The U.S. Department of Homeland Security (DHS), Customs and Border Protection (CBP), published a notice of proposed rulemaking in the Federal Register , 80 FR 53019, September 2, 2015, proposing to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements. DHS issued the new “DHS/CBP-020 Export Information System (EIS) System of Records” in the Federal Register , 80 FR 53181, September 2, 2015, to provide notice of the records maintained by CBP concerning individuals who participate in exporting goods from the United States.

DHS/CBP invited comments on both the notice of proposed rulemaking (NPRM) and System of Records Notice (SORN).

DHS received one non-substantive comment on the NPRM and one non-substantive comment on the SORN. After consideration of the public comments, the Department will implement the rulemaking as proposed.

For the reasons stated in the preamble, DHS amends chapter I of title 6, Code of Federal Regulations, as follows:

FSIS is finalizing its September 14, 2020, proposal to expand the circumstances in which FSIS will generically approve the labels of meat, poultry, and egg products (85 FR 56538). This final rule will expand generic approval to products only intended for export that deviate from domestic labeling requirements and permit generic approval of the labels of products that receive voluntary FSIS inspection. This final rule will also expand generic approval to: (1) “Organic” claims that appear in a product label's ingredients statement; (2) “Geographic landmarks” displayed on a product label; (3) “Negative” claims made on product labels that identify the absence of certain ingredients or types of ingredients. Furthermore, as of the effective date of this final rule, FSIS will no longer evaluate generically approved labels voluntarily submitted to the Agency for review. FSIS will, however, continue to provide industry with relevant resources, including updated generic labeling guidance, and timely answers to generic labeling questions via phone, askFSIS, and the Small Plant Help Desk.

Considering these changes, FSIS has revised and reissued the FSIS Guideline for Label Approval  1 to provide the public with updated information on the types of labels that must be submitted to FSIS for approval consistent with this final rule.

As is shown in Table 1, this final rule has net benefits of $799,507, annualized at the 7 percent discount rate over 10 years. Of which, industry will experience cost savings of $517,888, annualized at the 7 percent discount rate over 10 years, from the reduction in preparing and submitting certain labels for FSIS evaluation. FSIS will experience cost savings of $281,619, annualized at the 7 percent discount rate over 10 years, from the reduction in label evaluations. This final rule does not create any new cost burden for industry or FSIS.

The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ), Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq. ), and Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq. ) (hereinafter, “the Acts”) direct the Secretary of Agriculture to maintain inspection programs designed to ensure that meat, poultry, and egg products are safe, wholesome, not adulterated, and properly marked, labeled, and packaged. These laws prohibit the sale of products under any false or misleading name, marking, or labeling and require the Secretary to approve product marking and labeling (21 U.S.C. 457(c), 607(d), and 1036(b)). The Department's longstanding interpretation  2 of these provisions is that they require the Secretary or his or her representative to approve all labels to be used on federally inspected and passed, domestic and imported, meat, poultry and egg products, before the products may be distributed in commerce. To implement these provisions, FSIS uses a prior approval program for labels on federally inspected meat, poultry, and egg products (9 CFR part 412). Without approved labels, meat, poultry, and egg products may not be sold, offered for sale, or otherwise distributed in commerce.

To receive FSIS approval, meat, poultry, and egg product labels must comply with the Acts and the labeling regulations implemented thereunder. As discussed in the proposed rule (85 FR 56538, 56539), the regulations contain provisions to ensure that no statement, word, picture, design, or device that is false or misleading in any particular, or that conveys any false impression, or that gives any false indication of origin, identity, or quality, appears in any marking or other labeling (9 CFR 317.8, 381.129, and 590.411(f)(1)). Also, as discussed in the proposed rule, FSIS regulations require that meat, poultry, and egg product labels display up to eight features, to ensure that consumers have the information necessary to make informed purchasing decisions (85 FR 56538, 56539). The required features include: (1) The standardized, common or usual, or descriptive name, of the product (9 CFR 317.2(c)(1) and (e), 381.117, and 590.411(c)(1)); (2) an ingredients statement containing the common or usual name of each ingredient of the product listed in descending order of predominance (9 CFR 317.2(c)(2) and (f), 381.118, and 590.411(c)(1)); (3) the name and place of business of the manufacturer, packer, or distributor (9 CFR 317.2(c)(3) and (g), 381.122, and 590.411(c)(2)); (4) an accurate statement of the net quantity of contents (9 CFR 317.2(c)(4) and (h), 381.121, and 590.411(c)(4)); (5) the inspection legend, including the number of the official establishment  3 (9 CFR 312.2(b), 317.2(c)(5) and (i), 381.96, 381.123, and 590.411(c)(5)); (6) a handling statement if the product is perishable, e.g., “Keep Frozen” or “Keep Refrigerated” (9 CFR 317.2(k), 381.125(a), and 590.410(a)(1)-(2)); (7) nutrition labeling for applicable meat and poultry products (9 CFR part 317, subpart B; part 381, subpart Y; and 590.411(e));  4 and (8) safe handling instructions if the meat or poultry component of the product is not ready-to-eat (9 CFR 317.2(l) and 381.125(b)). In addition, imported meat, poultry, and egg products must bear the country of origin under the product name (9 CFR 327.14(b)(1), 381.205(a), and 590.950(a)(2)).

Under the prior label approval program, certain categories of labels receive “sketch approval,” meaning they must be submitted to FSIS for review and approval before use. However, FSIS regulations allow some product labels that bear all required labeling features and comply with the Agency's labeling regulations to be “generically approved” (9 CFR 412.2(a)(1)), meaning they may be used in commerce without prior FSIS review. Establishments, therefore, do not need to submit generically approved labels to FSIS' Labeling and Program Delivery Staff (LPDS) for evaluation. Instead, as discussed in the proposed rule, Inspection Program Personnel (IPP) perform surveillance and enforcement tasks in the field to verify that generically approved labels comply with labeling requirements (85 FR 56538, 56543).

Generic label approval has been in place in some form since 1983 (48 FR 11410, March 18, 1983). FSIS previously expanded the categories of labeling claims eligible for generic approval in 1995 (60 FR 67444, December 29, 1995). FSIS completed an assessment of the modified system in 1998 (76 FR 75809, December 5, 2011) and concluded that the great majority of establishments effectively used generically approved labels and that the gradual implementation of generic label provisions under the 1995 final rule was effective. FSIS expanded generic approval again in 2013 (78 FR 66826, November 7, 2013) and, in 2016, conducted a limited assessment of generic labels under the modified system, which found a high level of compliance with the requirements.

In June 2020, the USDA Office of Inspector General (OIG) concluded an audit of FSIS product labeling oversight (OIG audit #24601-0002-23, “Controls Over Meat, Poultry, and Egg Product Labels”). 5 In response to the audit recommendations concerning FSIS oversight of generic labeling, the Agency agreed that it would continue to enhance its outreach efforts to ensure establishments are aware of applicable mandatory labeling features for generic labels. FSIS also agreed to update its internal policies to improve IPP label verification activities. FSIS took subsequent action to satisfy OIG's audit recommendations and, based on such action, the USDA Office of the Chief Financial Officer (OCFO) closed the audit on June 29, 2021.

Since the 2013 rulemaking (78 FR 66826), FSIS has gained significant, additional experience evaluating labels required to be submitted and approved. From that experience, FSIS has observed through its prior label approval system that most labels in the categories discussed in this final rule are compliant and do not require changes. Therefore, the Agency concluded that the current label regulations continue to require industry to submit for approval a significant number of labels that could successfully be generically approved. Therefore, on September 14, 2020, FSIS published a proposed rule to amend the meat and poultry products inspection regulations to expand the circumstances under which labels of meat and poultry products would be deemed to be generically approved by the Agency (85 FR 56538). FSIS also proposed to cease evaluating generically approved labels submitted to FSIS for review (85 FR 56538, 56542). FSIS proposed these changes to its regulations to reduce the number of labels submitted for evaluation by FSIS and to lessen the paperwork burden on official establishments (85 FR 56538, 56541). As stated in the proposed rule, the reduction in staff time spent approving these labels will allow the Agency to better focus on other consumer protection and food safety activities, such as developing guidance materials, answering labeling policy questions, providing outreach to stakeholders, and ensuring IPP effectively verify that establishments meet labeling requirements (85 FR 56538, 56541). FSIS is now finalizing the proposed rule with minor changes to clarify label approval requirements with respect to voluntarily inspected poultry.

This final rule is consistent with the proposed rule. First, the final rule will extend generic label approval to products only intended for export that deviate from domestic labeling requirements, by removing 9 CFR 412.1(c)(2). As explained in the proposed rule, FSIS maintains an Export Library that lists requirements for exported products that foreign authorities have officially communicated to FSIS, including labeling requirements. 6 At times, foreign country labeling requirements conflict with domestic requirements. FSIS regulations (9 CFR 317.7 and 381.128) permit export product labels to deviate from FSIS' domestic labeling requirements in order to comply with foreign country requirements or to be marketed more easily in a foreign country. 7 FSIS IPP verify whether product for export meets requirements listed in the Export Library, including labeling, when certifying products for export. Verification of foreign requirements is ultimately determined by each foreign country's competent authority.

Second, the final rule will revise the types of “special statements and claims” requiring label submission by providing for generic approval of three additional types of claims. As explained in the proposed rule, FSIS has, through its prior label approval system, routinely evaluated these types of claims for several years. From that experience, FSIS has observed that errors, omissions, and misrepresentations are rare on these types of labels. FSIS has, therefore, decided to expand generic approval to such claims. As with all generically approved labels, IPP will continue to conduct routine verification tasks in establishments to verify ongoing compliance with labeling requirements. FSIS is amending 9 CFR 412.1(e) and 412.2(b) to make these changes.

Under this final rule, the following types of claims will be generically approved:

a. “Organic” claims that appear in a product label's ingredients statement, which designate an ingredient as certified “organic” under the Agricultural Marketing Service's (AMS's) National Organic Program. The ingredients statement on these product labels designates specific ingredients as “organic” ( e.g., “organic garlic”). Under this rule, FSIS will no longer require the submission and evaluation of supporting documentation to verify that such ingredients are indeed certified as “organic” by an AMS-recognized third-party certifier. However, FSIS will continue to require establishments to submit labels certifying a total product as organic to FSIS for evaluation.

b. “Geographic landmarks” displayed on a product label, such as a foreign country's flag, monument, or map. For example, the following claims displayed on a product label will no longer require FSIS review prior to entering commerce: a Polish flag depicted on a Polish sausage product label, or an outline of the State of Nevada depicted on a product label for beef produced in Nevada.

c. “Negative” claims made on product labels that identify the absence of certain ingredients or types of ingredients. For example, statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy,” on product labels that do not list these ingredients in the ingredients statement will no longer have to be evaluated by FSIS before use. However, FSIS evaluation of labels that bear negative claims relating to the raising of the animal from which the product is derived ( e.g., “no antibiotics administered”) or negative claims relating to the use of genetically modified ingredients will continue to be required.

Third, the final rule will permit generic approval of the labels of products that receive voluntary FSIS inspection. FSIS provides several types of voluntary inspection services under the authority of the Agricultural Marketing Act (AMA) (7 U.S.C. 1621 et seq. ), including inspection for: rabbits (9 CFR part 354), certain non-amenable species of livestock and poultry, such as elk, bison, and migratory waterfowl (9 CFR part 352, subpart A, and 9 CFR part 362); and products that contain meat or poultry but are not under FSIS jurisdiction, e.g., closed-faced sandwiches (9 CFR 350.3(c)and 362.2(a)). Before this final rule, labels for some products produced under these voluntary inspection programs were not covered under the Agency's generic approval regulations at 9 CFR part 412. This final rule will permit generic approval for them on the same basis as amenable meat, poultry, and egg products by amending the relevant regulations where needed to include references to 9 CFR part 412. 8 For clarity, the final rule will also modify 9 CFR 352.1 to update the section heading and remove unnecessary language.

Finally, under the final rule, FSIS will no longer evaluate generically approved labels submitted voluntarily for FSIS review. Over the years, producers have become more familiar with FSIS' generic labeling requirements, and FSIS has provided additional guidance to assist them in designing compliant labels. Because voluntarily submitted labels receive a lower review priority than other labels, industry can receive more timely labeling assistance by utilizing Agency resources or contacting FSIS for help. Therefore, FSIS' evaluation of otherwise generic labels no longer represents an efficient use of Agency resources.

FSIS will, however, continue to provide industry with generic labeling resources and assistance to help them comply with requirements. For example, FSIS has revised and reissued the FSIS Guideline for Label Approval  9 to provide updated information on the types of labels that must be submitted to FSIS for approval consistent with this final rule. FSIS will also continue to assist industry with generic labeling issues via phone, askFSIS, and the Small Plant Help Desk.

FSIS received 33 comments on the proposed rule from individuals, trade associations, private businesses, non-profit organizations, a consultant, a software company, the European Union (EU), and OIG. Fourteen commenters supported the proposed rule; though, some commenters requested revisions to or clarification on specific provisions of the rule. Most of these commenters stated that they supported the proposed rule because it will streamline the prior label approval system, reduce the label approval backlog, result in a cost savings for industry and government, and allow FSIS to utilize its resources more effectively.

Four commenters opposed the proposed rule, generally citing concerns over reduced oversight of meat, poultry, and egg product labeling claims. Twelve comments expressed concerns regarding specific provisions or language in the proposed rule but did not otherwise express opposition or support for the remainder of the rule. The remaining comments were outside the scope of the rule. A summary of the relevant issues raised by commenters and the Agency's responses follows.

Comment: OIG questioned FSIS' conclusion that its previous generic labeling assessments found a high level of industry compliance with requirements and its assertion in the proposed rule (85 FR 56538, 56543) that OIG's audit of FSIS' product labeling oversight (OIG audit #24601-0002-23) does not affect the proposed expansion of generic labeling eligibility. Unlike FSIS, OIG does not believe that the assessments or the audit found a high level of industry compliance with generic labeling requirements. As part of its audit, OIG reviewed 878 generic labels that industry voluntarily submitted to FSIS for review and found that FSIS requested changes to 74 percent of these labels. OIG also noted that three establishments OIG visited during its audit did not make required modifications to their generic labeling records. For these reasons, OIG recommended that FSIS consider performing a statistically valid assessment, before publishing this final rule, to ensure establishments have achieved a high level of compliance with generic label requirements. OIG also asked FSIS to consider ensuring that IPP select generic labels when performing General Labeling Tasks.

Response: As discussed in the proposed rule (85 FR 56538, 56541), FSIS completed an assessment of its generic labeling system in 1998 (76 FR 75809, December 5, 2011). Of the 1,513 labels that FSIS reviewed during its assessment, 1,434 (approximately 95 percent) were either in complete compliance or had only minor labeling errors ( e.g., insufficient spacing around the declaration of net weight or an error in the name of the manufacturer, packer, or distributor) that were not of public health or economic significance (76 FR 75813). As discussed in the proposed rule (85 FR 56538, 56541), FSIS also conducted a limited assessment in 2016, with similar results. Thus, FSIS maintains its view that its previous assessments found a high level of compliance from the labels reviewed.

In June 2020, OIG concluded an audit of FSIS' oversight of generically approved and sketch approved labeling. 10 In response to the official draft of the audit, FSIS expressed concerns that the audit was flawed in several areas, and that OIG misinterpreted specific labeling regulations and how they are applied to the labeling review process. FSIS also expressed concerns that OIG evaluated the label approval program on a rigid set of standards that did not accurately reflect FSIS regulations or consider FSIS' history and expertise in implementing the regulations and review of labels. OIG addressed some, but not all, of these concerns in its final audit report. Despite FSIS' misgivings about the audit, the Agency generally agreed with OIG's recommendations, and OIG accepted FSIS' decisions on all its recommendations.

FSIS took subsequent action to satisfy OIG's recommendations and, based on such action, OCFO closed the audit on June 29, 2021. For example, on June 7, 2021, the Agency revised FSIS Directive 7221.1, Prior Labeling Approval, 11 to clarify that IPP are to routinely select generically approved labels when performing General Labeling Tasks. 12 FSIS also documented internal Standard Operating Procedures to assist LPDS analysts with the label evaluation process, including formalizing a Quality Control program to randomly review label adjudications.

FSIS also took action to address OIG's finding that three establishments it visited during its audit did not make required modifications to their labeling records. Although this finding was only based on a review of four labels, FSIS nonetheless published a Constituent Update to remind all establishments that FSIS label approval, including approval of voluntarily submitted generic labels, is contingent on the establishment making the revisions noted by FSIS. 13 FSIS also recently updated FSIS Directive 7221.1 to clarify that, as part of the General Labeling Task, IPP are to routinely verify that establishments make required modifications to their labels.

FSIS acknowledges OIG's finding that FSIS requested changes to 74 percent of the generic labels voluntarily submitted to the Agency by industry, which OIG reviewed during its audit. For a number of reasons, however, this finding does not accurately reflect the overall compliance of generically approved labels. First, industry typically submits generically approved labels to FSIS to resolve questions about some aspect of the label's compliance. Thus, the labels OIG audited were, by their very nature, more likely to have minor deficiencies than generically approved labels not voluntarily submitted to FSIS. Second, nearly all the deficiencies identified were very minor and did not require label revocation. Moreover, none of the identified deficiencies created a health or safety concern or provided the establishment with an economic advantage.

Based on the above, FSIS maintains its view that generic labels typically comply with labeling regulations. The great majority of errors that do occur are minor, do not require label revocation, and are not of public health or economic significance. As such, FSIS did not conduct another assessment prior to publication of this final rule. However, as discussed, FSIS has already taken action to address OIG's recommendations and successfully close the audit, such as reissuing Directive 7221.1 to clarify that IPP are to include review of generic labels as part of the General Labeling Task and verify that establishments have made required modifications, if any, to such labels. In addition, FSIS will continue to train and support IPP on this issue via webinars, askFSIS, and other outreach including participating in IPP training conducted by the FSIS Center for Learning (CFL).

Comment: An individual commenter argued that the sample size of the 2016 assessment was not adequate to effectively gauge industry compliance with generic labeling requirements. The commenter also noted that FSIS did not provide a link to the results of that assessment in the proposed rule. The commenter recommended that, moving forward, FSIS perform additional generic labeling assessments.

Response: As discussed in the proposed rule, the 2016 assessment was a limited assessment conducted to address concerns about the effectiveness of generic labeling and establish protocols for a potential future national assessment (85 FR 56538, 56541). Labeling policy experts reviewed 270 labels for compliance with generic labeling requirements. 14 These 270 labels reflect a representative sample from the five Federally regulated establishments subject to the assessment. Thus, the sample size was adequate to gauge their compliance with generic labeling requirements.

FSIS did not produce a report outlining the comprehensive results of the assessment. Instead, in line with the assessment's methodology, FSIS drafted an assessment summary letter for each individual establishment. FSIS also discussed the overall results of the assessment in the proposed rule, noting that the assessment found a high level of compliance with the generic labeling requirements and identified only three labels with deficiencies necessitating label revocation (85 FR 56538, 56541). None of these deficiencies involved food safety.

FSIS may conduct future assessments, as needed, and as Agency time and resources permit to gauge ongoing industry compliance with generic labeling, including the provisions in this final rule. However, the Agency determined that an assessment was not necessary prior to publication of this final rule, given its previous assessments have shown a high level of industry compliance with generic labeling requirements.

Comment: One individual stated that the proposed rule is not necessary because the costs associated with FSIS' label review process are already relatively low.

Response: FSIS disagrees. The cost of label submissions and evaluations vary and is dependent on the complexity of the individual label. FSIS estimates that the total industry and Agency net cost savings under this rule from the reduction in FSIS label submissions to be $5,615,403 discounted at the 7 percent discount rate over a 10-year period, present value. FSIS is focused on making the label approval process more efficient while ensuring food safety and preventing misbranded products.

Comment: Several individuals expressed concerns that expanding generic approval to other categories of labels will substantially increase the number of deficient labels in commerce. Some individuals also suggested that expanding generic labeling will encourage establishments to intentionally abuse the labeling system. In addition, some individuals stated that periodic IPP verification of generic labels is insufficient to identify and prevent misbranded labels before they cause harm to consumers.

Response: FSIS disagrees. First, FSIS' experience with generic label approval does not support the assertion that expanding generic approval will substantially increase the number of deficient labels in commerce. Generic labeling has been in place in some form since 1983. This final rule, like previous expansions of generic approval eligibility, will continue to require that establishments comply with FSIS' labeling regulations. Establishments have been required to include the following features on their product labels for many years: product name (9 CFR 317.2(c)(1) and (e), 381.117, and 590.411(c)(1)); inspection legend/establishment number (9 CFR 312.2(b), 317.2(c)(5) and (i), 381.96, 381.123, and 590.411(c)(5)); handling statement (9 CFR 317.2(k), 381.125(a), and 590.410(a)(1)-(2)); net weight (9 CFR 317.2(c)(4) and (h), 381.121, and 590.411(c)(4)); ingredients statement (9 CFR 317.2(c)(2) and (f), 381.118, and 590.411(c)(1)); signature line (9 CFR 317.2(c)(3) and (g), 381.122, and 590.411(c)(2)); nutrition facts panels (9 CFR part 317, subpart B; part 381, subpart Y; and 590.411(e)); and safe-handling instructions (9 CFR 317.2(l) and 381.125(b)). FSIS IPP will continue to verify that establishments' labels include these features and otherwise comply with labeling requirements. Moreover, as discussed above, FSIS has evaluated the compliance of generically approved labels after previous expansions of generic approval eligibility and found that they typically comply with labeling regulations. FSIS expects that the categories of labels added to generic approval by this rule will have a similarly high compliance rate, and any increase in the number of deficient labels entering commerce resulting from the expansion of generic label approval by this rule will be minimal.

FSIS' experience with generic label approval also does not support the assertion that expanding generic label approval will encourage establishments to intentionally abuse the labeling system. Past incidents of establishments intentionally misusing generic label approval have been rare, and FSIS does not expect that to change with this rule. IPP routinely perform labeling verification activities in federally inspected establishments to identify and deter such activity. Moreover, the costs associated with noncompliance, such as the costs to replace deficient labels or the disruption of production, disincentive such behavior. In addition, if any such activity does occur, FSIS may take action to control misbranded products and take enforcement action under the FSIS Rules of Practice (9 CFR part 500).

In addition, FSIS disagrees with the assertion that IPP verification of generic labels is insufficient to identify and prevent misbranded labels before they cause harm to consumers. IPP have consistently demonstrated their ability to review generic labels and ensure a high level of compliance with labeling requirements. FSIS will revise and reissue instructions to IPP regarding the verification of generic labels as necessary. For instance, FSIS recently reissued FSIS Directive 7221.1 to provide IPP with updated instructions for conducting the General Labeling task in the Public Health Information System (PHIS)  15 that are consistent with this final rule. As discussed, the Agency has also updated the FSIS Guideline for Label Approval to be consistent with this final rule. FSIS will also update and administer generic labeling training webinars for IPP, as necessary. Moreover, this rule is expected to reduce the number of labels submitted to FSIS, freeing up resources that will allow the Agency to better focus on providing labeling support to industry and IPP. FSIS will focus its time and resources on preventing more non-compliances through new and improved labeling guidance, outreach, and other support services for its stakeholders, including via phone, askFSIS, and the Small Plant Help Desk. In addition, IPP will continue to verify generic labels for compliance on a routine basis and inform establishments of the need to correct any deficiencies they identify.

