Page:United States Statutes at Large Volume 124.djvu/3922

124 STAT. 3896 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(5) REVIEW.—In promulgating the regulations under para- graph (1)(A), the Secretary shall review regulatory hazard anal- ysis and preventive control programs in existence on the date of enactment of the FDA Food Safety Modernization Act, including the Grade ‘A’ Pasteurized Milk Ordinance to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized stand- ards in existence on such date. ‘‘(o) DEFINITIONS.—For purposes of this section: ‘‘(1) CRITICAL CONTROL POINT.—The term ‘critical control point’ means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level. ‘‘(2) FACILITY.—The term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415. ‘‘(3) PREVENTIVE CONTROLS.—The term ‘preventive controls’ means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under sub- section (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, prac- tices, and processes may include the following: ‘‘(A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment. ‘‘(B) Supervisor, manager, and employee hygiene training. ‘‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environ- ment. ‘‘(D) A food allergen control program. ‘‘(E) A recall plan. ‘‘(F) Current Good Manufacturing Practices (cGMPs) under part 110 of title 21, Code of Federal Regulations (or any successor regulations). ‘‘(G) Supplier verification activities that relate to the safety of food.’’. (b) GUIDANCE DOCUMENT.—The Secretary shall issue a guid- ance document related to the regulations promulgated under sub- section (b)(1) with respect to the hazard analysis and preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). (c) RULEMAKING.— (1) PROPOSED RULEMAKING.— (A) IN GENERAL.—Not later than 9 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the ‘‘Secretary’’) shall publish a notice of proposed rule- making in the Federal Register to promulgate regulations with respect to— (i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed Deadline. Federal Register, publication. Notice. 21 USC 350d note. 21 USC 350g note.