FDA Considering Changing Food Safety System

WASHINGTON (CN) - The Food and Drug Administration plans to add to Current Good Manufacturing Practice regulations relating to the manufacturing, processing, packing and holding of human food, to cut down on outbreaks of food-born illness and disease.

The regulatory additions, according to the FDA, are the basis for implementation of new preventative controls provisions as mandated by the Food Safety Modernization Act (FSMA) and would apply to facilities required to register with the FDA. The implementation of a food safety system in covered facilities would include a hazard analysis and "risk-based" preventative controls where needed, and a written food safety plan. It also would set requirements for monitoring, corrective actions, verification and associated records.

The Current Good Manufacturing Practice (CGMP) regulations were last updated in 1986. The FDA plans to update the regulations, revising where necessary and "clarifying certain requirements." Among those clarifications are rules on the exemption of farms and who is subject to current regulations for registration and recordkeeping, and the new preventative controls requirements.

The FDA also has released its "Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a farm." The document is a science-based risk analysis meant to satisfy requirements under the FSMA. The FDA is using this analysis in consideration of "exempt food facilities that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing or holding activities identified in the draft RA (risk analysis) as low-risk activity/food combinations from the requirements of the Federal Food, Drug and Cosmetic Act for hazard analysis and risk-based preventative controls."

In addition, the FDA is considering establishing science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables.

To learn more click the document icon for this regulation and others.

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