Qualified Success

By many measures, an initiative by chemical manufacturers, an environmental group, and the Environmental Protection Agency to generate basic data on hundreds of substances is turning out to be a success. Information on many compounds is now posted on the Web, and, early in 2005, the first entries in a relational database on these chemicals are expected to go online.

The effort, the High Production Volume (HPV) Challenge Program, is providing data on chemicals manufactured or imported in the U.S. in amounts of at least 1 million lb per year. Information generated and made public in the program covers basic health and ecological effects, environmental fate, and physical properties. The voluntary program was launched in 1998 as a cooperative effort among Environmental Defense, the American Chemistry Council (ACC), and EPA, though other industry trade groups are now involved. Triggering the initiative was a 1997 Environmental Defense report, "Toxic Ignorance," that decried the lack of publicly available information about chemicals produced in the greatest quantities.

"As it turns out, we were not in a state of 'toxic ignorance,' " says Steven K. Russell, assistant general counsel at ACC. More than half of the studies used as sources of data for HPV chemicals were unpublished and held privately by industry, Russell says. "The real issue isn't lack of data, but that much of the data is not easily accessible to EPA or the public," he says.

"This program has developed data [on chemicals] at a rate faster than ever before," says Richard A. Denison, senior scientist with Environmental Defense, an activist group. However, he adds, "There's still a long way to go" in gathering data on HPV chemicals.

On Dec. 1, EPA released a long-awaited status report on the HPV Challenge Program. According to this comprehensive report, companies or groups of businesses have committed to generate data on 2,222 chemicals thus far.

The agency says companies and consortia have sponsored data generation on 1,371 chemicals in the program. Information on another 851 HPV chemicals will be developed through the International Council of Chemical Associations (ICCA) HPV Initiative. That voluntary effort is providing data on about 1,000 HPV substances to the Organization for Economic Cooperation & Development (OECD), a bloc of 30 of the world's most industrialized countries. The OECD program, which was begun in 1993, involves a universe of 4,843 HPV chemicals--defined as those produced in volumes of at least 1,000 metric tons per year in at least one OECD country.

Within the U.S. initiative, EPA, Environmental Defense, and ACC agree that a major concern is 330 HPV substances that are "orphaned"--that is, no company has volunteered to produce data on them. Russell calls orphaned chemicals "the number one issue" facing the HPV Challenge Program.

Some orphaned HPV chemicals are manufactured or imported by more than one company, Russell says. Firms that volunteer for the testing program are at a competitive risk against those that produce the same chemical but do not join in the data-generating effort, he points out. Russell says ACC is eager for the agency to require tests on these orphaned substances. Such a regulation would force all manufacturers and importers of an HPV chemical to share the costs of providing data on that substance.

In December 2000, EPA proposed a rule covering 37 of the orphans. The report says the agency expects to issue a final version of the regulation in June 2005--but the rule will cover fewer than the 37 substances listed in the proposal. Denison says about a dozen of those 37 compounds now have sponsors in the voluntary program, so the final rule will cover no more than 25 chemicals.

Beginning in October 2005, the agency plans to propose a second rule to force companies to test orphan HPV chemicals that they produce. EPA expects to issue a final version in 2006. Plus, the agency would propose a third rule on testing orphan substances in September 2006. "The timeline for test rules is a long one," Denison says, adding that it can take two years for companies to provide results after EPA finalizes a testing rule.

A MAJOR LIMITATION to the HPV program, he says, is that chemicals can drop out--usually because they are no longer made in excess of 1 million lb per year--but the initiative includes no mechanism to add substances. According to the agency, there are 1,118 chemicals that would qualify for HPV status now that did not qualify in 1998. Denison says the voluntary program needs to evolve so that once a substance reaches the 1 million-lb annual production level, "industry collectively finds a way to develop and make data publicly available." This, he says, "would be consistent with the principles of Responsible Care," the code of conduct and product stewardship for the chemical industry.

The report says that EPA is "considering options" on addressing chemicals now manufactured at HPV levels but that weren't when the challenge program began in 1998. However, it did not elaborate on those options.

Another obstacle the initiative faces involves getting available data to the public in a timely fashion, Denison says. Information on hundreds of HPV chemicals is already posted on the Web. But Denison says the diversion of the hundreds of chemicals from the U.S. effort into the ICCA program is delaying the public availability of data on those substances. Information on many of the chemicals moving through the ICCA program may not be available for several years--but the goal of the U.S. effort was to have this data released by the end of 2004, he says.

Denison also cites the lack of public scrutiny in the ICCA effort. OECD gives "a fairly careful review" of testing plans, he says. However, he adds, "it's not a substitute for broad public access and input into the process," such as that of the HPV Challenge Program.

According to Environmental Defense's statistics on the U.S. program, either EPA or the environmental group gave feedback on 350 proposed test plans, commenting in 280 cases that more studies were needed or that industry had not supplied enough information for them to determine whether additional research was necessary. In other cases, comments challenged industry justifications for placing similar compounds into categories for testing purposes. Denison praises many companies and consortia that were "very responsive" to these comments in the final version of their testing plans.

