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TITLE 7—AGRICULTURE
this title, amending this section, sections 136a, 136a–1,
136d, 136q, 136s, 136w, 136w–3, 136x, and 136y of this title,
and sections 321, 331, 333, 342, and 346a of Title 21, Food
and Drugs, and enacting provisions set out as notes
under section 136i–2 of this title and sections 301 and
346a of Title 21] may be cited as the ‘Food Quality Protection Act of 1996’.’’
[Another Food Quality Protection Act of 1996 was enacted by Pub. L. 104–170, title IV, 110 Stat. 1513, see section 401(a) of Pub. L. 104–170, set out as a note under
section 301 of Title 21, Food and Drugs.]
SHORT TITLE OF 1988 AMENDMENT
Section 1(a) of Pub. L. 100–532 provided that: ‘‘This
Act [enacting section 136a–1 of this title, amending this
section and sections 136a to 136d, 136f to 136q, 136s, 136v
to 136w–2, and 136y of this title, and enacting provisions
set out as notes under this section and sections 136m
and 136y of this title] may be cited as the ‘Federal Insecticide, Fungicide, and Rodenticide Act Amendments
of 1988’.’’
SHORT TITLE OF 1978 AMENDMENT
Section 29 of Pub. L. 95–396 provided that: ‘‘This Act
[enacting sections 136w–1 to 136w–4 of this title, amending this section and sections 136a to 136f, 136h, 136j, 136l,
136o, 136q, 136r, 136u to 136w, 136x, and 136y of this title,
enacting provisions set out as notes under sections
136a, 136o, and 136w–4 of this title, and amending provisions set out as a note under this section] may be cited
as the ‘Federal Pesticide Act of 1978’.’’
SHORT TITLE
Section 1 of Pub. L. 92–516 provided: ‘‘That this Act
[amending this subchapter generally, enacting notes
set out under this section, and amending sections 1261
and 1471 of Title 15, Commerce and Trade, and sections
321 and 346a of Title 21, Foods and Drugs] may be cited
as the ‘Federal Environmental Pesticide Control Act of
1972’.’’
Section 1(a) of act June 25, 1947, as added by Pub. L.
92–516, § 2, provided that: ‘‘This Act [enacting this subchapter] may be cited as the ‘Federal Insecticide, Fungicide, and Rodenticide Act’.’’
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.
FEDERAL COMPLIANCE WITH POLLUTION CONTROL
STANDARDS
For provisions relating to the responsibility of the
head of each Executive agency for compliance with applicable pollution control standards, see Ex. Ord. No.
12088, Oct. 13, 1978, 43 F.R. 47707, set out as a note under
section 4321 of Title 42, The Public Health and Welfare.
§ 136a. Registration of pesticides
(a) Requirement of registration
Except as provided by this subchapter, no person in any State may distribute or sell to any
person any pesticide that is not registered under
this subchapter. To the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation
limit the distribution, sale, or use in any State
of any pesticide that is not registered under this
subchapter and that is not the subject of an
experimental use permit under section 136c of
this title or an emergency exemption under section 136p of this title.
(b) Exemptions
A pesticide which is not registered with the
Administrator may be transferred if—
§ 136a
(1) the transfer is from one registered establishment to another registered establishment
operated by the same producer solely for packaging at the second establishment or for use as
a constituent part of another pesticide produced at the second establishment; or
(2) the transfer is pursuant to and in accordance with the requirements of an experimental
use permit.
(c) Procedure for registration
(1) Statement required
Each applicant for registration of a pesticide
shall file with the Administrator a statement
which includes—
(A) the name and address of the applicant
and of any other person whose name will appear on the labeling;
(B) the name of the pesticide;
(C) a complete copy of the labeling of the
pesticide, a statement of all claims to be
made for it, and any directions for its use;
(D) the complete formula of the pesticide;
(E) a request that the pesticide be classified for general use or for restricted use, or
for both; and
(F) except as otherwise provided in paragraph (2)(D), if requested by the Administrator, a full description of the tests made
and the results thereof upon which the
claims are based, or alternatively a citation
to data that appear in the public literature
or that previously had been submitted to the
Administrator and that the Administrator
may consider in accordance with the following provisions:
(i) With respect to pesticides containing
active ingredients that are initially registered under this subchapter after September 30, 1978, data submitted to support
the application for the original registration of the pesticide, or an application for
an amendment adding any new use to the
registration and that pertains solely to
such new use, shall not, without the written permission of the original data submitter, be considered by the Administrator to
support an application by another person
during a period of ten years following the
date the Administrator first registers the
pesticide, except that such permission
shall not be required in the case of defensive data.
(ii) The period of exclusive data use provided under clause (i) shall be extended 1
additional year for each 3 minor uses registered after August 3, 1996, and within 7
years of the commencement of the exclusive use period, up to a total of 3 additional years for all minor uses registered
by the Administrator if the Administrator,
in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that—
(I) there are insufficient efficacious alternative registered pesticides available
for the use;
(II) the alternatives to the minor use
pesticide pose greater risks to the environment or human health;
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TITLE 7—AGRICULTURE
(III) the minor use pesticide plays or
will play a significant part in managing
pest resistance; or
(IV) the minor use pesticide plays or
will play a significant part in an integrated pest management program.
The registration of a pesticide for a minor
use on a crop grouping established by the
Administrator shall be considered for purposes of this clause 1 minor use for each
representative crop for which data are provided in the crop grouping. Any additional
exclusive use period under this clause shall
be modified as appropriate or terminated if
the registrant voluntarily cancels the
product or deletes from the registration
the minor uses which formed the basis for
the extension of the additional exclusive
use period or if the Administrator determines that the registrant is not actually
marketing the product for such minor
uses.
(iii) Except as otherwise provided in
clause (i), with respect to data submitted
after December 31, 1969, by an applicant or
registrant to support an application for
registration, experimental use permit, or
amendment adding a new use to an existing registration, to support or maintain in
effect an existing registration, or for reregistration, the Administrator may, without the permission of the original data
submitter, consider any such item of data
in support of an application by any other
person (hereinafter in this subparagraph
referred to as the ‘‘applicant’’) within the
fifteen-year period following the date the
data were originally submitted only if the
applicant has made an offer to compensate
the original data submitter and submitted
such offer to the Administrator accompanied by evidence of delivery to the original data submitter of the offer. The terms
and amount of compensation may be fixed
by agreement between the original data
submitter and the applicant, or, failing
such agreement, binding arbitration under
this subparagraph. If, at the end of ninety
days after the date of delivery to the original data submitter of the offer to compensate, the original data submitter and
the applicant have neither agreed on the
amount and terms of compensation nor on
a procedure for reaching an agreement on
the amount and terms of compensation, either person may initiate binding arbitration proceedings by requesting the Federal
Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The
procedure and rules of the Service shall be
applicable to the selection of such arbitrator and to such arbitration proceedings,
and the findings and determination of the
arbitrator shall be final and conclusive,
and no official or court of the United
States shall have power or jurisdiction to
review any such findings and determination, except for fraud, misrepresentation,
or other misconduct by one of the parties
to the arbitration or the arbitrator where
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there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation,
or other misconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. If the Administrator determines
that an original data submitter has failed
to participate in a procedure for reaching
an agreement or in an arbitration proceeding as required by this subparagraph, or
failed to comply with the terms of an
agreement or arbitration decision concerning compensation under this subparagraph,
the original data submitter shall forfeit
the right to compensation for the use of
the data in support of the application. Notwithstanding any other provision of this
subchapter, if the Administrator determines that an applicant has failed to participate in a procedure for reaching an
agreement or in an arbitration proceeding
as required by this subparagraph, or failed
to comply with the terms of an agreement
or arbitration decision concerning compensation under this subparagraph, the
Administrator shall deny the application
or cancel the registration of the pesticide
in support of which the data were used
without further hearing. Before the Administrator takes action under either of
the preceding two sentences, the Administrator shall furnish to the affected person,
by certified mail, notice of intent to take
action and allow fifteen days from the date
of delivery of the notice for the affected
person to respond. If a registration is denied or canceled under this subparagraph,
the Administrator may make such order as
the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Registration action by the Administrator shall not
be delayed pending the fixing of compensation.
