American Council for Food Safety & Quality

FDA Update: We are in the Business of Protecting Public Health

Sometimes it’s hard to know where an individual or an organization stands on an issue, which leads to a slurry of questions. Fortunately, this is not the case with the FDA. Luis Solórzano, Director of Investigation with FDA’s San Francisco District made it apparent where the FDA stands and his message resonated loud and clear. The January 21st district dinner meeting was packed wall to wall, and everyone, including members and non-members, were all-ears listening to Mr. Solórzano’s update.

Mr. Solórzano’s presentation focused on the recent changes to the FDA San Francisco District, including the hiring of 60 new inspectors and the recent shift of power as directed by leaders in Washington, D.C. One particular case he highlighted was the recent incident with the Peanut Corporation of America (PCA), and how this incident was an eye opener for FDA.

The FDA has created a system to identify the risk factors in a food operation. There are four primary factors that justify a visit:

Relative inherent risk of product
Recall history of product
Outbreak history of product
Adverse reactions from product

Mr. Solórzano summarized these points by saying that increased scrutiny from Congress and the public is a convincing reason for the increase in environmental sampling.

Mr. Solórzano could not stress enough the importance of validating your heat process. The old saying of “It worked then, so it must be working now” no longer cuts it; in today’s age pulling a printout off the internet will no longer suffice. Systems that have been in place for years may no longer be adequate. So, be ready to provide the data proving your claim. The FDA wants to see concrete evidence that your system works.

Investigators will be the ones to determine the quality of your control program. This could mean 100 to 300 swabs a day in your plant, especially in areas where food is exposed. As Mr. Solórzano put it, “We strive to find a firm that has proper controls for CRMs, conducts environmental sampling, has GMPs, and conducts verification testing and corrective actions.”

After his presentation, Mr. Solórzano answered audience questions. A brave attendee asked if by being at this meeting they were now going to be on FDA’s radar. After everyone chuckled nervously, Mr. Solórzano assured the audience the decision comes from Washington D.C., not himself.

While Mr. Solórzano is rigid on the FDA’s stance for public health, he is more than willing to talk to any industry or member that has questions or concerns. If you have any further questions for Mr. Solórzano please e-mail him at Luis.solorzano@fda.hhs.gov

Staff Contact: Kasey Harper Ferreria