Hazard Analysis, Preventive Controls, Verification, Corrective Actions, Recordkeeping.
Full text of the law can be found at: Food Safety Modernization Act (FSMA)
In general, the owner, operator, or agent in charge of a facility must evaluate the hazards that could affect food manufactured, processed, packed, or held by such a facility. They must also identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards by providing assurances that the food is not adulterated or misbranded. A system must be in place to further monitor the controls and maintain records of these practices. Now let's break this down a bit further:
Hazard Analysis-What known or foreseeable hazards can be identified?
(a) Biological, chemical, physical & radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives.
(b) Hazards that occur naturally, or may be unintentionally introduced.
Preventive Controls-What hazards may be intentionally introduced?
(a) Identify and implement controls, especially at critical control points to ensure
-Hazards identified in the hazard analysis will be significantly minimized or prevented
-Any hazards identified in the hazard analysis regarding intentionally introduced hazards, (including acts of terrorism) will be significantly minimized or prevented.
-The food manufactured, processed, packed or held will not be adulterated or misbranded.
Monitoring Effectiveness-The facility must monitor procedures in place for hazard
identification and preventive controls to ensure that they are effective and being implemented. If found ineffective or not enforced, corrective action must be established and documented.
Verification-Are the preventive controls adequate to control the identifiable hazards? Is there proof that the facility is effectively monitoring the written plan? Is there proof that the preventive controls foster evidence for preventing the occurrence of identifiable hazards? Is there any reanalysis of the plan to ensure its relevancy?
Recordkeeping-The facility has to maintain records documenting the monitoring of
preventive controls for no less than two years.
For more details on this topic of the FSMA, be sure to check out:FSMA on our website
Food Safety Preventive Controls Alliance
Background
The FDA is expected to issue proposed rules during early 2012, that would require facilities that make or handle food for people and animals to put measures in place to help prevent foodborne illness. The U.S. Food and Drug Administration in cooperation with the Illinois Institute of Technology's Institute for Food Safety and Health (IIT IFSH) has created the Food Safety Preventive Controls Alliance (FSPCA) to develop training courses and materials on preventing contamination for both human and animal food during production. The materials to be developed by the alliance will help industry-particulary small- and medium-size companies-- comply with the new preventive control rules.
The alliance is composed of members from the FDA, local and state food protection agencies, the food industry, and academia. It is funded by a one-year, $1 million grant to the Illinois Institute of Technology's Institute for Food Safety and Health (IIT IFSH), a nationally-recognized leader in food safety.
Food Tracking & Tracing
The U.S. Food and Drug Administration recently unveiled a new pilot program studying tracking and tracing technologies for high-risk foods. The pilot is contemplated in Sec. 204 of the Food Safety Modernization Act (FSMA), a legislative initiative aiming at reducing foodborne outbreaks and increasing the FDA's ability to quickly identify and report outbreaks to the American public. In a post on the FDA's Transparency Blog, Sherri McGarry, Senior Adviser, Coordinated Outbreak Response and Evaluation Network Office of Foods at FDA, communicated her view of the importance of this pilot; "When a foodborne outbreak occurs, it is up to us, the FDA, and others, such as our industry partners, other government regulators to make sure that contaminated food products are no longer available. By quickly tracing the food product, we can help to minimize the risk to consumers."
FDA has heard the proverbial call of tracking and tracing high-risk foods for years. But while FDA talked, many segments of the food supply chain advanced light years ahead of FDA from an IT/technology standpoint. FDA admits that, "It is clear that we cannot meet all of the deadlines in the statute. We are focusing first on those with the greatest public health benefit, such as preventive controls, inspection and compliance, and the import provisions."
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