Loading (50 kb)...'
(continued)
registrant from sales of the pesticide does not support the
registration or reregistration of the pesticide.
(G) If any fee prescribed by this paragraph with respect to the
registration of a pesticide is not paid by a registrant by the
time prescribed, the Administrator, by order and without hearing,
may cancel the registration.
(H) The authority provided under this paragraph shall terminate
on September 30, 2003.
(6) Other fees
During the period beginning on October 25, 1988, and ending on
September 30, 2003, the Administrator may not levy any other fees
for the registration of a pesticide under this subchapter except
as provided in paragraphs (1) through (5).
(7) Apportionment
(A) If two or more registrants are required to pay any fee
prescribed by paragraph (1), (2), or (3) with respect to a
particular active ingredient, the fees for such active ingredient
shall be apportioned among such registrants on the basis of the
market share in United States sales of the active ingredient for
the 3 calendar years preceding the date of payment of such fee,
except that -
(i) small business registrants that produce the active
ingredient shall pay fees in accordance with paragraph (4)(C);
and
(ii) registrants who have no market share but who choose to
reregister a pesticide containing such active ingredient shall
pay the lesser of -
(I) 15 percent of the reregistration fee; or
(II) a proportionate amount of such fee based on the lowest
percentage market share held by any registrant active in the
marketplace.
In no event shall registrants who have no market share but who
choose to reregister a pesticide containing such active
ingredient collectively pay more than 25 percent of the total
active ingredient reregistration fee.
(B) The Administrator, by order, may require any registrant to
submit such reports as the Administrator determines to be
necessary to allow the Administrator to determine and apportion
fees under this subsection, to determine the registrant's
eligibility for a reduction or waiver of a fee, or to determine
the volume usage for public health pesticides.
(C) If any such report is not submitted by a registrant after
receiving notice of such report requirement, or if any fee
prescribed by this subsection (other than paragraph (5)) for an
active ingredient is not paid by a registrant to the
Administrator by the time prescribed under this subsection, the
Administrator, by order and without hearing, may cancel each
registration held by such registrant of a pesticide containing
the active ingredient with respect to which the fee is imposed.
The Administrator shall reapportion the fee among the remaining
registrants and notify the registrants that the registrants are
required to pay to the Administrator any unpaid balance of the
fee within 30 days after receipt of such notice.
(j) Exemption of certain registrants
The requirements of subsections (d), (e), (f), and (i) of this
section (other than subsection (i)(5) of this section) regarding
data concerning an active ingredient and fees for review of such
data shall not apply to any person who is the registrant of a
pesticide to the extent that, under section 136a(c)(2)(D) of this
title, the person would not be required to submit or cite such data
to obtain an initial registration of such pesticide.
(k) Reregistration and expedited processing fund
(1) Establishment
There shall be established in the Treasury of the United States
a reregistration and expedited processing fund which shall be
known as the Reregistration and Expedited Processing Fund.
(2) Source and use
(A) All moneys derived from fees collected by the Administrator
under subsection (i) of this section shall be deposited in the
fund and shall be available to the Administrator, without fiscal
year limitation, specifically to offset the costs of
reregistration and expedited processing of the applications
specified in paragraph (3). Such moneys derived from fees may not
be expended in any fiscal year to the extent such moneys derived
from fees would exceed money appropriated for use by the
Administrator and expended in such year for such costs of
reregistration and expedited processing of such applications. The
Administrator shall, prior to expending any such moneys derived
from fees -
(i) effective October 1, 1997, adopt specific and cost
accounting rules and procedures as approved by the General
Accounting Office and the Inspector General of the
Environmental Protection Agency to ensure that moneys derived
from fees are allocated solely to the costs of reregistration
and expedited processing of the applications specified in
paragraph (3) in the same portion as appropriated funds;
(ii) prohibit the use of such moneys derived from fees to pay
for any costs other than those necessary to achieve
reregistration and expedited processing of the applications
specified in paragraph (3); and
(iii) ensure that personnel and facility costs associated
with the functions to be carried out under this paragraph do
not exceed agency averages for comparable personnel and
facility costs.
(B) The Administrator shall also -
(i) complete the review of unreviewed reregistration studies
required to support the reregistration eligibility decisions
scheduled for completion in accordance with subsection (l)(2)
of this section; and
(ii) contract for such outside assistance as may be necessary
for review of required studies, using a generally accepted
competitive process for the selection of vendors of such
assistance.
(3) Expedited processing of similar applications
(A) The Administrator shall use for each of the fiscal years
1997 through 2003, not more than 1/10 of the maintenance fees
collected in such fiscal year to obtain sufficient personnel and
resources to assure the expedited processing and review of any
application that -
(i) proposes the initial or amended registration of an
end-use pesticide that, if registered as proposed, would be
identical or substantially similar in composition and labeling
to a currently-registered pesticide identified in the
application, or that would differ in composition and labeling
from any such currently-registered pesticide only in ways that
would not significantly increase the risk of unreasonable
adverse effects on the environment;
(ii) proposes an amendment to the registration of a
registered pesticide that does not require scientific review of
data; or
(iii) proposes the initial or amended registration of an end
use pesticide that, if registered as proposed, would be used
for a public health pesticide.
