OMB releases Spring 2021 Unified Agenda of Regulatory Actions | Hogan Lovells

Table of Contents FDA prioritiesUSDA prioritiesFSISAMSNext stepsAppendix AReferences After highlighting the most significant priorities, we

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

Our team wants to caution that the dates included in the Unified Agenda[1] are not commitments to act on or by the date shown and simply indicate the agencies’ aspirations. Note, for example, that 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

The FDA’s regulatory priorities largely mirror those that were included in the Fall 2020 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. Three entries on rulemaking under the FDA Food Safety Modernization Act (FSMA) are worth highlighting: 

  • Requirements for Additional Traceability Records For Certain Foods: The FDA issued its Notice of Proposed Rulemaking on Requirements for Additional Traceability Records for Certain Foods on 23 September 2020. The FDA is required by a consent decree to issue a Final Rule by November 2022. Promulgation of a final rule is now a “long term action.”[3] (Final Rule: November 2022). 
  • Laboratory Accreditation for Analysis of Foods: The FDA is required to issue the final rule by 4 February 2022, also pursuant to a consent decree.[4] Promulgation of a final rule remains a “long term action.” (Final Rule: February 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, the FDA extended the compliance dates for agricultural provisions to 2022, following concerns from industry about the feasibility of implementation. As of the publication of this update, the proposed rule is under review at OMB.[5] (NPRM: August 2021). 

Additionally, the following rules may be of interest:   

  • Updated “healthy” definition
    • Nutrient Content Claims, Definition of Term: Healthy: The proposed rule would update the definition for the implied nutrient content claim “healthy,” and would revise the requirements for when the claim “healthy” can be voluntarily used in the labeling of human food products. In a separate but related action, on 7 May 2021 the FDA issued a notice in the Federal Register announcing that it is conducting preliminary quantitative consumer research on symbols that could be used in the future to convey the “healthy” claim on packaged foods.[6] Both of these efforts are part of the Nutrition Innovation Strategy (2018) that FDA first announced in 2018. (NPRM: September 2021).
  • Standards of Identity: There are four rules of interest concerning the FDA’s efforts to modernize standards of identity. 
    • Food Standards: General Principles and Food Standards Modernization: The FDA is proposing to establish general principles that could be used to update the framework for food standards. The FDA issued a proposed rule in 2005, but reopened the comment period in February 2020. The comment period has since closed and the FDA is reviewing comments and plans to publish an updated proposed rule in April 2022. (NPRM: April 2022). 
    • Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk: In December 2019, the FDA reopened comments on a 2005 proposal to amend the FDA regulations for cheese, allowing the use of fluid ultrafiltered milk in the manufacture of standardized cheeses and other products. Comments on the rule closed in March 2020 and the FDA plans to finalize a rule by December 2021.  (Final Rule: December 2021).
    • French Dressing; Proposed Revocation of a Standard of Identity: The FDA is looking to revoke the existing standards for the production of French dressing. The FDA issued a proposed rule in December and expects to issue a final rule by January 2022. (Final Rule: January 2022). 
    • Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality: The FDA is proposing to revoke standard of identity requirements for the manufacture of frozen cherry pies. The FDA issued a proposed rule in December and intends to issue a final rule in April 2022. (Final Rule: April 2022). 

USDA priorities

As with the FDA, the USDA priorities largely mirror those that appeared in the Fall 2020 Agenda, with two major differences: (1) the USDA plans to revive a long-running and controversial effort to conduct rulemaking under the Packers and Stockyards Act to reshape contractual relationships between poultry and livestock producers and processors; and (2) the USDA has downgraded to a “long term action” a proposal to increase certain poultry slaughter line speed limits, signaling the Department is no longer prioritizing that rulemaking. FSIS and AMS have a handful of regulatory priorities that are of particular interest. 

