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FDA finalises new intentional adulteration rule

31 May 2016  •  Author(s): Victoria White, Digital Content Producer

The US Food and Drug Administration (FDA) has finalised a new food safety rule under the FDA Food Safety Modernisation Act (FSMA).

intentional adulteration

The new rule will help to prevent wide-scale public health harm by requiring companies in the US and abroad to take steps to prevent intentional adulteration of the food supply.

Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defence plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defence monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

Commenting on the new rule, Stephen Ostroff, M.D., incoming deputy commissioner for foods and veterinary medicine, FDA, said: “Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply. The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

Manufacturers to comply within three to five years

The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.

The FDA says that implementation of the Intentional Adulteration rule and all FSMA final rules will require partnership, education, and training. The FDA and others will provide industry with valuable tools to make compliance with the final rules easier, such as guidances, training courses and a technical assistance center.

Food manufacturers are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the business.

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