(2) The proposal fails to outline a meaningful incentive to create demand for voluntary inspections, but still appears to assume that all existing accrediting bodies apply for and receive FDA recognition. Even though it has deferred stating the qualifications for inspectors, the FDA assumes that existing inspection firms continue to receive accreditation and meet dramatically increased demand in the number of facilities audited. This is not realistic. Nor, in light of the variability in the quality and capacity of current inspection firms, is unselective accreditation desirable.
(3) The proposal affirmatively excuses inspection firms from insurance requirements that international standards currently require. “Skin in the game” is a powerful, market-based protection against conflicts of interest, “paying for the grade,” and other low-quality audits. The FDA should bolster the liability system by requiring inspection firms to indemnify the first $1,000,000 in claims awarded based on adulterated food from
(4) The FDA errs in demanding “routine access” over all “records” of inspections, not just a regulatory report.4 Asserting that inspectors may be required to transmit recommendations for improvement threatens to disclose proprietary techniques and could even, perversely, diminish the quality of inspections. The FDA should seek more detailed feedback from industry and the public before striking the balance between regulatory access and commercial confidentiality.
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