First FSMA rules in effect July 3. Are you ready?

Earlier this week the U.S. Food and Drug Administration (FDA) announced the first set of rules under the landmark Food Safety Modernization Act (FSMA), legislation signed earlier this year which gives the FDA sweeping powers to prevent food safety disasters.

The two new rules, which take effect July 3, are pretty logical preventive measures that, in all fairness, probably should have been implemented a long time ago. The new rules are as follows:

  • Order on Administration Detention of Food: The first new rule gives the FDA the authority to hold food products that may be contaminated or mislabeled. Before now, the administration only had the right to detain food when it had sufficient evidence it was mislabeled or contaminated, thereby presenting a threat to humans or animals. Now if the FDA even suspects contamination or mislabeling, it can detain the product.
  • Rule on Imported Food:  Organizations importing food now have to disclose whether another country has rejected or refused the product. With this information, the FDA will be better equipped to target foods that may pose a risk to public health.

The new regulations are the first in what will be an ongoing stream of new rules determining how the FSMA affects organizations across the U.S., but also adds to the Act’s current scope, which includes legislative components that took affect earlier this year when it was signed into law, including the following:

  • If the FDA determines a reasonable probability of serious adverse health consequences in any food product, it may demand records of other food products affected in a similar manner.
  • If the FDA finds a “reasonable probability” food has been misbranded, adulterated, or capable of generating serious adverse health consequences, it may issue a mandatory recall.
  • Whistleblowers who report violations or testify benefit from increased protection from any form of reprisal.
  • The FDA has already increased the frequency of inspections and also uses a risk-based model to prioritize inspections.

As more FSMA rules are come down the pipes in the next 12 months, and as the new requirements take effect July 3, it is up to all U.S. Food and Beverage businesses to take action now, by implementing food safety management systems, documenting detailed food safety plans, focusing on companywide hazard identification and risk mitigation (along the lines spelled out in HACCP), and prepare for a higher frequency of inspection.


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