No End in Sight

A nearly nine-year-old voluntary testing program is making public basic information on hundreds of mass-produced chemicals. Now, anyone connected to the World Wide Web can simply click to find physiochemical properties, basic toxicity, and environmental fate information for many chemicals manufactured or imported in the U.S. in volumes of at least 1 million lb per year. Substances produced at this level are described as high-production-volume (HPV) chemicals.

Chemical manufacturers are making this information public through the HPV Challenge Program. That effort, launched in 1998, involves a partnership among the chemical industry, the advocacy group Environmental Defense, and the Environmental Protection Agency. The program was, in part, a response to a 1997 Environmental Defense report, "Toxic Ignorance," that decried the lack of publicly available health and safety information for some 2,800 chemicals produced in the greatest quantities.

But the HPV Challenge Program, which had a completion date of 2005, has yet to be entirely fulfilled.

Some companies are just now submitting plans for voluntary tests on their products. Other firms that had pledged to come up with the chemical data have withdrawn from the program. Still others, for what can be viewed as rational business reasons, are waiting for EPA to require testing on their products through a formal regulation. In addition, manufacturers and importers are simply not volunteering to test some HPV chemicals.

Meanwhile, the agency is just beginning to sort through the HPV chemical data it has received. Over the next few years, EPA plans to scrutinize the information and determine which, if any, chemicals must be tested further because of potential health or environmental problems.

The state of the HPV Challenge Program was critically evaluated at the first U.S. conference on Characterizing Chemicals in Commerce, held in Austin, Texas, on Dec. 12-14, 2006. The meeting, which focused on the data made public through the HPV Challenge Program, attracted some 200 people. It was presented by EPA and the Northeast Waste Management Officials' Association.

"The challenge is limping to the finish line," Richard A. Denison, senior scientist with Environmental Defense, said of the voluntary program.

"We're behind on completion," acknowledged Jim Willis, director of EPA's Chemical Control Division. Getting the last HPV Challenge Program submissions from industry may take another year, Willis said.

Denison identified a number of reasons why the program missed its 2005 deadline. For one, EPA fell behind in its review of chemical testing plans submitted by industry, he said. Companies are unable to begin their planned studies until EPA finishes those reviews.

Another reason, he said, is that industry has become increasingly resistant to EPA's recommended changes to those test plans, particularly requests for more studies than companies initially proposed. The agency needs to make these requests before the experiments start because it has little recourse if the data submitted are of poor quality, he said.

Chemical manufacturers and importers have pledged to provide data on about 1,400 chemicals through the HPV Challenge Program. Companies are producing information on another 900 via the International Council of Chemical Associations' (ICCA) HPV Initiative. Through that voluntary effort, industry is providing chemical information to the Organization for Economic Cooperation & Development (OECD), a group of 30 of the world's most industrialized countries, for use by all OECD governments.

Only about 10% of the HPV Challenge Program data submitted to EPA thus far was generated through new tests, Willis said. Steven Russell, senior director for the American Chemistry Council (ACC), said industry sponsors found that they had more toxicity and physiochemical data for HPV substances in company files than they initially believed existed. Sponsors have had to conduct only 313 new laboratory tests so far to complete the data sets, Russell added.

However, about 300 HPV chemicals remain without industry sponsors. EPA terms these "orphan" substances.

Charles M. Auer, director of EPA's Office of Pollution Prevention & Toxics, told the conference that there are a number of reasons why hundreds of HPV chemicals remain without sponsors.

Many of these orphan chemicals are both made in and imported into the U.S. Domestic producers are willing to voluntarily produce the data required in the HPV Challenge Program, but importers may not be willing to share the costs of generating this information, Auer said. Therefore, makers of some HPV chemicals are waiting for EPA to issue a regulation requiring all producers and importers to share the costs.

In addition, some chemical makers don't think the HPV Challenge Program "suits their purposes," Auer said. These firms, he added, are not part of the Responsible Care Initiative, which is the chemical industry's global, voluntary effort on safety and health.

