OMB releases Fall 2022 Unified Agenda of Regulatory Actions

After highlighting the most significant priorities, we provide charts (see Appendix A) that enumerate other relevant rules included on each agency’s agenda.

We caution that the dates included in the Unified Agenda¹ are not commitments to act on or by the date shown and simply indicate the agencies’ aspirations. Note, for example, the dates for some planned actions have already passed.  Rather than focusing on projected dates, the Unified Agenda is a valuable tool to identify the substantive issues the agencies consider to be priorities for rulemaking.

We note as well that in late 2022 and early 2023, the agencies acted on a few key items on their agendas, including issuing a proposed rule redefining the nutrient content claim “healthy” (FDA, September 2022).

FDA Priorities

FDA’s regulatory priorities largely mirror those that were included in the Spring 2022 Unified Agenda.² The vast majority of the rules remain in the same stage but with later targeted completion dates. 

• FSMA-Related Priorities: Six rulemakings under the FDA Food Safety Modernization Act (FSMA) are worth highlighting:

• • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: After issuing a proposed rule in December 2021 and supplemental proposed rule in July 2022, FDA is working to finalize its revisions to certain requirements for agricultural water under the Produce Safety Rule.    (Final Rule: October 2023).

• • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food: This proposed rule would eliminate certain written assurance requirements from 21 CFR § 117.136.  (Proposed Rule: February 2023).

• • Streamlining Provisions Requiring Disclosure to and Receipt of Written Assurances from Commercial Customers in the Foreign Supplier Verification Programs Rule:  Similar to above, this proposed rule concerns the elimination of certain written assurance requirements from the FSVP rule.  (Proposed Rule: August 2023)

• • The FDA Food Safety Modernization Act: Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation: This proposed rule would revise the exemptions from the produce safety regulation, including those related to foods “rarely consumed raw” and commodities that will receive commercial processing to adequately reduce the presence of microorganisms of public health significance.  Additionally, the proposed rule would revise certain requirements currently applicable to exempted produce.  (Proposed Rule: June 2023).

• • Amendments to Registration of Food Facilities: FDA would propose to amend general provisions in the Registration of Food Facilities rule, including changes to the definition of “farm.”  (Proposed Rule: April 2023).

• • Certifications Concerning Imported Foods: This proposed rule would allow FDA, based on authority granted in FSMA, to require a certification or other such assurance that food with known safety risks comply with US food safety requirements as a condition of importation.  (Proposed Rule: April 2023).

• Standards of Identity: There are three rules of interest concerning FDA’s efforts to modernize standards of identity.

• • Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods: This proposed rule would permit the use of salt substitutes in standardized foods in which salt is a required or optional ingredient.  The proposed rule, if finalized, would be intended to support industry efforts to reduce sodium content in standardized foods. (Proposed Rule: March 2023).

• • Food Standards: General Principles and Food Standards Modernization: FDA is proposing to establish general principles that could be used to update the framework for food standards.  FDA issued a proposed rule in 2005, but reopened the comment period in February 2020. (Proposed Rule: October 2023).

• • Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk: This final rule will amend FDA regulations to allow the use of ultrafiltered milks in the manufacture of standardized cheeses and related products with the goal of promoting honesty and fair dealing in the interest of consumers.  (Final Rule: October 2023).

• Additional Rule of Interest:

• • Prior Notice of Imported Foods: FDA is proposing to amend prior notice regulations to require additional information from prior notice submitters, to establish a timeframe for post-refusal submissions, and to clarify the process to destroy or export refused food.  (Proposed Rule: March 2023).

USDA Priorities

As with FDA, the USDA priorities largely mirror those that appeared in the Spring 2022 Agenda.  As noted above, the projected dates are not commitments to complete the action by the identified dates, but rather reflect the agency’s goal.  FSIS, AMS, and FNS have a handful of regulatory priorities that may be of particular interest.

FSIS

• Voluntary Labeling of Meat Products with “Product of USA” and Similar Statements: FSIS intends to propose to amend its regulations to define the conditions under which the labeling of meat product labels can bear voluntary statements indicating that the product is of United States origin, such as “Product of USA,” or “Made in the USA.”  Historically, FSIS has taken a position toward “Made in USA” claims that differs from that of the Federal Trade Commission.  (Proposed Rule: December 2022).

