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What Are IDFA's Regulatory Priorities for FDA in the Coming Year? Read On

Jan 13, 2020
cary_frye_18  Cary Frye, Senior Vice President of Regulatory Affairs





The White House Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Federal Regulatory Actions, which outlines the rulemaking actions that are under development at all federal regulatory agencies. The current agenda is of interest to the dairy industry because it includes status updates for key regulatory reform issues pending at the U.S. Food and Drug Administration (FDA) that IDFA has been advocating for on behalf of our members. It also provides insights into the key issues FDA considers to be priorities for rulemaking in the current fiscal year (October 2019 – September 2020).

It is important to note that dates included in the Unified Agenda are not a firm commitment for action, but rather indicate the proposed time frame which may be subject to change in the future. 

Listed below are the Unified Agenda priorities of most interest to the dairy industry.  The planned issuance dates are noted in parentheses following each “Agenda Stage of Rulemaking” description.

FDA

A. Food Safety Modernization Act

FDA has completed the seven major rulemakings under the FDA Food Safety Modernization Act (FSMA) and the agency has turned its efforts to more discrete actions to fine tune the regulations. FDA’s agenda for future FSMA-related rulemaking includes: 

1. Title: Streamlining Provisions Requiring Disclosure to and Receipt of Written Assurance From Commercial Customers in the Preventive Controls for Human Food and Animal Food Rules, and Foreign Supplier Verification Program Rule (1, 2, 3)
Agenda Stage of Rulemaking: Notice of Proposed Rule Stage 
FDA is streamlining the written assurance requirements that apply when a manufacturer/processor or importer of food identifies a hazard requiring a preventive control, but does not control the hazard (e.g., 21 CFR § 117.136). FDA plans to conduct parallel rulemaking for the Preventive Controls for Human Food (November 2019), Preventive Controls for Animal Food (July 2020) and Foreign Supplier Verification Program (November 2019) rules.
IDFA position: IDFA supports repeal of the written assurance requirements. At most, FDA should require only seller disclosure to commercial customers of the need to further process the food for safety.  

2. Title:
Laboratory Accreditation for Analyses of Foods
Agenda Stage of Rulemaking:
Notice of Proposed Rule Stage 
FDA is proposing a regulation on laboratory accreditation, which will enable FDA to recognize accreditation bodies that will accredit laboratories performing analyses of food under certain circumstances. This proposed rule was published on November 4, 2019. 
IDFA position: IDFA is currently seeking member comments and will provide feedback to FDA by the agency’s March 3, 2020 deadline. 
 
3. Title: Enhanced Traceability Record Requirements For Certain Foods
Agenda Stage of Rulemaking: Notice of Proposed Rule Stage 
The agency aims to enhance traceability requirements by proposing additional recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that are designated as high-risk foods, as required by consent decree (September 2020).
IDFA position: IDFA does not have a current position on whether any additional recordkeeping requirements might be appropriate, but we provided a set of concerns related to FDA’s draft model for determining what constitutes a “high-risk” food back in 2015. IDFA will seek member input once the proposed rule is released. 
 
B. Ultrafiltered Milk
Title: Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Reopening of Comment Period 
Agenda Stage of Rulemaking: Proposed Rule Stage 
In response to IDFA’s petition, in 2005 FDA issued a proposed rule that would amend regulations to provide for the use of fluid ultrafiltered milk in the manufacture of standardized cheeses and related cheese products which is still pending finalization. In 2017, FDA issued an enforcement discretion guidance allowing the use of fluid forms of UF milk for cheese making. At IDFA urging, FDA will reopen the comment period on the proposed rule to obtain current views of stakeholders and industry practices on a narrow set of issues and to invite comment on specific issues. This will be an opportunity for IDFA to also advocate to expand the use of filtered milk to include microfiltered milk and permit the ingredient to be labeled as “milk.” (November 2019)
IDFA Position: IDFA supports flexibility to use ultrafiltered and microfiltered milk in cheesemaking and for UF and MF fluid milk to be listed in the ingredient label as “milk.”

C. Gluten-free Labeling

Title: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods 
Agenda Stage of Rulemaking: Final Rule Stage 
FDA would establish requirements concerning ‘gluten-free’ labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. (December 2019)
IDFA Position: IDFA supported FDA’s final rule defining that food with less than 20 ppm of gluten—including foods such as milk that inherently do not contain gluten—could be labeled with gluten-free claims. We welcome FDA’s additional clarification of the use of claims for ferment and hydrolyzed foods.
 
D. Healthy Claims
Title:
Nutrient Content Claims, Definition of Term: Healthy
Agenda Stage of Rulemaking: Notice of Proposed Rule Stage 
FDA plans to update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and federal dietary guidelines. (November 2019)
IDFA Position: In 2017, IDFA provides comments to FDA urging the agency to consider the overall nutrient package of a food for healthy claims. IDFA argued that criteria should be set for different food groups such as dairy, and when appropriate, for different products within that group. We urged FDA to exempt limits on total fat and saturated fat when milkfat is the source of fat for a food making a health claim.

E. Partially Hydrogenated Oils (PHO) in Foods
Title:
Revocation of Uses of Partially Hydrogenated Oils in Foods  
Agenda Stage of Rulemaking: Notice of Proposed Rule Stage 
FDA is now proposing to update all regulations to remove all mention of partially hydrogenated oils from FDA’s GRAS regulations and as an optional ingredient in standards of identity and to revoke all prior sanctions for uses of PHOs in food. (March 2020)
IDFA Position: IDFA supported FDA’s actions to remove partially hydrogenated oils (PHOs) from food and beverage products in the United States by June 18, 2018. At IDFA’s urging, FDA clarified that products containing PHOs that are already shipped and in stores before the June compliance date can be sold through January 1, 2020. 

F. Food Standards: General Principles
Title:
Food Standards: General Principles and Food Standards Modernization (Reopening of Comment Period) 
Agenda Stage of Rulemaking: Notice of Proposed Rule Stage 
FDA is reopening the comment period on a proposed rule, issued jointly with USDA/FSIS in 2005, that proposed to establish general principles that would be the first step in modernizing and updating the framework for food standards (including standards of identity, standards of equability, and standards of fill of containers). (January 2020)
IDFA Position: The dairy industry is subject to outdated standards of identity that stifle innovation to use novel processes and ingredients to produce products consumer demand. IDFA’s petitions for modernizing specific standards of identity such as yogurt and cheese have languished at FDA for decades. IDFA strongly believes that FDA should consider a horizontal approach to modernizing food and dairy standards using the principles proposed in a 2006 Citizen Petition submitted by IDFA, the Grocery Manufacturers Association (GMA) and 10 other food trade associations. We support reopening comments on standards modernization and will advocate for adopting a horizontal approach.

G. Yogurt Standard of Identity
Title:
Milk and Cream Product and Yogurt Products, Final Rule to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for Yogurt 
Agenda Stage of Rulemaking: Final Rule Stage 
This final rule amends the standard of identity for yogurt and revokes the standards of identity for lowfat yogurt and nonfat yogurt. It modernizes the standard for yogurt to allow for technological advances, to preserve the basic nature and essential characteristics of yogurt, and to promote honesty and fair dealing in the interest of consumers. (May 2020)
IDFA Position: IDFA has urged FDA to complete work on the long-pending petition submitted by the dairy industry in 2000 followed by a proposed rule issued in 2009. IDFA has submitted comments on numerous occasions supporting a variety of changes to the proposed rule to allow for greater flexibility and innovation to keep up with market demands. 
 
For more information, contact Cary Frye at cfrye@idfa.org or John Allan at jallan@idfa.org.
 
 
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