Background

Under 5 U.S.C. 301, the “Housekeeping Statute,” and in response to a demand for official information that arises out of a legal proceeding, many agencies have regulations governing the production of official information and employee testimony relating to official information. Known as Touhy regulations, these regulations usually prohibit unauthorized disclosures of official information by employees. These regulations also establish procedures for agencies responding to subpoenas for official information or employee testimony relating to official information. ( See United States ex rel. v. Touhy v. Ragen, 340 U.S. 462 (1951)).

Currently, the Department's Touhy regulations are located at 7 CFR part 1, subpart K (§§ 1.210 to 1.219). Those regulations were established in 1990 and have not been amended since 1993. This direct final rule revises subpart K in its entirety, with the new regulations spanning §§ 1.210 through 1.224. The revised regulations are presented in a question-and-answer format to enhance clarity and readability.

The Department is amending its Touhy regulations to: (1) Promote consistent processing of Touhy requests among USDA agencies; (2) clarify the responsibilities of all parties in the Touhy process; and (3) provide additional information about criteria that USDA agencies should consider in the Touhy process. A discussion of certain specific changes follows.

The revised regulations set forth the procedures to be followed with respect to a demand seeking official information or employee testimony relating to official information for use in a legal proceeding. The revised regulations also set forth certain definitions that were not used in the existing regulations. The revised regulations define:

• The term “demand” to mean any effort or attempt to obtain, for use in a legal proceeding, official information or testimony relating to official information, including any request, order, subpoena, or other command, as well as any informal or other attempt (by any method) to obtain official information, or testimony relating to official information, by an attorney, investigator, or others.

• The term “legal proceeding” to mean all pretrial, trial, and post-trial stages of all existing or reasonably anticipated judicial or administrative actions, hearings, investigations, or similar proceedings before courts, commissions, boards, grand juries, or other tribunals. This phrase includes all phases of discovery as well as formal or informal requests by attorneys or others involved in legal proceedings.

• The term “official information” to mean all information of any kind, however stored, that is in the custody and control of the Department or relates to information in the custody and control of the Department, or information or knowledge acquired by a Department employee as part of the employee's official duties or because of the employee's official status with the Department.

• The term “Department” to mean the United States Department of Agriculture, its constituent agencies, and Department officials authorized to decide whether to allow disclosures of official information or testimony relating to official information in response to a demand.

• The term “employee” to mean all employees or officers of the Department, including individuals who are or have been appointed by the Department, or who are or have been subject to the Department's supervision, jurisdiction, or control, including individuals hired through contractual agreements by or on behalf of the Department, or performing services under such agreements for the Department, such as consultants, contractors, subcontractors, and their employees or other personnel. Also included in the definition are former Department employees where the demand seeks testimony relating to official information acquired while the person was an employee of the Department.

• The term “testimony” to mean any written or oral statement by an employee, including personal appearances in court or at depositions, interviews, or informal inquiries in person or by telephone, responses to written interrogatories or other written statements such as reports, declarations, or affidavits, or any response involving more than the delivery of documents.

• The term “appropriate Department official” to mean the head of a Department agency.

• The term “Office of the General Counsel” to mean the Office of the General Counsel of the Department.

• The term “United States” to means the Federal Government, its departments, and its agencies.

The revised regulations explicitly state that the following matters are not covered by the regulations:

• Congressional requests and subpoenas seeking official information or employee testimony relating to official information;

• Federal court civil proceedings in which the United States is a party;

• Federal administrative proceedings in which the Department is a party;

• The disclosure of official information or employee testimony relating to official information provided to other Federal agencies in connection with a legal proceeding conducted on behalf of or in defense of the United States or a legal proceeding in which the United States has an interest; and

• Employees who testify on their own time or in approved leave status as private citizens about facts or events that are unrelated to official business.

The revised regulations outline the responsibilities for those involved in the Touhy process, i.e., the parties submitting a demand to Department agencies, Department employees who receive a demand, and Department agencies deciding whether to grant or deny a demand.

Parties who submit a demand are to provide the following to the Department:

• Information about the underlying legal proceeding, including copies of the complaint and any relevant pleadings;

• The identity of the Department employee whose testimony is sought and a detailed summary about the relevance of the employee's testimony to the underlying legal proceeding;

• If the demand seeks documents or other materials, a description of the requested official information sought and a detailed summary about its relevance to the underlying legal proceeding;

• An explanation of the unavailability of the requested official information or employee testimony through other sources; and

• An explanation of how each of the factors set forth in 7 CFR 1.220(a) apply to their demand.

The revised regulations require that this information must be submitted at least 14 calendar days before the official information or employee testimony is needed and further require the submission of the above information even if parties serve a subpoena on the Department or a Department employee. A demand may not be granted if a party fails to follow the instructions set forth in the regulations.

Department employees who receive a demand are to:

• Inform their supervisors about the demand so the supervisors may inform an appropriate Department official and the Office of the General Counsel; and

• If appropriate Department officials deny the demand in accordance with the requirements of this regulation, refrain from providing official information and/or testimony in response to the demand.

Employees may be subject to disciplinary action, including termination, if they provide official information or testimony relating to official information pursuant to a demand without approval from appropriate Department officials.

The revised regulations provide that the Department will consider the following criteria when evaluating a demand:

• Whether complying with the demand would be unduly burdensome, disproportionate to the needs of the case, or otherwise inappropriate under the applicable rules of discovery or rules of procedure governing the legal proceeding underlying the demand;

• Whether complying with the demand is appropriate under the relevant substantive law concerning privilege or disclosure of information;

• The public interest;

• The need to conserve the time and expense of Department employees for conducting official business;

• The need to avoid spending the resources of the United States for non-Federal government purposes;

• The need to maintain impartiality between private litigants in cases in which a substantial Department interest is not involved;

• Whether complying with the demand would adversely affect the Department's mission and duties;

• The need to avoid involving the Department in issues unrelated to its mission; and

• Any other factor relevant to the interests of the Department.

In comparison with the existing regulations, the above-referenced factors provide additional detail regarding the considerations that the Department will weigh in deciding whether to grant or deny a demand. The existing regulations list only three factors for Department officials to consider in determining whether to authorize an employee's appearance in a legal proceeding where the Government is not a party. These above-referenced factors apply to all demands for official information or testimony relating to official information.

The revised regulations provide that a demand will be denied if a Department official determines that producing employee testimony or official information would result in:

• Violating a statute, rule of procedure, regulation, or executive order;

• Revealing classified information;

• Revealing confidential commercial or financial information or trade secrets without the owner's consent;

• Revealing the internal deliberative processes of the Executive Branch or other privileged information; or

• Potentially impeding or prejudicing an on-going law enforcement investigation.

The revised regulations clarify the role of USDA's Office of the General Counsel (OGC) and Counsel to the Inspector General in the Touhy process and describe how OGC may interact with a party that submits a demand. The proposed regulations also ensure that OGC reviews and concurs with any Touhy decision.

Finally, the revised regulations set forth conditions that the Department may place on producing official information or authorizing employee testimony in response to a demand. Specifically, the Department may:

• Require the parties in the legal proceeding underlying the demand obtain a protective order or execute a confidentiality agreement to limit access to the official information or testimony provided;

• Limit the scope of the subject matter areas of the permitted testimony;

• Prescribe the manner, time, location, and duration of any testimony provided by deposition; and

• Impose any other condition deemed to be in the best interests of the United States.

We are publishing this rule without a prior proposal because we view this action as noncontroversial and anticipate no adverse public comment. This rule will be effective, as published in this document, on April 29, 2022, unless we receive written adverse comments or written notice of intent to submit adverse comments on or before March 30, 2022.

Adverse comments are comments that suggest the rule should not be adopted or that suggest the rule should be changed.

If we receive written adverse comments or written notice of intent to submit adverse comments, we will publish a document in the Federal Register withdrawing this rule before the effective date. We will then publish a proposed rule for public comment.

If we receive no written adverse comments or written notice of intent to submit adverse comments within 30 days of publication of this direct final rule, this direct final rule will become effective 60 days following its publication.

The Office of Management and Budget has determined that this regulatory action does not require a significance designation under Executive Order 12866, Regulatory Planning and Review.

The regulations revised by this rule relate to the internal management of USDA insofar as they address the receipt and handling of requests for the production or disclosure of official information in legal proceedings. As such, it is for the use of Department personnel only and is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its agencies or other entities, its officers or employees, or any other person. Therefore, we expect the economic impact of this rule, if any, to be minimal and, accordingly, this action will not have a significant economic impact on a substantial number of small entities.

This rule contains no new reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Accordingly, we are amending 7 CFR part 1 as follows:

On December 21, 2000, the Secretary of Agriculture (“Secretary”) established the Agricultural Marketing Service's (AMS) National Organic Program (NOP) and the USDA organic regulations (65 FR 80547). Within the USDA organic regulations (7 CFR part 205) is the National List of Allowed and Prohibited Substances (or “National List”). The National List identifies the synthetic substances that may be used in organic crop and livestock production as well as the nonsynthetic (natural) substances that may not be used. It also identifies the nonorganic substances that may be used in or on processed organic products.

AMS is finalizing 16 amendments to the National List in accordance with the procedures detailed in the Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-6524). OFPA establishes what may be included on the National List and the procedures that the USDA must follow to amend the National List (7 U.S.C. 6517). OFPA also describes the NOSB's responsibilities in proposing amendments to the National List, including the criteria for evaluating amendments to the National List (7 U.S.C. 6518).

To remain on the National List, substances must be: (1) Reviewed every five years by the NOSB, a 15-member federal advisory committee; and (2) renewed by the Secretary (7 U.S.C. 6517(e)). This action of NOSB review and USDA renewal is commonly referred to as the “sunset review” or “sunset process.” AMS published information about this process in the Federal Register on September 16, 2013 (78 FR 56811). The sunset date ( i.e., the date by which the Secretary must renew a substance for the listing to remain valid on the National List) for each substance is included in the NOP Program Handbook (document NOP 5611).

The removal of substances from the National List addresses National Organic Standards Board (NOSB) recommendations submitted to the Secretary after the conclusion of the NOSB's public meetings on October 29, 2015; November 2, 2017; October 26, 2018; and October 30, 2020.

During a 60-day comment period that closed on October 25, 2021, AMS received 60 comments on the proposed rule. See below for a discussion of the comments received and AMS's responses to comments. Comments on the proposed rule can also be viewed through Regulations.gov . Use the search area on the homepage at https://www.regulations.gov to enter a keyword, title, or docket ID (the docket number for this rule is AMS-NOP-19-0106).

This rule removes fourteen ingredients and two substances from the National List and retains (or “renews”) two substances on the National List. Additional background on the NOSB's review of the substances may be found in the proposed rule (86 FR 47242; August 24, 2021).

This final rule removes the following synthetic substances, which are currently allowed in organic crop and livestock production (7 CFR 205.601 and 205.603):

• Vitamin B 1 (crop production); and

• Procaine (livestock production).

As noted in the DATES section, AMS is providing a one-year implementation period for these changes to provide time for certifying agents to communicate the changes to organic operations and for organic producers to cease use.

Additionally, AMS is removing the following nonorganic ingredients, which are currently allowed in organic handling (§§ 205.605 and 205.606):

• Alginic acid;

• Colors (black currant juice color, blueberry juice color, carrot juice color, cherry juice color, grape juice color, paprika color, pumpkin juice color, turmeric extract color);

• Kelp;

• Konjac flour;

• Sweet potato starch;

• Turkish bay leaves; and

• Whey protein concentrate.

Finally, this rule renews sucrose octanoate esters for organic crop and livestock production and oxytocin for organic livestock production. The new sunset date for the two substances (three listings on the National List) is March 15, 2027.

Below, AMS describes each substance in alphabetical order, sorted by use ( i.e., crop production, livestock production, handling). Sucrose octanoate esters is discussed first because it is used in both crop and livestock production. For each substance, AMS outlines the NOSB's sunset review, discusses comments received, and describes the final action by this rule.

Implementation Period. As noted in the DATES section, AMS is providing a one-year implementation period for producers to cease use of vitamin B 1 and procaine. For all other substances removed by this final rule, AMS is providing a two-year implementation period. A shorter implementation period for vitamin B 1 and procaine is appropriate because there is no evidence these substances are currently used in organic production. A 2-year implementation period is provided for organic handling operations to cease use of the nonorganic ingredients (including alginic acid) above. AMS believes that a two-year implementation period provides certifying agents with the necessary time to communicate the changes to organic operations and for operations to source organic forms of the ingredients (if necessary), revise labels, and/or adjust recipes. Public comment indicated a two-year implementation period would be adequate. AMS notes that while the final rule provides a two-year implementation period, organic handlers may not use nonorganic forms of ingredients when organic forms of the ingredients are commercially available (see 7 CFR 205.301(f)(6)).

This final rule renews the allowances for sucrose octanoate esters at 7 CFR 205.601(e)(10) and 205.603(b)(11). 1 Sucrose octanoate esters is a pesticide that targets mites ( e.g., Varroa mites, a pest that attacks honeybees) and certain soft-bodied insects ( e.g., aphids).

Following the sunset review of sucrose octanoate esters, the NOSB recommended removing sucrose octanoate esters from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

Prior to the NOSB's 2018 Fall meeting, the NOSB received information indicating there were no current U.S. Environmental Protection Agency (EPA) registrations for sucrose octanoate esters at the time and therefore no approved pesticide applications. Based on this information, the NOSB reasoned that no argument could be made that this substance remains an essential tool for organic production if there was no current legal use consistent with the National List restrictions. The Board then voted to remove both the crop use listing (at § 205.601(e)) and the livestock use listing (at § 205.603(b)). 2 3 In both organic crop and livestock production, sucrose octanoate esters are allowed as an insecticide and parasiticide, with the latter including treatment of Varroa mites in honeybees. Honeybees are regulated as livestock under the USDA organic regulations (see definition of “livestock” at § 205.2), allowing substances on the National List for livestock production to be used in organic apiculture (beekeeping).

Most comments on the proposed rule related to the proposed removal of sucrose octanoate esters from the National List.

Lack of approved alternatives. Most comments supported keeping sucrose octanoate esters on the National List. Commenters stated that removing this substance would have a negative impact on organic farmers and beekeepers, as it is a primary ingredient in OrganiShield—a common product used in Integrated Pest Management (IPM) systems. Commenters stressed that there is no comparable product on the market that is safe, effective, and approved for use in organic crop and livestock production.

Environmentally friendly pesticide. Commenters noted that the use of sucrose octanoate esters benefits crop-friendly insects such as pollinators, biodegrades rapidly after use, and does not negatively impact the environment. Multiple commenters highlighted that sucrose octanoate esters play a key role as an organic pesticide, specifically in controlling Varroa mites.

Change in market situation. Commenters highlighted that the NOSB voted to remove both the crop use listing at § 205.601(e) and the livestock use at § 205.603(b) during the Fall 2018 meeting. The NOSB's rationale was that sucrose octanoate esters could not be considered an essential tool for organic production if there were no legally approved uses ( i.e., there were no active EPA pesticide registrations at the time). Commenters noted that the market situation has changed since the NOSB's 2018 decision, as there have since been new EPA registrations for sucrose octanoate esters.

AMS had tentatively suggested removal of sucrose octanoate esters in the proposed rule based on the lack of EPA-approved uses for this substance back when the NOSB recommended its removal in 2018 (86 FR 47242, August 24, 2021). Following the 2018 NOSB meeting, the EPA received product registrations for sucrose octanoate esters in December 2020. Subsequent comments demonstrated that the market situation had changed since the 2018 NOSB recommendation, with recent product registrations and increased use of sucrose octanoate esters. Additionally, comments noted this substance is not harmful to the environment and cited the lack of alternatives approved for organic use. In response to comments identifying the recent registration, increased use, and a lack of alternatives, AMS is not removing sucrose octanoate esters from the National List at §§ 205.601(e)(10) and 205.603(b)(11). The substance will undergo another sunset review prior to the new March 15, 2027 sunset date. At that time, the Board will have another opportunity to evaluate the substance against OFPA criteria considering this recent registration and increase in use.

This final rule amends the National List to prohibit use of synthetic vitamin B 1 in organic crop production by removing vitamin B 1 from 7 CFR 205.601(j)(9).

NOSB Review and Recommendation

Following the sunset review of vitamin B 1 , the NOSB recommended removing vitamin B 1 from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

In support of their sunset review, 4 the NOSB requested a third-party technical report on the use of vitamins B 1 , C, and E in crop production. 5 The technical report stated these vitamins are generally used for stimulation of crop growth and plant protection but found that previous claims about root growth and reduction of transplant shock associated with vitamin B 1 were largely unsubstantiated outside of a laboratory environment. Due to this, and the lack of support voiced during the public comment process regarding efficacy or necessity, the NOSB recommended removal.

AMS received no comments in support of keeping synthetic vitamin B 1 on the National List for organic crop production. One commenter requested the NOP allow for a 12-month implementation timeline.

As commenters noted, the NOSB voted to remove vitamin B 1 from the National List at the Fall 2017 meeting on the basis that it is not essential for organic crop production and because its primary use for root growth and reduction of transplant shock was not substantiated by technical information. Given this information regarding use and efficacy, AMS is removing vitamin B 1 from the National List for organic crop production. Further, the 2015 technical report on vitamins for crop production identified several natural (nonsynthetic) alternatives to vitamin B 1, including yeast, various meals ( e.g., soybean meal, cottonseed meal), and other crop waste or residues. After considering public comments, technical reports, and the NOSB review, AMS is finalizing the removal of vitamin B 1 from the National List at § 205.601(j)(9). As specified in the DATES section, organic crop producers will have until March 15, 2023, to comply with this change.

This final rule renews the allowance for oxytocin (an animal drug) for use in post-parturition (birth) therapeutic applications at 7 CFR 205.603(a)(22). Oxytocin will not be prohibited, as proposed, in organic livestock production. A discussion of the compliant uses under the annotation, “postparturition therapeutic applications,” is included below in AMS's response.

