[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR159.165]
[Page 143-144]
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 regimen 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 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.
[[Page 144]]
(2) Long-term studies. A study using a test regimen 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]