II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. REGISTRATION OF CANADIAN PESTICIDES BY

4 STATES.

5 (a) IN GENERAL.—Section 24 of the Federal Insecti6 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136v) is

7 amended by adding at the end the following:

8 ‘‘(d) REGISTRATION OF CANADIAN PESTICIDES BY

9 STATES.—
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1 ‘‘(1) DEFINITIONS.—In this subsection:

2 ‘‘(A) CANADIAN PESTICIDE.—The term

3 ‘Canadian pesticide’ means a pesticide that—

4 ‘‘(i) is registered for use as a pesticide

5 in Canada;

6 ‘‘(ii) is identical or substantially simi7 lar in its composition to a comparable do8 mestic pesticide registered under section 3;

9 and

10 ‘‘(iii) is registered in Canada by the

11 registrant of the comparable domestic pes12 ticide or by an affiliated entity of the reg13 istrant.

14 ‘‘(B) COMPARABLE DOMESTIC PES15 TICIDE.—The term ‘comparable domestic pes16 ticide’ means a pesticide—

17 ‘‘(i) that is registered under section 3;

18 ‘‘(ii) the registration of which is not

19 under suspension;

20 ‘‘(iii) that is not subject to—

21 ‘‘(I) a notice of intent to cancel

22 or suspend under any provision of this

23 Act;

24 ‘‘(II) a notice for voluntary can25 cellation under section 6(f); or
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1 ‘‘(III) an enforcement action

2 under any provision of this Act;

3 ‘‘(iv) that is used as the basis for

4 comparison for the determinations required

5 under paragraph (4);

6 ‘‘(v) that is registered for use on each

7 site of application for which registration is

8 sought under this subsection;

9 ‘‘(vi) for which no use is the subject

10 of a pending interim administrative review

11 under section 3(c)(8);

12 ‘‘(vii) that is not subject to any limita13 tion on production or sale agreed to by the

14 Administrator and the registrant or im15 posed by the Administrator for risk mitiga16 tion purposes; and

17 ‘‘(viii) that is not classified as a re18 stricted use pesticide under section 3(d).

19 ‘‘(2) AUTHORITY TO REGISTER CANADIAN PES20 TICIDES.—

21 ‘‘(A) IN GENERAL.—A State may register

22 a Canadian pesticide for distribution and use in

23 the State if the registration—

24 ‘‘(i) complies with this subsection;

25 ‘‘(ii) is consistent with this Act; and
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1 ‘‘(iii) has not previously been dis2 approved by the Administrator.

3 ‘‘(B) PRODUCTION OF ANOTHER PES4 TICIDE.—A pesticide registered under this sub5 section shall not be used to produce a pesticide

6 registered under section 3 or subsection (c).

7 ‘‘(C) EFFECT OF REGISTRATION.—A reg8 istration of a Canadian pesticide by a State

9 under this subsection—

10 ‘‘(i) shall be deemed to be a registra11 tion under section 3 for all purposes of this

12 Act; and

13 ‘‘(ii) shall authorize distribution and

14 use only within that State.

15 ‘‘(D) REGISTRANT.—

16 ‘‘(i) IN GENERAL.—A State may reg17 ister a Canadian pesticide under this sub18 section on its own motion or on application

19 of any person.

20 ‘‘(ii) STATE OR APPLICANT AS REG21 ISTRANT.—

22 ‘‘(I) STATE.—If a State registers

23 a Canadian pesticide under this sub24 section on its own motion, the State

25 shall be considered to be the reg-
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1 istrant of the Canadian pesticide for

2 all purposes of this Act.

3 ‘‘(II) APPLICANT.—If a State

4 registers a Canadian pesticide under

5 this subsection on application of any

6 person, the person shall be considered

7 to be the registrant of the Canadian

8 pesticide for all purposes of this Act.

9 ‘‘(3) REQUIREMENTS FOR REGISTRATION

10 SOUGHT BY PERSON.—A person seeking registration

11 by a State of a Canadian pesticide in a State under

12 this subsection shall—

13 ‘‘(A) demonstrate to the State that the Ca14 nadian pesticide is identical or substantially

15 similar in its composition to a comparable do16 mestic pesticide; and

17 ‘‘(B) submit to the State a copy of—

18 ‘‘(i) the label approved by the Pes19 ticide Management Regulatory Agency for

20 the Canadian pesticide; and

21 ‘‘(ii) the label approved by the Admin22 istrator for the comparable domestic pes23 ticide.
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1 ‘‘(4) STATE REQUIREMENTS FOR REGISTRA2 TION.—A State may register a Canadian pesticide

3 under this subsection if the State—

4 ‘‘(A) obtains the confidential statement of

5 formula for the Canadian pesticide;

