[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: 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.