[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR172.46]

[Page 264-265]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 172--EXPERIMENTAL USE PERMITS--Table of Contents
 
   Subpart C--Notification for Certain Genetically Modified Microbial 
                               Pesticides
 
Sec. 172.46  Submission of a notification.

    (a) When to submit a Notification. A Notification shall be submitted 
for approval at least 90 days prior to the initiation of the proposed 
test.
    (b) Where to submit a Notification. A Notification shall be 
submitted to the Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
, Washington, DC 20460, and clearly marked ``ATTN: Biotechnology 
Notification Review.''
    (c) How to format a Notification. A Notification submitted under 
this section must comply with the following procedures, but is not 
required to comply with the format and other provisions governing 
submission of data in Secs. 158.32 and 158.33 of this chapter. However, 
because data submitted with the Notification may subsequently be used to 
support other regulatory actions (e.g., used in EUP or registration 
applications), it is recommended that such data comply with EPA 
requirements in Secs. 158.32 and 158.33 of this chapter.
    (1) Each Notification must be accompanied by a transmittal document 
that clearly identifies the EPA action supported as a Biotechnology 
Notification Review.
    (2) Five copies of each Notification must be submitted to EPA.
    (3) Any claims of confidentiality for information submitted in the 
Notification must be made as described in paragraph (d) of this section.
    (d) How to make confidential business information (CBI) claims in a 
Notification. Although it is strongly recommended that the submitter 
minimize the amount of data and other information claimed as CBI, a 
submitter may assert a claim of confidentiality for all or part of the 
information submitted to EPA in a Notification (See part 2, subpart B of 
this chapter). To assert such a claim, the submitter must comply with 
the following procedures:
    (1) Any claim of confidentiality must accompany the information at 
the time the information is submitted to EPA. Failure to assert a claim 
at that time will be considered a waiver of confidentiality for the 
information submitted, and the information may be made available to the 
public, subject to section 10(g) of the Act, with no further notice to 
the submitter.
    (2) Of the five copies of the Notification required by paragraph (c) 
of this section, four copies must be complete

[[Page 265]]

with the information that is claimed confidential clearly marked in the 
manner described in Sec. 2.203(b) of this chapter. All information 
claimed as confidential must be deleted from the fifth copy, but it must 
be otherwise complete. The first page of the fifth copy must be marked 
``Contains no information claimed as confidential.'' EPA may include the 
fifth copy in a public file without further notice. EPA will consider 
incomplete a Notification containing information claimed as CBI that is 
not submitted in accordance with this paragraph and will suspend the 
review period on the Notification until such procedures are followed.
    (3) Any claim of confidentiality must be accompanied, at the time 
the claim is made, by comments substantiating the claim and explaining 
why the submitter believes that the information should not be disclosed. 
The submitter should refer to Sec. 2.204(e)(4) of this chapter for 
points to address in the substantiation. If such comments are themselves 
claimed confidential and are marked confidential when submitted to EPA, 
they will be treated as such in accordance with Sec. 2.205(c) of this 
chapter. EPA will consider incomplete all Notifications containing 
information claimed as CBI that are not accompanied by substantiation, 
and will suspend the review period on such Notifications until the 
required substantiation is provided.
    (4) EPA will disclose information that is subject to a claim of 
confidentiality asserted under this section only to the extent and by 
means of the procedures set forth in section 10 of the Act, in this 
subpart, and in part 2 of this chapter.