(iv) After expiration of any period of exclusive use and any period for which compensation is required for the use of an item
of data under clauses (i), (ii), and (iii), the
Administrator may consider such item of
data in support of an application by any
other applicant without the permission of
the original data submitter and without an
offer having been received to compensate
the original data submitter for the use of
such item of data.
(v) The period of exclusive use provided
under clause (ii) shall not take effect until
1 year after August 3, 1996, except where an
applicant or registrant is applying for the
registration of a pesticide containing an
active ingredient not previously registered.
(vi) With respect to data submitted after
August 3, 1996, by an applicant or registrant to support an amendment adding a
new use to an existing registration that
does not retain any period of exclusive use,
if such data relates solely to a minor use
of a pesticide, such data shall not, without
the written permission of the original data
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TITLE 7—AGRICULTURE
submitter, be considered by the Administrator to support an application for a
minor use by another person during the period of 10 years following the date of submission of such data. The applicant or registrant at the time the new minor use is
requested shall notify the Administrator
that to the best of their knowledge the exclusive use period for the pesticide has expired and that the data pertaining solely
to the minor use of a pesticide is eligible
for the provisions of this paragraph. If the
minor use registration which is supported
by data submitted pursuant to this subsection is voluntarily canceled or if such
data are subsequently used to support a
nonminor use, the data shall no longer be
subject to the exclusive use provisions of
this clause but shall instead be considered
by the Administrator in accordance with
the provisions of clause (i), as appropriate.
(G) If the applicant is requesting that the
registration or amendment to the registration of a pesticide be expedited, an explanation of the basis for the request must be
submitted, in accordance with paragraph (10)
of this subsection.
(2) Data in support of registration
(A) In general
The Administrator shall publish guidelines
specifying the kinds of information which
will be required to support the registration
of a pesticide and shall revise such guidelines from time to time. If thereafter the Administrator requires any additional kind of
information under subparagraph (B) of this
paragraph, the Administrator shall permit
sufficient time for applicants to obtain such
additional information. The Administrator,
in establishing standards for data requirements for the registration of pesticides with
respect to minor uses, shall make such
standards commensurate with the anticipated extent of use, pattern of use, the public health and agricultural need for such
minor use, and the level and degree of potential beneficial or adverse effects on man and
the environment. The Administrator shall
not require a person to submit, in relation to
a registration or reregistration of a pesticide
for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be
registered for such use. In the development
of these standards, the Administrator shall
consider the economic factors of potential
national volume of use, extent of distribution, and the impact of the cost of meeting
the requirements on the incentives for any
potential registrant to undertake the development of the required data. Except as provided by section 136h of this title, within 30
days after the Administrator registers a pesticide under this subchapter the Administrator shall make available to the public the
data called for in the registration statement
together with such other scientific information as the Administrator deems relevant to
the Administrator’s decision.
§ 136a
(B) Additional data
(i) If the Administrator determines that
additional data are required to maintain in
effect an existing registration of a pesticide,
the Administrator shall notify all existing
registrants of the pesticide to which the determination relates and provide a list of
such registrants to any interested person.
(ii) Each registrant of such pesticide shall
provide evidence within ninety days after receipt of notification that it is taking appropriate steps to secure the additional data
that are required. Two or more registrants
may agree to develop jointly, or to share in
the cost of developing, such data if they
agree and advise the Administrator of their
intent within ninety days after notification.
Any registrant who agrees to share in the
cost of producing the data shall be entitled
to examine and rely upon such data in support of maintenance of such registration.
The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to
comply with this clause.
(iii) If, at the end of sixty days after advising the Administrator of their agreement to
develop jointly, or share in the cost of developing, data, the registrants have not further
agreed on the terms of the data development
arrangement or on a procedure for reaching
such agreement, any of such registrants may
initiate binding arbitration proceedings by
requesting the Federal Mediation and Conciliation Service to appoint an arbitrator
from the roster of arbitrators maintained by
such Service. The procedure and rules of the
Service shall be applicable to the selection
of such arbitrator and to such arbitration
proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the
United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator
where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or
other misconduct. All parties to the arbitration shall share equally in the payment of
the fee and expenses of the arbitrator. The
Administrator shall issue a notice of intent
to suspend the registration of a pesticide in
accordance with the procedures prescribed
by clause (iv) if a registrant fails to comply
with this clause.
(iv) Notwithstanding any other provision
of this subchapter, if the Administrator determines that a registrant, within the time
required by the Administrator, has failed to
take appropriate steps to secure the data required under this subparagraph, to participate in a procedure for reaching agreement
concerning a joint data development arrangement under this subparagraph or in an
arbitration proceeding as required by this
subparagraph, or to comply with the terms
of an agreement or arbitration decision con-
§ 136a
TITLE 7—AGRICULTURE
cerning a joint data development arrangement under this subparagraph, the Administrator may issue a notice of intent to suspend such registrant’s registration of the
pesticide for which additional data is required. The Administrator may include in
the notice of intent to suspend such provisions as the Administrator deems appropriate concerning the continued sale and use
of existing stocks of such pesticide. Any suspension proposed under this subparagraph
shall become final and effective at the end of
thirty days from receipt by the registrant of
the notice of intent to suspend, unless during that time a request for hearing is made
by a person adversely affected by the notice
or the registrant has satisfied the Administrator that the registrant has complied fully
with the requirements that served as a basis
for the notice of intent to suspend. If a hearing is requested, a hearing shall be conducted under section 136d(d) of this title.
The only matters for resolution at that
hearing shall be whether the registrant has
failed to take the action that served as the
basis for the notice of intent to suspend the
registration of the pesticide for which additional data is required, and whether the Administrator’s determination with respect to
the disposition of existing stocks is consistent with this subchapter. If a hearing is
held, a decision after completion of such
hearing shall be final. Notwithstanding any
other provision of this subchapter, a hearing
shall be held and a determination made
within seventy-five days after receipt of a
request for such hearing. Any registration
suspended under this subparagraph shall be
reinstated by the Administrator if the Administrator determines that the registrant
has complied fully with the requirements
that served as a basis for the suspension of
the registration.
(v) Any data submitted under this subparagraph shall be subject to the provisions of
paragraph (1)(D). Whenever such data are
submitted jointly by two or more registrants, an agent shall be agreed on at the
time of the joint submission to handle any
subsequent data compensation matters for
the joint submitters of such data.
(vi) Upon the request of a registrant the
Administrator shall, in the case of a minor
use, extend the deadline for the production
of residue chemistry data under this subparagraph for data required solely to support
that minor use until the final deadline for
submission of data under section 136a–1 of
this title for the other uses of the pesticide
established as of August 3, 1996, if—
(I) the data to support other uses of the
pesticide on a food are being provided;
(II) the registrant, in submitting a request for such an extension, provides a
schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;
(III) the Administrator has determined
that such extension will not significantly
delay the Administrator’s schedule for is-
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suing a reregistration eligibility determination required under section 136a–1 of
this title; and
(IV) the Administrator has determined
that based on existing data, such extension
would not significantly increase the risk
of any unreasonable adverse effect on the
environment. If the Administrator grants
an extension under this clause, the Administrator shall monitor the development of
the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator
determines that the registrant is not
meeting or has not met the schedule for
the production of such data, the Administrator may proceed in accordance with
clause (iv) regarding the continued registration of the affected products with the
minor use and shall inform the public of
such action. Notwithstanding the provisions of this clause, the Administrator
may take action to modify or revoke the
extension under this clause if the Administrator determines that the extension for
the minor use may cause an unreasonable
adverse effect on the environment. In such
circumstance, the Administrator shall provide, in writing to the registrant, a notice
revoking the extension of time for submission of data. Such data shall instead be
due in accordance with the date established by the Administrator for the submission of the data.
