2014-01-27 13:44:16 - On 24 December 2013 the United States Food and Drug Administration (US FDA) published their proposed rule on mitigation strategies to protect food against intentional adulteration. This proposal is another major rule of the Food Safety Modernization Act (FSMA). Comment period ends 31 March 2014.
Focused Mitigation Strategies to Prevent Food Adulteration
This proposed rule applies to both domestic and foreign facilities that manufacture, process, pack or hold food and are required to register with the US FDA. The following facilities/operations are exempted; farms, alcoholic beverages under certain conditions, feed for animals, holding foods except foods in liquid storage tanks and the packing, repacking, labeling or relabeling of food where the container that contacts the food remains intact. Exempt are very small business - which is a business with less than $10 million in total annual sales – but they require documentation to prove exemption. US FDA is seeking comments whether to exempt on-farm manufacturing, processing, packing or holding operations.
Key Elements of the Mitigation Strategies
US FDA has identified four key activities of concern for intentional adulteration:
- Bulk liquid receiving and loading,
- Liquid storage and handling,
- Secondary ingredient handling and
- Mixing and similar activities.
Facilities with any of these activities or other qualified operations would have to perform a vulnerability assessment of the operation. Facilities would need to identify the process points/steps that mitigation strategies would reduce the risk of intentional adulteration. Facilities would require having a written completed food defense plan. The food defense plan would have to include the actionable process steps to reduce intentional adulteration, the focused mitigation strategies, monitoring, correction actions, verification, training and record keeping at these steps.
The effective date will be 60 days after the final rule is published. Compliance dates will be 3 years after the final rule is published for very small business, 2 years after the final rule is published for small businesses - which is a business with less than 500 people - and 1 year after the final rule is published for all other businesses.
(1) Federal Register - Focused Mitigation Strategies To Protect Food Against Intentional Adulteration (www.federalregister.gov/articles/2013/12/24/2013-30373/focused-m ..
(2) Diagram 1: Would proposed 21 CFR part 121 to protect against international adulteration caused by acts of terrorism apply to me?
(3) FSMA Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration ( www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm?source=go ..
FDA Food Safety Modernization Act (FSMA)
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