R. A. Libby1
Regulations
The Procter & Gamble Co. Cincinnati, Ohio 45247
OSHA Proposals Reach into the Research Laboratory as Well as the Industrial Workplace Previous regulatory articles reported here have dealt with how regulations are formed and specific proposed rules and guidelines from the EPA and FDA. These articles were written to inform the analytical chemist of those proposed regulations that would affect the conduct of analytical chemistry. Basically, these regulations describe what analytical tasks to do and how to operate within the laboratory when performing these tasks. Emphasis is placed on having adequate, documented scientific procedures and records that allow a second party reconstruction of the details of the work. This month's article deals with a different type of regulation that, in its current form, applies to all chemical laboratories and seeks to assure the 1 Chairman, Ad-Hoc Committee on Regulatory Affairs, Analytical Division, American Chemical Society.
scientist's health in the workplace. The Occupational Safety and Health Administration (OSHA), the agency involved, is empowered to set standards covering workplace hazards and to inspect the workplace for possible violations. The initial act from which OSHA has authority to set regulations became enforceable in 1971. Citations may be issued by OSHA inspectors if violations of these regulations are found, and potential criminal and civil penalties are authorized under the act. One type of workplace hazard addressed by OSHA is that associated with worker exposure to toxic chemicals. After its inception, OSHA adopted national consensus standards governing worker exposure to approximately 400 chemical agents (1). For the most part, these regulations simply specified a "permissible level" of exposure for a particular agent with no auxiliary requirements specifying such activities as sampling and medical surveillance of exposed workers.
The standards adopted were primarily the Threshold Limit Values for Chemical Substances established by the American Conference of Governmental Industrial Hygienists. In 1974 OSHA established, in a single rule-making procedure, standards for 14 chemical carcinogens including such materials as bis-chloromethyl ether, benzidine, iV-nitrosodimethylamine, and /3-naphthylamine. These regulations required extensive special handling facilities in both manufacturing and laboratory operations, as well as medical monitoring of employees (2). Since that time, additional standards have been established for vinyl chloride, benzene, arsenic, acrylonitrile, and others. All of these new standards mandate such things as periodic air sampling to evaluate employee exposure, training programs, record keeping, and medical surveillance. Most recently, a policy that tentatively classifies chemicals into one of four categories based on the sub-
Analytical Division Forms Ad-Hoc Committee on Regulatory Affairs There is a sharply growing realization a m o n g chemists that government regulations that substantially affect both the operation of their laboratory and the conduct of their science are being set into place or being contemplated. The A C S Conference on " M e c h a n i s m s to Facilitate S o c i ety Participation in Regulatory M a t t e r s " in June and the President's Plenary Session at the last National A C S meeting illustrate this and demonstrate the Society's increased awareness and c o m m i t m e n t to more effective participation in the regulatory process. The Analytical D i vision has also joined in this process by appointing an adhoc c o m m i t t e e on regulatory affairs: Professor Donald T. Sawyer, University of California-Riverside, Riverside, Calif.; Dr. William T. Donaldson, Environmental Protection A g e n c y , Athens, Ga.; Dr. Warren B. Crummett, Dow Chemical Co., Midland, Mich.; and Dr. Robert A. Libby, The Procter & Gamble Co., Cincinnati, Ohio.
partment of Chemistry and Public Affairs (DCPA) in the Society's Washington Office to inform the Society of r e g ulatory matters that affect analytical chemists and to learn of analytical expertise needed by the various regulatory agencies monitored by the DCPA. We seek c o m m e n t s f r o m analytical chemists at large in identifying regulatory issues and in formulating a response that serves the good of agency and the profession. Ideally, this interaction bet w e e n the analytical chemist and the regulatory agency will occur during the rule-making stage, but dialog with the agencies will be facilitated at any stage in the regulatory process and on demand. In addition, this c o m m i t t e e will attempt to educate analytical chemists on regulatory matters. One vehicle will be this c o l u m n . Another will be the s y m p o s i u m scheduled for the National A C S meeting next fall in Washington, D.C., on regulatory issues affecting analytical chemists.
This c o m m i t t e e will establish a m e c h a n i s m with the De-
1326 A · ANALYTICAL CHEMISTRY, VOL. 50, NO. 14, DECEMBER 1978
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stance's known or suspected carcinogenicity was published in the Federal Register (3). Classification in Categories I or II would lead to regulatory action based on model standards for these categories. All chemicals within a category would be treated identically regardless of degrees of biological potency. Some of the compounds (see Table I) which may get final classification in Categories I and II are found in many analytical laboratories. Analytical chemists working with any of these chemicals, and most of us are, must become aware of the hazards, limits, and penalties associated with laboratory chemicals that, over the years, have become common tools of our profession. One problem with the initial OSHA proposal is that research laboratories would be covered by the same rules that apply to manufacturing, construction, maritime, and agricultural activities. Research scientists are concerned with safe working conditions and protecting the health of the laboratory worker. However, to control a research laboratory's use of toxic chemicals by the same set of rules that would apply to bulk manufacturing operations could drastically affect the progress of chemistry as a science since many of these compounds are necessary for the conduct of research experimentation. As the ACS has pointed out (4), it is important that the Agency recognize that in the research laboratory the nature of the exposure to the chemical is often in small amounts, coupled with infrequent use and/or of short duration. In addition, research laboratories have specialized facilities for use by qualified workers under a high level of technical supervision. These factors make the research laboratory unique and should allow greater freedom in the use of toxic chemicals without jeopardizing the health and safety of employees in these very special working areas. Trying to apply the same rules to laboratories and nontechnical facil-
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ities brings forward the real possibility that scientific experiments aimed at the heart of OSHA proposals—carcinogenic hazard assessment and control—will be curtailed. The analytical laboratory would be particularly affected by such blanket regulations since a great number of chemicals in small amounts are utilized as reagents and are often isolated, purified, and concentrated prior to analysis. To impose the same control, monitoring, construction of expensive isolation laboratories, and record keeping procedures appropriate for bulk manufacturing operations on chemical laboratories will be an additional burden on laboratory operations without commensurate additional benefit. Since regulations on specific chemicals will be issued based on their potential hazard, it will be necessary for scientists to help the Agency develop laboratory exposure rules and carcinogenic categories based on the best technical information available. Not to do so may lead to restrictions on which chemicals can be used in· analytical laboratories. The Federal Register is one of the best sources of information available for OSHA standards, amendments, corrections, insertions or deletions, but is not usually read by chemists. Ten regional OSHA offices can also serve to link the scientist and the Agency more closely, especially when the scientist has specific questions. In summary, while some regulations indicate how to conduct scientific experiments, OSHA rules go one step further to regulate laboratory facilities by establishing allowable exposure levels and work practices which would be applied in the same way that manufacturing operations are controlled. Only through input of scientists to the Agency on these standards can we hope to minimize the effect of such regulation on research without compromising the intended benefits of health protection. While scientists must be concerned with the hazards of their profession, they must fully dialog the impact of rules aimed at making our profession hazard free.
References
(1) Fed. Regist., 40, 27073 (May 28, 1975). (2) National Cancer Institute Safety Standards for Research Involving Chemical Carcinogens, Office of Research Safety, National Cancer Institute, DHEW Publication No. (NIH) 76-900, June 2, 1975. (3) Fed. Regist., 42, 54148-247 (Oct. 4, 1977). (4) Letter from Dr. Anna J. Harrison, President, American Chemical Society, to Dr. Eula Bingham, Assistant Secretary, Occupational Safety and Health, U.S. Department of Labor, Jan. 20, 1978.
