`[Congressional Record Volume 158, Number 124 (Friday, September 14, 2012)]
[House]
[Pages H6024-H6042]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




        PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF 2012

  Mr. LUCAS. Mr. Speaker, I ask unanimous consent to take from the 
Speaker's table the bill (S. 3552) to reauthorize the Federal 
Insecticide, Fungicide, and Rodenticide Act, and ask for its immediate 
consideration in the House.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore (Mr. Nugent). Is there objection to the 
request of the gentleman from Oklahoma?

[[Page H6025]]

  There was no objection.
  The text of the bill is as follows:

                                S. 3552

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Pesticide Registration 
     Improvement Extension Act of 2012''.

     SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT.

       (a) Maintenance Fees.--
       (1) Fees.--Section 4(i) of the Federal Insecticide, 
     Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)) is 
     amended--
       (A) in paragraph (5)--
       (i) in subparagraph (C), by striking ``aggregate amount 
     of'' and all that follows through the end of the subparagraph 
     and inserting ``aggregate amount of $27,800,000 for each of 
     fiscal years 2013 through 2017.'';
       (ii) in subparagraph (D)--

       (I) in clause (i), by striking ``shall be'' and all that 
     follows through the semicolon and inserting ``shall be 
     $115,500 for each of fiscal years 2013 through 2017;''; and
       (II) in clause (ii), by striking ``shall be'' and all that 
     follows through the period and inserting ``shall be $184,800 
     for each of fiscal years 2013 through 2017.'';

       (iii) in subparagraph (E)(i)--

       (I) in subclause (I), by striking ``shall be'' and all that 
     follows through the semicolon and inserting ``shall be 
     $70,600 for each of fiscal years 2013 through 2017;''; and
       (II) in subclause (II), by striking ``shall be'' and all 
     that follows through the period and inserting ``shall be 
     $122,100 for each of fiscal years 2013 through 2017.'';

       (iv) in subparagraph (F)--

       (I) by striking ``paragraph (3)'' and inserting ``this 
     paragraph''; and
       (II) by striking ``Humans'' and inserting ``Human'';

       (v) by redesignating subparagraphs (F) through (H) as 
     subparagraphs (G) through (I), respectively;
       (vi) by inserting after subparagraph (E) the following:
       ``(F) Fee reduction for certain small businesses.--
       ``(i) Definition.--In this subparagraph, the term 
     `qualified small business entity' means a corporation, 
     partnership, or unincorporated business that--

       ``(I) has 500 or fewer employees;
       ``(II) during the 3-year period prior to the most recent 
     maintenance fee billing cycle, had an average annual global 
     gross revenue from all sources that did not exceed 
     $10,000,000; and
       ``(III) holds not more than 5 pesticide registrations under 
     this paragraph.

       ``(ii) Waiver.--Except as provided in clause (iii), the 
     Administrator shall waive 25 percent of the fee under this 
     paragraph applicable to the first registration of any 
     qualified small business entity under this paragraph.
       ``(iii) Limitation.--The Administrator shall not grant a 
     waiver under clause (ii) to a qualified small business entity 
     if the Administrator determines that the entity has been 
     formed or manipulated primarily for the purpose of qualifying 
     for the waiver.''; and
       (vii) in subparagraph (I) (as redesignated by clause (v)), 
     by striking ``2012'' and inserting ``2017'';
       (B) in paragraph (6)--
       (i) by striking ``2014'' and inserting ``2019''; and
       (ii) by striking ``paragraphs (1) through (5)'' and 
     inserting ``paragraph (1)'';
       (C) by striking paragraphs (1), (2), (3), (4), and (7); and
       (D) by redesignating paragraphs (5) and (6) as paragraphs 
     (1) and (2), respectively.
       (2) Conforming amendments.--
       (A) Section 4 of the Federal Insecticide, Fungicide, and 
     Rodenticide Act (7 U.S.C. 136a-1) is amended--
       (i) in subsection (d)(5)(B)(ii)(III), by striking 
     ``subsection (i)(1)'' and inserting ``this section'';
       (ii) in subsection (j), by striking ``subsection (i)(5)'' 
     and inserting ``subsection (i)(1)''; and
       (iii) in subsection (k)(5)--

       (I) in the first sentence, by striking ``subsection 
     (i)(5)(C)(ii)'' and inserting ``subsection (i)(1)(C)(ii)''; 
     and
       (II) in the third and sixth sentences, by striking 
     ``subsection (i)(5)(C)'' each place it appears and inserting 
     ``subsection (i)(1)(C)''.

       (B) Section 33(b)(7)(F) of the Federal Insecticide, 
     Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)(7)(F)) is 
     amended--
       (i) by striking ``section 4(i)(5)(E)(ii)'' each place it 
     appears in clauses (i), (ii)(I), and (iv)(I) and inserting 
     ``section 4(i)(1)(E)(ii)'';
       (ii) by striking ``section 4(i)(5)(E)(ii)(I)(bb)'' each 
     place it appears in clauses (ii)(II) and (iv)(II) and 
     inserting ``section 4(i)(1)(E)(ii)(I)(bb)''; and
       (iii) in clause (iv)(II)--

       (I) by striking ``applicable.'' and inserting 
     ``applicable''; and
       (II) by striking ``revenues'' and inserting ``revenue''.

       (3) Extension of prohibition on tolerance fees.--Section 
     408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 346a(m)(3)) is amended by striking ``September 30, 
     2012'' and inserting ``September 30, 2017''.
       (4) Reregistration and expedited processing fund.--
       (A) Source and use.--Section 4(k)(2)(A) of the Federal 
     Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-
     1(k)(2)(A)) is amended--
       (i) by inserting ``, to enhance the information systems 
     capabilities to improve the tracking of pesticide 
     registration decisions,'' after ``paragraph (3)'' each place 
     it appears; and
       (ii) in clause (i)--

       (I) by inserting ``offset'' before ``the costs of 
     reregistration''; and
       (II) by striking ``in the same portion as appropriated 
     funds''.

       (B) Expedited processing of similar applications.--Section 
     4(k)(3)(A) of the Federal Insecticide, Fungicide, and 
     Rodenticide Act (7 U.S.C. 136a-1(k)(3)(A)) is amended--
       (i) in the matter preceding clause (i), by striking ``2008 
     through 2012, between \1/8\ and \1/7\'' and inserting ``2013 
     through 2017, between \1/9\ and \1/8\'';
       (ii) in clause (i), by striking ``new''; and
       (iii) in clause (ii), by striking ``any application'' and 
     all that follows through ``that--'' and inserting ``any 
     application that--''.
       (C) Enhancements of information technology systems for 
     improvement in review of pesticide applications.--Section 
     4(k) of the Federal Insecticide, Fungicide, and Rodenticide 
     Act (7 U.S.C. 136a-1(k)) is amended--
       (i) by redesignating paragraphs (4) and (5) as paragraphs 
     (5) and (6), respectively;
       (ii) by inserting after paragraph (3) the following:
       ``(4) Enhancements of information technology systems for 
     improvement in review of pesticide applications.--
       ``(A) In general.--For each of fiscal years 2013 through 
     2017, the Administrator shall use not more than $800,000 of 
     the amounts made available to the Administrator in the 
     Reregistration and Expedited Processing Fund for the 
     activities described in subparagraph (B).
       ``(B) Activities.--The Administrator shall use amounts made 
     available from the Reregistration and Expedited Processing 
     Fund to improve the information systems capabilities for the 
     Office of Pesticide Programs to enhance tracking of pesticide 
     registration decisions, which shall include--
       ``(i) the electronic tracking of--

       ``(I) registration submissions; and
       ``(II) the status of conditional registrations;

