[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR725.80]

[Page 479]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
       Subpart C--Confidentiality and Public Access to Information
 
Sec. 725.80  General provisions for confidentiality claims.


    (a) A person may assert a claim of confidentiality for any 
information submitted to EPA under this part. However,
    (1) Any person who asserts a claim of confidentiality for portions 
of the specific microorganism identity must provide the information as 
described in Sec. 725.85.
    (2) Any person who asserts a claim of confidentiality for a use of a 
microorganism must provide the information as described in Sec. 725.88.
    (3) Any person who asserts a claim of confidentiality for 
information contained in a health and safety study of a microorganism 
must provide the information described in Sec. 725.92.
    (b) Any claim of confidentiality must accompany the information when 
it is submitted to EPA.
    (1) When a person submits any information under this part, including 
any attachments, for which claims of confidentiality are made, the 
claim(s) must be asserted by circling the specific information which is 
claimed and marking the page on which that information appears with an 
appropriate designation such as ``trade secret,'' ``TSCA CBI,'' or 
``confidential business information.''
    (2) If any information is claimed confidential, the person must 
submit two copies of the document including the claimed information.
    (i) One copy of the document must be complete. In that copy, the 
submitter must mark the information which is claimed as confidential in 
the manner prescribed in paragraph (b)(1) of this section.
    (ii) The second copy must be complete except that all information 
claimed as confidential in the first copy must be deleted. EPA will 
place the second copy in the public file.
    (iii) If the submitter does not provide the second copy, the 
submission is incomplete and the review period does not begin to run 
until EPA receives the second copy, in accordance with Sec. 725.33.
    (iv) Any information contained within the copy submitted under 
paragraph (b)(2)(ii) of this section which has been in the public file 
for more than 30 days will be presumed to be in the public domain, 
notwithstanding any assertion of confidentiality made under this 
section.
    (3) A person who submits information to EPA under this part must 
reassert a claim of confidentiality and substantiate the claim each time 
the information is submitted to EPA.
    (c) Any person asserting a claim of confidentiality under this part 
must substantiate each claim in accordance with the requirements in 
Sec. 725.94.
    (d) EPA will disclose information that is subject to a claim of 
confidentiality asserted under this section only to the extent permitted 
by the Act, this subpart, and part 2 of this title.
    (e) If a submitter does not assert a claim of confidentiality for 
information at the time it is submitted to EPA, EPA may make the 
information public and place it in the public file without further 
notice to the submitter.