The scientific community has not reached consensus on the potential health effects of BPA to humans, but they are getting closer.

This week, an independent panel of scientists, the BSC reviewed the National Toxicology Program’s Draft Brief on BPA. The NTP’s highest levels of concern in the Draft did not reach “concern” or “serious concern” for any effect. Furthermore, the BSC peer review of this Draft recommended lowering the levels of concern about the effects of BPA on puberty in females and effects on the mammary gland from “some concern” to “minimal concern”.

This means that all but two effects are rated as of “negligible” or “minimal” concern and two (neural and behavioral and prostate) are of “some concern”. These levels of concern differ from those recommended by the NTP CERHR BPA Expert Panel in only 1 area (the prostate). http://ntp.niehs.nih.gov/files/BSCactionsBPA_508.pdf

For adults:
The Expert Panel expressed negligible concern for adverse reproductive effects following exposures in the general population to Bisphenol A. For highly exposed subgroups, such as occupationally exposed populations, the level of concern is elevated to minimal.
[The conclusions noted above are those of the Bisphenol A Expert Panel and should not be construed to represent the views of the NTP.]

Background on Bisphenol A
Bisphenol A is a high production volume chemical used primarily in the production of polycarbonate plastics and epoxy resins. Polycarbonate plastics are used in food and drink packaging; resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants and tooth coatings contain bisphenol A. Exposure to the general population can occur through direct contact with bisphenol A or by exposure to food or drink that has been in contact with a material containing bisphenol A. CERHR selected this chemical for evaluation because of (1) high production volume, (2) widespread human exposure, (3) evidence of reproductive toxicity in laboratory animal studies, and (4) public concern.
The expert panel reviewed and evaluated the available scientific data on bisphenol A in three primary areas: human exposure, reproductive toxicity, and developmental toxicity. In their deliberations, the expert panel considered the quality, quantity, and strength of the scientific evidence that exposure to bisphenol A might cause adverse effects on human reproduction and/or development of the fetus or infant. The expert panel identified gaps in the available scientific data on the possible effects of bisphenol A and suggested areas where additional research is needed.

Next Steps
The final expert panel report on bisphenol A will be posted on the CERHR web site (http://cerhr.niehs.nih.gov) and available in printed text from CERHR in fall 2007. CERHR will solicit public comments on this report through an announcement in the Federal Register. Following this comment period, CERHR will prepare the NTP-CERHR monograph on bisphenol A consisting of an NTP brief, the expert panel report, and all public comments on that report. The NTP brief contains the NTP’s opinion regarding whether current human exposures to bisphenol A are a risk for human development and reproduction. CERHR will solicit public comment on the NTP brief, after which it will undergo independent peer review. NTP will consider the public and peer review comments before finalizing the brief. The monographs will be available to the public in PDF format on the CERHR web site and in hardcopy by contacting CERHR and will be distributed to appropriate federal health and regulatory agencies.

Background on CERHR
The NTP established CERHR in 1998 as an environmental health resource to the public and to regulatory and health agencies. CERHR provides scientifically based, uniform assessments of the potential for adverse effects on reproduction and/or development caused to man-made or naturally occurring chemicals or chemical mixtures to which humans are exposed. CERHR convenes independent panels of scientific experts to conduct its evaluations. Expert panel meetings are open to the public and the public is invited to nominate scientists to serve on these panels. Following completion of the evaluation of a chemical, the NTP prepares an a NTP-CERHR monograph that contains its opinion on the potential for the chemical to be a reproductive and/or developmental hazard, the expert panel report, and public comments received on the final expert panel report. NTP-CERHR monographs on other chemicals evaluated by CERHR include seven phthalates, methanol, 1-bromopropane, 2-bromopropane, ethylene glycol, propylene glycol, fluoxetine, acrylamide, amphetamines, methylphenidate, and styrene. These monographs are available on the CERHR website and in hardcopy or CD from CERHR.
Questions about the expert panel review of bisphenol A or about CERHR can be directed to Dr. Michael Shelby, CERHR Director, at 919-541-3455 or shelby@niehs.nih.gov.
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Over the past few months, the National Toxicology Program (NTP) has undertaken a number of activities to address issues related to conflicts of interest (COI) and to ensure continued public confidence in its work. These included an independent review of its contracts for potential COI, development of a strong clause about COI for adding to NTP contracts, and an audit to assess the objectivity of information in draft reports prepared on the reproductive and developmental toxicity of bisphenol A (BPA). NTP would like to update you on these activities.

Review of NTP contracts
A working group of the NTP Board of Scientific Counselors conducted a review of NTP contracts to (1) assess potential COI, (2) develop recommendations appropriate for reducing the potential for conflicts to occur, and (3) address mechanisms for mitigating any current or future COI. The working group reviewed NTP contracts, information on contract performance provided by NTP staff, and information on policies and practices concerning COI provided by selected NTP contractors. The working group report was presented to the NTP Board of Scientific Counselors at its meeting on June 22, 2007, and following discussion, accepted unanimously without revision. The working group found no evidence of actual or apparent COI in its review of NTP contracts; however, it did recommend a number of best practices and areas where improvements could be made. The working group report is posted on the NTP web site
( http://ntp.niehs.nih.gov under “Latest News”).

COI clause for NTP contracts
A clause that specifically addresses contractor COI was developed and is being added to all NTP contracts. This action complements the review of NTP contracts by the NTP Board of Scientific Counselors Working Group, as noted above (see BSC Working Group report, Attachment 9, available
at http://ntp.niehs.nih.gov under “Latest News”).

Audit of draft BPA reports
The NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) conducts rigorous independent scientific evaluations to assess risk to human reproduction and development caused by environmental agents, such as bisphenol A, a chemical currently under review. In response to concerns raised about Sciences International, Inc. (SI), the former CERHR contractor (see March 2007 and April 2007 statements available at http://cerhr.niehs.nih.gov under “CERHR News”), NTP committed to a review of the contractor’s services to CERHR. As part of this review, NTP conducted an audit of two key activities carried out by SI: (1) selection of literature relevant for review by the expert panel on BPA and (2) incorporation of input from expert panel members into draft reports.

NTP found that SI made available to the expert panel members for their consideration appropriate references relevant to the BPA evaluation. NTP also found that SI reliably made changes to the draft reports requested by the expert panel. Based upon this audit, NTP concluded that the draft expert panel reports are useful for the BPA evaluation. The audit report is posted on the NTP
( http://ntp.niehs.nih.gov under “Latest News”) and CERHR
( http://cerhr.niehs.nih.gov under “CERHR News”) web sites.

Second BPA Expert Panel Meeting
The second BPA expert panel meeting is scheduled for August 6-8, 2007, at the Hilton Alexandria Old Town in Alexandria, Virginia. Details about the meeting are available on the CERHR web site for BPA ( http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol-mtg.html ).

This is extremely well written. I am someone concerned about this issue and the outcome, and appreciate you taking these actions to do something about the flawed regulatory process.

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