Title 21

SECTION 112.213

112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption

§ 112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?

(a) If the FDA Division Director in whose division your farm is located (or, in the case of a foreign farm, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition) determines that the farm has adequately resolved any problems with the conduct and conditions that are material to the safety of the food produced or harvested at such farm, and that continued withdrawal of the exemption is not necessary to protect the public health or prevent or mitigate a foodborne illness outbreak, the FDA Division Director in whose division your farm is located (or, in the case of a foreign farm, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition) will, on his or her own initiative or at the request of a farm, reinstate the qualified exemption.

(b) You may ask FDA to reinstate a qualified exemption that has been withdrawn under the procedures of this subpart as follows:

(1) Submit a request, in writing, to the FDA Division Director in whose division your farm is located (or, in the case of a foreign farm, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition); and

(2) Present, in writing, data and information to demonstrate that you have adequately resolved any problems with the conduct and conditions that are material to the safety of the food produced and harvested at your farm, such that continued withdrawal of the exemption is not necessary to protect the public health and prevent or mitigate a foodborne illness outbreak.

(c) If your qualified exemption was withdrawn under § 112.201(a)(1) and FDA later determines, after finishing the active investigation of a foodborne illness outbreak, that the outbreak is not directly linked to your farm, FDA will reinstate your qualified exemption under § 112.5, and FDA will notify you in writing that your exempt status has been reinstated.

(d) If your qualified exemption was withdrawn under § 112.201(a)(1) and (2) and FDA later determines, after finishing the active investigation of a foodborne illness outbreak, that the outbreak is not directly linked to your farm, FDA will inform you of this finding, and you may ask FDA to reinstate your qualified exemption under § 112.5, in accordance with the requirements of paragraph (b) of this section.

[80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]

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