Regulating Chemicals

If its annual conference on chemical regulations is any indication, the chemical industry's worries over U.S. government rules aren't as great as in years past. There are, however, emerging domestic concerns related to nanomaterials and biomonitoring.

The big anxiety for the industry is the European Union's draft legislation on the registration, evaluation, and authorization of chemicals (REACH), which may be implemented in 2007. Concerns about REACH came up repeatedly at the GlobalChem conference held March 22-23 in Arlington, Va. The conference was organized by the American Chemistry Council (ACC) and the Synthetic Organic Chemical Manufacturers Association.

"In many ways, REACH is the epitome of the regulatory challenges we face," Thomas E. Reilly Jr., president and chief executive officer of ACC, told attendees. Reilly warned chemical companies that the EU would like to see the concepts in REACH spread to the World Trade Organization, China, the rest of Asia, and into the U.S. ACC is lobbying hard to soften REACH.

REACH is far from being final, said Karl-Heinz Florenz, the German Christian Democrat who chairs the European Parliament's Committee on the Environment, Public Health & Food Safety. Florenz' panel is studying the legislation and will make a final decision on altering REACH by September. Florenz told the conference he anticipates that members of his committee will offer about 1,000 amendments to the pending REACH proposal.

Jan Backmann, international regulatory affairs manager at RRC Ltd., a Swiss contract research and consulting company, said he expects Parliament to make few changes to REACH that will be in industry's favor. Instead, he believes chemical companies will find a more sympathetic ear at the EU Council for revising the pending legislation so it is more to their liking.

Parliament serves as the lower house of the EU legislature, while the Council, composed of ministers from national governments of each of the 25 EU member countries, acts as the upper house. Parliament and the Council each hold two "readings" of legislation. If they do not agree on the language by the end of the second readings, they form a conciliation committee, similar to the U.S. Senate and House conference committees, to work out a compromise that must be approved individually by the Parliament and Council.

Backmann counseled U.S. chemical companies to prepare for REACH now. "Take the challenge seriously if you have business in Europe," he said.

Companies should analyze their product portfolios and determine whether any chemical they produce might be a candidate for authorization, the most stringent type of regulation REACH could impose on a substance. Backmann also suggested that manufacturers collate toxicity data on their substances now, since this information will be needed for registering chemicals under the new EU regulatory scheme.

In addition, each U.S. chemical company should check with its EU suppliers to ensure that they will continue to provide the products it depends on. Backmann said some suppliers may find it unprofitable to register all their chemicals under REACH and will drop some products.

Another international issue received considerable attention at the conference--the planned Strategic Approach to International Chemicals Management (SAICM). Being developed under the auspices of the United Nations Environment Program (UNEP), this will be a global agreement but not a legally binding treaty. It will guide countries, especially those with a weak regulatory system, in managing chemicals.

Talks on SAICM began in late 2003. The third and last round of global negotiations on SAICM will take place Sept. 19-24 in Vienna.

"Industry has been relatively quiet in these meetings. I think that's a bit of a shame," said James B. Willis, director of EPA's Chemical Control Division. Between 1995 and late 2004, Willis was director of chemicals for UNEP, where his duties included efforts to develop SAICM.

CHEMICAL MANUFACTURERS and users will likely bear the brunt of the measures the agreement will call for, and they should be involved in its drafting, Willis said. Industry groups and environmental organizations have the same right to participate in the talks on SAICM as do national governments, he added. Yet in the previous negotiating sessions, fewer than 5% of the delegates were from industry, he said.

The chemical industry needs to go through the draft SAICM document with a fine-tooth comb, Willis said. The September meeting in Vienna "is the last chance to edit this," he noted.

He warned that negotiators are batting around an idea for a tax on chemicals, either at the national level or globally, to fund SAICM activities in developing countries. Plus, the EU may propose to insert elements of its REACH legislation into the draft SAICM at the Vienna meeting, Willis said.

Willis suggested that the U.S. chemical industry prepare a paper in advance of the Vienna meeting describing how it sees its role under a global strategy for managing chemicals. For instance, chemical manufacturers might offer to form partnerships with industries in the developing world to help them devise environmental, safety, and health programs for chemicals. And chemical makers should take credit for work they have already done on product stewardship, he said.

