[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1579 Introduced in Senate (IS)]








109th CONGRESS
  1st Session
                                S. 1579

  To amend the Federal Insecticide, Fungicide, and Rodenticide Act to 
    permit the distribution and sale of certain pesticides that are 
        registered in both the United States and another country


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 29, 2005

   Mr. Burns (for himself, Mr. Dorgan, Mr. Johnson, Mr. Dayton, Mr. 
 Baucus, and Mr. Conrad) introduced the following bill; which was read 
  twice and referred to the Committee on Agriculture, Nutrition, and 
                                Forestry

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Insecticide, Fungicide, and Rodenticide Act to 
    permit the distribution and sale of certain pesticides that are 
        registered in both the United States and another country

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pesticide Harmonization and Joint 
Labeling Act ''.

SEC. 2. DEFINITIONS.

    (a) In General.--Section 2 of the Federal Insecticide, Fungicide, 
and Rodenticide Act (7 U.S.C. 136) is amended--
            (1) by redesignating subsections (jj) through (oo) as 
        subsections (ii) through (nn), respectively; and
            (2) by adding at the end the following:
    ``(oo) Harmonized Country.--The term `harmonized country' means a 
country--
            ``(1) with which the United States has entered into 
        negotiations to harmonize pesticide registration regulatory 
        processes and requirements; and
            ``(2) for which the Administrator determines, in the 
        discretion of the Administrator, that sufficient regulatory 
        harmonization has been achieved to carry out joint labeling of 
        agricultural pesticides.
    ``(pp) Interested Party.--The term `interested party' means--
            ``(1) an individual producer or group of producers; or
            ``(2) a nonprofit agriculture membership organization that 
        represents producers.
    ``(qq) Joint Label.--The term `joint label' means a label that--
            ``(1) has been approved for use in both the United States 
        and a harmonized country; and
            ``(2) includes a registration number of the Environmental 
        Protection Agency and any other license number provided by a 
        government regulatory agency for the purpose of registering 
        pesticides.
    ``(rr) Joint Registration.--The term `joint registration' means a 
product registration that--
            ``(1) has been approved by both the United States and a 
        harmonized country;
            ``(2) permits sale and distribution in both countries; and
            ``(3) includes a joint label.''.
    (b) Technical and Conforming Amendment.--The table of contents in 
section 1(b) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. prec. 121) is amended by adding at the end of the items 
relating to section 2 the following:

            ``(hh) Nitrogen stabilizer.
            ``(ii) Maintenance applicator.
            ``(jj) Service technician.
            ``(kk) Minor use.
            ``(ll) Antimicrobial pesticide.
            ``(mm) Public health pesticide.
            ``(nn) Vector.
            ``(oo) Harmonized country.
            ``(pp) Interested party.
            ``(qq) Joint label.
            ``(rr) Joint registration.''.

SEC. 3. JOINT LABELING OF REGISTERED PESTICIDES.

