Comment Period - Does Bisphenol-A Meet Regulatory Criteria for Administrative Listing
On July 15, 2009, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) received a petition from the Natural Resources Defense Council (NRDC) asking that OEHHA initiate the process for listing bisphenol-A (BPA) as a reproductive toxicant under the Safe Drinking Water and Toxic Enforcement Act of 19861.
The petition, asserted that OEHHA should take this action under the authoritative bodies listing mechanism2. The petition cited a report on BPA by the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR), one of several institutions designated as authoritative for the identification of chemicals as causing reproductive toxicity (Section 25306(l)3).
Also on July 15, 2009, the Proposition 65 Developmental and Reproductive Toxicant Identification Committee (DART-IC ) voted not to list BPA as a reproductive toxicant. The DART-IC considered the listing of BPA under the State’s Qualified Experts listing mechanism.
The State’s Qualified Experts and authoritative bodies mechanisms are two of the four listing mechanisms established by Health and Safety Code section 25249.8. Each of these four mechanisms is separate and distinct, and none takes precedence over the other. Therefore, regardless of the outcome of the DART-IC review, OEHHA is required to consider the listing of BPA under the authoritative bodies’ mechanism.
Background on listing via the authoritative bodies mechanism: A chemical must be listed under the Proposition 65 regulations when OEHHA determines that two conditions are met:
- The evidence considered by the authoritative body meets the sufficiency criteria contained in the regulations (Section 25306(g)).
- An authoritative body formally identifies the chemical as causing reproductive toxicity (Section 25306(d)).
However, the chemical is not listed if scientifically valid data that were not considered by the authoritative body clearly establish that the sufficiency of evidence criteria were not met (Section 25306(h)).
OEHHA is the lead agency for Proposition 65 implementation. After an authoritative body has made a determination about a chemical, OEHHA evaluates whether listing under Proposition 65 is required using the criteria contained in the regulations.
Bisphenol-A
OEHHA’s determination: BPA appears to meet the criteria for listing as known to the State to cause reproductive toxicity under Proposition 65, based on findings of the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2008).
| Chemical | CAS No. | Endpoint | Reference | Chemical Use |
|---|---|---|---|---|
| Bisphenol-A (BPA) | 80-05-7 |
Developmental |
NTP-CERHR (2008) | Component in polycarbonate plastic used in water and baby bottles, present in epoxy resins used to line food cans and in dental sealants. |
Formal identification and sufficiency of evidence: In 2008, the NTP-CERHR published a report on BPA (NTP-CERHR, 2008). This report concludes that the chemical causes developmental toxicity at high levels of exposure, and appears to satisfy the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.
OEHHA is relying on the NTP-CERHR’s conclusions in the report that BPA causes reproductive toxicity. The NTP-CERHR report concludes that there is clear evidence of adverse developmental effects in laboratory animals at “high” levels of exposure. Developmental effects include fetal death and reduced litter size in rats and mice exposed prenatally.
Based on the NTP-CERHR report and the references cited in the report, the evidence appears sufficient for listing by the authoritative bodies’ mechanism.
Request for relevant information: OEHHA is requesting public comment concerning whether this chemical meets the criteria set forth in the Proposition 65 regulations for authoritative bodies listings.
After reviewing all comments received, OEHHA will determine whether BPA meets the regulatory criteria for administrative listing. If listing proceeds, OEHHA will publish a Notice of Intent to List and provide an additional public comment period.
In order to be considered, comments must be received by OEHHA by 5:00 p.m. on Tuesday, April 13, 2010. We encourage you to submit comments in electronic form, rather than in paper form. Comments transmitted by e-mail should be addressed to sam.delson@oehha.ca.gov. Comments submitted in paper form may be mailed, faxed, or delivered in person to the addresses below:
Mailing Address:
Sam Delson
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916) 323-8803
Street Address: 1001 I Street Sacramento, California 95814
Optional public forum: Upon request, OEHHA will schedule a public forum to provide individuals an opportunity to present oral comments on the possible listing of BPA. At the forum, the public may discuss the scientific data and other relevant information on whether the chemical meets the criteria for listing in the regulations.
Requests for a public forum must be submitted in writing to the address noted above no later than March 12, 2010. If a public forum is requested, a notice will be posted on the OEHHA Web site at least ten days before the forum date. The notice will provide the date, time, location and subject matter of the forum. Notice will also be sent to those individuals requesting such notification.
If you have any questions, please contact Sam Delson at sam.delson@oehha.ca.gov or at (916) 445 6900.
References
NTP-CERHR (2008). NTP-CERHR Monograph on the Potential Human Reproductive And Developmental Effects of Bisphenol A. Research Triangle Park, NC, National Toxicology Program: NIH Publication No. 08 – 5994.
1 Commonly known as Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, codified at Health and Safety Code section 25249.5 et seq.
2 See Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25306.
3 All referenced sections are from Title 27 of the Cal. Code of Regulations.