HR 1084 IH

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.

March 15, 2001

Mr. POMEROY (for himself, Mr. BALDACCI, and Mr. MCHUGH) introduced the following bill; which was referred to the Committee on Agriculture

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 of this Act; and

`(iii) is registered in Canada by the registrant of the comparable domestic pesticide or 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 of this Act;

`(ii) the registration of which is not under suspension;

`(iii) that is not subject to a notice of intent to cancel or suspend, a notice for voluntary cancellation under section 6(f) of this Act, or an enforcement action under this Act;

`(iv) that is used as the basis for comparison for the determinations required under section 24(d)(4) of this Act;

`(v) that is registered for use on the site(s) 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) of this Act;

`(vii) that is not subject to sales limitations or production caps agreed upon between 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) of this Act.

`(2) AUTHORITY TO REGISTER CANADIAN PESTICIDES-

`(A) IN GENERAL- A State may register a Canadian pesticide for distribution and use only within the State if the registration complies with this subsection, is consistent with the purposes of this Act, and has not previously been denied or disapproved by the Administrator. A pesticide registered under this subsection shall not be used to produce a pesticide to be registered under section 3 or section 24(c) of this Act.

`(B) EFFECT OF REGISTRATION- A registration of a Canadian pesticide by a State under this subsection shall be deemed a registration under section 3 for all purposes of this Act, but shall authorize distribution and use only within such State.

`(C) REGISTRANT- Any person or State may seek registration of a Canadian pesticide pursuant to this subsection. Such person or State shall be deemed the registrant of the Canadian pesticide under this Act.

`(3) REQUIREMENTS FOR REGISTRATION SOUGHT BY PERSON- A person seeking registration

from a State of a Canadian pesticide under this subsection must--

`(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 the label approved by the Pest Management Regulatory Agency for the Canadian pesticide and 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 only if it--

`(A) has obtained the confidential statement of formula for the Canadian pesticide;

`(B) determines that the Canadian pesticide is identical or substantially similar in its 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 submissions made under subparagraph (D);

`(D) has obtained a label approved by the Administrator, that--

`(i) duplicates all statements, excluding the establishment number, from the approved labeling of the comparable domestic pesticide that are relevant to the uses registered by the State and deletes all labeling statements relating to uses 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 in 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 pursuant to this subsection; and

`(v) identifies the establishment number of the establishment in which the labeling approved by the Administrator will be affixed to the containers of the Canadian pesticide; and

`(E) notifies, within 10 working days after the State's issuance of a registration under this subsection, the Administrator in writing of the State's action, which notification shall include a statement of the determination made under this paragraph, the effective date of the registration, a confidential statement of formula, and a final printed copy of the labeling approved by the Administrator.

`(5) DISAPPROVAL OF REGISTRATION BY ADMINISTRATOR- A registration issued by a State under this subsection shall not be effective for more than 90 days if disapproved by the Administrator within that period. The Administrator may disapprove the registration of a Canadian pesticide by a State pursuant to this subsection if the Administrator determines that the registration of the Canadian pesticide by the State does not comply with this subsection or the Federal Food, Drug, and Cosmetic Act, or is inconsistent with the purposes of this Act.

`(6) LABELING OF CANADIAN PESTICIDES-

`(A) CONTAINERS- Each container containing a Canadian pesticide registered by a State shall at all times bear the label that is approved by the Administrator. The label must be securely attached to the container and must be the only label visible on the container. The original Canadian label on the container must be preserved underneath the label approved by the Administrator.

`(B) AFFIXING LABELS- After a Canadian pesticide is registered under this subsection, the registrant shall prepare labels approved by the Administrator for such Canadian pesticide and shall conduct or supervise all labeling of the Canadian pesticides with the approved labeling. Labeling of the Canadian pesticides pursuant to this subsection must be conducted at an establishment registered by the registrant pursuant to section 7 of this Act.

`(C) ESTABLISHMENT REPORTING REQUIREMENTS- Establishments registered for the sole purpose of labeling required under section 24(d)(6) of this Act are exempt from the reporting requirements provided in section 7(c) of this Act.

