June 2021 Regulatory Update | 2 of 2
These Regulatory Updates are brought to you by Michael Best & Friedrich. 
This Regulatory Update includes information from June 18-30, 2021. 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.
 

FDA UPDATES

  • FDA Releases List of Priority Guidance Topics for Next 12 Months MUST READ

  • FDA Provides Update on Sampling and Testing of Per- & Polyfluoroalkyl Substances (PFAS) in Food Supply

  • FDA’s Salmonella Weltevreden Outbreak Investigation Is Ongoing

FDA WARNING LETTERS (JUNE)

  • FDA Sends Warning Letter to Market of Choice, LLC for Violation of CGMP & PC Rule

  • FDA Sends Warning Letter to Jaramillo Spices Corp. for Foreign Supplier Verification Program (FSVP) Violation

  • FDA Sends Warning Letter to Tuty USA LLC for Foreign Supplier Verification Program (FSVP) Violation

USDA RULEMAKING

  • USDA-AMS Revises Standards for Split Peas and Lentils

  • USDA to Begin Rulemaking on Interpretation of the Organic Livestock and Poultry Practices (OLPP) Final Rule MUST READ

  • USDA-AMS Amends List of Allowed and Prohibited Substances for Its Organic Regulations MUST READ

USDA UPDATES

  • USDA Makes $55.2 Million in Funding Available through New Grant Program MUST READ

  • USDA Releases Study on Hurdles to Healthy Eating for SNAP Recipients

OTHER DEVELOPMENTS

  • State Legislatures Introduced Almost 400 of Food and Food Safety Bills During 2021


FDA UPDATES 

 

FDA Releases List of Priority Guidance Topics for Next 12 Months
June 29: FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics the completion of which will be prioritized over the next 12 months. The list focuses on Level 1 guidances, which “set forth the agency’s initial interpretations of new significant regulatory requirements; describe substantial changes in FDA’s earlier interpretation or policy; and deal with complex scientific or highly controversial issues,” according to the agency’s fact sheet on good guidance practices.

FDA’s list currently contains 25 anticipated guidance topics within the categories of allergens, dietary supplements, food additives, food safety, FSMA, labeling, and nutrition. Upcoming guidances will address lead action levels for baby foods, Listeria monocytogenes in human food, and labeling of plant-based milk alternatives.

The agency also announced that going forward, it will release a list of anticipated human food and cosmetic guidance topics at the beginning of each calendar year and will release scheduled updates mid-year.

Read FDA’s Constituent Update here, its list of priority guidance topics here, and its fact sheet on good guidance practices here.

 

FDA Provides Update on Sampling and Testing of Per- & Polyfluoroalkyl Substances (PFAS) in Food Supply
June 30: FDA released an update on its ongoing efforts to understand the occurrence of per- and polyfluoroalkyl substances (PFAS) – human-made chemicals that have been used in stain- and water-resistant fabrics and carpeting, cleaning products, paints, fire-fighting foams, cookware, food packaging, and food processing equipment since the 1940s – in the food supply.

First, the agency shared the results of recent testing for certain PFAS in foods from the general food supply. The foods tested were collected for the Total Diet Study (TDS), which monitors nutrient and contaminant levels in foods commonly eaten by people in the U.S.  According to FDA’s Constituent Update, the agency found that “all but one of the 94 food samples did not have detectable levels of PFAS.” A sample of cod, which did contain PFAS, did not appear to contain PFAS at levels presenting a human health concern.

Second, FDA shared that it had detected PFAS in three seafood samples from three TDS regional collections. Accordingly, the agency has launched a targeted survey of the most commonly consumed seafood in the U.S., which will “collect and analyze 80 retail seafood samples including shrimp, salmon, canned tuna, tilapia, pollock, cod, crab, and clams.”

Third, FDA shared that it recently had begun to use both EPA’s new PFAS reference dose and the finalized PFAS minimal risk levels (MRLs) from the Agency for Toxic Substances and Disease Registry in its evaluations of the safety of exposure to certain PFAS in foods.

Read FDA’s Constituent Update here and News Release here. Read about the TDS here.

 

FDA’s Salmonella Weltevreden Outbreak Investigation Is Ongoing
As of June 30, 2021, FDA’s investigation of a multistate outbreak of Salmonella Weltevreden infections, associated with six total illnesses and two hospitalizations, was ongoing. Traceback evidence linked the outbreak to the consumption of frozen cooked shrimp manufactured by Avanti Frozen Foods of India. On June 25, 2021, the firm recalled certain frozen cooked, peeled, and deveined shrimp products imported into the U.S. from December 2020 to February 2021.

