Document ID: EPA-HQ-OPP-2008-0156-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-04-02T04:00Z

Attachment A

Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act

SEC. 3. [7 U.S.C. 136a] REGISTRATION OF PESTICIDES.

REQUIREMENT OF REGISTRATION.—

Except as provided by this Act, no person in any State may distribute or
sell to any person any pesticide that is not registered under this Act.
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 Act and that is not the subject of an experimental use permit under
section 5 or an emergency exemption under section 18.

EXEMPTIONS.—A pesticide which is not registered with the Administrator
may be transferred if—

the transfer is from one registered establishment to an-other 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

the transfer is pursuant to and in accordance with the requirements of
an experimental use permit.

PROCEDURE FOR REGISTRATION.—

(1) STATEMENT REQUIRED.—Each applicant for registration of a pesticide
shall file with the Administrator a statement which includes—

the name and address of the applicant and of any other person whose name
will appear on the labeling;

the name of the pesticide;

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;

the complete formula of the pesticide;

a request that the pesticide be classified for general use or for
restricted use, or for both; and

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:

With respect to pesticides containing active ingredients that are
initially registered under this Act after the date of enactment of the
Federal Pesticide Act of 1978 [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.

The period of exclusive data use provided under clause (i) shall be
extended 1 additional year for each 3 minor uses registered after the
date of

enactment of this clause [Aug. 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—

there are insufficient efficacious alternative registered pesticides
available for the use;

the alternatives to the minor use pesticide pose greater risks to the
environment or human health;

the minor use pesticide plays or will play a significant part in
managing pest resistance; or

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 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 Act, 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.

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.

The period of exclusive use provided under clause (ii) shall not take
effect until 1 year after enactment of this clause [Aug. 3, 1996],
except where an applicant or registrant is applying for the registration
of a pesticide containing an active ingredient not previously
registered.

With respect to data submitted after enactment of this clause [Aug. 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 sub-section.

(2) DATA IN SUPPORT OF REGISTRATION.—

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 Act, 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 10, within 30 days
after the Administrator registers a pesticide under this Act 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.

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.

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.

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.

Notwithstanding any other provision of this Act, 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 6(d) of this Act. 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 Act. If a
hearing is held, a decision after completion of such hearing shall be
final. Notwithstanding any other provision of this Act, 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.

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.

Upon 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
4 for the other uses of the pesticide established as of the date of
enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996],
if—

the data to support other uses of the pesticide on a food are being
provided;

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;

the Administrator has determined that such extension will not
significantly delay the Administrator's schedule for issuing a
reregistration eligibility determination required under section 4; and

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.

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 nonfat 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 nonfat
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
the date of enactment of the Food Quality Protection Act of 1996 [Aug.
3, 1996], for the submission of data under section 4 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 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 6(f)(1).
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 6(f)(2). 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 effects 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 cause to the registrant by
multiple requirements on the registrant.

The Administrator may enter into a cooperative agreement with a

State to carry out subclause (I).

Not later than 1 year after the date of enactment of this clause, 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 the date of
enactment of this subparagraph [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—

submit or cite data pertaining to such purchased product; or

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) TIME FOR ACTING WITH RESPECT TO APPLICATION.—

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 Act in accordance with paragraph (6).

IDENTICAL OR SUBSTANTIALLY SIMILAR.—(i) The Administrator shall, as
expeditiously as possible, review and act on any application received by
the Administrator that—

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

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—

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;

within 90 days after receiving a complete application, notify the
registrant if the application has been granted or denied; and

if the application is denied, notify the registrant in writing of the
specific reasons for the denial of the application.

MINOR USE REGISTRATION.—

The Administrator shall, as expeditiously as possible, review and act on
any complete application—

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

for a registration or a registration amendment that proposes significant
minor uses.

For the purposes of clause (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

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 18 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.

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.

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—

its composition is such as to warrant the proposed claims for it;

its labeling and other material required to be submitted comply with the
requirements of this Act;

it will perform its intended function without unreasonable adverse
effects on the environment; and

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 24(c) of
this Act, a presumption is established that the Administrator shall
waive data requirements pertaining to efficacy for use of the pesticide
in such State.

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 6.

(7) REGISTRATION UNDER SPECIAL CIRCUMSTANCES.—Notwithstanding the
provisions of paragraph (5)—

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 Act.

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 Act, 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 Act.

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 Act, 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.

INTERIM ADMINISTRATIVE REVIEW.—Notwithstanding any other provision of
this Act, 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 Act, 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.

LABELING.—

ADDITIONAL STATEMENTS.—Subject to subparagraphs (B) and (C), it shall
not be a violation of this Act 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.

REQUIREMENT S.—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.

NOTIFICATION AND DISAPPROVAL.—

NOTIFICATION.—A registration may be modified under subparagraph (A)
if—

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

the Administrator does not disapprove of the modification under clause
(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.

RESTRICTION ON SALE.—A registrant may not sell or distribute a product
bearing a disapproved modification.

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.

