2798 Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Rules and Regulations 
1The latest revision of the FSIS Guideline for 
Label Approval is available at: https://
www.fsis.usda.gov/inspection/compliance- guidance. 2See, e.g., 60 FR 67444, December 29, 1995; 76 
FR 75809, 75810, December 5, 2011; 78 FR 66826, November 7, 2013; 85 FR 56538, 56539, September 14, 2020. DEPARTMENT OF AGRICULTURE 
Food Safety and Inspection Service 
9 CFR Parts 352, 354, 362, and 412 
[Docket No. FSIS–2019–0019] 
RIN 0583–AD78 
Prior Label Approval System: 
Expansion of Generic Label Approval 
AGENCY : Food Safety and Inspection 
Service (FSIS), U.S. Department of Agriculture (USDA). 
ACTION : Final rule. 
SUMMARY : FSIS is amending its 
regulations to expand the circumstances under which it will generically approve the labels of meat, poultry, and egg products. Also, as of the effective date of this final rule, FSIS will no longer evaluate generically approved labels that establishments and egg products plants voluntarily submit for FSIS review. FSIS is also announcing the availability of revised guidelines on the types of labels that must be submitted to FSIS for approval. 
DATES : This rule is effective March 20, 
2023. Submit comments on the revised FSIS Guideline for Label Approval on or before February 17, 2023. 
ADDRESSES : A downloadable version of 
the revised FSIS Guideline for Label Approval is available to view and print at https://www.fsis.usda.gov/inspection/ 
compliance-guidance. No hard copies of 
the guideline have been published. 
FSIS invites interested persons to 
submit comment on the revised FSIS Guideline for Label Approval. Comments may be submitted by one of the following methods. 
•Federal eRulemaking Portal: This 
website provides the ability to type short comments directly into the comment field on this web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow 
the on-line instructions at that site for submitting comments. 
•Mail: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250–3700. 
•Hand- or Courier-Delivered 
Submittals: Deliver to 1400 
Independence Avenue SW, Jamie L. Whitten Building, Room 350–E, Washington, DC 20250–3700. 
Instructions: All items submitted by 
mail or electronic mail must include the Agency name and docket number FSIS– 2019–0019. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https://www.regulations.gov. 
Docket: For access to background 
documents or comments received, call (202) 720–5627 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Washington, DC 20250–3700. 
FOR FURTHER INFORMATION CONTACT : 
Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development, by telephone at (202) 205–0495. 
SUPPLEMENTARY INFORMATION : 
Executive Summary 
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
1to 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. 
TABLE 1—N ETBENEFITS  
[Cost savings] 
Annualized 
net benefit 
(7% discount rate, 
10 years) 
Industry ................................ $517,888 
Agency ................................ 281,619 
Total ............................. 799,507 
Table of Contents 
I. Background 
II. Final Rule III. Summary of Comments and Responses 
A. Industry Compliance and Agency 
Oversight 
B. Cost of Label Review C. Increase in Deficient Labels D. Organic Claims E. Negative Claims F. Certified Claims 
G. Temporary Label Approval H. Voluntary Submissions I. Geographic Landmark Claims J. Front of Pack Nutrition Statements K. Miscellaneous Comments 
IV. Executive Orders 12866 and 13563 V. Regulatory Flexibility Act Assessment VI. Paperwork Reduction Act VII. USDA Non-Discrimination Statement VIII. E-Government Act IX. Executive Order 12988, Civil Justice 
Reform 
X. Executive Order 13175, Consultation and 
Coordination With Indian Tribal Governments 
XI. Environmental Impact XII. Additional Public Notification 
I. Background 
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
2of these 
provisions is that they require the Secretary or his or her representative to 
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3For purposes of this document, the term 
‘‘establishment’’ includes official meat and poultry 
establishments and egg products plants, unless otherwise indicated. 
4Nutrition labeling for egg products must comply 
with the provisions of 21 CFR part 101, promogulated under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act [9 CFR 590.411(e)]. 
5OIG’s audit report is available at: https://
www.usda.gov/sites/default/files/audit-reports/ 24601-0002-23.pdf. 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));
4and (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’’).
5In 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. 
II. Final Rule 
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 
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6The Export Library is available at: https://
www.fsis.usda.gov/wps/portal/fsis/topics/ 
international-affairs/exporting-products/export- library-requirements-by-country. 
