[Title 40 CFR 154]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY--(Continued)]
[Subchapter E - PESTICIDE PROGRAMS]
[Part 154 - SPECIAL REVIEW PROCEDURES]
[From the U.S. Government Publishing Office]




  40
  PROTECTION OF ENVIRONMENT
  11
  1996-07-01
  1996-07-01
  false
  
  154
  PART 154
  
    PROTECTION OF ENVIRONMENT
    ENVIRONMENTAL PROTECTION AGENCY--(Continued)
    PESTICIDE PROGRAMS
  


PART 154--SPECIAL REVIEW PROCEDURES--Table of Contents




                      Subpart A--General Provisions

Sec.
154.1  Purpose and scope.
154.3  Definitions.
154.5  Burden of persuasion in determinations under this part.
154.7  Criteria for initiation of Special Review.
154.10  Petitions to begin the Special Review process.
154.15  Docket for the Special Review.

                          Subpart B--Procedures

154.21  Preliminary notification to registrants and applicants for 
          registration.
154.23  Proposed decision not to initiate a Special Review.
154.25  Public announcement of final decision whether to initiate a 
          Special Review.
154.26  Comment opportunity.
154.27  Meetings with interested persons.
154.29  Informal public hearings.
154.31  Notice of Preliminary Determination.
154.33  Notice of Final Determination.

[[Page 44]]

154.34  Expedited procedures.
154.35  Finality of determinations.

    Authority: 15 U.S.C. 136a, d, and w.

    Source: 50 FR 49015, Nov. 27, 1985, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 154.1  Purpose and scope.

    (a) Purpose. The purpose of the Special Review process is to help 
the Agency determine whether to initiate procedures to cancel, deny, or 
reclassify registration of a pesticide product because uses of that 
product may cause unreasonable adverse effects on the environment, in 
accordance with sections 3(c)(6) and 6 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). The process is intended to 
ensure that the Agency assesses risks that may be posed by pesticides, 
and the benefits of use of those pesticides, in an open and responsive 
manner. The issuance of a Notice of Special Review means that the Agency 
has determined that one or more uses of a pesticide may pose significant 
risks and that, following completion of the Special Review process, the 
Agency expects to initiate formal proceedings seeking to cancel, deny, 
reclassify, or require modifications to the registration of the 
product(s) in question unless it has been shown during the Special 
Review that the Agency's initial determination was erroneous, that the 
risks can be reduced to acceptable levels without the need for formal 
proceedings, or that the benefits of the pesticide's use outweigh the 
risks. Following completion of the Special Review process, a pesticide 
in question may be returned to the registration process.
    (b) Scope. This part sets forth the substantive standards for 
initiating a Special Review of a pesticide product and the procedures 
for initiating and conducting the Special Review.



Sec. 154.3  Definitions.

    (a) Except as otherwise defined in this section, terms defined in 
section 2 of FIFRA shall have the same definitions for purposes of this 
part.
    (b) The term Act or FIFRA means the Federal Insecticide, Fungicide, 
and Rodenticide Act, as amended, 7 U.S.C. 136 et seq.
    (c) The term Administrator means the Administrator of the 
Environmental Protection Agency or any officer or employee thereof to 
whom authority has been delegated to act for the Administrator.
    (d) The term confidential business information means trade secrets 
or confidential commercial or financial information under FIFRA section 
10(b) or 5 U.S.C. 552(b) (3) or (4).
    (e) The term other significant evidence means factually significant 
information that relates to the uses of the pesticide and their adverse 
risk to man or to the environment but does not include evidence based 
only on misuse of the pesticide unless such misuse is widespread and 
commonly recognized practice.
    (f) The term person means an applicant, registrant, manufacturer, 
pesticide user, environmental group, labor union, or other individual or 
group of individuals interested in pesticide regulation.
    (g) The term pesticide use means a use of a pesticide (discribed in 
terms of the application site and other applicable identifying factors) 
that is included in the labeling of a pesticide product which is 
registered, or for which an application for registration is pending, and 
the terms and conditions (or proposed terms and conditions) of 
registration for the use.
    (h) Terms and conditions of registration means the terms and 
conditions governing lawful sale, distribution, and use approved in 
conjunction with registration, including labeling, use classification, 
composition, and packaging.
    (i) The term validated test means a test determined by the Agency to 
have been conducted and evaluated in a manner consistent with accepted 
scientific procedures



Sec. 154.5  Burden of persuasion in determinations under this part.

