[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

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.