7Although there is no specific equivalent 
regulation for egg products, FSIS follows the same policy because such products, intended exclusively for export, must comply with foreign countries’ requirements and are therefore not considered misbranded. 8Under existing regulations, non-FSIS- 
jurisdiction products that contain meat or poultry (9 CFR 350.3(c)) and products containing non- amenable species of poultry (9 CFR part 362), which are voluntarily inspected, are already subject to the label approval provisions of 9 CFR part 412. Nonetheless, this final rule adds additional 
regulatory language to 9 CFR part 362 to further clarify label approval requirements with respect to voluntarily inspected poultry. 
9The latest revision of the FSIS Guideline for 
Label Approval is available at: https://
www.fsis.usda.gov/inspection/compliance- guidance. labeling requirements.6At 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.
7FSIS 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.
8For 
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. 
II. Summary of Comments and 
Responses 
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. 
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10Audit Report 24601–0002–23 available at 
https://www.usda.gov/sites/default/files/audit- 
reports/24601-0002-23.pdf. 11FSIS Directive 7221.1 is available at: https://
www.fsis.usda.gov/policy/fsis-directives/7221.1. 
12The General Labeling Task is a set of 
surveillance procedures that IPP use to verify the ongoing compliance of labels, including generic labels, at establishments. FSIS Directive 7221.1, Prior Labeling Approval, provides instructions to IPP for conducting the General Labeling task. 
13FSIS Constituent Update: Tips for Faster Label 
Approval Process. August 9, 2019, available at: https://www.fsis.usda.gov/news-events/news-press- releases/constituent-update-august-9-2019-0. 14Methodology available at: https://
www.fsis.usda.gov/guidelines/2016-0019. A. Industry Compliance and Agency 
Oversight 
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.
10In 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,
11to 
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.
13FSIS 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.
14These 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 
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15PHIS is FSIS’ dynamic, comprehensive data 
analytic system, which was launched as part of the 
Agency’s effort to collect, consolidate and analyze data in order to improve public health. 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. 
B. Cost of Label Review 
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. 
C. Increase in Deficient Labels 
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)
15that 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. 
D. Organic Claims 
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, 
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167 CFR part 205. 
1765 FR 80548, December 21, 2000. 18See FSIS Directive 7221.1, Prior Labeling 
Approval and FSIS Directive 7000.1, Verification of 
Non-Food Safety Consumer Protection Regulatory Requirements. 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,
16which were first 
published in December 2000,17permit 
‘‘organic’’ claims to appear in the ingredient statements of non-certified products. FSIS did not propose to change those requirements. 
E. Negative Claims 
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.
18IPP 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 
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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’’. 
F. Certified Claims 
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. 
G. Temporary Label Approval 
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. 
H. Voluntary Submissions 
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 
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19Website available at: https://www.fsis.usda.gov/ 
inspection/compliance-guidance/labeling. 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.
19Moreover, 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.’’ 
I. Geographic Landmark Claims 
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 
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20See 9 CFR 317.8(b)(40) and 381.129(f). 
21See 9 CFR 412.2(b). 22FSIS’ Label Submission and Approval System 
(LSAS) is a web-based software application that 
integrates and implements an electronic label application process for establishments to submit label applications to FSIS. 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.’’
20Such claims are already 
eligible for generic approval.21It 
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. 
J. Front-of-Package Nutrition Statements 
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. 
K. Miscellaneous Comments 
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. 
IV. Executive Orders 12866 and 13563 
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 
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23FSIS Form 7234–1 Application for Approval of 
Labels, Marking or Device. Last modified 11/16/ 
2011. Available at: https://www.fsis.usda.gov/sites/ default/files/2020-08/FSIS_ 7234-1_ Approval_ of_
Labels_ 2.pdf. 
24BLS Occupational Employment Statistics, 
Occupational Employment and Wages, May 2021. 19–1021 Food Scientists and Technologists. <https://www.bls.gov/news.release/pdf/ ocwage.pdfoes/current/oes191012.htm#nat > 
Accessed on 9/16/2022. Last Modified 03/31/2022. 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. 
Economic Impact Analysis 
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. 
Need for the Rule 
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. Baseline 
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. 
TABLE 2—L ABEL EVALUATIONS AND ADJUDICATIONS , FY 2016–2019 
FSIS labels 2016 2017 2018 2019 
Labels FSIS Would Not have Evaluated Under the Final Rule ...................................... 8,534 5,812 6,025 5,229 
Total Labels FSIS Evaluated * .................................................................................. 22,846 17,958 17, 635 15,459 
Total Label Adjudications ** ...................................................................................... 30,857 25,125 27,580 26,158 
* This is the total number of labels FSIS evaluated, including the labels that would have been generically approved under the final rule. 
** Label adjudications include some labels being reevaluated. 
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. 
