Page:United States Statutes at Large Volume 124.djvu/3915

124 STAT. 3889 PUBLIC LAW 111–353—JAN. 4, 2011 under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain lan- guage the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section. (3) IMPORTED FOOD.—Section 801(l) (21 U.S.C. 381(l)) is amended by inserting ‘‘(or for which a registration has been suspended under such section)’’ after ‘‘section 415’’. (c) CLARIFICATION OF INTENT.— (1) RETAIL FOOD ESTABLISHMENT.—The Secretary shall amend the definition of the term ‘‘retail food establishment’’ in section in 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include— (A) the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed; (B) the sale and distribution of such food through a community supported agriculture program; and (C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary. (2) DEFINITIONS.—For purposes of paragraph (1)— (A) the term ‘‘community supported agriculture pro- gram’’ has the same meaning given the term ‘‘community supported agriculture (CSA) program’’ in section 249.2 of title 7, Code of Federal Regulations (or any successor regu- lation); and (B) the term ‘‘consumer’’ does not include a business. (d) CONFORMING AMENDMENTS.— (1) Section 301(d) (21 U.S.C. 331(d)) is amended by inserting ‘‘415,’’ after ‘‘404,’’. (2) Section 415(d), as redesignated by subsection (b), is amended by adding at the end before the period ‘‘for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)’’. SEC. 103. HAZARD ANALYSIS AND RISK -BASED PREVENTIVE CON - TROLS. (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.) is amended by adding at the end the following: ‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CON - TROLS. ‘‘(a) IN GENERAL.—The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this moni- toring as a matter of routine practice. 21 USC 350g. 21 USC 350d. 21 USC 350d note.