On December 28, 2020 (85 FR 84316-84319), DoD published a notice of a new system of records (SORN) establishing the DoD-0005, Defense Training Records system of records. This system covers DoD's collection, use, and maintenance of records about training delivered to DoD Service members, civilian personnel, and other DoD-affiliated individuals. The training data includes enrollment and participation information, information pertaining to class schedules, programs, and instructors, training trends and needs, testing and examination materials, and assessments of training efficacy. No comments on the Routine Uses were received during the SORN's 30-day public comment period.

The Privacy Act permits Federal agencies to exempt eligible records in a system of records from certain provisions of the Act, including the provisions providing individuals with a right to request access to and amendment of their own records and accountings of disclosures of such records. If an agency intends to exempt a particular system of records, it must first go through the rulemaking process to provide public notice and an opportunity to comment on the proposed exemption.

Because this system of records may contain classified information or information the release of which could compromise the fairness or objectivity of the testing or examination process, DoD proposed to exempt this system of records from certain provisions of the Privacy Act by a notice of proposed rulemaking (NPRM) published at 85 FR 84278-84279 concurrently with the SORN. The NPRM proposed to modify DoD's Privacy Act regulations at 32 CFR part 310 to exempt portions of records maintained in DoD-0005 from the requirements of 5 U.S.C. 552a(c)(3) and (d)(1)-(4) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(1) and (k)(6) of the Privacy Act. The public comment period ended on February 26, 2021, and DoD did not receive any comments on the NPRM. This final rule adds to the DoD's Privacy Act exemptions for Department-wide systems of records found in 32 CFR 310.13. Records in this system of records are only exempt from the Privacy Act to the extent the purposes underlying the exemption pertain to the record.

It has been previously determined that Privacy Act rules for the DoD are not significant rules. The rules do not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), it has been determined that Privacy Act rules for the DoD are not major rules, as defined by 5 U.S.C. 804(2).

It has been determined that the Privacy Act rules for the DoD do not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rules will not significantly or uniquely affect small governments.

The Director of Administration and Management certified that Privacy Act rules for the DoD do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the DoD.

It has been determined that Privacy Act rules for the DoD impose no additional reporting or recordkeeping requirements on the public under the Paperwork Reduction Act of 1995.

It has been determined that the Privacy Act rules for the DoD do not have federalism implications. The rules do 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.

It has been determined that Privacy Act rules for the DoD do not have substantial effects on Indian tribal governments. The rules do not impose substantial direct compliance costs on one or more Indian tribes, preempt tribal law, or effect the distribution of power and responsibilities between the Federal Government and Indian tribes.

Accordingly, 32 CFR part 310 is amended as follows:

On November 6, 2020, VA published a proposed rule in the Federal Register (85 FR 71020) that would eliminate the copayment requirement for opioid antagonists furnished to veterans who are at high risk of overdose of a specific medication or substance in order to reverse the effect of such an overdose and for the provision of education on the use of opioid antagonists. VA provided a 60-day comment period, which ended on January 5, 2021. VA received 19 comments on the proposed rule.

In an effort to reduce the incidence of overdose among the veteran population, Congress, in two separate statutes, has required that VA must exempt from copayment (1) opioid antagonists furnished under chapter 17 to a veteran who is at high risk for overdose of a specific medication or substance in order to reverse the effect of such an overdose, and (2) education on the use of opioid antagonists to reverse the effects of overdoses of specific medications or substances. See Public Law 114-198, sec. 915 (July 22, 2016) and Public Law 114-223, Division A, sec. 243 (Sept. 29, 2016). These provisions were effective upon enactment and have already been implemented. These provisions assist veterans by eliminating copayments for life-saving medication and education on the use of such medication, with the goal of reducing the incidence of overdose deaths among the veteran population. This final rule amends two of VA's copayment regulations, 38 Code of Federal Regulations (CFR) 17.108 and 17.110, to accurately implement these changes in law. This final rule also adds an explanation of how VA would identify a veteran at high risk for overdose under the new provisions.

Most commenters were in support of the proposed rule. One commenter stated that the rule would be a crucial part of VA's efforts to help veterans at an extreme risk of overdose. Another commenter stated that the rule is critical in creating cross-governmental cohesion in the fight against the opioid crisis in our veteran population, and it solidifies the message of a united front against the opioid crisis in our veteran community. The commenter suggested that adding a clear definition of who VA considers high risk is also an essential step in ensuring that any veteran needing these measures will have the availability of lifesaving opioid antagonists afforded to them. A commenter stated that the opioid crisis in the United State is getting worse every day and it is VA's duty to eliminate copays for opioid antagonists and education on use of opioid antagonists. Another commenter stated that high-risk veterans should have adequate access to opioid antagonists and that veterans should also have access to counseling and educational information on the subject of opioid addiction.

A commenter stated that eliminating the copayment for opioid antagonists and the education on the use of opioid antagonists will relieve a veteran of those financial burdens while receiving treatment. The commenter added that veterans have sacrificed enough to protect the people of this country and it is our responsibility to provide proper health care and encourage healthy living. Eliminating the copayment will allow veterans to fight this battle with focus and determination and removing a stressor such as a copayment can increase the chances of a successful recovery.

A commenter was in favor of the rule and added that VA has several programs in place to help veterans manage pain that do not include the use of opioids. This same commenter stated that the use of naloxone rescue treatments is an option for opioid risk mitigation and that proper education on naloxone should be given with frequent observation of the veteran and documentation in the veteran's medical records. This commenter also stated that eliminating the copayment will allow a veteran to fight this battle with focus and determination. Treatment timeframe varies per situation, but when trying to heal the mind and body simultaneously, removing a stressor can increase the chances of a successful recovery.

Another commenter was in support of the proposed rule and stated that the rule will be impactful to veterans battling opioid use disorder. Several commenters stated that by waiving the requirement to pay a copayment to receive opioid antagonists or education on their use for qualifying veterans, VA is recognizing that costs can pose a barrier for veterans to health care accessibility and it is taking the right steps to alleviate those barriers. A commenter added that this rule is a statement by VA of support of their at-risk patients and that it places the values of their patients' lives over the cost of this drug. Another commenter similarly stated that removing copayment requirements for veterans will likely result in increased access to these potentially life-saving medications. The commenter praised VA's efforts and believes that this rule will help reduce the incidence of overdose deaths among the veteran population.

A commenter stated that the proposed rule was a fine example of an executive agency ensuring compliance with Congressional direction.

VA thanks the commenters for their support of the rule. We are not making any changes based on these comments.

Comment on use of term opioid antagonist.

One commenter was in support of the rule but stated that VA should change the wording in the proposed rule from antagonist to something that is more relatable and not so demeaning to people who will interpret it the wrong way.

VA notes that the utilization of the term antagonist in the proposed rule is the correct medical term to describe the specific class of medications being authorized for provision to at risk veterans. An antagonist is a chemical that acts within the body to reduce the physiological activity of another chemical substance (such as an opioid). Since the term specifically describes this class of medication, VA is not making changes based on this comment.

Comments on education on opioid antagonists.

A commenter was in general support of the rule but indicated that the copayment for the outpatient visit should be eliminated regardless of whether the veteran's medical visit is solely for education on the use of opioid antagonists or the education is provided in conjunction with other types of care.

Under 38 United States Code (U.S.C.) 1710 and 38 CFR 17.108(c) VA is required to charge copayments for outpatient and inpatient health care services when certain criteria are met. VA clarifies, in 38 CFR 17.108(c)(2), a veteran will only be charged one copayment per day even if there are multiple encounters. In accordance with section 1710(g)(3)(B) of title 38, United States Code, VA is exempting from the copayment requirement those outpatient health care visits whose sole purpose is to provide education on the use of an opioid antagonist. However, when the outpatient visit provides health care services in addition to the education on an opioid antagonist, VA must assess the veteran's copayment for the additional services in accordance with 38 U.S.C. 1710. VA emphasizes that the veteran will not be charged a separate copayment for the education but will be assessed one copayment for the entire encounter. VA notes this results in the same outcome as the veteran would have experienced if the veteran had not received education on the use of an opioid antagonist. VA is not making any changes based on this comment.

Comments on definition of at high risk veterans.

Several commenters were generally in support of the rule but were concerned that the rule only focused on veterans who VA classified as high risk. The commenters stated that all veterans, not just those with a diagnosed risk of opioid overdose, should be eligible for the waived copayment. A commenter stated that if a veteran needs the opioid antagonist, then costs should not be a concern whether they are high risk or not. The commenter added that the fact the veteran is in need of the antagonist is sufficient evidence the veteran is at high risk. Also, the commenter stated that while the proposed rule would be an improvement and would lead to more lives being saved, more aggressive action to expand the target population to all veterans would be warranted and welcomed by the American people.

VA defined a high risk veteran in the proposed rule as a veteran who is prescribed or using opioids, or has an opioid use history, and who is at increased risk for opioid overdose as determined by VA. VA also stated that, in the alternative, a high risk veteran is one whose provider deems, based on their clinical judgment, that the veteran may benefit from ready availability of an opioid antagonist. VA believes this definition is broad enough to allow health care professionals the discretion to provide opioid antagonists and related education to any veteran who needs it without charging a copayment. In addition, VA has programs in place to assist veterans who are suffering financial hardship or who would face difficulties in making copayments; these efforts include measures to identify barriers for veterans at high risk due to substance use and to review the veteran's financial barriers and provide assistance as needed. VA is not making any changes based on this comment.

Another commenter stated that the proposed rule assumes that all those who are considered high risk would be appropriately identified to meet the requirements for the copayment waiver. The commenter added that this approach runs the risk of missing vulnerable individuals who may not fall within the parameters outlined by VA that are used to generate a high-risk status and thus, a waived copayment. The commenter recommended that VA expand the rule to capture not only those considered high-risk, but also those residing in highly impacted regions, such as rural communities. Another commenter similarly recommended including additional items in the definition of high risk, such as considering all veterans who requested opioid antagonists in geographical areas that see higher rates of opioid use and areas considered rural by the Federal Office of Rural Health Policy to be high risk. The commenter indicated that veterans in rural areas have limited access to health care and treatment centers, and delays in emergency medical services become critical when an accidental overdose occurs. The commenter added that VA should create the most inclusive definition possible and consider other, less obvious, circumstances veterans may face that could render them at “high risk” of opioid addiction. The commenter also stated that by utilizing a model which casts a wider net for assistance, more veterans and those in their immediate circles are likely to benefit from these proposals.

As previously stated in this rulemaking, VA's definition of high risk veteran is broad enough to allow health care professionals the discretion to provide opioid antagonists and education on those medications to any veteran without charging a copayment. In addition, VA has developed numerous resources to support identification of patients at risk for overdose, including the VA Opioid Overdose Education and Naloxone Distribution (OEND) Risk Report (which includes patients with various opioid pharmacotherapy and Opioid Use Disorder risk factors); VA Stratification Tool for Opioid Risk Mitigation (STORM), which uses predictive analytics to identify patients prescribed opioids who are at high risk for overdose and/or suicide; and incorporating the Risk Index for Overdose or Serious Opioid-induced Respiratory Depression (RIOSORD) into multiple reports to assist with patient identification. VA clinicians provide patient-centered care that takes into account the complexity of conditions and circumstances with which patients present—including their work, home, support system, and community—when conducting risk assessments and developing treatment plans. Based on the broad definition for this rule, which allows clinicians to provide opioid antagonists and related education to any veteran they deem may benefit from ready availability of an opioid antagonist, VA is not making any changes to its definition of high risk in response to this comment.

Another commenter stated that opioid overdoses can occur even when someone is taking an opioid exactly as prescribed by their doctor, and even veterans who are not considered “high risk” can still die of an overdose or be left with long term brain damage. Therefore, the commenter concluded, it is imperative that all veterans taking opioids are educated on the dangers of opioid induced respiratory depression (OIRD) and are provided the monitoring technology to help keep them safe. The commenter encouraged VA to utilize continuous physiologic monitoring with notifications for all patients using opioids, particularly during periods of sleep and rest. The commenter added that such monitoring has been shown to reduce opioid overdose deaths through earlier interventions and rapid response team activations when necessary. The commenter recommended that VA include the following in the list of factors that indicate that an individual is at high risk of overdose: Individuals taking other sedating medications, including alcohol, marijuana, benzodiazepines and/or gabapentin; older adults; depression or mental health conditions; sleep apnea.

VA notes the specific modalities for treatment, such as monitoring for OIRD, are determined by the VA national program office responsible for developing guidance to VA staff overseeing the provision of care at the facility level. The establishment of such modalities are outside the scope of the proposed rulemaking. VA believes that the proposed definition of a high risk veteran is broad enough to grant health care professionals the discretion to identify veterans who such professionals consider to be high risk; the addition of the factors identified by the commenter would not enhance the proposed definition. Moreover, VA's aforementioned STORM model takes into consideration many of the factors described by the commenter that are available in VA data ( e.g., substance use disorders, benzodiazepine and gabapentin prescriptions, age, mental health diagnoses, and sleep apnea). These factors are displayed in a VA-provider facing clinical dashboard for patients prescribed opioids as well as patients with opioid use disorders. VA is not making any changes based on these comments.

Comments on elimination of other types of copayments.

A commenter was generally in support of the rule but recommended the rule also eliminate any cost to veterans relating to substance use disorder counseling, rehabilitation, psychological treatment, and inpatient care. The commenter added that care coordination between providers must become an equal priority to prevent over-prescription. In addition, the commenter stated that opioid antagonists should be treated as the last resort in reducing overdose deaths and not a course of treatment. The commenter stated the proposed rule should be only the first step in ensuring that high risk veterans face no obstacles in gaining access to the treatment that they need ahead of any possible overdose incident.