FDA is working with Avanti Frozen Foods to determine if additional shrimp products need to be recalled. According to the agency’s Outbreak Investigation update, “Consumers, restaurants, and retailers should not eat, sell, or serve recalled shrimp from Avanti Frozen Foods. These products were sold under different names and package sizes and are listed on the FDA recall page so the public can identify the products and discard them if they are in consumers’ homes. Consumers, restaurants, retailers, and distributors should check their refrigerators and freezers and should throw away any recalled shrimp.”

Read FDA’s Outbreak Investigation update here.


 

FDA WARNING LETTERS (JUNE)

FDA Sends Warning Letter to Market of Choice, LLC for Violation of CGMP & PC Rule
June 1: FDA sent a warning letter to Oregon-based food manufacturer Market of Choice, LLC for its “serious” violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule). After a Class 1 recall of the firm’s Sour Cherry Baked Brie for its failure to declare a tree nut (almond) allergen, FDA inspected the firm’s manufacturing facility in December and January 2021. Thereafter, the agency received a summary of corrective actions and taken and planned by the firm. The agency responded to the firm’s corrective actions as follows.

First, FDA declared that Market of Choice had not submitted “a revised hazard analysis showing that the hazard of undeclared allergens [specifically almonds] requires a preventive control in [the firm’s] allergen-containing products.” Furthermore, the agency stated that the firm’s “New Product Label Verification Checklist,” submitted after FDA’s January 2021 inspection, “does not appear to address the root cause of the recall – failure to make electronic allergen labeling revisions after reformulations that add or change the allergens in a product.”

Second, FDA claimed that the firm had not, as promised, updated the agency on its corrective actions for environmental monitoring of contamination with environmental pathogens, including Listeria monocytogenes and Salmonella, in its ready-to-eat (RTE) salads. Additionally, the firm had not submitted “a revised hazard analysis showing that the hazard of contamination with environmental pathogens requires a preventive control for [its] RTE products exposed to the environment prior to packaging.”

FDA gave Market of Choice, LLC 15 working days from its receipt of the letter to address its violations.

Read FDA’s warning letter here.

 

FDA Sends Warning Letter to Jaramillo Spices Corp. for Foreign Supplier Verification Program (FSVP) Violation
June 8: FDA sent a warning letter to Texas-based food importer Jaramillo Spices Corp. for its “significant” violations of the Foreign Supplier Verification Program (FSVP) regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the importer had failed to develop, maintain, and follow FSVPs for any of its imported foods, including its imported fresh tamarind, black beans, and vanilla flavoring. Furthermore, the firm had failed to make any corrections to its FSVP violations, which FDA had noted at its initial FSVP inspection in November 2018 and at its follow-up inspection in April 2021.

FDA gave Jaramillo Spices Corp 15 working days from its receipt of the letter to address its violations.

Read FDA’s warning letter here. Read the FSVP final rule here and learn more about it here.

 

FDA Sends Warning Letter to Tuty USA LLC for Foreign Supplier Verification Program (FSVP) Violation
June 9: FDA sent a warning letter to Texas-based food importer Tuty USA LLC for its “significant” violations of the Foreign Supplier Verification Program (FSVP) regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the importer had failed to develop, maintain, and follow FSVPs for any of its imported foods, including its imported wheat snacks, Japanese peanuts, and Blackberry Tartlet Cookies. Furthermore, the firm’s certificates of analysis for its “Japanese Style Peanut” and “Snacks Tuty,” sent in response to FDA’s April 2021 investigation, did not constitute FSVPs under the FD&C Act.

FDA gave Tuty USA LLC 15 working days from its receipt of the letter to address its violations.

Read FDA’s warning letter here. Read the FSVP final rule here and learn more about it here.


USDA RULEMAKING

USDA-AMS Revises Standards for Split Peas and Lentils
June 15: In response to stakeholder input, USDA’s Agricultural Marketing Service (USDA-AMS) revised its methods of interpretation for the determination of whole peas in the U.S. Standards for Split Peas and for the determination of the special grade “Green” in the U.S. Standards for Lentils. The U.S. Standards for whole dry peas, split peas, feed peas, lentils, and beans, which previously appeared in the Code of Federal Regulations, are now maintained by USDA-AMS-Federal Grain Inspection Service (AMS-FGIS).

First, AMS-FGIS revised its split pea inspection criteria by increasing the percent needed for a split pea to be considered a whole pea from 55 percent or more to 60 percent or more.

Second, AMS-FGIS revised the definition for the special grade
“Green” in lentils, amending the Standards for Lentils to include the definition of “Green Lentils” as “Clear seeded (green) lentils possessing a natural, uniformly green color.” The agency also revised its lentil inspection criteria to include the following instruction regarding the special grade “Green”: “The portion size of approximately 60 grams for small seeded lentils and 125 grams for large seeded lentils must contain less than 0.5 percent lentils with mottling and be free of any lentils of contrasting color, before the removal of defects, and must be equal to or better than depicted on the Interpretive Line Print after the removal of dockage.”

