I

106TH CONGRESS

2D SESSION H. R. 5187

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 HOUSE OF REPRESENTATIVES

SEPTEMBER 14, 2000

Mr. POMEROY 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 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 of this Act; and

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

11 registrant of the comparable domestic pes12 ticide or 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 of this Act;

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

20 under suspension;

21 ‘‘(iii) that is not subject to a notice of

22 intent to cancel or suspend, a notice for

23 voluntary cancellation under section 6(f) of

24 this Act, or an enforcement action under

25 this Act;
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1 ‘‘(iv) that is used as the basis for

2 comparison for the determinations required

3 under section 24(d)(4) of this Act;

4 ‘‘(v) that is registered for use on the

5 site(s) of application for which registration

6 is sought under this subsection;

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

8 of a pending interim administrative review

9 under section 3(c)(8) of this Act;

10 ‘‘(vii) that is not subject to sales limi11 tations or production caps agreed upon be12 tween the Administrator and the registrant

13 or imposed by the Administrator for risk

14 mitigation purposes; and

15 ‘‘(viii) that is not classified as a re16 stricted use pesticide under section 3(d) of

17 this Act.

18 ‘‘(2) AUTHORITY TO REGISTER CANADIAN PES19 TICIDES.—

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

21 a Canadian pesticide for distribution and use

22 only within the State if the registration com23 plies with this subsection, is consistent with the

24 purposes of this Act, and has not previously

25 been denied or disapproved by the Adminis-
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1 trator. A pesticide registered under this sub2 section shall not be used to produce a pesticide

3 to be registered under section 3 or section 24(c)

4 of this Act.

5 ‘‘(B) EFFECT OF REGISTRATION.—A reg6 istration of a Canadian pesticide by a State

7 under this subsection shall be deemed a reg8 istration under section 3 for all purposes of this

9 Act, but shall authorize distribution and use

10 only within such State.

11 ‘‘(C) REGISTRANT.—Any person or State

12 may seek registration of a Canadian pesticide

13 pursuant to this subsection. Such person or

14 State shall be deemed the registrant of the Ca15 nadian pesticide under this Act.

16 ‘‘(3) REQUIREMENTS FOR REGISTRATION

17 SOUGHT BY PERSON.—A person seeking registration

18 from a State of a Canadian pesticide under this sub19 section must—

20 ‘‘(A) demonstrate to the State that the Ca21 nadian pesticide is identical or substantially

22 similar in its composition to a comparable do23 mestic pesticide; and

24 ‘‘(B) submit to the State a copy of the

25 label approved by the Pest Management Regu-
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1 latory Agency for the Canadian pesticide and

2 the label approved by the Administrator for the

3 comparable domestic pesticide.

4 ‘‘(4) STATE REQUIREMENTS FOR REGISTRA5 TION.—A State may register a Canadian pesticide

6 under this subsection only if it—

7 ‘‘(A) has obtained the confidential state8 ment of formula for the Canadian pesticide;

9 ‘‘(B) determines that the Canadian pes10 ticide is identical or substantially similar in its

11 composition to a comparable domestic pesticide;

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

13 by the registration—

14 ‘‘(i) determines that there exists an

15 adequate tolerance or exemption under the

16 Federal Food, Drug, and Cosmetic Act (21

17 U.S.C. 301 et seq.) that permits the resi18 dues of the pesticide on the food or feed;

19 and

20 ‘‘(ii) identifies the tolerances or ex21 emptions in the submissions made under

22 subparagraph (D);

23 ‘‘(D) has obtained a label approved by the

24 Administrator, that—
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1 ‘‘(i) duplicates all statements, exclud2 ing the establishment number, from the

3 approved labeling of the comparable do4 mestic pesticide that are relevant to the

5 uses registered by the State and deletes all

6 labeling statements relating to uses not

7 registered by the State;

8 ‘‘(ii) identifies the state in which the

9 product may be used;

10 ‘‘(iii) prohibits sale and use outside

11 the state identified in clause (ii);

12 ‘‘(iv) includes a statement indicating

13 that it is unlawful to use the Canadian

14 pesticide in the State in a manner that is

15 inconsistent with the labeling approved by

16 the Administrator pursuant to this sub17 section; and

18 ‘‘(v) identifies the establishment num19 ber of the establishment in which the label20 ing approved by the Administrator will be

21 affixed to the containers of the Canadian

22 pesticide; and

23 ‘‘(E) notifies, within 10 working days after

24 the State’s issuance of a registration under this

25 subsection, the Administrator in writing of the
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1 State’s action, which notification shall include a

