The food police are coming — liability and DOJ enforcement

Tom Stenzel — Thu, 29 Sep 2016 05:42:59 +0000

The notion that “the food police are coming” motivated attendees at the United Fresh Produce Association’s Washington Conference earlier this month to attend a session featuring Jeffrey Steger, assistant director in the Consumer Protection Branch of the U.S. Department of Justice, and prominent attorney Doug Fellman, a partner, at Hogan Lovells US LLP. There have been many visible examples of the DOJ’s evolving approach to criminal investigations and prosecution enforcing laws under the Food, Drugs and Cosmetic Act (FD&C). The Act provides for a concept of “strict liability,” meaning that corporate executives can be held criminally responsible for a case of foodborne illness, without regard to negligence or intent. Due diligence doesn’t matter. If illness is linked to a product, the CEO, quality assurance directors, or other corporate executives can be on the hook. While DOJ very rarely enforced such actions in years past, a new commitment to prosecuting individuals in the case of foodborne outbreaks has left members of the food industry extremely nervous. This is especially frightening for produce industry executives because fresh produce lacks a kill step. Much of it is grown outside. No matter what steps a company takes to reduce risk, there is no 100 percent way to guarantee zero chance of contamination. Even the Food and Drug Administration has been clear that fully implementing the Produce Safety Rule of the Food Safety Modernization Act (FSMA) can help reduce — but not eliminate — the risk of microbial contamination of fresh fruits and vegetables. And now, the use of whole genome sequencing means that regulators will increasingly be able to link cases of human illness to a particular food or specific facility. With the ability to link individual cases of illness to specific companies, company executives are at risk for prosecution, but at the same time, consumers may be misled to believe that produce-related illness are increasing and can be blamed on upstanding companies doing their best to prevent contamination. This runs directly counter to public health advice to eat a diet rich in fresh produce because of the health benefits. The risk of contamination — regardless of how low — along with the increasing risk of criminal prosecution, has caused enough concern that the United Fresh session with the attorneys from opposite perspectives drew a packed crowd. According to the presenters, there are things fresh produce operators can do to help or hurt themselves during an investigation. They offered the following suggestions:

Take any inspection or government inquiry seriously. What may sound like an innocent question or request for documents can lead to a personal criminal prosecution down the road. Make sure your senior management team is prepared.
Be nice: This seems simple, but when FDA, or worse, DOJ shows up, anxiety increases and there may be a natural tendency to get defensive. While you may not want to treat an investigator like an old buddy, it’s important to always remain courteous and professional.
Tell the truth: Hedging the truth never does anyone any good. The documentation required by various FSMA-related regulations means that there will be a lot of evidence to sift through. Consult with an attorney so that you understand the legal bounds of the requests, but always be honest and straightforward.
Long before an investigation, make sure that you demonstrate a commitment to food safety. How do you manage the company’s budget — do you invest in employee food safety training? Have you made investments in infrastructure where necessary? If the company has had prior food safety issues, what did you do about it — not just what the plant manager or QA director did, but what did the CEO and senior executives do? Your past actions paint a picture of the food safety culture within your company, and it is company leadership who set that culture.

People — and prosecutors — have little tolerance for bad people when bad things happen. But the risks to good people who are doing their best have never been higher. That calls for the CEO to demonstrate the highest commitment to food safety, and be prepared in the unlikely event that an illness is connected to your company’s product. We all recognize that sometimes bad things happen to good people. Do all you can to be one of the good people, knowing that, at the end of the day, the decision to prosecute is up to the DOJ. (To sign up for a free subscription to Food Safety News, click here.)

Produce group applauds extension of food safety deadlines

Tom Stenzel — Thu, 25 Aug 2016 05:00:18 +0000

The extension and clarification of compliance dates released Aug. 23 by FDA, combined with the draft guidance documents released Aug. 23-24, enable the fresh produce industry to better understand how to comply with the applicable rules. We appreciate that FDA heard and responded to our concerns and requests. FDA recognizes that packinghouses should have the same amount of time to prepare for regulatory compliance regardless of whether they are located on or off a farm. The extended compliance dates for packinghouses subject to the Preventive Controls Rule, beginning Jan. 26, 2018, allows us time to continue to work with FDA and the Food Safety Preventive Controls Alliance to develop a modified curriculum for these unique types of operations that are critical parts of the fresh produce supply chain. With the first compliance deadline for the Preventive Controls Rule less than a month away, our members continue to ask questions about which rule(s) they are subject to. We are hopeful that the draft guidance pertaining to industry classification for farms and facilities released Aug. 24 will provide examples that help the fresh produce industry understand which rules apply to them. United Fresh looks forward to reviewing the draft guidance on classifying farms and facilities, as well as draft guidance supporting implementation of the Preventive Controls for Human Food Rule. We will continue to work with FDA to ensure that the rules are practical and in the best interest of public health. Editor’s note: Tom Stenzel is president and CEO of the United Fresh Produce Association in Washington D.C. He has been with the organization for more than 20 years. The annual United Fresh Washington Policy Conference is set for Sept. 12-14 and registration is open. The agenda includes meetings with members of the U.S. House and Senate. Scheduled seminars include “The Food Police Are Coming – Liability Concerns and DOJ Enforcement.” (To sign up for a free subscription to Food Safety News, click here.)

Tom Stenzel | Food Safety News

The food police are coming — liability and DOJ enforcement

Produce group applauds extension of food safety deadlines