testing program gets under way
TRANSCRIPT
GOVERNMENT & POLICY
TESTING PROGRAM GETS UNDER WAY Voluntary effort on HPV chemicals gears up; animal welfare groups want program to stop CHERYL HOGUE, C&EN WASHINGTON
Ρ LANS FOR CONDUCTING BASIC toxicity testing on hundreds of industrial chemicals are starting to roll into the Environmental Protection Agency
For some substances, companies are summarizing existing toxicity information gleaned from scientific literature and
unpublished studies and expect to do no further testing. For others, companies are beginning to contract with laboratories to conduct studies that will fill in data gaps. EPA is preparing for an onslaught of data.
The high-production-volume (HPV) testing program is up and running.
"The ship is out of the harbor," says
DATA ROUNDUP Scientists are working to fill in information gaps about basic health and environmental effects, environmental fate, and even physical properties of HPV chemicals.
David Roe, senior attorney for Environmental Defense.
UNDER THE HPV program-launched in 1998 by industry, EPA, and Environmental Defense—chemical manufacturers are voluntarily testing some 2,800 substances made in or imported into the U.S. in amounts exceeding 1 million lb per year. The goal is to fill in information gaps about basic health and environmental effects, environmental fate, and even physical properties such as boiling points for HPV substances (C&EN, Nov 2,1998, page 19).
EPA, the American Chemistry Council (ACC), and Environmental Defense give the HPV program passing marks thus far. Animal welfare activists, meanwhile, are calling for an end to HPV chemical testing.
Jessica Sandler, federal agency liaison for People for the Ethical Treatment of Animals (PETA), says the HPV effort is "another meaningless, bureaucratic program that costs taxpayers money and will do nothing in the end to protect public health and the environment." What it will produce, she says, is "piles of bodies of dead animals and that's about it."
William H. Sanders III, director of EPAs Office of Pollution Prevention & Toxics, says the agency agrees with the animal welfare groups' goal of eliminating tests on animals. But, he says, "from a science standpoint, we're not there yet," because alternatives are not available for all forms of toxicology tests involving animals.
'We're not about testing animals. We're about getting information," Sanders adds.
Roe agrees. "Nobody wants unnecessary testing," he says. Those involved in the HPV program want reliable information, he adds.
According to EPA, 469 companies, either individually or as part of a consortium, signed up to test 2,155 HPV substances as of Aug. 1. The agency received 48 plans for testing 24 classes of related chemicals and 24 individual compounds. Those 48 plans cover 360 chemicals.
Sanders says the HPV program is "somewhat behind" on the number of test plans submitted thus far versus the number expected at this point. However, he thinks the program is ahead on the number of companies volunteering to sponsor tests.
Steven K. Russell, counsel for ACC's
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product stewardship team, says that the first stages of the HPV program turned out to be more expensive and time-consuming than chemical manufacturers originally anticipated. Forming consortia to test chemicals and doing literature searches for existing data take longer than estimated, he explained. Meanwhile, EPA expects a level of detail in test plans that makes preparing these documents more involved than industry originally envisioned, Russell tells C&EN.
"We significantly underestimated the administrative costs of drafting test plans"
A standardized set of toxicology data allows regulators to make "apples with apples" comparisons among chemicals.
and conducting thorough searches for existing data on HPV substances, Russell says. But this expense is roughly offset because chemical makers are finding they have less testing to do than they anticipated due to the existing data that was turned up through their efforts, he says. Companies collectively will still spend up to $500 million to complete the HPVpro-gram, Russell adds.
Environmental Defense's Roe says the delays in getting HPV testing under way are for "understandable reasons."
Regardless of the slow start, companies that signed up for the HPV program are keeping their commitments "in full and on time," Russell tells C&EN. He expects a flurry of activity later this year as test plans covering 600 additional chemicals are filed with EPA by the end of 2001. The effort remains on schedule for completion in 2004, he says.
"We don't detect any easing up on the pedal" by industry or EPA, Roe says.
