On December 21, 2000, the Secretary established the Agricultural Marketing Service's (AMS) National Organic Program 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 and the nonsynthetic (natural) substances that may not be used in organic crop and livestock production. It also identifies the nonorganic substances that may be used in or on processed organic products.

AMS is finalizing three 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 USDA must follow to amend the National List (sec. 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 (sec. 6518).

This final rule adds oxalic acid dihydrate, pullulan, and nonorganic collagen gel to the National List. Once effective, producers and handlers of organic products will be allowed to use these substances in organic production and in organic products. The permitted use of each substance is discussed in detail below.

To remain on the National List, these substances must be: (1) Reviewed every 5 years by the NOSB, a 15-member federal advisory committee; and (2) renewed by the Secretary (sec. 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 first sunset date for the substances in this final rule will be 5 years from the effective date in the DATES section of this final rule above.

This rule adds oxalic acid, pullulan, and nonorganic collagen gel to the National List for use in organic livestock production or handling. Additional background on the petitions and the NOSB's review of the substances may be found in the proposed rule (85 FR 35011; June 8, 2020).

During a 60-day comment period that closed on August 7, 2020, AMS received 20 comments on the proposed rule. See below for a discussion of the comments received and AMS' responses to comments. Comments can 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 folder for this rule is AMS-NOP-19-0053).

The final rule amends the National List to add oxalic acid dihydrate to 7 CFR 205.603 as a synthetic substance allowed for use in organic apiculture (beekeeping) only. Oxalic acid dihydrate is a pesticide used for Varroa mite control on bees. Oxalic acid is a naturally occurring substance, but this rule allows for the use of the synthetic form ( i.e., synthesized via chemical process) of oxalic acid dihydrate.

AMS is finalizing this amendment to the National List, as proposed by NOSB, to provide beekeepers that manage organic bees with an additional option to combat parasitic Varroa mites. Since arriving to the United States in 1987, Varroa mites have caused the death of massive numbers of honey bee colonies, and beekeepers have identified Varroa mites as their single most serious problem causing colony losses. 1 The mites damage honey bees both directly (by attaching to bees) and by serving as a vector for pathogenic viruses.

Oxalic acid dihydrate is one of a dozen substances currently registered by the EPA for the control of Varroa mites, 2 and only a subset of these are allowed under USDA organic regulations. For example, the National List includes formic acid (§ 205.603(b)(3)) as a pesticide to treat hives. The addition of oxalic acid dihydrate will be important addition to the National List, as rotating products to combat Varroa mites is an important tactic to prevent resistance development and to maintain the usefulness of individual pesticides. 3

AMS concluded that the addition of oxalic acid dihydrate to the National List is consistent with the requirements of OFPA sec. 2118(c) (7 U.S.C. 6517(c)). Namely, the substance is not harmful to human health or the environment when used as labeled; is necessary to production because of the unavailability of wholly natural substitute products; and is consistent with organic farming and handling. The amendment is made following the procedures established in section 2118(d) of the OFPA (7 U.S.C. 6517(d)).

NOSB submitted a recommendation to AMS in April 2019 to add oxalic acid dihydrate to the National List. 4 NOSB recommendation followed receipt of a petition to add the substance to the National List in October 2017. 5 In NOSB's evaluation of the petition, they considered information from a third-party technical evaluation report  6 and comments from the public. NOSB discussed the petition to amend the National List in subcommittee calls and at its public meetings in October 2018 and April 2019. 7

In its recommendation, NOSB concluded that adding oxalic acid dihydrate to the National List was consistent with OFPA evaluation criteria in section 2119(m) (7 U.S.C. 6518(m)). NOSB found that the use of oxalic acid dihydrate as a mite pest control would be compatible with and necessary for organic apiculture, providing additional use benefits over formic acid. NOSB noted that oxalic acid occurs naturally in the environment and noted no concerns about environmental or human health impacts or oxalic acid residues in food products.

Apiculture standards. Comments recommended that AMS act on NOSB recommendations from September 2001 and October 2010  8 to further develop organic apiculture standards. Some believed that AMS should promulgate detailed standards for managing organic bees prior to adding synthetic substances for organic apiculture to the National List.

AMS notes that the USDA organic regulations include “nonplant life” ( e.g., bees) in the definition of livestock (§ 205.2). Given that AMS permits USDA-accredited certifiers to certify organic apicultural operations under the regulations for livestock production, AMS will continue to consider recommendations from NOSB regarding substances for organic apiculture operations. Additionally, the National List includes other substances that may be used in organic apiculture, including formic acid (§ 205.603(b)(3)), which is permitted for the treatment of honeybee hives. Oxalic acid dihydrate provides some advantages compared to formic acid, and AMS is adding the substance to the National List to provide certified organic apiculture operations with an additional option to treat for Varroa.

General opposition. Some comments opposed the addition of oxalic acid dihydrate to the National List because they opposed any use of synthetic substances in organic production. AMS notes that OFPA permits the use of specific synthetic substances ( i.e., those on the National List) in organic production. OFPA describes the procedures for amending the National List and provides AMS and the NOSB with criteria and guidelines to consider in evaluating changes to the National List. NOSB and AMS followed these procedures, and this rule adds oxalic acid dihydrate to the National List.

Health effects. Finally, AMS received a comment opposing the addition of oxalic acid dihydrate that cites a source that suggests that the consumption of oxalic acid dihydrate inhibits calcium availability in the human body. AMS does not find merit in the comment. AMS notes that EPA's Final Registration Decision for oxalic acid states this compound is only used in beehives when honey supers are not present and that dietary exposures to oxalic acid from in-hive applications is indistinguishable from naturally occurring levels. 9

This final rule amends the National List to add pullulan to § 205.605(a) as an ingredient allowed only in products labeled, “Made with organic (specified ingredients or food group(s))” (or “made with”). The “made with” labeling category is distinct from the “organic” and “100% organic” labeling categories under USDA organic regulations (7 CFR 205.301). Products labeled “organic” or “100% organic” cannot contain nonorganic pullulan as an ingredient under this final rule. Additionally, the final rule only permits nonorganic pullulan in tablets and capsules for dietary supplements.

AMS is finalizing this amendment to the National List, as proposed by NOSB, to add pullulan to the National List for use in “made with” products to provide manufacturers of organic dietary supplements with an option to label products with additional dietary claims ( e.g., vegan, vegetarian). Nonorganic forms of pullulan are necessary because organic forms of pullulan are not readily available. By adding nonorganic pullulan to § 205.605 of the National List with a limitation on use for “made with” products, AMS is providing a limited exception for use of nonorganic pullulan.

Pullulan is a natural extracellular polysaccharide excretion resulting from carbohydrate fermentation by the yeast-like fungus Aureobasidium pullulans and other non-toxic fungi strains. 10 The fungus A. pullulans is ubiquitous in nature and is most common in temperate zones in locations such as forest soil, freshwater, on plant leaves, and on seeds. Pullulan has been self-affirmed as GRAS (Generally Recognized as Safe) for multiple uses, including as a multifunctional food ingredient, a film, and an excipient (GRN No. 99, pp. 26-30). 11

AMS concluded that the addition of pullulan to the National List is consistent with the requirements of OFPA sec. 6517(c). Namely, the substance is not harmful to human health or the environment; is necessary to production because of the unavailability of wholly natural substitute products; and is consistent with organic farming and handling. The amendment is made following the procedures established in OFPA (sec. 6517(d)).

NOSB submitted a recommendation to AMS in April 2019 to add pullulan to the National List. 12 NOSB recommendation followed receipt of a petition to add the substance to the National List in January 2018. 13 In NOSB's evaluation of the petition, they considered information from a third-party technical evaluation report  14 and comments from the public. NOSB discussed the petition to amend the National List in subcommittee calls and at its public meetings in October 2018 and April 2019. 15

In its recommendation, NOSB concluded that adding pullulan to the National List was consistent with OFPA criteria (sec. 6518(m)). In its recommendation, NOSB noted that there are few, if any, other encapsulation options available compliant with organic composition requirements at § 205.301 for consumers seeking a suitable alternative to gelatin for religious and dietary requirements ( e.g., vegan, halal, kosher).

Classification. In the proposed rule, AMS requested comments on whether pullulan should be classified as a nonsynthetic, nonagricultural substance, as proposed, or whether it should be considered as an agricultural substance that may be certifiable as organic.

An opposing comment argued that production of pullulan should be considered a form of agricultural production and compared production of A. pullulans to other types of fungi production. The comment suggested that pullulan is better described as an agricultural product than a nonagricultural product.

AMS also received comments that agreed with the classification of pullulan as nonagricultural. Comments that argued that pullulan is a nonsynthetic state that other products of microbial fermentation at § 205.605(a) ( e.g., citric acid, enzymes, microorganisms) are classified as nonsynthetic.

AMS received several comments that AMS' classification of pullulan as nonagricultural does not mean that pullulan cannot also be certified organic ( i.e., that pullulan could be certified organic if manufactured by alternative processes). Commenters pointed to published AMS guidance and to examples of other substances on the National List at § 205.605 that can be found in certified organic form ( e.g., yeast, flavors, citric acid).

AMS agrees with the classification of pullulan as nonsynthetic. The referenced guidance  16 provides examples and clarity on the definitions of “agricultural,” “synthetic,” and “nonsynthetic (natural)” as presented in § 205.2. Nonsynthetic substances are defined as “A substance that is derived from mineral, plant, or animal matter and does not undergo a synthetic process . . .”. Given that pullulan is manufactured by the isolation of a byproduct of fungal fermentation of a carbohydrate substrate, 17 it fits the definition of “nonsynthetic” and will be classified as such rather than “agricultural,” defined as “[a]ny agricultural commodity or product, whether raw or processed, including any commodity or product derived from livestock . . .”.

Comments were received which argued both that pullulan could and could not be certified under the USDA organic regulations. These comments offer differing interpretations of whether any of the manufacturing processes would result in a product which would be certifiable. AMS will maintain the requirement that nonorganic pullulan be used only in “made with” products, as we are aware there are certified organic pullulan products on the international market.

This final rule adds pullulan to the National List as a nonagricultural ingredient. AMS notes that similar National List substances produced by microbial fermentation are classified as nonagricultural ( e.g., citric acid, xanthan gum, and gellan gum). AMS agrees with NOSB determination that pullulan is a nonagricultural substance, as described in our response to comments regarding classification. The classification of pullulan as nonagricultural does not preclude the production of certified organic pullulan, as long as the process meets the requirements of § 205.105 and § 205.301.

Genetically modified organisms. A comment was opposed to the addition of pullulan to the National List because of the potential that genetically modified organisms (GMOs) might be used in the production of pullulan ( e.g., substrates as nutrient sources for the fermentation process).

AMS understands concerns regarding the use of genetically modified organisms in the production of National List materials. The USDA organic regulations (§ 205.105) include a prohibition on ingredients produced or handled with the use of excluded methods (including genetic engineering) as defined in § 205.2.

Digestibility concern. A comment cited a study comparing human digestion of pullulan to digestion of maltodextrin. AMS understands that NOSB considered the effects of slow digestion (including increased flatulence, as cited in the comment) and did not conclude these effects to be sufficiently detrimental to human health to disqualify the substance from addition to the National List per OFPA (7 U.S.C. 6518(m)).

General opposition. Two comments generally opposed changes to the National List and were opposed to the addition of pullulan. AMS notes that OFPA permits the use of specific synthetic substances ( i.e., those on the National List) in organic production. OFPA describes the procedures for amending the National List and provides AMS and NOSB with criteria and guidelines to consider in evaluating changes to the National List. These procedures were followed by NOSB and AMS, and this rule adds pullulan to the National List.

General support. Comments supporting the addition of pullulan cited its potential to be used as a vegetarian alternative for capsules used for oral supplements. These comments argued that while gelatin is on the National List and is used for capsules, it is an animal byproduct, which vegan and vegetarian consumers choose not to use. Another comment stated that gelatin-based capsules are not appropriate for many vegan and vegetarian supplement products and may cause issues among kosher and halal consumers.

AMS appreciates public engagement in the rulemaking process and agrees with the general support above which mirrors the recommendation by NOSB. AMS is moving forward with adding this substance to the National List as proposed.

This final rule amends the National List to add collagen gel as a casing to 7 CFR 205.605(b) as a nonorganic nonagricultural ingredient allowed in organic handling. The amendment will permit the use of nonorganic forms of collagen gel when organic collagen gel is not commercially available ( i.e., not available in an appropriate form, quality, or quantity, as determined by the certifying agent in the course of reviewing the organic plan). 18 The final rule only permits nonorganic collagen gel as a casing. This final rule adds collagen gel casing to § 205.605(b) rather than to § 205.606, as proposed. The change in AMS' classification of collagen gel (and, therefore, its location on the National List) is discussed in the “Comments Received and AMS' Response” section below.

AMS is finalizing the addition of collagen gel casing to the National List, as proposed by NOSB, as organic collagen gel is not commercially available as of the issuance of this final rule. This conclusion is based on AMS' review of comments made to NOSB and comments received in response to the proposed rule. Additionally, AMS searched the Organic Integrity Database and found no certified organic operations with certified organic collagen gel. 19

AMS expects that the allowance for nonorganic forms of collagen gel when organic forms are not available will encourage organic certification of products that have not been previously eligible for organic certification. This will encourage food manufacturers to develop new organic products, which could, in turn, create new demand for organic production (livestock production). There are no alternatives on the National List which are suitable for use in a co-extrusion system as a non-removable edible film.

Collagen gel is described as a multi-ingredient product made from collagen (3.0-4.5%), cellulose (<3.0%), and water (95.5-97.0%) in the commissioned third-party technical evaluation report. 20 Collagen is isolated from animal materials ( e.g., skin, bones) through thermal, acid, base, or enzymatic hydrolysis. Once isolated, the extract is decalcified and swollen with acid (generally hydrochloric or sulfuric) prior to use in a co-extrusion process.

When used in sausage production, collagen gel is used to enrobe the extruded product. The collagen gel forms an edible film that holds the form of the product and acts as a protective barrier. The collagen casing is an ingredient in the final product ( i.e., it is disclosed on the ingredients list). AMS understands that collagen gel may be formulated with additional substances to improve the appearance ( e.g., colors) or flavor of the final product. AMS expects these additional substances, when used, will be evaluated by USDA-accredited certifying agents for compliance with the National List and the USDA organic regulations.

AMS concluded that the addition of collagen gel to the National List is consistent with the requirements of OFPA sec. 6517(c). Namely, the substance is not harmful to human health or the environment; is necessary to production because of the unavailability of wholly natural substitute products; and is consistent with organic farming and handling. The amendment is made following the procedures established in OFPA (sec. 6517(d)).

NOSB submitted a recommendation to AMS in April 2019 to add collagen gel to the National List. 21 NOSB recommendation followed receipt of a petition to add the substance to the National List in February 2018. 22 In NOSB's evaluation of the petition, they considered information from a third-party technical evaluation report and comments from the public. NOSB discussed the petition to amend the National List in subcommittee calls and at its public meetings in October 2018 and April 2019. 23

In its recommendation, NOSB concluded that adding collagen gel to the National List was consistent with OFPA criteria (sec. 6518(m)). In its recommendation, NOSB noted that adding collagen gel to the National List would increase opportunity for production of organic products that are not possible with current ingredients on the National List, such as single-species sausage and meat products.

Classification. In the proposed rule, AMS requested additional information on whether the use of acid induces chemical change(s) in the collagen gel which should cause the substance to be classified as a nonagricultural, synthetic substance. In response, AMS received a comment stating that AMS guidance  24 indicates that synthetic acids used in a hydrolysis process would result in a synthetic product. The comment also stated that under this interpretation of program guidance, the use of synthetic acids as described in the technical evaluation report  25 would not be allowed in the production of nonsynthetic collagen gel.

Some comments received were neutral, neither in support of nor in opposition to the addition of collagen gel casing. One comment supported classifying collagen gel casing as an agricultural substance should it be added to the National List. This same comment also acknowledged that collagen gel casing's classification as an agricultural substance could be challenged during future NOSB meetings. However, the comment also stated that since the source material for collagen gel casing source is agricultural, its inclusion on § 205.606 would be appropriate.

Upon further review of the manufacturing process of collagen, as described in the petition and technical evaluation report, AMS agrees with the comment that the acid hydrolysis step typical in the manufacturing process of collagen is a non-biological chemical change that results in its classification as a nonagricultural, synthetic substance. In order to preserve the intent of NOSB to encourage future availability of certified organic collagen gel, AMS is listing collagen gel casing as a synthetic nonagricultural substance at § 205.605(b) with the annotation “may be used only when organic collagen gel is not commercially available.”

AMS understands that there are many different manufacturing processes for the production of collagen gel. 26 It is our understanding that while there are many different processes for manufacturing collagen gel, the current predominant manufacturing process renders the final collagen gel as synthetic. While the main manufacturing process results in a synthetic product, there are manufacturing processes described which would result in a nonsynthetic product and are consistent with § 205.270 ( i.e., could be a certifiable process). Aware of the fact that the addition of collagen gel to the National List would allow for the production of additional organic products, we classified collagen gel as synthetic due to the predominant manufacturing process to provide access to organic producers. Given that there are processing methods which could be certified, we are maintaining the commercial availability requirement to encourage the development of nonsynthetic, certified organic products.

General Opposition. AMS received comments opposed to adding collagen gel casing to the National List. Some of the opposing comments want organic products to be composed only of organic ingredients. AMS notes that OFPA permits the use of specific nonorganic substances ( i.e., those on the National List) in organic production and handling. OFPA describes the procedures for amending the National List and provides AMS and NOSB with criteria and guidelines to consider in evaluating changes to the National List. These procedures were followed by NOSB and AMS, and this rule adds collagen gel to the National List.

Misleading to Consumers. A comment argued AMS will confuse consumers, especially vegan consumers, should collagen gel casings be allowed for use in organic plant-based sausage products. AMS understands that labeling requirements implemented by other agencies would require disclosure of collagen casings in a product's ingredient list. AMS believes that disclosure of the collagen casing as an ingredient provides sufficient transparency for consumers.

AMS published notices in the Federal Register on August 9, 2018, announcing the Fall 2018 NOSB Meeting (83 FR 39376) and on November 26, 2018, announcing the Spring 2019 NOSB meeting (83 FR 60373). These notices invited public comments on NOSB recommendations addressed in this final rule. The AMS proposed rule that preceded this final rule was published on June 8, 2020 (85 FR 35011).

OFPA authorizes the Secretary to make amendments to the National List based on recommendations developed by NOSB. Sections 6518(k) and 6518(n) of OFPA authorize NOSB to develop recommendations for submission to the Secretary to amend the National List and establish a process by which persons may petition NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. 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. 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 Program Handbook on the NOP website at https://www.ams.usda.gov/rules-regulations/organic/handbook.

