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

This Regulatory Update includes information from July 10 – 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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COVID-19 DEVELOPMENTS

  • FDA Announces COVID-19 Risk-Assessment System in Preparation for Resumed Domestic Inspections MUST READ
  • FDA Summarizes CDC Recommendations for Food and Agriculture Employers MUST READ
  • OSHA Files Motion to Dismiss Meatpacking Employees’ Lawsuit Over Imminent Danger Complaint

INDUSTRY GUIDANCE

  • FDA Submits Draft CBD Guidance to White House OMB MUST READ
  • FDA Announces Final Rule on Use of Vitamin D2 Mushroom Powder
  • FDA Issues Final Compliance Policy Guide on Using the Seafood List 
  • FDA Announces New Protocol for Treating Preharvest Agricultural Water

FDA UPDATES

  • Inspections Under FSMA Intentional Adulteration Rule to Begin March 2021 MUST READ
  • FDA Releases Blueprint for New Era of Smarter Food Safety MUST READ
  • FDA Publishes FY2021 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program
  • FDA Announces Qualified Health Claim Regarding Cranberry Products and UTIs
  • FDA Launches Grade “A” Milk Search (GAMS) System

USDA UPDATES

  • USDA Publishes 2020 Dietary Guidelines Advisory Committee’s Scientific Report MUST READ
  • USDA-FSIS and FDA Launch Joint Webinar on Cultured Animal Cell Products MUST READ
  • USDA Updates Farmers.gov Website to Facilitate H-2A Employee Hiring
  • USDA-FSIS to Regulate Avian Leukosis as “Trimmable Condition”

COVID-19 DEVELOPMENTS

FDA Announces COVID-19 Risk Assessment System in Preparation for Resumed Domestic Inspections
July 10: FDA Commissioner Stephen M. Hahn, M.D, announced the development of the COVID-19 Advisory Rating System (COVID-19 Advisory Level), which “uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data” to help investigators determine “when and where it is safest to conduct prioritized domestic inspections.” FDA made the Advisory Level data available to state partners contracted to conduct inspections of FDA-regulated entities.

Commissioner Hahn also announced the goal of resuming on-site inspections during the week of July 20 and stated that “for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses.”

Read Commissioner Hahn’s statement here.

 

FDA Summarizes CDC Recommendations for Food and Agriculture Employers
July 17: FDA released an overview of recommendations from the Centers for Disease Control and Prevention (CDC), outlining “key steps that employers and workers can take to help prevent and slow the spread of COVID-19 and support continuity of essential operations if workers are diagnosed with, or exposed to, COVID-19, or show symptoms associated with COVID-19.”

FDA’s overview, which includes links to resources and guidance documents from CDC and the Occupational Safety and Health Administration (OSHA), summarizes CDC recommendations for continuity of operations when employees exhibit COVID-19 symptoms, test positive for COVID-19, and potentially have been exposed to COVID-19.

Read FDA’s summary here.

 

OSHA Files Motion to Dismiss Meatpacking Employees’ Lawsuit Over Imminent Danger Complaint
July 28: On July 23, a group of unnamed employees at a Pennsylvania meatpacking plant and the nonprofit Justice at Work sued the Occupational Safety and Health Administration (OSHA), alleging that the agency’s inadequate response to complaints about plant working conditions left employees in “imminent danger” from COVID-19. (Jane Does I, II, III et al. v. Eugene Scalia et al., case number 3:20-cv-01260.)

The employees filed formal complaints about conditions at the Maid-Rite Specialty Foods factory with OSHA in May 2020, claiming that the company had not provided adequate protective gear, imposed social distancing on the processing lines, separated sick employees, or informed employees in close contact with sick employees of the infections. In their lawsuit, they accused OSHA of not adequately responding to these complaints – specifically an “imminent danger” complaint, which would require OSHA either to order an inspection or notify employees that there are no reasonable grounds to believe that a danger exists.

