Page:United States Statutes at Large Volume 124.djvu/3924

124 STAT. 3898 PUBLIC LAW 111–353—JAN. 4, 2011 (A) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for pur- poses of section 415 of the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 350d), as amended by this Act; (B) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415; and (C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act, as added by this Act, from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities. (d) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not later than 180 days after the issuance of the regulations promulgated under subsection (n) of section 418 of the Federal Food, Drug, and Cos- metic Act (as added by subsection (a)), the Secretary shall issue a small entity compliance policy guide setting forth in plain lan- guage the requirements of such section 418 and this section to assist small entities in complying with the hazard analysis and other activities required under such section 418 and this section. (e) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331) is amended by adding at the end the following: ‘‘(uu) 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 not in compliance with section 418.’’. (f) NO EFFECT ON HACCP AUTHORITIES.—Nothing in the amendments made by this section limits the authority of the Sec- retary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce Hazard Analysis Critical Control programs and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards. (g) DIETARY SUPPLEMENTS.—Nothing in the amendments made by this section shall apply to any facility with regard to the manu- facturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa–1). (h) UPDATING GUIDANCE RELATING TO FISH AND FISHERIES PRODUCTS HAZARDS AND CONTROLS.—The Secretary shall, not later than 180 days after the date of enactment of this Act, update the Fish and Fisheries Products Hazards and Control Guidance to take into account advances in technology that have occurred since the previous publication of such Guidance by the Secretary. (i) EFFECTIVE DATES.— (1) GENERAL RULE.—The amendments made by this section shall take effect 18 months after the date of enactment of this Act. (2) FLEXIBILITY FOR SMALL BUSINESSES.—Notwithstanding paragraph (1)— (A) the amendments made by this section shall apply to a small business (as defined in the regulations promul- gated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added by this section)) beginning on the Applicability. Effective dates. 21 USC 350g. Deadline. 21 USC 342 note. Applicability. 21 USC 350g note. 21 USC 350g note. Deadline. 21 USC 350g note.