• Prior Label Approval System: Expansion of Generic Label Approval: FSIS plans to issue a final rule expanding the scope of meat and poultry products that are eligible for generic label approval.  FSIS last expanded the scope for generic approval in 2013.  (Final Rule: January 2023).

• Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed: FSIS plans to issue a final rule that would in large part harmonize FSIS nutrition labeling regulations with FDA’s updated regulations.  Currently, FSIS policy allows establishments to follow either existing FSIS nutrition labeling regulations or FDA’s updated labeling regulations.  (Final Rule: June 2023).

• Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology: FSIS sought initial public comments on the labeling of meat and poultry products made using animal cell culture technology through an Advanced Notice of Proposed Rulemaking in 2021.  The agency is now developing a proposed rule on the topic.  (Proposed Rule: August 2023).

• Food Standards: General Principles and Food Standards Modernization: FSIS intends to publish a proposed rule establishing general principles that would act as the first step in modernizing and updating the framework for food standards.  This revisits a 2005 proposed rule addressing the same issue, which would be withdrawn to address the technological advances and other changes in the food industry since 2005.  FSIS indicates it is coordinating its actions with FDA (see above entry for FDA’s comparable agenda item).  (Second Proposed Rule: October 2023).

AMS

• 2020 and 2021 Annual Updates to the List of Bioengineered Foods: AMS anticipates publishing a final rule responding to recommended amendments to the National List based on comments submitted on the 2020 updates. The agency will also seek comments on updates to the National List as part of its 2021 update.  (2020 Final Rule: February 2023; 2021 Advance Notice of Proposed Rulemaking: March 2023).

• Strengthening Organic Enforcement: This final rule will amend the USDA organic regulations to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. This rule received OMB clearance in January 2023.  (Final Rule: December 2022).

• Packers and Stockyards Act Rules: There are two planned proposed rules and two anticipated final rules that would amend regulations under the Packers and Stockyards Act.  The Administration has positioned these rules as efforts to address economic issues in the meat and poultry supply chains.  These rules appear to be a revival of an Obama-era attempt to make specific changes to how contractual relationships within the animal raising and slaughter portion of the supply chain are regulated under the Packers and Stockyards Act:

• • Unfair Practices, Undue Preferences, and Harm to Competition Under the Packers and Stockyards Act: This proposed rule would further define conduct that AMS believes may violate the Act, including whether all allegations of violations of the Act must be accompanied by a showing of harm or likely harm to competition.  (Proposed Rule: December 2022).

• • Inclusive Competition and Market Integrity Under the Packers and Stockyards Act: USDA proposes to identify conduct the Department considers unfair, unjustly discriminatory, or deceptive and a violation of sections 202(a) and (b) of the Act.  USDA would also address the criteria and types of conduct that would be considered unduly or unreasonably preferential, advantageous, prejudicial, disadvantageous, and violations of the Act.  Although the comment period on the proposed rule closes January 17, 2023, USDA has identified April 2023 as the target for a final rule.  (Final Rule: April 2023).

• • Transparency in Poultry Grower Contracting Tournaments: USDA has proposed regulations expanding the required disclosures and information currently furnished to poultry growers and sellers and to establish additional requirements for the poultry tournament system used to determine settlement payments.  (Final Rule: May 2023).

• • Poultry Growing Tournament Systems: Fairness and Related Concerns:  In tandem with its 2022 proposal on tournament systems in poultry growing arrangements (see above entry), USDA requested input on whether AMS should conduct rulemaking on additional aspects of poultry contracting through an advanced notice of proposed rulemaking.  USDA now plans to issue a proposed rule based on input received on the ANPR.  (Proposed Rule: July 2023).

FNS

• Child Nutrition Programs: Revisions to Meal Patterns Consistent With the 2020 Dietary Guidelines for Americans:  As required by statute, USDA will propose updates to the school meal standards to be consistent with the 2020 Dietary Guidelines for Americans, which could potentially include standards related to added sugars, among others. (Proposed Rule: January 2023)

Next Steps

We will continue to monitor the Federal Register for agency actions and will keep you notified of items of interest.  Please contact us if you have any questions.

Appendix A

Please click here for a chart summarizing the key planned regulatory activities of particular interest to the food industry.