Following its sunset review of oxytocin, the NOSB recommended removing oxytocin from the National List. 6 As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

The NOSB requested public comment on whether the substance was essential for organic production and whether there were natural alternative materials and methods that render it unnecessary. In response, the NOSB received public comments indicating the substance was no longer necessary and generally supporting its removal. The NOSB concluded there are numerous alternative methods and materials to oxytocin and that the use of oxytocin no longer meets the criteria at 7 U.S.C. 6518(m)(6). Additionally, the NOSB noted that oxytocin is a synthetic hormone and that hormones are not otherwise permitted in organic production (§§ 205.237(b)(1) and 205.238(c)(3)).

AMS received several comments in response to the proposed sunset removal of oxytocin from the National List.

General opposition. A certifying agent (“certifier”) noted that 35 of the organic dairies they certify include the substance in their Organic System Plans for use in post-parturition therapeutic applications. The commenter stated that those operations use oxytocin for various uses, including uterine care, milk letdown for first-time heifers or as a mastitis treatment, retained placenta, and strained labor treatment. The commenter noted they do not allow routine or repeated use of oxytocin nor permit operations to use oxytocin to promote milk production. The commenter requested that any prohibition of the substance occur following the 2022 spring birthing season.

A dairy manufacturer requested retention for oxytocin on the National List due to a lack of alternatives. The commenter also stated oxytocin is a veterinary control drug that should only be administered or prescribed under veterinary instruction. The commenter recognized alternatives can assist with topical inflammation; however, for uses to assist with inflammation caused by animals withholding milk or to assist with uterine cleaning, the commenter stated there were no compliant alternatives. Another commenter also requested oxytocin to remain an allowed substance on account of its effectiveness as a post-parturition therapeutic to transition a dry cow to a lactating cow.

General agreement. A comment stated that natural alternatives are available to address certain post-parturition complications that can arise in organic dairy cattle and that use of oxytocin would prevent organic producers from claiming their products are “hormone-free.” The commenter requested an implementation period of 12 months to allow for industry time to comply with the final rule.

After reviewing public comments, AMS is renewing the listing for oxytocin in this final rule. The substance will remain on the National List, with a new sunset date of March 15, 2027. AMS agrees with commenters that synthetic oxytocin remains essential to organic livestock production in the absence of alternative nonsynthetic (natural) medical treatments for post-parturition emergency treatments ( i.e., treatment for severe complications resulting from labor). AMS notes that under current FDA regulations, “Federal law restricts [oxytocin] to use by or on the order of a licensed veterinarian.” (21 CFR 522.1680(c)(3)). Although some annotations on the National List for animal drugs specify that they may be used only by or on the order of a veterinarian, the absence of this phrasing in the annotation for oxytocin would not alter a producer's obligations to comply with other federal laws.

By retaining oxytocin on the National List, organic livestock producers will continue to be permitted to use the drug to treat specific conditions within a limited timeframe following parturition without forfeiting the animal's organic status. Additional discussion of the permitted uses of the substance in organic production follows.

AMS is aware there is some confusion around what uses comply with the annotation for oxytocin that reads, “use in postparturition therapeutic treatments” (§ 205.603(a)(22)). This discussion is meant to inform certifying agents and organic operations of AMS's current thinking on uses that comply with the annotation.

The current annotation allows producers to use oxytocin to treat conditions related to labor and to an animal's postpartum survival. Its use is not permitted on a routine basis ( i.e., as protocol). Instead, it is available for emergency situations and severe complications in the immediate postpartum (following birth of young) period. It may not be administered to increase an animal's milk production (volume) or for milk letdown. As previously noted in this document, Federal law restricts this drug to use by or on the order of a licensed veterinarian (21 CFR 522.1680(c)(3)).

AMS's interpretation of the annotation for oxytocin at § 205.603, “for postparturition therapeutic applications,” is informed and supported by its prior discussion of oxytocin in its March 13, 2000 proposed rule (65 FR 13511). AMS believes that discussion is relevant to the meaning of the current annotation in the USDA organic regulations. In the discussion in the proposed rule, AMS noted that oxytocin, “has some uses that do not involve lactation but are instead related to an animal's postpartum survival” and that oxytocin was permitted by some certifiers for “animals that experience severe complications resulting from labor,” and described those as “emergency situations” (65 FR 13511, 13588).

AMS's expectation is that certifiers will always review an organic operation's use of oxytocin to ensure it is used only in postparturition therapeutic applications.

This final rule amends the National List to remove procaine at 7 CFR 205.603(b)(9) and prohibit its use in organic livestock production.

Following the sunset review of procaine, the NOSB recommended removing procaine from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

In support of their sunset review, the NOSB solicited public comment over two meetings on use of procaine and whether procaine can be sourced without prohibited antibiotics. The comments stated procaine is rarely used, is only available in drug formulations that are combined with prohibited antibiotics, and is not as effective as lidocaine (allowed for organic livestock use at § 205.603(b)(5)). After their review, the NOSB recommended removal of procaine from the National List.

AMS received no comments opposed to removing procaine from the National List. A certifying agent noted the importance of pain relievers but stated that procaine was not an active ingredient in any product currently used by organic operations that it certifies. Another comment highlighted that procaine products are already prohibited for use because they are always formulated with antibiotics that are prohibited in organic livestock production. One commenter requested an implementation timeline of 12 months to allow industry time to comply with the final rule.

As the NOSB referenced in their recommendation, procaine is not available on its own ( i.e., not compounded with an antibiotic). A search of the FDA's animal drug database ( https://animaldrugsatfda.fda.gov/ ) indicates that all 16 of the FDA approved drugs that contain procaine also contain an antibiotic ( e.g., Penicillin G Procaine). Furthermore, another National List material, lidocaine, could be used to perform the same function (as a local anesthetic). This information supports that procaine is not currently used in organic production and no longer meets the exemption requirement (7 U.S.C. 6517(c)(1)(A)(ii)). AMS agrees with commenters and the NOSB that procaine is not essential to organic livestock production. AMS is finalizing the removal of synthetic procaine from the National List at § 205.603(b)(9) to prohibit its use in organic livestock production. As specified in the DATES section, organic livestock producers will have until March 15, 2023, to comply with this change.

This final rule amends the National List to remove alginic acid at 7 CFR 205.605(b) and prohibit its use in organic processed products.

Following the sunset review of alginic acid, the NOSB recommended removing alginic acid from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

In support of their sunset review of alginic acid, the NOSB received a third-party technical report in 2015 and solicited public comment at their Spring 2019 meeting. 7 The NOSB received no comments in support of continuing the allowance of, or stating use of, alginic acid. In addition, no certifying agents (“certifiers”) reported this material in use by their certified operations. Further, the 2015 technical report cited other National List materials (including agar-agar, carrageenan, gellan gum, and xanthan gum) as possible alternatives to alginic acid. Based on this, the NOSB determined that there are readily available alternatives and recommended removal.

AMS received no comments in favor of retaining alginic acid on the National List. One comment agreed with the NOSB's rationale for removing alginic acid from the National List and requested a 24-month implementation period to comply with the final rule.

Given that there were no reports of operations using alginic acid and the availability of possible alternatives on the National List (as referenced in the technical report), this substance no longer appears to meet the requirements for inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS is finalizing the removal of alginic acid from the National List at § 205.605(b) to prohibit its use in organic processed products. As identified in the DATES section, organic processors will have until March 15, 2024, to comply with this change.

This final rule amends the National List to remove eight nonorganic colors from the National List at § 205.606(d):

• Black currant juice color—derived from Ribes nigrum L.;

• Blueberry juice color—derived from blueberries ( Vaccinium spp. );

• Carrot juice color—derived from Daucus carota L.;

• Cherry juice color—derived from Prunus avium (L.) L. or Prunus cerasus L.;

• Grape juice color—derived from Vitis vinifera L.;

• Paprika color—derived from dried powder or vegetable oil extract of Capsicum annuum L.;

• Pumpkin juice color—derived from Cucurbita pepo L. or Cucurbita maxima Duchesne;

• Turmeric extract color—derived from Curcuma longa L.

The NOSB recommended the removal of these colors at their Fall 2020 meeting. 8 The effect of these removals means that only organic forms of these colors will be allowed in organic handling. The NOSB solicited public comments in support of their sunset review of these colors at the Spring and Fall 2020 meetings. The NOSB noted these public comments were mixed regarding the availability and necessity of these colors. Additionally, in the case of carrot juice color and grape juice color, the NOSB noted that the availability of these crops in organic forms should provide an adequate supply of organic carrot juice and organic grape juice for color production and cited that as a reason for their recommended removal.

AMS received few comments in response to the proposed removal of eight nonorganic colors from the National List.

General opposition. A comment requested retaining turmeric extract color on the National List because there is no readily available organic alternative in the marketplace. Another comment requested retaining paprika color on the National List as there are no commercially-available, organic alternatives for the color; however, the commenter stated there are readily-available, organic raw materials that may allow an organic version of the color to be developed. The commenter estimated a two-year implementation period would provide enough time for color development, shelf-life trials, and commercialization.

General agreement. A certifier noted limited use of the nonorganic colors in this final rule among the organic handlers they certify. The comment noted there is limited use of nonorganic paprika color, grape juice color, and cherry juice powder. A certifying agent was particularly concerned about an insufficient supply of blueberry juice color, carrot juice color, paprika color, and turmeric extract color. The commenter cited an internal survey (of organic operations) that indicated the supply of organic colors is fragile and that removal from the National List may be premature, especially without a substantial implementation period. The commenter requested an implementation timeline of 24 months to allow industry time to comply with the final rule.

In the rule proposing removal of these colors, AMS requested comments regarding whether any of these colors are necessary and whether there are enough organic versions available to meet demand. Comments received suggested there may not be sufficient supplies of certain organic colors but that supply would likely develop over the course of the 24-month implementation period. None of these comments suggested an inability to produce or develop organic versions of these colors, given sufficient time. As such, AMS is finalizing the removal of these non-organic colors from the National List at § 205.606(d). To support the development of an adequate supply of organic colors, as requested by commentors, organic processors will have until March 15, 2024 (a 24-month implementation period) to comply with these changes.

This final rule amends the National List to remove kelp at 7 CFR 205.606(k) and prohibit its use. Wakame seaweed and Pacific kombu remain allowed in § 205.606 in organic processed products.

Following the sunset review of kelp at their Fall 2020 meeting, the NOSB recommended removing kelp from the National List. Only organic forms of kelp (other than wakame seaweed and Pacific kombu, which remain allowed in § 205.606), would be allowed in organic handling. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

During its sunset review, the NOSB received comments in support of removing, as well as relisting, kelp. The NOSB determined that there were alternatives to kelp on the National List (namely Pacific kombu and wakame) and therefore recommended removing kelp from the National List in § 205.606.

AMS received no comments in favor of retaining nonorganic kelp on the National List for organic handling. A comment requested an implementation period of 24 months to allow industry time to comply with the final rule.

According to the Organic Integrity Database, there are currently 104 certified crop, wild crop, and handling operations that list “kelp” as a certified organic product. 9 Organic kelp appears to be commercially available; therefore, this substance is no longer necessary and no longer meets the requirements for inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS did not receive any comments challenging this conclusion and is finalizing the removal of non-organic kelp from the National List at § 205.606(k). As identified in the DATES section, organic processors will have until March 15, 2024, to comply with this change.

This final rule amends the National List to remove konjac flour at 7 CFR 205.606(l) and prohibit its use in organic processed products.

Following the sunset review of konjac flour at their Fall 2017 meeting, the NOSB recommended removing konjac flour from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

In support of their recommendation, the NOSB solicited public comment regarding the use and necessity of konjac flour in organic handling as well as the availability of organic konjac flour. The NOSB received little feedback from industry in response. One trade organization reported one organic producer using konjac flour but was unsure if it was for products sold as “organic.” Several certifiers stated they had not received any feedback from their clients regarding the need for, or use of, nonorganic konjac flour in their products. Ultimately, the NOSB voted to recommend removal of konjac flour from the National List at § 205.606(l) due to available alternatives.

AMS received no comments in favor of retaining nonorganic konjac flour on the National List for organic handling. A comment requested an implementation period of 24 months to allow industry time to comply with the final rule.

A search in the Organic Integrity Database for “konjac” shows 30 operations with some form of certified organic konjac products ( e.g., powder, starch, konjac tubers). 10 Given the lack of reported use of, or need for, nonorganic konjac flour, and the availability of organic konjac flour and konjac tubers, nonorganic konjac flour no longer meets the requirements for inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS did not receive any comments challenging this conclusion and, as such, is finalizing the removal of non-organic konjac flour from the National List at § 205.606(l). As identified in the DATES section, organic processors will have until March 15, 2024, to comply with this change.

This final rule amends the National List to remove sweet potato starch at 7 CFR 205.606(s)(2) and prohibit the use of non-organic sweet potato starch in organic products.

Following the sunset review of sweet potato starch at their Fall 2020 meeting, the NOSB recommended removing sweet potato starch from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

During its sunset review, the NOSB solicited public comment on the use and necessity of sweet potato starch but received little feedback. The comments suggested there is scant use of nonorganic sweet potato starch, that alternatives are readily available, and that organic sweet potato starch is available. Further, comments noted that the continued listing of nonorganic sweet potato starch is inhibiting production of organic forms of sweet potato starch. Based on this information, the NOSB recommended the removal of this substance due to available alternatives.

AMS received no comments in favor of retaining nonorganic sweet potato starch on the National List for organic handling. A comment requested an implementation period of 24 months to allow industry time to comply with the final rule.

A search in the Organic Integrity Database for “potato starch” shows 60 operations with some form of certified organic potato starch and another 27 operations with some form of certified organic pea starch, a cited alternative to sweet potato starch. 11 Given the low reported use of nonorganic sweet potato starch and the availability of organic sweet potato starch and organic pea starch, nonorganic sweet potato starch no longer meets the requirements for inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS did not receive any comments challenging this conclusion and, as such, is finalizing the removal of non-organic sweet potato starch from the National List at § 205.606(s)(2). As identified in the DATES section, organic processors will have until March 15, 2024, to comply with this change.

This final rule amends the National List to remove Turkish bay leaves at 7 CFR 205.606(v) to prohibit its use in organic products.

Following the sunset review of Turkish bay leaves at their Fall 2020 meeting, the NOSB recommended removing Turkish bay leaves from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

During its sunset review, the NOSB received many comments supporting the removal of Turkish bay leaves due to the availability of organic versions. The NOSB called attention to one comment received at its Fall 2020 meeting from an organic producer who uses Turkish bay leaves in a wide range of organic canned soups. This food manufacturer noted that organic forms of Turkish bay leaves are readily available. Further comments from certifiers indicated that few, if any, of their operations use nonorganic Turkish bay leaves. Based on this information, the NOSB recommended the removal of this substance due to available alternatives. 12

AMS received no comments in favor of retaining nonorganic Turkish bay leaves on the National List for organic handling. A commenter noted that the NOSB received multiple comments supporting the removal of Turkish bay leaves from the National List during the 2020 sunset review. The commenter stated that Turkish bay leaves only remained on the National List after the NOSB's Fall 2015 meeting due to the lack of available, organic alternatives.

Previously, AMS proposed removing Turkish bay leaves from § 205.606 following a Fall 2015 NOSB recommendation. 13 At the time, AMS received comments stating organic whole Turkish bay leaves were not available in the quantity or quality to meet organic handling needs. As a result, AMS did not finalize removing Turkish bay leaves (82 FR 31241, July 6, 2017), and its sunset date was extended five years.

A search in the Organic Integrity Database for “bay leaves” shows 143 crop and handling operations with some form of certified organic bay leaves. A search using the term “Turkish bay leaves” shows six operations, as it appears that only one certifying agent identifies bay leaves with that level of specificity in the Organic Integrity Database. 14 Given that comments to the NOSB indicated organic Turkish bay leaves are readily available in all forms and the high number of operations reported in the Organic Integrity Database with organic bay leaves (of which a subset are Turkish bay leaves), nonorganic Turkish bay leaves no longer meet the requirements for inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). During this current rulemaking, AMS received no comments challenging this conclusion and is removing non-organic Turkish bay leaves from the National List at § 205.606(v). As identified in the DATES section, organic processors will have until March 15, 2024, to comply with this change.

This final rule amends the National List to remove whey protein concentrate at 7 CFR 205.606(x) and prohibit its use in organic processed products.

Following the sunset review of whey protein concentrate at their Fall 2020 meeting, the NOSB recommended removing whey protein concentrate from the National List. As described in the Background section, the sunset process is a system of regular evaluation of National List substances against criteria in the OFPA. If a substance is found to no longer satisfy these criteria, the NOSB may recommend removal of the substance.

During this sunset review, the NOSB received many comments supporting the removal of whey protein concentrate due to the availability of organic versions. The NOSB highlighted several commenters, who demonstrated that they produce a robust supply of organic whey protein concentrate in several forms and sell excess to the conventional market. A comment noted that the international supply chain of organic whey-based products is also robust. Further comments from at least one certifier indicated that none of their operations are using nonorganic whey protein concentrate. Based on this information, the NOSB recommended the removal of this substance based on available alternatives. 15

AMS received no comments in favor of retaining nonorganic whey protein concentrate on the National List for organic handling. A certifier noted that an organic operation they certify previously used non-organic whey protein concentrate but no longer does. Another commenter noted that the NOSB received many comments supporting the removal of whey protein from the National List during the 2020 sunset review, including from several manufacturers who demonstrated they produce a robust supply of organic whey protein concentrate. The commenter noted that removing the allowance of a nonorganic form will help support organic cheese manufacturers. A comment requested an implementation period of 24 months to allow industry time to comply with the final rule.

Previously, AMS proposed removing whey protein concentrate from § 205.606, following a Fall 2015 NOSB recommendation. 16 At that time, AMS received comments stating organic whey protein concentrate was essential for organic processed products and that there were no commercially available, organic products. As a result, AMS did not finalize the removal of whey protein concentrate from the National List (82 FR 31241, July 6, 2017).