    In making determinations under this part the Administrator shall be 
guided by the principle that the burden of persuasion that a pesticide 
product is entitled to registration or continued registration for any 
particular use or under any particular set of terms and

[[Page 45]]

conditions of registration is always on the proponent(s) of 
registration.



Sec. 154.7  Criteria for initiation of Special Review.

    (a) The Administrator may conduct a Special Review of a pesticide 
use if he determines, based on a validated test or other significant 
evidence, that the use of the pesticide (taking into account the 
ingredients, impurities, metabolites, and degradation products of the 
pesticide):
    (1) May pose a risk of serious acute injury to humans or domestic 
animals.
    (2) May pose a risk of inducing in humans an oncogenic, heritable 
genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or 
delayed toxic effect, which risk is of concern in terms of either the 
degree of risk to individual humans or the number of humans at some 
risk, based upon:
    (i) Effects demonstrated in humans or experimental animals.
    (ii) Known or predicted levels of exposure of various groups of 
humans.
    (iii) The use of appropriate methods of evaluating data and relating 
such data to human risk.
    (3) May result in residues in the environment of nontarget organisms 
at levels which equal or exceed concentrations acutely or chronically 
toxic to such organisms, or at levels which produce adverse reproductive 
effects in such organisms, as determined from tests conducted on 
representative species or from other appropriate data.
    (4) May pose a risk to the continued existence of any endangered or 
threatened species designated by the Secretary of the Interior or the 
Secretary of Commerce under the Endangered Species Act of 1973, as 
amended.
    (5) May result in the destruction or other adverse modification of 
any habitat designated by the Secretary of the Interior or the Secretary 
of Commerce under the Endangered Species Act as a critical habitat for 
any endangered or threatened species.
    (6) May otherwise pose a risk to humans or to the environment which 
is of sufficient magnitude to merit a determination whether the use of 
the pesticide product offers offsetting social, economic, and 
environmental benefits that justify initial or continued registration.
    (b) In making any determination that a pesticide use satisfies one 
of the criteria for issuance of a Special Review specified by paragraph 
(a) of this section, the Administrator shall consider available evidence 
concerning both the adverse effect in question and the magnitude and 
scope of exposure of humans and nontarget organisms associated with use 
of the pesticide.



Sec. 154.10  Petitions to begin the Special Review process.

    The Administrator may evaluate a pesticide use under the criteria of 
Sec. 154.7 either on his own initiative, or at the suggestion of any 
interested person.



Sec. 154.15  Docket for the Special Review.

    (a) Establishment of the docket. When the Agency first notifies 
registrants privately that it is considering issuance of a Notice of 
Special Review for a pesticide, it shall establish a docket concerning 
that particular pesticide.
    (b) Contents of the docket. For each pre-Special Review or Special 
Review, the docket shall contain:
    (1) The Notice of Special Review, any Notice of Preliminary 
Determination, and any Notice of Final Determination.
    (2) Any notice issued under Sec. 154.21 or Sec. 154.23.
    (3) Any documents (other than information claimed to be confidential 
business information) referred to by the Agency in those notices as 
relied upon by the Agency in reaching its determination.
    (4) Copies of all written comments or materials (other than 
information claimed to be confidential business information) responding 
to any notice furnished under Sec. 154.21 or Sec. 154.23 or submitted at 
any time during the Special Review process by any person outside of 
government.
    (5) Any written response to the Notice of Preliminary Determination 
from the Secretary of Agriculture or the Scientific Advisory Panel.
    (6) A transcript of all public meetings held by the Scientific 
Advisory Panel or conducted by the Agency for the purpose of gathering 
information.

[[Page 46]]

