[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: 40CFR158.32]



[Page 80-81]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  158.32  Format of data submission.



    (a) Transmittal document. All data submitted at the same time and 

for review in support of a single administrative action (e.g., an 

application for registration, reregistration, experimental use permit, 

or in response to a requirement for data under the authority of FIFRA 

sec. 3(c)(2)(B), must be accompanied by a single transmittal document 

including the following information:

    (1) The identity of the submitter, or the identity of each joint 

submitter and of the agent for joint submitters;

    (2) The date of the submission;

    (3) The identification of the Agency action in support of which the 

data are being submitted, such as the registration number or file 

symbol, petition number, experimental use permit number, or registration 

standard review; and

    (4) A bibliography of all specific documents included in the 

submission and covered by the transmittal.

    (b) Individual studies. (1) All data must be submitted in the form 

of individual studies. Unless otherwise specified by the Agency, each 

study should address a single data requirement, and be listed separately 

in the bibliography.

    (2) Each study must include the following elements in addition to 

the study itself:

    (i) A title page, as described in paragraph (c) of this section;

    (ii) A Statement of Data Confidentiality Claims and, if desired, a 

Supplemental Statement of Data Confidentiality Claims, in accordance 

with Sec.  158.33;

    (iii) A certification with respect to Good Laboratory Practice 

standards, if required by Sec.  160.12 of this chapter;

    (iv) If the original study is not in the English language, a 

complete and accurate English translation under the same cover; and

    (v) If the study is of a type listed in Sec.  158.34(b), the 

statement prescribed by paragraph (c) of that section.

    (3) Three identical copies of each study must be submitted. If the 

study is submitted in conjunction with a pending Special Review or 

Registration Standard under development, four copies must be submitted. 

Three copies



[[Page 81]]



must be identical and must conform to the requirements of Sec.  158.33 

with respect to claims of confidentiality. The fourth copy will be 

placed in the public docket and must conform to the requirements of 

Sec.  154.15(c) of this chapter or Sec.  155.30(c) of this chapter with 

respect to claimed confidential business information.

    (4) All copies must be in black ink on uniform pages of white, 8\1/

2\ x 11 inch paper. Copies must have high contrast and good resolution 

for microfilming. Frayed or oversize pages and glued bindings are not 

acceptable.

    (c) Contents of title page. Each individual study must have a title 

page bearing the following identifying information:

    (1) The title of the study, including identification of the 

substance(s) tested and the test name or data requirement addressed;

    (2) The author(s) of the study;

    (3) The date the study was completed;

    (4) If the study was performed in a laboratory, the name and address 

of the laboratory and any laboratory project numbers or other 

identifying codes;

    (5) If the study is a commentary on or supplement to another 

previously submitted study, full identification of the other study with 

which it should be associated in review; and

    (6) If the study is a reprint of a published document, all relevant 

facts of publication, such as the journal title, volume, issue, 

inclusive page numbers, and date of publication.

    (d) EPA identification number. EPA will assign each study an EPA 

Master Record Identification (MRID) number, and will promptly notify the 

submitter of the number assigned. This number should be used in all 

further communications with the Agency about the study.

    (e) Reference to previously submitted data. Data which previously 

have been submitted need not be resubmitted unless resubmission is 

specifically requested by the Agency. If an applicant or registrant 

wishes the Agency to consider such data in the review of an Agency 

action, he should cite the data by providing:

    (1) The title or adequate description of the study;

    (2) The transmittal information required by paragraph (a) (1), (2), 

and (3) of this section; and

    (3) The MRID number assigned in accordance with paragraph (d) of 

this section.



[53 FR 15991, May 4, 1988]