As required by the bipartisan Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) today proposed a rule that would require the largest food businesses in the U.S. and abroad to take steps to prevent facilities from being the target of intentional attempts to contaminate the food supply. The FDA will hold a public meeting on the proposed rule on Feb. 20, 2014, in College Park, MD (details below).

Under the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Proposed Rule, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process. Facilities then would have to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.

The proposed rule does not apply to farms and food for animals. Also in the proposed rule, the FDA describes its current thinking and is seeking comment on other issues, including economically motivated adulteration. The proposed rule is available for public comment until March 31, 2014.

The FDA will hold a public meeting to discuss the proposed rule on Feb. 20, 2014, from 8:30 a.m. to 3:00 p.m., at the Harvey W. Wiley Federal Building, FDA, Center for Food Safety and Applied Nutrition, Wiley Auditorium, 5100 Paint Branch Parkway, College Park, MD 20740. The meeting is also designed to solicit oral stakeholder and other public comments on the proposed rule, inform the public about the rulemaking process (including how to submit comments, data and other information to the rulemaking docket), and respond to questions about the proposed rule. FDA is considering additional public meetings on this subject or other public engagement opportunities, which would be announced at a later time in the Federal Register.

Public Meeting attendees are encouraged to register online or contact: Nick Cane, Nakamoto Group, Inc., 11820 Parklawn Drive, Suite 240, Rockville, MD 20852, telephone: 240-357-1176, FAX: 301-468-6536, e-mail: nick.cane@nakamotogroup.com. Early registration is recommended because seating is limited. In addition, the meeting will also be webcasted.

For general questions about the meeting, to request an opportunity to make an oral presentation, or to request special accommodations due to a disability, contact: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, telephone: 240-402-1731, e-mail: juanita.yates@fda.hhs.gov.

To register or for more information:

Please note the following important dates:

  • Jan. 17, 2014: Closing date for request to make oral comment
  • Jan. 17, 2014: Closing date to request special accommodation due to a disability
  • Feb. 7, 2014: Closing date for advance registration
  • March 31, 2014: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management. See Docket No. FDA-2013-N-1425 on http://www.regulations.gov.

Author(s): Heidi Parsons