October-November 2021 Regulatory Update
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update covers information from October 1-November 15. Please contact Paul Benson, Taylor 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, visit michaelbest.com.


FDA Issues Final Guidance on Sodium Reduction
In October, the FDA issued final guidance for voluntary, short-term sodium reduction targets for a variety of processed and packaged foods. FDA’s press release announcing the guidance stated that sodium reduction is critical to public health in America as the average American 14 years and older consumes 50% more sodium than the recommended amount. The guidance aims for a reduction in personal sodium intake by nearly 12% per day. FDA’s recommendations focus on packaged and prepared food with the agency reasoning that nearly 70% of sodium consumption derives from these sources.

Read the full guidance from the FDA here.


FDA Signs Domestic Mutual Reliance Agreements with California, Florida, Utah, and Wisconsin
In October, the FDA announced a new Mutual Reliance Agreement between the agency and the States of California, Florida, Utah, and Wisconsin. These agreements are designed to enhance coordination efforts aimed at reducing human foodborne illness outbreaks and the streamlining of oversight between states and federal agencies. To achieve its intended goals, the FDA will cooperate with state governments to leverage data and actions from various parts of the nation with a goal of creating a safer food supply. FDA said the mutual reliance agreements embodies the Food Safety Modernization Act, the Partnership for Food Protection, and the New Era of Smarter Food Safety blueprint designed to move the United States towards an integrated food safety system that coordinates safety standards and initiatives across the country into one cohesive strategy.

For more information, read the FDA press release here.


FDA Seeks Public Comment on Food Additive Petition Process
The FDA is looking for public comment concerning the collection of information by the agency associated with the process of submitting a food additive petition or a petition for an investigational exemption for a food additive. The notice estimates the reporting burden associated with the preparation of food additive and investigational food additive petitions.

For more information, view the notice here.


FDA Issues Guidance on Temporary Marketing Permits
In early November, FDA issued new guidance on the Temporary Marketing Permit (TMP) process. TMPs enable manufacturers to deviate from the established Standards of Identity by conducting research and obtaining data to support a petition to amend a food standard.  The changes are intended to streamline and improve efficiency in the application process. The updated guidance comes following comments from a public meeting in September 2019 suggesting the then current process was counterproductive disincentivizing technology and innovative ingredient use.

The full guidance can be found here.


Warning Letter Issued Regarding Safety Reviews for Foods Imported into the United States
In September and October 2021, the FDA issued two warning letters to companies citing their failure to comply with the Foreign Supplier Verification Program (FSVP), a foundational component of FDA’s implementation of the Food Safety Modernization Act. FSVP requires importers to conduct a set of risk-based activities intended to verify that human and animal foods brought to the United States meet the applicable food and safety standards. The violations included imports on goods such as rice, sweet corn, frozen noodle dishes, coco Amarillo, and more.

To view FDA Warning Letters, visit their database here.


USDA Awards over $243 Million to Strengthen the Specialty Crop Industry
In late October, the USDA announced an investment of more than $243 million in grants provided through the Specialty Crop Block Grant Program and the Specialty Crop Research Initiative grants program to support specialty crops, including fruits, vegetables, tree nuts, and nursery crops. This funding will provide financing for the departments of agriculture in all 50 states, the District of Colombia, and the five US territories. To coincide with this funding initiative, states were encouraged to prioritize projects which address the impacts of COVID-19.

In addition, the USDA announced investments of nearly $74 million to 21 recipients of its Specialty Crop Research Initiative grant programs. These funding initiatives seek to address the issues facing both conventional and organic food and agricultural production systems within the specialty crop industry. Intense focus was placed on the improvement of crop characteristics, the management of pest and disease threats, the improvement of production efficiency, profitability, technological innovation, and the mitigation of food safety hazards. Priority was given to multistate, multi-institutional, or trans-disciplinary projects.

For more information, visit the USDA’s website here.


USDA Announces Early Release of Select Commodity Tables for Agricultural Projections to 2031
Earlier this month, the USDA released selected tables outlining the upcoming department’s Agricultural Projections to 2031. The tables include long-term supply, use, and price projections to 2031 for all major crops and livestock products in the US. These projections align with the department’s consensus over decade-long representative scenarios for the agriculture sector. The projections represent a conditional scenario based on specified assumptions regarding macroeconomic conditions, policies, weather, and worldwide developments, with no changes to current domestic or external shocks to the global agriculture markets. Additionally, the projections do not represent USDA forecasts. The complete projections will be released in February 2022.

For more information, see the USDA press release here.


FSIS Extends Comment Period on the Labeling of Meat and Poultry Products Derived from Animal Cells (Revisions)

On September 2, 2021, FSIS announced an advance notice of proposed rulemaking (ANPR) to solicit comments and information regarding the labeling of meat and poultry products made using cultured cells derived from animals under FSIS jurisdiction. FSIS will use these comments to inform future regulatory requirements for the labeling of such food products.

Having received several stakeholder requests to extend the comment period, the agency has decided to extend the comment period by an additional 30 days. The comment period will now end on December 2, 2021.

This extension should provide interested stakeholders additional time to submit comments and information regarding the labeling of meat and poultry products comprised of or containing cultured cells derived from amenable livestock and poultry. FDA anticipates that the public will also have an additional opportunity to comment on these issues during future rulemaking. 

For additional information please view the September 3, 2021 Constituent UpdateTo view the ANPR and for details on how to comment or submit information, please visit the FSIS website.


Verification of Less Than Daily Sanitation Procedures in Meat and Poultry Processing Operations and Egg Products Establishments
In mid-October, the USDA Food Safety and Inspection Service (FSIS) issued new instructions to inspection program personnel on verifying compliance with regulations regarding the less-than-daily sanitation in meat and poultry processing operations and egg product establishments. Key measures of the revised procedures state producers are not required to notify or seek approval from FSIS prior to establishing a less-than-daily sanitization program. Slaughterhouses are not approved for such sanitation measures outlined, apart from poultry chillers that have met the outlined requirements to inhibit bacterial growth.

For the specific instructions outlined by the USDA, visit their information page here.


FY 2019 Pesticide Report: Consistent with Trends Over the Past 8 Years, Pesticide Residue Levels Remain Low 
In late October, the FDA released the Pesticide Residue Monitoring Program Report for FY 2019. Testing for 812 pesticides and industrial chemicals, the investigation found most samples had residue levels below the limits established by the Environmental Protection Agency. The results continue an eight-year trend of low levels. This annual investigation seeks to balance the needs of growers and public health by researching chemical residues that may remain in or on some foods when purchased by consumers. The FDA notes that producers and manufacturers of domestic food samples found in violation of pesticide samples may receive a warning letter or more explicit action, including seizure of food to remove it from the market or seeking an injunction to correct the violation. Imported food which violates EPA standards may result in the company responsible and the food in question placed on an Import Alert, preventing the product from entering the United States.

For more information about the specific results of the investigation, see the FDA press release here.