EPA Watch: Agency taken to task over animal testing - Environmental

EPA Watch: Agency taken to task over animal testing. Environ. Sci. Technol. , 1999, 33 (17), pp 357A–358A. DOI: 10.1021/es992966k. Publication Date ...
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"The action plans lead to pressure to act" and will probably result in new regulation for these chemicals, said Hamilton. But it will be a challenge for Mexico because the sources, thought to be backyard trash burning and backyard brick making, are diffuse and poorly understood, said Hamilton. No one knows for sure what the emissions are from these sources, he added.

Nitrate standard for drinking water too stringent, researcher finds Recent research indicates that blue baby syndrome, also known as acquired infantile methemoglobinemia, might be caused by gastrointestinal disorders such as bacterial and viral diarrhea or urinary tract infections as opposed to nitrates in drinking water as previously thought, according to a paper published in the July issue of Environmental Health Perspectives. As a consequence, EPA's nitrate standard for drinking water of 10 parts per million (ppm) could easily be doubled without any adverse health effects, while simultaneously eliminating the need for costly nitrate removal systems in drinking water nationwide, said Alex Avery, research associate with the Hudson Institute's Center for Global Food Issues and the study's author. Of the systems that do violate the standard periodically, "only a handful" exceed 20 ppm, according to Alan Roberson, director of regulatory affairs for the American Water Works Association, which represents drinking water facilities. The 10 ppm standard set in 1991 is based on a 1951 survey by the American Public Health Association that linked 278 cases of methemoglobinemia, which affects babies younger than six months and can lead to insufficient oxygenation of the blood and ultimately death, to nitrates in drinking water. Most of these cases occurred in rural areas served by poorly constructed wells located near barnyards or leaking septic tanks. The syndrome now is virtually nonexistent, with only two cases reported since the mid-1960s, according to Avery's study. Because no cases were observed below 10 ppm, however, EPA established its standard at this level.

Water plants would avoid costly controls if the nitrate standard is revised.

In 1995, the National Research Council (NRC) evaluated whether this level was adequate for protecting public health, concluding that it was, but the NRC did not consider whether the standard might be too stringent. "It might be that the standard could be safely raised because most of the nitrate that we take in—better than 90%—comes from food, not water," said Roger Smith, a professor at Dartmouth Medical School who was on the NRC panel. But since it is still not clear what exactly causes methemoglobinemia, he advocated keeping the standard as is. Roberson agreed, saying that he felt the Hudson Institute study only told half the story. "They looked at their data and said bacteria may be causing the problem, but they didn't do much to refute that nitrate might be the cause," Roberson said. Besides, most of the facilities that exceed the 10 ppm standard already have installed treatment systems for nitrate removal, so it is almost a nonissue for them now, Roberson said.

Citizens' right to sue under fire in courts In an unusual step, EPA has joined a lawsuit brought by a citizens group alleging that a company failed to report storage of more than 100 pounds of hydrofluoric acid. The agency has joined the lawsuit after several judgments in the case, to bolster the petitioner's

claim for a penalty based on the company's violation, according to Joshua Wirtschafter, assistant regional counsel for Region IX in San Francisco. Over the past decade, federal courts have been chipping away at the citizen's right to sue provisions in environmental laws, say attorneys representing businesses and environmental groups. And now the U.S. Supreme Court is considering a citizens suit case brought against Laidlaw Environmental Services. The justices will determine a number of issues, including whether the group can claim a penalty for violations that occurred before the case was brought. Under the citizen suit provisions, the penally is turned over to the government. The case in which EPA intervened, Don't Waste Arizona v. Precise Metal Products, Inc., was filed in 1995, alleging that the company failed to submit reports required by the Emergency Planning and Community Right-To-Know Act's Section 312. After several summary motions, the judge ruled that Precise Metal violated the law by failing to report in two separate years, company officials said. The remaining issue in the Precise Metals case is the amount of penalty the group can claim. EPA's petition seeks $25,000 per day for each violation. This case "is a reminder that the legal debate surrounding citizen suits should not suggest that companies can violate the law," Wirtschafter said. "EPA can still follow up on a violation that was investigated before the case was filed." Precise Metal officials maintain that the chemical was stored in volumes well below the level that triggers the requirement to report. "The whole thing is erroneous," said Alexander Allwing, Precise Metal's president.

Agency taken to task over animal testing Under heavy pressure from animal welfare advocates, EPA is continuing to refine its voluntary high-production volume (HPV) chemical testing program to reduce the number of animals likely to be required for testing. Using a battery of tests known as Screening Information Data Sets (SIDS) developed by the Paris-based Organization for Economic Coopera-

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tion and Development, the program is seeking to gather baseline data on the environmental and health effects of some 2800 chemicals produced in volumes greater than 1 million pounds per year (ES&T, 1998,3 (6), 251A). EPA now has chosen to substitute the classic "lethal dose" or LD50 test with an "up-and-down" procedure for acute toxicity screening, reducing animal usage by up to 60%, said Charles Auer, director of the Chemical Control Division in the Office of Pollution Prevention and Toxics. And allowing in vitro, or nonanimal, genetic toxicity tests, as well as a combination test rather than separate tests to obtain reproductive, developmental, and repeat-dose toxicity data, could bring the total reduction to 80%, Auer said. However, animal rights groups such as People for the Ethical Treatment of Animals and the Physician's Committee for Responsible Medicine (PCRM) contend that these actions do not go far enough. They voiced their concerns at a Congressional subcommittee hearing on the HPV program in June. Their primary objection to the HPV program is that extensive data already exist on many of these chemicals, rendering additional testing unnecessary. PCRM released a report earlier this year in which it claimed to have "easily located publicly available documentation of previously conducted animal experiments and known human health effects" for 13 of 22 chemicals for which they tried to track down information (ES&T, 1999, 4 (5), 191A). Both Democratic and Republican members of the House Science Subcommittee on Energy and Environment also took EPA to task during the hearing over these concerns. "I don't think there's convincing evidence available to support this view," Auer said, however, noting that EPA, the Environmental Defense Fund, and the Chemical Manufacturers Association all came to a similar conclusion in separate studies: that complete health and ecological effects screening data are lacking for more than 90% of the HPV chemicals in use today. "They [PCRM] found some information, but they found a lot of other information that isn't really relevant to SIDS endpoints," Auer said.