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IS A SEED PROCESSOR SUBJECT TO FDA FACILILTY REGISTRATION?

Remember, the registration deadline was December 12th, so act now

Some confusion remains about whether seed processors are subject to the FDA food facility registration requirements under the Bioterrorism Act. The answer is "yes," if the seed in question is destined for a food crop or for a crop to be used as an ingredient in animal feed/pet food.

Below is an excerpt from FDA's Question/Answer document on who must register as a food facility:

Q: Is a facility that manufactures/processes and sells seed to farmers required to be registered if the seed is intended for cultivation? What if the seed is an ingredient that will be included in animal feed?

A: FDA requires registration of any facility that manufactures/processes, packs, or holds food for consumption in the U.S. (emphasis added.) As noted in a response to a comment in the Interim Final Rule (Comment 62), FDA will consider a product as one that will be used for food if the owner, operator, or agent in charge of the facility reasonably believes that the substance is reasonably expected to be directed to a food use. Therefore, if the owner, operator, or agent in charge of the facility in this question reasonably believes that the seed is reasonably expected to be used as an ingredient for animal feed, the seed is considered "food" and thus, the facility is required to be registered. However, if the seed is reasonably expected only to be cultivated, the facility is not required to be registered.

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