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Issue

Volume 28, Issue 5 — May 1998

Articles

The Food Quality Protection Act + EPA's Pesticide Adverse Effects Reporting Rule = New Data and Better Pesticide Risk Decisions

by James Handley

Editors' Summary: With the enactment of the Food Quality Protection Act of 1996 (FQPA) amending both FIFRA and the Federal Food, Drug, and Cosmetic Act, EPA must perform a broad reassessment of pesticide risks and benefits, using more and better data than required previously. In response to this mandate, EPA recently promulgated an adverse effects reporting rule that will take effect on June 16, 1998. The new rule should provide EPA with an opportunity to obtain valuable data for performing the FQPA-mandated reassessment. This Article traces the events leading to the enactment of the FQPA, and discusses its broad reassessment requirements. The Article then reviews the substance of the new EPA adverse effects rule, including its pesticide registration requirements and reporting requirements. The Article further discusses enforcement of the new rule, and incentives for registrant compliance, such as EPA's Audit Policy and potential tort liability. To conclude, the author opines that the new rule provides EPA with a valuable window on the "real world" of pesticide adverse effects information.

Dialogue

Ecology and Economy: The Keynote Address Given at the 28th Annual American Law Institute-American Bar Association Environmental Law Course of Study

by Hon. Stephen F. Williams

Editors' Summary: This Dialogue analyzes nature as a model for environmental law. The author first identifies three valuable characteristics of nature and examines how they are created by ecosystems. Next, the author argues that the centralized and hierarchical regulation of environmental law ignores nature's valuable characteristics and, in fact, directly opposes nature's decentralized niche-based structure. The author asserts that such a centralized structure of environmental regulation lacks innovation, is subject to institutional bias, and results in incomplete decisionmaking. Last, the author notes that unregulated decentralized environmental regulation fails, but suggests that the use of some decentralized systems, such as marketable pollution permits, produces efficient self-regulating incentives to create innovative pollution control.

A Single Exposure to Many Carcinogens Can Cause Cancer

by Edward J. Calabrese, Ph.D. and Robyn Blain

Editors' Summary: This Dialogue addresses whether a single exposure to a carcinogenic agent can cause cancer. Using a database that contains nearly 5,000 studies that have assessed the ability of a single dose of a chemical to cause cancer, the authors discover that approximately 400 chemicals representing more than 30 chemical classes have been found to cause tumor development. These chemicals have been shown to induce tumors in numerous animal models, including more than 400 mouse and 100 rat strains, as well as in less frequently used models such as hamsters, guinea pigs, gerbils, rabbits, primates, and several fish species. Similarly, this phenomenon has been found in numerous tumor types, through multiple routes of exposure, in both genders, and during various stages of development and maturation. The authors argue that a single dose need not be exceedingly high nor approach acute toxicity in order to cause cancer. The implications of these findings for carcinogen testing and risk assessment procedures, particularly those concerning less than lifetime exposures, are also addressed in light of potential mechanistic interpretations by which single dose carcinogens can act. The authors conclude that episodic exposures to short-term high exposures may be an important yet generally overlooked area of concern.