Digesting the changes – FSMA is here

Published · 2 min read

The five essential ingredients

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016. As a food and beverage manufacturer, the stakes are high. You may need to make significant changes in how you operate – and who you operate with – in order to comply. In this first of a four-part series on the FSMA rule, we’ll provide a high-level look at the elements of the rule, so you can better understand what it entails. In subsequent posts, we’ll dive deeper into the rule and explore how your organization can obtain and retain compliance.

There are five primary components of FSMA that as a food producer you must be aware of.

  1. Preventative controls: Your company will have to produce a comprehensive plan detailing your food hazards, the steps you’ll take to minimize and monitor those hazards, and your plans in case a problem arises. In addition, you’ll have to keep records documenting the ongoing implementation of your food security plan.
  2. Inspection and compliance: To ensure that you follow all the new rules, the FDA is going to significantly expand its inspection, sampling, testing, and data collection activities. If you fail to follow the rules, the FDA will be able to seize company assets and take legal action.
  3. Imported food safety: If you import, you’ll have to ensure that your foreign suppliers have adequate preventive controls in place to ensure safety, and the FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
  4. Response: For the first time, FDA has mandatory recall authority for all food products. Your ability to rapidly and accurately respond to a recall is imperative. The agency has other new authorities that are also in effect: expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.
  5. Enhanced partnerships: The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve public health goals. For example, it directs FDA to improve training of state, local, territorial, and tribal food safety officials.

Special thanks to our partners at NexTec Group for contributing to this series.

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