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FDA Science Board Subcommittee on BPA, Scientific Peer Review of FDA's draft assessment of BPA use in food contact applications

FDA observes that this BPA Subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the Subcommittee's report by the Science Board on Oct. 31.(1) The Subcommittee Report states that its focus is the scientific peer-review of the draft Assessment prepared by FDA of BPA for use in food contact applications.(2) Subcommittee members were selected by the Science Board for their expertise in scientific disciplines relating specifically to the issues assessed in this FDA draft safety assessment. It is the purpose of the Subcommittee to provide advice and make preliminary recommendations regarding FDA draft safety assessment for subsequent action by the full Board.
The Subcommittee Report specifically finds that,

Coupling together the available qualitative and quantitative information (including application of uncertainty factors) provides a sufficient scientific basis to conclude that the Margins of Safety defined by the FDA as 'adequate' are, in fact, inadequate.

Following are additional, 'Specific Findings of the Subcommittee':
-BPA is present in food contact applications resulting in dietary exposure of BPA to infants, children and adults. The Subcommittee agrees with the focus of the draft assessment on dietary exposures to children because they are likely to have both greater exposures and susceptibility than adults as a function of food consumption patterns, metabolism, vulnerability of developing systems and other factors. Nevertheless it is [our] opinion that FDA assessment would be strengthened by considering cumulative exposures and differential risk in neonates.
-The draft FDA exposure assessment has important limitations including that it lacks an adequate number of infant formula samples and relies on mean values rather than accounting for the variability in samples.
-The draft FDA report does not articulate reasonable and appropriate scientific support or the criteria applied to select data for use in the assessment. Specifically the Subcommittee does not agree that the large number of non-GLP ['Good Laboratory Practices']studies should be excluded from use in the safety assessment.
-Consistent and credible criteria for study inclusion would be to use those studies that are judged as 'adequate' by CERHR in the FDA hazard, dose-response and safety assessment of BPA. In addition several studies of effects of BPA on adult humans and animal species that were published after the draft assessment was finished should be considered for inclusion in the final assessment.
- The Subcommittee finds that the assessment lacks an adequate characterization of uncertainties in its estimates of both exposure and effects.
The weight-of-the-evidence, including studies identified by CERHR as adequate and having utility provides scientific support for use of a point of departure substantially below... the 5 mg/kg bw/day level selected in the draft FDA assessment.

The Subcommittee Report concludes:
While the draft safety assessment had some strengths, the Subcommittee identified several significant concerns with the assessment in its current form....including:
-The draft lacks a clear description of the criteria for eliminating an increasing number of non-GLP studies that indicate the possibility of toxic effects that are not mediated by interaction of BPA with the estrogen receptor, and the Subcommittee does not agree with the exclusion of the non-GLP studies in the safety assessment.
-Additional concern is expressed with the calculation of the NOAEL [no observed adverse effect level] and specifically whether the exposure assessment to 'at risk' infants with minimal or impaired metabolic function and exposures from medical devices and procedures is as conservative as the assessment claims. In fact, it is the judgment of the Subcommittee that lack of consideration of the totality of exposures from others sources severely limits the usefulness of the safety assessment with respect to food contact applications.
-The Subcommittee identified a need for application for application of state -of-the-art risk assessment methods in this assessment which will enable utilizing all appropriate scientific info available on the potential toxicity of BPA.
CERHR: National Toxicology Program's (NTP) Center for the Evaluation of Risk to Human Reproduction
GLP: Good Laboratory Practices, see GLP, 21 CFR Part 58 , following GLP's is intended to ensure the quality and integrity of the safety data' and see also 'Redbook 2000', 'Guidance for Industry and Other Stakeholders Toxicological Principles for the Safety Assessment of Food Ingredients' to support the safe use of food additives. p15 FDA draft assessment


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