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

This Regulatory Update includes information from August 31 – September 15, 2020. 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.

 

COVID-19 UPDATES

  • Agriculture Ministers from Western Hemisphere Countries Issue Joint Statement on Trade During Pandemic

FDA UPDATES

  • FDA Issues Annual Pesticide Residue Monitoring Program Report for FY 2018 MUST READ

  • FDA and USDA Offer Preparatory Resources Ahead of Hurricane Sally

  • FDA Provides Updates on Machine Learning Import-Screening Pilot Program

USDA UPDATES

  • UDSA, Other Agencies Release Report on Seasonal and Perishable Produce MUST READ

  • USDA Issues Final Rule Modernizing Egg Products Inspection MUST READ

  • USDA Designates 18 Iowa Counties as Primary Natural Disaster Areas Following August 10 Derecho

  • USDA Announces Funding for U.S. Seafood Industry in Response to Retaliatory Tariffs

  • USDA Issues Request for Information, Seeking Ready-to-Go Technologies for Agriculture Innovation Agenda

UPCOMING MEETINGS & CONFERENCES

  • September 22:  Virtual meeting on Salmonella hosted by USDA-FSIS and USDA’s Office of Food Safety (USDA-OFS). Read USDA-FSIS’s News Release and register for the meeting here

  • September 22-25: Virtual NGA Executive Conference hosted by National Grocers Association (NGA) with address by FDA Deputy Commissioner Frank Yiannas. Register by September 20, 2020 here.

  • September 24-25:  Virtual meeting of the National Advisory Committee on Meat and Poultry Inspection (NACMPI). Read USDA-FSIS’s Federal Register Notice and register for the meeting here.

  • October 6:  Virtual meeting on consumer outreach and education hosted by USDA-FSIS. Read USDA-FSIS’s Federal Register Notice and register for the meeting here.
     
  • October 13-14: Virtual meeting on National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan hosted by FDA, CDC, and USDA. Register by September 22, 2020 here

 


COVID-19 DEVELOPMENTS

Agriculture Ministers from Western Hemisphere Countries Issue Joint Statement on Trade During Pandemic
September 14: Following the virtual G-20 Agriculture and Water Ministers Meeting hosted by the Kingdom of Saudi Arabia on September 12, agricultural officials from Argentina, Brazil, Canada, Mexico and the United States issued a statement “emphasizing their commitment to remaining reliable suppliers of food and agricultural products to the world,” according to USDA’s Press Release.

The statement noted the following: “As Western Hemisphere agricultural leaders, whose countries represent 35 percent of global exports in agricultural products, we reiterate the importance of maintaining agricultural trade flows, while avoiding unjustified trade-restrictive measures, in order to keep markets open and ensure global food security…Looking at the aftermath of this pandemic, we recognize that agriculture will be an important engine for economic recovery. Innovation and technological development will be vital to guarantee that food systems develop sustainably to feed the world’s growing population. How we emerge from this crisis will be our greatest legacy for a future of global food security and nutrition.”

Read USDA’s Press Release here.


FDA UPDATES

FDA Issues Annual Pesticide Monitoring Program Report for FY 2018
September 15: FDA released its annual Pesticide Residue Monitoring Report and Data for Fiscal Year (FY) 2018. According to the agency’s Constituent Update, FDA administers the Pesticide Residue Monitoring Program “to ensure that FDA-regulated foods in U.S. commerce comply with the pesticide tolerances, or maximum residue levels, set by the U.S. Environmental Protection Agency (EPA).” The program uses a three-fold strategy, selectively monitoring “a broad range of domestic and import commodities for residues of over 800 different pesticides and selected industrial compounds” and carrying out focused sampling surveys for specific commodities or pesticides. 

After testing 809 total pesticides and industrial chemicals across nearly 4,900 domestic and imported food samples for FY 2018, FDA found that “the majority of samples tested were in compliance with the tolerances set by the EPA.” The agency found that “[t]he violation rate (12.9%) for imported human foods sampled was slightly higher than in previous years (FY 2012-2017), due in part to a higher violation rate for cilantro and radishes, which were targeted for increased sampling based on previous findings.”

