II
109th CONGRESS
1st Session
S. 1579
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
Short title
This Act may be cited as the
Pesticide Harmonization and Joint
Labeling Act
.
Definitions
In general
Section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136) is amended—
by redesignating subsections (jj) through (oo) as subsections (ii) through (nn), respectively; and
by adding at the end the following:
Harmonized country
The term harmonized country means a country—
with which the United States has entered into negotiations to harmonize pesticide registration regulatory processes and requirements; and
for which the Administrator determines, in the discretion of the Administrator, that sufficient regulatory harmonization has been achieved to carry out joint labeling of agricultural pesticides.
Interested party
The term interested party means—
an individual producer or group of producers; or
a nonprofit agriculture membership organization that represents producers.
Joint label
The term joint label means a label that—
has been approved for use in both the United States and a harmonized country; and
includes a registration number of the Environmental Protection Agency and any other license number provided by a government regulatory agency for the purpose of registering pesticides.
Joint registration
The term joint registration means a product registration that—
has been approved by both the United States and a harmonized country;
permits sale and distribution in both countries; and
includes a joint label.
.
Technical and conforming amendment
The table of contents in section 1(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. prec. 121) is amended by adding at the end of the items relating to section 2 the following:
(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.
.
Joint labeling of registered pesticides
In general
Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)) is amended by adding at the end the following:
Joint labeling of registered pesticides
Definition of affiliate
In this paragraph, the term affiliate means a relationship among business entities in which—
1 business entity—
has effective control over the other business entity through a partnership or other agreement; or
is under common control with the other business entity by a third entity; or
1 business entity is a corporation related to another corporation as a parent to a subsidiary by an identity of stock ownership.
Date of effectiveness
With respect to joint labeling with a harmonized country, this paragraph shall apply on the date on which the Administrator publishes in the Federal Register a notice that—
the Administrator has made the finding required by section 2(oo)(2) for the country; and
includes guidelines for interested parties to petition the Administrator under subparagraph (C).
Petition by interested party
For an agricultural pesticide for which the same or substantially similar agricultural pesticide is registered in both the United States and a harmonized country, any interested party may petition the Administrator to require the registrant of the agricultural pesticide to apply for and use a joint label to facilitate movement between the United States and the harmonized country.
Determination by Administrator
In general
Not later than 120 days after the date of receipt of a request from an interested party under subparagraph (C), the Administrator shall make a determination that, in the discretion of the Administrator—
the agricultural pesticide registered in the United States is identical or substantially similar to the agricultural pesticide registered in the harmonized country;
the registrant or affiliate is the same in the United States and the harmonized country; and
there is sufficient interest from interested parties for a joint label.
Provision of information
In general
On request of the Administrator, the registrant shall submit information necessary for the Administrator to make the determination described in clause (i), including a product label, formula, and any other information that the Administrator determines, in the discretion of the Administrator, may be necessary to make the determination.
Disproving a determination
In response to a determination by the Administrator under clause (i), a registrant may provide information to the Administrator to disprove a determination under subclause (I) or (II) of clause (i), including providing a confidential statement of formula to demonstrate differences between agricultural pesticides.
Provision of CSF
Notwithstanding any other provision of this Act, the Administrator may share with appropriate officials in a harmonized country a confidential statement of formula provided under subclause (II).
Notification of joint label requirement
On making a determination under subparagraph (D) in regards to an agricultural pesticide, the Administrator shall notify the registrant that—
a joint label is required for the agricultural pesticide; and
the registrant shall propose to the Administrator and the harmonized country a joint label not later than 90 days after notification by the Administrator.
Review of joint label
In consultation with the harmonized country, the Administrator shall—
review the proposed joint label;
not later than 180 days after the date of receipt of a proposed joint label from the registrant, notify the registrant that—
the joint label has been approved in the United States and shall be used on all containers of the product not later than a date specified by the Administrator, except at the discretion of the Administrator; or
the registrant shall propose to the Administrator a revised joint label in accordance with guidance by the Administrator as to what revisions are necessary;
notify the petitioner of the approval of the joint label and provide the petitioner with a copy of the approved joint label; and
make a copy of the label available on the Internet, which may be used to purchase and transport the approved pesticide between the United States and the harmonized country.
