S 532 IS

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.

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

`(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.