than the current practice.

FEMA staff expect it will take approximately 3 days of labor (24 hours) of a General Schedule (GS) Federal employee in the National Capital Region, at the GS-14 Step 5 level ($63.64 hourly wage), 10 to establish the publication process under the redesign. After the publication process is established, FEMA anticipates that it will take a GS-14 employee approximately thirty minutes per future publication.

The average 25 notices per year result in a burden to FEMA of $3,392 the first year (($63.64 for GS 14 Step 5 wage × 1.46)  11 × (24 hours of work + (0.5 hour of work × 25 notices per year))) and $1,162 each subsequent year (($63.64 for GS 14 Step 5 wage × 1.46) × (0.5 hour of work × 25 notices per year)) for a 10-year total of $13,850.

Upon publication of this final rule, FEMA will aid in the transition from the publication of community loss of eligibility notices in the Federal Register to their posting on FEMA's website by publication of transitional announcements in the Federal Register . These announcements will alert stakeholders of the new location of these notices and they would be concise and tailored to notify stakeholders of the FEMA web address where the community loss of eligibility notices can be found. FEMA expects these transitional announcements to publish once a month for a 6-month phase-out period following the effective date of the rule.

FEMA is removing the requirement pursuant to § 64.6 that FEMA maintain an updated list of eligible communities in the CFR. FEMA does not currently publish updates to the list of communities eligible for flood insurance in the CFR and already maintains an online Community Status Book containing this information. 12 FEMA prepares quarterly reports on the current lists of communities in order to comply with the regulation. These reports are available upon stakeholder request, although they are not published. Modifying the regulations to eliminate the requirement to publish the list in the CFR in favor of publishing the notices in the same location as the community status list that is already maintained on FEMA's website (the Community Status Book) eliminates the preparation of these lists and saves the quarterly preparation burden of approximately 15 hours per quarter at $80 per hour, 13 yielding a cost savings of $4,800 ($80 per hour × 15 hours per quarter × 4 quarters a year) annually. This revision will save FEMA costs without affecting policyholders or other stakeholders.

PHMSA is amending the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) for certain commonly used DOT 4-series specification cylinders in non-corrosive gas service. This final rule authorizes 12-year initial and subsequent requalification periods for volumetric expansion testing and a 12-year initial requalification period for proof pressure testing. This final rule does not modify the existing 10-year subsequent requalification periods for proof pressure testing. In addition, it makes clarifying and conforming edits to the requalification table in § 180.209(a) and the text in paragraph (e). This final rule provides regulatory relief by reducing requalification-related costs for propane marketers, distributors, and others in non-corrosive gas service without reducing safety. PHMSA also withdraws its Statement of Enforcement Discretion issued on March 17, 2017, as of the effective date of this final rule.

As further discussed throughout this section, the requalification periods for volumetric expansion and proof pressure testing—to include the first requalification after manufacture (“initial requalification”) and the recurring requalifications required after the initial requalification (“subsequent requalification(s)”)—have evolved through various regulatory actions. Table 1 summarizes the history of changes to the timelines for requalification by volumetric expansion and proof pressure testing that are the subject of this rulemaking. The requalification time periods memorialized in Table 1 as having been in place “Prior to HM-233F” date from 1964. 1

Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006) and amendments. NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

The current baseline General and Reserve category quotas are 555.7 mt and 29.5 mt, respectively. See § 635.27(a). Each of the General category time periods (January, June through August, September, October through November, and December) is allocated a “subquota” or portion of the annual General category quota. The baseline subquotas for each time period are as follows: 29.5 mt for January; 277.9 mt for June through August; 147.3 mt for September; 72.2 mt for October through November; and 28.9 mt for December. Any unused General category quota rolls forward from one time period to the next, and is available for use in subsequent time periods. To date, NMFS has taken several actions that resulted in adjustments to the General and Reserve category quotas, resulting in currently adjusted quotas of 88.7 mt of quota for the Reserve category, 100 mt for the General category January through March 2020 subquota period, and 9.4 mt for the December 2020 subquota period (85 FR 17, January 2, 2020; 85 FR 6828, February 6, 2020; 85 FR 43148, July 16, 2020; 85 FR 59445, September 22, 2020; and 85 FR 61872, October 1, 2020). Most recently, NMFS transferred 40 mt to the General category and closed the General category fishery effective October 9, 2020, based on projections that landings would meet or exceed the adjusted October through November subquota of 112.2 mt by that date (85 FR 64411, October 13, 2020). In that action, NMFS indicated it planned to account for General category overharvest from the September 2020 subquota period, as well as additional landings from the June through August period not previously accounted for in 85 FR 59445 (September 22, 2020), in a subsequent notice. Preliminary landings data as of October 21, 2020, indicate that the amount of overharvest (through September 30, 2020) that needs to be accounted for is 53.2 mt.

Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria provided under § 635.27(a)(8). NMFS has considered all of the relevant determination criteria and their applicability to this inseason quota transfer. These considerations include, but are not limited to, the following:

Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen and provided by bluefin tuna dealers continue to provide valuable data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT in the General category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.

