Our regular readers may remember that back in March, environmental advocates raised concerns about the NationalÂ Toxicology ProgramÂ contractor preparing a draft report on bisphenol A, because the contractor had ties to companies that manufacture this particularÂ chemical. (Read past posts on theÂ issue.) After investigating the allegations, the NTP fired the contractor, Virginia-based Sciences International.
Now, Susanne Rust of the Milwaukee Journal Sentinel reports that the NTP has conducted an audit and found no imporpriety in the preparation of the report, which will provide background material for an expert panel evaluating the chemical's safety.Â Evironmental advocates interviewed say the auditÂ findings don't put their concerns to rest. From the article:
The [NTP] then audited the contract. The Virginia company's duties, in this case, were to search for studies related to bisphenol-A, provide summaries of these studies, and then prepare a draft report based on these studies, as well as from input provided by panel members.
On July 24, the toxicology program released the results of its audit. The government concluded Sciences International showed no impropriety.
"I feel vindicated," said Herman Gibb, president of Sciences International. But, he said, "It would have been nice if they had done this before they terminated the contract instead of after."
Others, however, are not swayed.
"It doesn't put our concerns to rest," said Anila Jacobs of the Environmental Working Group. The problem, she said, was not the literature search but the analysis provided by the firm.
Frederick vom Saal, a bisphenol-A researcher at the University of Missouri in Columbia, agreed.
He said the contractor not only misrepresented his studies in summaries they prepared but also included factual errors.
John Bucher, associate director of the toxicology program said the panel members will review the public comments and make corrections where needed.
The expert panel will evaluate and finalize the report next week in Alexandria.
It's not just the report's content that's at issue; it's also the NTP's contracting process. Marla Cone addressed this in the LA Times:
âFrankly, we feel weâve been unjustly treated,â said [Sciences International vice president Anthony] Scialli, who had been the federal centerâs chief scientific investigator.
If the institute âfelt it was necessary to have more stringent conflict of interest policies, they should develop them and make sure their contractors comply with them. But to end our contract because we didnât comply with policies that didnât exist doesnât make sense,â he said. âIf they want to hold us to standards, they should tell us what those standards are and we will cooperate.â
Scialli said his firm was fired because of political pressure from environmentalists, mainly the Environmental Working Group. Sciences International had one year left in a five-year, $5-million contract.
Institute spokeswoman Robin Mackar said the agency had no comment on the contract issue.
Court documents show that last year, Scialli was hired by 3M as an expert witness to testify in a lawsuit filed by Minnesota residents whose water was contaminated by a chemical that 3M formerly used in Scotchgard. The chemical has been detected in most peopleâs blood, and some studies suggest it can cause reproductive damage.
Scialli said he notified the federal health center that he was working for 3M but officials seemed unconcerned.
Environmentalists say that points to the need for the institute to develop a formal policy prohibiting conflicts of interest.
David Michaels summarized it this way in his post:
The issue is, and has been from the start, that NIH (or at least the National Toxicology Program) lacks the policies to deal with conflicts of interest - so when controversies like this arise, it is not possible to assure the public that the process and the scientists involved were unconflicted.
The audit may provide some closure for Sciences International, but it doesn't address the underlying problem of NTP lacking adequate policies for addressingÂ the issue ofÂ conflicted contractors.
This is an excerpt from Living on Earth's, "Bisphenol A Safety" story which aired on Aug. 3 (Link: http://www.loe.org/shows/segments.htm?programID=07-P13-00031&segmentID=4)
"AHEARN: But not all scientists are convinced that BPA is a serious health risk. Robert Chapin is the chair of the panel convening next week, under the National Toxicology Program, to draft a document that will advise the government on the risks of BPA. Heâs also a research advisor for the Pfizer pharmaceutical company.
CHAPIN: Actually I donât have a lot of concern about it at this point. The papers that we gave the greatest confidence in donât give me a lot of heartburn about the fact that humans are poisoning themselves because of BPA. But, weâre not done with the evaluation yet."
They aren't "done with the evaluation yet"? It sounds like Chapin is leaning towards a decision.