The State Department will hold a stakeholder meeting for those interested in SAICM before the Vienna meeting, Willis added.

SAICM will officially be adopted by the international community at a February 2006 meeting of UNEP's Governing Council to be held in Dubai, United Arab Emirates, he said.

The GlobalChem conference also focused on domestic chemical control issues including EPA regulations and policies.

EPA will continue to issue some rules to govern commercial chemicals, said Susan B. Hazen, principal deputy assistant administrator for the agency's Office of Prevention, Pesticides & Toxic Substances. But EPA is moving more into collaborative programs with industry focused on product stewardship efforts that extend beyond the gates of their plants, she said.

MEANWHILE, one part of the agency's chemical regulation program has garnered a great deal of industry attention in recent months, said Charles M. Auer, director of EPA's Office of Pollution Prevention & Toxics. That work concerns notices that companies must file with EPA if they generate or receive information that suggests a chemical they make potentially poses a substantial risk to human health or the environment. These reports are required under Section 8(e) of the Toxic Substances Control Act (TSCA), the federal law that governs commercial chemicals.

Last summer, this little-known provision of TSCA made headlines when EPA filed a case against DuPont for allegedly failing to report health data on perfluorooctanoic acid (C&EN, July 12, 2004, page 18). The agency could seek hundreds of millions of dollars in fines in the case, and DuPont is vigorously defending its actions (C&EN, Aug. 16, 2004, page 17).

Auer said EPA views Section 8(e) reporting as a critical information-gathering tool that serves the agency as an early warning system for newfound chemical risks. These data feed into assessment of a chemical's risk and hazard and factor into a company's product stewardship of that substance, he said.

In the past dozen years, EPA has received about 250 Section 8(e) reports annually, Auer said. But in the past five months, companies have filed nearly 300 notices, possibly in reaction to the enforcement case against DuPont. Submissions range from one-page letters to thousands of pages of toxicology reports, he added.

Walker B. Smith, director of civil enforcement in EPA's Office of Enforcement & Compliance Assurance, told the conference that Section 8(e) "is not that complicated." She said if chemical companies are unsure whether information they have triggers reporting, there is no penalty if they submit it to EPA. She added, however, that the agency does not want companies merely to dump any and all data they have on the agency.

Reporting under Section 8(e) also applies to nanomaterials, said James Alwood of EPA's Chemical Control Division. He said the agency has received a few of these substantial risk notices concerning nanosized materials that were undergoing research and development.

In addition, manufacturers of some nanomaterials must file new chemical notices, Alwood said. Makers of new materials that do not appear on the TSCA Inventory of chemicals in commerce, such as carbon-gold compounds, must file premanufacture notices just as manufacturers of new, conventional industrial substances do.

Meanwhile, EPA is mulling over a plan to ask manufacturers of nanomaterials to provide the agency with health and safety data on these products voluntarily, Alwood said. This would be separate from any Section 8(e) submissions, which are required by law, he added.

EPA needs voluntarily submitted information to evaluate nanomaterials for their benefits and risks. In the absence of health and safety data on nanomaterials, "expect conservative decisions" from regulators on substances that companies anticipate will be released to the environment, Alwood counseled.

Despite a rumor to the contrary, EPA is not planning a rule to control significant new uses of all nanomaterials, Alwood added.

Lynn L. Bergeson, a founder of the Washington, D.C., law firm Bergeson & Campbell, warned conference attendees that EPA may attempt to use its authority under the Clean Air Act, Clean Water Act, and federal waste disposal statute to control management and disposal of nanomaterials.

Biomonitoring--plus regulatory and legal issues linked to it--was another emerging matter that, in addition to nanomaterials, was hashed over at the GlobalChem Conference. Biomonitoring refers to technologies that can detect commercial chemicals in people's bodies.

ACC's Reilly stressed that the chemical industry must understand that detection of synthetic compounds in people stirs up concern about what those findings mean. "No one really knows at this time," he said.

Richard A. Becker, senior director of the public health team at ACC, said activists are using biomonitoring data to bolster their arguments for tougher regulation of chemicals along the lines of REACH. Among their allegations are that low levels of chemicals in the environment cause health problems, that there has been inadequate testing of commercial substances, and that manufacturers should prove that their chemicals are safe or substitute safer substances.

