[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: 40CFR159.165]



[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.

    (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 135]]



    (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]