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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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. REGISTRATION OF CANADIAN PESTICIDES.
(a) In General.--Section 3 of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 136a) is amended by adding at the end the
following:
``(i) Registration of Canadian Pesticides.--
``(1) Definitions.--In this subsection:
``(A) Canadian pesticide.--The term `Canadian
pesticide' means a pesticide that--
``(i) is registered for use as a pesticide
in Canada;
``(ii) is identical or substantially
similar in its composition to a comparable
domestic pesticide registered under this
section; and
``(iii) is registered in Canada by the
registrant of the comparable domestic pesticide
or by an affiliated entity of the registrant.
``(B) Comparable domestic pesticide.--The term
`comparable domestic pesticide' means a pesticide--
``(i) that is registered under this
section;
``(ii) the registration of which is not
under suspension;
``(iii) that is not subject to--
``(I) a notice of intent to cancel
or suspend under any provision of this
Act;
``(II) a notice for voluntary
cancellation under section 6(f); or
``(III) an enforcement action under
any provision of this Act;
``(iv) that is used as the basis for
comparison for the determinations required
under paragraph (4);
``(v) that is registered for use on each
site of application for which registration is
sought under this subsection;
``(vi) for which no use is the subject of a
pending interim administrative review under
subsection (c)(8);
``(vii) that is not subject to any
limitation on production or sale agreed to by
the Administrator and the registrant or imposed
by the Administrator for risk mitigation
purposes; and
``(viii) that is not classified as a
restricted use pesticide under subsection (d).
``(2) Authority to register canadian pesticides.--
``(A) In general.--The Administrator may register a
Canadian pesticide if the registration--
``(i) complies with this subsection;
``(ii) is consistent with this Act; and
``(iii) has not previously been disapproved
by the Administrator.
``(B) Production of another pesticide.--A pesticide
registered under this subsection shall not be used to
produce a pesticide registered under this section or
section 24(c).
``(C) Registrant.--
``(i) In general.--The Administrator may
register a Canadian pesticide under this
subsection on the application of any person.
``(ii) Application.--If the Administrator
registers a Canadian pesticide under this
subsection on application of any person, the
applicant shall be considered to be the
registrant of the Canadian pesticide for all
purposes of this Act.
``(D) Administrator.--Not later than 60 days after
a person submits a complete application for the
registration of a Canadian pesticide under this
subsection, the Administrator shall--
``(i) approve the application; or
``(ii)(I) disapprove the application; and
``(II) provide the applicant with a
statement of the reasons for the disapproval.
``(E) Delegation.--
``(i) In general.--Subject to clause (ii),
the Administrator may delegate a function of
the Administrator under this subsection.
``(ii) Approval.--The Administrator shall
approve or disapprove any final action taken
under this subsection as the result of a
function delegated to a State.
``(3) Applicant requirements.--A person seeking
registration of a Canadian pesticide under this subsection
shall--
``(A) demonstrate to the Administrator that the
Canadian pesticide is identical or substantially
similar in its composition to a comparable domestic
pesticide; and
``(B) submit to the Administrator a copy of--
``(i) the label approved by the Pesticide
Management Regulatory Agency for the Canadian
pesticide; and
``(ii) the label approved by the
Administrator for the comparable domestic
pesticide.
``(4) Criteria for registration.--The Administrator may
register a Canadian pesticide under this subsection if the
Administrator--
``(A) obtains the confidential statement of formula
for the Canadian pesticide;
``(B) determines that the Canadian pesticide is
identical or substantially similar in composition to a
comparable domestic pesticide;
``(C) for each food or feed use authorized by the
registration--
``(i) determines that there exists an
adequate tolerance or exemption under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) that permits the residues of the
pesticide on the food or feed; and
``(ii) identifies the tolerances or
exemptions in the notification submitted under
subparagraph (E);
``(D) obtains a label approved by the Administrator
that--
``(i) includes all statements, other than
the establishment number, from the approved
labeling of the comparable domestic pesticide
that are relevant to the uses registered by the
Administrator; and
``(ii) excludes all labeling statements
relating to uses that are not registered by the
Administrator; and
``(E) not later than 10 business days after the
issuance of the registration, publish in the Federal
Register a written notification of the action of the
Administrator that includes--
``(i) a description of the determination
made under this paragraph; and
``(ii) a statement of the effective date of
the registration;
``(5) Labeling of canadian pesticides.--
``(A) In general.--Each container containing a
Canadian pesticide registered by the Administrator
shall bear the label that is approved by the
Administrator under this subsection.