(vii) If the registrant does not commit to
support a specific minor use of the pesticide,
but is supporting and providing data in a
timely and adequate fashion to support uses
of the pesticide on a food, or if all uses of the
pesticide are nonfood uses and the registrant
does not commit to support a specific minor
use of the pesticide but is supporting and
providing data in a timely and adequate
fashion to support other nonfood uses of the
pesticide, the Administrator, at the written
request of the registrant, shall not take any
action pursuant to this clause in regard to
such unsupported minor use until the final
deadline established as of August 3, 1996, for
the submission of data under section 136a–1
of this title for the supported uses identified
pursuant to this clause unless the Administrator determines that the absence of the
data is significant enough to cause human
health or environmental concerns. On the
basis of such determination, the Administrator may refuse the request for extension
by the registrant. Upon receipt of the request from the registrant, the Administrator
shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being
supported will be voluntarily deleted from
the
registration
pursuant
to
section
136d(f)(1) of this title. If the Administrator
grants an extension under this clause, the
Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant
is meeting the schedule for the production of
such data. If the Administrator determines
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that the registrant is not meeting or has not
met the schedule for the production of such
data, the Administrator may proceed in accordance with clause (iv) of this subparagraph regarding the continued registration
of the affected products with the minor and
other uses and shall inform the public of
such action in accordance with section
136d(f)(2) of this title. Notwithstanding the
provisions of this clause, the Administrator
may deny, modify, or revoke the temporary
extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment.
In the event of modification or revocation,
the Administrator shall provide, in writing,
to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.
(viii)(I) If data required to support registration of a pesticide under subparagraph
(A) is requested by a Federal or State regulatory authority, the Administrator shall, to
the extent practicable, coordinate data requirements, test protocols, timetables, and
standards of review and reduce burdens and
redundancy caused to the registrant by multiple requirements on the registrant.
(II) The Administrator may enter into a
cooperative agreement with a State to carry
out subclause (I).
(III) Not later than 1 year after August 3,
1996, the Administrator shall develop a process to identify and assist in alleviating future disparities between Federal and State
data requirements.
(C) Simplified procedures
Within nine months after September 30,
1978, the Administrator shall, by regulation,
prescribe simplified procedures for the registration of pesticides, which shall include
the provisions of subparagraph (D) of this
paragraph.
(D) Exemption
No applicant for registration of a pesticide
who proposes to purchase a registered pesticide from another producer in order to formulate such purchased pesticide into the
pesticide that is the subject of the application shall be required to—
(i) submit or cite data pertaining to such
purchased product; or
(ii) offer to pay reasonable compensation
otherwise required by paragraph (1)(D) of
this subsection for the use of any such
data.
(E) Minor use waiver
In handling the registration of a pesticide
for a minor use, the Administrator may
waive otherwise applicable data requirements if the Administrator determines that
the absence of such data will not prevent the
Administrator from determining—
(i) the incremental risk presented by the
minor use of the pesticide; and
(ii) that such risk, if any, would not be
an unreasonable adverse effect on the environment.
§ 136a
(3) Application
(A) In general
The Administrator shall review the data
after receipt of the application and shall, as
expeditiously as possible, either register the
pesticide in accordance with paragraph (5),
or notify the applicant of the Administrator’s determination that it does not comply
with the provisions of the subchapter in accordance with paragraph (6).
(B) Identical or substantially similar
(i) The Administrator shall, as expeditiously as possible, review and act on any
application received by the Administrator
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 such currently-registered pesticide
only in ways that would not significantly
increase the risk of unreasonable adverse
effects on the environment; or
(II) proposes an amendment to the registration of a registered pesticide that
does not require scientific review of data.
(ii) In expediting the review of an application for an action described in clause (i), the
Administrator shall—
(I) review the application in accordance
with section 136w–8(f)(4)(B) of this title
and, if the application is found to be incomplete, reject the application;
(II) not later than the applicable decision review time established pursuant to
section 136w–8(f)(4)(B) of this title, or, if no
review time is established, not later than
90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and
(III) if the application is denied, notify
the registrant in writing of the specific
reasons for the denial of the application.
(C) Minor use registration
(i) The Administrator shall, as expeditiously as possible, review and act on any
complete application—
(I) that proposes the initial registration
of a new pesticide active ingredient if the
active ingredient is proposed to be registered solely for minor uses, or proposes a
registration amendment solely for minor
uses to an existing registration; or
(II) for a registration or a registration
amendment that proposes significant
minor uses.
(ii) For the purposes of clause (i)—
(I) the term ‘‘as expeditiously as possible’’ means that the Administrator shall,
to the greatest extent practicable, complete a review and evaluation of all data,
submitted with a complete application,
within 12 months after the submission of
the complete application, and the failure
of the Administrator to complete such a
§ 136a
TITLE 7—AGRICULTURE
review and evaluation under clause (i)
shall not be subject to judicial review; and
(II) the term ‘‘significant minor uses’’
means 3 or more minor uses proposed for
every nonminor use, a minor use that
would, in the judgment of the Administrator, serve as a replacement for any use
which has been canceled in the 5 years preceding the receipt of the application, or a
minor use that in the opinion of the Administrator would avoid the reissuance of
an emergency exemption under section
136p of this title for that minor use.
(D) Adequate time for submission of minor
use data
If a registrant makes a request for a minor
use waiver, regarding data required by the
Administrator, pursuant to paragraph (2)(E),
and if the Administrator denies in whole or
in part such data waiver request, the registrant shall have a full-time period for providing such data. For purposes of this subparagraph, the term ‘‘full-time period’’
means the time period originally established
by the Administrator for submission of such
data, beginning with the date of receipt by
the registrant of the Administrator’s notice
of denial.
(4) Notice of application
The Administrator shall publish in the Federal Register, promptly after receipt of the
statement and other data required pursuant to
paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new active ingredient or if it would
entail a changed use pattern. The notice shall
provide for a period of 30 days in which any
Federal agency or any other interested person
may comment.
(5) Approval of registration
The Administrator shall register a pesticide
if the Administrator determines that, when
considered with any restrictions imposed
under subsection (d) of this section—
(A) its composition is such as to warrant
the proposed claims for it;
(B) its labeling and other material required to be submitted comply with the requirements of this subchapter;
(C) it will perform its intended function
without unreasonable adverse effects on the
environment; and
(D) when used in accordance with widespread and commonly recognized practice it
will not generally cause unreasonable adverse effects on the environment.
The Administrator shall not make any lack of
essentiality a criterion for denying registration of any pesticide. Where two pesticides
meet the requirements of this paragraph, one
should not be registered in preference to the
other. In considering an application for the
registration of a pesticide, the Administrator
may waive data requirements pertaining to efficacy, in which event the Administrator may
register the pesticide without determining
that the pesticide’s composition is such as to
warrant proposed claims of efficacy. If a pesticide is found to be efficacious by any State
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under section 136v(c) of this title, a presumption is established that the Administrator
shall waive data requirements pertaining to
efficacy for use of the pesticide in such State.
(6) Denial of registration
If the Administrator determines that the requirements of paragraph (5) for registration
are not satisfied, the Administrator shall notify the applicant for registration of the Administrator’s determination and of the Administrator’s reasons (including the factual basis)
therefor, and that, unless the applicant corrects the conditions and notifies the Administrator thereof during the 30-day period beginning with the day after the date on which the
applicant receives the notice, the Administrator may refuse to register the pesticide.
Whenever the Administrator refuses to register a pesticide, the Administrator shall notify the applicant of the Administrator’s decision and of the Administrator’s reasons (including the factual basis) therefor. The Administrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor. Upon such notification, the applicant for registration or
other interested person with the concurrence
of the applicant shall have the same remedies
as provided for in section 136d of this title.
(7) Registration under special circumstances
Notwithstanding the provisions of paragraph
(5)—
(A) The Administrator may conditionally
register or amend the registration of a pesticide if the Administrator determines that
(i) the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and use thereof,
or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration or amendment in
the manner proposed by the applicant would
not significantly increase the risk of any unreasonable adverse effect on the environment. An applicant seeking conditional registration or amended registration under this
subparagraph shall submit such data as
would be required to obtain registration of a
similar pesticide under paragraph (5). If the
applicant is unable to submit an item of
data because it has not yet been generated,
the Administrator may register or amend
the registration of the pesticide under such
conditions as will require the submission of
such data not later than the time such data
are required to be submitted with respect to
similar pesticides already registered under
this subchapter.