This final rule has been determined to be not significant for purposes of Executive Order 12866, and, therefore, has not been reviewed by the Office of Management and Budget (OMB).

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 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. 27 SBA has classified 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 USDA's National Agricultural Statistics Service (NASS) and NOP indicate most of the certified organic production operations in the United States would be considered small entities. According to the 2019 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. 28 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, there are 19,059 organic handlers that are certified under the USDA organic regulations. 29 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 SBA's small business thresholds (500 to 1,250). Therefore, AMS expects that most organic handlers would qualify as small businesses.

Certifying agents. 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 77 USDA-accredited certifying agents, based on a query of NOP certified organic operations database, who provide organic certification services to producers and handlers. While many certifying agents are small entities that would be affected by this proposed 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 the economic impact on entities affected by this rule to be significant. The effect of this final rule will allow the use of three additional substances in organic crop production and organic handling. Adding three substances to the National List will increase regulatory flexibility and provide small entities with more options to use in day-to-day operations.

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 USDA to be accredited as a certifying agent, as described in section 6514(b) of OFPA. States are also preempted under sections 6503 through 6507 of OFPA 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 OFPA.

Pursuant to section 6507(b)(2) of OFPA, 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 § 6519(c)(6) of OFPA, 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 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, OMB clearance is not required by the Paperwork Reduction Act 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 will be shared during an upcoming quarterly call, and tribal leaders will be informed about the proposed revisions to the regulation and the opportunity to submit comments. AMS will work with USDA's 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 NOSB to the Secretary to add three substances to the National List.

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

The FCIC serves America's agricultural producers through effective, market-based risk management tools to strengthen the economic stability of agricultural producers and rural communities. FCIC is committed to increasing the availability and effectiveness of Federal crop insurance as a risk management tool. Approved Insurance Providers (AIP) sell and service Federal crop insurance policies in every state through a public-private partnership. FCIC reinsures the AIPs who share the risks associated with catastrophic losses due to major weather events. FCIC's vision is to secure the future of agriculture by providing world class risk management tools to rural America.

FCIC amends the Common Crop Insurance Regulations by revising 7 CFR 457.101, Small Grains Crop Insurance Provisions, and by removing and reserving 7 CFR 457.118, Malting Barley Price and Quality Endorsement, to be effective for the 2022 and succeeding crop years.

The changes to 7 CFR 457.101, Small Grains Crop Insurance Provisions, are as follows:

1. Throughout the Crop Provisions, FCIC is replacing all references of the “fall” type with “winter” type. Fall and spring-planted acreage are insured under the “winter” commodity type and “spring” commodity type, respectively, in the actuarial documents. This change is necessary for consistency between the Crop Provisions and actuarial documents.

2. Throughout the Crop Provisions, FCIC is replacing the phrase “initially planted” with the phrase “initially-planted,” where appropriate.

3. Throughout the Crop Provisions, FCIC is replacing all references of “growers” with “producers” to be consistent with the terminology used in the Common Crop Insurance Policy Basic Provisions.

4. Section 1—FCIC is revising the definition of “Khorasan” by replacing the phrase “is considered to be” with “is considered.” The phrase “to be” is not necessary.

FCIC is revising the definition of “latest final planting date” to replace all references to fall and spring-planted acreage to winter and spring types. This change will eliminate any confusion of whether a winter final planting date exists in the actuarial documents if the Winter Coverage Endorsement is not selected. For example, Asotin County, Washington lists a winter final planting date for barley that is only applicable if the Winter Coverage Endorsement is elected. Otherwise, there is no applicable date in the fall and only spring final planting dates exist for the spring types. The intent of these provisions is to address when a county has both winter and spring types designated in the Special Provisions, regardless if the Winter Coverage Endorsement is elected.

FCIC is revising the definition of “small grains” to allow the flexibility to insure additional small grains varieties that are not currently listed in the actuarial documents. This allows for insurance coverage to be offered via actuarial documents for varieties currently not insured when data become available, and it is appropriate to do so.

5. Section 2—FCIC is designating the undesignated paragraph in section 2 as paragraph (b) and adding a new paragraph (a) to allow enterprise units by type for wheat. For example, if insured has winter and spring types, they may elect one enterprise unit for the spring type or one enterprise unit for the winter type, or separate enterprise units for both types.

For the wheat types, allowing separate enterprise units allows producers to be indemnified separately by type. The benefit for producers is that a loss on one type will not be offset by the gain on another type.

If an insured elects enterprise units by type, these enterprise units are not allowed to be further divided by practice and the insured may not elect enterprise or optional units by irrigation practices for the policy.

Additionally, the insured must separately meet the requirements in section 34(a)(4) of the Basic Provision for each enterprise unit they elect to have.

If the insured elects enterprise units by type and does not qualify for separate enterprise units, there are options based upon whether enterprise units are elected for one or multiple types and the timing of the discovery:

• If the insured elects separate enterprise units for multiple types and the AIP discovers the enterprise unit qualifications are not separately met for all types:

(1) On or before the acreage reporting date the insured may elect to insure:

(a) All types in which they elected an enterprise unit for meeting the requirements in section 34(a)(4) of the Basic Provisions as separate enterprise units, and basic or optional units for any acreage that is not reported and insured as an enterprise unit, whichever the insured reports on the acreage report and for which the insured qualifies; or

(b) One enterprise unit for all acreage of the crop in the county provided the insured meets the requirements in section 34(a)(4) of the Basic Provisions; or

(c) Basic or optional units for all acreage of the crop in the county, whichever the insured reports on the acreage report and for which the insured qualifies.

(2) After acreage reporting date, the insured will have one enterprise unit for all acreage of the crop in the county provided they meet the requirements in section 34(a)(4) of the Basic Provisions. If they don't meet the requirements in section 34(a)(4), the AIP will assign a basic unit structure for all acreage of the crop in the county.

• If an insured elects an enterprise unit for only one type and the AIP discovers the enterprise unit qualifications are not met for that type:

(1) On or before the acreage reporting date, the insured's unit division for all acreage of the crop in the county will be based on basic or optional units, whichever the insured reports on the acreage report and for which the insured qualifies; or

(2) After the acreage reporting date, the AIP will assign the basic unit structure for all acreage of the crop in the county.

FCIC is also revising the first sentence in redesignated paragraph (b) to rephrase the language to eliminate the need to list all optional unit choices from the Basic Provisions. This allows the Small Grains Crop Provisions to follow the Basic Provisions optional unit division language when and if those provisions in the Basic Provisions are updated, without a new regulation.

In newly redesignated paragraph (b), FCIC is revising the reference to section 34(b) of the Common Crop Insurance Policy Basic Provisions to 34(c). Section 34(c) is the appropriate reference.

In newly redesignated paragraph (b), FCIC is simplifying the paragraph by removing the list of insurable types that may be insured as separate optional units and replacing with a statement that separate optional units may be established by any insured wheat type as long as each optional unit contains only initially-planted acreage of the type. The insured type can be listed in the actuarial documents or insured by written agreement to qualify. This change is needed in the event the insured elects enterprise units by type but does not qualify for enterprise units.

6. Section 3—FCIC is revising the lead-in to paragraph (b)(2). This paragraph addresses counties that have both winter and spring sales closing dates. In some counties, the winter sales closing date only applies if the Winter Coverage Endorsement is elected. While these specific counties have a winter and a spring sales closing date listed in the actuarial documents, paragraph (b)(2) is not referring to these counties. Paragraph (b)(2) is only intended to apply to those counties where both winter and spring sales closing dates are applicable regardless of the Winter Coverage Endorsement election. Therefore, the lead-in is revised to include, in parenthesis, a statement that excludes dates specific to the Winter Coverage Endorsement.

FCIC is also revising paragraphs (b)(2)(i) and (ii) to replace the phrase “insured fall planted acreage” with the phrase “insurable winter planted acreage.” This paragraph provides guidance regarding the date by which producers can make changes to their insurance coverage depending on whether they have insured fall-planted acreage. The provisions state that if producers have insured fall-planted acreage, no changes can be made after the fall sales closing date. If producers do not have insured fall-planted acreage, then they can make changes up until the spring sales closing. All acreage of the crop in the county must be insured. Therefore, if the producer plants fall-planted acreage and it meets the insurability requirements in section 6, then it must be insured. FCIC received input from AIPs that the phrase “insured fall planted acreage” indicates that if producers planted fall-planted acreage but do not insure it, then they have until the spring sales closing date to make changes to the insurance coverage on the spring-planted acreage. That is not the intent of the provisions. Therefore, FCIC is revising the language to indicate if producers planted insurable fall-planted acreage, then no changes may be made after the fall sales closing date. As explained above, “fall” is also being replaced with “winter,” as appropriate.

7. Section 5—FCIC is removing the phrase “Special Provisions” and replacing it with the phrase “actuarial documents.” The cancellation and termination dates identified in this section are also found in the actuarial documents, rather than the Special Provisions. If FCIC determines that the cancellation or termination dates need to differ than what is provided in the Crop Provisions, then the modified date would be identified in the actuarial documents.

8. Section 6—FCIC is removing paragraph (e). This paragraph refers to the Malting Barley Price and Quality Endorsement (MBPQE) published at 7 CFR 457.118. The MBPQE is no longer available to barley producers. Another endorsement, Malting Barley Endorsement was approved by the FCIC Board of Directors under Section 508(h) of the Federal Crop Insurance Act. The Malting Barley Endorsement replaced the MBPQE in 2016 and is not codified. Therefore, there's no need to include a reference to the MBPQE within the Small Grains Crop Provisions.

9. Section 7—FCIC is revising the lead-in sentence to paragraph (a)(1) to remove the reference to oats. FCIC is adding oats to paragraph (a)(2). Paragraph (a)(1) is for the crops for which there is only one planting season (either winter or spring); whereas paragraph (a)(2) is for the crops that have more than one planting season (winter and spring). In all counties where oats are insured, FCIC insures winter-planted oats, spring-planted oats or both. Therefore, oats are more appropriately placed in paragraph (a)(2) and are added within paragraph (a)(2) in every place there is a reference to barley and wheat.

FCIC is also revising paragraphs (a)(2)(ii) and (iii) to change the phrase “fall final planting date” and “fall and spring final planting dates” to “winter type” and “winter and spring types,” respectively.

FCIC is revising paragraph (a)(2)(iii)(A) to add the word “acreage” at the end of the following phrase: “Any winter barley, oat or wheat.” By adding “acreage” to this phrase, this lead-in phrase is consistent with the lead-in phrase in paragraph (a)(2)(iii)(B). FCIC is also revising the phrase “Any winter barley, oat or wheat” to add a comma after “oat.”

FCIC is also adding paragraph (a)(2)(iii)(D). This paragraph addresses situations, in counties with both winter and spring types listed in the actuarial documents, when acreage of the winter type is planted after the end of the late planting period. The Basic Provisions says that any acreage planted after the end of the late planting period may be insured if the producer chooses to insure it. If insured, then the acreage will be insured with a reduced guarantee equal to the production guarantee times the prevented planting coverage level percentage specified in the actuarial documents. In counties with both winter and spring types listed in the actuarial documents, winter types are not eligible for prevented planting so there is no prevented planting coverage level percentage listed in the actuarial documents to assign to it. Without a prevented planting coverage level, section 8(b)(2) of the Basic Provisions applies and the winter types are not insurable ( e.g., the appropriate rates are not available to insure the crop). This new provision allows the acreage to be insured in the spring as the spring type, if the producer chooses to insure it and the AIP determines there is an adequate stand. This change treats all producers similarly to producers who plant winter types in counties with only a spring type listed in the actuarial documents.

FCIC is revising paragraph (a)(2)(iv) by revising the phrase “. . .any acreage of spring barley, oat or wheat. . .” to read “. . .any spring barley, oat or wheat acreage. . .” Similarly, FCIC is revising paragraph (a)(2)(v) by revising the phrase “. . .any acreage of winter barley, oat or wheat. . .” to read “. . .any winter barley, oat or wheat acreage. . .” These revisions are consistent with revisions made in paragraph (a)(2)(iii).

In paragraphs (a)(2)(iv) and (v), FCIC is replacing the phrase “spring final planting date” with “spring type” in both places to be consistent with changes elsewhere in the Crop Provisions.

Also in paragraph (a)(2)(v), FCIC is revising the phrase “is not insured” to “will not be insured.” This is consistent with the language that was added in paragraph (a)(2)(iii)(D).

FCIC is also revising paragraph (a)(2)(v) to remove the phrase “agree in writing” as this could be misinterpreted to mean a written agreement, which is not the intent of the language, and could result in providing insurance via written agreement when it was not intended or appropriate. FCIC is replacing that phrase with language to clarify the AIP must inspect and give written confirmation that the acreage has an adequate stand in the spring to produce the yield used to determine your production guarantee. These clarifications will reduce the likelihood of fraud, waste, and abuse.

FCIC is revising paragraph (a)(2)(v)(D) by revising the phrase “. . . any acreage of such winter barley, oat or wheat. . .” to read “. . .any such winter barley, oat, or wheat acreage . . .” These revisions are consistent with revisions made in paragraphs (a)(2)(iii)-(v).

FCIC is also revising paragraphs (a)(2)(v) introductory text and (a)(2)(v)(A), (B), and (D) to change all references of “fall planted” to “winter” for consistency with changes elsewhere.

FCIC is revising paragraph (a)(2)(v)(E) to change the reference of “fall planted acreage” to “winter planted acreage” for consistency with changes elsewhere.

10. Section 9—FCIC is replacing the phrase “winter coverage endorsement” with “Winter Coverage Endorsement” because it is the title of an endorsement.

FCIC is replacing the phrase “spring final planting date” with the phrase “spring type” in paragraph (a)(4) to accurately refer to the Special Provisions where insurable types and practices are listed.

FCIC is revising paragraph (b). The phrase “fall final planting date (including final planting dates in December, January and February)” is replaced with “winter type” to accurately refer to the Special Provisions where insurable types and practices are listed.

FCIC is revising paragraph (e) to replace the phrase “crop type” with “type” in the five places it appears. This is the only paragraph in the Crop Provisions where “crop type” is used. For consistency throughout the Crop Provisions, the word “crop” is removed.

11. Section 11—FCIC is adding paragraph (d)(1)(v) to provide flexibility in the Special Provisions to update the moisture levels for each crop if it is determined that a level should be different than what is provided in the Crop Provisions.

FCIC is revising paragraph (d)(4) by replacing the phrase “contained in” with the phrase “calculated in accordance with.” The current provisions state that the quality adjustment factor is contained in the Special Provisions. However, there is no such factor stated in the Special Provisions. Instead, the quality adjustment factor is calculated using several different steps that are contained in the Special Provisions.

12. Section 13—FCIC is removing the phrase “spring final planting date” and replacing it with the phrase “spring type.” FCIC is also revising the paragraph to move the first sentence to the end of the paragraph for ease of reading.

Section 9(a)(5) states that damage must occur after the winter final planting date for the producer to be eligible for a replant payment, in counties with both winter and spring final planting dates. Provisions in section 7(a)(2)(iii) provide guidance on whether a crop should be replanted if damage occurs any time before the spring final planting date, which would also encompass any time before the winter final planting date since the winter final planting date comes before the spring final planting date in the crop year. As such, a producer is required to replant if damage occurs prior to the winter final planting date; however, no replanting payment is made in that timeframe. FCIC has received requests to remove this provision, thereby allowing replanting payments to be made in situations where damage occurs prior to the winter final planting date in counties with both winter and spring final planting dates. FCIC has also received opposing feedback requesting the provision remain intact because it is difficult or impossible to make a determination prior to the winter final planting date that acreage needs to be replanted or that it is practical to replant, except in cases of widespread weather events.

In addition to consideration of the future of section 9(a)(5), there are other provisions that may be affected by its removal. Section 9(b) states that no replanting payment is available in any circumstance for damage in counties with only a winter final planting date. Producers in these counties, like producers in counties with both winter and spring final planting dates, are required to replant if damage occurs prior to the winter final planting date, but no replanting payment is available. FCIC has received opposition to remove this provision, which, if removed, would allow replanting payments prior to the winter final planting date. In addition to the same opposing feedback FCIC received regarding removal of section 9(a)(5), FCIC also received feedback that in counties where only a winter type is insurable, there is a short window to replant a damaged crop. Replanting in these counties may contribute to later planting dates when soil temperatures may be too low for germination. Unlike in counties where both winter and spring types are insurable, there is not an opportunity for producers to replant a damaged winter crop in the spring to retain coverage using the winter guarantee.

Further, the Winter Coverage Endorsement (WCE) provides optional coverage for barley and wheat producers from the winter final planting date until the spring final planting date in counties with both winter and spring final planting dates. If damage occurs during the WCE coverage period, the producer has three options: (1) Continue to care for the damaged crop and coverage will continue under the terms of the Basic Provisions, the Small Grains Crop Insurance Provisions and the WCE; (2) replant the damaged acreage and receive a replanting payment; or (3) destroy all remaining acreage and accept an appraised amount of production determined in accordance with section 11(c)(1) of the Small Grains Crop Insurance Provisions to count against the unit production guarantee. The Common Crop Insurance Policy Basic Provisions says that no replanting payment will be made on acreage on which one replanting payment has already been allowed for the crop year. Assume section 9(a)(5) is removed, damage occurs prior to the winter final planting date, and a replanting payment is made. If the same acreage that received a replanting payment is damaged during the WCE coverage period, then the producer's options under the WCE have been narrowed down to two as he likely will not choose to replant knowing he will not receive a replanting payment. When the producer elected the WCE at sales closing time, he would have expected three options in the event of damage.

Finally, in general, a replanting payment will not be made if acreage is damaged and that acreage was planted before the earliest planting date if an earliest planting date is listed in the actuarial documents. There are counties with both winter and spring final planting dates that currently do not have an earliest planting date listed for the winter type. If section 9(a)(5) is removed, it is unclear if producers will plant earlier than they have historically planted knowing that there is a potential for a replanting payment if the crop fails before the winter final planting date.

Specifically, FCIC requests comments on the following questions; please provide any data and information that supports your comments:

1. Should FCIC provide a replanting payment for the winter type prior to the winter final planting date ( i.e., by removing section 9(a)(5))?

2. If section 9(a)(5) is removed, while section 9(b) is left intact, what concerns do you have that producers who plant a winter type in both counties would be treated differently regarding replanting payments: Where producers in counties with both winter and spring final planting dates would receive a replanting payment prior to the winter final planting date and producers in counties with only a winter final planting date would not receive a replanting payment prior to the winter final planting date?

3. If section 9(a)(5) is removed, what concerns do you have that the producer may not be eligible for a replanting payment under the WCE if he has already received a replanting payment on the same acreage?

