October 2020 Regulatory Update | 1 of 2

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

This Regulatory Update includes information from October 1 – October 15, 2020. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business.

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FDA UPDATES

  • FDA Issues Request for Information on Labeling of Food Made with Cultured Seafood Cells MUST READ

  • FDA Updates Employee Health and Personal Hygiene Handbook MUST READ

  • FDA Issues Warnings to Companies Illegally Selling Dietary Supplements with Cesium Chloride MUST READ

  • FDA and Mexico Sign Statement of Intent to Strengthen Food Safety Partnership

  • CDC Announces End to Salmonella Newport Outbreak Linked to Red Onions; FDA Updates Its Investigation

USDA UPDATES

  • USDA-FSIS Updates Guides and Models for Hazard Analysis, Sanitation Procedures, Swine Slaughter, and More MUST READ

  • USDA-AMS Closes Comment Period for Proposed Rule to Amend Organic Regulations MUST READ

  • USDA Launches New Process for Private Lenders to Invest in Rural Communities

UPCOMING MEETINGS & CONFERENCES

  • October 26 (3:00 – 4:00 PM EST): Webinar to review highlights of the first 100 days since FDA issued its New Era of Smarter Food Safety Blueprint, hosted by FDA. Register by October 22 (5 PM EST) here.

  • November 6 (8:30 AM – 4:30 PM EST): First virtual public meeting to discuss proposed rule “Requirements for Additional Traceability Records for Certain Foods,” hosted by FDA. Register by October 28 here and 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.

FDA UPDATES

FDA Issues Request for Information on Labeling of Food Made with Cultured Seafood Cells
October 6:With domestic and foreign companies rapidly developing products using animal cell culture technology, FDA issued a Request for Information (RFI) to determine how to label such foods properly. Its RFI specifically seeks data and other evidence “about names or statements of identity for foods made with cultured seafood cells,” according to the agency’s Constituent Update.

FDA and USDA have agreed to jointly regulate the production of food products derived from cultured livestock and poultry cells, with FDA regulating the products derived from the cells of species under its jurisdiction, including most seafood expect catfish. “The labeling of food derived from cultured seafood cells generally falls under the jurisdiction of the FDA while the labeling of food derived from cultured meat and poultry cells will be overseen by the USDA.”

Submit comments for consideration to the RFI Federal Register Notice by March 8, 2021.

Read FDA’s Constituent Update here and the RFI here.

 

FDA Updates Employee Health and Personal Hygiene Handbook
October 7:FDA released an updated version of its Employee Health and Personal Hygiene Handbook for retail food managers and employees. The handbook, which features best practices for preventing the spread of bacteria and viruses in food establishments, was revised to include updates from the most current full edition 2017 Food Code. Though it does not specifically address COVID-19, the handbook “emphasizes long-standing public health principles for preventing disease transmission – hand washing; excluding ill employees from the workplace, prohibiting bare-hand contact with ready-to-eat foods; and reporting of illness and symptoms, among others,” according to FDA’s Constituent Update.

Read FDA’s Constituent Update here and access the updated handbook here.

 

FDA Issues Warnings to Companies Illegally Selling Dietary Supplements with Cesium Chloride
October 13:FDA sent warning letters to five companies found illegally marketing and selling dietary supplements that contained cesium chloride. In July 2018, the agency moved cesium chloride to its category of substances that present significant safety risks in compounding, warning health care professionals of the safety risks associated with cesium chloride in compounded drugs. In February 2020, it issued a Public Health Alert to warn consumers about the significant safety risks of cesium chloride and other cesium salts, including heart toxicity and potential death.

According to FDA, because cesium chloride “has not previously been present in the food supply in a non-chemically altered form… firms must provide certain safety-related information about the ingredient to the FDA before including it in a dietary supplement. Companies marketing these products have not met this requirement, and as a result, their products cannot be legally marketed.” The five companies that received the warning letters – American Nutriceuticals, LLC; Complete H2O Minerals, Inc.; Daily Manufacturing, Inc.; Elemental Research, Inc. and The Mineral Store, Inc.; and Essence-of-Life, LLC – were given 15 working days to respond with their plans for correcting the violations.

Read FDA’s News Release here, its July 2018 Public Health Alert here, and its February 2020 Public Health Alert here.

 

FDA and Mexico Sign Statement of Intent to Strengthen Food Safety Partnership
October 5: In a virtual ceremony, FDA and its two regulatory counterparts in Mexico commemorated the signing of a Statement of Intent (SOI) to “broaden…and strengthen…the scope of the existing Produce Safety Partnership SOI, signed in 2014,” which focused solely on the safety or produce traded between the two countries, according to FDA’s Constituent Update. The enhanced partnership, now referred to as the Food Safety Partnership, will expand its focus from produce safety to the safety of all FDA-regulated human food that is traded between Mexico and the US.

The Food Safety Partnership will strengthen the three agencies’ collaboration on four priority areas: the prevention of foodborne illness outbreaks, outbreak response, regulatory laboratory collaboration, and outreach and training opportunities for industry. The significance of this expanded partnership reflects the high volume of food trade between the US and Mexico: “about a third of all imported food into the United States is from Mexico and 60% of all imported produce is from Mexico.”

