Prop 65 Trace Contaminant Draft Rule Goes Over Like Lead Balloon

Industry groups suggest California's proposal to lower Prop 65’s safe harbor for lead would increase litigation, consumer confusion and lead levels in products sold in the state. Stakeholders question the science behind the proposal and the timeframe allotted to consider the "highly technical" material.

Eliminating or reducing the California's Prop 65 program’s maximum allowable dose level for lead would confuse consumers and may not be scientifically justified, according to industry comments on a "pre regulatory" draft rule issued by the state Office of Environmental Health Hazard Assessment in October.

Additionally, personal care product firms likely would see increased litigation under either proposed change the state is scrambling to implement due to a suit it faces from a Prop 65 "bounty hunter," stakeholders say about the proposal to lower the lead MADL for daily exposure by 60%.

OEHHA made the proposal following a July petition from the Center for Environmental Health seeking a more consumer-protective position on lead exposure, but the agency also is being sued by the Mateel Environmental Justice Foundation, an organization with a penchant for Prop 65 private enforcement, which industry says has fast-tracked rulemaking to address the lead MADL issue.

CEH is asking OEHHA to repeal the 0.5 microgram-per-day MADL for lead "or amend it to establish a level that is protective of public health and compliant with Proposition 65."

"CEH's proposal might actually result in products with higher lead content as manufacturers find it cheaper to put a warning label on a product rather than to self-certify a safe level or reduce lead content and exposure." – ICMAD

The California law does not impose chemical use restrictions on companies, but requires manufacturers and retailers to label for exposure risks to substances identified by the state as "known" carcinogens or reproductive toxins when their presence in products exceeds established safe harbors.

The Personal Care Products Council's legal counsel has noted the sought-after revisions to Prop 65's lead listing – particularly Mateel's suit, which strictly seeks elimination of the lead MADL altogether – "could essentially require a Proposition 65 warning on virtually anything that has a detectable level of lead, including many cosmetic products."

But OEHHA's proposed fix, lowering the lead MADL from 0.5 µg/day to 0.2 µg/day, would be oppressive, too (Also see "Prop 65 Limits Point Downward For Lead, Other Reprotoxic Chemicals" - Pink Sheet, 26 Oct, 2015.).

In comments submitted Oct. 28, the California Chamber of Commerce, representing more than 80 industry associations including PCPC, businesses and other stakeholder organizations, says the revised MADL "will further arm private enforcers with even more opportunities to challenge businesses under Proposition 65."

According to CalChamber, of 800 substances on the Prop 65 list, lead has resulted in the most pre-litigation notices to the state's attorney general, the majority associated with alleged exposure through consumer product use.

The Independent Cosmetic Manufacturers and Distributors is concerned particularly about the potential impact on small businesses, which could be disproportionately affected by the measure and its legal implications.

According to the trade group, Prop 65 opportunists often target smaller companies to secure settlement payouts, banking on their lack of resources required to defend against protracted litigation.

"The costs of defending against these cases, even when the company makes an appropriate determination on the warning label, are high," it notes.

Change Could Cause Higher Lead Exposures

Potentially crippling burdens on industry aside, ICMAD and CalChamber question the logic and scientific grounds for the proposal and argue that it could be counterproductive.

OEHHA's proposed lead exposure cap of 0.2 µg/day actually is just one of 13 MADLs the California Environmental Protection Agency department is considering to cover exposure-duration scenarios. The 0.2 µg/day maximum would apply to products likely to expose users daily, while products anticipated to expose consumers to lead less frequently could do so at rates up to 8 µg/day.

The MADL matrix is OEHHA's answer to controversy in the courts about whether lead exposure can be averaged over time to demonstrate compliance with the per-day MADL under Prop 65. The approach allows for higher one-time exposure in a single day as long as it is not repeated on a daily basis (Also see "OEHHA Starts Prop 65 Rulemaking To Update Max Allowable Lead Level" - HBW Insight, 10 Aug, 2015.).

However, CalChamber says ”as a practical matter, many businesses that seek the certainty of knowing that they will not face an enforcement action will refer to the most conservative MADL — the single-day MADL — in considering their compliance options, even if those exposures clearly occur less frequently than every day."

In its comments, ICMAD suggests imposing the de facto 0.2 µg/day lead MADL on companies could have the unintended consequence of actually increasing lead content in consumer products.

Under the current lead safe harbor of 0.5 µg/day – which already was set, like all MADLs, at one one-thousandth of the level at which lead exposure was known at the time to have no observable effect – manufacturers are motivated to keep exposure below the threshold to avoid affixing warning labels to their products.

