Beveridge & Diamond
 

Alert Update: California Court Orders OEHHA to Remove BPA from Proposition 65 List

Beveridge & Diamond, P.C., April 23, 2013

On April 19, 2013, a California Superior Court issued a preliminary injunction ordering California’s Office of Environmental Health Hazard Assessment (“OEHHA”) to remove bisphenol A (“BPA”), CAS No. 80-05-7, from the Proposition 65 list.  The injunction was issued in a case brought by the American Chemistry Council challenging the validity of the BPA listing.[1]  The preliminary injunction will remain in place until a final decision in the case is rendered.

OEHHA published notices on its website the same day, announcing the agency’s removal of BPA from the Proposition 65 list[2] and withdrawl of its proposed Maximum Allowable Dose Level (“MADL”) for BPA, which had been proceeding as a parallel rulemaking to the BPA listing.[3]  OEHHA indicated that in the event that the preliminary injunction on the BPA listing is lifted, the agency may proceed with the MADL rulemaking for BPA.

Additional background on the recent BPA listing is included in the Beveridge & Diamond P.C. client alert below.  If you have questions regarding how the BPA listing or other Proposition 65 listings may affect your company, please contact Laura Duncan, a Shareholder (lduncan@bdlaw.com), or Steven Sarno, an Associate (ssarno@bdlaw.com), in Beveridge & Diamond’s San Francisco office.

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California Adds BPA to Proposition 65 List

Beveridge & Diamond, P.C., April 17, 2013

On April 11, California’s Office of Environmental Health Hazard Assessment added BPA to the list of chemicals known to the State to cause reproductive toxicity under Proposition 65.[4]  The warning requirements under Proposition 65 will take effect for BPA on April 11, 2014.  The deadline to comply with the discharge prohibition will follow on December 11, 2014.  This listing is separate from the parallel rulemaking underway to establish a Maximum Allowable Dose Level for BPA, which OEHHA proposed at 290 micrograms/day.[5]

Background

BPA is a key component in the manufacture of epoxy resins and polycarbonate plastic, materials which have numerous and diverse applications.  In 2008, the National Toxicology Program (“NTP”), through its Center for the Evaluation of Risks to Human Reproduction (“CERHR”), published a report entitled “NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A” (“NTP Monograph”).[6]  Later that year, the Natural Resources Defense Council (“NRDC”) petitioned the Federal Food and Drug Administration (“FDA”) to prohibit the use of BPA in human food packaging.  As one of its scientific bases, NRDC relied on the NTP Monograph.  In March 2012, FDA denied NRDC’s request,[7] citing work by its National Center for Toxicological Research (“NCTR”) which examined human exposure to BPA and the pharmacokinetics of BPA in pregnant rodents.  In finding that the scientific research (including the NTP Monograph) was insufficient to justify banning BPA, FDA noted that NCTR had not found evidence of BPA toxicity at low doses in rodent studies, including doses that were still above human exposure levels.[8]  FDA also dismissed the studies used by NRDC to support its assertion of reproductive effects, citing inappropriate study design and methodology.[9]  FDA reaffirmed its current safety assessment, but noted that it would continue to review emerging data and information on BPA.[10]  In July 2012, in response to a request by the American Chemistry Council, FDA amended the food additive regulations to reflect that BPA-based polycarbonate plastics are no longer used to produce baby bottles and toddler cups.[11]  The amendments did not address the use of BPA in other food additive or food contact applications.[12] 

California Listing

Proposition 65 provides for four separate mechanisms by which OEHHA can list a chemical, including the State’s Qualified Experts Mechanism and the Authoritative Body Mechanism.[13]  The NTP (solely as to final reports of the CERHR), and the FDA are two of several institutions designated as authoritative for the identification of chemicals causing reproductive toxicity.[14]  On January 25, 2013, OEHHA issued a Notice of Intent to List Bisphenol A (“NOIL”), relying on the authoritative bodies mechanism and citing the NTP Monograph as its scientific reference.[15]  In its April 11, listing decision, OEHHA stated that the NTP Monograph had formally concluded that BPA causes reproductive toxicity (development endpoint) at high doses.[16]

Possible Complications

Controversy over the listing of BPA was not unexpected and the conventional tension between the precautionary principle[17] and the cost-benefit analysis is present.[18]  But much of the debate has been driven by OEHHA’s process for listing BPA in this particular case.  In order to list a chemical pursuant to the authoritative body mechanism, OEHHA must find that an appropriate body “has determined that the chemical is a reproductive toxicant –i.e., that the experimental animal data are sufficient to support a conclusion that adverse effects in humans are biologically plausible.”[19]  In its NOIL for BPA, OEHHA states that the NTP Monograph alone “satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.”[20]  

Critics of OEHHA’s decision to list BPA have noted several inconsistencies.  First, the Development and Reproductive Toxicant Identification Committee, on July 15, 2009, voted unanimously not to list BPA as a reproductive toxicant after considering, among other reports, the NTP Monograph.[21]  Second, FDA (itself an “authoritative body,”) had reviewed the NTP Monograph and determined that it provided insufficient evidence to warrant banning BPA.5  Third, there is a surprising debate about what the NTP Monograph objectively says, as opposed to a subjective debate about the appropriateness of the conclusions.[22] 