       ``(ii) enhancing the database for information regarding 
     endangered species assessments for registration review;
       ``(iii) implementing the capability to electronically 
     review labels submitted with registration actions; and
       ``(iv) acquiring and implementing the capability to 
     electronically assess and evaluate confidential statements of 
     formula submitted with registration actions.''; and
       (iii) in the first sentence of paragraph (6) (as 
     redesignated by clause (i)), by striking ``to carry out the 
     goals established under subsection (l)'' and inserting ``for 
     the purposes described in paragraphs (2), (3), and (4) and to 
     carry out the goals established under subsection (l)''.
       (b) Pesticide Registration Service Fees.--
       (1) Amount of fees.--Section 33(b) of the Federal 
     Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
     8(b)) is amended--
       (A) by striking paragraph (3) and inserting the following:
       ``(3) Schedule of covered applications and registration 
     service fees.--Subject to paragraph (6), the schedule of 
     covered pesticide registration applications and corresponding 
     registration service fees shall be as follows:

                          ``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R010              1                New Active Ingredient, Food use (2) (3)     24                        569,221
----------------------------------------------------------------------------------------------------------------
R020              2                New Active Ingredient, Food use; reduced    18                        569,221
                                    risk (2) (3)
----------------------------------------------------------------------------------------------------------------

[[Page H6026]]

 
R040              3                New Active Ingredient, Food use;            18                        419,502
                                    Experimental Use Permit application;
                                    establish temporary tolerance; submitted
                                    before application for registration;
                                    credit 45% of fee toward new active
                                    ingredient application that follows (3)
----------------------------------------------------------------------------------------------------------------
R060              4                New Active Ingredient, Non-food use;        21                        395,467
                                    outdoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R070              5                New Active Ingredient, Non-food use;        16                        395,467
                                    outdoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R090              6                New Active Ingredient, Non-food use;        16                        293,596
                                    outdoor; Experimental Use Permit
                                    application; submitted before application
                                    for registration; credit 45% of fee
                                    toward new active ingredient (3)
----------------------------------------------------------------------------------------------------------------
R110              7                New Active Ingredient, Non-food use;        20                        219,949
                                    indoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R120              8                New Active Ingredient, Non-food use;        14                        219,949
                                    indoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R121              9                New Active Ingredient, Non-food use;        18                        165,375
                                    indoor; Experimental Use Permit
                                    application; submitted before application
                                    for registration; credit 45% of fee
                                    toward new active ingredient application
                                    that follows (3)
----------------------------------------------------------------------------------------------------------------
R122              10               Enriched isomer(s) of registered mixed-     18                        287,643
                                    isomer active ingredient (2) (3)
----------------------------------------------------------------------------------------------------------------
R123              11               New Active Ingredient, Seed treatment       18                        427,991
                                    only; includes agricultural and non-
                                    agricultural seeds; residues not expected
                                    in raw agricultural commodities (2) (3)
----------------------------------------------------------------------------------------------------------------
R125              12               New Active Ingredient, Seed treatment;      16                        293,596
New                                 Experimental Use Permit application;
                                    submitted before application for
                                    registration; credit 45% of fee toward
                                    new active ingredient application that
                                    follows (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                 ``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R130              13               First food use; indoor; food/food handling  21                        173,644
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
R140              14               Additional food use; Indoor; food/food      15                         40,518
                                    handling (3) (4)
----------------------------------------------------------------------------------------------------------------
R150              15               First food use (2) (3)                      21                        239,684
----------------------------------------------------------------------------------------------------------------
R160              16               First food use; reduced risk (2) (3)        16                        239,684
----------------------------------------------------------------------------------------------------------------
R170              17               Additional food use (3) (4)                 15                         59,976
----------------------------------------------------------------------------------------------------------------
R175              18               Additional food uses covered within a crop  10                         59,976
New                                 group resulting from the conversion of
                                    existing approved crop group(s) to one or
                                    more revised crop groups. (3) (4)
----------------------------------------------------------------------------------------------------------------
R180              19               Additional food use; reduced risk (3) (4)   10                         59,976
----------------------------------------------------------------------------------------------------------------

[[Page H6027]]

 
R190              20               Additional food uses; 6 or more submitted   15                        359,856
                                    in one application (3) (4)
----------------------------------------------------------------------------------------------------------------
R200              21               Additional food uses; 6 or more submitted   10                        359,856
                                    in one application; reduced risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R210              22               Additional food use; Experimental Use       12                         44,431
                                    Permit application; establish temporary
                                    tolerance; no credit toward new use
                                    registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R220              23               Additional food use; Experimental Use       6                          17,993
                                    Permit application; crop destruct basis;
                                    no credit toward new use registration (3)
                                    (4)
----------------------------------------------------------------------------------------------------------------
R230              24               Additional use; non-food; outdoor (3) (4)   15                         23,969
----------------------------------------------------------------------------------------------------------------
R240              25               Additional use; non-food; outdoor; reduced  10                         23,969
                                    risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R250              26               Additional use; non-food; outdoor;          6                          17,993
                                    Experimental Use Permit application; no
                                    credit toward new use registration (3)
                                    (4)
----------------------------------------------------------------------------------------------------------------
R251              27               Experimental Use Permit application which   8                          17,993
New                                 requires no changes to the tolerance(s);
                                    non-crop destruct basis (3)
----------------------------------------------------------------------------------------------------------------
R260              28               New use; non-food; indoor (3) (4)           12                         11,577
----------------------------------------------------------------------------------------------------------------
R270              29               New use; non-food; indoor; reduced risk     9                          11,577
                                    (3) (4)
----------------------------------------------------------------------------------------------------------------
R271              30               New use; non-food; indoor; Experimental     6                           8,820
                                    Use Permit application; no credit toward
                                    new use registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R273              31               Additional use; seed treatment; limited     12                         45,754
                                    uptake into raw agricultural commodities;
                                    includes crops with established
                                    tolerances (e.g., for soil or foliar
                                    application); includes food or non-food
                                    uses (3) (4)
----------------------------------------------------------------------------------------------------------------
R274              32               Additional uses; seed treatment only; 6 or  12                        274,523
                                    more submitted in one application;
                                    limited uptake into raw agricultural
                                    commodities; includes crops with
                                    established tolerances (e.g., for soil or
                                    foliar application); includes food and/or
                                    non-food uses (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


[[Page H6028]]


                       ``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R280              33               Establish import tolerance; new active      21                        289,407
                                    ingredient or first food use (2)
----------------------------------------------------------------------------------------------------------------
R290              34               Establish import tolerance; additional      15                         57,882
                                    food use
----------------------------------------------------------------------------------------------------------------
R291              35               Establish import tolerances; additional     15                        347,288
                                    food uses; 6 or more crops submitted in
                                    one petition
----------------------------------------------------------------------------------------------------------------
R292              36               Amend an established tolerance (e.g.,       11                         41,124
                                    decrease or increase); domestic or
                                    import; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R293              37               Establish tolerance(s) for inadvertent      12                         48,510
                                    residues in one crop; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R294              38               Establish tolerances for inadvertent        12                        291,060
                                    residues; 6 or more crops submitted in
                                    one application; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R295              39               Establish tolerance(s) for residues in one  15                         59,976
                                    rotational crop in response to a specific
                                    rotational crop application; applicant-
                                    initiated
----------------------------------------------------------------------------------------------------------------
R296              40               Establish tolerances for residues in        15                        359,856
                                    rotational crops in response to a
                                    specific rotational crop petition; 6 or
                                    more crops submitted in one application;
                                    applicant-initiated
----------------------------------------------------------------------------------------------------------------
R297              41               Amend 6 or more established tolerances      11                        246,744
New                                 (e.g., decrease or increase) in one
                                    petition; domestic or import; applicant-
                                    initiated
----------------------------------------------------------------------------------------------------------------
R298              42               Amend an established tolerance (e.g.,       13                         53,120
New                                 decrease or increase); domestic or
                                    import; submission of amended labels
                                    (requiring science review) in addition to
                                    those associated with the amended
                                    tolerance; applicant-initiated (3)
----------------------------------------------------------------------------------------------------------------
R299              43               Amend 6 or more established tolerances      13                        258,740
New                                 (e.g., decrease or increase); domestic or
                                    import; submission of amended labels
                                    (requiring science review) in addition to
                                    those associated with the amended
                                    tolerance; applicant-initiated (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                               ``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R300              44               New product; or similar combination         4                           1,434
                                    product (already registered) to an
                                    identical or substantially similar in
                                    composition and use to a registered
                                    product; registered source of active
                                    ingredient; no data review on acute
                                    toxicity, efficacy or CRP - only product
                                    chemistry data; cite-all data citation,
                                    or selective data citation where
                                    applicant owns all required data, or
                                    applicant submits specific authorization
                                    letter from data owner. Category also
                                    includes 100% re-package of registered
                                    end-use or manufacturing-use product that
                                    requires no data submission nor data
                                    matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------

