II 

109TH CONGRESS 

1ST SESSION S. 1579 

To amend the Federal Insecticide, Fungicide, and Rodenticide Act to permit 

the distribution and sale of certain pesticides that are registered in 

both the United States and another country 

IN THE SENATE OF THE UNITED STATES 

JULY 29, 2005 

Mr. BURNS (for himself, Mr. DORGAN, Mr. JOHNSON, Mr. DAYTON, Mr. BAUCUS, and Mr. CONRAD) 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 the distribution and sale of 

certain pesticides that are registered in both the United 

States and another country 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Pesticide Harmoni5 zation and Joint Labeling Act ’’. 
2 

•S 1579 IS

1 SEC. 2. DEFINITIONS. 

2 (a) IN GENERAL.—Section 2 of the Federal Insecti3 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136) is 

4 amended— 

5 (1) by redesignating subsections (jj) through 

6 (oo) as subsections (ii) through (nn), respectively; 

7 and 

8 (2) by adding at the end the following: 

9 ‘‘(oo) HARMONIZED COUNTRY.—The term ‘har10 monized country’ means a country— 

11 ‘‘(1) with which the United States has entered 

12 into negotiations to harmonize pesticide registration 

13 regulatory processes and requirements; and 

14 ‘‘(2) for which the Administrator determines, in 

15 the discretion of the Administrator, that sufficient 

16 regulatory harmonization has been achieved to carry 

17 out joint labeling of agricultural pesticides. 

18 ‘‘(pp) INTERESTED PARTY.—The term ‘interested 

19 party’ means— 

20 ‘‘(1) an individual producer or group of pro21 ducers; or 

22 ‘‘(2) a nonprofit agriculture membership orga23 nization that represents producers. 

24 ‘‘(qq) JOINT LABEL.—The term ‘joint label’ means 

25 a label that— 
3 

•S 1579 IS

1 ‘‘(1) has been approved for use in both the 

2 United States and a harmonized country; and 

3 ‘‘(2) includes a registration number of the En4 vironmental Protection Agency and any other license 

5 number provided by a government regulatory agency 

6 for the purpose of registering pesticides. 

7 ‘‘(rr) JOINT REGISTRATION.—The term ‘joint reg8 istration’ means a product registration that— 

9 ‘‘(1) has been approved by both the United 

10 States and a harmonized country; 

11 ‘‘(2) permits sale and distribution in both coun12 tries; and 

13 ‘‘(3) includes a joint label.’’. 

14 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

15 The table of contents in section 1(b) of the Federal Insec16 ticide, Fungicide, and Rodenticide Act (7 U.S.C. prec. 

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

18 to section 2 the following: 
4 

•S 1579 IS

‘‘(hh) Nitrogen stabilizer. 

‘‘(ii) Maintenance applicator. 

‘‘(jj) Service technician. 

‘‘(kk) Minor use. 

‘‘(ll) Antimicrobial pesticide. 

‘‘(mm) Public health pesticide. 

‘‘(nn) Vector. 

‘‘(oo) Harmonized country. 

‘‘(pp) Interested party. 

‘‘(qq) Joint label. 

‘‘(rr) Joint registration.’’. 

1 SEC. 3. JOINT LABELING OF REGISTERED PESTICIDES. 

2 (a) IN GENERAL.—Section 3(c) of the Federal Insec3 ticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)) 

4 is amended by adding at the end the following: 

5 ‘‘(11) JOINT LABELING OF REGISTERED PES6 TICIDES.— 

7 ‘‘(A) DEFINITION OF AFFILIATE.—In this 

8 paragraph, the term ‘affiliate’ means a relation9 ship among business entities in which— 

10 ‘‘(i) 1 business entity— 

11 ‘‘(I) has effective control over the 

12 other business entity through a part13 nership or other agreement; or 

14 ‘‘(II) is under common control 

15 with the other business entity by a 

16 third entity; or 

17 ‘‘(ii) 1 business entity is a corporation 

18 related to another corporation as a parent 

19 to a subsidiary by an identity of stock own20 ership. 
5 

•S 1579 IS

1 ‘‘(B) DATE OF EFFECTIVENESS.—With re2 spect to joint labeling with a harmonized coun3 try, this paragraph shall apply on the date on 

4 which the Administrator publishes in the Fed5 eral Register a notice that— 

6 ‘‘(i) the Administrator has made the 

7 finding required by section 2(oo)(2) for the 

8 country; and 

9 ‘‘(ii) includes guidelines for interested 

10 parties to petition the Administrator under 

11 subparagraph (C). 

12 ‘‘(C) PETITION BY INTERESTED PARTY.— 

13 For an agricultural pesticide for which the 

14 same or substantially similar agricultural pes15 ticide is registered in both the United States 

16 and a harmonized country, any interested party 

17 may petition the Administrator to require the 

18 registrant of the agricultural pesticide to apply 

19 for and use a joint label to facilitate movement 

20 between the United States and the harmonized 

21 country. 

