[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR154.7]

[Page 46]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 154--SPECIAL REVIEW PROCEDURES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 154.7  Criteria for initiation of Special Review.

    (a) The Administrator may conduct a Special Review of a pesticide 
use if he determines, based on a validated test or other significant 
evidence, that the use of the pesticide (taking into account the 
ingredients, impurities, metabolites, and degradation products of the 
pesticide):
    (1) May pose a risk of serious acute injury to humans or domestic 
animals.
    (2) May pose a risk of inducing in humans an oncogenic, heritable 
genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or 
delayed toxic effect, which risk is of concern in terms of either the 
degree of risk to individual humans or the number of humans at some 
risk, based upon:
    (i) Effects demonstrated in humans or experimental animals.
    (ii) Known or predicted levels of exposure of various groups of 
humans.
    (iii) The use of appropriate methods of evaluating data and relating 
such data to human risk.
    (3) May result in residues in the environment of nontarget organisms 
at levels which equal or exceed concentrations acutely or chronically 
toxic to such organisms, or at levels which produce adverse reproductive 
effects in such organisms, as determined from tests conducted on 
representative species or from other appropriate data.
    (4) May pose a risk to the continued existence of any endangered or 
threatened species designated by the Secretary of the Interior or the 
Secretary of Commerce under the Endangered Species Act of 1973, as 
amended.
    (5) May result in the destruction or other adverse modification of 
any habitat designated by the Secretary of the Interior or the Secretary 
of Commerce under the Endangered Species Act as a critical habitat for 
any endangered or threatened species.
    (6) May otherwise pose a risk to humans or to the environment which 
is of sufficient magnitude to merit a determination whether the use of 
the pesticide product offers offsetting social, economic, and 
environmental benefits that justify initial or continued registration.
    (b) In making any determination that a pesticide use satisfies one 
of the criteria for issuance of a Special Review specified by paragraph 
(a) of this section, the Administrator shall consider available evidence 
concerning both the adverse effect in question and the magnitude and 
scope of exposure of humans and nontarget organisms associated with use 
of the pesticide.