As previously stated in this rulemaking, section 915 of Public Law 114-198 and section 243 of Division A of Public Law 114-223 provide for the elimination of a copayment for the provision of opioid antagonists and for outpatient visits whose sole purpose is for the provision of education on the use of opioid antagonists. The elimination of copayments for substance use disorder counseling, rehabilitation, psychological treatment, and inpatient care are beyond the scope of the proposed rule. However, VA's implementation of opioid antagonist education emphasizes the importance of connecting patients, including those with opioid use disorder, with treatment ( e.g., a standardized patient education brochure recommends considering seeking help for substance use disorder [SUD] treatment and includes a link to the VA SUD Program Locator). VA has also streamlined Prescription Drug Monitoring Program (PDMP) checks—incorporating an integrated Information Technology solution that allows providers to check for controlled substance prescriptions outside VA. This mechanism makes it easy for providers to check the PDMP for opioid prescriptions external to VA within the Computerized Patient Record System. VA also has programs in place to assist veterans experiencing financial hardship, including measures to identify barriers for veterans at higher risk due to SUD. VA is not making any changes based on this comment.

One commenter suggested that the rule should also ensure that VA provide outreach services to identify high-risk veterans, encourage educational outpatient visits, and follow-up before or after both outpatient and inpatient visits for treatment and education. The commenter indicated that providing outreach services will increase the number of veterans who receive antagonist prescriptions, aid in tracking the most at risk of the high-risk population, aid in the dissemination of pain management alternatives, and overall reduce the risk of opioid misuse and overdose events. The commenter also stated that outreach has proven effective in several studies conducted all over the US for people suffering with Opioid Use Disorder and is a main factor is reducing repeat overdose events. The commenter stated that these outreach practices are already occurring in VA and should be folded into the regulation to ensure their continuation as outreach is an integral part of increasing the effectiveness of this rule's stated goal.

VA notes that this rulemaking is limited to the exemption of copayments for opioid antagonist education and dispensing of opioid antagonists to veterans identified by VA health care professionals as being at high risk of overdose. VA already has treatment programs and outreach programs in place for identification and treatment of veterans at risk of opioid use disorder. The provision of VA outreach programs for opioid use disorder is outside the scope of the proposed rulemaking, and VA generally seeks to avoid regulating outreach practices to allow for innovative approaches to be adopted to support safe and effective patient care. VA is not making any changes based on this comment.

Comments on the impact analysis.

A commenter had concerns regarding the impact analysis that accompanied the rulemaking. The commenter stated that the impact analysis projected a loss of revenue of more than $150,000 with increases for each year of this rule's existence due to the copayment exemptions. The commenter noted that the impact analysis did not state where this revenue stream would be diverted from internally and how this may impact other veteran services of equal or greater importance. The commenter queried whether VA plans to apply for a grant under the Food, Drug, and Cosmetic Act (chapter 9 of title 21, U.S.C.) for the emergency treatment of opioid overdose, which can offset at least $200,000 of antagonist costs that is greater than the yearly projected loss of revenue from this rule.

VA believes the benefits of educating veterans on the risks of opioids and utilization of opioid antagonists during an overdose to potentially save a life outweighs any loss of revenue from VA copayments. VA anticipates no reduction or diversion of funds from other programs as a result of this rulemaking. VA has already been implementing this authority, and VA's budget requests already reflect the loss identified in the impact analysis. We are not making any changes based on this comment.

Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA is adopting the proposed rule with no changes.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). The adoption of the rule does not directly affect any small entities. There are no small entities involved with VA's process or adjustment of veteran's copayments for medications or services. The provisions of this rulemaking only apply to the internal operations of VA and to individual veterans.

Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3521).

The Catalog of Federal Domestic Assistance program number and title for this final rule are as follows: 64.009, Veterans Medical Care Benefits; 64.012, Veterans Prescription Service; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.041, VHA Outpatient Specialty Care; 64.045, VHA Outpatient Ancillary Services; 64.047, VHA Primary Care; 64.048, VHA Mental Health Clinics.

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).

Denis McDonough, Secretary of Veterans Affairs, approved this document on September 10, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 17 as set forth below:

On December 18, 2020, VA published in the Federal Register (85 FR 82399) a proposed rule revising its regulations to clarify that, when determining eligibility for interment or memorialization benefits, NCA will refer cases involving OTH discharges or other character of discharge issues to VBA for an administrative decision. The public comment period ended on February 16, 2021.

VA received one comment that expressed disagreement with the proposed rule, stating that the referral of cases for a character of discharge determination was “morally and ethically reprehensible.” The commenter also asserted that the proposed rule sought to assume Congress's role “to write statute” by redefining the term “veteran,” and suggested that VA use an automated formula to evaluate whether an individual satisfies the statutory definition of veteran. We thank the commenter for this comment.

However, we disagree that this rule redefines the term “veteran” in any way. While the supplemental information in the proposed rule explained that eligibility for NCA-administered benefits is tied to an individual establishing “veteran” status or meeting other specified conditions, this rule does not affect the statutory definition of “veteran” as provided by Congress in 38 U.S.C. 101(2). The rule only amends 38 CFR 38.620 by adding a note following paragraph (i) to inform that a benefit request, pertaining to a decedent whose character of discharge may potentially bar eligibility to that benefit, may be referred to VBA for review in accordance with 38 CFR 3.12 (Character of discharge) or other applicable sections. As such, we make no changes based on the comment.

We appreciate the commenter's suggested alternative approach to determining whether an individual satisfies the statutory definition of “veteran”, but Congress has delegated to VA the authority to promulgate reasonable regulations on VA benefits eligibility, which it has done in 38 CFR 3.12. See Garvey v. Wilkie, 972 F.3d 1333 (Fed. Cir. 2020). It is not 38 CFR 38.620 or this rule (which merely clarifies NCA current practice), but 38 CFR 3.12, that seems to pertain more to the commenter's concern.

Under 38 CFR 3.12(a), some discharges, such as honorable and general (under honorable conditions) automatically convey “veteran” status. However, other types of discharges require in-depth examination under the provisions of 38 CFR 3.12(d) to determine whether the discharge should be considered to have been issued under dishonorable conditions. Moreover, the provisions of 38 CFR 3.12(c), commonly referred to as the statutory bars to benefits (since they are derived from 38 U.S.C. 5303(a)) may also be implicated. Because of VBA's expertise and familiarity with 38 CFR 3.12, NCA has historically referred character of discharge issues to VBA. Doing so helps ensure VA-wide consistency on benefits determinations and helps prevent confusion in claimants and beneficiaries that would likely result from VBA and NCA having differing standards. The amendment this final rule makes merely adds an explanatory note to inform the public of this long standing process. As such, we make no changes based on the comment regarding the complexity of character of discharge determinations, or the commentor's suggestion that VA utilize automated formulas to determine the character of a discharge.

Finally, the commenter indicated that the proposed rule was not available for comment for the entire 60 days following publication in the Federal Register , and requested an extended period for comment. We note that the proposed rule was published in the Federal Register on December 18, 2020, and the comment period closed on February 16, 2021, which is a period of 60 days. Consequently, we take no action based on this comment.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The provisions associated with this rulemaking are merely internal administrative processes to VA specifically and do not involve or impact any external entities outside of VA. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.201, National Cemeteries; and 64.202, Procurement of Headstones and Markers and/or Presidential Memorial Certificates.

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).

Denis McDonough, Secretary of Veterans Affairs, approved this document on September 14, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons set forth in the preamble, VA amends 38 CFR part 38 as set forth below:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2020-0245 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before November 19, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2020-0245, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of September 30, 2020 (85 FR 61681) (FRL-10014-74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E8827) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested the establishment of tolerances in 40 CFR 180.574 for residues of the herbicide fluazinam in or on multiple commodities. For a complete list, please refer to the September 30, 2020 notification (85 FR 61681) (FRL-10014-74). Additionally, the petitioner proposed removing established tolerances for residues of fluazinam in or on the raw agricultural commodities; vegetable, legume, edible podded, subgroup 6A, except pea at 0.10 ppm; pea and bean, succulent shelled, subgroup 6B, except pea at 0.04 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, except pea at 0.02 ppm; vegetable, brassica leafy, group 5, except cabbage at 0.01 ppm; and turnip, greens at 0.01 ppm. That document referenced a summary of the petition prepared by ISK Biosciences, the registrant, which is available in the docket, http://www.regulations.gov. Two comments were received in response to the notice of filing. One was about geographic pesticide concentration but not about fluazinam specifically, and the other was associated with a different chemical.

Based upon review of the data supporting the petition, EPA is establishing tolerances at different levels than petitioned-for and modified some of the commodity definitions used. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.”

This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fluazinam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluazinam follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary; EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published a number of tolerance rulemakings for fluazinam, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to fluazinam and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological profile. For a discussion of the Toxicological Profile of fluazinam, see Unit III.A. of the April 8, 2016 rulemaking (81 FR 20545) (FRL-9942-99).

Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment, see Unit III.B. of the November 7, 2012 rulemaking (77 FR 66723) (FRL-9366-6).

Exposure assessment. Much of the exposure assessment remains the same, although some updates have occurred to accommodate exposures from the petitioned-for tolerances. The updates are discussed in this section.

The acute dietary analysis is based on tolerance-level residues for all commodities and uses high-end residue estimates for the metabolite 3-[[4-amino-3-[[3-chloro-5- (trifloromethyl)-2-pyridinyl]amino]-2-nitro-6-(trifluoromethyl) phenyl] thio]-2-(beta-Dglucopyranosyloxy) propionic acid), known as AMGT. In addition, the acute assessment assumes 100 percent crop treated (PCT) and incorporates modeled EDWCs that account for both parent fluazinam and its transformation products. The chronic dietary analysis is based on tolerance level residues for all commodities except apples. For apples, the average field trial value was used. As with the acute assessment, the chronic assessment incorporates high-end estimates for AMGT and default processing factors for all relevant processed commodities without a separate tolerance, and modeled EDWCs that account for both parent and transformation products. The chronic assessment also incorporated PCT data.

Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The following average PCT estimates were used in the chronic dietary risk assessments for the crops that are currently registered for fluazinam: Apples (<1%), beans (5%), cabbage (<1%), carrots (<1%), dry beans/peas (<2.5%), lima beans (5%), onions (<1%), peanuts (<2.5%), potatoes (15%), pumpkin (<1%), and soybeans (<1%).

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figures for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which fluazinam may be applied in a particular area.

Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fluazinam in drinking water. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the FQPA Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model for Groundwater (PRZM-GW), EPA used an EDWC of 226 ppb for the acute dietary assessment and 141 ppb in the chronic dietary risk assessment.

Non-occupational exposure. See Unit III.C.3. of the April 8, 2016 rulemaking for a discussion of non-dietary exposure, which included residential exposures to golf course turf.

Cumulative exposure. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fluazinam and any other substances, and fluazinam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that fluazinam has a common mechanism of toxicity with other substances.

Safety factor for infants and children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor. See Unit III.D. of the April 8, 2016 rulemaking for a discussion of the Agency's rationale for that determination.

Aggregate risks and determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

Acute dietary risks are below the Agency's level of concern of 100% of the aPAD: They are 37% of the aPAD for females 13 to 49 years old, the population subgroup with the highest risk estimate. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD: they are 88% of the cPAD for all infants, the population subgroup with the highest exposure estimate. The short-term aggregate risk assessments resulted in MOEs that are greater than the Agency's level of concern of 100 and therefore are not of concern. The MOEs are 381 for children 6 to less than 11 years old; 470 for youths 11 to less than 16 years old; and 420 for adults. Intermediate-term and long-term residential exposures are not expected.

Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluazinam residues. More detailed information about the Agency's analysis can be found at http://www.regulations.gov in the document titled “Fluazinam. Human Health Risk Assessment for the Proposed Use on Individual Commodities of Proposed Crop Subgroup 6-19B; Edible Podded Pea Legume Vegetable Subgroup, Crop Subgroup 6-19D: Succulent Shelled Pea Subgroup, Crop Subgroup 6-19F: Dried Shelled Pea Subgroup, Crop Subgroup 8-10A: Tomato Subgroup, Papaya, and Crop Group Conversions.” in docket ID number EPA-HQ-OPP-2020-0245.

For a discussion of the available analytical enforcement method, see Unit IV.A of the April 8, 2016 rulemaking.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). No Codex MRLs have been established for fluazinam.

Most of the proposed commodity definitions have been modified to be consistent with Agency nomenclature. In addition, EPA adjusted the tolerances for the edible podded bean commodities by removing the trailing zero to be consistent with the OECD Rounding Practice.