IN THE 48 plans submitted so far, companies have proposed no testing for some of the HPV compounds, including ethanol, because existing studies provide the hazard data sought in the program. For other substances, manufacturers have found some—but not all—basic toxicity data by scouring company files and conducting literature searches. Those plans lay out an agenda for testing to fill in the gaps.
PETAs Sandler and Nicole Cardello, staff scientist for the Physicians Commit-
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GOVERNMENT & POLICY
tee for Responsible Medicine (PCRM), say their organizations want the HPV testing to stop. Instead of testing, industry and EPA should take steps to reduce exposure to chemicals known to be hazardous, they say According to Cardello, this would be the best course of action to protect public health from exposure to hazardous chemicals. Data generated through the HPV program will simply set the stage for further testing of chemicals and will delay further regulatory action to control exposure, Cardello tells C&EN.
PCRM focuses on preventive medicine and promotes high ethical standards and efficacy of research. It has 5,000 physician members and 100,000 lay members.
EPA officials say the animal welfare groups miss the point of the HPV program—to ensure that the hazards posed by chemicals produced in the most prodigious quantities are adequately characterized.
Sandler and Cardello also say the HPV program is overly focused on a standardized set of data for chemicals. This makes companies more apt to conduct a test because they know for certain regulators will accept it—rather than conducting "thoughtful analysis" of existing data that may obviate the need for a study, the animal protection advocates say
Cardello and Sandler call this a "check the box" attitude. Companies know that if they conduct new tests for the screening set, they will satisfy EPA, they explain. Sandler contends that in the HPV program, EPA is making it hard for companies supplying existing toxicology data to avoid more tests.
A standardized set of toxicology data allows regulators to make "apples with apples" comparisons among chemicals, Russell says. A basic set of hazard screening data may trigger regulators to seek more studies on a chemical or it can also be the basis for ruling out further testing, he adds.
EPAs Sanders believes that in many cases, existing studies can fill in data gaps for H P V chemicals. But even with "thoughtful analysis," he says, "there's always the area of interpretation of what is an adequate study" And in some cases, pre
viously conducted tests will not provide the information needed, he adds.
Once EPA receives a test plan, it posts the information on its Internet site and invites the public to comment. After a 120-day comment period, the agency offers its suggestions for the test plan. Sponsors consider the comments as they begin the testing process, but because the HPVprogram is a voluntary one, they are not required to adopt any recommendations or to respond to suggestions, Sanders says.
THE COMMENT PERIOD was not originally part of the HPV program—it was added in 1999 at the behest of animal welfare groups (C&EN, Nov 1,1999, page 7). The comment period "draws out the process" and introduces uncertainty about the testing, Russell says. Companies can-
SANDLER ROE
not contract with testing laboratories until that period ends and the comments are considered. Most comments are not filed until "the 119th day," he says.
In some cases, test sponsors have revised their plans in light of suggestions made in public comments, according to Russell.
EPA and ACC officials acknowledge that, except for a few comments by environmental activists, only animal welfare groups are giving feedback on the plans.
According to Sandler, animal protection groups have provided specific, technical comments on each HPV test plan posted so far. But those comments do not seem to be influencing the test plans, she says. Sandler says she fears that the comments of animal protection organizations are disappearing into a "black hole." EPA should respond to the public comments on test
plans, just as the agency responds to comments on its proposed regulations, she says.
Sanders says that besides not being required, "we would not have the resources" for responding to public comments on the test plans.
Many of the criticisms from animal welfare organizations revolve around a letter EPA issued in October 1999 in response to their, concerns about the HPVprogram. Those groups describe that letter as "the October agreement," though EPA officials tell C&EN that the letter is a guideline for the voluntary HPV testing effort by industry, not a formal, legally binding agreement. The letter lays out principles for reducing tests on animals.
Cardello says companies "are not playing by the rules" laid out in the guidance letter and EPA is not effectively administer
ing the HPV program. For instance, animal protection
activists criticize chemical makers for submitting plans to test single chemicals—rather than a cluster of related HPV substances. A set of principles for keeping the number of laboratory animals used to a minimum, issued by EPA in 1999, calls for companies to test categories of chemicals first, suggesting that they hold off on test plans focused on single compounds until November 2001.