Expected Costs of the Final Rule 
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. 
Expected Benefits of the Final Rule Industry Impacts 
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.
23FSIS 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.
24A benefits and 
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25To be consistent with analyses done by the 
Department of Health and Human Services, this 
analysis accounts for fringe benefits and overhead by multiplying wages by a factor of 2. 
26Salary Table 2021–DCB for the locality pay area 
of Washington-Baltimore-Arlington, DC-MD-VA- WV-PA. Effective January 2021. Available at: https://www.opm.gov/policy-data-oversight/pay- leave/salaries-wages/salary-tables/pdf/2021/DCB_h.pdf. 
27Nussle, Jim. (2008). M–08–13: 
MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES. 
Executive Office of the President. Available at: https://www.whitehouse.gov/sites/whitehouse.gov/ files/omb/memoranda/2008/m08-13.pdf. overhead factor of two25was 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. 
TABLE 3—E STIMATED INDUSTRY COSTSAVINGS  
[2021 Dollars] 
Total industry cost savings from reduced need for FSIS label evaluation Present value 
cost savings 
at 7% Present value 
cost savings 
at 3% 
Total over 10 years ............................................................................................................ .................................. $3,637,429 $4,417,690 
Annualized total over 10 years ................................................................................................. ........................... 517,888 517,888 
Total over 20 years ............................................................................................................ .................................. 5,486,513 7,704,866 
Annualized total over 20 years ................................................................................................. ........................... 517,888 517,888 
Agency Impacts 
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,
26with an adjusted benefits 
factor of 36.25 percent).27Prior 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. 
TABLE 4—E STIMATED AGENCY COSTSAVINGS  
[2021 Dollars] 
Total agency cost savings from reduced need for FSIS label evaluation Present value 
cost savings 
at 7% Present value 
cost savings 
at 3% 
Total over 10 years ............................................................................................................ .................................. $1,977,974 $2,402,267 
Annualized total over 10 years ................................................................................................. ........................... 281,619 281,619 
Total over 20 years ............................................................................................................ .................................. 2,983,476 4,189,780 
Annualized total over 20 years ................................................................................................. ........................... 281,619 281,619 
Net Benefits 
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. 
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TABLE 5—E STIMATED NETBENEFITS  
[2021 Dollars] 
Total agency and industry cost savings from reduced need for FSIS label evaluation Present value 
cost savings 
at 7% Present value 
cost savings 
at 3% 
Total over 10 years ............................................................................................................ .................................. $5,615,403 $6,819,957 
Annualized total over 10 years ................................................................................................. ........................... 799,507 799,507 
Total over 20 years ............................................................................................................ .................................. 8,469,989 11,894,645 
Annualized total over 20 years ................................................................................................. ........................... 799,507 799,507 
Alternative Regulatory Approaches 
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. 
TABLE 6—R EGULATORY ALTERNATIVES CONSIDERED  
Alternative Benefits Costs Net benefit 
(1) Take No Action .......................... No Benefit ...................................... No potential industry or Agency 
cost savings.Net benefits are less than alternative 3. 
(2) The Final Rule, Except Industry 
Would Still Have the Option to 
Have LPDS Evaluate Labels that Would Otherwise be Generically Approved.Industry could benefit from addi-
tional FSIS evaluation.Potential for inefficient use of 
Agency resources. Industry would also incur costs of submit-ting the labels and waiting for FSIS evaluation.Net benefits are less than alternative 3. Although in-
dustry could marginally benefit from additional FSIS evaluation, sufficient guidance is available for labels that can be generically approved. Also, industry and the Agency would incur costs from submitting and evaluating such labels. 
(3) The Final Rule ........................... Potential industry cost savings of 
$517,888 and Agency cost sav-ings of $281,619, annualized at the 7 percent discount rate over 10 years.No quantifiable costs ..................... Net benefits are $799,507 annualized at the 7 per-
cent discount rate over 10 years. 
(4) Allow All FSIS Labels to be Ge-
nerically Approved.The Agency and industry would 
benefit from time savings by eliminating FSIS label evaluation.Costs include potentially increasing 
the number of misbranded prod-ucts.Net benefits are less than alternative 3 as the po-
tential costs of misbranded products from elimi-nating FSIS label evaluation outweighs the time savings benefit. 
Alternative 1—No Action (Baseline) 
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. 
Alternative 2—The Final Rule, Except 
Industry Would Still Have the Option To Have LPDS Evaluate Labels That Would Otherwise Be Generically Approved 
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. 
Alternative 3—The Final Rule 
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. 
