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Sep 29

FDA Releases Proposed Rules under FSMA

On September 19, 2014, the U.S. Food and Drug Administration (FDA) released revisions to four proposed rules, opening them up for public comment. When these four rules are finalized in 2015, they will implement portions of the FDA Food Safety Modernization Act (FSMA) of 2011. The four new rules open for public comment set guidelines for the following food safety issues:

  1. Enhanced produce safety
  2. Preventative controls for human food
  3. Best practices and guidelines for animal food
  4. The foreign supplier verification program

The FDA is looking towards shifting its focus under the FSMA from after-the-fact responses, or a reactionary approach, to a more proactive, science-based prevention system. For example, the FDA is proposing to augment the water quality testing provisions in the produce safety rules, along with further testing of manure and compost used in crop production. The produce safety rule’s minimum applicable sales requirement, which will exempt very small farms from these new FDA regulations, is also open for public comment; right now it makes farms with less than $25,000 in annual produce sales exempt from its safety requirements.

The FSMA was signed into law in 2011 by President Obama and was the most significant food safety regulation in nearly 70 years. The FSMA seeks to promote better public health and to strengthen the nation’s food safety system. We have previously reported about the FSMA and FDA’s program priorities, including defining “gluten free,” regulating energy drinks, and establishing new rules for displaying nutritional facts.

The FSMA is a very important piece of legislation for companies to consider when developing and marketing their products. For the first time ever, under the FSMA, the FDA has the authority to recall food products. In the past, food distributors and manufacturers recalled food on a voluntary basis and through the urging by the FDA. The FSMA also calls for more frequent inspections of food and facilities. Facilities must also develop detailed preventative controls plans, which should spell out the risks to food safety, what is being done to minimize those risks, how the facility will monitor the risks, and what actions will be taken in the event of a problem.

If a company does not comply with the regulations promulgated under the FSMA, the FDA has a number of enforcement options. In addition to mandatory recalls, the FDA, under the FSMA, has expanded administrative detention of products that are potentially in violation of the law, can suspend the registration of facilities that pose a reasonable possibility of adverse health effects, and mandates increased recordkeeping for “high risk” foods. With this new authority, the FDA can suspend food facility registrations and prevent companies from producing and selling their products, like they did with a peanut butter factory in New Mexico.

The FSMA has the opportunity to change the landscape of food industry regulations. To read more about the FSMA, click here. It is important for any company in the food industry to ensure that they are complying will each new regulation. Failing to do so can mean having your company shut down. For that reason, it is important to have an understanding of your requirements under the law with respect to FDA regulations.

If you have any questions about the proposed rules, the FSMA, or compliance with other FDA regulations, please contact us at contact@giannamore-law.com

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