On March 1, 2013, the American Chemistry Council filed a lawsuit in California State Superior Court in Sacramento, arguing that OEHHA was not justified in using the NTP Monograph in listing BPA for these reasons among others.[23]

Probable Next Steps [Note:  this section is impacted by the Preliminary Injunction referenced in the update above]

Three things are likely to happen in the near term.  First, OEHHA’s responses to public comments received on the BPA NOIL will soon be posted on its website.  Second, a California Superior Court must soon decide whether OEHHA’s listing of BPA moots the American Chemistry Council’s lawsuit and, if not, whether the plaintiff is entitled to a preliminary injunction.  Third, now that BPA is listed, OEHHA will likely proceed with the adoption of a proposed MADL safe harbor.[24]  If the BPA listing remains in force, companies will have until April 11, 2014 to determine how to comply with the law, including evaluating the level and accessibility of BPA in their products and determining whether to phase out certain materials, alter manufacturing processes, or implement warnings.

Click here for PDF of this news alert.


[1] American Chemistry Council v Office of Environmental Health Hazard Assessment, et al., Sacramento County case number 34-2013-00140720.

[2] See http://www.oehha.ca.gov/prop65/law/041913BPAdelist.html.

[3] See http://www.oehha.ca.gov/prop65/law/041913MADLwithdrawal.html.

[4] The Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code §§ 25249.5 et seq.  The most recent version of the Proposition 65 list, maintained by OEHHA, contains over 800 chemicals and is available online at http://www.oehha.ca.gov/prop65/prop65_list/files/P65single041113.pdf.

[5] http://www.oehha.org/prop65/law/012513BPA_MADL.html.

[6] http://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf.

[7] http://www.fda.gov/Food/FoodborneIllnessContaminants/
ChemicalContaminants/ucm166145.htm
.

[8] FDA OC Letter to Natural Resources Defense Council Petition Denial, Mar. 30, 2012, at 7, http://www.regulations.gov/#!documentDetail;D=FDA-2008-P-0577-0007.

[9] Id. at 12.

[10] Id. at 6.

[11] https://www.federalregister.gov/articles/2012/07/17/2012-17366/indirect-food-additives-polymers.

[12] http://www.nytimes.com/2012/07/18/science/fda-bans-bpa-from-baby-bottles-and-sippy-cups.html.

[13] See Cal. Health & Saf. Code § 25249.8.  The members of the Science Advisory Board, which consists of the Carcinogen Identification Committee and the Developmental and Reproductive Toxicant Identification Committee (“DARTIC”), are the State’s Qualified Experts.  The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies mechanism” can be found in 27 Cal. Code of Regs. § 25306(g).

[14] 27 Cal. Code of Regs. § 25306(l).

[15] http://www.oehha.ca.gov/prop65/CRNR_notices/admin_listing/
intent_to_list/NOILABpkg42BPA.html
.

[16] http://www.oehha.ca.gov/prop65/CRNR_notices/
list_changes/041113listBPA.html
.

[17] See Comments by Consumers Union asserting that “the safety of BPA, at current exposure levels in the US population, has not been demonstrated.”    http://www.oehha.ca.gov/prop65/
CRNR_notices/admin_listing/intent_to_list/pdf_zip/11BPAUrvashi_com.pdf
.

[18] See Comments by the International Formula Council asserting that mandatory labeling of BPA would “not provide any meaningful benefit to consumers.”  http://www.oehha.ca.gov/prop65/
CRNR_notices/admin_listing/intent_to_list/pdf_zip/4IFC_BPA_com.pdf
.

[19] Exxon Mobil v. OEHHA, 169 Cal. App. 4th 1264, 1280 (2009).

[20] http://www.oehha.ca.gov/prop65/CRNR_notices/admin_listing/
intent_to_list/NOILABpkg42BPA.html
.

[21] Transcript of the “July 15, 2009 Meeting Synopsis and Slide Presentations Developmental and Reproductive Toxicant Identification Committee Meeting Held on July 15, 2009 [07/23/09]” at 254-55,  http://www.oehha.ca.gov/prop65/public_meetings/pdf/
DARTICTranscript71509.pdf
.

[22] For example, in its comments to OEHHA, the Grocery Manufacturers Association asserts that the NTP Monograph does not conclude that BPA causes selective reproductive toxicity and that OEHHA has confused certain observations about animal data with the actual conclusions of the NTP-CERHR.  http://www.oehha.ca.gov/prop65/CRNR_notices/
admin_listing/intent_to_list/pdf_zip/5_BPAGMA_com.pdf
.

See also comments by the North American Metal Packaging Alliance asserting that the NTP Monograph “does not provide a conclusion or determination of reproductive toxicity.  It only provides expressions of ‘levels of concern[.]’”  http://www.oehha.ca.gov/prop65/CRNR_notices/
admin_listing/intent_to_list/pdf_zip/7NAMPA_com.pdf
.

[23] See Complaint at ¶ 3, 12, American Chemistry Council v. Office of the Environmental Health Hazard Assessment, Case No. 34-2013-00140720-CU-MC-GDS, filed 03/01/2013.

[24] http://www.oehha.ca.gov/prop65/law/012513BPA_MADL.html.