(B) The Administrator may conditionally
amend the registration of a pesticide to permit additional uses of such pesticide notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if the Administrator determines that (i) the applicant has
submitted satisfactory data pertaining to
the proposed additional use, and (ii) amending the registration in the manner proposed
by the applicant would not significantly in-
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TITLE 7—AGRICULTURE
crease the risk of any unreasonable adverse
effect on the environment. Notwithstanding
the foregoing provisions of this subparagraph, no registration of a pesticide may be
amended to permit an additional use of such
pesticide if the Administrator has issued a
notice stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria associated in whole or in part with
human dietary exposure enumerated in regulations issued under this subchapter, and
during the pendency of any risk-benefit evaluation initiated by such notice, if (I) the additional use of such pesticide involves a
major food or feed crop, or (II) the additional
use of such pesticide involves a minor food
or feed crop and the Administrator determines, with the concurrence of the Secretary of Agriculture, there is available an
effective alternative pesticide that does not
meet or exceed such risk criteria. An applicant seeking amended registration under
this subparagraph shall submit such data as
would be required to obtain registration of a
similar pesticide under paragraph (5). If the
applicant is unable to submit an item of
data (other than data pertaining to the proposed additional use) because it has not yet
been generated, the Administrator may
amend the registration under such conditions as will require the submission of such
data not later than the time such data are
required to be submitted with respect to
similar pesticides already registered under
this subchapter.
(C) The Administrator may conditionally
register a pesticide containing an active ingredient not contained in any currently registered pesticide for a period reasonably sufficient for the generation and submission of
required data (which are lacking because a
period reasonably sufficient for generation
of the data has not elapsed since the Administrator first imposed the data requirement)
on the condition that by the end of such period the Administrator receives such data
and the data do not meet or exceed risk criteria enumerated in regulations issued under
this subchapter, and on such other conditions as the Administrator may prescribe. A
conditional registration under this subparagraph shall be granted only if the Administrator determines that use of the pesticide
during such period will not cause any unreasonable adverse effect on the environment,
and that use of the pesticide is in the public
interest.
(8) Interim administrative review
Notwithstanding any other provision of this
subchapter, the Administrator may not initiate a public interim administrative review
process to develop a risk-benefit evaluation of
the ingredients of a pesticide or any of its uses
prior to initiating a formal action to cancel,
suspend, or deny registration of such pesticide, required under this subchapter, unless
such interim administrative process is based
on a validated test or other significant evidence raising prudent concerns of unreasonable adverse risk to man or to the environ-
§ 136a
ment. Notice of the definition of the terms
‘‘validated test’’ and ‘‘other significant evidence’’ as used herein shall be published by
the Administrator in the Federal Register.
(9) Labeling
(A) Additional statements
Subject to subparagraphs (B) and (C), it
shall not be a violation of this subchapter
for a registrant to modify the labeling of an
antimicrobial pesticide product to include
relevant information on product efficacy,
product composition, container composition
or design, or other characteristics that do
not relate to any pesticidal claim or pesticidal activity.
(B) Requirements
Proposed labeling information under subparagraph (A) shall not be false or misleading, shall not conflict with or detract from
any statement required by law or the Administrator as a condition of registration,
and shall be substantiated on the request of
the Administrator.
(C) Notification and disapproval
(i) Notification
A registration may be modified under
subparagraph (A) if—
(I) the registrant notifies the Administrator in writing not later than 60 days
prior to distribution or sale of a product
bearing the modified labeling; and
(II) the Administrator does not disapprove of the modification under clause
(ii).
(ii) Disapproval
Not later than 30 days after receipt of a
notification under clause (i), the Administrator may disapprove the modification by
sending the registrant notification in writing stating that the proposed language is
not acceptable and stating the reasons
why the Administrator finds the proposed
modification unacceptable.
(iii) Restriction on sale
A registrant may not sell or distribute a
product bearing a disapproved modification.
(iv) Objection
A registrant may file an objection in
writing to a disapproval under clause (ii)
not later than 30 days after receipt of notification of the disapproval.
(v) Final action
A decision by the Administrator following receipt and consideration of an objection filed under clause (iv) shall be considered a final agency action.
(D) Use dilution
The label or labeling required under this
subchapter for an antimicrobial pesticide
that is or may be diluted for use may have
a different statement of caution or protective measures for use of the recommended
diluted solution of the pesticide than for use
of a concentrate of the pesticide if the Administrator determines that—
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TITLE 7—AGRICULTURE
(i) adequate data have been submitted to
support the statement proposed for the diluted solution uses; and
(ii) the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.
(10) Expedited registration of pesticides
(A) Not later than 1 year after August 3,
1996, the Administrator shall, utilizing public
comment, develop procedures and guidelines,
and expedite the review of an application for
registration of a pesticide or an amendment to
a registration that satisfies such guidelines.
(B) Any application for registration or an
amendment, including biological and conventional pesticides, will be considered for expedited review under this paragraph. An application for registration or an amendment shall
qualify for expedited review if use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of
the following:
(i) Reduce the risks of pesticides to human
health.
(ii) Reduce the risks of pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of groundwater, surface water, or other
valued environmental resources.
(iv) Broaden the adoption of integrated
pest management strategies, or make such
strategies more available or more effective.
(C) The Administrator, not later than 30
days after receipt of an application for expedited review, shall notify the applicant whether the application is complete. If it is found to
be incomplete, the Administrator may either
reject the request for expedited review or ask
the applicant for additional information to
satisfy the guidelines developed under subparagraph (A).
(d) Classification of pesticides
(1) Classification for general use, restricted
use, or both
(A) As a part of the registration of a pesticide the Administrator shall classify it as
being for general use or for restricted use. If
the Administrator determines that some of
the uses for which the pesticide is registered
should be for general use and that other uses
for which it is registered should be for restricted use, the Administrator shall classify
it for both general use and restricted use. Pesticide uses may be classified by regulation on
the initial classification, and registered pesticides may be classified prior to reregistration. If some of the uses of the pesticide are
classified for general use, and other uses are
classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from those directions
relating to its restricted uses. The Administrator may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its packaging and labeling
for general uses.
(B) If the Administrator determines that the
pesticide, when applied in accordance with its
directions for use, warnings and cautions and
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for the uses for which it is registered, or for
one or more of such uses, or in accordance
with a widespread and commonly recognized
practice, will not generally cause unreasonable adverse effects on the environment, the
Administrator will classify the pesticide, or
the particular use or uses of the pesticide to
which the determination applies, for general
use.
(C) If the Administrator determines that the
pesticide, when applied in accordance with its
directions for use, warnings and cautions and
for the uses for which it is registered, or for
one or more of such uses, or in accordance
with a widespread and commonly recognized
practice, may generally cause, without additional regulatory restrictions, unreasonable
adverse effects on the environment, including
injury to the applicator, the Administrator
shall classify the pesticide, or the particular
use or uses to which the determination applies, for restricted use:
(i) If the Administrator classifies a pesticide, or one or more uses of such pesticide,
for restricted use because of a determination
that the acute dermal or inhalation toxicity
of the pesticide presents a hazard to the applicator or other persons, the pesticide shall
be applied for any use to which the restricted classification applies only by or
under the direct supervision of a certified
applicator.
(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide,
for restricted use because of a determination
that its use without additional regulatory
restriction may cause unreasonable adverse
effects on the environment, the pesticide
shall be applied for any use to which the determination applies only by or under the direct supervision of a certified applicator, or
subject to such other restrictions as the Administrator may provide by regulation. Any
such regulation shall be reviewable in the
appropriate court of appeals upon petition of
a person adversely affected filed within 60
days of the publication of the regulation in
final form.
(2) Change in classification
If the Administrator determines that a
change in the classification of any use of a
pesticide from general use to restricted use is
necessary to prevent unreasonable adverse effects on the environment, the Administrator
shall notify the registrant of such pesticide of
such determination at least forty-five days before making the change and shall publish the
proposed change in the Federal Register. The
registrant, or other interested person with the
concurrence of the registrant, may seek relief
from such determination under section 136d(b)
of this title.
(3) Change in classification from restricted use
to general use
The registrant of any pesticide with one or
more uses classified for restricted use may petition the Administrator to change any such
classification from restricted to general use.
Such petition shall set out the basis for the
registrant’s position that restricted use classi-
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TITLE 7—AGRICULTURE
fication is unnecessary because classification
of the pesticide for general use would not
cause unreasonable adverse effects on the environment. The Administrator, within sixty
days after receiving such petition, shall notify
the registrant whether the petition has been
granted or denied. Any denial shall contain an
explanation therefor and any such denial shall
be subject to judicial review under section
136n of this title.
