Title 21

SECTION 112.201

112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5

§ 112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?

(a) We may withdraw your qualified exemption under § 112.5:

(1) In the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm; or

(2) If we determine that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with your farm that are material to the safety of the food that would otherwise be covered produce grown, harvested, packed or held at your farm.

(b) Before FDA issues an order to withdraw your qualified exemption, FDA:

(1) May consider one or more other actions to protect the public health and prevent or mitigate a foodborne illness outbreak, including a warning letter, recall, administrative detention, refusal of food offered for import, seizure, and injunction;

(2) Must notify the owner, operator, or agent in charge of the farm, in writing, of circumstances that may lead FDA to withdraw the exemption, and provide an opportunity for the owner, operator, or agent in charge of the farm to respond in writing, within 15 calendar days of the date of receipt of the notification, to FDA's notification; and

(3) Must consider the actions taken by the farm to address the circumstances that may lead FDA to withdraw the exemption.

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