Therefore, tolerances are established for residues of fluazinam in or on Bean, adzuki, dry seed at 0.02 ppm; Bean, American potato, dry seed at 0.02 ppm; Bean, asparagus, edible podded at 0.1 ppm; Bean, asparagus, dry seed at 0.02 ppm; Bean, black, dry seed at 0.02 ppm; Bean, broad, dry seed at 0.02 ppm; Bean, broad, succulent shelled at 0.04 ppm; Bean, catjang, edible podded at 0.1 ppm; Bean, catjang, dry seed at 0.02 ppm; Bean, catjang, succulent shelled at 0.04 ppm; Bean, cranberry, dry seed at 0.02 ppm; Bean, dry, dry seed at 0.02 ppm; Bean, field, dry seed at 0.02 ppm; Bean, French, dry seed at 0.02 ppm; Bean, French, edible podded at 0.1 ppm; Bean, garden, dry seed at 0.02 ppm; Bean, garden, edible podded at 0.1 ppm; Bean, goa, dry seed at 0.02 ppm; Bean, goa, edible podded at 0.1 ppm; Bean, goa, succulent shelled at 0.04 ppm; Bean, great northern, dry seed at 0.02 ppm; Bean, green, dry seed at 0.02 ppm; Bean, green, edible podded at 0.1 ppm; Bean, guar, dry seed at 0.02 ppm; Bean, guar, edible podded at 0.1 ppm; Bean, kidney, dry seed at 0.02 ppm; Bean, kidney, edible podded at 0.1 ppm; Bean, lablab, dry seed at 0.02 ppm; Bean, lablab, edible podded at 0.1 ppm; Bean, lablab, succulent shelled at 0.04 ppm; Bean, lima, dry seed at 0.02 ppm; Bean, lima, succulent shelled at 0.04 ppm; Bean, morama, dry seed at 0.02 ppm; Bean, moth, dry seed at 0.02 ppm; Bean, moth, edible podded at 0.1 ppm; Bean, moth, succulent shelled at 0.04 ppm; Bean, mung, dry seed at 0.02 ppm; Bean, mung, edible podded at 0.1 ppm; Bean, navy, dry seed at 0.02 ppm; Bean, navy, edible podded at 0.1 ppm; Bean, pink, dry seed at 0.02 ppm; Bean, pinto, dry seed at 0.02 ppm; Bean, red, dry seed at 0.02 ppm; Bean, rice, dry seed at 0.02 ppm; Bean, rice, edible podded at 0.1 ppm; Bean, scarlet runner, dry seed at 0.02 ppm; Bean, scarlet runner, edible podded at 0.1 ppm; Bean, scarlet runner, succulent shelled at 0.04 ppm; Bean, snap, edible podded at 0.1 ppm; Bean, sword, dry seed at 0.02 ppm; Bean, sword, edible podded at 0.1 ppm; Bean, tepary, dry seed at 0.02 ppm; Bean, urd, dry seed at 0.02 ppm; Bean, urd, edible podded at 0.1 ppm; Bean, wax, edible podded at 0.1 ppm; Bean, wax, succulent shelled at 0.04 ppm; Bean, yardlong, dry seed at 0.02 ppm; Bean, yardlong, edible podded at 0.1 ppm; Bean, yellow, dry seed at 0.02 ppm; Brassica, leafy greens, subgroup 4-16B at 0.01 ppm; Chickpea, dry seed at 0.04 ppm; Chickpea, edible podded at 0.15 ppm; Chickpea, succulent shelled at 0.03 ppm; Cowpea, dry seed at 0.02 ppm; Cowpea, edible podded at 0.1 ppm; Cowpea, succulent shelled at 0.04 ppm; Gram, horse, dry seed at 0.02 ppm; Grass pea, dry seed at 0.04 ppm; Grass pea, edible podded at 0.15 ppm; Jackbean, dry seed at 0.02 ppm; Jackbean, edible podded at 0.1 ppm; Jackbean, succulent shelled at 0.04 ppm; Kohlrabi at 0.01 ppm; Lentil, dry seed at 0.04 ppm; Lentil, edible podded at 0.15 ppm; Lentil, succulent shelled at 0.03 ppm; Longbean, Chinese, dry seed at 0.02 ppm; Longbean, Chinese, edible podded at 0.1 ppm; Lupin, Andean, dry seed at 0.02 ppm; Lupin, Andean, succulent shelled at 0.04 ppm; Lupin, blue, dry seed at 0.02 ppm; Lupin, blue, succulent shelled at 0.04 ppm; Lupin, grain, dry seed at 0.02 ppm; Lupin, grain, succulent shelled at 0.04 ppm; Lupin, sweet white, dry seed at 0.02 ppm; Lupin, sweet white, succulent shelled at 0.04 ppm; Lupin, sweet, dry seed at 0.02 ppm; Lupin, sweet, succulent shelled at 0.04 ppm; Lupin, white, dry seed at 0.02 ppm; Lupin, white, succulent shelled at 0.04 ppm; Lupin, yellow, dry seed at 0.02 ppm; Lupin, yellow, succulent shelled at 0.04 ppm; Papaya at 3 ppm; Pea, blackeyed, dry seed at 0.02 ppm; Pea, blackeyed, succulent shelled at 0.04 ppm; Pea, crowder, dry seed at 0.02 ppm; Pea, crowder, succulent shelled at 0.04 ppm; Pea, dry, dry seed at 0.04 ppm; Pea, dwarf, edible podded at 0.15 ppm; Pea, English, succulent shelled at 0.03 ppm; Pea, field, dry seed at 0.04 ppm; Pea, field, hay at 40 ppm; Pea, field, vines at 6 ppm; Pea, garden, dry seed at 0.04 ppm; Pea, garden, succulent shelled at 0.03 ppm; Pea, green, dry seed at 0.04 ppm; Pea, green, edible podded at 0.15 ppm; Pea, green, succulent shelled at 0.03 ppm; Pea, pigeon, dry seed at 0.04 ppm; Pea, pigeon, edible podded at 0.15 ppm; Pea, pigeon, succulent shelled at 0.03 ppm; Pea, snap, edible podded at 0.15 ppm; Pea, snow, edible podded at 0.15 ppm; Pea, southern, dry seed at 0.02 ppm; Pea, southern, succulent shelled at 0.04 ppm; Pea, sugar snap, edible podded at 0.15 ppm; Pea, winged, dry seed at 0.02 ppm; Pea, winged, edible podded at 0.1 ppm; Soybean, vegetable, dry seed at 0.02 ppm; Soybean, vegetable, edible podded at 0.1 ppm; Soybean, vegetable, succulent shelled at 0.04 ppm; Tomato subgroup 8-10A at 1.5 ppm; Vegetable, brassica, head and stem, group 5-16, except cabbage at 0.01 ppm; Velvetbean, dry seed at 0.02 ppm; Velvetbean, edible podded at 0.1 ppm; Velvetbean, succulent shelled at 0.04 ppm; and Yam bean, African, dry seed at 0.02 ppm.

Additionally, the following tolerances are removed as unnecessary: Pea and bean, dried shelled, except soybean, subgroup 6C, except pea; Pea and bean, succulent shelled, subgroup 6B, except pea; Turnip, greens; Vegetable, brassica, leafy, group 5, except cabbage; and Vegetable, legume, edible podded, subgroup 6A, except pea.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances and modifications in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule 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 . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

The Agency included in the April 7, 2021 final rule a list of those who may be potentially affected by this action.

EPA issued a final rule in the Federal Register of April 7, 2021 (86 FR 17907) (FRL-10020-24) that established tolerances for residues of spinetoram in or on multiple commodities and removed some tolerances in response to a petition filed by IR-4. EPA inadvertently reversed the instructions to the Federal Register regarding the entries for “vegetable, leafy, except Brassica, group 4” and “vegetable, leafy, group 4-16” in the tolerance table in paragraph (a) of 40 CFR 180.635. The instructions inadvertently directed the Federal Register to add an entry in the table for “vegetable, leafy, except Brassica, group 4”. The instructions should have directed the Federal Register to remove that entry from the table, as described in Unit V. of the April 7, 2021 final rule and as reflected in the amended table in the regulatory text of the final rule. Additionally, the instructions inadvertently directed the Federal Register to remove the entry in the table for “vegetable, leafy, group 4-16”. The instructions should have directed the Federal Register to add that entry to the table, as described in Unit V. of the April 7, 2021 final rule and as reflected in the amended table in the regulatory text of the final rule.

EPA's instructions in the April 7, 2021 final rule regarding tolerances for “vegetable, leafy, except Brassica, group 4” and “vegetable, leafy, group 4-16” were not consistent with its authority under FFDCA section 408(d)(4)(A) or with the preamble or regulatory text of the April 7, 2021 final rule. Therefore, EPA is rescinding those instructions and directing the Federal Register to remove the entry for “vegetable, leafy, except Brassica, group 4” and add an entry for “vegetable, leafy, group 4-16” in the tolerance table in paragraph (a) of 40 CFR 180.635.

Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B)) provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making these correcting amendments final without prior proposal and opportunity for comment, because EPA inadvertently reversed the instructions to the Federal Register so that the new tolerance for “vegetable, leafy, group 4-16” was not established and the existing tolerance for “vegetable, leafy, except Brassica, group 4” was not removed. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

No. For a detailed discussion concerning the statutory and Executive order review refer to Unit VI. of the April 7, 2021 final rule.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule 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 . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA corrects 40 CFR part 180 by making the following correcting amendments:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2020-0227 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before November 19, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2020-0227, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of September 30, 2020 (85 FR 61681) (FRL-10014-74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E8826) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested to establish tolerances in 40 CFR 180.582 for residues of the sum of pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenylcarbamate), calculated as the stoichiometric equivalent of pyraclostrobin, in or on the raw agricultural commodity pomegranate at 0.3 ppm. That document referenced a summary of the petition prepared by BASF, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the notice of filing.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pyraclostrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyraclostrobin follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The primary target tissues following repeated pyraclostrobin exposure appear to be mucosal membranes, with histopathology or secondary effects ( e.g., diarrhea) observed in different species. The primary effects were decreased body weight and food consumption in addition to diarrhea. There was no observed neurotoxicity, mutagenicity, genotoxicity, or immunotoxicity in the database. Also, there was no evidence of increased susceptibility following pre-natal exposure to rats and rabbits in the developmental toxicity studies, nor following pre- and post-natal exposure to rats in the multi-generation reproduction study. Pyraclostrobin is classified as “not likely to be carcinogenic to humans.”

Additional information on the toxicological profile can be found at http://www.regulations.gov in the document titled “Pyraclostrobin; Human Health Risk Assessment for a New Use on Pomegranate” (hereinafter “Pyraclostrobin Human Health Risk Assessment”) in docket ID number EPA-HQ-OPP-2020-0227.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.

A summary of the toxicological endpoints for pyraclostrobin used for human risk assessment can be found on pages 10-11 in the Pyraclostrobin Human Health Risk Assessment.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyraclostrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing pyraclostrobin tolerances in 40 CFR 180.582. EPA assessed dietary exposures from pyraclostrobin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for pyraclostrobin.

In conducting the acute dietary exposure assessment, EPA used the 2003-2008 food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). A partially refined acute dietary exposure assessment was conducted for pyraclostrobin. The analysis used tolerance-level residues or highest average field trial residues (HAFT) and 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the 2003-2008 food consumption data from the USDA's NHANES/WWEIA. A partially refined chronic dietary analysis was conducted for pyraclostrobin. The chronic dietary analysis included tolerance-level or average field trial residues and average PCT estimates when available.

iii. Cancer. Pyraclostrobin is classified as “Not Likely to Be Carcinogenic to Humans” therefore, a cancer assessment is not needed.

iv. Anticipated residue and PCT information. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The following average PCT estimates were used in the chronic dietary risk assessments for the crops that are currently registered for pyraclostrobin: Almonds 45%; apples 20%; apricots 30%; barley 10%; green beans 5%; blueberries 40%; broccoli 5%; Brussels sprouts 15%; cabbage 10%; caneberries 50%; cantaloupes 15%; carrots 35%; cauliflower 5%; celery 2.5%; cherries 55%; chicory 5%; corn 10%; cotton (seed treatment) 10%; cucumber 5%; dry beans/peas 10%; garlic 10%; grapefruit 35%; grapes 30%; hazelnuts 20%; lemons 5%; lettuce 5%; nectarines 15%; oats 5%; onions 30%; oranges 5%; peaches 25%; peanuts 20%; pears 20%; green peas 5%; pecans 5%; peppers 15%; pistachios 30%; potatoes 20%; pumpkins 15%; soybeans (seed treatment) 10%; spinach 5%; squash 15%; strawberries 65%; sugar beets 50%; sugarcane 5%; sweet corn 5%; tangerines 10%; tomatoes 25%; walnuts 10%; watermelons 25%; wheat 5%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case the Agency uses less than 2.5% as the maximum PCT.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which pyraclostrobin may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for pyraclostrobin in drinking water. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide in Water Calculator (PWC), for the acute dietary risk assessment, EPA used an estimated drinking water concentration (EDWC) of 22 ppb into the DEEM-FCID Model. For the chronic exposure assessment, EPA used a value of 0.99 ppb.

3. Non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Pyraclostrobin is currently registered for uses that may result in residential handler and post-application exposures, including commercial and residential use on lawns, as well as commercial use on ornamental turf and trees, golf courses, and parks.

Based upon the hazard analysis for pyraclostrobin, short-term residential exposure that is available to be aggregated include incidental oral exposure ( e.g., hand-to-mouth or object-to-mouth). Hand-to-mouth and object-to-mouth scenarios are considered inter-related, and it is likely that they occur interspersed amongst each other across time; combining these scenarios would be overly conservative. Residential short and intermediate-term dermal exposures (from children, youth, or adult scenarios) are not being combined with incidental oral exposure due to differing endpoints selected. Based upon the available scenarios, incidental oral (hand-to-mouth) exposures were used in the pyraclostrobin short-term aggregate assessment.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to pyraclostrobin and any other substances and pyraclostrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that pyraclostrobin has a common mechanism of toxicity with other substances.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. In the rat developmental toxicity study, skeletal variations occurred at doses greater than or equal to those doses causing maternal toxicity ( i.e., diarrhea, decreased body weight, food consumption, and clinical signs of toxicity). In the rabbit developmental study, increased resorptions per litter, increased post-implantation loss, and dams with total resorptions were observed. Since the cause of fetal death is undetermined and may be attributed to either maternal or direct embryo fetal toxicity, the effect is part of both the maternal and developmental LOAEL. In one rat reproduction study, systemic toxicity manifested as decreased body weights in both the parents and offspring, with offspring effects occurring at a higher dose level than parental toxicity. In the second rat reproduction study, no toxicity was observed in both parents and offspring. Therefore, there was no evidence of increased susceptibility (quantitatively) following pre-natal exposure to rats and rabbits in the developmental studies nor following pre- and post-natal exposure to rats in the multi-generation reproduction studies.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for acute exposure, EPA has concluded that acute exposure to pyraclostrobin from food and water will utilize 86% of the aPAD for females 13 to 49 years old, the only population group of concern because no appropriate toxicological effect attributable to a single dose was observed for the general US population or any other population subgroup.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pyraclostrobin from food and water will utilize 28% of the cPAD for all children 1 to 2 years old, the population group receiving the greatest exposure. Chronic residential exposure to residues of pyraclostrobin is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Pyraclostrobin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pyraclostrobin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 430 for children 1 to 2 years old. Because EPA's level of concern for pyraclostrobin is a MOE of 100 or below, this MOE is not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

A separate intermediate-term adverse effect was identified for pyraclostrobin. However, pyraclostrobin is not registered for any use patterns that would result in intermediate-term residential exposures that can be combined with background dietary exposures. Because there is no intermediate-term residential aggregate exposures and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pyraclostrobin.