(e) Products with same formulation and claims
Products which have the same formulation,
are manufactured by the same person, the labeling of which contains the same claims, and the
labels of which bear a designation identifying
the product as the same pesticide may be registered as a single pesticide; and additional
names and labels shall be added to the registration by supplemental statements.
(f) Miscellaneous
(1) Effect of change of labeling or formulation
If the labeling or formulation for a pesticide
is changed, the registration shall be amended
to reflect such change if the Administrator determines that the change will not violate any
provision of this subchapter.
(2) Registration not a defense
In no event shall registration of an article
be construed as a defense for the commission
of any offense under this subchapter. As long
as no cancellation proceedings are in effect
registration of a pesticide shall be prima facie
evidence that the pesticide, its labeling and
packaging comply with the registration provisions of the subchapter.
(3) Authority to consult other Federal agencies
In connection with consideration of any registration or application for registration under
this section, the Administrator may consult
with any other Federal agency.
(4) Mixtures of nitrogen stabilizers and fertilizer products
Any mixture or other combination of—
(A) 1 or more nitrogen stabilizers registered under this subchapter; and
(B) 1 or more fertilizer products,
shall not be subject to the provisions of this
section or sections 136a–1, 136c, 136e, 136m, and
136o(a)(2) of this title if the mixture or other
combination is accompanied by the labeling
required under this subchapter for the nitrogen stabilizer contained in the mixture or
other combination, the mixture or combination is mixed or combined in accordance with
such labeling, and the mixture or combination
does not contain any active ingredient other
than the nitrogen stabilizer.
(g) Registration review
(1) General rule
(A) Periodic review
(i) In general
The registrations of pesticides are to be
periodically reviewed.
(ii) Regulations
In accordance with this subparagraph,
the Administrator shall by regulation es-
§ 136a
tablish a procedure for accomplishing the
periodic review of registrations.
(iii) Initial registration review
The Administrator shall complete the
registration review of each pesticide or
pesticide case, which may be composed of
1 or more active ingredients and the products associated with the active ingredients, not later than the later of—
(I) October 1, 2022; or
(II) the date that is 15 years after the
date on which the first pesticide containing a new active ingredient is registered.
(iv) Subsequent registration review
Not later than 15 years after the date on
which the initial registration review is
completed under clause (iii) and each 15
years thereafter, the Administrator shall
complete a subsequent registration review
for each pesticide or pesticide case.
(v) Cancellation
No registration shall be canceled as a result of the registration review process unless the Administrator follows the procedures and substantive requirements of section 136d of this title.
(B) Docketing
(i) In general
Subject to clause (ii), after meeting with
1 or more individuals that are not government employees to discuss matters relating to a registration review, the Administrator shall place in the docket minutes of
the meeting, a list of attendees, and any
documents exchanged at the meeting, not
later than the earlier of—
(I) the date that is 45 days after the
meeting; or
(II) the date of issuance of the registration review decision.
(ii) Protected information
The Administrator shall identify, but
not include in the docket, any confidential
business information the disclosure of
which is prohibited by section 136h of this
title.
(C) Limitation
Nothing in this subsection shall prohibit
the Administrator from undertaking any
other review of a pesticide pursuant to this
subchapter.
(2) Data
(A) Submission required
The Administrator shall use the authority
in subsection (c)(2)(B) of this section to require the submission of data when such data
are necessary for a registration review.
(B) Data submission, compensation, and exemption
For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and
(c)(2)(D) of this section shall be utilized for
and be applicable to any data required for
registration review.
§ 136a
TITLE 7—AGRICULTURE
(h) Registration requirements for antimicrobial
pesticides
(1) Evaluation of process
To the maximum extent practicable consistent with the degrees of risk presented by an
antimicrobial pesticide and the type of review
appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to
the antimicrobial registration process that
would reduce review periods existing as of August 3, 1996, for antimicrobial pesticide product registration applications and applications
for amended registration of antimicrobial pesticide products, including—
(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial pesticides; and
(D) amendments to antimicrobial pesticide
registrations.
(2) Review time period reduction goal
Each reform identified under paragraph (1)
shall be designed to achieve the goal of reducing the review period following submission of
a complete application, consistent with the
degree of risk, to a period of not more than—
(A) 540 days for a new antimicrobial active
ingredient pesticide registration;
(B) 270 days for a new antimicrobial use of
a registered active ingredient;
(C) 120 days for any other new antimicrobial product;
(D) 90 days for a substantially similar or
identical antimicrobial product;
(E) 90 days for an amendment to an antimicrobial registration that does not require
scientific review of data; and
(F) 120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this paragraph.
(3) Implementation
(A) Proposed rulemaking
(i) Issuance
Not later than 270 days after August 3,
1996, the Administrator shall publish in
the Federal Register proposed regulations
to accelerate and improve the review of
antimicrobial pesticide products designed
to implement, to the extent practicable,
the goals set forth in paragraph (2).
(ii) Requirements
Proposed regulations issued under clause
(i) shall—
(I) define the various classes of antimicrobial use patterns, including household, industrial, and institutional disinfectants and sanitizing pesticides, preservatives, water treatment, and pulp
and paper mill additives, and other such
products intended to disinfect, sanitize,
reduce, or mitigate growth or development of microbiological organisms, or
protect inanimate objects, industrial
processes or systems, surfaces, water, or
other chemical substances from contamination, fouling, or deterioration
caused by bacteria, viruses, fungi, protozoa, algae, or slime;
Page 222
(II) differentiate the types of review
undertaken for antimicrobial pesticides;
(III) conform the degree and type of review to the risks and benefits presented
by antimicrobial pesticides and the function of review under this subchapter,
considering the use patterns of the product, toxicity, expected exposure, and
product type;
(IV) ensure that the registration process is sufficient to maintain antimicrobial pesticide efficacy and that
antimicrobial pesticide products continue to meet product performance
standards and effectiveness levels for
each type of label claim made; and
(V) implement effective and reliable
deadlines for process management.
(iii) Comments
In developing the proposed regulations,
the Administrator shall solicit the views
from registrants and other affected parties
to maximize the effectiveness of the rule
development process.
(B) Final regulations
(i) Issuance
The Administrator shall issue final regulations not later than 240 days after the
close of the comment period for the proposed regulations.
(ii) Failure to meet goal
If a goal described in paragraph (2) is not
met by the final regulations, the Administrator shall identify the goal, explain why
the goal was not attained, describe the element of the regulations included instead,
and identify future steps to attain the
goal.
(iii) Requirements
In issuing final regulations, the Administrator shall—
(I) consider the establishment of a certification process for regulatory actions
involving risks that can be responsibly
managed, consistent with the degree of
risk, in the most cost-efficient manner;
(II) consider the establishment of a
certification process by approved laboratories as an adjunct to the review process;
(III) use all appropriate and cost-effective review mechanisms, including—
(aa) expanded use of notification and
non-notification procedures;
(bb) revised procedures for application review; and
(cc) allocation of appropriate resources to ensure streamlined management of antimicrobial pesticide registrations; and
(IV) clarify criteria for determination
of the completeness of an application.
(C) Expedited review
This subsection does not affect the requirements or extend the deadlines or review
periods contained in subsection (c)(3) of this
section.
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TITLE 7—AGRICULTURE
(D) Alternative review periods
If the final regulations to carry out this
paragraph are not effective 630 days after
August 3, 1996, until the final regulations become effective, the review period, beginning
on the date of receipt by the Agency of a
complete application, shall be—
(i) 2 years for a new antimicrobial active
ingredient pesticide registration;
(ii) 1 year for a new antimicrobial use of
a registered active ingredient;
(iii) 180 days for any other new antimicrobial product;
(iv) 90 days for a substantially similar or
identical antimicrobial product;
(v) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and
(vi) 120 days for an amendment to an
antimicrobial registration that requires
scientific review of data and that is not
otherwise described in this subparagraph.
