Here is a report on updated compliance guidance issued today by the Food and Drug Administration concerning the on-farm exemption under the bioterrorism recordkeeping regulations:
Bioterrorism/Facility Security
· FDA Issues Updated Guidance Concerning Farm Exemption Under Bioterrorism Recordkeeping Regulations: The Food and Drug Administration (FDA) today (Sept. 22) issued the fourth update of its guidance document concerning compliance with the agency’s bioterrorism recordkeeping regulations, with all six of the new or revised questions-and-answers focusing on the farm exemption granted by Congress when enacting the Bioterrorism Act in 2002. The FDA regulation requires grain elevators, feed and flour mills, grain processors, exporters and other agricultural enterprises to establish and maintain records identifying the immediate previous source and immediate subsequent recipient of food, feed and feed ingredients (including the transporters used to ship and receive such products). In essence, the regulation is a one-step-back, one-step-forward product-tracing requirement.
Four of the six new questions contained in the updated guidance document address whether and when the recordkeeping requirement applies in situations involving the harvesting and further processing of hay on-farm. Here’s the bottom line: FDA says it considers harvesting of grains and hay to be traditional farming activities covered under the farm exemption, and hence excluded from recordkeeping. These “traditional” activities include drying, chopping, baling, ensiling and transporting alfalfa from the field to storage. Further, FDA states that records are not required if the producer sells hay that is grown on the farm, since it defines the harvesting activity to include selling of the crop (akin to selling and delivering grain to an elevator). “Thus, activities associated with selling…the crop, such as transportation of the hay by a farmer either directly or through a third-party transporter to a buyer, is included within the farm exemption,” FDA states in its newly updated guidance.
But if the farmer subsequently removes the hay from storage and further processes it (for instance, chops the hay to make hay cubes) for sale to another person not associated with the same farm or another farm under the same ownership as the harvesting farmer, records are required of the next immediate recipient and transporter used for this activity (but records are not required for the growing and harvesting of the hay). Likewise, FDA states, if a farmer purchases hay from another farm that is under a different ownership to resell to another party, the producer is required to establish and maintain records for such transactions.
Importantly, FDA also responds to two questions concerning on-farm processing operations that have relevance to feed manufacturers and integrators:
-- In response to a question concerning whether a producer who mixes corn and haylage with a commercial protein supplement on-farm to make cattle feed, FDA states that recordkeeping is not required for this on-farm mixed feed “as long as the mixture is fed to animals on the farm or another farm under the same ownership.” However, FDA states that the producer is required to establish and maintain records associated with releasing the mixed feed “to someone other than a farm under the same ownership.” FDA states: “Mixing the corn and haylage with a commercial supplement constitutes manufacturing/processing and falls outside the traditional farming activity once the feed is distributed to anyone other than another farm under the same ownership.”
-- In response to another question, FDA states that an egg-packing facility situated in a different location than the egg-laying operation is required to establish and maintain records. “The farm definition extends to facilities located on the farm that pack or hold food if all food packed or held is grown, raised or consumed on that farm or another farm under the same ownership,” FDA states. “Because the final regulation defines ‘farm’ in terms of its location, the packing activities must be co-located with the activities associated with growing food or raising animals…to be exempt.”
The NGFA will be updating its heavily demanded comprehensive bioterrorism recordkeeping compliance guide to reflect the latest FDA guidance. See the Sept. 28 edition of the NGFA Newsletter for information on how to obtain a copy from the NGFA’s website. Meanwhile, access the latest 42-page FDA guidance document by clicking here.