A search in the Organic Integrity Database for “whey protein concentrate” shows 23 operations with some form of certified organic whey protein concentrate. The NOSB also received comments suggesting a substantial supply of all forms of organic whey protein concentrate and cited the diversion of some quantity to the conventional market as evidence that there is enough supply to meet the demand for organic whey protein concentrate. Given the comments submitted to the NOSB outlining the lack of use and stated abundance of supply, nonorganic whey protein concentrate no longer meets the requirement for inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). During this current rulemaking, AMS received no comments challenging this conclusion and is removing non-organic whey protein concentrate from the National List at § 205.606(x). As identified in the DATES section, organic processors will have until March 15, 2024, to comply with this change.

AMS published notices in the Federal Register to announce the NOSB meetings where the Board discussed these substances. The notices invited public comments on the NOSB recommendations addressed in this final rule. Transcripts of the meetings, along with the NOSB recommendations, can be found on the AMS website at: https://www.ams.usda.gov/rules-regulations/organic/nosb/meetings. The AMS proposed rule that preceded this final rule was published on August 24, 2021 (86 FR 47242).

The OFPA authorizes the Secretary to make amendments to the National List based on recommendations developed by the NOSB. The OFPA authorizes the NOSB to develop recommendations for submission to the Secretary to amend the National List and establish a process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List (7 U.S.C. 6518(k) and (n)). Section 205.607 of the USDA organic regulations permits any person to petition to add or remove a substance from the National List and directs petitioners to obtain the petition procedures from USDA (7 CFR 205.607). The current petition procedures published in the Federal Register (81 FR 12680, March 10, 2016) for amending the National List can be accessed through the NOP Handbook on the NOP website as document NOP 3011 at https://www.ams.usda.gov/rules-regulations/organic/handbook .

This final rule does not meet the criteria of a significant regulatory action under Executive Order 12866 as supplemented by Executive Order 13563. Therefore, the Office of Management and Budget (OMB) has not reviewed this rule under those Orders.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

The Small Business Administration (SBA) sets size criteria for each industry described in the North American Industry Classification System (NAICS) to delineate which operations qualify as small businesses. 17 The SBA classifies small agricultural producers that engage in crop and animal production as those with average annual receipts of less than $1,000,000 (13 CFR 121.201). Handlers are involved in a broad spectrum of food production activities and fall into various categories in the NAICS Food Manufacturing sector. The small business thresholds for food manufacturing operations are based on the number of employees and range from 500 to 1,250 employees, depending on the specific type of manufacturing. Certifying agents fall under the NAICS subsector “all other professional, scientific, and technical services.” For this category, the small business threshold is average annual receipts of less than $16.5 million.

Producers. AMS has considered the economic impact of this final rulemaking on small agricultural entities. Data collected by the USDA National Agricultural Statistics Service (NASS) and the NOP indicate most of the certified organic production operations in the United States would be considered small entities. According to the 2017 Census of Agriculture, 16,585 organic farms in the United States reported sales of organic products and total farmgate sales more than $9.9 billion. 18 Based on that data, organic sales average just under $600,000 per farm. Assuming a normal distribution of producers, we expect that most of these producers would fall under the $1,000,000 sales threshold to qualify as a small business.

Handlers. According to the NOP's Organic Integrity Database (OID), there are 10,971 U.S.-based organic handlers that are certified under the USDA organic regulations. 19 The Organic Trade Association's 2020 Organic Industry Survey has information about employment trends among organic manufacturers. The reported data are stratified into three groups by the number of employees per company: Fewer than 5; 5 to 49; and 50 plus. These data are representative of the organic manufacturing sector and the lower bound (50) of the range for the larger manufacturers is significantly smaller than the SBA's small business thresholds (500 to 1,250). Therefore, AMS expects that most organic handlers would qualify as small businesses.

Certifying agents. The SBA defines “all other professional, scientific, and technical services,” which include certifying agents, as those having annual receipts of less than $16,500,000 (13 CFR 121.201). There are currently 76 USDA-accredited certifying agents, based on a query of the OID database, who provide organic certification services to producers and handlers. While many certifying agents are small entities that would be affected by this final rule, we do not expect that these certifying agents would incur significant costs as a result of this action as certifying agents already must comply with the current regulations ( e.g., maintaining certification records for organic operations).

AMS does not expect this rule to have a significant economic impact on entities affected by this rule. Alternatives exist to the substances that this rule prohibits, as determined by the NOSB and AMS. Additionally, AMS is providing a 12- to 24-month implementation period, depending on the substance or ingredient, to allow affected entities time to modify practices.

Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This final rule is not intended to have a retroactive effect. Accordingly, to prevent duplicative regulation, states and local jurisdictions are preempted under OFPA from creating programs of accreditation for private persons or state officials who want to become certifying agents of organic farms or handling operations. A governing state official would have to apply to the USDA to be accredited as a certifying agent, as described in the OFPA (7 U.S.C. 6514(b)). States are also preempted from creating certification programs to certify organic farms or handling operations unless the state programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA (7 U.S.C. 6503-6507).

Pursuant to the OFPA (7 U.S.C. 6507(b)(2)), a state organic certification program that has been approved by the Secretary may, under certain circumstances, contain additional requirements for the production and handling of agricultural products organically produced in the state and for the certification of organic farm and handling operations located within the state. Such additional requirements must: (a) Further the purposes of OFPA, (b) not be inconsistent with OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary.

In addition, pursuant to 7 U.S.C. 6519(c)(6), this final rule does not supersede or alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056) concerning meat, poultry, and egg products, respectively, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq. ), nor the authority of the Administrator of the EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq. ).

No additional collection or recordkeeping requirements are imposed on the public by this final rule. Accordingly, Office of Management and Budget (OMB) clearance is not required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501, Chapter 35.

This final rule has been reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments. Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on: (1) Policies that have tribal implication, including regulation, legislative comments, or proposed legislation; and (2) other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes.

AMS has assessed the impact of this final rule on Indian tribes and determined that this rule would not have tribal implications that require consultation under Executive Order 13175. AMS hosts a quarterly teleconference with tribal leaders where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the proposed changes to the regulations are shared during quarterly calls with Tribal leaders, who have the opportunity to submit comments. AMS works with the USDA Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the NOP regulations.

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).

This final rule reflects recommendations submitted by the NOSB to the Secretary to remove fourteen nonorganic ingredients and two substances from the National List. This final rule retains (or “renews”) two substances on the National List.

For the reasons set forth in the preamble, 7 CFR part 205 is amended as follows:

Rural Development administers a multitude of programs, ranging from housing and community facilities to infrastructure and business development. Its mission is to increase economic opportunity and improve the quality of life in rural communities by providing leadership, infrastructure, capital, and technical support that can support rural communities, helping them to prosper.

To achieve its mission, Rural Development provides financial support (including direct loans, grants, loan guarantees, and direct payments) and technical assistance to help enhance the quality of life and provide support for economic development in rural areas.

On July 14, 2020, at 85 FR 42494, the Agency promulgated 7 CFR part 5001, the OneRD guaranteed loan regulation, which combined four Agency guaranteed loan program regulations, including REAP, into one comprehensive guaranteed loan processing and servicing regulation. The final rule being confirmed amends 7 CFR part 4280, subpart B accordingly to remove references to the guaranteed loan provisions of REAP as these references have become superfluous in light of the promulgation of 7 CFR part 5001. Furthermore, program modifications required by the Agriculture Improvement Act of 2018 (2018 Farm Bill), as well as provisions that have been previously published via funding opportunities in Federal Register publications, have been incorporated into this final rule to eliminate the need for annual notification and to enhance program delivery.

RBCS invited comments on the final rule published on April 27, 2021, in the Federal Register (86 FR 22304). RBCS received twenty-eight (28) comments from five commenters. The commenters were: The American Biogas Council (ABC), Agriculture Energy Coalition (AgEC), Ebenezer MGMT, LLC, Environmental Law & Policy Center (ELPC) and CROPP Cooperative (CROPP). The Agency's responses to the 28 comments, of which six (6) were duplicative, are as follows:

Comment 1: Both the ABC and the AgEC believe the March 31 grant application deadline creates a barrier to a timely transition between the grant process and project initiation for companies who want to partner with farms to produce biogas. As grant application reviews typically last a few months, and applications are not guaranteed to be successful, small businesses are often forced to delay capital outlays for construction until a grant is awarded. By the time the grant is awarded, it is usually summer, and the awardee has missed out on a significant portion of construction season and faces unnecessary challenges securing labor and equipment that is already obligated to projects that began in the spring. Thus, these projects are often delayed until the following year. For companies who want to partner with farms to convert manure or other organic materials into biogas, this nine-month delay is too frequently an impediment initiating a reciprocal business relationship between small farms and small biogas companies. Additionally, the ABC and the AgEC feel the current practice requires that projects seeking a REAP grant as well as participation in the loan guarantee program complete a combination application. Coupling these separate paths together creates a significant obstacle to small and mid-size applicants because lenders often do not count potential REAP grant funding among a borrower's assets. Specifically, in the loan application process, some companies rely on REAP grant funding to demonstrate the viability of the projects for which they are seeking loans. Lenders are typically less likely to approve loans when the applicant is relying on uncertain federal grant funding to demonstrate the viability of the project. The result is an increased rate of loan denials for small businesses. If, however, loan guarantee applicants were allowed to begin that process with grant funding already in-hand, their proposed projects would present as more stable to lenders.

Agency response: Applications for REAP assistance can be filed any time during the year and once a complete application is filed it can be processed and readied for competition. The receipt of program funds to make awards are contingent upon the federal budget process. Historically, the Agency has received REAP funds in January. REAP grants are typically very competitive given the limited amount of grant funds available. The Agency must meet the statutory provision of obligating no less than 20 percent of REAP funds for grants applications requesting $20,000 and less by June 30. Therefore, the Agency utilizes an October 31 deadline for these grants so that the statutory provision can be met each year. The Agency has also adopted a single deadline (March 31) for grant applications requesting more than $20,000 to ensure that there is a fair and transparent process for competition across the nation.

Furthermore, the Agency desires to fund applications that are shovel ready and can be completed when REAP funding is awarded. As such, part of the application requirements is to demonstrate how the project will be financed and that those funds, both grant, loan and other are available. The Agency acknowledges that grant funds are much more competitive than guaranteed loan funds and it can take longer to process the volume of grant applications received compared to guaranteed loan applications.

Comment 2: Ebenezer MGMT, LLC stated that the final rule “was published April 27th with an effective date of July 26th. USDA released a NOSA published 11/25/2020 that substantially changed how applications are reviewed and scored, with no comment period. The final program due date each year is currently March 31st. All proposed changes to procedure or scoring should occur or become effective on the day following the final due date for applications.

Applicants submit applications throughout the year, after reading current rules and with guidance from USDA staff. All applicants have an expectation of consistency. To make changes mid-year puts some applicants at a disadvantage to others. It requires enormous amounts additional staff time to rescore or gather additional information when changes are made mid-year. By announcing ahead of time that the changes would occur each April 1st. Applicants would be better served; and state staff could manage their workload more efficiently.”

Agency response: REAP applications can be filed at any time during the year which makes it difficult to find an ideal time to initiate program changes. The Agency ensures that all applicants are afforded the same opportunity to supplement application materials as necessary when program changes are initiated after complete applications have been filed.

Comment 3: ABC and AgEC both raised the same concerns that the scoring criteria do not properly support project diversity and commercial yet underserved renewable technologies. ABC and AgEC are both very supportive of REAP and its broad reach. However, they are concerned that several elements of the scoring criteria outlined in § 4280.121 “Scoring RES and EEI grant applications” risk continued limits on the diversity of applicants and technologies supported by the program.

ABC and AgEC are concerned that “the following scoring criteria risk further inhibiting underserved renewable technologies for REAP grants, such as biogas systems and distributed wind:

(1) “The quantity of energy generated or replaced per grant dollar requested” is a key scoring criterion outlined in the final rule. While efficient use of program funds is a worthwhile objective, this criterion favors the most established renewable energy technologies over underserved technologies.

(2) The emphasis on “energy replaced” also favors technologies with the best economics based on energy alone, pushing toward technology that has penetrated the market more successfully to date, rather than underserved technologies that may support additional environmental and economic benefits and also might accommodate the specific needs of the applicant. For example, a significant component of the economic value of biodigesters comes from reduced manure disposal costs. This underserved technology would be at a disadvantage relative to an energy-only project.

(3) The criteria for “energy saved” also favors technologies with the highest economic efficiency in today's market, limiting diversity.

(4) Awarding points for firm letters of credit for cost share favors those with access to capital, rather than marginalized communities or borrowers. Because one of the objectives of REAP is to support economic development and to strengthen rural communities, ensuring access to all eligible members of the rural community should be reflected in the final rule.

(5) Awarding points for firms already in the market poses a potential barrier against new entrants and marginalized communities. Strengthening rural communities should include efforts to support fledgling businesses rather than place them at a disadvantage to their peers.

(6) REAP is solely concentrated on energy production and does consider any of the environmental aspects of digesters. The qualities include preventing the emissions of methane, recycling of nutrients, cleaning and recycling of water or protecting water quality, requesting carbon by reusing nutrients. All of these elements are part of the reasons that farmers want to use digesters but none of them are taken into consideration by the current REAP scoring system. Given the USDA's renewed focus on fighting climate change, we, again, urge USDA to update its scoring criteria to include not only aspects of energy generation but also aspects of GHG emission reduction and environmental savings.”

Agency response: The Agency acknowledges that technology diversity is important. In fact, the Administrator has added discretionary points for underserved technology for the past several years in an effort to diversify the REAP portfolio. In response to the six individual issues raised, the Agency submits the following:

ISSUE 1: This criterion is evaluating the energy savings/generation impact of the dollars being invested in the project. The installation cost is one variable, but the amount of the request is a second variable. Some technologies may have lower installation costs, but the amount of the request is defined by the applicant.

ISSUES 2 and 3: RBCS acknowledges the concerns raised. REAP has always looked at only direct project benefits such as kWh/BTU's saved/generated or by-products. The Agency is open to further discussion on additional project benefits; however, the Agency is concerned about how alternatives could be quantified and valued in a fair manner to ensure consistent program delivery.

ISSUE 4: The Agency removed financial need from the program in 2014. The Agency's goal is to participate in projects that are shovel ready to ensure timely and prudent investment of REAP program dollars. Commitment of funds demonstrates project support, backing, and a higher probability of project completion.

ISSUE 5: The Agency is assuming this concern is related to the five (5) points for existing businesses. The points for an existing business were added to strengthen opportunity for main street businesses as opposed to creating a barrier for new entities. REAP has a primary focus on energy generation and savings.

ISSUE 6: The current scoring criteria does award up to five (5) points for environmental benefits. The concern is being raised that more emphasis should be placed on GHG emission reduction and environmental savings, including water, etc. The Agency acknowledges the importance of environmental benefits and will consider how the priority system could place more value on such benefits.

Comment 4: ABC expressed concerns the provisions outlined in § 4280.121(h) “State Director and Administrator priority points” providing discretionary points to underrepresented technologies, geographic diversity, and underserved populations are a great step in the right direction, and ABC strongly supports this, but they are concerned that the points are insufficient to offset the criteria favoring lowest cost technologies and certain applications outlined above.

Agency response: While the Agency appreciates the comment, the Agency will continue to apply State Director and/or Administrator points in order to meet the objectives of the program. The Agency is open to further discussion on additional project benefits, however, the Agency is concerned about how alternatives could be quantified and valued in a fair manner to ensure consistent program delivery.

Comment 5: Ebenezer MGMT, LLC states that “Administrator points should not be available in the pooling rounds of competition. The State Directors have an intimate knowledge of their states and the needs of residents. The Administrator does not have this knowledge and should not have the ability to add 10 points to an application score. All funding determinations at the National Office should be by initial score alone. If Administrator points are used, the Administrator should state what conditions will receive additional points at the beginning of each fiscal year. Historically it appears the National Office has skewed results to penalize states proficient in utilizing the program; eliminating the Administrator points would alleviate this problem.”

Agency response: The concern regarding awarding Administrator points for national office competition is acknowledged. However, the competition is a national competition and the Administrator has discretion to apply additional points to support administration goals and objectives from a national perspective. Recent application of Administrator points has focused on underserved technology to diversify the national portfolio and assisting projects located in distressed communities.

Comment 6: CROPP requested an adjustment to the scoring criteria to accommodate local utility net-metering restrictions, specifically in scoring criteria #2 (quantity of energy replaced), sub-criteria 2a (energy replacement) and #6 (simple payback). CROPP believes this decreases the competitiveness of their producer applications and put producers at a disadvantage. Producers are disadvantaged by these criteria due to the net-metering limitations imposed by utilities. Those net-metering limits restrict the size of a RES an agriculture producer can install and thereby preclude producers from gaining the maximum scorable points.

“Net metering restrictions that limit the size of a RES that a farmer can install are pervasive from coast-to-coast across nearly all electric utility providers. Farmers should not be at a REAP disadvantage simply because their utility restricts the size of a RES; it is largely out of their hands and represents a scoring-criteria that should be rectified.”

Agency response: The Agency acknowledges the concern that net-metering can lead potential REAP applicants to design smaller systems; however, the Agency has no control over state or utility net-metering limitations.

Comment 7: “AgEC and ABC as a member of AgEC has received considerable support from the agriculture community and representatives in Congress for bolstering underserved and nascent renewable technologies to help ensure continued development and penetration into the marketplace, especially through a reserve of funds for these technologies. To that end AgEC would propose an addition to “§ 4280.121 Scoring RES and EEI grant applications.”

Specifically, AgEC and ABC would propose adding section (i) at the end: “(i) Notwithstanding the scoring rules above, no less than 15% of funding for a competition shall be awarded to nascent and/or underserved renewable [commercial] technologies separately from the remainder of the competition(s), on an annualized basis.”

A complimentary definition in “§ 4280.103 Definitions” would include “Nascent and underserved (or underused) renewable technologies. Nascent and underserved/underused technologies are those renewable energy technologies that have received less than 10 percent of program funding support in the last three years.”

AgEC and ABC also continue to advocate for a grants reserve fund for underserved renewable technologies, to support these technologies in achieving cost and scale.”