22 ‘‘(D) DETERMINATION BY ADMINIS23 TRATOR.— 

24 ‘‘(i) IN GENERAL.—Not later than 

25 120 days after the date of receipt of a re-
6 

•S 1579 IS

1 quest from an interested party under sub2 paragraph (C), the Administrator shall 

3 make a determination that, in the discre4 tion of the Administrator— 

5 ‘‘(I) the agricultural pesticide 

6 registered in the United States is 

7 identical or substantially similar to 

8 the agricultural pesticide registered in 

9 the harmonized country; 

10 ‘‘(II) the registrant or affiliate is 

11 the same in the United States and the 

12 harmonized country; and 

13 ‘‘(III) there is sufficient interest 

14 from interested parties for a joint 

15 label. 

16 ‘‘(ii) PROVISION OF INFORMATION.— 

17 ‘‘(I) IN GENERAL.—On request 

18 of the Administrator, the registrant 

19 shall submit information necessary for 

20 the Administrator to make the deter21 mination described in clause (i), in22 cluding a product label, formula, and 

23 any other information that the Ad24 ministrator determines, in the discre-
7 

•S 1579 IS

1 tion of the Administrator, may be nec2 essary to make the determination. 

3 ‘‘(II) DISPROVING A DETERMINA4 TION.—In response to a determination 

5 by the Administrator under clause (i), 

6 a registrant may provide information 

7 to the Administrator to disprove a de8 termination under subclause (I) or 

9 (II) of clause (i), including providing 

10 a confidential statement of formula to 

11 demonstrate differences between agri12 cultural pesticides. 

13 ‘‘(III) PROVISION OF CSF.—Not14 withstanding any other provision of 

15 this Act, the Administrator may share 

16 with appropriate officials in a har17 monized country a confidential state18 ment of formula provided under sub19 clause (II). 

20 ‘‘(E) NOTIFICATION OF JOINT LABEL RE21 QUIREMENT.—On making a determination 

22 under subparagraph (D) in regards to an agri23 cultural pesticide, the Administrator shall notify 

24 the registrant that— 
8 

•S 1579 IS

1 ‘‘(i) a joint label is required for the 

2 agricultural pesticide; and 

3 ‘‘(ii) the registrant shall propose to 

4 the Administrator and the harmonized 

5 country a joint label not later than 90 days 

6 after notification by the Administrator. 

7 ‘‘(F) REVIEW OF JOINT LABEL.—In con8 sultation with the harmonized country, the Ad9 ministrator shall— 

10 ‘‘(i) review the proposed joint label; 

11 ‘‘(ii) not later than 180 days after the 

12 date of receipt of a proposed joint label 

13 from the registrant, notify the registrant 

14 that— 

15 ‘‘(I) the joint label has been ap16 proved in the United States and shall 

17 be used on all containers of the prod18 uct not later than a date specified by 

19 the Administrator, except at the dis20 cretion of the Administrator; or 

21 ‘‘(II) the registrant shall propose 

22 to the Administrator a revised joint 

23 label in accordance with guidance by 

24 the Administrator as to what revisions 

25 are necessary; 
9 

•S 1579 IS

1 ‘‘(iii) notify the petitioner of the ap2 proval of the joint label and provide the pe3 titioner with a copy of the approved joint 

4 label; and 

5 ‘‘(iv) make a copy of the label avail6 able on the Internet, which may be used to 

7 purchase and transport the approved pes8 ticide between the United States and the 

9 harmonized country. 

10 ‘‘(G) USE OF PRODUCT.—After approval 

11 by the Administrator of the joint label, con12 sumers in the United States may obtain and 

13 use the product that is registered in a har14 monized country, notwithstanding the fact that 

15 the joint label has not been approved in the 

16 harmonized country, provided that the con17 sumer has a copy of the joint label, as approved 

18 for use in the United States. 

19 ‘‘(H) SUSPENSION.—The Administrator 

20 may undertake suspension proceedings regard21 ing registration of an agricultural pesticide in 

22 accordance with the procedures described in 

23 section 3(c)(2)(B)(iv) if the Administrator de24 termines that the registrant or affiliate— 
10 

•S 1579 IS

1 ‘‘(i) within the time period required by 

2 the Administrator, has failed— 

3 ‘‘(I) to propose a joint label 

4 under subparagraph (E)(ii); 

5 ‘‘(II) to revise a joint label under 

6 subparagraph (F)(ii)(II); 

7 ‘‘(III) to use a joint label under 

8 subparagraph (F)(ii)(I); or 

9 ‘‘(IV) to provide information re10 quested by the Administrator under 

11 subparagraph (D)(ii); or 

12 ‘‘(ii) has withdrawn an application for 

13 registration of a pesticide from a har14 monized country after receiving approval of 

15 the joint label in the United States. 

16 ‘‘(I) FEES.—The Administrator may not 

17 charge fees for joint registration under this 

18 paragraph. 

19 ‘‘(J) PROHIBITION.—The joint registration 

20 and labeling provisions of this paragraph may 

21 not be used to add new uses to an agricultural 

22 pesticide. 

