[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: 40CFR152.99]



[Page 24-26]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 152_PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of 

Contents

 

  Subpart E_Procedures To Ensure Protection of Data Submitters' Rights

 

Sec.  152.99  Petitions to cancel registration.



    An original data submitter may petition the Agency to deny or cancel 

the registration of a product in accordance with this section if he has 

submitted to the Agency a valid study which, he claims, satisfies a data 

requirement that an applicant purportedly has failed to satisfy.

    (a) Grounds for petition. (1) If an applicant has offered to pay 

compensation to an original data submitter of a study (either 

specifically or by filing a general offer to pay statement), the 

original data submitter may petition the Agency to deny or cancel the 

registration to which the offer related on any of the following grounds:

    (i) The applicant has failed to participate in an agreed-upon 

procedure for reaching an agreement on the amount and terms of 

compensation. The petitioner shall submit a copy of the agreed-upon 

procedure and describe the applicant's failure to participate in the 

procedure.

    (ii) The applicant has failed to comply with the terms of an 

agreement on



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compensation. The petitioner shall submit a copy of the agreement, and 

shall describe how the applicant has failed to comply with the 

agreement.

    (iii) The applicant has failed to participate in an arbitration 

proceeding. The petitioner shall submit evidence of such failure.

    (iv) The applicant has failed to comply with the terms of an 

arbitration decision. The petitioner shall submit a copy of the 

arbitration decision, and describe how the applicant has failed to 

comply with the decision.

    (2) When no offer to pay has been made, the petitioner shall state 

in his petition the basis for the challenge, and describe how the 

failure of the applicant to comply with the procedures of this subpart 

has deprived him of the rights accorded him under FIFRA section 

3(c)(1)(D). Possible grounds for challenge include, but are not limited 

to, the following:

    (i) The applicant has failed to list a data requirement applicable 

to his product, or has failed to demonstrate compliance with all 

applicable data requirements.

    (ii) The applicant has submitted or cited a study that is not valid.

    (iii) The applicant has submitted or cited a study that does not 

satisfy the data requirement for which it was submitted or cited.

    (iv) The applicant has failed to comply with the procedure for 

showing that a data gap exists.

    (v) The applicant has improperly certified that a data gap exists. 

An original data submitter who has failed without good cause to respond 

to an applicant's request for confirmation of a data gap may not 

petition the Agency for review on this basis.

    (vi) The applicant has submitted or cited a study originally 

submitted by the petitioner, without the required authorization or offer 

to pay.

    (b) Procedure for petition to the Agency--(1) Time for filing. A 

petition under paragraph (a)(1) of this section may be filed at any time 

that the circumstances warrant. A petition under paragraph (a)(2) of 

this section must be filed within one year after the Agency makes public 

the issuance of the registration.

    (2) Notice to affected registrant. At the same time that the 

petitioner files his petition with the Agency, he shall send a copy by 

certified mail to the affected applicant or registrant. The applicant or 

registrant shall have 60 days from the date of his receipt of the 

petition to submit written comments to the Agency.

    (c) Disposition of petitions. The Agency will consider the material 

submitted by the petitioner and the response, if any, by the affected 

applicant or registrant.

    (1) If the Agency determines that the petition is without merit, it 

will inform the petitioner and the affected applicant or registrant that 

the petition is denied. Denial of a petition is a final Agency action.

    (2) If the Agency determines that an applicant has acted in any way 

described by paragraph (a)(1) of this section, the Agency will notify 

the petitioner and the affected applicant or registrant that it intends 

to deny or cancel the registration of the product in support of which 

the data were cited. The affected applicant or registrant will have 15 

days from the date of delivery of this notice to respond. If the Agency 

determines, after considering any response, that the affected applicant 

or registrant has acted in the ways described by paragraph (a)(1) of 

this section, the Agency will deny or cancel the registration without 

further hearing. Refer to FIFRA section 3(c)(1)(D)(ii). Denial or 

cancellation of a registration is a final Agency action.

    (3) Except as provided in paragraph (c)(2) of this section, if the 

Agency determines that an applicant for registration of a product has 

acted in any way that deprives an original data submitter of rights 

under FIFRA section 3(c)(1)(D), the Agency will take steps to deny the 

application or cancel the registration, as appropriate. The procedures 

in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or 

cancellation is a final Agency action.

    (d) Hearing. Any hearing will be conducted in accordance with the 

procedures in 40 CFR part 164. The only matter for resolution at the 

hearing shall be whether the registrant failed to comply with the 

requirements and procedures of FIFRA section 3(c)(1)(D) or



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of this subpart, in the manner described by the petitioner. A decision 

following a hearing shall be final.