Wednesday, March 05, 2014 by Lee Mannering
For those members interested in the implications of the U.S. Food and Drug Administration’s Food Safety Modernization Act proposed rule on intentional adulteration of foods, last week PMA added a summary of this proposal to our FSMA Resource Center. The proposed rule acknowledges that protecting the food supply from intentional adulteration requires an approach different from food safety programs and practices that reduce the likelihood of unintentional adulteration of foods. Therefore, the FDA proposed approach targets only vulnerable activities within food facilities, and the agency has not taken an approach of targeting specific foods or hazards.
In our summary, we note that this proposed regulation may or may not apply to produce businesses that are FDA-registered food facilities such as fresh-cut processors, packinghouses and distribution centers depending on enterprise size and the types of activities in which they are engaged. The proposed rule does not apply to:
- Farms or other food facilities not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, for example, facilities engaged in activities that are covered by the FDA produce safety rule.
- Very small businesses with less than $10 million total annual sales of food.
- Facilities solely engaged in packing, re-packing, labeling, or re-labeling of food where the container that contacts the food remains intact.
- Facilities engaged solely in the holding of food other than holding food in liquid storage tanks.
- Manufacturing, processing, packing, or holding of animal feed.
We also highlight the additional food defense plan elements that FDA-registered food facilities (domestic and foreign) that are not exempted and have actionable process step(s) would be required to develop and implement.
For more details on this proposed rule, visit our FSMA Resource Center to access the proposal’s summary along with additional resources regarding FSMA and its implementation.