6 ‘‘(B) determines that the Canadian pes7 ticide is identical or substantially similar in

8 composition to a comparable domestic pesticide;

9 ‘‘(C) for each food or feed use authorized

10 by the registration—

11 ‘‘(i) determines that there exists an

12 adequate tolerance or exemption under the

13 Federal Food, Drug, and Cosmetic Act (21

14 U.S.C. 301 et seq.) that permits the resi15 dues of the pesticide on the food or feed;

16 and

17 ‘‘(ii) identifies the tolerances or ex18 emptions in the notification submitted

19 under subparagraph (E);

20 ‘‘(D) obtains a label approved by the Ad21 ministrator that—

22 ‘‘(i)(I) includes all statements, other

23 than the establishment number, from the

24 approved labeling of the comparable do-
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1 mestic pesticide that are relevant to the

2 uses registered by the State; and

3 ‘‘(II) excludes all labeling statements

4 relating to uses that are not registered by

5 the State;

6 ‘‘(ii) identifies the State in which the

7 product may be used;

8 ‘‘(iii) prohibits sale and use outside

9 the State identified under clause (ii);

10 ‘‘(iv) includes a statement indicating

11 that it is unlawful to use the Canadian

12 pesticide in the State in a manner that is

13 inconsistent with the labeling approved by

14 the Administrator under this subsection;

15 and

16 ‘‘(v) identifies the establishment num17 ber of the establishment in which the label18 ing approved by the Administrator will be

19 affixed to each container of the Canadian

20 pesticide; and

21 ‘‘(E) not later than 10 business days after

22 the issuance by the State of the registration,

23 submit to the Administrator a written notifica24 tion of the action of the State that includes—
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1 ‘‘(i) a description of the determination

2 made under this paragraph;

3 ‘‘(ii) a statement of the effective date

4 of the registration;

5 ‘‘(iii) a confidential statement of the

6 formula of the registered pesticide; and

7 ‘‘(iv) a final printed copy of the label8 ing approved by the Administrator.

9 ‘‘(5) DISAPPROVAL OF REGISTRATION BY AD10 MINISTRATOR.—

11 ‘‘(A) IN GENERAL.—The Administrator

12 may disapprove the registration of a Canadian

13 pesticide by a State under this subsection if the

14 Administrator determines that the registration

15 of the Canadian pesticide by the State—

16 ‘‘(i) does not comply with this sub17 section or the Federal Food, Drug, and

18 Cosmetic Act (21 U.S.C. 301 et seq.); or

19 ‘‘(ii) is inconsistent with this Act.

20 ‘‘(B) EFFECTIVE PERIOD.—If the Admin21 istrator disapproves a registration by a State

22 under this subsection by the date that is 90

23 days after the date on which the State issues

24 the registration, the registration shall be inef25 fective after the 90th day.
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1 ‘‘(6) LABELING OF CANADIAN PESTICIDES.—

2 ‘‘(A) IN GENERAL.—Each container con3 taining a Canadian pesticide registered by a

4 State shall bear the label that is approved by

5 the Administrator under this subsection.

6 ‘‘(B) DISPLAY OF LABEL.—The label shall

7 be securely attached to the container and shall

8 be the only label visible on the container.

9 ‘‘(C) ORIGINAL CANADIAN LABEL.—The

10 original Canadian label on the container shall

11 be preserved underneath the label approved by

12 the Administrator.

13 ‘‘(D) PREPARATION AND USE OF LA14 BELS.—After a Canadian pesticide is registered

15 under this subsection, the registrant shall—

16 ‘‘(i) prepare labels approved by the

17 Administrator for the Canadian pesticide;

18 and

19 ‘‘(ii) conduct or supervise all labeling

20 of the Canadian pesticide with the ap21 proved labeling.

22 ‘‘(E) REGISTERED ESTABLISHMENTS.—

23 Labeling of a Canadian pesticide under this

24 subsection shall be conducted at an establish-
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1 ment registered by the registrant under section

2 7.

3 ‘‘(F) ESTABLISHMENT REPORTING RE4 QUIREMENTS.—An establishment registered for

5 the sole purpose of labeling under this para6 graph shall be exempt from the reporting re7 quirements of section 7(c).

8 ‘‘(7) REVOCATION.—

9 ‘‘(A) IN GENERAL.—After the registration

10 of a Canadian pesticide, if the Administrator

11 finds that the Canadian pesticide is not iden12 tical or substantially similar in composition to

13 a comparable domestic pesticide, the Adminis14 trator may issue an emergency order revoking

15 the registration of the Canadian pesticide.

