OMB releases Spring 2024 Unified Agenda of Regulatory Actions

We caution that the dates included in the Unified Agenda¹ are not commitments to act on or by the date shown.  Rather, they simply indicate the agencies’ aspirations. Note also that  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 Fall 2023 Unified Agenda.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: Four rulemakings under the FDA Food Safety Modernization Act (FSMA) are worth highlighting:

• • 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: November 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: April 2025).

• • 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: January 2025).

• • 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: October 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 final rule would permit the use of salt substitutes in standardized foods in which salt is a required or optional ingredient. The rule is intended to support industry efforts to reduce sodium content in standardized foods. (Final Rule: April 2025).

• • 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: April 2025).

• • 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: October 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: October 2024).

• • Nutrient Content Claims, Definition of Term: Healthy: This final rule would update the definition for the implied nutrient content claim "healthy" to be consistent with current nutrition science and federal dietary guidelines. The rule would revise the requirements for when the claim "healthy" can be voluntarily used in the labeling of human food products to indicate that a food, because of its nutrient content, may be useful in achieving a total diet that conforms to current dietary recommendations and helps consumers maintain healthy dietary practices. (Final Rule: September 2024).

• • Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-refusal and Post-hold Submissions: This final rule would amend FDA’s prior notice regulations to require additional information from prior notice submitters, establish a timeframe for post-refusal submissions, and clarify the process to destroy or export refused food. (Final Rule: July 2024).

USDA Priorities

As with FDA, the USDA priorities largely mirror those that appeared in the Fall 2023 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 and AMS 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: July 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: July 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: October 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: April 2025).

• 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 2025).

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. AMS had originally anticipated issuing a proposed rule in August 2023 and has now delayed the expected timing until March 2025, possibly to allow for the appeal in the underlying lawsuit to play out. (Proposed Rule: March 2025).

• National Bioengineered Food Disclosure Standard; 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.  (Proposed Rule: December 2024).

• Packers and Stockyards Act Rules: USDA has issued two new proposed rules expanding regulations under the Packers and Stockyards Act, with yet another proposal planned, continuing a multi-part rulemaking to advance the Administration's competition agenda. The Administration has positioned these rules as efforts to address economic issues in the meat and poultry supply chains. These rules are 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: FDA’s final 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. This rule has been proposed under the name “Fair and Competitive Livestock and Poultry Markets.”⁴ (Comment Period Ends: August 2024; Final Rule: December 2024).

• • Poultry Grower Payment Systems and Capital Improvement Systems: USDA has proposed a rule that would impose additional requirements on poultry grower compensation systems, including creating a duty of fair comparison, requiring that contracts specify a guaranteed minimum pay for comparison-based systems, requiring integrators develop processes to ensure fair comparison, and requiring special disclosures before requiring additional capital investments.  (Comment Period Ends: August 2024; Final Rule: November 2024).

• • Price Discovery and Transparency in Markets for Fed Cattle: AMS plans to propose an additional rule focused on price discovery and contracting transparency in the fed cattle markets.  The rule would improve price discovery and transparency in fed cattle markets and protect producers from unfair and deceptive practices, market manipulation, and being subject to the exercise of market power by regulated entities in the fed cattle markets. (Proposed Rule: September 2024; Final Rule: May 2025).

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: October 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: November 2024).

Next Steps

We will continue to monitor the Federal Register for agency actions and will provide updates on 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.

Authored by Elizabeth Fawell, Maile Gradison, Brian Eyink, Veronica Colas, and Jamie Hannah.

References

1 White House Office of Management and Budget Fall 2024 Unified Agenda of Regulatory and Deregulatory Actions, available here.

2 See Hogan Lovells Update: OMB releases Fall 2023 Unified Agenda of Regulatory Actions, Hogan Lovells Engage (Dec. 114, 2023), available here.

3 For a summary of the National Grocers v. Vilsack decision, see Hogan Lovells Update: Court invalidates text message option under Bioengineered Food Disclosure Standard, Hogan Lovells Engage (September 15, 2022), available here.

4 For a more detailed summary of the proposed rule, see Hogan Lovells Update: USDA announces fair and competitive livestock and poultry markets proposed rule, Hogan Lovells Engage, (July 1, 2024), available here.