Comment: A consulting firm and a trade association asked FSIS to expand generic approval to all “organic” labeling on a product, rather than limiting it to “organic” claims listed in the ingredients statement.

Response: FSIS will not expand generic approval to all “organic” labeling at this time. There are additional requirements for labeling a total product as “organic” as opposed to just a particular ingredient. For example, approving an entire product as “organic” requires the review of supporting documentation on “organic” processing, including “organic” certificates. Such claims need to be reviewed by LPDS staff that have expertise in the types of supporting documentation needed to determine compliance. Such “organic” claims are, therefore, not easily verifiable by IPP. Thus, FSIS will continue to require prior approval for labels that display “organic” claims outside the ingredients statement, including those certifying a total product as “organic.”

Comment: Several individuals stated that the rule will weaken regulatory oversight of “organic” claims on meat, poultry, and egg products. They also stated that allowing “organic” claims in the ingredients statement will mislead consumers into believing they are buying certified organic products.

Response: The final rule will not weaken oversight of “organic” claims. FSIS regulations will continue to require that all “organic” claims be truthful and not misleading. LPDS analysts will continue to evaluate and approve “organic” claims displayed outside of the ingredients statement. IPP will verify the truthfulness of generically approved “organic” ingredient claims made in the ingredients statement. IPP verify, through record review and observation, that all ingredients used in the production of the product are present on the product formulation record and that all ingredients in the product formulation are declared in the ingredients statement on the product label by common or usual name in descending order of predominance. IPP also verify, through record review and observation, that the appropriate label is applied to the product. IPP directly observe that all ingredients used in a product formulation are appropriately declared on the final meat, poultry, or egg product labels. The AMS National Organic Program will also continue to provide oversight of organic claims.

FSIS also disagrees that listing some ingredients as “organic” in the ingredients statement will mislead consumers. So long as they are truthful, the AMS National Organic Program regulations, 16 which were first published in December 2000, 17 permit “organic” claims to appear in the ingredient statements of non-certified products. FSIS did not propose to change those requirements.

Comment: One producer asked FSIS to clarify whether “gluten free” claims qualify for generic approval under the rule. Another individual specifically opposed any action that would deregulate “gluten free” labeling.

Response: The term “gluten free” is considered a negative claim and will receive generic approval under this final rule. However, the final rule will not deregulate “gluten free” labeling or change recordkeeping requirements. Such claims must still be truthful and not misleading in accordance with 9 CFR 317.8, 381.1, and 381.129. As discussed above, IPP will routinely verify the accuracy of generically approved labels. Specifically, for “gluten free” claims, IPP will verify that the product does not have any gluten containing ingredients and that there is adequate support for the claims in the labeling record.

Comment: Some individuals stated that the rule will increase the likelihood that meat, poultry, and egg products in commerce contain undeclared allergens or other ingredients that consumers must avoid for health, ethical, or religious reasons. A few individuals also stated that generic approval of “negative” claims would encourage producers to publish fraudulent ingredients statements.

Response: FSIS disagrees that the expansion of generic labeling will increase the likelihood that meat, poultry, or egg products will contain undeclared ingredients or allergens. The final rule will not change the requirement that “negative” claims must be truthful and not misleading. This final rule also will not change any requirements pertaining to product ingredient statements, which must continue to be truthful and list all ingredients in the product formula (9 CFR 317.2 and 381.118).

When LPDS evaluates labels during prior label review, they ensure that: the up to eight labeling features required by the meat, poultry, and egg products inspection regulations are present on the label; any claims are appropriately supported; and that any undefined claims, ad copy, or other information that may be false or misleading is not included on the label. As part of this process, LPDS compares written product formulations provided by establishments to the ingredients listed on their product labels. LPDS does not, however, physically inspect products as they are being made to ensure that only the ingredients listed on the label are used in final food products. IPP conduct reviews of this kind in the establishment, after the relevant label has been approved, whether generically or on a per-case basis by LPDS analysts. 18 IPP review labels and compare them to actual product formulations to verify that the ingredients used in the production of the product are listed accurately on the label, that the label is not misleading, and that it is otherwise in compliance with all labeling requirements. IPP will also continue to perform general labeling tasks to verify the accuracy of “negative” claims.

IPP will also continue to verify that establishments accurately control and label the most common food allergens. In accordance with FSIS Directive 7230.1, Ongoing Verification of Product Formulation and Labeling Targeting the Eight Most Common (“BIG 8”) Food Allergens, IPP identify products that may contain allergens and routinely conduct allergen formulation verification tasks at the establishment. These tasks include a record review and direct observation component to ensure that all ingredients, including allergens, used in a product formulation are appropriately declared on the final meat, poultry, or egg product labels.

Additionally, the final rule will not expand generic approval to all types of “negative” claims ( e.g., “no antibiotics administered”). FSIS is only expanding generic approval to “negative” claims that identify the absence of certain ingredients or types of ingredients that are not listed in the ingredients statement and are easily verifiable by IPP. In FSIS' experience, errors or omissions for these types of claims are rare.

Comment: A trade association stated that some “negative” claims, including “preservative free,” “no artificial ingredients,” and “no MSG added,” are difficult for IPP to verify. Thus, the commenter asked that FSIS either provide updated guidance on these terms before publication of the final rule or modify the rule to exclude problematic claims from generic approval.

Response: FSIS disagrees that “negative” ingredient claims are difficult for IPP to verify. IPP have access to product formulas for all products produced at Federal establishments, including those products with labeling bearing “negative” ingredient claims. The General Labeling Task and “Big 8” Formulation Verification Task in PHIS require IPP to compare the product formula with the ingredients listed on the label. In doing so, IPP will also verify that “negative” ingredient claims are truthful and not misleading. In addition, FSIS has updated and reissued FSIS Directive 7221.1 and the FSIS Guideline for Label Approval to include additional guidance and instructions pertaining to “negative” claims. FSIS will also continue to answer questions and provide labeling support to IPP and industry through askFSIS. In addition, FSIS will perform more outreach and develop webinars about “negative” claims.

Comment: Some non-profit organizations and individual commenters stated that FSIS should not generically approve animal raising claims, including “negative” claims pertaining to the raising of the animal.

Response: FSIS agrees. As discussed in the proposed rule, some claims, including animal raising claims, benefit from LPDS evaluation due to their complex nature and need for supporting documentation (85 FR 56538, 56545). Therefore, this final rule does not revise any Agency policy or regulation concerning animal raising claims. As stated in the proposed rule (85 FR 56538, 56542), generic approval will not apply to “negative” claims relating to the raising of the animal from which the product is derived, e.g., “no antibiotics administered”.

Comment: One trade association requested that FSIS allow generic approval of any certified claims, e.g., “certified non-GMO,” that are preapproved by a third-party certifier. In the alternative, the commenter asked that FSIS develop specific standards for third-party certifiers, approve certifiers based on those standards, and allow the generic approval of certified claims where the certification was issued by an approved certifier. The commenter argued that IPP can easily verify such claims by reviewing the labeling record.

Response: FSIS will not expand generic approval to certified claims, preapproved by a third-party certifier. FSIS will continue to review such claims, including certified animal raising claims, certified non-GMO claims, and other certifications issued by third party certifiers. Certified claims include the specific claim, identification of the certifying entity verifying the claim, and a web-address for interested parties to obtain additional information on the standards applied that are being certified. Evaluation of these claims includes reviewing the claim, standards for the claim, as well as certificates for applicable products and establishments. The labeling record must include proof of current certification, accompanied by certification criteria, which must be evaluated by labeling experts. Therefore, certified claims are not easily verifiable by IPP.

Comment: A few trade associations requested that FSIS expand generic approval to cover temporary label extensions for time sensitive claims ( e.g., “new,” “now,” or “improved”).

Response: FSIS will not expand generic approval to extensions of the use of time sensitive label claims ( e.g., “new,” “now” or “improved”). Temporary use of labels bearing a time sensitive claim beyond six months may not extend longer than 180 days, as stated in the Policy Book, unless FSIS LPDS grants an applicant's request for additional time (9 CFR 412.1(f)). To receive such an extension, an applicant must demonstrate that denial of the request would create undue economic hardship and that extending use of the label would not misrepresent the product, give the applicant an unfair competitive advantage, or present any health, safety, or dietary problems to the consumer (9 CFR 412.1(f)(1)). Furthermore, according to the Policy Book, applicants seeking an extension for time sensitive claims must demonstrate that production or distribution delays precluded the use of the approved labeling as scheduled or that labeling inventory needs for the 180-day period, were overestimated due to poor sales. The Policy Book also allows the extended use of time sensitive claims in situations where it is customary to distribute “new” products to various geographical regions if the processor can assure adequate controls over the segregation and distribution of the products. In addition, the Policy Book allows FSIS to approve the extended use of time sensitive claims in situations where the applicant is test marketing a product, but only if it can demonstrate that just 15 percent or less of the total market is involved in the test marketing.

Because applicants must demonstrate compliance with several detailed requirements in order to use time sensitive claims beyond 180 days, such extensions are not good candidates for generic approval. IPP cannot easily verify compliance with such criteria and, thus, the Agency is concerned that allowing the extension of time sensitive claims on a generic basis would result in use of the labels well beyond the 180-day limit. FSIS LPDS will continue to evaluate all extension requests for the use of time-sensitive claims to ensure that applicants have demonstrated compliance with pertinent regulations and policy.

Comment: One trade association requested that FSIS allow establishments to submit temporary and permanent label approval requests simultaneously. According to the commenter, companies sometimes need to submit labels for a temporary label approval to account for an alternate ingredient substitution that requires a change to the ingredients statement, after which the labels are updated, or the company reverts to the original ingredient. If the ingredient substitution is made permanent and the label bears a special statement or claim potentially affected by the ingredient change, the company must again submit the same label to obtain sketch approval for the special statement or claim affected by the ingredient substitution. The result is that the company must submit—and FSIS must review—the same label twice. The commenter states that FSIS should streamline this process by allowing establishments to submit a combined temporary and permanent approval request.

Response: Extending temporary label approval of labeling with deficiencies to include a sketch approval of the corrected label is outside the scope of this rule. Temporary approval of the use of deficient labels requires that the label meets the criteria described in 9 CFR 412.1(f)(1)(i-iv), which is a different set of criteria than that used to evaluate the corrected label.

Comments: Several commenters, including a consulting firm and a few trade associations, stated that FSIS should continue to evaluate generically approved labels voluntarily submitted to the Agency, because, according to the commenters, it is necessary to protect establishments from legal liability. These commenters also noted that the proposal to eliminate this review may lead to more non-compliant labels and product recalls.

Response: FSIS' decision to no longer review generic labels voluntarily submitted to the Agency will not likely lead to more non-compliant labels and product recalls. FSIS remains committed to helping its stakeholders navigate labeling requirements. However, evaluating generic labels submitted for voluntary review is an inefficient use of Agency resources as the labels may be applied to products entering commerce without formal FSIS approval, provided they meet the conditions in 9 CFR 412.2. Moreover, industry can receive more timely assistance by utilizing Agency resources or contacting FSIS, given that voluntarily submitted labels receive a lower review priority than other labels. Thus, rather than review generically approved labels, FSIS will focus its time and resources on preventing more non-compliances through new and improved labeling guidance, outreach, and other support services for its stakeholders, including via phone, askFSIS, and the Small Plant Help Desk. In addition, IPP will continue to verify generic labels for compliance on a routine basis and inform establishments of the need to correct any deficiencies they identify.

In addition, FSIS review of generic labels was never intended to protect industry from legal liability. Ultimately, establishments bear full legal responsibility for ensuring that their final product labels are truthful, accurate, and otherwise in compliance with all applicable regulations.

Comment: Some commenters, including a few trade associations, stated that FSIS' review of generically approved labels is sometimes necessary to help industry and IPP resolve labeling issues. The commenters asked FSIS to clarify whether it will continue to assist industry and IPP with generic labeling issues by other means. If voluntary review is eliminated, the commenters requested that FSIS develop additional generic labeling guidance and resources for industry and IPP. One trade association also asked FSIS to establish a help desk for rapid answers to generic labeling questions.

Response: Given voluntarily submitted labels are not prioritized for review, submission of such labels is not an efficient means to resolve labeling questions or other issues for IPP or industry. It is more efficient for industry and IPP to resolve such issues by referencing Agency resources, such as published labeling guidance and webinars, or by contacting FSIS. FSIS will continue to provide IPP and industry with generic labeling assistance and timely answers to generic labeling questions via phone or askFSIS. Thus, there is no need for FSIS to create a new help desk for answering questions or resolving issues. Moreover, a benefit of the final rule is that staff hours that were previously spent adjudicating generic labels, will be redirected toward other Agency priority initiatives that better support IPP and industry through, amongst other things, the development of new and improved training for inspectors, updated instructions for IPP, outreach, and guidance on labeling, including generic labeling.

Comment: Some trade associations and individual commenters stated that the proposal to eliminate review of labels that can be generically approved will hurt new or small producers who do not have the expertise or resources to navigate complex labeling requirements. In addition, one trade association stated the Agency must continue the practice of reviewing generic labeling to fulfill its mission under the Small Business Regulatory Enforcement Fairness Act (SBREFA).

Response: FSIS disagrees with these comments. Although FSIS will no longer review generic labels, the Agency will continue to be responsive to small business inquiries about compliance with the Agency's regulations and otherwise fulfill its obligations under SBREFA. FSIS will continue to answer inquiries by new or small producers seeking information and advice on compliance with Agency statutes and regulations and the interpretation and application of law to specific sets of facts supplied by the producers. As discussed above, FSIS will continue to provide many resources to help industry, including new and small producers, comply with generic labeling requirements. For example, such producers can directly contact LPDS, whose staff members are readily available to provide detailed answers to their generic labeling questions via phone or askFSIS. Small producers can also utilize FSIS' Small Plant Help Desk to find answers to common questions from small and very small plant owners and operators across the country or submit a question to FSIS subject matter experts. In addition, new and small producers can easily access FSIS' comprehensive labeling guidance, which is readily available on its website. 19 Moreover, FSIS plans to develop additional generic labeling materials, training, webinars, and other support services to assist new or small producers. Thus, new or small producers should not need to hire experts or additional staff to comply with FSIS' labeling requirements.

Comment: One trade association stated that FSIS has a legal duty to continue reviewing any label submitted to the Agency, including generically approved labels.

Response: FSIS disagrees. The Acts require that the labels be “approved” by the Secretary (21 U.S.C. 457(c), 607(d), and 1036(b)); however, they do not require that the approval system be centralized or decentralized. They also do not prescribe any particular type of system for the granting of label approvals. Therefore, the Acts permit the Agency to classify certain types of labels and labeling features as eligible for “generic” approval.

Comment: One individual asked FSIS to clarify whether it conducted a cost-benefit analysis of its decision to stop reviewing voluntarily submitted labels.

Response: The cost-benefit analysis that FSIS published in the proposed rule (85 FR 56538, 56546) and the updated analysis in the “Alternative Regulatory Approaches” section of this final rule considered the alternative of having LPDS continue to evaluate labels that would otherwise be generically approved. FSIS rejected this alternative because, among other things, these labels are reviewed at a slower pace and industry could more quickly get FSIS assistance on these types of labels via phone, askFSIS, the Small Plant Help Desk, or other Agency resources. Additional information on the analysis of this alternative is found below under the heading “Alternative 2— The Final Rule, Except Industry Would Still Have the Option to Have LPDS Evaluate Labels that Would Otherwise be Generically Approved.”

Comment: Some trade associations, individual commenters, and the EU opposed generic approval of geographic landmark claims. They are concerned that the rule will eliminate regulatory oversight for such claims, increase the prevalence of misbranded products, and allow establishments to mislead consumers regarding the origin of their products by, for example, using foreign flags on domestic product labels. These commenters also stated that prior label approval of geographic landmark claims is necessary to preempt violations of international agreements.

Response: FSIS disagrees with these comments. This final rule does not change current regulations pertaining to the use of geographic landmarks, such as foreign flags, on product labels or the recordkeeping requirements to support such claims. The Acts require all labeling to be truthful and not misleading (21 U.S.C. 601(n)(1), 453(h)(1), and 1036(b)). Moreover, geographic landmark claims must continue to specifically comply with 9 CFR 317.8(b)(1) and 381.129(b)(2). These regulations permit, under certain conditions, the display of foreign flags on domestic products. As discussed in the proposed rule, IPP will routinely conduct verification and enforcement activities to verify that geographic landmark claims comply with all requirements (85 FR 56538, 56543).

FSIS will also continue to conduct export certification activities for FSIS-regulated products intended for export to foreign countries. During this process, IPP verify that such products meet country-specific requirements, including labeling requirements, that have been officially communicated to FSIS by the importing country. Thus, the Agency does not expect any issues with regards to obligations it may have to its international trade partners.

Comment: A trade association and a non-profit organization stated that allowing generic approval of geographic landmark claims may weaken, delay, or otherwise conflict with future “Product of USA ” rulemaking. Thus, they asked that FSIS delay any geographic landmark or country of origin specific label rule changes until after such rulemaking is complete. In addition, the comments stated that this final rule may weaken the oversight and integrity of “Product of USA” labels and similar claims, such as “local” or “regional.” They therefore asked that these geographic landmark labels continue to go through the prior label review process.

Response: This final rule will not conflict or interfere with any future “Product of USA” rulemaking. The rule simply modifies the label approval process to allow for generic approval of graphical representations of geographic landmarks displayed on a product label, such as a foreign country's flag, monument, or map. It does not modify the provisions of 9 CFR 317.8 and 381.129, which regulate the use of geographic claims to prevent false or misleading labeling. It also does not modify the label approval process for written claims related to geographical significance or those that make a country of origin statement on the label of any meat or poultry product “covered commodity.”  20 Such claims are already eligible for generic approval. 21 It likewise does not affect the current labeling requirements or the label approval process for similar types of written statements, such as “local” or “regional.”

The final rule will also not weaken regulatory oversight of labels that display geographic landmarks. Although geographic landmark claims will now be generically approved, the rule does not change any labeling requirements for such labels. The use of geographic landmarks must be truthful and not misleading. Moreover, IPP will routinely verify the accuracy of such labels.

Comment: A trade association requested that FSIS expand generic approval to include front-of-package (FOP) statements that repeat information from the nutrition facts panel.

Response: FSIS will not expand generic approval to include FOP statements that repeat information from the nutrition facts panel. FSIS considers certain FOP labeling statements, such as those highlighting select nutrients from the nutrition facts panel placed on the principal display panel, to be nutrient content claims. The requirements for defined nutrient content claims are listed in the regulations. However, unlike traditional nutrient content claims which are defined in FSIS regulations and are eligible for generic approval, such as “low fat,” there are no guidelines for the multiple types of FOP labeling statements on product labels. Therefore, FSIS needs to continue to require prior evaluation by the Agency to ensure these statements are truthful and not misleading.

Comment: A non-profit organization requested that FSIS modify the final rule to state that illustrations and depictions of farms, animals grazing, and animals' living environments are animal raising claims and, as such, are not eligible for generic approval. A few non-profit organizations also asked FSIS to adopt uniform standards for common animal raising claims and require third-party verification of all such claims, whether made pictorially or textually.

Response: The purpose of this final rule is to expand eligibility for generic approval to specific categories of labeling. The final rule will not, and is not intended to, exclude certain types of labeling from eligibility or to establish any new regulations or policies regarding animal raising claims.

Comment: One trade association asked FSIS to engage with stakeholders before it updates its labeling guidance to assure the updated guidance meets the needs of end users. The commenter stated that updating guidance without industry input, especially when substantive changes are being made to the guidance, can cause confusion and, in the case of labeling, delay bringing products to market.

Response: Consistent with its current practices for developing all guidance, FSIS is committed to a public process for updating or publishing new labeling guidance. The availability of all FSIS guidance is announced in the Federal Register or elsewhere and made available for public comment. FSIS considers all input received from its stakeholders and makes changes, as appropriate, to any guidance documents.

Comment: One individual and a software company stated that FSIS should use existing software to automatically review labels. According to the commenters, this would reduce the time spent by FSIS reviewing labels and allow the Agency to concentrate on other priorities. The software company also proposed that FSIS adopt a public-private label review partnership much like AMS uses for organic certification.

Response: These comments are outside the scope of this rulemaking, as they do not pertain to the Agency's proposed expansion of generic labeling. Regardless, FSIS is not convinced that existing software can adequately review labels for compliance with FSIS regulations and policies. FSIS does, however, use an electronic label system to allow for easier label submission. Using the Label Submission and Approval System  22 (LSAS), establishments can submit label applications, supporting materials, and appeals to FSIS via the internet. While the system will not check labels automatically for errors, it will scan them for some common mistakes in the label submission process, including illegibility, missing information on the transmittal form, and missing supporting documentation. The system also includes a feature that helps submitters determine whether a label can be generically approved, or if it must be submitted to FSIS for prior approval.

Comment: An individual recommended that FSIS take steps to improve its generic labeling surveillance and enforcement program.

Response: IPP have consistently demonstrated their ability to review generic labels and ensure a high level of compliance with labeling requirements. Moreover, FSIS has already taken steps to improve its verification system by reissuing FSIS Directive 7221.1 to clarify that, as part of the General Labeling Task, IPP are to routinely review generic labels and verify that establishments have made required modifications to such labels. FSIS has also updated Directive 7221.1 to be consistent with this final rule. In addition, FSIS will continue to train and support IPP on generic labeling via webinars, askFSIS, and other outreach, including having LPDS participate in IPP training conducted by CFL. This final rule promotes the effective use of Agency resources and will allow FSIS to devote more time to better supporting IPP through the development of new and improved training and guidance on, amongst other things, the surveillance, enforcement, and verification activities related to generic labeling.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated by the Office of Information and Regulatory Affairs a “significant” regulatory action under section 3(f) of E.O. 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget under E.O. 12866.

FSIS has updated the benefits estimates in this final regulatory impact analysis as compared to the preliminary regulatory impact analysis published in the proposed rule. These changes include: updating wage rates to 2021 dollars for food scientists and technologists; updating wage rates to 2021 dollars for labeling analysts in LPDS; and updating the number of labeling analysts in LPDS during fiscal year 2021.

The final rule will expand the types of meat, poultry and egg product labels that are generically approved by FSIS. Therefore, this rule will reduce the number of labels evaluated by FSIS and will reduce the costs to industry. The labels submitted for FSIS evaluation are becoming more complex and more time-consuming for industry to prepare and for FSIS to evaluate. The final rule will improve the efficiency of the label approval system by expanding generic labeling and making the system more convenient and cost efficient for the industry. This final rule also will enhance market efficiency by promoting a faster introduction of new products into the marketplace to meet consumer demand.

Based on FSIS' LSAS data, FSIS evaluated 15,459 unique labels during the 2019 fiscal year (FY). Of these, 5,229 (approximately 34 percent) would have been generically approved if this final rule was in place in 2019. This amount (5,229) includes 632 labels currently eligible for generic approval, which firms voluntarily submitted for FSIS review. Many of the 15,459 labels were evaluated by FSIS more than once because they were returned to the producer to make corrections and then resubmitted for FSIS evaluation. FSIS has observed through its prior label approval system that corrections are rare on the types of claims that can now be generically approved under this final rule. In FY 2019, there were 26,158 label adjudications, which includes the total number of evaluations and reevaluations of labels reviewed. See Table 2 below for additional details.