23 ‘‘(K) COOPERATION AND

24 PRIORITIZATION.—An interested party may pe25 tition the Administrator— 
11 

•S 1579 IS

1 ‘‘(i) individually or in consultation 

2 with interested parties in the harmonized 

3 country; and 

4 ‘‘(ii) for multiple agricultural pes5 ticides at once, in priority order. 

6 ‘‘(L) PRIORITY FOR REGISTRANTS.—A reg7 istrant of an agricultural pesticide registered in 

8 the United States or the harmonized country 

9 that voluntarily applies for a joint label shall be 

10 given priority consideration.’’. 

11 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

12 The table of contents in section 1(b) of the Federal Insec13 ticide, Fungicide, and Rodenticide Act (7 U.S.C. prec. 

14 121) (as amended by section 2(b)) is amended by adding 

15 at the end of the items relating to section 3(c) the fol16 lowing: 

‘‘(9) Labeling. 

‘‘(10) Expedited registration of pesticides. 

‘‘(11) Joint registration of registered pesticides.’’. 

17 SEC. 4. JOINT REGISTRATION OF NEW PESTICIDES OR 

18 USES. 

19 (a) IN GENERAL.—Section 3(c)(4) of the Federal In20 secticide, Fungicide, and Rodenticide Act (7 U.S.C. 

21 136a(c)(4)) is amended— 

22 (1) in the first sentence, by striking ‘‘The Ad23 ministrator’’ and inserting the following: 

24 ‘‘(A) IN GENERAL.—The Administrator’’; 
12 

•S 1579 IS

1 (2) in the second sentence, by striking ‘‘The no2 tice’’ and inserting the following: 

3 ‘‘(B) COMMENT PERIOD.—The notice’’; 

4 and 

5 (3) by adding at the end the following: 

6 ‘‘(C) JOINT LABEL.— 

7 ‘‘(i) IN GENERAL.—The notice shall 

8 request comments from interested parties 

9 that are interested in a joint label for the 

10 pesticide. 

11 ‘‘(ii) DETERMINATION OF SIGNIFI12 CANT INTEREST.— 

13 ‘‘(I) IN GENERAL.—After the ex14 piration of the comment period, the 

15 Administrator shall determine if there 

16 is significant interest in a joint label 

17 for the pesticide. 

18 ‘‘(II) SIGNIFICANT INTEREST.— 

19 If the Administrator determines that 

20 there is significant interest in a joint 

21 label for the pesticide, the Adminis22 trator shall inform the registrant that, 

23 as a condition of registering the pes24 ticide, the registrant shall dem25 onstrate to the satisfaction of the Ad-
13 

•S 1579 IS

1 ministrator that the registrant has 

2 provided the harmonized country with 

3 sufficient information for the har4 monized country to begin the process 

5 of reviewing the application for the 

6 pesticide.’’. 

7 (b) AUTHORITY TO REQUIRE JOINT LABEL FOR NEW

8 PESTICIDES OR USES.— 

9 (1) IN GENERAL.—Section 3(c) of the Federal 

10 Insecticide, Fungicide, and Rodenticide Act (7 

11 U.S.C. 136a(c)) (as amended by section 3(a)) is 

12 amended by adding at the end the following: 

13 ‘‘(12) AUTHORITY TO REQUIRE JOINT LABEL

14 FOR NEW PESTICIDES OR USES.—After making a de15 termination of significant interest under section 

16 3(c)(4)(C), the Administrator may notify the reg17 istrant that, in accordance with the procedures de18 scribed in subparagraphs (F), (G), (H), and (I) of 

19 paragraph (11)— 

20 ‘‘(A) a joint label is required for the agri21 cultural pesticide; and 

22 ‘‘(B) the registrant shall propose to the 

23 Administrator and the harmonized country a 

24 joint label not later than 90 days after notifica25 tion by the Administrator.’’. 
14 

•S 1579 IS

1 (2) TECHNICAL AND CONFORMING AMEND2 MENT.—The table of contents in section 1(b) of the 

3 Federal Insecticide, Fungicide, and Rodenticide Act 

4 (7 U.S.C. prec. 121) (as amended by section 3(b)) 

5 is amended by adding at the end of the items relat6 ing to section 3(c) the following: 

‘‘(12) Authority to require joint label for new pesticides or 

uses.’’. 

7 SEC. 5. MEMORANDUM OF UNDERSTANDING. 

8 (a) IN GENERAL.—The Administrator of the Envi9 ronmental Protection Agency may enter into a memo10 randum of understanding with any harmonized country to 

11 address joint registration and joint labeling procedures, as 

12 those terms are defined in section 2 of the Federal Insecti13 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136) (as 

14 amended by section 2). 

15 (b) REQUIREMENTS.—A memorandum of under16 standing entered into under this section shall address— 

17 (1) sharing of information; and 

18 (2) the protection of the confidential statement 

19 of formula as confidential business information. 

Æ