Saturday 18 November 2017

New FSMA Rule Announced; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Amid an ongoing investigation into pet deaths from an unknown food source the US Food and Drug Administration announced new pet safety regulations. The regulations are unrelated to the current investigation. Instead they are part of the Food Safety Modernization Act and joint a recent outburst of new rules. The Food Court team will review the rules and provide more detail. Below is the FDA’s highlights from the proposed rule.

 

Highlights of the Proposed Rule

The proposed rule would establish for the first time Current Good Manufacturing Practices that specifically address the manufacturing, processing, packing, and holding of animal food. FDA considered it important to establish CGMPs for animal food as prerequisite requirements to ensure that these products are manufactured under conditions and practices that protect against contamination. The proposed rule also would establish Hazard Analysis and Risk-based Preventive Controls for Food for Animals to implement the provisions in section 103 of the FDA Food Safety Modernization Act. The new requirements would be called “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.”

New Current Good Manufacturing Practices

The proposed animal food CGMPs address similar safety requirements as those contained in the proposed rule to update the human food Current Good Manufacturing Practice (CGMP) regulations. These areas include:

  • Hygienic personnel practices and training;
  • Facility operations, maintenance, and sanitation;
  • Equipment and utensil design, use, and maintenance
  • Processes and controls; and
  • Warehousing and distribution.

However, the CGMP provisions of the proposed rule for animal food are not identical to the human food CGMPs in the proposed rule for preventive controls for human food. The animal food CGMPs, for example, would not address certain practices that don’t pertain to animal food, such as allergen cross-contact.

Hazard Analysis and Risk-Based Preventive Controls

Under the proposal, each owner, operator, or agent in charge of a facility (those required to register with FDA under Section 415 of the FD&C Act), with certain exceptions described below, would be required to comply with the hazard analysis and risk-based preventive controls. The preventive controls are science- and risk-based in that they would require controls that are necessary to protect human and animal health and exempt certain facilities from requirements or modify requirements for certain low-risk activities. Second, they areflexible in that firms can develop preventive controls that fit their products and operations, as long as they are adequate to significantly minimize or prevent all food safety hazards that are reasonably likely to occur.

The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems, which were pioneered by the human food industry and are required for juice and seafood. They would require operators of a facility to understand the hazards that are reasonably likely to occur in their operation and to put in place preventive controls to minimize or prevent the hazards. Although this proposed rule aligns well with HACCP, it differs in part in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls.

Each facility would be required to prepare and implement a written food safety plan, which would include the following:

  • A Hazard analysis that would identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility.
  • Preventive controls, which would be identified and implemented to provide assurances that hazards that are reasonably likely to occur would be significantly minimized or prevented. These preventive controls would need to be appropriate for the facility and the animal food being produced, and could address, for example, animal food processing, prevention of cross-contamination, and sanitation affecting animal food safety. A recall plan for animal food for which there are hazards that are reasonably likely to occur would be required. It is unlikely that all possible prevention measures and verification procedures would be applied to all animal 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. Although it is not included in the proposed requirements, it is discussed in the preamble and FDA is seeking comment on such a program.
  • Monitoring procedures that would 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 animal food for safety, and prevent affected animal food from entering commerce. If specific corrective action procedures were not established for the problem, or if a preventive control is 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 records review of monitoring, correction actions, or instrument calibration. Preventive controls would also be required to be validated to ensure they are effective in controlling the hazard. In addition, the food safety plan must be reassessed at least every three years and otherwise when necessary. FDA recognizes that product and environmental testing programs are science‐based verification activities that are commonly accepted in many sectors of the food industry. Although they are not included in the proposed requirements, they are discussed in the preamble and FDA is seeking comment on these programs. FDA also is asking for comments regarding review of customer and other complaints as part of verification.
  • Recordkeeping: Firms would be required to keep a written food safety plan, including the hazard analysis. They would also be required to keep records of preventive controls, monitoring, corrective action, and verification procedures.
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