``(B) Display of label.--The label shall be
securely attached to the container and shall be the
only label visible on the container.
``(C) Original canadian label.--The original
Canadian label on the container shall be preserved
underneath the label approved by the Administrator.
``(D) Preparation and use of labels.--After a
Canadian pesticide is registered under this subsection,
the registrant shall--
``(i) prepare labels approved by the
Administrator for the Canadian pesticide; and
``(ii) conduct or supervise all labeling of
the Canadian pesticide with the approved
labeling.
``(E) Registered establishments.--Labeling of a
Canadian pesticide under this subsection shall be
conducted at an establishment registered by the
registrant under section 7.
``(6) Revocation.--
``(A) In general.--After the registration of a
Canadian pesticide, if the Administrator finds that the
Canadian pesticide is not identical or substantially
similar in composition to a comparable domestic
pesticide, the Administrator may issue an emergency
order revoking the registration of the Canadian
pesticide.
``(B) Terms of order.--The order--
``(i) shall be effective immediately;
``(ii) may prohibit the sale, distribution,
and use of the Canadian pesticide in a State;
and
``(iii) may require the registrant of the
Canadian pesticide to purchase and dispose of
any unopened product subject to the order.
``(C) Request for hearing.--Not later than 10 days
after issuance of the order, the registrant of the
Canadian pesticide subject to the order may request a
hearing on the order.
``(D) Final order.--If a hearing is not requested
in accordance with subparagraph (C), the order shall
become final and shall not be subject to judicial
review.
``(E) Judicial review.--If a hearing is requested
on the order, judicial review may be sought only at the
conclusion of the hearing on the order and following
the issuance by the Administrator of a final revocation
order.
``(F) Procedure.--A final revocation order issued
following a hearing shall be reviewable in accordance
with section 16.
``(7) Limits on liability.--No action for monetary damages
may be heard in any Federal or State court against--
``(A) the Administrator acting as a registering
agency under the authority of and consistent with this
subsection for injury or damage resulting from the use
of a product registered by the Administrator under this
subsection; or
``(B) a registrant for damages resulting from
adulteration or compositional alteration of a Canadian
pesticide registered under this subsection if the
registrant did not have and could not reasonably have
obtained knowledge of the adulteration or compositional
alteration.
``(8) Provision of information by registrants of comparable
domestic pesticides.--
``(A) In general.--On request by the Administrator
the registrant of a comparable domestic pesticide shall
provide to the Administrator that is seeking to
register a Canadian pesticide under this subsection
information that is necessary for the Administrator to make the
determinations required by paragraph (4).
``(B) Penalty for noncompliance.--
``(i) In general.--If the registrant of a
comparable domestic pesticide fails to provide
to the Administrator, not later than 15 days
after receipt of a written request by the
Administrator, information possessed by or
reasonably accessible to the registrant that is
necessary to make the determinations required
by paragraph (4), the Administrator may assess
a penalty against the registrant of the
comparable pesticide.
``(ii) Amount.--The amount of the penalty
shall be equal to the product obtained by
multiplying--
``(I) the difference between the
per-acre cost of the application of the
comparable domestic pesticide and the
application of the Canadian pesticide,
as determined by the Administrator; and
``(II) the number of acres in the
United States devoted to the commodity
for which the registration is sought.
``(C) Notice and opportunity for hearing.--No
penalty under this paragraph shall be assessed unless
the registrant is given notice and opportunity for a
hearing in accordance with section 14(a)(3).
``(D) Issues at hearing.--The only issues for
resolution at the hearing shall be--
``(i) whether the registrant of the
comparable domestic pesticide failed to timely
provide to the Administrator the information
possessed by or reasonably accessible to the
registrant that was necessary to make the
determinations required by paragraph (4); and
``(ii) the amount of the penalty.
``(9) Penalty for disclosure.--
``(A) In general.--The Administrator shall not make
public information obtained under paragraph (8) that is
privileged and confidential and contains or relates to
trade secrets or commercial or financial information.
``(B) Disclosure.--Any employee of the
Environmental Protection Agency who willfully discloses
information described in subparagraph (A) shall be
subject to penalties described in section 10(f).
``(10) Data compensation.--The Administrator and a person
registering a Canadian pesticide under this subsection shall
not be liable for compensation for data supporting the
registration if the registration of the Canadian pesticide in
Canada and the registration of the comparable domestic
pesticide are held by the same registrant or by affiliated
entities.
``(11) Formulation changes.--
``(A) In general.--The registrant of a comparable
domestic pesticide shall notify the Administrator of
any change in the formulation of a comparable domestic
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