FSIS expanded the types of labels and label changes that may be generically approved several times, starting in 1983 when the Agency evaluated 130,000 labels. In 1991, the number of labels evaluated peaked at 167,500. The 1995 final rule (60 FR 67444) amended the prior label approval process by expanding the types of labels and label changes that may be generically approved. From 2003-2010, the number of label adjudication per year averaged 57,457, with a minimum of 43,255 in 2003 and a maximum of 66,061 in 2010. The 2013 final rule (78 FR 66826, November 7, 2013) further expanded generic labeling, decreasing the number of label adjudications to 30,857 in FY 2016 (Table 2). FSIS also finalized a rule permitting generic approval for certain egg product labels in 2020 (85 FR 68640, October 29, 2020).

The number of FSIS label adjudications decreased after the expansions of generically approved labels. However, the remaining label submissions after each expansion are more time-consuming for industry to prepare and for FSIS to evaluate. This is because the labels requiring submission after each expansion are generally more complex, with special statements or claims that require FSIS to evaluate a significant amount of supporting documentation.

The final rule will not impose any new quantifiable costs on producers that submit labels for FSIS evaluation. Instead, the final rule will reduce the regulatory burden on producers that submit labels for evaluation and does not change the recordkeeping requirements. Producers already are using generically approved labels and maintaining all labeling records and thus are experienced in submitting labels for FSIS evaluation.

Industry will realize cost savings from the reduction in FSIS label submissions under the final rule. Industry is required to use FSIS Form 7234-1 (OMB control number: 0583-0092) for the initial FSIS label submission. The estimated time to complete this form is 75 minutes per response, which includes reviewing instructions, searching existing data sources, gathering and maintaining the data needed (recordkeeping), and completing and reviewing the collection of information. 23 FSIS estimates 15 minutes of the 75 minutes are dedicated to recordkeeping. The recordkeeping time is not included in the final rule's regulatory impact analysis because the recordkeeping requirements will not change under the final rule; that is, even if the establishment does not need to submit the label to FSIS, the establishment is still required to maintain records to support the label. Therefore, the average industry time to prepare one label submission for FSIS evaluation is 60 minutes (75 minutes minus 15 minutes). FSIS also assumed food scientists and technologists perform this work at a mean hourly wage of $40.46. 24 A benefits and overhead factor of two  25 was applied to estimate the total labor cost per label submission of $80.92.

To determine the annual reduction of label submissions, FSIS relied on the average number of labels that FSIS would not have evaluated under the final rule from 2016 to 2019, which was 6,400 labels, ((8,534 + 5,812 + 6,025 + 5,229)/4), Table 2. Accordingly, FSIS estimates a decrease of 64,000 label evaluations over 10 years under the final rule (6,400 * 10). As shown in Table 3, FSIS estimates that industry will realize a discounted cost savings of $3,637,429 (at a 7 percent discount rate) and $4,417,690 (at a 3 percent discount rate) by FSIS generically approving an additional 64,000 labels over a 10-year period. The cost savings is $517,888 when annualized at the 7 and 3 percent discount rate, over 10 years. The primary estimate is over 10 years, but for illustrative purposes, Table 3 shows the potential cost savings at the 7 and 3 percent discount rate over 20 years.

During FY 2021, FSIS employed 15 labeling analysts in LPDS with an average hourly salary of $72.21 (($53.00 * 36.25%) + $53.00 = $72.21 for a GS-13 step 3, 26 with an adjusted benefits factor of 36.25 percent). 27 Prior to this final rule, on average, LPDS analysts evaluated labels four hours per day, five days a week, at a cost of $21,663 per week. Under the final rule, LPDS analysts will evaluate labels for three hours per day, five days a week, at a cost of $16,247 per week, because of the reduction in labels submitted to FSIS.

Under the final rule, the Agency will realize a discounted cost savings of $1,977,974 (at a 7 percent discount rate) and $2,402,267 (at a 3 percent discount rate) for adjudicating fewer labels over a 10-year period. The cost savings is $281,619 when annualized at the 7 and 3 percent discount rate over 10 years. The primary estimate is over 10 years, but for illustrative purposes, Table 4 shows the potential cost savings at the 7 and 3 percent discount rate over 20 years. See Table 4 for additional details.

The Agency plans to utilize any resources made available by this final rule to work on other Agency priority initiatives, such as developing and updating policy and guidance documents, answering questions from askFSIS and other sources, and performing outreach activities. This change in Agency workload will result in more resources for the industry, which improves efficiencies for the Agency and industry alike.

FSIS also anticipates an overall faster label review process from the decline in LPDS label evaluations. This will allow new labels to enter the market faster.

This final rule will be net beneficial because it will reduce the costs to establishments, from submitting fewer labels for FSIS evaluation, while imposing no additional cost burden. The net benefit derived from the final rule is estimated to be $5,615,403 ($3,637,429 in establishment savings plus $1,977,974 in Agency savings) discounted at the 7 percent discount rate over a 10-year period. When annualized at the 7 percent discount rate over 10 years, the net cost savings is estimated to be $799,507. For illustrative purposes, we also included the net cost savings over 20 years in Table 5. See Table 5 for details.

The Agency considered three alternatives to the final rule. The final rule was chosen as the least burdensome regulatory approach. The summary of the costs and benefits for the considered alternatives are outlined in Table 6 below.

FSIS considered keeping the current regulations and taking no action. Taking no action would mean that industry and the Agency would not experience costs savings from the reduction of labels submitted for FSIS evaluation under the final rule. Industry would therefore not realize the estimated reduction of 64,000 label submissions over 10 years and would not experience an annualized cost savings of $517,888 at the 7 percent discount rate over 10 years. The Agency would not experience time savings from the reduction of label evaluations. Therefore, the Agency rejects this alternative.

FSIS considered an alternative of finalizing the same generically approved label categories except FSIS would continue to evaluate those labels that would otherwise be generically approved. Prior to the final rule, industry could submit labels that could be generically approved for voluntary FSIS evaluation, although this evaluation was not needed prior to entering the market. When industry submitted these types of labels for voluntary FSIS evaluation, they were reviewed with a lower priority than other labels, and thus took more time for FSIS to approve. Although industry may marginally benefit from the additional FSIS evaluation, the process is inefficient and raises unnecessary costs. Industry can more quickly get FSIS assistance on these types of labels through other guidance, such as askFSIS.

In addition, FSIS would have to take the time to process and evaluate these labels, when reviewer time could be spent on higher priorities, such as policy related issues ( e.g., updating priority labeling regulations or labeling guidance). Industry would also incur costs in preparing and submitting the labels for FSIS evaluation while they can get FSIS help through other outlets without incurring these expenses. For these reasons, FSIS rejects this alternative.

The final rule yields cost savings for both the industry and the Agency. There is no additional cost burden from the final rule. The potential cost savings for industry is $517,888, annualized at the 7 percent discount rate over 10 years. This covers the time industry saves from not preparing and submitting the labels for FSIS evaluation.

The potential cost savings for FSIS is $281,619, annualized at the 7 percent discount rate over 10 years. This covers the time FSIS saves from not evaluating the generically approved labels. Since there is no additional burden for this final rule, FSIS determined this to be the preferred alternative.

FSIS also considered an alternative that would allow all labels to be generically approved, requiring no prior approval by FSIS. This alternative may increase the number of misbranded products going into commerce, as LPDS would no longer verify the information on complex labels. An increase in misbranded products that contain incorrect, false, or misleading information may result in a loss of consumer confidence in information on food labels. There is also cost associated with discarding and reprinting misbranded labels that the industry may suffer. Therefore, FSIS believes the labels that will still require prior evaluation under the final rule, such as labels with animal raising, natural, or front of package nutrition labeling claims, benefit from LPDS evaluation due to the complex nature and need for supporting documentation of these claims.

This alternative would yield time savings for industry from no longer preparing and submitting labels for FSIS evaluation. FSIS would also experience time savings from no longer evaluating these labels. However, the potential costs of misbranded products entering commerce, resulting from the elimination of all LPDS label evaluation, would outweigh the benefits of the time savings.

The FSIS Administrator certifies that, for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will not have a significant economic impact on a substantial number of small entities in the United States. This determination was made because small producers will experience costs savings from the reduced number of label submissions for FSIS evaluation.

Based on LSAS and PHIS data, FSIS estimates 92.3 percent (4,825/5,229) of the label submissions in 2019, which would have been generically approved under the final rule, are from small or very small Hazard Analysis and Critical Control Point (HACCP) sized establishments. Under the HACCP size definitions, large establishments have 500 or more employees and small establishments have fewer than 500 but more than 10 employees. Very small establishments have fewer than 10 employees or annual sales of less than $2.5 million. Small and very small establishments, like large establishments, follow the same standards for generic and sketch approval of labels. Small and very small producers, therefore, will not be disadvantaged because the final rule will minimize the regulatory burden on all producers.

Based on 2019 LSAS data, about 12 percent (627/5,229) of labels that would have been generically approved under the final rule, were submitted from 19 label consultant firms. These firms are very small, usually having one to four employees. Many of these firms provide a range of services, including label courier services, label consultation and regulatory compliance, or label design. This final rule may impact their label courier business. However, the impact on these firms is small as their other business, such as label consultations, will not be affected. Therefore, this final rule will not have a significant economic impact on the small label consultant firms.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements have been submitted for approval to the Office of Management and Budget (OMB).

FSIS is expanding the circumstances under which it will generically approve the labels of meat, poultry, and processed egg products. Under this final rule, more official and foreign establishments will be able to use the generic approval of product labels. As a result, fewer labels will need to be submitted and evaluated by FSIS. The relevant information collection, 0583-0092, Marking, Labeling, and Packaging, has a net reduction of 6,400 burden hours because of the increased use of generic labeling.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Mission Areas, agencies, staff offices, 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/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.

Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information ( e.g., Braille, large print, audiotape, American Sign Language) should contact the responsible Mission Area, agency, or staff office; the USDA TARGET Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service at (800) 877-8339.

To file a program discrimination complaint, a complainant should complete a Form AD-3027, USDA Program Discrimination Complaint Form, which can be obtained online at https://www.ocio.usda.gov/document/ad-3027, from any USDA office, by calling (866) 632-9992, or by writing a letter addressed to USDA. The letter must contain the complainant's name, address, telephone number, and a written description of the alleged discriminatory action in sufficient detail to inform the Assistant Secretary for Civil Rights (ASCR) about the nature and date of an alleged civil rights violation. The completed AD-3027 form or letter must be submitted to USDA by:

(1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410;

(2) Fax: (833) 256-1665 or (202) 690-7442; or

(3) Email: program.intake@usda.gov.

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

FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq. ) by, among other things, promoting the use of the internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) no administrative proceedings will be required before parties may file suit in court challenging this rule.

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.

The USDA's Office of Tribal Relations (OTR) 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. If a tribe requests consultation, FSIS will work with the OTR to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress.

Each USDA agency is required to comply with 7 CFR part 1b of the Departmental regulations, which supplements the National Environmental Policy Act regulations published by the Council on Environmental Quality. Under these regulations, actions of certain USDA agencies and agency units are categorically excluded from the preparation of an Environmental Assessment (EA) or an Environmental Impact Statement (EIS) unless the agency head determines that an action may have a significant environmental effect (7 CFR 1b.4 (b)). FSIS is among the agencies categorically excluded from the preparation of an EA or EIS (7 CFR 1b.4 (b)(6)).

FSIS has determined that this final rule, which refines the Agency's existing label approval program, will not create any extraordinary circumstances that would result in this normally excluded action having a significant individual or cumulative effect on the human environment. Therefore, this action is appropriately subject to the categorical exclusion from the preparation of an environmental assessment or environmental impact statement provided under 7 CFR 1b.4(6) of the U.S. Department of Agriculture regulations.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https://www.fsis.usda.gov/federal-register.

FSIS will also announce and provide a link to it through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

For the reasons set forth in the preamble, FSIS is amending 9 CFR chapter III as follows:

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act)  1 to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The Inflation Adjustment Act provides for the regular evaluation of CMPs and requires FCSIC, and every other Federal agency with authority to impose CMPs, to ensure that CMPs continue to maintain their deterrent values. 2

FCSIC must enact regulations that annually adjust its CMPs pursuant to the inflation adjustment formula of the amended Inflation Adjustment Act and rounded using a method prescribed by the Inflation Adjustment Act. The new amounts are applicable to penalties assessed on or after January 15, 2023, for conduct occurring on or after November 2, 2015. Agencies do not have discretion in choosing whether to adjust a CMP, by how much to adjust a CMP, or the methods used to determine the adjustment.

First, section 5.65(c) of the Farm Credit Act, as amended (Act), provides that any insured Farm Credit System bank that willfully fails or refuses to file any certified statement or pay any required premium shall be subject to a penalty of not more than $100 for each day that such violations continue, which penalty FCSIC may recover for its use. 3 Second, section 5.65(d) of the Act provides that, except with the prior written consent of the Farm Credit Administration, it shall be unlawful for any person convicted of any criminal offense involving dishonesty or a breach of trust to serve as a director, officer, or employee of any System institution. 4 For each willful violation of section 5.65(d), the institution involved shall be subject to a penalty of not more than $100 for each day during which the violation continues, which FCSIC may recover for its use.

FCSIC's current § 1411.1 provides that FCSIC can impose a maximum penalty of $231 per day for a violation under section 5.65(c) and (d) of the Act.

The 2015 Act requires agencies to make annual adjustments for inflation. Annual inflation adjustments are based on the percent change between the October Consumer Price Index for all Urban Consumers (CPI-U) preceding the date of the adjustment, and the prior year's October CPI-U. Based on the CPI-U for October 2022, not seasonally adjusted, the cost-of-living adjustment multiplier for 2023 is 1.07745. 5 Multiplying 1.07745 times the current penalty amount of $231, after rounding to the nearest dollar as required by the 2015 Act, results in a new penalty amount of $249.

In accordance with the 2015 Act, Federal agencies shall adjust civil monetary penalties “notwithstanding” Section 553 of the Administrative Procedures Act. This means that public procedure generally required for agency rulemaking—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.

For the reasons stated in the preamble, part 1411 of chapter XIV, title 12 of the Code of Federal Regulations is amended as follows:

A copy of the Miscellaneous Amendments final rule may be viewed online at https://www.regulations.gov using the docket number listed above. A copy of this correction will be placed in the same docket. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register's website at https://www.federalregister.gov and the Government Publishing Office's website at https://www.govinfo.gov. A copy may also be found at the FAA's Regulations and Policies website at https://www.faa.gov/regulations_policies.

Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket or notice number of this rulemaking.

All documents the FAA considered in developing this correction, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.

On December 9, 2022, the Miscellaneous Amendments final rule (RIN 2120-AL53) published in the Federal Register at 87 FR 75704. After publication, the FAA discovered that it inadvertently identified the Amendment Nos. for parts 25, 33, 47, 73, and 101 as 25-146, 33-1, 47-32, 73-1, and 101-9. The correct Amendment Nos. are 25-148, 33-35, 47-34, 73-9, and 101-11. This document makes those corrections.

In FR Doc. 2022-23327, beginning on page 75704, in the Federal Register of December 9, 2022, make the following correction in the header of the document. On page 75704, in the first column, in the header of the document, the listing of docket number and amendment nos. is corrected to read as follows:

[Docket No. FAA-2022-1355; Amdt. Nos. 21-106, 23-65, 25-148, 29-58, 33-35, 36-32, 47-34, 49-11, 60-7, 61-151, 67-22, 73-9, 91-366, 97-1339, 101-11, 107-10, 121-387, 125-72, 129-54, 135-143, 141-24, 183-18, 440-6]

This action confirms the effective date of the Increase the Duration of Aircraft Registration direct final rule  1 and provides FAA's response to the public comments. The direct final rule amends the duration of all Certificates of Aircraft Registration (certificates) issued under part 47 of Title 14 of the Code of Federal Regulations (14 CFR) from three years to seven years. Aircraft owners will be required to confirm their registration information and renew their certificate every seven years, unless an event or circumstance necessitates a new registration being submitted prior to the expiration of the certificate. Accordingly, the direct final rule adds a paragraph to § 47.40 to require aircraft owners to submit new registration forms to update their certificates prior to the seven-year expiration date if the Administrator determines that their registration information is inaccurate. These amendments apply to initial and renewed certificates, in accordance with § 47.40(b) and (c).

The FAA also corrects its amendment to 14 CFR 47.31(c)(1) to remove the requirement that the FAA issue a letter extending the temporary authority for an aircraft to operate when a certificate of aircraft registration has not been issued or denied within 90 days after the date the application was signed.

The FAA is also removing expired regulations pertaining to the re-registration requirement detailed in § 47.40(a) and references to re-registration in §§ 47.15(i)(1) and 47.17(a)(7). The re-registration regulations became obsolete January 1, 2014.

The FAA received a total of twelve comments in response to the published direct final rule. Commenters included Airlines for America (A4A), Aircraft Owners and Pilots Association (AOPA), National Business Aviation Association (NBAA), and nine individuals. Six individual commenters supported the direct final rule without change. Three individuals expressed alternative approaches to the duration of aircraft registration. However, the FAA has determined that those three comments are outside of the scope of the rulemaking because this rulemaking was solely in response to the statutory requirement contained in Sec. 556, which requires a seven-year duration of aircraft registration. For reasons described in the direct final rule, the FAA does not distinguish between non-commercial general aviation aircraft and commercial aircraft because that distinction could change from one operation to the next. Accordingly, this rule merely effectuates a statutory requirement. Because those three comments are outside of the scope of the rulemaking, the FAA does not consider them to be adverse comments. Regarding comments about implementation, the FAA will provide follow-on information explaining how the FAA will effectuate this rule for existing aircraft registrations.

The NBAA recommended a technical correction regarding a misplaced comma in the regulatory text of 14 CFR 47.31. The FAA agrees with NBAA that a correction is necessary, and has revised the sentence to remove the misplaced comma, as indicated in the correction included in this document. After consideration of the comments submitted in response to the Increase the Duration of Aircraft Registration direct final rule, the FAA has determined that no further rulemaking action is necessary. Therefore, the direct final rule published November 22, 2022 at 87 FR 71210, Amendment No. 47-33, will become effective January 23, 2023. The FAA is making one typographical correction as noted previously.

A copy of this confirmation document, the direct final rule, all comments received, and all background material may be viewed online at https://www.regulations.gov using the docket number listed above. A copy of this confirmation document will be placed in the docket. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register's website at https://www.federalregister.gov and the Government Publishing Office's website at https://www.govinfo.gov. A copy may also be found at the FAA's Regulations and Policies website at https://www.faa.gov/regulations_policies.

Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Interested persons must identify the docket or amendment number of this rulemaking.

All documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.

In FR Doc. 2022-25289, appearing at 87 FR 71210 in the issue of Tuesday, November 22, 2022, on page 71217, in the third column, in amendatory instruction 4, § 47.31(c)(1) is corrected to read as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends airspace in Manchester and Nashua, NH, to support IFR operations in the area.

The FAA published a notice of proposed rulemaking in the Federal Register (87 FR 60356, October 5, 2022) for Docket No. FAA-2022-1207 to amend Class E surface airspace, Class E airspace designated as an extension to a Class C surface area, and Class E airspace extending upward from 700 feet above the surface at Manchester Boston Regional Airport (formerly Manchester Airport), Manchester, NH, and updating the airport's coordinates. Also, this action proposed to amend Class D airspace, Class E airspace designated as an extension to Class D surface area, and Class E airspace extending upward from 700 feet above the surface at Boire Field Airport (formerly Boire Field), by updating the names of each airport, and removing unnecessary verbiage from the airport description.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in Paragraphs 5000, 6002, 6003, 6004, and 6005, respectively, of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

This document amends FAA Order JO 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic routes, and reporting points.

The FAA is amending 14 CFR part 71 by amending Class E surface airspace, Class E airspace designated as an extension to a Class C surface area, and Class E airspace extending upward from 700 feet above the surface at Manchester Boston Regional Airport (formerly Manchester Airport) Manchester, NH. This action also updates the coordinates of Manchester Boston Regional Airport. Also, this action amends Class D airspace, Class E airspace designated as an extension to Class D surface area, and Class E airspace extending upward from 700 feet above the surface at Boire Field Airport (formerly Boire Field), by removing unnecessary verbiage from the airport description, as the Class E extensions are not part time, as per Order 7400.2N. This action also replaces the term Notice to Airmen with the term Notice to Air Missions, and the term Airport/Facility Directory with the term Chart Supplement in the airspace descriptions, and updates the name of both airports.

Class D and E airspace designations are published in Paragraphs 5000, 6002, 6003, 6004, and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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 minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a.

This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

The FAA published a notice of proposed rulemaking (NPRM) for Docket No. FAA-2021-0822 in the Federal Register (86 FR 60421; November 2, 2021), amending VOR Federal airways V-214, V-285, and V-305, and revoking V-96. The proposed amendment and revocation actions were due to the planned decommissioning of the VOR portion of the Kokomo, IN, VORTAC NAVAID. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

VOR Federal airways are published in paragraph 6010(a) of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document will be published subsequently in FAA Order JO 7400.11.

Subsequent to the NPRM, the FAA published a rule for Docket No. FAA-2021-1030 in the Federal Register (87 FR 29039; May 12, 2022), amending VOR Federal airway V-305 by removing the airway segment between the Walnut Ridge, AR, VORTAC and the Cunningham, KY, VOR/Distance Measuring Equipment (VOR/DME). That airway amendment, effective July 14, 2022, is included in this rule.

Also subsequent to the NPRM, the FAA published a rule for Docket No. FAA-2021-0972 in the Federal Register (87 FR 38913; June 30, 2022), amending VOR Federal airway V-285 by removing the airway segment between the Victory, MI, VOR/DME and the White Cloud, MI, VOR/DME. That airway amendment, effective September 8, 2022, is also included in this rule.

Additionally, subsequent to the NPRM, the FAA published a rule for Docket No. FAA-2022-0646 in the Federal Register (87 FR 54878; September 8, 2022), amending VOR Federal airway V-214 by removing the airway segment between the Martinsburg, WV, VORTAC and the Teterboro, NY, VOR/DME. That airway amendment, effective November 3, 2022, is also included in this rule.

Lastly, in the NPRM, the FAA erroneously stated that, although the VOR portion of the Kokomo VORTAC was planned for decommissioning, the co-located DME would be retained. The DME will be decommissioned; however, the co-located Tactical Air Navigation (TACAN) is being retained to provide navigational service for military operations and DME service in support of current and future Next Generation Air Transportation System Performance Based Navigation procedures. This does not affect the changes to the airways in this rule.

This document amends FAA Order JO 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by modifying VOR Federal airways V-214, V-285, and V-305, and removing VOR Federal airway V-96 due to the planned decommissioning of the Kokomo, IN, VOR NAVAID. The VOR Federal airway actions are described below.

V-96: V-96 extends between the Brickyard, IN, VORTAC and the intersection of the Fort Wayne, IN, VORTAC 071° and Flag City, OH, VORTAC 289° radials (TWERP fix). The airway is removed in its entirety.