[[Page H6029]]

 
R301              45               New product; or similar combination         4                           1,720
                                    product (already registered) to an
                                    identical or substantially similar in
                                    composition and use to a registered
                                    product; registered source of active
                                    ingredient; selective data citation only
                                    for data on product chemistry and/or
                                    acute toxicity and/or public health pest
                                    efficacy, where applicant does not own
                                    all required data and does not have a
                                    specific authorization letter from data
                                    owner. (2) (3)
----------------------------------------------------------------------------------------------------------------
R310              46               New end-use or manufacturing-use product    7                           4,807
                                    with registered source(s) of active
                                    ingredient(s); includes products
                                    containing two or more registered active
                                    ingredients previously combined in other
                                    registered products; requires review of
                                    data package within RD only; includes
                                    data and/or waivers of data for only:
                                    product chemistry and/or
                                     acute toxicity and/or
                                    public health pest efficacy and/
                                    or
                                    child resistant packaging. (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R314              47               New end use product containing two or more  8                           6,009
New                                 registered active ingredients never
                                    before registered as this combination in
                                    a formulated product; new product label
                                    is identical or substantially similar to
                                    the labels of currently registered
                                    products which separately contain the
                                    respective component active ingredients;
                                    requires review of data package within RD
                                    only; includes data and/or waivers of
                                    data for only:
                                    product chemistry and/or
                                    acute toxicity and/or
                                    public health pest efficacy and/
                                    or
                                    child resistant packaging. (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R315              48               New end-use non-food animal product with    9                           8,000
New                                 submission of two or more target animal
                                    safety studies; includes data and/or
                                    waivers of data for only:
                                    product chemistry and/or
                                    acute toxicity and/or
                                    public health pest efficacy and/
                                    or
                                    animal safety studies and/or
                                    child resistant packaging (2) (3)
----------------------------------------------------------------------------------------------------------------
R320              49               New product; new physical form; requires    12                         11,996
                                    data review in science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R331              50               New product; repack of identical            3                           2,294
                                    registered end-use product as a
                                    manufacturing-use product; same
                                    registered uses only (2) (3)
----------------------------------------------------------------------------------------------------------------
R332              51               New manufacturing-use product; registered   24                        256,883
                                    active ingredient; unregistered source of
                                    active ingredient; submission of
                                    completely new generic data package;
                                    registered uses only; requires review in
                                    RD and science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R333              52               New product; MUP or End use product with    10                         17,993
New                                 unregistered source of active ingredient;
                                    requires science data review; new
                                    physical form; etc. Cite-all or selective
                                    data citation where applicant owns all
                                    required data. (2) (3)
----------------------------------------------------------------------------------------------------------------
R334              53               New product; MUP or End use product with    11                         17,993
New                                 unregistered source of the active
                                    ingredient; requires science data review;
                                    new physical form; etc. Selective data
                                    citation. (2) (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


[[Page H6030]]


                        ``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS TO REGISTRATION
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R340              54               Amendment requiring data review within RD   4                           3,617
                                    (e.g., changes to precautionary label
                                    statements) (2) (3)
----------------------------------------------------------------------------------------------------------------
R345              55               Amending non-food animal product that       7                           8,000
New                                 includes submission of target animal
                                    safety data; previously registered (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R350              56               Amendment requiring data review in science  9                          11,996
                                    divisions (e.g., changes to REI, or PPE,
                                    or PHI, or use rate, or number of
                                    applications; or add aerial application;
                                    or modify GW/SW advisory statement) (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
R351              57               Amendment adding a new unregistered source  8                          11,996
New                                 of active ingredient. (2) (3)
----------------------------------------------------------------------------------------------------------------
R352              58               Amendment adding already approved uses;     8                          11,996
New                                 selective method of support; does not
                                    apply if the applicant owns all cited
                                    data (2) (3)
----------------------------------------------------------------------------------------------------------------
R371              59               Amendment to Experimental Use Permit;       6                           9,151
                                    (does not include extending a permit's
                                    time period) (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                              ``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R124              60               Conditional Ruling on Preapplication Study  6                           2,294
                                    Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R272              61               Review of Study Protocol applicant-         3                           2,294
                                    initiated; excludes DART, pre-
                                    registration conference, Rapid Response
                                    review, DNT protocol review, protocol
                                    needing HSRB review
----------------------------------------------------------------------------------------------------------------
R275              62               Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------
R370              63               Cancer reassessment; applicant-initiated    18                        179,818
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.


                         ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A380              64               Food use; establish tolerance exemption     24                        104,187
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
A390              65               Food use; establish tolerance (2) (3)       24                        173,644
----------------------------------------------------------------------------------------------------------------
A400              66               Non-food use; outdoor; FIFRA Sec. 2(mm)     18                         86,823
                                    uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A410              67               Non-food use; outdoor; uses other than      21                        173,644
                                    FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A420              68               Non-food use; indoor; FIFRA Sec. 2(mm)      18                         57,882
                                    uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A430              69               Non-food use; indoor; uses other than       20                         86,823
                                    FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------

[[Page H6031]]

 
A431              70               Non-food use; indoor; low-risk, low-        12                         60,638
                                    toxicity food-grade active ingredient(s);
                                    efficacy testing for public health claims
                                    required under GLP and following DIS/TSS
                                    or AD-approved study protocol (2) (3)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                ``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A440              71               First food use; establish tolerance         21                         28,942
                                    exemption (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
A450              72               First food use; establish tolerance (2)     21                         86,823
                                    (3) (4)
----------------------------------------------------------------------------------------------------------------
A460              73               Additional food use; establish tolerance    15                         11,577
                                    exemption (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A470              74               Additional food use; establish tolerance    15                         28,942
                                    (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A471              75               Additional food uses; establish             15                        173,652
New                                 tolerances; 6 or more submitted in one
                                    application (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A480              76               Additional use; non-food; outdoor; FIFRA    9                          17,365
                                    Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A481              77               Additional non-food outdoor uses; FIFRA     9                         104,190
New                                 Sec. 2(mm) uses; 6 or more submitted in
                                    one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A490              78               Additional use; non-food; outdoor; uses     15                         28,942
                                    other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A491              79               Additional non-food; outdoor; uses other    15                        173,652
New                                 than FIFRA Sec. 2(mm); 6 or more
                                    submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A500              80               Additional use; non-food, indoor, FIFRA     9                          11,577
                                    Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A501              81               Additional non-food; indoor; FIFRA Sec.     9                          69,462
New                                 2(mm) uses; 6 or more submitted in one
                                    application (4) (5)
----------------------------------------------------------------------------------------------------------------
A510              82               Additional use; non-food; indoor; uses      12                         11,577
                                    other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A511              83               Additional non-food; indoor; uses other     12                         69,462
New                                 than FIFRA Sec. 2(mm); 6 or more
                                    submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.