    (7) A memorandum describing each meeting between Agency personnel 
and any person or party outside of government which concerns a pending 
pre-Special Review or Special Review decision. Each such memorandum 
shall be based on notes taken at the meeting and shall specify the date 
and time of the meeting, the participants and their affiliations, who 
requested the meeting, the subject matter of the meeting, and the person 
who prepared the memorandum. Except for information claimed to be 
confidential business information, each memorandum shall describe fully 
and accurately all significant positions taken, arguments made, and 
facts presented by each participant in the meeting, and shall identify 
all documents, proposals, or other materials distributed or exchanged at 
the meeting. Any discussion of claimed confidential business information 
shall be identified in meeting notes and referenced in the memorandum.
    (8) All comments, correspondence, or other materials concerning a 
pending pre-Special Review or Special Review decision provided to the 
Agency by a person or party outside of government (other than 
information claimed to be confidential business information).
    (9) All documents, proposals, or other materials concerning a 
pending pre-Special Review or Special Review decision, provided by the 
Agency to any person or party outside of government (other than 
information claimed to be confidential business information).
    (c) Assertion of confidential business information claims. (1) 
Information, comments, data, or other written material submitted to the 
Agency concerning a Special Review may be claimed by the submitter to be 
confidential business information. The burden of identifying claimed 
confidential business information rests with the submitter, or, in 
meetings, with the participants who wish to assert a claim of 
confidentiality.
    (2) To assert a claim of confidentiality for all or any part of a 
written submission concerning a Special Review, the submitter must 
furnish three copies of the material. Two copies must be complete, with 
claimed confidential business information clearly marked in the text. 
Items in the document that are claimed confidential should be numbered 
consecutively throughout the text. The third copy must have the claimed 
confidential business information excised from the text without closing 
up or paraphrasing the remaining text. The deletions should be 
consecutively numbered to correspond to the numbering of the complete 
copies. Each copy must be marked on the cover as to whether it contains 
claimed confidential business information.
    (3) Any written material concerning a Special Review received by the 
Agency that is not marked as confidential will be deemed to be 
nonconfidential, and may be made available through the public docket or 
otherwise disclosed without prior notice to the submitter.
    (d) Placement of materials in the docket. Any memorandum identified 
under paragraph (b)(7) of this section shall be placed in the docket 
within 10 working days of the subject meeting. Materials identified 
under paragraph (b)(8) of this section shall be placed in the docket 
within 10 working days of receipt by the Office of Pesticide Programs, 
or within 15 working days of receipt by the Office of Pesticide Programs 
if the submitter has asserted a confidential business information claim 
concerning the submittal. Materials identified under paragraph (b)(9) of 
this section shall be placed in the docket within 15 working days of 
transmittal to such person or party outside of government.
    (e) Index. The Agency shall prepare and maintain a current index of 
all materials included in the docket. The index will include a list 
identifying, for each meeting between Agency personnel and a person or 
party outside of government for which a memorandum has been prepared, 
the date, the subject, participants, and person who requested the 
meeting. The index will also list any document included in the docket by 
its title, its source, its recipient, and the date it was received or 
provided by the Agency.
    (f) Access to the docket. (1)(i) For each chemical in Special 
Review, the docket shall be available for public inspection and copying 
and its index kept current and made available to the public on request. 
The docket and index for any pesticide for which the Agency has issued a 
pre-Special Review notification

[[Page 47]]

under Sec. 154.21 will only be made available for public inspection and 
copying following issuance of a proposed decision not to start a Special 
Review under Sec. 154.23, a Notice of Special Review under 
Sec. 154.25(c), or as otherwise specified in Sec. 154.34.
    (ii) The docket and index will be available at the Program 
Management and Support Division, in Rm. 236, CM2, 1921 Jefferson Davis 
Highway, Arlington, VA, from 8 a.m. to 4 p.m. Monday through Friday, 
excluding legal holidays.
    (2) Information contained in the docket shall not be disclosed to 
the public to the extent that FIFRA or any other statute or regulation 
(including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its 
disclosure.
    (3) The Agency will distribute a compendium of indices for new 
materials in the public docket by mail, on a monthly basis, to those 
members of the public who have specifically requested such material. The 
Agency will announce the availability of docket indices both annually in 
the Federal Register and in each Federal Register Notice concerning pre-
Special Review or Special Review for specific pesticides. The Agency may 
also periodically require parties on the mailing list to renew their 
previous request for such materials.



                          Subpart B--Procedures



Sec. 154.21  Preliminary notification to registrants and applicants for registration.

    (a) Preliminary notification. If the Administrator decides that he 
may initiate a Special Review of a pesticide use, he shall send written 
notice by certified mail to the affected registrant(s) and applicant(s) 
setting forth his decision and a general description of the information 
which supports it.
    (b) Comment opportunity. Registrant(s) and applicant(s) will be 
allowed 30 days from the receipt of notification to respond in writing 
to dispute the validity of the Agency's conclusions or to present 
information in response to the notification.



Sec. 154.23  Proposed decision not to initiate a Special Review.

