|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Q: What is FSIS’ response to the recommendations contained within the GAO report on HIMP?
A: FSIS appreciates that GAO’s intent in its recommendations is to strengthen the Agency’s ongoing efforts to enhance public health through innovative, science-based programs and activities. FSIS will consider the report’s recommendations – in addition to suggestions from employees, industry, and the general public – and will address them as we seek public comment for any proposed regulatory changes.
The HIMP study design was established to measure the accomplishments of the traditional inspection system with the accomplishments of the models inspection system. Data collection conducted by Research Triangle Institute, an independent consulting firm, has indicated that HIMP has improved the safety of poultry products and increased overall consumer protection, as compared to traditional inspection.
Moreover, FSIS inspector verification data has shown that the redesigned system of inspection that we are testing has shown marked reductions in defects in young chickens as compared to the traditional inspection system. While no food safety or non-food safety defects are acceptable to FSIS, this project is showing important food safety gains.
Q: Does FSIS agree with GAO’s recommendation that only plants with a good history of regulatory compliance be eligible to participate in the inspection program?
A: Yes. As part of FSIS’ efforts to evaluate and continuously seek improvements for the HIMP pilot, the Agency is considering several improvements to the pilot project. Among these improvements is the consideration to phase in the implementation of HIMP over time. The program would also be voluntary. Plants volunteering for inspection under HIMP would need to demonstrate that they have successfully performed under an HACCP-based inspection system before being allowed to participate in the voluntary inspection system. This is an idea the Agency has been entertaining for a while, and are glad to learn that it is included in the GAO recommendations.
Q: Does FSIS agree with GAO’s recommendation that formalized training should be required of plant personnel?
A: Yes. Another improvement FSIS will consider for the HIMP pilot is to mandate formalized training for plant personnel. This is something that the Agency had considered independently of the GAO recommendations. In keeping with the Agency’s appropriate role in an HACCP environment, FSIS would allow plants flexibility in selecting a formal training program.
Q: Will FSIS consider suggestions from Agency inspectors and veterinarians when developing rulemaking on HIMP?
A: FSIS employees have provided valuable comments and suggestions during the course of the pilot program, particularly inspectors working in HIMP plants, and FSIS will continue to examine ways to improve how it receives this information. In addition, USDA will continue to seek input from all interested parties – including public health, industry, and consumer groups as well as the general public – to strengthen the program. Notice and comment rulemaking for each species, with opportunities for open public comment, will be conducted before any regulatory changes are made.
Q: How does FSIS respond to GAO’s conclusion that the Agency did not employ a random sample of plants when selecting participants for this project?
A: FSIS’ use of volunteer plants is a legitimate and valid practice. In many real-world applications, especially those involving animal experiments, it is impossible or impractical to use truly random samples. In this specific instance, because this is a pilot project and not mandated by rulemaking, FSIS could not require plants to participate in this project and therefore solicited volunteers.
Although not randomly selected, the volunteer plants participating in the HIMP study are representative of industry (i.e., diversity in geography, corporate structure, management styles, numbers of evisceration lines, product distribution patterns, inspection systems in use prior to the pilot, and other variables).
Q: Does FSIS agree with GAO’s conclusion that design and methodology limitation of the project design compromise the overall validity and reliability of its results?
A: No. As previously stated, FSIS disagrees with GAO’s conclusion about the limitations of design and methodology. The Agency believes that the HIMP study design was structurally sound, and could support future regulatory changes. Additionally, the design was previously peer reviewed by an external expert and discussed at public meetings.
The HIMP study is a commonly used "before and after" quality measurement design – one that has been used in many real world applications – especially those involving animal experiments. Such applied studies have been previously conducted by the Agency and independent researchers, and are found throughout peer reviewed literature.
Consequently, FSIS believes any data collected under the project is reliable and valid.
Q: Is FSIS considering GAO’s recommendation that plants be required to implement statistical process controls to manage and control production?
A: FSIS believes that statistical process control systems, which help to determine whether a plant’s production processes are performing within established performance standards, are important tools for plants to use to manage and control their production. Another proposed improvement that FSIS is considering for the HIMP pilot is to mandate that participating plants use statistical process control for quality defects. Statistical process control does not apply to food safety defects because they already are set at zero.
For Further Information, Contact:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-9113
Fax: (202) 690-0460
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