Title 21

SECTION 112.204

112.204 What must I do if I receive an order to withdraw a qualified exemption applicable to my farm

§ 112.204 What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?

The owner, operator, or agent in charge of a farm that receives an order to withdraw a qualified exemption applicable to that farm under § 112.5 must either:

(a) Comply with applicable requirements of this part within 120 calendar days of the date from receipt of the order or, if operations have ceased and will not resume within 120 calendar days, before the beginning of operations in the next growing season, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; or

(b) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 112.206.

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