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This Regulatory Update includes information from October 15 – October 31, 2020. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business.

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FOOD LABELING

• FDA Issues Final Guidance and Request for Information on Nutrition Labeling of Certain Sugars MUST READ
• FDA Proposes Updating Allergy Label When Allergenic Portions of Major Allergens Are Removed

FOOD SAFETY

• FDA Establishes U.S. Agent Voluntary Identification System for Food Facility Registration MUST READ
• FDA Launches Pilot Program to Evaluate Third-Party Food Safety Standards MUST READ
• USDA-FSIS Announces Final Rule on Egg Products Inspection Regulations MUST READ
• USDA-FSIS Releases Foodborne Illness Outbreak Investigation Summary Reports for FY 2017-2019 

USDA UPDATES

• USDA Announces Early Release of Select Commodity Tables for Agricultural Projections to 2030
• USDA and Office of U.S. Trade Representative (USTR) Release Report on U.S.-China Agricultural Trade

UPCOMING MEETINGS & CONFERENCES

• November 6 (8:30 AM – 5:00 PM EST): First virtual public meeting to discuss proposed rule “Requirements for Additional Traceability Records for Certain Foods,” hosted by FDA. Registration closed on October 28, 2020. Read about the proposed rule here.
  
  
• November 18 (9:30 AM – 5:30 PM EST): Second virtual public meeting to discuss proposed rule “Requirements for Additional Traceability Records for Certain Foods,” hosted by FDA. Register by November 6 here and read about the proposed rule here.
  
  
• December 2 (11:30 AM – 7:30 PM EST): Third and final virtual public meeting to discuss proposed rule “Requirements for Additional Traceability Records for Certain Foods,” hosted by FDA. Register by November 18 here and read about the proposed rule here.
  
  
• View slide decks from past USDA-FSIS meetings and presentations here.

FOOD LABELING

FDA Issues Final Guidance and Request for Information on Nutrition Labeling of Certain Sugars
October 16:FDA issued both a final guidance and a request for information (RFI) on the nutrition labeling of sugars that are metabolized differently than traditional sugars. According to FDA’s Constituent Update, it received “multiple requests from industry to treat certain sugars that are metabolized differently than traditional sugars as distinct for the purpose of nutrition labeling.” Unlike sucrose (table sugar), which has 4 calories per gram, nontraditional sugars like allulose, D-tagatose, and isomaltulose are metabolized differently, are not associated with dental decay, and have fewer than 4 calories per gram – as low as 0.4 calories per gram from allulose.

In response to these industry requests, FDA issued a final guidance on allulose. The agency advised manufacturers that the sugar still must be included in the amount of total carbohydrates on the Nutrition Facts label. FDA also indicated that it would exercise enforcement discretion regarding both “the use  of 0.4 calories per gram for allulose when determining calories” and “the requirement that allulose be included in the amount of total sugars and added sugars” on the label.

FDA’s RFI concerns the nutrition labeling of other nontraditional sugars “that provide fewer calories, that are not associated with dental caries, and that result in a lower glycemic and insulinemic response than other sugars.” FDA requested public and scientific comment on the following: how to identify additional nontraditional sugars beyond allulose, D-tagatose, and isomaltulose; how to account for nontraditional sugars in the “Total Sugars” label declaration; ; how to account for nontraditional sugars in the “Added Sugars” label declaration; and whether to allow the voluntary declaration of nontraditional sugars on the Nutrition Facts label.

Submit either electronic or written comments for consideration by December 18, 2020.

Read FDA’s Constituent update here, final guidance here, and RFI here. 

FDA Proposes Updating Allergy Label When Allergenic Portions of Major Allergens Are Removed
October 28: FDA proposed exempting ingredients derived from major food allergens from certain labelling requirements – as long as the allergenic proteins within those ingredients have been eliminated.

Under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), foods regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are considered misbranded “unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived,” according to FDA’s Federal Register Notice. The FD&C Act defines a major food allergen as milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, or an ingredient that contains protein derived from such foods.

Yet in some instances, “the production of an ingredient derived from a major food allergen may alter or eliminate the allergenic proteins in that derived ingredient to such an extent that it does not contain allergenic protein.” FDA proposed exempting such ingredients from the FALCPA labeling requirement in its Federal Register Notice, which is a “collection of information” calling for public input. Submit either electronic or written comments for consideration by December 28, 2020.

Read FDA’s Federal Register Notice here.

FOOD SAFETY 

FDA Establishes U.S. Agent Voluntary Identification System for Food Facility Registration
October 16:FDA issued guidance establishing a U.S. Agent Voluntary Identification System (VIS) for use in conjunction with its food facility registration database, the Food Facility Registration Module (FFRM). Under the Federal Food, Drug and Cosmetics Act (FD&C Act), all foreign food facilities registered with FDA are required to have “a U.S. Agent who acts as a communications link with FDA,” according to the agency’s Constituent Update. The newly established VIS is intended to “streamline and expedite” this required verification process for registered foreign food facilities.

Specifically, the VIS and the FFRM will allow the U.S. agents acting as communications links with foreign food facilities “to independently identify the facility or facilities they are representing.” The agents will be given an identification number that the facilities may use during the registration process. Then, “[w]hen a foreign facility uses a U.S. agent identification number in accordance with the VIS and the name of the facility matches the facility name and address the U.S. agent has identified, FDA will consider that verification without taking any additional steps to verify the U.S. agent—thus facilitating the process of providing a food facility registration number.”

