[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: 40CFR159.158]

[Page 131-133]
 
                   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. 159.158   What information must be submitted.

    (a) General. Information which is reportable under this part must be 
submitted if the registrant possesses or receives the information, and 
the information is relevant to the assessment of the risks or benefits 
of one or more specific pesticide registrations currently or formerly 
held by the registrant. Information relevant to the assessment of the 
risks or benefits also includes conclusion(s) or opinion(s) rendered by 
a person who meets any of the following:
    (1) Who was employed or retained (directly or indirectly) by the 
registrant, and was likely to receive such information.
    (2) From whom the registrant requested the opinion(s) or 
conclusion(s) in question.
    (3) Who is a qualified expert as described in Sec. 159.153(b).
    (b)  Exceptions--(1) Clearly erroneous information. Information need 
not be submitted if before that date on which

[[Page 132]]

the registrant must submit such information if all of the following 
conditions are met:
    (i) The registrant discovers that any analysis, conclusion, or 
opinion was predicated on data that were erroneously generated, 
recorded, or transmitted, or on computational errors.
    (ii) Every author of each such analysis, conclusion, or opinion, or 
as many authors as can be contacted through the use of reasonable 
diligence, has acknowledged in writing that the analysis, conclusion, or 
opinion was improper and has either corrected the original analysis, 
conclusion, or opinion accordingly, or provided an explanation as to why 
it cannot be corrected.
    (iii) As a result of the correction, the information is no longer 
required to be reported under FIFRA section 6(a)(2), or if no correction 
was possible, the authors agree that the original analysis, conclusion 
or opinion has no scientific validity.
    (2) Previously submitted information. Information regarding an 
incident, study, or other occurrence need not be submitted if before the 
date on which the registrant must submit such information, the 
registrant is aware that the reportable information concerning that 
incident, study, or other occurrence is contained completely in one of 
the following:
    (i) Documents officially logged in by the EPA Office of Pesticide 
Programs.
    (ii) EPA publications, EPA hearing records, or publications cited in 
EPA Federal Register notices.
    (iii) Any other documents which are contained in the official files 
and records of the EPA Office of Pesticide Programs.
    (iv) Any documents officially logged in by the EPA Office of 
Pollution Prevention and Toxics under the provisions of section 8(e) of 
the Toxic Substances Control Act, provided that if the information 
pertains to a chemical compound which, subsequent to the submission of 
data under section 8(e), becomes the subject of an application for 
registration as a pesticide active ingredient, information is submitted 
to the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
    (3) Publications. A published article or report containing 
information otherwise reportable under this part need not be submitted 
if it fits into either of the following categories:
    (i) Any scientific article or publication which has been abstracted 
in a recognized database of scientific and medical literature, such as 
Medline, ENBASE, Toxline or Index Medicus, if the abstract in question 
clearly identified the active ingredient or the registered pesticide(s) 
to which the information pertains. Otherwise reportable information 
received by or known to the registrant prior to publication of an 
abstract concerning the information must be reported and may not be 
withheld pending such publication.
    (ii) Reports or publications which have been made available to the 
public by any of the following Federal agencies: Centers for Disease 
Control and Prevention, Consumer Products Safety Commission, Department 
of Agriculture, Department of the Interior, Food and Drug Administration 
or any other agency or institute affiliated with the Department of 
Health and Human Services. Otherwise reportable information concerning 
research which was performed, sponsored, or funded by the registrant 
which may also appear in forthcoming Government reports or publications 
must be reported and may not be withheld pending publication.
    (4) Information concerning former inerts, contaminants or 
impurities. Notwithstanding any other provisions of this part, a 
registrant need not report information concerning a chemical compound 
that was at one time an inert ingredient or a contaminant or impurity of 
a pesticide product, and would otherwise be reportable under this part, 
if both of the following conditions are met:
    (i) The compound has been eliminated from its registered product due 
to changes in manufacturing processes, product formulation or by other 
means.
    (ii) The registrant has informed the appropriate product manager in 
the Office of Pesticide Programs in writing of the presence previously 
of the inert,

[[Page 133]]

contaminant or impurity in the product and its subsequent elimination 
from the product.

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