(B) Any amounts made available under subparagraph (A) shall be
used to obtain sufficient personnel and resources to carry out
the activities described in such subparagraph that are in
addition to the personnel and resources available to carry out
such activities on October 25, 1988.
(C) So long as the Administrator has not met the time frames
specified in clause (ii) of section 136a(c)(3)(B) of this title
with respect to any application subject to section 136a(c)(3)(B)
of this title that was received prior to August 3, 1996, the
Administrator shall use the full amount of the fees specified in
subparagraph (A) for the purposes specified therein. Once all
applications subject to section 136a(c)(3)(B) of this title that
were received prior to August 3, 1996, have been acted upon, no
limitation shall be imposed by the preceding sentence of this
subparagraph so long as the Administrator meets the time frames
specified in clause (ii) of section 136a(c)(3)(B) of this title
on 90 percent of affected applications in a fiscal year. Should
the Administrator not meet such time frames in a fiscal year, the
limitations imposed by the first sentence of this subparagraph
shall apply until all overdue applications subject to section
136a(c)(3)(B) of this title have been acted upon.
(4) Unused funds
Money in the fund not currently needed to carry out this
section shall be -
(A) maintained on hand or on deposit;
(B) invested in obligations of the United States or
guaranteed thereby; or
(C) invested in obligations, participations, or other
instruments that are lawful investments for fiduciary, trust,
or public funds.
(5) Accounting and performance
The Administrator shall take all steps necessary to ensure that
expenditures from fees authorized by subsection (i)(5)(C)(ii) of
this section are used only to carry out the goals established
under subsection (l) of this section. The Reregistration and
Expedited Processing Fund shall be designated as an Environmental
Protection Agency component for purposes of section 3515(c) of
title 31. The annual audit required under section 3521 of such
title of the financial statements of activities under this
subchapter under section 3515(b) of such title shall include an
audit of the fees collected under subsection (i)(5)(C) of this
section and disbursed, of the amount appropriated to match such
fees, and of the Administrator's attainment of performance
measures and goals established under subsection (l) of this
section. Such an audit shall also include a review of the
reasonableness of the overhead allocation and adequacy of
disclosures of direct and indirect costs associated with carrying
out the reregistration and expedited processing of the
applications specified in paragraph (3), and the basis for and
accuracy of all costs paid with moneys derived from such fees.
The Inspector General shall conduct the annual audit and report
the findings and recommendations of such audit to the
Administrator and to the Committees on Agriculture of the House
of Representatives and the Senate. The cost of such audit shall
be paid for out of the fees collected under subsection (i)(5)(C)
of this section.
(l) Performance measures and goals
The Administrator shall establish and publish annually in the
Federal Register performance measures and goals. Such measures and
goals shall include -
(1) the number of products reregistered, canceled, or amended,
the status of reregistration, the number and type of data
requests under section 136a(c)(2)(B) of this title issued to
support product reregistration by active ingredient, the progress
in reducing the number of unreviewed, required reregistration
studies, the aggregate status of tolerances reassessed, and the
number of applications for registration submitted under
subsection (k)(3) of this section that were approved or
disapproved;
(2) the future schedule for reregistrations, including the
projection for such schedules that will be issued under
subsection (g)(2)(A) and (B) of this section in the current
fiscal year and the succeeding fiscal year; and
(3) the projected year of completion of the reregistrations
under this section.
(m) Judicial review
Any failure of the Administrator to take any action required by
this section shall be subject to judicial review under the
procedures prescribed by section 136n(b) of this title.
(n) Authorization of funds to develop public health data
(1) "Secretary" defined
For the purposes of this section, "Secretary" means the
Secretary of Health and Human Services, acting through the Public
Health Service.
(2) Consultation
In the case of a pesticide registered for use in public health
programs for vector control or for other uses the Administrator
determines to be human health protection uses, the Administrator
shall, upon timely request by the registrant or any other
interested person, or on the Administrator's own initiative may,
consult with the Secretary prior to taking final action to
suspend registration under section 136a(c)(2)(B)(iv) of this
title, or cancel a registration under section 136a-1, 136d(e), or
136d(f) of this title. In consultation with the Secretary, the
Administrator shall prescribe the form and content of requests
under this section.
(3) Benefits to support family
The Administrator, after consulting with the Secretary, shall
make a determination whether the potential benefits of continued
use of the pesticide for public health or health protection
purposes are of such significance as to warrant a commitment by
the Secretary to conduct or to arrange for the conduct of the
studies required by the Administrator to support continued
registration under section 136a of this title or reregistration
under this section.