5. Aggregate cancer risk for U.S. population. Pyraclostrobin is classified as “Not Likely to Be Carcinogenic to Humans”; therefore, EPA does not expect pyraclostrobin exposures to pose an aggregate cancer risk.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pyraclostrobin residues.

Two adequate methods are available for enforcement purposes for residues of pyraclostrobin and its metabolites in/on plant commodities: a liquid chromatography with tandem mass spectroscopy (LC/MS/MS) method (BASF Method D9908) and a high-performance liquid chromatography/ultraviolet (HPLC/UV) method (Method D9904).

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).

There is no Codex MRL for pyraclostrobin in or on pomegranate.

Therefore, a tolerance is established for residues of pyraclostrobin in or on pomegranate at 0.3 ppm. Additionally, the Agency is putting back a footnote that states “There is no U.S. registration on coffee, bean, green as of September 30, 2009” to the table in paragraph (a)(1) that was inadvertently removed in 2013.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the CRA (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule 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 . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

This is a summary of the Commission's Report and Order, ET Docket No. 20-382, FCC 21-72, adopted and released June 17, 2021. The complete text of this document is available by downloading the text from the Commission's website at https://www.fcc.gov/document/allowing-earlier-equipment-marketing-and-importation-opportunities-1. When the FCC Headquarters reopens to the public, the full text of this document also will be available for public inspection and copying during regular business hours in the FCC Reference Center, 45 L Street NE, Washington, DC 20554. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format) by sending an email to FCC504@fcc.gov or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

The Regulatory Flexibility Act of 1980, as amended (RFA) requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” As required by the RFA, an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rulemaking ( NPRM ) (86 FR 2337, Jan. 12, 2021). The Commission sought written public comment on the proposals in the NPRM, including comments on the IRFA. No comments were filed addressing the IRFA. Accordingly, the Commission has prepared a Final Regulatory Flexibility Analysis (FRFA) concerning the possible impact of the rule changes contained in this document on small entities. This present FRFA conforms to the RFA.

This document contains modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens will invite the general public to comment on the information collection requirements contained in this document as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees.

In this present document, we have assessed the effects of requiring marketing disclosures on RF equipment manufacturers, some of which may be small entities, to market and import RF equipment, and find that the Commission's rules are not unduly burdensome. We believe the regulatory burdens the Commission is implementing are necessary to ensure that the public receives the benefits of innovative products and technologies in a prompt and efficient manner, and those burdens apply equally to large and small entities without differential impact.

The Commission has determined, and Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs, that this rule is “non-major” under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of the First Report and Order and Order of Proposed Modification to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).

The Commission's rules generally require that RF devices may be marketed within or imported to the United States only after they have been subjected to the appropriate equipment authorization procedure—certification or supplier's declaration of conformity (SDoC). These procedures require, among other things, that RF devices are tested to show compliance with the Commission's rules and technical standards. Currently the Commission's rules include some exceptions that provide for limited marketing and importation of RF devices that have not yet been subject to a complete equipment authorization process. For example, some marketing prior to equipment authorization is permitted in the form of conditional sales contracts between manufacturers and retailers of RF devices; and, in the early stages of the production process, such devices may be marketed to business, commercial, industrial, scientific, or medical users. In both instances, marketing to the general public is not permitted and the devices may not be delivered prior to equipment authorization. Similarly, limited quantities of unauthorized devices may be imported, but not marketed, for testing, demonstration, or personal use.

In June 2020, the Consumer Technology Association (CTA) filed a petition seeking to modify the rules pertaining to RF device marketing and importation. See Petition of Consumer Technology Association to Expand Marketing Opportunities for Innovative Technologies, RM-11857 (filed June 2, 2020) (CTA Petition). CTA asserted that the Commission's current equipment authorization rules can slow the process of developing and deploying new products and services, and it proposed rule revisions targeting the prohibition on conditional sales to consumers and the limited ability to import devices prior to authorization. In December 2020, after considering the petition, and the general support expressed in the associated record, the Commission initiated this proceeding, in which it proposed changes to the Commission's equipment marketing and importation rules that were informed to a large extent by the CTA Petition.

In the NPRM, the Commission proposed to broaden the existing conditional sales contract marketing exception beyond the limitation of “retailers and wholesalers.” The Commission acknowledged that new sales models increasingly involve online marketplaces that provide product developers and manufacturers direct access to consumers, thus involving customers in the product development process to a greater extent than before. As a result, device developers are provided with investment and incentive to produce innovative products and consumers benefit by seeing new products and features rolled out in a much shorter timeframe. While the Commission proposed the new marketing rule to allow manufacturers to better leverage this new development paradigm, it nonetheless recognized the continued importance of keeping unauthorized RF devices from becoming available, and it proposed that, even under the new rule, delivery or physical transfer of devices to consumers prior to equipment authorization would still be prohibited.

In addition, acknowledging industry's desire to speed the launch of new products to keep pace with the increasingly compressed innovation cycle, the Commission also proposed to broaden the conditions under which RF devices can be imported prior to equipment authorization. The Commission proposed to allow up to 4,000 RF devices to be imported prior to equipment authorization for the purposes of certain pre-sale activities, such as packaging and physical transfer to retail locations. Under this proposal, the RF devices could not be displayed to consumers prior to equipment authorization and the party responsible for importation would be required to take steps to ensure that appropriate device control is maintained until authorization is obtained.

Sixteen comments and one reply comment were filed in response to the NPRM. While some commenters suggest modifications to the Commission's proposals, all filers are generally supportive of the overall marketing and importation proposals.

The Commission recognizes that, in some instances, developments in the modern device marketplace have outpaced those in the Commission's equipment authorization regime. As a result, the Commission's rules may limit the ability to market and import RF devices in new efficient and cost-effective ways. The Commission therefore takes this opportunity to adopt the rule changes proposed in the NPRM, with clarifying revisions, which will provide additional options for taking advantage of modern product development practices while ensuring against the use of unauthorized RF devices. Accordingly, the Commission modifies its rules to include an additional option that will allow for more importation of RF devices prior to equipment authorization. Further, the Commission modifies its rules to allow conditional sales of RF devices prior to authorization, subject to certain requirements. In both instances, the Commission is adopting rules that are crafted in a manner to not undermine the Commission's equipment authorization program by continuing to prevent end users from having access to unauthorized RF devices. The Commission also makes targeted changes to its proposals to clarify its intent regarding the interaction between the revised marketing and importation rules. These changes eliminate a potential conflict between the proposed importation and marketing provisions, whereby imported and domestically-produced devices could be subject to disparate requirements. The rules the Commission are adopting remove this disparity and provide more consistent treatment by permitting similar opportunities prior to equipment authorization regardless of the device's country of origin.

In summary, the Commission is adopting a new condition under § 2.1204 and a revised exception under § 2.803 of the Commission's rules to allow the importation and marketing of certain RF devices, under specified constraints, prior to equipment authorization. In general, the Commission is allowing the importation of a maximum of 12,000 RF devices for pre-sale activity if those devices: (1) Are subject to a certification application that has been submitted to a Telecommunication Certification Body (TCB); (2) include an externally-visible temporary label prohibiting display to consumers, operation, and delivery of the device prior to the grant of certification; and, (3) remain under legal ownership of the device manufacturer, developer, importer or ultimate consignee, or their designated customs broker (who has a device retrieval process in place). Further, the Commission is revising an existing exception in the Commission's rules to expand to consumers the limited marketing and conditional sales of certain RF devices prior to equipment authorization. The existing exception generally allows conditional sales contracts between manufacturers and wholesalers or retailers provided that delivery is made contingent upon compliance with the applicable equipment authorization and technical requirements. The Commission's revisions to this condition expand conditional sales, and advertisements for such sales, to include other entities, including consumers, provided that the prospective buyer is advised at the time of marketing that delivery of the device is conditional upon successful completion of the applicable equipment authorization process. All devices must remain under the legal ownership of the initiating party ( i.e., the manufacturer or developer), but physical transfer may be permissible depending on the applicable device authorization requirement. Physical transfer is prohibited for devices subject to the Supplier's Declaration of Conformity equipment authorization process. Devices subject to certification can be physically transferred to contracting parties, other than the end user, for pre-sale activity if the devices include a temporary label and the initiating party has retrieval processes in place. The Commission also adopts the proposed revision to § 95.391, which prohibits the manufacturing, importation, and sales of non-certified equipment for the Personal Radio Services, to reflect the marketing exception the Commission adopts and adds an additional reference to reflect the import condition the Commission adopts.

The Commission is adopting the proposal to modernize its rules to allow a limited number of RF devices to be imported into the United States prior to equipment authorization for pre-sale activities, including packaging and transferring physical possession to retail locations, if those devices are subject to equipment authorization via the certification process. The rule the Commission adopt adds a new condition to § 2.1204 of the Commission's rules to allow the importation of up to 12,000 RF devices for pre-sale activity before the equipment successfully completes certification. The imported devices must be subject to the equipment authorization certification process ( i.e., excluding devices subject to Supplier's Declaration of Conformity process) for which an application has been submitted to a TCB. As noted above, the imported devices must include an externally-visible temporary label noting the prohibition of display to consumers, operation, and delivery of the device prior to the issuance of certification. The devices must also remain under legal ownership of the device manufacturer, developer, importer or ultimate consignee, or their designated customs broker, who must have in place a device retrieval process to be implemented in the event that the certification process is not successfully completed. The Commission believes this action will allow device manufacturers to better prepare for new product launches while guarding against a proliferation of unauthorized and non-compliant devices that might increase the risk of causing harm to consumers or other radio operations.

The rule proposed by the Commission in the NPRM largely reflected the proposal made by CTA in its petition. The Commission proposed to allow up to 4,000 RF devices to be imported for pre-sale activities prior to being certified. In this case, such pre-sale activities would include imaging, packaging, and delivery of devices to retail locations, but “exclude the displaying of the device to consumers prior to equipment authorization.” CTA Petition at 12, n. 44. Under the proposal, limited importation could occur if the manufacturer has a reasonable belief that the device would receive authorization within thirty days of importation. Additionally, the Commission proposed that the device include a temporary label regarding related compliance restrictions and the manufacturer would be required to maintain legal ownership of the devices, even after delivery to retail locations, until authorization is received, and have a process in place to retrieve the devices in the event that authorization is not obtained.

While all comments received support the proposal's intent, they include several requests to modify specific aspects, including the numerical limitation on the devices imported, the requirement that a manufacturer have a reasonable belief that authorization will be granted within 30 days of importation, and labeling requirements. The Commission addresses the various issues below and modifies the Commission's proposed rules, as appropriate, based on the comments received.

Numerical Limitation. The Commission is adopting rules that limit to 12,000 the number of RF devices that can be imported for pre-sale activities. While the Commission proposed to limit this new import condition to 4,000 devices, it asked whether a higher level, such as 8,000, would be more appropriate, whether a smaller number of devices would provide less risk of unauthorized devices becoming available to the general public, and whether any safeguards beyond a simple numerical limit would be necessary in this regard. Only HP Enterprise supports the proposed 4,000 device limit. Otherwise, commenters generally suggest that the Commission increases the device limit. Suggestions ranged from a non-specific increase, to a 10,000 device limit, and a more widely supported 12,000 device limit. Comments proposing 12,000 devices generally state the larger limit would account for the number of potential retailers throughout the country based upon the estimated numbers of “big box” stores and wireless provider locations, among others. Comments also note that a limit greater than 10,000 devices would increase the likelihood of more even distribution to both urban and rural areas while still being small enough to mitigate the potential risk of unauthorized widescale distribution.

Based on the record, the Commission finds that the proposed importation limit of 4,000 devices would not be sufficient to achieve the intended benefits. The Commission therefore adopts rules permitting up to 12,000 units of a particular device to be imported for pre-sale activities prior to the equipment being certified. As proposed, the Commission also adopts a provision to allow the importation of devices in excess of 12,000 subject to prior written approval from the Chief of the Office of Engineering and Technology. Overall, the Commission finds that a device limit of 12,000 will meet manufacturer and importer needs while not compromising the integrity of the Commission's equipment authorization program. The 12,000-unit limit is a maximum limit for a particular device across all ports of entry into the United States. Importation in excess of 12,000 units without prior written approval of the FCC is prohibited and may subject the manufacturer or importer to enforcement action.

The Commission's proposal did not specifically address how to differentiate devices when determining compliance with the maximum import quantity. Garmin provided comments suggesting that, in defining the importation limit for a device, the Commission applies the permissible quantity based on SKU number rather than to general product names or model brands. The Commission notes that restricting the importation limit to product name or model brand would restrict manufacturers from importing the full range of a new product, such as different sizes and product options. The Commission agrees with Garmin that additional clarification is necessary to provide certainty to manufacturers and importers that take advantage of the additional flexibility the Commission is providing regarding importation for pre-sale activity. As such, the Commission is adopting an additional provision to clarify that devices with different FCC IDs are considered to be separate devices; i.e., up to 12,000 devices with the same FCC ID number may be imported for pre-sale activities. The Commission adopts this requirement as opposed to a SKU number-based requirement as suggested by Garmin because FCC ID is the officially recognized method for identifying equipment, is required by FCC rules to be labelled on the device, and can be tracked through the FCC equipment authorization system database; SKU numbers, on the other hand, have no regulatory meaning under FCC rules. Moreover, use of FCC ID will not be burdensome for manufacturers and importers because, as discussed below, devices subject to the Commission's new rules may not be imported until an application for certification has been submitted and therefore an FCC ID will already be associated with such equipment.

