Response to Petition by the Mateel Environmental Justice Foundation et al.

Oct 28, 2016

RESPONSE TO PETITION TO
THE OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT (OEHHA)
Pursuant to California Government Code section 11340.6 to amend California Code of Regulations
Title 27, Section 27001(c) to add delayed onset of puberty in females
as a reproductive toxic endpoint for which lead is known to cause reproductive toxicity

Submitted September 22, 2016 by
Mateel Environmental Justice Foundation, Californians for Alternatives to Toxics
and Ecological Rights Foundation

In a petition submitted on September 22, 2016, Mateel Environmental Justice Foundation, Californians for Alternatives to Toxics, and Ecological Rights Foundation request that the California Office of Environmental Health Hazard Assessment (OEHHA) amend California Code of Regulations, title 27, section 27001(c) to list lead as a female reproductive toxicant under Proposition 65,^[1],[2] using as the basis for this listing findings by the US Environmental Protection Agency (US EPA) and the National Toxicology Program (NTP) that lead is known to cause delayed onset of puberty in females. Lead and related chemicals are currently listed under Proposition 65 for cancer and reproductive toxicity (male reproductive, female reproductive, and developmental toxicity endpoints). For the reasons discussed below, OEHHA is unable to grant this petition.

US EPA is a body designated as authoritative for purposes of identifying chemicals as causing reproductive toxicity under Proposition 65^[3]. In support of their request, the petitioners identify an Integrated Science Assessment for Lead published by US EPA in 2013. However, that document identified delayed puberty as an effect on development rather than on female reproductive function (Table ES-1, page lxxxvi). US EPA concluded that there was a causal relationship between exposure to lead and delayed pubertal onset for girls, based on concurrent blood levels of lead in girls aged 6-18 years. Although delayed puberty is a developmental effect relevant to Proposition 65, OEHHA’s longstanding interpretation of the statute is that only developmental effects resulting entirely or predominantly from prenatal exposure to a chemical are relevant to listing chemicals under the Proposition. Since US EPA concluded that the association between lead exposure and delayed onset of puberty was dependent on blood lead levels at ages 6-18 years, this does not provide a basis for identifying this developmental effect under Proposition 65.

NTP is designated as authoritative for purposes of identifying chemicals as causing reproductive toxicity under Proposition 65 solely as to final reports of the National Toxicology Program's Center for Evaluation of Risks to Human Reproduction^[4]. In support of their request, the petitioners identify a Monograph on the Health Effects of Low-Level Lead published by NTP in 2012. However, that Monograph was published by the NTP Office of Health Assessment and Translation. Therefore, it does not meet the provision of the regulation that limits NTP’s designation as an authoritative body to final reports of the NTP's Center for Evaluation of Risks to Human Reproduction. Even if the document had been issued by the Center for Evaluation of Risks to Human Reproduction, NTP identified delayed puberty as an effect on development rather than female reproduction, and specifically concluded that the evidence for prenatal exposure causing this effect was inadequate, although there was sufficient evidence for exposure in children causing the effect (page 118, Table 8.6). As discussed above, developmental effects resulting from postnatal exposure are not considered relevant under Proposition 65.

^[1] The Safe Drinking Water and Toxics Enforcement Act of 1986, codified at Health and Safety Code section 25249.5 et seq. commonly referred to as “Proposition 65”.

^[2] The Petition cites Government Code section 11340.6 as authority, however, this provision of law does not apply to listings of chemicals under Proposition 65. See Health and Safety Code section, 25249.8(e) which states that the listing of chemicals under Proposition 65 is not subject to the provisions of the Administrative Procedure Act.

^[3] Title 27, California Code of Regulation, section 25306(l).

^[4] Title 27, California Code of Regulation, section 25306(l).