[[Page H6032]]

 
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


                      ``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A530              84               New product; identical or substantially     4                           1,159
                                    similar in composition and use to a
                                    registered product; no data review or
                                    only product chemistry data; cite-all
                                    data citation, or selective data citation
                                    when applicant owns all required data, or
                                    applicant submits specific authorization
                                    letter for data owner. Category also
                                    includes 100% re-package of registered
                                    end-use or manufacturing-use product that
                                    requires no data submission nor data
                                    matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------
A531              85               New product; identical or substantially     4                           1,654
                                    similar in composition and use to a
                                    registered product; registered source of
                                    active ingredient: selective data
                                    citation only for data on product
                                    chemistry and/or acute toxicity and/or
                                    public health pest efficacy, where
                                    applicant does not own all required data
                                    and does not have a specific
                                    authorization letter from data owner. (2)
                                    (3)
----------------------------------------------------------------------------------------------------------------
A532              86               New product; identical or substantially     5                           4,631
                                    similar in composition and use to a
                                    registered product; registered active
                                    ingredient; unregistered source of active
                                    ingredient; cite-all data citation except
                                    for product chemistry; product chemistry
                                    data submitted (2) (3)
----------------------------------------------------------------------------------------------------------------
A540              87               New end use product; FIFRA Sec. 2(mm) uses  5                           4,631
                                    only (2) (3)
----------------------------------------------------------------------------------------------------------------
A550              88               New end-use product; uses other than FIFRA  7                           4,631
                                    Sec. 2(mm); non-FQPA product (2) (3)
----------------------------------------------------------------------------------------------------------------
A560              89               New manufacturing-use product; registered   12                         17,365
                                    active ingredient; selective data
                                    citation (2) (3)
----------------------------------------------------------------------------------------------------------------
A570              90               Label amendment requiring data review (3)   4                           3,474
                                    (4)
----------------------------------------------------------------------------------------------------------------
A572              91               New Product or amendment requiring data     9                          11,996
New                                 review for risk assessment by Science
                                    Branch (e.g., changes to REI, or PPE, or
                                    use rate) (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.

[[Page H6033]]

 
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.


          ``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A520              92               Experimental Use Permit application, Non-   9                           5,789
                                    Food Use (2)
----------------------------------------------------------------------------------------------------------------
A521              93               Review of public health efficacy study      3                           2,250
                                    protocol within AD, per AD Internal
                                    Guidance for the Efficacy Protocol Review
                                    Process; Code will also include review of
                                    public health efficacy study protocol and
                                    data review for devices making pesticidal
                                    claims; applicant-initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522              94               Review of public health efficacy study      12                         11,025
                                    protocol outside AD by members of AD
                                    Efficacy Protocol Review Expert Panel;
                                    Code will also include review of public
                                    health efficacy study protocol and data
                                    review for devices making pesticidal
                                    claims; applicant-initiated; Tier 2
----------------------------------------------------------------------------------------------------------------
A524              95               New Active Ingredient, Experimental Use     18                        138,916
New                                 Permit application; Food Use Requires
                                    Tolerance. Credit 45% of fee toward new
                                    active ingredient application that
                                    follows. (2)
----------------------------------------------------------------------------------------------------------------
A525              96               New Active Ingredient, Experimental Use     18                         83,594
New                                 Permit application; Food Use Requires
                                    Tolerance Exemption. Credit 45% of fee
                                    toward new active ingredient application
                                    that follows. (2)
----------------------------------------------------------------------------------------------------------------
A526              97               New Active Ingredient, Experimental Use     15                         86,823
New                                 Permit application; Non-Food, Outdoor
                                    Use. Credit 45% of fee toward new active
                                    ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A527              98               New Active Ingredient, Experimental Use     15                         58,000
New                                 Permit application; Non-Food, Indoor Use.
                                    Credit 45% of fee toward new active
                                    ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A528              99               Experimental Use Permit application, Food   15                         20,260
New                                 Use; Requires Tolerance or Tolerance
                                    Exemption (2)
----------------------------------------------------------------------------------------------------------------
A529              100              Amendment to Experimental Use Permit;       9                          10,365
New                                 requires data review or risk assessment
                                    (2)
----------------------------------------------------------------------------------------------------------------
A523              101              Review of protocol other than a public      9                          11,025
New                                 health efficacy study (i.e., Toxicology
                                    or Exposure Protocols)
----------------------------------------------------------------------------------------------------------------
A571              102              Science reassessment: Cancer risk, refined  18                         86,823
New                                 ecological risk, and/or endangered
                                    species; applicant-initiated
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


   ``TABLE 11. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
                                               ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B580              103              New active ingredient; food use; petition   19                         46,305
                                    to establish a tolerance (2)
----------------------------------------------------------------------------------------------------------------

[[Page H6034]]

 
B590              104              New active ingredient; food use; petition   17                         28,942
                                    to establish a tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B600              105              New active ingredient; non-food use (2)     13                         17,365
----------------------------------------------------------------------------------------------------------------
B610              106              New active ingredient; Experimental Use     10                         11,577
                                    Permit application; petition to establish
                                    a temporary tolerance or temporary
                                    tolerance exemption
----------------------------------------------------------------------------------------------------------------
B611              107              New active ingredient; Experimental Use     12                         11,577
New                                 Permit application; petition to establish
                                    permanent tolerance exemption
----------------------------------------------------------------------------------------------------------------
B612              108              New active ingredient; no change to a       10                         15,918
New                                 permanent tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B613              109              New active ingredient; petition to convert  11                         15,918
New                                 a temporary tolerance or a temporary
                                    tolerance exemption to a permanent
                                    tolerance or tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B620              110              New active ingredient; Experimental Use     7                           5,789
                                    Permit application; non-food use
                                    including crop destruct
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time,
  except where the new inert approval decision review time is greater than that for the new active ingredient,
  in which case the associated new active ingredient will be subject to the new inert approval decision review
  time. In the case of a new active ingredient application, until that new active ingredient is approved, any
  subsequent application for another new product containing the same active ingredient or an amendment to the
  proposed labeling will be deemed a new active ingredient application, subject to the registration service fee
  and decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.