4. If section 9(a)(5) is removed, will FCIC need to create an earliest planting date for the winter types in counties where no earliest planting date exists to require that producers plant no earlier than a specific date in order to be eligible for a replanting payment?

The Administrative Procedure Act (APA, 5 U.S.C. 553) provides that the notice and comment and 30-day delay in the effective date provisions do not apply when the rule involves specified actions, including matters relating to contracts. This rule governs contracts for crop insurance policies and therefore falls within that exemption.

This rule is exempt from the regulatory analysis requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996.

For major rules, the Congressional Review Act requires a delay the effective date of 60 days after publication to allow for Congressional review. This rule is not a major rule under the Congressional Review Act, as defined by 5 U.S.C. 804(2). Therefore, this final rule is effective on the date of publication in the Federal Register . Although not required by APA or any other law, FCIC has chosen to request comments on this rule.

Executive Order 12866, “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The requirements in Executive Orders 12866 and 13563 for the analysis of costs and benefits apply to rules that are determined to be significant.

The Office of Management and Budget (OMB) designated this rule as not significant under Executive Order 12866, “Regulatory Planning and Review,” and therefore, OMB has not reviewed this rule and analysis of the costs and benefits is not required under either Executive Order 12866 or 13563.

Executive Order 12866, as supplemented by Executive Order 13563, requires each agency to write all rules in plain language. In addition to your substantive comments on this rule, we invite your comments on how to make the rule easier to understand. For example:

• Are the requirements in the rule clearly stated? Are the scope and intent of the rule clear?

• Does the rule contain technical language or jargon that is not clear?

• Is the material logically organized?

• Would changing the grouping or order of sections or adding headings make the rule easier to understand?

• Could we improve clarity by adding tables, lists, or diagrams?

• Would more, but shorter, sections be better? Are there specific sections that are too long or confusing?

• What else could we do to make the rule easier to understand?

In general, the environmental impacts of rules are to be considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347) and the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508). FCIC conducts programs and activities that have been determined to have no individual or cumulative effect on the human environment. As specified in 7 CFR 1b.4, FCIC is categorically excluded from the preparation of an Environmental Analysis or Environmental Impact Statement unless the FCIC Manager (agency head) determines that an action may have a significant environmental effect. The FCIC Manager has determined this rule will not have a significant environmental effect. Therefore, FCIC will not prepare an environmental assessment or environmental impact statement for this action and this rule serves as documentation of the programmatic environmental compliance decision.

This rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” This rule will not preempt State or local laws, regulations, or policies unless they represent an irreconcilable conflict with this rule. Before any judicial actions may be brought regarding the provisions of this rule, the administrative appeal provisions of 7 CFR part 11 are to be exhausted.

This rule has been reviewed in accordance with the requirements of 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 policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

RMA has assessed the impact of this rule on Indian Tribes and determined that this rule does not, to our knowledge, have Tribal implications that require Tribal consultation under E.O. 13175. The regulation changes do not have Tribal implications that preempt Tribal law and are not expected have a substantial direct effect on one or more Indian Tribes. If a Tribe requests consultation, RMA will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified in this rule are not expressly mandated by Congress.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. 104-4) requires Federal agencies to assess the effects of their regulatory actions of State, local, and Tribal governments or the private sector. Agencies generally must prepare a written statement, including cost benefits analysis, for proposed and final rules with Federal mandates that may result in expenditures of $100 million or more in any 1 year for State, local or Tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates, as defined in Title II of UMRA, for State, local, and Tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The title and number of the Federal Domestic Assistance Program listed in the Catalog of Federal Domestic Assistance to which this rule applies is No. 10.450—Crop Insurance.

In accordance with the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, subchapter I), the rule does not change the information collection approved by OMB under control numbers 0563-0053.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA TARGET Center at (202) 720-2600 or 844-433-2774 (toll-free nationwide). Additionally, program information may be made available in languages other than English.To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by mail to: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410 or email: OAC@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

For the reasons discussed above, FCIC amends 7 CFR part 457 as follows:

This rule affecting 7 CFR part 1206 (the Order) is authorized under the Commodity Promotion, Research, and Information Act of 1996 (1996 Act) (7 U.S.C. 7411-7425).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. AMS has assessed the impact of this final rule on Indian tribes and determined that this rule will 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 changes to the regulations will be shared during an upcoming quarterly call, and tribal leaders will be informed about these revisions to the regulation.

In addition, this rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have a retroactive effect. Section 524 of the 1996 Act (7 U.S.C. 7423) provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.

Under section 519 of the 1996 Act (7 U.S.C. 7418), a person subject to an order issued under the Act may file a written petition with USDA stating that the order, any provision of the order, or any obligation imposed in connection with the order, is not established in accordance with the law, and request a modification of the order or an exemption from the order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, USDA will issue a ruling on the petition. The Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of USDA's final ruling.

The Mango Promotion, Research, and Information Order (Order) took effect in November 2004 (69 FR 59120), and assessment collection began in January 2005 for fresh mangos. The Order is administered by the National Mango Board (Board) with oversight by the U.S. Department of Agriculture. Originally, the program was funded by assessments on first handlers and importers of fresh mangos, and was focused on maintaining and expanding existing markets and uses for fresh mangos through its research, promotion and information efforts.

Frozen mangos as a covered commodity was added to the Order on February 21, 2019 (84 FR 5335), and a referendum was held in 2019 to determine whether the industry favored the inclusion of frozen mangos as a covered commodity under the Order. In the 2019 referendum, 52.5 percent of first handlers and importers of fresh and frozen mangos were in favor of the amendment to add frozen mangos to the Order. Since the vote passed by a small margin, the frozen mango industry asked the Board to conduct another referendum on whether frozen mangos should continue as a covered commodity under the Order.

The Order prescribes that every five years, the USDA conduct a referendum to determine if first handlers and importers of mangos favor the continuation of the Order. Such a referendum was required to be conducted in 2020. At the Board's September 2019 meeting, it was unanimously recommended to the USDA to add a second question to the continuance referendum ballot concerning frozen mangos as a covered commodity. USDA conducted a referendum from September 21 through October 9, 2020, among eligible first handlers and importers to (1) ascertain whether the continuance of the Order is favored by eligible first handlers and importers covered under the Order, and (2) ascertain whether the continuance of frozen mangos as a covered commodity in the Order is favored by eligible first handlers and importers (including frozen mango importers) covered under the Order. The results were announced on October 20, 2020, stating that 60 percent of mango first handlers and importers voting were in favor of continuing the Order. On the question as to whether to continue frozen mangos as a covered commodity in the Order, 42 percent voted to keep frozen mangos in the Order, 49 percent voted to eliminate frozen mangos and 9 percent did not vote on this question. Of those representing frozen mangos, 83 percent voted to eliminate frozen mangos as a covered commodity.

Section 522 of the 1996 Act (7 U.S.C. 7421) and § 1206.72 of the Order (7 CFR 1206.72) provide that if the Secretary determines that provisions of the Order are not favored by persons voting in a referendum, the Secretary shall terminate those provisions. An interim final rule was published in the Federal Register on February 24, 2021, providing a 60-day comment period that ended April 26, 2021. In accordance with the 1996 Act and Order, this rule adopts the interim rule, with a few minor changes to sections 1206.34 and 1206.43. The interim final rule proposed removal of the provisions of frozen mangos as a covered commodity under the Order and the final rule is adopting these changes from the interim final rule without change. They include: Removing definitions for frozen mangos and foreign processor of frozen mangos; reducing the Board's membership from 21 to 18 by eliminating two importers of frozen mangos and one foreign processor of frozen mangos; removing assessment collection provisions for frozen mangos at a rate of $0.01 per pound and thereby eliminating assessments on frozen mango imports; and removing the exemption of assessment for importers who import less than 200,000 pounds of frozen mangos annually. In addition, the interim final rule proposed clarifying and conforming changes to other provisions of the Order.

Sections 1206.34 and 1206.43 are being revised in this rule from the interim final rule for further clarification.

The interim rule set forth the following proposed changes that are being adopted without change. In accordance with § 1206.72, the following changes are necessary to terminate and remove the provisions regarding frozen mangos from the Order. Sections 1206.6 and 1206.9 which define the terms “first handler” and “importer,” respectively, were revised to add the reference that first handlers and importers, respectively, must receive or import 500,000 or more pounds of mangos; this volume was added for the purpose of clarity.

Section 1206.8, which defines the term “foreign producers and foreign processor of frozen mangos or foreign processor”, was revised to remove the definitions of “foreign processor of frozen mangos or foreign processor” because they are no longer covered under the Order. The definition for “foreign producer” will remain.

The definition of “mangos” in § 1206.11 was revised to mean all fresh fruit of Mangifera indica L. of the family Anacardiaceae. The term “frozen mangos” was removed as it is no longer a covered commodity.

Section 1206.30, which establishes the Board's membership, was revised to reduce its size from 21 to 18 members due to the removal of three members, i.e., two importers of frozen mangos and one foreign processor. The three members have been removed from the Board. The remaining 18-member Board will be comprised of 8 importers, 1 first handler, 2 domestic producers, and 7 foreign producers. In addition, eligibility requirements for Board members from the frozen mango industry are removed, and only those eligibility requirements for the first handler and fresh mango importers remain. Lastly, the four “Importer Districts” that were unintentionally removed from the CFR when this section was amended, were restored to section 1206.30 as paragraphs (b)(1)-(b)(4).

Section 1206.31, which describes the procedures for nominating and appointing Board members to the Board, was revised to remove procedures for nominating foreign processors and importers of frozen mangos. Section 1206.32, which specifies that Board members serve for a 3-year term of office and may serve a maximum of two consecutive 3-year terms, was revised to remove the references to importers of frozen mangos and foreign processors.

Section 1206.42 specifies the assessment rate for fresh mangos and frozen mangos. Paragraph (b) was revised to remove the provisions assessing importers of frozen mangos one cent ($0.01) per pound, and paragraph (d)(2), which includes the Harmonized Tariff Schedule (HTS) of the United States that applies to imported frozen mangos (number 0811.90.5200), was removed from the Order. Assessments on frozen mango importers have been terminated.

Subpart B of part 1206 specifies procedures for conducting a referendum. In § 1206.101, paragraphs (c), (d), and (e) were revised to delete the references to eligibility of frozen mango importers to vote in referenda, as frozen mangos are no longer a covered commodity, and to restore definitions prior to when this section was amended.

Finally, the interim final rule updated the OMB control number specified in § 1206.108 from 0581-0209 to 0581-0093.

Sections 1206.34 and 1206.43 from the interim final rule are being further revised. Section 1206.34 specifies quorum requirements for Board meetings, and with the reduction of the Board from 21 to 18, a decrease in quorum requirements is necessary. Therefore, this section was revised to specify that a quorum at a Board meeting exists when at least 10 of the 18 Board members are present. A comment was received requesting a quorum at Board meetings be when at least one more than half of the voting members are present. The comment was accepted, and the section is revised in this final rule.

In § 1206.43, paragraphs (a) and (b) were revised to remove references to frozen mango exemptions as frozen mangos are no longer a covered commodity. In making these changes, paragraph (a) was inadvertently changed to exempting domestic first handlers when the intent was to simply remove frozen mangos as a covered commodity, and therefore, further revision is needed.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of the rule on small entities. Accordingly, AMS has considered the economic impact of this action on such entities.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (first handlers and importers) as those having annual receipts of no more than $7.5 million.

According to the Board, there are five first handlers of fresh mangos. Based on 2019 Customs data, the majority of first handlers handled less than $7.5 million worth of fresh mangos and would thus be considered small entities.

Based on 2019 Customs data, 1 there are about 100 importers of fresh mangos and 70 importers of frozen mangos. The majority of fresh and frozen mango importers import less than $7.5 million worth of fresh or frozen mangos and would also be considered small entities. This action will remove frozen mango importers from the requirements associated with this research and promotion Order and result in a regulatory relaxation, and is therefore expected to reduce costs for frozen mango importers.

This rule amends AMS's regulations regarding the mango research and promotion program to remove frozen mangos as a covered commodity under the Order. A continuance referendum was conducted September 21 through October 9, 2020, among eligible first handlers and importers to (1) ascertain whether the continuance of the Order is favored by eligible first handlers and importers covered under the Order, and (2) ascertain whether the continuance of frozen mangos as a covered commodity in the Order is favored by eligible first handlers and importers (including frozen mango importers) covered under the Order. The results were announced on October 20, 2020, stating that 60 percent of mango first handlers and importers voting were in favor of continuing the Order. On the question as to whether to continue frozen mangos as a covered commodity in the Order, 42 percent voted to keep frozen mangos in the Order, 49 percent voted to eliminate frozen mangos, and 9 percent did not vote on this question. Of those representing frozen mangos, 83 percent voted to eliminate frozen mangos as a covered commodity.

This rule adopts the following proposed changes in the interim rule without change and removes references to frozen mangos as a covered commodity under the Order including: Removing definitions for frozen mangos and foreign processor of frozen mangos; reducing the Board's membership from 21 to 18 by eliminating two importers of frozen mangos and one foreign processor of frozen mangos; removing assessment collection provisions for frozen mangos at a rate of one cent ($0.01) per pound and thereby eliminating assessments on frozen mango imports; removing the exemption of assessment for importers who import less than 200,000 pounds of frozen mangos annually; removing definitions for frozen mango importers concerning eligibility in a referendum; and clarifying and conforming changes to other provisions of the Order. This rule will also update the OMB number 0581-0209 listed in § 1206.108 to OMB number 0581-0093.

Sections 1206.34 and 1206.43 from the interim final rule are being further revised for clarification in this rule.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the information collection and recordkeeping requirements previously approved by the OMB and titled Frozen Mango Research, Promotion and Information Program, and assigned OMB No. 0581-0314 will be submitted to OMB for withdrawal as these forms and information collection regarding frozen mangos are no longer needed.

The information collection package (0581-0314) that imposes a total burden of 166 hours and 475 responses for 190 respondents will be terminated.

The industry voted in a referendum held September 21, through October 9, 2020, to remove frozen mangos as a covered commodity from the Order. On October 20, 2020, the Department announced through a notice to trade that 42 percent of mango first handlers and importers voted to keep frozen mangos as a covered commodity, 49 percent of mango first handlers and importers voting were not in favor of frozen mangos as a covered commodity and 9 percent did not vote on this question. Of those representing frozen mangos 83 percent voted to eliminate frozen mango as a covered commodity under the Order.

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

An interim final rule was published in the Federal Register on February 24, 2021, providing a 60-day comment period that ended April 26, 2021. This rule will adopt most of the changes in the interim final rule. One comment was received requesting a change to section 1206.34 Procedures, concerning what constitutes a quorum at a Board meeting. Section 1206.34 was changed due to the reduction of the Board from 21 to 18, a decrease in quorum requirements was necessary, and therefore, changed from 11 to at least 10 of the 18 Board members are present. The commenter stated that this is problematic when the Board is not at full capacity and recommends a quorum at Board meetings be when at least one more than half of the voting members are present. USDA believes that this comment has merit and is revising section 1206.34 Procedures to specify that a quorum at a Board meeting exists when at least one more than half of the voting members are present.

In addition, USDA made a correction to section 1206.43 Exemptions to clarify a change that was made inadvertently exempting domestic first handlers when the intent was to simply remove frozen mangos as a covered commodity. Therefore, the section has been corrected to exempt first handlers or importers of less than 500,000 pounds of mangos per calendar year, and domestically exported mangos.

After consideration of all relevant matters presented, including comments, the referendum vote and other available information, it is hereby found that finalizing the interim final rule, with the changes below, as published in the Federal Register [86 FR 11094] on February 24, 2021, will tend to effectuate the purposes of the 1996 Act.

Accordingly, the interim final rule amending 7 CFR part 1206, which was published in the February 24, 2021, Federal Register [86 FR 11094], is adopted as final with the following changes:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain GE GEnx-1B and GEnx-2B model turbofan engines. The NPRM published in the Federal Register on September 24, 2020 (85 FR 60103). The NPRM was prompted by a report from the manufacturer that an inspection had found two stages 6-10 compressor rotor spools in the HPC assembly damaged at similar locations on the webs. The subsequent investigation determined that tool marks were created during the manufacturing process. In addition, the manufacturer also reported that certain stages 6-10 compressor rotor spool webs did not undergo a required FPI during production.

In the NPRM, the FAA proposed to require inspection of the stages 6-10 compressor rotor spool. Operators of certain affected GEnx-1B or GEnx-2B model turbofan engines have already completed acceptable inspections of the aft web of stage 6, stage 7, and stage 8 of the stages 6-10 compressor rotor spool. The FAA proposed to require operators of those affected engines to complete the inspection of the stages 6-10 compressor rotor spool no later than the next engine shop visit. The FAA proposed to require all other remaining affected GEnx-1B and GEnx-2B model turbofan engines to complete this inspection by the next engine shop visit, before the stages 6-10 compressor rotor spools accumulate 6,500 cycles since new, or before further flight if 6,500 cycles since new has already been accumulated as of the effective date of this AD. Depending on the results of the inspection, the FAA proposed to require replacement of the stages 6-10 compressor rotor spool with a part eligible for installation. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from seven commenters. The commenters were American Airlines (American), GE Aviation, Japan Airlines, Nippon Cargo Airlines (NCA), the Air Line Pilots Association, International, United Airlines Engineering, and Boeing Commercial Airplanes. Three commenters supported the proposed rule without change. One commenter requested that the FAA add a term to the Definitions paragraph of the proposed rule, and use the latest version of the service information. Three commenters requested certain clarifications or changes to the Required Actions and Previous Credit sections. The following presents the comments received on the NPRM and the FAA's response to each comment.

GE Aviation requested that the FAA define the term “rejectable indication” to avoid confusion in the event an indication is found during inspection. GE Aviation requested that the FAA define rejectable indication as an indication that does not meet the serviceable or repairable limits defined in the special procedure referenced in GE GEnx-1B Service Bulletin (SB) 72-0472 R02, dated November 5, 2020 (GEnx-1B SB 72-0472) and GE GEnx-2B SB 72-0415 R02, dated November 5, 2020 (GEnx-2B SB 72-0415).

The FAA agrees to define a “rejectable indication” as used in paragraph (g)(2) of the Required Actions section of this AD and added the definition in paragraph (h), Definitions, of this AD.

American requested that the FAA clarify paragraph (g)(2) and paragraph (i), Credit for Previous Actions, regarding installation of parts that initially failed inspection with a rejectable indication but were later reworked and found acceptable. American stated that GE has been accepting parts that were reworked using GE Subtask 72-00-00-210-012 in the GEnx-1B EM 72-00-00, Special Procedure 023, in accordance with approved GE Departure Recommendations.