(4) Additional time
If the Administrator determines that such a commitment is
warranted and in the public interest, the Administrator shall
notify the Secretary and shall, to the extent necessary, amend a
notice issued under section 136a(c)(2)(B) of this title to
specify additional reasonable time periods for submission of the
data.
(5) Arrangements
The Secretary shall make such arrangements for the conduct of
required studies as the Secretary finds necessary and appropriate
to permit submission of data in accordance with the time periods
prescribed by the Administrator. Such arrangements may include
Public Health Service intramural research activities, grants,
contracts, or cooperative agreements with academic, public
health, or other organizations qualified by experience and
training to conduct such studies.
(6) Support
The Secretary may provide for support of the required studies
using funds authorized to be appropriated under this section, the
Public Health Service Act [42 U.S.C. 201 et seq.], or other
appropriate authorities. After a determination is made under
subsection (d) of this section, the Secretary shall notify the
Committees on Appropriations of the House of Representatives and
the Senate of the sums required to conduct the necessary studies.
(7) Authorization of appropriations
There is authorized to be appropriated to carry out the
purposes of this section $12,000,000 for fiscal year 1997, and
such sums as may be necessary for succeeding fiscal years.
-SOURCE-
(June 25, 1947, ch. 125, Sec. 4, formerly Sec. 3A, as added and
renumbered Sec. 4, Pub. L. 100-532, title I, Sec. 102(a), title
VIII, Sec. 801(q)(2)(A), Oct. 25, 1988, 102 Stat. 2655, 2683;
amended Pub. L. 101-624, title XIV, Sec. 1493, Nov. 28, 1990, 104
Stat. 3628; Pub. L. 102-237, title X, Sec. 1006(a)(4), (e), (f),
Dec. 13, 1991, 105 Stat. 1895-1897; Pub. L. 104-170, title I, Sec.
103, title II, Secs. 210(c)(2), (f)(1), 232, 237, title V, Sec.
501, Aug. 3, 1996, 110 Stat. 1490, 1496, 1498, 1508, 1509, 1536;
Pub. L. 107-73, title III, [(1)-(4)], Nov. 26, 2001, 115 Stat. 686;
Pub. L. 108-7, div. K, title III, [(1)-(4)], Feb. 20, 2003, 117
Stat. 513.)
-REFTEXT-
REFERENCES IN TEXT
The effective date of this section, referred to in subsecs. (a),
(c)(1), (2), and (e)(4)(A), is 60 days after Oct. 25, 1988. See
Effective Date note below.
Section 136a(c)(1)(D) of this title, referred to in subsecs.
(e)(1)(I) and (h), was redesignated section 136a(c)(1)(F) of this
title by Pub. L. 102-237, title X, Sec. 1006(a)(3)(B), Dec. 13,
1991, 105 Stat. 1894.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(g)(2)(E)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of Title 21, Food and Drugs. For complete classification of
this Act to the Code, see section 301 of Title 21 and Tables.
The Public Health Service Act, referred to in subsec. (n)(6), is
act July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is
classified generally to chapter 6A (Sec. 201 et seq.) of Title 42,
The Public Health and Welfare. For complete classification of this
Act to the Code, see Short Title note set out under section 201 of
Title 42 and Tables.
-MISC1-
PRIOR PROVISIONS
A prior section 4 of act June 25, 1947, which was classified to
section 136b of this title was transferred to section 11(a)-(c) of
act June 25, 1947, which is classified to section 136i(a)-(c) of
this title.
Another prior section 4 of act June 25, 1947, was classified to
section 135b of this title prior to amendment of act June 25, 1947,
by Pub. L. 92-516.
AMENDMENTS
2003 - Pub. L. 108-7, which directed the amendment of "Section
136a-1 of title 7, U.S.C.", was executed by making the amendments
to this section, which is section 4 of the Federal Insecticide,
Fungicide, and Rodenticide Act, to reflect the probable intent of
Congress. See below.
Subsec. (i)(5)(C)(i). Pub. L. 108-7, [(1)], substituted
"$21,500,000 for fiscal year 2003" for "$17,000,000 fiscal year
2002".
Subsec. (i)(5)(H). Pub. L. 108-7, [(2)], substituted "2003" for
"2002".
Subsec. (i)(6). Pub. L. 108-7, [(3)], substituted "2003" for
"2002".
Subsec. (k)(3)(A). Pub. L. 108-7, [(4)], substituted "2003" for
"2002".
2001 - Pub. L. 107-73, which directed the amendment of "Section
136a-1 of title 7, U.S.C.", was executed by making the amendments
to this section, which is section 4 of the Federal Insecticide,
Fungicide, and Rodenticide Act, to reflect the probable intent of
Congress. See below.
Subsec. (i)(5)(C)(i). Pub. L. 107-73, [(1)], substituted
"$17,000,000" for "$14,000,000" and "fiscal year 2002" for "each
fiscal year".
Subsec. (i)(5)(H). Pub. L. 107-73, [(2)], substituted "2002" for
"2001".