Drastically reducing the lead MADL could eliminate that incentive, ICMAD says.

"CEH's proposal might actually result in products with higher lead content as manufacturers find it cheaper to put a warning label on a product rather than to self-certify a safe level or reduce lead content and exposure," the group reasons.

Potential For Conflicting State, Federal Safety Messages

Rampant and unnecessary labeling with Prop 65 warnings, as a solution adopted by cosmetic manufacturers to avoid costly product analysis and private lawsuits, would confuse consumers about which products truly contain lead, and at what levels, and about the risks associated with lead exposure in general, industry stakeholders say.

ICMAD notes lipstick makers could opt to put warnings on their products out of an abundance of caution, even though the trace levels in their products, typically attributable to FDA-approved color additives, are deemed safe by FDA following multiple market surveys and testing initiatives in recent years (Also see "FDA Issues Final Lead-In-Lipstick Report, Postpones Decision On Cosmetic Lead Limits" - HBW Insight, 12 Dec, 2011.).

An excess of Prop 65 labeling in the lipstick category would misinform consumers "as to the actual risks associated with a product found to be safe by the FDA," ICMAD says.

The group also addresses CEH's alternative proposal to strike the MADL for lead completely, which Mateel also has recommended based on the position that no level of lead exposure is safe.

The massive swell in Prop 65 warnings certain to follow the move would be a marked disservice for consumers, ICMAD suggests, arguing that established MADLs benefit both the public and product marketers.

Under the current lead listing, "if a product does not have a warning label, consumers will know that a product presents a lead exposure risk at less than [one one-thousandth] of the level at which no observable effect exists. If a product contains a warning label, consumers will know the concrete number at which a warning is required rather than guessing at what level the product has been self-certified as safe," ICMAD says.

The trade association adds: "In other words, a MADL does more to inform consumers as to actual risks than the absence of a MADL."

Generally, ICMAD says OEHHA's proposed revision of the lead safe harbor is not in the interests of industry or consumers, and the potential added costs from the change could drive smaller companies out of business or compel them to pass the expense along to consumers.

Stakeholders Question Rationale, Timing

ICMAD and the industry groups CalChamber represents question the scientific justification for OEHHA's proposal to lower the MADL for daily lead exposure, as well as the timeframe imposed on stakeholders to consider the latest evidence informing the department's action.

There has not been ample opportunity to determine whether OEHHA's conclusions have "a generally-accepted scientific basis," according to ICMAD. The group says data OEHHA cited in a recent hearing as rationale for the lead MADL reduction had been available to the public for two weeks at the time of its comment submission.

CalChamber similarly is disappointed by OEHHA's refusal to extend the comment period, particularly given the "highly technical" nature of the issue, and urged the agency to accept further comment before issuing a rule.

Based on its review of the proposed rule in the limited time allotted, CalChamber rejects OEHHA's deduction that a blood lead level of 15mcg per deciliter is the lowest level with no observable effect. The group says the study cited OEHHA showed no effects at BLLs as high as 45mcg per deciliter.

CEH has suggested a 15mcg/dL BLL is too high, exceeding maximum levels used by other agencies and health care practitioners in their work, but CalChamber urges OEHHA to "not be misled by such statements, because it is well known that other BLL targets or recommendations are based on toxicological endpoints other than the limited endpoints that are relevant under Proposition 65."

Further, the industry proponent suggests OEHHA's use of a 1,000-fold uncertainty factor to inform the draft MADLs for lead "is unjustified as a matter of science, policy and law" and deviates from standard toxicology principles.

CalChamber points out the 1,000-fold uncertainty factor was developed to "address scientific uncertainties to ensure that exposures at the warning threshold will not cause reproductive harm," and was intended for application in instances where substances have limited animal safety data.

That is not the case with lead, an ingredient extensively studied, CalChamber notes.

ICMAD says ordinarily OEHHA's failure to explain the science behind a proposed Prop 65 listing change would not be a major issue in the context of a "pre-rulemaking proceeding," as the department would have opportunity to present a more robust defense of its position in the formal rulemaking phase.

"Here, however, as explained by OEHHA's counsel at the Oct. 14, 2015 hearing, it is expected that this will be an abbreviated rulemaking because OEHHA is currently in litigation over the existing MADL with” Mateel ICMAD says. "As a result of that litigation, OEHHA has indicated that it will move forward to a final rule rather quickly."

The group concludes: "ICMAD hopes that despite this expedited process, OEHHA will provide a more detailed explanation of the scientific basis for the rule."