The FAA disagrees. Paragraph (g)(2) of this AD requires that if during an inspection, a stages 6-10 compressor rotor spool is found to have a rejectable indication, as defined in paragraph (h) of this AD, then the stages 6-10 compressor rotor spool must be removed from service. If the stages 6-10 compressor rotor spool is subsequently repaired or reworked, operators would need to submit an alternative methods of compliance (AMOC) request to the FAA to allow use of the repaired or reworked stages 6-10 compressor rotor spool.

GE Aviation requested that the FAA update the specified service information by referencing Revision 2 of GE GEnx-1B SB 72-0472 and GE GEnx-2B SB 72-0415. GE noted that Revision 2 of these SBs had not been issued at the time of publication of the NPRM.

The FAA agrees and has updated this AD to reference GEnx-1B SB 72-0472 R02 and GEnx-2B SB 72-0415 R02, both dated November 5, 2020. This change to this AD imposes no additional burden on operators.

Japan Airlines requested that the FAA grant credit for the borescope inspection (BSI) or eddy current inspection (ECI) required by paragraph (g)(1) of this AD if inspections were previously performed in accordance with GE GEnx-1B SB 72-0472 R01, dated July 24, 2020.

The FAA agrees and has updated paragraph (i), Credit for Previous Actions, to allow credit for inspections performed using GE GEnx-1B SB 72-0472 R01, dated July 24, 2020 or GE GEnx-2B SB 72-0415 R01, dated July 24, 2020, as applicable.

NCA requested that the FAA clarify the meaning of “previously undergone” in paragraph (g)(1)(ii) of this AD. NCA commented that one of its engines underwent an inspection during an engine shop visit using GEnx-2B SB 72-0385 R02, dated July 29, 2019 and GE GEnx-2B SB 72-0398 R00, dated October 30, 2019, before the effective date of this AD but after publication of GEnx-2B SB 72-0415 R01. NCA noted that the reference to “previously undergone” means that it has been implemented in accordance with SB in the past without any specific timeframe, so it is not clear if the NCA's engine can apply the no cycles since new (CSN) limit.

The FAA clarified paragraph (g)(1)(i) and (ii) of this AD by removing the phrase “previously undergone” and referring instead to engines that have undergone inspections “before the effective date of this AD.”

The FAA updated Table 1 to paragraph (g)(1) of this AD by allowing operators 100 flight cycles to perform the inspections required by paragraph (g)(1) of this AD when an engine has a stages 6-10 compressor rotor spool with 6,400 CSN or greater as of the effective date of this AD. This change allows operators a grace period to complete the required inspections without unnecessary grounding of airplanes and still meets the safety intent of this AD.

The FAA reviewed the relevant data, considered any 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 products. 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 GE GEnx-1B Service Bulletin (SB) 72-0472 R02, dated November 5, 2020 (GEnx-1B SB 72-0472) and GE GEnx-2B SB 72-0415 R02, dated November 5, 2020 (GEnx-2B SB 72-0415).

GEnx-1B SB 72-0472 describes procedures for performing a BSI or an ECI of stage 6, stage 7, and stage 8 webs, web transitions, and bore faces of the stages 6-10 compressor rotor spool for GEnx-1B model turbofan engines. GEnx-1B SB 72-0472 also provides the affected part and serial numbers of the stages 6-10 compressor rotor spools installed on GEnx-1B model turbofan engines.

GEnx-2B SB 72-0415 describes procedures for performing a BSI or an ECI of stage 6, stage 7, and stage 8 webs, web transitions, and bore faces of the stages 6-10 compressor rotor spool for GEnx-2B model turbofan engines. GEnx-2B SB 72-0415 also provides the affected part and serial numbers of the stages 6-10 compressor rotor spools installed on GEnx-2B model turbofan engines.

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 also reviewed Subtask 72-31-45-160-002 of TASK 72-31-45-200-807 in GE GEnx-1B Engine Manual 05-21-00, Life Limits 001 Mandatory Inspections, Rev. 31 dated, January 31, 2020; and Subtask 72-31-45-160-002 of TASK 72-31-45-200-801 in GE GEnx-2B Engine Manual 05-21-00, Life Limits 001 Mandatory Inspections, Rev. 24 dated, January 31, 2020. The Subtasks provide guidance on performing the ECI on the stages 6-10 compressor rotor spool on GE GEnx-1B and GEnx-2B model turbofan engines.

The FAA also reviewed the following GE SBs: GEnx-1B SB 72-0448 R00, dated July 29, 2019 (GEnx-1B SB 72-0448); GEnx-1B SB 72-0460 R00, dated October 30, 2019 (GEnx-1B SB 72-0460); GEnx-2B SB 72-0385 R02, dated July 29, 2019 (GEnx-2B SB 72-0385); and GEnx-2B SB 72-0398 R00, dated October 30, 2019 (GEnx-2B SB 72-0398).

GEnx-1B SB 72-0448 describes procedures for performing a BSI or an ECI of the stage 8 aft web of the HPC stages 6-10 rotor spool for GEnx-1B model turbofan engines. GEnx-1B SB 72-0460 describes procedures for performing a BSI or an ECI of the stage 6 and stage 7 aft web of the HPC stages 6-10 rotor spool for GEnx-1B model turbofan engines.

GEnx-2B SB 72-0385 describes procedures for performing a BSI or an ECI of the stage 8 aft web of the HPC stages 6-10 spool for GEnx-2B model turbofan engines. GEnx-2B SB 72-0398 describes procedures for performing a BSI or an ECI of the stage 6 and stage 7 aft web of the HPC stages 6-10 rotor spool for GEnx-2B model turbofan engines.

The FAA estimates that this AD affects 268 engines installed on 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 replacements that would be required based on the results of the inspection. The agency has no way of determining the number of aircraft that might need these replacements:

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 EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0271, dated December 8, 2020 (EASA AD 2020-0271) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for Leonardo S.p.A. (formerly Finmeccanica S.p.A, AgustaWestland S.p.A., Agusta S.p.A.; and AgustaWestland Philadelphia Corporation, formerly Agusta Aerospace Corporation) Model AB139, AW139, and AW189 helicopters, all serial numbers. Although EASA AD 2020-0271 applies to Model AB139, AW139, and AW189 helicopters, all serial numbers, this AD applies to helicopters with an affected part installed instead.

This AD was prompted by a report of the in-flight failure of one of the three stainless steel external rings bonded to the main rotor swashplate boot installed on Model AB139 and AW139 helicopters. The broken ring, under the effects of the centrifugal force, was released from the main rotor swashplate boot and impacted one tail rotor blade, causing extensive damage. Investigation revealed that the failure of the external ring was caused by fatigue initiated by corrosion. A contributing factor to the external ring failure was disbonding at the four points where the affected ring was bonded to the main rotor swashplate boot. Leonardo S.p.a. Model AW189 helicopters have a similar design, therefore, this model may be subject to the same unsafe condition revealed on the Model AB139 and AW139 helicopters. Since EASA AD 2020-0271 was published, there have been two more reports of discrepant main rotor boots.

The FAA is issuing this AD to address corrosion, cracking, and damage to the adhesive ( e.g., disbonding) of any stainless steel external ring bonded to the main rotor swashplate boot, which could result in release of a ring from the main rotor swashplate boot, resulting in damage to, and reduced control of, the helicopter. See the EASA AD for additional background information.

EASA AD 2020-0271 specifies procedures for repetitive detailed inspections (DET) of the affected external rings for corrosion (including superficial oxidation), and cracks, and, depending on findings, polishing corrosion, and replacing an affected external ring with a serviceable part. EASA AD 2020-0271 also requires repetitive inspections for damage of the adhesive ( e.g., disbonding) between the bonding areas of the affected external rings and the main rotor swashplate boot and re-applying the adhesive if necessary. For certain helicopters, EASA AD 2020-0271 requires a one-time restoring of the adhesive between the bonding areas of the affected external rings and the main rotor swashplate boot. For all helicopters, EASA AD 2020-0271 allows, under certain conditions, (re)installation of an affected part on a helicopter.

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.

These products have been approved by the aviation authority of another country, and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after evaluating all pertinent information and determining that the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

This AD requires accomplishing the actions specified in EASA AD 2020-0271, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, EASA AD 2020-0271 is incorporated by reference in the FAA final rule. This AD would, therefore, require compliance with EASA AD 2020-0271 in its entirety, through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in the EASA AD does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in the EASA AD. Service information specified in EASA AD 2020-0271 that is required for compliance with EASA AD 2020-0271 is available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0512.

Section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because the in-flight failure of a stainless steel external ring bonded to the main rotor swashplate boot could result in damage to, and reduced control of, the helicopter. In addition, the compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule. Based on the average utilization rate for the affected Model AB139 and AW139 helicopters, it would take approximately one month for an affected helicopter to reach 25 hours time-in-service. Therefore, notice and opportunity for prior public comment are impracticable and contrary to public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forego notice and comment.

The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0512; Project Identifier MCAI-2020-01621-R” at the beginning of your comments. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this AD because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Darren Gassetto, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7323; email Darren.Gassetto@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 142 helicopters of U.S. registry. The FAA estimates the following costs to comply with this AD:

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to 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 current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Pkwy., 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.

The FAA determined that this AD would not have federalism implications under Executive Order 13132. This AD would 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 this regulation:

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

(2) Will not affect intrastate aviation in Alaska.

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

This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers or aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the typed of SIAPS, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CRF part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, CFR part 97, (is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

The United States is a party to the 1971 United Nations Convention on Psychotropic Substances (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are governed domestically by 21 U.S.C. 811(d)(2)(4). When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971 Convention adding a drug or other substance to a specific schedule, the Secretary of the Department of Health and Human Services (HHS), 1 after consultation with the Attorney General, shall determine whether existing legal controls under subchapter I of the Controlled Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. 21 U.S.C. 811(d)(3). In the event that the Secretary of HHS did not so consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control. Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, schedule or transfer between schedules any drug or other substance, if he finds that such drug or other substance has a potential for abuse, and makes the findings prescribed by 21 U.S.C. 812(b) to schedule the drug or other substance. The Attorney General has delegated this scheduling authority to the Administrator of the Drug Enforcement Administration (DEA). 28 CFR 0.100.

para- Methoxymethamphetamine (PMMA) is a substituted phenethylamine and shares structural similarity to methamphetamine, a schedule II controlled substance, and para -methoxyamphetamine (PMA), a schedule I controlled substance. PMMA shares a similar pharmacological profile with 3,4-methylenedioxymethamphetamine (MDMA or ecstasy), a schedule I controlled substance with high potential for abuse. Data obtained from preclinical studies show that, similar to MDMA, PMMA's effects are mediated by monoaminergic (dopamine, norepinephrine, and serotonin) transmission, mostly via activation of the serotonergic system. In animals, PMMA mimics MDMA in producing discriminative stimulus effect, which is indicative of similar subjective effects. Law enforcement has encountered PMMA on the recreational drug market where it is sold as “ecstasy,” either alone or in combination with MDMA or PMA for oral consumption. For many years, PMMA has been involved in non-fatal and fatal overdoses, primarily in Europe. PMMA has no accepted medical use in treatment in the United States. In March 2016, the Commission on Narcotic Drugs (CND) voted to place PMMA in Schedule I of the 1971 Convention (CND Dec/59/3) during its 59th Session due to its dependence and abuse potential.

On December 18, 2018, in accordance with 21 U.S.C. 811(b), and in response to DEA's April 7, 2017 request, HHS provided to DEA a scientific and medical evaluation and scheduling recommendation for PMMA. DEA reviewed HHS' evaluation and recommendation for schedule I placement, and all other relevant data, pursuant to 21 U.S.C. 811(b) and (c), and conducted its own analysis under the eight factors stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 812(b)(1), that this substance warrants control in schedule I. Both DEA and HHS 8-Factor analyses are available in their entirety under the tab “Supporting Documents” of the public docket for this action at http://www.regulations.gov under Docket Number “DEA-509.”

On May 15, 2020 (85 FR 29359), DEA published a notice of proposed rulemaking (NPRM) to permanently control PMMA in schedule I. Specifically, DEA proposed to add PMMA to the hallucinogenic substances list under 21 CFR 1308.11(d), and assign paragraph number 79 under paragraph (d) to PMMA. The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before June 15, 2020. No requests for such a hearing were received by DEA. The NPRM also provided an opportunity for interested persons to submit comments on or before June 15, 2020. DEA did not receive any comments.

After consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and after its own eight-factor evaluation, DEA finds that these facts and all other relevant data constitute substantial evidence of the potential for abuse of PMMA. DEA is permanently scheduling PMMA as a controlled substance under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also specifies the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all other available data, the Acting Administrator of DEA (Acting Administrator), pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:

PMMA has a mechanism of action similar to that of MDMA, a schedule I controlled substance. Similar to MDMA, PMMA increases levels of monoamines, specifically DA and 5-HT, in the brain reward circuitry. Data from animal studies demonstrate that PMMA fully substitutes for the discriminative stimulus effect of MDMA, which is indicative of similar subjective effects. Although there is currently no data that has directly assessed the psychological or physiological dependence liability of PMMA, its pharmacological similarities to MDMA suggest it likely has low physical dependence liability. Evidence demonstrates that users of PMMA are often seeking MDMA, which may be mixed with PMMA. PMMA shares a pharmacological mechanism of action and psychoactive effects similar to the schedule I controlled substance MDMA and therefore has a high potential for abuse.

According to HHS, the Food and Drug Administration (FDA) has not approved any marketing application for a drug product containing PMMA for any indication. In addition, there are no clinical studies or petitioners that have claimed an accepted medical use of PMMA in the United States. Thus, PMMA has no currently accepted medical use in treatment in the United States. 2

The safety of PMMA for use under medical supervision has not been determined because it has no approved medical use in treatment in the United States and has not been investigated as a new drug. Therefore, there is a lack of accepted safety for use of PMMA under medical supervision.

Based on these findings, the Acting Administrator concludes that PMMA as well as its salts, isomers, and salts of isomers whenever the existence of such isomers and salts is possible within the specific chemical designation warrants control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

As discussed in the above NPRM section, DEA proposed to place PMMA in 21 CFR 1301.11(d) as paragraph number 79. Since the publication of this NPRM, DEA has issued several final rules which updated the numbering of listed hallucinogenic substances in paragraph (d). As a result, this final rule assigns paragraph number 88 to PMMA.

PMMA is subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, import, export, engagement in research, conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, PMMA must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.

2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle PMMA must surrender all quantities of currently held PMMA, or transfer all quantities of currently held PMMA to a person registered with DEA. PMMA must be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.

3. Security. PMMA is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71-1301.76. Non-practitioners handling PMMA must also comply with the employee screening requirements of 21 CFR 1301.90-1301.93.

4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of PMMA must comply with 21 U.S.C. 825, and be in accordance with 21 CFR part 1302.

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

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

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

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

7. Records and Reports. Every DEA registrant must maintain records and submit reports for PMMA, or products containing PMMA, pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and 1317. Manufacturers and distributors must submit reports regarding PMMA to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312.

8. Order Forms. Every DEA registrant who distributes PMMA must comply with order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.

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

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

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

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

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-612, has reviewed this final rule, and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.

DEA is placing the substance PMMA (chemical name 1-(4-methoxyphenyl)- N -methylpropan-2-amine), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the CSA to enable the United States to meet its obligations under the 1971 Convention. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle PMMA.

Based on the review of HHS' scientific and medical evaluation and all other relevant data, DEA determined that PMMA has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks accepted safety for use under medical supervision. DEA's research confirms that there is no legitimate commercial market for PMMA in the United States. Therefore, DEA estimates that no United States entity currently handles PMMA and does not expect any United States entity to handle PMMA in the foreseeable future. DEA concludes that no legitimate United States entity would be affected by this rule. As such, this rule will not have a significant effect on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to the Government Accountability Office, the House, and the Senate under the CRA.

For the reasons set out above, 21 CFR part 1308 is amended as follows:

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 is impracticable. We must establish this safety zone immediately and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

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 respond to the potential safety hazards associated with a fireworks display on July 3, 2021.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with a fireworks display on July 3, 2021 will be a safety concern for anyone in the navigable waters of Conn Brown Harbor within a 600-foot radius of a fireworks display launched from Conn Brown Harbor Point Park in Corpus Aransas Pass, Texas. The purpose of this rule is to ensure safety of vessels and persons on these navigable waters in the safety zone during the fireworks show.

This rule establishes a temporary safety zone from 9 p.m. through 10 p.m. on July 3, 2021. The fireworks will be launched in position 27°54′05.37″ N, 097°08′01.24″ W. No vessel or person is permitted to enter the temporary safety zone during the effective period without obtaining permission from the COTP or a designated representative, who may be contacted on Channel 16 VHF-FM (156.8 MHz) or by telephone at 361-939-0450. The Coast Guard will issue Local Notices to Mariners, Safety Marine Information Broadcasts, and Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

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 safety zone. This safety zone covers a 600-foot radius for a fireworks display launched in Aransas Pass, Texas. The temporary safety zone will be enforced for a short period of only 60 minutes on July 3, 2021. The rule does not completely restrict the traffic within a waterway and allows mariners to request 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 temporary safety 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 contact 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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 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 establishment of a temporary safety zone for navigable waters of Conn Brown Harbor within a 600-foot radius of a fireworks display launched at position 27°54′05.37″ N, 097°08′01.24″ W, in Aransas Pass, Texas. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a fireworks display. It is categorically excluded from further review under paragraph L60 Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1 .

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact 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:

On April 6, 2021, a construction company contracted by Portsmouth Naval Shipyard (PNSY) notified the Coast Guard that in mid-May they intend to tow the Weeks 2701 barge with the new PNSY Dry Dock No.1 Superflood Basin entrance structure, commonly referred to as the “structure,” aboard to PNSY for final lifting and setting. The structure is a 5500 ton pre-fabricated concrete caisson. The construction is critical to the PNSY Superflood Basin project. The lift and placement of the structure will take approximately two tide cycles and requires no wake or swell from passing vessels or weather during critical and sensitive lifting operations. The heavy lift is critical to the success of the PNSY Superflood Basin project and the future of PNSY operations. The heavy lift will be north of the federal navigation channel in the area of PNSY Berth No. 1.

The Coast Guard is issuing this temporary final 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 publishing an NPRM would be impracticable. A delay or cancellation of the currently ongoing PNSY Superflood Basin project in order to accommodate a full notice and comment period would delay necessary operations, result in increased costs, and delay the date when the PNSY Superflood Basin is expected to open for critical naval operations. For these reasons, the Coast Guard finds it impracticable to delay this regulation for purposes of a comment period.

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 impracticable for the same reasons specified above.

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 Sector Northern New England (COTP) has determined that potential hazards associated with the heavy lift will be a safety concern for anyone transiting the Piscataqua River in the vicinity of the PNSY Berth 1. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while during the heavy lift.

