Page:United States Statutes at Large Volume 124.djvu/3916

124 STAT. 3890 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(b) HAZARD ANALYSIS.—The owner, operator, or agent in charge of a facility shall— ‘‘(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including— ‘‘(A) biological, chemical, physical, and radiological haz- ards, natural toxins, pesticides, drug residues, decomposi- tion, parasites, allergens, and unapproved food and color additives; and ‘‘(B) hazards that occur naturally, or may be uninten- tionally introduced; and ‘‘(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and ‘‘(3) develop a written analysis of the hazards. ‘‘(c) PREVENTIVE CONTROLS.—The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that— ‘‘(1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be significantly minimized or pre- vented; ‘‘(2) any hazards identified in the hazard analysis conducted under subsection (b)(2) will be significantly minimized or pre- vented and addressed, consistent with section 420, as applicable; and ‘‘(3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 or mis- branded under section 403(w). ‘‘(d) MONITORING OF EFFECTIVENESS.—The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under subsection (c) to provide assurances that the outcomes described in subsection (c) shall be achieved. ‘‘(e) CORRECTIVE ACTIONS.—The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under subsection (c) are not properly implemented or are found to be ineffective— ‘‘(1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; ‘‘(2) all affected food is evaluated for safety; and ‘‘(3) all affected food is prevented from entering into com- merce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w). ‘‘(f) VERIFICATION.—The owner, operator, or agent in charge of a facility shall verify that— ‘‘(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under sub- section (b); ‘‘(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d); ‘‘(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e); ‘‘(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and Procedures.