The State of Regulation

Industry's annual conference on chemical regulation, held for more than a decade, traditionally has focused almost exclusively on policies related to one U.S. law--the Toxic Substances Control Act (TSCA). Extensive discussions by Environmental Protection Agency officials on getting new chemicals to market and on testing older compounds are always a key part of the gathering, hosted by the Synthetic Organic Chemical Manufacturers Association (SOCMA) and the American Chemistry Council (ACC). But international issues, most notably the European Union's proposed Registration, Evaluation & Authorization of Chemicals (REACH) program, took up a significant share of this year's conference, held March 9-10.

Robert H. Donkers, environment counselor at the EU office in Washington, D.C., warned chemical industry representatives that REACH is practically a done deal. He disparaged notions that the new EU chemicals legislation will not be adopted. "It will be law, I guarantee," he said. However, he allowed that some details of the pending legislation could change in coming months.

The current projection is for REACH to go into force in 2006. The chemical industry should begin preparing for REACH now, Donkers advised. "There's no need to wait," he said. Preparations could include discussions with downstream users of chemicals, who, under REACH, would have to implement risk-management measures established by suppliers for specific uses of substances.

Donkers also questioned chemical manufacturers' estimates that REACH will cost them billions of dollars because the new legislation will require toxicity tests on commercial compounds. He countered that chemical manufacturers should have--and may well have--conducted basic testing on their existing products before bringing them to market. Companies will not face huge testing costs under REACH if they already have some data in their files about their products, he said.

According to Donkers, attitudes within the chemical industry, once extremely negative toward REACH, are shifting. There is a growing awareness that, if the EU does not adopt a new system for controlling the manufacture of chemicals, member countries likely would develop their own programs. This would leave the EU with perhaps 10 different regulatory systems for chemical production, which would be a headache for multinational companies, he said.

He also stressed that maintaining the viability of the chemical industry is important to the EU as it develops REACH. "In Europe, we don't want to kill the chemical industry. That would be stupid," he told the conference.

Donkers noted that the EU is accepting comments from other governments on its REACH proposal and wants to ensure that the new legislation comports with the rules of the World Trade Organization. "We don't want to have a war over REACH at the WTO," he said.

Despite some changes made to the proposal last fall, the Bush Administration remains dissatisified with REACH, said Charles M. Auer, director of EPA's Office of Pollution Prevention & Toxics. "We think an unworkable approach will fail to achieve full realization of the EU's health and environmental policy objectives and could adversely impact innovation and disrupt trade," he told the conference.

U.S. AND EU OFFICIALS continue to consult on REACH's details, Auer said. The pending legislation will be a major topic at the U.S.-EU Chemicals Conference scheduled for April 26-28. That gathering will bring together top officials from EPA and the European Commission directorates for environment and for enterprise to discuss environmental policy issues related to chemicals, he said.

While REACH was a major part of the agenda at the conference, EPA policies on new chemicals and regulations requiring tests on existing industrial substances were also key items.

Auer described the growing success of EPA's new hazard and exposure screening tools designed for use by companies during the research and development of new chemicals. These will help businesses screen product alternatives to identify safer new chemicals.

One of those tools screens chemicals for environmental persistence, bioaccumulation, and toxicity and was developed with SOCMA, ACC, and the Chlorine Chemistry Council (C&EN, Oct. 7, 2002, page 10). Auer said this Web-based profiler has become the most widely used chemical screening tool in the world and has been used for 34,000 chemical-specific analyses during the past 18 months.

The hazard and exposure screening tools, along with technical assistance, public recognition, and special help to small companies, are part of EPA's Sustainable Futures program. Chemical firms participating in this effort that submit premanufacture notices to EPA for qualifying low-hazard, low-risk chemicals can begin producing their substances 45 days after submitting paperwork to the agency. In contrast, companies generally have to wait 90 days after giving their premanufacture notices to EPA before making new chemicals.

Meanwhile, Greg Schweer, chief of EPA's Chemical Information & Testing Branch, discussed the agency's plans to require U.S. chemical manufacturers and importers to conduct toxicity studies on their products.

In late March or early April, EPA expects to issue a rule that will generate data for the Occupational Safety & Health Administration. The rule will require tests to determine the rates at which dozens of industrial chemicals are absorbed into the skin, Schweer explained. These dermal absorption rates eventually will help refine calculations of total workplace exposure --which also includes inhalation--for each of the chemicals.