``TABLE 12. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B630              111              First food use; petition to establish a     13                         11,577
                                    tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B631              112              New food use; petition to amend an          12                         11,577
                                    established tolerance (3)
----------------------------------------------------------------------------------------------------------------
B640              113              First food use; petition to establish a     19                         17,365
                                    tolerance (2)
----------------------------------------------------------------------------------------------------------------
B643              114              New Food use; petition to amend tolerance   10                         11,577
New                                 exemption (3)
----------------------------------------------------------------------------------------------------------------
B642              115              First food use; indoor; food/food handling  12                         28,942
New                                 (2)
----------------------------------------------------------------------------------------------------------------
B644              116              New use, no change to an established        8                          11,577
New                                 tolerance or tolerance exemption (3)
----------------------------------------------------------------------------------------------------------------
B650              117              New use; non-food (3)                       7                           5,789
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page H6035]]

 
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


   ``TABLE 13. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
                                                    PRODUCTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B652              118              New product; registered source of active    13                         11,577
New                                 ingredient; requires petition to amend
                                    established tolerance or tolerance
                                    exemption; requires 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of scientifically-
                                    sound rationale based on publicly
                                    available literature or other relevant
                                    information that addresses the data
                                    requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply (2)
----------------------------------------------------------------------------------------------------------------
B660              119              New product; registered source of active    4                           1,159
                                    ingredient(s); identical or substantially
                                    similar in composition and use to a
                                    registered product; no change in an
                                    established tolerance or tolerance
                                    exemption. No data review, or only
                                    product chemistry data; cite-all data
                                    citation, or selective data citation
                                    where applicant owns all required data or
                                    authorization from data owner is
                                    demonstrated. Category includes 100% re-
                                    package of registered end-use or
                                    manufacturing-use product that requires
                                    no data submission or data matrix. For
                                    microbial pesticides, the active
                                    ingredient(s) must not be re-isolated.
                                    (2)
----------------------------------------------------------------------------------------------------------------
B670              120              New product; registered source of active    7                           4,631
                                    ingredient(s); no change in an
                                    established tolerance or tolerance
                                    exemption; requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B671              121              New product; unregistered source of active  17                         11,577
                                    ingredient(s); requires a petition to
                                    amend an established tolerance or
                                    tolerance exemption; requires: 1)
                                    submission of product specific data; or
                                    2) citation of previously reviewed and
                                    accepted data; or 3) submission or
                                    citation of data generated at government
                                    expense; or 4) submission or citation of
                                    a scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B672              122              New product; unregistered source of active  13                          8,269
                                    ingredient(s); non-food use or food use
                                    with a tolerance or tolerance exemption
                                    previously established for the active
                                    ingredient(s); requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B673              123              New product MUP/EP; unregistered source of  10                          4,631
New                                 active ingredient(s); citation of
                                    Technical Grade Active Ingredient (TGAI)
                                    data previously reviewed and accepted by
                                    the Agency. Requires an Agency
                                    determination that the cited data
                                    supports the new product. (2)
----------------------------------------------------------------------------------------------------------------
B674              124              New product MUP; Repack of identical        4                           1,159
New                                 registered end-use product as a
                                    manufacturing-use product; same
                                    registered uses only (2)
----------------------------------------------------------------------------------------------------------------
B675              125              New Product MUP; registered source of       10                          8,269
New                                 active ingredient; submission of
                                    completely new generic data package;
                                    registered uses only. (2)
----------------------------------------------------------------------------------------------------------------

[[Page H6036]]

 
B676              126              New product; more than one active           13                          8,269
New                                 ingredient where one active ingredient is
                                    an unregistered source; product chemistry
                                    data must be submitted; requires: 1)
                                    submission of product specific data, and
                                    2) citation of previously reviewed and
                                    accepted data; or 3) submission or
                                    citation of data generated at government
                                    expense; or 4) submission or citation of
                                    a scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------
B677              127              New end-use non-food animal product with    10                          8,000
New                                 submission of two or more target animal
                                    safety studies; includes data and/or
                                    waivers of data for only:
                                    product chemistry and/or
                                    acute toxicity and/or
                                    public health pest efficacy and/
                                    or
                                    animal safety studies and/or
                                    child resistant packaging (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.


     ``TABLE 14. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES;
                                                   AMENDMENTS
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B621              128              Amendment; Experimental Use Permit; no      7                           4,631
                                    change to an established temporary
                                    tolerance or tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B622              129              Amendment; Experimental Use Permit;         11                         11,577
New                                 petition to amend an established or
                                    temporary tolerance or tolerance
                                    exemption.
----------------------------------------------------------------------------------------------------------------
B641              130              Amendment of an established tolerance or    13                         11,577
                                    tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B680              131              Amendment; registered source of active      5                           4,631
                                    ingredient(s); no new use(s); no changes
                                    to an established tolerance or tolerance
                                    exemption. Requires data submission. (2)
----------------------------------------------------------------------------------------------------------------
B681              132              Amendment; unregistered source of active    7                           5,513
                                    ingredient(s). Requires data submission.
                                    (2)
----------------------------------------------------------------------------------------------------------------
B683              133              Label amendment; requires review/update of  6                           4,631
New                                 previous risk assessment(s) without data
                                    submission (e.g., labeling changes to
                                    REI, PPE, PHI). (2)
----------------------------------------------------------------------------------------------------------------
B684              134              Amending non-food animal product that       8                           8,000
New                                 includes submission of target animal
                                    safety data; previously registered (2)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.


 ``TABLE 15. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B690              135              New active ingredient; food or non-food     7                           2,316
                                    use. (2)
----------------------------------------------------------------------------------------------------------------
B700              136              Experimental Use Permit application; new    7                           1,159
                                    active ingredient or new use.
----------------------------------------------------------------------------------------------------------------
B701              137              Extend or amend Experimental Use Permit.    4                           1,159
----------------------------------------------------------------------------------------------------------------

[[Page H6037]]

 
B710              138              New product; registered source of active    4                           1,159
                                    ingredient(s); identical or substantially
                                    similar in composition and use to a
                                    registered product; no change in an
                                    established tolerance or tolerance
                                    exemption. No data review, or only
                                    product chemistry data; cite-all data
                                    citation, or selective data citation
                                    where applicant owns all required data or
                                    authorization from data owner is
                                    demonstrated. Category includes 100% re-
                                    package of registered end-use or
                                    manufacturing-use product that requires
                                    no data submission or data matrix. (3)
----------------------------------------------------------------------------------------------------------------
B720              139              New product; registered source of active    5                           1,159
                                    ingredient(s); requires: 1) submission of
                                    product specific data; or 2) citation of
                                    previously reviewed and accepted data; or
                                    3) submission or citation of data
                                    generated at government expense; or 4)
                                    submission or citation of a
                                    scientifically-sound rationale based on
                                    publicly available literature or other
                                    relevant information that addresses the
                                    data requirement; or 5) submission of a
                                    request for a data requirement to be
                                    waived supported by a scientifically-
                                    sound rationale explaining why the data
                                    requirement does not apply. (3)
----------------------------------------------------------------------------------------------------------------
B721              140              New product; unregistered source of active  7                           2,426
                                    ingredient. (3)
----------------------------------------------------------------------------------------------------------------
B722              141              New use and/or amendment; petition to       7                           2,246
                                    establish a tolerance or tolerance
                                    exemption. (4) (5)
----------------------------------------------------------------------------------------------------------------
B730              142              Label amendment requiring data submission.  5                           1,159
                                    (4)
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time,
  except where the new inert approval decision review time is greater than that for the new active ingredient,
  in which case the associated new active ingredient will be subject to the new inert approval decision review
  time. In the case of a new active ingredient application, until that new active ingredient is approved, any
  subsequent application for another new product containing the same active ingredient or an amendment to the
  proposed labeling will be deemed a new active ingredient application, subject to the registration service fee
  and decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.


                   ``TABLE 16. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- OTHER ACT
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B614              143              Conditional Ruling on Preapplication Study  3                           2,294
New                                 Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
B615              144              Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------
B682              145              Protocol review; applicant initiated;       3                           2,205
                                    excludes time for HSRB review
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.


