A Technical Information Bulletin
of the
Northwest Horticultural Council

Bioterrorism Act

I. Food Facility Registration:

According to the Bioterrorism Act (the Public Health Security and Bioterrorism Preparedness and Response Act of 2002), all domestic or foreign facilities that manufacture, process, pack, or hold food for human or animal consumption are required to register with the U.S. Food and Drug Administration (FDA).

Farms are exempt from this requirement. The Preventive Controls for Human Food rule, which became effective on November 16, 2015, modifies the definition of a farm to include all orchards and packinghouses or storage facilities that are either a) located on or near the growing operation, or b) where more than 50 percent of the fruit handled comes from an orchard that is owned by the owner or owners of the facility (packinghouse). FDA has been unclear on the exact meaning of this requirement (i.e. does the orchard have to be owned by the same business structure name, the same principal owners, etc.) and announced in February 2017 that the agency is reconsidering the farm definition in its entirety.  In the meantime, FDA is exercising enforcement discretion regarding whether a packinghouse falls under the farm definition.

In the meantime, owners that believe their facilities fall under the farm definition are encouraged to de-register or let their registration expire. This is because FDA is using the registration list for a basis for inspections under the Preventive Controls for Human Food rule. While FDA may request documentation to show why a facility may fall under the farm definition, agency leadership has assured the NHC that their inspectors are expected to be lenient as FDA works through its own process of modifying or clarifying the farm definition.

For those facilities that do not fall under the farm definition and are required to register: each facility is assigned a registration number and is required to renew registration every other year. Additionally, major facility changes, such as a change in ownership, must be reported.

General information on facility registration and instructions on how to register using the internet are available on the FDA’s Industry Systems website.

II. Record Keeping:

FDA requires registered facilities to maintain records identifying immediate sources and recipients. This requirement is the result of a provision of the Bioterrorism Act. Existing records must be made available to FDA upon request.

For all food received or released by a registered facility, records must be maintained including the following information: the firm’s name and the name of the responsible individual, facility address, telephone number, fax number, 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 the name and contact information for the transporter. Any changes to this information must be reported within 60 days. Existing records, such as those developed 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 packing or storage facility be assigned the task of filing any required registration with FDA and ensuring that any such registration is kept current. This 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 updating the records as may become necessary with 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, contact Kate Tynan, senior vice president, at 509-453-3193.

Updated 2/6/2023