This rule establishes a temporary safety zone from June 16, 2021, through August 31, 2021. The safety zone will cover all navigable waters within 350 yards of position 43°04′50.38″ N, 070°44′39.62″ W (NAD83) of the Piscataqua River, Portsmouth, NH, in the vicinity of PNSY Berth No. 1. The size and duration of this safety zone is intended to ensure the safety of waterway users on these navigable waters during heavy lift operations.

We anticipate enforcing the safety zone during the heavy lift operations for installation of the structure during three high tide cycles sometime from July 1, 2021, through July 4, 2021. No vessel may enter, transit through, anchor in, or remain in the zone during periods of enforcment enforcement unless permission is obtained from the COTP or a designated representative. Persons or vessels seeking to enter the safety zones must request permission from the COTP or a designated representative on VHF-FM channel 16. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative. The COTP or a designated representative will inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate. The Coast Guard is publishing this rule to be effective through August 31, 2021 in case the project is delayed due to unforeseen circumstances.

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 following reasons: (1) The safety zone only impacts a small designated area of the Piscataqua River, Portsmouth, NH, (2) the zone will only be enforced during actual lift operations, (3) persons or vessels desiring to enter the safety zone may do so with permission from the COTP or a designated representative.

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

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant 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 a safety zone lasting approximately 24 to 36 hours that will prohibit entry within 350 yards of position 43°04′50.38″ N, 070°44′39.62″ W (NAD83), Piscataqua River, Portsmouth, NH, during heavy lift operations in Berth No. 1 at PNSY. It is categorically excluded from further review under paragraph L60a 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:

The Coast Guard will enforce the safety zone established in 33 CFR 165.1191, Table 1, Item number 18, for the Lights on the Lake Fourth of July Fireworks; South Lake Tahoe, CA from July 1, 2021 to July 4, 2021. The Coast Guard will enforce a 100-foot safety zone around the three fireworks barges during the loading, standby, transit, and arrival of the fireworks barges from the loading location to the display location and until the start of the fireworks display. On July 1, 2021 through July 4, 2021, the three fireworks barges will be loaded with equipment only beginning at approximately 7 a.m. at Tahoe Keys Marina in South Lake Tahoe, CA. On July 1 2021, the three fireworks barges will be loaded with pyrotechnics at approximately 7 a.m. at Edgewood, Stateline, Nevada, taking approximately 3 to 4 hours to load. The fireworks barges will remain on standby at the loading location until their transit to the display location. On July 4 2021, from 8 a.m. to 11 a.m. the loaded fireworks barges will transit from Edgewood, Stateline, Nevada to the launching area off Stateline Beach, Stateline, Nevada, approximately at position 38°57″ 56.0″ N 119°57″ 21.2″ W (NAD 83), where they will remain until the conclusion of the fireworks display. As set forth in 33 CFR 165.1191, Table 1, Item number 15, upon the commencement of the 25 to 30-minute fireworks display, the safety zone will expand to encompass all navigable waters, from surface to bottom, within a circle formed by connecting all points 1,000 feet out from the fireworks barges near Stateline Beach, Stateline, NV. The approximate position for firework display is 38°57″ 56.0″ N 119°57″ 21.2″ W (NAD 83). The safety zone will be enforced until 10:30 p.m. on July 4 2021, or as announced via Local Notice to Mariners.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from anchoring, blocking, loitering, or impeding the through transit of participants or official patrol vessels in the safety zone during all applicable effective dates and times. All vessels in the safety zone during the effective dates and times are subject to movement control by the PATCOM or other Official Patrol, defined as a federal, state, or local law enforcement agency on scene to assist the Coast Guard in enforcing the safety zone. During the enforcement period, if you are the operator of a vessel in one of the safety zones you must comply with directions from the Patrol Commander or other Official Patrol.

In addition to this notice of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

The Coast Guard will enforce the safety zone in the Table to 33 CFR 165.506, entry (a)(16) for the Coopers Ferry Fireworks display from 9 p.m. through 10:30 p.m. on July 4, 2021. This action is necessary to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after the fireworks displays. Our regulation for safety zones of fireworks displays within the Fifth Coast Guard District, table to § 165.506, entry (a)(16), specifies the location of the regulated area as all waters of Delaware River, adjacent to Penn's Landing, Philadelphia, PA, within 500 yards of a fireworks barge at approximate position latitude 39°56′49″ N, longitude 075°08′11″ W. During the enforcement period, as reflected in § 165.506(d), vessels may not enter, remain in, or transit through the safety zone during the enforcement period unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on scene.

In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide notification of this enforcement period via broadcast notice to mariners.

The Coast Guard will enforce the safety zone established in 33 CFR 165.1191 table 1, item number 1 for the San Francisco Giants Fireworks Display from 10 a.m. on June 25, 2021, until 11:15 p.m. on June 25, 2021. The Coast Guard will enforce a 100-foot safety zone around the fireworks barge, from surface to bottom, during the loading, transit of the fireworks barge from the loading location to the display location, and arrival at the display location, and until the start of the fireworks display. From 10:00 a.m. on June 25, 2021 until 8 p.m. on June 25, 2021, the fireworks barge will be loading pyrotechnics from Pier 50 in San Francisco, CA. The fireworks barge will remain at the loading location until its transit to the display location. From 8:30 p.m. to 8:45 p.m. on June 25, 2021, the loaded fireworks barge will transit from Pier 50 to the launch site near Pier 48 in approximate position 37°46′36″ N, 122°22′56″ W (NAD 83) where it will remain until the conclusion of the fireworks display. Upon the commencement of the 10-minute fireworks display, scheduled to begin at the conclusion of the baseball game, between approximately 9:30 p.m. and 10 p.m. on June 25, 2021, the safety zone will increase in size and encompass all navigable waters of the San Francisco Bay, from surface to bottom, within a circle formed by connecting all points 700 feet out from the fireworks barge near Pier 48 in approximate position 37°46′36″ N, 122°22′56″ W (NAD 83).

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from anchoring, blocking, loitering, or impeding the through transit of participants or official patrol vessels in the safety zone during all applicable effective dates and times. All vessels in the safety zone during the effective dates and times are subject to movement control by the PATCOM or other Official Patrol, defined as a federal, state, or local law enforcement agency on scene to assist the Coast Guard in enforcing the safety zone. During the enforcement period, if you are the operator of a vessel in one of the safety zones you must comply directions from the Patrol Commander or other Official Patrol.

In addition to this notice of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

The Coast Guard will enforce the safety zone in 33 CFR 165.801, Table 4, Line 3, for the City of Port Aransas Fourth of July Fireworks Display from 9 p.m. through 11:30 p.m. on July 4, 2021, with a rain date set for July 5, 2021 and July 6, 2021. This action is being taken to provide for the safety of persons, vessels, and the marine environment on navigable waterways during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the Port Aransas Fourth of July Fireworks Display, which encompasses portions of Corpus Christi Ship Channel, Port Aransas, TX. As reflected in §§ 165.23 and 165.801(a), if you are the operator of a vessel in the regulated area you must comply with directions from the Captain of the Port Sector Corpus Christi (COTP) or any designated representative. Persons or vessels desiring to enter the zone must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16 or by telephone at (361) 939-0450.

If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

In addition to this notice of enforcement in the Federal Register , the COTP or a designated representative will inform the public through Broadcast Notice to Mariners (BNM), Local Notices to Mariners (LNM), Marine Safety Information Broadcasts (MSIBs), and/or through other means of public notice as appropriate at least 24 hours in advance of each enforcement.

The Coast Guard will enforce the safety zones established in 33 CFR 165.1191, Table 1, Item numbers 3, 4, 7, 12, 14, and 16 during the dates, times, and locations indicated in the table below. The dates, times, and locations will also be published in the Local Notice to Mariners at least 20 days prior to the date of each event.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from anchoring, blocking, loitering, or impeding the through transit of participants or official patrol vessels in the safety zone during all applicable effective dates and times. All vessels in the safety zone during the effective dates and times are subject to movement control by the PATCOM or other Official Patrol defined as a Federal, state, or local law enforcement agency on scene to assist the Coast Guard in enforcing the safety zones. During the enforcement period, if you are the operator of a vessel in one of the safety zones you must comply with directions from the Patrol Commander or other Official Patrol.

In addition to this notice of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

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

On March 25, 2021, EPA proposed to approve a revision to the Indiana SIP to address changes to the monitoring requirements at 326 IAC 3-5-1 for Portland cement plants (86 FR 15838). An explanation of the CAA requirements, a detailed analysis of the revision, and EPA's reasons for proposing approval were provided in the notice of proposed rulemaking and will not be restated here. The public comment period for this proposed rule ended on April 26, 2021. EPA received no comments on the proposal. Therefore, we are finalizing our action as proposed.

EPA is approving revisions to 326 IAC 3-5-1, continuous monitoring requirements, into the Indiana SIP.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Indiana Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the 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. 1

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

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

• 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).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 24, 2021. 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:

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

This rule approves IEPA's January 23, 2020, submission to amend requirements applicable to certain coal-fired EGUs in the Illinois Administrative Code, also known as the MPS Rule. The background for this action is discussed in detail, and EPA's reasons for proposing approval were provided, in EPA's notice of proposed rulemaking (NPRM), dated March 8, 2021 (86 FR 13260), and will not be restated here.

In the NPRM, EPA provided a 30-day review and comment period for the proposed rule. The comment period ended on April 7, 2021. We received one comment supportive of the proposed rule and no adverse comments were received.

EPA is approving IEPA's January 23, 2020 request to revise the Illinois SIP to amend all the provisions of MPS Rule, section 225.233, except for subsections 225.233(c), (d), and (i).

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and/or at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the 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. 1

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

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

• 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).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 24, 2021. 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) of the CAA.)

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

On October 28, 2020, the EPA proposed to approve, under Clean Air Act (CAA) section 110(k)(3), and to conditionally approve, under CAA section 110(k)(4), all or portions of three submittals from the California Air Resources Board (CARB) and the Eastern Kern Air Pollution Control District (EKAPCD or “District”) as revisions to the California SIP for the Eastern Kern ozone nonattainment area. 1 The three SIP revisions include the “2017 Ozone Attainment Plan For 2008 Federal 75 ppb 8-Hour Ozone Standard” (“Eastern Kern 2017 Ozone Plan”), 2 the Eastern Kern portion of the “2018 Updates to the California State Implementation Plan” (“2018 SIP Update”), 3 and the “Transportation Conformity Budget State Implementation Plan Update for the Eastern Kern 2017 Ozone Attainment Plan” (“2020 Conformity Budget Update”). 4 Collectively, we refer to the relevant portions of the three SIP revisions as the “2017 Eastern Kern Ozone SIP,” and we refer to our October 28, 2020 proposed rule as the “proposed rule.”

In our proposed rule, we provided background information on the ozone standards, 5 area designations, related SIP revision requirements under the CAA, and the EPA's implementing regulations for the 2008 ozone standards, referred to as the 2008 Ozone SIP Requirements Rule (“2008 Ozone SRR”). To summarize, at the time of our proposed rule, the Eastern Kern ozone nonattainment area was classified as “Serious” for the 2008 ozone NAAQS, and the 2017 Eastern Kern Ozone SIP was developed to address the statutory and regulatory requirements for revisions to the SIP for the Eastern Kern Serious ozone nonattainment area. 6

In our proposed rule, we also discussed a decision issued by the D.C. Circuit Court of Appeals in South Coast Air Quality Management Dist. v. EPA (“ South Coast II” )  7 that vacated certain portions of the EPA's 2008 Ozone SRR. The only aspect of the South Coast II decision that affects this action is the vacatur of the provision in the 2008 Ozone SRR that allowed states to use an alternative baseline year for demonstrating reasonable further progress (RFP). To address this, in the 2018 SIP Update, CARB submitted an updated RFP demonstration that relied on a 2011 baseline year as required. 8

For our proposed rule, we reviewed the various SIP elements contained in the 2017 Eastern Kern Ozone SIP (other than the reasonably available control measures (RACM) demonstration or the attainment demonstration), evaluated them for compliance with statutory and regulatory requirements, and concluded that they meet all applicable requirements, except for the contingency measure requirement, for which the EPA proposed conditional approval. More specifically, in our proposal rule, we based our proposed actions on the following determinations:

• CARB and the District met all applicable procedural requirements for public notice and hearing prior to the adoption and submittal of the Eastern Kern 2017 Ozone Plan, 2018 SIP Update, and 2020 Conformity Budget Update (see 85 FR 68271 from the proposed rule);

• The 2012 base year emissions inventory from the Eastern Kern 2017 Ozone Plan is comprehensive, accurate, and current and thereby meets the requirements of CAA sections 172(c)(3) and 182(a)(1) and 40 CFR 51.1115 for the 2008 ozone NAAQS. Additionally, the future year baseline projections reflect appropriate calculation methods and the latest planning assumptions and are properly supported by the SIP-approved stationary and mobile source measures (see 85 FR 68271-68273, 68274-68276 from the proposed rule);

• The emissions statement element of the Eastern Kern 2017 Ozone Plan, including District Rule 108.2 (“Emission Statement Requirements”) meets the requirements for emissions statements under CAA section 182(a)(3)(B) and 40 CFR 51.1102 for the 2008 ozone NAAQS (see 85 FR 68273-68274 from the proposed rule);

• The 15 percent rate-of-progress (ROP) demonstration element in the Eastern Kern 2017 Ozone Plan meets the requirements of CAA section 182(b)(1) for the Eastern Kern ozone nonattainment area for the 2008 ozone NAAQS based on the previously-approved ROP demonstration for the Eastern Kern  9 1-hour ozone nonattainment area (see 85 FR 68274-68276 from the proposed rule);

• The RFP demonstration in the 2018 SIP Update, as corrected in the 2020 Conformity Budget Update, provides for emissions reductions of VOC or NO X of at least 3 percent per year on average for each three-year period from a 2011 baseline year through the attainment year and thereby meets the requirements of CAA sections 172(c)(2) and 182(c)(2)(B), and 40 CFR 51.1110(a)(2)(ii) for the 2008 ozone NAAQS (see 85 FR 68274-68276 from the proposed rule);

• The motor vehicle emissions budgets in the 2020 Conformity Budget Update for the RFP milestone/attainment year of 2020 are consistent with the RFP demonstration, are clearly identified and precisely quantified, and meet all other applicable statutory and regulatory requirements in 40 CFR 93.118(e), including the adequacy criteria in 40 CFR 93.118(e)(4) and (5) (see 85 FR 68279-68280 from the proposed rule); and

• Through previous EPA approvals of the 1993 Photochemical Assessment Monitoring Station SIP revision and the “Annual Network Plan Covering Monitoring Operations in 25 California Air Districts, July 2019” with respect to the Eastern Kern element, 10 we find that the enhanced monitoring requirements under CAA section 182(c)(1) and 40 CFR 51.1102 for Eastern Kern have been met with respect to the 2008 ozone NAAQS (see 85 FR 68280-68282 from the proposed rule). 11

In our proposed rule, in light of the Bahr decision, 12 we determined that the contingency measures element of the 2017 Eastern Kern Ozone SIP could not be fully approved without supplementation by the District and CARB. However, we also determined that the element could be conditionally approved as meeting the requirements of CAA sections 172(c)(9) and 182(c)(9) for the 2008 ozone NAAQS, based upon commitments by the District  13 and CARB  14 to supplement the element through submission, as a SIP revision (within one year of our final conditional approval action), of a revised District rule or rules that would add new limits or other requirements if an RFP milestone is not met or if Eastern Kern fails to attain the 2008 ozone NAAQS by the applicable attainment date. See 85 FR 68276-68279 from the proposed rule.

Please see our proposed rule for more information concerning the background for this action and for a more detailed discussion of the rationale for approval or conditional approval of the above-listed elements of the 2017 Eastern Kern Ozone SIP.

The public comment period on the proposed rule opened on October 28, 2020, the date of its publication in the Federal Register , and closed on November 27, 2020. During this period, the EPA received one comment letter submitted by Air Law for All on behalf of the Center for Biological Diversity (referred to herein as “CBD” or “commenter”). We address CBD's comments in the following paragraphs of this final rule.

Comment #1: Citing certain statutory provisions and selected excerpts from the EPA's implementation rules for the 1997 and 2008 ozone NAAQS, CBD asserts that, for Serious areas, the RFP demonstration must meet both the general RFP requirements in section 172(c)(2) that are tied to attainment of the ozone standards and the specific RFP requirements in section 182(c)(2)(B) for reductions in emissions of VOCs from baseline emissions. In short, CBD contends that the RFP “targets” cannot be severed from the attainment demonstration and control strategy and independently approved, and because the EPA has not proposed to approve an attainment demonstration and control strategy for the Eastern Kern nonattainment area, there is no basis to conclude that the RFP demonstration in the 2017 Eastern Kern Ozone SIP meets the general RFP requirements in section 172(c)(2).

Response to Comment #1: As CBD notes, Serious ozone nonattainment areas are subject to both the general requirements for nonattainment plans in subpart 1, and the specific requirements for ozone areas in subpart 2, including the requirements related to RFP and attainment. This is consistent with the structure of the CAA as modified under the 1990 amendments, which introduced additional subparts to part D of title I of the CAA to address requirements for specific NAAQS pollutants, including ozone (subpart 2), carbon monoxide (CO) (subpart 3), particulate matter (subpart 4), and sulfur oxides, nitrogen dioxide, and lead (subpart 5).

These subparts apply tailored requirements for these pollutants, including those based on an area's designation and classification, in addition to and often in place of the generally applicable provisions retained in subpart 1. While CAA section 172(c)(2) of subpart 1 states only that nonattainment plans “shall require reasonable further progress,” CAA sections 182(b)(1) and 182(c)(2)(B) of subpart 2 provide specific percent reduction targets for ozone nonattainment areas to meet the RFP requirement. Put another way, subpart 2 further defines RFP for ozone nonattainment areas by specifying the incremental amount of emissions reduction required by set dates for those areas. 15 For Moderate ozone nonattainment areas, CAA section 182(b)(1) defines RFP by setting a specific 15% VOC reduction requirement over the first six years of the plan. For Serious and above ozone nonattainment areas, CAA section 182(c)(2)(B) defines RFP by setting specific annual percent reductions for the period following the first six-year period and allows averaging over a 3-year period. With respect to the 1-hour ozone NAAQS, the EPA stated that, by meeting the specific percent reduction requirements in CAA sections 182(b)(1) and 182(c)(2)(B), the State will also satisfy the general RFP requirements of section 172(c)(2) for the time period discussed. 16

We agree with CBD that the EPA has adapted the RFP requirements under the CAA to implement the three 8-hour-average ozone NAAQS that have been promulgated since the 1990 CAA Amendments. In the “Phase 2” SIP Requirements Rule  17 for the 1997 Ozone NAAQS (“Phase 2 rule”), the Agency adapted the RFP requirements of CAA sections 172(c)(2) and 182(a)(1) so as to require plans to provide for the minimum required percent reductions and, for certain Moderate areas, to provide for the reductions as necessary for attainment. See, e.g., 40 CFR 51.910(a)(1)(ii)(A) and (b)(2)(ii)(C).

