Green Chemistry Update: Maine Releases List of Chemicals of High Concern

Since its enactment, Maine's Green Chemistry law has given the state broad authority to regulate the manufacture, sale, and distribution of various chemicals in children's products.[1] Known as the Toxic Chemicals in Children's Products law, the Maine law applies to children's products only, and currently enumerates only a few "priority chemical" substances. Critically, the law not only requires reporting of priority chemicals in children's products, but also requires submittal of an "alternatives assessment." Failure to submit an alternatives assessment, or submittal of one deemed inadequate by the state, may trigger commissioning of an independent assessment, with costs to be passed on to reporting industry members. With Maine's recent designation of an additional 49 "chemicals of high concern," affected industry members should take note that the state may soon designate other priority chemicals.

Background

Maine adopted a so-called Green Chemistry law in 2008, a period of significant state activity at a time when Congress was considering, and ultimately enacted, the Consumer Product Safety Improvement Act of 2008 (CPSIA). Arguably, the CPSIA addressed the major substances of concern in children's products. Nevertheless, Maine and other states have enacted broader Green Chemistry laws, partly to address perceived chemical control gaps in the absence of comprehensive Toxic Substances Control Act (TSCA) reform.

Maine's Green Chemistry framework is complex, involving multiple statutes, amendments and rules, as well as multiple chemical lists. This framework includes a July 1, 2012, statutory deadline requiring the Maine Department of Environmental Protection (DEP) to publish a list of no more than 70 chemicals of high concern.[2] Pursuant to this mandate, the DEP released a list of 49 chemicals that meet the statutory criteria for listing. The full list is available at: http://www.maine.gov/dep/safechem/highconcern/index.html and includes chemicals that have broad applications across numerous industries. Examples include vinyl chloride, styrene, mercury and mercury compounds, nickel and nickel compounds, cadmium, and quartz, along with specific phthalates and parabens.

Chemicals of High Concern: Criteria for Inclusion

Maine's Green Chemistry designation process began with 1,700 chemicals of concern (COCs) the DEP listed previously pursuant to its authority under 38 MRSA § 1693(1). The COC list was subsequently amended to eliminate about 300 substances, so the current list includes about 1,400 substances.[3] Drawing from this list, the DEP designated as chemicals of high concern those substances for which:

- There is strong credible scientific evidence that the chemical is a reproductive or developmental toxicant, endocrine disruptor or human carcinogen; and

- There is strong credible scientific evidence that the chemical meets one or more of the following criteria:

o The chemical has been found through biomonitoring studies to be present in human blood, human breast milk, human urine or other bodily tissues or fluids;

o The chemical has been found through sampling and analysis to be present in household dust, indoor air or drinking water or elsewhere in the home environment; or

o The chemical has been added to or is present in a consumer product used or present in the home.

Designation of a substance as a chemical of high concern imposes no immediate obligations for manufacturers. Nevertheless, industry groups will likely submit comments objecting to some listings as priority chemicals subject to reporting and the alternatives assessment must be drawn from the list of chemicals of high concern. Whether some or all of the chemicals of high concern will be added to the list of priority chemicals remains to be seen. The criteria for listing a priority chemical are virtually identical to the three criteria for listing a substance on the chemicals of high concern list.[4] Because the law establishes no objective criteria to differentiate chemicals of high concern from priority chemicals, the industry cannot predict which substances may be targeted in the future. Maine's DEP conceivably could designate new priority chemicals on the basis of subjective factors, such as political pressure or consumer outcry.

Implications for Industry

Designation of a substance as a priority chemical triggers reporting requirements and a mandatory assessment of the availability, cost, feasibility, and performance of safe alternatives. Depending on the existence of one or more comparably priced safer alternatives, Maine's Green Chemistry statute also authorizes the DEP to enforce a ban on the manufacture, sale, or distribution of children's products containing the priority chemical.

To date, Maine has designated as priority chemicals nonylphenol, nonylphenol ethoxylates, and bisphenol A (BPA). If any of these substances has been intentionally added to a children's product, then the manufacturer must report its presence in the product at levels above the practical quantitation threshold. Priority chemicals present only as contaminants must be reported if present in amounts above 100 ppm unless the company can demonstrate to the DEP's satisfaction that a system of manufacturing controls is in place to minimize the contamination. Initial reports were due in October, 2011.

Maine's Green Chemistry law applies to children's products, a category defined to exclude various Food and Drug Administration (FDA)- and Environmental Protection Agency (EPA)-regulated goods, namely foods, beverages, food additives, drugs, biologics, tobacco products, FDA-regulated packaging, paper products, and pesticides.[5] Even with these exclusions, however, the scope of the law remains broad, and the prospect of additional laws that circumvent the exclusions remains a possibility given the DEP's separate action on BPA.

In this regard, Maine requires manufacturers of children's products, including infant formula and baby food packaging, that contain intentionally-added BPA to report on the presence, quantity, and function of BPA in their products. In addition, these manufacturers must assess the feasibility of using potential BPA alternatives and submit these findings to the state.[6] As of January 1, 2012, moreover, Maine banned the sale or distribution of reusable food or beverage containers that contain intentionally-added BPA.[7] Environmental groups have nevertheless filed petitions seeking a broader ban on BPA, and demanding that the state conduct its own alternatives assessment because manufacturer assessments were "inadequate." The state's treatment of BPA foreshadows the potential impact on private industry if Maine designates additional substances from the list of chemicals of high concern as priority chemicals in the future. FDA also recently amended its food additive regulations to prohibit the use of BPA in baby bottles and sippy cups.[8] FDA acted in response to an industry petition based on the abandonment of BPA for these uses, and continued to maintain that BPA is safe. The tension between state laws that force assessments of "safer" alternatives, particularly in situations where multiple substances are approved by a federal agency like FDA, and thus are "safe," will continue.

The future designation of new priority chemicals may affect manufacturers and distributors of a host of products, including children's apparel, footwear, jewelry, cosmetics, and toys.

There is no official comment period or deadline for those who either oppose or favor listing of any substance as a chemical of high concern, but interested parties may submit input to the DEP.

For more information on state Green Chemistry requirements, contact Sheila A. Millar (+1 202.434.4143, millar@khlaw.com), Jean-Cyril Walker (+1 202.434.4181, walker@khlaw.com), or Alissa Jijon (+1 202.434.4109, jijon@khlaw.com).

Technical questions can be directed to Diana G. Graham (+1 415.948.2805, graham@khlaw.com).