Subsec. (i)(6). Pub. L. 107-73, [(3)], substituted "2002" for
"2001".
Subsec. (k)(3)(A). Pub. L. 107-73, [(4)], substituted "2002" for
"2001" and " 1/10 " for " 1/7 " in introductory provisions.
1996 - Pub. L. 104-170, Sec. 501, which directed amendment of
section 4 without specifying the name of the Act being amended, was
executed to this section, which is section 4 of the Federal
Insecticide, Fungicide, and Rodenticide Act, to reflect the
probable intent of Congress.
Subsec. (d)(4)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at
end provisions authorizing extension of deadline for production of
residue chemistry data in case of minor use and setting forth
conditions to be met for such extension in cls. (i) to (iv).
Subsec. (d)(6). Pub. L. 104-170, Sec. 210(f)(1)(A), inserted at
end provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there
are health or environmental concerns, authorizing publication of
notice in Federal Register and monitoring of development of data,
setting forth procedures where registrant is not meeting or has not
met schedule for production of data, and authorizing denial,
modification, or revocation of temporary extension where use may
cause adverse effect on environment and requiring notice of such
revocation to registrant.
Subsec. (e)(2)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at
end provisions authorizing extension of deadline for production of
residue chemistry data in case of minor use and setting forth
conditions to be met for such extension in cls. (i) to (iv).
Subsec. (e)(3)(A). Pub. L. 104-170, Sec. 210(f)(1)(B), inserted
at end provisions delaying upon written request action with regard
to unsupported minor uses, authorizing refusal of request where
there are health or environmental concerns, authorizing publication
of notice in Federal Register and monitoring of development of
data, setting forth procedures where registrant is not meeting or
has not met schedule for production of data, and authorizing
denial, modification, or revocation of temporary extension where
use may cause adverse effect on environment and requiring notice of
such revocation to registrant.
Subsec. (f)(2)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at
end provisions authorizing extension of deadline for production of
residue chemistry data in case of minor use and setting forth
conditions to be met for such extension in cls. (i) to (iv).
Subsec. (f)(3). Pub. L. 104-170, Sec. 210(f)(1)(A), inserted at
end provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there
are health or environmental concerns, authorizing publication of
notice in Federal Register and monitoring of development of data,
setting forth procedures where registrant is not meeting or has not
met schedule for production of data, and authorizing denial,
modification, or revocation of temporary extension where use may
cause adverse effect on environment and requiring notice of such
revocation to registrant.
Subsec. (g)(2)(E). Pub. L. 104-170, Sec. 103, added subpar. (E).
Subsec. (i)(4)(B) to (D). Pub. L. 104-170, Sec. 232(1), added
subpar. (B) and redesignated former subpars. (B) and (C) as (C) and
(D), respectively.
Subsec. (i)(5)(C). Pub. L. 104-170, Sec. 501(a)(2), designated
existing provisions as cl. (i) and added cl. (ii).
Subsec. (i)(5)(F), (G). Pub. L. 104-170, Sec. 232(2), added
subpar. (F) and redesignated former subpar. (F) as (G).
Subsec. (i)(5)(H). Pub. L. 104-170, Sec. 501(a)(1), substituted
"2001" for "1997".
Pub. L. 104-170, Sec. 232(2), redesignated subpar. (G) as (H).
Subsec. (i)(6). Pub. L. 104-170, Sec. 501(a)(1), substituted
"2001" for "1997".
Subsec. (i)(7)(B). Pub. L. 104-170, Sec. 232(3), substituted ",
to determine the registrant's eligibility" for "or to determine the
registrant's eligibility" and inserted before period at end ", or
to determine the volume usage for public health pesticides".
Subsec. (k)(1). Pub. L. 104-170, Sec. 501(b), inserted "which
shall be known as the Reregistration and Expedited Processing Fund"
before period at end.
Subsec. (k)(2). Pub. L. 104-170, Sec. 501(c), amended heading and
text of par. (2) generally. Prior to amendment, text read as
follows: "All fees collected by the Administrator under subsection
(i) of this section shall be deposited into the fund and shall be
available to the Administrator, without fiscal year limitation, to
carry out reregistration and expedited processing of similar
applications."
Subsec. (k)(3)(A). Pub. L. 104-170, Sec. 501(d)(1), which
directed the amendment of introductory provisions by substituting
"for each of the fiscal years 1997 through 2001, not more than 1/7
of the maintenance fees collected in such fiscal year" for "for
each of the fiscal years 1992, 1993, and 1994, 1/7 th of the
maintenance fees collected, up to 2 million each year", was
executed by making the substitution for text which contained the
phrase "$2 million", to reflect the probable intent of Congress.
Subsec. (k)(3)(A)(iii). Pub. L. 104-170, Sec. 232(4), added cl.
(iii).
Subsec. (k)(3)(C). Pub. L. 104-170, Sec. 501(d)(2), added subpar.