Use of product
After approval by the Administrator of the joint label, consumers in the United States may obtain and use the product that is registered in a harmonized country, notwithstanding the fact that the joint label has not been approved in the harmonized country, provided that the consumer has a copy of the joint label, as approved for use in the United States.
Suspension
The Administrator may undertake suspension proceedings regarding registration of an agricultural pesticide in accordance with the procedures described in section 3(c)(2)(B)(iv) if the Administrator determines that the registrant or affiliate—
within the time period required by the Administrator, has failed—
to propose a joint label under subparagraph (E)(ii);
to revise a joint label under subparagraph (F)(ii)(II);
to use a joint label under subparagraph (F)(ii)(I); or
to provide information requested by the Administrator under subparagraph (D)(ii); or
has withdrawn an application for registration of a pesticide from a harmonized country after receiving approval of the joint label in the United States.
Fees
The Administrator may not charge fees for joint registration under this paragraph.
Prohibition
The joint registration and labeling provisions of this paragraph may not be used to add new uses to an agricultural pesticide.
Cooperation and prioritization
An interested party may petition the Administrator—
individually or in consultation with interested parties in the harmonized country; and
for multiple agricultural pesticides at once, in priority order.
Priority for registrants
A registrant of an agricultural pesticide registered in the United States or the harmonized country that voluntarily applies for a joint label shall be given priority consideration.
.
Technical and conforming amendment
The table of contents in section 1(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. prec. 121) (as amended by section 2(b)) is amended by adding at the end of the items relating to section 3(c) the following:
(9) Labeling.
(10) Expedited registration of pesticides.
(11) Joint registration of registered pesticides.
.
Joint registration of new pesticides or uses
In general
Section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(4)) is amended—
in the first sentence, by striking
The Administrator
and inserting the following:
In general
The Administrator
;
in the second sentence, by striking
The notice
and inserting the following:
Comment period
The notice
; and
by adding at the end the following:
Joint label
In general
The notice shall request comments from interested parties that are interested in a joint label for the pesticide.
Determination of significant interest
In general
After the expiration of the comment period, the Administrator shall determine if there is significant interest in a joint label for the pesticide.
Significant interest
If the Administrator determines that there is significant interest in a joint label for the pesticide, the Administrator shall inform the registrant that, as a condition of registering the pesticide, the registrant shall demonstrate to the satisfaction of the Administrator that the registrant has provided the harmonized country with sufficient information for the harmonized country to begin the process of reviewing the application for the pesticide.
.
Authority to require joint label for new pesticides or uses
In general
Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)) (as amended by section 3(a)) is amended by adding at the end the following:
Authority to require joint label for new pesticides or uses
After making a determination of significant interest under section 3(c)(4)(C), the Administrator may notify the registrant that, in accordance with the procedures described in subparagraphs (F), (G), (H), and (I) of paragraph (11)—
a joint label is required for the agricultural pesticide; and
the registrant shall propose to the Administrator and the harmonized country a joint label not later than 90 days after notification by the Administrator.
.
Technical and conforming amendment
The table of contents in section 1(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. prec. 121) (as amended by section 3(b)) is amended by adding at the end of the items relating to section 3(c) the following:
(12) Authority to require joint label for new pesticides or uses.
.
Memorandum of understanding
In general
The Administrator of the Environmental Protection Agency may enter into a memorandum of understanding with any harmonized country to address joint registration and joint labeling procedures, as those terms are defined in section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136) (as amended by section 2).
Requirements
A memorandum of understanding entered into under this section shall address—
sharing of information; and
the protection of the confidential statement of formula as confidential business information.