Alternative 4—All Labels Are 
Generically Approved 
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 
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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. 
V. Regulatory Flexibility Act 
Assessment 
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. 
VI. Paperwork Reduction Act 
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. 
VII. USDA Non-Discrimination 
Statement 
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. 
VIII. E-Government Act 
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. 
IX. Executive Order 12988, Civil Justice 
Reform 
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. 
X. Executive Order 13175, Consultation 
and Coordination With Indian Tribal Governments 
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. 
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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. 
XI. Environmental Impact 
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. 
XII. Additional Public Notification 
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. 
List of Subjects 9 CFR Part 352 
Food labeling, Meat inspection, 
Reporting and recordkeeping 
requirements. 
9 CFR Part 354 
Administrative practice and 
procedure, Animal diseases, Food 
labeling, Meat inspection, Rabbits and rabbit products, Reporting and recordkeeping requirements, Signs and symbols. 
9 CFR Part 362 
Food labeling, Poultry and poultry 
products, Reporting and recordkeeping 
requirements. 
9 CFR Part 412 
Food labeling, Food packaging, Meat 
and meat products, Meat inspection, 
Poultry and poultry products, Reporting and recordkeeping requirements. 
For the reasons set forth in the 
preamble, FSIS is amending 9 CFR chapter III as follows: 
PART 352—EXOTIC ANIMALS AND 
HORSES; VOLUNTARY INSPECTION 
■1. The authority citation for part 352 
continues to read as follows: 
Authority: 7 U.S.C. 1622, 1624; 7 CFR 
2.17(g) and (i), 2.55. 
■2. In § 352.7: 
■a. Revise the section heading; 
■b. Remove the first sentence of the 
introductory text; 
■c. Add a sentence to the end of the 
introductory text. 
The revision and addition read as 
follows: 
§ 352.7 Marking and labeling of inspected 
products. 
* * * All labels intended for use on 
inspected and passed exotic animal 
products must be approved in accordance with Part 412 of this chapter. 
* * * * * PART 354—VOLUNTARY INSPECTION 
OF RABBITS AND EDIBLE PRODUCTS THEREOF 
■3. The authority citation for part 354 
continues to read as follows: 
Authority: 7 U.S.C. 1622, 1624; 7 CFR 
2.17(g) and (i), 2.55. 
■4. Revise § 354.60 to read as follows: 
§ 354.60 Approval of official identification. 
All labels intended for use on 
inspected and passed rabbit products which bear any official identification must be approved in accordance with part 412 of this chapter. 
PART 362—VOLUNTARY POULTRY 
INSPECTION REGULATIONS 
■5. The authority citation for part 362 
continues to read as follows: 
Authority: 7 U.S.C. 1622; 7 CFR 2.18(g) 
and (i) and 2.53. 
■6. In § 362.2, revise the second 
sentence of paragraph (a) to read as follows: 
§ 362.2 Types and availability of service. 
* * * * * 
(a) * * * All provisions of Part 381, 
Part 412, and §§ 416.1 through 416.6 of this chapter shall apply to the slaughter of poultry, and the preparation, labeling, and certification of the poultry and poultry products processed under this poultry inspection service except for the following provisions: the definitions of ‘‘Act,’’ ‘‘animal food manufacturer,’’ ‘‘Inspection Service,’’ ‘‘inspector,’’ ‘‘Inspector in Charge,’’ ‘‘poultry,’’ ‘‘poultry product,’’ ‘‘poultry food 
product,’’ ‘‘poultry products broker,’’ ‘‘renderer,’’ and ‘‘U.S. Refused Entry’’ in §§ 381.1 b), 381.3 (a), 381.6, 381.10, 381.13 through 381.17, 381.21, 381.29, 381.39 through 381.42, 381.175(a)(2) and (3), 381.179, 381.185 through 381.187, 381.192, and 381.195 through 381.225. 
* * * * * 
PART 412—LABEL APPROVAL 
■7. The authority citation for part 412 
continues to read as follows: 
Authority: 21 U.S.C. 451–470, 601–695; 7 
CFR 2.18, 2.53. 
■8. In § 412.1, remove and reserve 
paragraph (c)(2) and revise paragraph 
(e). 
The revision reads as follows: 
§ 412.1 Label approval. 
* * * * * 
(e) ‘‘Special statements and claims’’ 
are statements, claims, logos, trademarks, and other symbols on labels as defined in this paragraph (e). 
