Three public workshops on the Reportable Food Registry (the Registry) established by the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085) were announced in the June 26, 2009 Federal Register. The public workshops are intended 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.
FDA announced in the Federal Register of June 11 that the agency is asking for comment on its Reportable Food Registry Draft Guidance for the food industry. 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 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. The Reportable Food Registry Draft Guidance can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm165626.htm. For further information about how to comment on the Reportable Food Registry Draft Guidance, see http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm165569.htm.
To maximize opportunities for food industry personnel affected by 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
-- 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 http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ and click on 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,
e-mail: [email protected]iates.com.