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e-CFR data is current as of August 4, 2020

Title 40Chapter ISubchapter EPart 159Subpart D → §159.158

Title 40: Protection of Environment
Subpart D—Reporting Requirements for Risk/Benefit Information

§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 §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 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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