FDA today issued Federal Register notices to extend the comment periods on the proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (the Preventive Controls proposed rule) and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety proposed rule) until September 16, 2013.

These proposals, originally published in the Federal Register for public comment on January 16, 2013, are the first of five proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The other three proposed rules, Preventive Controls for Animal Food; Foreign Supplier Verification Program (FSVP); and Accreditation of Third Party Auditors, are under review.

The Agency granted the extension of the comment period based on formal, written requests from many interested persons and groups that indicated more time was needed to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues in the two proposed rules.

The comment period is being extended for 120 days for the 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, as well as for the information collection provisions for the preventive controls and the produce safety proposed rules.

We invite interested persons to submit comments by September 16, 2013.

To submit comments electronically visit:

• Comment on the Produce Safety Proposed Rule
• Comment on the Preventive Controls Proposed Rule
• Comment on the Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations: Activities Outside the Farm Definition Conducted in a Facility Co-Located on a Farm

For more information on submitting comments to the docket, please see Comment on Proposed Regulations and Submit Petitions.

For more information:

• Federal Register Notice: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food: Extension of Comment Period
• Federal Register Notice: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Extension of Comment Period
• Federal Register Notice: Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in Facility Co-Located on Farm; Availability: Extension of Comment Period
• Overview of the FSMA Proposed Rules on Produce Safety Standards and Preventive Controls for Human Food
• 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 (PDF: 660KB)