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

This Regulatory Update includes information from August 1 – 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 Final Rule on Use of “Gluten-Free” Label for Fermented and Hydrolyzed Foods MUST READ
  • FDA Issues Request for Information Re: Exempting Certain Produce Commodities from Produce Safety Rule MUST READ
  • FDA Releases Final Guidance on Inorganic Arsenic in Infant Rice Cereals
  • FDA Releases Investigation Update on Salmonella Newport Outbreak from Red Onions

USDA UPDATES

  • USDA-AMS Issues Proposed Rule on Amending Organic Regulations MUST READ
  • USDA-FSIS to Host Virtual Public Meeting on Reducing Salmonella Contamination
  • Center for Food Safety Sues USDA Over GMO Labeling Rule
  • USDA Announces Assistance for Midwestern Agricultural Producers Affected by Severe Derecho Wind Storm

COVID-19 DEVELOPMENTS

  • USDA Announces Additional Commodities Eligible for Coronavirus Food Assistance Program, Extends Application Deadline
  • Labor Unions Sue USDA-FSIS for Granting Waivers to Increase Poultry Processing Speed During Pandemic

FDA UPDATES

FDA Issues Final Rule on Use of “Gluten-Free”Label for Fermented and Hydrolyzed Foods
August 12:FDA issued a final rule establishing compliance requirements for fermented foods, hydrolyzed foods, and foods containing fermented or hydrolyzed ingredients that bear the ‘gluten-free’ claim – including “yogurt, sauerkraut, pickles, cheese, green olives, FDA-regulated beers and wines…hydrolyzed plant proteins used to improve flavor or texture in processed foods,” and distilled foods like distilled vinegar – according to FDA’s Constituent Update (“Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” 85 Fed. Reg. 49,240).

According to the agency’s News Release, “[t]he rule requires manufacturers of these food products to make and keep records providing adequate assurance that: the food meets the definition of ‘gluten-free’ before fermentation or hydrolysis; the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process.” The final rule does not change FDA’s 2013 definition of “gluten-free.”

Read FDA’s Constituent Update here, its News Release here, and the final rule here.

 

FDA Issues Request for Information Re: Exempting Certain Produce Commodities from Produce Safety Rule
August 6:FDA opened a Request for Information (RFI) to collect “data and information related to produce that has been known to have no or low reported consumption,” according to the agency’s Constituent Update. Based on results from the RFI, the agency will determine which produce commodities “should be added to the ‘rarely consumed raw’ (RCR) list and thereby exempt from the Produce Safety rule.”

All produce commodities on the Produce Safety Rule’s current RCR list meet three criteria: (1) They are consumed uncooked by less than 0.1% of the U.S. population, (2) They are not cooked by the consumer on less than 0.1% of eating occasions, and (3) At least 1% of the weighted number of survey respondents reported consuming the commodity in any form. FDA’s RFI is now seeking input on two types of commodities that did not qualify for the RCR list during its creation: (1) Those that met only the first two criteria (referred to as “produce commodities with low reported consumption”) and (2) those that did not appear in the National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA) dataset (referred to as “produce commodities with no reported consumption”).

The RFI will remain open for submissions of “data, information, and/or comments regarding U.S. consumption patterns of those commodities with no or low reported consumption” until November 9, 2020.

Read FDA’s Constituent Update here and access its RFI Public Docket here.

 

FDA Releases Final Guidance on Inorganic Arsenic in Infant Rice Cereals
August 5: FDA announced its finalization of “the 2016 draft guidance for inorganic arsenic in infant rice cereals” (i.e. white, brown, organically grown, and conventionally grown rice cereals) in response to the link between exposure to inorganic arsenic and neurodevelopmental effects, according to the agency’s Constituent Update. Its announcement was part of a broader effort by the Toxic Elements Working Group “to identify, target, and prioritize FDA efforts to reduce exposure to toxic elements from food.”

