[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 3108 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 3108

  To amend the Federal Insecticide, Fungicide, and Rodenticide Act to 
 permit a State to register a Canadian pesticide for distribution and 
                         use within that State.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

           September 26 (legislative day, September 22), 2000

  Mr. Dorgan 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 a State to register a Canadian pesticide for distribution and 
                         use within that State.

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

SECTION 1. REGISTRATION OF CANADIAN PESTICIDES BY STATES.

    (a) In General.--Section 24 of the Federal Insecticide, Fungicide, 
and Rodenticide Act (7 U.S.C. 136v) is amended by adding at the end the 
following:
    ``(d) Registration of Canadian Pesticides by States.--
            ``(1) Definitions.--In this subsection:
                    ``(A) Canadian pesticide.--The term `Canadian 
                pesticide' means a pesticide that--
                            ``(i) is registered for use as a pesticide 
                        in Canada;
                            ``(ii) is identical or substantially 
                        similar in its composition to a comparable 
                        domestic pesticide registered under section 3; 
                        and
                            ``(iii) is registered in Canada by the 
                        registrant of the comparable domestic pesticide 
                        or by an affiliated entity of the registrant.
                    ``(B) Comparable domestic pesticide.--The term 
                `comparable domestic pesticide' means a pesticide--
                            ``(i) that is registered under section 3;
                            ``(ii) the registration of which is not 
                        under suspension;
                            ``(iii) that is not subject to--
                                    ``(I) a notice of intent to cancel 
                                or suspend under any provision of this 
                                Act;
                                    ``(II) a notice for voluntary 
                                cancellation under section 6(f); or
                                    ``(III) an enforcement action under 
                                any provision of this Act;
                            ``(iv) that is used as the basis for 
                        comparison for the determinations required 
                        under paragraph (4);
                            ``(v) that is registered for use on each 
                        site of application for which registration is 
                        sought under this subsection;
                            ``(vi) for which no use is the subject of a 
                        pending interim administrative review under 
                        section 3(c)(8);
                            ``(vii) that is not subject to any 
                        limitation on production or sale agreed to by 
                        the Administrator and the registrant or imposed 
                        by the Administrator for risk mitigation 
                        purposes; and
                            ``(viii) that is not classified as a 
                        restricted use pesticide under section 3(d).
            ``(2) Authority to register canadian pesticides.--
                    ``(A) In general.--A State may register a Canadian 
                pesticide for distribution and use in the State if the 
                registration--
                            ``(i) complies with this subsection;
                            ``(ii) is consistent with this Act; and
                            ``(iii) has not previously been disapproved 
                        by the Administrator.
                    ``(B) Production of another pesticide.--A pesticide 
                registered under this subsection shall not be used to 
                produce a pesticide registered under section 3 or 
                subsection (c).
                    ``(C) Effect of registration.--A registration of a 
                Canadian pesticide by a State under this subsection--
                            ``(i) shall be deemed to be a registration 
                        under section 3 for all purposes of this Act; 
                        and
                            ``(ii) shall authorize distribution and use 
                        only within that State.
                    ``(D) Registrant.--
                            ``(i) In general.--A State may register a 
                        Canadian pesticide under this subsection on its 
                        own motion or on application of any person.
                            ``(ii) State or applicant as registrant.--
                                    ``(I) State.--If a State registers 
                                a Canadian pesticide under this 
                                subsection on its own motion, the State 
                                shall be considered to be 
the registrant of the Canadian pesticide for all purposes of this Act.
                                    ``(II) Applicant.--If a State 
                                registers a Canadian pesticide under 
                                this subsection on application of any 
                                person, the person shall be considered 
                                to be the registrant of the Canadian 
                                pesticide for all purposes of this Act.
            ``(3) Requirements for registration sought by person.--A 
        person seeking registration by a State of a Canadian pesticide 
        in a State under this subsection shall--
                    ``(A) demonstrate to the State that the Canadian 
                pesticide is identical or substantially similar in its 
                composition to a comparable domestic pesticide; and
                    ``(B) submit to the State a copy of--
                            ``(i) the label approved by the Pesticide 
                        Management Regulatory Agency for the Canadian 
                        pesticide; and
                            ``(ii) the label approved by the 
                        Administrator for the comparable domestic 
                        pesticide.
            ``(4) State requirements for registration.--A State may 