More chemicals than ever can be measured in the body through biomonitoring techniques that are increasingly better, safer, and less expensive, Becker said. And on the horizon are genomic tests that will provide biomarkers of actual effects from chemicals--rather than today's results that merely confirm exposure to substances.

"ACC supports responsible and appropriate use of biomonitoring information in risk assessment and in creating public policy," Becker said. Just because biomonitoring finds synthetic chemicals in people, an automatic trigger for regulatory actions should not be assumed, he added.

In the meantime, biomonitoring data are coming into play in lawsuits filed by people claiming harm due to exposure to synthetic chemicals, said William K. Rawson, partner in the Washington, D.C., law office of Latham & Watkins.

Biomonitoring data can provide definitive proof of exposure to a substance, but exposure by itself does not show harm, Rawson said. Plus, biomonitoring information can exonerate a company defending itself, for example, by demonstrating that the plaintiffs' exposure is not significant when compared with the levels of the chemical found in the general population.

Arguments are emerging, however, that companies have a legal duty to warn people when biomonitoring data confirm widespread exposure to a chemical, especially if the substance may cause serious health effects such as cancer or if it persists in the environment, Rawson continued. And in several pending cases filed in the past three years, plaintiffs are arguing that a company has the duty to perform biomonitoring and that chemicals found in people's bodies that they did not intentionally ingest amount to trespass or battery by a company.

"The emotional dimension of chemical body burden data poses, I believe, a major communications and stewardship challenge to industry," Rawson said.

The Centers for Disease Control & Prevention has included biomonitoring of chemicals found in blood and urine as part of its National Health & Nutrition Examination Survey for the past several years, said John Osterloh, chief medical officer for the Laboratory Sciences Division at CDC's National Center for Environmental Health.

This spring, CDC will be releasing the most recent biomonitoring results from the survey as the third National Report on Human Exposure to Environmental Chemicals, he said. The report, which will be the most extensive evaluation of the U.S. population's exposures to chemicals, will cover 148 substances including several phthalates, polychlorinated biphenyls, dioxins, furans, and phytoestrogens, Osterloh said.

He told conference attendees that biomonitoring can be helpful for researchers who are trying to estimate the risk posed by a substance. This kind of data can indicate exposure to a substance better than information that epidemiologists have traditionally gathered about how close a person worked or lived to a source of a chemical release, he said. And biomonitoring data can help scientists develop relationships between the concentration of a chemical in the body and the effects the substance may have, he said. 

AS ANOTHER ASPECT to the conference, EPA unveiled two new tools aimed at chemical manufacturers. One is focused on helping research and development efforts screen out new chemicals that are likely to be toxic or persist in the environment. A second is designed to assist companies in complying with federal requirements for substances that are imported into the U.S.

Kelly Mayo, a chemist with EPA's Risk Assessment Division, described EPA's Analog Identification Methodology (AIM). This Web-based program will help researchers determine appropriate analogs for new chemicals and then find toxicity and persistence data, if the information exists, on those analogs. Data about analogs may shed light on whether the novel substances could pose a risk to health or the environment. Information on analogs is gleaned primarily from federal databases, she added.

EPA recognizes that users of this system want to protect proprietary information on their new chemical. Mayo stressed that all connections to AIM are secure and anonymous and no chemical information is saved by the system.

The agency is running a beta test on AIM through this summer and is gathering comments from users on how to improve the tool, Mayo continued. Those interested in joining the beta test can send an e-mail to Jim Santory, who works for EPA contractor Consortium for Environmental Risk Management, at jsantory@cermonline.com, she added.

A second EPA tool made public at the conference is a draft checklist that companies can use to help determine the regulatory status of chemicals and certain genetically modified organisms they import into the U.S. An importer must certify that its shipments either comply with TSCA or are not subject to the chemical control law because they are regulated under other statutes. Examples falling into the latter category are pesticides, foods, food additives, drugs, or cosmetics.

Roy Seidenstein, an attorney in EPA's Chemical Control Division, said the agency was distributing the draft checklist at the GlobalChem conference to get feedback from chemical companies. Once the checklist is finalized, EPA will post it on its website, Seidenstein said. He asked that comments on the draft be directed to him at seidenstein.roy@epa.gov.