[[Page H6038]]


     ``TABLE 17. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- PLANT INCORPORATED PROTECTANTS (PIPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Registration
     EPA No.         New CR No.                      Action                      Decision Review     Service Fee
                                                                                Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B740              146              Experimental Use Permit application; no     6                          86,823
                                    petition for tolerance/tolerance
                                    exemption. Includes:
                                   1) non-food/feed use(s) for a new (2) or
                                    registered (3) PIP;
                                   2) food/feed use(s) for a new or
                                    registered PIP with crop destruct;
                                   3) food/feed use(s) for a new or
                                    registered PIP in which an established
                                    tolerance/tolerance exemption exists for
                                    the intended use(s). (4)
----------------------------------------------------------------------------------------------------------------
B750              147              Experimental Use Permit application; with   9                         115,763
                                    a petition to establish a temporary or
                                    permanent tolerance/tolerance exemption
                                    for the active ingredient. Includes new
                                    food/feed use for a registered (3) PIP.
                                    (4)
----------------------------------------------------------------------------------------------------------------
B770              148              Experimental Use Permit application; new    15                        173,644
                                    (2) PIP; with petition to establish a
                                    temporary tolerance/tolerance exemption
                                    for the active ingredient; credit 75% of
                                    B771 fee toward registration application
                                    for a new active ingredient that follows;
                                    SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B771              149              Experimental Use Permit application; new    10                        115,763
                                    (2) PIP; with petition to establish a
                                    temporary tolerance/tolerance exemption
                                    for the active ingredient; credit 75% of
                                    B771 fee toward registration application
                                    for a new active ingredient that follows.
----------------------------------------------------------------------------------------------------------------
B772              150              Application to amend or extend an           3                          11,577
                                    Experimental Use Permit; no petition
                                    since the established tolerance/tolerance
                                    exemption for the active ingredient is
                                    unaffected.
----------------------------------------------------------------------------------------------------------------
B773              151              Application to amend or extend an           5                          28,942
                                    Experimental Use Permit; with petition to
                                    extend a temporary tolerance/tolerance
                                    exemption for the active ingredient.
----------------------------------------------------------------------------------------------------------------
B780              152              Registration application; new (2) PIP; non- 12                        144,704
                                    food/feed.
----------------------------------------------------------------------------------------------------------------
B790              153              Registration application; new (2) PIP; non- 18                        202,585
                                    food/feed; SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B800              154              Registration application; new (2) PIP;      12                        231,585
                                    with petition to establish permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B810              155              Registration application; new (2) PIP;      18                        289,407
                                    with petition to establish permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
                                    SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B820              156              Registration application; new (2) PIP;      15                        289,407
                                    with petition to establish or amend a
                                    permanent tolerance/tolerance exemption
                                    of an active ingredient.
----------------------------------------------------------------------------------------------------------------
B840              157              Registration application; new (2) PIP;      21                        347,288
                                    with petition to establish or amend a
                                    permanent tolerance/tolerance exemption
                                    of an active ingredient. SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B851              158              Registration application; new event of a    9                         115,763
                                    previously registered PIP active
                                    ingredient(s); no petition since
                                    permanent tolerance/tolerance exemption
                                    is already established for the active
                                    ingredient(s).
----------------------------------------------------------------------------------------------------------------
B870              159              Registration application; registered (3)    9                          34,729
                                    PIP; new product; new use; no petition
                                    since a permanent tolerance/tolerance
                                    exemption is already established for the
                                    active ingredient(s). (4)
----------------------------------------------------------------------------------------------------------------
B880              160              Registration application; registered (3)    9                          28,942
                                    PIP; new product or new terms of
                                    registration; additional data submitted;
                                    no petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    (6) (7)
----------------------------------------------------------------------------------------------------------------
B881              161              Registration application; registered (3)    15                         86,823
                                    PIP; new product or new terms of
                                    registration; additional data submitted;
                                    no petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    SAP review. (5) (6) (7)
----------------------------------------------------------------------------------------------------------------
B883              162              Registration application; new (2) PIP,      9                         115,763
New                                 seed increase with negotiated acreage cap
                                    and time-limited registration; with
                                    petition to establish a permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient based on an existing
                                    temporary tolerance/tolerance exemption.
                                    (8)
----------------------------------------------------------------------------------------------------------------
B884              163              Registration application; new (2) PIP,      12                        144,704
New                                 seed increase with negotiated acreage cap
                                    and time-limited registration; with
                                    petition to establish a permanent
                                    tolerance/tolerance exemption for the
                                    active ingredient. (8)
----------------------------------------------------------------------------------------------------------------

[[Page H6039]]

 
B885              164              Registration application; registered (3)    9                          86,823
New                                 PIP, seed increase; breeding stack of
                                    previously approved PIPs, same crop; no
                                    petition since a permanent tolerance/
                                    tolerance exemption is already
                                    established for the active ingredient(s).
                                    (9)
----------------------------------------------------------------------------------------------------------------
B890              165              Application to amend a seed increase        9                          57,882
                                    registration; converts registration to
                                    commercial registration; no petition
                                    since permanent tolerance/tolerance
                                    exemption is already established for the
                                    active ingredient(s).
----------------------------------------------------------------------------------------------------------------
B891              166              Application to amend a seed increase        15                        115,763
                                    registration; converts registration to a
                                    commercial registration; no petition
                                    since a permanent tolerance/tolerance
                                    exemption already established for the
                                    active ingredient(s); SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B900              167              Application to amend a registration,        6                          11,577
                                    including actions such as extending an
                                    expiration date, modifying an IRM plan,
                                    or adding an insect to be controlled.
                                    (10) (11)
----------------------------------------------------------------------------------------------------------------
B901              168              Application to amend a registration,        12                         69,458
                                    including actions such as extending an
                                    expiration date, modifying an IRM plan,
                                    or adding an insect to be controlled. SAP
                                    review. (10) (11)
----------------------------------------------------------------------------------------------------------------
B902              169              PIP protocol review                         3                           5,789
----------------------------------------------------------------------------------------------------------------
B903              170              Inert ingredient tolerance exemption;       6                          57,882
                                    e.g., a marker such as NPT II; reviewed
                                    in BPPD.
----------------------------------------------------------------------------------------------------------------
B904              171              Import tolerance or tolerance exemption;    9                         115,763
                                    processed commodities/food only (inert or
                                    active ingredient).
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to
  sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-
  target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The
  scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to
  make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the
  environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with
  the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.


                   ``TABLE 18. -- INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
                                                                                 Decision Review    Registration
     EPA No.         New CR No.                      Action                     Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
I001              172              Approval of new food use inert ingredient   12                         18,000
                                    (2) (3)
----------------------------------------------------------------------------------------------------------------
I002              173              Amend currently approved inert ingredient   10                          5,000
New                                 tolerance or exemption from tolerance;
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I003              174              Amend currently approved inert ingredient   8                           3,000
New                                 tolerance or exemption from tolerance; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I004              175              Approval of new non-food use inert          8                          10,000
New                                 ingredient (2)
----------------------------------------------------------------------------------------------------------------
I005              176              Amend currently approved non-food use       8                           5,000
New                                 inert ingredient with new use pattern;
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I006              177              Amend currently approved non-food use       6                           3,000
New                                 inert ingredient with new use pattern; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
I007              178              Approval of substantially similar non-food  4                           1,500
New                                 use inert ingredients when original inert
                                    is compositionally similar with similar
                                    use pattern (2)
----------------------------------------------------------------------------------------------------------------
I008              179              Approval of new polymer inert ingredient,   5                           3,400
New                                 food use (2)
----------------------------------------------------------------------------------------------------------------

[[Page H6040]]

