Bioterrorism Act A Technical Information Bulletin of the Northwest Horticultural Council I. Food Facility Registration: All commercial fruit warehouses, packing sheds, cold storages and other similar buildings need to be registered with the U.S. Food and Drug Administration (FDA).  Farms are exempt from this requirement.  (All domestic or foreign facilities that manufacture, process, pack or hold food for human or animal consumption are required to register under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—the Bioterrorism Act.) General information on facility registration and instructions on how to register using the Internet are available on the FDA’s Industry Systems website at https://www.access.fda.gov/. II. Record Keeping:  FDA requires all packers, distributors, processors, receivers, holders, manufacturers, transporters and importers of food to maintain records identifying immediate sources and recipients.  This requirement is a result of a provision of the Bioterrorism Act.  Existing records must be made available to FDA upon its request.  Although farms are exempt from the record-keeping requirement, most post-harvest activities are not exempt, for example, waxing, sizing, packing and holding. The most recent final guidance document (Edition 4), issued in September 2006 by FDA, provides clarification of these rules for industry.  For all food received or released you must have a record of the firm’s name and the name of the responsible individual; address; telephone number, fax number, and email address (if available); type of food, including brand name and specific variety; date received or released; lot number; quantity and type of packaging; and name and contact information for the transporter.  Existing records, such as those under the Perishable Agricultural Commodities Act, may be used to meet this requirement as long as they include the information required by FDA.  The record retention period is based on the shelf life of the product.   Product/Shelf Life Non-transporter Retention Record Requirement Transporter Retention Record Requirement Food having significant risk of spoilage within 60 days 6 months 6 months Food having significant risk of spoilage after 60 days but within 6 months 1 year 1 year  Food having significant risk of spoilage no sooner than 6 months 2 years 1 year Requested records must be made available within 24 hours of receipt of the official request. These records do not need to include any pricing or sales data.   III. General:   The NHC strongly suggests that a responsible person in each Pacific Northwest company that packs and stores tree fruit be assigned the task of filing any required registration with FDA and assuring that any such registration is kept current. That same person should also be given the task of reviewing that firm’s existing record keeping system to confirm that it satisfies the Bioterrorism Act and for making any record keeping changes as may become necessary over the passage of time. The Northwest Horticultural Council represents the deciduous tree fruit industry of Idaho , Oregon and Washington on national and international policy issues affecting growers and shippers. For further information, please contact Mike Willett, Vice President for Scientific Affairs, or Deborah Carter, Technical Issues Manager, at (509) 453-3193. 7/9/07 Northwest Horticultural Council 105 South 18th Street, Suite 105 Yakima, Washington 98901, USA Voice: (509) 453-3193, Fax: (509) 457-7615 E-mail general@nwhort.org