What is currently unfolding in Texas is both tragic and unprecedented. Early reports have estimated the reconstruction costs alone to be around $40 billion dollars. As Texas continues to grapple with the effects of Hurricane Harvey, we thought it would be helpful to supply our clients and friends in the food and agricultural sectors with some relevant regulatory information and potential sources of assistance.
Producers and Manufacturers
As a result of the unprecedented levels of rainfall, food production and manufacturing facilities may have been flooded or lost power. In some areas crops as well as processed food may have been submerged in floodwater. Such flooding potentially exposes food products to certain harmful contaminants (e.g., sewage, chemicals, heavy metals, pathogenic microorganisms). As a result, the Food and Drug Administration (FDA) advises that foods exposed to floodwater and perishable foods that are not adequately refrigerated are generally considered adulterated within the meaning of Section 402(a) of the Federal Food, Drug and Cosmetic Act (FDCA) and thus should not enter the human food supply. Individual/case-by-case evaluations are suggested for foods that may not have been completely submerged (e.g., crops as well as grains or similar products stored in bulk containers). Many of you have likely provided a certain level of assurances concerning the regulatory status of your products (i.e., not adulterated) in your contracts. Thus, we take this opportunity to encourage you to be mindful of the impact this aforementioned presumption of adulteration may have on your contracts. We encourage you to conduct additional due diligence and review your standard operating procedures as well as follow current good manufacturing practices for guidance. However, when in doubt, throw it out. The premise behind such an assumption is that both exposure to floodwater and inadequate refrigeration compromise food safety—thus the introduction of an adulterated product into commerce constitutes a violative offense under the FDCA. However, we also note that not all potentially exposed foods are presumed adulterated. FDA has indicated that hermetically sealed (top and bottom double-seam) cans may be reconditioned and relabeled under certain conditions.
For additional FDA information on food safety, please visit FDA’s emergencies website. In a similar vein, owners of meat and poultry producing businesses who have questions or concerns should contact the Food Safety and Inspection Service (FSIS) Small Plant Help Desk by phone at +1.877.FSIS.HELP (+1.877.374.7435) or by email at email@example.com. In addition, the US Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) is providing information on its website for farmers, ranchers, and businesses that have been affected by Hurricane Harvey.
If you have any specific questions concerning Hurricane Harvey’s impact on your business (e.g., regulatory compliance, cGMP issues), please do not hesitate to contact Kathleen Sanzo or Bob Hibbert from Morgan Lewis’s FDA practice.
Restaurants and Food Retail Establishments
Similarly, FDA advises that restaurants and food retail establishments that have resumed activities do the following:
- Ensure that any rodents/pests that may have entered the facility are no longer present.
- Discard all food and packaging materials that have been submerged in floodwater, unless the food is sealed in a hermetically sealed can that has not been damaged and has its label intact.
- Inspect physical facilities for possible water damage and consult professional service technicians, as needed.
- Verify that all equipment used for food preparation (e.g., cooking, cooling, and reheating) is clearly functioning and properly calibrated prior to use.
- All foods, including raw, fresh, frozen, prepackaged, shelf-stable, and ready-to-eat foods, should only be received from licensed and approved food sources. This includes food distributors and vendors licensed by local or state regulatory food authorities.
It is important to understand that your food supply chain will likely be disrupted. As a result, additional due diligence is necessary to identify existing new sources and these efforts should be documented.
For a complete listing of FDA’s advice for restaurants and food retail establishments and retail food protection, please see FDA’s publication on this topic.
Reports have indicated that more than 1.2 million beef cows may have been affected by Hurricane Harvey. APHIS, working alongside the Texas Animal Health Commission (TAHC), is providing emergency assistance in caring for animals. The TAHC has advised the public to call 211 or to contact the area emergency management department for assistance in finding large or small animal shelter/holding facilities in your area or evacuation area.
If cattle have strayed onto your property, property owners are encouraged to contact the Texas Southwestern Cattle Raisers Association (TSCRA) at +1.817.332.7064 or the TAHC at +1.512.719.0733 or +1.806.354.9335. Under Texas law you may be eligible for reasonable payment for maintenance of or damages caused by the stray livestock. For additional information, contact your local Sheriff’s department.
Disaster Assistance Programs
To assist businesses in their recovery efforts, please find a few federal disaster assistance programs below.
Small Business Administration
The US Small Business Administration (SBA) offers low-interest, long-term loans for losses not fully covered by insurance or other means. Additional information can be found on the SBA website.
The USDA Farm Service Agency (FSA) administers many disaster assistance programs to help producers recover from eligible losses, including the following:
- Emergency Conservation Program: Provides funding to rehabilitate farmland damaged by natural disasters.
- Emergency Forest Restoration Program: Provides payments to eligible owners of rural nonindustrial private forest land to carry out emergency measures to restore forest health on land damaged by natural disaster events.
- Emergency Assistance for Livestock, Honeybees, and Farm-Raised Fish Program: Provides payments to eligible producers of livestock, honeybees, and farm-raised fish to help compensate for losses due to disease (including cattle tick fever) and adverse weather.
- Emergency Farm Loan Program: Provides loans to help producers recover from production and physical losses due to drought, flooding, other natural disasters, or quarantine.
- Livestock Indemnity Program: Provides benefits to livestock producers for livestock deaths in excess of normal mortality caused by adverse weather.
- Noninsured Crop Disaster Assistance Program: Provides financial assistance for noninsurable crop losses due to drought, flood, hurricane, or other natural disasters.
USDA encourages farmers and ranchers to contact their local FSA office to learn what documents they can produce to help the local office expedite assistance, such as farm records, receipts, and pictures of damages or losses.