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7 USC 136a - Registration of pesticides |
U.S. Code > Title 7 > Chapter 6 > Subchapter II > § 136a - Registration of pesticidesCurrent as of: February 2010 (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 -
(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;
(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 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 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.
(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 concerning 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
issuing 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 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.
(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 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 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
increase 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 environment. 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 -
(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 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 classification 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 establish 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.
(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;
(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.
(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 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.Prev ________________________________________________________________________ Next |
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