Regulations
Improving the Analytical Chemistry/Regulatory Interface Regulators and the regulated recently met each other on neutral turf, the National Bureau of Standards (NBS) headquarters in Gaithersburg, Md. The occasion was a Symposium on Improving the Analytical Chemistry/Regulatory Interface, sponsored by the Division of Analytical Chemistry of the ACS and the NBS Center for Analytical Chemistry, in cooperation with the Chemical Manufacturers Association. The symposium included sessions on Regulatory Reform, Environmental Sciences and Health Effects, Innovative Approaches to Improving the Interface, and Risk-Benefit Assessment and Public Perception. What seemed to come out of the meeting was a greater interest on the part of the regulators to consider science more carefully in formulating realistic regulations and a stronger resolution on the part of the regulated to participate in the process at an early stage, while a proposed regulation is still being formulated within the agency. According to Robert Smerko of the American Chemical Society (ACS), some of the agencies are a lot more receptive to this than they used to be. "The ACS Regulatory Affairs staff has worked diligently," said Smerko, "to establish the credibility of the Society and its staff with agency personnel. We are now frequently involved at the start of discussions on regulations." And the agencies seem to be listening, as when ACS recently spoke out in support of two separate Occupational Safety and Health Administration (OSHA) policies for protection of workers from toxic chemical exposure: one for laboratory workers and one for manufacturing workers. The recommendation was based on an ACS survey of nearly 1500 research laboratories, which found that chemicals tend to be used in small quantities in laboratories, and then only for limited or irregular periods. ACS's conclusion was that personal monitoring, as implemented in a manufacturing environment, would not be appropriate for 0003-2700/83/0351-269A$01.50/0 © 1983 American Chemical Society
the research laboratory environment. Although it is not yet known if the OSHA regulation will reflect this recommendation, it is clear that OSHA appreciated ACS's input. In a recent letter to the ACS, OSHA administrator Thorne Auchter wrote, "I consider this to be an outstanding example of constructive private sector participation in the cooperative approach to regulation which the Reagan administration is determined to promote." As Robert Libby of Procter & Gamble put it, "Clearly, scientific input at the beginning of the rule-making stage is preferable to input during the postproposal comment period. Here the adage is simple. It's better to get the scientific issue right the first time than to waste time in correcting the science later on." Arthur Hull Hayes, commissioner of the Food and Drug Administration (FDA), one of the regulators at the conference, expressed concern about the strength of the regulatory science base in announcing the formation of an FDA Science Coordinating Committee. The committee will design FDA's research program and will pro vide a forum for "establishing and articulating policies on issues," said Hayes. A talk by two other FDA scientists, Thomas Cairns and W. Michael Rogers, appeared in the REGULATIONS column of the January issue, p. 55 A. Conferees were also interested to hear about publication of the first edition of the "Unified Agenda of Federal Regulations" from another speaker, Christopher DeMuth, executive director of the Presidential Task Force on Regulatory Relief, Office of Management and Budget (OMB). The "Unified Agenda" appeared several days after the conference, in the Oct. 28 issue of the Federal Register, The regulatory agendas of the different agencies have in the past been widely variable in content and thoroughness. In addition, they have been widely scattered through different editions of the Federal Register. As part of OMB's regulatory reform effort, these agen-
das, now more standardized in content and combined into the "Unified Agenda," will be published together in the Federal Register twice a year, said DeMuth, in April and October. For further information on the "Unified Agenda," see the Oct. 28 Federal Register or contact Mark G. Schoenberg, Regulatory Information Service Center, Room 5216, New Executive Office Bldg., 726 Jackson Place, N.W., Washington, D.C. 20503. According to Robert Libby, the policy development apparatus of the federal government is "moving slowly but steadily down the path toward an improved science base in its rule-making efforts." To further improve the scientific basis for regulatory decision making, Libby supports the concept of a centralized science panel, as proposed by the American Industrial Health Council and other organizations, for the resolution of those few scientific issues that are exceedingly complex and that involve more than one agency. Libby's other recommendations for improving the interface included the following: • Scientists must step forward to provide technical input to regulators in a manner that is as useful as possible to the agency. • This input should occur during the drafting phase of the regulatory process if at all possible. « The agencies must continue to strengthen their internal scientific resources and make their scientists accessible to scientists outside those agencies. « Peer-reviewed science must be a guiding standard for all parties. More than anything the symposium was concerned about involvement of the analytical chemist in the process of regulation. "The days when scientists could limit their expertise to their own laboratories or specialties are gone," said Libby. "Scientists need to stop thinking about regulations as burdensome political or legal baggage that is beneath their dignity." Stuart A. Borman
ANALYTICAL CHEMISTRY, VOL. 55, NO. 2, FEBRUARY 1983 · 269 A