The guidance caps the allowable level of inorganic arsenic in the rice cereals at “100 micrograms per kilogram (µg/kg) or 100 parts per billion (ppb),” the same action level it proposed in its 2016 draft guidance. FDA claimed that this level will be “achievable by industry.” Some consumer advocacy groups and nonprofit organizations like Consumer Reports and Healthy Babies Bright Futures, however, expressed concern that the final guidance is not sufficiently aggressive in combatting heavy metals in food. Charlotte Brody, the national director of Healthy Babies Bright Futures, said in a statement: “Setting a standard for the maximum amount of arsenic allowed in baby foods is a start to keeping them safe — but 100 ppb is still far too high … No amount of arsenic, lead or other toxic heavy metal is safe for babies.”

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

 

FDA Releases Investigation Update on Salmonella Newport Outbreak from Red Onions
August 13: FDA released an update on its investigation of a multistate Salmonella Newport outbreak that had resulted in 640 total illnesses and 85 hospitalizations as of August 13. Although its traceback investigation was ongoing as of that date, the agency identified Thomson International, Inc. of Bakersfield, CA “as a likely source of potentially contaminated red onions.”

According to FDA’s Constituent Update, “On August 1, 2020, Thomson International, Inc. recalled all varieties of onions [i.e. red, yellow, white, and sweet yellow onions that were shipped nationwide between May 1 and August 1, 2020] that could have come in contact with potentially contaminated red onions, due to the risk of cross-contamination.”

Products containing the recalled onions continue to be identified and recalled; USDA-FSIS released a list of “Ready-to-Eat Meat and Poultry Products Containing Recalled Onions,” last updated on August 6. For an up-to-date list of recall information related to the outbreak, see FDA’s Outbreak Investigation page.

Read about FDA’s outbreak investigation here.


USDA UPDATES

USDA-AMS Issues Proposed Rule on Amending Organic Regulations
August 5:USDA’s Agricultural Marketing Service (USDA-AMS) announced a proposed rule “amending the USDA organic regulations to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products” as established by the Organic Foods Production Act of 1990 (OFPA) (“National Organic Program; Strengthening Organic Enforcement,” 85 Fed. Reg. 47,536).

The proposed rule constitutes a response to industry stakeholders’ continuous calls for increased oversight and enforcement by USDA’s National Organic Program (NOP). As the proposed rule acknowledges, “The absence of direct enforcement authority over some entities in the organic supply chain, in combination with price premiums for organic products, presents the opportunity and incentive for organic fraud… The amendments in this proposed rule are designed to mitigate the occurrence of organic fraud.”

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.”

Read the proposed rule here

 

USDA-FSIS to Host Virtual Public Meeting on Reducing Salmonella Contamination
On Tuesday, September 22, 2020, from 9 AM – 3:15 PM EST, USDA-FSIS will host a virtual public meeting on issues related to Salmonella contamination with speakers from the Agricultural Research Service (ARS), FDA, and CDC.

According to the agency’s Federal Register Notice, USDA-FSIS “will present its Roadmap to Reducing Salmonella, which describes how FSIS advances programs and policies that are science-based, data-driven, and promote innovation to reduce Salmonella and other pathogens in meat, poultry, and egg products.” Other meeting topics will include the modernization of inspection systems, the role of USDA-FSIS laboratories and sampling methods in reducing Salmonella, and future strategies for controlling Salmonella.

Pre-registration is mandatory for attendance.

Read USDA-FSIS’s Federal Register Notice and access the registration link here.

 

Center for Food Safety Sues USDA Over GMO Labeling Rule
July 27:The Center for Food Safety (CFS), representing a coalition of food labeling nonprofits (Natural Grocers, Citizens for GMO Labeling, Label GMOS, Rural Vermont, Good Earth Natural Foods, and Puget Consumers Co-Op), filed a lawsuit challenging USDA’s 2018 National Bioengineered Food Disclosure Standard, which implemented the Bioengineered Food Disclosure Act of 2016.