V-214: V-214 extends between the Kokomo, IN, VORTAC and the Muncie, IN, VOR/DME; and between the intersection of the Appleton, OH, VORTAC 236° and Zanesville, OH, VOR/DME 274° radials (GLOOM fix) and the Bellaire, OH, VOR/DME. The airway segment between the Kokomo, IN, VORTAC and the Muncie, IN, VOR/DME is removed. As amended, the airway is changed to extend between the intersection of the Appleton VORTAC 236° and Zanesville VOR/DME 274° radials (GLOOM Fix) and the Bellaire VOR/DME.

V-285: V-285 extends between the Brickyard, IN, VORTAC and the Victory, MI, VOR/DME. The airway segment between the Brickyard, IN, VORTAC and Goshen, IN, VORTAC is removed. As amended, the airway is changed to extend between the Goshen VORTAC and the Victory VOR/DME.

V-305: V-305 extends between the El Dorado, AR, VOR/DME and the Walnut Ridge, AR, VORTAC; and between the Cunningham, KY, VOR/DME and the Kokomo, IN, VORTAC. The airway segment between the Brickyard, IN, VORTAC and Kokomo, IN, VORTAC is removed. As amended, the airway is changed to extend between the El Dorado VOR/DME and the Walnut Ridge VORTAC and between the Cunningham VOR/DME and the Brickyard VORTAC.

All NAVAID radials listed in the VOR Federal airway descriptions below are unchanged and stated in True degrees.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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 Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of modifying VOR Federal airways V-214, V-285, and V-305, and revoking V-96, due to the planned decommissioning of the VOR portion of the Kokomo, IN, VORTAC NAVAID, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points) and paragraph 5-6.5k, which categorically excludes from further environmental impact review the publication of existing air traffic control procedures that do not essentially change existing tracks, create new tracks, change altitude, or change concentration of aircraft on these tracks. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface at Carrington Municipal Airport, Carrington, ND; Cooperstown Municipal Airport, Cooperstown, ND; Harvey Municipal Airport, Harvey, ND; Rolla Municipal Airport/Leonard Krech Field, Rolla, ND; and Walhalla Municipal Airport, Walhalla, ND, to support instrument flight rule operations at these airports.

The FAA published a notice of proposed rulemaking in the Federal Register (87 FR 66634; November 4, 2022) for Docket No. FAA-2022-1316 to amend the Class E airspace at Carrington, ND; Cooperstown, ND; Harvey, ND; Rolla, ND; and Walhalla, ND. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

This document amends FAA Order JO 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71:

Amends the Class E airspace extending upward from 700 feet above the surface at Carrington Municipal Airport, Carrington, ND, by removing the Devils Lake VOR/DME and the airspace extending upward from 1,200 feet above the surface from the airspace legal description as it is redundant with the airspace extending upward from 1,200 feet above the surface over the State of North Dakota;

Amends the Class E airspace extending upward from 700 feet above the surface to within a 6.3-mile (decreased from a 6.4-mile) radius of Cooperstown Municipal Airport, Cooperstown, ND; and removes the Devils Lake VOR/DME, Hector International Airport, Grand Forks AFB, Jamestown VOR/DME, Barnes City Municipal Airport, and the airspace extending upward from 1,200 feet above the surface from the airspace legal description as it is redundant with the airspace extending upward from 1,200 feet above the surface over the State of North Dakota;

Amends the Class E airspace extending upward from 700 feet above the surface at Harvey Municipal Airport, Harvey, ND, by removing Minot AFB, Bismarck VOR/DME, Devils Lake VOR/DME, and the airspace extending upward from 1,200 feet above the surface from the airspace legal description as it is redundant with the airspace extending upward from 1,200 feet above the surface over the State of North Dakota;

Amends the Class E airspace extending upward from 700 feet above the surface to within a 6.4-mile (decreased from a 7.3-mile) radius of Rolla Municipal Airport/Leonard Krech Field, Rolla, ND; removes the exclusion north of lat. 49°00′00″N. as it is no longer required; removes the Devils Lake VOR/DME and the airspace extending upward from 1,200 feet above the surface from the airspace legal description as it is redundant with the airspace extending upward from 1,200 feet above the surface over the State of North Dakota; and updates the name of the airport (previously Rolla Municipal Airport) to coincide with the FAA's aeronautical database;

And amends the Class E airspace extending upward from 700 feet above the surface at Walhalla Municipal Airport, Walhalla, ND, by removing the Devils Lake VOR/DME and the airspace extending upward from 1,200 feet above the surface from the airspace legal description as it is redundant with the airspace extending upward from 1,200 feet above the surface over the State of North Dakota.

This action is due to airspace reviews conducted as part of the decommissioning of the Devils Lake VOR, which provided navigation information for the instrument procedures at these airports, as part of the VOR MON Program.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue a rule regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it amends airspace for Athens/Ben Epps Airport, Athens, GA, to support IFR operations in the area.

The FAA published a notice of proposed rulemaking in the Federal Register (87 FR 67584, November 9, 2022) for Docket No. FAA-2022-1333 to amend Class D airspace, Class E surface airspace, Class E airspace designated as an extension to a Class D surface area, and Class E airspace extending upward from 700 feet above the surface at Athens/Ben Epps Airport, Athens, GA, as a result of the biennial airspace evaluation.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in Paragraphs 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

Subsequent to the publication of the Notice of Proposed Rulemaking, the FAA found the distances on each side of the Athens Point of Origin 195° bearing and the Athens Point of Origin 076° bearing were incorrect. The dimensions were correct in the Proposal section of the Preamble but were mistakenly transposed in the airspace description. This action corrects the error. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.

This document amends FAA Order 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022. FAA Order 7400.11G is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic routes, and reporting points.

The FAA is amending 14 CFR part 71 by extending the Class D airspace for Athens/Ben Epps Airport from a 4-mile radius to a 4.6-mile radius surrounding the airport and by updating the airport's geographic coordinates to coincide with the FAA's database. Also, Class E surface airspace, extension to Class D airspace, and transition airspace are being amended for the above airport. Class E surface airspace for Athens/Ben Epps Airport is being extended from a 4-mile radius to a 4.6-mile radius surrounding the airport. The Class E airspace used for an extension to Class D is being reduced from 3 miles to 1.4 miles on each side of the Athens Point of Origin 195° bearing extending from the 4.6-mile radius of the Athens/Ben Epps Airport to 7.6 miles south of the Point of Origin and is being reduced from 3 miles to 2.4 miles each side of the Athens Point of Origin 076° bearing extending from the 4.6-mile radius of the airport to 7 miles east of the Point of Origin. The Class E5 transition airspace extending upward from 700 feet above the surface is being amended to within a 7.7-mile radius of Athens/Ben Epps Airport (reduced from an 11.5-mile radius). This eliminates the excess airspace that remained after the decommissioning of the Bulldog (BJT) non-directional beacon (NDB) and subsequent cancellation of the NDB Rwy 27 approach, effective October 15, 2015 (80 FR 61978). In addition, this action replaces the outdated terms Airport/Facility Directory with Chart Supplement and Notice to Airmen with the term Notice to Air Missions in the airspace descriptions. This action also replaces the VORTAC used for airspace definition with a point-of-origin.

Subsequent to the publication of the Notice of Proposed Rulemaking, the FAA found the distances on each side of the Athens Point of Origin 195° bearing and the Athens Point of Origin 076° bearing were incorrect. The dimensions were correct in the Proposal section of the Preamble but were mistakenly transposed in the airspace description. This action corrects the error. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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 minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraphs 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances warrant the preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

On October 7, 2022, the Bureau of Industry and Security (BIS) put on public display the interim final rule, Implementation of Additional Export Controls: Certain Advanced Computing and Semiconductor Manufacturing Items; Supercomputer and Semiconductor End Use; Entity List Modification (October 7 advanced computing and semiconductor manufacturing equipment rule) (87 FR 62186), which amended the Export Administration Regulations (15 CFR 730-774) (EAR) to implement necessary controls on advanced computing integrated circuits (ICs), computer commodities that contain such ICs, and certain semiconductor manufacturing items, and to make other changes to the EAR to ensure that appropriate controls are in place for these items, including specific activities of “U.S. persons.”

On October 13, 2022, (BIS) published the October 7 advanced computing and semiconductor manufacturing equipment rule, which made critical changes to the Export Administration Regulations (15 CFR 730-774) (EAR) in two areas to address U.S. national security and foreign policy concerns. First, BIS imposed additional export controls on certain advanced computing semiconductor chips (chips, advanced computing chips, integrated circuits (ICs)), transactions for supercomputer end uses, and transactions involving certain entities on the Entity List (supplement no. 4 to part 744). Second, BIS adopted additional controls on certain semiconductor manufacturing items and transactions for certain IC production end uses. See the Overview of New Controls section in the October 7 advanced computing and semiconductor manufacturing equipment rule for additional information about both. The October 7 advanced computing and semiconductor manufacturing equipment rule, which BIS published on an interim basis, also solicited public comments on the changes it implemented. See the ADDRESSES section for instruction on how to submit comments to that rule and information on how to view the public comments submitted in response to the October 7 advanced computing and semiconductor manufacturing equipment rule on www.regulations.gov.

The restrictions implemented in the October 7 advanced computing and semiconductor manufacturing equipment rule followed extensive consideration by the United States government of technologies that are force multipliers for military modernization and human rights abuses. The assessment considered included, among other factors, whether the items could provide direct contributions to advancing military decision making, designing and testing weapons of mass destruction (WMD), producing semiconductors for use in advanced military systems, and developing advanced surveillance systems that can be used for military applications and human rights abuses. The Government of the People's Republic of China (PRC or China) has mobilized vast resources to support its defense modernization, including the implementation of its military-civil fusion development strategy, which is contrary to U.S. national security and foreign policy interests.

This rule makes initial updates to the October 7 advanced computing and semiconductor manufacturing equipment rule's controls to more effectively achieve the identified policy objectives by adding the same controls implemented on China in that rule to Macau. These changes are informed by BIS's review of the October 7 advanced computing and semiconductor manufacturing equipment rule and the questions BIS has received since October 7, 2022. The comment period on the October 7 advanced computing and semiconductor manufacturing equipment rule, originally to close on December 12, 2022 but, in a rule published on December 7, 2022 (87 FR 74966) was extended to close on January 31, 2023. The public may submit comments on the controls in the October 7 advanced computing and semiconductor manufacturing equipment rule, which BIS is extending to Macau in this rule. BIS intends to publish a subsequent rule to respond to the comments, including additional updates to the controls in the October 7 advanced computing and semiconductor manufacturing equipment rule. The updates to the October 7 advanced computing and semiconductor manufacturing equipment rule in this rule are described under Section II below.

This rule adds the destination of Macau to the scope of the Regional Stability (RS) controls that were implemented specific to China in the October 7 advanced computing and semiconductor manufacturing equipment rule. For purposes of the EAR, this rule does not change the status of Macau; it will continue to be treated as a separate destination from China. According to the U.S. Department of State's fact sheet, U.S. Relations with Macau, Bilateral Relations Fact Sheet of June 1, 2021 (see https://www.state.gov/u-s-relations-with-macau/ ), Macau has been a Special Administrative Region of China since 1999, when it was returned to Chinese sovereignty from Portuguese administration; therefore, its foreign relations and defense are the responsibility of China. China grants Macau limited autonomy in economic and commercial relations. U.S. policy toward Macau is grounded in the U.S. Macau Policy Act of 1999 and reflects U.S. support for Macau's autonomy under the “One Country, Two Systems” framework established in Macau's Basic Law.

Because of Macau's position as a Special Administrative Region of China, and the potential risk of diversion of items subject to the EAR from Macau to China, this rule adds Macau as a destination to which a license will be required to prevent the diversion to China of items determined to be critical to protecting U.S. national security and foreign policy interests. This rule implements this change by adding Macau to the RS control paragraph in the following seven Export Control Classification Numbers (ECCNs): 3A090, 3B090, 3D001, 3E001, 4A090, 4D090, and 4E001.

In parallel with the addition of Macau to the RS control paragraph of the ECCNs identified above, and as part of the RS control structure implemented in the October 7 advanced computing and semiconductor manufacturing equipment rule, this rule also adds Macau to the general restriction on the use of license exceptions for these RS-controlled ECCNs in § 740.2(a)(9). Additionally, in § 742.6, this rule adds Macau to paragraphs (a)(6) and (b)(10), as part of the RS control structure implemented in the October 7 advanced computing and semiconductor manufacturing equipment rule.

In § 734.9, this rule adds Macau to the destination scope of the Advanced computing FDP rule under paragraph (h) and to the “Supercomputer” FDP rule under paragraph (i) by adding Macau to paragraphs (h)(2)(i) and (ii) and paragraphs (i)(2)(i) and (ii), respectively. BIS is adding Macau to these two FDP rules as part of the RS control structure implemented in the October 7 advanced computing and semiconductor manufacturing equipment rule.

In supplement no. 1 to part 734—Model Certification for Purposes of Advanced Computing FDP rule, this rule makes a conforming change by adding Macau to the certification under paragraph (b)(2).

This rule adds Macau as an additional destination in the end-use controls under §§ 744.6 and 744.23. Because China has invested large amounts of capital to develop a special economic zone to develop semiconductors in Macau and the diversion concerns to China referenced above, there is a need to include Macau as an additional destination under §§ 744.6 and 744.23 at this time. This rule makes the following changes to add Macau to §§ 744.6 and 744.23.

In § 744.6, this rule adds Macau to the additional prohibitions on “U.S. persons” informed by BIS paragraphs (c)(2)(i) through (ix) and to the license review standards under paragraph (e)(3).

In § 744.23, this rule adds Macau to the end-use scope under paragraphs (a)(2)(i) through (v) and to the license review standards in paragraph (d).

In supplement no. 1 to part 736—General Orders, this rule revises paragraph (d) (General Order No. 4), as a conforming change to the addition of Macau to the RS controls and FDP rules, as described above, to add Macau to the scope of the temporary general license (TGL).

The savings clause for the advanced computing rule has already passed and is not being renewed or extended with the publication of this rule. This rule does include a savings clause which is specific and limited to the new controls for Macau.

Shipments of items removed from license exception eligibility or eligibility for export, reexport, or transfer (in-country) without a license to or within Macau as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting carrier, or en route aboard a carrier to a port of export, on January 17, 2023, may continue to the destination under the previous license exception eligibility or without a license so long as they have been exported, reexported or transferred (in-country) before February 16, 2023. Any such items not actually exported, reexported or transferred (in-country) before midnight, on February 16, 2023, require a license in accordance with this interim final rule.

On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (codified, as amended, at 50 U.S.C. Sections 4801-4852). ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule. To the extent it applies to certain activities that are the subject of this rule, the Trade Sanctions Reform and Export Enhancement Act of 2000 (TSRA) (codified, as amended, at 22 U.S.C. Sections 7201-7211) also serves as authority for this rule.

1. This interim final rule is not a “significant regulatory action” because it “pertain[s]” to a “military or foreign affairs function of the United States” under sec. 3(d)(2) of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number.

This rule involves the following OMB-approved collections of information subject to the PRA:

• 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 29.4 minutes for a manual or electronic submission;

• 0694-0096 “Five Year Records Retention Period,” which carries a burden hour estimate of less than 1 minute; and

• 0607-0152 “Automated Export System (AES) Program,” which carries a burden hour estimate of 3 minutes per electronic submission.

BIS does not anticipate any changes in these estimates as a result of the changes include in today's rule. Additional information regarding these collections of information—including all background materials—can be found at https://www.reginfo.gov/public/do/PRAMain by using the search function to enter either the title of the collection or the OMB Control Number.

3. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.

4. Pursuant to section 1762 of ECRA (50 U.S.C. 4821), this action is exempt from the Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date. While section 1762 of ECRA provides sufficient authority for such an exemption, this action is also independently exempt from these APA requirements because it involves a military or foreign affairs function of the United States (5 U.S.C. 553(a)(1)).

5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

For the reasons stated in the preamble, parts 734, 736, 740, 742, 744, 762, 772, and 774 of the Export Administration Regulations (15 CFR parts 730 through 774) are amended as follows:

On January 10, 2022, VA published a proposed rule in the Federal Register , 87 FR 1087, to amend its regulations to add new approval requirements for accredited and nonaccredited programs designed to prepare an individual for licensure and certification in a State and to allow VA to waive the added approval requirements under certain circumstances. VA provided a 60-day comment period, which ended on March 10, 2022. We received two comments on the proposed amendments. Both comments supported the rulemaking, but requested clarifying information, which we provide below.

One comment requested that VA clarify the “undefined terms in 38 U.S.C. 3676 (approval of nonaccredited courses),” listing as undefined: “Quality,” “Qualifications,” “Financially Sound,” “Substantial Misrepresentation,” “Good Reputation and Character,” “Licensure and Certification,” “Such Additional Criteria. . . ,” and “Administrative Support.” The commenter stated that the standards to protect student veterans and GI Bill funds in 38 U.S.C. 3676 have been undefined and rarely enforced resulting in the abuse of veteran benefits and taxpayer funds.

VA shares the concern for the protection of student veterans and their VA education benefits and wants to provide assurances that the standards in sec. 3676 are clearly defined and upheld. The regulatory amendments implementing the provisions of the Jeff Miller and Richard Blumenthal Veterans Healthcare and Benefits Improvement Act of 2016 will provide safeguards against abuse of veterans and their VA educational benefits with regard to programs that are designed to prepare an individual for licensure or certification. The new approval requirements will ensure that courses designed to prepare an individual for licensure or certification meet all instructional curriculum licensure and certification requirements, and courses designed to prepare an individual for employment meet the standards developed by a board or agency. Likewise, for courses designed to prepare an individual for licensure to practice law, the new approval requirements will ensure that the courses are accredited by a specialized accrediting agency for programs of legal education, or an association recognized by the Department of Education. We believe our implementation in this rulemaking of the legal standards will ensure the protection of student Veterans and GI Bill funds, and further clarification is not necessary. Thus, we will not make any changes based on this comment.

Also, the State Approving Agency's (SAA) authority in new 38 CFR 21.4253(d) and 21.4254(c)(15) to impose additional approval criteria and the requirement in these provisions that SAAs consult with VA before imposing the new criteria to ensure that the criteria are necessary and equitable with regard to public, private, and proprietary educational institutions will provide protection against abuse of veterans benefits and taxpayer funds. In addition, the requirement in new 38 CFR 21.4259(e) to publicly disclose the conditions or requirements for obtaining the license, certification, or approval or face disapproval will protect veterans from being deceived about the skills they need for licensure or certification. Therefore, we do not think it is necessary to further define terms in sec. 3676 and will not make any additional changes based on these comments.

A second comment requested that VA collaborate with the Department of Education to determine common language and direction, where possible, when addressing institution responsibilities to manage student aid for postsecondary programs leading to a license or certification. VA is happy to consider the request to collaborate with the Department of Education when necessary to address an institution's responsibilities concerning managing student aid for programs that lead to licensure or certification to make any processes less confusing for students; however, we will not make any changes to the rule based on this comment as it is beyond the scope of this rulemaking.

This comment also requested clarification on implementation of proposed 38 CFR 21.4253(d)(9)(i) with regard to how VA will advise the SAA and the institution seeking State program approval to address interstate programs provided by distance education that lead to a license or certification. For SAA approval, § 21.4253(d)(9)(i) requires that a course designed to prepare an individual for licensure or certification in a State meet all instructional curriculum licensure or certification requirements of such State. Such courses are required to meet the same instructional curriculum licensure or certification requirements established by their State whether the program is conducted via distance learning or in person. The comment referenced confusion with regard to jurisdiction for obtaining SAA approval of “interstate distance education.” Section 21.4253(d)(9)(i) does not address SAA jurisdiction for purposes of approval of licensure or certifications courses, and therefore, we will not address the jurisdictional issue in this rulemaking. However, the general provisions in 38 CFR 21.4250, governing licensing and certification test approval and jurisdiction, remain applicable.

Additionally, this comment requested clarification concerning the specific additional requirements that must be part of the notifications that are intended by the requirement in proposed 38 CFR 21.4259(e) directing an SAA to disapprove a course leading to a license or certification when an institution fails to publicly disclose “any conditions or additional requirements, including training, experience, or examinations, required to obtain the license, certification, or approval for which the course of education is designed to provide preparation.” The additional requirements that must be part of the notifications refer to any requirements set by a state licensing or certifying agency, such as training required for licensure, certification, or approval, any prior experience that is a prerequisite for obtaining the license, certification, or approval, or any examinations that must be taken before a student can obtain a license, certification, or approval. Because each state licensing or certifying agency establishes their own distinct requirements, we are unable to be more specific about the requirements in this rulemaking. If there are any requirements beyond training, prior experience, or examinations that a student must meet to obtain a particular license, certification, or approval, an institution or training facility must disclose those requirements. Thus, we will not make any changes based on this comment.

For the reasons stated above, VA will adopt the proposed rule as final, without change.

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

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). VA has determined that, although there may be a number of educational training facilities and SAAs considered small entities which may be affected by this rule, they will not be significantly impacted by this rule.

Allowing waiver of the added approval requirements under certain circumstances, as well as requiring SAAs to present a written proposal to VA justifying the need for adding additional approval criteria for approving either accredited or nonaccredited programs, will likely have some impact on both educational training institutions and SAAs. However, the impact will be minimal. VA estimates that five educational facilities will request a waiver per year and that the estimated cost for any educational institution seeking a waiver will be less than $300. Also, VA estimates that approximately eleven requests per year from SAAs will be received to add additional approval criteria and the estimated cost for SAAs making these requests will also be less than $300. Accordingly, the number of schools and SAAs affected will not be substantial and the impact on each will not be significant. Therefore, under 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

The provisions requiring institutions to meet certain criteria to maintain eligibility for receipt of VA educational benefits could also entail costs to these institutions, such as the cost of making program changes to meet the new requirements or the loss of funding derived from VA benefit payments because of an inability to meet the new requirements or obtain a waiver. However, such provisions merely restate existing provisions of statute and thus will have no additional impact on such small entities. Therefore, under 5 U.S.C. 605(b), these provisions are exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

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

This final rule includes provisions constituting two new collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) that require approval by the Office of Management and Budget (OMB). Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking action to OMB for review and approval. OMB has reviewed and approved these new collections of information and assigned OMB Control Numbers 2900-0907, 2900-0908.

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

Denis McDonough, Secretary of Veterans Affairs, approved this document on December 30, 2022, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 21 as set forth below:

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

On December 28, 2015, EPA promulgated a revised 8-hour ozone NAAQS of 0.070 parts per million (ppm) (October 26, 2015, 80 FR 65292). The Allegan County (partial county), Berrien County, and Muskegon County (partial county) nonattainment areas were designated as marginal nonattainment areas for the 2015 ozone NAAQS (June 4, 2018, 83 FR 25776).