Agency response: The Agency continues to support the requirement for technology to be commercially available to be eligible for REAP assistance. The Agency has and continues to apply State Director and Administrator points to underserved technology in efforts to diversify the REAP portfolio. The commenters propose reserving a set amount of funds to facilitate the selection of underrepresented technologies. The REAP statute does not provide the flexibility to establish reserve funding. If such a provision came to fruition, careful planning must occur to ensure that REAP projects continue to realize benefit. The current program contains state allocated and national competitions for funding and also includes a set-aside of funds (reserve of funds) for $20,000 or less applications for renewable energy systems and energy efficiency. If funds are subdivided further to represent each under-represented technology for state allocations, grant requests would need to be smaller. It is likely that a state would not be able to fully utilize its allocation as any remaining funds after the subdivision would be below the minimum required grant amount. Additionally, any administrative burden costs to implement another reserve must be included in the planning.

Comment 8: “AgEC and ABC believe a robust loan guarantee component of REAP remains important as well.

AgEC and ABC greatly appreciates USDA's efforts under the OneRD program to remove regulatory barriers to make it easier for private lenders to use USDA programs and invest in rural America.

Yet it is vital that energy efficiency and renewable energy systems find full support under the consolidated program.

We urge USDA to ensure that the availability of OneRD funding is clearly communicated under all REAP funding opportunities, and urge REAP program officers to support grant applicants in obtaining complimentary loan funding where appropriate.

In addition, we would urge a new category of loan guarantee of 90% for distributed generation projects of less than $1,000,000. This would serve to support smaller-scale, and smaller businesses and/or individual applicants in the market.

Distributed generation is an important public policy area that the Administration wants to help for all of the myriad benefits it provides, including local economic development, localized energy production and ownership, grid and community resilience, and energy security (ex., much harder to succeed in cyber-attacks against millions of small solar and distributed wind installations)”.

Agency response: The Agency appreciates the comment and will continue to amplify the availability of REAP guarantee funding in our external communication strategies. We understand the importance of distributed generation projects and will continue to finance them under the REAP guaranteed loan and grant programs. The 2018 Farm Bill specifically outlines how REAP funds should be used ( i.e., technical assistance, small grants, energy efficient equipment and systems, etc.). Changes to the 2018 Farm Bill would be needed to create a new category of loan guarantees for distributed generation projects.

Comment 9: AgEC and ABC believe it is “incumbent upon USDA to properly staff the Rural Development mission area for better implementation of REAP and related energy or bioeconomy programs such as 9003. We would urge USDA to look at this further, hire and train as needed, and continue to communicate to Congress the importance of a robust staffing budget to efficiently support the administration of important programs.”

Agency response: Thank you for the comment, the Agency recognizes the importance of proper staffing and training.

Comment 10: AgEC and ABC “urge USDA again to further streamline, and simplify the REAP applications process across the board, but with a particular emphasis on lower cost grant applications for individual farmers and others. This is an issue we've raised for years.

We recognize the vital importance of due diligence, and agency fiduciary responsibilities, but the arduous applications process is inhibiting equity and opportunity in ag based energy. For example, some prospective applicants have to hire consultants, paying over $1,000 for an under $20,000 grant application for the hope of an award. The time that it takes, the cost, can have a “chilling effect” on program participation.

As Congress increasingly looks at REAP as a climate change and rural economic development program worthy of greater funding, the stakes grow as to program application simplification. More REAP funding in conjunction with a more streamlined approach will equal greater success, in terms of lowered costs to constituents, greater energy production, deployment of renewables and energy efficiency investments.”

Agency response: The Agency continues to look for additional efficiencies while remaining compliant with federal grant requirements. The updated rule adopts certifications related to applicant eligibility, modifies the feasibility study requirement, lessens the technical report requirements, and streamlines the annual reporting process.

Comment 11: The ELPC believes “REAP's complex application burden has been often discussed and is a drag on program success. It's important to note that the application burden has the effect of skewing the program towards those with the financial wherewithal to hire application writers and consultants and away from those with the most need.

Over the years, the USDA has taken steps to simplify the REAP application process. Most recently, the USDA expended great effort to simplify the application process for guaranteed loans and adopted innovative solutions for the OneRD Guarantee Loan Initiative. ELPC supports REAP simplification efforts and encourages USDA to expend a similar level of effort to simplify the application process for grants as the agency applied to OneRD. The USDA has demonstrated an ability to substantially revise and simplify the loan guarantee portion of REAP and should now apply as much effort to simplifying the majority of the program.

With new attention focused on REAP as a key USDA climate program it is more important and pressing than ever that the agency take strong action to simplify the REAP grant application process.”

Agency response: The updated rule adopts certifications related to applicant eligibility, modifies the feasibility study requirement, lessens the technical report requirements, and streamlines the annual reporting process. The Agency continues to look for additional efficiencies while remaining compliant with federal grant requirements and the REAP statute which mandates three tiers of applications.

Comment 12: Ebenezer MGMT, LLC commented that in “4280.103 Definitions, Small business means (A) Number of employees If Number of Employees is the SBA criteria to determine eligibility. Tax returns or annual receipt information should not be required as part of the submission. Tax returns are not needed for any other portion of applications that are under $200,000 in size. Tax returns should not be required if not needed for eligibility or scoring.”

“4280.103 Definitions, Small business means (B) Calculation of annual receipts Requiring 5 years of annual receipts information is excessive. Current rule utilizes three years. The extra paperwork and time spent accumulating and reviewing will not add substantially to any changes in eligibility. Rule does not state what types of records are required to document; it is hoped tax returns would not be the only source of documentation that could be used.”

Agency response: The Agency agrees that employee numbers can be verified using means other than tax returns and this is consistent with existing Agency policy. The Agency is bound to use the SBA definitions which have moved to a 5-year average. The alternative size standard may also be used. Please note that the new rule allows for certification of eligibility without providing all documentation to streamline the application process. If the Agency determines that the application needs additional documentation to support the applicant's eligibility, the Agency will accept tax return information, financial statements or other means that support the income or employee numbers.

Comment 13: Ebenezer MGMT, LLC commented that “the current DUNS (UEI) and System for Awards Management process continues to be slow and onerous on applicants. Applicants need to register in SAM.gov which most recently revised the website making the site less user friendly than the past, if there are problems the applicant must contact the Federal Service Desk or the Defense Logistics Agency depending on what stage the registration is in, making the process for the applicant difficult and cumbersome. These agencies have little knowledge of agriculture and the types of businesses and structures they use. Obtaining the SAM registration is the biggest roadblock to applicant participation in the program. Simply put, the process is not set up for grant purposes. Since USDA Rural Development NRCS does not require DUNS/SAM registration for their grant programs; REAP should also be exempt for any requirement.”

Agency response: The Agency acknowledges the concerns with the SAM registration process but must require SAM registration in accordance with 2 CFR part 25. The 2 CFR part 25.110(c)(2)(iii) allows recipients a 30-day window after award to complete their registration in exigent circumstances.

Comment 14: Since the guarantee program components have been removed from the regulation; Ebenezer MGMT, LLC questions “why such excessive financial information is required. This is a grant program; other than to prove eligibility and ability to operate; additional information should not be required. For a simple solar installation or energy efficiency installation when a feasibility study is not required; the financial information adds nothing to the grant review process. The financial information would be important for a guarantee review; however, for a grant program it is unnecessary and a waste of staff time to review. Nothing is gained by having the additional information.”

Agency response: The statute requires more documentation for applications with larger project costs. Financial statements are used by staff to review the financial stability of the applicant entity and to ensure the viability of the proposed project. A risk evaluation is required for grants as noted in 2 CFR 200.206(b).

Comment 15: ELPC commented that “REAP benefits should be available to all in agriculture, including historically underserved and disadvantaged farmers. We welcome Secretary Vilsack's commitment to addressing historical discrimination against Black Farmers by USDA. This commitment should include REAP.

ELPC supports awarding State Director and Administrator priority points for applications from unserved or under-served socially-disadvantaged groups. These points should be required across the country, so the USDA ensures equity in the program, with increased attention, outreach and education. USDA should engage in specific outreach to these communities to help them learn of program availability and benefits and to assist in the application process.”

Agency response: The Agency agrees with the commentor and continues to look for ways to diversify program participation. REAP is a pilot program for the Justice40 Initiative where at least 40 percent of overall benefits from Federal investments in climate and clean energy go to disadvantaged communities.

Comment 16: ELPC states that “to substantially simplify the REAP program, the USDA should adopt a rebate program to broadly deliver energy savings and clean energy savings. A REAP rebate would cover pre-approved technologies that cut energy costs and carbon pollution. This could be applied to grants under $20,000 to ease access to the program and facilitate more rapid deployment of energy efficiency and renewable energy systems in rural communities.

Such approaches are used in some state energy programs and they provide funding on a first-come, first-served basis. Adopting a rebate program would help the USDA address several program priorities, including simplification, improving equity and providing broader geographic coverage.”

Agency response: The REAP statute does not provide flexibility to administer a rebate or other payment program. As such, the Agency can only administer grant and guaranteed loan program funding.

Comment 17: “ELPC encourages the USDA to enable dual or combined applications and awards under the Energy Audits and Renewable Energy Development Assistance (EA/REDA) subprogram as much as possible in program application and administration. This change would allow grant recipients to apply for and receive grants for providing both energy audits and renewable energy development assistance. Importantly, the enabling legislation does not call for separation.

This change will improve EA/REDA continuity from learning with energy audits to acting with investments for energy savings and renewable energy production. Energy audits, in themselves, do not result in energy changes but with follow through in development advice more action is likely. Facilitating dual EA and REDA awards will help move projects forward in the development pipeline from problem identification to understanding options and implementing solutions.

As regards a specific program change mentioned in the draft rule, we encourage the USDA to allow for “funding to train individuals to become qualified to perform EA or REDA assistance” in those cases where the applicant has already demonstrated they have “experienced resource providers at time of application.” Especially in this economy, organizations need to address inevitable turnover in staff over time. This change also helps states to build REAP capacity by growing the ranks of energy experts.

ELPC supports the “minimum score of 40 points to compete for EA/REDA funding” for the purpose of maintaining program quality.”

Agency response: The Agency allows an applicant to apply for one EA and one REDA in a fiscal year so that both tasks may be undertaken by the same entity; however, separation allows for an easier way to track project impacts. For example, the Agency could verify if EEI applications for a particular state increased in future years as a result of having EA audit services. Furthermore, the EA component requires that 25 percent of the cost of the energy audit be paid by the ag producer or rural small business where the REDA component does not have a similar requirement. Separation allows the Agency to easily track that this requirement is met for EA projects. The Agency has limited funding for EA/REDA and wants to ensure that funds are used for services that directly support rural small businesses and ag producers rather than professional development for the recipient organization to train auditors.

Comment 18: “ELPC supports State Director and Administrator priority points for applications including under-represented technologies. But the USDA needs to take steps beyond point scoring to diversify technology support.

The USDA has taken steps in the past to increase technology diversity in determining REAP awards. The USDA employed a “normalization” process developed by the National Renewable Energy Laboratory (NREL). The normalization process took place after proposals were all scored and sought to preserve some degree of balance among the technologies supported in the program. The normalization process, however, was abandoned after it became burdensome.

The USDA should implement a simpler approach with a grants reserve fund as described by the Ag Energy Coalition to maintain technology diversity among major energy types such as solar, wind, biomass, energy efficiency, hydropower, etc. In implementing the grants reserve fund and to the extent adequate applications are available, the agency should apply a minimum score of 40 points or more, as used elsewhere in program administration.”

Agency response: The Agency acknowledges that there are other ways beyond scoring to maintain technology diversity. However, with limited staffing resources, it would be difficult for the Agency to complete the normalization process and still meet statutory obligation deadlines. Limited staff resources and the program's continued growth challenges the Agency's ability to add another layer of complexity in processing applications.

Comment 19: ELPC states that “in the 2016 the USDA released a report, USDA Building Blocks for Climate Smart Agriculture and Forestry. The Building Blocks report identified REAP as a key USDA program for addressing climate change. In Congress, REAP is often regarded as a key program for reducing carbon pollution from the agricultural sector and is included in legislation to scale up the program.

The USDA needs to act now to increase the emphasis on environmental benefits of the REAP program, beginning with increasing the share of program points attributed to environmental benefits. For example, scoring should increase for projects that provide non-energy environmental benefits such as water conservation and protection.

With the growing climate crisis, the agency also needs to act now to develop practice and standards for carbon pollution reduction by technology that reflect modern science on life cycle impacts of each technology. This is urgent and requires USDA action as soon as possible.”

Agency response: The Agency acknowledges this concern and is exploring environmental project benefits via the Justice40 Initiative.

Comment 20: CROPP commented that “the revised RES residential language will significantly limit program access and increase the application burden experienced by small and mid-size family farms; farms owned and operated by a single-family unit that resides on the farm. The majority of CROPP Cooperative's nearly 1,800 farmer-members live and work on the same property that comprises the family farm. The final rule's revised RES residential language does not specify what “greater degree of documentation” will be required for a RES project where a residence is closely associated with an agriculture operation to ensure that 50 percent or greater of energy generated by the RES will benefit the farm.

Providing no explanation of the “greater degree of documentation” required could prove costly and time consuming, especially for small to mid-size farms, and may require professional services above and beyond that which is typically provided by a RES installer/vendor.

CROPP Cooperative uses a residential audit to verify if 50 percent or greater of energy generated by the RES, will benefit the farm. It is not clear if a residential audit satisfies the intent of the rule change.

More generally, this continually elevated residential-use prohibition seems a distraction and does not seem to recognize the dynamic of many family-run businesses which may have home offices or connected facilities.”

Agency response: The updated rule removes the “certification only” option for projects. All other processes remain the same with the goal of ensuring sufficient documentation that 50 percent or more of the proposed energy to be generated will benefit the agricultural producer or rural small business. The Agency has been requiring clarifying documentation on this provision for some time. The Agency did not intend to add burden by removing the “certification only” option. Instead, it was intended to facilitate consistency in processing applications while ensuring there is adequate file documentation that 50 percent or more of the projected renewable energy will benefit the agricultural producer or rural small business. The residential audit should be acceptable to meet the requirement provided it clearly establishes the amount of historical energy consumed by the residence to allow for the calculation of historical business energy use from total energy consumption.

Comment 21: CROPP would like an adjustment to $20,000 or Less Funding Pool.

“With nearly 15 years' experience with REAP applications, we believe that increasing the maximum award request in the smaller project funding pool is long overdue and will significantly increase program access and accelerate renewable energy projects in rural areas.

Currently, the average small to mid-size Organic Valley dairy requires a 40kW-50kW RES to offset 100% of the farm's non-renewable energy consumption. Our estimation is a solar array to service this energy need is in the range of $130,000-$150,000, which would exceed the threshold of maximum allowed cost-share in the $20,000 funding pool. We recommend increasing the maximum award request to $40,000 in the smaller project funding pool. A simple adjustment for inflation since the program's start would validate an increase and be more reflective of the overall needs of farmers and rural businesses in this category of need. It is our experience that RES in the 40kW-50kW range do not receive support in the larger, unrestricted funding pool. This pool is typically obligated to a very small number of large RES projects.”

Agency response: The Agency has concern that fewer projects would be funded by the suggested change. The $20,000 or less maximum award request limitation would require a statutory change.

Comment 22: CROPP says it has been their experience that “significant delays (12+ months) in the obligation of funds at the state level is impacting project success and farmer interest in the program. Historically, the obligation of funds has been within a timeframe of three to six months. Within the previous two years, we have seen the obligation timeframe extend to 12+ months.

Administrative delays need to be addressed to ensure that project bids and farmer costs remain timely and relevant to avoid significant unexpected cost and installation burdens. It is unacceptable to expect an applicant to maintain contractual obligations that extend out as far as a year, as material and labor costs, as well as service availability, fluctuate sometimes monthly.”

Agency response: Obligation of funds is tied to annual application and statutory obligation deadlines. October 31 is the application deadline for grant requests of $20,000 or less that wish to compete for the first half of the state allocation of set-aside funds. March 31 is the application deadline for grants requests of $20,000 or less that wish to compete for the second half of the state allocation of set-aside funds. March 31 is also the deadline for all other REAP applications regardless of the size of the grant request. Complete and eligible projects with completed environmental reviews are able to compete for funding. Applicants should contact Agency staff early in the process to discuss application requirements including the environmental review process.

The Agency appreciates the interest of the American Biogas Council, Agriculture Energy Coalition, Ebenezer MGMT, LLC, Environmental Law & Policy Center and CROPP Cooperative with regard to the Rural Energy for America Program final rule and thanks them for their submissions. The Agency confirms the rule without change.

The Board is issuing this interim final rule pursuant to its authority under the Federal Credit Union Act. 1 The Act grants the Board a broad mandate to issue regulations that govern both federal credit unions and, more generally, all FICUs. For example, Section 120 of the Act is a general grant of regulatory authority and authorizes the Board to prescribe rules and regulations for the administration of the Act. 2 Section 209 of the Act is a plenary grant of regulatory authority to issue rules and regulations necessary or appropriate for the Board to carry out its role as share insurer for all FICUs. 3 Other provisions of the Act confer specific rulemaking authority to address prescribed issues or circumstances. 4 Such specific rulemaking authority is set forth in Section 216(b) about PCA. 5

In 1998, Congress enacted the Credit Union Membership Access Act (“CUMAA”). 6 CUMAA amended the Federal Credit Union Act (“the Act”) to require the NCUA to adopt, by regulation, a system of PCA consisting of minimum capital standards and corresponding remedies to improve the net worth of federally-insured “natural person” credit unions. 7 The purpose of PCA is to “resolve the problems of insured credit unions at the least possible long-term loss to the [National Credit Union Share Insurance Fund (`NCUSIF')].”  8 The PCA section of the Act does not apply to corporate credit unions. 9

The statute designated three principal components of PCA: (1) A framework combining mandatory actions prescribed by statute with discretionary actions developed by the NCUA; (2) an alternative system of PCA to be developed by the NCUA for FICUs which CUMAA defines as “new;” and (3) a risk-based net worth requirement to apply to FICUs which the NCUA defines as “complex.” Besides those FICUs that meet the statutory definition of a “new” FICU, CUMAA mandated a framework of mandatory and discretionary supervisory actions indexed to five statutory net worth categories. These categories are: “well capitalized,” “adequately capitalized,” “undercapitalized,” “significantly undercapitalized,” and “critically undercapitalized.” The mandatory actions and conditions triggering conservatorship and liquidation are expressly prescribed by statute. 10 To supplement the mandatory actions, the statute directed the NCUA to develop discretionary actions which are “comparable” to the “discretionary safeguards” available under Section 38 of the Federal Deposit Insurance Act, which is the statute that applies PCA to other federally-insured depository institutions. 11

The Act addresses the earnings retention requirement applicable to FICUs that are not well capitalized. 12 Such FICUs are required to annually set aside as net worth an amount equal to not less than 0.4 percent of their total assets. 13 The Board has the authority to decrease the earnings retention requirement. 14 To do this, the Board may issue an order if it determines that the decrease is necessary to avoid a significant redemption of shares and further the purpose of that PCA provision of the Act. The Act also requires the Board to periodically review any order issued under that section. 15

Separately, the Act sets forth requirements related to NWRPs, which FICUs must submit to the NCUA when it becomes undercapitalized. 16 The regulatory provisions addressing the procedures and documentation requirements for NWRPs are codified at 12 CFR 702.111 and are detailed below.