        register a Canadian pesticide under this subsection if the 
        State--
                    ``(A) obtains the confidential statement of formula 
                for the Canadian pesticide;
                    ``(B) determines that the Canadian pesticide is 
                identical or substantially similar in composition to a 
                comparable domestic pesticide;
                    ``(C) for each food or feed use authorized by the 
                registration--
                            ``(i) determines that there exists an 
                        adequate tolerance or exemption under the 
                        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                        301 et seq.) that permits the residues of the 
                        pesticide on the food or feed; and
                            ``(ii) identifies the tolerances or 
                        exemptions in the notification submitted under 
                        subparagraph (E);
                    ``(D) obtains a label approved by the Administrator 
                that--
                            ``(i)(I) includes all statements, other 
                        than the establishment number, from the 
                        approved labeling of the comparable domestic 
                        pesticide that are relevant to the uses 
                        registered by the State; and
                            ``(II) excludes all labeling statements 
                        relating to uses that are not registered by the 
                        State;
                            ``(ii) identifies the State in which the 
                        product may be used;
                            ``(iii) prohibits sale and use outside the 
                        State identified under clause (ii);
                            ``(iv) includes a statement indicating that 
                        it is unlawful to use the Canadian pesticide in 
                        the State in a manner that is inconsistent with 
                        the labeling approved by the Administrator 
                        under this subsection; and
                            ``(v) identifies the establishment number 
                        of the establishment in which the labeling 
                        approved by the Administrator will be affixed 
                        to each container of the Canadian pesticide; 
                        and
                    ``(E) not later than 10 business days after the 
                issuance by the State of the registration, submit to 
                the Administrator a written notification of the action 
                of the State that includes--
                            ``(i) a description of the determination 
                        made under this paragraph;
                            ``(ii) a statement of the effective date of 
                        the registration;
                            ``(iii) a confidential statement of the 
                        formula of the registered pesticide; and
                            ``(iv) a final printed copy of the labeling 
                        approved by the Administrator.
            ``(5) Disapproval of registration by administrator.--
                    ``(A) In general.--The Administrator may disapprove 
                the registration of a Canadian pesticide by a State 
                under this subsection if the Administrator determines 
                that the registration of the Canadian pesticide by the 
                State--
                            ``(i) does not comply with this subsection 
                        or the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 301 et seq.); or
                            ``(ii) is inconsistent with this Act.
                    ``(B) Effective period.--If the Administrator 
                disapproves a registration by a State under this 
                subsection by the date that is 90 days after the date 
                on which the State issues the registration, the 
                registration shall be ineffective after the 90th day.
            ``(6) Labeling of canadian pesticides.--
                    ``(A) In general.--Each container containing a 
                Canadian pesticide registered by a State shall bear the 
                label that is approved by the Administrator under this 
                subsection.
                    ``(B) Display of label.--The label shall be 
                securely attached to the container and shall be the 
                only label visible on the container.
                    ``(C) Original canadian label.--The original 
                Canadian label on the container shall be preserved 
                underneath the label approved by the Administrator.
                    ``(D) Preparation and use of labels.--After a 
                Canadian pesticide is registered under this subsection, 
                the registrant shall--
                            ``(i) prepare labels approved by the 
                        Administrator for the Canadian pesticide; and
                            ``(ii) conduct or supervise all labeling of 
                        the Canadian pesticide with the approved 
                        labeling.
                    ``(E) Registered establishments.--Labeling of a 
                Canadian pesticide under this subsection shall be 
                conducted at an establishment registered by the 
                registrant under section 7.
                    ``(F) Establishment reporting requirements.--An 
                establishment registered for the sole purpose of 
                labeling under this paragraph shall be exempt from the 
                reporting requirements of section 7(c).
            ``(7) Revocation.--
                    ``(A) In general.--After the registration of a 
                Canadian pesticide, if the Administrator finds that the 
                Canadian pesticide is not identical or substantially 
                similar in composition to a comparable domestic 
                pesticide, the Administrator may issue an emergency 
                order revoking the registration of the Canadian 
                pesticide.
                    ``(B) Terms of order.--The order--
                            ``(i) shall be effective immediately;
                            ``(ii) may prohibit the sale, distribution, 
                        and use of the Canadian pesticide; and
                            ``(iii) may require the registrant of the 
