Bick Law LLP Explains FDA’s Oversight of the Food and Agriculture Sector During the COVID-19 Pandemic

As defined by the federal government, the food supply, including all food facilities and the agriculture industry, makes up critical infrastructure from farm to table and includes assets, systems, networks, and functions that provide vital services to the nation. It is essential that the food supply and associated supply chains are protected, and remain operational, including a workforce that is vital to production of the food supply. Promoting the ability of our workers within the food and agriculture industry to continue to work during periods of community restrictions, social distances, and closure orders, among others, is crucial to community continuity and community resilience. In fact, before COVID-19, in 2003, the U.S. designated the Food and Agriculture Sector as a critical infrastructure sector, recognizing its significant contribution to national security and the economy.

In a guidance issued by Department of Homeland Security on March 19 Guidance on the Essential Critical Infrastructure workforce: Ensuring Community and National Resilience in COVID-19, workers in the Food and Agriculture sector – agricultural production, food processing, distribution, retail and food service and allied industries – are named as essential critical infrastructure workers and should continue to show up for work.

Similarly, California Governor Gavin Newsome’s Executive Order N-33-20 establishes agriculture is one of “16 Critical Infrastructure Sectors” that must continue to operate during the Governor’s ordered lockdown. “Agriculture” is defined to include, but is not limited to, establishments engaged in growing crops, including nurseries and garden centers and cut flowers, raising animals, harvesting timber, and harvesting fish and other animals, food and beverage processors and manufacturers, and wholesale and retailers distributing products to consumers.

In addition, the U.S. Department of Homeland Security’s Cybersecurity & Infrastructure Security Agency issued an Advisory Memorandum on Coronavirus Guidance that identified two designations within the Food & Agriculture Sector of critical infrastructure:

• Employees of companies engaged in the production of chemicals, medicines, vaccines, and other substances used by the food and agriculture industry, including pesticides, herbicides, fertilizers, minerals, enrichments, and other agricultural production aids.
• Employees engaged in the manufacture and maintenance of equipment and other infrastructure necessary to agricultural production and distribution.

FDA-regulated food manufacturers are required to register with section 415 of the Food, Drug, & Cosmetic Act and must comply with the risk-based preventive controls mandated by the FDA’s Food Safety Modernization Act (“FSMA”) as well as the Current Good Manufacturing Practices (“CGMP”). This CGMP has been in place since 2015. It requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls. CGMPs and food safety plans have requirements for maintaining clean and sanitized facilities and food contact surfaces. Food facilities are required to use EPA-registered “sanitizer” products in their cleaning and sanitizing practices. There is a list of EPA-registered “disinfectant” products for COVID-19 on the Disinfectants for Use Against SARS-CoV-2 list that have qualified under EPA’s emerging viral pathogen program for use against SARS-CoV-2, the coronavirus that causes COVID-19. 

FDA’s Food Code recommendations for hand washing and glove use in food service and retail food stores have not changed as a result of the pandemic. (Food Code 2017 Section 2-301.11). Per the FDA Food Code: with limited exceptions, employees may not contact exposed, ready-to-eat foods with their bare hands and shall use suitable utensils such as deli tissue, spatulas, tongs, single use-gloves, or dispensing equipment (Food Code 2017 Section 3-301.11). Gloves are not a substitute for hand washing or hand hygiene.

Farms are required to comply with the same regulations governing the food facilities. In addition, farms must comply with the Produce Safety Rule, a regulation pursuant to the FMSA, which established science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. This rule requires measures to prevent contamination of produce and food-contact surfaces by ill or infected persons.

How safe is our food?

Currently there is no evidence that food (including animal food) or food packaging is associated with transmission of COVID-19.  Unlike foodborne gastrointestinal (GI) viruses like norovirus and hepatitis A that can make people ill through contaminated food, COVID-19 is a virus that causes respiratory illness. Foodborne exposure to this virus is not known to be a route of transmission. The virus is thought to spread mainly from person-to-person. This includes between people who are in close contact with one another (within about 6 feet), and through respiratory droplets produced when an infected person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

Where’s my cheese?

There are no nationwide shortages of food, although in some cases the inventory of certain foods at your grocery store might be temporarily low before stores can restock. Food production and manufacturing are widely dispersed throughout the United States and no widespread disruptions have been reported in the supply chain. FDA is closely monitoring the food supply chain for any shortages and stays in regular contact with food manufacturers and grocery stores.

A joint statement by the California Farm Bureau and the California Grocers’ Association indicates that “food is plentiful and safe”:

People on farms and ranches, in packinghouses, processing plants, trucking firms and grocery stores, have been working diligently to harvest, pack, process, ship and stock the food and grocery products we all need. It’s a 24-hour-a-day job, and by working around the clock, we’re catching up with demand.

Food is plentiful and safe. The supply chain will replenish itself. There’s no need to buy more than you can use. We’ll all get through this, together.

What about imported food? 

According to the FDA and the California Farm Bureau, there is no evidence to support transmission of COVID-19 associated with imported goods and there are no reported cases of COVID-19 in the United States associated with imported goods.

What else is the FDA doing to manage COVID-19?

In addition to closely monitoring and regulating the food supply industry, the FDA established a new program to expedite the development of potentially safe and effective COVID-19 treatments, known as the Coronavirus Treatment Acceleration Program (“CTAP”). As of April 1, 2020, there are 10 therapeutic agents in active trials and another 15 therapeutic agents in planning stages.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The same environmental laws apply to the food and agriculture sector that apply to other regulated entities. Discharges to surface waters are regulated under the federal Clean Water Act, requiring a general or individual permit. Solid waste disposal is regulated under the federal Solid Waste Disposal Act. Disposal of hazardous waste is regulated under the federal Resource Conservation and Recovery Act. Individual states have jurisdiction over water rights, groundwater use, and impacts to waters of the state by food and ag. Discharges to air, including from confined animal feeding operations, are regulated under the federal Clean Air Act. Chemical use is regulated under the Toxic Substance Control Act, the Federal Insecticide and Fungicide Act, and the Emergency Planning and Community Right‐to‐Know Act, as well as state laws. The Occupational Safety and Health Act (both federal and California) also provide regulations and guidance to farm workers and food facility workers. Proposition 65 and other labeling requirements will still apply to food products and packaging offered for sale in California.  Food warnings will vary by product and must include the chemical name(s) in the warning and whether the chemicals are known to cause cancer, or birth defects and other reproductive harm, or both.

The California environmental lawyers at Bick Law LLP specialize in the agriculture industry, a vital source of the nation’s food supply.  We will continue to monitor and update the status of FDA’s work to ensure a safe and continuous food supply during this unprecedented time.

Resources:

• World Health Organization – How to Protect Yourself, FAQ, Updates, Travel Recommendations
• Center For Disease Control (CDC) – Symptoms of Corona Virus, How to Protect Yourself and Adults over 65
• Important updates and information on response to the Coronavirus by the State of California