CAA sections 172(c)(3) and 182(a)(1), 42 U.S.C. 7502(c)(3) and 7511a(a)(1), require states to develop and submit, as SIP revisions, emission inventories for all areas designated as nonattainment for any NAAQS, including the ozone NAAQS. An emissions inventory for ozone is an estimation of actual emissions of air pollutants that contribute to the formation of ozone in an area. Ozone is a gas that is formed by the reaction of volatile organic compounds (VOC) and oxides of nitrogen (NO X ) in the atmosphere in the presence of sunlight (VOC and NO X are referred to as ozone precursors). Therefore, an emissions inventory for ozone focuses on the emissions of VOC and NO X . VOC is emitted by many types of pollution sources including power plants, industrial sources, on-road and off-road mobile sources, smaller stationary sources (collectively referred to as area sources), and biogenic sources. NO X is primarily emitted by combustion sources, both stationary and mobile.

Emissions inventories provide emissions data for a variety of air quality planning tasks including:

As stated above, the CAA requires the states to submit emission inventories for areas designated as nonattainment for ozone. For the 2015 ozone NAAQS, EPA specifies that states submit ozone season day emissions estimates for an inventory calendar year to be consistent with the baseline year for RFP plan as required by 40 CFR 51.1310(b). For the RFP baseline year for the 2015 ozone NAAQS under 40 CFR 51.1310(b), states may use a calendar year for the most recently available complete triennial (3-year cycle) emissions inventory (40 CFR 51, subpart A) preceding the year of the area's effective date of designation as a nonattainment area (December 6, 2018, 83 FR 62998). 1 States are required to submit estimates of VOC and NO X emissions for four general classes of anthropogenic sources: stationary point sources; area sources; on-road mobile sources; and off-road mobile sources.

Section 182(a)(3)(B) of the CAA requires states with ozone nonattainment areas to submit revisions to their SIP to require the owner or operator of each major stationary source of NO X or VOC to provide the state with an annual statement documenting the actual emissions of NO X and VOC from their source. Under section 182(a)(3)(B)(ii), a state may waive the emissions statement requirement for any class or category of stationary sources which emits less than 25 tons per year of VOC or NO X if the state, in its base year emissions inventory, provides an inventory of emissions from such class or category of sources. States and EPA have generally interpreted this waiver provision to apply to sources (without specification of a specific source class or source category) emitting less than 25 tons per year of VOC or NO X .

Many states have adopted these emissions statement rules for a prior ozone NAAQS that covers all the state's nonattainment areas and relevant classes and categories of sources. For these states, EPA is accepting certifications that their previously adopted emissions statement rules remain in place and are adequate to meet the emissions statement rule requirement under the 2015 ozone standard (December 6, 2018, 83 FR 62998).

On December 18, 2020, EGLE submitted a request to revise the Michigan SIP to address the emissions inventory requirement of CAA section 182(a)(1). EGLE provided documentation of a 2017 NO X and VOC base year emissions inventory to meet requirements for the Allegan County, Berrien County, Detroit and Muskegon County nonattainment areas. EPA approved emissions inventories for the Detroit nonattainment area under the 2015 ozone NAAQS in a separate action on July 6, 2022 (87 FR 40097). EGLE selected 2017 as the base year because this was the most recent comprehensive, accurate, and quality assured (QA) triennial emissions inventory in the National Emissions Inventory (NEI) database, available at the time the state began preparing the emissions inventory submittal for the Allegan County, Berrien County, and Muskegon County areas and is consistent with baseline year for the RFP plan as required by 40 CFR 51.1310(b). The baseline year for RFP would be the calendar year for the most recently available triennial emissions inventory at the time ROP/RFP plans are developed ( e.g., 2017 for initial designations effective in 2018) (83 FR 62998). At the time that EGLE prepared its inventory of 2017 emissions to address the requirements of section 182(a)(1), several improvements in data sources were not yet available. Specifically, EGLE relied upon a version of the 2017 NEI that did not include a revised point source inventory to correct airport emissions. Additionally, EGLE relied upon the 2016v1 modeling platform (which did not yet include improvements from the 2016v2 modeling platform) including updated information from the 2017 NEI, MOVES3, and revised inventory methodologies. EPA is not evaluating Michigan's 2017 emissions inventory against platforms or data sources that were not available at the time of submission. Table 1 shows the Allegan County, Berrien County, and Muskegon County areas' 2017 NO X emissions in tons per ozone season day. 2 Table 2 shows the Allegan County, Berrien County, and Muskegon County areas' 2017 VOC emissions in tons per ozone season day.

EGLE estimated NO X and VOC emissions for all source categories in the Allegan County, Berrien County, and Muskegon County ozone nonattainment areas. Emissions for these counties were totaled by source category for each ozone nonattainment area.

To develop emissions inventories for the year 2017, Michigan began with annual emissions data contained in the 2017 NEI for the point, nonpoint, on-road, nonroad, biogenic, and event categories. Ozone season day emissions were calculated by determining the representative typical ozone season month during the May 1-September 30 ozone season period by defining all days with ambient air monitor values at or above 70 parts per billion as “typical ozone season” days. EGLE then assessed which months contained the most typical ozone season days or the days with the highest measured values or greatest impact on the design values. Using this methodology, EGLE selected July as the representative typical ozone season month. To convert annual emissions data to ozone season day values, EGLE extracted data from EPA's 2016v1 modeling platform and calculated a conversion factor for the point, nonpoint, on-road, nonroad, and biogenic data categories. EGLE determined the event category emissions were too low and too variable from year to year to benefit from applying a conversion factor. For partial county nonattainment areas, a scaling factor was also applied before obtaining the emissions. EGLE also analyzed the impact of weekend day emissions on monitored design values. EGLE determined that weekend day emissions have a large impact on individual monitor design values and included weekend days in the calculation of typical ozone season day emission values.

For point sources, EGLE calculates and stores emissions data annually in the state's air emissions inventory database. Under the authority of Michigan Air Pollution Control Rule 2 (R 336.202) and AQD-013, EGLE requires any facility in the state that emits a pollutant above the thresholds specified to submit emissions inventory statements annually. These reports contain detailed source type-specific or annual source unit-specific and seasonal actual emissions for all source units in a facility. QA is performed when the data are submitted to the Emissions Inventory System Gateway.

For area source (sometimes referred to as non-point source) emissions, EGLE relied on a variety of state-specific data to estimate emissions based on EPA's procedures and guidance for the 2017 base emissions inventory. Area sources are spread over wide areas with no distinct discharge points or are comprised of a large number of small point sources that are difficult to describe separately and whose emissions are not well characterized ( e.g., heating furnaces in individual homes, architectural surface coating, automobile refueling, dry cleaning, etc. ). To develop an accurate and complete area source inventory, EGLE used annual emissions from the 2017 NEI and monthly emissions profiles from 2016v1 platform data. EGLE calculated 2017 emissions estimations by applying conversion factors to the July monthly emission profile to obtain daily emissions. A scaling factor was applied to the area source emissions for the partial county 2015 ozone NAAQS nonattainment areas.

On-road and non-road mobile source emissions were developed by EGLE using annual emissions from the 2017 NEI and monthly emissions profiles from 2016v1 platform data. On-road mobile sources include emissions from motorized vehicles that are normally operated on public roadways. This includes passenger cars, motorcycles, minivans, sport-utility vehicles, light-duty trucks, heavy duty trucks, and buses. Non-road mobile sources include emissions from locomotives, aircraft, marine, off-road vehicles and non-road equipment such as lawn and garden equipment.

For biogenics, which comprise of emissions that come from natural sources, EGLE utilized the annual emissions from the 2017 NEI and monthly emissions profiles from 2016v1 platform data. EGLE applied a conversion factor 2016v1 platform July emissions to obtain ozone season day emissions for the 2017 NEI annual values. For the event category, which is primarily comprised of wildfire emissions, EGLE relied on the 2017 NEI emissions in entirety.

Section 182(a)(3)(B) of the CAA requires states to include regulations in the SIP to require sources (source facilities) to submit annual statements characterizing sources of NO X and VOC emissions within the source facilities and to report actual NO X and VOC emissions for these sources. EPA approved the majority of EGLE's December 18, 2020, submittal pertaining to the certification of EGLE's stationary annual emissions statement regulation under the 2015 ozone NAAQS in a separate EPA action on July 6, 2022 (87 FR 40097). The remaining request included in EGLE's December 18, 2020, submittal, which was not addressed in EPA's separate action, was the removal of Act 348, Section 14a from the SIP. Act 348, Section 14a was repealed in 1995 and required annual fee payment by certain sources to EGLE as part of the elements for the Michigan Title V Renewable Operating Permit Program.

EPA reviewed Michigan's December 18, 2020, submittal for consistency with sections 172(c)(3) CAA and 182(a)(1) of the CAA and with EPA's emissions inventory requirements. In particular, EPA reviewed the techniques used by EGLE to derive and quality assure the emissions estimates. EPA has also considered whether Michigan provided the public with the opportunity to review and comment on the development of the emissions estimates, whether Michigan confirmed that source facility emissions statements are required for the 2015 ozone standard, and whether the state addressed all public comments. EGLE documented the procedures used to estimate the emissions for each of the major source types. The documentation of the emissions estimation procedures is thorough and is adequate for EPA to determine that Michigan followed acceptable procedures to estimate the emissions. Accordingly, EPA concludes that Michigan has developed inventories of NO X and VOC emissions that are comprehensive and complete.

As mentioned earlier, EPA approved the portions of EGLE's December 18, 2020, submittal pertaining to the certification of EGLE's stationary annual emissions statement regulation under the 2015 ozone NAAQS in a separate EPA action on July 6, 2022 (87 FR 40097). EGLE requested the removal of Act 348, Section 14a from the SIP which was repealed in 1995 and required annual fee payment by certain sources to EGLE. Act 348, Section 14a does not address the requirements related to attainment and maintenance of the NAAQS under Section 110 of the CAA. EPA has determined that Act 348, Section 14a was erroneously incorporated into the SIP. Instead, Act 348, Section 14a addresses the requirements under title V of the CAA for operating permit programs. EPA fully approved Michigan's title V Renewable Operating Permit Program on November 10, 2003 (68 FR 63735). Since Act 348, Section 14a has been repealed and does not address the requirements related to attainment and maintenance of the NAAQS under Section 110 of the CAA, EPA is approving EGLE's request to remove Act 348, Section 14a from the Michigan SIP.

Title 40 of the Code of Federal Regulations, part 51, appendix V requires that the State provide sufficient notice and opportunity for public comment and hearing on all SIP submittals. On September 7, 2020, EGLE notified the public of the 30-day period for the opportunity to comment, with respect to the requested SIP revisions pertaining to the emission inventories for the 2015 ozone NAAQS nonattainment areas and updates to the statewide emission statement program. The notification was published on EGLE's website at: https://www.michigan.gov/documents/deq/deq-aqd-sip-pub_notice_Info_610029_7.pdf. EGLE did not receive any public comments or requests for a public hearing by the stated date in the public notice, therefore, EGLE canceled the public hearing.

EPA is approving Michigan's SIP revision submitted on December 18, 2020, to address the ozone-related emissions inventory requirements for the Allegan County, Berrien County, and Muskegon County ozone nonattainment areas for the 2015 ozone NAAQS. The emissions inventories we are approving into the SIP are specified in Tables 1 and 2, above. We are approving the emissions inventories because they contain comprehensive, accurate, and current inventories of actual emissions for all relevant sources in accordance with CAA sections 172(c)(3) and 182(a), and because Michigan adopted the emissions inventories after providing for reasonable public notice and opportunity for a public hearing. We are also approving the removal of the repealed Act 348, Section 14a from the Michigan SIP, which does not address the requirements related to attainment and maintenance of the NAAQS under Section 110 of the CAA, but rather addresses the requirements under title V of the CAA for operating permit programs. In addition, we are also correcting a typographical error contained in the codification of our own July 6, 2022 (87 FR 40097), action. In that action, on page 40009, we incorrectly identified that we were approving sections 324.5003, 324.5524 and 324.5525 of Act 451 of 1994, as amended, where the correct citations for the approved sections are 324.5503, 324.5524 and 324.5525.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective March 20, 2023 without further notice unless we receive relevant adverse written comments by February 17, 2023. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective March 20, 2023.

In this document, EPA is amending regulatory text that includes incorporation by reference. As described in Section III of this preamble and set forth in the amendments to 40 CFR part 52 below, EPA is removing provisions of the EPA-Approved Michigan Regulations from the Michigan 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, 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).

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

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 March 20, 2023. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. 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, “we,” “us,” and “our” refer to the EPA.

On October 13, 2021, the EPA proposed to approve the Indian Wells Second Maintenance Plan submitted by the California Air Resources Board (CARB) on July 30, 2020, as a revision to the California SIP. 1 In doing so, we proposed to find that the Indian Wells Second Maintenance Plan adequately demonstrates that the Indian Wells Valley planning area will maintain the 1987 annual national ambient air quality standards (NAAQS or “standards”) for particulate matter of ten microns or less (PM 10 ) through the year 2025 ( i.e., for more than 10 years beyond the first 10-year maintenance period). We also proposed to find that the Plan includes sufficient contingency provisions to promptly correct any violation of the PM 10 standards that may occur. Lastly, we proposed to find the motor vehicle emissions budgets in the Plan for direct PM 10 for the years 2020 and 2025 adequate and to approve the budgets for transportation conformity purposes because they meet all applicable criteria for such budgets including the adequacy criteria under 40 CFR 93.118(e).

The motor vehicle emissions budgets that the EPA proposed to find adequate and to approve are shown in Table 1. The EPA announced the availability of the Plan and related motor vehicle emissions budgets on the EPA's transportation conformity website on October 13, 2021, and requested comments by November 12, 2021. We received no comments in response to the adequacy review posting.

The EPA's proposed action provided a 30-day public comment period that ended on November 12, 2021. We received one comment submission from a private citizen. 2 The comments are included in the docket for this action and the remainder of this section provides a summary of the comments and the EPA's responses.

The commenter raises two main concerns with the EPA's proposed approval of the Indian Wells Second Maintenance Plan. The commenter's first concern is that the Plan is “mostly informed by models that may have inadequate data supporting them.” The commenter acknowledges that “models can be helpful at providing insight into trends in data and helping to predict what will happen in the future” but expresses concern that the Plan “relies too heavily on them.” The commenter notes that there is only one monitoring station in the Indian Wells Valley planning area and recommends that additional monitoring stations throughout the planning area (including near one of the airports in the city of Ridgecrest) would provide greater insight into PM 10 emissions trends. The commenter also notes that emissions data were obtained from owners and operators of industrial point sources and states that these data may not be accurate because they rely on the owners to track their emissions.

The commenter's second main concern is “that the plan does not address how emissions would be limited.” The commenter asserts that “the plan shows projections for how the emissions in the area of concern are expected to change between now and 2025, [but that] they never specifically stated why there would be any increases in emissions or how they are hoping to combat these increases in emissions.” The commenter asserts that the maintenance plan would be more effective if it addressed off-road emissions from airplanes and questions the contribution of emissions from the Naval Air Weapons Station China Lake, asserting that the facility may contribute fugitive dust emissions to the Indian Wells Valley planning area.

Aside from these two concerns, the commenter states that “the plan is well laid out and should work quite well for the area once it is implemented.”

As discussed in the EPA's proposal, the EPA interprets, through guidance, CAA section 175A's requirement that the state submit a revision to the SIP “to provide for the maintenance” of the NAAQS, to permit the state to do so using different methods. 3 One method permits a state to demonstrate maintenance of the NAAQS in an area by showing that projected emissions of a pollutant or its precursors in a future year will not exceed the actual levels of those same pollutants and precursors in the attainment inventory, i.e., an inventory of actual emissions from one of the three years making up the design value during which the area was attaining the NAAQS. The Indian Wells Second Maintenance Plan relies on this approach and includes an emissions inventory representing actual emissions in 2013 ( i.e., 10 years after redesignation, or the final year of the first maintenance period). The Plan also provides an updated inventory of actual emissions in 2017 and projected emissions through 2025 ( i.e., 12 years beyond the expiration of the first 10-year maintenance period) for sources in the Indian Wells Valley planning area. We note that CAA section 175A requires only that the plan provide for maintenance for 20 years after an area is redesignated, but the State provided projections demonstrating maintenance for 22 years.

With regards to the commenter's concern that the emissions inventories in the Plan rely too heavily on models, we note that the requirements for PM 10 emissions inventories are set forth in the Air Emissions Reporting Requirements (AERR) rule. 4 The EPA has provided additional guidance to states for developing PM 10 emissions inventories in “PM 10 Emissions Inventory Requirements,” EPA-454/R-94-033 (September 1994) and “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations” (May 2017).

Under the AERR, states are required to report comprehensive emissions inventories to the EPA every three years. 5 All states, including California, require facilities within their jurisdictions to report their emissions to the states. CARB estimates stationary point source emissions based on annual reports submitted by the local air districts, which reflect actual emissions from industrial point sources reported to local air districts by facility operators. The local air districts are responsible for working with facility operators to compile estimates, using source testing, direct measurement, or engineering calculations. Because area sources often occur over a large geographic area, emissions for these source categories are estimated using various models and methodologies. Similarly, emissions from on-road mobile sources are estimated using the latest EPA-approved version of CARB's EMission FACtor model (EMFAC) based on activity data from the Kern Council of Governments, and off-road mobile source emissions are estimated using a suite of category-specific models. Projected inventories are derived by applying expected growth trends for each source category based on historical trends, current conditions, and economic and demographic forecasts. CARB provides website links to additional information on each of the methodologies and models used in the Plan and has established quality assurance and quality control processes to ensure the integrity and accuracy of the emissions inventories. 6

As discussed in the EPA's proposal, the EPA reviewed CARB's emissions inventory development methodologies and the resulting emissions inventories in the Indian Wells Second Maintenance Plan and determined that the inventories were developed consistent with EPA regulations and guidance;  7 that the projected inventories are based on reasonable methods, growth factors, and assumptions; and that the inventories are based on the most current information available at the time the Plan was being developed. Projections of direct PM 10 emissions show that future emissions increases through 2025 are within 1.6 percent of emissions in 2017 and below emissions in 2013, both of which reflected attainment conditions in the Indian Wells Valley planning area. 8 Therefore, we find that the emissions inventories in the Indian Wells Second Maintenance Plan rely on actual emissions information, where available, and that where the State relies on models and other methodologies to supplement actual emissions information, that reliance is appropriate. We also find that CARB has quality assurance and quality control procedures that are complete, adequate, and acceptable to ensure the accuracy of the model inputs and model results. Furthermore, to address potential uncertainties in the emissions inventories, the Eastern Kern Air Pollution Control District has committed to continue to review the inputs and assumptions used to develop the emissions inventories on an annual basis and to monitor ambient air quality to verify continued attainment. 9

Regarding ambient air quality monitoring, the EPA disagrees with the commenter's concerns about the need for additional monitors in the Indian Wells Valley area. Each year, CARB is required to submit an Annual Network Plan to establish that its monitoring network meets applicable statutory requirements and is consistent with applicable guidance. CARB's most recent Annual Network Monitoring plan addressing the PM 10 NAAQS requirements in the Indian Wells Valley planning area is the “Annual Network Plan, Covering Monitoring Operations in 25 California Air Districts, July 2022” (“Annual Network Plan”), which contains additional information and analysis on the planning area's monitoring sites and instrumentation. 10 This Annual Network Plan reflects CARB's approach to meeting the federal monitoring requirements for PM 10 , 11 which are based on population and air quality conditions in each Metropolitan Statistical Area (MSA). The Indian Wells Valley is located within the Bakersfield, California MSA (“Bakersfield, CA MSA”). Based on population and air quality conditions in the Bakersfield, CA MSA, a minimum of four to eight monitoring sites are required. 12 There are a total of six PM 10 monitoring sites in the Bakersfield, CA MSA, including the Ridgecrest monitoring site located in the Indian Wells Valley planning area, and the minimum monitoring requirement for PM 10 is met. The Ridgecrest monitoring site is a “neighborhood scale” site within the Bakersfield, CA MSA. 13 Neighborhood scale PM 10 sites “represent conditions throughout some reasonably homogeneous urban sub-region with dimensions of a few kilometers” . . . and these “PM 10 sites provide information about trends and compliance with standards because they often represent conditions in areas where people commonly live and work for extended periods.”  14

In addition, CARB is required to submit to the EPA a network assessment every five years that includes a determination of whether the network meets monitoring objectives, such as compliance with ambient air quality standards and providing air pollution data to the public in a timely manner, and whether any new sites are needed to meet these objectives. 15 This regular review by CARB evaluates whether the existing PM 10 monitoring network provides an adequate measure of PM 10 air quality in the Indian Wells Valley. CARB's 2020 Monitoring Network Assessment stated that “the Eastern Kern Air Pollution Control District (EKAPCD) believes the existing monitoring network adequately captures population exposure, transport, and high concentrations and should be maintained in its current configuration.”  16 CARB provides the public opportunities to comment on any proposed changes to the monitoring network in the Annual Network Plan before the plan is submitted to the EPA for formal approval of all network modifications. The EPA approved CARB's Annual Network Plan on October 28, 2022. 17

In response to the commenter's concern that the Plan does not sufficiently address how emissions would be limited, we note that the Indian Wells Second Maintenance Plan discusses the development of rules controlling PM 10 emissions in section II.B (“Rule Development”) and lists the control measures that contributed to attainment of the PM 10 NAAQS in section III.B (“Factors that Contributed to Attainment”). These control measures will continue to limit emissions in the Indian Wells Valley PM 10 planning area. The Plan describes the methods and assumptions CARB used to develop the emissions projections upon which the maintenance demonstration relies, including the growth forecasts for point, areawide, and mobile sources. Appendix C (“CEPAM Emission Projections by Summary Category”) presents detailed emissions information for the years 2017 through 2025 by source category, and Appendix D (“IWV Precursor Emission Inventories”) provides emissions inventory documentation. The Indian Wells Second Maintenance Plan discusses anticipated population and industry growth in the area in section IV (“IWV Growth”), noting that the area “. . . has not had any significant changes since 1990, and no significant changes are projected to occur during the second maintenance period.” As noted above, the EPA finds that these methods and assumptions are reasonable and that the inventories are based on the most current information available at the time the Plan was developed.

Regarding fugitive dust emissions from the Naval Air Weapons Station, China Lake, we note that the “Fugitive Dust Control Plan for the Naval Air Weapons Station, China Lake, California (September 1, 1994)” (“Fugitive Dust Control Plan”), prepared pursuant to District Rule 402 (“Fugitive Dust”), 18 established controls to limit emissions from unpaved roads, disturbed vacant land, and open storage piles at Naval Air Weapons Station, China Lake. On May 7, 2003, as part of our action redesignating the Indian Wells Valley planning area to attainment, the EPA approved the Fugitive Dust Control Plan. 19 We found that the plan meets the reasonably available control measures requirement of CAA section 189(a)(1)(C) and concluded that the measure was responsible, in part, for bringing the Indian Wells Valley planning area into attainment of the PM 10 NAAQS. 20 The Indian Wells Second Maintenance Plan references the Fugitive Dust Control Plan in section III.B (“Factors that Contributed to Attainment”).