2 statement of the determination made under this

3 paragraph, the effective date of the registration,

4 a confidential statement of formula, and a final

5 printed copy of the labeling approved by the

6 Administrator.

7 ‘‘(5) DISAPPROVAL OF REGISTRATION BY AD8 MINISTRATOR.—A registration issued by a State

9 under this subsection shall not be effective for more

10 than 90 days if disapproved by the Administrator

11 within that period. The Administrator may dis12 approve the registration of a Canadian pesticide by

13 a State pursuant to this subsection if the Adminis14 trator determines that the registration of the Cana15 dian pesticide by the State does not comply with this

16 subsection or the Federal Food, Drug, and Cosmetic

17 Act, or is inconsistent with the purposes of this Act.

18 ‘‘(6) LABELING OF CANADIAN PESTICIDES.—

19 ‘‘(A) CONTAINERS.—Each container con20 taining a Canadian pesticide registered by a

21 State shall at all times bear the label that is ap22 proved by the Administrator. The label must be

23 securely attached to the container and must be

24 the only label visible on the container. The

25 original Canadian label on the container must
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1 be preserved underneath the label approved by

2 the Administrator.

3 ‘‘(B) AFFIXING LABELS.—After a Cana4 dian pesticide is registered under this sub5 section, the registrant shall prepare labels ap6 proved by the Administrator for such Canadian

7 pesticide and shall conduct or supervise all la8 beling of the Canadian pesticides with the ap9 proved labeling. Labeling of the Canadian pes10 ticides pursuant to this subsection must be con11 ducted at an establishment registered by the

12 registrant pursuant to section 7 of this Act.

13 ‘‘(C) ESTABLISHMENT REPORTING RE14 QUIREMENTS.—Establishments registered for

15 the sole purpose of labeling required under sec16 tion 24(d)(6) of this Act are exempt from the

17 reporting requirements provided in section 7(c)

18 of this Act.

19 ‘‘(7) REVOCATION.—At any time after the reg20 istration of a Canadian pesticide, if the Adminis21 trator finds that the Canadian pesticide is not iden22 tical or substantially similar in composition to a

23 comparable domestic pesticide, the Administrator

24 may issue an emergency order revoking the registra25 tion of the Canadian pesticide. Such order shall be
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1 immediately effective and may prohibit sale, dis2 tribution and use of the Canadian pesticide. Such

3 order may also prescribe terms of a requirement for

4 the registrant of any such Canadian pesticide to

5 purchase and dispose of any unopened product sub6 ject to a revocation order. The registrant of a prod7 uct subject to a revocation order may request a

8 hearing on such order within 10 days of the issuance

9 of such order. If no hearing is requested within the

10 prescribed period, the order shall become final and

11 shall not be subject to judicial review. If a hearing

12 is requested, judicial review may be sought only at

13 the conclusion of the hearing and following the

14 issuance by the Agency of a final revocation order.

15 A final revocation order issued following a hearing

16 shall be reviewable in accordance with section 16 of

17 this Act.

18 ‘‘(8) SUSPENSION OF STATE AUTHORITY TO

19 REGISTER CANADIAN PESTICIDES.—

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

21 finds that a State that has registered 1 or more

22 Canadian pesticides under this subsection is not

23 capable of exercising adequate controls to en24 sure that registration under this subsection is

25 consistent with this subsection, other provisions
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1 of this Act, or the Federal Food, Drug, and

2 Cosmetic Act,, or has failed to exercise ade3 quate controls of one or more Canadian pes4 ticides registered under this subsection, the Ad5 ministrator may suspend the authority of the

6 State to register Canadian pesticides under this

7 subsection until such time as the Administrator

8 determines that the State can and will exercise

9 adequate control of the 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) advise the State that the Admin15 istrator proposes to suspend the authority

16 and the reasons for the proposed suspen17 sion; and

18 ‘‘(ii) before taking final action to sus19 pend under this subsection, the Adminis20 trator shall provide the State an oppor21 tunity to respond to the proposal to sus22 pend within 30 calendar days of the

23 State’s receipt of the Administrator’s pro24 posal to suspend.

25 ‘‘(9) TORT LIABILITY.—
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1 ‘‘(A) STATE AS REGISTERING AGENCY.—

2 No action for monetary damages may be main3 tained in any Federal court against a State act4 ing as a registering agency under the authority

5 of and consistent with this section for injury or

6 damage resulting from the use of a product reg7 istered by the State pursuant to this subsection.