Submission of Application for Certification. In the NPRM, the Commission proposed to require that manufacturers importing devices under the proposed exception have “a reasonable belief that authorization will be granted within 30 days of importation.” The Commission asked several questions related to how manufacturers could comply with this requirement. Most commenters stating that 30 days would not be sufficient suggest that 90 days would be more appropriate. Two filers, Information Technology Industry Council and the Joint Commenters (Telecommunications Industry Association, Association of Home Appliance Manufacturers, Engine, The internet Association, INCOMPAS, the Rural & Agriculture Council of America, and TechFreedom), suggest that 60-90 days would be generally sufficient and, for devices that require a TCB to coordinate with the OET Lab prior to taking action on the certification application, via the pre-approval guidance procedure, 120-180 days would be “reasonable.” One commenter, Information Technology and Innovation Foundation, states that the increased complexity of devices would make enforcing an expectation requirement difficult and suggests that the Commission allow manufacturers options for “demonstrating reasonable belief of imminent authorization,” such as relying on process milestones. Similarly, Samsung suggests that delivery to an accredited test lab or TCB for testing would be an appropriate basis for a reasonable expectation of authorization. R Street Institute (R Street) also notes that determining compliance with the criterion would be difficult and suggests that the Commission provides manufacturers flexibility in this regard, provided that they maintain documentation “demonstrating their internal logic regarding authorization.”

The Commission believes that parties who avail themselves of the new importation exception should be permitted to do so only if they reasonably believe that a certification will be issued as close to the importation date as is possible. However, based upon the record, the Commission declines to adopt the 30-day timeframe. As many commenters suggest that the timeframe needed for certification can be unpredictable depending on device complexity and other factors, the Commission is adopting a rule that does not include a specific timeframe but is instead based on the submission of the equipment certification application. As the commenters' recommendations are informed by their experiences with the equipment authorization process, requiring a reasonable belief of completion of certification activities within a specific timeframe would not accurately reflect the “real world” process in many circumstances. Similarly, if the Commission were to specify multiple timeframes to cover different situations, there would still be numerous scenarios not covered, thus adding an unnecessary level of complexity to the rule that could limit its utility and result in confusion and inconsistent applicability.

Accordingly, the Commission is adopting a requirement that importation for pre-sale activities prior to the device receiving certification can only occur after compliance testing is complete and an application for certification has been submitted, in good faith, to a TCB. At that point, an applicant will have expended considerable time, effort, and money to develop a product as well as entered into a testing and approval process that requires expending additional resources. The Commission finds that this specific milestone reflects a point in the certification process by which the applicant can reasonably expect a grant. Allowing importation prior to the completion of compliance testing would increase the risk associated with distributing the unauthorized devices because the testing could reveal compliance issues that require device modification. The Commission will not require any additional process milestones to be tracked to demonstrate compliance with the adopted rule. The Commission notes that some aviation and maritime devices subject to the equipment certification process require additional reviews and approvals, such as from the Federal Aviation Administration and the United States Coast Guard. In some cases those additional approvals from other agencies must be done prior to submitting an application for FCC equipment certification and in some instances approval may be obtained concurrently. The rule the Commission adopts here has no impact on those requirements, but entities intending to avail themselves of this new import condition should consider the processing time and technical requirements of those reviews and approvals in relation to the certification process to determine when to begin importation under the new condition. Further, the Commission notes that parties must satisfy all conditions required for their equipment and comply with all conditions imposed by all relevant agencies under which the equipment is regulated; permission to market devices under FCC rules does not provide similar approval from other relevant agencies and all requirements must be satisfied in accordance with those agencies' rules. The Commission expects applications to be filed in good faith, with accurate data and as completely as possible, and applicants must be responsive to any TCB requests for additional data.

The Commission is adopting its proposal to allow expanded conditional sales of RF devices prior to authorization, with appropriate clarifications regarding applicability and conditions. The internet provides today's consumer with numerous opportunities to obtain innovative new products both directly—via crowd-funding platforms at the developmental stages, and through sales and distribution services offered by manufacturers and developers—and indirectly, through third party marketplaces, both online and in person. This new-found ability to more easily obtain the latest products has led to savvier consumers, who have a greater awareness of technological developments and expect to obtain the newest products as soon as possible. At the same time, the ability to deal directly with consumers at the earliest stages of development has created new efficiencies and investment opportunities that provide smaller entities a chance to enter the competitive marketplace. The Commission's new rule will allow innovators to take advantage of modern product development practices and better satisfy the expectations of today's consumer without diminishing the protections that the Commission's overall marketing rules provide.

In the NPRM, the Commission proposed to modify its marketing rules in a manner that would allow consumers to participate in the conditional sales of devices that have not received authorization. The Commission did not receive any comments objecting to its overall marketing proposal. Commenters did note generally that, in addition to allowing consumers to receive new devices sooner, the proposal would provide benefits throughout the supply chain that would allow production to better match expected demand, thus providing efficiencies that would lower costs and reduce waste in raw materials and energy. One comment suggests that the new marketing exception apply to the broadest category of devices and no commenters suggest excluding any devices.

The Commission remains mindful that it must continue to protect against the possibility of unauthorized RF devices making their way to consumers and adopt rules intended to prevent such occurrences while expanding marketing opportunities for innovators. Additionally, the rules the Commission proposed in the NPRM to allow pre-sale activities for imported devices would not have permitted similar flexibility for domestically-produced devices. Thus, in adopting rules to permit marketing activities prior to equipment certification, the Commission also provides flexibility in the Commission's marketing provisions to allow for pre-sale activities similar to those that the Commission is allowing for imported devices. This action implements more consistent measures for similarly-situated devices with similar safeguards to prevent unauthorized devices from getting to consumers. Further, the Commission's action will also benefit consumers, who will be able to see and examine devices earlier so that they can make more timely purchase decisions, and retailers, who will gain the opportunity to become familiar with the features associated with new devices to better prepare those devices for display and sale once they are certified and may be operated.

As proposed in the NPRM, the Commission is broadening the applicability of the prior conditional sales contract provision found in § 2.803(c) of the Commission's rules, which now will allow for conditional sales to consumers. Specifically, the Commission is modifying § 2.803(c)(2)(i) to allow conditional sales contracts and advertising for RF devices that have not yet received authorization, under particular delivery and physical transfer conditions and a requirement that the contracting party advises the buyer at the time of marketing that the equipment is subject to FCC rules and delivery is conditional upon successful completion of the applicable equipment authorization process.

In the NPRM, the Commission proposed to allow conditional sales contracts between manufacturers and potential customers. The intent was to broaden the rule that originally limited conditional sales to contracts between manufacturers and wholesalers or retailers, which was based on a concern that unauthorized devices that made their way to consumers could cause harmful interference to radio communications. Ensuring that unauthorized RF devices do not cause harm remains among the Commission's highest concerns. However, recognizing that product marketing and distribution methods have evolved due to the internet and new crowd-funding practices which bring the consumer into direct contact with the developer or manufacturer, and based on the comments received in response to the NPRM, the Commission is adopting a more flexible rule that does not limit conditional sales contracts to transactions only between manufacturers and potential customers.

In the NPRM, the Commission declined to propose a rule that included the term “responsible party” in lieu of “manufacturer” as suggested by CTA, and instead proposed conditional sales contracts between manufacturers and potential customers. The Commission explained its concerns that, given the specific meaning of the term, “responsible party” would not be appropriate in this context. Further, the Commission asked for comment on this determination and asked questions about more suitable alternatives. While no commenter suggests replacing “manufacturer” with “responsible party,” Samsung Electronics America (Samsung) suggests that the Commission clarifies that affiliates and related corporate entities should be considered acceptable in the context of “manufacturer.” Additionally, while not providing specific rule changes, Samsung and CTA suggest the Commission clarifies that the rule would also cover contracts between manufacturers and retailers/wholesalers.

The Commission's intent in proposing to expand conditional sales contract to “manufacturers and potential customers” was to broaden the pool of parties allowed to enter into conditional sales contracts with manufacturers, specifically to include consumers. Considering the information in the record, the Commission finds that inclusion of the phrase “between manufacturers and potential customers” would raise confusion as to who may enter into conditional sales contracts. The Commission recognizes that modern product development and distribution systems can be complex and involve multiple entities in various roles. As discussed in the NPRM, the Commission understands that, with the proliferation of internet-based direct-to-consumer sales and e-commerce platforms, various entities can access multiple distribution models to reach consumers. To ensure that the language of the Commission's revised marketing regulation does not hinder innovation or provide unfair advantage or disadvantage to particular entities, the Commission finds that it is not necessary to specify the permissible parties to the conditional sales contracts. Thus, manufacturers, developers, or other entities responsible for new device creation, development, or production will be able to define their own role in the distribution and supply chain of their devices. The Commission finds this to be particularly important for smaller or new device developers who may not manufacture their devices but wish to engage in the sale and distribution process so they can appropriately plan for manufacturing and distribution. By expanding the pool of parties to the conditional sales contracts, the Commission is implementing rules that encourage and expand opportunities for innovation and allow developers or other parties that are not themselves a manufacturer to participate in the sale and marketing of a device. At the same time, as noted below, the Commission continues to prohibit delivery to consumers prior to completion of the equipment authorization process.

In this regard, the Commission modifies § 2.803(c)(2)(ii), a separate provision that allows limited marketing, in the form of sales, to a narrow class of specialized entities. As noted in the NPRM, CTA had asked that the provision be deleted or replaced with language specifically addressing manufacturers' ability to engage in activities related to the Commission's importation proposal. The Commission in the NPRM sought comment on whether a change to the provision was necessary to achieve the proposal's discrete objective and whether doing so could eliminate an important avenue for limited marketing that exists outside the conditional sales contract context. In response to the NPRM, CTIA requests that the Commission deletes § 2.803(c)(2)(ii), as it believes the new rule would eliminate the need for this section and retaining it in the rules would be confusing.

In light of the information in the record and the changes the Commission is making to § 2.803(c)(2)(i) by expanding applicability to all parties, the Commission finds that § 2.803(c)(2)(ii) is no longer necessary and the Commission removes it. The language that the Commission is adopting in § 2.803(c)(2)(i) encompasses conditional sales to all parties, including business, commercial, industrial, scientific, or medical users, thereby negating the need for a separate exception targeted at those users.

The Commission also clarifies the conditions under which conditional sales contracts may be made. The proposed rule would have provided that delivery of devices subject to conditional sales contracts would be conditional upon a determination that the equipment complies with the applicable equipment authorization and technical requirements. To clarify the requirement, the rule the Commission is adopting instead states that delivery is conditional upon “successful completion of the equipment authorization process.” This change does not eliminate the need for determining compliance with the Commission's technical requirements, but it more accurately reflects both of the Commission's equipment authorization processes and the required milestone for delivery. This better conveys the Commission's intent by removing the ambiguity of a subjective condition referenced only to “a determination that the equipment complies with the applicable equipment authorization and technical requirements” rather than the actual completion of the equipment authorization process.

While the Commission now will permit conditional sales of RF devices prior to equipment authorization, the Commission reiterates the importance of continuing to ensure that unauthorized RF devices do not reach consumers. No commenter suggests otherwise and several explicitly express support for retaining the prohibition. Thus, the rule the Commission is adopting continues to prohibit delivery of RF devices to consumers prior to completion of the equipment authorization process. The Commission expects that the disclosure requirements discussed below will ensure that there is no consumer expectation of early delivery. Likewise, the other process safeguards the Commission discusses below should ensure that sellers take all necessary steps to prevent operation of unauthorized devices and delivery to consumers. These safeguards include provisions, previously introduced in the NPRM' s proposed importation provision, to allow devices subject to certification to physically move through the supply chain as far as the retailer, stopping short of the consumer.

In the NPRM, the Commission noted that the proposed rule could be seen as lessening the barriers between device developers, manufacturers, distributers, and consumers and asked whether any additional safeguards would be warranted to protect against harmful interference. Specifically, the Commission asked, with regard to both marketing and importation, whether there are certain types of devices for which conditional sales to consumers would not be appropriate, citing as examples devices that would operate in bands that are subject to rigorous coordination or installation requirements and devices that operate to ensure safety of life onboard ships and aircraft. The Commission also asked whether there are ways to prevent devices from being marketed that have no likelihood of being approved due to compliance issues and whether equipment that could operate only under a Commission waiver should be prohibited from marketing prior to the Commission granting a waiver. One comment suggests that the new rule permitting conditional sales apply to the broadest category of devices and no commenters suggest excluding any devices.

Equipment authorization of RF devices can be completed by one of two processes. Certification involves rigorous testing by an FCC-recognized accredited testing laboratory and listing in a Commission database. By contrast, SDoC is a self-certification process that gives the manufacturer substantially greater control over determining when a product meets the Commission's equipment authorization requirements. While not adopting any specific device exclusions at this time, the Commission finds that requiring devices to complete the existing equipment authorization processes will facilitate movement of devices through the supply chain while maintaining controls to ensure against unauthorized use and delivery to consumers. Specifically, the Commission sees the two equipment authorization processes as providing a means by which to distinguish between types of devices in implementing various controls to limit physical access to unauthorized RF devices.

Upon further analysis of its proposals, the Commission observes that the proposal to permit conditional sales prior to completion of the applicable equipment authorization process applied to all devices whether they originated from domestic or foreign sources. However, the Commission's new importation rules as adopted herein allow for pre-sale activities where certain imported devices can be physically transferred to retail locations, but the same flexibility was not specifically proposed for other devices. Allowing transfer of physical possession of certain imported devices to retailers, but not other devices, would result in a disparity in the treatment of similar devices based on whether they are imported or manufactured or developed in the U.S. To ensure consistent measures between similarly situated devices regardless of their origin, the Commission will permit devices subject to the equipment authorization certification process to engage in the same pre-sale activities and under similar conditions the Commission adopts for imported devices. Specifically, the Commission will allow the physical possession of devices subject to certification to be transferred to distributers and retailers. Neither in the Commission's import nor marketing provision does it extend this flexibility to devices subject to SDoC because, unlike the more rigorous requirements associated with the certification process, the SDoC process provides manufacturers more flexibility in determining compliance with the FCC's technical requirements.

