Food & Beverages | HARPC (Preventive Control Rule)

On September 17, 2015, FDA published the final rule for Hazard Analysis and Risk-Based Preventive Controls (HARPC or Preventive Controls) under the Food Safety Modernization Act (FSMA). Similar to the better-known Hazard Analysis and Critical Control Point (HACCP) program, HARPC requires that food facilities identify the hazards that can occur based on the food and the processing steps a manufacturer uses to process the food and to implement controls to prevent or minimize these hazards. Although HACCP applies only to seafood and juice, HARPC applies to nearly all food facilities. Exempt facilities are (1) those subject to Standards of Produce Safety, (2) those subject to HACCP, (3) those subject to Dietary Supplement current Good Manufacturing Practices, (4) on-farm packing or holding eligible food by very small businesses, (5) on-farm manufacturing or processing by small or very small businesses, (6) alcoholic beverages and other food in eligible facilities, (7) facilities for storage of RAC (raw agricultural commodities). Low acid canned food facilities are exempt from the microbiological hazards element of HARPC provided they comply with FDAs LACF regulations (FCE and SID requirements).

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Under HARPC, food facilities need to have a written food safety plan whereby they:

  1. conduct hazard analysis;
  2. develop the preventive controls;
  3. write recall plan;
  4. monitor the implementation of the controls;
  5. set up the corrective actions procedures;
  6. verify the effectiveness of the controls;
  7. reanalyze the food safety plan at least every three years;
  8. maintain records of all the previous steps.

In addition, a facility that receives raw material must conduct a hazard analysis for the raw material. The hazard analysis reveals an identifiable food safety hazard, the facility must establish and implement a risk-based supply-chain program to assure that the hazards are significantly minimized or prevented. The program should include:

  1. approval of suppliers;
  2. conducting appropriate supplier verifictaion activities;
  3. documenting supplier verification activities.

Preventive Control Rules under FSMA- What will be Expected of You? (February 2017)


Understanding the Preventive Control Rules under FSMA (2017)

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