FSIS
  • Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology: The FSIS plans to publish an advance notice of proposed rulemaking seeking public comments on the labeling of meat and poultry products made using animal cell culture technology. Through this ANPR, the FSIS signals an intent to engage in rulemaking to govern the labeling of these products. (ANPRM: July 2021).
  • Voluntary Labeling of Meat Products With “Product of USA” and Similar Statements: The 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 (U.S.) origin, such as “Product of USA,” or “Made in the USA.” Historically, the FSIS has taken a position toward “Made in USA” claims that differs from that of FTC. (NPRM: November 2021).
  • Eliminating Unnecessary Requirements for Sampling Pumped Bacon: Although this rulemaking’s title is focused on sampling, of most significant impact, the FSIS is proposing to amend its labeling requirements for meat and poultry products to establish new definitions for “cured” and “uncured” products. These actions are made partially in response to a Center for Science in Public Interest (CSPI) petition regarding nitrate/nitrite claims on meat and poultry products, which FSIS granted in part on 10 December 2020. (NPRM: December 2021).[7]  
  • Prior Label Approval System: Expansion of Generic Label Approval: The FSIS plans to issue a final rule expanding the scope of meat and poultry products that are eligible for generic label approval. The FSIS last expanded the scope for generic approval in 2013. (Final Rule: December 2021). 
  • Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed: The FSIS has moved its proposed nutrition labeling update from “long term action” to the final rule stage. The update would in large part harmonize FSIS nutrition labeling regulations with the FDA’s updated regulations. Currently, FSIS policy allows establishments to follow either existing FSIS nutrition labeling regulations or the FDA’s updated labeling regulations. (Final Rule: December 2021). 
  • Maximum Line Speed under the New Poultry Inspection System: the FSIS indicated that it is delaying publication of the 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 was moved from December 2020, to a “long term action,” signaling the action is being tabled for the time being. (Long Term Action). 
AMS
  • Packers and Stockyards Act Rules: There are three planned proposed rules that would amend regulations under the Packers and Stockyards Act, all of which are planned to be published in November 2021. These rules appear to be a revival of an Obama administration-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: 
    • Poultry Grower Ranking System: This proposed rule would address the use of poultry grower ranking systems as a method of payment and settlement grouping for poultry growers under contract in poultry growing arrangements with live poultry dealers. The proposed regulation would establish certain requirements for live poultry dealers if a ranking system is used to determine grower payment. Failing to comply would be considered an unfair, unjustly discriminatory, and deceptive practice. (NPRM: November 2021).
    • Clarification of Scope of the Packers and Stockyards Act: This proposed rule would further define conduct that 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. (NPRM: November 2021).
    • Unfair Practices in Violation of the Packers and Stockyards Act: The 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. The 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. (NPRM: November 2021). 

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. 

References

1    Office of Management and Budget Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions, available at https://www.reginfo.gov/public/do/eAgendaMain

2    See Hogan Lovells update, OMB Releases Fall 2020 Unified Agenda of Regulatory Actions, (6 January 2021), available at https://www.engage.hoganlovells.com/knowledgeservices/insights/omb-releases-fall-2020-unified-agenda-of-regulatory-actions

3    See Hogan Lovells update, Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions (12 June 2019), available at https://www.hoganlovells.com/en/publications/settlement-reached-in-lawsuit-to-compel-fda-to-implement-fsma-traceability-provisions.

4    See Center for Food Safety v. Azar, No.: 3:19-cv-05168-VC (N.D. Cal. 2 Feb. 2020). The Consent Decree is available at https://www.centerforfoodsafety.org/files/2020-02-11–doc-31-order-consent-decree_70062.pdf.   

5    See OMB Executive Order Submissions Under Review, available at https://www.reginfo.gov/public/do/eoDetails?rrid=173663

6    See Hogan Lovells update, FDA to test voluntary “healthy” symbols through consumer research (7 May 2021), available at https://www.engage.hoganlovells.com/knowledgeservices/news/fda-to-test-voluntary-healthy-symbols-through-consumer-research.

7    See Hogan Lovells update, FSIS partially grants CSPI petition on nitrate/nitrite claims (14 December 2020) available at https://www.engage.hoganlovells.com/knowledgeservices/news/fsis-partially-grants-cspi-petition-on-nitratenitrite-claims.