OSHA filed a motion to dismiss the case on July 28, claiming that an inspector who had visited the Maid-Rite plant had not found an imminent danger and arguing that “because OSHA has concluded that there is no imminent danger — and thus has made no recommendation that the secretary correct such a danger — there is no secretarial rejection of a recommendation for this court to review." A judge was scheduled to hear arguments in Scranton, Pennsylvania on July 31, 2020.

The lawsuit was one of multiple filed between May and July 2020 attempting to compel OSHA to enforce COVID-19 worker protections more strictly. Throughout the pandemic, employees, labor advocates, and former OSHA officials have criticized OSHA for its response to workplace safety issues. As of mid-July 2020, the agency had declined to issue emergency regulations to enforce national COVID-19 work safety standards, instead arguing that its existing regulations and updated guidelines were sufficient to protect workers.


INDUSTRY GUIDANCE

FDA Submits Draft CBD Guidance to White House OMB
July 22: In a move that inspired hopes for forthcoming clarity on federal hemp oversight, FDA sent its proposed "Cannabidiol Enforcement Policy" and draft industry guidance on regulating the CBD market to the White House Office of Management and Budget (OMB) for approval. Whether OMB will approve the public release of the unpublished guidance is unknown.

OMB announced receipt of FDA’s proposed guidance shortly after FDA released a draft guidance on “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry.” The draft guidance “covers sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating tetrahydrocannabinol (THC) levels,” according to FDA’s July 21 announcement. Notably, the guidance also recognizes the limited usefulness of the legal definition of hemp (which has less than 0.3% THC on a dry-weight basis) post-extraction and -processing

Hemp industry members will be watching for updates on FDA’s stance toward CBD dietary supplements and CBD dosage thresholds. FDA has not yet released regulations on the use of CBD as a dietary supplement. In November 2020, it denied CBD the status of “generally recognized as safe,” and it has stated that marketing CBD as an additive in foods or as a dietary supplement is illegal since March 2020.

Read FDA’s announcement on “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry” here and access it here. Read Michael Best’s Client Alert on the draft guidance here.

 

FDA Announces Final Rule on Use of Vitamin D2 Mushroom Powder
July 13: FDA amended its food additive regulations “to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories” in a final rule effective July 13, 2020 (85 FR 41916).

FDA granted Oakshire Natural, LP’s petition proposing an amendment to the food additive regulations in part 172 (21 CFR part 172), Food Additives Permitted for Direct Addition to Food for Human Consumption. The agency concluded that “there is a reasonable certainty that no harm will result from the uses of vitamin D2 mushroom powder, produced using UV light treatment, as a source of vitamin D2” in various food categories described in the final rule.

Read the final rule here.

 

FDA Issues Final Compliance Policy Guide on Using the Seafood List
July 14: FDA issued a final Compliance Policy Guide (CPG) on the “Use of The Seafood List to Determine Acceptable Seafood Names.” The Seafood List is FDA’s September 1993 guidance for industry, formally titled “FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce” (revised January 2009, November 2010, and July 2012). This new CPG, which FDA said should be used with the Seafood List to determine acceptable market names for seafood, “finalizes a draft CPG issued in November 2016.”

Read FDA’s Constituent Update here, its Federal Register Notice here, and the Seafood List here.

 

FDA Announces New Protocol for Treating Preharvest Agricultural Water
July 30: FDA announced a new protocol created jointly with the U.S. Environmental Protection Agency (EPA) “for the development and registration of antimicrobial treatments for preharvest agricultural water,” according to FDA’s Constituent Update. The agency made the announcement during its webinar on the 2020 Leafy Greens STEC Action Plan, which delineates FDA’s steps for advancing work on prevention, response, and addressing knowledge gaps about the safety of leafy greens. The action fulfilled one of the plan’s action items.

FDA scientists and EPA subject matter experts developed the testing protocol to address the current lack of “registered antimicrobial treatment products that are authorized to control microorganisms…for use on agricultural fields, or for treatment of irrigation water systems or ponds.” Companies may use the protocol to “develop data on the effectiveness of their products in inactivating pathogens…in preharvest agricultural water,” which may support the registration of “new treatment products, or amendments to current products’ labels, for use against foodborne pathogens in preharvest agricultural water.”