    If the Administrator proposes not to initiate a Special Review after 
having given notice under Sec. 154.21, he shall issue a proposed 
decision for publication in the Federal Register. The proposal shall 
include a description of the concerns which were the original basis for 
placement of the pesticide in pre-Special Review status and the Agency's 
rationale for its proposed decision, announce the availability of a 
public docket, and provide a period generally not less than 30 days for 
submission of comments. A notice under Sec. 154.25(b) may not be 
published unless it has been preceded by a notice under this section. A 
proposal under this section shall not be based on the benefits of use of 
a pesticide product.



Sec. 154.25  Public announcement of final decision whether to initiate a Special Review.

    (a) The Administrator shall evaluate the available information and 
the comments received in response to the notice under Sec. 154.21 and 
any notice issued under Sec. 154.23, and shall issue for publication in 
the Federal Register a notice under paragraph (b) or (c) of this 
section.
    (b) If the Administrator determines after having given notice under 
Sec. 154.21 not to initiate a Special Review, he shall issue his 
decision for publication in the Federal Register with a statement of 
reasons.
    (c) If the Administrator determines after having given notice under 
Sec. 154.21 that one or more of the risk criteria set forth in 
Sec. 154.7 have been satisfied, the Agency shall issue a notice for 
publication in the Federal Register which shall include:
    (1) Identification of the pesticide uses for which a Special Review 
has been initiated and an identification of the criteria which have been 
satisfied.
    (2) A brief discussion of the Agency's reasons for determining that 
the criteria have been satisfied.
    (3) A statement indicating that EPA has established a docket for the 
Special Review, the contents of the docket, the location of the docket, 
and the times during which the docket will be available for inspection 
and copying.

[[Page 48]]

    (4) An invitation to all interested persons to submit further 
information concerning the risks and benefits associated with each use 
of the pesticide subject to the Special Review.
    (5) A brief description of the Special Review process and a 
statement that registrants and applicants bear an affirmative burden of 
supporting registration of a pesticide product.
    (6) A date by which information in response to the Agency's request 
for further information must be submitted.
    (d) In his discretion, the Administrator may request that the 
Scientific Advisory Panel hold a public meeting to review the scientific 
issues related to the Special Review.



Sec. 154.26  Comment opportunity.

    After issuance of a Notice of Special Review that applies to a use 
of a pesticide product (or category of products), any person may submit 
to the Agency any information, argument, or both, pertinent to:
    (a) Whether the use of a pesticide product satisfies any of the 
Sec. 154.7 risk criteria, with respect to the composition, labeling, 
packaging, and restrictions on use of the product as currently 
registered.
    (b) Whether the use of a pesticide product would satisfy any of the 
Sec. 154.7 risk criteria if its composition, labeling, packaging, and 
restrictions on use were approved in accordance with an application for 
registration or amended registration pending before the Agency. For 
further information see Sec. 154.27(b).
    (c) Whether any risks posed by the use or proposed use of the 
product that satisfy the Sec. 154.7 risk criteria are unreasonable, 
taking into account the economic, social, and environmental costs and 
benefits of the use of the product.
    (d) What regulatory action, if any, the Agency should take with 
respect to the use of the product.



Sec. 154.27  Meetings with interested persons.

    (a) In the Special Review process, to assure openness and 
responsiveness, no person or party outside of government will be 
afforded special or preferential access to Agency Special Review 
decisionmakers or to the Agency's Special Review process. At the same 
time, however, Agency personnel are free to meet and otherwise 
communicate with persons or parties outside of government, including 
registrants and manufacturers, users, trade unions, environmental groups 
and other interested persons, to obtain information, exchange views, 
explore factual and substantive positions, or discuss regulatory options 
concerning Special Review decisions.
    (b) Meetings between EPA and any person or party outside of 
government will not result in undue delay in reaching Special Review 
decisions. During such meetings, the Agency will not commit to take any 
particular action concerning a pending decision. The Agency may receive 
and consider information and recommendations from persons or parties 
outside of government; however, the Agency will make the final 
administrative decision on a wholly independent basis and in accordance 
with law.
    (c) Any interested person may ask to meet with Agency officials to 
discuss factual information available to the Agency, to present any 
factual information, to respond to presentations by other persons, or to 
discuss what regulatory actions should be taken regarding a pesticide 
which is or may be the subject of a Special Review. If, at its 
discretion, the Agency holds such meetings with any person outside of 
government concerning a use of a pesticide product, the Agency will 
prepare and file in the docket a memorandum of such meeting, meeting the 
requirements specified in Sec. 154.15(b)(7).
    (d) Meetings described in this section may include meetings held 
after issuance of a Notice of Special Review with any registrant who 
proposes to change voluntarily the composition, packaging, and labeling, 
or other terms and conditions of registration of his pesticide product 
in a way which he believes would reduce the risks of use of the product 
so that it would no longer meet or exceed the risk criteria of 
Sec. 154.7. Meetings for this purpose will be most helpful and 
productive for both registrants and the Agency if they are requested by 
registrants shortly after

