55 Cal.App.5th 1113
Cal. Ct. App.2020Background:
- Proposition 65 requires OEHHA to publish a list of chemicals "known to the state" to cause cancer or reproductive toxicity and provides four independent listing mechanisms (including the state’s qualified experts and authoritative body routes).
- Bisphenol A (BPA) is widely used in food-contact plastics/epoxies; NTP-CERHR issued a 2008 monograph finding "clear evidence" of adverse developmental effects in laboratory animals at high doses, limited/controversial low‑dose animal findings, and insufficient direct human evidence but stating humans could "possibly" be affected.
- California’s DART-IC (the gubernatorially appointed expert panel) reviewed the monograph in 2009 and unanimously voted not to list BPA under the state’s qualified-expert mechanism.
- NRDC petitioned OEHHA to list BPA under the authoritative‑body mechanism based on the NTP monograph; OEHHA later issued a notice and listed BPA as a developmental/reproductive toxicant relying on the monograph’s high‑dose animal findings and a presumption permitting extrapolation to humans absent contrary evidence.
- American Chemistry Council (ACC) sued seeking to enjoin the listing, arguing OEHHA improperly ignored DART-IC, misread the monograph (no "formal identification"), and lacked evidence of biological plausibility; trial court and the Court of Appeal upheld OEHHA’s listing.
Issues:
| Issue | Plaintiff's Argument (ACC) | Defendant's Argument (OEHHA/NRDC) | Held |
|---|---|---|---|
| Whether OEHHA abused discretion by not giving effect to DART‑IC’s declination | DART‑IC (state experts) reviewed same record and unanimously declined to list; OEHHA should have deferred | The qualified‑experts and authoritative‑body listing mechanisms are separate; regulations do not require OEHHA to adopt DART‑IC’s prior conclusion | OEHHA did not abuse discretion; regulations treat the mechanisms as independent and OEHHA need not defer absent formal post‑notice comment or reconsideration request |
| Whether the NTP monograph "formally identified" BPA as a reproductive toxicant under Reg. 25306(d) | The monograph’s language (e.g., "possibility" and "insufficient evidence" for humans) does not amount to a formal identification | The monograph states clear evidence of adverse developmental effects in animals at high doses; formal identification need not use a magic phrase | OEHHA reasonably concluded NTP formally identified BPA based on monograph language showing "clear evidence" in animals |
| Whether OEHHA had substantial evidence of "biological plausibility" under Reg. 25306(g) to extrapolate animal effects to humans | Monograph shows controversy over low‑dose findings and little human evidence; OEHHA cannot assume human plausibility from animal high‑dose data alone | Regulations and precedent permit OEHHA to review the authoritative report plus the underlying record; a presumption allows extrapolation absent evidence to the contrary | OEHHA’s finding of biological plausibility was supported: it considered the record, applied the accepted presumption of extrapolating animal data, and identified no contrary evidence |
| Whether OEHHA abused discretion by discounting dissenting experts and subsequent studies (e.g., Dr. Tyl) | OEHHA ignored persuasive contrary expert analysis and later work showing BPA safe for humans | OEHHA considered contrary submissions but was not bound by them when the authoritative report and underlying studies supported listing | OEHHA acted within its discretion; it could weigh and reject contrary expert views after reviewing the record |
Key Cases Cited
- Exxon Mobil Corp. v. Office of Envtl. Health Hazard Assessment, 169 Cal.App.4th 1264 (Cal. Ct. App. 2009) (OEHHA may rely on authoritative body reports plus underlying record and apply presumption extrapolating animal harm to humans for biological plausibility).
- Deukmejian v. Brown, 212 Cal.App.3d 425 (Cal. Ct. App. 1989) (Proposition 65 listing may be based on animal evidence; listing requirement concerns chemicals "known" to cause toxicity, not limited to human data).
- Western Crop Protection Assn. v. Davis, 80 Cal.App.4th 741 (Cal. Ct. App. 2000) (agency must follow regulatory listing procedures; OEHHA may examine the authoritative record under Reg. 25306).
- Styrene Info. & Research Ctr. v. Office of Envtl. Health Hazard Assessment, 210 Cal.App.4th 1082 (Cal. Ct. App. 2012) (distinguishes cases where authoritative body only finds a chemical "possibly" carcinogenic and where animal evidence is lacking).
- California Chamber of Commerce v. Brown, 196 Cal.App.4th 233 (Cal. Ct. App. 2011) (discusses OEHHA authority and role of DART‑IC in the regulatory scheme).
- American Chemistry Council v. Office of Envtl. Health Hazard Assessment, 51 Cal.App.5th 918 (Cal. Ct. App. 2020) (confirming that listing may be based on animal data and that regulatory mechanisms are distinct).