Read FDA’s Constituent Update here. Read the 2020 Leafy Greens STEC Action Plan here (PDF) and our explanation of the action plan in the March 2020 Regulatory Update here.


FDA UPDATES

Inspections Under FSMA Intentional Adulteration Rule to Begin March 2021
July 15: FDA announced that “routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule” will begin in March 2021.

The FSMA IA rule, finalized in 2016, “address[es] hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide scale public health harm,” according to FDA’s Constituent Update. Food facilities covered by the rule must “develop and implement a food defense plan that identifies vulnerabilities and puts in place mitigation strategies to address those vulnerabilities.” July 27, 2020 is the compliance date for small businesses (those with fewer than 500 employees).

The COVID-19 pandemic led FDA to postpone most of its routine IA rule inspections of large businesses, which had been set for March 2020 “following a compliance date of July 2019.” The agency scheduled its small business inspections for March 2021 to “help facilitate industry’s continuing efforts to put in place measures that will protect public health while allowing the FDA additional time to conduct outreach to stakeholders.” When routine IA rule inspections begin, they will consist of food defense plan “quick checks,” which “allow FDA to verify that the facility has satisfied the basic requirements of the rule.”

Read FDA’s Constituent Update here and learn more about food defense plans, the upcoming compliance date, and draft guidance in an updated conversation piece featuring FDA food defense experts Ryan Newkirk and Jon Woody here.

 

FDA Releases Blueprint for New Era of Smarter Food Safety
July 13: After delaying a planned March 2020 release due to the nascent COVID-19 pandemic, FDA Commissioner Stephen M. Hahn, M.D., reported the availability of FDA’s “New Era of Smarter Food Safety Blueprint,” which was announced as part of the New Era of Smarter Food Safety initiative.

The blueprint has four core elements, each of which has a designated implementation team led by senior FDA leaders. These elements are 1. “Tech-Enabled Traceability” (a focus on providing “greater supply chain visibility” and preventing “temporary shortages of certain commodities and…food waste”); 2. “Smarter Tools and Approaches for Prevention and Outbreak Response” (a focus on using predictive analytics, root cause analyses, artificial intelligence, and machine learning); 3. “New Business Models and Retail Modernization (a focus on using “novel ways of producing foods and ingredients” and “new digital tools that will support food safety practices”); and (4) “A New Culture of Food Safety” (a focus on “strengthening the food safety culture on farms and in food facilities” and “educating consumers…on safe food handling practices”).

Read Commissioner Hahn’s Statement here and the New Era Blueprint here (PDF). Visit the New Era of Smarter Food Safety website here.

 

FDA Publishes FY2021 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program
July 30: FDA announced the fiscal year (FY) 2021 fee rates for “importers approved to participate in the Voluntary Qualified Importer Program (VQIP), and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP),” according to FDA’s Constituent Update.

The user fee rate for VQIP, “a voluntary, fee-based program for the expedited review and importation of foods” from certain qualifying importers, will be effective on August 1, 2020 and will support program benefits from October 1, 2020 through September 30, 2021.

The rate for TPP, a voluntary program recognizing bodies that can accredit third-party certification bodies to “conduct food safety audits and issue certifications of foreign food facilities,” will be effective on October 1, 2020 through September 30, 2021.

Read FDA’s Constituent Update here.

 

FDA Announces Qualified Health Claim Regarding Cranberry Products and UTIs
July 21: Responding to a health claim petition submitted on behalf of Ocean Spray Cranberries, Inc., FDA announced that “it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.”

Ocean Spray had requested an authorized health claim about the relationship between consuming cranberry products and the reduced risk of recurrent UTI in healthy women, but the agency determined that evidence supporting the claim “did not meet the ‘significant scientific agreement’ standard required for an authorized health claim” and instead evaluated the petition as a qualified health claim petition. FDA concluded that there is “limited credible scientific evidence to support a qualified health claim for the consumption of cranberry dietary supplements and a reduced risk of recurrent UTI in healthy women.” Nevertheless, it indicated that it would not object to the use of certain qualified health claims about the consumption of cranberry juice beverages and dietary supplements.

