21 U.S.C. § 350g Hazard Analysis and Risk-Based Preventive Controls

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 350g

(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 342 of this title or misbranded under section 343(w) of this title, monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

(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 hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and

(B) hazards that occur naturally, or may be unintentionally 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 prevented;

(2) any hazards identified in the hazard analysis conducted under subsection (b)(2) will be significantly minimized or prevented and addressed, consistent with section 350i of this title, as applicable; and

(3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(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 commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(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 subsection (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

(5) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.

(g) Recordkeeping

The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under subsection (f)(4), instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

(h) Written plan and documentation

The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. Such written plan, together with the documentation described in subsection (g), shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.