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1See 9 CFR 317.8(b)(40) and 381.129(f). 1Public Law 101–410, 104 Stat. 890 (Oct. 5, 
1990), as amended by Public Law 104–134, title III, 
§ 31001(s)(1), 110 Stat. 1321–373 (Apr. 26, 1996); Public Law 105–362, title XIII, § 1301(a), 112 Stat. 3293 (Nov. 10, 1998); Public Law 114–74, title VII, § 701(b), 129 Stat. 599 (Nov. 2, 2015), codified at 28 U.S.C. 2461 note. 2Under the amended Inflation Adjustment Act, a 
CMP is defined as any penalty, fine, or other sanction that: (1) Either is for a specific monetary amount as provided by Federal law or has a maximum amount provided for by Federal law; (2) is assessed or enforced by an agency pursuant to Federal law; and (3) is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal courts. All three requirements must be met for a fine to be considered a CMP. 
312 U.S.C. 2277a–14(c). 
412 U.S.C. 2277a–14(d). (1) The following are considered 
special statements and claims: 
(i) Those not defined in the Federal 
meat and poultry products inspection 
regulations or the Food Standards and Labeling Policy Book; 
(ii) ‘‘Natural’’ claims, regardless of 
whether they are defined in the Food Standards and Labeling Policy Book; and 
(iii) Health claims (including graphic 
representations of hearts), ingredient and processing method claims (e.g., high-pressure processing), structure- function claims, claims regarding the raising of animals (e.g., ‘‘no antibiotics 
administered’’), products labeled as organic (except for those where only individual ingredients are labeled as organic), and instructional or disclaimer statements concerning pathogens (e.g., ‘‘for cooking only’’ or ‘‘not tested for E. coli O157:H7’’). 
(2) The following are not considered 
special statements and claims: 
(i) Allergen statements (e.g., ‘‘contains 
soy’’) applied in accordance with the Food Allergen Labeling and Consumer Protection Act; 
(ii) Negative claims regarding 
ingredients not listed in the ingredients statement (e.g., ‘‘No MSG Added,’’ 
‘‘Preservative Free,’’ ‘‘No Milk,’’ ‘‘No Pork,’’ or ‘‘Made Without Soy’’); 
(iii) Statements that characterize a 
product’s nutrient content in compliance with Title 9 of the CFR, such as ‘‘low fat’’; and 
(iv) Claims related to geographical 
significance, such as ‘‘German Brand Made in the US,’’ or those that make a country of origin statement on the label of any meat or poultry product ‘‘covered commodity,’’
1or displays of geographic 
landmarks, such as a foreign country’s flag, monument, or map. 
* * * * * 
■9. In § 412.2, revise paragraph (b) to 
read as follows: 
§ 412.2 Approval of generic labels. 
* * * * * 
(b) Generically approved labels are 
labels that bear all applicable mandatory 
labeling features (i.e., product name, 
handling statement, ingredients statement, the name and place of 
business of the manufacturer, packer 
or distributor, net weight, legend, safe handling instructions, and nutrition labeling) in accordance with Federal regulations and do not bear special statements and claims as defined in § 412.1(e). Done at Washington, DC. 
Paul Kiecker 
Administrator. 
[FR Doc. 2023–00693 Filed 1–17–23; 8:45 am] 
BILLING CODE 3410–DM–P 
FARM CREDIT SYSTEM INSURANCE 
CORPORATION 
12 CFR Part 1411 
RIN 3055–AA19 
Rules of Practice and Procedure; 
Adjusting Civil Money Penalties for Inflation 
AGENCY : Farm Credit System Insurance 
Corporation. 
ACTION : Final rule. 
SUMMARY : This rule implements 
inflation adjustments to civil money penalties (CMPs) that the Farm Credit System Insurance Corporation (FCSIC) may impose under the Farm Credit Act of 1971, as amended. These adjustments are required by 2015 amendments to the Federal Civil Penalties Inflation Adjustment Act of 1990. 
DATES : 
Effective date: This regulation is 
effective on January 18, 2023. 
Applicability date: The adjusted 
amounts of civil money penalties in this rule are applicable to penalties assessed on or after January 15, 2023, for conduct occurring on or after November 2, 2015. 
FOR FURTHER INFORMATION CONTACT : 
Lynn M. Powalski, General Counsel, Farm Credit System Insurance Corporation, 1501 Farm Credit Drive, McLean, Virginia 22102, (703) 883– 4380, TTY (703) 883–4390. 
SUPPLEMENTARY INFORMATION : 
I. Background 
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)
1to 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. 
II. CMPs Imposed Pursuant to Section 
5.65 of the Farm Credit Act 
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.
3Second, 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. 
III. Required Adjustments 
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 
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