Prop 65 Limits Point Downward For Lead, Other Reprotoxic Chemicals

California issues a pre-regulatory draft rule to amend Prop 65 with a 60% lower maximum allowable dose level for lead in personal care products sold without exposure warnings. The proposal also clarifies that MADLs for listed chemicals are single-day limits, a change that could trigger new warnings and lawsuits.

In response to a petition from the Center for Environmental Health, California proposes lowering the maximum allowable dose level that would trigger Proposition 65 warnings for dietary supplements, personal care products and others containing lead.

At an Oct. 14 hearing, the state's Office of Environmental Health Hazard Assessment officials discussed a newly issued pre-regulatory draft rule to reset the lead MADL under Prop 65 at 0.2 micrograms per day, down from the existing MADL of 0.5 micrograms per day. Comments will be accepted on the proposal through Oct. 28.

The lower regulatory threshold likely would snare many firms 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.

“This is this kind of like double jeopardy. All of the companies they didn’t get at the 0.5 level, well now they can come back and get them at the 0.2 level,” said Daniel Fabricant, CEO of the Natural Products Association.

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

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."

Oakland, Calif.-based CEH is 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 (Also see "California AG Proposes Prop 65 Changes To Reduce Incentives For Abuse" - HBW Insight, 16 Oct, 2015.).

Detractors have identified CEH among Prop 65 "bounty hunters," along with the Mateel Environmental Justice Foundation, which filed suit against OEHHA earlier in 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 Mar, 2015.).

Attorneys predicted OEHHA would be receptive to CEH's petition, as a demonstration of rulemaking from the California Environmental Protection Agency office could help shore up its defense in the Mateel suit pending in Alameda County Superior Court.

At the OEHHA hearing, Carolyn Cox, CEH research director, offered the group’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."

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

Fabricant also doubts OEHHA’s reasoning for deeming a 0.2 MADL any safer than 0.5.

“For years and years and years people of California have been suffering indignity and suffering numerous cases of injury because of that three-tenths of a microgram difference? I don’t think there’s a scientist on the planet who would support that, but this had to be done?” he said.

“It’s just bad policy and it’s bad science making bad policy. I think it’s really time folks should start talking about some pre-emption of [state laws that conflict with FDA regulations] because it’s completely arbitrary.”

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 the law requires warnings at one one-thousandth of the no observable effect level for a listed chemical, making the proposal to further lower lead’s 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. 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," Samson said.

"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 urges OEHHA to take this position categorically due to what it sees as a concerning trend in courts' interpretation of Prop 65 requirements.

In recent cases, defendants in Prop 65 litigation 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.

“In other words, if a product contained lead and it exceeded the limit, it wasn’t a slam dunk [to prove a Prop 65 violation] because a defendant could always argue that on the average use of this product, it does not exceed the MADL,” said Tami Wahl, the American Herbal Products Association’s special regulatory counsel.

According to CEH, the averaging approach to determining exposure risks 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 Jul, 2015.).

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

Trent Norris, a partner with Arnold & Porter LLP in San Francisco, elaborated on the California Chamber of Commerce’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. There's really no justification for restricting the type of evidence that a court could see on these issues," he said.

Norris noted a recent ruling that allowed baby food and fruit-juice manufacturer Beech-Nut Nutrition Corp. to average lead exposures over a 14-day period.

He suggested courts already show "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 before comments are due.

Representing the Independent Cosmetic Manufacturers and Distributors, Jon Kendrick, an attorney with Locke Lord LLP in Atlanta, said while ICMD appreciates that the proposal maintains a MADL fo lead, rather than listing it as a known toxin when present at any level, the trade group still is reviewing the science behind lowering the MADL.

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

“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, Kendrick said.

"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.

Lead in supplements also is a naturally occurring substituent of ingredients, but firms still are compelled to prove they do not include the substance in their formulations.

“I think it’s a natural deterrent, whether it’s a regulatory agency, whether it’s the attorney general or a consumer organization that’s trying to bring suit and issue these [violation] notice letters. However, it’s not a complete bar because anything can happen,” AHPA’s Wahl said.

“In other words someone could issue a notice letter and come up with the argument … that even though it was captured as naturally occurring, ‘I don’t believe as it occurred in your product that it is naturally occurring,’ and develop an argument around that,” she said.

OEHHA's website also offers a more comprehensive document that discusses in greater detail the regulatory amendments under consideration.

[Editor's note: “The Rose Sheet” also published this article. "The Tan Sheet" brings selected complementary coverage from our sister publications to our subscribers.]