Food Safety for Dairy Processors / Operations
Rules and regs

FDA seeks comments on Listeriosis draft; FSMA rules

The Listeriosis risk assessment is a joint effort between FDA and Health Canada. FDA seeks FSMA comments at meetings in Illinois, Oregon.

The U.S. Food and Drug Administration is announcing two additional public meetings on the Food Safety Modernization Act (FSMA): Proposed Rules for Produce Safety and for the Preventive Controls for Human Food.

Last week the agency announced a draft quantitative assessment of the risk of listeriosis from soft-ripened cheese consumption in the United States and Canada. The risk assessment is a joint effort between FDA and Health Canada. View the Federal Register Notice for the assessment.

The new FDA/Health Canada draft risk assessment found that the risk of listeriosis from soft-ripened cheeses made with raw milk is estimated to be 50 to 160 times higher than that from soft-ripened cheese made with pasteurized milk. This finding is consistent with the fact that consuming raw milk and raw milk products generally poses a higher risk from pathogens than do pasteurized milk and its products.

While raw milk and raw milk products put all consumers at risk, the bacteria they may contain can be especially dangerous to people with weakened immune systems, older adults, pregnant women and children. View guidelines for avoiding illness by choosing milk and milk products carefully.

FDA invites comments that can help FDA and Health Canada improve:

  • the approach used;
  • the assumptions made;
  • the modeling techniques;
  • the data used; and
  • the clarity and transparency of the draft quantitative risk assessment documentation.

To submit comments electronically, go to docket FDA-2012-N-1182 on regulations.gov. The comment period opens February 11, 2013 for 75 days.

To submit your comments to the docket by mail, use the following address:

The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Be sure to include docket number FDA-2012-N-1182 on each page of your written comments.

FDA to hold public meetings in Chicago, Portland on proposed FSMA rules

The U.S. Food and Drug Administration (FDA) is announcing two additional public meetings on the Food Safety Modernization Act (FSMA): Proposed Rules for Produce Safety and for the Preventive Controls for Human Food. These meetings are the second and third in a series of public meetings announced in the January 31, 2013 Federal Register Notice and on FDA’s FSMA website. The first meeting will be held February 28-March 1, 2013, at the U.S. Department of Agriculture in Washington, DC.

The purpose of the public meetings is to discuss the proposed rules to establish standards for growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls for human food proposed rule). They 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. The meetings are also designed to solicit oral and public comments from stakeholders on the proposed rules, inform the public about the rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules. 

Specific information for the Chicago and Portland, Ore. Public Meetings is provided below.

Please note the following important dates:

March 11-12, 2013 Meeting in Chicago

  • February 21, 2013: Closing date for request to make oral comment
  • February 21, 2013: Closing date to request special accommodation due to a disability
  • March 1, 2013: Closing date for advance registration
  • May 16, 2013: closing Date to submit either electronic or written comments to FDA's Division of Dockets Management; for the proposed rule on Preventive Controls see Docket No. FDA-2011-N-0920 and for the proposed rule on Produce Safety Standards see Docket No. FDA-2011-N-0921

March 27-28, 2013 Meeting in Portland, Ore.

  • March 8, 2013: Closing date for request to make oral comment
  • March 8, 2013: Closing date to request special accommodation due to a disability
  • March 18, 2013: Closing date for advance registration
  • May 16, 2013: closing Date to submit either electronic or written comments to FDA's Division of Dockets Management; for the proposed rule on Preventive Controls see Docket No. FDA-2011-N-0920 and for the proposed rule on Produce Safety Standards see Docket No. FDA-2011-N-0921

Public meeting attendees are encouraged to register on-line.

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