[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: 40CFR159.179]

[Page 136]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 159--STATEMENTS OF POLICIES AND INTERPRETATIONS--Table of Contents
 
     Subpart D--Reporting Requirements for Risk/Benefit Information
 
Sec. 159.179   Metabolites, degradates, contaminants, and impurities.

    (a) Metabolites and degradates. Information which shows the 
existence of any metabolite or degradate of a pesticide product must be 
submitted if either of the following conditions is met:
    (1) The metabolite or degradate may occur or be present under 
conditions of use of the pesticide product, and the existence of the 
metabolite or degradate or the association of the metabolite or 
degradate with the pesticide product has not been previously reported to 
EPA.
    (2) The metabolite or degradate has been previously reported, but it 
is detected at levels higher than any previously reported; and either of 
the following conditions is met:
    (i) Any person described in Sec. 159.158(a) has concluded that the 
metabolite or degradate may pose a toxicological or ecological risk 
based on any one or more of the following:
    (A) The physical or chemical properties of the metabolite or 
degradate.
    (B) Data regarding structurally analogous chemicals.
    (C) Data regarding chemical reactivity of the metabolite or 
degradate and structurally analogous substances.
    (D) Data on the metabolite or degradate.
    (ii) The registrant has concluded, or has been advised by any person 
described in Sec. 159.158(a) that the metabolite or degradate, or 
analogous chemicals, may have any experimentally determined half-life 
greater than 3 weeks as shown from laboratory aerobic soil metabolism 
studies or field dissipation studies, or may have any experimentally 
determined resistance to hydrolytic degradation, or photolytic 
degradation on soil or in water, under any conditions, resulting in 
degradation of less than 10 percent in a 30-day period.
    (b) Contaminants and impurities. The presence in any pesticide 
product of a contaminant or impurity not previously identified by the 
registrant as part of the pesticide product's approved composition must 
be reported pursuant to this part if the contaminant or impurity is 
present in the product in any of the following quantities:
    (1) Quantities greater than 0.1 percent by weight (1,000 parts per 
million).
    (2) Quantities that EPA considers, and so informs registrants, to be 
of toxicological significance.
    (3) Quantities that the registrant considers to be of toxicological 
significance.
    (4) Quantities above a level for which the registrant has 
information indicating that the presence of the contaminant or impurity 
may pose a risk to health or the environment.
    (5) Quantities that a person described in Sec. 159.158(a) has 
informed the registrant is likely to be of toxicological significance.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]