[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: 40CFR172.46]



[Page 263-264]

 

                   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 Office of Pesticide Programs' Document Processing Desk 

at the appropriate address as set forth in 40 CFR 150.17(a) or (b), 

Attention: 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 Sec. Sec.  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 Sec. Sec.  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.



[[Page 264]]



    (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 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.



[59 FR 45612, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006]