| S 1406 IS
108th CONGRESS
1st Session
S. 1406
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 SENATE OF THE UNITED
STATES
July 15, 2003
Mr. DORGAN (for himself, Mr.
BURNS, Mr. BAUCUS, Mr. JOHNSON, Mr. CRAPO, Mr. DASCHLE, 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 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).
`(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.
`(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.
`(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 pesticide or a Canadian
pesticide registered by the registrant or an affiliated entity not later
than 30 days before any sale or distribution of the pesticide containing
the new formulation.
`(B) STATEMENT OF FORMULA-
The registrant of the comparable domestic pesticide shall submit, with
the notice required under subparagraph (A), a confidential statement of
the formula for the new formulation if the registrant has possession of
or reasonable access to the information.
`(C) SUSPENSION OF REGISTRATION
FOR NONCOMPLIANCE-
`(i) IN GENERAL- 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 not less than 1 year.
`(ii) EFFECTIVE DATE- The
suspension shall become final not later than the end of the 30-day period
beginning on the date of the issuance by the Administrator of the notice
of intent to suspend the registration, unless during the period the registrant
requests a hearing.
`(iii) HEARING PROCEDURE-
If a hearing is requested, the hearing shall be conducted in accordance
with section 6(d).
`(iv) ISSUES- The only issues
for resolution at the hearing shall be whether the registrant has failed
to provide notice or submit a confidential statement of formula as required
by this paragraph.'.
(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 3 the following:
`(4) Mixtures of
nitrogen stabilizers and fertilizer products.
`(g) Registration review.
`(h) Registration requirements
for antimicrobial pesticides.
`(1) Evaluation of process.
`(2) Review time period
reduction goal.
`(3) Implementation.
`(4) Annual report.
`(i) Registration of Canadian
pesticides.
`(1) Definitions.
`(2) Authority to register
Canadian pesticides.
`(3) Applicant requirements.
`(4) Criteria for registration.
`(5) Labeling of Canadian
pesticides.
`(6) Revocation.
`(7) Limits on liability.
`(8) Provision of information
by registrants of comparable domestic pesticides.
`(9) Penalty for disclosure.
`(10) Data compensation.
`(11) Formulation changes.'.
(c) EFFECTIVE DATE- This
section and the amendments made by this section take effect 180 days after
the date of enactment of this Act.
END
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