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Independent Science Panel Rebukes FDA on Toxic Plastic

Side-by-Side Comparison of EWG’s public comments to FDA’s Science Board and BPA Subcommittee determiniations

By Sonya Lunder, MPH, Senior Analyst, October 2008

FDA’s advisory Science Board convened a BPA panel to evaluate an FDA staff risk assessment that termed bisphenol A (BPA) safe in food packaging. In its testimony to the panel, EWG highlighted 7 key shortcomings in the staff assessment. In every instance, the panel agreed with EWG and disagreed with the FDA staff report. The panel conclusions, released on October 28, will be formally presented to the full Science Board on October 31.

Issue	EWG says	Advisory panel says
FDA estimates of infant exposure to BPA from formula	"FDA’s so called 'conservative' exposure assessment for infants significantly underestimates exposures from BPA contamination of infant formula. ...[A]nalysis of formula concentrations shows that many infants are exposed to BPA above the levels calculated by FDA." (9/12/08 pg. 10, also 9/16/08, 9/24/08)"	"The draft FDA exposure assessment...lacks an adequate number of infant formula samples and relies on mean values rather than accounting for the variability in samples." (pg. 3) "[FDA] did not adequately account for variability in potential exposures, which the invited Panel [including EWG analyst Sonya Lunder] noted could be very large." (pg. 5)
FDA's exclusion of studies showing effects of exposure to low doses of BPA	"FDA uses inconsistent and illogical criteria to reject [independent] studies, notably the 12 studies NTP highlights as evidence of ‘low dose’ toxicity." (9/12/08 pg. 2, also 9/16/08)	"The draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment." (pg. 4)
Differences between FDA and the National Toxicology Program	"FDA’s findings stand in contrast to conclusions of the NIH’s National Toxicology Program’s recently completed monograph assessing the developmental and reproductive effects of BPA." (9/12/08 pg. 2, also 9/16/08.)	"Consistent and credible criteria for study inclusion, recommended by the Subcommittee, would be to use those studies that are judged as “adequate” by CERHR [Center for the Evaluation of Risks to Human Reproduction, an arm of the National Toxicology Program] in the FDA hazard, dose-response and safety assessment of BPA." (pg. 4)
FDA's reliance on studies that are certified for "Good Laboratory Practices"	"FDA’s assessment of BPA...excludes information gathered from academic scientists who find sensitive effects to the reproductive system and behavior. (9/12/08 pg. 4, also 9/16/08)	"The Subcommittee does not agree with the exclusion of the non-GLP studies in the safety assessment." (pg. 6)
The availability of new evidence	"FDA did not review very recent studies finding brain effects in primates and linking BPA exposures in American adults to heart disease and diabetes." (10/24/08 pg. 2)	"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." (pg. 7 & 12)
FDA's determination of a "No Effect Level" at 5 mg per kilogram per day	"FDA should use the lowest dose toxicity studies to calculate risk. Particularly the number of studies finding permanent effects to brain and behavior and the male reproductive system at 10 ug/kg-bodyweight per day." 9/16/08, 10/24/08 pg. 2)	"The weight-of-the-evidence...provides scientific support for use of a point of departure substantially below (i.e., at least one or more orders of magnitude lower than) the 5 mg/kg bw/day level selected in the draft FDA assessment." (pg. 4)
FDA's statement that infant's exposures are 2,000 times lower than the "No Effect Level" and therefore safe	"FDA has failed to acheive [its] safety standard." and "Using the low dose studies recommended by expert advisors as a “point of departure” would decrease the margin of safety by a factor of 500, meaning that FDA’s estimated exposures for a formula-fed baby would be just 4 times less than the doses that cause permanent brain and behavior impairment in laboratory tests." (10/24/08 pg. 2)	"Coupling together the available qualitative and quantitative information...provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as “adequate” are, in fact, inadequate." (pg. 4)

FDA’s has failed to support its claim that current uses of BPA are safe. FDA must start from the ground up with a new assessment that accurately characterizes BPA risks for infants, children and adults. In the meantime FDA must take immediate actions to reduce infant exposures to this toxic chemical. At a minimum this would involve Canadian-type precautions to reduce immediately infant exposures from infant formula and food containers. Formula-makers can and should reduce BPA levels while safer packaging is investigated. Parents should be advised to use non-polycarbonate bottles and powdered formula wherever possible. These dramatic measures are needed to assure that infants are not exposed to harmful amounts of BPA while a health-protective safety assessment is being drafted.

References

EWG written comments to BPA subcommittee September 12, 2008. EWG oral comments to BPA subcommittee by EWG Senior Analyst Sonya Lunder, participant on Invited Panelist and Anila Jacob, public commentor, Rockville MD, September 16, 2008. EWG written comments to BPA subcommittee September 24, 2008. EWG written comments to FDA Science Board, October 24, 2008. FDA Science Advisory Board Subcommittee on Bisphenol A. 2008. Scientific Peer-Review of the Draft Assessment of Bisphenol A for Use in Food Contact Applications. Draft October 31, 2008. Posted online 10/28/08. http://www.fda.gov/oc/advisory/scienceboard/2008-0038b1-05.pdf