August 2021 Regulatory Update
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update covers information from August 2021. Please contact Paul Benson, Taylor Fritsch, Leah Ziemba or Nancy Cruz 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, visit Michael Best’s COVID-19 Resource Center and CARES Act Relief Resource Center.


Updates to Agency Information Collection Activities
The FDA recently announced that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

From 1998 to 2008, FDA’s National Retail Food Team conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors most commonly reported to the CPC as contributing factors to foodborne illness outbreaks at the retail level. In 2013/2014, FDA initiated a new 10-year study period, for which FDA completed the baseline data collection in select healthcare, schools, and retail food store facility types. Data collections will continue through 2024, pending the COVID-19 pandemic.

The results of this 10-year study period will be used to (1) develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors; (2) provide technical assistance to State, local, tribal, and territorial regulatory professionals; (3) identify FDA retail work plan priorities; and (4) inform FDA resource allocation to enhance retail food safety nationwide.

Notice of the study and information submission can be found here.


FDA Files Petition Proposing Amendments to Color Additive Regulations
The FDA recently announced that the Agency filed a petition submitted by Australian Laboratory Services, PTY LTD., on behalf of Piotrovska, PTY LTD., proposing that the color additive regulations be amended to expand the permitted uses of synthetic iron oxide as a color additive to include use in edible decorative paint. Specifically, the petition proposes to amend the color additive regulations at 21 CFR 73.200 (“Listing of Color Additives Exempt from Certification”) by expanding the permitted uses of synthetic iron oxide as a color additive to include use in edible decorative paint.

More information about the petition and the notice of filing can be found here.


FDA and Mexican Counterparts Report Progress and Next Steps for Food Safety Partnership
The FDA and its regulatory counterparts in Mexico—Cofepris and SENASICA—held the first Food Safety Partnership Annual Meeting on August 20, an important milestone in food safety, according to the Agency. This meeting stems from the Statement of Interest signed in September 2020 to enhance the partnership between all three agencies to work together on food safety in both countries. The FDA plans to work closely and collaborate with SENASICA and Cofepris on activities that will enhance communication and oversight and efforts to improve food establishment inspections and responses to foodborne illness outbreaks, as well as develop and implement plans to enhance food safety in other areas of mutual public health interest.

More information about the partnership and the most recent meeting can be found here.


FDA Releases PFAS Testing Results from First Survey of Processed Foods
FDA conducted a survey of nationally distributed processed foods collected for the Total Diet Study. Results of this survey showed that 164 of the 176 foods tested had no detectable levels of the PFAS measured. Three food samples had detectable levels of PFAS, including: fish sticks, canned tuna, and protein powder. However, based on the best available current science, the Agency did not find any scientific evidence that the levels of PFAS found in the TDS samples tested since 2019 indicating a need to avoid any particular foods in the general food supply.

More information about the Total Diet Study and the PFAS Testing Results can be found here.


Warning letters were issued in the month of July related to the Foreign Supplier Verification Program and for Seafood HACCP regulations and Current Good Manufacturing Practices violations. To find more information about warning letters issued by the FDA in the month of August, please visit their database here.


USDA FSIS Issues New HAACP Model for Thermally Processed, Commercially Sterile Products
The USDA recently announced the issuance of an HACCP model for thermally processed, commercially sterile products (TPCS). Processors of TPCS products must identify their biological, physical, and chemical food safety hazards when performing a hazard analysis. However, establishments are not required to address the microbiological food safety hazards identified in its hazard analysis if the product is produced in accordance with the requirements of 9 CFR Part 431. Establishments are not required by the regulations to address microbiological hazards in their HACCP plan because FSIS recognized that the canning regulations were based on HACCP concepts and provide for the analysis of thermal processing systems and controls to exclude biological food safety hazards. However, canning establishments that identify chemical or physical food safety hazards as reasonably likely to occur (RLTO) are to address those hazards in their HACCP plan.

The HACCP model illustrates the scenario when an establishment does not address microbiological hazards in a HACCP plan and does not identify chemical or physical food safety hazards as reasonably likely to occur. This model includes the required product description, list of product ingredients and materials, flowchart, and hazard analysis. However, this model may not necessarily apply to all operations or products.

TPCS products, also known as “canned products”, include metal cans, glass jars, flexible pouches, paperboard, and other types of hermetically sealed containers.

More information on the generic model can be found here.


USDA FSIS Announces Virtual Meeting of the National Advisory Committee on Meat and Poultry Inspection
The FSIS recently announced a virtual meeting of the National Advisory Committee on Meat and Poultry Inspection (NACMPI). The purpose of the Committee is to provide advice to the Secretary of Agriculture about State and Federal programs with respect to meat, poultry and processed egg products inspection, food safety, and other matters that fall within the scope of the Federal Meat Inspection Act and the Poultry Products Inspection Act. Two sets of charges will be presented to the Committee: (1) to consider how FSIS should clarify the Agency’s positions on the custom and retail exemptions to ensure that meat, poultry, and egg products produced under the exemptions are safe, wholesome, and correctly labeled and packaged, and (2) to consider actions FSIS should take to prevent and reduce illnesses associated with the handling or consumption of frozen, raw, stuffed not ready-to-eat poultry products, which may be breaded and par-fried and may appear ready-to-eat to consumers.

The meeting will be held virtually and publicly on September 27 and 28, 2021.

More information about the meeting and registration details can be found here.


USDA Announces Improvements to the Dairy Safety Net and New Pandemic Market Volatility Assistance Program
The USDA recently announced the details of the Pandemic Market Volatility Assistance Program. Secretary Vilsack committed to providing additional pandemic assistance for dairy farmers in an exchange at a hearing with Senate Appropriations Committee Chairman Leahy. Through the program, USDA will provide about $350 million in pandemic assistance payments to dairy farmers who received a lower value for their products due to market abnormalities caused by the pandemic. Under this program, payments will reimburse qualified dairy farmers for 80 percent of the revenue difference per month based on an annual production of up to 5 million pounds of milk marketed and on fluid milk sales from July through December 2020. USDA will contact eligible handlers and cooperatives to notify them of the opportunity to participate in the Program.

More information about the program can be found here.


FSIS Updates Dataset on Import Refusals
On August 16, 2021, FSIS updated the publicly posted dataset on import refusals for products that the agency regulates. Federal law requires every commercial shipment of imported meat, poultry, and egg products to be re-inspected prior to product entering U.S. commerce. FSIS re-inspects each shipment to verify labeling, proper certification, general condition, and any signs of tampering and to identify product adulterated by transportation damage. FSIS also performs additional activities on a random and/or for-cause basis, such as physical product examination and laboratory sampling for pathogens and chemical residues. Any product that does not meet FSIS requirements is refused entry, and the importer has up to 45 days (or 30 days for egg products) to have the product destroyed for use as human food, re-exported/returned to the foreign country, converted to animal food, or brought into compliance with FSIS requirements, if applicable. This dataset is updated on the 15th of each month.

The Dataset and more information about the same can be found here.


FSIS Posts Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella
On August 20, 2021, FSIS updated the individual establishment Salmonella performance standard category information for raw poultry carcasses, raw chicken parts, and comminuted poultry products on the Salmonella Verification Testing Program Monthly Posting page. Additionally, FSIS will post the aggregate sampling results showing the number of establishments in categories 1, 2, or 3 for establishments producing young chicken or turkey carcasses, raw chicken parts, or not ready-to-east comminuted poultry products at the location linked above.

More information about the Program and monthly testing can be found here.