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[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3319 Introduced in House (IH)]

  1st Session
                                H. R. 3319

  To amend the Federal Insecticide, Fungicide, and Rodenticide Act to 
  permit the Administrator of the Environmental Protection Agency to 
                     register a Canadian pesticide.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            October 16, 2003

     Mr. Rehberg (for himself, Mr. Pomeroy, Mr. Case, Mr. Green of 
  Wisconsin, Mr. Paul, Mr. Sherwood, and Mr. Janklow) introduced the 
   following bill; which was referred to the Committee on Agriculture

_______________________________________________________________________

                                 A BILL

 
  To amend the Federal Insecticide, Fungicide, and Rodenticide Act to 
  permit the Administrator of the Environmental Protection Agency to 
                     register a Canadian pesticide.

    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.

    (a) In General.--Section 3 of the Federal Insecticide, Fungicide, 
and Rodenticide Act (7 U.S.C. 136a) is amended by adding at the end the 
following:
    ``(i) Registration of Canadian Pesticides.--
            ``(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 this 
                        section; 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 this 
                        section;
                            ``(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 
                        subsection (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 subsection (d).
            ``(2) Authority to register canadian pesticides.--
                    ``(A) In general.--The Administrator may register a 
                Canadian pesticide 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 this section or 
                section 24(c).
                    ``(C) Registrant.--
                            ``(i) In general.--The Administrator may 
                        register a Canadian pesticide under this 
                        subsection on the application of any person.
                            ``(ii) Application.--If the Administrator 
                        registers a Canadian pesticide under this 
                        subsection on application of any person, the 
                        applicant shall be considered to be the 
                        registrant of the Canadian pesticide for all 
                        purposes of this Act.
                    ``(D) Administrator.--Not later than 60 days after 
                a person submits a complete application for the 
                registration of a Canadian pesticide under this 
                subsection, the Administrator shall--
                            ``(i) approve the application; or
                            ``(ii)(I) disapprove the application; and
                            ``(II) provide the applicant with a 
                        statement of the reasons for the disapproval.
                    ``(E) Delegation.--
                            ``(i) In general.--Subject to clause (ii), 
                        the Administrator may delegate a function of 
                        the Administrator under this subsection.
                            ``(ii) Approval.--The Administrator shall 
                        approve or disapprove any final action taken 
                        under this subsection as the result of a 
                        function delegated to a State.
            ``(3) Applicant requirements.--A person seeking 
        registration of a Canadian pesticide under this subsection 
        shall--
                    ``(A) demonstrate to the Administrator that the 
                Canadian pesticide is identical or substantially 
                similar in its composition to a comparable domestic 
                pesticide; and
                    ``(B) submit to the Administrator 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) Criteria for registration.--The Administrator may 
        register a Canadian pesticide under this subsection if the 
        Administrator--
                    ``(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) 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 
                        Administrator; and
                            ``(ii) excludes all labeling statements 
                        relating to uses that are not registered by the 
                        Administrator; and
                    ``(E) not later than 10 business days after the 
                issuance of the registration, publish in the Federal 
                Register a written notification of the action of the 
                Administrator that includes--
                            ``(i) a description of the determination 
                        made under this paragraph; and
                            ``(ii) a statement of the effective date of 
                        the registration;
            ``(5) Labeling of canadian pesticides.--
                    ``(A) In general.--Each container containing a 
                Canadian pesticide registered by the Administrator 
                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.
            ``(6) 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 in a State; 
                        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.
            ``(7) Limits on liability.--No action for monetary damages 
        may be heard in any Federal or State court against--
                    ``(A) the Administrator 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 Administrator 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.
            ``(8) Provision of information by registrants of comparable 
        domestic pesticides.--
                    ``(A) In general.--On request by the Administrator 
                the registrant of a comparable domestic pesticide shall 
                provide to the Administrator that is seeking to 
                register a Canadian pesticide under this subsection 
information that is necessary for the Administrator to make the 
determinations required by paragraph (4).
                    ``(B) Penalty for noncompliance.--
                            ``(i) In general.--If the registrant of a 
                        comparable domestic pesticide fails to provide 
                        to the Administrator, not later than 15 days 
                        after receipt of a written request by the 
                        Administrator, 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 
                                United States devoted to the commodity 
                                for which the 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 Administrator 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.
            ``(9) Penalty for disclosure.--
                    ``(A) In general.--The Administrator shall not make 
                public information obtained under paragraph (8) that is 
                privileged and confidential and contains or relates to 
                trade secrets or commercial or financial information.
                    ``(B) Disclosure.--Any employee of the 
                Environmental Protection Agency who willfully discloses 
                information described in subparagraph (A) shall be 
                subject to penalties described in section 10(f).
            ``(10) Data compensation.--The Administrator and a 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.
            ``(11) 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) 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 3 the following:

            ``(4) Mixtures of nitrogen stabilizers and fertilizer 
                            products.
        ``(g) Registration review.
        ``(h) Registration requirements for antimicrobial pesticides.
            ``(1) Evaluation of process.
            ``(2) Review time period reduction goal.
            ``(3) Implementation.
            ``(4) Annual report.
        ``(i) Registration of Canadian pesticides.
            ``(1) Definitions.
            ``(2) Authority to register Canadian pesticides.
            ``(3) Applicant requirements.
            ``(4) Criteria for registration.
            ``(5) Labeling of Canadian pesticides.
            ``(6) Revocation.
            ``(7) Limits on liability.
            ``(8) Provision of information by registrants of comparable 
                            domestic pesticides.
            ``(9) Penalty for disclosure.
            ``(10) Data compensation.
            ``(11) 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.
                                 <all>
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