[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: 40CFR159.158]



[Page 131-132]

 

                   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 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



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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, 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]



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