Read FDA’s Constituent Update here and News Release here.

 

CDC Announces End to Salmonella Newport Outbreak Linked to Red Onions; FDA Updates its Investigation
October 8:As of this date, CDC declared the multistate outbreak of Salmonella Newport infections linked to contaminated red onions over. Though FDA concluded its traceback portion of the investigation in identifying Thomson International, Inc. of Bakersfield, California as the likely source of the contaminated red onions, FDA’s root cause investigation was ongoing as of that date.

In its Investigation Update, FDA warned that “recalled products should no longer be available in stores, but onions have a long shelf-life and recalled products could still be in consumer’s homes or in restaurants, especially if recalled products were frozen.” It provided recommendations for consumers, restaurants, retailers, suppliers, and distributors to prevent cross contamination and the distribution of contaminated onions.

Read FDA’s Investigation Update here and initial news on the outbreak in our August 2020 (Part 1) Regulatory Update here.


USDA UPDATES

USDA-FSIS Updates Guides and Models for Hazard Analysis, Sanitation Procedures, Swine Slaughter, and More
October 2:USDA-FSIS updated its Hazard Analysis and Critical Control Point (HACCP) guide and three generic HACCP models, in addition to developing a new Sanitation Standard Operating Procedures (SSOP) guide. The revisions include “updated scientific references and footnotes containing explanatory guidance and links to related sources of information,” according to the agency’s Constituent Update. “The guides and the models are intended to assist establishments,” including “small and very small plants that need to develop their first HACCP plan…Businesses that are seeking a federal grant of inspection to operate a meat or poultry establishment…[and] Existing establishments that need to create a new HACCP plan or that need guidance when performing a HACCP plan reassessment,” with meeting regulatory requirements.

The revised Guideline for the Preparation of HACCP Plans details the process of developing an HACCP plan and includes templates and links to additional reference materials. The three revised generic models now available – the Swine Slaughter (traditional), New Poultry Inspection System (NPIS), and Raw Non-Intact Pork Sausage HACCP models – serve as an example of how to meet food safety regulatory requirements. Finally, the new Sanitation Standard Operating Procedures Model “provides an overview of the SSOP requirements, a SSOP model, and procedures for pre-operational and operational sanitation, sanitation information for establishment grounds and facilities, and sanitations forms.”

Read USDA-FSIS’s Constituent Update here and access the new and revised materials here.

 

USDA-AMS Closes Comment Period for Proposed Rule to Amend Organic Regulations
October 5:The comment period for USDA’s proposed rule to amend organic regulations for strengthened oversight closed on this date (“National Organic Program; Strengthening Organic Enforcement,” 85 Fed. Reg. 47536). According to USDA’s Agricultural Marketing Service (USDA-AMS), the proposed amendments  would “protect integrity in the organic supply chain and build consumer and industry trust in the USDA organic label by strengthening organic control systems, improving farm to market traceability, and providing robust enforcement of the USDA organic regulations.” The proposed rule constitutes a response to industry stakeholders’ continuous calls for increased oversight and enforcement by USDA’s National Organic Program (NOP) amidst concerns about the fraudulent mislabeling, marketing, and sale of non-organic products as organic.

The proposed amendments would strengthen enforcement of USDA’s organic regulations through various acts mandated by the Agriculture Improvement Act of 2018, including (1) “Reduc[ing] the types of uncertified entities in the organic supply chain that operate without USDA oversight, (2) “Requir[ing] the use of NOP Import Certificates, or equivalent data, for all organic products entering the United States,” and (3) “Clarify[ing] the NOP's authority to oversee certification activities, including the authority to act against an agent or office of a certifying agent.”

Between August 5 and October 5, the proposed changes drew 1,511 formal comments from industry stakeholders, including such major players as the Organic Trade Association (OTA), which represents 9,500 organic growers in 50 states; the Produce Marketing Association; the United Fresh Produce Association; Western Growers; and the National Farmers Union (NFU). Based on these comments, the organic community broadly appears to support USDA’s advancement to the final rule writing phase.

Read the proposed rule here and USDA-AMS’s summary of the proposed rule here.

 

USDA Launches New Process for Private Lenders to Invest in Rural Communities
October 1:USDA announced the new OneRD Guarantee Loan Initiative, under which the agency “officially eliminated duplicative processes and…launched a common loan guarantee application” for its four key loan guarantee programs: the Water and Waste Disposal Loan Guarantee Program; Community Facilities Guaranteed Loan Program; Business and Industry Guaranteed Loan Program; and Rural Energy for America Guaranteed Loan Program.

Through the OneRD Guarantee Loan Initiative, USDA “standardized requirements for credit reviews, loan processing, loan servicing and loss claims…[to] make the application process simpler and faster for lenders” seeking to invest in rural communities. USDA also will automatically approve program participation for lenders in good standing who are supervised or created by state or federal regulatory agencies.

Read USDA’s Press Release here and its July 2020 final rule to increase private investment in rural communities here. Learn about the OneRD Guarantee Loan Initiative here.

 

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