In February 2000, the Board adopted part 702 and subpart L of part 747 establishing a comprehensive system of PCA that combines mandatory supervisory actions prescribed by the statute with discretionary supervisory actions developed by the NCUA (2000 final rule). 17 Each of these supervisory actions is indexed to the five statutory net worth categories noted above. The 2000 final rule also permits the NCUA to impose “other action to better carry out the purpose of PCA” than any discretionary supervisory action available in that category. 18 In the proposal that provided the basis for the 2000 final rule, the Board noted that “[p]art 702 also amplifies the terms of the statutory exception to the 0.4 percent minimum set aside. Specifically, the Board stated that it interprets the phrase by order to indicate that exceptions to the 0.4 percent statutory minimum are to be granted on a case-by-case basis.”  19 But the Board revisited this interpretation in the May 2020 interim final rule on this subject, finding that the Act does not require FICUs to send a specific application or the NCUA to issue individual orders for each FICU. 20 The Board also notes that the current, specific requirements on earnings retention waivers are based on a regulatory provision rather than a specific statutory directive. 21 Thus, issuing a broadly applicable order is consistent with the overall statutory structure of PCA, which combines both mandatory and discretionary provisions. During the COVID-19 pandemic, many FICUs have broadly faced similar economic circumstances that affect net worth and earnings. Given these experiences, and the potential for similar volatility and uncertainty in the future, the Board has determined it is appropriate to implement the changes in this rule to extend the provisions that authorize a broadly applicable order to decrease the earnings-retention requirements for multiple FICUs and to allow a streamlined NWRP in certain circumstances.

On May 21, 2020, the Board approved an interim final rule that temporarily amended two provisions in the PCA regulations in part 702. 22 The first amendment addressed the earnings retention requirement in § 702.201 for FICUs classified as adequately capitalized. 23 The second amendment addressed the NWRPs for FICUs in § 702.206(c) that have become undercapitalized. 24

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-06-06, Amendment 39-21473 (86 FR 14366, March 16, 2021) (AD 2021-06-06), for Bell Textron Canada Limited Model 505 helicopters, serial number (S/N) 65011 and subsequent. The NPRM published in the Federal Register on September 14, 2021 (86 FR 51035). In the NPRM, the FAA proposed to retain some of the requirements of AD 2021-06-06, including, before further flight, revising Section 1, the Limitations section of the existing RFM for your helicopter to prohibit single pilot operations from the right crew seat, require the pilot in command (PIC) to occupy the left crew seat for dual pilot operations, and depending on configuration, prohibit the use of SPLIT-COM mode. The NPRM also proposed to require, before further flight, and thereafter at intervals not to exceed 25 hours time-in-service (TIS), removing the pilot collective stick and grip assembly and performing an FPI for a crack and depending on the inspection results, removing a certain part from service. The NPRM proposed to require, within 12 months, removing a certain part-numbered pilot collective stick tube from service and installing an improved pilot collective stick tube in accordance with the manufacturers service information and thereafter, removing a certain part-numbered pilot collective stick tube from service before it accumulates 300 total hours TIS.

Additionally, the NPRM would consider certain proposed actions to be a terminating action for other actions proposed in the NPRM. The NPRM also proposed to prohibit installing any pilot collective stick and grip assembly unless certain proposed actions were accomplished. Finally, the NPRM proposed to require revising the Limitations section of the existing RFM for your helicopter; the owner/operator (pilot) may incorporate the RFM revisions and the owner/operator must enter compliance with the applicable paragraphs of the AD into the aircraft records in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). This is an exception to the FAA's standard maintenance regulations.

The NPRM was prompted by Transport Canada AD CF-2021-05R3, dated March 19, 2021 (Transport Canada AD CF-2021-05R3), issued by Transport Canada, which is the aviation authority for Canada, to correct an unsafe condition for Bell Textron Canada Limited Model 505 helicopters, S/Ns 65011 through 65347. Transport Canada advises that the pilot collective stick and grip assembly has been redesigned to address the root cause of the cracking. Accordingly, Transport Canada AD CF-2021-05R3 retains the requirements of Transport Canada Emergency AD CF-2021-05R2, dated March 4, 2021 (Transport Canada Emergency AD CF-2021-05R2), which prompted AD 2021-06-06, and requires installing the newly designed pilot collective stick and grip assembly, which is a terminating action for the requirements of Transport Canada Emergency AD CF-2021-05R2. Transport Canada AD CF-2021-05R3 also revises the applicability to include only helicopters that have not incorporated the redesigned pilot collective stick and grip assembly during production.

Therefore, the FAA determined that it is necessary to supersede AD 2021-06-06 and the required actions as proposed in the NPRM include a terminating action for the repetitive FPI inspections.

The FAA received comments from one commenter; Bell. The following presents the comments received on the NPRM and the FAA's response to each comment.

Bell requested that the FAA revise the life limit of pilot collective stick tube part number (P/N) M207-20M301-043. Bell stated that 300 total hours TIS was only an interim life limit and after the completion of fatigue testing, the life limit of 6,250 total hours TIS has been approved by Transport Canada. Specifically, Bell requested that the FAA change the required action to, “Replace the pilot collective stick tube P/N M207-20M301-043 at or before reaching its Life Limit as defined in Table 1 of the Maintenance Planning Information (MPI) Chapter 4 Airworthiness Limitations Schedule (ALS), BHT-505-MPI Chapter 4 Issue 09, dated 12 March 2021, or later revisions of the ALS approved by Transport Canada.”

The FAA partially agrees. The FAA disagrees with changing the action from removing the pilot collective stick tube from service to “replace the pilot collective stick tube” because this is a life limit and, once the life limit is reached, the part must be removed from service and never installed on any aircraft again. Additionally, due to eligibility requirements in 1 CFR part 51, the FAA cannot mandate use of “later revisions” of service information directly in an AD. However, the FAA agrees with the life limit threshold increasing from 300 total hours TIS to 6,250 total hours TIS and, accordingly has changed that life limit in this final rule.

Bell requested that the FAA revise paragraph (g)(6) of the Required Actions that states relief under any Master Minimum Equipment List or Minimum Equipment List for the Audio Panel is prohibited when the aircraft is operated with a single pilot. Bell stated that this restriction is only applicable when operated from the left hand seat, and the aircraft must be flown from the right hand seat when SPLIT-COM mode is enabled. Bell further stated this is consistent with the limitations of the flight manual.

The FAA agrees and has revised the required actions in this final rule accordingly.

Bell requested that the FAA allow credit for the required actions through an approved AMOC and service information. Bell stated that the FAA approved an AMOC to AD 2021-06-06 on March 26, 2021, which allowed operators to implement a terminating action based on the instructions contained in Bell Alert Service Bulletin 505-21-20, Revision C, dated March 11, 2021 (ASB 505-21-20 Rev C). Bell requested that the approved AMOC and ASB 505-21-20 Rev C be included in the Credit for Previous Actions paragraph.

The FAA agrees with the request to allow credit; however, the FAA disagrees with putting this information in the Credit for Previous Actions paragraph. The FAA agrees that the previously approved AMOC to AD 2021-06-06 continues to be valid to address the unsafe condition. Accordingly, the FAA has revised the AMOC paragraph in this final rule by adding paragraph (j)(3), which states “AMOCs approved previously for AD 2021-06-06 are approved as AMOCs for the corresponding requirements in paragraph (g) of this AD.” Additionally, the purpose of the Credit for Previous Actions paragraph is to allow credit for required actions accomplished previously in accordance with previous revision(s) of service information. Since ASB 505-21-20 Rev C is required to accomplish certain actions in paragraph (g) of this AD, previous accomplishment of those actions in ASB 505-21-20 Rev C could be considered accomplished by paragraph (f) of this AD.

In this final rule, the FAA has changed the effective date of paragraph (g)(1) from “after the effective date of this AD” to “from March 31, 2021 (the effective date of AD 2021-06-06),” because this paragraph carries-over identical required actions from paragraph (g)(1) of AD 2021-06-06.

These helicopter have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with Canada, Transport Canada, its technical representative, has notified the FAA of the unsafe condition described in its AD. The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these helicopters. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed ASB 505-21-20 Rev C, which provides instructions for an initial and repetitive FPIs for cracks in the pilot collective stick and grip assembly P/N M207-20M478-041/-043/-047 on Bell Textron Canada Limited Model 505 helicopters, serial numbers 65011 through 65347. ASB 505-21-20 Rev C also specifies inserting a temporary revision (TR) into the RFM that prohibits single pilot operations from the right crew seat until further notice, and specifies that if the right crew seat pilot collective stick and grip assembly was previously confirmed serviceable following an FPI, then the 25 flight hour repetitive FPI of the right crew seat pilot collective stick and grip assembly is no longer required provided that the helicopter is only operated single PIC from the left crew seat. ASB 505-21-20 Rev C also introduces procedures to install an improved pilot collective stick tube assembly, along with its initial life limit, and which is also terminating action for the repetitive FPIs and temporary RFM revision.

The FAA also reviewed Bell 505 RFM TR for Pilot Collective (ASB 505-21-20), BHT-505-FM-1, Temporary Revision (TR-6) (BHT-505-FM-1, TR-6) and Bell 505 RFM TR for Pilot Collective (ASB 505-21-20), BHT-505-FM-2, Temporary Revision (TR-1), each dated March 3, 2021. These temporary revisions specify changes to Section 1 of the RFM Limitations Section that the minimum flight crew consists of one pilot that shall operate from the left crew seat and that dual operation is approved provided that the PIC occupies the left crew seat. BHT-505-FM-1, TR-6 also prohibits use of SPLIT-COM mode.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA reviewed Bell ASB 505-21-20, dated February 20, 2021 (ASB 505-21-20), Bell ASB 505-21-20, Revision A, dated February 26, 2021 (ASB 505-21-20 Rev A), and Bell ASB 505-21-20, Revision B, dated March 3, 2021 (ASB 505-21-20 Rev B). ASB 505-21-20 specifies a one-time inspection for cracks of the pilot collective stick and grip assembly. ASB 505-21-20 Rev A removes the visual inspection and adds a repetitive FPI. ASB 505-21-20 Rev B adds the RFM temporary revision and clarifies the compliance time of the repetitive FPI.

This AD prohibits relief under any Master Minimum Equipment List or Minimum Equipment List for the Audio Panel when the aircraft is operated with a single pilot from the left seat, whereas Transport Canada AD CF-2021-05R3 does not. Transport Canada AD CF-2021-05R3 requires the repetitive FPIs if the aircraft is not flown solely from the left crew seat whereas this AD requires repetitive FPIs regardless.

Transport Canada AD CF-2021-05R3 requires operators to “advise all flight crews” of changes to the RFM, and thereafter to “operate the helicopter accordingly.” However, this AD does not specifically require those actions. 14 CFR 91.9 requires that no person may operate a civil aircraft without complying with the operating limitations specified in the RFM. Therefore, including a requirement in this AD to operate the helicopter according to the revised RFM would be redundant and unnecessary. Further, compliance with such a requirement in an AD would be impracticable to demonstrate or track on an ongoing basis; therefore, a requirement to operate the helicopter in such a manner would be unenforceable.

This AD prohibits installing any pilot collective stick and grip assembly on any helicopter unless the actions required by paragraphs (g)(2) and (3) of this AD have been accomplished, whereas Transport Canada AD CF-2021-05R3 does not.

The FAA estimates that this AD affects 98 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Revising the existing RFM for your helicopter takes about 0.5 work-hour for an estimated cost of $43 per helicopter and up to $4,214 for the U.S. fleet.

Removing, cleaning, and performing an FPI of the pilot collective stick and grip assembly takes about 3 work-hours for an estimated cost of $255 per helicopter and up to $24,990 for the U.S. fleet per inspection cycle.

Installing an improved pilot collective stick tube takes about 5 work-hours and parts cost about $1,256 for an estimated cost of $1,681 per helicopter and up to $164,738 for the U.S. fleet per replacement cycle.

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The TCCA, which is the aviation authority for Canada, has issued TCCA AD CF-2021-25, dated July 22, 2021 (TCCA AD CF-2021-25) (also referred to as the MCAI), to correct an unsafe condition for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The NPRM published in the Federal Register on December 17, 2021 (86 FR 71589). The NPRM was prompted by a report that some tie-rod assemblies may have been overtightened during the installation of interior monuments (such as galleys, lavatories, and forward stowage or wardrobes). The NPRM proposed to require adjusting the tie-rod assemblies, as specified in TCCA AD CF-2021-25.

The FAA is issuing this AD to address overtightened (pre-loaded) tie-rods that induce unwanted stress in a monument and may cause the monument to become unconstrained in an emergency landing, potentially blocking exits or injuring occupants. See the MCAI for additional background information.

The FAA received no comments on the NPRM or on the determination of the cost to the public.

The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products.

TCCA AD CF-2021-25 specifies procedures for, among other actions, adjustment of the affected tie-rod assemblies to remove any pre-load. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 21 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, part A, subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0181, dated July 30, 2021 (EASA AD 2021-0181) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and B4-203 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus SAS Model A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and B4-203 airplanes. The NPRM published in the Federal Register on December 17, 2021 (86 FR 71592). The NPRM was prompted by a determination that new or more restrictive airworthiness limitations related to pylon maintenance are necessary. The NPRM proposed to require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations for pylon maintenance, as specified in EASA AD 2021-0181.

The FAA is issuing this AD to address fatigue cracking, damage, and corrosion in principal structural elements; such fatigue cracking, damage, and corrosion could result in reduced structural integrity of the airplane. See the MCAI for additional background information.

The FAA received no comments on the NPRM or on the determination of the cost to the public.

The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products.

EASA AD 2021-0181 specifies new or more restrictive airworthiness limitations for pylon maintenance. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 1 airplane of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the agency estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, part A, subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain AVOX System Inc. (formerly Scott Aviation) oxygen cylinder and valve assemblies, and oxygen valve assemblies, installed on but not limited to various transport airplanes. The NPRM published in the Federal Register on May 1, 2020 (85 FR 25353). The NPRM was prompted by reports of cylinder and valve assemblies having oxygen leakage from the valve assembly vent hole, caused by the absence of a guide that maintains appropriate spacing between certain parts. In the NPRM, the FAA proposed to require an inspection of the oxygen valve assemblies, and oxygen cylinder and valve assemblies, to determine the serial number of the valve, cylinder, and entire assembly. For assemblies and parts with certain serial numbers, the NPRM proposed to require a detailed inspection for correct spacing of the gap between the bottom of the packing retainer and top of the valve body on the assemblies, and replacement of assemblies having unacceptable gaps (removing affected assemblies and installing serviceable assemblies). The NPRM also proposed to require reporting and returning of affected parts to the manufacturer. The FAA is issuing this AD to address oxygen leakage from the cylinder, which could result in decreased or insufficient oxygen supply during a depressurization event; and heating or flow friction, which could cause an ignition event in the valve assembly.

The FAA received comments from one commenter, Air Line Pilots Association, International (ALPA), who supported the NPRM without change.

The FAA received additional comments from five commenters, including American Airlines (AAL), Delta Air Lines (DAL), FedEx Express (FedEx), United Airlines (UAL), and an individual. The following presents the comments received on the NPRM and the FAA's response to each comment.

AAL and UAL suggested revising the applicability statement to include more aircraft manufacturers and models. AAL suggested adding all airplane models that affected assemblies could be installed on, in particular, Boeing Model 737-NG (Next Generation models are 737-600, -700, -700C, -800, -900, and -900ER series), 737-MAX, 777-200, and 777-300 series airplanes. UAL also suggested adding Model 737-NG airplanes. AAL stated that the applicability statement as proposed in the NPRM could mislead operators into believing that the AD would apply only to the airplanes identified in paragraphs (c)(1) through (12) of the AD. UAL believed the suggested change will be beneficial and assist operators in determining if their fleets are affected.

The FAA disagrees with the commenters' request. The FAA does not have a comprehensive list of all possible affected aircraft. To address the incomplete list, paragraph (c) of this AD identifies specific airplane models in paragraph (c) of this AD, but also notes that the assemblies are “not limited to.” The FAA has not changed the AD in this regard.

AAL stated that the 60-day compliance time should apply only to valve assemblies that are installed on the aircraft and not ones in stock. AAL believes the unsafe condition only exists when an assembly is installed on an airplane, and for those assemblies that are not installed on an airplane, the proposed requirements in paragraph (k) of the proposed AD would ensure that the unsafe condition is addressed before that assembly is installed on an aircraft.

The FAA disagrees with the request to revise the compliance time. The FAA agrees that an affected spare part that is uninstalled and stored off an aircraft would not cause an unsafe condition on an aircraft. The 60-day compliance time applies to parts already installed on an aircraft, and paragraph (k) requires that action to be done on affected spare parts before installation, which could result in a spare part being inspected before the 60-day compliance time. In developing the compliance time for this AD, the FAA considered the urgency associated with the subject unsafe condition and the availability of required parts. The FAA determined that the 60-day compliance time for parts already installed on an aircraft is appropriate for accomplishing the actions required by this AD while maintaining an adequate level of safety. The FAA has not changed this AD in this regard.

