Tobacco Documents Online

. - I Animal Tests as Risk Clues: i The Best Data May Fall Short . ByJOELKRINKLEY .0NI-e~ ~ryty~MVMYorkTmea GAITHERSBURG, Md., March 20 - Doaena of caged rats and mice spend t Price Cleanup? Wha a fErICA 9'huf(,NrfIFJ°q( their iMytibere In a taboratory, chewing the natfMt'a enNUU6 on PJttna rodent chow laced with as is tkY+Wn iaio much boric acid as they can tolerate As a result, even br. Kenneth Olden, without risk of death from poisoning. director ot the National Institute of These rodents and more than 1,000 Environmental Health Sciences, the others are being used to study seven branch of the National Institutes of common environmental and household He~th that direct ; the animal studies, - chemicals to see if any cause reproduc- ask whether Ihe nation is wasting i9ve problems. The rats and mice are billions of dollars reguiating sub- allowed to breed at will. Then scientists stancr~ Ihat might pose little risk. , here at R.O.W. Sciences, a research ~ Thc findings from about 450 animal laboratory that works under Federal studies over the last several decades, contract, examine several generations of offspring for abnormalities or de- fects. This project is just one of roughly 65 rodent studies under way at 15 labora- tories across lhe country at an average cost of about $2 million each. For much of the last two decades, these studies have been the Government's most im- portant diagnostic tool for identifying environmental problems that are health hazards and setting priorities - for Federalregulation. Billions Down the Drain? But now the animal-studies program "is being hobbled by doubts about its worth. So much evidence has accumu- lated that chemicals frequently have wholly different effects in animals and humans that officials throughout Gov-' ' ernment and industry often do not act ' on the studies' findings. And with that growing skepticism, the raatlonale behind a large portion of Continued on Page A16, Column I i L66£ti4tiLOZ Continued From Page Af Dr. Olden said, have led Federal and state governments to write thousands of regulations forcing government and industry to spend tens of billions of dollars a year regulating the use and disposal of several dozen chemicals, or finding alternatives for chemicals that have been restricted or banned. For instance, it was data from ro- dent studies that led the Government to ban or restrict the use of two kinds of artificial sweeteners, cyclamates and saccharin, as well-as the pesticide DDT and the industrial byproduct dioxin. In Dr. Olden's view, "That's art awful lot of money to be spending to be regulating sub- stances we might not have to be regulating at all if we had more information." After spending many billions of dollars to *clean up dioxin, the Government is midway through a reassessment because new studies of people exposed to dioxin - once consid- ered one of the most poisonous substances in the world - show it is not nearly as harmful as originally believed. Similarly, John A. Moore, a former assist- ant administrator for the Environmental Protection Agency who now heads the pri- vate Institute for Evaluating Health~Risks, noted that DDT was banned because it was believed to be a carcinogen. But new data show that it poses "a rela- tively modest cancer risk," Dr. Moore said, though DDT does present other environmen- tal hazards. And as for some of the other chemicals that have caused cancer in ro- dents, Dr. Richard A. Griesemer, deputy director of Dr. Olden's institute, offered some additional revisionist ideas. "Saccharin doesn't have much risk," he said, "and I don't think cyclamates have any risk at all." Scott Green understands the weaknesses of his research. He is R.O.W.'s laboratory, manager, and he did note that the reproduc- tive studies "are already finding snme ef- fects." Some rats and mice are producing fewer litters that are smaller than average. "But is that relevant to what's happening out there in the environment?" he asked. "I can't tell you." •