Denison expresses concern, however, that EPA has commented on few test plans since February. "Prior to that, EPA had consistently reviewed virtually every submission," he tells C&EN. The agency has received 57 industry submissions since February, and three of these are incomplete. Of the 54 remaining, EPA posted no reviews for 47 test plans and commented on just seven, he says. Denison believes that review by EPA is "critical" to the quality of test plans.

Part of the U.S. program meeting with qualified success has been the use of chemical categories. Sponsors are placing similar compounds into a category and using studies on two or more of the substances to predict the toxicity of the other chemicals in the group. Industry, EPA, and Environmental Defense endorse the concept of using categories, in part because it saves money and the use of many laboratory animals.

Before testing begins, a company or consortium must provide a justification for placing chemicals together into a category. EPA and the public get a chance to comment on the industry rationale. After the testing for the group is completed, the agency will review the results and deem whether the category for those chemicals is "held" or will tell the industry sponsor that more studies are needed, the EPA report says.

Denison says test sponsors need to estimate toxicity values for each individual substance in a category rather than making general conclusions about the group as a whole, as do some submissions. "I want to know about dimethyl doorknob, not the category it's in," Denison says.

Another issue the HPV Challenge Program faces is an information technology one. Data submitted by industry are posted in Portable Document Format at http://www.epa.gov/chemrtk/volchall.htm. While this EPA site includes some simple search capabilities, it is not as powerful as a relational database. Such a database is in the plans, though.

As the voluntary testing program began, ACC suggested that data for chemical categories be submitted to the agency in the format used in the EU's International Uniform Chemical Information Database (IUCLID), Russell says. He adds that the agency, however, insisted it would accept the information in any format to facilitate submission of data. Denison says EPA did this because some smaller chemical makers did not want to invest in the expensive IUCLID software.

Russell says industry is now vexed about EPA's recent request to reformat the HPV data into IUCLID. For many chemicals and categories, consortia have finished their HPV work and disbanded. But the agency is now asking consortia for 40 to 80 hours of extra work to enter data on chemicals into the IUCLID format, Russell says.

"IT'S FRUSTRATING in the extreme," he says. Not requiring data to be submitted in the IUCLID format in the first place is delaying public access to a searchable HPV database, Russell adds. "If [EPA] had really thought through this earlier on," Denison agrees, "it would have saved a lot of problems now."

EPA hopes to have its first IUCLID database entries online in early 2005. But having chemical data in an IUCLID database is part of a larger plan. The EPA report says the agency is working collaboratively with the EU and in consultation with OECD to develop a Web-based portal that will allow users to access consolidated data repositories for HPV chemical data. The idea is "to provide seamless information sharing" between the EU's chemical information database and the HPV site at EPA, the agency says. The unified system would also allow industry to submit information on a chemical once, rather than sending it to EPA and the EU individually. Canada and Japan are interested in the HPV portal system as well, the report says. "The planning around the portal is still in the conceptual stages," it adds.

MEANWHILE, some in the U.S. chemical industry are raising concerns that the EU's proposed legislation to control chemicals could undermine the HPV program. The EU plan calls for the registration, evaluation, and authorization of chemicals and is known as REACH. The pending legislation would require companies to provide basic physical and toxicity characteristics of any chemical produced in quantities of 1 metric ton or more per year. Russell says the REACH proposal does not explicitly require that companies submitting data for registration of chemicals actually own the rights to the underlying studies that produced the data. Firms that lack data on the substances they manufacture can easily go to the HPV Challenge Program's website to get the information, he says.

Denison says ACC did not express concerns about chemical data ownership until REACH was developed, noting that many in the U.S. chemical industry oppose the EU plan.

"They didn't start raising these concerns for the many years these programs have been going," Denison says, noting that data from both the HPV Challenge Program and the OECD effort have been posted to the Web. "This is making a mountain out of a molehill."

Denison reports hearing similar arguments that REACH could also endanger the OECD effort on testing HPV chemicals. The pace of that international initiative is slower than that of the HPV Challenge Program--data are being produced for about 70 substances per year in the OECD program, Denison says.

"I'm aware it's a topic that's receiving discussion" within some parts of the chemical industry, Russell says, but adds that ACC has no official position on conflicts between REACH and the OECD chemical testing effort.

EU officials have repeatedly said that REACH would not endanger either the OECD effort or the HPV Challenge Program. Last month, the EU filed a document with the World Trade Organization that responded to industry concerns. That document said REACH "requires registrants to demonstrate that they have the right to use studies that have been generated under these [HPV and OECD] programs" rather than allowing companies to submit information potentially copied from websites.

Denison points out that the EU won't officially adopt REACH until at least 2006 and the legislation would not go into effect until 2009 or 2010. Completion of the HPV Challenge Program is expected in late 2005 or early 2006, Denison notes.

Meanwhile, EPA is still formulating its plans on how it should review the HPV data. Early in 2005, the agency's National Pollution Prevention & Toxics Advisory Committee will offer suggestions on how the agency should screen the HPV Challenge data, say Russell and Denison, who are both members of that panel. The screening is so EPA can determine which HPV chemicals need further testing for possible ecological or health effects and what kind of extra studies are required.

Overall, Denison and Russell believe the HPV Challenge Program is making reasonable progress. "We're doing pretty well. We're largely on track," says Denison. Russell adds, "The chemical industry is extremely proud of this."

EPA's report is available electronically at http://www.epa.gov/chemrtk/hpvreport.pdf.