AAL requested that the inspection to verify the serial number of the oxygen cylinder and entire assembly not be required. DAL requested that paragraphs (c), (h), (i), and (k) of the proposed AD be revised to remove reference to cylinder part numbers (P/Ns) and apply only to valve assembly P/Ns. AAL stated that it reviewed the service information and it seems that the defective part is only the valve assembly or “hand valve.” DAL also reasoned that the unsafe condition applies only to the valve assembly and not the cylinder. AAL then reasoned that the inspection to verify the serial number should apply only to the valve assembly or “hand valve.” AAL also stated that paragraph (i) of the proposed AD also seems to require the actions of paragraph (h)(1) through (3) of the proposed AD if a serial number of a cylinder was affected and a valve assembly not affected, even though it seems that it should not require those actions.

The FAA disagrees with the request. The parts of the oxygen cylinder and valve assemblies are interrelated, and valves from matched sets could have fit-up issues between parts or be mixed up or swapped during maintenance operations. The serial number inspection as proposed would address this interchangeability. The valve and cylinder that are part of those assemblies must also be inspected to address the unsafe condition, not just the assemblies themselves. Therefore, the FAA specifies to inspect the oxygen valve assemblies, and oxygen cylinder and valve assemblies, to determine the serial number of the valve, cylinder, and entire assembly. The FAA has not changed this AD in this regard.

UAL requested a change to the wording of which components need the serial number inspection. UAL stated that the statement in paragraph (h) of the proposed AD can be misconstrued as requiring that each of the three components (valve, cylinder, and entire assembly) be inspected individually for suspect serial numbers. UAL inferred that the intention is to inspect for the serial number of the entire cylinder and valve assembly, and not the individual components. UAL also stated that, for new oxygen cylinder assemblies from AVOX, there are individual placards that itemize the P/N and serial number for each component, and that for some cylinder assemblies, the serialization of the entire cylinder and valve assembly is nearly identical in format to the serialization of sub-component valve assemblies, which could lead to inaccurate reporting of results. The FAA infers that UAL suggested that the relevant numbers on the placards could be confused with other numbers.

The FAA disagrees. Each part and assembly stated in paragraph (h) of this AD are interrelated and must be inspected. The valve and cylinder components that are part of those assemblies must also be inspected for serial numbers, not just the assemblies themselves. If the serial number markings are unclear or missing, the service information contains information on identifying the parts and part assemblies. The FAA has not changed this AD in this regard.

AAL and DAL requested changes to address concerns about what actions are required if a part is missing a blue dot. DAL stated that it seems best to prohibit all affected serial numbers to avoid a case where an inspected and marked part is installed, but the blue dot fades. AAL pointed to paragraph (i) of the proposed AD that would clarify that only the affected serial numbers of the valve assembly would need additional work, and, for valve assemblies marked with a blue dot, a detailed inspection for correct spacing of the gap between the bottom of the packing retainer and top of the valve body would not be required. AAL stated that, as written, the proposed AD seems to suggest that an inspection of the gap would be required regardless of the presence of a blue dot.

The FAA disagrees with the request. The service information specifies that if there is a doubt on the condition of a part, such as missing serial numbers or a blue dot not definitively identified, then the follow-on inspections are required to ensure that no discrepant or affected part is missed. Paragraph (k) of this AD prohibits installation of assemblies with affected serial numbers unless the actions of paragraph (i) of this AD are accomplished. The FAA has not changed this AD in this regard.

DAL requested that the compliance times for the inspection report be removed from paragraph (j)(1) of the proposed NPRM, and if not, the inspection report itself be removed. AAL requested removing the proposed requirement to submit an inspection report after accomplishing the requirements ( i.e., gap inspection) of paragraph (i) of the proposed AD. FedEx stated reporting should not be required for units that pass the inspection, and that sending units that failed the inspection to the vendor should be sufficient for reporting those failures. FedEx noted that any reporting requirements should consider the difficulties in reporting findings in a short period of time and noted that the inspector might not have access to the internet, email, and a device capable of printing and scanning. FedEx opined that its proposal would maintain accurate reporting and accommodate the realities of a global workplace. AAL and DAL stated that the reporting seems unnecessary and does not contribute to any additional level of safety. AAL added that the NPRM would give operators the responsibility of ensuring that any affected part is returned to the manufacturer, and asserted that an equivalent level of safety would be maintained even if the reporting is not accomplished. DAL reasoned that if a cylinder valve assembly is unacceptable, it would be in the operator's best interest to report that finding to AVOX anyways so that it can receive a replacement assembly.

The FAA disagrees. In this case, the inspection results need to be reported to assist in tracking affected parts that are in circulation. In addition, reporting all findings gives assurance that an inspection was performed on an assembly with a given serial number. The FAA has not changed this AD in this regard.

AAL, DAL, and UAL requested revising paragraph (j)(2) of the proposed AD to remove a compliance time for returning discrepant parts to the manufacturer. AAL stated that a compliance time would not contribute to the level of safety. AAL also stated that all discrepant assemblies would be returned in a timely manner that is sufficient to the operator. DAL stated that it would be an unnecessary burden on operators to wait for AVOX's response before sending an unacceptable or discrepant part back within the compliance time in exchange for a free-of-charge replacement. DAL also stated that it would also be in the operator's best interest to send in the assembly so that it can qualify for a free-of-charge replacement if AVOX determines the part is unacceptable or discrepant. UAL stated it also believes the instruction to contact AVOX for shipping instructions could impede compliance with the 30-day limit to ship discrepant parts back to AVOX. UAL also stated that it wants to know how, for accurate AD-compliance reporting, it would be determined that a part is being shipped back as a result of this finding from AD-required inspections, or as a result of other, normal repair order processes.

The FAA agrees to clarify. Paragraph (j)(2) of this AD requires returning the assembly to the manufacturer in accordance with paragraph 3.D.(2) or 3.D.(3), as applicable, of the applicable service information. However, the service information does not include instructions to wait for a response from AVOX before returning the part. In addition, the FAA has revised paragraph (j)(2) of this AD to clarify that contacting AVOX for shipping instructions in not required. AVOX is tracking parts that are returned to it during accomplishment of the AD for data collection or analysis of manufacturing issues, and AVOX is also re-conditioning parts where possible. The FAA determined that having a 30-day compliance time for returning the part after an inspection finding is appropriate for this AD. However, under the provisions of paragraph (m) of this AD, an operator may request an approval of an alternative method of compliance (AMOC). The FAA has not changed this AD in this regard.

AAL requested that all the references to the AVOX service information be revised to allow use of subsequent revisions. AAL reasoned that this revision would reduce the number of AMOC requests each time a referenced service bulletin is revised.

The FAA disagrees. In an AD, the FAA may not refer to any document that does not yet exist. In general terms, the FAA is required by the Office of the Federal Register (OFR) regulations for approval of materials incorporated by reference, as specified in 1 CFR 51.1(f), to either publish the service document contents as part of the actual AD language; or submit the service document to the OFR for approval as referenced material, in which case the FAA may only refer to such material in the text of an AD. The AD may refer to the service document only if the OFR approved it for incorporation by reference. See 1 CFR part 51. The FAA disagrees with revising the AD to include specific airplane models based on the corresponding service information because the agency does not have a comprehensive list of the applicable aircraft to which specific AVOX service information could apply. The FAA has not changed this AD in this regard.

A commenter requested clarifying paragraph (c) of the proposed AD by including reference to the service information that was identified in paragraph (h) of the proposed AD. The commenter suggested revising the paragraph so that the applicability would include information on the service information definition of the affected units. AAL also requested adding the airplane configuration information in the text of the AD to add further clarification to operators and release the technical data in a more organized fashion.

The FAA disagrees. The definition of the affected units does not need to be moved to paragraph (c) of the AD. The effectivity of the service information is limited to specific airplane models, but the applicability of this AD applies to all aircraft. Because the affected parts could be installed on additional aircraft models, the FAA has determined that the affected parts could later be installed on aircraft that were initially delivered with acceptable parts, thereby subjecting those aircraft to the unsafe condition. The FAA has not changed this AD in this regard.

DAL and UAL requested revising the compliance time proposed in paragraph (h) of the proposed NPRM. DAL and UAL stated that since many operators have parked their aircraft or severely reduced usage of aircraft, an extension of the compliance time (either with additional calendar days or adding an option for flight hours and flight cycles), would allow operators additional time for compliance. UAL also stated that the supply chain could be affected due to potential increased shipping time and workforce reductions.

The FAA disagrees with the request to extend the compliance time. The FAA acknowledges the effects that the pandemic response might have on operators' fleet use, supply chain, and maintenance personnel. In developing an appropriate compliance time for this action, the FAA considered the degree of urgency associated with addressing the subject unsafe condition, the manufacturer's recommendation for an appropriate compliance time, and the practical aspect of accomplishing the required inspection within a period of time that corresponds to the normal scheduled maintenance for most affected operators. In addition, the FAA notes that some aircraft may have been in service during the pandemic and must comply within the required compliance time. Operators do have the option to inspect the airplane before the first flight following storage if the airplane is in storage for more than 27 months. However, under the provisions of paragraph (m) of this AD, the FAA will consider requests for an extension of the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. The FAA has not changed this AD in this regard.

FedEx requested that the specification to use oil-based blue ink markers be modified to allow alternative methods and colors such as black indelible ink. FedEx stated that oil-based blue paint markers are not readily available or kept in stock regularly. FedEx suggested that a list of part numbers for approved, aircraft grade, oil-based paint be provided.

The FAA disagrees. While the FAA realizes this is a limitation, there must be one standard to help avoid confusion. The procedures required by this AD specify actions based on the presence or absence of a blue dot in a specific location. The FAA has not seen any difficulties in obtaining the paint markers. However, under the provisions of paragraph (m) of this AD, any person may request an approval of an AMOC. The FAA has not revised this AD in this regard.

FedEx requested that the proposed AD be revised to allow use of feeler gauges, calipers, and other means of measuring the gap in imperial units of measure. FedEx stated that the service information specifies use of pin gauges that are made for metric units of measure, and that acquiring those metric pin gauges is an extra expense and logistical complication. FedEx recommended adding a tolerance to the gap measurement and specifying a fractional imperial measure ( 3/32 -inch) that is close to the metric unit specified. FedEx suggested that if a tolerance or other measurement is not added, then a manufacturer part number (MPN) for a specific tool or supplier should be provided.

The FAA disagrees. Using other means of measuring could introduce or increase variables that could affect the accuracy of the measurement. The FAA understands that not everyone has the same resources, tools, or supplies; however, the FAA also understands that this means of measurement is easily accessible. Under the provisions of paragraph (m) of this AD, operators may request approval of an AMOC if sufficient data are submitted to substantiate that the tolerance would provide an acceptable level of safety. The FAA has not changed this AD in this regard.

FedEx requested that the proposed AD be revised to allow operators to use their own procedures for shipping dangerous goods such as unopened cylinder valve assemblies (CVAs) instead of the procedure specified in the service information. FedEx explained that it has established and accepted procedures for shipping dangerous goods, and that the disposition of an unopened CVA would be done by a department separate from the one doing the inspection. FedEx stated that following the procedures in the service information would require additional coordination time, and that the wording of the procedures would not function properly with its AD compliance mechanisms.

The FAA agrees to clarify. The design approval holder (DAH) of the affected valve assemblies has specified a method for shipping, or returning, an unopened CVA that has been found to be unacceptable or discrepant, specifically a shipping method that is compliant with DOT standard HM-224B. If FedEx has procedures that are compliant with DOT standard HM-224B, then those procedures are acceptable for compliance with this AD. For procedures that are not compliant with DOT standard HM-224B, under the provisions of paragraph (m) of this AD, the FAA will consider requests for an AMOC. The FAA has not changed this AD in this regard.

FedEx requested clarification on whether the proposed AD is written “against” the MPN or the serial numbers within that MPN. FedEx explained the effects on the operator's workload and also on the operational impact of a unit's overhaul cycle in conjunction with a 60-day compliance time and the scope of the applicability. FedEx added that a 180-day compliance time would be more reasonable.

The FAA agrees to clarify. The applicability of this AD is written against the MPN and specific serial numbers, in addition to manufacture dates of the assemblies. The FAA disagrees to revise the compliance time because the FAA has determined that requirement based on a risk calculation. The FAA has not changed this AD in that regard.

UAL requested clarification on what actions are required in the event the P/N or serial number information cannot be determined. UAL stated that as a result of in-service activity, that information might be illegible, unintentionally obliterated, or missing from the placard. UAL added that under its normal practices, whenever a part or serial number cannot be determined, the part is considered suspect, made unserviceable, and removed from service. UAL stated that, when the P/N of the entire cylinder and valve assembly can be determined but not the serial number, and the date of manufacture is between January and November 2018, it wants to still be able to establish conformity by inspecting for the presence of the blue dot and accomplish the applicable service information instruction if the blue dot is missing. UAL also stated that depending on the FAA's response to this request, it may apply for an AMOC.

The FAA agrees to clarify. The service information states to inspect for the manufacturing date, serial number, and the presence of a blue dot. The service information then states that if there is doubt or a determination cannot be made (such as the numbers or dot is not clearly identified), to proceed with the follow-on inspection for proper gap spacing (this follow-on inspection is required by paragraph (i) of this AD). The FAA has not changed this AD in this regard.

UAL requested clarification on how a 30-day requirement for the inspection report was determined, and if a “comprehensive” report is acceptable. UAL stated that it understands the need for the information gathered from the reports; however, it does not understand why or how a 30-day compliance time was established. UAL also stated that it assumed that reporting of the results should be done as a single, comprehensive report and not piece-wise (individually for each assembly or aircraft), and that the report does not need to be an exact copy of the report form in the service information.

The FAA agrees to clarify. The FAA determined that the 30-day compliance time is appropriate for this AD. Also, the manufacturer is collecting information for analysis of manufacturing issues. The format of the report may be done as UAL assumed, as long as all documents are labeled correctly. However, under the provisions of paragraph (m) of this AD, an operator may request an approval of an AMOC. The FAA has not changed this AD in this regard.

UAL requested clarification on the definition of “manufacture date” in a recording column of a report form in the service information. UAL stated that it is implied that “manufacture date” in that column is the manufacture date of the entire cylinder and valve assembly and not of the valve assembly.

The FAA agrees to clarify. The “manufacturer date” is not limited to the date of the entire cylinder and valve assembly, but is the manufacture date of each part or assembly that might be recorded in the inspection report, such as the assemblies listed in Appendix 1 of the service information. The FAA has not changed this AD in this regard.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed AVOX Systems Inc. Alert Service Bulletins 10015804-35-01, Revision 02, dated October 16, 2019; 10015804-35-02, Revision 2, dated October 31, 2019; and 10015804-35-03, Revision 02, dated October 15, 2019. This service information describes procedures for an inspection to determine the serial numbers of the oxygen cylinder and valve assemblies, and the oxygen valve assemblies, a detailed inspection for correct spacing of the gap between the bottom of the packing retainer and top of the valve body on the assemblies, parts marking, inspection report, and return of parts to the manufacturer. These documents are distinct since they apply to different assembly part numbers. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

The FAA estimates that this AD affects up to 3,034 oxygen cylinder and valve assemblies, and oxygen valve assemblies, installed on various transport category airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary follow-on actions that would be required based on the results of the inspection. The FAA has no way of determining the number of aircraft that might need these actions:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators. The FAA does not control warranty coverage for affected operators. As a result, the FAA has included all known costs in the cost estimate.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to take approximately 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

I. Approvals

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2021, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, “Approved Animal Drug Products Online (Green Book)” at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.

FDA has verified the website addresses as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 093-329 for use of a sustained-release bolus containing sulfamethazine in cattle because the product is no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this action. Elsewhere in this issue of the Federal Register , FDA gave notice that approval of NADA 093-329, and all supplements and amendments thereto, is withdrawn.

VetDC, Inc., 320 E Vine Dr., Suite 218, Fort Collins, CO 80524, has informed FDA that it has transferred ownership of, and all rights and interest in, newly approved NADA 141-545 for TANOVEA (rabacfosadine) for Injection to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. The codification of this application in new 21 CFR 522.2065 will reflect this change of sponsorship.

FDA is making the following amendments to improve the accuracy of the animal drug regulations:

• 21 CFR 500.1410 is amended to add uncooked edible tissues of swine to the standard for residues of n -methyl-2-pyrrolidone.

• 21 CFR 510.600 is amended to have sponsor addresses conform to the current style.

• 21 CFR 520.905c is amended to reflect the current label indications for use of fenbendazole paste in horses.

• 21 CFR 520.1044c is amended to reflect a current swine pathogen name for gentamicin soluble powder.

• 21 CFR 520.1660d is amended to revise conditions of use of oxytetracycline in drinking water of swine to reflect approved applications.

• 21 CFR 520.1780 is amended to revise the indications for use of pimobendan tablets in dogs.

• 21 CFR 520.2130 is amended to remove the 90-milligram strength for spinosad chewable tablets.

• 21 CFR 520.2220a is amended to add human food safety warnings for use of sulfadimethoxine concentrate solution and soluble powder.

• 21 CFR 520.2260b is amended to reflect the voluntary withdrawal of approval of an application for sustained-release boluses containing sulfamethazine and to correct the spelling of a disease condition.

• 21 CFR 520.2604 is amended to revise indications for use of tablets in dogs containing trimeprazine with prednisolone.

• 21 CFR 522.558 is amended to reflect the drug labeler code for the current sponsor of a dexmedetomidine injectable solution.

• 21 CFR 522.840 is amended to reflect the current classes of cattle approved for use of estradiol ear implants.

• 21 CFR 522.842 for testosterone propionate and estradiol benzoate implants is renamed to list the drug with the higher concentration first and redesignated to be listed in alphabetical order.

• 21 CFR 522.955 is amended to reflect the current scientific name of a bovine pathogen and the withdrawal periods for different formulations of florfenicol injectable solution.

