[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1084 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 1084
To amend the Federal Insecticide, Fungicide, and Rodenticide Act to
permit a State to register a Canadian pesticide for distribution and
use within that State.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 15, 2001
Mr. Pomeroy (for himself, Mr. Baldacci, and Mr. McHugh) 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 a State to register a Canadian pesticide for distribution and
use within that State.
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 BY STATES.
(a) In General.--Section 24 of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 136v) is amended by adding at the end the
following:
``(d) Registration of Canadian Pesticides by States.--
``(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 section 3
of this Act; and
``(iii) is registered in Canada by the
registrant of the comparable domestic pesticide
or an affiliated entity of the registrant.
``(B) Comparable domestic pesticide.--The term
`comparable domestic pesticide' means a pesticide--
``(i) that is registered under section 3 of
this Act;
``(ii) the registration of which is not
under suspension;
``(iii) that is not subject to a notice of
intent to cancel or suspend, a notice for
voluntary cancellation under section 6(f) of
this Act, or an enforcement action under this
Act;
``(iv) that is used as the basis for
comparison for the determinations required
under section 24(d)(4) of this Act;
``(v) that is registered for use on the
site(s) 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
section 3(c)(8) of this Act;
``(vii) that is not subject to sales
limitations or production caps agreed upon
between 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 section 3(d) of
this Act.
``(2) Authority to register canadian pesticides.--
``(A) In general.--A State may register a Canadian
pesticide for distribution and use only within the
State if the registration complies with this
subsection, is consistent with the purposes of this
Act, and has not previously been denied or disapproved
by the Administrator. A pesticide registered under this
subsection shall not be used to produce a pesticide to
be registered under section 3 or section 24(c) of this
Act.
``(B) Effect of registration.--A registration of a
Canadian pesticide by a State under this subsection
shall be deemed a registration under section 3 for all
purposes of this Act, but shall authorize distribution
and use only within such State.
``(C) Registrant.--Any person or State may seek
registration of a Canadian pesticide pursuant to this
subsection. Such person or State shall be deemed the
registrant of the Canadian pesticide under this Act.
``(3) Requirements for registration sought by person.--A
person seeking registration from a State of a Canadian
pesticide under this subsection must--
``(A) demonstrate to the State that the Canadian
pesticide is identical or substantially similar in its
composition to a comparable domestic pesticide; and
``(B) submit to the State a copy of the label
approved by the Pest Management Regulatory Agency for
the Canadian pesticide and the label approved by the
Administrator for the comparable domestic pesticide.
``(4) State requirements for registration.--A State may
register a Canadian pesticide under this subsection only if
it--
``(A) has obtained the confidential statement of
formula for the Canadian pesticide;
``(B) determines that the Canadian pesticide is
identical or substantially similar in its 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 submissions made under
subparagraph (D);
``(D) has obtained a label approved by the
Administrator, that--
``(i) duplicates all statements, excluding
the establishment number, from the approved
labeling of the comparable domestic pesticide
that are relevant to the uses registered by the
State and deletes all labeling statements
relating to uses not registered by the State;
``(ii) identifies the state in which the
product may be used;
``(iii) prohibits sale and use outside the
state identified in clause (ii);
``(iv) includes a statement indicating that
it is unlawful to use the Canadian pesticide in
the State in a manner that is inconsistent with
the labeling approved by the Administrator
pursuant to this subsection; and
``(v) identifies the establishment number
of the establishment in which the labeling
approved by the Administrator will be affixed
to the containers of the Canadian pesticide;
and
``(E) notifies, within 10 working days after the
State's issuance of a registration under this
subsection, the Administrator in writing of the State's
action, which notification shall include a statement of
the determination made under this paragraph, the
effective date of the registration, a confidential
statement of formula, and a final printed copy of the
labeling approved by the Administrator.
``(5) Disapproval of registration by administrator.--A
registration issued by a State under this subsection shall not
be effective for more than 90 days if disapproved by the
Administrator within that period. The Administrator may
disapprove the registration of a Canadian pesticide by a State
pursuant to this subsection if the Administrator determines
that the registration of the Canadian pesticide by the State
does not comply with this subsection or the Federal Food, Drug,
and Cosmetic Act, or is inconsistent with the purposes of this
Act.
``(6) Labeling of canadian pesticides.--
``(A) Containers.--Each container containing a
Canadian pesticide registered by a State shall at all
times bear the label that is approved by the
Administrator. The label must be securely attached to
the container and must be the only label visible on the
container. The original Canadian label on the container
must be preserved underneath the label approved by the
Administrator.
``(B) Affixing labels.--After a Canadian pesticide
is registered under this subsection, the registrant
shall prepare labels approved by the Administrator for
such Canadian pesticide and shall conduct or supervise
all labeling of the Canadian pesticides with the
approved labeling. Labeling of the Canadian pesticides
pursuant to this subsection must be conducted at an
establishment registered by the registrant pursuant to
section 7 of this Act.
``(C) Establishment reporting requirements.--
Establishments registered for the sole purpose of
labeling required under section 24(d)(6) of this Act
are exempt from the reporting requirements provided in
section 7(c) of this Act.
``(7) Revocation.--At any time 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. Such order shall be
immediately effective and may prohibit sale, distribution and
use of the Canadian pesticide. Such order may also prescribe
terms of a requirement for the registrant of any such Canadian
pesticide to purchase and dispose of any unopened product
subject to a revocation order. The registrant of a product
subject to a revocation order may request a hearing on such
order within 10 days of the issuance of such order. If no
hearing is requested within the prescribed period, the order
shall become final and shall not be subject to judicial review.