Read FDA’s Constituent Update here and access the FY 2018 report here.

 

FDA and USDA Offer Preparatory Resources Ahead of Hurricane Sally
September 14:  FDA and USDA provided resources for farmers affected by severe weather conditions ahead of Hurricane Sally, which the National Hurricane Center warned would affect approximately 10 million Americans on the Gulf Coast – including Mississippi, Alabama, and the Florida Panhandle – with “life-threatening” and “historic” flooding from Tuesday, September 14 through Thursday, September 17.

In its Constituent Update, FDA included links to its industry guidance on “Evaluating the Safety of Flood-affected Food Crops for Human Consumption” and to its Constituent Update on “Resources for Animal Food Producers in Puerto Rico and the Southeastern U.S. Affected by Hurricane Isaias,” which provided information on salvaging crops that have been deemed unsuitable for human use for use as animal food instead.

Meanwhile, USDA directed farmers to its Disaster Assistance Discovery Tool and its Disaster Resource Center, a “central source of information [that] uses a searchable knowledgebase of disaster-related resources powered by agents with subject matter expertise…[and] provide[s] an easy access point to find USDA disaster information and assistance.”

Read FDA’s Constituent Update here and USDA’s Press Release here. Access FDA’s industry guidance on “Evaluating the Safety of Flood-affected Food Crops for Human Consumption” here and “Resources for Animal Food Producers in Puerto Rico and the Southeastern U.S. Affected by Hurricane Isaias” here. Access USDA’s Disaster Assistance Discovery Tool here. Visit USDA’s Disaster Resource Center here.

 

FDA Provides Updates on Machine Learning Import-Screening Pilot Program
August 31:  FDA Commissioner Stephen M. Hahn, M.D gave updates on an ongoing pilot program that was launched in Spring 2019 “to learn the added benefits of using AI [artificial intelligence], specifically machine learning (ML), in our import-screening processes,” according to his “FDA Voices” article. The pilot taps into two FDA initiatives: the New Era of Smarter Food Safety and the Technology Modernization Action Plan (TMAP).

Phase 1 of the pilot was a “proof of concept” assessing “the utility of using AI/ML to better target seafood at the border that may be unsafe.” To carry out Phase 1, the agency trained a ML screening tool “using years of retrospective data from past seafood shipments that were refused entry or subjected to additional scrutiny.” The results of the proof of concept “demonstrated that AI/ML could almost triple the likelihood that we will identify a shipment containing products of public health concern.” Phase 2 will also examine imported seafood. FDA staff will apply the AI/ML model “to the screening methods used to help FDA staff decide which shipments to examine” and which foods in each shipment to sample. The staff then will compare the recommendations of the model with those of its current system.

Read the “FDA Voices” article here.


USDA UPDATES

USDA, Other Agencies Release Report on Seasonal and Perishable Produce
September 1:Following public hearings in August 2020,USDA, the Office of the U.S. Trade Representative (USTR), and the Department of Commerce released a report outlining the Trump Administration’s strategies for combatting “the threat posed by increased foreign imports to American producers of seasonal and perishable fruits and vegetables,” according to USDA’s Press Release.

As part of the “Plan to Support American Producers of Seasonal and Perishable Fruits and Vegetables” delineated in the report, USTR will pursue senior-level discussions with the Mexican government to address concerns about U.S. imports of Mexican perishable produce; the Department of Commerce will “establish an outreach program to connect with Southeastern and other growers of seasonal and perishable fruits and vegetables”; and USDA will “develop a market promotion strategy for domestically produced produce,” among other tasks. Furthermore, the three agencies plan to establish an “interagency working group to monitor seasonal and perishable fruit and vegetable products, coordinate as appropriate regarding future investigations and trade actions, and provide technical assistance to Members of Congress in developing legislation on this issue.”