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 Act 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—

adequate data have been submitted to support the statement proposed for
the diluted solution uses; and

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 the date of enactment of this paragraph
[Aug. 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:

Reduce the risks of pesticides to human health.

Reduce the risks of pesticides to nontarget organisms.

Reduce the potential for contamination of groundwater, surface water, or
other valued environmental resources.

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.

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.

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:

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.

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 6(b).

(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 16 of
this Act.

(e) PRODUCTS WITH SAME FORMULATION AND CLAIM S.—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.—

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 Act.

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 Act. 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 Act.

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.

MIXTURES OF NITROGEN STABILIZERS AND FERTILIZER PRODUCTS.—Any mixture
or other combination of—

1 or more nitrogen stabilizers registered under this Act; and

1 or more fertilizer products,

shall not be subject to the provisions of this section or sections 4, 5,
7, 15, and 1 7(a)(2) if the mixture or other combination is accompanied
by the labeling required under this Act 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)(A) GENERAL RULE.—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 6.

(B) LIMITATION.—Nothing in this subsection shall prohibit the
Administrator from undertaking any other review of a pesticide pursuant
to this Act.

(2)(A) DATA.—The Administrator shall use the authority in subsection
(c)(2)(B) 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) 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 reforms to the
antimicrobial registration process that would evaluate the risks, the
Administrator shall identify and reduce review periods existing as of
the date

of enactment of product registration applications and applications for
amended this subsection [Aug. 3, 1996] for antimicrobial pesticide
registration of antimicrobial pesticide products, including—

new antimicrobial active ingredients;

new antimicrobial end-use products;

substantially similar or identical antimicrobial pesticides; and

amendments to antimicrobial pesticide registrations.

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—

540 days for a new antimicrobial active ingredient pesticide
registration;

270 days for a new antimicrobial use of a registered active ingredient;

120 days for any other new antimicrobial product;

90 days for a substantially similar or identical antimicrobial product;

90 days for an amendment to an antimicrobial registration that does not
require scientific review of data; and

120 days for an amendment to an antimicrobial registration that requires
scientific review of data and that is not otherwise described in this
paragraph.

IMPLEMENTATION.—

(A) PROPOSED RULEMAKING.—

ISSUANCE.—Not later than 270 days after the date of enactment of this
subsection [Aug. 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).

REQUIREMENTS.—Proposed regulations issued under clause (i) shall—

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 organisms, or protect inanimate objects, industrial
growth or development of microbiological processes or systems, surfaces,
water, or other chemical substances from contamination, fouling, or
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or
slime;

differentiate the types of review undertaken for antimicrobial
pesticides;

conform the degree and type of review to the risks and benefits
presented by antimicrobial pesticides and the function of review under
this Act, considering the use patterns of the product, toxicity,
expected exposure, and product type;

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.

FINAL REGULATIONS.—

ISSUANCE.—The Administrator shall issue final regulations not later
than 240 days after the close of the comment period for the proposed
regulations.

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.

REQUIREMENT S.—In issuing final regulations, the Administrator
shall—

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;

consider the establishment of a certification process by approved
laboratories as an adjunct to the review process;

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

clarify criteria for determination of the completeness of an
application.

EXPEDITED REVIEW.—This subsection does not affect the requirements or
extend the deadlines or review periods contained in subsection (c)(3).

ALTERNATIVE REVIEW PERIODS.—If the final regulations to carry out

this paragraph are not effective 630 days after the date of enactment of
this subsection

[Aug. 3, 1996], until the final regulations become effective, the
re-view period,

beginning on the date of receipt by the Agency of a complete
application, shall be—

2 years for a new antimicrobial active ingredient pesticide
registration;

1 year for a new antimicrobial use of a registered active ingredient;

180 days for any other new antimicrobial product;

90 days for a substantially similar or identical antimicrobial product;

90 days for an amendment to an antimicrobial registration that does not
require scientific review of data; and

120 days for an amendment to an antimicrobial registration that requires

scientific review of data and that is not otherwise described in this
subparagraph.

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 2(mm) 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.—

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.

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,
United States Code.

EXEMPTION.—This subparagraph does not apply to an application for an
antimicrobial pesticide that is filed under subsection (c)(3)(B) prior
to 90 days after the date of enactment of this subsection [Aug. 3,
1996].

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—

the time period specified in subparagraph (D)(vi), in the absence of a

final regulation under subparagraph (B); or

the time period specified in paragraph (2)(F), if adopted in a final
regulation under subparagraph (B).

(4) ANNUAL REPORT.—

SUBMISSION.—Beginning on the date of enactment of this subsection
[Aug. 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 Committee
on Agriculture, Nutrition, and Agriculture of the House of
Representatives and the Forestry of the Senate.

REQUIREMENTS.—A report submitted under subparagraph (A) shall include
a description of—

measures taken to reduce the backlog of pending registration
applications;

progress toward achieving reforms under this subsection; and

recommendations to improve the activities of the Agency pertaining to
antimicrobial registrations.

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