I 

108TH CONGRESS 

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.

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. 

4 (a) IN GENERAL.—Section 3 of the Federal Insecti5 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136a) is 

6 amended by adding at the end the following: 

7 ‘‘(i) REGISTRATION OF CANADIAN PESTICIDES.—

8 ‘‘(1) DEFINITIONS.—In this subsection: 
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1 ‘‘(A) CANADIAN PESTICIDE.—The term 

2 ‘Canadian pesticide’ means a pesticide that—

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

4 in Canada; 

5 ‘‘(ii) is identical or substantially simi6 lar in its composition to a comparable do7 mestic pesticide registered under this sec8 tion; and 

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

10 registrant of the comparable domestic pes11 ticide or by an affiliated entity of the reg12 istrant. 

13 ‘‘(B) COMPARABLE DOMESTIC PES14 TICIDE.—The term ‘comparable domestic pes15 ticide’ means a pesticide—

16 ‘‘(i) that is registered under this sec17 tion; 

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 subsection (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 subsection (d). 

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

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

22 may register a Canadian pesticide if the reg23 istration—

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 this section or section 24(c). 

7 ‘‘(C) REGISTRANT.—

8 ‘‘(i) IN GENERAL.—The Administrator 

9 may register a Canadian pesticide under 

10 this subsection on the application of any 

11 person. 

12 ‘‘(ii) APPLICATION.—If the Adminis13 trator registers a Canadian pesticide under 

14 this subsection on application of any per15 son, the applicant shall be considered to be 

16 the registrant of the Canadian pesticide for 

17 all purposes of this Act. 

18 ‘‘(D) ADMINISTRATOR.—Not later than 60 

19 days after a person submits a complete applica20 tion for the registration of a Canadian pesticide 

21 under this subsection, the Administrator shall—

22 ‘‘(i) approve the application; or 

23 ‘‘(ii)(I) disapprove the application; 

24 and 
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1 ‘‘(II) provide the applicant with a 

2 statement of the reasons for the dis3 approval. 

4 ‘‘(E) DELEGATION.—

5 ‘‘(i) IN GENERAL.—Subject to clause 

6 (ii), the Administrator may delegate a 

7 function of the Administrator under this 

8 subsection. 

9 ‘‘(ii) APPROVAL.—The Administrator 

10 shall approve or disapprove any final ac11 tion taken under this subsection as the re12 sult of a function delegated to a State. 

13 ‘‘(3) APPLICANT REQUIREMENTS.—A person 

14 seeking registration of a Canadian pesticide under 

15 this subsection shall—

16 ‘‘(A) demonstrate to the Administrator 

17 that the Canadian pesticide is identical or sub18 stantially similar in its composition to a com19 parable domestic pesticide; and

20 ‘‘(B) submit to the Administrator a copy 

21 of—

22 ‘‘(i) the label approved by the Pes23 ticide Management Regulatory Agency for 

24 the Canadian pesticide; and
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1 ‘‘(ii) the label approved by the Admin2 istrator for the comparable domestic pes3 ticide. 

4 ‘‘(4) CRITERIA FOR REGISTRATION.—The Ad5 ministrator may register a Canadian pesticide under 

6 this subsection if the Administrator—

7 ‘‘(A) obtains the confidential statement of 

8 formula for the Canadian pesticide; 

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

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 notification submitted 

22 under subparagraph (E); 

23 ‘‘(D) obtains a label approved by the Ad24 ministrator that—
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1 ‘‘(i) includes all statements, other 

2 than the establishment number, from the 

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

5 uses registered by the Administrator; and 

6 ‘‘(ii) excludes all labeling statements 

7 relating to uses that are not registered by 

8 the Administrator; and 

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

10 the issuance of the registration, publish in the 

11 Federal Register a written notification of the 

12 action of the Administrator that includes—

13 ‘‘(i) a description of the determination 

14 made under this paragraph; and 

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

16 of the registration; 

17 ‘‘(5) LABELING OF CANADIAN PESTICIDES.—

18 ‘‘(A) IN GENERAL.—Each container con19 taining a Canadian pesticide registered by the 

20 Administrator shall bear the label that is ap21 proved by the Administrator under this sub22 section. 

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

24 be securely attached to the container and shall 

25 be the only label visible on the container. 
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1 ‘‘(C) ORIGINAL CANADIAN LABEL.—The 

2 original Canadian label on the container shall 

3 be preserved underneath the label approved by 

4 the Administrator. 