Read FDA’s Constituent Update here and its letter of enforcement discretion here (PDF).

 

FDA Launches Grade “A” Milk Search (GAMS) System
July 14: FDA launched the Grade “A” Milk Search (GAMS) System, a tool to help stakeholders (dairy industry members and state and local milk regulatory and rating agencies) search the agency’s new online Grade “A” Milk Memoranda database. Specifically, the GAMS System is a “new searchable inventory” that “contains all active memoranda issued by the FDA related to oversight of the Grade ‘A’ Program,” according to FDA’s Constituent Update. The system’s search capabilities “include both basic and advanced functions with options to allow for additional search fields, including document title/subject, type of memoranda and specific date ranges.”

Read FDA’s Constituent Update here and visit the GAMS System here.


USDA UPDATES

UDSA Publishes 2020 Dietary Guidelines Advisory Committee’s Scientific Report
July 15: USDA posted the 2020 Dietary Guidelines Advisory Committee’s final scientific report, “an objective review of the latest available science on specific nutrition topics,” according to USDA’s Press Release. USDA and the U.S. Department of Health and Human Services (HHS) will “leverage the scientific advice in the committee’s report, as well as comments from the public and other federal agencies,” to develop their 2020-2025 Dietary Guidelines for Americans. The departments plan to publish these dietary guidelines by the end of December 2020.

Read USDA’s Press Release here and access the report here.

 

UDSA-FSIS and FDA Launch Joint Webinar on Cultured Animal Cell Products
July 31:USDA-FSIS and FDA announced the launch of their “Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products Webinar.” Interest stakeholders must register to view the webinar, which will be available after completing registration.

According to FDA’s Constituent Update, “[d]uring the webinar, experts will provide information on FDA and USDA’s respective statutory authorities, roles and responsibilities for cultured animal cell human and animal food products, and regulatory points of contact for new food production technology.” The webinar supports the agencies’ 2019 formal agreement on using “regulatory tools to help ensure that foods comprising or containing cultured animal cells entering the U.S. market are safe and properly labeled.”

Read FDA’s Constituent Update and access the webinar registration link here.

 

UDSA Updates Farmers.gov Website to Facilitate H-2A Employee Hiring
July 27: USDA launched new features on its Farmers.gov website, which was launched in 2018, to “to help farmers navigate the complex H-2A program” and hire H-2A employees more easily, noted USDA’s Press Release. According to the Department of Labor (DOL)’s website, the H-2A program, which is jointly administered by DOL, the Department of Homeland Security (DHS), and the State Department, “allows U.S. employers or U.S. agents who meet specific regulatory requirements to bring foreign nationals to the United States to fill temporary agricultural jobs.”

New H-2A features on the Farmers.gov website include “[a] real-time dashboard that enables farmers to track the status of their eligible employer application and visa applications for temporary nonimmigrant workers,” easier access to the DOL’s Foreign Labor Application Gateway (FLAG), and the ability to access all application forms online.

Read USDA’s Press Release here and visit Farmers.gov here.

 

USDA-FSIS to Regulate Avian Leukosis as “Trimmable Condition”
July 16: USDA-FSIS granted the National Chicken Council’s March 2019 petition “to treat lesions that could be suspected as being caused by avian leukosis as a trimmable condition and not a condition that requires whole bird condemnation.”

Under the New Poultry Inspection System (NPIS), the first 300 birds in an incoming flock must be checked for avian leukosis. Prior to granting the National Chicken Council’s petition, USDA-FSIS mandated “whole bird condemnation” of birds with lesions suspected to be caused by avian leukosis. In the agency’s letter to the council granting their petition, Rachel Edelstein, Assistant Administrator of the FSIS Office of Policy and Program Development, wrote: “We have determined that current scientific evidence supports treating avian leukosis as a trimmable condition and that the actions requested in your petition would reduce regulatory burdens on the industry. A description of the proposed rulemaking initiated in response to your petition is included in the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions.”

 

 

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