Is our food chain safe and secure in the face of the COVID-19 global pandemic? In a word, yes. At the moment, there is no evidence of transmission on imported foods or other goods, and no reported cases in the United States tied to the global food chain.
In a recent webinar, Venable attorneys representing the International Trade and Food and Drug Law practices shared their observations and guidance for remaining informed and proactive as the impact of coronavirus unfolds. Fundamentally, our food chain remains intact as the Food and Drug Administration (FDA) takes steps to enhance security. The FDA is also working closely with Customs and Border Patrol (CBP), the Centers for Disease Control (CDC), and the Occupational Safety and Health Administration (OSHA) to provide timely and accurate information to those in – and those associated with – the food industry. For the purposes of this discussion, dietary supplements were included as part of the food chain.
The presenting attorneys emphasized several key points:
- this situation is highly fluid and is changing constantly
- relying on partnerships at the federal, state, and local levels is critical
- contingency planning and defining policies and/or terms to eliminate ambiguity are necessary
- remaining informed will be challenging but is important to remaining viable
The FDA continues to offer guidance as new information becomes available, which can happen quickly and can render recent guidance outdated. In its message to the food industry, FDA recommended staying close to verifiable sources of information. The attorneys linked this guidance back to the firm’s efforts to disseminate accurate, timely, and relevant information related to COVID-19, and reiterated the firm’s position as a reliable source.
Consumer Concerns
To address increased consumer concerns related to food handling, packaging, and overall safety, remaining committed to following Good Manufacturing Practices (GMPs) is more critical than ever. An evaluation of any extra steps that might be taken will also work toward addressing consumer fears over virus transmission. These extra steps might include policies on addressing employee protection and responding to reports of employee infection, plans for increased sanitation, and training on terms like “social distancing” in the workplace. It is worth noting that FDA guidance states that companies do not need to jump to recall if an employee tests positive for COVID-19, but case-by-case reviews should determine whether a step like recall is necessary.
Business Operations
Food and agriculture, and transportation and logistics, have been identified as part of the “critical infrastructure,” which impacts the industry’s response to shelter-in-place orders being issued in localities and states nationwide. Business operations across multiple states require examination of the legalities and nuances across each of those states. The Department of Homeland Security (DHS) guidance outlining essential business services is still evolving, and states are working to complement the DHS guidance on a state level. States may address which workers are considered “essential” and how companies should comply with curfew hours. The National Business Emergency Center of the Federal Emergency Management Agency (FEMA) can help businesses respond to any potential issues.
Global Logistics
Also on the compliance front, the FDA has significantly cut its foreign inspections through April 2020. Critical inspections deemed “high risk” will continue, but routine inspections overseas have been scaled back. It is possible that CBP officials may be asked by the FDA to intervene in international cases requiring physical inspection. In the U.S., federal agencies are up and running, but delays are rampant. The FDA can conduct inspections through document requests, which may be treated the same way as on-site facility inspections. Ensuring records are ready and easily retrievable will position a business to respond to these FDA requests. Foreign Supplier Verification Programs (FSVPs) are requiring reexamination. FDA guidance states that companies will not be required to conduct on-site audits as a component of their FSVPs; alternatively, companies will need to modify their plans and implement temporary measures to remain compliant with requirements.
CBP is not handling origin of shipments differently, including shipments from China. From a supply chain perspective, China is returning to a pre-COVID position. Air travel restrictions are impacting global transportation logistics more than anything else because air travel accounts for approximately 60% of the transportation of goods globally. At the ports, there is no specific change to policies, but FDA is mindful of special issues, like companies that are “port shopping.” Companies should be extra transparent on goods they’re importing in order to avoid the impression of misconduct. Looking ahead, the U.S. government may be entertaining additional exclusion requests, and it’s important to remain aware of those.
Recommendations for remaining nimble moving forward include staying informed on health conditions through the CDC, as well as state and local health departments, and establishing good lines of communication with officials at the federal and local levels. To address both employee and consumer expectations, preparing clear and transparent communications plans – while noting that any information in those plans is fluid – will reinforce consistency in a time of uncertainty. Finally, maintaining poise and being thoughtful about business strategies will enable grounded decision-making.
The full webinar and additional resources related to the COVID-19 pandemic are available here.