16 ‘‘(B) TERMS OF ORDER.—The order—

17 ‘‘(i) shall be effective immediately;

18 ‘‘(ii) may prohibit the sale, distribu19 tion, and use of the Canadian pesticide;

20 and

21 ‘‘(iii) may require the registrant of the

22 Canadian pesticide to purchase and dispose

23 of any unopened product subject to the

24 order.
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1 ‘‘(C) REQUEST FOR HEARING.—Not later

2 than 10 days after issuance of the order, the

3 registrant of the Canadian pesticide subject to

4 the order may request a hearing on the order.

5 ‘‘(D) FINAL ORDER.—If a hearing is not

6 requested in accordance with subparagraph (C),

7 the order shall become final and shall not be

8 subject to judicial review.

9 ‘‘(E) JUDICIAL REVIEW.—If a hearing is

10 requested on the order, judicial review may be

11 sought only at the conclusion of the hearing on

12 the order and following the issuance by the Ad13 ministrator of a final revocation order.

14 ‘‘(F) PROCEDURE.—A final revocation

15 order issued following a hearing shall be review16 able in accordance with section 16.

17 ‘‘(8) SUSPENSION OF STATE AUTHORITY TO

18 REGISTER CANADIAN PESTICIDES.—

19 ‘‘(A) IN GENERAL.—If the Administrator

20 finds that a State that has registered 1 or more

21 Canadian pesticides under this subsection is not

22 capable of exercising adequate controls to en23 sure that registration under this subsection is

24 consistent with this subsection, other provisions

25 of this Act, or the Federal Food, Drug, and
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1 Cosmetic Act (21 U.S.C. 301 et seq.), or has

2 failed to exercise adequate controls of 1 or more

3 Canadian pesticides registered under this sub4 section, the Administrator may suspend the au5 thority of the State to register Canadian pes6 ticides under this subsection until such time as

7 the Administrator determines that the State

8 can and will exercise adequate control of the

9 Canadian pesticides.

10 ‘‘(B) NOTICE AND OPPORTUNITY TO RE11 SPOND.—Before suspending the authority of a

12 State to register a Canadian pesticide, the Ad13 ministrator shall—

14 ‘‘(i) notify the State that the Adminis15 trator proposes to suspend the authority

16 and the reasons for the proposed suspen17 sion; and

18 ‘‘(ii) before taking final action to sus19 pend authority under this subsection, pro20 vide the State an opportunity to respond to

21 the proposal to suspend within 30 calendar

22 days after the State receives notice under

23 clause (i).
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1 ‘‘(9) LIMITS ON LIABILITY.—No action for

2 monetary damages may be heard in any Federal

3 court against—

4 ‘‘(A) a State acting as a registering agency

5 under the authority of and consistent with this

6 subsection for injury or damage resulting from

7 the use of a product registered by the State

8 under this subsection; or

9 ‘‘(B) a registrant for damages resulting

10 from adulteration or compositional alteration of

11 a Canadian pesticide registered under this sub12 section if the registrant did not have and could

13 not reasonably have obtained knowledge of the

14 adulteration or compositional alteration.

15 ‘‘(10) DISCLOSURE OF INFORMATION BY AD16 MINISTRATOR TO THE STATE.—The Administrator

17 may disclose to a State that is seeking to register a

18 Canadian pesticide in the State information that is

19 necessary for the State to make the determinations

20 required by paragraph (4) if the State certifies to

21 the Administrator that the State can and will main22 tain the confidentiality of any trade secrets and com23 mercial or financial information provided by the Ad24 ministrator to the State under this subsection to the

25 same extent as is required under section 10.
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1 ‘‘(11) PROVISION OF INFORMATION BY REG2 ISTRANTS OF COMPARABLE DOMESTIC PES3 TICIDES.—

4 ‘‘(A) IN GENERAL.—On request by a

5 State, the registrant of a comparable domestic

6 pesticide shall provide to the State that is seek7 ing to register a Canadian pesticide in the State

8 under this subsection information that is nec9 essary for the State to make the determinations

10 required by paragraph (4) if the State certifies

11 to the registrant that the State can and will

12 maintain the confidentiality of any trade secrets

13 and commercial and financial information pro14 vided by the registrant to the State under this

15 subsection to the same extent as is required

16 under section 10.

17 ‘‘(B) PENALTY FOR NONCOMPLIANCE.—

18 ‘‘(i) IN GENERAL.—If the registrant

19 of a comparable domestic pesticide fails to

20 provide to the State, not later than 15

21 days after receipt of a written request by

22 the State, information possessed by or rea23 sonably accessible to the registrant that is

24 necessary to make the determinations re25 quired by paragraph (4), the Administrator
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1 may assess a penalty against the registrant

2 of the comparable pesticide.