(C).
Subsec. (k)(5). Pub. L. 104-170, Sec. 501(e), amended heading and
text of par. (5) generally. Prior to amendment, text read as
follows: "The Administrator shall -
"(A) provide an annual accounting of the fees collected and
disbursed from the fund; and
"(B) take all steps necessary to ensure that expenditures from
such fund are used only to carry out this section."
Subsec. (l). Pub. L. 104-170, Sec. 501(f), added subsec. (l).
Former subsec. (l) redesignated (m).
Subsec. (m). Pub. L. 104-170, Sec. 501(f), redesignated subsec.
(l) as (m). Former subsec. (m) redesignated (n).
Pub. L. 104-170, Sec. 237, added subsec. (m).
Subsec. (n). Pub. L. 104-170, Sec. 501(f), redesignated subsec.
(m) as (n).
1991 - Subsec. (f)(3). Pub. L. 102-237, Sec. 1006(a)(4),
realigned margin.
Subsec. (i)(5). Pub. L. 102-237, Sec. 1006(e), amended par. (5)
generally, substituting, in subpar. (A), provisions relating to
January 15 for provisions relating to March 1, in subpar. (A)(i),
provisions relating to fee of $650 for first registration for
provisions relating to fee of $425 for each registration for
registrants holding not more than 50 registrations, and in subpar.
(A)(ii), provisions relating to fee of $1,300 for each additional
registration up to 200 registrations, with no fee thereafter, for
provisions relating to fee of $425 for each registration up to 50,
$100 for each registration over 50, with no fee after 200
registrations, redesignating provisions formerly set out in subpar.
(A), following cl. (ii), as subpar. (B), and substituting
provisions relating to fee under this par. for provisions relating
to fee under this subpar., redesignating former subpar. (B) as (C),
striking former subpar. (C), which set maximum annual fee for
registrants under subpar. (A)(i) at $20,000, and for registrants
under subpar. (A)(ii) at $35,000, adding subpars. (D) and (E), and
redesignating former subpars. (D) and (E) as (F) and (G),
respectively.
Subsec. (k)(3)(A). Pub. L. 102-237, Sec. 1006(f), substituted
"for each of the fiscal years 1992, 1993, and 1994, 1/7 th of the
maintenance fees collected, up to $2 million each year" for "each
fiscal year not more than $2,000,000 of the amounts in the fund".
1990 - Subsec. (i)(5)(A). Pub. L. 101-624 inserted sentence at
end relating to reduction or waiver of fee where pesticide is
registered for minor agricultural use.
EFFECTIVE DATE
Section effective on expiration of 60 days after Oct. 25, 1988,
see section 901 of Pub. L. 100-532, set out as an Effective Date of
1988 Amendment note under section 136 of this title.
ADJUSTMENT OF MAXIMUM ANNUAL FEE PAYABLE BY PESTICIDE REGISTRANTS
Pub. L. 108-11, title II, Apr. 16, 2003, 117 Stat. 603, provided
that: "Within 30 days of enactment of this Act [Apr. 16, 2003], the
Administrator of the Environmental Protection Agency shall adjust
each 'maximum annual fee payable' pursuant to 7 U.S.C.
136a-1(i)(5)(D) and (E) in a manner such that maintenance fee
collections made to reach the level authorized in division K of
Public Law 108-7 [see Tables for classification] shall be
established in the same proportion as those maintenance fee
collections authorized in Public Law 107-73 [see Tables for
classification]."
-SECREF-
SECTION REFERRED TO IN OTHER SECTIONS
This section is referred to in sections 136a, 136d, 136j of this
title; title 21 section 346a.
-FOOTNOTE-
(!1) See References in Text note below.
(!2) See References in Text note below.
(!3) So in original. Probably should be "Human".
-End-
-CITE-
7 USC Sec. 136b 01/19/04
-EXPCITE-
TITLE 7 - AGRICULTURE
CHAPTER 6 - INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II - ENVIRONMENTAL PESTICIDE CONTROL
-HEAD-
Sec. 136b. Transferred
-COD-
CODIFICATION
Section, act June 25, 1947, ch. 125, Sec. 4, as added Oct. 21,
1972, Pub. L. 92-516, Sec. 2, 86 Stat. 983; amended Nov. 28, 1975,
Pub. L. 94-140, Secs. 5, 11, 89 Stat. 753, 754; Sept. 30, 1978,
Pub. L. 95-396, Sec. 9, 92 Stat. 827; Oct. 25, 1988, Pub. L.
100-532, title VIII, Sec. 801(c), (q)(1)(A), (B), 102 Stat. 2681,
2683, which related to use of restricted use pesticides and
certification of applicators, was transferred to subsecs. (a) to
(c) of section 11 of act June 25, 1947, by section 801(q)(1)(A) of
Pub. L. 100-532 and is classified to section 136i(a) to (c) of this
title.
