The long-awaited proposed rules for preventive controls for human food will appear in the Jan. 7 Federal Register. The rules were made public on Jan. 4. Dietary supplement facilities in compliance with 21 CFR Part 111 are proposed to be exempted from these provisions.
FDA proposes that each covered facility prepare and implement a written food safety plan, which would include the following: hazard analysis, risk-based preventive controls, monitoring procedures, corrective actions, verification, and record keeping. Once the regulations are made final, staggered effective dates, based on facility size, will dictate the compliance requirement.
At the same time, FDA proposed science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms.
Food and Drug Administration
January 4, 2013
FDA has released for public comment its proposed rule on preventive controls for human food that focuses on preventing problems that can cause foodborne illness. The proposed rule on standards for the safe production and harvesting of produce is being published at the same time. These are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (FSMA). FDA will soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors for imported food.
The proposed rule on preventive controls applies to many domestic and foreign firms that manufacture, process, pack or hold human food. The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly. FDA is proposing that the requirements be effective one year after a final rule is published in the Federal Register.
Recognizing that smaller businesses may need more time to comply with the requirements, FDA is proposing to allow two years for small businesses and three years for very small businesses to comply.
Comments on the proposed rule are due 120 days after the rule is published in the Federal Register. FDA will hold public meetings to explain the proposal and to provide additional opportunity for input.
Who is covered?
The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. Activities within the definition of "farm" would not be subject to the proposed rule, and the proposed rule would clarify those activities.
Highlights of the proposed rule
The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:
- Hazard analysis
- Risk based preventive controls
- Monitoring procedures
- Corrective actions, verification
The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems, which were pioneered by the food industry and are required by FDA for juice and seafood.