5 ‘‘(D) PREPARATION AND USE OF LA6 BELS.—After a Canadian pesticide is registered 

7 under this subsection, the registrant shall—

8 ‘‘(i) prepare labels approved by the 

9 Administrator for the Canadian pesticide; 

10 and 

11 ‘‘(ii) conduct or supervise all labeling 

12 of the Canadian pesticide with the ap13 proved labeling. 

14 ‘‘(E) REGISTERED ESTABLISHMENTS.—

15 Labeling of a Canadian pesticide under this 

16 subsection shall be conducted at an establish17 ment registered by the registrant under section 

18 7. 

19 ‘‘(6) REVOCATION.—

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

21 of a Canadian pesticide, if the Administrator 

22 finds that the Canadian pesticide is not iden23 tical or substantially similar in composition to 

24 a comparable domestic pesticide, the Adminis-
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1 trator may issue an emergency order revoking 

2 the registration of the Canadian pesticide. 

3 ‘‘(B) TERMS OF ORDER.—The order—

4 ‘‘(i) shall be effective immediately; 

5 ‘‘(ii) may prohibit the sale, distribu6 tion, and use of the Canadian pesticide in 

7 a State; and 

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

9 Canadian pesticide to purchase and dispose 

10 of any unopened product subject to the 

11 order.

12 ‘‘(C) REQUEST FOR HEARING.—Not later 

13 than 10 days after issuance of the order, the 

14 registrant of the Canadian pesticide subject to 

15 the order may request a hearing on the order. 

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

17 requested in accordance with subparagraph (C), 

18 the order shall become final and shall not be 

19 subject to judicial review. 

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

21 requested on the order, judicial review may be 

22 sought only at the conclusion of the hearing on 

23 the order and following the issuance by the Ad24 ministrator of a final revocation order. 
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1 ‘‘(F) PROCEDURE.—A final revocation 

2 order issued following a hearing shall be review3 able in accordance with section 16. 

4 ‘‘(7) LIMITS ON LIABILITY.—No action for 

5 monetary damages may be heard in any Federal or 

6 State court against—

7 ‘‘(A) the Administrator acting as a reg8 istering agency under the authority of and con9 sistent with this subsection for injury or dam10 age resulting from the use of a product reg11 istered by the Administrator under this sub12 section; or 

13 ‘‘(B) a registrant for damages resulting 

14 from adulteration or compositional alteration of 

15 a Canadian pesticide registered under this sub16 section if the registrant did not have and could 

17 not reasonably have obtained knowledge of the 

18 adulteration or compositional alteration.

19 ‘‘(8) PROVISION OF INFORMATION BY REG20 ISTRANTS OF COMPARABLE DOMESTIC PES21 TICIDES.—

22 ‘‘(A) IN GENERAL.—On request by the Ad23 ministrator the registrant of a comparable do24 mestic pesticide shall provide to the Adminis25 trator that is seeking to register a Canadian
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1 pesticide under this subsection information that 

2 is necessary for the Administrator to make the 

3 determinations required by paragraph (4). 

4 ‘‘(B) PENALTY FOR NONCOMPLIANCE.—

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

6 of a comparable domestic pesticide fails to 

7 provide to the Administrator, not later 

8 than 15 days after receipt of a written re9 quest by the Administrator, information 

10 possessed by or reasonably accessible to 

11 the registrant that is necessary to make 

12 the determinations required by paragraph 

13 (4), the Administrator may assess a pen14 alty against the registrant of the com15 parable pesticide. 

