[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: 40CFR158.33]



[Page 81-82]

 

                   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.  158.33  Procedures for claims of confidentiality of data.



    (a) General. A data submitter must clearly identify any information 

which he claims is entitled to confidential treatment under FIFRA sec. 

10. The procedures in this section must be followed to assert a claim of 

confidentiality.

    (b) Claims of confidentiality for information described by FIFRA 

sec. 10(d)(1) (A), (B), and (C). Any information claimed to be 

confidential under FIFRA sec. 10(d)(1) (A) through (C) must be submitted 

in accordance with the following procedures:

    (1) The information must be contained in a separate attachment to 

the study. If any information is included in the body of the study 

rather than in the confidential attachment, the submitter waives a claim 

of confidentiality for such information under FIFRA sec. 10(d)(1) (A), 

(B), or (C).

    (2) The attachment must have a cover page which is clearly marked to 

indicate that the material contained in the attachment falls within the 

scope of FIFRA sec. 10(d)(1) (A), (B), or (C).

    (3) Each item in the attachment must be numbered. For each item, the 

submitter must cite the applicable portion of FIFRA sec. 10(d)(1) (A), 

(B), or (C) on which the claim of confidentiality is based. In addition, 

for each item, the submitter must provide a list of page numbers in the 

study where the item is cited (i.e., identified by number).

    (4) Each item in the attachment must be referenced in the body of 

the study by its number in the attachment.

    (5) The following statement must appear on the Statement of Data 

Confidentiality Claims:



    Information claimed confidential on the basis of its falling within 

the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) has been removed to a 

confidential appendix, and is cited by cross-reference number in the 

body of the study.





[[Page 82]]







The statement must bear the name, title, and signature of the submitter 

or his properly designated agent, and the date of signature.

    (c) No claim of confidentiality under FIFRA sec. 10(d)(1)(A), (B), 

or (C). If no claim of confidentiality is being made for information 

described by FIFRA sec. 10(d)(1)(A), (B), or (C), or if such information 

is not contained in the body of the study, the Statement of Data 

Confidentiality Claims must include the following statement:



    No claim of confidentiality is made for any information contained in 

this study on the basis of its falling within the scope of FIFRA sec. 

10(d)(1)(A), (B), or (C).





This statement must bear the name, title and signature of the submitter 

or his properly designated agent, and the date of signature.

    (d) Claim of confidentiality for information not described by FIFRA 

sec. 10(d)(1) (A), (B), or (C). Any information not described by FIFRA 

sec. 10(d)(1) (A), (B), or (C) for which a claim of confidentiality is 

made must be submitted in accordance with the following procedures:

    (1) The information must be clearly marked in the body of the study 

as being claimed confidential.

    (2) A separate Supplemental Statement of Data Confidentiality Claims 

must be submitted identifying by page and line number the location 

within the study of each item claimed confidential, and stating the 

basis for the claim.

    (3) The Supplemental Statement of Data Confidentiality Claims must 

bear the name, title, and signature of the submitter or his properly 

designated agent, and the date of signature.



[53 FR 15991, May 4, 1988]