In response to a petition from NGO the Center for Environmental Health, California's Office of Environmental Health Hazard Assessment has proposed lowering the maximum allowable dose level that would trigger Proposition 65 warnings for products containing lead.

OEHHA held a hearing Oct. 14 on the matter. Officials from the agency discussed a newly issued pre-regulatory draft rule that would reset the lead MADL under Prop 65 at 0.2 micrograms per day, down from the existing MADL of 0.5 micrograms per day.

If adopted, the lower regulatory threshold likely would snare many cosmetics marketers that do not need to affix Prop 65 warnings to their products in California currently, as trace lead levels generally fall below 0.5 µg/day. Sub-MADL exposures are exempt from the warning requirement under Prop 65.

Comments will be accepted on the proposal through Oct. 28.

The proposed lowering of Prop 65's lead MADL "will substantially increase the amount of businesses vulnerable to litigation, undermining the governor's recent calls for reform." – California Chamber of Commerce Policy Advocate Anthony Samson

A July 2 petition from Lexington Law Group, representing CEH, asked OEHHA to repeal the 0.5 µg/day MADL for lead or "or amend it to establish a level that is protective of public health and compliant with Proposition 65."

Founded in 1996, CEH is an Oakland, Calif.-based nonprofit focused on "protecting the public from environmental health hazards and toxic exposures." Much of its work to that end has taken the form of litigation under Prop 65 against alleged violators for failure to warn consumers about risks of exposure to listed substances ([A#02151019007]).

Detractors have identified CEH among Prop 65 "bounty hunters," along with the Mateel Environmental Justice Foundation, which filed suit against OEHHA at the start of 2015 seeking elimination of the program's safe harbor for lead Also see "Brace For Impact: Lawsuit Challenges Prop 65 Safe Harbor For Lead" - HBW Insight, 12 March, 2015..

Attorneys predicted that OEHHA would be receptive to CEH's petition, as demonstrated rulemaking movement from the California Environmental Protection Agency department could help shore up its defense in the Mateel suit, which is pending in Alameda County Superior Court.

At the hearing, Carolyn Cox, research director for CEH, offered the NGO's perspective on lead safety. "As science has improved over the last decades, we've found problems with lead exposure in smaller and smaller amounts of exposure."

She maintained that the Prop 65 program's current 0.5 µg/day MADL for lead was set based on data more than 20 years old, urging OEHHA to revise the limit in light of recent data linking lead to adverse reproductive effects at lower exposure levels.

Industry representatives at the hearing conversely asked OEHHA to maintain the status quo.

Changing the MADL for lead from 0.5 µg/day to 0.2 µg/day amounts to a 60% reduction in the lead threshold, according to Anthony Samson, a policy advocate with the California Chamber of Commerce representing more than two dozen trade groups, including the Personal Care Products Council.

"This reduction is particularly harsh and unjustified, and the overall public health justification is questionable," he said.

Samson pointed out that the law requires warnings at one one-thousandth of a listed chemical's no observable effect level, which makes the proposal to further lower the lead MADL especially egregious.

"Slashing the lead MADL by the amount proposed would mean that many businesses that had previously determined that no warning is required will now have to provide a warning," he said. "Many will choose to warn as they do today solely to protect themselves from litigation, which will in turn exacerbate this over-warning problem on the heels of the governor's calls for reform in 2013 to do just the opposite."

He continued: "Further, this cut will substantially increase the amount of businesses vulnerable to litigation – again, undermining the governor's recent calls for reform."

Single-Day Exposure Clarification Also Concerning

The draft update to Prop 65 regulations for "chemicals causing reproductive toxicity" also includes language to "clarify OEHHA's intent that all the existing MADLs for listed chemicals are set as the highest exposures that can occur in a single day."

CEH has pushed for OEHHA to take this position categorically due to what it sees as a concerning trend in the courts' interpretation of Prop 65 requirements.

In recent cases, defendants in Prop 65 suits have argued successfully that their products do not expose consumers to listed substances at levels above established safe harbors when daily exposure is averaged over an extended timeline.

According to CEH, the averaging approach to determining exposure risks associated with product use underestimates the potential health impact of exposing consumers to large single-day doses of potentially hazardous substances Also see "Prop 65 Safe Harbor For Lead Challenged In CEH Petition" - HBW Insight, 16 July, 2015..

Samson suggested that the proposed "clarification" actually tightens restrictions and could result in a proliferation of new warnings and lawsuits against companies subject to Prop 65.

Also speaking on behalf of the California Chamber of Commerce, Trent Norris, a partner with Arnold and Porter, elaborated on the chamber's views regarding the proposal for single-day limits.

"Defendants in Prop 65 cases should have the ability to present evidence showing what the appropriate averaging is for a given chemical exposure and should not be limited to a single-day exposure," he said. "There's really no justification for restricting the type of evidence that a court could see on these issues."

Norris pointed to a recent case, Environmental Law Foundation v. Beech-Nut Nutrition Corp., where the court permitted the baby food and fruit-juice manufacturer to average lead exposures over a 14-day period.

He suggested that there's already "plenty of deference to safety factors" in the Prop 65 regulation without depriving companies of reasonable flexibility in how they assess daily exposure to substances in products that likely are not used by consumers every day.

Norris asked OEHHA to give companies more time to assess the proposal and the related science before comments are due.

Representing the Independent Cosmetic Manufacturers and Distributors, Jon Kendrick, an attorney with Locke Lord, said that while the trade group appreciates that the proposal preserves a MADL (rather than listing lead as a known toxin when present at any level at all), it is still reviewing the science behind the proposed lower MADL versus the existing standard.

He emphasized that lead in cosmetic products is primarily from natural sources and is not intentionally included in formulations. Additionally, he expressed concern that firms may incur expense to self-certify products to ensure they are below the safe level.

According to Kendrick, "consumers may be less informed and could end up paying more for products and have fewer product choices because of the uncertainty associated with self-certification and the cost of later defending" against potential litigation.

"Producers will be left with the choice of either putting a warning label on products that don't need a warning label, which misinforms consumers as to risks, or spending money on needless and repetitive self-certification," he said.

A more comprehensive document on OEHHA's website discusses the regulatory amendments under consideration and the issues at stake in greater detail.

OEHHA Eyes Prop 65 Amendments For Reprotoxic Chemicals, Including Lead

More from Archive

More from HBW Insight