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rl 1 S" :me 42 iber 4 Industrial Health Foundation 5231 Centre Avenue Pittsburgh, Pennsylvania 15232 INDUSTRIAL HYGIENE DIGEST NEWS ITEMS 78 A Lab's Troubles Raise Doubts About Quality of Drug Tests in U.S. j. S. Lublin. Wall Street Journal 191: 1, 35 Feb. 21, 1978. Two years ago Industrial Bio-Test Laboratories, Inc. (IBT) was a giant in its little industry. Every major manufacturer in the U.S. relies to some extent on independent labs like IBT to test the safety of new drugs, cosmetics, pesticides, plastics and food additives. These labs can run tests cheaper than the manufacturers can, and until very recently their findings had an aura of impartiality important to federal regulators who are responsible for keeping unsafe products off the market. IBTs 1976 sales of 97 million made it one of the biggest of some 200 independent labs in the business. Its reputation for top-quality testing had clients waiting in line. But the line has disappeared. IBT, a subsidiary of Nalco Chemical Co., stands accused by federal investigators of doctoring data and doing haphazard research on scores of animal tests over the past decade. The accusations have been made in testimony by the Food and Drug Administration and in an announcement by the Environmental Protection Agency. No charges have been filed, but the EPA has asked the Justice Department to consider criminal indictments of IBT and a former client for fraud and gross negligence. The FDA is also expected to seek indictment of IBT. 18 Asbestos: Internal Panel at OSHA Examining Policy on Medical Exam Requirements. Occup. Safety & Health Reporter 7: 1641-1642, ^arcAJO, 1978. The Occupational Safety and Health Administration has been examining its policy on medical examination require ments for employees exposed to asbestos fibers to decide if the policy should be continued in present form or changed. According to William D'Emery, OSHA office of field coordination, the agency's policy during the past year has been not to cite employers for failure to provide medical examinations to employees when exposures remained below 0.1 fibers of asbestos per cubic centimeter of air. D'Emery said the three-member panel at OSHA reviewing the policy, which includes himself, Charles McClure of the compliance programming office and John Martonik, also of field coordination, should be making recommendations to OSHA Administrator Eula Bingham in about two weeks. D'Emery declined to say what the recommendations might be. He said one question being studied is what to do about an employer which controls the release of asbestos fibers to the point where no fibers are added to the "background level" of asbestos already present. McClure added that "theoretically any office or space has a few fibers" of asbestos. OSHA has received a number of requests from employers asking for clarification of the policy on medical examination requirements, he added. McClure suggested the review and recommendation could result in issuance of a program directive by OSHA but he added, "a program directive can't change the way a standard is written." U.S.. Citing Health Risks. May Restrict A Gas Used to Sterilize Medical Devices. Wall Street Journal 191_: 5, Jan. 30, 1978. A gas used to kill germs on medical instruments and bandages may itself be a danger to human health, and several federal agencies are considering restricting or banning its use. The Environmental Protection Agency said the widely used gas, ethylene oxide, has been found in laboratoiy experiments to damage the testicles of test animals. Industrial Health Foundation 5231 Centre Avenue ' ' Pittsburgh, Pennsylvania 1523^: NEWS ITEMS 327/76 A Lab's Troubles Raise Doubts About Quality of Drug Tests in ll.S. J. S. Lublin. Wall Street Journal 191: 1, 35 Feb. 21, 1978. Two years ago Industrial Bio-Test Laboratories, Inc. (IBT) was a giant in its little industry. Every major manufacturer in the U.S. relies to some extent on independent labs like IBT to test the safety of new drugs, cosmetics, pesticides, plastics and food additives. These labs can run tests cheaper than the manufacturers can, and until very recently their findings had an aura of impartiality important to federal regulators who are responsible for keeping unsafe products off the market. IFTs 1976 sales of $7 million made it one of the biggest of some 200 independent labs in the business. Its reputation for top-quality testing had clients waiting in line. But the line has disappeared. IBT, a subsidiary of Nalco Chemical Co., stands accused by federal investigators of doctoring data and doing haphazard research on scores of animal tests over the pest decade. The accusations have been made in testimony by the Food and Drug Administration and in an announcement by the Environmental Protection Agency. No charges have been filed, but the EPA has asked the Justice Department to consider criminal indictments of IBT and a former client for fraud and gross negligence. The FDA is also expected to seek indictment of IBT. 328/78 Asbestos: Internal Panel at OSHA Examining Policy on Medical Exam Requirements. Occup. Safety & Health Reporter T: 1641-1642, ^arch.30, 1978. The Occupational Safety and Health Administration has been examining its policy on medical examination require ments for employees exposed to asbestos fibers to decide if the policy should be continued in present form or changed. According to William D'Emery, OSHA office of field coordination, the agency's policy during the past year has been not to cite employers for failure to provide medical examinations to employees when exposures remained below 0.1 fibers of asbestos per cubic centimeter of air. D'Emery said the three-member panel at OSHA reviewing the policy, which includes himself, Charles McClure of the compliance programming office and John Martonik, also of field coordination, should be making recommendations to OSHA Administrator Eule Bingham in about two weeks. D'Emery declined to say what the recommendations might be. He said one question being studied is what to do about an employer which controls the release of asbestos fibers to the point where no fibers are added to the background level" of asbestos already present. McClure added that "theoretically any office or space has a few fibers" of asbestos. OSHA has received a number of requests from employers asking for clarification of the policy on medical examination requirements, he added. McClure suggested the review and recommendation could result in issuance of a program directive by OSHA but he added, "a program directive can't change the way a standard is written." 329/78 U.S.. Citinr Health Risks. Mav Restrict A Gas Used to Sterilize Medical Devices. Wall Street Journal 191: 5, Jan. 30, 1978. A gas used to kill germs on medical instruments and bandages may itself be a danger to human health, and several federal agencies are considering restricting or banning its use. The Environmental Protection Agency said the widely used gas, ethylene oxide, has been found in laboratory experiments to damage the testicles of test animals. PMiua|||BI",BI i