In 2015, the EPA replaced the regulations promulgated through the Phase 2 rule with the regulations promulgated through the 2008 Ozone SIP Requirements Rule (SRR). 18 In the 2008 Ozone SRR, the EPA established RFP requirements for the 2008 ozone NAAQS that are similar, in most respects, to those in the Phase 2 rule for the 1997 ozone NAAQS but that do not carry forward the aspect of the RFP requirement for the 1997 ozone NAAQS that defined RFP for certain years for certain Moderate areas in terms of the reductions needed for attainment. 19 More explicitly, in the 2008 Ozone SRR, the EPA defined RFP as meaning both the “emissions reductions required under CAA section 172(c)(2) which the EPA interprets to be an average 3 percent per year emissions reductions of either VOC or NO X and CAA sections 182(c)(2)(B) and (c)(2)(C) and the 15 percent reductions over the first six years of the plan and the following three percent per year average under 40 CFR 51.1110.”  20 (emphasis added). Thus, under the 2008 Ozone SRR, the RFP emissions reductions required for Serious and above ozone nonattainment areas under CAA section 172(c)(2) are based on a set annual percentage found in the CAA, not on the specific attainment needs for the area. In this regard, we have been even more explicit in our SRR for the 2015 ozone NAAQS:  21 “Reasonable further progress (RFP) means the emissions reductions required under CAA sections 172(c)(2), 182(c)(2)(B), 182(c)(2)(C), and § 51.1310. The EPA interprets RFP under CAA section 172(c)(2) to be an average 3 percent per year emissions reduction of either VOC or NO X. ”  22

In the 2008 Ozone SRR, which is the set of regulations that governs the EPA's action here, RFP is defined in terms of percent reduction requirements, not in terms of the reductions necessary for attainment. In other words, for the 2008 ozone NAAQS, the RFP “targets” represent the minimum progress that is required under the CAA and our regulations, not necessarily all of the reductions necessary to achieve attainment of the ozone NAAQS, which could vary largely from one nonattainment area to another.

Eastern Kern is a Serious nonattainment area for the 2008 ozone NAAQS, and the RFP demonstration in the 2017 Eastern Kern Ozone SIP was developed to meet the applicable requirements of the CAA and our 2008 Ozone SRR, not the Phase 2 rule for the 1997 ozone NAAQS. Specifically, we reviewed the RFP demonstration in the 2017 Eastern Kern Ozone SIP for compliance with the requirements under 40 CFR 51.1110(a)(2)(i), which adapts the requirements under CAA sections 172(c)(2) and 182(b)(1) for Moderate areas, and 40 CFR 51.1110(a)(2)(ii), which adapts the requirements of CAA section 182(c)(2)(B) for Serious areas. 23 The requirements under 40 CFR 51.1110(a)(2)(i) and 40 CFR 51.1110(a)(2)(ii) are cumulative and, together, they require a 15 percent emission reduction from the baseline year within 6 years after the baseline year and an average emissions reduction of 3 percent per year for all remaining 3-year periods after the first 6-year period until the year of the area's attainment date. As explained further in our proposed rule, based on our evaluation, we found that the 2017 Eastern Kern Ozone SIP provided for the percent reductions required under the 2008 Ozone SRR. 24

Importantly, under the 2008 Ozone SRR, the RFP demonstration for the 2008 ozone NAAQS does not need to provide for the reductions needed for attainment. Thus, contrary to CBD's assertion, the RFP demonstration for Eastern Kern can be severed from the attainment demonstration and control strategy and can be independently approved, and we do so in this final rule by taking final action to approve the RFP demonstration in the 2017 Eastern Kern Ozone SIP while deferring action on the attainment demonstration.

Comment #2: CBD comments that the submittal fails to show that the substitute NO X emissions reductions will “result in a reduction in ozone concentrations at least equivalent” to the required three percent per annum VOC emissions reductions, and as a result, the EPA's proposed approval of the RFP demonstration is arbitrary and capricious.

The commenter describes the relative roles of VOC and NO X in ozone formation, including the existence of an “optimum” VOC to NO X ratio for a given level of VOC ( i.e., a NO X concentration at which the maximum amount of ozone is produced). As explained by the commenter, in a “NO X saturated” situation where NO X levels exceed this optimum ratio, a reduction in NO X emissions can lead to increases in ozone levels, whereas in a “NO X limited” situation with NO X levels below the optimum ratio, a reduction in NO X emissions decreases ozone levels. The commenter quotes the EPA's report to Congress as including, “ozone response to precursor control can vary greatly with each area” and “the relative effectiveness of controls of volatile organic compounds (VOCs) and oxides of nitrogen (NO X ) in ozone abatement varies widely.”  25 The commenter argues that language in the CAA, including CAA sections 185B, 182(f), and 182(c)(2)(C), indicates that Congress was aware of the issue of the relative roles of NO X and VOC in ozone formation, including that in some scenarios NO X reductions may actually increase ozone concentrations or at least not help to reduce ozone concentrations.

The commenter then points to the EPA's consideration of the relative effectiveness of NO X and VOC controls for interpollutant offset trading under the new source review (NSR) permitting program and in applying requirements for major stationary sources of VOC to NO X sources under CAA section 182(f), noting that in these situations EPA guidance indicates that photochemical grid modeling of multiple scenarios should be conducted to support demonstrations related to the relative effectiveness of controls. Through comparison of the contexts of these guidance documents, which recommended photochemical modeling, and that of section 182(c)(2)(C), the commenter suggests that the 2017 Eastern Kern Ozone SIP should have included similar photochemical grid modeling to determine whether the substitute NO X emission reductions result in equivalent ozone reductions.

Response to Comment #2: In general, we agree with the commenter's descriptions of the relative roles of VOC and NO X in ozone formation and geographic differences in the ozone response to precursor control, depending on whether an area is “NO X -saturated” or “NO X -limited.” We also agree with the commenter that Congress was aware of these issues and provided for the EPA to address them under provisions of the CAA.

However, we disagree with the commenter's characterization of the 2017 Eastern Kern Ozone SIP and the EPA's proposed approval. While the preamble of the EPA's proposed approval did not provide an analysis showing that NO X substitution would “result in a reduction in ozone concentrations at least equivalent” to the required VOC emissions reductions needed for RFP, the supporting documentation in the docket for the proposed approval, as further clarified in our response to comments herein, provides such analysis. As described below, we find that the analysis included with the modeling and control strategy in the 2017 Eastern Kern Ozone SIP adequately demonstrates that annual and cumulative NO X reductions in Eastern Kern will result in a reduction in ozone concentrations that is at least equivalent to the ozone reductions that would be achieved by VOC emission reductions alone. We therefore agree with the use of NO X substitution in the RFP demonstration for Eastern Kern.

Under CAA section 182(c)(2)(B), the RFP demonstration for a Serious ozone nonattainment area will demonstrate RFP based solely on the prescribed annual rate of VOC emission reductions. Alternatively, under CAA section 182(c)(2)(C), the demonstration may satisfy the RFP requirement based on a combination of VOC and NO X reductions if it demonstrates that reductions of VOC and NO X would result in a reduction in ozone concentrations at least equivalent to that which would result from the amount of VOC emission reductions otherwise required. For Eastern Kern, the RFP demonstration for milestone years 2017 and 2020 both rely on a combination of VOC reductions and NO X reductions from the RFP baseline year of 2011.

The revised RFP demonstration in the 2018 SIP Update, as corrected in the 2020 Conformity Budget Update, shows the extent to which the area is relying on NO X emissions reductions to substitute for otherwise-required VOC reductions in milestone years 2017 and 2020. For milestone year 2017, the RFP demonstration relies on a combination of 1.4 tons per day (tpd) VOC reductions and 0.4 tpd NO X reductions from the 2011 RFP baseline year rather than the otherwise-required VOC reductions of 1.6 tpd. That is, 0.4 tpd of NO X reductions substitutes for 0.2 tpd of VOC reductions otherwise required, which represents a 2:1 ratio for substitution of NO X for VOC in RFP milestone year 2017. This substitution of NO X reductions for VOC reductions is acceptable under CAA section 182(c)(2)(C) so long as the ozone concentration reductions from 2011 to 2017 in Eastern Kern under the combined VOC/NO X emissions reduction scenario are at least equivalent to that which would result under the VOC-only reduction scenario.

The same applies to milestone year 2020. For that year, the RFP demonstration relies on a combination of 1.5 tpd VOC reductions and 3.1 tpd NO X reductions from the 2011 RFP baseline year rather than the otherwise-required VOC reductions of 2.3 tpd. That is, 3.1 tpd of NO X reductions substitutes for 0.8 tpd of VOC reductions otherwise required, which means that NO X is substituted for VOC in RFP milestone year 2020 at roughly a 4:1 ratio. Again, this substitution of NO X reductions for VOC reductions is acceptable under CAA section 182(c)(2)(C) so long as the ozone concentration reductions from 2011 to 2020 in Eastern Kern under the combined VOC/NO X emissions reduction scenario are at least equivalent to that which would result under the VOC-only reduction scenario.

The 2017 Eastern Kern Ozone SIP contains a demonstration supporting the use of NO X substitution in the Eastern Kern nonattainment area. This is based on evidence that the Eastern Kern nonattainment area is NO X -limited, and also on evidence that NO X reductions are more effective at reducing ozone than VOC reductions alone. In this notice, we use “NO X -limited” as meaning a situation where reducing NO X emissions decreases ozone, not that it is more effective than reducing VOC. Elsewhere, including in the 2017 Eastern Kern Ozone SIP, the term “NO X -limited” is sometimes used to mean the condition where NO X reductions are more effective than VOC reductions at decreasing ozone.

Evidence that the Eastern Kern nonattainment area is NO X -limited is presented in Figure 14 in Appendix F of the Eastern Kern 2017 Ozone Plan. Figure 14 and the explanatory text document weekday and weekend monitored ozone data at the Mojave monitoring site from 2000-2015. 26 The results show that in nearly all years, weekdays with their higher NO X emissions have increased ozone, while weekends with their lower NO X , have decreased ozone. Figure 14 includes a 1:1 line on which weekday and weekend ozone are the same. 27 Of the sixteen years examined, thirteen are above the 1:1 line, indicating higher weekday ozone and NO X -limited ozone formation. All years after 2007 are above the 1:1 line. The three years ( i.e., 2001, 2003, and 2007) below the 1:1 line indicate slightly higher ozone from reducing NO X . However, all three of those years are in the “transitional” regime close to the 1:1 line; this indicates the three years have only a weak ozone response to NO X reductions, as opposed to a disbenefit. This data analysis is strong evidence that ozone formation is NO X -limited in the Eastern Kern nonattainment area.

The Eastern Kern 2017 Ozone Plan also included photochemical modeling results reflecting base year (2012) emissions and meteorology. The weekday-weekend analysis discussed above was repeated for modeled concentrations, which were found to be “NO X -limited.”  28 The degree of NO X -limitation, that is the response of ozone to NO X emissions reductions, was found to be comparable to and somewhat greater than that in the ambient data. Given the Eastern Kern 2017 Ozone Plan's usage of the term “NO X -limited,” the photochemical modeling also indicates that NO X reductions are more effective than VOC at reducing ozone. 29

Throughout this document, the terms “we,” “us” and “our” refer to the EPA.

On February 22, 2021, the EPA proposed to approve the following rules into the MCAQMD portion of the California SIP. 1

The EPA previously finalized a limited approval and limited disapproval of Rule 1-220 on July 3, 2017. 2 We listed the following two deficiencies in our final limited approval and limited disapproval of Rule 1-220:

• Rule 1-220 does not contain any provisions specifying that required air quality modeling shall be based on the applicable models, databases, and other requirements specified in part 51 Appendix W; therefore, the requirements of 40 CFR 51.160(f) and 51.166(l) have not been met.

• The requirements of 40 CFR 51.166(r)(2)  3 have not been met because the rule does not include the necessary information about a source's obligations.

The District resolved the first deficiency by adding the required air quality modeling provisions to Rule 1-220 and addressed the second deficiency by revising Rule 1-230 to include information about a source's obligations under the CAA. We have determined that the amended sections of these rules satisfy the statutory and regulatory requirements for a PSD program as set forth in the applicable provisions of part C of title I of the Act and in 40 CFR 51.160-51.164 and 51.166.

Our proposed action contains more information on the rules and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received one comment, which is included in the docket for this action. We do not consider this comment to be germane or relevant to this action, thus this comment is not adverse to this action. Moreover, the comment lacks the required specificity to the proposed SIP revisions and the relevant CAA requirements, and does not address the specific regulations or provisions in question, or recommend an action on the SIP submission different from what the EPA proposed. Therefore, we are finalizing our action as proposed.

No comments were submitted that change our assessment of the rules as described in our proposed action. We continue to find that MCAQMD Rules 1-220 and 1-230 correct the previously identified deficiencies and fulfill all relevant CAA requirements. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving these rules into the MCAQMD portion of the California SIP. The April 7, 2020 versions of Rules 1-220 and 1-230 will replace the previously approved versions of the rules in the SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the MCAQMD rules described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through https://www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

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

• 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The 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 August 24, 2021. 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 CAA section 307(b)(2).)

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document “we,” “us,” and “our” refer to EPA.

The EPA is amending Nebraska's SIP to include revisions to title 129 of the Nebraska Administrative Code. The EPA is approving revisions to the Nebraska SIP received on July 16, 2020. Specifically, the EPA is amending the Nebraska SIP by removing a portion of the SIP as follows: Title 129. Chapter 39. Visible Emissions from Diesel-powered Motor Vehicles. EPA is approving these revisions as they do not substantively change any existing statutory or regulatory requirement. These revisions do not impact the stringency of the SIP or air quality. The EPA solicited comments on the proposed revision to Nebraska's SIP, and received no comments.

The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice of the SIP revision from September 28, 2019, to November 6, 2019, and held a public hearing on November 7, 2019. In a letter to the state dated November 7, 2019, the EPA stated that the agency “has no comment on the proposed repeal of this regulation.” EPA further recommended that NDEE include a justification that the rule is redundant to state statute. The SIP revision meets the substantive requirements of the CAA, including section 110 and implementing regulations.

The EPA is taking final action to amend the Nebraska SIP by approving the State's request to remove Title 129 section 39. Visible Emissions from Diesel-powered Vehicles. The removal of this portion of the SIP will ensure consistency between state and federally-approved rules. The EPA has determined that these changes will not adversely impact air quality because the regulation duplicates the State's statute, which applies in the same jurisdiction.

In this document, the EPA is amending regulatory text that includes incorporation by reference. As described in the amendments to 40 CFR part 52 set forth below, the EPA is removing provisions of the EPA-Approved Nebraska Regulations from the Nebraska State Implementation Plan, which is incorporated by reference in accordance with the requirements of 1 CFR part 51.

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

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

• 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 the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 24, 2021. 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, the EPA amends 40 CFR part 52 as set forth below:

Throughout this document, “we,” “us” and “our” refer to the EPA.

On February 25, 2021 (86 FR 11482), the EPA proposed to approve the following rule into the California SIP.

We proposed to approve this amended rule based on our finding that it is consistent with the relevant requirements, policy, and guidance regarding SIP relaxations because the rule revisions only clarify and extend the applicability of the rule to certain additional development projects. This revision strengthens the current SIP-approved rule. Once approved into the SIP, Rule 9510 will become federally enforceable under the CAA by its terms only for certain development projects within the geographic jurisdiction covered by the SJVUAPCD. However, as explained in our February 25, 2021 proposed rule, we continue to conclude that the rule is not fully consistent with the relevant requirements, policy, and guidance on enforceability such that the State may rely on the rule for specific emissions credit in an attainment plan. While Rule 9510 does not meet all the evaluation criteria for full enforceability such that emissions credit can be taken, we proposed to fully approve the submitted rule because it would strengthen the SIP compared to the current SIP-approved rule. Our proposed action contains more information on the rule and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received four comments on the proposal. One comment expresses general support for the proposed action. The three other comments are essentially the same comment, with minor variations in wording, for which we provide a summary and response below.

Comment: Three comments stated that the rules “should be strengthened to a tolerable criteria for further enforceability” before being approved.

Response: As this version of Rule 9510 would be enforceable on its terms once approved into the SIP, we are assuming that the comments are referring to amended Rule 9510 being “fully enforceable,” such that the State may rely on it for emissions credit. Regarding whether amended Rule 9510 is “fully enforceable,” we disagree that the State needs to resolve enforceability issues identified in our proposal before we can approve it into the SIP. As described in our proposal, we previously approved an earlier version of this rule on May 9, 2011 (76 FR 26609) where “we identified a number of concerns about the enforceability of the rule's provisions, e.g., provisions that allow project developers to pay a fee instead of implementing on-site pollution mitigation plans, and noted that the State would need to resolve these enforceability issues before relying on this rule for credit in an attainment plan.”  1 We noted that “[t]he District has not addressed these concerns in the submitted rule, and we therefore continue to conclude that the rule does not qualify for emission reduction credit for the purpose of any attainment or progress demonstration in any area.”  2 In the amended version of Rule 9510 that we are approving herein, “the District revised the rule applicability to include large development projects that are not currently subject to the rule and made editorial and clarifying changes. The revisions are generally clear and strengthen the rule.”  3 While this revision of Rule 9510 would continue to not meet all the evaluation criteria for full enforceability such that the rule would qualify for emission reduction credit, it would strengthen the SIP compared to the current SIP-approved rule and therefore warrants approval into the SIP.

No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP. The December 21, 2017 version of Rule 9510 will replace the previously-approved version of this rule in the SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the SJVUAPCD rule described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

• 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, this rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The 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 August 24, 2021. 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, the EPA amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:

Throughout this document “we,” “us,” and “our” refer to the EPA.

EPA is approving a submission from the State of Iowa to revise its SIP and the Operating Permits Program. On August 12, 2020, the Iowa Department of Natural Resources (IDNR) submitted a request to revise the SIP to incorporate recent changes to Iowa Administrative Code, including provisions relating to electronic submittal of information to IDNR that were revised in previous state rulemakings. The following chapters are impacted:

• Chapter 20, “Scope of Title—Definitions;”

• Chapter 22, “Controlling Pollution;”

• Chapter 23, “Emission Standards for Contaminants;”

• Chapter 25, “Measurement of Emissions;” and

• Chapter 33, “Special Regulations and Construction Permit Requirements for Major Stationary Sources—Prevention of Significant Deterioration (PSD) of Air Quality.”