Finally, in response to the commenter's suggestion that the Plan would be more effective if it addressed emissions from aircraft, we note that of the 1.15 tons per day (tpd) of PM 10 emissions from aircraft in the Indian Wells Valley, 80 percent (0.92 tpd) are from military aircraft at the Naval Air Weapons Station, China Lake. 21 As discussed above, the fugitive dust sources that contribute to these emissions are subject to controls outlined in the Fugitive Dust Control Plan. Thus, a majority of off-road emissions from aircraft are addressed by the Plan. With regards to aviation, we note that the authority to establish emissions standards for aircraft lies with the EPA and that states are preempted from adopting any emissions standard for aircraft or aircraft engines that differs from any standards promulgated by the EPA. 22 Given that the District does not have authority to control emissions from aircraft engines, including government aircraft from military flight operations at the Naval Air Weapons Station, China Lake, it focused its control strategy on the fugitive dust source categories.

As part of our proposal, we evaluated quality-assured, certified, and complete data available at the time ( i.e., through 2020). 23 These data indicated that there had been one exceedance of the PM 10 NAAQS in the Indian Wells Valley planning area in 2019 and one exceedance in 2020, resulting in an attaining three-year design value of 0.7. 24 In 2021, there were three additional exceedances of the PM 10 NAAQS in the area. These additional exceedances in 2021 caused the number of exceedances recorded at the air monitor averaged over three consecutive years ( i.e., 2019-2021) to be greater than 1.05. However, we do not think these data contradict the EPA's finding that the State's plan provides for maintenance of the PM 10 NAAQS under CAA section 175A(b). The District and CARB provided information to the EPA about the five exceedances that occurred in 2019-2021 that explained that the exceedances were not within the State's control. 25 The information provided indicates that the 2019 exceedance was caused by wildfire smoke and wind gusts, the 2020 and two of the 2021 exceedances were caused by wildfire smoke, and the third 2021 exceedance was a result of fugitive dust transported by a high wind event. The EPA has reviewed the information provided by the State regarding the 2019-2021 exceedances, and we agree that this information does not call into question the EPA's proposed approval of the Indian Wells Second Maintenance Plan as providing for maintenance of the PM 10 NAAQS. We note as well that the State's analysis and the EPA's evaluation are consistent with the proposed changes to the maintenance plan that the EPA is approving in this final action to evaluate data that may have been influenced by certain events in determining whether contingency provisions should be triggered.

As part of this final action, the EPA has also reviewed data available through June 2022, and so far, there has been one additional exceedance in the Indian Wells Valley planning area. 26 Given the EPA's agreement that the 2021 exceedances do not call into question the EPA's proposal to approve the Indian Wells Second Maintenance Plan as providing for maintenance of the NAAQS, the State is not required at this time to submit additional information and analyses for the 2022 exceedance, because such exceedance, without the 2021 exceedances, would not on its own cause a violation of the NAAQS. Upon the effective date of this final action, if additional exceedances occur in 2022 or a later year such that the number of exceedances averaged over three consecutive years is greater than 1.05, per section V of the Plan, the State will be required to submit information regarding those exceedances if it wishes to request that the exceedances be excluded from the contingency trigger calculation. The EPA will review such information and will notify the State whether or not the contingency provisions have been triggered per the schedule outlined in the Plan.

For the reasons discussed in our proposed action and herein, the EPA is taking final action to approve the Indian Wells Second Maintenance Plan, submitted by CARB on July 30, 2020, as a revision to the California SIP. We are approving the maintenance demonstration and contingency provisions as meeting all of the applicable requirements for maintenance plans and related contingency provisions in CAA section 175A. We are also finding the motor vehicle emissions budgets shown in Table 1 for 2020 and 2025 adequate and approving the budgets for transportation conformity purposes because we find they meet all applicable criteria for such budgets including the adequacy criteria under 40 CFR 93.118(e).

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); and

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

The State did not evaluate environmental justice considerations as part of its SIP submittal. There is no information in the record inconsistent with the stated goals of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.

In addition, there are no areas of Indian country within the Indian Wells Valley planning area, and the state plan 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 March 20, 2023. 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).)

Chapter I, title 40 of the Code of Federal Regulations is amended as follows:

GSA published a proposed rule at 87 FR 32106 on May 27, 2022, to clarify the calculation of “constructive cost” as it relates to temporary duty (TDY) travel. This rule finalizes the proposed changes to section 301-10.309, regarding what method of transportation agencies should compare privately owned vehicle (POV) costs to when preparing a constructive cost analysis, and makes minor editorial adjustments in order to clarify intent.

When employees perform official business away from their official station, agencies must, in authorizing the TDY travel, select the transportation method most advantageous to the Government, when cost and other factors are considered. Travel must be by the most expeditious means of transportation practicable and commensurate with the nature and purpose of the duties. In addition, the agency must consider energy conservation, total cost to the Government (including costs of per diem, overtime, lost work time, and actual transportation cost), total distance traveled, number of points visited, and number of travelers. The most advantageous transportation method by order of precedence is common carrier, Government-furnished automobile, rental car, and POV.

Regardless of the method of transportation the agency selects in the travel authorization, Federal employees may choose to use a POV while on TDY. However, if the agency has selected a method of transportation other than POV for the employee's use because it is more advantageous to the Government, the agency must perform a cost comparison, known as “constructive cost”, to determine how much the agency should reimburse the traveler when the traveler chooses a POV over the agency-selected method of transportation. If the constructive cost of the agency-selected method of transportation is less than the cost of traveling by POV, the employee only receives that limited amount, regardless of how much it costs to use a POV. If the constructive cost shows that the POV cost is less than the agency-selected method, then the employee will receive the total POV-related costs (as listed in 41 CFR 301-10.304). (Agencies are reminded that the FTR does not authorize agencies to require that employees use their POV for TDY travel, even if the costs will be less for the Government.)

GSA is aware that agencies may mistakenly calculate TDY constructive costs by only comparing the selected transportation method with the POV mileage rates without also factoring in related travel costs, such as per diem expenses, parking, baggage fees, etc. Not factoring in these other costs leads to an incomplete calculation of the total constructive travel cost that employees may incur.

The Civilian Board of Contract Appeals (CBCA) and its predecessor, the General Services Board of Contract Appeals (GSCBA) have, in their decisions on TDY constructive costs, opined that when comparing the total allowable costs for travel by a method other than that most advantageous to the Government, with the constructive cost of traveling by the agency-selected method, agencies should think through the complete travel experience and include other potential costs. ( See In the Matter of Russell E. Yates, GSBCA No. 15109-TRAV (Jan. 28, 2000); In the Matter of Stephen M. England, CBCA 3903-TRAV (Jan. 30, 2015)). For example, if the agency selected travel by air via common carrier but the employee chose to travel by POV, in calculating the constructive cost of air travel the agency should include potential costs such as the expected cost of lodging as well as meals, incidental expenses, airfare, baggage, use of a rental car, and transportation to and from the airport using a taxi or transportation network company (TNC), and perhaps others depending on the individual situation. Even though these costs may not actually be incurred when the employee uses the POV instead of flying via a common carrier, the relevant travel costs should be included in the agency's constructive cost analysis to determine how much the agency-selected method would have cost the agency in total.

Additionally, GSA is clarifying the constructive cost methodology stated in § 301-10.309. GSA amended this section in 2015 to include the use of rental cars as a potential transportation option, in addition to the use of common carriers (80 FR 27259). However, when determining the constructive cost, the section currently states that agencies should not exceed the total constructive cost of the “authorized method of common carrier transportation,” when it should read “authorized method of transportation” as is consistent with 41 CFR 301-70.105(a).

GSA did not receive any public comments related to the proposed rule and has not made any substantive changes to the regulatory language from the proposed to final rule.

While difficult to quantify, GSA expects some savings in travel costs as a result of this final rule; GSA anticipates that no additional travel costs will result from agencies performing more comprehensive constructive cost comparisons as agencies will better understand the impact of method of transportation decisions, and therefore should be better positioned to select the method of transportation most advantageous to the Government. Agencies also should be able to better limit TDY costs incurred by employees who choose to use their POV instead of the agency-selected transportation method. Common carrier, Government-furnished automobile, and rental car are presumed to be the most advantageous methods of transportation, and are often less expensive than travel by POV. Administrative savings from having a more comprehensive process should also lessen the time agencies and employees spend working through confusion or differences in interpretation, hopefully with fewer employees requesting CBCA review of claims for entitlement to travel expenses.

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

OIRA has determined that this rule is not a “major rule” as defined by 5 U.S.C. 804(2). Additionally, this rule is excepted from Congressional Review Act reporting requirements prescribed under 5 U.S.C. 801 since it relates to agency management or personnel under 5 U.S.C. 804(3)(b).

This final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the changes are administrative in nature and only affect Government employees. Therefore, a Final Regulatory Flexibility Analysis has not been performed.

The Paperwork Reduction Act does not apply because the changes to the Federal Travel Regulation do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

For the reasons set forth in the preamble GSA amends 41 CFR parts 301-10 and 301-70 as set forth below:

In a notice of proposed rulemaking (NPRM) published in May 2022, the Administrator of the WTC Health Program (Administrator) and the Secretary of HHS proposed the addition of uterine cancer  1 to the List of WTC-Related Health Conditions (List) in 42 CFR 88.15. 2 In this final rule, the WTC Health Program summarizes and responds to both independent peer reviews and public comments on the NPRM and finalizes the addition of uterine cancer to the List.

This final rule adds malignant neoplasms of corpus uteri and uterus, part unspecified (uterine cancer) to the List.

The addition of uterine cancer to the List through this rulemaking is estimated to cost the WTC Health Program between $1,706,454 and $3,805,173 annually from 2023 through 2026. All of the costs to the WTC Health Program are transfers. 3 Benefits to current and future WTC Health Program members  4 are expected to include improved access to care and better treatment outcomes than members would have experienced in the absence of Program coverage.

The case numbers used to develop the cost estimates are, themselves, only estimates; the certification of individual cancer diagnoses will be conducted on a case-by-case basis, as required by the Zadroga Act. Interested parties should visit the WTC Health Program website for information about how to apply for enrollment in the Program  5 and about health condition certification. 6

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, as amended, revised the Public Health Service Act (PHS Act) to establish the WTC Health Program, which is administered by the National Institute for Occupational Safety and Health (NIOSH), within CDC, provides medical monitoring and treatment to eligible responders to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In an NPRM published in May 2022, 7 the Administrator of the WTC Health Program and the Secretary of HHS proposed the addition of uterine cancer  8 to the List of WTC-Related Health Conditions in 42 CFR 88.15. In this final rule, the WTC Health Program summarizes and responds to both independent peer reviews and public comments on the NPRM and finalizes the addition of uterine cancer to the List in § 88.15(d).

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347, as amended by Pub. L. 114-113 and Pub. L. 116-59), added Title XXXIII to the PHS Act  9 establishing the WTC Health Program within HHS. The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors).

All references to the Administrator in this document mean the Director of NIOSH, within CDC, or his or her designee. Section 3312(a)(6) of the PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List codified in 42 CFR 88.15.

In 2020, the Administrator received requests from WTC responders, survivors, and five of the WTC Health Program Clinical Centers of Excellence (CCEs) to add “uterine cancer” to the List. The letter from the CCEs raised important questions about the potential association between endocrine disrupting chemicals (EDCs) present at the WTC sites and uterine cancer, and noted that a previous WTC Health Program evaluation of the evidence regarding a causal association between endometrial cancer and 9/11 exposure did not address the potential role of EDCs. In response to the requests, the Administrator directed the WTC Health Program's Science Team to assess the available scientific evidence for adding uterine cancer to the List pursuant to the Policy and Procedures for Adding Types of Cancer to the List of WTC-Related Health Conditions ( Policy and Procedures ). 10

The Policy and Procedures describes four methods for determining whether to add a type of cancer to the List, summarized below:

• Method 1. Epidemiologic Studies of September 11, 2001, Exposed Populations: A type of cancer may be added to the List if peer-reviewed, published, epidemiologic studies of cancers in the 9/11-exposed populations demonstrate a causal association between 9/11 exposures and that cancer.

• Method 2. Established Causal Associations: A type of cancer may be added to the List if there is well-established scientific support published in multiple peer-reviewed epidemiologic studies for a causal association between a health condition already on the List and that type of cancer.

• Method 3. Review of Evaluations of Carcinogenicity in Humans: A type of cancer may be added to the List if a 9/11 agent  11 included in the Inventory of 9/11 Agents   12 has been determined by the National Toxicology Program (NTP) to be a known human carcinogen or reasonably anticipated to be a human carcinogen and the World Health Organization's International Agency for Research on Cancer (IARC) has determined there is sufficient or limited evidence in humans that the 9/11 agent causes that type of cancer.

• Method 4. Review of Information by the WTC Health Program Scientific/Technical Advisory Committee (STAC): A type of cancer may be added to the List if the STAC recommends the addition and provides a reasonable basis for the recommendation.

The Science Team evaluated the available evidence and presented its findings to the Administrator in a white paper (2021 White Paper)  13 that was shared with the STAC and the public before the STAC's public meeting on September 28-29, 2021 ( see discussion below). The 2021 White Paper concluded that insufficient evidence exists under Method 1 and Method 3 to support a decision to add uterine cancer to the List. The Science Team found that evidence considered under Method 2 supports the addition of uterine cancer to the List, but only for those WTC Health Program members who have a certified WTC-related estrogen-secreting tumor. 14 Finally, the 2021 White Paper included additional information for the STAC to consider in its deliberations, conducted pursuant to Method 4 and discussed below, including: mechanisms of endometrial cancer development; other evidence from studies of uterine cancer from exposure to the 9/11 agents 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD), polychlorinated biphenyls, cadmium, asbestos, and chloroethane; sex disparities in occupational cohort studies; and other cancers causally associated with EDCs.

Pursuant to Method 4 of the Policy and Procedures, the Administrator exercised his discretion to request a recommendation from the STAC regarding whether the available evidence provides a reasonable basis for adding uterine cancer to the List. The STAC held a public meeting on September 28 and 29, 2021, during which it heard public comments and deliberated on the evidence, including the evidence presented in the Science Team's 2021 White Paper, and created a workgroup to write a report describing the STAC's findings on uterine cancer. In a subsequent public STAC meeting on November 18, 2021, the full Committee voted unanimously to approve the workgroup report and recommend that the Administrator add uterine cancer to the List.

In a letter received by the Administrator on November 29, 2021, 15 the STAC formally recommended the addition of “all types of uterine cancer” to the List. In its rationale, the STAC noted that the Inventory of 9/11 Agents includes certain 9/11 agents which are recognized as EDCs, and that EDC exposure-related imbalances in sex steroid hormones are a “plausible mechanism” for the development of uterine cancer among WTC responders and survivors. Moreover, the STAC argued that other hormone-related cancers thought to be caused by EDC exposure are on the List, including thyroid cancer, breast cancer, testicular and prostate cancers, and all other female reproductive organ cancers. Finally, the STAC commented on the likelihood that future epidemiologic studies in the extensively studied 9/11-exposed responder population may be unable to accurately capture uterine cancer incidence because of the small number of female responders.

The Administrator reviewed the available body of evidence, including the evidence presented in the Science Team's 2021 White Paper and the STAC's comprehensive rationale and recommendation, and concluded that the totality of the available information provided a sufficient evidentiary basis to propose adding uterine cancer to the List. Subsequently, the Administrator and Secretary of HHS published an NPRM in May 2022 proposing the addition of uterine cancer to the List in 42 CFR 88.15. 16 The NPRM described the methodology used by the Science Team to evaluate the scientific evidence and included a full discussion of the Science Team's 2021 White Paper, the STAC recommendation and rationale, and the Administrator's decision to propose the addition of uterine cancer to the List.

The NPRM was published on May 10, 2022. The Administrator provided a 45-day public comment period and invited interested persons and organizations to submit written views, opinions, recommendations, and data. 17 The Administrator received 27 comments in the rulemaking docket from the public, including current WTC Health Program members and non-members who experienced 9/11 exposures who have or have had uterine cancer; unaffiliated individuals; and the WTC Health Program Survivors Steering Committee. Concurrently, as required by statute, the Administrator solicited an assessment of the WTC Health Program's evaluation of evidence supporting the proposal to add uterine cancer to the List by three independent peer reviewers. 18

Comments received from the three peer reviewers were de-identified and compiled into one document which was published in the docket on June 9, 2022, 30 days after the NPRM publication. This permitted the public an additional 15 days to comment on the peer reviewers' assessment of the proposed rulemaking. The three peer reviewers were asked to respond to the following questions:

1. Are you aware of any other studies which should be considered? If so, please identify them.

2. Have the requirements of this Policy and Procedures   19 been fulfilled? If not, please explain which requirements are missing or deficient.

3. Is the interpretation of the available information appropriate, and does it support the conclusion to add the health condition, as described in the regulatory text, to the List? If not, please explain why.

The peer reviews and public comments are found in the docket for this rulemaking. Summaries of all peer reviews and public comments, as well as the Administrator's responses, are found below.

The Administrative Procedure Act (APA) requires the publication of a rule “not less than 30 days before its effective date,” unless the agency finds and publishes with the rule good cause for such exception. 20 In the context of the requirement for notice and comment on rulemakings, the APA specifies that such procedures may be avoided if an agency “for good cause finds” that “notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.”  21 To the extent that the same standard for establishing “good cause” applies to both excepting a rulemaking from notice and comment requirements and excepting a rulemaking from the 30-day post-publication effective date requirement, the “impracticable” and “contrary to the public interest” prongs of the good-cause exemption are particularly relevant to situations such as this, where the typical delayed effective date would defer the agency's ability to provide life-saving treatment and result in less favorable treatment outcomes and survival rates for covered individuals.

The purpose of the post-publication waiting period is to give affected parties time to adjust their behavior before the final rule takes effect. In this instance, however, the affected parties are current and prospective members of the WTC Health Program who need treatment for uterine cancer. Currently enrolled WTC Health Program members who have already been diagnosed with uterine cancer do not require an additional 30 days to ready themselves for implementation of this rule; indeed, any delay in effective date could result in postponed medical care for such members or necessitate their paying out of pocket for care in the interim.

As discussed in the economic analysis in Section VI.A. of this rulemaking, the WTC Health Program estimates that over 200 enrolled members currently have uterine cancer; the Program anticipates these members will submit requests for certification of their uterine cancers as WTC-related as soon as the rule is issued. It is in these members' best interest that treatment for their cancer is made available as soon as possible. Neither these members nor the WTC Health Program require additional time to prepare for the implementation of this rule. 22 Treatment of cancer at the earliest stages has been shown to result in the best outcomes and higher survival rates. 23 As such, there is no public interest served in further delaying the effective date of this rulemaking.

For the forgoing reasons, the Administrator and the Secretary of HHS find that good cause exists to make this rulemaking effective immediately on publication.

The WTC Health Program has considered whether the public comments and the peer reviews of the evidence comprising the basis for the proposed rulemaking warrant any revision to the findings and determinations described in the NPRM. The public comments and the independent peer reviews are summarized below, followed by the WTC Health Program's response.

Twenty-seven public commenters submitted comments to the docket for this rulemaking. Twenty-six expressed unequivocal agreement with the addition of uterine cancer to the List. One commenter expressed displeasure with the WTC Health Program's process for adding health conditions to the List; that comment is outside the scope of this rulemaking and is not further addressed.

Of the 26 supportive public comments, one asked that the Administrator also consider adding fibroid tumors, endometriosis, and infertility to the List. Another of the supportive comments described concerns with inequities in the WTC Health Program's research agenda, faulting the Program for “routinely pass[ing] over” research proposals to study survivor cohorts. These comments are also outside the scope of this rulemaking but are discussed further below.

No public commenter suggested additional references to scientific evidence regarding causes of uterine cancer, nor did any commenter indicate that there were any flaws in the WTC Health Program's evaluation of the available evidence or the Administrator's determination.

The de-identified peer reviewers were labelled as Reviewer A, Reviewer B, and Reviewer C; their reviews of the content of the NPRM are summarized below.

Question 1: Are you aware of any other studies which should be considered? If so, please identify them.

Reviewer A suggested that a study by Curtis et al. [2019]  24 should be included in the evaluation.

Reviewer B was not aware of any “additional epidemiology studies that should have been considered using Method 1,” nor any other studies using Method 2. Reviewer B described two concerns with the WTC Health Program's analysis of evidence pursuant to Method 3 of the Policy and Procedures. First, Reviewer B stated that the Science Team did not consider the Endocrine Society's definition of EDCs (“an exogenous chemical, or mixture of chemicals, that interferes with any aspect of hormone action”) and noted that the list of EDCs found in the Inventory of 9/11 Agents “is almost certainly incomplete.” According to the reviewer, the WTC Health Program should have evaluated several other EDCs in the Inventory, including but not limited to benzo[a]pyrene, carbazole, chlordane, chromium, dibenzofuran, dieldrin, endosulfan, heptachlor, mirex, and oxychlordane. Second, Reviewer B found some of the references cited in the 2021 White Paper concerning U.S. Environmental Protection Agency (EPA) determinations of carcinogenicity to be too dated to be authoritative. Reviewer B ultimately found that the STAC's conclusions, pursuant to its review under Method 4, are supported by a “large body of evidence.”

Finally, Reviewer C also indicated that the Method 3 review in the 2021 White Paper does not include EDCs that have “estrogenic activity,” but are not carcinogens, including: polyvinyl chloride, trichloroethylene, TCDD, and some pesticides. Reviewer C provided references to support that assertion and also asked that the WTC Health Program add a discussion of studies demonstrating the association between EDCs and uterine hyperplasia and other alterations to the uterine lining that may have a causal relationship with uterine cancer. The reviewer found the assertion in the 2021 White Paper that “[n]one of the 9/11 Agents identified as EDCs have been found by NTP, IARC, or EPA to be known to cause or be reasonably anticipated to cause uterine cancer” to be misleading because (1) the exposures studied by these organizations may not be comparable to the extensive exposures experienced by WTC responders and survivors; (2) the reviews conducted by NTP, IARC, and EPA are often outdated; and (3) many studies have been conducted in male mice, precluding examination of uterine cancer. Finally, Reviewer C indicated that “women's health and women's health related cancers have been under examined and grossly understudied,” and offered a reference  25 to demonstrate that breast and ovarian cancer are associated with EDCs and that the mechanisms of action through which EDCs can impair endocrine system function and cause those cancers are similar to the known causes of uterine cancer.

Question 2: Have the requirements of this Policy and Procedures been fulfilled? If not, please explain which requirements are missing or deficient.

All three peer reviewers found that the WTC Health Program's scientific evaluation and proposed rulemaking fulfilled the requirements in the Policy and Procedures.

Question 3: Is the interpretation of the available information appropriate, and does it support the conclusion to add the health condition, as described in the regulatory text, to the List? If not, please explain why.

Reviewer A agreed that it was appropriate for the Administrator “to use Method 4 of the Policy and Procedures to include uterine cancer.” Reviewer A argued, however, that the WTC Health Program should consider the addition of uterine cancer to the List pursuant to Method 2, based on the association of uterine cancer with estrogen-secreting tumors, which may themselves be associated with EDCs. Reviewer A also pointed to their own research on polybrominated biphenyl, a type of flame retardant, which is similar to a chemical found at the WTC site and shows “considerable overlap with endogenous estrogen.”

Reviewer B stated that they believed the rationale used by the Administrator to support the addition of uterine cancer to the List was sound.

Reviewer C agreed that the interpretation of the available information was appropriate but thought that “some important evidence of risk factors for developing uterine cancer were under identified.” Reviewer C suggested EDCs and other toxins contained in WTC dust may lead to risk factors that, in turn, may lead to uterine cancer.