Read USDA-AMS’s Federal Register Notice on split peas here and on lentils here.

 

USDA to Begin Rulemaking on Interpretation of the Organic Livestock and Poultry Practices (OLPP) Final Rule
June 17: USDA announced its plans to draft regulation establishing the agency’s interpretation of the Organic Foods Production Act. According to the agency’s Press Release, USDA intends to reconsider the Trump Administration’s interpretation of the act as not authorizing USDA “to regulate the practices that were the subject of the 2017 Organic Livestock and Poultry Practices (OLPP) final rule.” The proposed rulemaking will also include “a proposal to disallow the use of porches as outdoor space in organic production over time.”

USDA anticipates sending the proposed rule to the Office of Management and Budget (OMB) within six to nine months.    

Read USDA’s Press Release here.

 

USDA-AMS Amends List of Allowed and Prohibited Substances for Its Organic Regulations
June 25: USDA’s Agricultural Marketing Service (USDA-AMS) issued a final rule amending the “National List of Allowed and Prohibited Substances” (National List) section of the agency’s organic regulations. The amendment implements recommendations submitted by the National Organic Standards Board (NOSB).

Specifically, the final rule adds the following substances to the National List of allowed substances for use in organic livestock production or handling: oxalic acid for use as a beekeeping pesticide against Varroa mites; pullalan for use in organic handling in products labeled “Made with organic [specified ingredients or food group(s)]”; and nonorganic collagen gel for use as a sausage casing when organic forms are commercially unavailable.

Effective July 26, 2021, “producers and handlers of organic products will be allowed to use these substances in organic production and in organic products.”

Read USDA-AMS’s final rule here.


 

USDA UPDATES

 

SDA Makes $55.2 Million in Funding Available through New Grant Program
June 21: USDA announced that it was making available $55.2 million in competitive grant funding through its new Meat and Poultry Inspection Readiness Grant (MPIRG) program, which is funded by the Consolidated Appropriations Act of 2021.

MPIRG’s Planning for a Federal Grant of Inspection (PFGI) project is open to processing facilities that are currently in operation and working toward Federal inspection; applicants can be located anywhere in the states and territories. Meanwhile, MPIRG’s Cooperative Interstate Shipment (CIS) Compliance project is open only to processing facilities located in states with a Food Safety and Inspection Service (FSIS) CIS program, i.e. Indiana, Iowa, Maine, Missouri, North Dakota, Ohio, South Dakota, Vermont, and Wisconsin. Applicants for the CIS Compliance project “must be working toward CIS program compliance requirements to operate a state-inspected facility or make a good faith effort toward doing so,” according to USDA’s Press Release.

USDA encourages eligible meat and poultry slaughter and processing facilities to submit applications focused on “improving meat and poultry slaughter and processing capacity and efficiency; developing new and expanding existing markets; increasing capacity and better meeting consumer and producer demand; maintaining strong inspection and food safety standards; obtaining a larger commercial presence; and increasing access to slaughter or processing facilities for smaller farms and ranches, new and beginning farmers and ranchers, socially disadvantaged producers, and veteran producers.”

Applications must be submitted through www.grants.gov by 11:59 p.m. Eastern Time on Monday, August 2, 2021.

Read USDA’s Press Release here.

 

USDA Releases Study on Hurdles to Healthy Eating for SNAP Recipients
June 23: USDA released the results of a 2018 study that found that 88% of participants in the Supplemental Nutrition Assistance Program (SNAP) faced barriers to providing their households with a healthy diet (“Barriers that Constrain the Adequacy of Supplemental Nutrition Assistance Program (SNAP) Allotments”). Close to 42 million Americans currently rely on SNAP benefits every month.

According to the study, the most common challenge to eating a healthy diet, reported by 61% of SNAP participants, is the cost of healthy foods. “Other barriers,” USDA’s Press Release noted, “range from a lack of time to prepare meals from scratch (30%) to the need for transportation to the grocery store (19%) to no storage for fresh or cooked foods (14%).”

Read USDA’s Press Release here and access the study here


 

OTHER DEVELOPMENTS

 

State Legislatures Introduced Almost 400 Food and Food Safety Bills During 2021
June 28: In an article written for Food Safety News, Doug Farquhar, JD, director of the Government Affairs department of the National Environmental Health Association (NEHA), shared a survey of food- and food safety-related bills introduced during the 2021 legislative sections. NEHA tracked 382 bills regarding food in 36 states. Of those bills, the main issues were cottage foods and food freedom (12 bills); meat (9 bills); COVID-19 and food (4 bills); food deserts (4 bills); cannabis in food (3 bills);  food delivery (3 bills); the Supplemental Nutrition Assistance Program (SNAP) (2 bills); micro-markets (1 bill); and raw milk (1 bill).

 

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