The marketing rule provision the Commission is adopting will permit physical transfer of devices subject to certification procedures, and for which an application has been submitted to a TCB and compliance testing is complete, for the sole purpose of pre-sale activity, which includes packaging and transferring physical possession of devices to distribution centers and retailers. Pre-sale activity does not include display or demonstration of devices to consumers. This provision prohibits physical transfer of RF devices subject to Supplier Declaration of Conformity prior to completion of that process. It also requires that the party initiating the first conditional sales contract maintain legal ownership of the relevant devices.

The NPRM proposed to require manufacturers that engage in pre-sale activities to maintain legal ownership of imported RF devices that had not received equipment authorization, even after physically transferring them to retailers. When it made the proposal, the Commission asked whether the requirement would further the Commission's goal of keeping unauthorized devices from causing harm to consumers or other radio operations, whether additional restrictions related to the delivery and location of devices after importation would be necessary, and about the manufacturer's responsibility in the event of unauthorized operation. The Commission also asked several questions related to the specific process of complying with the requirement and whether the benefits of the rule would outweigh any burdens that it would place on those involved in the process, such as manufacturers and retailers.

Samsung states that requiring manufacturers to retain legal ownership of imported RF devices will incentivize manufacturers to ensure that retailers and other partners abide by the labeling rules and other safeguards. Samsung recommends that the Commission clarify that agreements exercising the new importation condition to deliver devices to retail locations prior to authorization do not violate the § 2.803 marketing rules. Samsung argues that the current text of § 2.803(c)(2) may constrain the ability of manufacturers and retailers (as well as others in the distribution chain) to exercise the new importation condition to deliver devices to retail locations while extracting representations and warranties to abide by the Commission's safeguards. As an alternative to adding a new subsection to § 2.803, Samsung recommends that the Commission clarifies that contracts exercising the new condition, including physical transfer to retail partner locations, do not constitute marketing pursuant to § 2.803. Similarly, CTA recommends that the Commission clarifies that the proposed new importation condition does not violate the Commission's marketing rules, but rather allows physical transfer of RF devices to retail locations with the safeguard of a manufacturer retaining legal ownership of those devices. CTA observes that manufacturers and retailers must have agreements in place to ensure that those devices are properly labeled, delivered, and stored until they are authorized for consumer use.

The intent of the Commission's proposed rule on ownership of imported RF devices was to protect consumers by ensuring that devices that have not yet been authorized are not operated. The Commission finds that it can achieve that important goal for both marketed and imported devices that have completed certification testing and been submitted to a TCB for approval by providing a process that allows for physical transfer of marketed devices while legal ownership is maintained by the first party to initiate a conditional sales contract ( i.e., a developer or manufacturer, or similar party) or, in the case of imported devices, by the device manufacturer, developer, importer or ultimate consignee, or their designated customs broker.

By permitting the physical transfer of devices, the Commission will allow entities to take full advantage of modern marketing and importation practices while still protecting against unauthorized use of devices that have not completed the equipment authorization process. The Commission is adding a new subsection to § 2.803 of the Commission's rules establishing the requirements applicable to ownership and physical transfer of such devices.

The Commission believes that most consumers today are generally familiar with conditional sales and delayed delivery of new devices. However, it needs to ensure that consumers purchasing devices that have not yet received authorization are aware of the conditions for delivery before entering into a conditional sales agreement. The Commission is therefore adopting, as proposed, a requirement that the prospective buyer be advised at the time of marketing, through a prominent disclosure, that the equipment is subject to FCC rules and delivery to the end user is conditional upon successful completion of the applicable equipment authorization process.

In the NPRM, the Commission asked several questions regarding the implementation and scope of this disclosure requirement. For example, the Commission asked whether additional disclosures should be required throughout the equipment authorization process and, in the event that authorization is not obtained, how consumers would be notified, and whether the Commission should require refund information to be provided in the required disclosure. The Commission also asked about the responsibility of online retailers to ensure that all device advertisements involving conditional sales include the required disclosures, and whether unique identifying information ( e.g., model numbers, expected FCC ID) that may be known at the time of marketing, should be required in online advertisements. Finally, the Commission asked whether it should require manufacturers to include a label on device packaging noting that it must not be delivered to consumers prior to obtaining equipment authorization and, if so, what additional information to require on the label.

While two commenters suggest that the Commission provide specific disclosure language, most commenters suggest a more general requirement. However, INCOMPAS suggests that the Commission specifically require a refund for consumers when device authorization is not obtained. Information Technology Industry Council also argues in favor of a refund requirement and disclosures on how consumers can obtain refunds. The Public Interest Organizations (New America's Open Technology Institute, Public Knowledge, Consumer Reports, and Access Humboldt) went further, requesting the Commission require companies utilizing the marketing exception to establish escrow funds for such refunds. On the other hand, regarding a consumer refund process, many commenters state the Commission should not adopt specific requirements or, generally, that no additional requirements beyond the proposal are necessary.

The Commission finds that it is necessary and appropriate for parties initiating conditional sales contracts to advise buyers at the time of marketing, through a prominent disclosure, that the equipment is subject to FCC rules and delivery is conditional upon successful completion of the appropriate equipment authorization process. To ensure that the Commission's new rules for conditional sales to consumers do not lead to unanticipated problems, the Commission will also require this disclosure to make clear that these rules do not address the applicability of consumer protection, contractual, or other provisions under federal or state law. The contractual nature of these conditional sales, along with the relevant contractual remedies available to the buyers, should provide sufficient incentive for the sellers to ensure that buyers are adequately informed of the conditions of sale, including a refund process, if device authorization is not successfully completed. Nevertheless, the Commission will require the initiating party to include in their disclosure notification of any responsibility of the initiating party to the buyer in the event that the applicable equipment authorization process is not successfully completed, including information regarding any applicable refund policy. While most consumers are familiar with conditional sales, the Commission finds that requiring this information will minimize potential confusion for consumers who are unfamiliar with conditional sales. Although CTA suggests that such disclosure could confuse consumers who are already aware of the applicable refund policy, the Commission finds such confusion unlikely, and finds on balance that the public interest is better served by making this information available to all consumers as part of the disclosure the Commission is requiring here. The Commission does not find that it is necessary to require standardized language for the disclosures nor does the Commission believes that it needs to take any additional measures to ensure that buyers are informed of the conditional nature of the sales contracts.

However, the Commission does find that it is important to ensure that devices are not delivered to consumers and that distributers, retailers, consumers, and other relevant entities are aware that the devices must not be operated before equipment authorization is complete. In addition to disclosures, the Commission is adopting the temporary labeling requirement for RF devices when parties engage in pre-sale activities that the Commission proposed for imported devices and extending that requirement to devices under the marketing provisions adopted by this document for those same pre-sale activities. In the NPRM, the Commission requested comment about requiring a temporary label on device packaging and what information that label should include. The Commission went on to propose that devices imported prior to certification under the new exception include a temporary removable label that includes a specific warning against premature operation, display, offers for sale, marketing, or sales and asked whether additional information should be incorporated into such a label. Garmin, INCOMPAS, and Hewlett Packard Enterprise specifically opposed such a requirement, generally stating that it would not be worth the investment in time and material. While R Street agreed with the requirement, other supportive comments generally suggested that existing labeling requirements would be sufficient, or pointed to Commission guidance for temporary physical labels under the e-labeling procedures for RF devices. No comments supported a temporary labeling requirement beyond that proposed by the Commission.

The Commission continues to believe that a temporary label indicating the status of RF devices will provide a necessary safeguard against the inadvertent transfer of such devices to consumers and the Commission is adopting the rule in both the importation and marketing provisions with some modifications to the required language for consistency with other provisions in the new rules. Specifically, when parties engage in pre-sale activities, the Commission clarifies that the device or its packaging must prominently display a visible temporary label. This will ensure that the temporary label is not hidden inside the device packaging where it would not be visible. The Commission also clarifies that the device cannot be displayed to consumers, operated, or delivered to end users until successful completion of the applicable FCC equipment authorization process. The Commission is not adopting the Commission's proposal that the label on imported devices include language prohibiting offers of sale and marketing, thus ensuring consistency in labeling for both imported and domestic devices. The devices must not be available to consumers until after the successful completion of the certification process and the Commission expects that at the time of sale they will be in compliance with all pertinent information, technical, labeling, and other requirements within the Commission's rules. Because the labels are temporary, the Commission finds that it would be unduly burdensome to require the inclusion of any additional information such as authorization status or specific contact information or otherwise include any specific compliance guidance with the rules. As to compliance via the Commission's existing requirements for electronic labeling (e-labeling) of RF devices, it appears likely that commenters are referring to § 2.935(f) of the Commission's rules which requires an external removable label that addresses compliance with any applicable Commission requirements. However, in this case, as the temporary label requirement is specifically codified in the Commission's new rule, strict compliance with § 2.935(f) is not necessary and would likely not be desirable.

Once authorization has been completed, the RF devices must comply with all pertinent Commission labeling and disclosure requirements. The Commission adopts its proposal to allow, but not require, the anticipated FCC ID to be included if obscured by a temporary label until equipment authorization is successfully completed. Otherwise, the Commission is not adopting requirements that specifically detail actions required to ensure compliance in this regard.

As proposed in the importation provision of the NPRM, the Commission is requiring processes to retrieve equipment to be in place prior to the commencement of pre-sale activities, and clarifying that those processes must be implemented, in the event that authorization is not successfully completed. In this regard, the Commission also asked several questions about the level of detail of the process that should be codified and the requirements for records retention and submission. With the exception of R Street, commenters do not offer any specific suggestions regarding retrieving equipment if authorization were to be denied, but generally indicate that existing Commission processes are adequate, and advocate a “light touch” regulatory approach. R Street recommends that the Commission require RF device manufacturers to submit formal plans to retrieve devices to limit the ability for bad actors to let devices simply remain in the public sphere, rather than bear the cost of retrieving the devices. R Street suggests that these risks could be further limited by features such as a remote shutdown requirement on the devices, but notes that the benefits of such an approach may be limited by the costs of implementing it. The Commission had asked about this remote shutdown approach, noting some similarity to scenarios in which unauthorized devices operate under a part 5 experimental authorization.

In light of the expanded physical transfer provisions the Commission is adopting in its marketing rule, the Commission finds it necessary that the marketing provisions also require a process for retrieval of devices, and completion of that process, in the event that authorization is not successfully completed when parties engage in pre-sale activities. Although the Commission is adopting this retrieval requirement in both the Commission's importation and marketing rules, the language of the two provisions varies slightly to accurately designate the party responsible for the retrieval activities. For marketed devices, the burden is on the first party to initiate a conditional sales contract or to physically transfer devices, while for imported devices, the burden is on the device manufacturer, developer, importer or ultimate consignee, or their designated customs broker. In both instances, this will ensure that the party in legal ownership of the devices, regardless of the devices' physical location, will be responsible for maintaining and implementing a process for retrieval if the applicable equipment authorization cannot be successfully completed. The language the Commission adopts in the importation provision, which was limited to the manufacturer in the Commission's proposal, is consistent with party designations referenced in the Commission's other existing importation conditions.

In the NPRM, the Commission proposed a recordkeeping requirement for devices imported prior to equipment authorization that would require manufacturers to maintain, for a period of 5 years, records identifying the recipient of the devices along with information about the devices and the shipping. The Commission asked several questions related to the need for recordkeeping and related reporting and responsibility issues. The Commission's recordkeeping questions were informed by its concerns about situations where pre-ordered devices are not ultimately authorized and enforcement actions may be required. Commenters generally recommend either no new recordkeeping or minimal requirements. No commenter supports additional reporting requirements. Samsung states that adopting new record retention requirements is not necessary because manufacturers regularly retain records related to equipment authorization that must be presented to the Commission upon request. Amazon states that an overly prescriptive approach or burdensome reporting and recordkeeping requirements are not necessary to protect consumers.

The Commission finds that the recordkeeping requirement proposed in the NPRM is the minimal required to ensure that, should it become necessary, the Commission will have access, as needed for enforcement or other purposes, to information regarding devices imported prior to authorization. The Commission therefore adopts the recordkeeping requirement with a change to the party responsible for recordkeeping. Specifically, recordkeeping will be the responsibility of the device manufacturer, developer, importer or ultimate consignee, or their designated customs broker. In addition to being consistent with other importation recordkeeping requirements in the Commission's rules, this change also acknowledges that entities other than a device manufacturer may be responsible for the importation of these devices.

Because the new marketing exception the Commission adopts here expressly prohibits the delivery to end users any of the subject devices prior to authorization, it follows that compliant entities would maintain legal or physical possession, as appropriate, of the pre-ordered devices as provided in the Commission's rules. Thus, the Commission does not see a benefit to imposing reporting requirements, as they would not directly further the Commission's underlying goal of keeping unauthorized devices from becoming available to the general public. Further, the Commission believes that it is good business practice to maintain sales documentation and thoroughly track customers, particularly when, as with the Commission's marketing exception, sales are conducted through conditional sales contracts. The Commission expects that sellers, through the normal course of business, will maintain records of the conditional sales contract permitted by the marketing rule the Commission is adopting through this Report and Order. So, the Commission is not adopting any new reporting requirements, but the it is adopting a recordkeeping requirement consistent with that adopted for devices imported prior to equipment authorization. The party initiating a conditional sales contract or physically transferring devices under the Commission's new marketing exception must maintain, for a period of five years, records identifying each entity to whom a device is conditionally sold or physically transferred, the device name and product identifier, the quantity conditionally sold or physically transferred, the date on which the device authorization was submitted, and the expected FCC ID number. The party initiating the conditional sales contract or physically transferring devices must provide these records upon the request of Commission personnel.

In the NPRM, the Commission asked several questions about the appropriate enforcement actions that should be taken in the event of non-compliance with any of the new importation requirements and the effect the marketing proposal would have on enforcement activities. It specifically asked questions about appropriate sanctions for instances where unauthorized devices are delivered to consumers prior to receipt of the equipment authorization, including, for example, whether the base forfeiture for such violations should be based on the number of units delivered and whether the Commission should deny future equipment authorization applications from grantees who deliver unauthorized devices to consumers. Additionally, the Commission asked about how to hold online vendors accountable and what penalties would apply to any consumer who operates an unauthorized device that was obtained through a violation of the Commission's conditional sale procedure.

