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FDA’s Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice (Part 3 of 3)

ARegistrar Corp, a FDA compliance consultant, presented the food and beverage industry with a series of articles introducing FDA’s new Food Safety Rules.

1. FDA’s Hazard Analysis and Risk-Based Preventive Controls (Part 1 of 3)
2. FDA’s Current Good Manufacturing Practices (cGMP) (Part 2 of 3)

Registrar Corp’s final installment discusses FDA’s proposed Food Safety Plan requirements.

FDA’s proposed rule would require that the owner, operator, or agent in charge of a facility prepare, or have prepared, and implement a written food safety plan. FDA’s proposed rule allows a facility to prepare its own written food safety plan or to have the plan prepared, in whole or in part, on behalf of a facility. In addition, FDA provides flexibility for facilities in the development of their food safety plans by allowing facilities to group food types or production methods types if the hazards, control measures, parameters, and required procedures, such as monitoring, are essentially identical. Furthermore, to make clear that the written plan is related to food safety rather than to other plans (such as quality control plans or food defense plans), the FDA has designated, in the proposed rule, the “written plan” to be a “food safety plan.”

FDA would require each covered facility to prepare and implement a written food safety plan, which would include the following:

• A written Hazard analysis that identifies and evaluates known or reasonably foreseeable hazards (biological, chemical, physical, and radiological) for each type of food manufactured, processed, packed or held at the facility.

• Preventive controls, which would be required to be identified and implemented to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented. Preventive controls would be required to include, as appropriate: (1) process controls, (2) food allergen controls, (3) sanitation controls, and (4) a recall plan. However, the preventive controls required would depend on which, if any, hazards are reasonably likely to occur. It is unlikely that all possible prevention measures and verification procedures would be applied to all foods at all facilities. FDA believes a supplier approval and verification program is a risk-based and appropriate control to significantly minimize or prevent hazards from raw materials and ingredients that is consistent with current scientific understanding of food safety practices and is seeking comment on such a program. As appropriate, the preventive controls must include specific “parameters” (akin to “critical limits” in HACCP) required to effectively control the hazard. The proposed rule used the broader term parameters instead of critical limit because not all preventive controls will take place at critical control points. Further, FDA recognizes that not all possible preventive controls have measurable parameters, such as preventive maintenance, some aspects of sanitation, and label control for food allergens. When the control has associated documented parameters, these parameters must be proven effective at controlling the hazard. This proof can be obtained by using published scientific studies or conducting an independent, scientifically valid study.

• Monitoring procedures to provide assurance that preventive controls are consistently performed and records to document the monitoring.

• Corrective actions that would be used if preventive controls are not properly implemented. Facilities would be required to correct problems and minimize the likelihood of reoccurrence, evaluate the food for safety and prevent affected food from entering commerce when necessary. If specific corrective action procedures were not identified for the problem, or if a preventive control were found to be ineffective, the facility would also be required to re-evaluate the food safety plan to determine if modifications are needed.

• Verification activities to ensure that preventive controls are consistently implemented and are effective. Verification activities might include validation that the preventive controls are adequate for their purpose and are effective in controlling the hazard, activities to verify that controls are operating as intended and review of monitoring records. In addition, the proposed rule would require reassessment of the food safety plan at least every three years and at other times as appropriate. FDA recognizes that product and environmental testing programs are science-based verification activities that are commonly accepted in many sectors of the food industry and is seeking comment on these programs. FDA also is asking for comments regarding review of customer and other complaints as part of verification.

• The proposed rule would require that the owner, operator, or agent in charge of a facility establish a written recall plan for food in which there is a hazard that is reasonably likely to occur. Time is critical during a recall. A written plan is essential to minimize that time needed to accomplish a recall; additional time during which the food is on the market can result in additional consumer exposure.

Registrar Corp is a FDA regulatory compliance firm that assists companies with U.S. FDA Regulations. For more information about FDA’s new proposed rules or any FDA regulation, please contact Registrar Corp 24/7 at Live Help or call us at +1-757-224-0177.

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