But companies have submitted single-chemical test plans already EPA officials say that since the HPV testing pro
gram is voluntary, they cannot force study sponsors to abide by the November 2001 date. Russell says many companies wanted to draw up a test plan for single chemicals first so they could get experience in doing so and because a test plan for a category of 10 to 15 substances involves "a lot more prep work."
Industry wants to test as many HPV substances in as many categories as possible, Russell says. "Nobody has a greater interest in maximizing the use of chemical categories than our members do," the ACC attorney says. But there are times when the category approach is not possible for technical reasons.
Russell says ACCs Olefins Panel created a category of 12 HPV chemicals. By doing so, it reduced the potential number of tests needed to be done on these sub-
The first stages of the HPV program turned out to be more expensive and time-consuming than chemical manufacturers originally anticipated.
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stances from 72 down to 2. "PCRM should be thanking them for avoiding 70 other tests," he says.
Sandler also criticizes the HPVprogram because companies are not required to produce information about exposures to HPV chemicals. If no one is exposed to a ω chemical, even if it is produced in large | quantities, the need for toxicological ^ data is not urgent, she says. χ
A report PCRM issued earlier this m month states, "The H P V program s excludes exposure and use informa- * tion that would make hazard information meaningful." It says exposure data could be used to prioritize testing of the HPV chemicals "so that companies are not wasting resources on studying naturally occurring substances and food additives, or chemicals that are present at undetectable levels in the environment."
'That's just not true," responds Russell of ACC. Nothing in the HPV program prevents companies from supplying use and exposure data along with hazardous information, he says. EPA, ACC, and Environmental Defense are urging companies to provide exposure data for HPV chemicals, Russell says.
PCRM's report also criticizes the voluntary testing program for focusing exclusively on nonhuman data, even though some human toxicity, exposure, and epidemiology studies have been done on some HPV chemicals.
Russell and Sanders agree that nothing in the HPV effort prevents companies from providing human data. "Fd always say [epidemiology data are} better than animal data," Sanders says. But the point of the program, Russell says, is to amass a specified set of toxicology data on HPV chemicals.
THOUGH HPV wasapet project of former vice president Al Gore, the Bush Administration seems to be supporting the effort, Roe and Russell note. According to Russell, Stephen L.Johnson, a longtime EPA staffer who was tapped by President George W. Bush to head the agency's Office of Prevention, Pesticides & Toxic Substances, is "squarely behind the HPV challenge program."
Sanders says because the HPVprogram is a voluntary partnership among the agency, industry, and environmental activists, it fits in well with the Bush Administration's perspective on the role of government.
Some members of Congress also are lending support to the HPVprogram, Roe says. An effort such as HPV where busi
nesses volunteer to foot the bill "generally has bipartisan appeal," he adds.
Bush asked Congress to provide EPA with about $14 million in fiscal 2002 to administer the HPVprogram. The House boosted this figure by $3 million in the bill
SANDERS RUSSELL
it passed to fund the agency in fiscal 2002, but the Senate did not in its version of the legislation. The House and the Senate will work out their differences on EPAs fiscal 2002 appropriations after Congress returns from its summer recess in September.
Roe and Russell say Environmental
Defense and ACC support an increase in EPAs budget for administering the HPV program because the agency will need more resources as HPV data begin coming in.
Sanders acknowledges that the onslaught of data submissions will be "a
challenge" for EPA, but a number of factors make it manageable. Industry scientists, rather than EPA scientists, will be summarizing the HPV data, and the information will be sent to the agency electronically, rather than on paper, he says.
As the voluntary program moves from an idea into a reality that involves making public basic hazard data on chemicals, Sanders says the chemical industry's investment in the HPV testing effort shows that companies are "walking the talk of their product stewardship ethic" set forth in the Responsi
ble Care program. But animal welfare advocates say they
will not give up on opposing the HPV program.
"We're fully determined to show what a waste of money and lives this do-nothing program is," Sandler says. •
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