If a hearing is requested, judicial review may be sought only
at the conclusion of the hearing and following the issuance by
the Agency of a final revocation order. A final revocation
order issued following a hearing shall be reviewable in
accordance with section 16 of this Act.
``(8) Suspension of state authority to register canadian
pesticides.--
``(A) In general.--If the Administrator finds that
a State that has registered 1 or more Canadian
pesticides under this subsection is not capable of
exercising adequate controls to ensure that
registration under this subsection is consistent with
this subsection, other provisions of this Act, or the
Federal Food, Drug, and Cosmetic Act, or has failed to
exercise adequate controls of one or more Canadian
pesticides registered under this subsection, the
Administrator may suspend the authority of the State to
register Canadian pesticides under this subsection
until such time as the Administrator determines that
the State can and will exercise adequate control of the
Canadian pesticides.
``(B) Notice and opportunity to respond.--Before
suspending the authority of a State to register a
Canadian pesticide, the Administrator shall--
``(i) advise the State that the
Administrator proposes to suspend the authority
and the reasons for the proposed suspension;
and
``(ii) before taking final action to
suspend under this subsection, the
Administrator shall provide the State an
opportunity to respond to the proposal to
suspend within 30 calendar days of the State's
receipt of the Administrator's proposal to
suspend.
``(9) Tort liability.--
``(A) State as registering agency.--No action for
monetary damages may be maintained in any Federal court
against a State acting as a registering agency under
the authority of and consistent with this section for
injury or damage resulting from the use of a product
registered by the State pursuant to this subsection.
``(B) Registrant.--Actions in tort may not be
maintained in any Federal court against a registrant
for damages resulting from adulteration or
compositional alterations of the registrants product
registered under this subsection if the registrant did
not and could not reasonably have knowledge of the
adulteration or compositional alterations.
``(10) Disclosure of information by administrator to the
state.--The Administrator may disclose to a State that is
seeking to register a Canadian pesticide in the State
information that is necessary for the State to make the
determinations required by paragraph (4) if the State certifies
to the Administrator that the State can and will maintain the
confidentiality of any trade secrets or commercial or financial
information provided by the Administrator to the State under
this subsection to the same extent as is required under section
10 of this Act.
``(11) Provision of information by registrants of
comparable domestic pesticides.--Upon request, the registrant
of a comparable domestic pesticide shall provide to a State
that is seeking to register a Canadian pesticide in the State
pursuant to this subsection information that is necessary for
the State to make the determinations required by section
24(d)(4) of this Act if the State certifies to the registrant
that the State can and will maintain the confidentiality of any
trade secrets or commercial or financial information provided
by the registrant to the State under this subsection to the
same extent as is required under section 10 of this Act. If the
registrant of a comparable domestic pesticide fails to provide to the
State, within 15 days of its receipt of a written request by the State,
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 based on the Administrator's estimate of the
difference between the per-acre cost of the application of the
comparable domestic pesticide and the application of the Canadian
pesticide multiplied by the acreage in the State of the commodity for
which the State registration is sought. No penalty under this
subsection shall be assessed unless the registrant assessed shall have
been given notice and opportunity for a hearing as provided by section
14(a)(3) of this Act. The only matters for resolution at that hearing
will be whether the registrant of the comparable domestic pesticide
failed to timely provide to the State the information possessed by or
reasonably accessible to the registrant that was necessary to make the
determinations required by paragraph (4) and the amount of the penalty.
``(12) Penalty for disclosure by state employee.--The State
shall not make public information obtained under paragraphs
(10) and (11) of this subsection that is privileged and
confidential and contains or relates to trade secrets or
commercial or financial information. Any State employee who has
willfully disclosed information described in this paragraph
shall be subject to penalties prescribed in section 10(f) of
this Act.
``(13) Data compensation.--A State or person registering a
Canadian pesticide under this subsection shall not be liable
for compensation for data supporting such 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.
``(14) Formulation change.--The registrant of a comparable
domestic pesticide must notify the Administrator of any change
in the formulation of a comparable domestic pesticide or a
Canadian pesticide registered by such registrant or its
affiliate at least 30 days prior to any sale or distribution of
the pesticide containing the new formulation. The registrant of
the comparable domestic pesticide must submit, with its notice
to the Administrator pursuant to this paragraph, the
confidential statement of formula for the new formulation if
the registrant has possession of or reasonable access to such
information. If the registrant fails to provide notice or
submit a confidential statement of formula as required by this
paragraph, the Administrator may issue a notice of intent to
suspend the registration of the comparable domestic pesticide
for a period of no less than one year. Suspension shall become
final within 30 days of the Administrator's issuance of the
notice of intent to suspend, unless during that time the
registrant requests a hearing. If a hearing is requested, a
hearing shall be conducted under section 6(d) of this Act. The
only matter for resolution at that hearing will be whether the
registrant has failed to provide notice or submit a
confidential statement of formula as required by this
paragraph.''.
(b) Conforming Amendment.--Section 24(c)(4) is amended in the first
sentence by striking ``If the Administrator'' and inserting the
following: ``Except as otherwise provided in section 24(d)(8), if the
Adminstrator''.
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