Food & Beverages | HARPC (Risk Prevention)

Under the FSMA, effective July 4, 2012, food facilities must maintain Hazard Analysis and Risk-Based Preventive Controls (HARPC). The HARPC requirements are similar to the Hazard Analysis and Critical Control Point (HACCP) requirements which apply to processors of low-acid canned foods, seafood and juice, except that HARPC applies to nearly all food facilities. Exempt facilities are (1) those subject to Standards of Produce Safety, (2) those subject to HACCP and low-acid canned food standards, and (3) those subject to Dietary Supplement current Good Manufacturing Practices.

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Under HARPC each facility must:

  1. conduct hazard analysis;
  2. develop and implement preventive controls and monitor the controls effectiveness;
  3. develop a written plan for controlling the hazards;
  4. reanalyze processes for potential hazards at least every three years;
  5. verify the effectiveness of the controls; and,
  6. maintain records of the verification process.

FSMA requires FDA to issue regulations which will define a small and very small business, entities exempt from HARPC requirements.

Proposed Rule Update (January 2013)


Summary of the Provision (2011)

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