-End-
-CITE-
7 USC Sec. 136c 01/19/04
-EXPCITE-
TITLE 7 - AGRICULTURE
CHAPTER 6 - INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II - ENVIRONMENTAL PESTICIDE CONTROL
-HEAD-
Sec. 136c. Experimental use permits
-STATUTE-
(a) Issuance
Any person may apply to the Administrator for an experimental use
permit for a pesticide. The Administrator shall review the
application. After completion of the review, but not later than one
hundred and twenty days after receipt of the application and all
required supporting data, the Administrator shall either issue the
permit or notify the applicant of the Administrator's determination
not to issue the permit and the reasons therefor. The applicant may
correct the application or request a waiver of the conditions for
such permit within thirty days of receipt by the applicant of such
notification. The Administrator may issue an experimental use
permit only if the Administrator determines that the applicant
needs such permit in order to accumulate information necessary to
register a pesticide under section 136a of this title. An
application for an experimental use permit may be filed at any
time.
(b) Temporary tolerance level
If the Administrator determines that the use of a pesticide may
reasonably be expected to result in any residue on or in food or
feed, the Administrator may establish a temporary tolerance level
for the residue of the pesticide before issuing the experimental
use permit.
(c) Use under permit
Use of a pesticide under an experimental use permit shall be
under the supervision of the Administrator, and shall be subject to
such terms and conditions and be for such period of time as the
Administrator may prescribe in the permit.
(d) Studies
When any experimental use permit is issued for a pesticide
containing any chemical or combination of chemicals which has not
been included in any previously registered pesticide, the
Administrator may specify that studies be conducted to detect
whether the use of the pesticide under the permit may cause
unreasonable adverse effects on the environment. All results of
such studies shall be reported to the Administrator before such
pesticide may be registered under section 136a of this title.
(e) Revocation
The Administrator may revoke any experimental use permit, at any
time, if the Administrator finds that its terms or conditions are
being violated, or that its terms and conditions are inadequate to
avoid unreasonable adverse effects on the environment.
(f) State issuance of permits
Notwithstanding the foregoing provisions of this section, the
Administrator shall, under such terms and conditions as the
Administrator may by regulations prescribe, authorize any State to
issue an experimental use permit for a pesticide. All provisions of
section 136i of this title relating to State plans shall apply with
equal force to a State plan for the issuance of experimental use
permits under this section.
(g) Exemption for agricultural research agencies
Notwithstanding the foregoing provisions of this section, the
Administrator may issue an experimental use permit for a pesticide
to any public or private agricultural research agency or
educational institution which applies for such permit. Each permit
shall not exceed more than a one-year period or such other specific
time as the Administrator may prescribe. Such permit shall be
issued under such terms and conditions restricting the use of the
pesticide as the Administrator may require. Such pesticide may be
used only by such research agency or educational institution for
purposes of experimentation.
-SOURCE-
(June 25, 1947, ch. 125, Sec. 5, as added Pub. L. 92-516, Sec. 2,
Oct. 21, 1972, 86 Stat. 983; amended Pub. L. 94-140, Sec. 10, Nov.
28, 1975, 89 Stat. 754; Pub. L. 95-396, Sec. 10, Sept. 30, 1978, 92
Stat. 828; Pub. L. 100-532, title VIII, Sec. 801(d), (q)(1)(D),
Oct. 25, 1988, 102 Stat. 2681, 2683; Pub. L. 102-237, title X, Sec.
1006(b)(1), Dec. 13, 1991, 105 Stat. 1895.)
-MISC1-
PRIOR PROVISIONS
A prior section 5 of act June 25, 1947, was classified to section
135c of this title prior to amendment of act June 25, 1947, by Pub.
L. 92-516.
AMENDMENTS
1991 - Subsecs. (b), (e), (f). Pub. L. 102-237 substituted "the
Administrator" for "he" before "may" in subsec. (b), before "finds"
in subsec. (e), and before "may" in subsec. (f).
1988 - Subsec. (f). Pub. L. 100-532, Sec. 801(q)(1)(D),
substituted "136i" for "136b".
Subsec. (g). Pub. L. 100-532, Sec. 801(d), substituted "require.
Such pesticide" for "require: Provided, That such pesticide".
1978 - Subsec. (a). Pub. L. 95-396, Sec. 10(1), provided for
review of application, issuance or nonissuance of experimental use
permit within prescribed period including reasons for denial,
correction of application, and waiver of conditions and substituted
provision for filing an application for experimental use permit at
any time for prior provision for filing at the time of or before or
after an application for registration is filed.
Subsec. (f). Pub. L. 95-396, Sec. 10(2), substituted in first
sentence "shall" for "may" where first appearing.
1975 - Subsec. (g). Pub. L. 94-140 added subsec. (g).
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as
a note under section 136 of this title.
EFFECTIVE DATE
For effective date of section, see section 4 of Pub. L. 92-516,
set out as a note under section 136 of this title.
