The Food and Drug Administration is reopening the comment period for a draft risk assessment for certain food facilities that includes farm packing operations for fresh fruits and vegetables. The risk assessment is mandated by the Food Safety Modernization Act.

Comments on the document “Draft Qualitative Risk Assessment of Risk Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” are now due May 16, FDA officials said March 12.

May 16 is the same day comments are due on FDA’s proposed preventive controls rule and the proposed produce safety rule.

The FDA said the extension was scheduled to be published in the Federal Register on March 13.

The extension is in response to three comments the agency received that stated the original 30-day comment period on the document did not provide enough time to gather information.

The FDA originally published the draft risk assessment Jan. 16 in the Federal Register, with the comment period closing Feb. 15.

“We announced that we had used the results of the draft (risk assessment) to propose to exempt … 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 (risk assessment) as low-risk activity/food combinations … from the proposed preventive controls rule,” the FDA release said.

People can submit electronic comments at or written comments to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852.

All comments must include the docket number FDA-2012-N-1258.