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

 

USDA Issues Final Rule Modernizing Egg Products Inspection
September 9:With its Egg Products Inspection Regulations final rule (publication forthcoming), USDA is modernizing egg products inspection methods “for the first time since Congress passed the Egg Products Inspection Act (EPIA) in 1970,” according to USDA-FSIS’s Constituent Update. The new rule, which was proposed in February 2018 (83 Fed. Reg. 6314), “aligns the egg products regulations to be consistent with current requirements in the meat and poultry products inspection regulations.”

The Egg Products Inspection Regulations rule will require federally inspected egg products plants to develop Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation Standard Operating Procedures (SSOPs). According to USDA-FSIS, “Under the HACCP system, plants will be able to tailor a food safety system that best fits their particular facility and equipment. Furthermore, by removing prescriptive regulations, egg products plants will have the flexibility and the incentive to innovate new means to achieve enhanced food safety.”

USDA-FSIS will continue testing for Salmonella and Listeria monocytogenes (Lm) in egg products, and it also will assume regulatory authority over egg substitutes and freeze-dried egg products, which previously were regulated by FDA. As soon as the rule is published in the Federal Register, it will take effect at 83 USDA-inspected plants.

Read USDA-FSIS’s Constituent Update here and view a pre-publication copy of the rule here (PDF). Read the 2018 proposed version of the rule here.

 

USDA Designates 18 Iowa Counties as Primary Natural Disaster Areas Following August 10 Derecho
September 3:Following the August 10-11 Midwest Derecho that damaged millions of acres of crops across the Midwest, USDA designated 18 counties in Iowa as primary natural disaster areas, making producers who suffered losses from the severe storm eligible for Emergency Farm Loans through USDA’s Farm Service Agency (USDA-FSA).

In addition to designating the counties as primary natural disaster areas, USDA-FSA “streamlined the environmental compliance review process for the Emergency Conservation Program, Emergency Forest Restoration Program, Emergency Loan Program, Farm Storage Facility Program, and Tree Assistance Program.” Furthermore, USDA’s Natural Resources Conservation Service (USDA-NRCS) made $4 million in recovery assistance available through a special Environmental Quality Incentives Program (EQIP) signup; applications will be accepted through Oct. 2, 2020.

Read USDA’s Press Release here and read more about Emergency Farm Loans here.

 

USDA Announces Funding for U.S. Seafood Industry in Response to Retaliatory Tariffs
September 9: The Farm Service Agency’s (USDA-FSA) Seafood Trade Relief Program will provide $530 million in funding “to support the U.S. seafood industry and fishermen impacted by retaliatory tariffs from foreign governments,” according to its Press Release. Funding comes from the Commodity Credit Corporation (CCC). The program will cover multiple seafood types, including flounder, lobster, Pacific cod, salmon, and tuna. “Fishermen can sign-up for relief through the program from September 14, 2020 to December 14, 2020.”

Read USDA’s Press Release here and apply for the Seafood Trade Relief Program here.

 

USDA Issues Request for Information, Seeking Ready-to-Go Technologies for Agriculture Innovation Agenda
September 10: As part of its Agriculture Innovation Agenda (AIA), USDA announced its search for “ready-to-go technologies and practices to achieve its goal of increasing agricultural production by 40% to meet global population needs in 2050 while cutting U.S. agriculture’s environmental footprint in half,” according to its Press Release. Launched in February 2020, the AIA is a department-wide, multi-phase initiative to prepare the U.S. agricultural system for future global demand.

USDA issued a Request for Information (RFI) through which it will accept public comments and written stakeholder input on ready-to-go technologies and practices through November 9, 2020. It also announced the launch of its AIA website, “where visitors can access information on the latest research and data, innovative conservation technologies offered via USDA programs, and other conservation resources.”

Read USDA’s Press Release here and its RFI here. Read USDA’s Press Release on the AIA here. Visit the AIA website here.

 

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