R. A. Libby 1 and F. E. Freeberg
Regulations
The Procter & Gamble Co. Cincinnati, Ohio 45247
Methodology Development and Rigorous Analyses Are Called for by New EPA Regulations
A series of regulations and guidelines covering testing standards for environmental and h u m a n safety testing is being drafted by the Environmental Protection Agency (EPA). These regulations and guidelines will apply to pesticides, selected existing chemicals currently being marketed, and to all new chemicals. Because of the broad scope of the substances regulated, these rules will apply across the entire chemical industry, and t h u s affect a great many, if not all, industrial analytical facilities. Although the materials being regulated cover a broad range of chemicals and are regulated by different organizational units within the EPA, the Agency has decided to make all regulations and guidelines as consistent as the laws will permit. Therefore, the testing standards proposed to regulate pesticides, for example, will be t h e same as those proposed for chemicals. These standards include record keeping, facility operation and personnel requirements, detailed specific test methods for environmental and toxicological testing, and detailed analytical characterization requirements. In addition to being internally consistent, the E P A intends to make their standards as consistent as possible with testing requirements issued by other Federal regulatory bodies. To accomplish this, an Interagency Regulatory Liaison Group has been established to review the regulations being proposed by other regulatory agencies including the Food and Drug Administration (FDA) and the Consumer P r o d u c t Safety Commission (CPSC). Because of this interagency regulatory activity, we can expect t h a t many of t h e testing standards being developed by the E P A will be adopted across other regulatory agencies resulting in the development of generic proce-
1 Chairman, Ad Hoc Committee on Regulatory Affairs, Analytical Division, American Chemical Society.
0003-2700/78/A350-1229$01.00/0 © 1978 American Chemical Society
dures. This desire for consistency in regulations is attractive to many. However, to specify detailed tests and how they are to be conducted for such a wide variety of chemicals risks the elimination of professional scientific judgment regarding the selection of the most meaningful and appropriate tests. Since the Agency's methods and procedures will be designed to cover the most serious and critical cases, this could result in excessive and inappropriate effort for noncritical cases and result in wasteful use of scarce scientific resources. T o demonstrate the impact the various regulatory activities of the E P A will have on analytical chemists, we will now discuss in some detail regulations and guidelines proposed or being drafted.
Pesticide Testing Guidelines T h e pesticide testing guidelines proposed by the E P A in the Federal Register on July 10 and August 22, 1978, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA for short) describe the chemistry requirements as well as safety and environmental tests necessary to supply data required for Federal approval and marketing of pesticides. A "pesticide" covered by these rules ranges from an agricultural insecticide to a household antibacterial product such as liquid bleach. One disadvantage of generic guidelines is t h a t all materials get the same treatment. In F I F R A the chemical requirements seek establishment of limits not only for the pesticide active chemical and all intentionally added inert ingredients, but each impurity, each reactiop product, and each degradation product that is known or theorized to be present in a formulation down to ppm levels. Similarly, rigorous analyses are required for materials undergoing safety testing. These guidelines illustrate the broad, discretionary power the E P A has in requesting analytical
data. Further, the applicant must certify and maintain all these product limits under penalty of regulatory action. In practice, the only way for a manufacturer to ensure t h a t a finished product meets these certified limits, particularly for ppm level impurities, is by development of analytical methods for finished product assay. Since most commercial chemicals and products can contain many chemical species at p p m levels, an exhaustive analytical methods development program would be required, especially for trace level methods. Some have suggested a more viable approach could be to focus effort against those materials t h a t are present at a level having a likely adverse affect on health or the environment. Such an approach would more efficiently utilize the nation's already limited analytical resources.
Testing Standards for Existing Chemicals and New Chemicals Probably t h e most broadly applicable rules being drafted by the EPA are those involved with implementation of the new Toxic Substances Control Act (TSCA). Under Section 4 and 5 of the legislation, the E P A is empowered to issue regulations and guidelines covering testing standards needed to establish t h a t a chemical does not present an unreasonable risk to the environment or to h u m a n health. Currently, the Agency is in the final stages of drafting what tests should be run and detailed step-by-step methods for running them. TSCA regulations will contain General Quality Assurance Procedures (QAP) t h a t are to be adopted by all laboratories involved in safety testing required by the EPA, including associated analytical laboratories. These QAP's are the EPA's version of the FDA's proposed Good Laboratory Practices (GLP) regulations ( i ) . As in the GLP's, these regulations describe in detail the personnel qualifications, record keeping requirements, d a t a handling proce-
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dures, laboratory operations, facility design, and the establishment of a quality assurance unit as a distinct or ganizational entity. Since regulations such as GLP's and QAP's describe laboratory operating procedures that must be followed when conducting safety studies, it is most important that all agencies work hard at adopt ing common procedures if we are to avoid multiple procedures in the same laboratory. The toxicity testing for TSCA regu lations will involve considerable ana lytical effort in the safety test proto cols prescribed by toxicologists. For example, a two-year chronic feeding study specifies repeated analyses for the test substance in animal fluids and tissues. This will require exhaustive analytical method development of trace levels in complex biological ma trixes because chronic testing pre cludes the use of radiolabeled materi als. We must be certain that the ana lytical chemists and the toxicologists have the opportunity to use their col lective scientific judgment in design ing the appropriate toxicity tests. Conclusions
New regulations and guidelines being developed by the EPA will have
a considerable impact on the field of analytical chemistry. Although one can understand the desire on the Agency's part to have all data devel oped under standard methods, it may not be appropriate or scientifically feasible to develop standard safety procedures that are applicable to all chemicals. As stated by the ACS (2) in a statement to the Senate subcom mittee during the drafting stages of TSCA, "Testing requirements should be reasonable and should be deter mined for each specific case." It was further stated that it is "unwise to uti lize scientific resources and manpower for conducting extensive tests that sci entific judgment indicates would have little chance of providing significant data" (2). Finally, although the EPA has ob tained the help of professional toxicol ogists during the drafting of these testing standards, it appears that input from analytical chemists has been much less. Analytical chemistry as a discipline is greatly impacted by both FIFRA and TSCA. Yet as a group, analytical chemists have not been active enough in the regulatory formation process. Representatives of the EPA working on regulations have stated on numerous occasions that input from all fields is needed and
would be welcomed. It is only through direct involvement of analytical ex perts, as well as other scientists, that regulations can be developed that· will both meet Agency objectives and yet be scientifically sound and practical. Analytical chemists cannot afford to stand aside and let others debate and determine how their science is to be conducted. Comments on FIFRA guidelines can be sent to: Federal Register Section Technical Services Division (WH-569) Office of Pesticide Programs, EPA Room 401, East Tower 401 M Street, S.W. Washington, D.C. 20460 For more information on testing standards being considered under TSCA, contact: Office of Toxic Substances (WH-557) EPA 401 M Street, S.W. Washington, D.C. 20460 References (1) R. A. Libby, Anal. Chem., 50,975A (1978). (2) Official Public Policy Statements and Communications, ACS, VII, ρ 24 (ACS 75-003) (1976).
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