[[Page 49]]

the issuance of the Notice of Special Review.
    (e) If the Agency meets with any person or party outside of 
government concerning a pending Special Review decision, the Agency will 
not issue a final Special Review decision until 30 days after inclusion 
of a memorandum concerning that meeting in the public docket. During 
those 30 days, any person or party may submit written comments to the 
Agency regarding the subject matter of the meeting in question. The 
Agency may issue a final Special Review decision without allowing this 
30-day period if expedited action is necessary to protect public health 
or the environment, or if the Agency has invited other parties with 
potentially opposing viewpoints to the meeting in question (e.g., 
registrants, users, labor, and environmental groups).
    (f) The Agency may decline to meet subsequently with any person or 
party who asserts unreasonable confidential business information claims 
pursuant to Sec. 154.15(c) for the purpose of circumventing the 
docketing procedures described in Sec. 154.15(b).



Sec. 154.29  Informal public hearings.

    (a) Timing. At any time after issuance of a Notice of Special Review 
and prior to issuance of a Notice of Final Determination, the 
Administrator may conduct an informal public hearing to gather relevant 
information or otherwise assist Agency decisionmaking.
    (b) Federal Register notice. The Administrator shall issue a notice 
for publication in the Federal Register of any informal public hearing 
to be held under this section. The notice shall contain the following 
information:
    (1) The time, date, and place of the hearing.
    (2) A brief description of the procedures governing participation in 
the hearing by interested persons.
    (3) The issues to be considered at the hearing.
    (c) Transcript. A verbatim transcript of the hearing shall be 
prepared and filed in the public docket.



Sec. 154.31  Notices of Preliminary Determination.

    The Administrator shall prepare a Notice of Preliminary 
Determination after the close of the comment period on a Notice of 
Special Review.
    (a) Contents of notice. The Notice of Preliminary Determination 
shall respond to all significant comments submitted in response to the 
Notice of Special Review. For each use of a pesticide product that was 
the subject of the Notice of Special Review, the Notice of Preliminary 
Determination shall also include, as appropriate:
    (1) A determination whether the use satisfies any of the risk 
criteria set forth in Sec. 154.7, and a discussion of the reasons for 
the determination.
    (2) A determination of whether any changes in the composition, 
packaging, labeling, or restrictions on use of a pesticide product that 
were proposed in an application for new or amended registration 
submitted after issuance of the Notice of Special Review would reduce 
the risk so that the use no longer would satisfy any of the risk 
criteria in Sec. 154.7.
    (3) If the use satisfies any of the risk criteria set forth in 
Sec. 154.7, a determination of whether the adverse effects posed by the 
use are unreasonable, taking into account the economic, social, and 
environmental costs and benefits of the use of the product, and a 
discussion of reasons for the determination.
    (4) If the use is determined to pose an unreasonable adverse effect, 
a statement of the regulatory action, if any, which the Agency intends 
to initiate with respect to the use, and a discussion of the reasons for 
initiating that regulatory action.
    (5) A statement that the Administrator is requesting comments from 
the Secretary of Agriculture and the Scientific Advisory Panel on the 
notices and analysis specified in paragraph (b) of this section, and 
that the notices and analysis are available on request.
    (6) Instructions to interested persons on how to submit comments 
(including the deadline for submission of comments).
    (7) The location of the docket under Sec. 154.15 and the times 
during which the

[[Page 50]]

docket will be available for inspection and copying.
    (b) Referral to Secretary of Agriculture and Scientific Advisory 
Panel. If the Administrator proposes to cancel, deny, or change the 
classification of the registration of a pesticide product which is the 
subject of a Special Review, or to hold a hearing under FIFRA section 
6(b)(2) on whether to take any of those actions, he shall:
    (1) Prepare a proposed form of a Notice of Intent to Cancel, a 
Notice of Intent to Deny Registration, a Notice of Intent to Hold a 
Hearing, and/or a Notice of Intent to Change Classification, as 
appropriate.
    (2) Prepare an Agricultural Impact Analysis, analyzing the impact of 
the proposed action on production and prices of agricultural 
commodities, retail food prices, and otherwise on the agricultural 
economy.
    (3) Send the proposed notices and analysis to the Secretary of 
Agriculture and the Scientific Advisory Panel for comment, as provided 
by the Act.
    (4) Send the Notice of Preliminary Determination and the other 
notices and analysis prepared under this section to all registrants and 
applicants for registration of products that are subject to the Special 
Review.
    (c) Publication. The Agency shall issue the Notice of Preliminary 
Determination for publication in the Federal Register.