Read FDA’s Constituent Update here and access the guidance here. 

FDA Launches Pilot Program to Evaluate Third-Party Food Safety Standards
October 23:FDA launched a voluntary pilot program that will “evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations under the FDA Food Safety Modernization Act (FSMA) - the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.”

According to the agency’s Constituent Update, the pilot program will support FDA’s goal of exploring “how reliable third-party audits can help ensure food safety” under the New Era of Smarter Food Safety Blueprint. Because “[b]uyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product,” any determinations that these third-party audits’ safety standards align with FSMA regulations “would give those relying on audits…confidence that they are meeting certain FDA requirements for supplier verification audits.”

Under the year-long pilot running until October 26, 2021, FDA will assess “up to five third-party food safety standards for alignment with the requirements in the PC Human Food and/or Produce Safety rules.” The agency will evaluate the pilot program on multiple factors, including “the resources required to review and assess third-party standards for alignment with relevant FDA regulations, the ability of pilot participants to provide adequate information to enable FDA to make a determination of alignment, and whether FDA Audit Comparison Templates are a helpful tool in making alignment determinations.”

Members of the public, including owners of third-party human food safety standards, must submit their request to participate in the pilot program by November 25, 2020.

Read FDA’s Constituent Update here and Federal Register Notice here.

USDA-FSIS Announces Final Rule on Egg Products Inspection Regulations
October 29:USDA-FSIS announced a final rule amending its egg products inspection regulations “to require official plants that process egg products…to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with FSIS's meat and poultry regulations.”

According to the agency’s Federal Register Notice, the final rule’s “less burdensome regulations” will increase the efficiency of egg product processing because the “HACCP system allows greater flexibility for producers to realize increased production efficiency” and because the final rule permits plants to use different pasteurization methods. “By operating under the HACCP system alone, egg products plants can use plant resources in a more efficient manner while controlling for hazards in innovative ways in their HACCP plans.”

The final rule’s specific details and requirements for HACCP Systems and Sanitation SOPs are provided in the Notice. The rule will take effect December 28, 2020.

Read USDA-FSIS’s Federal Register Notice here.

USDA-FSIS Releases Foodborne Illness Outbreak Investigation Summary Reports for FY 2017-2019
October 30: USDA-FSIS posted an overview of its outbreak investigation process and summaries of its outbreak investigations for fiscal years (FY) 2017, 2018, and 2019 on its website.

According to the agency’s Constituent Update, the outbreak investigation overview “provides information about how FSIS is notified about outbreaks, the types of information FSIS evaluates to help inform Agency actions, and how FSIS captures and applies outbreak lessons learned.” Meanwhile, the three annual outbreak reports “summarize information about outbreaks investigated during each FY, including the number of outbreaks, pathogens, products, illnesses, and how many outbreaks resulted in a product recall.”

Read USDA-FSIS’s Constituent Update here and access the reports here.

USDA UPDATES

USDA and Office of U.S. Trade Representative Release Report on U.S.-China Agricultural Trade
October 23: The Office of the U.S. Trade Representative (USTR) and USDA jointly issued a report on the progress of the agricultural provisions of the U.S.-China Phase One Economic and Trade Agreement, which President Trump signed on January 15, 2020.

As of October 23, China had “implemented at least 50 of the 57 technical commitments under the Phase One Agreement” and “purchased over $23 billion in agricultural products, approximately 71% of its target under the Phase One Agreement,” according to USDA’s Press Release. The report also includes trade updates on exports of corn, soybeans, sorghum, pork, beef, pet food, alfalfa hay, pecans, peanuts, prepared foods, and other U.S. agricultural products to China.

“This agreement finally levels the playing field for U.S. agriculture and is a bonanza for America’s farmers, ranchers, and producers…Being able to participate in this market in a more fair and equitable way has generated more sales that are supporting higher prices and strengthening the rural economy,” U.S. Secretary of Agriculture Sonny Perdue said of the Phase One Agreement.

Read USDA-FSIS’s Press Release here and read the report here (PDF).

USDA Announces Early Release of Select Commodity Tables for Agricultural Projections to 2030
October 26:USDA will release select commodity tables prepared for the upcoming “USDA Agricultural Projections to 2030” report on November 6, 2020 at 3:00 PM ET. (The complete report will be released in February 2021.) The select tables posted early will contain “long-term supply, use, and price projections to 2030 for major U.S. crops and livestock products, as well as supporting U.S. and international macroeconomic assumptions,” according to the agency’s Press Release. They will be posted in MS Excel format to both the Office of the Chief Economist’s (OCE) website and the Economic Research Service’s (ERS) website.

These agricultural projections “represent a departmental consensus on a ten-year representative scenario for the agricultural sector” and are “a composite of model results and judgment-based analyses, prepared from August 2020 through February 2021.” The projections are based on assumptions about “macroeconomic conditions, policy, weather, and international developments, with no domestic or external shocks to global agricultural markets.”

Read USDA’s Press Release here. Visit the Office of the Chief Economist’s (OCE) website here and the Economic Research Service’s (ERS) website here.