                        Canadian pesticide to purchase and dispose of 
                        any unopened product subject to the order.
                    ``(C) Request for hearing.--Not later than 10 days 
                after issuance of the order, the registrant of the 
                Canadian pesticide subject to the order may request a 
                hearing on the order.
                    ``(D) Final order.--If a hearing is not requested 
                in accordance with subparagraph (C), the order shall 
                become final and shall not be subject to judicial 
                review.
                    ``(E) Judicial review.--If a hearing is requested 
                on the order, judicial review may be sought only at the 
                conclusion of the hearing on the order and following 
                the issuance by the Administrator of a final revocation 
                order.
                    ``(F) Procedure.--A final revocation order issued 
                following a hearing shall be reviewable in accordance 
                with section 16.
            ``(8) Suspension of state authority to register canadian 
        pesticides.--
                    ``(A) In general.--If the Administrator finds that 
                a State that has registered 1 or more Canadian 
                pesticides under this subsection is not capable of 
                exercising adequate controls to ensure that 
                registration under this subsection is consistent with 
                this subsection, other provisions of this Act, or the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
                seq.), or has failed to exercise adequate controls of 1 
                or more Canadian pesticides registered under this 
                subsection, the Administrator may suspend the authority 
                of the State to register Canadian pesticides under this 
                subsection until such time as the Administrator 
                determines that the State can and will exercise 
                adequate control of the Canadian pesticides.
                    ``(B) Notice and opportunity to respond.--Before 
                suspending the authority of a State to register a 
                Canadian pesticide, the Administrator shall--
                            ``(i) notify the State that the 
                        Administrator proposes to suspend the authority 
                        and the reasons for the proposed suspension; 
                        and
                            ``(ii) before taking final action to 
                        suspend authority under this subsection, 
                        provide the State an opportunity to respond to 
                        the proposal to suspend within 30 calendar days 
                        after the State receives notice under clause 
                        (i).
            ``(9) Limits on liability.--No action for monetary damages 
        may be heard in any Federal court against--
                    ``(A) a State acting as a registering agency under 
                the authority of and consistent with this subsection 
                for injury or damage resulting from the use of a 
                product registered by the State under this subsection; 
                or
                    ``(B) a registrant for damages resulting from 
                adulteration or compositional alteration of a Canadian 
                pesticide registered under this subsection if the 
                registrant did not have and could not reasonably have 
                obtained knowledge of the adulteration or compositional 
                alteration.
            ``(10) Disclosure of information by administrator to the 
        state.--The Administrator may disclose to a State that is 
        seeking to register a Canadian pesticide in the State 
        information that is necessary for the State to make the 
        determinations required by paragraph (4) if the State certifies 
        to the Administrator that the State can and will maintain the 
        confidentiality of any trade secrets and commercial or 
        financial information provided by the Administrator to the 
        State under this subsection to the same extent as is required 
        under section 10.
            ``(11) Provision of information by registrants of 
        comparable domestic pesticides.--
                    ``(A) In general.--On request by a State, the 
                registrant of a comparable domestic pesticide shall 
                provide to the State that is seeking to register a 
                Canadian pesticide in the State under this subsection 
                information that is necessary for the State to make the 
                determinations required by paragraph (4) if the State 
                certifies to the registrant that the State can and will 
                maintain the confidentiality of any trade secrets and 
                commercial and financial information provided by the 
                registrant to the State under this subsection to the 
                same extent as is required under section 10.
                    ``(B) Penalty for noncompliance.--
                            ``(i) In general.--If the registrant of a 
                        comparable domestic pesticide fails to provide 
                        to the State, not later than 15 days after 
                        receipt of a written request by the State, 
                        information possessed by or reasonably 
                        accessible to the registrant that is necessary 
                        to make the determinations required by 
                        paragraph (4), the Administrator may assess a 
                        penalty against the registrant of the 
                        comparable pesticide.
                            ``(ii) Amount.--The amount of the penalty 
                        shall be equal to the product obtained by 
                        multiplying--
                                    ``(I) the difference between the 
                                per-acre cost of the application of the 
                                comparable domestic pesticide and the 
                                application of the Canadian pesticide, 
                                as determined by the Administrator; and
                                    ``(II) the number of acres in the 
                                State devoted to the commodity for 
