[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: 40CFR159.165]

[Page 134-135]
 
                   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. 159.165  Toxicological and ecological studies.

    Adverse effects information must be submitted as follows:
    (a) Toxicological studies. (1) The results of a study of the 
toxicity of a pesticide to humans or other non-target domestic organisms 
if, relative to all previously submitted studies, they show an adverse 
effect under any of the following conditions:
    (i) That is in a different organ or tissue of the test organism.
    (ii) At a lower dosage, or after a shorter exposure period, or after 
a shorter latency period.
    (iii) At a higher incidence or frequency.
    (iv) In a different species, strain, sex, or generation of test 
organism.
    (v) By a different route of exposure.
    (2) Acute oral, acute dermal, acute inhalation or skin and eye 
irritation studies in which the only change in toxicity is a numerical 
decrease in the median lethal dose (LD50), median lethal 
concentration (LC50) or irritation indices, are not 
reportable under this part unless the results indicate a more 
restrictive toxicity category for labeling under the criteria of 40 CFR 
156.10(h).
    (b) Ecological studies. The results of a study of the toxicity of a 
pesticide to terrestrial or aquatic wildlife or plants if, relative to 
all previously submitted studies, they show an adverse effect under any 
of the following conditions:
    (1) At levels 50 percent or more lower than previous acute toxicity 
studies with similar species, including determinations of the median 
lethal dose (LD50), median lethal concentration 
(LC50), or median effective concentration (EC50).
    (2) At lower levels in a chronic study than previous studies with 
similar species.
    (3) In a study with a previously untested species the results 
indicate the chronic no observed effect level (NOEL) is 10 percent or 
less of the lowest LC50 or LD50 for a similar 
species.
    (4) For plants when tested at the maximum label application rate or 
less, if either of the following conditions is met:
    (i) More than 25 percent of terrestrial plants show adverse effects 
on plant life cycle functions and growth such as germination, emergence, 
plant vigor, reproduction and yields.
    (ii) More than 50 percent of aquatic plants show adverse effects on 
plant life cycle functions and growth such as germination, emergence, 
plant vigor, reproduction and yields.
    (c) Results from a study that demonstrates any toxic effect (even if 
corroborative of information already known to the Agency), must be 
submitted if the pesticide is or has been the subject of a Formal Review 
based on that effect within 5 years of the time the results are 
received. Within 30 calendar days of the publication of a Notice of 
Commencement of a Formal Review in the Federal Register, all information 
which has become reportable due to the commencement of the Formal Review 
must be submitted.
    (d) Incomplete studies. Information from an incomplete study of the 
toxicity to any organism of a registered pesticide product or any of its 
ingredients, impurities, metabolites, or degradation products which 
would otherwise be reportable under paragraphs (a), (b) or (c) of this 
section must be submitted if the information meets any one of the 
folowing three sets of criteria:
    (1) Short-term studies. A study using a test regimine lasting 90 
calendar days or less, and all of the following conditions are met:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.

[[Page 135]]

    (iv) A reasonable period for completion of the final analysis not 
longer than 90 calendar days following completion of testing has 
elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (2) Long-term studies. A study using a test regimine lasting 90 
calendar days or less, and all of the following conditions are met:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.
    (iv) A reasonable period of completion of final analysis (not longer 
that 1 year following completion of testing) has elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (3) Serious adverse effects. Any study in which testing or analysis 
of results is not yet complete but in which serious adverse effects have 
already been observed which may reasonably be attributed to exposure to 
the substances tested, because the effects observed in exposed organisms 
differ from effects observed in control organisms, are atypical in view 
of historical experience with the organism tested, or otherwise support 
a reasonable inference of causation, and 30 days have passed from the 
date the registrant first has the information.

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