[Code of Federal Regulations]
[Title 40, Volume 22]
[Revised as of July 1, 2004]
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]