The WTC Health Program finds that the comment regarding the addition of other female reproductive health conditions ( i.e., fibroid tumors, endometriosis, and infertility) to the List to be outside the scope of this rulemaking, which only contemplates the sufficiency of the scientific evidence for the addition of uterine cancer to the List.

Although the comment about purported inequities in the WTC Health Program research agenda is also outside the scope of the rulemaking, the Administrator notes that the Program continually evaluates its research priorities and is committed to funding research that includes all 9/11-exposed populations. The WTC Health Program manages and solicits research on a broad range of health conditions related to the 9/11-exposed population of workers and community members, including health conditions among women, members of minority groups, and persons exposed as children. With input from researchers and community members, the WTC Health Program monitors the progress of each award cycle and adjusts solicitations as needed to promote an appropriate balance of health conditions and exposure cohorts. 26 All extramural research funded by grant or cooperative agreement is awarded under a competitive process following the widely accepted National Institutes of Health framework. 27 Each research proposal is rigorously reviewed by an independent panel of experts and is subsequently scored according to its merits, including aims that address health equity. The research portfolio has been and continues to be the product of the quantity and quality of the proposed research. 28

The public comments were overwhelmingly supportive of the proposal to add uterine cancer to the List. Moreover, public commenters did not suggest any additional references or identify concerns with the evaluation of evidence presented in the NPRM or the Administrator's determination. Therefore, there are no changes to this rulemaking as a result of the public comments.

The WTC Health Program has considered the independent peer reviews of the scientific and technical evidence presented in the NPRM. The peer reviewers favored the addition of uterine cancer to the List and offered supplemental evidence in support of the addition. Many of the reviewers' suggestions for improving the Program's evaluation of the evidence supporting the addition of uterine cancer to the List were compelling. As a result, the Science Team has revised and finalized the White Paper (final White Paper) to address the peer reviewers' suggestions. 29 The final White Paper is included in the docket for this rulemaking. The WTC Health Program's evaluation of the supplemental evidence provided by the peer reviewers is discussed below.

Upon careful evaluation of the information provided by all three reviewers in response to Question 1, the WTC Health Program has found that the scientific analysis described in the NPRM did not fully capture all of the 9/11 agents identified in the Inventory of 9/11 Agents that are known or potential endocrine disruptors. Accordingly, the Science Team has reevaluated whether the 9/11 agents that are included as known or potential EDCs in Table 3 of the 2021 White Paper  30 was comprehensive or if additional 9/11 agents may also be considered known and potential EDCs. Following the reevaluation, the Science Team concluded that 9/11 agents beyond those listed in the 2021 White Paper, might also exhibit endocrine disrupting properties. The Science Team's process and conclusion are described below.

In the absence of an internationally harmonized list of known and potential EDCs, the Science Team has evaluated 9/11 agents by comparing each 9/11 agent listed in the Inventory to publicly available lists of known and potential endocrine disruptors. Comparison lists included the following:

• The Endocrine Disruptor Lists published by the national authorities in six European Union (EU) member countries: List of Substances Identified as Endocrine Disruptors at EU Level, the L ist of Substances Under Evaluation for Endocrine Disruption Under an EU Legislation, and the List of Substances Considered, by the Evaluating National Authority, to Have Endocrine Disrupting Properties, 31 which altogether identify 194 chemicals recognized as known or potential endocrine disruptors. The EU lists are updated at least bi-annually and were most recently updated in June 2022.

• The United Nations Environment Programme's List of Identified Endocrine Disrupting Chemicals, 32 which identifies 45 chemical substances as endocrine disruptors and was last updated in July 2017.

• The Endocrine Disruption Exchange's List of Potential Endocrine Disruptors, a master list of 1,482 chemicals with at least one study demonstrating endocrine disrupting properties, last updated in September 2018. 33

• The SIN (Substitute It Now) List developed by the non-profit International Chemical Secretariat (ChemSec). 34 ChemSec recommends ceasing use of 32 EDCs on the SIN List, last updated in 2014, because of their threat to human health and the environment.

As a result of this reevaluation, the Science Team has concluded that additional 9/11 agents and categories of 9/11 agents should be added to the 9/11 agents and categories previously listed in Table 3 of the 2021 White Paper as known or potential EDCs. Accordingly, Table 3 of the final White Paper now includes 136 individual 9/11 agents, one mixture (diesel exhaust), and 10 categories of 9/11 agents that may be evaluated as a group.

Of the 9/11 agents and categories of 9/11 agents that are now included in Table 3 and recognized by the WTC Health Program as known or potential EDCs, 78 have been evaluated by IARC for carcinogenicity. EDC 9/11 agents have been classified by IARC as follows:

• 12 EDC 9/11 agents and categories as carcinogenic to humans (Group 1),

• 8 EDC 9/11 agents and categories as probably carcinogenic to humans (Group 2A),

• 20 EDC 9/11 agents and categories as possibly carcinogenic to humans (Group 2B), and

• 38 EDC 9/11 agents and categories as not classifiable as to carcinogenicity to humans (Group 3).

The remainder—55 individual EDC 9/11 agents and three categories—have not been evaluated by IARC. 35 NTP classifies seven EDC 9/11 agents and categories as known to be human carcinogens and 23 EDC 9/11 agents and categories as reasonably anticipated to be human carcinogens;   36 the rest of the EDCs—101 individual 9/11 agents and 5 categories—have not been evaluated by NTP. For each cancer site, IARC identifies chemical, physical, and biological entities or exposure circumstances with sufficient or limited evidence of carcinogenicity in humans. IARC does not identify any EDC 9/11 agents, categories, or any other hazard included in the Inventory of 9/11 Agents as having sufficient or limited evidence in humans of causing cancer in the uterus. 37

The Science Team also has acknowledged Reviewer B's concerns that the EPA classifications of carcinogenicity are not always up to date and should not be relied upon for current scientific knowledge. Some EPA evaluations of the carcinogenicity of 9/11 agents in the Inventory were conducted decades ago ( e.g., evaluations for phthalates such as benzyl butyl phthalates and dibutyl phthalate were last updated between 1987 and 1990) and some assessments are currently in development ( e.g., chloroform, chromium, cobalt, formaldehyde, mercury, naphthalene, perfluorodecanoic acid, perfluorohexanesulfonic acid, polychlorinated biphenyls, uranium, and vanadium). 38 Additionally, the Science Team has found that use of EPA references may be confusing since they are not required for review under any of the methods in the Policy and Procedures discussed above. To address these concerns, the Science Team has decided to remove the EPA carcinogenicity classification column from Table 3 of the final White Paper.

The Science Team also has evaluated the references provided by peer reviewers to supplement the STAC's discussion of some potential mechanisms of action  39 through which EDCs might cause uterine cancer in humans. Much of the available research on EDCs' mechanisms of action has focused on EDCs which are not also identified 9/11 agents in the Inventory of 9/11 Agents. Indeed, some of the specific chemicals and toxins identified as EDCs by the peer reviewers based on supplemental sources have not been identified by the WTC Health Program as 9/11 agents. The Science Team has recognized, however, that the list of 9/11 agents identified by the WTC Health Program in the Inventory may not be complete and that WTC-related uterine cancer may be associated with chemicals and toxins that exhibit estrogenic properties that may be identified as 9/11 agents in the future. Regardless of whether there are EDCs that may be associated with uterine cancer that may be added to the Inventory in the future, the Science Team has found it instructive to examine mechanisms of action for endocrine disruption even for those EDCs that have not been recognized as 9/11 agents. The supplemental references' descriptions of mechanisms of endocrine disruption illustrate the various ways in which exposure to EDCs could impact the female reproductive system and result in uterine cancer. The similar mechanisms of action for other EDCs help provide a complete picture of the possible causal relationship between the September 11, 2001, terrorist attacks, and uterine cancer among WTC responders and survivors. 40

Most endometrial tumors are hormonally driven through estrogen signaling via estrogen receptors α and β acting as an oncogenic signal. The main risk factors ( i.e., estrogen therapy without progestins, tamoxifen for the treatment of breast cancer, parity, oral contraceptive use, age at menarche) and some treatment options ( i.e., progestin therapies) for endometrial cancer patients underscore a key role for estrogen signaling in the disease. 41 Estrogen-like chemicals have been shown to mimic the estrogen pathway and affect the normal function of female sex hormones. This mechanism is suspected to lead to carcinogenesis in women, including the development of endometrial cancer, breast and ovarian cancers, and prostate cancer in men. 42 EDCs can interfere with the function and metabolism of estrogen; breast and ovarian cancers are associated with EDCs and their current known mechanisms of action are similar to those of uterine cancer. 43 For example, experimental studies in animals exposed to endocrine-disrupting alkylphenols such as nonylphenol and oxylphenol, as well as a case-control study, suggest an association between exposure to EDCs and endometrial cancer. 44 Experimental animal and in vitro studies have shown that exposure to the EDCs bisphenol A (BPA) and 2,4-dichlorodiphenyltrichloroethane (DDT) result in changes that could lead endometrial cells towards malignancy. 45

Studies in animal models show that exposure to some EDCs can cause endometrial hyperplasia (a proliferation of endometrial glands) and other alterations to the uterine lining. 46 Endometrial hyperplasia with atypia is of clinical significance because it may progress to, or coexist with, endometrial carcinoma. However, no human studies that showed an association between EDCs and endometrial hyperplasia were identified. Nonetheless, experimental animal studies have identified some evidence that suggests the likelihood of occurrence in humans.

EDCs such as di(2-ethylhexyl)phthalate (DEHP) and cadmium have also been associated with uterine leiomyoma (a benign smooth muscle tumor, also known as a fibroid, that causes symptoms such as uterine bleeding and severe pelvic pain, which may result in infertility or major surgery). A meta-analysis of five studies showed that urinary DEHP metabolites were statistically significantly associated with an increased risk of uterine leiomyoma, although the mechanism is still not well understood. 47 Moreover, an in vitro study showed that fibroid cells subjected to cadmium exposure for two months show enhanced migration potential, augmented anchorage-independent growth, and increased DNA synthesis, suggesting EDC-induced potential progression towards uterine cancer. 48

In addition to interacting with estrogen receptors α and β, EDCs are known to bind to and activate the estrogen-related receptor gamma (ERRγ). BPA has weak estrogenic activity due to its limited capacity to bind to nuclear estrogen receptors α and β. Nonetheless, ERRγ is activated by BPA and interacts with the ligand domain of estrogen receptors. 49 Multiple studies show that BPA may increase the risk of estrogen-related cancers. 50

EDCs are also known to play a role in endocrine disruption leading to epigenetic  51 changes. An instructive example is a study among Michigan residents accidentally exposed to the EDC polybrominated biphenyl (PBB). The study's authors found differences in epigenetic marks (chemicals which turn genes “on” and “off”) that suggest that PBB acts similarly to estrogen and is associated with dysregulated immune system pathways. The authors also found evidence that PBB could be acting like an estrogen, impacting gene expression. 52 Furthermore, EDCs may increase uterine sensitivity to estrogens due to epigenetic alterations. Another example is a study in female mice in which BPA administered in utero increased the expression of the developmental homeobox gene Hoxa10 that controls uterine organogenesis. Alterations in methylation of Hoxa10 have been associated with several human cancers. 53

In addition, endocrine disruption caused by some 9/11 agents alters reproductive and sexual development, and may lead to other health outcomes such as obesity and diabetes that affect the risk of uterine cancer development. 54 The following identified EDC 9/11 agents may pose such risks for the development of uterine cancer: polyvinyl chloride plastics, which contain phthalates;  55 trichloroethylene and its major metabolites;  56 TCDD, which is an EDC that has antiestrogenic properties;  57 and pesticides such as chlordane, DDT, dieldrin, endosulfan, hexachlorobenzene, lindane, heptachlor, metribuzin, and mirex. 58

Finally, the development of most endocrine cancers is likely to be the result of low-dose exposures to complex chemical mixtures in the environment throughout a person's life. 59 WTC dust is a complex mixture of EDCs and other environmental chemicals. Exposure to WTC dust, when added to the usual low-dose environmental chemical exposures experienced in a person's lifetime, may directly or indirectly influence the development of uterine cancer. Combined exposures have simultaneous effects on the endocrine system that could affect the development of uterine cancer and its risk factors. 60

In response to the peer reviews, the Science Team has updated its analysis and issued the final White Paper  61 including the Endocrine Society's definition of EDC and a reference to the Society's position statement on EDCs; the final White Paper recognizes 84 additional 9/11 agents in the Inventory of 9/11 Agents as known or potential EDCs in Table 3. The Science Team has also clarified in the final White Paper that among all 9/11 agents that are known or potential EDCs and that have been evaluated for their carcinogenicity by NTP and IARC, none are currently known to cause or reasonably anticipated to cause uterine cancer. Finally, the Science Team has modified the final White Paper to incorporate an appendix reflecting the discussion about mechanisms of endocrine disruption in this preamble.

The evidence provided by independent peer reviewers is compelling. However, the additional information does not alter the evaluations and conclusions found in the Science Team's final White Paper because the scope of the White Paper was limited to an assessment of the evidence for adding uterine cancer to the List based on Methods 1-3 of the Policy and Procedures described above. The peer reviewers did not suggest any epidemiologic studies of uterine cancer in the 9/11-exposed population; therefore, no further analysis was conducted under Method 1. No studies were suggested to demonstrate support for a causal association between a health condition already on the List and uterine cancer; therefore, no further analysis was conducted under Method 2. Finally, Method 3 relies on: (1) an NTP finding that the 9/11 agent is known or reasonably anticipated to be a human carcinogen, and (2) an IARC finding that there is sufficient or limited evidence in humans that the 9/11 agent causes that cancer. Although some of the 9/11 agents identified as known or potential EDCs that have been added to Table 3 of the final White Paper are considered by NTP to be known human carcinogens or reasonably anticipated to be human carcinogens, IARC has not determined that there is sufficient or limited evidence in humans that any 9/11 agent EDC or any other hazard in the Inventory causes uterine cancer. Therefore, the Science Team has continued to find that there is insufficient evidence available to support the addition of uterine cancer to the List pursuant to Method 3.

For the reasons discussed above, the Science Team's analysis and conclusion are unchanged: there continues to be no evidence to support the addition of uterine cancer to the List pursuant to Methods 1 or 3, but sufficient evidence supports the addition of uterine cancer to the List for qualified WTC Health Program members, pursuant to Method 2 ( i.e., only for those Program members who have a certified WTC-related estrogen-secreting tumor). However, the Science Team has found that the evaluations and supplemental information provided by the peer reviewers in response to the NPRM provide additional support for the STAC recommendation and rationale provided to the Administrator under Method 4.

The Administrator and Secretary of HHS proposed the addition of uterine cancer  62 to the List after reviewing the available body of scientific evidence describing the causal relationship between 9/11 exposures and uterine cancer, including certain 9/11 agents which are known or potential EDCs, as well as evaluating the STAC's comprehensive rationale and recommendation. In accordance with the WTC Health Program's Policy and Procedures, the Administrator evaluated the available information under the four methods developed for determining whether to add a type of cancer to the List. The Administrator's evaluation was discussed in full in Section III.E. of the NPRM. 63 During the NPRM public comment period, 26 public commenters and three independent peer reviewers expressed unanimous support for the addition of uterine cancer to the List based on the STAC's recommendation. Peer reviewers found that the totality of evidence points to a causal association between 9/11 agents that are known or potential EDCs and uterine cancer in the 9/11-exposed population.

The Administrator considered the public comments and peer reviews as well as the Science Team's description and evaluation of the supplemental evidence regarding mechanisms by which EDCs could affect the development of uterine cancer and its risk factors. First, the Administrator assessed whether there was sufficient evidence in peer-reviewed, published, epidemiologic studies of 9/11-exposed populations to support adding uterine cancer to the List under Method 1. The Administrator concurred with the Science Team's evaluation of the literature pursuant to Method 1 and found that the available literature did not provide sufficient support for the addition of uterine cancer to the List under Method 1. Because no peer-reviewed, published, epidemiologic studies of uterine cancer in 9/11-exposed populations were identified by peer reviewers or public commenters, the Administrator has determined that the evidence available under Method 1 is insufficient to support the addition of uterine cancer to the List.

Next, the Administrator reviewed whether multiple peer-reviewed epidemiologic studies establish a causal association between a condition already on the List and that type of cancer to permit an addition to the List under Method 2. In the NPRM, the Administrator agreed with the Science Team's finding that there is evidence of a causal association between estrogen-secreting tumors, which are considered rare cancers within the WTC Health Program, and uterine cancer. Thus, the Administrator found that uterine cancer may be proposed for addition to the List pursuant to Method 2, but such an addition would be limited to only those WTC Health Program members who have a certified WTC-related estrogen-secreting tumor. Neither peer reviewers nor public commenters provided studies refuting a causal association between estrogen-secreting tumors and uterine cancer. Therefore, the Administrator has determined that uterine cancer may be added to the List pursuant to Method 2, but only for those WTC Health Program members with a qualifying certified WTC-related estrogen-secreting tumor.

Pursuant to Method 3, the Administrator examined NTP and IARC evaluations of carcinogenicity of 9/11 agents. Method 3 permits an addition to the List if: (1) NTP has determined that a specific 9/11 agent is known to be a human carcinogen or reasonably anticipated to be a human carcinogen, and (2) IARC has determined that there is sufficient or limited evidence in humans that the 9/11 agent causes uterine cancer. As described in the NPRM, the Administrator concurred with the Science Team's conclusion that there was insufficient evidence to add uterine cancer to the List because IARC has not determined there is sufficient or even limited evidence in humans that any of the 9/11 agents in the Inventory of 9/11 Agents cause uterine cancer. Following publication of the NPRM, the Administrator also reviewed the 9/11 agents added to the list of EDCs in Table 3 of the final White Paper in response to the peer reviews. He agrees that 9/11 agents that are considered by NTP to be known or reasonably anticipated human carcinogens but that are not determined by IARC to have sufficient or limited evidence of uterine carcinogenicity in humans do not meet the requirements of Method 3. Because IARC has not identified any EDCs among the 136 EDC 9/11 agents and categories of EDC 9/11 agents now recognized in Table 3 of the final White Paper, nor any other hazard included in the Inventory as having sufficient or limited evidence in humans of uterine carcinogenicity, the Science Team's analysis and the Administrator's determination remains unchanged. Accordingly, the Administrator has determined that the evidence available under Method 3 is insufficient to support the addition of uterine cancer to the List but acknowledges that some 9/11 agents in the Inventory have never been evaluated for carcinogenicity by NTP or IARC.

The Administrator ultimately proposed adding uterine cancer to the List pursuant to Method 4, which permits an addition where the STAC recommends such an addition and provides a reasonable basis for the recommendation. As explained in the NPRM, the Administrator found that the STAC's recommendation provided a reasonable basis for the addition of uterine cancer under Method 4 and the recommendation was further supported by the supplemental information presented by the Science Team in the 2021 White Paper.

Specifically, the Administrator agreed with the STAC that mechanisms of initiation and progression of uterine cancer are similar to those for several other cancers on the List. 64 The Administrator agreed with the STAC's finding that the shared etiology and pathogenesis described in the scientific literature suggest it would be unlikely that uterine cancer would be the only cancer type not related to 9/11 exposures. The Administrator also agreed that an association between exposure to EDCs in WTC dust and uterine cancer risk is plausible. 65

Following publication of the NPRM and upon review of the public comments and peer reviews and the Science Team's response, including the final White Paper, the Administrator has found that the supplemental scientific evidence complements the evidence provided by the STAC by comprehensively demonstrating the variety of mechanisms of endocrine disruption and providing additional general support for the addition of uterine cancer to the List. Given the growing body of scientific evidence suggesting that exposure to EDCs may be a risk factor for female reproductive organ cancers, the Administrator has found that it is reasonable to assume that exposure to EDCs in WTC dust may contribute to uterine cancer risk, even in the absence of a robust body of evidence conclusively demonstrating EDC carcinogenic risks in occupational cohorts of women. The Administrator continues to recognize that the disproportionally low representation of women in the most studied cohorts of exposed responders makes it epidemiologically unlikely that a definitive association between 9/11 exposures and the occurrence of uterine cancer will be identified during the lifetime of even the most highly exposed WTC Health Program members. 66

After final review of the analyses by the STAC in its recommendation, the WTC Health Program Science Team's 2021 White Paper, public comments on the NPRM, the independent peer reviews of the scientific and technical evidence comprising the basis for the proposed rule, the Science Team's response to those comments, and the final White Paper, the Administrator has concluded that evidence continues to support the addition of uterine cancer to the List. For the reasons discussed above, the Administrator has determined that there is insufficient evidence to add uterine cancer to the List pursuant to Methods 1 and 3 of the Policy and Procedures. Sufficient evidence exists for the addition of uterine cancer pursuant to Method 2, restricted to those members who have a qualifying estrogen-secreting tumor. Finally, pursuant to Method 4, because the STAC provided a reasonable basis for an association between 9/11 agents listed in the Inventory of 9/11 Agents and uterine cancer, the Administrator has determined that there is sufficient evidence to add uterine cancer to the List for all eligible members.

With this rulemaking, the Administrator and the Secretary of HHS finalize the addition of uterine cancer to the List of WTC-Related Health Conditions. Adding uterine cancer to the List in a final rule with an immediate effective date allows the WTC Health Program to begin offering treatment services as soon as possible to members whose uterine cancers are certified as WTC-related.

For the reasons discussed above, the Administrator amends 42 CFR 88.15 by adding a new paragraph (d)(15) to include “malignant neoplasms of corpus uteri and uterus, part unspecified”  67 on the List of WTC-Related Health Conditions. The existing paragraph (d)(15)—malignant neoplasm of the ovary—and the remainder of the cancer types identified in existing paragraphs (d)(16) through (24)—rare cancers—are renumbered paragraphs (d)(16) through (25), accordingly. Finally, in renumbered paragraphs (d)(24) and (d)(25), the terms “Childhood cancers” and “Rare cancers” are unitalicized but are otherwise unchanged.

In addition to the changes described above, the Authority citation for part 88 is revised to remove the Public Law citations, retaining only the U.S. Code citations.

Executive Orders (E.O.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.

This final rule has been determined not to be a significant regulatory action under section 3(f) of E.O. 12866, and therefore has not been reviewed by the Office of Management and Budget (OMB). The addition of uterine cancer finalized by this rulemaking is estimated to cost the WTC Health Program between $1,706,454 and $3,805,173 per annum for 2023 through 2026. 68 All costs to the WTC Health Program will be transfers due to the implementation of provisions of the Patient Protection and Affordable Care Act (Pub. L. 111-148) in 2014 and as required under the authorizing statute for the WTC Health Program. 69 The rule will not interfere with state, local, or tribal governments in the exercise of their governmental functions.

The WTC Health Program estimates that approximately 84,000 WTC responders and approximately 34,000 survivors, or approximately 118,000 individuals in total, are current, living Program members. Of that total population, approximately 60,000 individuals were participants in previous WTC medical programs and were enrolled as “legacy” members in the WTC Health Program established by Title XXXIII of the PHS Act. For the purpose of calculating a baseline estimate of cancer prevalence only, the Administrator assumed that a steady rate of enrollment would continue, based on the trend in enrollees through September 2021.