(E) Wood preservatives
An application for the registration, or for
an amendment to the registration, of a wood
preservative product for which a claim of
pesticidal activity listed in section 136(mm)
of this title is made (regardless of any other
pesticidal claim that is made with respect to
the product) shall be reviewed by the Administrator within the same period as that established under this paragraph for an antimicrobial pesticide product application, consistent with the degree of risk posed by the
use of the wood preservative product, if the
application requires the applicant to satisfy
the same data requirements as are required
to support an application for a wood preservative product that is an antimicrobial pesticide.
(F) Notification
(i) In general
Subject to clause (iii), the Administrator
shall notify an applicant whether an application has been granted or denied not later
than the final day of the appropriate review period under this paragraph, unless
the applicant and the Administrator agree
to a later date.
(ii) Final decision
If the Administrator fails to notify an
applicant within the period of time required under clause (i), the failure shall be
considered an agency action unlawfully
withheld or unreasonably delayed for purposes of judicial review under chapter 7 of
title 5.
(iii) Exemption
This subparagraph does not apply to an
application for an antimicrobial pesticide
that is filed under subsection (c)(3)(B) of
this section prior to 90 days after August 3,
1996.
(iv) Limitation
Notwithstanding clause (ii), the failure
of the Administrator to notify an applicant for an amendment to a registration
§ 136a
for an antimicrobial pesticide shall not be
judicially reviewable in a Federal or State
court if the amendment requires scientific
review of data within—
(I) the time period specified in subparagraph (D)(vi), in the absence of a
final regulation under subparagraph (B);
or
(II) the time period specified in paragraph (2)(F), if adopted in a final regulation under subparagraph (B).
(4) Annual report
(A) Submission
Beginning on August 3, 1996, and ending on
the date that the goals under paragraph (2)
are achieved, the Administrator shall, not
later than March 1 of each year, prepare and
submit an annual report to the Committee
on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate.
(B) Requirements
A report submitted under subparagraph
(A) shall include a description of—
(i) measures taken to reduce the backlog
of pending registration applications;
(ii) progress toward achieving reforms
under this subsection; and
(iii) recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.
(June 25, 1947, ch. 125, § 3, as added Pub. L. 92–516,
§ 2, Oct. 21, 1972, 86 Stat. 979; amended Pub. L.
94–140, § 12, Nov. 28, 1975, 89 Stat. 755; Pub. L.
95–396, §§ 2(a), 3–8, Sept. 30, 1978, 92 Stat. 820,
824–827; Pub. L. 100–532, title I, §§ 102(b), 103, title
VI, § 601(b)(1), title VIII, § 801(b), Oct. 25, 1988, 102
Stat. 2667, 2677, 2680; Pub. L. 101–624, title XIV,
§ 1492, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102–237,
title X, § 1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991,
105 Stat. 1894–1896; Pub. L. 104–170, title I,
§§ 105(b), 106(b), title II, §§ 210(b), (c)(1), (d), (e),
(f)(2), 222–224, 231, 250, Aug. 3, 1996, 110 Stat. 1491,
1494–1497, 1499, 1503, 1504, 1508, 1510; Pub. L.
108–199, div. G, title V, § 501(b), Jan. 23, 2004, 118
Stat. 419; Pub. L. 110–94, §§ 2, 3, Oct. 9, 2007, 121
Stat. 1000.)
PRIOR PROVISIONS
A prior section 3 of act June 25, 1947, was classified to
section 135a of this title prior to amendment of act
June 25, 1947, by Pub. L. 92–516.
AMENDMENTS
2007—Subsec. (c)(3)(B)(ii)(I). Pub. L. 110–94, § 2(1), substituted ‘‘review the application in accordance with
section 136w–8(f)(4)(B) of this title and,’’ for ‘‘within 45
days after receiving the application, notify the registrant whether or not the application is complete
and,’’.
Subsec. (c)(3)(B)(ii)(II). Pub. L. 110–94, § 2(2), substituted ‘‘not later than the applicable decision review
time established pursuant to section 136w–8(f)(4)(B) of
this title, or, if no review time is established, not later
than’’ for ‘‘within’’.
Subsec. (g)(1)(A). Pub. L. 110–94, § 3(1), designated first
sentence as cl. (i) and inserted heading, designated second sentence as cl. (ii), inserted heading, and substituted ‘‘In accordance with this subparagraph, the
Administrator’’ for ‘‘The Administrator’’, added cls.
(iii) and (iv), designated fourth sentence as cl. (v) and
§ 136a
TITLE 7—AGRICULTURE
inserted heading, and struck out third sentence which
read as follows: ‘‘The goal of these regulations shall be
a review of a pesticide’s registration every 15 years.’’
Subsec. (g)(1)(B), (C). Pub. L. 110–94, § 3(2), (3), added
subpar. (B) and redesignated former subpar. (B) as (C).
2004—Subsec. (h)(2)(F). Pub. L. 108–199, § 501(b)(1), substituted ‘‘120 days’’ for ‘‘90 to 180 days’’.
Subsec. (h)(3)(D)(vi). Pub. L. 108–199, § 501(b)(2)(A),
substituted ‘‘120 days’’ for ‘‘240 days’’.
Subsec. (h)(3)(F)(iv). Pub. L. 108–199, § 501(b)(2)(B),
added cl. (iv).
1996—Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104–170,
§ 210(b), added cls. (ii), (v), and (vi), redesignated former
cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl.
(iv) substituted ‘‘(i), (ii), and (iii)’’ for ‘‘(i) and (ii)’’.
Subsec. (c)(1)(G). Pub. L. 104–170, § 250(1), added subpar. (G).
Subsec. (c)(2)(A). Pub. L. 104–170, §§ 210(d)(1), 231, inserted heading, inserted ‘‘the public health and agricultural need for such minor use,’’ after ‘‘pattern of use,’’,
and substituted ‘‘potential beneficial or adverse effects
on man and the environment’’ for ‘‘potential exposure
of man and the environment to the pesticide’’.
Subsec. (c)(2)(B). Pub. L. 104–170, § 210(d)(2), inserted
heading.
Subsec. (c)(2)(B)(vi). Pub. L. 104–170, § 210(c)(1), added
cl. (vi).
Subsec. (c)(2)(B)(vii). Pub. L. 104–170, § 210(f)(2), added
cl. (vii).
Subsec. (c)(2)(B)(viii). Pub. L. 104–170, § 222, added cl.
(viii).
Subsec. (c)(2)(C). Pub. L. 104–170, § 210(d)(3), inserted
heading.
Subsec. (c)(2)(E). Pub. L. 104–170, § 210(d)(4), added subpar. (E).
Subsec. (c)(3)(A), (B). Pub. L. 104–170, § 210(e)(1), (2),
inserted headings.
Subsec. (c)(3)(C), (D). Pub. L. 104–170, § 210(e)(3), added
subpars. (C) and (D).
Subsec. (c)(9). Pub. L. 104–170, § 223, added par. (9).
Subsec. (c)(10). Pub. L. 104–170, § 250(2), added par. (10).
Subsec. (f)(4). Pub. L. 104–170, § 105(b), added par. (4).
Subsec. (g). Pub. L. 104–170, § 106(b), added subsec. (g).
Subsec. (h). Pub. L. 104–170, § 224, added subsec. (h).
1991—Subsec. (c)(1)(D). Pub. L. 102–237, § 1006(a)(3)(B),
(C), added subpar. (D) and redesignated former subpar.
(D) as (F).
Subsec. (c)(1)(E). Pub. L. 102–237, § 1006(a)(3)(A), (C),
added subpar. (E) and struck out former subpar. (E)
which read as follows: ‘‘the complete formula of the
pesticide; and’’.
Subsec. (c)(1)(F). Pub. L. 102–237, § 1006(a)(3)(A), (B),
(D), redesignated former subpar. (D) as (F), in cl. (i)
substituted ‘‘With’’ for ‘‘with’’ and a period for semicolon at end, in cl. (ii) substituted ‘‘Except’’ for ‘‘except’’ and a period for semicolon at end, in cl. (iii) substituted ‘‘After’’ for ‘‘after’’ and a period for semicolon
at end, and struck out former subpar. (F) which read as
follows: ‘‘a request that the pesticide be classified for
general use, for restricted use, or for both.’’
Subsec. (c)(2)(A). Pub. L. 102–237, § 1006(b)(1), (2), substituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘requires’’, ‘‘shall permit’’, ‘‘shall make’’, and ‘‘deems’’,
and substituted ‘‘the Administrator’s’’ for ‘‘his’’.