-SECREF-
SECTION REFERRED TO IN OTHER SECTIONS
This section is referred to in sections 136, 136a, 136j of this
title.
-End-
-CITE-
7 USC Sec. 136d 01/19/04
-EXPCITE-
TITLE 7 - AGRICULTURE
CHAPTER 6 - INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II - ENVIRONMENTAL PESTICIDE CONTROL
-HEAD-
Sec. 136d. Administrative review; suspension
-STATUTE-
(a) Existing stocks and information
(1) Existing stocks
The Administrator may permit the continued sale and use of
existing stocks of a pesticide whose registration is suspended or
canceled under this section, or section 136a or 136a-1 of this
title, to such extent, under such conditions, and for such uses
as the Administrator determines that such sale or use is not
inconsistent with the purposes of this subchapter.
(2) Information
If at any time after the registration of a pesticide the
registrant has additional factual information regarding
unreasonable adverse effects on the environment of the pesticide,
the registrant shall submit such information to the
Administrator.
(b) Cancellation and change in classification
If it appears to the Administrator that a pesticide or its
labeling or other material required to be submitted does not comply
with the provisions of this subchapter or, when used in accordance
with widespread and commonly recognized practice, generally causes
unreasonable adverse effects on the environment, the Administrator
may issue a notice of the Administrator's intent either -
(1) to cancel its registration or to change its classification
together with the reasons (including the factual basis) for the
Administrator's action, or
(2) to hold a hearing to determine whether or not its
registration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In
determining whether to issue any such notice, the Administrator
shall include among those factors to be taken into account the
impact of the action proposed in such notice on production and
prices of agricultural commodities, retail food prices, and
otherwise on the agricultural economy. At least 60 days prior to
sending such notice to the registrant or making public such notice,
whichever occurs first, the Administrator shall provide the
Secretary of Agriculture with a copy of such notice and an analysis
of such impact on the agricultural economy. If the Secretary
comments in writing to the Administrator regarding the notice and
analysis within 30 days after receiving them, the Administrator
shall publish in the Federal Register (with the notice) the
comments of the Secretary and the response of the Administrator
with regard to the Secretary's comments. If the Secretary does not
comment in writing to the Administrator regarding the notice and
analysis within 30 days after receiving them, the Administrator may
notify the registrant and make public the notice at any time after
such 30-day period notwithstanding the foregoing 60-day time
requirement. The time requirements imposed by the preceding 3
sentences may be waived or modified to the extent agreed upon by
the Administrator and the Secretary. Notwithstanding any other
provision of this subsection and section 136w(d) of this title, in
the event that the Administrator determines that suspension of a
pesticide registration is necessary to prevent an imminent hazard
to human health, then upon such a finding the Administrator may
waive the requirement of notice to and consultation with the
Secretary of Agriculture pursuant to this subsection and of
submission to the Scientific Advisory Panel pursuant to section
136w(d) of this title and proceed in accordance with subsection (c)
of this section. When a public health use is affected, the
Secretary of Health and Human Services should provide available
benefits and use information, or an analysis thereof, in accordance
with the procedures followed and subject to the same conditions as
the Secretary of Agriculture in the case of agricultural
pesticides. The proposed action shall become final and effective at
the end of 30 days from receipt by the registrant, or publication,
of a notice issued under paragraph (1), whichever occurs later,
unless within that time either (i) the registrant makes the
necessary corrections, if possible, or (ii) a request for a hearing
is made by a person adversely affected by the notice. In the event
a hearing is held pursuant to such a request or to the
Administrator's determination under paragraph (2), a decision
pertaining to registration or classification issued after
completion of such hearing shall be final. In taking any final
action under this subsection, the Administrator shall consider
restricting a pesticide's use or uses as an alternative to
cancellation and shall fully explain the reasons for these
restrictions, and shall include among those factors to be taken
into account the impact of such final action on production and
prices of agricultural commodities, retail food prices, and
otherwise on the agricultural economy, and the Administrator shall
publish in the Federal Register an analysis of such impact.
(c) Suspension
(1) Order
If the Administrator determines that action is necessary to
prevent an imminent hazard during the time required for
cancellation or change in classification proceedings, the
Administrator may, by order, suspend the registration of the
pesticide immediately. Except as provided in paragraph (3), no
order of suspension may be issued under this subsection unless
the Administrator has issued, or at the same time issues, a
notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b) of this
section. Except as provided in paragraph (3), the Administrator
shall notify the registrant prior to issuing any suspension
order. Such notice shall include findings pertaining to the
question of "imminent hazard". The registrant shall then have an
opportunity, in accordance with the provisions of paragraph (2),
for an expedited hearing before the Administrator on the question
of whether an imminent hazard exists.
(2) Expedite hearing
If no request for a hearing is submitted to the Administrator
within five days of the registrant's receipt of the notification
provided for by paragraph (1), the suspension order may be issued
and shall take effect and shall not be reviewable by a court. If
a hearing is requested, it shall commence within five days of the
receipt of the request for such hearing unless the registrant and
the Administrator agree that it shall commence at a later time.
