[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: 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]