16 ‘‘(ii) AMOUNT.—The amount of the 

17 penalty shall be equal to the product ob18 tained by multiplying—

19 ‘‘(I) the difference between the 

20 per-acre cost of the application of the 

21 comparable domestic pesticide and the 

22 application of the Canadian pesticide, 

23 as determined by the Administrator; 

24 and 
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1 ‘‘(II) the number of acres in the 

2 United States devoted to the com3 modity for which the registration is 

4 sought. 

5 ‘‘(C) NOTICE AND OPPORTUNITY FOR

6 HEARING.—No penalty under this paragraph 

7 shall be assessed unless the registrant is given 

8 notice and opportunity for a hearing in accord9 ance with section 14(a)(3). 

10 ‘‘(D) ISSUES AT HEARING.—The only 

11 issues for resolution at the hearing shall be—

12 ‘‘(i) whether the registrant of the 

13 comparable domestic pesticide failed to 

14 timely provide to the Administrator the in15 formation possessed by or reasonably ac16 cessible to the registrant that was nec17 essary to make the determinations required 

18 by paragraph (4); and 

19 ‘‘(ii) the amount of the penalty. 

20 ‘‘(9) PENALTY FOR DISCLOSURE.—

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

22 shall not make public information obtained 

23 under paragraph (8) that is privileged and con24 fidential and contains or relates to trade secrets 

25 or commercial or financial information. 
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1 ‘‘(B) DISCLOSURE.—Any employee of the 

2 Environmental Protection Agency who willfully 

3 discloses information described in subparagraph 

4 (A) shall be subject to penalties described in 

5 section 10(f). 

6 ‘‘(10) DATA COMPENSATION.—The Adminis7 trator and a person registering a Canadian pesticide 

8 under this subsection shall not be liable for com9 pensation for data supporting the registration if the 

10 registration of the Canadian pesticide in Canada and 

11 the registration of the comparable domestic pesticide 

12 are held by the same registrant or by affiliated enti13 ties. 

14 ‘‘(11) FORMULATION CHANGES.—

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

16 comparable domestic pesticide shall notify the 

17 Administrator of any change in the formulation 

18 of a comparable domestic pesticide or a Cana19 dian pesticide registered by the registrant or an 

20 affiliated entity not later than 30 days before 

21 any sale or distribution of the pesticide con22 taining the new formulation. 

23 ‘‘(B) STATEMENT OF FORMULA.—The reg24 istrant of the comparable domestic pesticide 

25 shall submit, with the notice required under 
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1 subparagraph (A), a confidential statement of 

2 the formula for the new formulation if the reg3 istrant has possession of or reasonable access to 

4 the information. 

5 ‘‘(C) SUSPENSION OF REGISTRATION FOR

6 NONCOMPLIANCE.—

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

8 fails to provide notice or submit a con9 fidential statement of formula as required 

10 by this paragraph, the Administrator may 

11 issue a notice of intent to suspend the reg12 istration of the comparable domestic pes13 ticide for a period of not less than 1 year. 

14 ‘‘(ii) EFFECTIVE DATE.—The suspen15 sion shall become final not later than the 

16 end of the 30-day period beginning on the 

17 date of the issuance by the Administrator 

18 of the notice of intent to suspend the reg19 istration, unless during the period the reg20 istrant requests a hearing. 

21 ‘‘(iii) HEARING PROCEDURE.—If a 

22 hearing is requested, the hearing shall be 

23 conducted in accordance with section 6(d). 

24 ‘‘(iv) ISSUES.—The only issues for 

25 resolution at the hearing shall be whether 
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1 the registrant has failed to provide notice 

2 or submit a confidential statement of for3 mula as required by this paragraph.’’. 

4 (b) TECHNICAL AND CONFORMING AMENDMENT.—

5 The table of contents in section 1(b) of the Federal Insec6 ticide, Fungicide, and Rodenticide Act (7 U.S.C. prec. 

7 121) is amended by adding at the end of the items relating 

8 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.’’.

9 (c) EFFECTIVE DATE.—This section and the amend10 ments made by this section take effect 180 days after the 

11 date of enactment of this Act.

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