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Regulatory Watch

Regulatory Watch

FDA issues draft chapter for preventive controls guidance

Newest chapter of guidance on hazard analysis released

Regulatory Watch
October 4, 2017

FDA has announced the availability of another draft chapter of “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.”

The multi-chapter draft guidance is an explanation of how to comply with hazard analysis and risk-based preventive controls. The new chapter is entitled “Chapter Six—Use of Heat Treatments as a Process Control.”

Comments are open until Feb. 27, and can be submitted electronically through the federal eRulemaking Portal at https://www.regulations.gov. They can also be submitted in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The draft guidance and comments can be read by visiting https://www.fda.gov/FoodGuidances or https://www.regulations.gov. The docket number is FDA-2016-D-2343.

KEYWORDS: FDA HARPC preventive controls

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