Commenters did not specifically address enforcement related to the importation proposal. While some commenters expressed concerns about risks to consumers in the event that equipment authorization is not ultimately obtained, none cited this concern as a reason to not adopt the proposed rule. No commenters provided specific recommendations regarding the consideration of violations or the determination of appropriate penalties. Any comments that addressed enforcement generally stated that existing enforcement tools would provide sufficient means to address compliance issues without any modification.

Commenters generally concurred that the FTC and state agencies and courts would be appropriate venues for consumer contractual complaints. Information Technology and Innovation Foundation states that there is always a risk of bad actors knowingly flouting regulations or small, unsophisticated parties unknowingly failing to comply, but that the risk of non-compliant radios becoming publicly available does not seem to increase with the Commission's proposed rule changes. However, Information Technology and Innovation Foundation recommends that the Commission should always view enforcement as a primary concern. Information Technology Industry Council notes existing safeguards that are currently in place via not only the Commission, but also the FTC and states' attorneys general, and argues that new Commission enforcement mechanisms are not necessary. Similarly, CTA argues that consumer redress mechanisms are in place, if necessary, and that if a manufacturer does not deliver a device where a customer remitted some consideration, the FTC and state consumer protection agencies are experts in redressing such harms.

The Commission finds that other agencies, including the Federal Trade Commission and the various states' attorneys general, would be the appropriate venues for consumer complaints about these issues and the Commission will not implement additional enforcement measures at this time. The Commission's rules already include exceptions for marketing prior to equipment authorization. Although the exception that the Commission adopts today provides for a greater scale of pre-authorization device marketing, the Commission believes that its existing enforcement measures will be sufficient to mitigate and address potential harm.

In the NPRM, the Commission acknowledged an open equipment authorization proceeding, ET Docket 15-170, which also asked questions about importation, and tentatively concluded that the Commission's new marketing and importation proposals may be acted upon separately. See Amendment of Parts 0, 1, 2, 15 and 18 of the Commission's Rules regarding Authorization of Radiofrequency Equipment, ET Docket No. 15-170, Notice of Proposed Rulemaking, 30 FCC Rcd 7725 (2015) ( 2015 Equipment Authorization Notice ); and Amendment of Parts 0, 1, 2, 15 and 18 of the Commission's Rules regarding Authorization of Radiofrequency Equipment, ET Docket No. 15-170, First Report and Order, 32 FCC Rcd 8746 (2017) ( 2017 Equipment Authorization Order ). Two commenters specifically requested that the Commission also take action on two proposals from ET Docket 15-170.

In the context of the Commission's importation exception, Garmin suggests that the Commission revisit its outstanding proposal for “provisional certification.” In the 2015 Equipment Authorization Notice, the Commission discussed the idea of a “provisional certification” as a potential method for addressing the confidentiality concerns of applicants for certification in which granted certifications would not be included in the Commission's public database before the RF device is made available for sale. The Commission also suggested that a provisionally certified device could also be imported prior to acknowledgement in the Commission's database. Garmin submitted several filings in support of the proposal in ET Docket 15-170. As a provisional grant of certification procedure would affect all stakeholders in the equipment authorization process, it goes beyond the narrow focus of this proceeding, the marketing and importation rules. Thus, the Commission does not believe that this Report and Order provides an appropriate venue for the proposal's consideration. Additionally, as an alternative to the provisional grant proposal, Garmin also includes an entirely new proposal for a “deferred grant eligibility confirmation letter” which would be issued by a TCB prior to the grant of certification. Such a letter would indicate the device has met the equipment authorization requirements and the grant would not occur until a date specified by the applicant. This proposal would similarly impact many aspects of the equipment authorization process, and the responsibilities of TCBs, in particular, so the Commission likewise believes it is beyond the scope of this proceeding.

Additionally, one commenter, CTIA suggested that the Commission also act on outstanding proposals related to the certification of modular transmitters. A modular transmitter is a completely self-contained RF transmitter device that typically is incorporated into another product and is subject to, among others, the requirements of § 15.212 of the Commission's rules. The 2015 Equipment Authorization Notice included proposed changes to these requirements and compliance with such requirements in the context of the certification process. These proposals relate to the certification process and it is not necessary for us to take action at this time to allow us to adopt the instant marketing and importation rules.

In June 2020, the Consumer Technology Association (CTA) filed a petition for rulemaking seeking modification of the Commission's rules pertaining to the marketing and importation of radiofrequency (RF) devices. CTA argued that those rules were out-of-date and may hinder development and deployment of state-of-the-art RF products and services. In December 2020, after considering the petition, and the general support expressed in the associated record, the Commission initiated this proceeding, proposing changes to the Commission's marketing and equipment rules that were informed to a large extent by the CTA Petition.

In this Report and Order the Commission adopts targeted enhancements to the Commission's marketing and importation rules that will allow equipment manufacturers to better gauge consumer interest and prepare for new product launches. Given the rapid and widespread deployment of the radiofrequency (RF) devices integral to nearly all aspects of modern life, these steps will further the communications sector's ability to drive innovation and promote economic growth. As product development cycles have accelerated, new marketplace models and assessment tools have emerged that rely on individual interest to fund products and allow sellers to optimize the number of products they produce or import to match anticipated sales. The rules the Commission adopts will allow manufacturers to better utilize these tools to speed the newest technologies and must-have devices to consumers. The Commission has crafted these rules in a manner that will not harm the underlying goals of the Commission's equipment authorization program: Ensuring that the communications equipment Americans rely on every day, such as their cellphones and Wi-Fi devices, comply with the Commission's technical rules; and providing assurance to all spectrum users that their devices will work as intended and operate free from harmful interference.

There were no comments filed that specifically addressed the rules and polices proposed in the IRFA.

Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those comments. The Chief Counsel did not file any comments in response to the proposed rules in this proceeding.

The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

Small Businesses, Small Organizations, Small Governmental Jurisdictions. The Commission's actions, over time, may affect small entities that are not easily categorized at present. The Commission therefore describes here, at the outset, three broad groups of small entities that could be directly affected herein. First, while there are industry specific size standards for small businesses that are used in the regulatory flexibility analysis, according to data from the Small Business Administration's (SBA) Office of Advocacy, in general a small business is an independent business having fewer than 500 employees. These types of small businesses represent 99.9% of all businesses in the United States, which translates to 30.7 million businesses.

Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2018, there were approximately 571,709 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.

Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2017 Census of Governments indicate that there were 90,075 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 36,931 general purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment populations of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, the Commission estimates that at least 48,971 entities fall into the category of “small governmental jurisdictions.”

Radio Frequency Equipment Manufacturers (RF Manufacturers). Neither the Commission nor the SBA has developed a small business size standard applicable to Radio Frequency Equipment Manufacturers (RF Manufacturers). There are several analogous SBA small entity categories applicable to RF Manufacturers—Fixed Microwave Services, Other Communications Equipment Manufacturing, and Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing. A description of these small entity categories and the small business size standards under the SBA rules are detailed below.

Fixed Microwave Services. Microwave services include common carrier, private-operational fixed, and broadcast auxiliary radio services. They also include the Upper Microwave Flexible Use Service, Millimeter Wave Service, Local Multipoint Distribution Service (LMDS), the Digital Electronic Message Service (DEMS), and the 24 GHz Service, where licensees can choose between common carrier and non-common carrier status. There are approximately 66,680 common carrier fixed licensees, 69,360 private and public safety operational-fixed licensees, 20,150 broadcast auxiliary radio licensees, 411 LMDS licenses, 33 24 GHz DEMS licenses, 777 39 GHz licenses, and five 24 GHz licenses, and 467 Millimeter Wave licenses in the microwave services. The Commission has not yet defined a small business with respect to microwave services. The closest applicable SBA category is Wireless Telecommunications Carriers (except Satellite) and the appropriate size standard for this category under SBA rules is that such a business is small if it has 1,500 or fewer employees. For this industry, U.S. Census Bureau data for 2012 show that there were 967 firms that operated for the entire year. Of this total, 955 firms had employment of 999 or fewer employees and 12 had employment of 1,000 employees or more. Thus under this SBA category and the associated size standard, the Commission estimates that a majority of fixed microwave service licensees can be considered small.

The Commission does not have data specifying the number of these licensees that have more than 1,500 employees, and thus is unable at this time to estimate with greater precision the number of fixed microwave service licensees that would qualify as small business concerns under the SBA's small business size standard. Consequently, the Commission estimates that there are up to 36,708 common carrier fixed licensees and up to 59,291 private operational-fixed licensees and broadcast auxiliary radio licensees in the microwave services that may be small and may be affected by the rules and policies discussed herein. The Commission notes, however, that the microwave fixed licensee category includes some large entities.

Other Communications Equipment Manufacturing. This industry comprises establishments primarily engaged in manufacturing communications equipment (except telephone apparatus, and radio and television broadcast, and wireless communications equipment). Examples of such manufacturing include fire detection and alarm systems manufacturing, Intercom systems and equipment manufacturing, and signals ( e.g., highway, pedestrian, railway, traffic) manufacturing. The SBA has established a size standard for this industry as all such firms having 750 or fewer employees. U.S. Census Bureau data for 2012 shows that 383 establishments operated in that year. Of that number, 379 operated with fewer than 500 employees and 4 had 500 to 999 employees. Based on this data, the Commission concludes that the majority of Other Communications Equipment Manufacturers are small.

Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing. This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment. The SBA has established a small business size standard for this industry of 1,250 employees or less. U.S. Census Bureau data for 2012 show that 841 establishments operated in this industry in that year. Of that number, 828 establishments operated with fewer than 1,000 employees, 7 establishments operated with between 1,000 and 2,499 employees and 6 establishments operated with 2,500 or more employees. Based on this data, the Commission concludes that a majority of manufacturers in this industry are small.

In the Report and Order, the Commission adopts rules that affect reporting, recordkeeping, and other compliance requirements for small entities. Regarding marketing of RF devices, the Report and Order will require that the seller of a conditionally-purchased RF device advise the conditional purchaser that the device is subject to FCC rules, and that delivery of the device to the purchaser is contingent upon device compliance with applicable FCC equipment authorization and technical requirements. Regarding importation of RF devices into the United States prior to equipment authorization for pre-sale activities—including imaging, packaging, and delivery to retail locations—the Report and Order will require that each imported RF device display a temporary removable label stating that it cannot be displayed, operated, offered for sale, marketed to consumers, or sold prior to proper FCC equipment authorization has been granted, and will further require that importing manufacturers have processes in place to retrieve any equipment transferred to a conditional purchaser, in the event that such authorization is denied by the FCC. Moreover, importing manufacturers will be required to maintain, for a period of 60 months, records identifying the recipients of RF devices imported for pre-sale activities. Such records must identify several factors such as the device name and product identifier, the quantity shipped, the date on which the device authorization was sought, the expected FCC ID number, and the identity of the recipient, including address and telephone number.

The Report and Order also particular recordkeeping requirements that will be imposed on RF manufacturers so that RF equipment that is conditionally sold can be accounted for if equipment authorization is ultimately not granted or enforcement action needs to be taken, and the period of time that manufacturers should be required to retain those records and provide them to the FCC upon request. Additionally, the Report and Order requests that a manufacturer that imports an RF device should be required to document (and provide such documentation to the FCC upon request) the basis for its belief that the FCC will authorize that device.

The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.

The Report and Order rules set forth are minimal, and the Commission believes would significantly assist RF equipment manufacturers, some of which may be small entities, to market and import RF equipment. Although the Commission believe that the Commission's rules are not unduly burdensome, the Commission sought comment on a number of alternatives or supplements to those rules and procedures, such as whether the Commission should require marketing disclosures at all or just some points of the pre-authorization process, whether the Commission should require specific language or instead permit parties to choose how they word their disclosures, and whether all or only certain importation safeguards are needed.

The Commission believes that the regulatory burdens that the Commission is implementing are necessary in order to ensure that the public receives the benefits of innovative products and technologies in a prompt and efficient manner, and those burdens apply equally to large and small entities, thus without differential impact. The Commission will continue to examine alternatives in the future with the objectives of eliminating unnecessary regulations and minimizing any significant impact on small entities.

It is ordered that, pursuant to sections 4(i), 301, 302, 303(c), 303(f), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 302a, 303(c), 303(f), and 303(r), this Report and Order is adopted as set forth above.

It is further ordered that the amendments of the Commission's rules as set forth in Appendix A are adopted , effective thirty days from the date of publication in the Federal Register , except for §§ 2.803(c)(2) and 2.1204(a)(11), which contain new or modified information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act and will become effective after the Commission publishes a notice in the Federal Register announcing such approval and the relevant effective date.

It is further ordered that the Commission's Consumer & Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

It is further ordered that the Commission shall send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 2 and 95 as follows:

This document announces that OMB approved the information collection requirements in 47 CFR 5.64(b) and 97.207(g)(1), on July 21, 2021. These rules were modified in the Report and Order in IB Docket No. 18-313, FCC 20-54, Mitigation of Orbital Debris in the New Space Age, published at 85 FR 52422 on August 25, 2020. The Commission publishes this document as an announcement of the compliance date of the rules. The Report and Order also modified rules in part 25 and there is a separate PRA information collection review for the part 25 rules. Rule amendments adopted in the Report and Order which did not require OMB approval became effective on September 24, 2020.

If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams at Cathy.Williams@fcc.gov or Office of Managing Director, Federal Communications Commission, 45 L Street NE, Washington, DC 20554, regarding OMB Control Number 3060-1013. Please include the applicable OMB Control Number(s) in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on July 21, 2021, for the information collection requirements contained in 47 CFR 5.64(b) and 97.207(g)(1). Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number for the information collection requirements in these rules is 3060-1013.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1013.

OMB Approval Date: July 21, 2021.