8 ‘‘(B) REGISTRANT.—Actions in tort may

9 not be maintained in any Federal court against

10 a registrant for damages resulting from adulter11 ation or compositional alterations of the reg12 istrants product registered under this sub13 section if the registrant did not and could not

14 reasonably have knowledge of the adulteration

15 or compositional alterations.

16 ‘‘(10) DISCLOSURE OF INFORMATION BY AD17 MINISTRATOR TO THE STATE.—The Administrator

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

19 Canadian pesticide in the State information that is

20 necessary for the State to make the determinations

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

22 the Administrator that the State can and will main23 tain the confidentiality of any trade secrets or com24 mercial or financial information provided by the Ad25 ministrator to the State under this subsection to the
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1 same extent as is required under section 10 of this

2 Act.

3 ‘‘(11) PROVISION OF INFORMATION BY REG4 ISTRANTS OF COMPARABLE DOMESTIC PES5 TICIDES.—Upon request, the registrant of a com6 parable domestic pesticide shall provide to a State

7 that is seeking to register a Canadian pesticide in

8 the State pursuant to this subsection information

9 that is necessary for the State to make the deter10 minations required by section 24(d)(4) of this Act if

11 the State certifies to the registrant that the State

12 can and will maintain the confidentiality of any

13 trade secrets or commercial or financial information

14 provided by the registrant to the State under this

15 subsection to the same extent as is required under

16 section 10 of this Act. If the registrant of a com17 parable domestic pesticide fails to provide to the

18 State, within 15 days of its receipt of a written re19 quest by the State, information possessed by or rea20 sonably accessible to the registrant that is necessary

21 to make the determinations required by paragraph

22 (4), the Administrator may assess a penalty against

23 the registrant of the comparable pesticide based on

24 the Administrator’s estimate of the difference be25 tween the per-acre cost of the application of the
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1 comparable domestic pesticide and the application of

2 the Canadian pesticide multiplied by the acreage in

3 the State of the commodity for which the State reg4 istration is sought. No penalty under this subsection

5 shall be assessed unless the registrant assessed shall

6 have been given notice and opportunity for a hearing

7 as provided by section 14(a)(3) of this Act. The only

8 matters for resolution at that hearing will be wheth9 er the registrant of the comparable domestic pes10 ticide failed to timely provide to the State the infor11 mation possessed by or reasonably accessible to the

12 registrant that was necessary to make the deter13 minations required by paragraph (4) and the

14 amount of the penalty.

15 ‘‘(12) PENALTY FOR DISCLOSURE BY STATE

16 EMPLOYEE.—The State shall not make public infor17 mation obtained under paragraphs (10) and (11) of

18 this subsection that is privileged and confidential

19 and contains or relates to trade secrets or commer20 cial or financial information. Any State employee

21 who has willfully disclosed information described in

22 this paragraph shall be subject to penalties pre23 scribed in section 10(f) of this Act.

24 ‘‘(13) DATA COMPENSATION.—A State or per25 son registering a Canadian pesticide under this sub-
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1 section shall not be liable for compensation for data

2 supporting such registration if the registration of

3 the Canadian pesticide in Canada and the registra4 tion of the comparable domestic pesticide are held by

5 the same registrant or by affiliated entities.

6 ‘‘(14) FORMULATION CHANGE.—The registrant

7 of a comparable domestic pesticide must notify the

8 Administrator of any change in the formulation of a

9 comparable domestic pesticide or a Canadian pes10 ticide registered by such registrant or its affiliate at

11 least 30 days prior to any sale or distribution of the

12 pesticide containing the new formulation. The reg13 istrant of the comparable domestic pesticide must

14 submit, with its notice to the Administrator pursu15 ant to this paragraph, the confidential statement of

16 formula for the new formulation if the registrant has

17 possession of or reasonable access to such informa18 tion. If the registrant fails to provide notice or sub19 mit a confidential statement of formula as required

20 by this paragraph, the Administrator may issue a

21 notice of intent to suspend the registration of the

22 comparable domestic pesticide for a period of no less

23 than one year. Suspension shall become final within

24 30 days of the Administrator’s issuance of the notice

25 of intent to suspend, unless during that time the
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1 registrant requests a hearing. If a hearing is re2 quested, a hearing shall be conducted under section

3 6(d) of this Act. The only matter for resolution at

4 that hearing will be whether the registrant has failed

5 to provide notice or submit a confidential statement

6 of formula as required by this paragraph.’’.

7 (b) CONFORMING AMENDMENT.—Section 24(c)(4) is

8 amended in the first sentence by striking ‘‘If the Adminis9 trator’’ and inserting the following: ‘‘Except as otherwise

10 provided in section 24(d)(8), if the Adminstrator’’.

Æ