Pesticide Harmonization and Joint Labeling Act - Amends the Federal Insecticide, Fungicide, and Rodenticide Act to establish procedures for the joint labeling of registered pesticides by the United States and any country which has a harmonized pesticide registration regulatory process (harmonized country). Requires the Administrator of the Environmental Protection Agency (EPA), in consultation with a harmonized country, to review and approve joint labels.
Authorizes the Administrator to: (1) require joint labeling of new pesticides or uses; and (2) enter into a memorandum of understanding with any harmonized country to address joint registration and labeling procedures.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1579 Introduced in Senate (IS)]
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
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Pesticide Harmonization and Joint
Labeling Act ''.
SEC. 2. DEFINITIONS.
(a) In General.--Section 2 of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 136) is amended--
(1) by redesignating subsections (jj) through (oo) as
subsections (ii) through (nn), respectively; and
(2) by adding at the end the following:
``(oo) Harmonized Country.--The term `harmonized country' means a
country--
``(1) with which the United States has entered into
negotiations to harmonize pesticide registration regulatory
processes and requirements; and
``(2) 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.
``(pp) Interested Party.--The term `interested party' means--
``(1) an individual producer or group of producers; or
``(2) a nonprofit agriculture membership organization that
represents producers.
``(qq) Joint Label.--The term `joint label' means a label that--
``(1) has been approved for use in both the United States
and a harmonized country; and
``(2) 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.
``(rr) Joint Registration.--The term `joint registration' means a
product registration that--
``(1) has been approved by both the United States and a
harmonized country;
``(2) permits sale and distribution in both countries; and
``(3) includes a joint label.''.
(b) 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.''.
SEC. 3. JOINT LABELING OF REGISTERED PESTICIDES.
(a) 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:
``(11) Joint labeling of registered pesticides.--
``(A) Definition of affiliate.--In this paragraph,
the term `affiliate' means a relationship among
business entities in which--
``(i) 1 business entity--
``(I) has effective control over
the other business entity through a
partnership or other agreement; or
``(II) is under common control with
the other business entity by a third
entity; or
``(ii) 1 business entity is a corporation
related to another corporation as a parent to a
subsidiary by an identity of stock ownership.
``(B) 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--
``(i) the Administrator has made the
finding required by section 2(oo)(2) for the
country; and
``(ii) includes guidelines for interested
parties to petition the Administrator under
subparagraph (C).
``(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.
``(D) Determination by administrator.--
``(i) 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--
``(I) the agricultural pesticide
registered in the United States is
identical or substantially similar to
the agricultural pesticide registered
in the harmonized country;
``(II) the registrant or affiliate
is the same in the United States and
the harmonized country; and
``(III) there is sufficient
interest from interested parties for a
joint label.
``(ii) Provision of information.--
``(I) 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.
``(II) 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.
``(III) 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).
``(E) 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--
``(i) a joint label is required for the
agricultural pesticide; and
``(ii) the registrant shall propose to the
Administrator and the harmonized country a
joint label not later than 90 days after
notification by the Administrator.
``(F) Review of joint label.--In consultation with
the harmonized country, the Administrator shall--
``(i) review the proposed joint label;
``(ii) not later than 180 days after the
date of receipt of a proposed joint label from
the registrant, notify the registrant that--
``(I) 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
``(II) the registrant shall propose
to the Administrator a revised joint
label in accordance with guidance by
the Administrator as to what revisions
are necessary;
``(iii) notify the petitioner of the
approval of the joint label and provide the
petitioner with a copy of the approved joint
label; and
``(iv) 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.
``(G) 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.
``(H) 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--
``(i) within the time period required by
the Administrator, has failed--
``(I) to propose a joint label
under subparagraph (E)(ii);
``(II) to revise a joint label
under subparagraph (F)(ii)(II);
``(III) to use a joint label under
subparagraph (F)(ii)(I); or
``(IV) to provide information
requested by the Administrator under
subparagraph (D)(ii); or
``(ii) has withdrawn an application for
registration of a pesticide from a harmonized
country after receiving approval of the joint
label in the United States.
``(I) Fees.--The Administrator may not charge fees
for joint registration under this paragraph.
``(J) Prohibition.--The joint registration and
labeling provisions of this paragraph may not be used
to add new uses to an agricultural pesticide.
``(K) Cooperation and prioritization.--An
interested party may petition the Administrator--
``(i) individually or in consultation with
interested parties in the harmonized country;
and
``(ii) for multiple agricultural pesticides
at once, in priority order.
``(L) 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.''.
(b) 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.''.
SEC. 4. JOINT REGISTRATION OF NEW PESTICIDES OR USES.
(a) In General.--Section 3(c)(4) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(4)) is amended--
(1) in the first sentence, by striking ``The
Administrator'' and inserting the following:
``(A) In general.--The Administrator'';
(2) in the second sentence, by striking ``The notice'' and
inserting the following:
``(B) Comment period.--The notice''; and
(3) by adding at the end the following:
``(C) Joint label.--
``(i) In general.--The notice shall request
comments from interested parties that are
interested in a joint label for the pesticide.
``(ii) Determination of significant
interest.--
``(I) 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.
``(II) 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.''.
(b) Authority to Require Joint Label for New Pesticides or Uses.--
(1) 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:
``(12) 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) a joint label is required for the
agricultural pesticide; and
``(B) the registrant shall propose to the
Administrator and the harmonized country a joint label
not later than 90 days after notification by the
Administrator.''.
(2) 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.''.
SEC. 5. MEMORANDUM OF UNDERSTANDING.
(a) 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).
(b) Requirements.--A memorandum of understanding entered into under
this section shall address--
(1) sharing of information; and
(2) the protection of the confidential statement of formula
as confidential business information.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S9497-9498)
Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry.
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