The lawsuit makes four arguments. First, it challenges USDA’s allowance of electronic or digital disclosure of GMO ingredients on packaging through QR codes or digital links. Second it, challenges USDA’s use of the term “bioengineered” on packaging instead of the more commonly used, recognizable terms “genetically engineered (GE)” and “genetically modified” (GMO). Third, it challenges USDA’s exclusion of “highly refined” foods with GE ingredients from coverage unless the GE material is detectable, noting that “[a]pproximately eighty-seven percent of foods containing genetically engineered ingredients on supermarket shelves are not whole foods (like genetically engineered squash), but contain highly refined GE ingredients (like sugar or corn or their derivatives).” Fourth, it challenges “long-standing guidance permitting voluntary disclosures for both presence and absence of genetic engineering, showing that and how such disclosures are not false or misleading.”

The plaintiffs asked the court to “[s]et aside or vacate all or portions of the final rule based on Defendants’ violations of the [Bioengineered Food Disclosure Act and the Administrative Procedure Act (APA)], and set aside any portions of the rule and the Act unlawfully restricting speech as violations of the 1st Amendment.”

 

USDA Announces Assistance for Midwestern Agricultural Producers Affected by Severe Derecho Wind Storm
August 12:USDA announced the availability of assistance for agricultural producers whose farms and ranches were affected by the derecho (a severe wind storm or so-called “land hurricane”) that swept throughout the Midwest the week of August 10.

In its Press Release, the agency listed multiple available resources for combatting the financial effects of weather-related disasters and facilitating economic recovery, including USDA’s Livestock Indemnity Program; Emergency Assistance for Livestock, Honeybees and Farm-Raised Fish Program; Noninsured Crop Disaster Assistance Program; Environmental Quality Incentives Program; Emergency Watershed Protection Program; Tree Assistance Program; and emergency loan program “that provides eligible farmers low-interest loans to help them recover from production and physical losses.”

Read USDA’s Press Release here.


COVID-19 DEVELOPMENTS

USDA Announces Additional Commodities Eligible for Coronavirus Food Assistance Program, Extends Application Deadline
August 11: In response to public comments and data, USDA announced that it had made additional commodities eligible for coverage under the Coronavirus Food Assistance Program (CFAP) and that it had extended the deadline to apply to September 11, 2020.

Additional covered commodities include multiple special crops (including bananas, escarole, maple sap for maple syrup, microgreens, nectarines, parsley, pomegranates, pumpkins, shallots, and many more); non-specialty crops and livestock (specifically “liquid eggs, frozen eggs and all sheep,” according to USDA’s  Press Release); aquaculture (including catfish, crawfish, salmon, and more fish species); and “nursery crops and cut flowers.” 

USDA also made seven commodities (green onions, pistachios, peppermint, spearmint, walnuts and watermelons) eligible for Coronavirus Aid, Relief, and Economic Stability (CARES) Act funding for sales losses, and it corrected “payment rates for onions (green), pistachios, peppermint, spearmint, walnuts, and watermelons.”

Read USDA’s Press Release here.

 

Labor Unions Sue USDA-FSIS for Granting Waivers to Increase Poultry Processing Speed During Pandemic
July 28:The international United Food and Commercial Workers Union (representing Tyson Foods, Inc. employees from Kentucky and southern Indiana), along with labor unions from Alabama, Arkansas, Kentucky, and Tennessee, filed a lawsuit against USDA-FSIS for granting Tyson and Wayne Farms poultry processing plants a waiver to exceed the maximum line speed during the pandemic.

The lawsuit challenges USDA-FSIS’s implementation of a 2018 waiver program that increased the maximum line speed at meatpacking plants from 140 bpm to 175 bpm without allowing for public comment. It also challenges the agency’s rationale for the change in maximum line speed. Furthermore, the plaintiffs argue that “FSIS failed to consider the risks to workers’ health of increasing the maximum line speed” at a workplace already characterized by high rates of injury and that it had “ignored its commitment in the 2014 Final Rule that it would take worker safety into account in implementing the Final Rule.”

 

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