Teting methodology in environmental monitoring
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By Davii Friedman The purpose of this article is twofold first, to acquaint the environmental testing community with the different organizations within EF!A involved with the development and approval of testing methods, and second, to examine the steps required to issue a method. Those of us involved in method development at EPA hope that by explaining the process we can encourage more participation and subsequently improve upon the methods we issue. We feel that, though a better understanding of how EPA is organized and the actual steps involved in method approval, the testing community will be better able to participate and take on a greater role in this process. Agency organization We find that, in many cases, people outside of EPA are not aware of how the agency is organized. I'm often asked what is the difference in responsibility between the Office of Solid Waste, which publishes Test Methods for Evaluating Solid Waste (SW-SM), and, for example, the Environmental Monitoring and Support Laboratory in Cincinnati, Ohio, which publishes the manual Methods for the Analysis of Water and Wastes. People often ask me how a method actually gets approved. To answer this question one must first understand how the agency is organized. This will provide a framework for explaining the regulatory process by which methods are approved. There are four program offices at EPA that are responsible for developing and issuing environmental regulations. Each office is headed by an assistant administrator. Each of these offices is responsible for implementing several environmental statutes. For example, the Office of Water is responsible for implementing both the Clean Water 786
Environ. Sci.Technoi.. Vol. 24. No. 6, 1990
David Friedman
Act, which deals with the protection of surface waters (e.g., rivers and lakes), and the Safe Drinking Water Act, which deals with ensuring the safety of drinking water. Because of its scope and complexity, the Office of Water is further divided into two subsidiary offices, each headed by an office director. The Office of Water Regulations and Standards is responsible for implementing the Clean Water Act, and the Office of Drinking Water for implementing the Safe Drinking Water Act. Each of these offices develops the regulations needed to implement its respective statutes and, as such, issues any test methods that are required by its regulations. Similarly, the assistant administrator for the Office of Solid Waste and Emergency Response (OSWER) is responsible for administering EPA's programs under the Resource Conservation and Recovery Act (RCRA); the Comprehensive Emergency Response, Compensation and Liability Act (CERCLA, otherwise known as Superfund); and the Leaking Underground Storage Tank Act (LUST). As you can see, OSWERs responsibilities are complex; therefore it has been divided into four subsidiary offices. The Office of Solid Waste (OSW) is responsible for RCRA, the Office of Emergency and Remedial Response for CERCLA, the Office of Underground Storage Tanks for LUST, and the Office of Waste Programs Enforcement for enforcement policy and
direction on all the OSWER regulatory programs. TI e same type of organization is employed by the Office of Air and Radiation for the clean air, radiation, and global climate protection programs, and by the Office of Pesticides and Toxic Substances (OPTS) for the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act. All of EPA's regulatory program offices issue testing methods to one degree or another. For example, the Office of Solid Waste develops and issues the methods for implementing the RCRA program. These methods are published in Test Methodr for Evaluating Solid Waste (SW-846). Similarly, the Officeof Emergency and Remedial Response issues the invitation-for-bid methods used in the Superfund Contract Laboratory Program, and the Office of Water Regulations and Standards issues the 600 Series Methods and approves the use of the manual Methods for the Analysis of ffiterand Wastes for use in the National Pollutant Discharge Elimination System permit program under the Clean Water Act. In addition to program offices, EPA has several support offices such as the Office of Research and Development (ORD)and the Office of General Council. It is the responsibility of the Office of Modeling, Monitoring Systems and Quality Assurance within the ORD to develop and validate the methods and quality assurance procedures needed by the agency to implement the regulatory programs and to evaluate the state of the environment. Although program offices [e.g., OSW, the Office Water Regulations and Standards (OWRS), OPTS] sometimes develop testing methods, most of the test methods the agency uses are developed by ORD. Although ORD is responsible for methods development and validation, a p proval of specific testing methods for regulatory applications is the responsibility of the regulatory program offices. ORD does not approve methods for regulatory use; only the program of-
This article not subject to US. copyright. Published I990 American Chemical Society
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