Halogenated Solvents Industry Alliance, Inc
UPDATE
Legislative and Regulatory News for the Solvents Industry

April/May 2008

European Scientists: No Need for More PERC Testing

According to the European Union’s (EU) Scientific Committee on Health and Environmental Risks (SCHER) review of perchloroethylene, there is "no need . . . for risk reduction measures for [consumer or co-located exposures] beyond those which are being applied already." In commenting on the EU risk assessment report on perchloroethylene, the SCHER also concluded that the report "covers all studies relevant for exposure and hazard assessment" of the solvent and that "there is at present no need for further information and/or testing."

The risk assessment report considered six scenarios (typical and "realistic, worst-case") for occupational exposures, with drycleaning as the major application, in addition to exposure to consumers from drycleaned clothes and exposure to individuals living or working in the vicinity of drycleaning facilities. SCHER members agreed with the report’s recommendation for additional occupational exposure reduction to address the worst-case (but not typical) exposure scenarios, taking into account measures that are being applied already. The Committee also agreed with the recommendation for reduction in exposures from coin-operated drycleaning machines that continue to operate in a some parts of Europe. (Coin-operated drycleaning no longer exists in the United States.)

The Committee concluded that perchloroethylene (also known as tetrachloroethylene) is not mutagenic (i.e., does not affect genetic material) under typical conditions of oxidative metabolism. (Mutagenicity is important in the consideration of carcinogenic potential.) SCHER members also agreed that liver tumors observed in laboratory mice after exposure to the solvent are not relevant to an assessment of risks to humans. Historically, the mouse liver tumors have been the basis for quantitative estimates of cancer risk for perchloroethylene developed by both US and California regulators.

Industry Fights Paint Stripper Ban in Europe

The European Chlorinated Solvents Association (ECSA) and the Paint Strippers Formulators Group (PSFG) have raised a number of objections to the proposal by the European Commission to prohibit the use of methylene chloride-based paint strippers in consumer and commercial applications. The proposal would prohibit the marketing and use of paint strippers containing methylene chloride for consumer applications based on concerns about potentially fatal effects to the central nervous system “associated with bad working/operational conditions” and a conclusion that safe use among consumers “can not be ensured by training or monitoring.” For similar reasons, the Commission also has proposed to prohibit the use of these paint strippers for “professional use.”

The proposal would allow methylene chloride-based products to be used in industrial applications where it is concluded that exposure controls could be more easily enforced. In addition, the proposal would permit individual member countries to allow continued professional use of these products through special licensing.

ECSA and PSFG argue that the EC’s concerns are unfounded, noting that only one (unconfirmed) fatal consumer accident has been attributed to the use of a paint stripper containing methylene chloride since 1990. They have suggested that a more reasonable approach to addressing the Commission’s concern is through voluntary labeling regarding the need for adequate ventilation, to supplement verbal advice provided at the point of sale. Such label warnings have been required in the United States since 1997. ECSA and PSFG also have suggested smaller container sizes and narrower container neck diameters, the addition of strong smelling components, and formulation changes to enhance vapor retardation.

The industry groups have challenged the EC’s assertion that a ban on methylene chloride products would eliminate risks to consumers and professionals. They note that a consumer fatality also has occurred with an alternative chemical paint stripping product during the last 18 years. Since the alternative products have comprised 10 percent or less of the market over that time period, the groups suggest that the risks associated with the alternative chemicals may actually be greater. ECSA and PSFG also note that the Commission’s analysis does not consider the risks associated with heat and flame stripping methods that likely would be used as an alternative to methylene chloride.

The consumer and professional prohibition was officially proposed in mid-February. No timetable has been set for consideration by the European Parliament.

DC Court Considers What's Acceptable Risk

In a case that could have broad implications for federal regulation of hazardous air pollutants (HAPs), the U.S. Court of Appeals for the District of Columbia Circuit recently heard oral arguments regarding the Environmental Protection Agency’s (EPA) 2006 decision not to require additional control of HAP emissions from chemical manufacturing plants. The National Resources Defense Council (NRDC) and the Louisiana Environmental Action Network challenged the EPA decision arguing, in part, that the Clean Air Act requires the Agency to reduce potential cancer risks to one-in-a-million (10-6) to the maximum exposed individual (MEI), regardless of the cost.

The rule in question – the hazardous organic NESHAP, or HON – applies to over 200 chemical manufacturing facilities nationwide. These facilities were originally subject to maximum available control technology (MACT) standards promulgated in 1994. Section 112 of the Clean Air Act requires EPA to subsequently evaluate MACT standards to determine whether additional controls are necessary to provide an "ample margin of safety." In its oral argument, NRDC contended that the Agency’s conclusion that a residual risk to the MEI of 100-in-a-million (10-4) was sufficiently health protective violated the law. The three-judge panel questioned the NRDC lawyer’s argument that the 10-6 language in Section 112 of the Act represents a "bright line" standard. Counsel for the Department of Justice, representing EPA, also challenged the environmentalists’ interpretation of the statute.

The Court did not indicate when it would rule in the case. Although the risk level is not a central part of the industry and Sierra Club challenges of EPA’s drycleaning standard currently before the same Court, decisions on that and other issues in the HON case may impact the drycleaning challenge.

Information in this Update is believed to be correct as of the date of publication, but HSIA cannot guarantee its completeness or accuracy.  In publishing this information, HSIA is not providing legal advice and does not assume or undertake any duty imposed by law or regulation.  Mention of particular products, practices, or services does not constitute HSIA endorsement.