by Len Steed

Industry and trade associations have been buzzing for months about how FDA and state food-regulatory agencies will implement FSMA’s rules, particularly with the new Good Manufacturing Practices (GMPs) and Preventive Controls rules effective in September. Some inspection activities may be truly different, but preventing and limiting the effects of foodborne disease will not change.

Q: What documentation will regulators expect to see, and can I use my existing HACCP Plan? Regulatory investigators have attended the Food Safety Preventive Controls Alliance training with industry attendees and will have their own internal regulatory training as well. It’s safe to say that they will expect to see summary forms similar to what was presented in that course which would include:

  • Documented hazard analysis to identify preventive controls that will be monitored similar to a critical control point (CCP) in HACCP:
  • Consideration for known or foreseeable hazards in raw materials, formulations, and site-specific conditions (e.g., building, equipment, sanitation, hygiene) that could allow significant food safety hazards.
  • Evaluation of likelihood and severity of known hazard(s) if an effective preventive control(s) is not in place.
  • Hazard evaluation for environmental pathogens for ready-to-eat (RTE) products, as applicable.
  • Supporting documentation for conclusions made during hazard analysis using illness data, scientific reports, regulatory guidance, or other information.

While you can use any part of your existing food safety plans, process controls, sanitation programs, or other GMP programs as part of your preventive controls for specified food safety hazards, site-specific hazard evaluation still must be part of the evaluation. If there are known food safety issues with your building, equipment, or operational conditions, they should be represented in the hazard analysis, identifying any necessary controls you have in place.

Q: How do we prepare for these regulatory inspections? Training, training, and more training is the best course of action. With FDA’s expanded powers to review and request food safety records to be delivered within 24 hours, all personnel need thorough training on how to interact with regulators. The preventive control qualified individual (PCQI) will be at the center of those questions, but supervisors and plant employees carrying out and verifying preventive controls are likely to be interviewed to assess the plant’s food safety culture as compared to the GMP conditions observed at the facility. With preparation being key to success, it is advisable to test your readiness by performing an internal mock regulatory inspection or consulting a third-party provider that specializes in GMP compliance.

Q: FDA said it will bring technical expertise and efficiencies to inspections. What can we expect to see and when? FDA’s strategy for its “culture shift” is to have food commodity-specific training to improve the reliability of the inspection process by having internal and external subject matter experts (SMEs) available to inspectors for questions that arise during inspections. The goal is to improve inspection consistency. There are plans to launch FDA’s Observation Corrective Action Report (OCAR), an online IT platform that merges inspection preparation, onsite reporting, and compliance follow-up into one system. This system is scheduled to be operational by 2019 and will include compliance data, sampling results, consumer complaints, guidance documents, SME list, training videos, Reportable Food Registry lists, and inspection reports. The new focus will be on systems-based inspections with the goal of gaining industry compliance with FSMA rather than observation-focused enforcement (preventive vs reactive). Additionally, this initiative will create a vertically integrated, commodity-based program between FDA and state agencies with specialized inspectors and regulatory lab staff.

Q: What is likely to present the greatest challenges for FSMA? Undeclared allergens and pathogenic bacteria continue to dominate recalls, so any food safety plans associated with preventing these recalls must be effectively implemented and have decisive corrective action. Additionally, the supply chain program to identify, verify, and document what entity is controlling a significant food safety hazard will present challenges and added documentation. The rule section is complex, and guidance from FDA is still pending, so there is anxiety over the exact expectations for domestic and foreign suppliers. Another concept under FDA review is that of a two-tier approach for large firms by checking the adequacy of new food safety plans at the corporate level and checking the implementation of those at the facility level. Some corporations have already taken advantage of this as it offers many efficiencies for regulators and industry.

Len Steed is Manager, Global Innovation, AIB International.