Subsec. (c)(2)(D). Pub. L. 102–237, § 1006(c), clarified
amendment made by Pub. L. 100–532, § 102(b)(2)(A). See
1988 Amendment note below.
Subsec. (c)(3)(A). Pub. L. 102–237, § 1006(b)(2), substituted ‘‘the Administrator’s’’ for ‘‘his’’.
Subsec. (c)(5). Pub. L. 102–237, § 1006(b)(1), substituted
‘‘the Administrator’’ for ‘‘he’’ before ‘‘determines’’.
Subsec. (c)(6). Pub. L. 102–237, § 1006(b)(1), (2), substituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘shall notify’’ in two places and ‘‘the Administrator’s’’ for ‘‘his’’
in four places.
Subsec. (d)(1). Pub. L. 102–237, § 1006(b)(1), substituted
‘‘the Administrator’’ for ‘‘he’’ before ‘‘shall classify it
for both’’ in subpar. (A), before ‘‘will classify’’ in subpar. (B), and before ‘‘shall classify’’ in subpar. (C).
Subsec. (d)(2). Pub. L. 102–237, § 1006(b)(1), substituted
‘‘the Administrator’’ for ‘‘he’’ before ‘‘shall notify’’.
Page 224
1990—Subsec. (c)(2)(A). Pub. L. 101–624 inserted after
third sentence ‘‘The Administrator shall not require a
person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under
this subchapter, any field residue data from a geographic area where the pesticide will not be registered
for such use.’’
1988—Subsec. (a). Pub. L. 100–532, § 601(b)(1), substituted ‘‘Requirement of registration’’ for ‘‘Requirement’’ in heading and amended text generally. Prior to
amendment, text read as follows: ‘‘Except as otherwise
provided by this subchapter, no person in any State
may distribute, sell, offer for sale, hold for sale, ship,
deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any
pesticide which is not registered with the Administrator.’’
Subsec. (c)(1)(D). Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted ‘‘paragraph (2)(D)’’
for ‘‘subsection (c)(2)(D) of this section’’, in cl. (i), substituted ‘‘(i) with’’ for ‘‘(i) With’’ and ‘‘, except that’’
for ‘‘: Provided, That’’, in cl. (ii), substituted ‘‘clause
(i)’’ for ‘‘subparagraph (D)(i) of this paragraph’’, and in
cl. (iii), substituted ‘‘clauses (i) and (ii)’’ for ‘‘subparagraphs (D)(i) and (D)(ii) of this paragraph’’.
Subsec. (c)(2)(A). Pub. L. 100–532, § 801(b)(5)(A), (B),
substituted ‘‘(2) Data in support of registration.—
‘‘(A) The’’
for ‘‘(2)(A) Data in support of registration.—The’’, and
directed that subpar. (A) be aligned with left margin of
subsec. (d)(1)(A) of this section.
Subsec. (c)(2)(B). Pub. L. 100–532, §§ 102(b)(1),
801(b)(5)(C)–(F), substituted ‘‘(B)(i) If’’ for ‘‘(B) Additional data to support existing registration.—(i) If’’, directed that cls. (ii) to (v) be aligned with left margin of
subpar. (A), in cls. (ii) and (iii), inserted ‘‘The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to
comply with this clause.’’, in cl. (iv), substituted ‘‘title.
The only’’ for ‘‘title: Provided, that the only’’, and in cl.
(v), substituted ‘‘paragraph (1)(D)’’ for ‘‘subsection
(c)(1)(D) of this section’’.
Subsec. (c)(2)(C). Pub. L. 100–532, § 801(b)(5)(G), (H),
struck out ‘‘Simplified procedures’’ after ‘‘(C)’’ and directed that text be aligned with left margin of subpar.
(A).
Subsec. (c)(2)(D). Pub. L. 100–532, § 102(b)(2)(A), and
Pub. L. 102–237, § 1006(c), substituted ‘‘the pesticide that
is the subject of the application’’ for ‘‘an end-use product’’.
Subsec. (c)(2)(D)(i). Pub. L. 100–532, § 102(b)(2)(B),
struck out ‘‘the safety of’’ after ‘‘data pertaining to’’.
Subsec. (c)(3). Pub. L. 100–532, § 103, substituted ‘‘(A)
The Administrator’’ for ‘‘The Administrator’’ and
added subpar. (B).
Subsec. (c)(7). Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted ‘‘paragraph (5)’’ for ‘‘subsection (c)(5) of this section’’, in subpars. (A) and (B),
substituted ‘‘paragraph (5). If’’ for ‘‘subsection (c)(5) of
this section: Provided, That, if’’, and in subpar. (C), substituted ‘‘prescribe. A’’ for ‘‘prescribe: Provided, that
a’’.
Subsec. (d)(1)(A). Pub. L. 100–532, § 801(b)(7), substituted ‘‘restricted use. If’’ for ‘‘restricted use, provided that if’’ and ‘‘restricted uses. The Administrator’’
for ‘‘restricted uses: Provided, however, That the Administrator’’.
Subsec. (f)(2). Pub. L. 100–532, § 801(b)(8), substituted
‘‘this subchapter. As’’ for ‘‘this subchapter: Provided,
That as’’.
Subsec. (g). Pub. L. 100–532, § 801(b)(9), struck out subsec. (g) which read as follows: ‘‘The Administrator shall
accomplish the reregistration of all pesticides in the
most expeditious manner practicable: Provided, That,
to the extent appropriate, any pesticide that results in
a postharvest residue in or on food or feed crops shall
be given priority in the reregistration process.’’
1978—Subsec. (c)(1)(D). Pub. L. 95–396, § 2(a)(1), added
subpar. (D), and struck out provisions which required
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the applicant for registration of a pesticide to file with
the Administrator a statement containing ‘‘if requested by the Administrator, a full description of the
tests made and the results thereof upon which the
claims are based, except that data submitted on or
after January 1, 1970, in support of an application shall
not, without permission of the applicant, be considered
by the Administrator in support of any other application for registration unless such other applicant shall
have first offered to pay reasonable compensation for
producing the test data to be relied upon and such data
is not protected from disclosure by section 136h(b) of
this title. This provision with regard to compensation
for producing the test data to be relied upon shall apply
with respect to all applications for registration or reregistration submitted on or after October 21, 1972. If
the parties cannot agree on the amount and method of
payment, the Administrator shall make such determination and may fix such other terms and conditions
as may be reasonable under the circumstances. The Administrator’s determination shall be made on the
record after notice and opportunity for hearing. If either party does not agree with said determination, he
may, within thirty days, take an appeal to the Federal
district court for the district in which he resides with
respect to either the amount of the payment or the
terms of payment, or both. Registration shall not be
delayed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.’’.
Subsec. (c)(2). Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, designated existing provisions as subpar. (A), inserted in
second sentence ‘‘under subparagraph (B) of this paragraph’’ after ‘‘kind of information’’, struck out from introductory text of third sentence ‘‘subsection (c)(1)(D)
of this section and’’ after ‘‘Except as provided by’’, and
inserted provisions relating to establishment of standards for data requirements for registration of pesticides
with respect to minor uses and consideration of economic factors in development of standards and cost of
development, and added subpars. (B) to (D).
Subsec. (c)(5). Pub. L. 95–396, § 5, provided for waiver
of data requirements pertaining to efficacy.
Subsec. (c)(7), (8). Pub. L. 95–396, § 6, added pars. (7)
and (8).
Subsec. (d)(1)(A). Pub. L. 95–396, § 7(1), authorized
classification of pesticide uses by regulation on the initial classification and registered pesticides prior to reregistration.
Subsec. (d)(2). Pub. L. 95–396, § 7(2), substituted
‘‘forty-five days’’ for ‘‘30 days’’.
Subsec. (d)(3). Pub. L. 95–396, § 7(3), added par. (3).
Subsec. (g). Pub. L. 95–396, § 8, added subsec. (g).