Though the 1999 proposed version of this regulation covered 47 chemicals, Schweer said the final rule will include fewer substances. This is because production of some of these compounds has declined since the proposal was issued, he explained. TSCA allows EPA to require chemical testing based on concerns about human exposure only if the substance is manufactured or imported in volumes of at least 1 million lb per year. Production and import of some of those 47 chemicals have dropped below that threshold since 1999, Schweer said.

In addition, Schweer said, EPA plans to issue in 2004 a final rule requiring tests on many high-production-volume (HPV) chemicals. HPV substances are made in or imported into the U.S. in amounts exceeding 1 million lb per year.

Chemical makers joined with EPA and the environmental organization Environmental Defense in a voluntary initiative to produce basic toxicity information for thousands of HPV chemicals. More than 330 manufacturers and importers have agreed to generate data on health and environmental effects, environmental fate, and physical properties for more than 2,200 of the approximately 2,800 HPV substances in U.S. commerce, according to Auer.

But hundreds of HPV compounds are "orphans"--no company has agreed to produce basic toxicity information for them. In December 2000, EPA proposed a regulation that would require makers and importers of 37 of the orphan HPV substances to conduct studies on their products. Schweer said the agency plans to issue the final version of that regulation later this year. That rule will cover fewer than the 37 substances initially proposed because companies have volunteered to test some of the compounds and other materials are no longer considered HPV chemicals because they are produced in quantities less than 1 million lb per year, he said.

Schweer said EPA does not now have formal plans to issue rules requiring tests on other orphan HPV chemicals. According to Auer, EPA will work through its newly formed National Pollution Prevention & Toxics Advisory Committee to develop the next steps for dealing with these orphan chemicals.

In addition to its program for HPV chemicals, EPA solicits voluntary toxicity testing by manufacturers for other substances of interest to the agency. By working out enforceable consent agreements with companies, EPA often gets the toxicity information it needs about commercial substances faster than by going through the formal procedure of issuing regulations to require testing.

THE AGENCY currently is seeking enforceable consent agreements to obtain data on 21 chemicals classified as hazardous air pollutants, which are also known as air toxics, Schweer said. Information sought by EPA for the air toxics involves more extensive--and expensive--testing than the data for HPV chemicals. Tests sought for the hazardous air pollutants include long- and short-term, reproductive, and developmental effects studies, as well as carcinogenicity studies.

In its efforts to get data on the air toxics, EPA so far has struck agreements with industry for testing phenol, methyl isobutyl ketone, 1,1,2-trichloroethane, and ethylene dichloride, Schweer continued. The agency is consulting with companies in hopes of developing enforceable consent agreements within the next year for eight other air toxics: 1,1-diphenyl, creosols, chloroprene, diethanolamine, hydrogen fluoride, maleic anhydride, methyl methacrylate, and phthalic anhydride.

Schweer said EPA is also working to develop enforceable consent agreements with makers of fluoropolymers and fluorinated telomers--which are short polymers--in connection with the agency's investigation into perfluorooctanoic acid and its salts, collectively known as PFOA. The agency is concerned about PFOA because of its toxicity and because it is increasingly found in people's blood (C&EN, April 21, 2003, page 9).

EPA wants tests to determine whether PFOA is released when fluoropolymers and fluorinated telomers are incinerated, when articles made with fluoropolymers age, or as fluorinated telomers biodegrade, Schweer said.

In addition to chemical testing, part of the SOCMA-ACC conference focused on international efforts to reduce the amount of paperwork companies must file before manufacturing new chemicals. The Organization for Economic Cooperation & Development (OECD), which is a group of 30 of the world's most industrialized countries, and the Business & Industry Advisory Committee to the OECD (BIAC) are working on an international standardized notification form for new chemicals.

Rebecca S. Cool, chief of EPA's New Chemicals Prenotice Management Branch, said the standardized form would reduce costs for companies that submit notifications to several governments for the same chemical. Marianne U. Heinrich, project manager for product assurance at Castrol, said companies would fill out an electronic form and then a computer program would use the information provided to generate the required regulatory forms for various OECD nations, such as an EPA premanufacture notice.

Heinrich said an OECD-BIAC task force hopes eventually to develop an international system through which companies can submit one notification, then market their new chemicals globally.