FDA seeks comment on preventive controls against foodborne illness

The FSMA requires registered food and feed facilities to evaluate the food safety hazards that could affect food and feed they manufacture, process, pack, or hold and to identify and implement preventive controls to address those hazards. The agency opened the docket to solicit specific recommendations from stakeholders on what preventive control measures are appropriate, and any other pertinent information and recommendations, including measures that are workable for small businesses. 

FDA is required to issue guidance with respect to hazard analysis and preventive controls, and information submitted to the docket will be considered in the development of that guidance.

“The preventive-controls requirement of FSMA is one of the most important aspects of this historic law on food safety,” said Michael R. Taylor, deputy FDA commissioner for foods.  “It’s imperative that we get information, data and feedback from industry and other stakeholders.”

Under the FSMA, preventive controls plans are to include information on: evaluating the hazards that could affect food safety and specifying what preventive steps or controls will be put in place to significantly minimize or prevent the hazards. 

The preventive control plans must also specify how the facility will monitor these controls to ensure they are working, how it will maintain routine records of the monitoring, and what actions the facility will take to correct problems that arise.

Comments may be submitted either electronically or in writing until August 22, 2011. Submit electronic comments at http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0238-0001.

Submit written comments to:
The Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Under FSMA, the FDA is required to issue a rule on preventive controls for food facilities. The proposed rule is expected to be published this fall.

FDA has engaged in extensive outreach to stakeholders on various provisions of the FSMA.   The opening of the docket on preventive control measures follows an April 20 public meeting convened by the agency on the same topic.

For more information:

• FDA Food Safety Modernization Act (FSMA)  


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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