 
I009              180              Approval of new polymer inert ingredient,   4                           2,800
New                                 non food use (2)
----------------------------------------------------------------------------------------------------------------
I010              181              Petition to amend a tolerance exemption     6                           1,500
New                                 descriptor to add one or more CASRNs; no
                                    new data (2)
----------------------------------------------------------------------------------------------------------------
M001              182              Study protocol requiring Human Studies      9                           7,200
New                                 Review Board review as defined in 40 CFR
                                    26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M002              183              Completed study requiring Human Studies     9                           7,200
New                                 Review Board review as defined in 40 CFR
                                    26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M003              184              External technical peer review of new       12                         58,000
New                                 active ingredient, product, or amendment
                                    (e.g., consultation with FIFRA Scientific
                                    Advisory Panel) for an action with a
                                    decision timeframe of less than 12
                                    months. Applicant initiated request based
                                    on a requirement of the Administrator, as
                                    defined by FIFRA Sec.  25(d), in support
                                    of a novel active ingredient, or unique
                                    use pattern or application technology.
                                    Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M004              185              External technical peer review of new       18                         58,000
New                                 active ingredient, product, or amendment
                                    (e.g., consultation with FIFRA Scientific
                                    Advisory Panel) for an action with a
                                    decision timeframe of greater than 12
                                    months. Applicant initiated request based
                                    on a requirement of the Administrator, as
                                    defined by FIFRA Sec.  25(d), in support
                                    of a novel active ingredient, or unique
                                    use pattern or application technology.
                                    Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------
M005              186              New Product: Combination, Contains a        9                          20,000
New                                 combination of active ingredients from a
                                    registered and/or unregistered source;
                                    conventional, antimicrobial and/or
                                    biopesticide. Requires coordination with
                                    other regulatory divisions to conduct
                                    review of data, label and/or verify the
                                    validity of existing data as cited. Only
                                    existing uses for each active ingredient
                                    in the combination product. (6) (7)
----------------------------------------------------------------------------------------------------------------
M006              187              Request for up to 5 letters of              1                             250
New                                 certification (Gold Seal) for one
                                    actively registered product.
----------------------------------------------------------------------------------------------------------------
M007              188              Request to extend Exclusive Use of data as  12                          5,000
New                                 provided by FIFRA Section 3(c)(1)(F)(ii)
----------------------------------------------------------------------------------------------------------------
M008              189              Request to grant Exclusive Use of data as   10                          1,500
New                                 provided by FIFRA Section 3(c)(1)(F)(vi)
                                    for a minor use, when a FIFRA Section
                                    2(ll)(2) determination is required
----------------------------------------------------------------------------------------------------------------
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
  to end on the next business day.
(2) If another covered application is associated with and dependent upon a pending application for an inert
  ingredient action, each application will be subject to its respective registration service fee. The decision
  review time for the other associated covered application will be extended to match the PRIA due date of the
  pending inert ingredient action, unless the PRIA due date for the other associated covered action is further
  out, in which case it will be subject to its own decision review time. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
  its separate registration service fee. The decision review times for the associated actions run concurrently,
  but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.'';

       (B) in paragraph (6)--
       (i) in subparagraph (A)--

       (I) by striking ``October 1, 2008'' and inserting ``October 
     1, 2013''; and
       (II) by striking ``September 30, 2010'' and inserting 
     ``September 30, 2015''; and

       (ii) in subparagraph (B)--

       (I) by striking ``October 1, 2010'' and inserting ``October 
     1, 2015''; and
       (II) by striking ``September 30, 2010'' and inserting 
     ``September 30, 2015''; and

       (C) in paragraph (8)(C)(ii)--
       (i) in subclause (I), by striking ``or'' at the end;
       (ii) in subclause (II), by striking the period at the end 
     and inserting ``; or''; and
       (iii) by adding at the end the following:

       ``(III) on the basis that the Administrator rejected the 
     application under subsection (f)(4)(B).''.

       (2) Pesticide registration fund.--Section 33(c)(3)(B) of 
     the Federal Insecticide, Fungicide, and Rodenticide Act (7 
     U.S.C. 136w-8(c)(3)(B)) is amended--
       (A) in clause (i), by striking ``2008 through 2012'' and 
     inserting ``2013 through 2017'';
       (B) in clause (ii), by striking ``grants'' and all that 
     follows through the end of the clause and inserting ``grants, 
     for each of fiscal years 2013 through 2017, $500,000.''; and
       (C) in clause (iii), by striking ``2008 through 2012'' and 
     inserting ``2013 through 2017''.
       (3) Assessment of fees.--Section 33(d) of the Federal 
     Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-
     8(d)) is amended--

[[Page H6041]]

       (A) in paragraph (2), by striking ``2002'' each place it 
     appears and inserting ``2012'';
       (B) by striking paragraph (4); and
       (C) by redesignating paragraph (5) as paragraph (4).
       (4) Reforms to reduce decision time review periods.--
     Section 33(e) of the Federal Insecticide, Fungicide, and 
     Rodenticide Act (7 U.S.C. 136w-8(e)) is amended by striking 
     ``Pesticide Registration Improvement Act of 2003'' and 
     inserting ``Pesticide Registration Improvement Extension Act 
     of 2012''.
       (5) Decision time review periods.--Section 33(f) of the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136w-8(f)) is amended--
       (A) in paragraph (1), by striking ``Pesticide Registration 
     Improvement Renewal Act, the Administrator shall publish in 
     the Federal Register'' and inserting ``Pesticide Registration 
     Improvement Extension Act of 2012, the Administrator shall 
     make publicly available'';
       (B) in paragraph (2), by striking ``appearing in the 
     Congressional Record on pages S10409'' and all that follows 
     through the period and inserting ``provided under subsection 
     (b)(3).''; and
       (C) in paragraph (4)--
       (i) in subparagraph (A), by inserting ``and fee'' before 
     the period; and
       (ii) in subparagraph (B)--

       (I) by striking ``(B) Completeness of application'' and all 
     that follows through ``Not later'' in clause (i) and 
     inserting the following:

       ``(B) Initial content and preliminary technical 
     screenings.--
       ``(i) Screenings.--

       ``(I) Initial content.--Not later'';
       (II) in clause (i) (as so designated) by adding at the end 
     the following:
       ``(II) Preliminary technical screening.--After conducting 
     the initial content screening described in subclause (I) and 
     in accordance with clause (iv), the Administrator shall 
     conduct a preliminary technical screening--

       ``(aa) not later than 45 days after the date on which the 
     decision time review period begins (for applications with 
     decision time review periods of not more than 180 days); and
       ``(bb) not later than 90 days after the date on which the 
     decision time review period begins (for applications with 
     decision time review periods greater than 180 days).'';

       (III) by striking clause (ii) and inserting the following:

       ``(ii) Rejection.--

       ``(I) In general.--If the Administrator determines at any 
     time before the Administrator completes the preliminary 
     technical screening under clause (i)(II) that the application 
     failed the initial content or preliminary technical screening 
     and the applicant does not correct the failure before the 
     date that is 10 business days after the applicant receives a 
     notification of the failure, the Administrator shall reject 
     the application.
       ``(II) Written notification.--The Administrator shall make 
     every effort to provide a written notification of a rejection 
     under subclause (I) during the 10-day period that begins on 
     the date the Administrator completes the preliminary 
     technical screening.'';
       (IV) in clause (iii)--

       (aa) in the heading, by inserting ``initial content'' 
     before ``screening'' ;
       (bb) in the matter preceding subclause (I), by inserting 
     ``content'' after ``initial''; and
       (cc) in subclause (II), by striking ``contains'' and 
     inserting ``appears to contain''; and

       (V) by adding at the end the following:

       ``(iv) Requirements of preliminary technical screening.--In 
     conducting a preliminary technical screening of an 
     application, the Administrator shall determine if--

       ``(I) the application and the data and information 
     submitted with the application are accurate and complete; and
       ``(II) the application, data, and information are 
     consistent with the proposed labeling and any proposal for a 
     tolerance or exemption from the requirement for a tolerance 
     under section 408 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 346a), and are such that, subject to full review 
     under the standards of this Act, could result in the granting 
     of the application.''.