! oxk Dhnni NEW YORK, TUESDAY, MARCH 23, IJ9J Animal Tests as Risk Clues; ~ The Best Data May Fall Shorti . ByJOELBRINKLEY Spocla b•R e an Yark Tlmn GAITHERSBURG, Md., March 20- Dozens of caged rats and mice spend their days here in a laboratory chewing on Purina rodent chow laced with as much boric acid as they can tolerate without risk of death from poisoning. These rodents and more than I,606 others are being used to study seven common environmental and househo(d chemicals to see if any cause reproduc- tive problems. The rats and mice are allowed to breed at will. Then scientists here at R•O.W. Sciences, a research laboratory that works under Federal contract, examine several generations of offspring for abnormalities or de- fects. This project is just one of roughly 65 rodent studies under way at 151abora- tories across the country at an average cost of about $2 million each. For much of the last two decades, these studies have been the Government's most im- portant diagnostic tool for identifying environmental problems that are health hazards and setting priorities for Federal regulation. • Bllllons Down the Drain? But now the animal-studies program is being hobbled by doubts about its worth. So much evidence has accumu- lated that chemicals frequently have wholly different effects in animals and humans that officials throughout Gov-' ernment and industry often do not act on the studies' findinp. And with that growing skepticism, the rationale behind a large portion of What Price Cleanup? Third lAic(e pf . wrfas. the nation's Mp! ,tlittlalis thrown inttt = >' s ' As a result, even Dn Kenneth Oiden, director of the National Institute of Environmental HealU Sciences, the branch of the National Inatitutes of He th that direcc+ the animal studies, - ask whether the nation is wasting billions of dollars regulating sub- slamtr:Ihat might pose little risk. . 7hc Ilndings from about 450 animal sutdies over the last several decades, Continued on Page AI8, Column I ebbChih L0-C Continued From Page Al Dr. Olden said, have led Federal and state governments to write thousands of regulations forcing government and industry to spend tens of billions of dollars a year regulating the use and disposal of several dozen chemicals, or finding alternatives for chemicals that have been restricted or banned. For instance, it was data from ro- dent sttidies that led the Government to ban or restrict the use of two kinds of artificial sweeteners, cyclamates and saccharin, as welPas the pesticide DDT and the industrial byproduct dioxin. In Dr. Olden's view, "That's at5 awful lot of money to be spending to be regulating sub- stances we might not have to be regulating at all if we had more information." After spending many billions of dollars to clean up dioxin, the Government ts midway through a reassessment because new studies of people exposed to dioxin - once consid- ered one of the most poisonous substances in the world - show it is not nearly as harmful as originally believed, Similarly, John A. Moore, a former assist- ant administrator for the Environmental Protection Agency who now heads the pri- vate Institute for Evaluating Health~Risks, noted that DDT was banned because it was believed to be a carcinogen. But new data show that it poses "a rela-tively modest cancer risk," Dr. Moore said, though DDT does present other environmen- tal hazards. And as for some of the other chemicals that have caused cancer in ro- denls, Dr. Richard A. Griesemer, deputy director of Dr. Olden's institute, offered some additional revisionist ideas. "Saccharin doesn't have much risk," he said,'•and I don't think cyclamates have any risk at all." Scott Green understands the weaknesses of his research. He is R.O.W.'s laboratory, manager, and he did note that the reproduc- tive studies "are already finding some ef- fects." Some rats and mice are producing fewer litters that are smaller than average. "But is that relevant to what's happeningout there in the environment?" he asked. "1 can't Irll vou."