The hearing shall be held in accordance with the provisions of
subchapter II of chapter 5 of title 5, except that the presiding
officer need not be a certified administrative law judge. The
presiding officer shall have ten days from the conclusion of the
presentation of evidence to submit recommended findings and
conclusions to the Administrator, who shall then have seven days
to render a final order on the issue of suspension.
(3) Emergency order
Whenever the Administrator determines that an emergency exists
that does not permit the Administrator to hold a hearing before
suspending, the Administrator may issue a suspension order in
advance of notification to the registrant. The Administrator may
issue an emergency order under this paragraph before issuing a
notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b) of this
section and the Administrator shall proceed to issue the notice
under subsection (b) of this section within 90 days of issuing an
emergency order. If the Administrator does not issue a notice
under subsection (b) of this section within 90 days of issuing an
emergency order, the emergency order shall expire. In the case of
an emergency order, paragraph (2) shall apply except that (A) the
order of suspension shall be in effect pending the expeditious
completion of the remedies provided by that paragraph and the
issuance of a final order on suspension, and (B) no party other
than the registrant and the Administrator shall participate
except that any person adversely affected may file briefs within
the time allotted by the Agency's rules. Any person so filing
briefs shall be considered a party to such proceeding for the
purposes of section 136n(b) of this title.
(4) Judicial review
A final order on the question of suspension following a hearing
shall be reviewable in accordance with section 136n of this
title, notwithstanding the fact that any related cancellation
proceedings have not been completed. Any order of suspension
entered prior to a hearing before the Administrator shall be
subject to immediate review in an action by the registrant or
other interested person with the concurrence of the registrant in
an appropriate district court, solely to determine whether the
order of suspension was arbitrary, capricious or an abuse of
discretion, or whether the order was issued in accordance with
the procedures established by law. The effect of any order of the
court will be only to stay the effectiveness of the suspension
order, pending the Administrator's final decision with respect to
cancellation or change in classification. This action may be
maintained simultaneously with any administrative review
proceedings under this section. The commencement of proceedings
under this paragraph shall not operate as a stay of order, unless
ordered by the court.
(d) Public hearings and scientific review
In the event a hearing is requested pursuant to subsection (b) of
this section or determined upon by the Administrator pursuant to
subsection (b) of this section, such hearing shall be held after
due notice for the purpose of receiving evidence relevant and
material to the issues raised by the objections filed by the
applicant or other interested parties, or to the issues stated by
the Administrator, if the hearing is called by the Administrator
rather than by the filing of objections. Upon a showing of
relevance and reasonable scope of evidence sought by any party to a
public hearing, the Hearing Examiner shall issue a subpena to
compel testimony or production of documents from any person. The
Hearing Examiner shall be guided by the principles of the Federal
Rules of Civil Procedure in making any order for the protection of
the witness or the content of documents produced and shall order
the payment of reasonable fees and expenses as a condition to
requiring testimony of the witness. On contest, the subpena may be
enforced by an appropriate United States district court in
accordance with the principles stated herein. Upon the request of
any party to a public hearing and when in the Hearing Examiner's
judgment it is necessary or desirable, the Hearing Examiner shall
at any time before the hearing record is closed refer to a
Committee of the National Academy of Sciences the relevant
questions of scientific fact involved in the public hearing. No
member of any committee of the National Academy of Sciences
established to carry out the functions of this section shall have a
financial or other conflict of interest with respect to any matter
considered by such committee. The Committee of the National Academy
of Sciences shall report in writing to the Hearing Examiner within
60 days after such referral on these questions of scientific fact.
The report shall be made public and shall be considered as part of
the hearing record. The Administrator shall enter into appropriate
arrangements with the National Academy of Sciences to assure an
objective and competent scientific review of the questions
presented to Committees of the Academy and to provide such other
scientific advisory services as may be required by the
Administrator for carrying out the purposes of this subchapter. As
soon as practicable after completion of the hearing (including the
report of the Academy) but not later than 90 days thereafter, the
Administrator shall evaluate the data and reports before the
Administrator and issue an order either revoking the
Administrator's notice of intention issued pursuant to this
section, or shall issue an order either canceling the registration,
changing the classification, denying the registration, or requiring
modification of the labeling or packaging of the article. Such
order shall be based only on substantial evidence of record of such
hearing and shall set forth detailed findings of fact upon which
the order is based.
(e) Conditional registration
(1) The Administrator shall issue a notice of intent to cancel a
registration issued under section 136a(c)(7) of this title if (A)
the Administrator, at any time during the period provided for
satisfaction of any condition imposed, determines that the
registrant has failed to initiate and pursue appropriate action
toward fulfilling any condition imposed, or (B) at the end of the
period provided for satisfaction of any condition imposed, that
condition has not been met. The Administrator may permit the (continued)