June 26, 2009
In the June 26, 2009 Federal Register, FDA announced three public workshops on the Reportable Food Registry (the Registry) established by the Food and Drug Administration Amendments Act of 2007. The intent of the public workshops is to explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal. In addition, the role of federal, state and local public health officials in voluntarily reporting instances of reportable food to FDA will be discussed.
In order to maximize the opportunity for parties subject to the Registry to attend, the public workshops will be held in three locations across the country. Dates and locations are:
- July 23, 2009, from 9:00 a.m. to noon at the Harvey W. Wiley Federal Building, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park MD 20740. July 17, 2009 is the closing date for advance registration and requests for special accommodations due to disability, and July 20, 2009 is the closing date to request onsite parking.
- August 5, 2009, from 9:00 a.m. to noon at the Hyatt Regency Chicago, 151 East Wacker Drive, Chicago, IL 60601. July 27, 2009 is the closing date for advance registration and requests for special accommodations due to disability.
- August 25, 2009, from 9:00 a.m. to noon at the Ronald V. Dellums Federal Building, Edward Roybal Auditorium, 1301 Clay St., 3d floor, Oakland, CA 94612. August 14, 2009 is the closing date for advance registration and requests for special accommodations due to disability.
Registration: Electronic registration is encouraged. Please go to "Workshops, Meetings & Conferences" and select the link to the Reportable Food Registry Public Workshops. Registration may also be done by email, mail or fax. Please include your name, title, firm name, address, telephone and fax numbers in your registration information and send to:
Deborah Harris, EDJ Associates, Inc.,
11300 Rockville Pike, Suite 1001,
Rockville, MD 20852,
Background: In the June 11, 2009 Federal Register, FDA announced that the agency is asking for comment on its Reportable Food Registry Draft Guidance for the food industry, developed in response to section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085). The Registry is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods except dietary supplements and infant formula. The Registry requires a responsible party to file a report through an FDA internet portal when there is reason to believe that an adulterated food/feed (other than infant formula and dietary supplements) will cause serious adverse health consequences or death to humans or animals. "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food/feed for human or animal consumption in the U.S. Federal, state, and local government officials may also use the portal to report information that may come to them about such foods or feed.