• 21 CFR 522.1156 is amended to add subcutaneous administration to the approved conditions of use of imidocarb dipropionate solution in dogs.

• 21 CFR 522.2477 is amended to reorganize an approved use of trenbolone acetate and estradiol implants in steers.

• 21 CFR 524.770 is amended to reflect current label dosage information and human food safety warnings.

• 21 CFR 529.1030 is redesignated as § 529.1004 in conformity with an announced FDA numbering system (40 FR 13802, March 27, 1975).

• 21 CFR 529.1940 is amended to add limitations to the use of progesterone intravaginal inserts in cows.

• 21 CFR 558.59 is amended to reference apramycin's status as a veterinary feed directive (VFD) drug and to add current limitations on VFD refills for apramycin medicated feeds.

• 21 CFR 558.205 is amended to reflect a current egg food safety warning for broiler chickens and growing turkeys fed Type C medicated feeds containing diclazuril.

• 21 CFR 558.254 is amended to remove an erroneous table title.

• 21 CFR 558.261 is amended to correct the upper inclusion rate for florfenicol in Type C medicated feed for freshwater-reared salmonids.

• 21 CFR 558.311 is being amended to codify free-choice Type C medicated cattle feeds containing lasalocid.

• 21 CFR 558.450 is amended to add conditions of use in honey bees for a Type C extender patty containing oxytetracycline.

• 21 CFR 558.633 is amended to add manufacturing limitations for use of Type C medicated swine feeds containing tylvalosin.

• 21 CFR 558.635 is amended to reflect a current egg food safety warning for broiler chickens fed Type C medicated feeds containing virginiamycin and diclazuril.

FDA is incorporating by reference an analytical method approved by the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. To obtain a copy of the analytical method, go to: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday.

This standard adds a method of detection for total for residues of the carcinogenic excipient n -methyl-2-pyrrolidone in uncooked edible swine tissues to a section established for a method for residues of n -methyl-2-pyrrolidone in uncooked edible cattle tissues.

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 500, 510, 516, 520, 522, 524, 529, 556, and 558 are amended as follows:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector New Orleans DHS Department of Homeland Security FR Federal Register TFR Temporary Final Rule § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it would be impracticable. We must establish this security zone by February 25, 2022 in order to provide proper security for these visiting personnel, and we do not have sufficient time to request and respond to comments.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to provide adequate security to protect the public.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port New Orleans (COTP) has determined that the increased number of personnel anticipated to be visiting the city during the Mardi Gras Celebration requires certain security measures to ensure that the persons and property are kept secure during the events. The Coast Guard determined that a temporary security zone is needed for this and related events that will be taking place adjacent to a portion of Lower Mississippi River (LMR).

This rule establishes a security zone from 6 p.m. on February 25, 2022 through 11:59 p.m. on March 1, 2022. The security zone will cover all navigable waters within 400 yards of the Left Descending Bank (LDB) of the LMR from MM 94.4 and MM 95.1, Above Head of Passes (AHP), New Orleans, LA. This zone is necessary in order to provide to provide waterside security for the protection of visitors attending the events related to the Mardi Gras Celebrations. No vessel or person will be permitted to enter the security zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector New Orleans. They may be contacted on VHF-FM Channel 16 or 67 or by telephone at 504-365-2545.

Persons and vessels permitted to enter this security zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.

The COTP or a designated representative will inform the public of the enforcement times and date for this regulated area through Broadcast Notices to Mariners (BNMs), Local Notice to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, and duration of the security zone. Vessel traffic will be able to safely transit around this security zone which would impact a small designated area of the Mississippi River near New Orleans, LA for a limited number of days and will not overly impede vessel traffic during the period in effect. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the security zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishing a security zone to protect the public in a small designated area of the Mississippi River near New Orleans, LA for a limited number of days. It is categorically excluded from further review under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

In the Federal Register on Feb. 2, 2022, 87 FR 5692, on page 5692, in the second column, correct the Docket No. caption to read: “Docket No. ATBCB-2022-0003”.

The Mecklenburg County LIP was submitted to EPA on June 14, 1990, and EPA approved the plan on May 2, 1991. See 56 FR 20140. Mecklenburg County prepared three submittals in order to update the LIP and reflect regulatory and administrative changes that NCDAQ made to the North Carolina SIP  1 since EPA's 1991 LIP approval. 2 The three submittals were submitted as follows: NCDAQ transmitted the October 25, 2017, submittal to EPA but later withdrew it from review through a letter dated February 15, 2019. On April 24, 2020, NCDAQ resubmitted the October 25, 2017, update to EPA and also submitted the January 21, 2016, and January 14, 2019, updates. Due to an inconsistency with public notices at the local level, these submittals were withdrawn from EPA through a letter dated February 15, 2019. Mecklenburg County corrected this error, and NCDAQ submitted the updates to EPA in a submittal dated April 24, 2020. 3

The April 24, 2020, submittal updates several MCAPCO rules incorporated into the LIP, removes two rules, and adds three rules to better align the LIP with the North Carolina SIP. The January 21, 2016, changes include updates to MCAPCO Rules 2.0926, Bulk Gasoline Plants; 2.0927, Bulk Gasoline Terminals; 2.0928, Gasoline Service Stations Stage 1; and 2.0958, Work Practice for Sources of Volatile Organic Compounds. The submittal also seeks to remove MCAPCO Rules 2.0910, Alternative Compliance Schedules and 2.0929, Petroleum Refinery Sources and add MCAPCO Rules 2.0947, Manufacture of Synthesized Pharmaceutical Products; 2.0948, VOC Emissions from Transfer Operations; and 2.0949, Storage of Miscellaneous Volatile Organic Compounds. 4

The January 21, 2016, submittal also asks EPA to reincorporate the following rules with no changes or very few minor grammatical edits into the LIP with a new effective date: MCAPCO Rules 2.0906, Circumvention; 2.0918, Can Coating; 2.0919, Coil Coating; 2.0924, Magnet Wire Coating; 2.0925, Petroleum Liquid Storage in Fixed Roof Tanks; 2.0930, Solvent Metal Cleaning; 2.0931, Cutback Asphalt; 2.0933, Petroleum Liquid Storage in External Floating Roof Tanks; 2.0937, Manufacture of Pneumatic Rubber Tires; and 2.0944, Manufacture of Polyethylene, Polypropylene and Polystyrene. 5

On November 17, 2021, EPA published a notice of proposed rulemaking (NPRM) proposing to approve the April 24, 2020, SIP revision regarding updates to Mecklenburg's VOC rules. See 86 FR 64101. The November 17, 2021, NPRM provides additional detail regarding the background and rationale for EPA's action. Comments on the November 17, 2021, NPRM were due on or before December 17, 2021, and EPA received one comment.

As mentioned above, EPA received one comment on the November 17, 2021, NPRM. EPA's comment summary and response are provided below.

Comment: The commenter limits their comment to the removal of Rule 2.0929— Petroleum Refinery Sources from the LIP and reiterates the fact that removal is based, in part, on the absence of refineries in Mecklenburg County. The commenter notes that the “surrounding bi-state metro area is comprised of more than six different counties in two different states” and that the “petition to remove the Rule 2.0929 does not clarify if Rock Hill or Gastonia have refineries that pose a leak hazard to the nearby inhabitants.” The commenter goes on to state that when Rule 2.0929 was implemented, there were more local areas in the United States that did not have refineries than local areas that did have refineries and that each local area does not have to petition the CAA for removal of Rule 2.0929. The commenter provides population data for Mecklenburg County and expresses concern that removal might encourage an entrepreneur to construct a refinery in the Charlotte local area to “avoid implementing the provisions of the [CAA] rather than building a refinery in an area that strictly reaches attainment of the refinery leak Rule 2.0929.”

Response: Rule 2.0929 was first adopted into the MCAPCO in 1979, establishing requirements to meet the 1978 Petroleum Refinery Leaks Control Technique Guidelines (CTG) for controlling VOC emissions from petroleum refinery equipment, 6 and incorporated into the LIP on May 2, 1991. See 56 FR 20140. Mecklenburg County was designated as a Moderate ozone nonattainment area for the 1979 1-hour ozone national ambient air quality standards (NAAQS) and the 1997 8-hour ozone NAAQS. 7 CAA section 182(b)(2) requires each state with an ozone nonattainment area classified as Moderate or higher to include requirements in its SIP implementing RACT for certain VOC sources within the area, including for all VOC sources in the nonattainment area that are covered by a CTG.

The April 24, 2020, SIP revision, submitted by North Carolina on behalf of MCAQ, seeks to remove Rule 2.0929 from the LIP because there are no petroleum refineries in Mecklenburg County  8 and because MCAQ would like the LIP to better align with the SIP. 9 EPA's role, with respect to a SIP revision, is focused on reviewing the submission to determine whether it meets the minimum criteria of the CAA. Where it does, EPA must approve the submission. EPA has reviewed the SIP revision and determined that removal of Rule 2.0929 is consistent with the CAA because, among other things, the rule does not apply to any facilities in Mecklenburg County and, therefore, removal will not impact air quality and because Mecklenburg County is designated as attainment or attainment/unclassifiable for all ozone NAAQS and, therefore, CAA section 182 no longer requires the LIP to implement the Petroleum Refinery CTG.

The commenter correctly notes that the SIP revision does not discuss whether petroleum refineries exist in Rock Hill, South Carolina or Gastonia, North Carolina. It was not necessary for the SIP revision or the November 17, 2021, NPRM to discuss whether petroleum refineries are located in those areas because Rule 2.0929 only applies within Mecklenburg County.

Since Rule 2.0929 is limited to Mecklenburg County, EPA does not find the statement regarding the number of local areas in the United States with and without refineries to be relevant for this rulemaking. It is also not clear what the commenter means by stating that each local area does not have to petition the CAA for removal of Rule 2.0929 or how this statement is relevant. The scope of this action is limited to Mecklenburg County. To the extent that other areas of the country need to address RACT for sources covered by the Petroleum Refinery CTG, EPA would evaluate the RACT requirement in the context of other rulemakings for those other areas. As discussed above, a SIP must include RACT for sources covered by the Petroleum Refinery CTG only when the state contains an ozone nonattainment area classified as Moderate or higher, and implementation is only required within the nonattainment area.

The commenter is concerned that removal might encourage a refinery to locate in the Charlotte local area to “avoid implementing the provisions of the CAA rather than building a refinery in an area that strictly reaches attainment of the refinery leak Rule 2.0929” and provides population data for Mecklenburg County. However, this comment is unclear because Rule 2.0929 does not apply in areas outside of Mecklenburg County and the population of Mecklenburg County is irrelevant. Furthermore, only those areas in the country that are designated as a Moderate or higher ozone nonattainment area must have SIPs that implement the Petroleum Refinery CTG and there are no ozone nonattainment areas in North Carolina or South Carolina. If a petroleum refinery wants to locate in the Charlotte area, it would have to meet all relevant CAA requirements, including new source review permitting requirements that apply before construction and are designed to protect the NAAQS. Should the Charlotte area become an ozone nonattainment area with a Moderate or higher classification in the future, the area would be required to address RACT for all sources covered by all CTGs applicable at that time.

In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of MCAPCO Rules 2.0906, Circumvention; 2.0918, Can Coating; 2.0919, Coil Coating; 2.0924, Magnet Wire Coating; 2.0925, Petroleum Liquid Storage in Fixed Roof Tanks; 2.0926, Bulk Gasoline Plants; 2.0927, Bulk Gasoline Terminals; 2.0928, Gasoline Service Stations Stage I; 2.0930, Solvent Metal Cleaning; 2.0931, Cutback Asphalt; 2.0933, Petroleum Liquid Storage in External Floating Roof Tanks; 2.0937, Manufacture of Pneumatic Rubber Tires; 2.0944, Manufacture of Polyethylene, Polypropylene and Polystyrene; 2.0947, Manufacture of Synthesized Pharmaceutical Products; 2.0948, VOC Emissions from Transfer Operations; 2.0949, Storage of Miscellaneous Volatile Organic Compounds; and 2.0958, Work Practice for Sources of Volatile Organic Compounds, all of which have an effective date of December 15, 2015, into the Mecklenburg County portion of the North Carolina SIP to update the rules to more closely align with their analog North Carolina rules in the SIP. Also in this document, EPA is finalizing the removal of Rules 2.0910, Alternative Compliance Schedules and 2.0929, Petroleum Refinery Sources from the Mecklenburg portion of the North Carolina SIP, which were incorporated by reference in accordance with the requirements of 1 CFR part 51. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, the revised materials as stated above, have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 10

EPA is approving the aforementioned changes to the Mecklenburg LIP. Specifically, EPA is approving changes to MCAPCO Rules 2.0926, Bulk Gasoline Plants; 2.0927, Bulk Gasoline Terminals; 2.0928, Gasoline Service Stations Stage 1; and 2.0958, Work Practice for Sources of Volatile Organic Compounds. EPA is finalizing the removal of Rules 2.0910, Alternative Compliance Schedules and 2.0929, Petroleum Refinery Sources and the addition of Rules 2.0947, Manufacture of Synthesized Pharmaceutical Products; 2.0948, VOC Emissions from Transfer Operations; and 2.0949, Storage of Miscellaneous Volatile Organic Compounds. EPA is taking final action to approve these changes to the LIP because they are consistent with the CAA.

EPA is also taking final action to reincorporate the following rules with no changes or very few minor grammatical edits with a new effective date into the LIP: MCAPCO Rules 2.0906, Circumvention; 2.0918, Can Coating; 2.0919, Coil Coating; 2.0924, Magnet Wire Coating; 2.0925, Petroleum Liquid Storage in Fixed Roof Tanks; 2.0930, Solvent Metal Cleaning; 2.0931, Cutback Asphalt; 2.0933, Petroleum Liquid Storage in External Floating Roof Tanks; 2.0937, Manufacture of Pneumatic Rubber Tires; and 2.0944, Manufacture of Polyethylene, Polypropylene and Polystyrene.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

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

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

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

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 29, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

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

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 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-2021-0337 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 April 29, 2022. 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-2021-0337, by one of the following methods:

• Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.

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

EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is establishing time-limited tolerances for residues of fluridone, in or on peanut at 0.1 parts per million (ppm) and peanut, hay at 0.1 ppm. These time-limited tolerances expire on December 31, 2024.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement of a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18-related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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. . . .”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The Arkansas and Missouri Departments of Agriculture submitted specific emergency exemptions for the use of fluridone on peanut to control Palmer amaranth, Amaranthus palmeri, populations in peanut fields where glyphosate-resistant Palmer amaranth biotypes are present. According to the States, peanut growers in Arkansas and Missouri are experiencing widespread multiple herbicide-resistant populations of Palmer amaranth. These States reported that an urgent and non-routine situation exists because a registered effective soil residual herbicide is currently unavailable to reduce the impact and prevent the expansion of this destructive weed species. Significant economic losses are expected for peanut growers due to yield and quality decreases without a suitable pesticide control.

After having reviewed the submission, EPA determined that an emergency condition exists for these States, and that the criteria for approval of these emergency exemptions have been met.

As part of its evaluation of these emergency exemption applications, EPA assessed the potential risks presented by residues of fluridone in or on peanut at 0.1 ppm and peanut, hay at 0.1 ppm. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on these emergency exemptions in order to address an urgent non-routine situation in these States and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2024, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on peanut after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether fluridone meets FIFRA's registration requirements for use on peanut or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these time-limited tolerance decisions serve as a basis for registration of fluridone by a State for special local needs under FIFRA section 24(c). Nor do these tolerances by themselves serve as the authority for persons in States other than Arkansas and Missouri to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemptions for fluridone, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 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 expected as a result of these emergency exemption requests and the time-limited tolerances for residues of fluridone on peanut at 0.1 ppm and peanut, hay at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing these time-limited tolerances 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 EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considers in making its safety determination for the new rulemaking.

In the Federal Register of May 18, 2020 (85 FR 29633) (FRL-10007-09), EPA published a final rule that established tolerances for residues of fluridone in or on multiple commodities based on the Agency's determination that aggregate exposure to fluridone resulting from the residues subject to those tolerances is safe for the U.S. general population, including infants and children. EPA is incorporating sections from that final rule as described further in this rulemaking, as they remain unchanged.

Toxicological profile. The toxicological profile for fluridone has not changed since the May 18, 2020, final rule was published; therefore, EPA is relying upon the discussion of that profile in Unit III. A. as part of this rulemaking.

Toxicological points of departure/Levels of concern. The toxicological points of departure and levels of concern for fluridone have not changed since the May 18, 2020, final rule was published; therefore, EPA is relying upon the discussion in Unit III. B. as part of this rulemaking.

Exposure assessment. Much of the exposure assessment for fluridone remains unchanged from the discussion in Unit III. C. of the May 18, 2020, final rule, except that EPA considered the additional dietary exposure from the time-limited tolerances established by this action. Specifically, EPA conducted acute and chronic dietary exposure assessments to determine if the emergency use on peanut increases the dietary exposure to fluridone. Updated acute and chronic Dietary Exposure Evaluation Model (DEEM) runs were conducted with peanut included at a 0.1 ppm residue level. These results compared to the most recent dietary assessment supporting the May 18, 2020, final rule showed no exposure changes to two significant figures. Therefore, the previous assessment is protective of dietary exposure potential from the emergency use of fluridone on peanut.

Safety factor for infants and children. EPA continues to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the Food Quality Protection Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for that determination are articulated in Unit III. D. of the May 18, 2020, final rule.

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 population-adjusted dose (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 (PODs) to ensure that an adequate margin of exposure (MOE) exists.

The results of the acute and chronic analyses for fluridone do not exceed the Agency's level of concern (LOC). That is, all risk estimates were <100% of the aPAD or <100 of the cPAD and are not of concern for the general U.S. population and all population subgroups. The acute dietary exposure from food and water will occupy 2.3% of the aPAD for all infants (1-year old), the population with the highest estimated risk. Chronic exposure to fluridone from food and water will utilize 7% of the cPAD for children aged 1 to 2, the population with the highest estimated risk.