The revision includes a request for EPA to approve references in Chapter 22 to allow for electronic submittal of air quality permit applications, streamlined alternatives to traditional applications, such as registrations, notifications, and template applications, construction permit applications, acid rain permit applications, notifications, emissions inventory, certifications, determination requests, fees, forms, and payments.

The revision includes the new definitions of “electronic format”, “electronic submittal”, and “electronic submittal format”. The revisions also update the construction permit application provisions to specify the types of submittals that may be included in an electronic submittal option, updates methods and procedures for stack sampling and associated analytical methods, updates the definition of “volatile organic compounds” for prevention of significant deterioration (PSD) and updates the applicability of the PSD rule to construction of any new “major stationary source”. The specific changes and EPA analysis are discussed in more detail the proposed rule included in the docket for this action.

The EPA solicited comments on the proposed revision to Iowa's SIP, and did not receive any comments.

The August 12, 2020 submission met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The State held a public comment period from March 11 to April 13, 2020, with a public hearing on April 13, 2020. No public comments were received.

The items related to electronic submittal of permit applications and emissions inventories, were placed on public notice at various dates specified above. The supporting documentation has been included in the docket. The only comment made specifically regarding the language pertaining to Iowa's electronic document receiving system was made by EPA and was resolved by EPA's approval of Iowa's electronic document receiving systems pursuant to CROMERR requirements.

The above submittals satisfy the completeness criteria of 40 CFR part 51, appendix V. In addition, these revisions meet the substantive SIP requirements of the CAA, including section 110 and implementing regulations. Finally, the revisions are also consistent with applicable EPA requirements of Title V of the CAA and 40 CFR part 70.

The EPA is taking final action to approve revisions to the Iowa SIP and the Operating Permits Program. The revisions update the definitions of “EPA Reference Method” and “volatile organic compounds”, updates the definitions to adopt the most current EPA methods for measuring air pollutant emissions, performance testing, and continuous monitoring, and to reflect changes EPA has made to the definitions. The revisions also add regulatory cross-references, and define “electronic format,” “electronic submittal,” and “electronic submittal format” to facilitate the Department's launch of EASY Air, a new online electronic method for submitting air quality permit applications.

EPA has determined that approval of these revisions will not impact air quality and will ensure consistency between the state and federally-approved rules, and ensure Federal enforceability of the state's revised air program rules.

In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Iowa Regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 7 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Therefore, these materials have been approved by the EPA for inclusion in the State Implementation Plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

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

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

• 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 the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

• Does not provide the 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 the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The 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 August 24, 2021. 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, the EPA amends 40 CFR parts 52 and 70 as set forth below:

Throughout this document “we,” “us,” and “our” means the EPA.

The background for this action is discussed in detail in our April 19, 2021 proposal (86 FR 20353). In that document, we proposed to approve the LMP for the Butte NAA and the State's request to redesignate the Butte NAA from nonattainment to attainment for the 1987 24-hour PM 10 NAAQS. Additionally, we proposed to determine that the Butte NAA has attained the NAAQS for PM 10 . That determination was based upon monitored air quality data for the PM 10 NAAQS during the years 2014 through 2018. Finally, in our April 19, 2021 proposal, EPA proposed to approve the Butte LMP as meeting the appropriate transportation conformity requirements found in 40 CFR part 93, subpart A.

The public comment period on the EPA's proposed rule opened on April 19, 2021, the date of its publication in the Federal Register (86 FR 20353) and closed on May 19, 2021. During this time, the EPA received two comments, both in support of this action and neither require response to comment.

For the reasons explained in our proposed action, we are approving the LMP for the Butte NAA and the State's request to redesignate the Butte NAA from nonattainment to attainment for the 1987 24-hour PM 10 NAAQS. Additionally, the EPA is determining that the Butte NAA has attained the NAAQS for PM 10 . This determination is based upon monitored air quality data for the PM 10 NAAQS during the years 2014 through 2018. The EPA is approving that the Butte LMP as meeting the appropriate transportation conformity requirements found in 40 CFR part 93, subpart A.

In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the EPA is finalizing the incorporation by reference of maintenance plans for the Butte PM 10 NAA and the Governor of Montana's redesignation requests for the Butte PM 10 NAAs to attainment. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 8 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the State implementation plan, have been incorporated by reference by the 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 the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

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

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

• 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, 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).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 24, 2021. 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)).

40 CFR parts 52 and 81 are amended as follows:

The Commission made a submission for non-substantive changes to an existing collection for review and approval by OMB, as required by the Paperwork Reduction Act (PRA) of 1995, on June 7, 2021, which were approved by the OMB on June 8, 2021. The information collection requirements are contained in the Commission's Category Two Order, FCC 19-117, published at 84 FR 70026, December 20, 2019. The OMB Control Number is 3060-0853. The Commission publishes this document as an announcement of the effective date of the rules published December 20, 2019. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, 45 L St., NE, Washington, DC 20554. Please include the OMB Control Number, 3060-0853, in your correspondence. We ask that requests for accommodations be made as soon as possible in order to allow the agency to satisfy such requests whenever possible. Send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received OMB approval on June 8, 2021, for the information collection requirements contained in 47 CFR 54.513(d), published at 84 FR 70026, December 20, 2019. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0853.

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

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

OMB Control Number: 3060-0853. OMB Approval Date: June 8, 2021.

OMB Expiration Date: December 31, 2022.

Title: Certification by Administrative Authority to Billed Entity Compliance with the Children's internet Protection Act Form, FCC Form 479; Receipt of Service Confirmation and Certification of Compliance with the Children's internet Protection Act Form, FCC Form 486; and Funding Commitment and Adjustment Request Form, FCC Form 500.

Form Numbers: FCC Forms 479, 486 and 500.

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

Number of Respondents and Responses: 58,500 respondents, 58,500 responses.

Estimated Time per Response: 1 hour for FCC Form 479, 1 hour for FCC Form 486, 1 hour for FCC Form 500, and .75 hours for maintaining and updating the internet Safety Policy.

Frequency of Response: On occasion and annual reporting requirements, recordkeeping requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 1, 4(i), 4(j), 201-205, 214, 254, 312(d), 312(f), 403 and 503(b) of the Communications Act of 1934, as amended. 5 U.S.C. 553(b)(3), 601-612; 15 U.S.C. 1, 632; 44 U.S.C. 3506(c)(4); 47 U.S.C. 1, 4(i), 4(j), 201-205, 214, 254, 312(d), 312(f), 403, 503(b).

Total Annual Burden: 53,575 hours.

Total Annual Cost: No cost.

Nature and Extent of Confidentiality: There is no assurance of confidentiality provided to respondents concerning this information collection. However, respondents may request materials or information submitted to the Commission or the Administrator be withheld from public inspection under 47 CFR 0.459 of the FCC's rules.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: The requirements contained herein are necessary to implement the Congressional mandate for universal service. It provides the Commission and USAC with the necessary information to administer the E-Rate program, determine the amount of support entities seeking funding are eligible to receive, to determine if entities are complying with the Commission's rules, and to prevent waste, fraud, and abuse. The information will also allow the Commission to evaluate the extent to which the E-Rate program is meeting the statutory objectives specified in section 254 of the 1996 Act, the Commission's own performance goals set in the 2014 First E-Rate Order, and to evaluate the need and feasibility for any future revisions to program rules.

Further, the purpose of this information is to ensure that schools and libraries that are eligible to receive discounted internet Access services (Category One), and Broadband Internal Connections, Managed Internal Broadband Services, and Basic Maintenance of Broadband Internal Connections (Basic Maintenance) (known together as Category Two Services) have in place internet safety policies. Schools and libraries receiving these services must certify, by completing a FCC Form 486 (Receipt of Service Confirmation and Certification of Compliance with the Children's internet Protection Act), that respondents are enforcing a policy of internet safety and enforcing the operation of a technology prevention measure. Also, respondents who received a Funding Commitment Decision Letter indicating services eligible for universal service funding must file FCC Form 486 to indicate their service start date and to start the payment process. In addition, all members of a consortium must submit signed certifications to the Billed Entity of their consortium using a FCC Form 479; Certification by Administrative Authority to Billed Entity of Compliance with Children's internet Protection Act, in language consistent with the certifications adopted for the FCC Form 486.

Consortia must, in turn, certify collection of the FCC Forms 479 on the FCC Form 486. FCC Form 500 is used by E-rate participants to make adjustments to previously filed forms, such as changing the contract expiration date filed with the FCC Form 471, changing the funding year service start date filed with the FCC Form 486, cancelling or reducing the amount of funding commitments, requesting extensions of the deadline for nonrecurring services, and notifying USAC of equipment transfers.

The proposed rule was published at 86 FR 21258 on April 23, 2021. The Petitioner filed comments in support of the petition, as required by the Commission's rules, reaffirming its commitment to apply for channel 9 and if authorized, to build a station promptly. No other comments were filed. We believe the public interest would be served by allotting channel 9 at Freeport, Illinois. Freeport (pop. 25,638) is the county seat and largest city in Stephenson County, and clearly qualifies for community of license status for allotment purposes. In addition, the proposal would result in a first local service to Freeport; channel 41 at Freeport will be deleted since WIFR(TV), which previously occupied the channel, submitted a winning bid to go off the air in the broadcast television incentive auction and subsequently suspended operations. Moreover, the allotment is consistent with the minimum geographic spacing requirements for new DTV allotments in the Commission's rules, and the allotment point complies with the rules as the entire community of Freeport is encompassed by the 43 dBμ contour.

This is a synopsis of the Commission's Report and Order, MB Docket No. 21-152; RM-11899; DA 21-701, adopted June 16, 2021, and released June 16, 2021. The full text of this document is available for download at https://www.fcc.gov/edocs. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

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

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

In FR Doc. 2021-12049, published in the Federal Register of June 16, 2021, appearing on page 31954, the following corrections are made:

1. On page 31954, in the third column, correct the SUMMARY caption to read:

2. On page 31955, in the first column, correct the FOR FURTHER INFORMATION CONTACT caption to read:

At the request of the Mid-Atlantic Fishery Management Council, NMFS published a final rule on December 21, 2020 (85 FR 82944) that implemented emergency action for the Tilefish Fishery Management Plan (FMP) to allow a one-time carryover of unharvested Individual Fishing Quota (IFQ) from fishing year 2020 to 2021, up to 5 percent of the original 2020 allocation. A proposed rule for this action was published on November 13, 2020 (85 FR 72616) with a comment period through November 30, 2020. No comments were received on the emergency action.

The tilefish IFQ program does not normally allow any carryover of unharvested allocation from one fishing year into the next. Unforeseen changes in the market for seafood resulting from the COVID-19 pandemic, particularly the loss of restaurant sales due to local closure orders, substantially reduced demand for golden tilefish during the 2020 fishing year. Because of this unprecedented impact on the fishery, we implemented this one-time carry over under our emergency rulemaking authority specified in section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act.

This action extends this emergency action past the current expiration date of June 19, 2021, until the start of the next golden tilefish fishing year on November 1, 2021. This will allow tilefish IFQ quota shareholders who have not yet had an opportunity to harvest the IFQ pounds they carried over additional time to take full advantage of this opportunity.

Each IFQ quota shareholder was eligible to carry over 2020 golden tilefish quota pounds that were not harvested before the end of the 2020 fishing year, up to a maximum amount of 5 percent of their initial 2020 quota pounds. Of the 10 entities that hold quota share in the golden tilefish IFQ program, 5 had unharvested quota pounds at the end of the 2020 fishing year and were able to carry over some of those quota pounds into the 2021 fishing year. Some quota shareholders have already harvested their carryover while others have not yet taken full advantage of this opportunity. Extending this emergency action ensures that all those who received carryover are able to fully benefit from these measures.

NMFS's policy guidelines for the use of emergency rules (62 FR 44421; August 21, 1997) specify the following three criteria that define what an emergency situation is, and justification for final rulemaking: (1) The emergency results from recent, unforeseen events or recently discovered circumstances; (2) the emergency presents serious conservation or management problems in the fishery; and (3) the emergency can be addressed through emergency regulations for which the immediate benefits outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rulemaking process. NMFS's policy guidelines further provide that emergency action is justified for certain situations where emergency action would prevent significant direct economic loss, or to preserve a significant economic opportunity that otherwise might be foregone. As noted in the December 21, 2020, final rule, NMFS has determined that allowing the carryover of unharvested tilefish IFQ quota pounds as described above meets the three criteria for emergency action.

Section 305(c) of the Magnuson-Stevens Act specifies that emergency regulations may only remain in effect for 180 days from the date of publication and may be extended for one additional period of not more than 186 days. Extending this action until the start of the next fishing year on November 1, 2021, would only be 135 days.

NMFS is issuing this temporary rule pursuant to section 305(c) of the Magnuson Stevens Act, which authorizes NMFS to implement regulations at the request of the Council to address an emergency in the fishery. The Acting Assistant Administrator Fisheries, NOAA has determined that this rule is consistent with the Tilefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

Pursuant to 5 U.S.C. 553(d)(3), the Acting Assistant Administrator Fisheries, NOAA finds good cause to waive the 30-day delay in effectiveness for this rule. This rule extends some measures of the rule currently in place through the end of the current fishing year. The need for this extension was fully anticipated and announced to the public in the initial emergency rule which published on December 21, 2020. Accordingly, the entities affected by this rule and the public have no need to be made aware of or adjust to this rule by delaying its effectiveness for 30 days. The primary reason for delaying the effectiveness of Federal regulations is not present, and, therefore, such a delay would serve no public purpose. It would be contrary to the public interest if the emergency measures are allowed to expire on June 19, 2021, because tilefish IFQ quota shareholders could lose any remaining carryover granted by this emergency action. Moreover, allowing the emergency measures to lapse between June 19, 2021, and a later effective date of this extension may lead to confusion in the fishing community. For these reasons, there is good cause to waive the requirement for delayed effectiveness.

The December 21, 2020, final rule that implemented the emergency action was determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

On November 20, 2019, pursuant to section 304(a)(3) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), NMFS approved the Omnibus Deep-Sea Coral Amendment in its entirety as recommended by the New England Fishery Management Council. The Council developed this action, and the measures described in this rule, under the discretionary provisions for deep-sea coral protection in section 303(b) of the Magnuson-Stevens Act. This provision gives the Regional Fishery Management Councils the authority to:

(A) Designate zones where, and periods when, fishing shall be limited, or shall not be permitted, or shall be permitted only by specified types of fishing vessels or with specified types and quantities of fishing gear; and

(B) Designate such zones in areas where deep-sea corals are identified under section 408 (this section describes the deep-sea coral research and technology program), to protect deep-sea corals from physical damage from fishing gear or to prevent loss or damage to such fishing gear from interactions with deep-sea corals, after considering long-term sustainable uses of fishery resources in such areas.

This final rule implements the Amendment, which prohibits the use of all bottom-tending gear (with an exception for red crab pots) along the outer continental shelf in waters no shallower than 600 m to the Exclusive Economic Zone (EEZ) and prohibits the use of bottom-tending mobile gear in two areas in the Gulf of Maine (Mount Desert Rock and Outer Schoodic Ridge). In addition, this action creates a dedicated habitat research area in Jordan Basin but does not impose any additional restrictions on fishing in this area. This action also establishes provisions for vessels transiting through these areas and adds framework provisions for future modifications to the New England Deep-Sea Coral Protection Area measures. The Magnuson-Stevens Act requires NMFS to approve, partially approve, or disapprove measures proposed by the Council based on whether the measures are consistent with fishery management plans (FMP), the Magnuson-Stevens Act and its National Standards, and other applicable law.

NMFS published a Notice of Availability (NOA) announcing its review of the Amendment on August 26, 2019 (84 FR 44596). The public comment period on the NOA ended on October 25, 2019. Following the Amendment's approval in November 2019, NMFS published a proposed rule for this action on January 3, 2020, including implementing regulations (85 FR 285). The public comment period on the proposed rule ended on February 18, 2020.

The Omnibus Deep-Sea Coral Amendment establishes a deep-sea coral protection area on the outer continental shelf in New England waters. It complements the Frank R. Lautenberg Deep-Sea Coral Protection Area established by the Mid-Atlantic Fishery Management Council in Amendment 16 to the Atlantic Mackerel, Squid, and Butterfish FMP (81 FR 90246; December 14, 2016) as described in § 648.372. The Georges Bank Deep-Sea Coral Protection Area runs along the outer continental shelf in waters no shallower than 600 meters (m) and extends to the outer limit of the EEZ boundary to the east and north, and south to the inter-council boundary as described in § 600.105(a).

This area is designated with the landward boundary drawn between the 600-m contour as a hard landward boundary and the 650-m contour as a hard seaward boundary. In some areas the boundary crosses the 650-m contour to draw this line as straight as possible; however, the boundary was constrained on its shallow side by the 600-m contour. From the landward boundary, the boundaries extend along the northern and southern boundaries of the New England Council's management region and to the edge of the EEZ as the eastward boundary.

This action prohibits the use of bottom-tending commercial fishing gear within the designated Georges Bank Deep-Sea Coral Protection Area, including: Bottom-tending otter trawls; bottom-tending beam trawls; hydraulic dredges; non-hydraulic dredges; bottom-tending seines; bottom longlines; pots and traps; and sink or anchored gillnets. The prohibition on these gears protects deep-sea corals from interaction with and damage from bottom-tending fishing gear. Red crab pot gear is exempt from the prohibition.

This action designates a coral protection area in an 8-square mile (mi 2 ) (21-square kilometer (km 2 )) area southwest of Mount Desert Rock, a small, rocky island off the eastern Maine coast, about 20 nautical miles (nmi) (37 km) south of Mount Desert Island, encompassing depths of 100-200 m. Vessels are prohibited from fishing with bottom-tending mobile gear within the Mount Desert Rock Coral Protection Area. Bottom-tending mobile gear includes but is not limited to: Bottom-tending otter trawls; bottom-tending beam trawls; hydraulic dredges; non-hydraulic dredges; and seines (with the exception of a purse seine). This protects corals in this area from fishing impacts from these gears. Vessels are still able to fish for lobster in this area using trap gear.

This action designates a coral protection area in a 31-mi 2 (79-km 2 ) area on the Outer Schoodic Ridge, roughly 25 nmi (46 km) southeast of Mount Desert Island, encompassing depths of 104-248 m. Vessels are prohibited from fishing with bottom-tending mobile gear within the Outer Schoodic Ridge Coral Protection Area. Bottom-tending mobile gear includes but is not limited to: Bottom-tending otter trawls; bottom-tending beam trawls; hydraulic dredges; non-hydraulic dredges; and seines (with the exception of a purse seine). This protects corals in this area from fishing impacts from these gears. Vessels are still be able to fish for lobster in this area using trap gear.

