July 2021 Regulatory Update
These Regulatory Updates are brought to you by Michael Best & Friedrich. 
This Regulatory Update includes information from July 1-31, 2021. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, to help navigate this challenging time, please follow these hyperlinks to Michael Best’s COVID-19 Resource Center and CARES Act Relief Resource Center.


FDA Announces Fiscal Year 2022 Annual Fee Rates for Several Programs
The FDA has announced fiscal year 2022 annual fee rates for the following programs:

  • Voluntary Qualified Importer Program (VQIP) user fee rates. Notice of updated user fees for the VQIP can be found here.
  • Annual fee rates for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program. Notice of updated user fees for this program can be found here.
  • Fee rates for certain domestic and foreign facility re-inspections, failures to comply with a recall order, and importer re-inspections that are authorized by the FD&C Act. Notice of updated user fees for this program can be found here.


FDA Issues Draft Guidance on Oversight of Food Products Covered by System Recognition Activities (MUST READ)
On July 9, FDA issued draft guidance addressing how the agency plans to adjust regulatory oversight for covered foods imported from countries that have been determined to produce similar food safety outcomes as the United States through FDA assessment. “Systems recognition” is a voluntary partnership between FDA and foreign regulatory counterparts or food safety authorities. For covered food products imported from a country with an active Systems Recognition Arrangement (a list that currently includes Canada, Australia, and New Zealand, and which may include the European Union in the future) the draft guidance describes how FDA’s oversight model will be adjusted. The agency touts the draft guidance as the latest effort to advance a risk-based approach to food safety under the Food Safety Modernization Act and its New Era of Smarter Food Safety initiative.

Comments should be submitted by September 10, 2021 to ensure consideration.


Several warning letters were issued in the month of July related to the Foreign Supplier Verification Program for products including baked rice chips, candy, and certain dried chili peppers. To find more information about warning letters issued by the FDA in the month of July, please visit their database here.


USDA FSIS Proposes a Unified 30-Day Timeline for Filing Appeals of FSIS Decisions or Actions Related to Inspection Activities (MUST READ)
The USDA FSIS published a proposed rule titled, “Establishing a Uniform Time Period Requirement and Clarifying Related Procedures for the Filing of Appeals of Agency Inspection Decisions or Actions”. The proposed rule would amend the current regulatory requirements for appeals of FSIS decisions or actions related to inspection activities. Currently, for example, while several subsections of the regulations specify time period requirements for the filing of appeals between 48 hours and ten days, the majority of the subsections specify no time period requirement.

In addition to clarifying and simplifying inspection appeal procedures generally, the proposed action would establish a unified appeals time period requirement of 30 calendar days from receipt of notification of the contested inspection decision or action. Examples of the types of decisions and appeals that would fall under the proposed framework include Agency decisions and actions related to inspection activities mandated under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA) and Egg Products Inspection Act.

Read the USDA-FSIS’s Federal Register Notice and Proposed Rule here.


USDA Funding to Expand Meat and Poultry Processing Capacity (MUST READ)
USDA announced the agency’s intention to invest $500M in expanding meat and poultry processing capacity as part of its efforts to build a stronger and more resilient supply chain and food system.  The initiative uses American Rescue Plan funds to give farmers, ranchers and consumers more choices in the marketplace by providing grants, loans and technical assistance to support new meat and poultry processing facilities to relieve supply chain bottlenecks. In addition, USDA announced more than $150M for existing small and very small establishments to help these establishments recover from the market impacts of COVD-19 while maintaining strong inspection and food safety standards and reducing the burden of overtime inspection fees. 


“Product of USA” Labeling Under Review (MUST READ)
The Federal Trade Commission (FTC) recently voted to strengthen its enforcement of the Made in USA standard which, according to USDA, will allow the agency to revisit the “Product of USA” label on meat products. Last year USDA announced its intention to conduct its own rulemaking to address the concern that the voluntary “Product of USDA” label may confuse consumers about the origin of FSIS regulated products and may no longer serve the purposes of consumers, producers and fair and competitive markets. The FTC’s new rule regarding “Made in the USA” can be reviewed here.  The new rule includes a broader range of remedies by the FTC, including the ability to seek redress, damages, penalties, and other relief from those who lie about a Made in USA label. In addition, for the first time, the FTC will be the authority to seek civil penalties of up to $43,280 per violation of the rule.


USDA FSIS Issues New HAACP Model for Beef Slaughter
The USDA recently announced the issuance of an updated guidebook and generic models for use by establishments when developing an establishment-specific HACCP plan. FSIS initially issued the guidebook and generic model for each food processing category defined in the Code of Federal Regulation pursuant to the 1996 Rule Pathogen Reduction/Hazard Analysis Critical Control Point (HACCP) Systems. The HACCP regulations require establishments to develop and implement a system of controls designed to improve the safety of their products. The updated generic model illustrates the slaughter processing category. However, while the generic model issued is a beef slaughter model, the model may be used as a starting point for developing a slaughter HACCP plan for other classes of livestock.

More information on the updated guidebook and generic model can be found here.


USDA FSIS Issues Two Revised Industry Guidelines for Minimizing the Risk of Shiga Toxin-Producing E. coli (STEC) in Beef (including Veal) Slaughter and Processing Operations
The USDA FSIS issued two updates to the industry guidelines for minimizing the risk of STEC in beef slaughter and processing operations. This guideline replaces the 2017 version of the guideline and provides beef and veal slaughter establishments information concerning best practices at slaughter and processing that may be used to prevent, eliminate, or reduce levels of fecal and associated microbiological contamination in beef, specifically Shiga toxin-producing E. coli and Salmonella. The updated guideline for slaughter practices is intended to assist establishments that slaughter beef and veal to (i) implement effective sanitary dressing procedures designed to prevent carcass contamination, (ii) implement effective decontamination and antimicrobial interventions; (iii) properly assess microbial testing results, including results for indicators of process control, at any point during slaughter; and (iv) use the results from the implementation of these components of the food safety system to assess the effectiveness of the overall HAACP system. The update to the processing practices is intended to assist establishments to (i) understand the adultered status of STEC in beef products, (ii) design supportable control measures for STEC, (iii) develop ongoing verification measures to ensure that STEC control measures are functioning as intended, and (iv) respond when the HACCP system fails to prevent, or reduce STEC to below detectable levels.

The updated Industry Guideline can be found here.


USDA FSIS Issues Two Updates to Industry Guideline for Controlling Salmonella and Campylobacter in Raw Poultry
The USDA FSIS issued the 2021 edition of industry guideline for controlling Salmonella and Campylobacter in raw poultry. The 2021 edition separates the guideline into two separate documents: one for Salmonella and one for Campylobacter. These guidelines are intended to help poultry establishments, including those that are small and very small, in controlling hazards and meeting the FSIS pathogen performance standards. Specifically, these guidelines are designed to help establishments to (i) identify and implement pre- and post-harvest interventions to control Campylobacter and Salmonella as part of their HACCP system and (ii) utilize microbial testing results to monitor the performance of the HACCP system and inform decision-making.

Read the Industry Guideline for controlling Salmonella here and the Industry Guideline for controlling Campylobacter here.