OMB releases Fall 2023 Unified Agenda of Regulatory Actions

After highlighting the most significant priorities, we provide charts (see Appendix A) that list other relevant rulemakings 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.

FDA Priorities

FDA’s regulatory priorities largely mirror those that were included in the Spring 2023 Unified Agenda, and the agency continues to give particular emphasis to its planned work on front-of-package nutrition labeling and updating the definition for “Healthy” nutrient content claims.² The vast majority of the rules remain in the same stage but with new dates of completion. As noted above, the projected dates are not commitments to complete the action by the identified dates, but rather reflect the agency’s goal.

• 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: February 2024).

• • 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: May 2024).

• • 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: October 2024).

• • 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: August 2024).

• • Amendments to Registration of Food Facilities: FDA intends to propose changes to general provisions in the Registration of Food Facilities rule, including changes to the definition of “farm.” (Proposed Rule: February 2024).

• • Certifications Concerning Imported Foods: FDA intends to issue a proposed rule that would require foods with a known safety risk imported to the U.S. receive a certification or other assurance that the food complies with U.S. food safety requirements. (Proposed Rule: January 2024).

• Standards of Identity: There are three rulemakings 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, is intended to support industry efforts to reduce sodium content in standardized foods. (Final Rule: August 2024).

• • 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, reopened the comment period in February 2020, and then withdrew the 2005 proposed rule in February 2023. (Proposed Rule: October 2024).

• • Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk: This final rule would 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: June 2024).

• Additional Items of Interest:

• • Front-of-Package Nutrition Labeling: This proposed rule would require the front of food labels to display certain nutrition information to help consumers, especially those with lower nutrition knowledge, make more informed dietary choices. (Proposed Rule: June 2024).

• • Nutrient Content Claims, Definition of Term: Healthy: FDA is working to finalize a rule to update the definition of “healthy” as an implied nutrient content claim.  The agency issued its proposed rule in September 2022 with the comment period ending in February 2023.  (Final Rule: April 2024).

• • Recalls of Products Subject to the Jurisdiction of the Food and Drug Administration: FDA intends to initiate rulemaking to revise its guidance on policy, procedures, and industry responsibilities for recalls.  FDA will begin by seeking comments, research, information, data, and responses from certain stakeholders.  (Advanced Notice of Proposed Rulemaking: November 2023).

• • The Revocation of Authorization of Use of Brominated Vegetable Oil in Food: This proposed rule would amend the FDA’s regulations to remove the authorization of the use of brominated vegetable oil (BVO) as a food ingredient. BVO is currently authorized by a food additive regulation for use as a stabilizer in flavoring oils in fruit-flavored beverages. However, FDA has indicated that new scientific information FDA reviewed as part of its reassessment of this ingredient demonstrates that there is not a reasonable certainty of no harm from the continued use of BVO in food. (Proposed Rule Issued: October 25, 2023; Comment Period Ends: January 17, 2024).

USDA Priorities

As with FDA, the USDA priorities largely mirror those that appeared in the Spring 2023 Agenda, with the notable addition of FSIS’s Salmonella Framework. 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

• Salmonella Framework: FSIS intends to propose a new regulatory framework aimed at reducing the number of Salmonella illnesses associated with poultry products through the development and implementation of final product standards, monitoring and documentation of microbial prevention procedures, and controls on incoming flocks. (Proposed Rule: February 2024).

• Voluntary Labeling of FSIS-Regulated Products With U.S. Origin Claims: FSIS proposed to amend its regulations to define the conditions under which meat, poultry, or egg 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.” The proposed rule limited the use of these statements to products derived from animals born, raised, slaughtered, and processed in the U.S. (Final Rule: March 2024).

• 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: May 2024).

• Changing the Labeling Requirements for Processed Products That Contain Nitrate or Nitrite: FSIS is proposing to amend its labeling requirements for meat and poultry products to establish new definitions for “cured” and “uncured” products. Additionally, FSIS seeks to rescind regulations requiring sampling of pumped bacon for nitrosamines. (Proposed Rule: June 2024).

• 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 2024).

• 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: April 2024).

• Clarifying Time Limits for Waivers From FSIS Regulatory Requirements for Meat, Poultry, and Egg Products: FSIS is proposing to revise its waiver authorization regulations to specify how long waivers may remain in place after being granted.  FSIS indicates it is contemplating terminating waivers automatically when new regulatory requirements related to the granted waiver take effect.  (Proposed Rule: January 2024).

AMS

• National Bioengineered Food Disclosure Standard; Text Message Disclosures: AMS plans to publish a proposed rule to amend the National Bioengineered Food Disclosure Standard to align with the court decision in National Grocers, et al., v. Thomas Vilsack,³ removing the standalone text message disclosure option. The proposed rule would add an additional comparable option to the electronic or digital disclosure option. (Proposed Rule: November 2023).

• Second Update to the List of Bioengineered Foods: AMS is pursuing its second update to the AMS List of Bioengineered Foods. The agency anticipates issuing a request for information in advance of publishing a proposed rule in 2024.  (Request for Information: November 2023; Proposed Rule: March 2024).

• Packers and Stockyards Act Rules: There are two planned proposed rules, one anticipated final rule, and one recently finalized rule aimed at expanding 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: February 2024).

• • 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. (Final Rule: December 2023).

• • Transparency in Poultry Grower Contracting and Tournaments: USDA finalized 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 Effective: February 12, 2024).

• • Poultry Grower Payment Systems and Capital Improvement Systems: 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: January 2024).

FNS

• Child Nutrition Programs: Revisions to Meal Patterns Consistent With the 2020 Dietary Guidelines for Americans: As required by statute, USDA proposed 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.⁴ (Final Rule: April 2024).

TTB Priorities

TTB’s regulatory priorities are focused on labeling initiatives and updated standards of identity and definitions.

• Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages: TTB will request public comment on proposals to include major allergen information on alcohol beverage products. (Proposed Rule: January 2024).

• Ingredient Labeling of Distilled Spirits, Wines, and Malt Beverages: In response to a U.S. Department of Treasury report, TTB is initiating rulemaking proposing ingredient labeling on alcohol beverage products. (Advanced Notice of Proposed Rulemaking: December 2023).

• Proposal to Allow for the Use of Molasses and Grain in Wine and to Address Sugar as a Fermentable in the Production of Wine and Beer: TTB intends to propose amending the wine and beer regulations and receive comment on the use of grain, cereal, malt, and molasses as ingredients in wine. The proposal would also address the use of sugar as a fermentable in the production of wine and beer. (Proposed Rule: March 2024).

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 see Appendix A for a chart summarizing the key planned regulatory activities of particular interest to the food industry