       (6) Reports.--Section 33(k) of the Federal Insecticide, 
     Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is 
     amended--
       (A) in paragraph (1), by striking ``March 1, 2014'' and 
     inserting ``March 1, 2017'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) in clause (vi)(V), by striking ``and'' at the end;
       (II) in clause (vii)(II), by inserting ``and'' at the end; 
     and
       (III) by adding at the end the following:

       ``(viii) the number of extensions of decision time review 
     periods agreed to under subsection (f)(5) along with a 
     description of the reason that the Administrator was unable 
     to make a decision within the initial decision time review 
     period;'';
       (ii) in subparagraph (E), by striking ``and'' at the end;
       (iii) in subparagraph (F), by striking the period and 
     inserting a semicolon; and
       (iv) by adding at the end the following:
       ``(G) a review of the progress made toward--
       ``(i) carrying out section 4(k)(4) and the amounts from the 
     Reregistration and Expedited Processing Fund used for the 
     purposes described in that section;
       ``(ii) implementing systems for the electronic tracking of 
     registration submissions by December 31, 2013;
       ``(iii) implementing a system for tracking the status of 
     conditional registrations, including making nonconfidential 
     information related to the conditional registrations publicly 
     available by December 31, 2013;
       ``(iv) implementing enhancements to the endangered species 
     knowledge database, including making nonconfidential 
     information related to the database publicly available;
       ``(v) implementing the capability to electronically submit 
     and review labels submitted with registration actions;
       ``(vi) acquiring and implementing the capability to 
     electronically assess and evaluate confidential statements of 
     formula submitted with registration actions by December 31, 
     2014; and
       ``(vii) facilitating public participation in certain 
     registration actions and the registration review process by 
     providing electronic notification to interested parties of 
     additions to the public docket;
       ``(H) the number of applications rejected by the 
     Administrator under the initial content and preliminary 
     technical screening conducted under subsection (f)(4);
       ``(I) a review of the progress made in updating the 
     Pesticide Incident Data System, including progress toward 
     making the information contained in the System available to 
     the public (as the Administrator determines is appropriate); 
     and
       ``(J) an assessment of the public availability of summary 
     pesticide usage data.''; and
       (C) by adding at the end the following:
       ``(4) Other report.--
       ``(A) Scope.--In addition to the annual report described in 
     paragraph (1), not later than October 1, 2016, the 
     Administrator shall submit to the Committee on Agriculture of 
     the House of Representatives and the Committee on 
     Agriculture, Nutrition, and Forestry of the Senate a report 
     that includes an analysis of the impact of maintenance fees 
     on small businesses that have--
       ``(i) 10 or fewer employees; and
       ``(ii) annual global gross revenue that does not exceed 
     $2,000,000.
       ``(B) Information required.--In conducting the analysis 
     described in subparagraph (A), the Administrator shall 
     collect, and include in the report under that subparagraph, 
     information on--
       ``(i) the number of small businesses described in 
     subparagraph (A) that are paying maintenance fees; and
       ``(ii) the number of registrations each company holds.''.
       (7) Termination of effectiveness.--Section 33(m) of the 
     Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
     136w-8(m)) is amended--
       (A) in paragraph (1), by striking ``2012'' and inserting 
     ``2017''; and
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) in the heading, by striking ``2013'' and inserting 
     ``2018'';
       (II) by striking ``2013,'' and inserting ``2018,''; and
       (III) by striking ``September 30, 2012'' and inserting 
     ``September 30, 2017'';

       (ii) in subparagraph (B)--

       (I) in the heading, by striking ``2014'' and inserting 
     ``2019'';
       (II) by striking ``2014,'' and inserting ``2019,''; and
       (III) by striking ``September 30, 2012'' and inserting 
     ``September 30, 2017'';

       (iii) in subparagraph (C)--

       (I) in the heading, by striking ``2014'' and inserting 
     ``2019''; and
       (II) by striking ``September 30, 2014'' and inserting 
     ``September 30, 2019''; and

       (iv) in subparagraph (D), by striking ``2012'' each place 
     it appears and inserting ``2017''.
       (c) Effective Date.--This section and the amendments made 
     by this section take effect on October 1, 2012.
       (d) Relationship to Other Law.--In the case of any conflict 
     between this section (including the amendments made by this 
     section) and a joint resolution making continuing 
     appropriations for fiscal year 2013 (including any amendments 
     made by such a joint resolution), this section and the 
     amendments made by this section shall control.

  Mr. LUCAS. Mr. Speaker, I rise to voice my support of S. 3552, the 
Pesticide Registration Improvement Extension Act of 2012, and recognize 
myself for such time as I may consume.
  I want to first thank my colleague, the Ranking Member for his 
assistance with this legislation. This bill has been included in the 
Agriculture Committee reported farm bill which we hope to consider in 
due course.
  While there are many USDA-related programs reauthorized in the 
committee legislation, this one is among a small list of anomalies in 
that it is a program administered by the EPA. Additionally, the absence 
of this reauthorization would necessitate significant increases in 
appropriations to cover the shortfall, as well as risk the imposition 
of exorbitant costs on our constituents further jeopardizing an already 
abysmal economic recovery.
  The original Pesticide Registration Improvement Act, PRIA, was a 
landmark law enacted on January 23, 2004. Congress reauthorized PRIA, 
now known as ``PRIA 2'', for another five years on October 9, 2007. 
PRIA reinvented EPA's procedures for processing applications for 
pesticide registrations and other related actions, including 
establishing specific timelines with corresponding fee schedules.

[[Page H6042]]

  Under PRIA 1, the Agency's Office of Pesticide Programs was required 
to process applications within timeframes specified for each of the 50 
categories of registration actions. That number has since increased, 
and would be set at 189 under the proposed reauthorization.
  PRIA retained and increased the product maintenance fees that support 
re-registration and tolerance reassessment authorized under the Food 
Quality Protection Act. Pesticide registrants paid $110 million in 
maintenance fees during the authorization of PRIA and registrants are 
scheduled to pay $139 million in maintenance fees for the five year 
period to be covered by the proposed ``PRIA 3.''
  PRIA established a prohibition against the collection of other 
registration fees, as distinct from registration service fees, 
authorized under the Federal Insecticide, Fungicide and Rodenticide 
Act, FIFRA. PRIA also suspended the Agency's authority to collect 
tolerance fees which had been authorized by the Federal Food, Drug and 
Cosmetic Act, FFDCA.
  In the absence of this reauthorization, substantially higher fees 
whose authority is suspended by this legislation would be collected 
with the revenue going directly to the U.S. Treasury where it would be 
unavailable to EPA's Pesticide Program. This would necessitate the 
discretionary appropriation of new funds to carry out pesticide review 
activities and eliminate the transparency and accountability measures 
enacted in PRIA which have placed effective checks on the EPA.
  The legislation before us today: extends the authority of EPA to 
collect maintenance fees until 2017; extends the prohibition on 
collection of other registration and tolerance fees to 2019 and 2017, 
respectively; establishes a small business cap; allocates funds for EPA 
to use for the enhancement and improvement of ``IT'' systems for the 
registration of pesticides and tracking of key information; amends the 
percentage of maintenance fees devoted to review of inert ingredients; 
increases registration service fees during the life of PRIA 3 by 2.5 
percent; provides that the Administrator shall identify reforms in 
processing that would allow it to improve decision times beyond those 
provided for in the Act; and cites new schedule of decision review 
times.
  I urge my colleagues to support this legislation.
  The bill was ordered to be read a third time, was read the third 
time, and passed, and a motion to reconsider was laid on the table.


                             General Leave

  Mr. LUCAS. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks on 
the bill just considered.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Oklahoma?
  There was no objection.

                          ____________________`