Vessels are allowed to transit the Georges Bank, Mount Desert Rock, and Outer Schoodic Ridge Coral Protection Areas provided the vessels bring bottom-tending fishing gear onboard the vessel, and reel bottom-tending trawl gear onto the net reel. These transiting provisions are consistent with those established by the Mid-Atlantic Council for the Frank R. Lautenberg Deep-Sea Coral Protection Area.

This action designates the area around Jordan Basin in the Gulf of Maine as a dedicated habitat research area, but it does not impose any additional restrictions on fishing in this area. The purpose of this designation is to encourage further exploration of coral habitats at the site, and to encourage research on fishing gear impacts on these habitats.

This action adds framework adjustment provisions to facilitate future modifications to the New England Deep-Sea Coral Protection Areas. The new measures that may be changed using a framework adjustment include adding, revising, or removing coral areas; changing fishing restrictions in coral areas; and developing new, or changing existing, coral area fishery access or exploratory fishing programs.

The Council requested that researchers seek a Letter of Acknowledgement (LOA) from NMFS before conducting research in these areas. Scientific research on a scientific research vessel is not considered fishing and is therefore exempt from the requirements of the Magnuson-Stevens Act (Magnuson-Stevens Act, Sec. 3, 50 CFR 600.10 and 600.512). NMFS cannot require that scientific research institutions request an LOA when conducting scientific research at sea on a scientific research vessel, but we will encourage researchers to do so, consistent with regulations implementing the Magnuson-Stevens Act provisions at 50 CFR 600.512.

We received six comments on the NOA. Five comments were in support of our approval of the amendment, and the sixth comment, from the New England Field Office of the U.S. Fish and Wildlife Service, was a statement of no comment on the action. We received 16 comments on the proposed rule. Thirteen of these comments were in support of the proposed rule, and the remaining three comments were in opposition to the rule because the commenters did not believe it went far enough to protect deep-sea corals.

The Atlantic Offshore Lobstermen's Association, Oceana, Conservation Law Foundation (CLF), the Pew Charitable Trust (Pew), and Wild Oceans commented in general support of the action on both the NOA and the proposed rule. One individual commented on the NOA in support of the rule. The New England Aquarium (NEAq) and seven individuals commented in support of the proposed rule. CLF, Pew, and Wild Oceans ( collectively referred to as “joint commenters” below ) submitted a joint comment also in general support of the action. Supporting this joint comment was a comment from Pew including 7,628 signatures. Oceana also included a letter with 193 signatures supporting the proposed rule. While all of these comments recommended that NMFS approve the amendment in full, Oceana, NEAq, and the joint commenters suggested that the amendment could have done more to protect deep-sea corals and recommended additional actions the Council and NMFS could take to support the deep-sea coral protection areas.

Comment 1: Oceana, NEAq, and one individual commented that the amendment leaves some coral habitat vulnerable to damage from fishing gear, and the joint commenters noted that this action still allows for expansion into coral areas untouched by fishing. NEAq noted that 20 percent of the suitable deep-sea coral habitat is present in the top 50-600 m of seafloor and that the Council should add protections to that area in a future action. NEAq stated that the 50- to 600-m region is designated as essential fish habitat for several species, including commercially important species. Two additional individuals commented that the Council should ban commercial fishing in the areas and leave them open only for subsistence fishing.

Response: We agree that this action does not protect all deep-sea coral habitat in New England waters and allows the possibility of future expansion of fishing. We note that this action also allows for the possibility of further expansion of deep-sea coral protections. The Council is not obligated to permanently protect all habitat suitable for deep-sea corals. This amendment was developed under the discretionary authority granted in section 303(b)(2)(B) of the Magnuson-Stevens Act that provides for protecting deep-sea coral after considering long-term sustainable uses of fishery resources. However, the Council's recommendation, which substantially protects deep-sea coral while allowing fishing to continue in a relatively small portion of the area, strikes a balance between continued operation of fisheries and deep-sea coral protection in a practical way. NMFS will encourage the Council to continue to consider further protections for areas of known-coral presence after considering the long-term sustainable uses of fishery resources in such areas.

Comment 2: CLF, Pew, and Wild Oceans jointly requested that NMFS require the Council to revisit the management exemption provided to the deep-sea red crab fishery. Oceana commented that the Council should regularly review the effects of red crab gear on coral and sponge habitat to ensure that the Amendment is achieving its goals. If the red crab gear is found to be threatening coral and sponge habitats, they suggest that revisions to the exemption may be warranted. They also requested that NMFS require the Council to consider a prohibition on anchoring to provide full protections from gears that can harm corals.

Response: NMFS does not have the authority to require the Council to consider a prohibition on anchoring of red crab gear to protect deep-sea corals. NMFS determined that the Council considered and complied with all the National Standards and the MSA's requirement to consider long-term sustainable uses of the fishery resources. Should the Council consider red crab gear prohibitions, NMFS will support the Council in the development of subsequent actions to further protect deep-sea coral.

Comment 3: The joint commenters also requested that NMFS require fishery managers to expand framework adjustment provisions in New England fishery management plans for future modifications to the deep-sea coral areas and management measures as new data become available.

Response: This action adds framework adjustment provisions to facilitate future modifications to the New England Deep-Sea Coral Protection Areas. The new measures that may be changed using a framework adjustment include: Adding, revising, or removing coral areas; changing fishing restrictions in coral areas; and developing new, or changing existing, coral area fishery access or exploratory fishing programs.

Comment 4: Oceana and NEAq discouraged the use of a framework to allow fishing in these newly protected areas. Oceana encouraged NMFS to carefully consider the suite of framework provisions included in the Amendment, only approve minor modifications that will strengthen conservation measures, and clearly state the qualifying actions required to approve framework measures. NEAq insisted that there be a full consultation with a wide variety of stakeholders, including scientists, fishermen, and non-governmental organizations, among others before allowing fishing within these areas.

Response: While the framework adjustment provisions included in the Amendment do allow for changes to coral protection areas and restrictions in those areas, NMFS will work with the Council to ensure that any framework adjustments are consistent with the goals and objectives of the Amendment and that the public is given the ability to participate, as with any Council action.

Comment 5: Both Oceana and the joint commenters requested that NMFS notify the Council if new information indicates the presence of corals outside of the protection area and instruct the Council to amend protections and conserve additional area. In addition, they encouraged NMFS to include a directive for the Council to review and revise the regulations implemented by the Amendment in the near future to ensure they are achieving the Amendment's goals and objectives.

Response: NMFS staff and members of the Council's Habitat Plan Development Team (PDT) actively inform the PDT and the Council of the results of new studies and deep-sea explorations and will continue to do so moving forward. However, NMFS does not have the authority to require the Council to increase protections. NMFS will work with the Council and its PDT on future actions to ensure that they consider new information that is relevant to the actions, consistent with MSA requirements.

Comment 6: Two individuals expressed concern that the vessel trip report (VTR) analysis used to consider financial impacts indicates that large and small businesses are facing substantially similar financial impacts overall, although the most highly exposed small businesses generate a larger fraction of their overall revenue from areas within the preferred alternative when compared to large businesses.

Response: The VTR data analysis indicates that between $6.5-$8.5 million in gross revenue will be potentially displaced under the preferred alternative, although analysis of the vessel monitoring system data suggests this revenue number is an overestimate. After Council discussions at the Council's coral workshops in March 2017, the Council determined that the designation of a broad coral protection zone in waters no shallower than 600 m would cause little change in bottom trawl, trap/pot, and gillnet effort, and that the use of the VTR data was leading to an overestimate of the potential displacement of effort because of the lack of precision in the data. The VTR's provide a single geographic location for a given trip. The VTR analysis puts uncertainty buffers around that point (in the form of concentric circles, representing the 25th, 50th, 75th, and 90th percentile confidence intervals based on statistical analyses of the distance between self-reported VTR points and observed hauls based on trip characteristics) and attribute the revenue from that trip proportionally across the buffer. For trips that occur close to the closure, that circle may bleed into the closure area, when, based on industry feedback, it is likely that no part of the trip actually occurred inside the closure. The industry input from the NEFMC coral workshops was that, due to the distribution of target species, the trawl fishery is active out to depths of about 500 m, the lobster fishery to 550 m, and the red crab fishery to 800 m. For those fisheries where it was possible, a comparison of VTR data and Vessel Monitoring System data, which provides more granular position data but lacks the relevant information on revenue and fishing effort, additionally suggest the values from VTR are overestimates in line with the workshop input.

Furthermore, this is an estimate of gross revenue from displaced effort, and fishermen could relocate that displaced effort to an area outside the closure and still generate revenue. The effort and costs associated with obtaining the catch elsewhere is likely to be higher than the that associated with any displaced fishing (if it is even economically, biologically, or geographically feasible). Otherwise, fishermen would presumably be fishing these other locations. Nevertheless, the gross revenue displaced can be viewed as a likely overestimated upper bound on impacts to the fishery.

The commenters did not provide any additional information to consider.

Comment 7: NEAq and two individuals commented that the economic benefit provided by deep-sea coral habitat to the ecosystem and the nation outweighs the economic impacts of prohibiting fishing in these areas. NEAq further commented that, “Deep-sea corals may provide a number of other ecosystem services, including serving as paleoclimatic records of past ocean conditions, providing sources of material that may be used in the production of novel pharmaceutical compounds, and sequestering excess carbon dioxide in the atmosphere. If deep-sea corals in the proposed protected area provide just 1 percent of the value that NOAA prescribes to shallow-water coral ecosystems, the deep-sea coral ecosystems protected through this proposed rule may be valued at over $42 million annually, or about 6 times the revenue extracted by fishing. We urge NMFS to continue studying and exploring deep-sea coral communities to understand better and properly evaluate the contribution of deep-sea corals to biological diversity, habitat, and human health.”

Response: NOAA continues to conduct research on deep-sea coral. For example, after the Council developed this action, in 2019 NOAA's Office of Ocean Exploration and Research conducted surveys in both areas and documented many previously unknown high-density coral and sponge communities, as well as coexisting commercially harvested species. On one expedition alone, 26 of the 35 samples collected extended known species' habitat ranges, and some may be previously unknown to science. Surveys also discovered the deepest high-density community known in the Northeast U.S. at 2,700 m (8,750 ft) deep. The NOAA Deep Sea Coral Research and Technology Program (DSCRTP) is supporting analysis of this new information to inform future decision-making.

Also in 2019, NOAA's Office of Science and Technology, National Systematics Lab, Northeast Fisheries Science Center, Dalhousie University, and Fisheries and Oceans Canada led a U.S.-Canada transboundary expedition. Compared to the deeper New England slope and canyons, extremely high coral densities were observed in the Gulf of Maine. Remotely operated vehicle surveys documented commercially important fish and shellfish in previously unknown deep-sea coral gardens. The DSCRTP intends to begin the next New England and Mid-Atlantic Deep-Sea Coral Initiative starting in 2022, continuing fieldwork through 2024, followed by analysis of this data in 2025. This information was unavailable to the Council at the time this rule was developed. We expect the Council will consider this information and any other newly discovered and available information in future deep-sea coral actions.

Further, attempting to balance the value of all coral in areas managed through the Deep Sea Coral Amendment against the value of fishing in these areas does not provide an accurate view of the benefits of this action. The benefits derived from conservation actions undertaken in the Deep Sea Coral Amendment stem from the difference between no action (status quo) and the alternatives chosen. This is primarily the change in coral function and extent before and after this action. We expect that this action will preserve coral and promote its vitality, which is expected to provide benefits as noted by NEAq. However, comparing the total value generated from the stock of deep sea coral against the value of past fishing activity provides an inapt description of the benefits of this action. A more accurate view is a consideration of the net benefits due to increased conservation of deep sea coral along with the net benefits maintained by the fishery from its potential displacement of effort as compared to status quo.

Pursuant to section 304(b)(3) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this Amendment and final rule are consistent with the Omnibus Deep-Sea Coral Amendment, other provisions of the Magnuson-Stevens Act, and other applicable law.

The Office of Management and Budget determined this rule to be significant for purposes of Executive Order 12866. The suite of preferred alternatives in this action mitigate a substantial proportion of the negative impacts to the commercial fisheries compared to other alternatives in the document. However, this comes along with a trade-off with any conservation benefits associated with deep sea coral protection, the value of which are uncertain at this time. As described above, the intent of this action is to freeze the footprint of existing fishing, and this action was developed through the Council process with significant input from the fishing industry. The VTR data analysis indicates that between $10-$15 million in gross revenue will be potentially displaced under the preferred alternative, although analysis of the vessel monitoring system data suggests this revenue number is an overestimate. 1 Furthermore, this is an estimate of gross revenue from displaced effort, and fishermen could relocate that displaced effort to an area outside the closure and still generate revenue. A description of and caveats associated with the impact analyses undertaken in support of this action can be found in section 7.1 of the EA. The discussion in section 7.1 of the EA includes issues associated with quantifying the full range of costs and benefits associated with the Amendment. The expected effects of each alternative relative to the status quo for the fishery-related businesses and communities are discussed in sections 7.2-7.4 of the EA, and a discussion of the benefits and costs of the preferred alternative can be found in section 1.2 of the FRFA.

This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.

This action does not contain any collection-of-information requirements subject to the Paperwork Reduction Act.

Pursuant to section 604 of the Regulatory Flexibility Act (RFA), NMFS has completed a FRFA in support of this action. The FRFA incorporates the IRFA, a summary of the significant issues raised by public comments in response to the IRFA (see below), NMFS responses to those comments (as described above in the Comments and Responses section of this final rule), and a summary of the analyses completed in the Omnibus Deep-Sea Coral Amendment EA in section 11.3. In addition, because of the unusual delay between the Council's adoption of the Amendment and this final rule, NMFS prepared a standalone FRFA to recast analyses from 2014 constant dollars to 2020 constant dollars to be more accessible to the general public. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in the Amendment and in the preambles to the proposed rule and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and/or the Council, and a copy of the IRFA, RIR, the FRFA, and the EA are available upon request (see ADDRESSES ). Following are additional elements of the FRFA.

The proposed rule solicited public comment on whether the VTR analysis indicates that large and small businesses are facing substantially similar impact levels overall, although the most highly exposed small businesses generate a larger fraction of their overall revenue from areas within the preferred alternative when compared to large businesses. Two individuals expressed concern regarding this issue but did not provide any additional information to consider. See Comment 6 above.

The proposed rule also solicited public comment on value estimates for the benefits associated with deep-sea coral conservation. The NEAq and two individuals commented that the economic benefit of the ecosystem services that deep-sea coral habitat provides outweighs the economic impacts of prohibiting fishing in these areas. NEAq further commented that, “Deep-sea corals may provide a number of other ecosystem services, including serving as paleoclimatic records of past ocean conditions, providing sources of material that may be used in the production of novel pharmaceutical compounds, and sequestering excess carbon dioxide in the atmosphere. If deep-sea corals in the proposed protected area provide just 1 percent of the value that NOAA prescribes to shallow-water coral ecosystems, the deep-sea coral ecosystems protected through this proposed rule may be valued at over $42 million annually, or about 6 times the revenue extracted by fishing.” See Comment 7 above. As explained above, NMFS did not make any changes to the proposed rule as a result of these comments.

The description and estimate of the number of small entities that is available in the proposed rule was presented in 2014 constant dollars. However, because of the unusual delay between the Council's completion of the Amendment and this final rule, NMFS recast this analysis from 2014 constant dollars to 2020 constant dollars to be more accessible to the general public.

The RFA recognizes three kinds of small entities: Small businesses, small organizations, and small governmental jurisdictions. Small organizations and small governmental jurisdictions are not directly regulated by this action. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates) and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. Throughout this section, revenue is presented in 2020 dollars, for consistency with the remainder of the document, although classification was made using 2017 dollars, consistent with SBA guidelines. Further, SBA rules of affiliation are used to define a business entity. Thus, the following analysis is conducted upon unique business interests, which can represent multiple vessel-level permits.

The Deep-Sea Coral Amendment regulates all fishermen with federal permits allowing the holder to fish in the federal waters off Southern New England, Georges Bank, and the Gulf of Maine. In 2017, this represents 10 large commercial fishing businesses, 3,832 small commercial fishing businesses and 351 recreational for-hire businesses. However, based on VTR data, only ~200 of these small businesses had any documented fishing activity in the coral protection zone from 2015 to 2017, annually. Total revenue from estimates used in entity classification can be found in Table 1.

Taking the recast analysis in 2020 constant dollars and public comments into consideration, NMFS has identified no additional significant alternatives that accomplish statutory objectives and minimize any significant economic impacts of the rule on these small entities. This is because the recreational for-hire sector is not active in the management regions identified in this action, and the alternatives considered were developed to take into account impacts on entities fishing in these areas. Further, the new size standards for for-hire vessels do not affect the decision to prepare a final regulatory flexibility analysis as opposed to a certification for this action. This is because all for-hire entities in the region are already classified as small businesses.

This action contains no new collection-of-information, reporting, or recordkeeping requirements. There are potential economic impacts to small entities associated with this rule. Those impacts are described in detail in the Final Omnibus Deep Sea Coral Amendment, specifically, in the FRFA section 1.2.4.2 and in the analysis of the impacts on human communities in section 7.1.3 of the EA, which is still applicable.

Throughout the development of this action the Council considered public comments on how fisherman would be impacted. On March 13 and 15, 2017, the Council held workshops in New Bedford, MA, and Portsmouth, NH, respectively, to discuss the coral zone boundaries, considering the canyon and slope zones on Georges Bank (broad zone) at the first meeting, and the offshore Gulf of Maine zones at the second. Based on these discussions at the Council's coral workshops, it was determined that the designation of a broad coral protection zone in waters no shallower than 600 m causes little change in bottom trawl, trap/pot, and gillnet effort, and that the use of the VTR data was leading to an overestimate of the potential displacement of effort because of the lack of precision in the data. Furthermore, the VTR analysis provides an estimate of gross revenue of displaced effort, and fishermen could relocate that displaced effort to an area outside the closure and still generate revenue. The preferred alternative that this action implements is a direct result of input gathered at these workshops. In addition, the Council exempted the red crab fishery from these restrictions in the Georges Bank Deep-Sea Coral Protection Area because it is a small fishery that takes place entirely within the protection area, and prohibiting the red crab effort from the area would essentially end the red crab fishery.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency will publish one or more guides to assist small entities in complying with the rule, and will designate such publications as “small entity compliance guides.” The agency will explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a bulletin to permit holders that also serves as a small entity compliance guide was prepared. This final rule and the guide ( i.e., bulletin) will be sent via email to the Greater Atlantic Regional Fisheries Office scallop email list and are available on the website at: http://www.greateratlantic.fisheries.noaa.gov/. Hard copies of the guide and this final rule will be available upon request (see ADDRESSES ).

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: