September 2020 Regulatory Update | 2 of 2

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

This Regulatory Update includes information from September 14 – September 30, 2020. 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.

 

COVID-19 UPDATES

  • FDA Announces Additional Flexibility Regarding Updated Nutrition and Supplement Facts Labels Amidst Pandemic MUST READ

  • Expansion of the Coronavirus Food Assistance Program (CFAP 2) Begins September 21

FDA UPDATES

  • FDA Announces Proposed Rule on FSMA Food Traceability MUST READ

  • FDA Finalizes First-Ever Equivalence Determination, Resuming Shellfish Trade with Netherlands and Spain MUST READ

  • HHS Secretary’s Memo Bars FDA, Other Agencies from Signing New Rules MUST READ

  • FDA Releases New “Feed Your Mind” Educational Materials

  • First-Ever Produce Safety Rule Permanent Injunction Entered in Federal Court

USDA UPDATES

  • USDA-FSIS Issues Proposed Rule to Expand Generic Label Approval MUST READ

  • USDA-FSIS Updates Guidance for Importing Meat, Poultry, and Processed Egg Products MUST READ

  • USDA-FSIS and USDA-OFS Release Roadmap to Address Salmonella MUST READ

  • USDA Announces Contracts for Round 3 of Farmers to Families Food Box Program

  • USDA Announces Assistance for Residents and Producers Affected by Western Wildfires

UPCOMING MEETINGS & CONFERENCES

  • October 1: Webinar for the shellfish industry and state shellfish control authorities hosted by FDA and the Interstate Shellfish Sanitation Conference (ISSC). Register here.   

  • October 6: Virtual meeting on consumer outreach and education hosted by USDA-FSIS. Read USDA-FSIS’s Federal Register Notice and register for the meeting here

  •  

    October 13-14: Virtual meeting on National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan hosted by FDA, CDC, and USDA. Register by Friday, October 2, 2020, 4:00 PM ET here

 


COVID-19 DEVELOPMENTS

FDA Announces Additional Flexibility Regarding Updated Nutrition and Supplement Facts Labels Amidst Pandemic
September 18:Amidst concerns about timely regulatory compliance during the pandemic, FDA announced additional flexibility for manufacturers expected to comply with the updated Nutrition and Supplement Facts label requirements by January 1, 2021.

Although this compliance date, which applies to “manufacturers with less than $10 million in annual food sales,” will remain in place, “FDA will not focus on enforcement actions during 2021 for these smaller food manufacturers,” according to the agency’s Constituent Update. This additional flexibility also includes “manufacturers of packages and containers of single-ingredient sugars, regardless of the size of the manufacturer.”

Previously, FDA provided the same flexibility for “manufacturers with $10 million or more in annual sales, who were required to comply with the Nutrition and Supplement Facts label requirements by January 1, 2020, by indicating it would not focus on enforcement actions during 2020.”

Read FDA’s Constituent Update here and the May 2016 final rule on “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” here.

 

Expansion of the Coronavirus Food Assistance Program (CFAP 2) Begins September 21
September 17: President Trump and USDA Secretary Sonny Perdue announced CFAP 2, an expansion of the Coronavirus Food Assistance Program (CFAP) through “an additional $14 billion dollars for agricultural producers who continue to face market disruptions and associated costs because of COVID-19,” according to USDA’s Press Release.

USDA will draw upon funds made available from the Commodity Credit Corporation (CCC) Charter Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Specifically, USDA will provide CFAP 2 payments for Price Trigger Commodities (“major commodities that meet a minimum 5-percent price decline over a specified period of time”); Flat-rate Crops (crops “that either do not meet the 5-percent price decline trigger or do not have data available to calculate a price change”); and Sales Commodities (“specialty crops; aquaculture; nursery crops and floriculture; other commodities not included in the price trigger and flat-rate categories…and other livestock…not included under the price trigger category that were grown for food, fiber, fur, or feathers.”)

CFAP 2 eligible producers may apply for assistance at USDA’s Farm Service Agency (USDA-FSA) county offices from September 21, 2020 through December 11, 2020. 

Read USDA’s Press Release here. Learn about CFAP 2 and access a complete list of CFAP 2 eligible commodities, payment rates, and calculations here.


FDA UPDATES

FDA Announces Proposed Rule on FSMA Food Traceability
September 21:FDA announced a proposed rule to establish additional traceability recordkeeping requirements for specific foods on a draft “Food Traceability List” (FTL) (“Requirements for Additional Traceability Records for Certain Foods,” 85 Fed. Reg. 59984). The rule would constitute a major milestone in the New Era of Smarter Food Safety and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA) to help the agency prevent or mitigate foodborne illness outbreaks.

The proposed rule would require persons who manufacture, process, pack, or hold a food on the FTL “to keep certain records describing their traceability operations and the listed foods they handle to help FDA investigators understand their traceability procedures and records when reviewing them during a foodborne illness outbreak or a routine inspection,” according to the rule’s text. Specifically, persons subject to the rule would be required “to establish and maintain records containing key data elements (KDEs) associated with different critical tracking events (CTEs) in a listed food's supply chain, including the growing, receiving, transforming, creating, and shipping of listed foods.” They also would be required to maintain records related to their internal traceability programs. “If finalized,” FDA’s Constituent Update notes, “the proposal would standardize the data elements and information firms must establish and maintain, and the information they would need to send to the next entity in the supply chain to facilitate rapid and accurate traceability.”

The proposed requirements would only apply to foods that are on the FTL, which includes foods that have FTL foods as ingredients. FDA identified foods to include on the FTL based on multiple criteria: “frequency of outbreaks and occurrences of illnesses; severity of illnesses; likelihood of contamination; the potential for pathogen growth, with consideration of shelf life; manufacturing process contamination probability and industry-wide intervention; consumption rate and amount consumed; and cost of illness.” The proposed FTL includes cheeses other than hard cheeses, shell eggs, nut butter, fresh herbs, leafy greens, fresh-cut fruit and vegetables, and other food products, but the proposed rule includes a process by which FDA could update the FTL.

FDA hopes that improved traceability would help the agency limit the adverse impacts of foodborne illness outbreaks by enabling it to “more quickly identify the source of a contaminated product, reduce the scope of product recalls, and conduct more timely root-cause investigations to learn more about how contamination occurred in order to prevent future outbreaks.”

Submit comments for consideration by January 21, 2021.

Read FDA’s Constituent Update here, the proposed rule here, and the draft “Food Traceability List” here

 

FDA Finalizes First-Ever Equivalence Determination, Resuming Shellfish Trade with Netherlands and Spain
September 23: In an important step towards reopening trade in raw and processed molluscan shellfish between the U.S. and European Union (EU),FDA announced its first-ever equivalence determination to allow the Netherlands and Spain to export raw bivalve molluscan shellfish to the U.S. The determination, which finalized a proposed equivalence determination published in 2018, marks a turning point in the industry: the U.S. and EU “have not allowed the import of raw molluscan shellfish from each other since 2010,” according to FDA’s Constituent Update.

The equivalence determination found that the Netherlands and Spain’s implementation of EU food safety control measures for raw molluscan bivalve shellfish (e.g. oysters, clams, mussels, roe-on and whole scallops) and “application of additional measures specifically adopted for export to the United States” provide “at least the same level of sanitary protection as comparable food safety measures in the United States and is therefore equivalent.”

Meanwhile, the EU’s food safety regulatory authority separately determined that the U.S. food safety control system for raw and processed molluscan shellfish was equivalent to that of the EU system; it will begin accepting shellfish from growing areas in Massachusetts and Washington. “Although Spain and the Netherlands in the EU and Massachusetts and Washington in the United States will be the first participants, arrangements have been made to use a streamlined process for expanding market access between these two trading partners,” according to an “FDA Voices” article by Mark Abdoo (FDA’s Associate Commissioner of Global Policy and Strategy) and Susan Mayne, Ph.D. (Director of the Center for Food Safety and Applied Nutrition).

To provide more information about bilateral trade under FDA’s historical equivalence determination, FDA and the Interstate Shellfish Sanitation Conference (ISSC) will host a webinar for the shellfish industry and state shellfish control authorities on Thursday, October 1, 2020. There will be two identical sessions, one from 10 AM–12 PM EST and one from 2 PM–4 pm EST.

Read FDA’s Constituent Update here, the “FDA Voices” article here, and the Federal Register Notice here. Read about the webinar and register to attend here.

 

HHS Secretary’s Memo Bars FDA, Other Agencies from Signing New Rules
September 19:The New York Times obtained a September 15 memo by Alex M. Azar II, the Secretary of the U.S. Department of Health and Human Services (HHS), that barred the entire health department, including FDA and 26 other agencies and offices, from signing any new rules about foods, medicines, medical devices, other products, and vaccines from that date onward. In the memo, which was sent to heads of HHS operating and staff divisions, Azar wrote, “The authority to sign and issue any rule for which notice and comment would normally be required, irrespective of whether notice and comment is waived, is reserved for the Secretary. Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded.”

The memo requires the HHS Secretary to sign any new rules issued by federal health agencies like FDA. Previously, many such rules were signed by lawyers or the heads of agencies. Some outside observers expressed alarm about the memo, concerned that it could be perceived as a political “power grab,” could constitute political meddling in scientific regulatory decisions, or could create inefficiency in the regulatory process or the vetting and approval process for coronavirus vaccines. According to the Times, however, Azar’s Chief of Staff Brian Harrison “described the new policy as ‘a housekeeping matter,’ aimed at no agency in particular…[that] would have no bearing on how the agency dealt with coronavirus vaccines.”

Furthermore, HHS released a statement clarifying Azar’s memo on September 20: “The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him. Any speculation about this memo being motivated by policy considerations is utterly misinformed…The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization. This action will not slow any HHS agencies’ work. It is simply the ministerial, administrative act of attaching a signature to a document.”

Despite these assurances from Harrison and HHS, some former senior officials from FDA and HHS conjectured that the memo was intended “to remove rule-making power from [FDA commissioner] Dr. Stephen Hahn…and to send a signal to President Trump that no surprises would come from the agency in the weeks before the election,” according to the Times.

Read HHS’s September 20 statement on the memo here.

 

FDA Releases New “Feed Your Mind” Educational Materials
September 29:FDA posted additional consumer education materials as part of FDA, USDA, and Environmental Protection Agency’s (EPA) “Feed Your Mind” consumer education initiative, launched in March 2020. The new materials include two videos about GMOs, four fact sheets about GMOs and genetic modification, and Spanish translations of the fact sheets and infographics. In July 2020, FDA made the “Science and Our Food Supply: Exploring Food Agriculture and Biotechnology” high school curriculum available for the 2020-2021 school year as part of the initiative.

Funding for “Feed Your Mind” was provided by Congress in the Consolidated Appropriations Act of 2017 to conduct “consumer outreach and education regarding agricultural biotechnology and biotechnology derived food products and animal feed, including through publication and distribution of science-based educational information,” according to FDA’s Constituent Update.

Read FDA’s Constituent Update here and visit the “Feed Your Mind” webpage here.

 

First-Ever Produce Safety Rule Permanent Injunction Entered in Federal Court
September 15: FDA entered into its first-ever consent decree for a permanent injunction in connection with alleged violations of public safety standards under the Produce Safety Rule. The Produce Safety Rule is one of several “foundational rules” issued under the 2011 Food Safety Modernization Act (FSMA).

The consent decree is between FDA and an Illinois-based sprout and soy product processor, Fortune Food Product, Inc., its majority owner and a supervisor. In July 2018, FDA sent a warning letter to the firm outlining its food safety violations after several inspections revealed unsanitary conditions in which sprouts and soy products may have been contaminated with filth or rendered harmful to health. According to FDA’s News Release, the sprout-specific portion of the Produce Safety Rule requires “that covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting; test spent sprout irrigation water…for the presence of certain pathogens; test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes; and take corrective actions when needed.”

The consent decree, entered in the U.S. District Court for the Northern District of Illinois, “prohibits the defendants from growing, harvesting, packing and holding sprouts and soy products at or from their facility, or any other facility, until certain requirements are met.” It also “requires the defendants to…take corrective actions and notify the FDA before such operations may resume.” As of September 15, no confirmed illnesses related to Fortune Food’s products had been reported to FDA.

Read FDA’s News Release here.


USDA UPDATES

USDA-FSIS Issues Proposed Rule to Expand Generic Label Approval
September 14: USDA-FSIS issued a proposed rule “to amend its inspection regulations to expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products” (“Prior Label Approval System: Expansion of Generic Label Approval,” 85 Fed. Reg. 56538).

Under current USDA-FSIS regulations, labels that have been generically approved (i.e. labels that comply with the agency’s labeling rules) “do not need to be submitted to or reviewed by FSIS before they can be used on product in commerce,” according to the agency’s Constituent Update. Only “certain categories of labels must be submitted to FSIS for review and approval before use.” Under the proposed rule, “labels on products for export that deviate from FSIS requirements but meet the requirements of the foreign country would be deemed generically approved.”

In addition to amending the regulation of products labeled for export, the proposed rule would extend generic approval to the following labeling claims: “labels that list ingredients in the ingredients statement as being certified ‘organic’…under the Agricultural Marketing Service (AMS) National Organic Program”; “labels that display geographic landmarks, such as a foreign country's flag, monument, or map”; “labels that make ‘negative’ claims identifying the absence of certain ingredients or types of ingredients”; and “labels of products that receive voluntary FSIS inspection” on the same basis as amenable meat, poultry, and egg products.

Furthermore, the proposed rule would enable USDA-FSIS to “cease evaluating labels submitted to FSIS that are eligible for generic approval.” Submit comments for consideration by November 13, 2020.

Read USDA-FSIS’s Constituent Update here and the proposed rule here.

 

** USDA-FSIS Updates Guidance for Importing Meat,

Poultry, and Processed Egg Products
September 24:Based on comments from one trade association and two non-profit consumer groups, USDA-FSIS revised its July 7, 2017 guidance for importing meat, poultry, and processed egg products into the U.S. (85 Fed. Reg. 60126). According to USDA’s Constituent Update, the revised guidance contains “updates to industry supply chain best practices, clarifies FSIS’ approach to applying different levels of re-inspection to imported product, and adds information about generic labeling approvals, food defense, slaughter dates on import certification, and barcoding.”

Read USDA’s Constituent Update here and the guidance here.

 

USDA-FSIS and USDA-OFS Release Roadmap to Address Salmonella
September 18: USDA-FSIS and USDA’s Office of Food Safety (USDA-OFS) released their “Roadmap to Reducing Salmonella: Driving Change through Science-Based Policy,” which outlines programs and policies to decrease the occurrence of Salmonella – one of the leading causes of foodborne illness –in meat, poultry, and egg products.

The roadmap includes goals for the future modernization of egg products inspection and beef slaughter inspection through the adoption of principles from the Hazard Analysis and Critical Control Points (HACCP) inspection system. It also describes ongoing evaluation of laboratory sampling approaches to maximize sample collection rates and optimize sampling. Furthermore, the roadmap notes that USDA is “currently developing or revising a number of guidance documents focused specifically on controlling Salmonella.” Finally, it describes its encouragement of new technologies, its findings from consumer research, and its collaboration with public health partners.

On September 22, the two offices presented the roadmap at a virtual public meeting with participation by USDA’s Agricultural Research Service (USDA-ARS), FDA, and the Centers for Disease Control and Prevention (CDC).

Read USDA’s Constituent Update here and the roadmap here

 

USDA Announces Contracts for Round 3 of Farmers to Families Food Box Program
September 17: In the same week that USDA reached the milestone of having distributed over 90 million food boxes to families affected by the pandemic through the Farmers to Families Food Box Program, the agency approved up to $1 billion in contracts for the program’s third round.

For this third round of food box purchases, USDA solicited proposals that “illustrate[d] how coverage would be provided to areas identified as opportunity zones, detail[ed] subcontracting agreements, and address[ed] the ‘last mile’ delivery of product into the hands of the food insecure population,” according to the agency’s Press Release. Contracts were awarded “based on the pricing submitted for the delivery locations proposed, box content, last mile delivery plans, means testing compliance, and support of small and local/regional food systems,” and USDA sought to purchase combination boxes containing fresh produce, dairy products, fluid milk, and meat products.

The first round of Farmers to Families purchases occurred from May 15 through June 30, 2020 and resulted in the delivery of 35.5 million boxes in the first 45 days. In the second round, which occurred from July 1 through September 18, 2020, USDA purchased “more than $1.113 billion of food through extended contracts of select vendors from the first round of the program as well as new contracts focused on Opportunity Zones.”

Read USDA’s Press Release here.

 

USDA Announces Assistance for Residents and Producers Affected by Western Wildfires
September 16:USDA offered resources for residents and producers affected by the 60-plus wildfires that had burnt nearly 6.9 million acres across 11 states as of September 16. In its Press Release, the agency provided links to various programs to offset the financial impacts of severe weather events.

The agency provided information about food waivers and flexibilities in California. It cited the USDA Food and Nutrition Service’s (USDA-FNS) approval of California’s waiver requests regarding the purchase of hot foods with Supplemental Nutrition Assistance Program (SNAP) benefits and the replacement of 50% of August SNAP benefits for certain households affected by wildfires and power outages.

The Press Release also included links to information about USDA’s emergency loan program, Livestock Indemnity Program, Livestock Forage Disaster Program, Noninsured Crop Disaster Assistance Program, Environmental Quality Incentives Program, Emergency Conservation Program, Emergency Forest Restoration Program, Emergency Watershed Protection Program, and Tree Assistance Program.

Read USDA’s Press Release here.

 

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