The Office of Management and Budget (OMB) recently released the Spring 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA), the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS), Animal Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS).
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.
FDA’s regulatory priorities largely mirror those that were included in the Fall 2021 Unified Agenda.2 The vast majority of the rules remain in the same stage, but with new estimated 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 Prorities: Six rulemakings under the FDA Food Safety Modernization Act (FSMA) are worth highlighting:
- Requirements for Additional Traceability Records For Certain Foods: FDA issued its Notice of Proposed Rulemaking on Requirements for Additional Traceability Records for Certain Foods on September 23, 2020. FDA is required by a consent decree to issue a Final Rule no later than November 2022.3 (Final Rule: November 2022).
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: This proposed rule would revise certain requirements for agricultural water under the Produce Safety Rule. In 2019, FDA extended the compliance dates for agricultural provisions to 2022, following concerns from industry about the feasibility of implementation. (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: December 2022).
- Streamlining Provisions Requiring Disclosure to and Receipt of Written Assurances From Commercial Customers in the Foreign Supplier Verification Programs Rule: Similar to the above, this proposed rule concerns the elimination of certain written assurance requirements from the FSVP rule. (Proposed Rule: January 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 rule would revise certain requirements currently applicable to exempted produce. (Proposed Rule: January 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: September 2022).
- Standards of Identity: There are two 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 support industry efforts to reduce sodium content in standardized foods. (Proposed Rule: February 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: August 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).
As with FDA, the USDA priorities largely mirror those that appeared in the Fall 2021 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.
- 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: August 2022).
- 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: February 2023).
- Maximum Line Speed under the New Poultry Inspection System: FSIS indicated that it is delaying publication of this proposed rule to amend the poultry products inspection regulations to permit young chicken slaughter establishments operating under the New Poultry Inspection System (NPIS) to increase the line speed from 140 bpm to 175 bpm if certain criteria are met. In the Agenda, the proposed publication date continues to be a “long term action,” signaling the action is being tabled for the time being. (Long Term Action).
- Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology: FSIS sought public comments on the labeling of meat and poultry products made using animal cell culture technology. The rule has been moved to long-term actions. (Long Term Action).
- Packers and Stockyards Act Rules: There are three planned proposed rules that would amend regulations under the Packers and Stockyards Act, plus an advanced notice of proposed rulemaking seeking additional information to inform future actions. 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 significant changes to how contractual relationships within the animal raising and slaughter portion of the supply chain are regulated under the Packers and Stockyards Act:
- Clarification of Scope of 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: August 2022).
- Unfair Practices in Violation of the Packers and Stockyards Act: USDA proposes to supplement a recent revision to regulations issued under the Packers and Stockyards Act that provided criteria for the Secretary to consider when determining whether certain conduct or action by packers, swine contractors, or live poultry dealers is unduly or unreasonably preferential or advantageous. The proposed supplemental amendments would clarify the conduct the Department considers unfair, unjustly discriminatory, or deceptive and a violation of sections 202(a) and (b) of the Act. USDA would also clarify the criteria and types of conduct that would be considered unduly or unreasonably preferential, advantageous, prejudicial, disadvantageous and violations of the Act. This rulemaking is anticipated to significantly expand the criteria established through the Trump Administration’s rulemaking on this topic. (Proposed Rule: August 2022).
- Transparency in Poultry Grower Contracting and Tournaments: To encourage transparency in poultry production, USDA is proposing to modify regulations concerning required disclosures and information currently furnished to poultry growers and sellers and to establish additional parameters to the poultry tournament system to determine settlement payments. The comment period ends August 8, 2022. (Proposed Rule: June 2022).
- Poultry Growing Tournament Systems: Fairness and Related Concerns: USDA is currently seeking public comment regarding proposed future rulemaking concerning tournament systems used in the poultry industry. USDA is gathering this information in direct response to concerns from poultry growers about the fairness of the present system. (ANPRM: June 2022).
- 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)
We will continue to monitor the Federal Register for agency actions and will keep you notified of items of interest.
Please click here for a chart summarizing the key planned regulatory activities of particular interest to the food industry.
1 Office of Management and Budget Spring 2022 Unified Agenda of Regulatory and Deregulatory Actions, available here.
2 See HL Update, OMB Releases Fall 2021 Unified Agenda of Regulatory Actions, (20 December 2021), available here.
3 See HL Update, Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions (12 June 2019), available here.