27 Regulatory Aspects: An Introduction PHILIP C. K E A R N E Y
Downloaded by NATL UNIV OF SINGAPORE on May 5, 2018 | https://pubs.acs.org Publication Date: August 10, 1981 | doi: 10.1021/bk-1981-0160.ch027
Chief of Pesticide Degradation Laboratory, U.S. Department of Agriculture, Beltsville, MD 20705
Toxicology is playing an increasingly important role in the pesticide registration process. As the various mammalian toxicological tests for carcinogenicity, mutagenicity, and teratogenicity become more sophisticated and complex, their interpretation vis-a-vis adverse effects on man also becomes increasingly complex and, therefore, subject to considerable debate. These data are used now as a major component in risk-benefit decisionmaking for the registration of new pesticides and the reevaluation of registered pesticides under the Rebuttable Presumption Against Registration process. The debate involves industry, represented by the manufacturers; government, represented by the regulatory agencies; and the public sector, represented largely by environmental and consumer groups. Major issues in this wide-ranging debate include questions of the need for additional toxicological testing and ensuing guidelines, regulations and rules, the quality and validity of data submitted to the regulatory agencies, the use of laboratory animals as human surrogates for evaluating safety, and the development of a reasonable formula for evaluating both risks and benefits. Each group may perceive the need for and interpretation of toxicological data in judging human safety from a different perspective. The viewpoint of each of these groups and the issues are presented in this symposium. The Congress of the United States, i n the 1972 amendments to the F e d e r a l I n s e c t i c i d e , Fungicide, and Rodenticide Act (FIFRA), granted the Environmental P r o t e c t i o n Agency (EPA) broad powers to regulate p e s t i c i d e s . The t o x i c o l o g i c a l requirements under EPA are defined i n a s e r i e s of expanding g u i d e l i n e s . On an i n t e r n a t i o n a l b a s i s , requirements f o r t o x i c o l o g i c a l data vary considerably among the nations that make extensive use of p e s t i cides f o r crop production or p u b l i c h e a l t h programs. In Western Europe, the current r e g i s t r a t i o n process i s l e s s s t r i n g e n t than that i n the United States. There i s emerging among the v a r i o u s c o u n t r i e s i n Western Europe an e f f o r t to harmonize the needs f o r t o x i c o l o g i c a l data i n p e s t i c i d e r e g i s t r a t i o n . In c o n t r a s t to the r e g u l a t i o n s evolved i n North America, represented by the United
This chapter not subject to U.S. copyright. Published 1981 American Chemical Society Bandal et al.; The Pesticide Chemist and Modern Toxicology ACS Symposium Series; American Chemical Society: Washington, DC, 1981.
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States and Canada, and the p o l i c i e s and needs of Western Europe, the Peoples' Republic of China i s only now i n the process of developing r e g i s t r a t i o n standards and determining the r o l e that t o x i c o l o g y w i l l play i n these standards. This symposium presents the d i f f e r e n c e s and s i m i l a r i t i e s between the United S t a t e s , Canada, Western Europe, and the Peoples' Republic of China as to t o x i c o l o g y and i t s r o l e i n p e s t i c i d e r e g i s t r a t i o n .
Downloaded by NATL UNIV OF SINGAPORE on May 5, 2018 | https://pubs.acs.org Publication Date: August 10, 1981 | doi: 10.1021/bk-1981-0160.ch027
RECEIVED March 10, 1981.
Bandal et al.; The Pesticide Chemist and Modern Toxicology ACS Symposium Series; American Chemical Society: Washington, DC, 1981.