                                which the State registration is sought.
                    ``(C) Notice and opportunity for hearing.--No 
                penalty under this paragraph shall be assessed unless 
                the registrant is given notice and opportunity for a 
                hearing in accordance with section 14(a)(3).
                    ``(D) Issues at hearing.--The only issues for 
                resolution at the hearing shall be--
                            ``(i) whether the registrant of the 
                        comparable domestic pesticide failed to timely 
                        provide to the State the information possessed 
                        by or reasonably accessible to the registrant 
                        that was necessary to make the determinations 
                        required by paragraph (4); and
                            ``(ii) the amount of the penalty.
            ``(12) Penalty for disclosure by state.--
                    ``(A) In general.--The State shall not make public 
                information obtained under paragraph (10) or (11) that 
                is privileged and confidential and contains or relates 
                to trade secrets or commercial or financial 
                information.
                    ``(B) Disclosure.--Any State employee who willfully 
                discloses information described in subparagraph (A) 
                shall be subject to penalties described in section 
                10(f).
            ``(13) Data compensation.--A State or person registering a 
        Canadian pesticide under this subsection shall not be liable 
        for compensation for data supporting the registration if the 
        registration of the Canadian pesticide in Canada and the 
        registration of the comparable domestic pesticide are held by 
        the same registrant or by affiliated entities.
            ``(14) Formulation changes.--
                    ``(A) In general.--The registrant of a comparable 
                domestic pesticide shall notify the Administrator of 
                any change in the formulation of a comparable domestic 
pesticide or a Canadian pesticide registered by the registrant or an 
affiliated entity not later than 30 days before any sale or 
distribution of the pesticide containing the new formulation.
                    ``(B) Statement of formula.--The registrant of the 
                comparable domestic pesticide shall submit, with the 
                notice required under subparagraph (A), a confidential 
                statement of the formula for the new formulation if the 
                registrant has possession of or reasonable access to 
                the information.
                    ``(C) Suspension of registration for 
                noncompliance.--
                            ``(i) In general.--If the registrant fails 
                        to provide notice or submit a confidential 
                        statement of formula as required by this 
                        paragraph, the Administrator may issue a notice 
                        of intent to suspend the registration of the 
                        comparable domestic pesticide for a period of 
                        not less than 1 year.
                            ``(ii) Effective date.--The suspension 
                        shall become final not later than the end of 
                        the 30-day period beginning on the date of the 
                        issuance by the Administrator of the notice of 
                        intent to suspend the registration, unless 
                        during the period the registrant requests a 
                        hearing.
                            ``(iii) Hearing procedure.--If a hearing is 
                        requested, the hearing shall be conducted in 
                        accordance with section 6(d).
                            ``(iv) Issues.--The only issues for 
                        resolution at the hearing shall be whether the 
                        registrant has failed to provide notice or 
                        submit a confidential statement of formula as 
                        required by this paragraph.''.
    (b) Conforming Amendments.--
            (1) Section 24(c) of the Federal Insecticide, Fungicide, 
        and Rodenticide Act (7 U.S.C. 136v(c)) is amended--
                    (A) in paragraph (1), by inserting ``In general.--
                '' after ``(1)``;
                    (B) in paragraph (2), by inserting ``Disapproval.--
                '' after ``(2)'';
                    (C) in paragraph (3), by inserting ``Consistency 
                with federal food, drug, and cosmetic act.--'' after 
                ``(3)''; and
                    (D) by striking ``(4) If the Administrator'' and 
                inserting the following:
            ``(4) Suspension of authority to register pesticides.--
        Except as provided in subsection (d)(8), if the 
        Administrator''.
            (2) 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 striking the item relating to section 24(c) 
        and inserting the following:

        ``(c) Additional uses.
            ``(1) In general.
            ``(2) Disapproval.
            ``(3) Consistency with Federal Food, Drug, and 
            Cosmetic Act.
            ``(4) Suspension of authority to register 
            pesticides.
        ``(d) Registration of Canadian pesticides by 
            States.
            ``(1) Definitions.
            ``(2) Authority to register Canadian 
            pesticides.
            ``(3) Requirements for registration sought by 
            person.
            ``(4) State requirements for registration.
            ``(5) Disapproval of registration by 
            Administrator.
            ``(6) Labeling of Canadian pesticides.
            ``(7) Revocation.
            ``(8) Suspension of State authority to register 
            Canadian pesticides.
            ``(9) Limits on liability.
            ``(10) Disclosure of information by 
            Administrator to the State.
            ``(11) Provision of information by registrants 
            of comparable domestic pesticides.
            ``(12) Penalty for disclosure by State.
            ``(13) Data compensation.
            ``(14) Formulation changes.''.
    (c) Effective Date.--This section and the amendments made by this 
section take effect 180 days after the date of enactment of this Act.
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