. ally exposed to low levels of the suspect subslances. And even if they suffer unusual health problems, it is hard to know whether the illnesses were caused by the substance or something else - smoking, poor diet, etc. "Epidemiology is a real crude tool for looking for associations," Dr. Wilcox ac- knowledged. It is also lime-consuming. As a result, his department, like the pathology laboratory, is able to examine only a tiny percentage ot the substances subjected to animal studies. That nt>"ans the institute and the rest of the Government can seldom offer much more than the animal studies as warnings of a substance's possible danger to humans. ""We're looking for alternative approach- es," Dr. Griesemer said. "But right now, that's what we've got." Quite often, that means no one takes the institute's warnings se'riously any longer. P1'oWms Frustrations Grow With Knowledge Almost two years ago, the results came in from rat and mouse studies of 1,2,3-Irichloroo- propane, an industrial solvent used as a paint and varnish remover or a degreasing agent. Almost every animal exposed to the sub- stance was riddled with tumors "in several organs; " said Dr. Richard D. Irwin, the insti- tute toxicologist who wrote the report. "This is the type of chemical that shows the great- est potential for human effect." "Our understanding is that workers wash themselves in this," Dr. Criesemer said. And since the chemical is absorbed in the skin, he and others said, the finding was particularly. troubling. In Dr. Irwin's view, "It would be real good to get some human data because I'm sure there were people who were exposed to it in the past, maybe even now." £66£tr 4trL6Z • So did the epidemiologists look for people who had been exposed to the substance? "This isn't one we're looking at,° Dr. W il- cox said- Bu1 maybe, he added, the National Cancer Institute's epidemiologists did look at it. The cancer institute has what is probably the world's largest cancer epidemiology de- partment - 100 scientists and support staff. - and they get the animal-study reports automatically. But they seldom choose to begin a study based on the animal research, and they did not initiate one in this case. In 1990, when a rodent study suggested that fluoride might be a carcinogen, "we took that one on," said Dr. Fraumeni, head of epidemi-, ~ ology for the cancer institme. "We found i'nothing, and that was the last time." As for trichloropropane, he said,'9 haven't, heard of it." Dr. Irwin wondered if the Occupational Safety and Health Administration might: have done a survey or found a way to check on workers exposed to the chemical. But Dr. Edward Stein, a health scientist for O.S.H.A., said the agency had done no sur- veys and had not changed its standards for , trichloropt'opane since January 1989, when it Isaued a regulation limiting airborne emis- sions of the substance. , Up to the Manufacturer? As for telling people of the dangers, Dr. Stein added, "The primary manufacturers of, the product would be responsible." "I presume whetl updating training pro- grams at companies that use this, say annu- ally, whoever is doing that would be aware of the new information," Dr. Stein said. "They would make the employees aware of it, but I'm not sure if that is actually being done." "We always have a battle on the Issue of• what to do with the animal data," Dr. Stein. added. "I'm not trying to downplay it, but I do believe other things ought to have priority." So back in North Carolina, Dr. Irwin said: "I really haven't heard of anything happen- ing. It's almost as if our work just goes into a black box." Acknowledging that problem, Dr. Olden said: "I have to say we don't serve the American people very well right now. But that's where we are." I

• . "A victory for the environment is a victory for the environment," she said. But it is not completely clear that a ban on dumping was such an environ- mental triumph. The negative effecfs of burying sludge close to thR shores have been documented with precision. But the dangers of dumping it In deep~ er water are leas r.~le~~r,. - Studies have shown that -sludge de- posited 106 miles out does reach the. ocean floor and, in the words of Dr. Frederick Grassle, director of the Rutgers Institute of Marine and Coast• al Sciences, "it has a minute but meas- urable impact an the deep-sea ecosys~ tem." However, Dr. Grassle also saidd that health risks from the dumping appeared to be minimal - primarily because the ocean rapidly diluted the waste below dangerous concentrations:- Somc researchers have proposed the nearly lifeless plains at the bottom of the oceans as a relatively inexpensive,and safe, disposal site for sludge. They argue that at the deepest levels of the sea - several hundred miles away from any coastline and under neariy,. 16,000 feet of water - the sludge wi{} rest undisturbed and harmless. "' . Short-Sighted Proposal? „ However, many environmentalisYc and some scientists view the researcir proposals for deep-sea burial of slud&; asshm't-sighted. "It will take 10 seconds of logic a4-d: $10 million to prove that this too wflf' have adverse effects on the environ-. ment," said Dr. Elliott A. Norse; a marine ecologist who is chfef scientfsi;: for the Center for Marine Conserva=tion. But John Edmond, professor tsf chemical oceanography at the Massa- chusetts Institute of Technology, said;;; • "There are going to be impacts on oar- society of anything we throw awa}!',; . That includes ocean dumping. Bat.. there is a real crisis in land disposal bf our waste, and we have acted to 6aneven the consideration of ocean dunep=;r ing. "Even if we don't use the uppW , ocean -d and perhaps we should not---t we should think about the sea floor. Bt1(_' people are so emotional about these- issues that they can hardly see or thitkstraight." Next: The problems with laboratory~ testing. N O A ~ 4 3 ~ W ~ tD ~