OMB Expiration Date: July 31, 2024.

Title: Mitigation of Orbital Debris.

Form Number: N/A.

Respondents: Business or other for-profit, not-for-profit institutions.

Number of Respondents: 46 respondents; 46 responses.

Estimated Time per Response: 8 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 301, 303, 307, 308, 309, and 310.

Total Annual Burden: 368 hours.

Annual Cost Burden: $88,550.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information.

Needs and Uses: On April 24, 2020, the Commission released a Report and Order in IB Docket No. 18-313, FCC 20-54, Mitigation of Orbital Debris in the New Space Age, (Orbital Debris Report and Order). In this Orbital Debris Report and Order, the Commission updated its rules related to orbital debris mitigation, including application requirements. The new rules are designed to ensure that the Commission's actions concerning radio communications, including licensing U.S. spacecraft and granting access to the U.S. market for non-U.S. spacecraft, mitigate the growth of orbital debris, while at the same time not creating undue regulatory obstacles to new satellite ventures. The action will help to ensure that Commission decisions are consistent with the public interest in space remaining viable for future satellites and systems and the many services that those systems provide to the public. The rule revisions also provide additional detail to applicants on what information is expected under the Commission's rules, which can help to increase certainty in the application filing process. While this information collection represents an overall increase in the burden hours, the information collection serves the public interest by ensuring that the Commission and public have necessary information about satellite applicants' plans for mitigation of orbital debris.

Specifically, FCC 20-54 contains the new or modified information collection requirements listed below, applicable to applicants seeking experimental licenses for satellite operations under part 5 of the Commission's rules, as well as to license grantees under part 97 submitting notifications to the Commission prior to launch of a satellite amateur station:

(1) Existing disclosure requirements have been revised to include specific metrics in several areas, including: Probability that the space stations will become a source of debris by collision with small debris and meteoroids that would cause loss of control and prevent disposal; probability of collision between any non-geostationary orbit (NGSO) space station and other large objects; and casualty risk associated with any individual spacecraft that will be disposed by atmospheric re-entry.

(2) Where relevant, the disclosures must include the following: Use of separate deployment devices, distinct from the space station launch vehicle, that may become a source of orbital debris; potential release of liquids that will persist in droplet form; and any planned proximity operations and debris generation that will or may result from the proposed operations, including any planned release of debris, the risk of accidental explosions, the risk of accidental collision, and measures taken to mitigate those risks.

(3) The existing disclosure requirement to analyze potential collision risk associated with space station(s) orbits has been modified to specify that the disclosure identify characteristics of the space station(s)' orbits that may present a collision risk, including any planned and/or operational space stations in those orbits, and indicate what steps, if any, have been taken to coordinate with the other spacecraft or system, or what other measures the operator plans to use to avoid collision.

(4) For NGSO space stations that will transit through the orbits used by any inhabitable spacecraft, including the International Space Station, the disclosure must include the design and operational strategies, if any, that will be used to minimize the risk of collision and avoid posing any operational constraints to the inhabitable spacecraft.

(5) The disclosure must include a certification that upon receipt of a space situational awareness conjunction warning, the operator will review and take all possible steps to assess the collision risk, and will mitigate the collision risk if necessary. As appropriate, steps to assess and mitigate the collision risk should include, but are not limited to: Contacting the operator of any active spacecraft involved in such a warning; sharing ephemeris data and other appropriate operational information with any such operator; and modifying space station attitude and/or operations.

(6) For NGSO space stations the disclosure must describe the extent of satellite maneuverability.

(7) The disclosure must address trackability of the space station(s). For NGSO space stations the disclosure must also include: (a) How the operator plans to identify the space station(s) following deployment and whether the space station tracking will be active or passive; (b) whether, prior to deployment the space station(s) will be registered with the 18th Space Control Squadron or successor entity; and (c) the extent to which the space station operator plans to share information regarding initial deployment, ephemeris, and/or planned maneuvers with the 18th Space Control Squadron or successor entity, other entities that engage in space situational awareness or space traffic management functions, and/or other operators.

(8) For NGSO space stations, additional disclosures must be provided regarding spacecraft disposal, including, for some space stations, a demonstration that the probability of success of the chosen disposal method is 0.9 or greater for any individual space station, and for multi-satellite systems, a demonstration including additional information regarding efforts to achieve a higher probability of success.

These information collection requirements are contained in 47 CFR 5.64 and 97.207.

This document announces that OMB approved the information collection requirements in 47 CFR 25.136(h) on August 26, 2021. This rule was adopted in Further Streamlining FCC Rules Governing Satellite Services, FCC 20-159. The Commission publishes this document as an announcement of the effective date for this new rule. The other rule amendments adopted in Further Streamlining FCC Rules Governing Satellite Services did not require OMB approval and became effective on March 31, 2021. See 86 FR 11880 (Mar. 1, 2021).

If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 3.317, 45 L Street NE, Washington, DC 20554, regarding OMB Control Number 3060-1215. Please include the OMB Control Number in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received final OMB approval on August 26, 2021, for the information collection requirements contained in 47 CFR 25.136(h). Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number for the information collection requirements in 47 CFR 25.136(h) is 3060-1215. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1215.

OMB Approval Date: August 26, 2021.

OMB Expiration Date: August 31, 2024.

Title: Use of Spectrum Bands Above 24 GHz for Mobile Radio Services.

Form Number: N/A.

Respondents: Business or other for-profit, not-for-profit institutions, and state, local and tribal government.

Number of Respondents and Responses: 1,670 respondents; 1,670 responses.

Estimated Time per Response: .5-10 hours.

Frequency of Response: On occasion reporting requirement; third party disclosure requirement; upon commencement of service, or within 3 years of effective date of rules; and at end of license term, or 2024 for incumbent licensees.

Obligation to Respond: Statutory authority for this collection are contained in sections 1, 2, 3, 4, 5, 7, 10, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, and 336 of the Communications Act of 1934, 47 U.S.C. 151, 152, 153, 154, 155, 157, 160, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, 336, Section 706 of the Telecommunications Act of 1996, as amended, 47 U.S.C. 1302.

Total Annual Burden: 790 hours.

Total Annual Cost: $581,250.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: On November 19, 2020, the Commission released a Report and Order, FCC 20-159, in IB Docket No. 18-314, titled, “Further Streamlining Part 25 Rules Governing Satellite Services.” In this Report and Order, among other rule changes, the Commission adopted an optional, extended build-out period for earth station licensees. The optional build-out period increases the allowable time for an earth station to be brought into operation from within one year after licensing, to within: Up to five years and six months for earth stations operating with geostationary satellites; or, up to six years and six months for earth stations operating with non-geostationary satellites. As a companion provision to this new build-out period option, the Commission adopted a requirement for earth station licensees subject to 47 CFR 25.136 to re-coordinate with licensees of Upper Microwave Flexible Use Service (UMFUS) stations if the earth station is brought into operation later than one year after the date of the license grant. The earth station licensee must complete re-coordination within one year before its commencement of operation. The re-coordination should account for any demographic or geographic changes as well as changes to the earth station equipment or configuration. A re-coordination notice must also be filed with the Commission before commencement of earth station operations.

This information collection is used by UMFUS licensees to provide accurate information on the earth station operations notwithstanding the substantially longer earth station build-out period that was adopted. The collection also counterbalances the potential chilling of some UMFUS developments that might otherwise result from the extended earth station build-out periods, and thereby serves as an important check on potential warehousing. Without such information, the Commission would not be able to regulate the shared use of radiofrequencies among earth stations and UMFUS stations in the public interest, in accordance with the Communications Act of 1934, as amended.

NMFS manages the Gulf reef fish fishery, which includes the mid-water snapper complex (silk snapper, queen snapper, blackfin snapper, and wenchman) under the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP). The FMP was prepared by the Gulf of Mexico Fishery Management Council. The FMP is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All weights described in this temporary rule apply as round weight.

The ACL for the mid-water snapper complex is 166,000 lb (75,296 kg) during the fishing year of January 1 through December 31. As specified in 50 CFR 622.41(i), if NMFS estimates that the sum of commercial and recreational landings (total landings) exceed the stock complex ACL, then during the following fishing year, if total landings again reach or are projected to reach the stock complex ACL, NMFS will close the commercial and recreational sectors for the remainder of that fishing year by filing a notification to that effect with the Office of the Federal Register.

In the 2020 fishing year, combined commercial and recreational landings of species in the mid-water snapper complex exceeded the stock ACL. As of September 7, 2021, available commercial and recreational landings data from the NMFS Southeast Fishery Science Center indicate that stock ACL for the mid-water snapper complex for the 2021 fishing year has been exceeded.

Accordingly, NMFS closes the Gulf EEZ to all harvest of species from the mid-water snapper complex from 12:01 a.m., local time, on September 18, 2021, through December 31, 2021, the end of the current fishing year. During the closure, the commercial sale or purchase of species from the mid-water snapper complex harvested from the Gulf EEZ is prohibited, and the recreational bag and possession limits are zero. Commercial and recreational harvest of species in the mid-water snapper complex will reopen on January 1, 2022.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.41(i), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the stock complex ACL and the associated AM has already been subject to notice and public comment, and all that remains is to notify the public of the closure. Such procedures are also contrary to the public interest because of the need to immediately implement the closure to protect the mid-water snapper stock complex. The capacity of the fishing fleet allows for rapid harvest of the ACL and the ACL has already been met. Prior notice and opportunity for public comment would require time and could result in additional harvest.

For the aforementioned reasons, there is good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

The snapper-grouper fishery of the South Atlantic includes golden tilefish and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

On January 4, 2019, NMFS implemented management measures for golden tilefish through a final rule for Amendment 28 to the Snapper-Grouper FMP (83 FR 233; December 4, 2018). That final rule set a recreational ACL of 2,316 fish (50 CFR 622.193(a)(2)(i)) and revised the recreational AM. The inseason recreational AM states that if recreational landings reach or are projected to reach the recreational ACL, then the recreational sector will be closed for the remainder of the fishing year (50 CFR 622.193(a)(2)(i)).

Landings data from the NMFS Southeast Fisheries Science Center indicate that the golden tilefish recreational ACL of 2,316 fish has been reached. Therefore, this temporary rule implements an AM to close the golden tilefish recreational sector of the snapper-grouper fishery for the remainder of the 2021 fishing year. As a result, the recreational sector for golden tilefish in the South Atlantic EEZ will be closed effective 12:01 a.m., local time September 20, 2021. The recreational sector for golden tilefish will open on January 1, 2022, the beginning of the 2022 fishing year and the recreational fishing season. During the closure, the bag and possession limits for golden tilefish in or from the South Atlantic EEZ are zero.

NMFS also closed the commercial sector for golden tilefish for the remainder of the 2021 fishing year (86 FR 29209; June 1, 2021). Therefore, as of the date of this recreational closure, all harvest and possession of golden tilefish in the South Atlantic EEZ is prohibited.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.193(a)(2)(i), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), the NMFS Assistant Administrator (AA) finds good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule that established the recreational ACL and AM for golden tilefish has already been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect the golden tilefish stock. The recreational ACL has been reached and prior notice and opportunity for public comment would require time, potentially resulting in a harvest well in excess of the established ACL.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

Regulations governing fishing activity in the Sea Scallop Access Areas can be found in 50 CFR 648.59 and 648.60. These regulations authorize vessels issued a valid Limited Access General Category (LAGC) Individual Fishing Quota (IFQ) scallop permit to fish in the Closed Area I Scallop Access Area under specific conditions, including a total of 856 trips that may be taken during the 2021 fishing year. Section 648.59(g)(3)(iii) requires NMFS to close the Closed Area I Scallop Access Area to LAGC IFQ permitted vessels for the remainder of the fishing year once it determines that the allocated number of trips for the fishing year are projected to be taken.

Based on trip declarations by LAGC IFQ scallop vessels fishing in the Closed Area I Scallop Access Area, analysis of fishing effort, and other information, NMFS projects that 856 trips will be taken as of September 15, 2021. Therefore, in accordance with § 648.59(g)(3)(iii), NMFS is closing the Closed Area I Scallop Access Area to all LAGC IFQ scallop vessels as of September 17, 2021. No vessel issued an LAGC IFQ permit may fish for, possess, or land scallops in or from the Closed Area I Scallop Access Area after 0001 local time, September 17, 2021. Any LAGC IFQ vessel that has declared into the Closed Area I Access Area scallop fishery, complied with all trip notification and observer requirements, and crossed the Vessel Monitoring System demarcation line on the way to the area before 0001, September 17, 2021, may complete its trip without being subject to this closure. This closure is in effect for the remainder of the 2021 scallop fishing year, through March 31, 2022.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Fishery Conservation and Management Act. This action is required by 50 CFR part 648, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. The Closed Area I Scallop Access Area opened for the 2021 fishing year on April 1, 2021. The regulations at § 648.59(g)(3)(iii) require this closure to ensure that LAGC IFQ scallop vessels do not take more than their allocated number of trips in the area. The projected date on which the LAGC IFQ fleet will have taken all of its allocated trips in an Access Area becomes apparent only as trips into the area occur on a real-time basis and as activity trends begin to appear. As a result, NMFS can only make an accurate projection very close in time to when the fleet has taken all of its trips. To allow LAGC IFQ scallop vessels to continue to take trips in the Closed Area I Scallop Access Area during the period necessary to publish and receive comments on a proposed rule would likely result in the vessels taking much more than the allowed number of trips in the Closed Area I Scallop Access Area. Excessive trips and harvest from the Closed Area I Scallop Access Area would result in excessive fishing effort in the area, where effort controls are critical, thereby undermining conservation objectives of the Atlantic Sea Scallop Fishery Management Plan and requiring more restrictive future management measures. Also, the public had prior notice and full opportunity to comment on this closure process when it was enacted, as well as during the public comment period on the action to set specifications for the 2021 fishing year. For these same reasons, NMFS further finds, under 5 U.S.C 553(d)(3), good cause to waive the 30-day delayed effectiveness period.