§ 136a. — Registration of pesticides.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 7USC136a]
TITLE 7--AGRICULTURE
CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL
Sec. 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--
(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) within 45 days after receiving the application,
notify the registrant whether or not the application is
complete and, if the application is found to be incomplete,
reject the application;
(II) within 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
The registrations of pesticides are to be periodically
reviewed. The Administrator shall by regulation establish a
procedure for accomplishing the periodic review of
registrations. The goal of these regulations shall be a review
of a pesticide's registration every 15 years. 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) 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) 90 to 180 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) 240 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.
(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, Sec. 3, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 979; amended Pub. L. 94-140, Sec. 12, Nov. 28, 1975,
89 Stat. 755; Pub. L. 95-396, Secs. 2(a), 3-8, Sept. 30, 1978, 92 Stat.
820, 824-827; Pub. L. 100-532, title I, Secs. 102(b), 103, title VI,
Sec. 601(b)(1), title VIII, Sec. 801(b), Oct. 25, 1988, 102 Stat. 2667,
2677, 2680; Pub. L. 101-624, title XIV, Sec. 1492, Nov. 28, 1990, 104
Stat. 3628; Pub. L. 102-237, title X, Sec. 1006(a)(3), (b)(1), (2), (c),
Dec. 13, 1991, 105 Stat. 1894-1896; Pub. L. 104-170, title I,
Secs. 105(b), 106(b), title II, Secs. 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.)
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
1996--Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104-170, Sec. 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, Sec. 250(1), added subpar. (G).
Subsec. (c)(2)(A). Pub. L. 104-170, Secs. 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, Sec. 210(d)(2), inserted
heading.
Subsec. (c)(2)(B)(vi). Pub. L. 104-170, Sec. 210(c)(1), added cl.
(vi).
Subsec. (c)(2)(B)(vii). Pub. L. 104-170, Sec. 210(f)(2), added cl.
(vii).
Subsec. (c)(2)(B)(viii). Pub. L. 104-170, Sec. 222, added cl.
(viii).
Subsec. (c)(2)(C). Pub. L. 104-170, Sec. 210(d)(3), inserted
heading.
Subsec. (c)(2)(E). Pub. L. 104-170, Sec. 210(d)(4), added subpar.
(E).
Subsec. (c)(3)(A), (B). Pub. L. 104-170, Sec. 210(e)(1), (2),
inserted headings.
Subsec. (c)(3)(C), (D). Pub. L. 104-170, Sec. 210(e)(3), added
subpars. (C) and (D).
Subsec. (c)(9). Pub. L. 104-170, Sec. 223, added par. (9).
Subsec. (c)(10). Pub. L. 104-170, Sec. 250(2), added par. (10).
Subsec. (f)(4). Pub. L. 104-170, Sec. 105(b), added par. (4).
Subsec. (g). Pub. L. 104-170, Sec. 106(b), added subsec. (g).
Subsec. (h). Pub. L. 104-170, Sec. 224, added subsec. (h).
1991--Subsec. (c)(1)(D). Pub. L. 102-237, Sec. 1006(a)(3)(B), (C),
added subpar. (D) and redesignated former subpar. (D) as (F).
Subsec. (c)(1)(E). Pub. L. 102-237, Sec. 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, Sec. 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, Sec. 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, Sec. 1006(c), clarified
amendment made by Pub. L. 100-532, Sec. 102(b)(2)(A). See 1988 Amendment
note below.
Subsec. (c)(3)(A). Pub. L. 102-237, Sec. 1006(b)(2), substituted
``the Administrator's'' for ``his''.
Subsec. (c)(5). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator'' for ``he'' before ``determines''.
Subsec. (c)(6). Pub. L. 102-237, Sec. 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, Sec. 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, Sec. 1006(b)(1), substituted ``the
Administrator'' for ``he'' before ``shall notify''.
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, Sec. 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, Sec. 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, Sec. 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, Secs. 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, Sec. 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, Sec. 102(b)(2)(A), and Pub. L.
102-237, Sec. 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, Sec. 102(b)(2)(B), struck out
``the safety of'' after ``data pertaining to''.
Subsec. (c)(3). Pub. L. 100-532, Sec. 103, substituted ``(A) The
Administrator'' for ``The Administrator'' and added subpar. (B).
Subsec. (c)(7). Pub. L. 100-532, Sec. 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, Sec. 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, Sec. 801(b)(8), substituted ``this
subchapter. As'' for ``this subchapter: Provided, That as''.
Subsec. (g). Pub. L. 100-532, Sec. 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, Sec. 2(a)(1), added subpar.
(D), and struck out provisions which required 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, Secs. 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, Sec. 5, provided for waiver of data
requirements pertaining to efficacy.
Subsec. (c)(7), (8). Pub. L. 95-396, Sec. 6, added pars. (7) and
(8).
Subsec. (d)(1)(A). Pub. L. 95-396, Sec. 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, Sec. 7(2), substituted ``forty-five
days'' for ``30 days''.
Subsec. (d)(3). Pub. L. 95-396, Sec. 7(3), added par. (3).
Subsec. (g). Pub. L. 95-396, Sec. 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 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, Sec. 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 (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, 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 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.''
Section Referred to in Other Sections
This section is referred to in sections 136, 136a-1, 136c, 136d,
136h, 136i-1, 136j, 136k, 136l, 136m, 136o, 136q, 136v, 136w-7 of this
title; title 21 section 346a; title 42 section 300j-13.