    (a) In General.--Section 3(c) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)) is amended by adding 
at the end the following:
            ``(11) Joint labeling of registered pesticides.--
                    ``(A) Definition of affiliate.--In this paragraph, 
                the term `affiliate' means a relationship among 
                business entities in which--
                            ``(i) 1 business entity--
                                    ``(I) has effective control over 
                                the other business entity through a 
                                partnership or other agreement; or
                                    ``(II) is under common control with 
                                the other business entity by a third 
                                entity; or
                            ``(ii) 1 business entity is a corporation 
                        related to another corporation as a parent to a 
                        subsidiary by an identity of stock ownership.
                    ``(B) Date of effectiveness.--With respect to joint 
                labeling with a harmonized country, this paragraph 
                shall apply on the date on which the Administrator 
                publishes in the Federal Register a notice that--
                            ``(i) the Administrator has made the 
                        finding required by section 2(oo)(2) for the 
                        country; and
                            ``(ii) includes guidelines for interested 
                        parties to petition the Administrator under 
                        subparagraph (C).
                    ``(C) Petition by interested party.--For an 
                agricultural pesticide for which the same or 
                substantially similar agricultural pesticide is 
                registered in both the United States and a harmonized 
                country, any interested party may petition the 
                Administrator to require the registrant of the 
                agricultural pesticide to apply for and use a joint 
                label to facilitate movement between the United States 
                and the harmonized country.
                    ``(D) Determination by administrator.--
                            ``(i) In general.--Not later than 120 days 
                        after the date of receipt of a request from an 
                        interested party under subparagraph (C), the 
                        Administrator shall make a determination that, 
                        in the discretion of the Administrator--
                                    ``(I) the agricultural pesticide 
                                registered in the United States is 
                                identical or substantially similar to 
                                the agricultural pesticide registered 
                                in the harmonized country;
                                    ``(II) the registrant or affiliate 
                                is the same in the United States and 
                                the harmonized country; and
                                    ``(III) there is sufficient 
                                interest from interested parties for a 
                                joint label.
                            ``(ii) Provision of information.--
                                    ``(I) In general.--On request of 
                                the Administrator, the registrant shall 
                                submit information necessary for the 
                                Administrator to make the determination 
                                described in clause (i), including a 
                                product label, formula, and any other 
                                information that the Administrator 
                                determines, in the discretion of the 
                                Administrator, may be necessary to make 
                                the determination.
                                    ``(II) Disproving a 
                                determination.--In response to a 
                                determination by the Administrator 
                                under clause (i), a registrant may 
                                provide information to the 
                                Administrator to disprove a 
                                determination under subclause (I) or 
                                (II) of clause (i), including providing 
                                a confidential statement of formula to 
                                demonstrate differences between 
                                agricultural pesticides.
                                    ``(III) Provision of csf.--
                                Notwithstanding any other provision of 
                                this Act, the Administrator may share 
                                with appropriate officials in a 
                                harmonized country a confidential 
                                statement of formula provided under 
                                subclause (II).
                    ``(E) Notification of joint label requirement.--On 
                making a determination under subparagraph (D) in 
                regards to an agricultural pesticide, the Administrator 
                shall notify the registrant that--
                            ``(i) a joint label is required for the 
                        agricultural pesticide; and
                            ``(ii) the registrant shall propose to the 
                        Administrator and the harmonized country a 
                        joint label not later than 90 days after 
                        notification by the Administrator.
                    ``(F) Review of joint label.--In consultation with 
                the harmonized country, the Administrator shall--
                            ``(i) review the proposed joint label;
                            ``(ii) not later than 180 days after the 
                        date of receipt of a proposed joint label from 
                        the registrant, notify the registrant that--
                                    ``(I) the joint label has been 
                                approved in the United States and shall 
                                be used on all containers of the 
                                product not later than a date specified 
                                by the Administrator, except at the 
                                discretion of the Administrator; or
                                    ``(II) the registrant shall propose 
                                to the Administrator a revised joint 
                                label in accordance with guidance by 
                                the Administrator as to what revisions 
                                are necessary;
                            ``(iii) notify the petitioner of the 
                        approval of the joint label and provide the 
                        petitioner with a copy of the approved joint 
                        label; and
                            ``(iv) make a copy of the label available 
                        on the Internet, which may be used to purchase 
                        and transport the approved pesticide between 
                        the United States and the harmonized country.
                    ``(G) Use of product.--After approval by the 
                Administrator of the joint label, consumers in the 
                United States may obtain and use the product that is 
                registered in a harmonized country, notwithstanding the 
                fact that the joint label has not been approved in the 
                harmonized country, provided that the consumer has a 
                copy of the joint label, as approved for use in the 
                United States.
                    ``(H) Suspension.--The Administrator may undertake 
                suspension proceedings regarding registration of an 
                agricultural pesticide in accordance with the 
                procedures described in section 3(c)(2)(B)(iv) if the 
                Administrator determines that the registrant or 
                affiliate--
                            ``(i) within the time period required by 
                        the Administrator, has failed--
                                    ``(I) to propose a joint label 
                                under subparagraph (E)(ii);
                                    ``(II) to revise a joint label 
                                under subparagraph (F)(ii)(II);
                                    ``(III) to use a joint label under 
                                subparagraph (F)(ii)(I); or
                                    ``(IV) to provide information 
                                requested by the Administrator under 
                                subparagraph (D)(ii); or
                            ``(ii) has withdrawn an application for 
                        registration of a pesticide from a harmonized 
                        country after receiving approval of the joint 
                        label in the United States.
                    ``(I) Fees.--The Administrator may not charge fees 
                for joint registration under this paragraph.
                    ``(J) Prohibition.--The joint registration and 
                labeling provisions of this paragraph may not be used 
                to add new uses to an agricultural pesticide.
                    ``(K) Cooperation and prioritization.--An 
                interested party may petition the Administrator--
                            ``(i) individually or in consultation with 
                        interested parties in the harmonized country; 
                        and
                            ``(ii) for multiple agricultural pesticides 
                        at once, in priority order.
                    ``(L) Priority for registrants.--A registrant of an 
                agricultural pesticide registered in the United States 
                or the harmonized country that voluntarily applies for 
                a joint label shall be given priority consideration.''.
    (b) Technical and Conforming Amendment.--The table of contents in 
section 1(b) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. prec. 121) (as amended by section 2(b)) is amended by adding 
at the end of the items relating to section 3(c) the following:

            ``(9) Labeling.
            ``(10) Expedited registration of pesticides.
            ``(11) Joint registration of registered 
            pesticides.''.

SEC. 4. JOINT REGISTRATION OF NEW PESTICIDES OR USES.

    (a) In General.--Section 3(c)(4) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(4)) is amended--
            (1) in the first sentence, by striking ``The 
        Administrator'' and inserting the following:
                    ``(A) In general.--The Administrator'';
            (2) in the second sentence, by striking ``The notice'' and 
        inserting the following:
                    ``(B) Comment period.--The notice''; and
            (3) by adding at the end the following:
                    ``(C) Joint label.--
                            ``(i) In general.--The notice shall request 
                        comments from interested parties that are 
                        interested in a joint label for the pesticide.
                            ``(ii) Determination of significant 
                        interest.--
                                    ``(I) In general.--After the 
                                expiration of the comment period, the 
                                Administrator shall determine if there 
                                is significant interest in a joint 
                                label for the pesticide.
                                    ``(II) Significant interest.--If 
                                the Administrator determines that there 
                                is significant interest in a joint 
                                label for the pesticide, the 
                                Administrator shall inform the 
                                registrant that, as a condition of 
                                registering the pesticide, the 
                                registrant shall demonstrate to the 
                                satisfaction of the Administrator that 
                                the registrant has provided the 
                                harmonized country with sufficient 
                                information for the harmonized country 
                                to begin the process of reviewing the 
                                application for the pesticide.''.
    (b) Authority to Require Joint Label for New Pesticides or Uses.--
            (1) In general.--Section 3(c) of the Federal Insecticide, 
        Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)) (as amended 
        by section 3(a)) is amended by adding at the end the following:
            ``(12) Authority to require joint label for new pesticides 
        or uses.--After making a determination of significant interest 
        under section 3(c)(4)(C), the Administrator may notify the 
        registrant that, in accordance with the procedures described in 
        subparagraphs (F), (G), (H), and (I) of paragraph (11)--
                    ``(A) a joint label is required for the 
                agricultural pesticide; and
                    ``(B) the registrant shall propose to the 
                Administrator and the harmonized country a joint label 
                not later than 90 days after notification by the 
                Administrator.''.
            (2) Technical and conforming amendment.--The table of 
        contents in section 1(b) of the Federal Insecticide, Fungicide, 
        and Rodenticide Act (7 U.S.C. prec. 121) (as amended by section 
        3(b)) is amended by adding at the end of the items relating to 
        section 3(c) the following:

            ``(12) Authority to require joint label for new 
            pesticides or uses.''.

SEC. 5. MEMORANDUM OF UNDERSTANDING.

    (a) In General.--The Administrator of the Environmental Protection 
Agency may enter into a memorandum of understanding with any harmonized 
country to address joint registration and joint labeling procedures, as 
those terms are defined in section 2 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136) (as amended by section 
2).
    (b) Requirements.--A memorandum of understanding entered into under 
this section shall address--
            (1) sharing of information; and
            (2) the protection of the confidential statement of formula 
        as confidential business information.
                                 <all>