Russell offered other reasons why some HPV chemicals are orphaned. He said some manufacturers don't want to spend money on testing a particular substance because their profit margin on that HPV product is slim. Those companies are prepared to stop making the chemical if EPA issues a regulation requiring testing of the compound, he told the conference.

The agency has begun issuing rules to get the data on these orphans from makers and importers. The first action was in March 2006, with a regulation requiring makers and importers of 17 of these orphan chemicals to test their products (C&EN, March 27, 2006, page 32).

Then EPA issued regulations in August 2006 requiring companies to send the agency all unpublished health and safety studies they have in their possession on 243 additional orphan HPV chemicals and to provide use information and production or import volumes for these substances (C&EN, Aug. 21, 2006, page 36). After this rule took effect, companies volunteered to sponsor testing of 22 of these substances through the HPV Challenge Program and another four through the ICCA effort, Willis said. The agency also has determined that seven of the chemicals covered by the August rule are no longer manufactured in amounts greater than 1 million lb per year.

These formal actions, Russell said, have helped level the competitive playing field for companies that volunteered to furnish information on their products through the HPV Challenge Program.

Besides implementation problems such as the outstanding data submissions, the voluntary program has some inherent shortcomings as well, according to Russell and Denison.

A drawback of the HPV Challenge Program, Russell said, is its focus on the hazards a chemical may pose rather than on risk, which factors together both hazard and exposure information. And the program has left a lasting false impression that if toxicity data on a chemical are not publicly available, they do not exist, he said.

Denison said that since the HPV Challenge Program was launched in 1998, an additional 574 chemicals are now made in amounts of 1 million lb annually. Only 232 of those compounds have sponsors that will provide data through the chemical industry's Extended HPV Program, he said.

ACC, the Synthetic Organic Chemical Manufacturers Association, and the Soap & Detergent Association launched the Extended HPV Program in 2005. It is designed to compile and make public hazard data on the additional chemicals whose manufacture or import has reached HPV levels in recent years (C&EN, March 21, 2005, page 34). In addition, the program aims to provide use and exposure data on all HPV chemicals, including those in the HPV Challenge Program.

Denison also took issue with the suite of data provided for each chemical in the voluntary effort. The HPV Challenge Program was designed to provide a package of test results called a screening information data set. Some 20 years ago, OECD decided what sort of testing data would go into each of these data sets.

"This is old toxicology," Denison said. These packages of information do not include screening for potential hazards, such as disruption of hormone systems, that were not recognized when OECD established the standard decades ago, he explained.

Meanwhile, EPA plans to take a closer look at the information produced through the HPV Challenge Program, in what could be the first step toward tighter regulation of some of these substances.

Willis said EPA hopes to review, within three years, the data on the HPV chemicals flagged as potentially of greatest concern because of possible toxicity or environmental persistence. The agency's National Pollution Prevention & Toxics Advisory Committee devised the procedure for initially selecting the HPV substances of potentially greatest concern (C&EN, Feb. 28, 2005, page 42).

James Gulliford, EPA assistant administrator for prevention, pesticides, and toxic substances, told the conference that the Bush Administration is committed to completion of the HPV Challenge Program. Despite tightening federal budgets, EPA will continue, in years to come, to invest in the data review effort and the database for making this information public, Gulliford stated.

Also at the conference, Ken Geiser, director for the Lowell Center for Sustainable Production at the University of Massachusetts, called for industry to supply data on chemicals that are made in volumes somewhat less than 1 million lb per year. Although lacking HPV status, these substances nonetheless account for a significant number of chemicals in commerce, he said.

Auer also said EPA needs data on substances made at volumes below the HPV threshold. He pointed out that the Canadian government recently reviewed some 23,000 chemicals in commerce—including those produced at less than the 1 million-lb-per-year threshold—and has selected 4,300 for further risk analysis (C&EN Online, Dec. 18, 2006).

"It's a body of work we intend to take a closer look at," Auer said of the Canadian review.

The chemicals market, Geiser said, at present is based on function, price, and performance. Information on the toxicity of substances needs to be a part of this commerce as well, he said, and the HPV Challenge Program has helped bring this about.

"A sustainable future requires good information to make solid decisions" about health and environmental attributes of products, Geiser said.