OMB releases Fall 2020 Unified Agenda of Regulatory Actions

Insights and Analysis

OMB releases Fall 2020 Unified Agenda of Regulatory Actions

06 January 2021

The Office of Management and Budget (OMB) recently released the Fall 2020 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), the Federal Trade Commission (FTC), and the U.S. Consumer Safety Protection Commission (CSPC).

After highlighting the most significant priorities, we provide charts (see Appendix A) that enumerate other relevant rules included on each agency’s agenda. More information can be found by clicking on the blue “RIN” link, which will direct you to a page on OMB’s website dedicated to each agenda item.

We want to caution that the dates included in the Unified Agenda 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 2020 Unified Agenda.¹The 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. 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. The deadline for comments on the Proposed Rule recently was extended until February 22, 2021. FDA is required by a court-ordered consent decree to issue a Final Rule by November 2022.² (November 2022).
Laboratory Accreditation for Analysis of Foods: The comment period for the proposed rule on the Laboratory Accreditation for Analysis of Foods closed in July 2020. FDA is required to issue the final rule by February 4, 2022, also pursuant to a consent decree.³ Promulgation of a final rule remains a “long term action.” (February 2022).

Additionally, there are two rules appearing for the first time in the FDA Unified Agenda that may be of general interest:

Amendment of Procedural Requirements for Color Additive Petitions: FDA is proposing to modernize the procedural requirements related to the data requirements, submission procedures, review process, and regulatory timeframes for color additive petitions. The Unified Agenda says that the rulemaking would revise the regulations to provide additional transparency, streamline current procedures, ease regulatory burden, and modernize requirements. The rulemaking is categorized as “deregulatory,” and according to the agency, if finalized, it would improve regulatory efficiencies by implementing data requirements that are specific to the requested action. (August 2021).
Amendment of Procedural Requirements for Food Additive Petitions: FDA similarly seeks to modernize the procedural requirements for food additive petitions, including providing additional transparency, streamlining current procedures, easing regulatory burdens, and modernizing the regulations. Like the rulemaking for color additive petitions, this rulemaking is categorized as “deregulatory,” and FDA asserts that, if finalized, the rulemaking will improve regulatory efficiencies by implementing petition data requirements that are specific to the requested action. (November 2020).

USDA Priorities

FSIS and AMS have a handful of regulatory priorities that are of particular interest.

Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology: 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, FSIS signals an intent to engage in rulemaking to govern the labeling of these products. (April 2021).
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 FTC. (April 2021).
Eliminating Unnecessary Requirements for Sampling Pumped Bacon: Although this rulemaking’s title is focused on sampling, of most significant impact, 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 December 10, 2020.⁴ (May 2021).
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. (September 2021).
Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed: 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 FDA’s updated regulations. Currently, FSIS policy allows establishments to follow either existing FSIS nutrition labeling regulations or FDA’s updated labeling regulations. (May 2021).
Maximum Line Speed under the New Poultry Inspection System: FSIS is proposing 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. (December 2020).

AMS

Establishment of a Domestic Hemp Production Program: In January 2020, AMS closed the comment period for the interim final rule initiating a new Part 990 establishing rules and regulations for domestic hemp production. AMS has been implementing the provisions of the Agriculture Improvement Act of 2018 (Farm Bill) under the interim final rule since November 2019, and AMS considered a final rule as a “long term action” in the Spring 2020 Regulatory Agenda; however, AMS now plans to issue a final rule in February 2021. (February 2021).
Undue and Unreasonable Preferences and Advantages Under the Packers and Stockyards Act: AMS plans to issue a final rule specifying the criteria the Secretary will consider when determining whether conduct by packers, swine contractors, or live poultry dealers constitutes an undue or unreasonable preference or advantage in violation of the Packers and Stockyards Act. This action is part of a long-running rulemaking stemming from the 2008 Farm Bill. (December 2020).

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.