The 1997 National Conference on Interstate Milk Shipments (NCIMS) appointed a committee to address how a voluntary Hazard Analysis and Critical Control Point (HACCP) System should be implemented, evaluated, monitored and enforced under the NCIMS as an alternative to the traditional Inspection/Rating/Check Rating System. This program will:
A proposal was presented to the voting delegates at the 1999 NCIMS Conference and a voluntary pilot was authorized to evaluate the proposed plan. The study was conducted in six plants from different states and FDA regions. The plants were chosen to represent a range of plant sizes and product mixes. Sites were selected from volunteer plants with state regulatory approval. While the pilot project is ongoing, this interim report presents the findings of the onsite visits of the evaluation team.
The evaluation team, composed of members from state regulatory, industry, FDA and academia, visited all six pilot sites during the summer and fall of 2001. The team presented questionnaires to plant management and personnel, state regulators, listing officers, Grade A milk program directors, and Regional Milk Specialists, then conducted follow-up interviews to evaluate the development, implementation, and maintenance of the pilot program. On-site visits were used to evaluate the pilot first-hand at the participating plant and at the regulatory agency.
The team found that the states have the capability to uniformly implement the NCIMS HACCP pilot program. The program, as presented, forms an adequate basis for reciprocity between states. The level of food safety was found to be at least equivalent to that provided under the traditional program based on inspection, rating and check-rating. The assurance of food safety appears to be enhanced. Voluntary application of the program seems to be appropriate at the present time.
As would be expected from piloting a new system, the team found areas where the pilot document needed clarification as well as opportunities for improvement. These have been presented in a detailed list of interim findings and recommendations. These findings were developed from onsite observations, questionnaires and interviews.
In order to provide uniform interpretation of the pilot, and to answer technical questions arising from the pilot, a Technical Resource Team consisting of NCIMS HACCP Committee members from state regulatory, industry and FDA was formed. The team functioned effectively throughout the pilot and communicated its decisions utilizing the FDA web site.
Resources were found to be an issue for both industry and regulatory agencies. The authority to provide these resources presupposes upper management commitment in these organizations. Industry resources that were needed included technical expertise, training, and supervisory oversight. Time was necessary for outside training of key technical personnel and in-house training of team members, supervisors and operators. Further time commitments were required to develop, implement and maintain the program. Documentation and verification of the applied program required the time of a coordinator. Due to the demands of the pilot schedule, program development and in-plant training was rushed. Resources required for the development and implementation phases of the pilot were greater than originally anticipated.
It was necessary for the regulatory agency to commit the personnel resources normally required for the plant inspection effort, plus additional time for training of regulators and listing officers in the basics of HACCP and auditing. Increased communications with the plant and extra visits were necessary in the development and implementation phases. The team found that time spent on the audit will take longer than the traditional inspection time, at least until the auditor becomes comfortable and familiar with the plant's system.
The training that was provided for the pilot program was adequate for the start-up of the pilot, however additional training will be necessary to implement the proposed program. The pilot study pointed out areas for increased training emphasis. There is confusion among the participants about the relative difference between the prerequisite programs (PPs), associated Sanitation Standard Operating Procedures (SSOPs), and Critical Control Points (CCPs). Participants requested more "hands-on" training and more guidance in the technical aspects of hazard identification, control and verification. There is a need to provide enhanced training in auditing techniques.
Since HACCP is science-based, there is the presumption of technical expertise in the identification of hazards, choosing controls, and system verification. In order to provide assistance in conducting the hazard analysis and developing the rest of the plan, the team recommends the development of a "hazards and controls guide." Models of HACCP plans and a model prerequisite program as well as guidelines for the implementation of SSOPs and PPs should be included.
The majority of recommendations from the evaluation team deal with the issues of auditing and oversight. Some regulators were challenged by a system that they perceived to be more subjective and less prescriptive. Because of this, the team recommends the formation of a subcommittee to clarify the audit procedures and help develop training and standardization models. In addition, the training should emphasize the proper application of compliance tools available to the regulator.
The team found that the relationships among industry, state regulatory and FDA were positive and were necessary to effectively implement the pilot. Roles and coordination will be somewhat different under HACCP and may change as the program matures and more experiences are gained.
The evaluation team recommends that the NCIMS HACCP Committee should modify the pilot document incorporating the team's interim findings and recommendations. The committee should produce a proposal that the NCIMS implement HACCP as a voluntary program. The current pilot study will continue and a final report will be presented to the NCIMS HACCP Committee.
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