3 ‘‘(ii) AMOUNT.—The amount of the

4 penalty shall be equal to the product ob5 tained by multiplying—

6 ‘‘(I) the difference between the

7 per-acre cost of the application of the

8 comparable domestic pesticide and the

9 application of the Canadian pesticide,

10 as determined by the Administrator;

11 and

12 ‘‘(II) the number of acres in the

13 State devoted to the commodity for

14 which the State registration is sought.

15 ‘‘(C) NOTICE AND OPPORTUNITY FOR

16 HEARING.—No penalty under this paragraph

17 shall be assessed unless the registrant is given

18 notice and opportunity for a hearing in accord19 ance with section 14(a)(3).

20 ‘‘(D) ISSUES AT HEARING.—The only

21 issues for resolution at the hearing shall be—

22 ‘‘(i) whether the registrant of the

23 comparable domestic pesticide failed to

24 timely provide to the State the information

25 possessed by or reasonably accessible to
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1 the registrant that was necessary to make

2 the determinations required by paragraph

3 (4); and

4 ‘‘(ii) the amount of the penalty.

5 ‘‘(12) PENALTY FOR DISCLOSURE BY STATE.—

6 ‘‘(A) IN GENERAL.—The State shall not

7 make public information obtained under para8 graph (10) or (11) that is privileged and con9 fidential and contains or relates to trade secrets

10 or commercial or financial information.

11 ‘‘(B) DISCLOSURE.—Any State employee

12 who willfully discloses information described in

13 subparagraph (A) shall be subject to penalties

14 described in section 10(f).

15 ‘‘(13) DATA COMPENSATION.—A State or per16 son registering a Canadian pesticide under this sub17 section shall not be liable for compensation for data

18 supporting the registration if the registration of the

19 Canadian pesticide in Canada and the registration of

20 the comparable domestic pesticide are held by the

21 same registrant or by affiliated entities.

22 ‘‘(14) FORMULATION CHANGES.—

23 ‘‘(A) IN GENERAL.—The registrant of a

24 comparable domestic pesticide shall notify the

25 Administrator of any change in the formulation
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1 of a comparable domestic pesticide or a Cana2 dian pesticide registered by the registrant or an

3 affiliated entity not later than 30 days before

4 any sale or distribution of the pesticide con5 taining the new formulation.

6 ‘‘(B) STATEMENT OF FORMULA.—The reg7 istrant of the comparable domestic pesticide

8 shall submit, with the notice required under

9 subparagraph (A), a confidential statement of

10 the formula for the new formulation if the reg11 istrant has possession of or reasonable access to

12 the information.

13 ‘‘(C) SUSPENSION OF REGISTRATION FOR

14 NONCOMPLIANCE.—

15 ‘‘(i) IN GENERAL.—If the registrant

16 fails to provide notice or submit a con17 fidential statement of formula as required

18 by this paragraph, the Administrator may

19 issue a notice of intent to suspend the reg20 istration of the comparable domestic pes21 ticide for a period of not less than 1 year.

22 ‘‘(ii) EFFECTIVE DATE.—The suspen23 sion shall become final not later than the

24 end of the 30-day period beginning on the

25 date of the issuance by the Administrator
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1 of the notice of intent to suspend the reg2 istration, unless during the period the reg3 istrant requests a hearing.

4 ‘‘(iii) HEARING PROCEDURE.—If a

5 hearing is requested, the hearing shall be

6 conducted in accordance with section 6(d).

7 ‘‘(iv) ISSUES.—The only issues for

8 resolution at the hearing shall be whether

9 the registrant has failed to provide notice

10 or submit a confidential statement of for11 mula as required by this paragraph.’’.

12 (b) CONFORMING AMENDMENTS.—

13 (1) Section 24(c) of the Federal Insecticide,

14 Fungicide, and Rodenticide Act (7 U.S.C. 136v(c))

15 is amended—

16 (A) in paragraph (1), by inserting ‘‘IN

17 GENERAL.—’’ after ‘‘(1)‘‘;

18 (B) in paragraph (2), by inserting ‘‘DIS19 APPROVAL.—’’ after ‘‘(2)’’;

20 (C) in paragraph (3), by inserting ‘‘CON21 SISTENCY WITH FEDERAL FOOD, DRUG, AND

22 COSMETIC ACT.—’’ after ‘‘(3)’’; and

23 (D) by striking ‘‘(4) If the Administrator’’

24 and inserting the following:
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1 ‘‘(4) SUSPENSION OF AUTHORITY TO REGISTER

2 PESTICIDES.—Except as provided in subsection

3 (d)(8), if the Administrator’’.

4 (2) The table of contents in section 1(b) of the

5 Federal Insecticide, Fungicide, and Rodenticide Act

6 (7 U.S.C. prec. 121) is amended by striking the item

7 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.’’.

8 (c) EFFECTIVE DATE.—This section and the amend9 ments made by this section take effect 180 days after the

10 date of enactment of this Act.

Æ