Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA or we) is amending a final rule that published in the
Effective January 22, 2016.
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS–300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2166.
In the
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements.
Food packaging, Foods.
15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 360ccc, 360ccc–1, 360ccc–2, 362, 371, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.
21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
(b) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act or subpart C, D, E, F, or G of this part is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act.
The revisions read as follows:
(1) Is located:
(a) Except as provided by subpart E of this part, subparts C and G of this part do not apply to a qualified facility. * * *
(h) * * *
(3) * * *
(v) Extracting (including by pressing, by distilling, and by solvent extraction) dried/dehydrated herb and spice products (
(a) * * *
(2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in this subpart to ensure that the identified hazard will be significantly minimized or prevented and you:
(5) You have established, documented, and implemented a system that ensures control, at a subsequent distribution step, of the hazards in the food you distribute and you document the implementation of that system.
(b) * * *
(5) Your system, in accordance with paragraph (a)(5) of this section, that ensures control, at a subsequent distribution step, of the hazards in the food you distribute.
(a)
(b) * * *
(2) * * *
(i) * * *
(B) Write to the U.S. Food and Drug Administration (HFS–681), 5100 Paint Branch Pkwy., College Park, MD 20740; or
(ii) Send a paper Form FDA 3942a to the U.S. Food and Drug Administration (HFS–681), 5100 Paint Branch Pkwy., College Park, MD 20740. We recommend that you submit a paper copy only if your facility does not have reasonable access to the Internet.
(e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 117.287;
(a) * * *
(1) Submit the appeal in writing to the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition), at the mailing address, email address, or facsimile number identified in the order within 15 calendar days of the date of receipt of confirmation of the order; and