`(7) REVOCATION- At any time 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. Such order shall be immediately effective and may prohibit sale, distribution and use of the Canadian pesticide. Such order may also prescribe terms of a requirement for the registrant of any such Canadian pesticide to purchase and dispose of any unopened product subject to a revocation order. The registrant of a product subject to a revocation order may request a hearing on such order within 10 days of the issuance of such order. If no hearing is requested within the prescribed period, the order shall become final and shall not be subject to judicial review. If a hearing is requested, judicial review may be sought only at the conclusion of the hearing and following the issuance by the Agency of a final revocation order. A final revocation order issued following a hearing

shall be reviewable in accordance with section 16 of this Act.

`(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, or has failed to exercise adequate controls of one 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) advise 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 under this subsection, the Administrator shall provide the State an opportunity to respond to the proposal to suspend within 30 calendar days of the State's receipt of the Administrator's proposal to suspend.

`(9) TORT LIABILITY-

`(A) STATE AS REGISTERING AGENCY- No action for monetary damages may be maintained in any Federal court against a State acting as a registering agency under the authority of and consistent with this section for injury or damage resulting from the use of a product registered by the State pursuant to this subsection.

`(B) REGISTRANT- Actions in tort may not be maintained in any Federal court against a registrant for damages resulting from adulteration or compositional alterations of the registrants product registered under this subsection if the registrant did not and could not reasonably have knowledge of the adulteration or compositional alterations.

`(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 or commercial or financial information provided by the Administrator to the State under this subsection to the same extent as is required under section 10 of this Act.

`(11) PROVISION OF INFORMATION BY REGISTRANTS OF COMPARABLE DOMESTIC PESTICIDES- Upon request, the registrant of a comparable domestic pesticide shall provide to a State that is seeking to register a Canadian pesticide in the State pursuant to this subsection information that is necessary for the State to make the determinations required by section 24(d)(4) of this Act if the State certifies to the registrant that the State can and will maintain the confidentiality of any trade secrets or commercial or financial information provided by the registrant to the State under this subsection to the same extent as is required under

section 10 of this Act. If the registrant of a comparable domestic pesticide fails to provide to the State, within 15 days of its 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 based on the Administrator's estimate of the difference between the per-acre cost of the application of the comparable domestic pesticide and the application of the Canadian pesticide multiplied by the acreage in the State of the commodity for which the State registration is sought. No penalty under this subsection shall be assessed unless the registrant assessed shall have been given notice and opportunity for a hearing as provided by section 14(a)(3) of this Act. The only matters for resolution at that hearing will be 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 the amount of the penalty.

`(12) PENALTY FOR DISCLOSURE BY STATE EMPLOYEE- The State shall not make public information obtained under paragraphs (10) and (11) of this subsection that is privileged and confidential and contains or relates to trade secrets or commercial or financial information. Any State employee who has willfully disclosed information described in this paragraph shall be subject to penalties prescribed in section 10(f) of this Act.

`(13) DATA COMPENSATION- A State or person registering a Canadian pesticide under this subsection shall not be liable for compensation for data supporting such 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 CHANGE- The registrant of a comparable domestic pesticide must notify the Administrator of any change in the formulation of a comparable domestic pesticide or a Canadian pesticide registered by such registrant or its affiliate at least 30 days prior to any sale or distribution of the pesticide containing the new formulation. The registrant of the comparable domestic pesticide must submit, with its notice to the Administrator pursuant to this paragraph, the confidential statement of formula for the new formulation if the registrant has possession of or reasonable access to such information. 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 no less than one year. Suspension shall become final within 30 days of the Administrator's issuance of the notice of intent to suspend, unless during that time the registrant requests a hearing. If a hearing is requested, a hearing shall be conducted under section 6(d) of this Act. The only matter for resolution at that hearing will be whether the registrant has failed to provide notice or submit a confidential statement of formula as required by this paragraph.'.

(b) CONFORMING AMENDMENT- Section 24(c)(4) is amended in the first sentence by striking `If the Administrator' and inserting the following: `Except as otherwise provided in section 24(d)(8), if the Adminstrator'.

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