DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
June 18, 2012
Senior Vice President for Scientific and Regulatory Affairs and Chief Science Officer
Grocery Manufacturers Association
1350 I (Eye) Street, Suite 300
Washington, DC 20005
Dear Dr. Bruner,
This responds to your letter of May 7, 2012, concerning FDA's plans regarding the preventive controls and foreign supplier verification provisions in sections 103 and 301 of the Food Safety Modernization Act (FSMA). Your letter was prompted by the approaching statutory effective date of July 3, 2012, for the preventive controls provision.
FDA is committed to full and timely implementation of FSMA and will be issuing proposed rules to implement sections 103 and 301. Those rules, when final, will contain provisions that clarify industry's responsibilities and will foster compliance with FSMA's new requirements in an orderly and effective manner. FDA will expect to enforce compliance with these new FSMA requirements in timeframes that will be described in the fmal rules.
Other food safety provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations for human and animal food continue in effect. If we find a food that poses a public health risk to humans or animals, or if an inspection reveals a facility operating under insanitary conditions or otherwise failing to operate safely, we will continue to take action as appropriate under the FD&C Act.
Michael R. Taylor
Deputy Commissioner for Foods