I looked at the Panel Roster and wondered how these individuals were chosen? It seems like not much has been said about the expertise or possible conflict of interest of the panel members. A few experts on BPA have raised this point, but more of the media reports on the review have been about the controversy with the contractor. Since the panel is making the final decision it seems that there should be more focus on making sure that those individuals have no conflict of interests and know the science, than who puts together the studies they look at (since they can still look at ones the contractors don't include).
I don't fault a person for being connected to industry or feel it automatically makes them suspect of immoral behavior, but I feel it is important for decisions like these to be made by experts who don't have competing interests. There are scientists that are extremely devoted to the specific study of BPA (like Dr. Fred vom Saal). I'm curious why he and others like him aren't on the panel?
That's a good question about the panel roster. Here's what CERHR's website says about how panelists are chosen:
"Expert Panels are the independent working groups of scientists that produce the individual reports. The Panels are comprised of individuals with expertise in one or several scientific areas integral to a chemical evaluation. These scientists are selected from a registry built and maintained by CERHR staff and represent academia, industry, and government research and regulatory agencies. Suggestions for additional scientists for this Registry may be sent to CERHR accompanied by a description of expertise and a curriculum vitae."
Until recently, Science International was running CERHR, so they would have built and maintained the expert registry.
Here's what the Federal Register notice (12/21/05) says about panelists:
"CERHR invites nominations of qualified scientists to serve on the individual expert panels for (1) bisphenol A and (2) hydroxyurea. Panelists are primarily drawn from the CERHR Expert Registry and/or the nomination of other scientists who meet the criteria for listing in that registry which include: formal academic training and experience in a relevant scientific field, publications in peer-reviewed journals, membership in relevant professional societies, and certification by an appropriate scientific board or other entities. Expert panel members are subject to applicable guidelines for conflict of interest in accordance with Federal Advisory Committee Act (5 U.S.C. Appendix 2).
"All panel members serve as individual experts and not as representatives of their employers or other organizations. Scientists on the expert panel will be selected to represent a wide range of expertise including, but not limited to, developmental toxicology, reproductive toxicology, epidemiology, general toxicology, pharmacokinetics, exposure assessment, and biostatistics. Nominations should include contact information and a current curriculum vitae (if possible) and be forwarded to
the CERHR at the address given above."
DRAFT MEETING SUMMARY
NATIONAL TOXICOLOGY PROGRAM CENTER FOR THE EVALUATION OF RISKS TO HUMAN REPRODUCTION
EXPERT PANEL EVALUATION OF BISPHENOL A AUGUST 6-8, 2007
The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) convened an expert panel on August 6-8, 2007, in Alexandria, Virginia to evaluate bisphenol A. This was the second public meeting of the expert panel, a group of 12 independent scientists convened to review and assess scientific studies on the potential reproductive and developmental hazards of Bisphenol A.
Expert Panel Conclusions For pregnant women and fetuses:
The Expert Panel expressed some concern that exposure to Bisphenol A in utero causes neural and behavioral effects
The Expert Panel had expressed minimal concern that exposure to Bisphenol A in utero causes effects on the prostate.
The Expert Panel expressed minimal concern that exposure to Bisphenol A in utero potentially causes accelerations in puberty.
The Expert Panel expressed negligible concern that exposure to Bisphenol A in utero produces birth defects and malformations.
For infants and children:
The Expert Panel expressed some concern that exposure to Bisphenol A causes neural and behavioral effects
The Expert Panel had expressed minimal concern that exposure to Bisphenol A potentially causes accelerations in puberty.
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 the following areas where additional research is needed.
The final expert panel report on bisphenol A will be posted on the CERHR web site (http://cerhr.niehs.nih.gov) and available in printe d 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 NTPâs 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 firstname.lastname@example.org.
Hello Dr. Shelby,
I'm a concerned parent worried about the possible dangers of BPA in my child's baby bottle. Many times I would boil water and pour it directly into the baby bottle and let in cool in it. Could this of leached BPA at higher amounts into my sons baby formula? What are the possible dangers/risks with using polycarbonate bottles?
Ivy, you may want to check this San Francisco Chronicle article for more about what parents are doing. It also includes links to sites that have further information.