[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR154.31]

[Page 50-51]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 154_SPECIAL REVIEW PROCEDURES--Table of Contents
 
                          Subpart B_Procedures
 
Sec. 154.31  Notices of Preliminary Determination.

    The Administrator shall prepare a Notice of Preliminary 
Determination after the close of the comment period on a Notice of 
Special Review.
    (a) Contents of notice. The Notice of Preliminary Determination 
shall respond to all significant comments submitted in response to the 
Notice of Special Review. For each use of a pesticide product that was 
the subject of the Notice of Special Review, the Notice of Preliminary 
Determination shall also include, as appropriate:
    (1) A determination whether the use satisfies any of the risk 
criteria set forth in Sec. 154.7, and a discussion of the reasons for 
the determination.
    (2) A determination of whether any changes in the composition, 
packaging, labeling, or restrictions on use of a pesticide product that 
were proposed in an application for new or amended registration 
submitted after issuance of the Notice of Special Review would reduce 
the risk so that the use no longer would satisfy any of the risk 
criteria in Sec. 154.7.
    (3) If the use satisfies any of the risk criteria set forth in Sec. 
154.7, a determination of whether the adverse effects posed by the use 
are unreasonable, taking into account the economic, social, and 
environmental costs and benefits of the use of the product, and a 
discussion of reasons for the determination.
    (4) If the use is determined to pose an unreasonable adverse effect, 
a statement of the regulatory action, if any, which the Agency intends 
to initiate with respect to the use, and a discussion of the reasons for 
initiating that regulatory action.
    (5) A statement that the Administrator is requesting comments from 
the Secretary of Agriculture and the Scientific Advisory Panel on the 
notices and analysis specified in paragraph (b) of this section, and 
that the notices and analysis are available on request.
    (6) Instructions to interested persons on how to submit comments 
(including the deadline for submission of comments).
    (7) The location of the docket under Sec. 154.15 and the times 
during which the docket will be available for inspection and copying.
    (b) Referral to Secretary of Agriculture and Scientific Advisory 
Panel. If the Administrator proposes to cancel, deny,

[[Page 51]]

or change the classification of the registration of a pesticide product 
which is the subject of a Special Review, or to hold a hearing under 
FIFRA section 6(b)(2) on whether to take any of those actions, he shall:
    (1) Prepare a proposed form of a Notice of Intent to Cancel, a 
Notice of Intent to Deny Registration, a Notice of Intent to Hold a 
Hearing, and/or a Notice of Intent to Change Classification, as 
appropriate.
    (2) Prepare an Agricultural Impact Analysis, analyzing the impact of 
the proposed action on production and prices of agricultural 
commodities, retail food prices, and otherwise on the agricultural 
economy.
    (3) Send the proposed notices and analysis to the Secretary of 
Agriculture and the Scientific Advisory Panel for comment, as provided 
by the Act.
    (4) Send the Notice of Preliminary Determination and the other 
notices and analysis prepared under this section to all registrants and 
applicants for registration of products that are subject to the Special 
Review.
    (c) Publication. The Agency shall issue the Notice of Preliminary 
Determination for publication in the Federal Register.