The Center for Environmental Health is confident that it will have success with its petition to California's Office of Environmental Health Hazard Assessment seeking administrative review of the safe harbor for lead under Prop 65, even if a related lawsuit comes up short.

In a July 2 petition from Lexington Law Group representing CEH, a non-profit "dedicated to protecting the public from environmental health hazards and toxic exposures," the group asks OEHHA to repeal the 0.5 microgram-per-day maximum allowable dose level for lead, "or amend it to establish a level that is protective of public health and compliant with Proposition 65."

Lead is listed under Prop 65 as a reproductive toxicant. Currently, cosmetics firms can avoid affixing warnings to products containing lead in trace amounts below that MADL.

The CEH petition comes less than six months after the Mateel Environmental Justice Foundation filed suit against OEHHA seeking to eliminate the safe harbor, claiming that no level of lead exposure is safe for consumers Also see "Brace For Impact: Lawsuit Challenges Prop 65 Safe Harbor For Lead" - HBW Insight, 12 March, 2015..

The Personal Care Products Council's Elizabeth Anderson, executive vice president, legal and general counsel, noted earlier this year that the suit "could essentially require a Proposition 65 warning on virtually anything that has a detectable level of lead, including many cosmetic products."

The Mateel case is still pending in Alameda County Superior Court. A case management conference is scheduled for July 27.

Meanwhile, CEH is optimistic about its petition's prospects.

"Our expectation is that the administrative process is a good process for this issue," a rep said in an email to "The Rose Sheet," adding that OEHHA told CEH they plan to respond in 30 days.

CEH does not go as far as Mateel in its request, noting that it would be satisfied with a reduction of the MADL based on current science.

"The existing safe harbor level or [MADL] for lead of 0.5 microgram per day is too high to protect Californians from the well-established reproductive effects of lead that can and do occur at levels below 500 micrograms per day (1,000 times the 0.5 µg/day level)," CEH asserts.

MADLs are derived by finding the maximum level of exposure to a substance that yields "no observable effect" and dividing by a safety factor of 1,000. The lead MADL was established by regulation in 1989 and affirmed in 2013 when OEHHA changed the formal basis for listing the substance under Prop 65 without revisiting the safe harbor.

CEH suggests that OEHHA did not base the 0.5 µg/day level on scientific testing and analysis, but rather, set the safe harbor via an unconventional approach using the federal Occupational Safety and Health Administration's permissible exposure limit and documentation that was "already 14 years old."

Even if the data were not deemed outdated, CEH takes issue with OEHHA's calculations and methodology for translating worker-safety exposure limits to a consumer-protective MADL. The group maintains "there was nothing in the OSHA PEL or its rulemaking file that 'suggested' – let alone established – that exposure to certain regulated levels does not produce the reproductive effect of concern.”

CEW cites testimony from former OEHHA Staff Toxicologist and Acting Chief of the Reproductive Toxicology Unit James Donald, in which he said “it is arguable that any amount of lead is harmful.”

According to the NGO, such a position has not been refuted with appropriate scientific analysis pinpointing a lead exposure level that does not carry risk of adverse effects.

"In sum, while there can be no serious question that the 0.5 µg/day safe harbor level was set too high in 1989, the science since then has confirmed that the level must be much lower to satisfy Proposition 65’s mandate that a warning be provided unless the exposure will have no observable effect at 1,000 times the level in question," CEH says.

The group is critical of OEHHA's decision not to reevaluate lead's safety and MADL when it relisted the substance to Prop 65 in 2013, suggesting that the state Environmental Protection Agency department is required to reconsider new evidence as it emerges.

"Under OEHHA’s interpretation of Proposition 65, the science around lead exposure should essentially be frozen in time. This absurd construction of the statute does not withstand scrutiny," CEH says, holding that "in passing Proposition 65, Californians wanted to be protected from unwarned exposures to chemicals based on the latest and best science."

Trend In Courts Raises Concerns

The organization also says courts are interpreting Prop 65's terms in a way that potentially puts consumers at risk, allowing defendants to average daily lead exposure over a period of weeks before deciding whether a warning label is necessary.

Again, CEH points to Donald's testimony in 1991. "By averaging the amount of exposure on days on which lead is ingested with other days on which lead is not ingested, one would underestimate the potential harm that could be caused by large doses on a single day," the former OEHHA scientist said.

However, in recent litigation waged in California, Environmental Law Foundation v. Beech-Nut Nutrition Corp., the court gave no weight to Donald's remarks, deciding there was insufficient evidence that his views represent the authorized formal policy of OEHHA. The baby food and fruit-juice manufacturer was permitted to average lead exposures over a 14-day period accordingly.

In effect, averaging allows a company to expose consumers to 7 micrograms of lead in a single day (over an otherwise unexposed 14-day period), which equates to a NOEL of 7,000 micrograms – "a level far above any observable effect level," CEW says.

"While CEH believes that the decision in BeechNut is limited to the facts of that case, defendants in Proposition 65 enforcement actions involving other products have already begun raising the decision as a defense to enforcement actions pursued by CEH and other enforcers (including the California Attorney General)," the group notes in its petition.

"While the issue of averaging can and should be separately addressed by OEHHA, the serious scientific and legal flaws with the 0.5 microgram-per-day level could be even worse in the meantime due to the repercussions of Beech-Nut."

Prop 65 Safe Harbor For Lead Challenged In CEH Petition

More from Archive

More from HBW Insight