Eliminating or reducing the maximum allowable dose level for lead under California's Prop 65 program would make for less informed consumers and may not be scientifically justified, and cosmetic firms are likely to see increased litigation under either proposed change – which state authorities are scrambling to put in place due to a suit they face themselves from a reputed Prop 65 "bounty hunter."

Such are the takeaways from recent industry comments on a "pre regulatory" draft rule issued by California's Office of Environmental Health Hazard Assessment in October, which proposed lowering the lead MADL for daily exposure by 60% under the monumental industry headache that is the state's Prop 65 law.

The move follows a July petition from NGO the Center for Environmental Health seeking a more consumer-protective position from OEHHA on lead exposure Also see "Prop 65 Safe Harbor For Lead Challenged In CEH Petition" - HBW Insight, 16 July, 2015.. At the same time, OEHHA is being sued by the Mateel Environmental Justice Foundation, another organization with a penchant for Prop 65 private enforcement, which industry says has fast-tracked rulemaking to address the lead MADL issue.

Specifically, 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 suggests.

The California law does not impose chemical use restrictions on companies, but requires manufacturers and/or retailers to notify consumers of 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 that 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."

OEHHA's proposed fix, lowering the lead MADL from 0.5 µg/day to 0.2 µg/day, would be oppressive in its own right Also see "OEHHA Eyes Prop 65 Amendments For Reprotoxic Chemicals, Including Lead" - HBW Insight, 19 October, 2015..

In comments submitted Oct. 28, business advocacy group the California Chamber of Commerce, representing more than 80 industry associations (PCPC included), 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, out 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 particularly concerned about the potential impact on small businesses, which could be disproportionately affected by the measure and its legal implications, it says.

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 Result In Higher Lead Exposures

Potentially crippling burdens on industry aside, ICMAD and CalChamber question the logic and scientific grounds for the proposed change, and argue that it could very well 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 a range of 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. Such an approach allows for higher one-time exposure in a single day as long as it isn't repeated on a daily basis ([A#02150810007]).

However, CalChamber says that "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 that 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 that 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, gratuitous Prop 65 warning-labeling, as a solution adopted by cosmetic manufacturers to avoid costly product analysis and private lawsuits, would serve only to 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 that 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, have been 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 December, 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 – that the MADL for lead be struck completely – which CEH and Mateel have recommended based on their position that no level of lead exposure is safe.

The massive swell in Prop 65 warnings certain to follow such a 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."

The trade association continues: "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 those Prop 65 was enacted to protect, and the potential added costs resulting 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 represented by CalChamber question the scientific justification for OEHHA's proposal to lower the MADL for daily lead exposure, as well as the timeframe that's been imposed on stakeholders to consider the latest evidence, or lack thereof, 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 cited by OEHHA in a recent hearing as rationale for the lead MADL reduction had been available to the public for just two weeks at the time of its comment submission.

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

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

CEH has suggested that a 15 mcg/dL BLL is too high, exceeding maximum levels used by other agencies and healthcare 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 that 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 that 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.

Such is not the case with lead, an ingredient that has been extensively studied, CalChamber notes.

ICMAD says that 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 Environmental Justice Foundation," 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."

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