1975—Subsec. (c)(1)(D). Pub. L. 94–140 inserted exception relating to test data submitted on or after January 1, 1970, in support of application, inserted provision
that compensation for producing test data shall apply
to all applications submitted on or after October 21,
1972, and provision relating to delay of registration
pending determination of reasonable compensation,
struck out requirement that payment determined by
court not be less than amount determined by Administrator, and substituted ‘‘If either party’’ for ‘‘If the
owner of the test data’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided
that: ‘‘This Act [see Short Title of 2007 Amendment
note set out under section 136 of this title] and the
amendments made by this Act take effect on October 1,
2007.’’
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108–199, div. G, title V, § 501(h), Jan. 23, 2004,
118 Stat. 434, provided that: ‘‘Except as otherwise provided in this section [enacting section 136w–8 of this
title, amending this section and sections 136a–1, 136x,
and 136y of this title, and enacting provisions set out as
notes under sections 136 of this title and section 346a of
§ 136a
Title 21, Food and Drugs] and the amendments made by
this section, this section and the amendments made by
this section take effect on the date that is 60 days after
the date of enactment of this Act [Jan. 23, 2004].’’
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 OF 1978 AMENDMENT
Section 2(b) of Pub. L. 95–396 provided that: ‘‘The
amendment to section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and Rodenticide Act [subsec. (c)(1)(D)
of this section] made by [subsec. (a)(1) of] this section
shall apply with respect to all applications for registration approved after the date of enactment of this Act
[Sept. 30, 1978].’’
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.
BIOLOGICAL PESTICIDE HANDLING STUDY
Section 1498 of Pub. L. 101–624 provided that:
‘‘(a) STUDY.—Not later than September 30, 1992, the
National Academy of Sciences shall conduct a study of
the biological control programs and registration procedures utilized by the Food and Drug Administration,
the Animal and Plant Health Inspection Service, and
the Environmental Protection Agency.
‘‘(b) DEVELOPMENT OF PROCEDURES.—Not later than 1
year after the completion of the study under subsection
(a), the agencies and offices described in such subsection shall develop and implement a common process
for reviewing and approving biological control applications that are submitted to such agencies and offices
that shall be based on the study conducted under such
subsection and the recommendation of the National
Academy of Sciences, and other public comment.’’
EDUCATION, STUDY, AND REPORT
Pub. L. 100–478, title I, § 1010, Oct. 7, 1988, 102 Stat.
2313, provided that:
‘‘(a) EDUCATION.—The Administrator of the Environmental Protection Agency in cooperation with the Secretary of Agriculture and the Secretary of the Interior,
promptly upon enactment of this Act [Oct. 7, 1988],
shall conduct a program to inform and educate fully
persons engaged in agricultural food and fiber commodity production of any proposed pesticide labeling program or requirements that may be imposed by the Administrator in compliance with the Endangered Species
Act [of 1973] (16 U.S.C. 1531 et seq.). The Administrator
also shall provide the public with notice of, and opportunity for comment on, the elements of any such program and requirements based on compliance with the
Endangered Species Act [of 1973], including (but not
limited to) an identification of any pesticides affected
by the program; an explanation of the restriction or
prohibition on the user or applicator of any such pesticide; an identification of those geographic areas affected by any pesticide restriction or prohibition; an
identification of the effects of any restricted or prohibited pesticide on endangered or threatened species; and
an identification of the endangered or threatened species along with a general description of the geographic
areas in which such species are located wherein the application of a pesticide will be restricted, prohibited, or
its use otherwise limited, unless the Secretary of the
Interior determines that the disclosure of such information may create a substantial risk of harm to such
species or its habitat.
‘‘(b) STUDY.—The Administrator of the Environmental Protection Agency, jointly with the Secretary
of Agriculture and the Secretary of the Interior, shall
conduct a study to identify reasonable and prudent
means available to the Administrator to implement the
endangered species pesticides labeling program which
§ 136a–1
TITLE 7—AGRICULTURE
would comply with the Endangered Species Act of 1973,
as amended, and which would allow persons to continue
production of agricultural food and fiber commodities.
Such study shall include investigation by the Administrator of the best available methods to develop maps
and the best available alternatives to mapping as
means of identifying those circumstances in which use
of pesticides may be restricted; identification of alternatives to prohibitions on pesticide use, including, but
not limited to, alternative pesticides and application
methods and other agricultural practices which can be
used in lieu of any pesticides whose use may be restricted by the labeling program; examination of methods to improve coordination among the Environmental
Protection Agency, Department of Agriculture, and Department of the Interior in administration of the labeling program; and analysis of the means of implementing the endangered species pesticides labeling program
or alternatives to such a program, if any, to promote
the conservation of endangered or threatened species
and to minimize the impacts to persons engaged in agricultural food and fiber commodity production and
other affected pesticide users and applicators.
‘‘(c) REPORT.—The Administrator of the Environmental Protection Agency in cooperation with the Secretary of Agriculture and the Secretary of the Interior
shall submit a report within one year of the date of enactment of this Act [Oct. 7, 1988], presenting the results
of the study conducted pursuant to subsection (b) of
this section to the Committee on Merchant Marine and
Fisheries and the Committee on Agriculture of the
United States House of Representatives, and the Committee on Environment and Public Works and the Committee on Agriculture, Nutrition, and Forestry of the
United States Senate.’’
§ 136a–1. Reregistration of registered pesticides
(a) General rule
The Administrator shall reregister, in accordance with this section, each registered pesticide
containing any active ingredient contained in
any pesticide first registered before November 1,
1984, except for any pesticide as to which the Administrator has determined, after November 1,
1984, and before the effective date of this section, that—
(1) there are no outstanding data requirements; and
(2) the requirements of section 136a(c)(5) of
this title have been satisfied.
(b) Reregistration phases
Reregistrations of pesticides under this section shall be carried out in the following phases:
(1) The first phase shall include the listing
under subsection (c) of this section of the active ingredients of the pesticides that will be
reregistered.
(2) The second phase shall include the submission to the Administrator under subsection
(d) of this section of notices by registrants respecting their intention to seek reregistration, identification by registrants of missing
and inadequate data for such pesticides, and
commitments by registrants to replace such
missing or inadequate data within the applicable time period.
(3) The third phase shall include submission
to the Administrator by registrants of the information required under subsection (e) of this
section.
(4) The fourth phase shall include an independent, initial review by the Administrator
under subsection (f) of this section of submissions under phases two and three, identifica-
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tion of outstanding data requirements, and the
issuance, as necessary, of requests for additional data.
(5) The fifth phase shall include the review
by the Administrator under subsection (g) of
this section of data submitted for reregistration and appropriate regulatory action by the
Administrator.
(c) Phase one
(1) Priority for reregistration
For purposes of the reregistration of the pesticides described in subsection (a) of this section, the Administrator shall list the active
ingredients of pesticides and shall give priority to, among others, active ingredients (other
than active ingredients for which registration
standards have been issued before the effective
date of this section) that—
(A) are in use on or in food or feed and may
result in postharvest residues;
(B) may result in residues of potential toxicological concern in potable ground water,
edible fish, or shellfish;
(C) have been determined by the Administrator before the effective date of this section to have significant outstanding data requirements; or
(D) are used on crops, including in greenhouses and nurseries, where worker exposure
is most likely to occur.
(2) Reregistration lists
For purposes of reregistration under this
section, the Administrator shall by order—
(A) not later than 70 days after the effective date of this section, list pesticide active
ingredients for which registration standards
have been issued before such effective date;
(B) not later than 4 months after such effective date, list the first 150 pesticide active
ingredients, as determined under paragraph
(1);
(C) not later than 7 months after such effective date, list the second 150 pesticide active ingredients, as determined under paragraph (1); and
(D) not later than 10 months after such effective date, list the remainder of the pesticide active ingredients, as determined
under paragraph (1).
Each list shall be published in the Federal
Register.
(3) Judicial review
The content of a list issued by the Administrator under paragraph (2) shall not be subject
to judicial review.
(4) Notice to registrants
On the publication of a list of pesticide active ingredients under paragraph (2), the Administrator shall send by certified mail to the
registrants of the pesticides containing such
active ingredients a notice of the time by
which the registrants are to notify the Administrator under subsection (d) of this section
whether the registrants intend to seek or not
to seek reregistration of such pesticides.
(d) Phase two
(1) In general
The registrant of a pesticide that contains
an active ingredient listed under subparagraph
| File Type | application/pdf |
| File Modified | 2011-05-06 |
| File Created | 2011-05-06 |