OMB Releases Fall 2021 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Fall 2021 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 identify other relevant rules included on each agency’s agenda.

We want to 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, 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

FDA’s regulatory priorities largely mirror those that were included in the Spring 2021 Unified Agenda.2 The 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.  Two entries on rulemaking 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 by November 2022.3 Promulgation of a final rule is currently a “long term action.”4  (Final Rule: November 2022).

  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: This proposed rule revising certain requirements for agricultural water under the Produce Safety Rule has been issued and extends the 2022 compliance dates until a final rule is issued. (NPRM: November  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. (NPRM: December 2021).

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

    • 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.  The comment period has since closed and  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, FDA reopened comments on a 2005 proposal to amend FDA regulations for cheese, allowing the use of fluid ultrafiltered milk in the manufacture of standardized cheeses and other products. FDA expects to issue a final rule by September 2022.  (Final Rule: September 2022).

    • French Dressing; Proposed Revocation of a Standard of Identity: FDA is looking to revoke the existing standards for the production of French dressing.  FDA issued a proposed rule in December and expects to issue a final rule by April 2022. (Final Rule: April 2022).

    • Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality: FDA is proposing to revoke the standard of identity requirements for the manufacture of frozen cherry pies. FDA issued a proposed rule in December and intends to issue a final rule in August 2022. (Final Rule: August 2022).

 

USDA Priorities

As with FDA, the USDA priorities largely mirror those that appeared in the Spring 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 several regulatory priorities that may be of 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 (U.S.) 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 FTC.  (NPRM: October 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: April 2022).

  • Changing the Labeling Requirements for Processed Products That Contain Nitrate or Nitrite: The 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.  (NPRM: May 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 which 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 2022).

  • 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 comment period has since closed and  FSIS is reviewing comments. (ANPRM comment close: November 2021).

  • Maximum Line Speed under the New Poultry Inspection System: FSIS indicated that it is delaying publication of a 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).

  • Changes to Accreditation of Non-Federal Laboratories for Analytical Testing of Meat, Poultry, and Processed Egg Products: FSIS plans to issue a final rule which would amend methods used to measure laboratory performance and expand its Accredited Laboratory Program (ALP) by including pathogen testing.  (Final Rule: February 2022).

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 January 2022.  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:

    • 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: January 2022).

    • 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: January 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. (NPRM: January 2022).

FNS
  • Child Nutrition Programs: Temporary Standards for Milk, Whole Grains, and Sodium.  FNS intends to issue a final rule that would provide flexibility in the whole grains, sodium, and fluid milk standards for school meals, following a court decision that struck down a previous attempt under the Trump Administration to codify such flexibilities. The final rule is under review at OMB. (Final Rule: January 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. (NPRM: October 2022)

 

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 Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions, available at https://www.reginfo.gov/public/do/eAgendaMain.
2 See HL Update, OMB Releases Spring 2021 Unified Agenda of Regulatory Actions, (8 July 2021), available at https://www.engage.hoganlovells.com/knowledgeservices/news/omb-releases-spring-2021-unified-agenda-of-regulatory-actions.
3 See HL 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 OMB Requirements For Additional Traceability Records For Certain Foods, available at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0910-AI44.

 

 

Authored by Maile Gradison, Brian D. Eyink, Veronica Colas, and Mary Lancaster.

Contacts
Maile Gradison
Partner
Washington, D.C.
Brian Eyink
Partner
Washington, D.C.
Veronica Colas
Counsel
Washington, D.C.
Mary Grywatch
Senior Associate
Washington, D.C.

 

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