Food Safety Magazine

FSM eDigest | May 19, 2015

Implementing FSMA: Records Management

By Q&A with Ronald J. Levine

Implementing FSMA: Records Management

Food Safety Magazine (FSM) spoke with Ronald J. Levine, Esq., of Herrick, Feinstein LLP, a New York law firm, on his recommendations for handling records management under the Food Safety Modernization Act (FSMA).

FSM: Why is it vital to place an emphasis on document management when it comes to food safety?

Levine: The [U.S. Food and Drug Administration] FDA has broad access to records. Records are the company’s best opportunity to show the FDA that it is in control of its food safety, and it also helps the company tell the best possible story. In the event of a potential food safety violation, there will always be a serious question whether the appropriate action was taken if it has not been documented. Also, inadequate compliance with documentation can have serious ramifications for the company.

FSM: Are there some records which are more important than others?

Levine: The short answer is no. Every record is equally important because almost every conceivable type of record has the potential to be implicated in the courtroom. That means that everyone in the company and at all facilities needs to be fully engaged and aware of potential ramifications when considering and handling records management. The requisite food safety plan and the host of records involving everything from sanitation to allergen controls to good manufacturing process has the potential to be implicated in litigation concerns for the company.

One thing to note is that the FSMA’s special focus on foreign supplier verification will also involve record maintenance and review on an international basis, meaning the company’s records management specialists will need to understand both U.S. and foreign records management practices and laws.

FSM: Do you have any recommended rules for companies to follow?

Levine: As a food industry attorney, my first commandment is “thou shalt watch your language.” All companies and employees need to assume that anything written or typed has the potential to be taken out of context, read by competitors, and used against you and/or the company.

Not to mention, it should also be assumed that electronic documents and especially emails can become permanent records. An employee might throw out a note. It may not be possible to delete an email. Employees don’t always understand how a choice phrase can be taken out of context and twisted by an adversary. I also recommend all employees within a food company go through a mandatory training session with the legal team, so they can understand the potential implications of their correspondence.

FSM: Do you have recommendations for legal-friendly email drafting?

Levine: As a general rule, try not to commit anything to writing which you would not want to see on the front page of The New York Times. Avoid emails on sensitive topics when a phone call or meeting would be sufficient. Absolutely don’t send emails during a fit of anger or frustration and don’t use emails to vent. Employees should also be told to avoid speculating on potential liability or any pending cases. They should also be encouraged to avoid conclusive legal words, such as violated and liability.

If and when potentially harmful emails get into the system, I would encourage employees receiving the problematic email to consider whether they should “correct the record.” Sometimes, it will be important to reply to potentially harmful emails—and that reply email may be a critical document if the matter goes to trial.

Employees need to be reminded that the signature on the email is the company’s signature, not just the employee’s signature. Though it may sound harsh, remember that everyone who receives an email can become a potential witness.

Ronald J. Levine, Esq., is an attorney with Herrick, Feinstein LLP, a New York law firm.

> Categories: Regulatory: FDA, FSMA

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