SAFEGUARDS | Food NO. 114/16

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On May 27, 2016 the US Food and Drug Administration (US FDA) published the Rule for Mitigation Strategies to Protect Food against Intentional Adulteration [1], the last of the seven core Food Safety Modernization Act (FSMA) rules. This rule is design to help prevent acts intended to cause wide-scale harm to public health, which would include acts of terrorism targeting the food supply.

This rule applies to both domestic and foreign large human food companies. Exempted are farms holding food, providing it is not bulk liquid storage, packing, re-packing, labeling or re-labeling food where the container that contacts the food remains intact, as well as animal foods, alcoholic beverages under specific conditions. On-farm manufacturing is also exempted as well as processing, packing or holding by a small or very small business of certain food, such as eggs and game meats identified as low-risk production activities, as long as very small businesses, upon request by the US FDA, provide proof that they are a very small business.

Facilities Required To Comply With This Rule

Facilities that are required to comply with this rule must develop and implement a food defense plan utilizing the principles of HACCP. They must perform an assessment to identify vulnerabilities and actionable steps for each type of food manufactured, processed, packed or held at that facility.

Focus mitigation strategies are to be developed to minimize or prevent the risks of intentional adulteration at these actionable steps.

Monitoring procedures, including their frequency, are to be established. Corrective actions are to be established in the event that these strategies fail. Verification activities are to be implemented to ensure that monitoring is performed correctly and that corrective actions are suitable.  

As with all the FSMA rules, the training of personnel and record keeping will be required.

Compliance Dates

Very Small Businesses – those businesses with less than $10,000,000 USD annual average of three years human food sales and unsold human food – must comply with the modified requirements by May 27, 2021.

Small Businesses – those operations with fewer than 500 full time equivalent employees – have to comply by May 27, 2020.

Other Business – all those not meeting the previous criteria – have to comply by May 27, 2019.

The US FDA recognizes that this rule will require education and outreach, so is providing the industry with a long period within which to comply. In addition, the US FDA is providing information at the food defense web portal [2] and food defense mitigation strategies database [3] to aid the industry in implementation of this rule.

What Does This Mean For The Food Industry?

Since the seven core rules are now finalized, the industry must work on developing the procedures and training for the programs in order to achieve compliance with the FSMA requirements. SGS has the global resources and technical knowledge to help businesses to achieve compliance.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website.

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager

t: +01 973 461 1493

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