According to WTC Health Program data, 12 percent of the current responder members (approximately 10,000 individuals) and 50 percent of survivor members (approximately 17,000 individuals) are female. 70 Finally, because there are no existing data on cancer cases related to 9/11 exposures at either the Pentagon or in Shanksville, Pennsylvania, the Administrator has used only data from studies of individuals who were responders or survivors in the New York City disaster area.

The Administrator estimated the treatment costs associated with covering uterine cancer in this rulemaking in U.S. dollars. The costs of treatment are divided into three treatment phases: the first year of treatment following diagnosis; the intervening years or continuing treatment after the first year; and treatment during the last year of life. The first-year costs of cancer treatment are higher due to the initial need for aggressive medical ( e.g., radiation or chemotherapy) and surgical care. The costs during the last year of life are often dominated by increased hospitalization costs. 71 Therefore, three different treatment phase costs were used to provide a best estimate of treatment costs in conjunction with expected incidence and long-term survival rates for uterine cancer. Average 2022 treatment costs for uterine cancer, the last year for which complete data were available, are in Table A below.

These cost figures were based on a study of cancer patients from the Surveillance, Epidemiology, and End Results (SEER) Program maintained by the National Cancer Institute and using Medicare files. 72 The average costs of treatment described above are given in 2022 prices, adjusted using the Medical Consumer Price Index for all urban consumers. 73

For the purpose of illustrating a lower-bound incidence estimate, the Administrator used the same baseline analysis described in the NPRM, calculating the number of cases of uterine cancer expected to be observed in the cohort of approximately 27,000 female responders and survivors in the WTC Health Program, based on U.S. population cancer rates. 74 Demographic characteristics of the cohort were assigned since the actual data are not available for individuals in the responder and survivor populations who have not yet enrolled in the WTC Health Program. Sex and age (at the time of exposure) distributions for responders and survivors were assumed to be the same as current members in the WTC Health Program. Because uterine cancer occurs only in females, 75 all calculations only consider female WTC Health Program members.

The Administrator assumed race and ethnic origin distributions for responders and survivors, respectively, according to distributions in the WTC Health Registry cohort:  76 57 percent non-Hispanic white, 15 percent non-Hispanic black, 20 percent Hispanic, and 8 percent other race/ethnicity for responders; 50 percent non-Hispanic white, 17 percent non-Hispanic black, 15 percent Hispanic, and 18 percent other race/ethnicity for survivors. Registry follow-up for cancer morbidity for each person began on January 1, 2002, or at age 15 years, whichever occurred later. Age 15 was used because the cancer incidence rate file did not include rates for persons of less than 15 years of age. Follow-up ended on December 31, 2016, or the estimated last year of life, whichever was earlier. The estimated last year of life was used since not all persons would be expected to remain alive at the end of 2016. The estimated last year of life was based on sex, race, age, and year-specific death rates from CDC WONDER. 77 A life-table analysis program, LTAS.NET, was used to estimate the expected number of incident cancers for uterine cancer. 78 The Administrator calculated cancer incidence rates using data through 2018 from the SEER Program and estimated uterine cancer incidence in the WTC Health Program for 2002-2026. 79 The resulting sex, race, age, and year-specific cancer incidence rates were applied to the estimated person-years at risk to estimate the expected number of cancer cases for uterine cancer starting from year 2002, the first full year following the September 11, 2001, terrorist attacks, to 2026.

For the purpose of illustrating an upper-bound incidence estimate, the Administrator reviewed WTC Health Program records and Program Data Center monitoring exam questionnaires to identify self-reported uterine cancer diagnoses among current members. The Administrator found 254 self-reports of uterine cancer among members who filled out monitoring exam questionnaires from January 2013 to November 2022; of those members, 11 are now deceased. The limitations associated with the review of WTC Health Program data are that some of the reported cases of uterine cancer may have been diagnosed prior to 2001 and some members may have mistakenly self-reported uterine cancer. The Administrator calculated a WTC Health Program uterine cancer incidence rate based on the January 2013-November 2022 WTC Health Program data and used that rate to estimate incidence of uterine cancer among Program members for 2023 through 2026.

These case numbers are offered as estimates only; the certification of individual cancer diagnoses will be conducted on a case-by-case basis, as required by the Zadroga Act. 80 Please see the WTC Health Program website for information about how to apply for enrollment in the Program  81 and about health condition certification. 82

To determine the potential number of persons in the responder and survivor populations with cancer, the Administrator conducted two different analyses for the purposes of illustrating lower- and upper-bound cost estimates.

As discussed above and in the NPRM, for the lower-bound, baseline analysis, the Administrator used the number of incident uterine cancer cases expected, based on U.S. population rates, for each year starting with 2002 and estimated the prevalence of uterine cancer using SEER survival rate statistics for corpus uteri through 2026. 83 Using the incident cases and survival rate statistics, the Administrator estimated the lower-bound prevalence (number of persons living with cancer) of cases during the 23-year period (2002-2026) since September 11, 2001. The resulting Table B summarizes those results for each year from 2023 through 2026, the number of new cases estimated to have occurred in that year (incidence), the number of persons surviving up to 23 years beyond their first diagnosis (prevalence), and the number of individuals who might be expected to have died from their cancer in that year. 84

For the upper-bound estimate, the Administrator used the incidence rate calculated based on a review of data from the WTC Health Program and the Program Data Centers of self-reported uterine cancer diagnoses among current members, discussed above, and SEER survival rate statistics for corpus uteri to estimate uterine cancer prevalence during the 4-year period from 2023 through 2026. 85 The resulting Table C summarizes those results for each year from 2023 through 2026, including the number of new cases estimated to have occurred in each year, the number of persons surviving beyond their first diagnosis, and the number of individuals who might be expected to have died from their cancer in each year.

To compute the lower-bound costs for uterine cancer, the Administrator assumed that the rate of uterine cancer in the WTC Health Program is equal to the rate of uterine cancer in the U.S. population. The treatment costs for the first year of treatment (Table A, year adjusted) were applied to the predicted newly incident (Year 1) cases for each year ( see Table B). Likewise, the costs of treatment for the last year of life were applied in each year to the number of people predicted to die from their cancer in that year. The costs of continuing treatment from Table A were applied to the number of individuals who had survived their cancers beyond their year of diagnosis, for each year of survival (years two to four). Because some of the members estimated to be living with uterine cancer may not meet the WTC Health Program's exposure  86 and latency  87 requirements as necessary for certification, the Administrator assumed that 11 percent of uterine cancer certification requests will not be approved. 88 Costs for future years are discounted at both seven percent and three percent to reflect net present value. 89

To compute the upper-bound costs, the Administrator assumed that cases of uterine cancer in the WTC Health Program will continue to increase at the WTC Health Program incidence rate derived from self-reported uterine cancer diagnoses. He further assumed that 243 cases of uterine cancer in 2023 will be considered “new” and certified by the WTC Health Program for treatment and monitoring and that every new case in 2023 will incur first-year costs ( see Table A) because no information is available about the stage of treatment for each Program member who has reported a uterine cancer diagnosis. For treatment costs in future years, the Administrator applied the same formula as above for the lower-bound estimate and assumed that 11 percent of uterine cancer certification requests will not be granted.

The sum of the annual costs in the table for the years 2023 through 2026 represents the estimated treatment costs to the WTC Health Program for coverage of uterine cancer for the 12 percent of approximately 84,000 WTC responders who are female and the 50 percent of approximately 34,000 WTC survivors who are female.

Because HHS lacks data to account for recoupment from workers' compensation insurance or primary payment by either private health insurance or Medicare/Medicaid payments specific to uterine cancer, the estimates offered here are reflective of estimated WTC Health Program costs only and assume the Program is the primary payer. This analysis offers assumptions about the number of current and future WTC Health Program members who are and will likely be diagnosed with uterine cancer and have their certification requests granted, to provide a conservative estimate of treatment costs to the WTC Health Program. The U.S. population average uterine cancer rate is used to identify a baseline number of expected cases among WTC Health Program members for the lower bound; an upper-bound estimate was based on a review of the number of WTC Health Program members who self-reported uterine cancer diagnoses in questionnaires completed from January 2013 to November 2022. This analysis does not include administrative costs associated with certifying additional WTC-related uterine cancers that might result from this action.

Since the implementation of provisions of the Patient Protection and Affordable Care Act on January 1, 2014, all members and future members are assumed to have or have access to medical insurance coverage other than through the WTC Health Program. 90 Therefore, all treatment costs to be paid by the WTC Health Program from 2023 through 2026 are considered transfers.

The Administrator found the total cost estimate range—$1,706,454 to $3,805,173 annually—by adding the low estimate for 2023, $1,785,423 (U.S. cancer rate average), and the low 2024-2026 estimate in Table D, $5,040,394 (7 percent discount rate, U.S. cancer rate average, 89 percent certification rate), and dividing the sum by four to find the annual low-cost estimate ( i.e., $1,706,454). The same calculation was done for the annual high-cost estimates, adding the high estimate for 2023, $9,508,626.20 (WTC Health Program average uterine cancer rate), to the high 2024 through 2026 estimate, $5,712,066 (3 percent discount rate, WTC Health Program average uterine cancer rate, 89 percent certification rate), and dividing the sum by four ( i.e., $3,805,173).

This section qualitatively describes the potential benefits of this rulemaking to add uterine cancer to the List in terms of the expected improvements in the health and health-related quality of life of potential uterine cancer patients treated through the WTC Health Program, compared to not conducting the rulemaking.

The Administrator does not have information on the health of the population that may have experienced 9/11 exposures and is not currently enrolled in the WTC Health Program. In addition, the Administrator has only limited information about health insurance and healthcare services available for cases of uterine cancer potentially caused by 9/11 exposures and suffered by any population of responders and survivors, among responders and survivors both currently enrolled in the WTC Health Program and those who are not enrolled. For the purposes of this analysis, the Administrator assumed that all unenrolled responders and survivors are now covered by health insurance due to access provided by the Patient Protection and Affordable Care Act and may be receiving treatment outside the WTC Health Program.

Although the Administrator cannot quantify the benefits associated with the WTC Health Program, members with certified WTC-related uterine cancer are expected to experience better treatment outcomes with WTC Health Program physicians as compared to receiving care outside of the WTC Health Program. A recent study found that “WTC-exposed responder cancer patients enrolled in the Fire Department of the city of New York Clinical Center of Excellence or in the General Responder Cohort had higher survival rates compared with those not so enrolled.”  91 Moreover, under other insurance plans, patients would likely have deductibles and copays, which impact access to care and, particularly, its timeliness. 92 WTC Health Program members have first-dollar coverage and hence are likely to seek care sooner, when indicated, resulting in improved treatment outcomes.

Finally, during public meetings, WTC Health Program members have expressed that the lack of social and clinical support, and lack of recognition that their diagnosed uterine cancer is a WTC-related health condition, have had a significant negative impact on their morale and quality of life.

The analysis presented here was limited by the dearth of verifiable data on the uterine cancer status of responders and survivors who have yet to apply for enrollment in the WTC Health Program. Because of the limited data, the Administrator is not able to estimate benefits in terms of averted healthcare costs; nor is the Administrator able to estimate administrative costs, or indirect costs, such as averted absenteeism, short- and long-term disability, and productivity losses averted due to premature mortality.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires each agency to consider the potential impact of its regulations on small entities, including small businesses, small governmental units, and small not-for- profit organizations. The Administrator certifies that this final rule has “no significant economic impact upon a substantial number of small entities” within the meaning of the RFA.

The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires an agency to invite public comment on, and to obtain OMB approval of, any regulation that requires 10 or more people to report information to the agency or to keep certain records. The Administrator has determined that this rulemaking does not contain any new information collection requirements or recordkeeping requirements; thus, the PRA does not apply to this rulemaking. Data collection and recordkeeping requirements for the WTC Health Program are approved by OMB under “World Trade Center Health Program Enrollment, Appeals & Reimbursement” (OMB Control No. 0920-0891, exp. September 30, 2025).

As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801 et seq., HHS will report the promulgation of this rule to Congress prior to its effective date.

Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 et seq., directs agencies to assess the effects of Federal regulatory actions on state, local, and tribal governments, and the private sector “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this final rule does not include any Federal mandate that may result in increased annual expenditures in excess of $100 million in 1995 dollars by state, local, or tribal governments in the aggregate, or by the private sector.

This final rule has been drafted and reviewed in accordance with Executive Order 12988, “Civil Justice Reform,” and will not unduly burden the Federal court system. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.

The Administrator has reviewed this final rule in accordance with Executive Order 13132 regarding federalism and has determined that it does not have “Federalism implications.” The rule does not “have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.”

In accordance with Executive Order 13045, the Administrator has evaluated the environmental health and safety effects of this final rule on children. The Administrator has determined that the rule will have no environmental health and safety effect on children.

In accordance with Executive Order 13211, the Administrator has evaluated the effects of this final rule on energy supply, distribution, or use, and has determined that the rule will not have a significant adverse effect.

Under Public Law 111-274 (October 13, 2010), Executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. The Administrator has attempted to use plain language in promulgating the final rule consistent with the Federal Plain Writing Act guidelines.

For the reasons discussed in the preamble, the Administrator and HHS Secretary amend 42 CFR part 88 as follows:

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) requires, in pertinent part, agencies to make an annual adjustment for inflation by January 15th every year. OMB, M-16-06, Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Feb. 24, 2016). The Office of Management and Budget (OMB) annually publishes guidance on the adjustment multiplier to assist agencies in calculating the mandatory annual adjustments for inflation.

The NTSB's most recent adjustment was for fiscal year (FY) 2022, allowing the agency to impose a civil penalty up to $1,850, effective January 14, 2022 for violations involving 49 U.S.C. 1132 (Civil aircraft accident investigations), 1134(b) (Inspection, testing, preservation, and moving of aircraft and parts), 1134(f)(1) (Autopsies), or 1136(g) (Prohibited actions when providing assistance to families of passengers involved in aircraft accidents). Civil Monetary Penalty Annual Inflation Adjustment, 87 FR 2352 (Jan. 14, 2022).

OMB has since published updated guidance for FY 2023. OMB, M-23-05, Implementation of Penalty Inflation Adjustments for 2023, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Dec. 15, 2022). Accordingly, this final rule reflects the NTSB's 2023 annual inflation adjustment and updates the maximum civil penalty from $1,850 to $1,993.

The 2023 annual adjustment is calculated by multiplying the applicable maximum civil penalty amount by the cost-of-living adjustment multiplier, which is based on the Consumer Price Index and rounding to the nearest dollar. OMB, M-23-05, Implementation of Penalty Inflation Adjustments for 2023, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Dec. 15, 2022). For FY 2023, OMB's guidance states that the cost-of-living adjustment multiplier is 1.07745.

Accordingly, multiplying the current penalty of $1,850 by 1.07745 equals $1,993.2825, which rounded to the nearest dollar equals $1,993. This updated maximum penalty for the upcoming fiscal year applies only to civil penalties assessed after the effective date of this final rule. The next civil penalty adjustment for inflation will be calculated by January 15, 2024.

The Office of Information and Regulatory Affairs has determined that agency regulations that exclusively implement the annual adjustment are consistent with OMB's annual guidance, and have an annual impact of less than $100 million are generally not significant regulatory actions under Executive Order (E.O.) 12866. OMB, M-23-05, Implementation of Penalty Inflation Adjustments for 2023, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Dec. 15, 2022). An assessment of its potential costs and benefits under E.O. 12866, Regulatory Planning and Review and E.O. 13563, Improving Regulation and Regulatory Review is not required because this final rule is not a “significant regulatory action.” Likewise, this rule does not require analyses under the Unfunded Mandates Reform Act of 1995 because this final rule is not significant.

The Regulatory Flexibility Act (5 U.S.C. 801 et seq. ) requires each agency to review its rulemaking to assess the potential impact on small entities, unless the agency determines a rule is not expected to have a significant economic impact on a substantial number of small entities. In accordance with 5 U.S.C. 605(b), the NTSB certifies that the final rule will not have a significant economic impact on a substantial number of small entities; only those entities that are determined to have violated Federal law and regulations would be affected by the increase in penalties made by this rule.

This final rule complies with all applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988 “Civil Justice Reform,” to minimize litigation, eliminate ambiguity, and reduce burden. In addition, the NTSB has evaluated this rule under E.O. 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights”; and E.O. 13045, “Protection of Children from Environmental Health Risks and Safety Risks.”

The NTSB does not anticipate this rule will have a substantial direct effect on state government or will preempt state law. Accordingly, this rule does not have implications for federalism under E.O. 13132, Federalism.

The NTSB also evaluated this rule under E.O. 13175, Consultation and Coordination with Indian Tribal Governments. The agency has concluded that this final rule will 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 Paperwork Reduction Act of 1995 is inapplicable because the final rule imposes no new information reporting or recordkeeping necessitating clearance by OMB.

The Regulatory Flexibility Act of 1980 does not apply because, as a final rule, this action is not subject to prior notice and comment. See 5 U.S.C. 604(a).

The NTSB has concluded that this final rule neither violates nor requires further consideration under the aforementioned Executive Orders and acts.

Accordingly, for the reasons stated in the Preamble, the NTSB amends 49 CFR part 831, as follows:

The Regional Administrator of the Greater Atlantic Regional Office monitors herring fishery catch in each Management Area based on vessel and dealer reports, state data, and other available information. Regulations at 50 CFR 648.201(a)(1)(i)(B)( 2 ) require that NMFS implement a 2,000-lb (907.2-kg) possession limit for herring for Area 3 beginning on the date that catch is projected to reach 98 percent of the sub-annual catch limit (ACL) for that area.

Based on vessel reports, dealer reports, and other available information, the Regional Administrator projects that the herring fleet will have caught 98 percent of the Area 3 sub-ACL by January 10, 2023. Therefore, effective 00:01 hr local time January 13, 2023, through December 31, 2023, a person may not attempt or do any of the following: Fish for; possess; transfer; purchase; receive; land; or sell more than 2,000 lb (907.2 kg) of herring per trip or more than once per calendar day in or from Area 3.

Vessels that enter port before 00:01 local time on January 13, 2023, may land and sell more than 2,000 lb (907.2 kg) of herring from Area 3 from that trip, provided that catch is landed in accordance with state management measures. Vessels may transit or land in Area 3 with more than 2,000 lb (907.2 kg) of herring on board, provided that: The herring were caught in an area not subject to a 2,000-lb (907.2-kg) limit; all fishing gear is stowed and not available for immediate use; and the vessel is issued a permit appropriate to the amount of herring on board and the area where the herring was harvested.

Also effective 00:01 hr local time, January 13, 2023, through 24:00 hr local time, December 31, federally permitted dealers may not attempt or do any of the following: Purchase; receive; possess; have custody or control of; sell; barter; trade; or transfer more than 2,000 lb (907.2 kg) of herring per trip or calendar day from Area 3, unless it is from a vessel that enters port before 00:01 local time on January 13, 2023 and catch is landed in accordance with state management measures.

This 2,000-lb possession limit bypasses the 40,000-lb (18,143.7-kg) possession limit that is required when NMFS projects that 90 percent of the sub-ACL will be caught. Regulations at § 648.201(a)(1)(i)(B)( 1 ) require NMFS to implement a 40,000-lb (18,143.7-kg) possession limit for herring for Area 3 beginning on the date that catch is projected to reach 90 percent of the herring sub-ACL for that area. Based on dealer reports, state data, and other available information, we estimate that 90 percent of the Area 3 sub-ACL was harvested by January 9, 2023. However, due to the low 2023 sub-ACLs, the high volume nature of this fishery, and the progress of catch this fishing year, we project that 98 percent of the sub-ACL in Area 3 will be harvested by January 10, 2023. Implementing the 40,000-lb limit before the 2,000-lb limit is impracticable due to the small amount of time between the 90-percent and 98 percent catch projection dates and substantially increases the risk of exceeding the sub-ACL due to the low amount of available catch remaining under the sub-ACL. The limited time for the two different notices is logistically difficult and could result in substantial confusion. The limited time between projected dates and the relatively low available catch could also encourage significantly increased fishing effort if we first implemented the 40,000-lb limit in Area 3. This increase could require a quicker implementation of the 2,000 lb limit than possible. To minimize the chance of a potential sub-ACL overage occurring and to avoid incentivizing potential changes in fishing behavior that could contribute to an overage, NMFS is bypassing the 40,000-lb (18,143.7-kg) possession limit and implementing the 2,000-lb (907.2-kg) possession limit in Area 3.

The projected catch is 98 percent of the current Area 3 sub-ACL. The current Area 3 sub-ACL is equal to the 2023 Area 3 sub-ACL that was previously implemented through Framework Adjustment 8 to the Atlantic Herring Fishery Management Plan (FMP), which will remain in place until it is revised through the specification process. NMFS is working on implementing updated 2023 specifications as soon as practicable consistent with the specifications process.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

NMFS finds good cause pursuant to 5 U.S.C. 553(b)(3)(B) to waive prior notice and the opportunity for public comment because it is unnecessary, contrary to the public interest, and impracticable. Ample prior notice and opportunity for public comment on this action has been provided for the required implementation of this action. The requirement to implement this possession limit was developed by the New England Fishery Management Council using public meetings that invited public comment on the measures when they were developed and considered along with alternatives. Further, the regulations requiring NMFS to implement this possession limit also were subject to public notice and opportunity to comment when they were first adopted in 2021. Herring fishing industry participants monitor catch closely and anticipate potential possession limit adjustments as catch totals approach Area sub-ACLs. The regulation provides NMFS with no discretion and is designed for implementation as quickly as possible to prevent catch from exceeding limits designed to prevent overfishing while allowing the fishery to achieve optimum yield.

The 2023 herring fishing year began on January 1, 2023. Data indicating that the herring fleet will have landed at least 98 percent of the 2023 sub-ACL allocated to Area 3 only recently became available. High-volume catch and landings in this fishery can increase total catch relative to the sub-ACL quickly, especially in this fishing year where annual catch limits are unusually low. If implementation of this possession limit adjustment is delayed to solicit prior public comment, the 2023 sub-ACL for Area 3 will likely be exceeded; thereby undermining the conservation objectives of the Herring FMP. If sub-ACLs are exceeded, the excess must be deducted from a future sub-ACL and would reduce future fishing opportunities. The public expects these actions to occur in a timely way consistent with the FMP's objectives. For the reasons stated above, NMFS also finds good cause to waive the 30-day delayed effectiveness in accordance with 5 U.S.C 553(d)(3).

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The A season apportionment of the 2023 Pacific cod TAC allocated to catcher vessels greater than or equal to 60 feet (18.3 m) LOA using pot gear in the BSAI is 5,168 metric tons (mt) as established by the final 2022 and 2023 harvest specifications for groundfish in the BSAI (87 FR 11626, March 2, 2022) and inseason adjustment (87 FR 80090, December 29, 2022).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the A season apportionment of the 2023 Pacific cod TAC allocated as a directed fishing allowance to catcher vessels greater than or equal to 60 feet (18.3 m) LOA using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels greater than or equal to 60 feet (18.3 m) LOA using pot gear in the BSAI.

While this closure is effective, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion, and would delay the closure of Pacific cod by catcher vessels greater than or equal to 60 feet (18.3 m) LOA using pot gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 10, 2023.

The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

Authority: 16 U.S.C. 1801 et seq.