Sec. 154.33  Notice of Final Determination.

    (a) Publication and notice to registrants and applicants. The 
Administrator shall prepare a Notice of Final Determination after the 
close of the comment period on a Notice of Preliminary Determination. As 
necessary, the Administrator shall also prepare Notices of Intent to 
Cancel, Notices of Denial, Notices of Intent to Hold a Hearing under 
FIFRA section 6(b)(2), or Notices of Intent to Change Classification.
    (b) Contents. The Notice of Final Determination shall include:
    (1) For each pesticide use subject to the Notice of Preliminary 
Determination, the Agency's final determination with respect to each 
use, along with a discussion of the reasons for the determination.
    (2) Any comments submitted by the Secretary of Agriculture or the 
Scientific Advisory Panel, and the responses of the Administrator to 
these comments.
    (3) The response of the Administrator to any significant public 
comments submitted on the Notice of Preliminary Determination.
    (4) Instructions to registrants, applicants for registration, and 
other interested persons concerning the procedures which will be used to 
implement any regulatory action which the Administrator has decided 
upon, including instructions concerning how to request hearings, if 
hearings are available as of right under the Act or have been made 
available by the Administrator under the Act.
    (5) The location of the docket under Sec. 154.15 and the times 
during which the docket will be available for inspection and copying.
    (c) Publication and notification of registrants and applicants. The 
Notice of Final Determination and any Notice of Intent to Cancel, Notice 
of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to 
Change Classification shall be published in the Federal Register. If the 
Administrator issues a Notice of Intent to Cancel, Notice of Denial, 
Notice of Intent to Hold a Hearing, or Notice of Intent to Change 
Classification, such notice, along with the Notice of Final 
Determination, also shall be sent by certified mail to all affected 
registrants and applicants.



Sec. 154.34  Expedited procedures.

    (a) The Agency may elect to issue a Notice of Special Review and a 
Notice of Preliminary Determination simultaneously; or, to initiate 
cancellation, suspension, or denial proceedings concerning a pesticide 
or any of its uses without first conducting a Special Review or issuing 
a Notice of Preliminary Determination.
    (b) If the Agency elects to issue a simultaneous Notice of Special 
Review and Notice of Preliminary Determination, the Agency will make the 
docket for that decision available for public inspection no more than 3 
months after the Agency privately notifies the registrant of its risk 
concerns pursuant to Sec. 154.21(a).

[[Page 51]]



Sec. 154.35  Finality of determinations.

    (a) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposes registration of a product for a use 
which earlier had been the subject of a notice under Sec. 154.21(a);
    (2) After the Administrator issued the notice, he determined not to 
initiate a Special Review, because of a proposal by an applicant for 
registration or amended registration to change the terms and conditions 
of registration of the product in a way which would reduce the risk 
sufficiently to eliminate the need for a Special Review; and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions which served as the basis of the 
earlier determination be eliminated, or be modified in a way which might 
increase the risk which was the subject of the notice under 
Sec. 154.21(a).
    (b) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposed registration of a product for a use 
which earlier had been the subject of a Notice of Special Review issued 
under Sec. 154.25;
    (2) After the Administrator issued that Notice, he determined not to 
issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal 
by an applicant for registration or amended registration to change the 
terms and conditions of registration of the product in a way which would 
reduce the risk sufficiently to eliminate the need for issuance of a 
notice under FIFRA section 3(c)(6) or 6(b); and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions of registration which served as 
the basis for the earlier determination now be eliminated or be modified 
in a way which might increase the risk which was the subject of the 
Notice of Special Review.
    (c) An application to which paragraph (a) or (b) of this section 
applies may not be approved until:
    (1) The Administrator issues a notice for publication in the Federal 
Register which describes why the application is subject to the 
provisions of this section, states that the Administrator proposes to 
approve the application and his reasons, solicits public comment on 
whether the application should be approved, and provides a period not 
less than 30 days for comments to be submitted; and
    (2) If any substantive comments are submitted in response to the 
notice, the Administrator issues a second notice for publication in the 
Federal Register responding to the comments.