NMFS also considered the catches of the General category quota to date (including during the fall and winter fisheries in the last several years), and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). Preliminary landings data as of October 26, 2020, indicate that the General category landed 88.5 mt for the October through November period. This represents 79 percent of the adjusted October through November subquota (112.2 mt), and means that 23.7 mt remains available (112.2 mt-88.5 mt). Transferring 68.7 mt of quota from the Reserve category accounts for 53.2 mt of accrued overharvest from the prior time periods and results in an additional 15.5 mt being available for the October through November 2020 subquota period, thus effectively providing limited additional opportunities to harvest the U.S. bluefin tuna quota while avoiding exceeding it.

Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT quota transferred before the end of the fishing year (§ 635.27(a)(8)(iii)), a portion of the transferred quota covers the 53.2-mt overharvest of the General category subquotas through September 30, 2020. NMFS anticipates that General category participants will be able to harvest the 39.2 mt of BFT quota that remains available for the October through November subquota (23.7 mt remaining + 15.5 mt from the transfer), following this action, by the end of the subquota time period, but this is also subject to weather conditions and BFT availability. In the unlikely event that any of this quota is unused by November 30, such quota will roll forward to the next subperiod within the calendar year ( i.e., the December period), and NMFS anticipates that it would be used before the end of the fishing year. Thus, this quota transfer would allow fishermen to take advantage of the availability of fish on the fishing grounds, and provide a reasonable opportunity to harvest the full U.S. BFT quota.

NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2020 landings and dead discards. In the last several years, total U.S. BFT landings have been below the available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2020 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and anticipates having sufficient quota to do that. NMFS anticipates that General category participants in all areas and time periods will have opportunities to harvest the General category quota in 2020, through active inseason management such as the timing of quota transfers, as practicable. Thus, this quota transfer would allow fishermen to take advantage of the availability of fish on the fishing grounds to the extent consistent with the available amount of transferrable quota and other management objectives, while avoiding quota exceedance.

NMFS also considered the effects of the adjustment on the BFT stock and the effects of the transfer on accomplishing the objectives of the FMP (§ 635.27(a)(8)(v) and (vi)). This transfer would be consistent with the current quotas, which were established and analyzed in the 2018 BFT quota final rule (83 FR 51391, October 11, 2018), and with objectives of the 2006 Consolidated HMS FMP and amendments and is not expected to negatively impact stock health or to affect the stock in ways not already analyzed in those documents. Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)). Specific to the General category, this includes providing opportunity equitably across all time periods.

Based on the considerations above, NMFS is transferring 68.7 mt of the available 88.7 mt of Reserve category quota to the General category. Of this amount, 53.2 mt accounts for preliminary overharvest of the January through March, June through August, and September time period subquotas, and 15.5 mt is added to the October through November subquota. Therefore, NMFS adjusts the General category October through November subquota 2020 subquota to a total of 127.7 mt after accounting for the 53.2 mt of overharvest through for the prior 2020 time periods, and adjusts the Reserve category quota to 20 mt.

Based on early October landings rates, NMFS has determined that reopening the General category fishery for two days is appropriate given the amount of quota that remains available for October through November, following this action ( i.e., 39.2 mt).

Therefore, the General category fishery will reopen at 12:30 a.m., October 28, 2020, and close at 11:30 p.m., October 29, 2020. The General category daily retention limit during this reopening remains the same as prior to closing: One large medium or giant ( i.e., measuring 73 inches (185 cm) curved fork length or greater) bluefin tuna per vessel per day/trip. This action applies to Atlantic tunas General category (commercial) permitted vessels and HMS Charter/Headboat category permitted vessels with a commercial sale endorsement when fishing commercially for BFT. Retaining, possessing, or landing large medium or giant BFT by persons aboard vessels permitted in the General and HMS Charter/Headboat categories must cease at 11:30 p.m. local time on October 29, 2020.

The General category will automatically reopen December 1, 2020, for the December 2020 subquota time period at the default one-fish level. In January 2020, NMFS adjusted the General category base subquota for the December 2020 period to 9.4 mt (85 FR 17, January 2, 2020). Based on quota availability in the Reserve, NMFS may consider transferring additional quota to the December subquota period, as appropriate.

Fishermen may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at https://www.fisheries.noaa.gov/resource/outreach-and-education/careful-catch-and-release-brochure/.

NMFS will continue to monitor the BFT fisheries closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register . In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 635, which was issued pursuant to section 304(c), and is exempt from review under Executive Order 12866.

The Assistant Administrator for NMFS finds that pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice of, and an opportunity for public comment on, for the following reasons: The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer is impracticable and contrary to the public interest. The General category recently closed, but based on available BFT quotas, fishery performance in recent weeks, and the availability of BFT on the fishing grounds, responsive reopening of the fishery is warranted to allow fishermen to take advantage of availability of fish and of quota. NMFS could not have proposed this action earlier, as it needed to consider and respond to updated data and information about fishery conditions and this year's landings. If NMFS was to offer a public comment period now, after having appropriately considered that data, it would preclude fishermen from harvesting BFT that are legally available. This action does not raise conservation and management concerns. Transferring quota from the Reserve category to the General category does not affect the overall U.S. BFT quota, and available data shows the adjustment would have a minimal risk of exceeding the ICCAT-allocated quota. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the U.S. BFT quota and the inseason adjustment criteria. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.