The short-term aggregate exposure assessment for fluridone is based on food and drinking water as well as residential uses. For short-term aggregate risk assessment, potential residential exposures (dermal, inhalation, and incidental ingestion from swimming in treated waters for children; dermal and inhalation from applications via pouring into recreational ponds for adults) were combined with background dietary exposures. The combined short-term food, water, and residential exposures result in aggregate MOEs for of 1,300 for adults and 1,600 for children, which are greater than the LOC of 100. Because EPA's level of concern for fluridone is an MOE of 100 or below, these MOEs are not of concern. Fluridone is not registered for any use patterns that would result in intermediate-term residential exposure.

Further, since there is no evidence of carcinogenicity in the toxicological database for fluridone, EPA concluded that fluridone is not carcinogenic and is classified as “not likely” to be a human carcinogen.

Therefore, based on the risk assessments and information described above, EPA concludes that there is reasonable certainty that no harm will result to the U.S. general population, or to infants and children from aggregate exposure to fluridone residues. More detailed information on the subject action to establish time-limited tolerances in or on peanut and peanut, hay can be found at https://www.regulations.gov in the document entitled, “Fluridone: ID# 21AR03 Section 18 Specific Exemption for Use on Peanut in Arkansas.” This document can be found in docket ID number EPA-HQ-OPP-2021-0337.

An adequate enforcement methodology (high performance liquid chromatography (HPLC) method (originally submitted as method AM-AA-CA-RO52-AA-755)) is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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). The Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for fluridone.

Therefore, time-limited tolerances are established for residues of fluridone, in or on peanut at 0.1 ppm and peanut, hay at 0.1 ppm. These tolerances expire on December 31, 2024.

This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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 in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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, but does not regulate 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, or 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:

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 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2021-0364 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 April 29, 2022. 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-2021-0364, by one of the following methods:

• Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

In the Federal Register of August 3, 2021 (86 FR 41809) (FRL-8792-01), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11506) by Exponent, Inc. (1150 Connecticut Ave., Suite 1100, Washington, DC 20036) on behalf of Lamberti USA, Incorporated (P.O. Box 1000, Hungerford, TX 77448). The petition requested that the 40 CFR be amended by establishing an exemption from the requirement of a tolerance for residues of 20ETO (CAS Reg No. 68605-38-9) and 10ETO (CAS Reg No. 2464873-19-4) when used as inert ingredients (surfactant) in pesticide formulations applied to growing crops pre- and post-harvest under 40 CFR 180.910. That document referenced a summary of the petition prepared by Exponent, Inc. on behalf of Lamberti USA, Incorporated, the petitioner, which is available in the docket, https://www.regulations.gov. No comments were received on the notice of filing.

Based upon review of the data supporting the petition, EPA has limited the maximum concentration of 20ETO or 10ETO to not more than 10% in pesticide formulations for use under 40 CFR 180.910. This limitation is based on the Agency's risk assessment which can be found at https://www.regulations.gov in the document titled “Fatty acids, Tall-Oil, Esters with Triethanolamine, Ethoxylated (20ETO) and Fatty Acids, C 8-18 or C 18 -Unsatd., Esters with Polyethylene Glycol Ether with Triethanolamine (3:1) (10ETO); Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2021-0364.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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 . . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 20ETO and 10ETO including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with 20ETO and 10ETO follows.

EPA has evaluated the available toxicity data and considered their 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. Specific information on the studies received and the nature of the adverse effects caused by 20ETO and 10ETO as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

EPA considered studies on either substance to evaluate the toxicity of both substances. Based on the available data, the acute oral toxicity is expected to be low for 20ETO and 10ETO because the oral LD 50 (lethal dose) for 20ETO is greater than 2,000 milligrams/kilogram (mg/kg). Both substances are also not expected to be acutely toxic via dermal exposure, as the LD 50 for 20ETO is greater than 2,000 mg/kg in rats. The substances are also not expected to be irritating to the skin in the rat and rabbit nor sensitizing to the guinea pig. However, the substances are expected to be minimally irritating to the rabbit eye.

No repeated-dose toxicity studies are available for 10ETO or 20ETO. Therefore, data for triethanolamine (TEA) and fatty acids, tall oil were used, based on the predicted degradation pathways of 20ETO and 10ETO. Subchronic oral toxicity studies in guinea pigs via gavage (TEA) and rats (fatty acids, tall oil) via the diet resulted in hepatocellular cloudy swelling and fatty change in the liver and cloudy swelling of the convoluted tubules and Henle's loop in the kidney at 400 and 450 mg/kg/day, respectively, following 60- and 120-day exposures. The no observed adverse effect level (NOAEL) in these studies is 200 and 225 mg/kg/day for the guinea pig and rat, respectively. Increased liver and kidney weights and histological lesions are observed at 730 mg/kg/day in a 90-day oral toxicity study in rats. The NOAEL in this study is 170 mg/kg/day. Chronic exposure via drinking water (TEA) resulted in an increased incidence and severity of chronic nephropathy at 455 mg/kg/day in rats. No LOAEL was established in this study. In mice, decreased body weight was observed at 1,688 mg/kg/day following chronic exposure via drinking water (TEA).

In subchronic dermal toxicity studies, no systemic toxicity was observed up to 1,000 mg/kg/day, the limit dose, in rats. However, in the same study, an increased incidence of hypertrophy of the pituitary gland pars intermedia was observed at 2,000 mg/kg/day and dermal effects manifested as increased incidence and severity of acanthosis and inflammation at 500 mg/kg/day. In mice, no systemic toxicity was observed up to 4,000 mg/kg/day following 13 weeks of exposure. Mild dermal hyperplasia was observed at 140 mg/kg/day and an increased incidence and severity of acanthosis was seen at 250 mg/kg/day.

Following chronic dermal exposure in rats, an increased incidence of acanthosis and inflammation along with ulcers and dermal erosion was observed at 63 mg/kg/day.

A developmental toxicity study showed no maternal or developmental toxicity up to 1,125 mg/kg/day in mice. Another developmental toxicity study via the dermal exposure showed no toxicity up to 30 mg/kg/day, which was the highest dose tested in rats. Further, no parental, offspring, or reproduction toxicity was observed in a 2-generation reproduction toxicity study in rats (fatty acid, tall oil) up to 5,000 mg/kg/day. In a combined reproduction/developmental toxicity test, a decrease in the number of implantation sites and litter size, and an increase in the number of post-implantation loss were observed at 1,000 mg/kg/day. The NOAEL is 300 mg/kg/day. However, there is no concern for fetal susceptibility or reproduction toxicity since the cRfD (0.455 mg/kg/day) is protective of effects seen at 1,000 mg/kg/day.

Several mutagenicity studies with TEA and fatty acids, tall oil ( e.g., Ames, chromosome aberration, micronucleus assay, sister chromatid exchange, and cell dominant lethal assay) were reviewed and the results for these studies are negative.

Two chronic/carcinogenicity studies in which the test substance was administered via drinking water were also reviewed. In mice, decreased bodyweight was observed at 1,688 mg/kg/day. The NOAEL is 673 mg/kg/day. No evidence of an increased incidence of tumors was seen in this study. In rats, chronic nephropathy is observed in female rats at 455 mg/kg/day. A NOAEL was not established in this study. An increased incidence of hepatocellular adenomas was observed at doses greater than 1,000 mg/kg/day. The chronic reference dose (cRfD) is based on this study.

Neurotoxicity and immunotoxicity studies are not available for review. However, evidence of neurotoxicity and immunotoxicity was not observed in the submitted studies.

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for 20ETO and 10ETO used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to 20ETO and 10ETO, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from 20ETO and 10ETO in food as follows:

In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, EPA used food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for 10ETO and 20ETO. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

Generally, in the dietary exposure assessments for inert ingredients, the Agency assumes that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest levels of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentrations of active ingredient in agricultural products are generally at least 50 percent of the product and often can be much higher. However, in assessing this petition request, the Agency assumed that a product consisted of 10% percent 10ETO and 20ETO. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.

Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity.

Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, this conservative assumption will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for 10ETO and 20ETO, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, for lawn and garden pest control, indoor pest control, termiticides, flea and tick control on pets, and hard surface disinfection on walls, floors, tables).

20ETO and 10ETO may be used as an inert ingredient in pesticide products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home. For residential handlers, the Agency assumed handlers may receive short-term dermal and inhalation exposure to 20ETO and 10ETO from formulations containing the inert ingredient in outdoor and indoor scenarios. Short- and intermediate-term dermal exposures were not quantitated since no systemic toxicity is observed in dermal toxicity studies. Also, intermediate- and long-term inhalation exposures are not expected because applications are not expected to occur daily or for more than 30 days. Therefore, only short-term inhalation exposures were estimated and were based on the NOAEL of 43.39 mg/kg/day and a LOC for an MOE of 100. The short-term residential handler MOE is 36000, which is not a risk of concern because EPA considers MOEs of 100 or less to be of concern. The Agency also considered intermediate-term incidental oral exposures to children due to residential exposure associated with contact with treated surfaces (dermal and hand-to-mouth exposures). The MOE is 1964 for children, which is not a risk of concern because EPA considers MOEs of 100 or less to be of concern.

As introduced above, 10ETO and 20ETO are expected to biodegrade into TEA and fatty acids, tall oil. Residential exposure to TEA may occur from existing pesticide uses as well as from non-pesticide products that may be used in and around the home, such as cosmetics. Dermal contact is the primary route of exposure to TEA in cosmetics. However, a dermal endpoint of concern was not identified, and therefore a quantitative dermal exposure assessment is not necessary. TEA can be used in products that may be sprayed, however, so there is the potential for inhalation exposure. The Cosmetic Ingredient Review (CIR) Expert Panel has noted that 95% to 99% of TEA particles produced in cosmetic aerosols are not respirable. This assumption, coupled with the small actual exposure in the breathing zone and the concentrations at which TEA is used, suggests that inhalation would not be a significant route of exposure that might lead to local respiratory or systemic toxic effects (Fiume et. al., 2013). Small amounts of TEA may also be ingested (oral exposure) from lipsticks as they are reported to potentially contain up to 1% TEA. However, any contribution to the estimated oral pesticide exposure resulting from cosmetic uses is likely to be insignificant in comparison to the estimates for exposure from the pesticide use.

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.”

EPA has not found 20ETO and 10ETO to share a common mechanism of toxicity with any other substances, and 20ETO and 10ETO do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 20ETO and 10ETO do not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

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.

The Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1X for the chronic dietary assessment for the following reasons. The toxicity database for 20ETO and 10ETO contains developmental, 2-generation reproduction, combined reproduction/developmental toxicity and mutagenicity studies. There is no indication of immunotoxicity or neurotoxicity in the available studies; therefore, there is no need to require an immunotoxicity or neurotoxicity study. Additionally, no fetal susceptibility or reproduction toxicity was observed in the available studies. Based on the adequacy of the toxicity database, the conservative nature of the exposure assessment and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1X.

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. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, 20ETO and 10ETO is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to 20ETO and 10ETO from food and water will utilize 32.6% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

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

20ETO and 10ETO may be used as inert ingredients in pesticide products that could result in short-term residential exposure. The Agency has determined that it is not appropriate to aggregate chronic exposure through food and water with short-term residential exposures to 20ETO and 10ETO since toxicological effects were different depending on the route of exposure.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term residential exposures result in aggregate MOEs of 36000 for adult males and females. Because EPA's level of concern for 20ETO and 10ETO is an 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).

20ETO and 10ETO may be used as inert ingredients in pesticide products that could result in intermediate-term residential exposure, and the Agency has determined that it is not appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to 20ETO and 10ETO since toxicological effects were different depending on the route of exposure.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 1964 for children. Children's residential exposure includes total exposures associated with contact with treated surfaces (dermal and hand-to-mouth exposures). Because EPA's level of concern for children's residential exposure (incidental oral exposure) to 20ETO and 10ETO is an MOE of 100 or below, this MOE is not of concern.

5. Long-term risk. Long-term aggregate exposure takes into account long-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Long-term residential exposures are not expected from the use of 20ETO and 10ETO in pesticides used in and around the home. Therefore, long-term aggregate exposure considers chronic food and water. The MOE is 10833 based on the cPAD of 0.455 mg/kg/day. As the level of concern is for an MOE that is lower than 1000, this MOE is not of concern.

TEA, a metabolite of 10ETO and 20ETO, may be used as inert ingredients in non-pesticide products that could result in long-term residential exposure. Based on the exposure assumptions described in unit IV. C. 3, the Agency anticipates that the contribution to the estimated oral non-pesticide exposure due to its use in cosmetics is likely to be insignificant in comparison to the estimates for exposure from the pesticide use. Therefore, the Agency believes the assessments of aggregate exposures due to pesticide uses more than adequately protect for exposure from uses in cosmetics products.

6. Aggregate cancer risk for U.S. population. Based on the lack of tumors in the carcinogenicity studies in rats and mice and the lack of mutagenicity, 20ETO and 10ETO are not expected to pose a cancer risk to humans.

7. Determination of safety. Taking into consideration all available information on 20ETO and 10ETO, EPA concludes that there is a reasonable certainty that no harm will result to the general population, including infants and children, from aggregate exposure to 20ETO and 10ETO residues.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of 20ETO and 10ETO in or on any food commodities. EPA is establishing a limitation on the amount of 20ETO and 10ETO that may be used in pesticide formulations. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for food use that exceeds 10% in the final pesticide formulations for indoor and outdoor residential use.

Therefore, an exemption from the requirement of a tolerance is established for residues of 20ETO (CAS Reg No. 68605-38-9) and 10ETO (CAS Reg No. 2464873-19-4) when used as inert ingredients (surfactant) in pesticide formulations applied to growing crops pre- and post-harvest under 40 CFR 180.910.

This action establishes a tolerance exemption 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), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population.

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 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 part 180 as follows:

DoD published a proposed rule in the Federal Register at 84 FR 50811 on September 26, 2019, to amend DFARS 206.001 to implement section 815 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016 (Pub. L. 114-92). Section 815 repeals and replaces section 845 of the NDAA for FY 1994 (Pub. L. 103-160; 10 U.S.C. 2371 note) with 10 U.S.C. 2371b, which modifies the authority of DoD to carry out other transaction (OT) agreements for prototype projects, as well as the criteria required to award an associated follow-on production contract to the participants in the other transaction agreement without the use of competitive procedures. One respondent submitted comments on the proposed rule.

The purpose of this rule is to provide contracting officers with updated internal guidance when awarding a follow-on production contract that is exempt from the competitive procedures of Federal Acquisition Regulation part 6, as set forth in 10 U.S.C. 2371b. The rule is not intended to implement policy, regulation, or guidance on DoD's authority to enter into OT prototype agreements at 10 U.S.C. 2371b. As such, this final rule changes the rule text to specify that the agreements officer for the OT agreement for the prototype project is responsible for providing to the contracting officer information that confirms the requirements to award a noncompetitive follow-on production contract, as specified in 10 U.S.C. 2371b and DoD OT agreement policy, have been met.

DoD reviewed the public comments in the development of the final rule. A discussion of the comments and the changes made to the rule as a result of those comments is provided, as follows:

Comment: The respondent advised that DoD should provide clear guidance on what constitutes “successful completion” of a prototype transaction; the rule text should be clarified to explain what it means to award a follow-on production contract to “the participants in the transaction,” as contracts are usually made between the Government and a single entity; the rule should clarify what a “participant” is, given that not all parties to a transaction necessarily participate in the project.

The respondent also advised that the rule should be revised to clarify the prerequisites for awarding the OT for the prototype project and the prerequisites for awarding a follow-on production contract. Specifically, one of the criteria for awarding a follow-on production contract is that the OT for the prototype project is based on specific determinations made by certain acquisition officials according to different threshold values. The proposed rule, however, applies these determination requirements only to the follow-on production contract, when they should instead apply only to the initial OT agreement.

Response: This rule is not intended to implement policy, regulation, or guidance on DoD's authority to enter into OT prototype agreements at 10 U.S.C. 2371b. Instead, the Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)) is the organization responsible for promulgation of policy for OT agreements, which can be viewed at https://aaf.dau.edu/aaf/ot-guide/. As a result, this rule is modified to clarify that the contracting officer does not make the determination that the prototype project was successfully completed and, instead, should receive that information from the agreements officer for the OT agreement.

Comment: The respondent advised that 32 CFR part 3 should be updated to reflect the current authority at 10 U.S.C. 2371b.

Response: This comment is outside the scope of this rule, which amends 48 CFR chapter 2.

The proposed numbering of the DFARS text is redesignated as DFARS 206.001-70 from 206.001(S-70) to align with FAR system drafting conventions.

This rule only impacts the internal operating procedures of the agency. The rule does not impose any new requirements on contracts at or below the simplified acquisition threshold, for commercial products including commercially available off-the-shelf items, or for commercial services.

E.O.s 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.

As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the Federal Register . The Office of Information and Regulatory Affairs has determined that this rule is not a major rule as defined by 5 U.S.C. 804.

A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The FRFA is summarized as follows:

The Department of Defense is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 815 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016 (Pub. L. 114-92), which repeals and replaces section 845 of the NDAA for FY 1994 (Pub. L. 103-160; 10 U.S.C. 2371 note) with 10 U.S.C. 2371b.

The objective of this rule is to provide contracting officers with updated internal guidance when awarding a follow-on production contract that is exempt from the competitive procedures of Federal Acquisition Regulation part 6, as set forth in 10 U.S.C. 2371b.

No public comments were received in response to the initial regulatory flexibility analysis.

DoD does not collect data on the number of follow-on production contracts that are awarded annually and associated with a prototype project transaction agreement made under the authority of 10 U.S.C. 2371b; therefore, DoD is unable to estimate the number of small entities that will be impacted by this rule. However, DoD does not expect small entities to be significantly impacted by this rule, because the rule does not change any existing processes or impose any additional burdens. Instead, the rule simply clarifies instructions to contracting officers on the criteria that must be met in order to award an associated follow-on production contract without using competitive procedures.

This rule does not include any new reporting, recordkeeping, or other compliance requirements for small entities. This rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known alternative approaches to the rule that would meet the stated objectives.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, 48 CFR part 206 is amended as follows: