[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Notices]
[Pages 57166-57178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24064]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0614; FRL-9933-75]


Pesticides; Revised Fee Schedule for Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is publishing a revised list of pesticide registration 
service fees applicable to specified pesticide applications and 
tolerance actions. Under the Pesticide Registration Improvement 
Extension Act, the registration service fees for covered pesticide 
registration applications received on or after October 1, 2015, 
increase by 5% rounding up to the nearest dollar from the fees 
published for fiscal year 2015. The new fees for FY'2016 become 
effective on October 1, 2015.

FOR FURTHER INFORMATION CONTACT: Peter Caulkins (7501P), Immediate 
Office, Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6550; fax number: (703) 308-4776; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you register 
pesticide products under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). Potentially affected entities may include, but 
are not limited to:
     Agricultural pesticide manufacturers (NAICS code 32532).
     Antimicrobial pesticide manufacturers (NAICS code 32561).
     Antifoulant pesticide manufacturers (NAICS code 32551).
     Wood preservative manufacturers (NAICS code 32519).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in the notice and in 
FIFRA section 33. If you have any questions regarding the applicability 
of this action to a particular entity, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPP-2015-0614, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional

[[Page 57167]]

information about the docket available at http://www.epa.gov/dockets.

II. Background

A. What action is the agency taking?

    The Pesticide Registration Improvement Act of 2003 established a 
new section 33 of FIFRA creating a registration service fee system for 
certain types of pesticide applications, establishment of tolerances, 
and certain other regulatory decisions under FIFRA and the Federal 
Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a 
schedule of decision review times for applications covered by the 
service fee system. The Agency began administering the registration 
service fee system for covered applications received on or after March 
23, 2004.
    On September 28, 2012, the Pesticide Registration Improvement 
Extension Act was signed by the President, revising, among other 
things, FIFRA section 33. The new law reauthorized the service fee 
system through fiscal year 2017 and established fees and review times 
for applications received during fiscal years 2013 through 2017. As 
required by section 33(b)(6)(A) of FIFRA, the registration service fees 
for covered pesticide registration applications received on or after 
October 1, 2015, increase by 5% rounding up to the nearest dollar from 
the fees published in the September 26, 2013, ``Pesticides: Fee 
Schedule for Registration Applications,'' FRN Vol. 78. No. 187 pp. 
59347-59359.

B. What is the agency's authority for taking this action?

    The publication of this fee schedule is required by section 
33(b)(6)(C) of FIFRA as amended.

III. Elements of the Fee Schedule

    This unit explains how to read the fee schedule tables, and 
includes a key to terminology published with the table.

A. The Pesticide Registration Improvement Extension Act Fee Schedule

    The fee schedule published in the Pesticide Registration 
Improvement Extension Act of September 28, 2012, identifies the 
registration service fees and decision times and is organized according 
to the organizational units of the Office of Pesticide Programs (OPP) 
within EPA. Thereafter, the categories within the organizational unit 
sections of the table are further categorized according to the type of 
application being submitted, the use patterns involved, or, in some 
cases, upon the type of pesticide that is the subject of the 
application. The fee categories differ by Division. Not all application 
types are covered by, or subject to, the fee system.

B. Fee Schedule and Decision Review Times

    In today's notice, EPA has retained the format of the tables 
included in the Pesticide Registration Improvement Extension Act of 
September 28, 2012. The schedules are presented as 19 tables, organized 
by OPP Division and by type of application or pesticide subject to the 
fee. Unit IV presents fee tables for the Registration Division (RD) (6 
tables), the Antimicrobials Division (AD) (4 tables), the Biopesticides 
and Pollution Prevention Division (BPPD) (7 tables), Inert Ingredients 
(1 table), Miscellaneous (1 table).

C. How To Read the Tables

    1. Each table consists of the following columns:
     The column titled ``EPA No.'' assigns an EPA identifier to 
each fee category. There are 189 categories spread across the 3 
Divisions. There are 63 RD categories, 39 AD categories, 69 BPPD 
categories, 10 inert categories, and 8 miscellaneous categories. For 
tracking purposes, OPP has assigned a 3-digit identifier to each 
category, beginning with RD categories, followed by AD, BPPD, inert and 
miscellaneous categories. The categories are prefaced with a letter 
designation indicating which Division of OPP is responsible for 
applications in that category (R=Registration Division, 
A=Antimicrobials Division, B=Biopesticides and Pollution Prevention 
Division, I=inert ingredients, M=miscellaneous).
     The column titled ``CR No.'' cross-references the current 
Congressional Record category number for convenience. However, EPA will 
be using the categories as numbered in the ``EPA No.'' column in its 
tracking systems.
     The column titled ``Action'' ' describes what registration 
actions are covered by each category.
     The column titled ``Decision Time'' lists the decision 
times in months for each type of action.
     The column titled ``FY' 2016/17 Registration Service Fee 
($)'' lists the registration service fee for the action for fiscal year 
2016 (October 1, 2015 through September 30, 2016) and fiscal year 2017 
(October 1, 2016 through September 30, 2017).
     Footnote text has been removed to save on Federal Register 
costs but remains unchanged from what was published in FY' 2013. The 
tables and footnote text will be available in full after October 1, 
2015 at http://www.epa.gov/pesticides/regulating/fees/tool/category-table.html.
    2. The following acronyms are used in some of the tables:
     DART--Dose Adequacy Response Team.
     DNT--Developmental Neurotoxicity.
     HSRB--Human Studies Review Board.
     GW/SW--Ground Water/Surface Water.
     PHI-Pre--Harvest Interval.
     PPE--Personal Protective Equipment.
     REI--Restricted Entry Interval.
     SAP--FIFRA Scientific Advisory Panel.

IV. PRIA Fee Schedule Tables--Effective October 1, 2015

A. Registration Division (RD)

    The Registration Division of OPP is responsible for the processing 
of pesticide applications and associated tolerance petitions for 
pesticides that are termed ``conventional chemicals,'' excluding 
pesticides intended for antimicrobial uses. The term ``conventional 
chemical'' is a term of art that is intended to distinguish synthetic 
chemicals from those that are of naturally occurring or non-synthetic 
origin, synthetic chemicals that are identical to naturally occurring 
chemicals and microbial pesticides. Tables 1 through 6 cover RD 
actions.

                             Table 1--Registration Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
R010.............................               1  New Active Ingredient, Food                24         627,568
                                                    use.
R020.............................               2  New Active Ingredient, Food                18         627,568
                                                    use; reduced risk.

[[Page 57168]]

 
R040.............................               3  New Active Ingredient, Food                18         462,502
                                                    use; Experimental Use Permit
                                                    application; establish
                                                    temporary tolerance;
                                                    submitted before application
                                                    for registration; credit 45%
                                                    of fee toward new active
                                                    ingredient application that
                                                    follows.
R060.............................               4  New Active Ingredient, Non-                21         436,004
                                                    food use; outdoor.
R070.............................               5  New Active Ingredient, Non-                16         436,004
                                                    food use; outdoor; reduced
                                                    risk.
R090.............................               6  New Active Ingredient, Non-                16         323,690
                                                    food use; outdoor;
                                                    Experimental Use Permit
                                                    application; submitted
                                                    before application for
                                                    registration; credit 45% of
                                                    fee toward new active
                                                    ingredient application that
                                                    follows.
R110.............................               7  New Active Ingredient, Non-                20         242,495
                                                    food use; indoor.
R120.............................               8  New Active Ingredient, Non-                14         242,495
                                                    food use; indoor; reduced
                                                    risk.
R121.............................               9  New Active Ingredient, Non-                18         182,327
                                                    food use; indoor;
                                                    Experimental Use Permit
                                                    application; submitted
                                                    before application for
                                                    registration; credit 45% of
                                                    fee toward new active
                                                    ingredient application that
                                                    follows.
R122.............................              10  Enriched isomer(s) of                      18         317,128
                                                    registered mixed-isomer
                                                    active ingredient.
R123.............................              11  New Active Ingredient, Seed                18         471,861
                                                    treatment only; includes
                                                    agricultural and non-
                                                    agricultural seeds; residues
                                                    not expected in raw
                                                    agricultural commodities.
R125.............................              12  New Active Ingredient, Seed                16         323,690
                                                    treatment; Experimental Use
                                                    Permit application;
                                                    submitted before application
                                                    for registration; credit 45%
                                                    of fee toward new active
                                                    ingredient application that
                                                    follows.
----------------------------------------------------------------------------------------------------------------


                                    Table 2--Registration Division--New Uses
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
R130.............................              13  First food use; indoor; food/              21         191,444
                                                    food handling.
R140.............................              14  Additional food use; Indoor;               15          44,672
                                                    food/food handling.
R150.............................              15  First food use...............              21         264,253
R160.............................              16  First food use; reduced risk.              16         264,253
R170.............................              17  Additional food use..........              15          66,124
R175.............................              18  Additional food uses covered               10          66,124
                                                    within a crop group
                                                    resulting from the
                                                    conversion of existing
                                                    approved crop group(s) to
                                                    one or more revised crop
                                                    groups..
R180.............................              19  Additional food use; reduced               10          66,124
                                                    risk.
R190.............................              20  Additional food uses; 6 or                 15         396,742
                                                    more submitted in one
                                                    application.
R200.............................              21  Additional food use; 6 or                  10         396,742
                                                    more submitted in one
                                                    application; reduced risk.
R210.............................              22  Additional food use;                       12          48,986
                                                    Experimental Use Permit
                                                    application; establish
                                                    temporary tolerance; no
                                                    credit toward new use
                                                    registration.
R220.............................              23  Additional food use;                        6          19,838
                                                    Experimental Use Permit
                                                    application; crop destruct
                                                    basis; no credit toward new
                                                    use registration.
R230.............................              24  Additional use; non-food;                  15          26,427
                                                    outdoor.
R240.............................              25  Additional use; non-food;                  10          26,427
                                                    outdoor; reduced risk.
R250.............................              26  Additional use; non-food;                   6          19,838
                                                    outdoor; Experimental Use
                                                    Permit application; no
                                                    credit toward new use
                                                    registration.
R251.............................              27  Experimental Use Permit                     8          19,838
                                                    application which requires
                                                    no changes to the
                                                    tolerance(s); non-crop
                                                    destruct basis.
R260.............................              28  New use; non-food; indoor....              12          12,764
R270.............................              29  New use; non-food; indoor;                  9          12,764
                                                    reduced risk.
R271.............................              30  New use; non-food; indoor;                  6           9,725
                                                    Experimental Use Permit
                                                    application; no credit
                                                    toward new use registration.
R273.............................              31  Additional use; seed                       12          50,445
                                                    treatment; 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.
R274.............................              32  Additional uses; seed                      12         302,663
                                                    treatment only; 6 or 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.
----------------------------------------------------------------------------------------------------------------


                           Table 3--Registration Division--Import and Other Tolerances
----------------------------------------------------------------------------------------------------------------
                                                                                                    FY '16/17--
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
R280.............................              33  Establish import tolerance;                21         319,072
                                                    new active ingredient or
                                                    first food use.

[[Page 57169]]

 
R290.............................              34  Establish Import tolerance;                15          63,816
                                                    Additional new food use.
R291.............................              35  Establish import tolerances;               15         382,886
                                                    additional food uses; 6 or
                                                    more crops submitted in one
                                                    petition.
R292.............................              36  Amend an established                       11          45,341
                                                    tolerance (e.g., decrease or
                                                    increase); domestic or
                                                    import; applicant-initiated.
R293.............................              37  Establish tolerance(s) for                 12          53,483
                                                    inadvertent residues in one
                                                    crop; applicant-initiated.
R294.............................              38  Establish tolerances for                   12         320,894
                                                    inadvertent residues; 6 or
                                                    more crops submitted in one
                                                    application; applicant-
                                                    initiated.
R295.............................              39  Establish tolerance(s) for                 15          66,124
                                                    residues in one rotational
                                                    crop in response to a
                                                    specific rotational crop
                                                    application; applicant-
                                                    initiated.
R296.............................              40  Establish tolerances for                   15         396,742
                                                    residues in 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                11         272,037
                                                    tolerances (e.g., decrease
                                                    or increase) in one
                                                    petition; domestic or
                                                    import; applicant-initiated.
R298.............................              42  Amend an established                       13          58,565
                                                    tolerance (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).
R299.............................              43  Amend 6 or more established                13         285,261
                                                    tolerances (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).
----------------------------------------------------------------------------------------------------------------


                                  Table 4--Registration Division--New Products
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
R300.............................              44  New product; or similar                     4           1,582
                                                    combination 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.
R301.............................              45  New product; or similar                     4           1,897
                                                    combination 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.
R310.............................              46  New end-use or manufacturing-               7           5,301
                                                    use product 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.
R314.............................              47  New end use product                         8           6,626
                                                    containing two or more
                                                    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.
R315.............................              48  New end-use non-food animal                 9           8,820
                                                    product with 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.
R320.............................              49  New product; new physical                  12          13,226
                                                    form; requires data review
                                                    in science divisions.
R331.............................              50  New product; repack of                      3           2,530
                                                    identical registered end-use
                                                    product as a manufacturing-
                                                    use product; same registered
                                                    uses only.

[[Page 57170]]

 
R332.............................              51  New manufacturing-use                      24         283,215
                                                    product; registered active
                                                    ingredient; unregistered
                                                    source of active ingredient;
                                                    submission of completely new
                                                    generic data package;
                                                    registered uses only;
                                                    requires review in RD and
                                                    science divisions.
R333.............................              52  New product; MUP or End use                10          19,838
                                                    product with 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.
R334.............................              53  New product; MUP or End use                11          19,838
                                                    product with unregistered
                                                    source of the active
                                                    ingredient; requires science
                                                    data review; new physical
                                                    form; etc Selective data
                                                    citation.
----------------------------------------------------------------------------------------------------------------


                           Table 5--Registration Division--Amendments to Registration
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
R340.............................              54  Amendment requiring data                    4           3,988
                                                    review within RD (e.g.,
                                                    changes to precautionary
                                                    label statements).
R345.............................              55  Amending non-food animal                    7           8,820
                                                    product that includes
                                                    submission of target animal
                                                    safety data; previously
                                                    registered.
R350.............................              56  Amendment requiring data                    9          13,226
                                                    review in science 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).
R351.............................              57  Amendment adding a new                      8          13,226
                                                    unregistered source of
                                                    active ingredient.
R352.............................              58  Amendment adding already                    8          13,226
                                                    approved uses; selective
                                                    method of support; does not
                                                    apply if the applicant owns
                                                    all cited data.
R371.............................              59  Amendment to Experimental Use               6          10,090
                                                    Permit; (does not include
                                                    extending a permit's time
                                                    period).
----------------------------------------------------------------------------------------------------------------


                                  Table 6--Registration Division--Other Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (Months)           ($)
----------------------------------------------------------------------------------------------------------------
R124.............................              60  Conditional Ruling on                       6           2,530
                                                    Preapplication Study
                                                    Waivers; applicant-initiated.
R272.............................              61  Review of Study Protocol                    3           2,530
                                                    applicant-initiated;
                                                    excludes DART, pre-
                                                    registration conference,
                                                    Rapid Response review, DNT
                                                    protocol review, protocol
                                                    needing HSRB review.
R275.............................              62  Rebuttal of agency reviewed                 3           2,530
                                                    protocol, applicant
                                                    initiated.
R370.............................              63  Cancer reassessment;                       18         198,250
                                                    applicant-initiated.
----------------------------------------------------------------------------------------------------------------

B. Antimicrobials Division (AD)

    The Antimicrobials Division of OPP is responsible for the 
processing of pesticide applications and associated tolerances for 
conventional chemicals intended for antimicrobial uses, that is, uses 
that are defined under FIFRA section 2 (mm)(1)(A), including products 
for use against bacteria, protozoa, non-agricultural fungi, and 
viruses. AD is also responsible for a selected set of conventional 
chemicals intended for other uses, including most wood preservatives 
and antifoulants. Tables 7 through 10 cover AD actions.

                            Table 7--Antimicrobials Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (Months)           ($)
----------------------------------------------------------------------------------------------------------------
A380.............................              64  New Active Ingredient Food                 24         114,867
                                                    use, establish tolerance
                                                    exemption.
A390.............................              65  New Active Ingredient Food                 24         191,444
                                                    use, establish tolerance.
A400.............................              66  New Active Ingredient, Non-                18          95,724
                                                    food use, outdoor, FIFRA
                                                    Sec.   2 (mm) uses.
A410.............................              67  New Active Ingredient Non-                 21         191,444
                                                    food use, outdoor, uses
                                                    other than FIFRA Sec.
                                                    2(mm).
A420.............................              68  New Active Ingredient Non-                 18          63,816
                                                    food use, indoor, FIFRA Sec.
                                                      2(mm) uses.

[[Page 57171]]

 
A430.............................              69  New Active Ingredient, Non-                20          95,724
                                                    Food Use Indoor, uses other
                                                    than FIFRA Sec.   2(mm) uses.
A431.............................              70  New Active Ingredient, Non-                12          66,854
                                                    food use; indoor; low-risk;
                                                    low-toxicity food grade
                                                    active ingredient(s);
                                                    efficacy testing for public
                                                    health claims required under
                                                    GLP and following DIS/TSS or
                                                    AD-approved study protocol.
----------------------------------------------------------------------------------------------------------------


                                   Table 8--Antimicrobials Division--New Uses
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (Months)           ($)
----------------------------------------------------------------------------------------------------------------
A440.............................              71  New Use, First Food Use,                   21          31,910
                                                    establish tolerance
                                                    exemption.
A450.............................              72  New use, First food use,                   21          95,724
                                                    establish tolerance.
A460.............................              73  New use, additional food use;              15          12,764
                                                    establish tolerance
                                                    exemption.
A470.............................              74  New use, additional food use,              15          31,910
                                                    establish tolerance.
A471.............................              75  Additional food uses;                      15         191,452
                                                    establish tolerances; 6 or
                                                    more submitted in one
                                                    application.
A480.............................              76  New use, Additional use, non-               9          19,146
                                                    food, outdoor; FIFRA Sec.
                                                    2(mm) uses.
A481.............................              77  Additional non-food outdoor                 9         114,870
                                                    uses; FIFRA Sec.   2(mm)
                                                    uses; 6 or more submitted in
                                                    one application.
A490.............................              78  New use, additional use, non-              15          31,910
                                                    food, outdoor, uses other
                                                    than FIFRA Sec.   2(mm).
A491.............................              79  Additional non-food; outdoor;              15         191,452
                                                    uses other than FIFRA Sec.
                                                    2(mm); 6 or more submitted
                                                    in one application.
A500.............................              80  New use, additional use, non-               9          12,764
                                                    food, indoor FIFRA Sec.
                                                    2(mm) uses.
A501.............................              81  Additional non-food; indoor;                9          76,583
                                                    FIFRA Sec.   2(mm) uses; 6
                                                    or more submitted in one
                                                    application.
A510.............................              82  New use, additional use, non-              12          12,764
                                                    food, indoor, other than
                                                    FIFRA Sec.   2(mm).
A511.............................              83  Additional non-food; indoor;               12          76,583
                                                    uses other than FIFRA Sec.
                                                    2(mm); 6 or more submitted
                                                    in one application.
----------------------------------------------------------------------------------------------------------------


                          Table 9--Antimicrobials Division-New Products and Amendments
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (Months)           ($)
----------------------------------------------------------------------------------------------------------------
A530.............................              84  New product, identical or                   4           1,278
                                                    substantially 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 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.
A531.............................              85  New product; identical or                   4           1,824
                                                    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.
A532.............................              86  New product; identical or                   5           5,107
                                                    substantially 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.
A540.............................              87  New end use product; FIFRA                  5           5,107
                                                    Sec.   2(mm) uses only (2)
                                                    (3).
A550.............................              88  New end-use product; uses                   7           5,107
                                                    other than FIFRA Sec.
                                                    2(mm); non-FQPA product.
A560.............................              89  New manufacturing use                      12          19,146
                                                    product; registered active
                                                    ingredient; selective data
                                                    citation.
A570.............................              90  Label amendment requiring                   4           3,831
                                                    data review.
A572.............................              91  New Product or amendment                    9          13,226
                                                    requiring data review for
                                                    risk assessment by Science
                                                    Branch (e.g., changes to
                                                    REI, or PPE, or use rate).
----------------------------------------------------------------------------------------------------------------


[[Page 57172]]


              Table 10--Antimicrobials Division--Experimental Use Permits and Other Type of Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (Months)           ($)
----------------------------------------------------------------------------------------------------------------
A520.............................              92  Experimental Use Permit                     9           6,383
                                                    application, non-food use.
A521.............................              93  Review of public health                     3           2,482
                                                    efficacy study 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                    12          12,156
                                                    efficacy study 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..
A523.............................             101  Review of protocol other than               9          12,156
                                                    a public health efficacy
                                                    study (i.e., Toxicology or
                                                    Exposure Protocols).
A524.............................              95  New Active Ingredient,                     18         153,156
                                                    Experimental Use Permit
                                                    application; Food Use
                                                    Requires Tolerance. Credit
                                                    45% of fee toward new active
                                                    ingredient application that
                                                    follows.
A525.............................              96  New Active Ingredient,                     18          92,163
                                                    Experimental Use Permit
                                                    application; Food Use
                                                    Requires Tolerance
                                                    Exemption. Credit 45% of fee
                                                    toward new active ingredient
                                                    application that follows.
A526.............................              97  New Active Ingredient,                     15          95,724
                                                    Experimental Use Permit
                                                    application; Non-Food,
                                                    Outdoor Use. Credit 45% of
                                                    fee toward new active
                                                    ingredient application that
                                                    follows.
A527.............................              98  New Active Ingredient,                     15          63,945
                                                    Experimental Use Permit
                                                    application; Non-Food,
                                                    Indoor Use. Credit 45% of
                                                    fee toward new active
                                                    ingredient application that
                                                    follows.
A528.............................              99  Experimental Use Permit                    15          22,337
                                                    application, Food Use;
                                                    Requires Tolerance or
                                                    Tolerance Exemption.
A529.............................             100  Amendment to Experimental Use               9          11,429
                                                    Permit; requires data review
                                                    or risk assessment.
A571.............................             102  Science reassessment: Cancer               18          95,724
                                                    risk, refined ecological
                                                    risk, and/or endangered
                                                    species; applicant-initiated.
----------------------------------------------------------------------------------------------------------------

C. Biopesticides and Pollution Prevention Division (BPPD)

    The Biopesticides and Pollution Prevention Division of OPP is 
responsible for the processing of pesticide applications for 
biochemical pesticides, microbial pesticides, and plant-incorporated 
protectants (PIPs).
    The fee tables for BPPD actions are presented by type of pesticide 
rather than by type of action: Microbial and biochemical pesticides, 
straight chain lepidopteran pheromones (SCLPs), and PIPs. Within each 
table, the types of application are the same as those in other 
divisions. Tables 11 through 17 cover BPPD actions.

   Table 11--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Active
                                                   Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY'16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
B580.............................             103  New active ingredient; food                19          51,053
                                                    use; petition to establish a
                                                    tolerance.
B590.............................             104  New active ingredient; food                17          31,910
                                                    use; petition to establish a
                                                    tolerance exemption.
B600.............................             105  New active ingredient; non-                13          19,146
                                                    food use.
B610.............................             106  New active ingredient;                     10          12,764
                                                    Experimental Use Permit
                                                    application; petition to
                                                    establish a temporary
                                                    tolerance or temporary
                                                    tolerance exemption.
B611.............................             107  New active ingredient;                     12          12,764
                                                    Experimental Use Permit
                                                    application; petition to
                                                    establish permanent
                                                    tolerance exemption.
B612.............................             108  New active ingredient; no                  10          17,550
                                                    change to a permanent
                                                    tolerance exemption.
B613.............................             109  New active ingredient;                     11          17,550
                                                    petition to convert a
                                                    temporary tolerance or a
                                                    temporary tolerance
                                                    exemption to a permanent
                                                    tolerance or tolerance
                                                    exemption.
B620.............................             110  New active ingredient;                      7           6,383
                                                    Experimental Use Permit
                                                    application; non-food use
                                                    including crop destruct.
----------------------------------------------------------------------------------------------------------------


[[Page 57173]]


    Table 12--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Uses
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
B630.............................             111  First food use; petition to                13          12,764
                                                    establish a tolerance
                                                    exemption.
B631.............................             112  New food use; petition to                  12          12,764
                                                    amend an established
                                                    tolerance.
B640.............................             113  New food use; petition to                  19          19,146
                                                    amend an established
                                                    tolerance.
B642.............................             115  First food use; indoor; food/              12          31,910
                                                    food handling.
B643.............................             114  New Food use; petition to                  10          12,764
                                                    amend tolerance exemption.
B644.............................             116  New use, no change to an                    8          12,764
                                                    established tolerance or
                                                    tolerance exemption.
B650.............................             117  New use; non-food............               7           6,383
----------------------------------------------------------------------------------------------------------------


  Table 13--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Products
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
B652.............................             118  New product; registered                    13          12,764
                                                    source of active 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.
B660.............................             119  New product; registered                     4           1,278
                                                    source of active
                                                    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.
B670.............................             120  New product; registered                     7           5,107
                                                    source of active
                                                    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.
B671.............................             121  New product; unregistered                  17          12,764
                                                    source of active
                                                    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.
B672.............................             122  New product; unregistered                  13           9,118
                                                    source of active
                                                    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.
B673.............................             123  New product MUP/EP;                        10           5,107
                                                    unregistered source of
                                                    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.
B674.............................             124  New product MUP; Repack of                  4           1,278
                                                    identical registered end-use
                                                    product as a manufacturing-
                                                    use product; same registered
                                                    uses only.

[[Page 57174]]

 
B675.............................             125  New Product MUP; registered                10           9,118
                                                    source of active ingredient;
                                                    submission of completely new
                                                    generic data package;
                                                    registered uses only.
B676.............................             126  New product; more than one                 13           9,118
                                                    active 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.
B677.............................             127  New end-use non-food animal                10           8,820
                                                    product with submission of
                                                    two or more target animal
                                                    safety studies; includes
                                                    data and/or waivers of data.
----------------------------------------------------------------------------------------------------------------


   Table 14--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; Amendments
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
B621.............................             128  Amendment; Experimental Use                 7           5,107
                                                    Permit; no change to an
                                                    established temporary
                                                    tolerance or tolerance
                                                    exemption.
B622.............................             129  Amendment; Experimental Use                11          12,764
                                                    Permit; petition to amend an
                                                    established or temporary
                                                    tolerance or tolerance
                                                    exemption.
B641.............................             130  Amendment of an established                13          12,764
                                                    tolerance or tolerance
                                                    exemption.
B680.............................             131  Amendment; registered source                5           5,107
                                                    of active ingredient(s); no
                                                    new use(s); no changes to an
                                                    established tolerance or
                                                    tolerance exemption Requires
                                                    data submission.
B681.............................             132  Amendment; unregistered                     7           6,079
                                                    source of active
                                                    ingredient(s) Requires data
                                                    submission.
B683.............................             133  Label amendment; requires                   6           5,107
                                                    review/update of previous
                                                    risk assessment(s) without
                                                    data submission (eg.,
                                                    labeling changes to REI,
                                                    PPE, PHI).
B684.............................             134  Amending non-food animal                    8           8,820
                                                    product that includes
                                                    submission of target animal
                                                    safety data; previously
                                                    registered.
----------------------------------------------------------------------------------------------------------------


    Table 15--Biopesticides and Pollution Prevention Division--Straight Chain Lepidopteran Pheromones (SCLPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
B690.............................             135  New active ingredient; food                 7           2,554
                                                    or non-food use.
B700.............................             136  Experimental Use Permit                     7           1,278
                                                    application; new active
                                                    ingredient or new use.
B701.............................             137  Extend or amend Experimental                4           1,278
                                                    Use Permit.
B710.............................             138  New product; registered                     4           1,278
                                                    source of active
                                                    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.
B720.............................             139  New product; registered                     5           1,278
                                                    source of 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.
B721.............................             140  New product; unregistered                   7           2,676
                                                    source of active ingredient.

[[Page 57175]]

 
B722.............................             141  New use and/or amendment;                   7           2,477
                                                    petition to establish a
                                                    tolerance or tolerance
                                                    exemption.
B730.............................             142  Label amendment requiring                   5           1,278
                                                    data submission.
----------------------------------------------------------------------------------------------------------------


                    Table 16--Biopesticides and Pollution Prevention Division--Other Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
B614.............................             143  Conditional Ruling on                       3           2,530
                                                    Preapplication Study
                                                    Waivers; applicant-initiated.
B615.............................             144  Rebuttal of agency reviewed                 3           2,530
                                                    protocol, applicant
                                                    initiated.
B682.............................             145  Protocol review; applicant                  3           2,432
                                                    initiated; excludes time for
                                                    HSRB review.
----------------------------------------------------------------------------------------------------------------


        Table 17--Biopesticides and Pollution Prevention Division--Plant Incorporated Protectants (PIPS)
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
B740.............................             146  Experimental Use Permit                     6          95,724
                                                    application; no petition for
                                                    tolerance/tolerance
                                                    exemption. Includes: Non-
                                                    food/feed use(s) for a new
                                                    or registered PIP; food/feed
                                                    use(s) for a new or
                                                    registered PIP with crop
                                                    destruct; food/feed use(s)
                                                    for a new or registered PIP
                                                    in which an established
                                                    tolerance/tolerance
                                                    exemption exists for the
                                                    intended use(s).
B750.............................             147  Experimental Use Permit                     9         127,630
                                                    application; with a petition
                                                    to establish a temporary or
                                                    permanent tolerance/
                                                    tolerance exemption for the
                                                    active ingredient. Includes
                                                    new food/feed use for a
                                                    registered PIP.
B770.............................             148  Experimental Use Permit                    15         191,444
                                                    application; new 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.
B771.............................             149  Experimental Use Permit                    10         127,630
                                                    application; new 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                     3          12,764
                                                    extend an Experimental Use
                                                    Permit; no petition since
                                                    the established tolerance/
                                                    tolerance exemption for the
                                                    active ingredient is
                                                    unaffected.
B773.............................             151  Application to amend or                     5          31,910
                                                    extend an Experimental Use
                                                    Permit; with petition to
                                                    extend a temporary tolerance/
                                                    tolerance exemption for the
                                                    active ingredient.
B780.............................             152  Registration application; new              12         159,537
                                                    PIP; non-food/feed.
B790.............................             153  Registration application; new              18         223,351
                                                    PIP; non-food/feed; SAP
                                                    review.
B800.............................             154  Registration application; new              12         255,324
                                                    PIP; 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              18         319,072
                                                    PIP; with petition to
                                                    establish permanent
                                                    tolerance/tolerance
                                                    exemption for the active
                                                    ingredient based on an
                                                    existing temporary tolerance/
                                                    tolerance exemption. SAP
                                                    review.
B820.............................             156  Registration application; new              15         319,072
                                                    PIP; with petition to
                                                    establish or amend a
                                                    permanent tolerance/
                                                    tolerance exemption of an
                                                    active ingredient.
B840.............................             157  Registration application; new              21         382,886
                                                    PIP; with petition to
                                                    establish or amend a
                                                    permanent tolerance/
                                                    tolerance exemption of an
                                                    active ingredient. SAP
                                                    review.
B851.............................             158  Registration application; new               9         127,630
                                                    event of a 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;                   9          38,290
                                                    registered PIP; new product;
                                                    new use; no petition since a
                                                    permanent tolerance/
                                                    tolerance exemption is
                                                    already established for the
                                                    active ingredient(s).

[[Page 57176]]

 
B880.............................             160  Registration application;                   9          31,910
                                                    registered 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).
B881.............................             161  Registration application;                  15          95,724
                                                    registered 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.
B883.............................             162  Registration application; new               9         127,630
                                                    PIP, 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.
B884.............................             163  Registration application; new              12         159,537
                                                    PIP, seed increase with
                                                    negotiated acreage cap and
                                                    time-limited registration;
                                                    with petition to establish a
                                                    permanent tolerance/
                                                    tolerance exemption for the
                                                    active ingredient.
B885.............................             164  Registration application;                   9          95,724
                                                    registered 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).
B890.............................             165  Application to amend a seed                 9          63,816
                                                    increase 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                15         127,630
                                                    increase registration;
                                                    converts registration to a
                                                    commercial registration; no
                                                    petition since a permanent
                                                    tolerance/tolerance
                                                    exemption already
                                                    established for the active
                                                    ingredient(s); SAP review.
B900.............................             167  Application to amend a                      6          12,764
                                                    registration, including
                                                    actions such as extending an
                                                    expiration date, modifying
                                                    an IRM plan, or adding an
                                                    insect to be controlled.
B901.............................             168  Application to amend a                     12          76,578
                                                    registration, including
                                                    actions such as extending an
                                                    expiration date, modifying
                                                    an IRM plan, or adding an
                                                    insect to be controlled. SAP
                                                    review.
B902.............................             169  PIP Protocol review..........               3           6,383
B903.............................             170  Inert ingredient tolerance                  6          63,816
                                                    exemption; e.g., a marker
                                                    such as NPT II; reviewed in
                                                    BPPD.
B904.............................             171  Import tolerance or tolerance               9         127,630
                                                    exemption; processed
                                                    commodities/food only (inert
                                                    or active ingredient).
----------------------------------------------------------------------------------------------------------------


                                           Table 18--Inert Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
I001.............................             172  Approval of new food use                   12          19,845
                                                    inert ingredient.
I002.............................             173  Amend currently approved                   10           5,513
                                                    inert ingredient tolerance
                                                    or exemption from tolerance;
                                                    new data.
I003.............................             174  Amend currently approved                    8           3,308
                                                    inert ingredient tolerance
                                                    or exemption from tolerance;
                                                    no new data.
I004.............................             175  Approval of new non-food use                8          11,025
                                                    inert ingredient.
I005.............................             176  Amend currently approved non-               8           5,513
                                                    food use inert ingredient
                                                    with new use pattern; new
                                                    data.
I006.............................             177  Amend currently approved non-               6           3,308
                                                    food use inert ingredient
                                                    with new use pattern; no new
                                                    data.
I007.............................             178  Approval of substantially                   4           1,654
                                                    similar non-food use inert
                                                    ingredients when original
                                                    inert is compositionally
                                                    similar with similar use
                                                    pattern.
I008.............................             179  Approval of new polymer inert               5           3,749
                                                    ingredient, food use.
I009.............................             180  Approval of new polymer inert               4           3,087
                                                    ingredient, non food use.
I010.............................             181  Petition to amend a tolerance               6           1,654
                                                    exemption descriptor to add
                                                    one or more CASRNs; no new
                                                    data.
----------------------------------------------------------------------------------------------------------------


[[Page 57177]]


                                         Table 19--Miscellaneous Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     FY '16/17
                                                                                     Decision      registration
             EPA No.                 New CR No.                Action               review time     service fee
                                                                                     (months)           ($)
----------------------------------------------------------------------------------------------------------------
M001.............................             182  Study protocol requiring                    9           7,938
                                                    Human Studies Review Board
                                                    review as defined in 40 CFR
                                                    Part 26 in support of an
                                                    active ingredient.
M002.............................             183  Completed study requiring                   9           7,938
                                                    Human Studies Review Board
                                                    review as defined in 40 CFR
                                                    Part 26 in support of an
                                                    active ingredient.
M003.............................             184  External technical peer                    12          63,945
                                                    review of 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.
M004.............................             185  External technical peer                    18          63,945
                                                    review of 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.
M005.............................             186  New Product: Combination,                   9          22,050
                                                    Contains a 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.
M006.............................             187  Request for up to 5 letters                 1             277
                                                    of certification (Gold Seal)
                                                    for one actively registered
                                                    product.
M007.............................             188  Request to extend Exclusive                12           5,513
                                                    Use of data as provided by
                                                    FIFRA Section 3(c)(1)(F)(ii).
M008.............................             189  Request to grant Exclusive                 10           1,654
                                                    Use of data as provided by
                                                    FIFRA Section 3(c)(1)(F)(vi)
                                                    for a minor use, when a
                                                    FIFRA Section 2(ll)(2)
                                                    determination is required.
----------------------------------------------------------------------------------------------------------------

V. How To Pay Fees

    Applicants must submit fee payments at the time of application, and 
EPA will reject any application that does not contain evidence that the 
fee has been paid. EPA has developed a Web site at http://www.epa.gov/pesticides/fees/tool/index.htm to help applicants identify the fee 
category and the fee. All fees should be rounded up to the whole 
dollar. Due to changes mandated by the U.S. Department of the Treasury, 
checks, bank drafts and money orders are no longer acceptable as of 
September 30, 2015. Credit card payments are only acceptable for 
amounts less than or equal to $25,000. All payments above $25,000 can 
be made by electronic funds transfer via www.pay.gov.

A. Online

    You may pay electronically through the government payment Web site 
www.pay.gov.
    1. From the pay.gov home page, under ``Find Public Forms.''
    2. Select ``search by Agency name.''
    3. On the A-Z Index of Forms page, select ``E.''
    4. Select ``Environmental Protection Agency.''
    5. From the list of forms, select ``Pre-payment of Pesticide 
Registration Improvement Act Fee.''
    6. Complete the form entering the PRIA fee category and fee.
    7. Keep a copy of the pay.gov acknowledgement of payment. A copy of 
the acknowledgement must be printed and attached to the front of the 
application to assure that EPA can match the application with the 
payment.

VI. How To Submit Applications

    Submissions to the Agency should be made at the address given in 
Unit VII. The applicant should attach documentation that the fee has 
been paid which in most cases will be pay.gov payment acknowledgement. 
If the applicant is applying for a fee waiver, the applicant should 
provide sufficient documentation as described in FIFRA section 33(b)(7) 
and http://www.epa.gov/pesticides/fees/questions/waivers.htm. The fee 
waiver request should be easy to identify and separate from the rest of 
the application and submitted with documentation that at least 25% of 
the fee has been paid.
    If evidence of fee payment (electronic acknowledgement) is not 
submitted with the application, EPA will reject the application and 
will not process it further.
    After EPA receives an application and payment, EPA performs a 
screen on the application to determine that the category is correct and 
that the proper fee amount has been paid. If either is incorrect, EPA 
will notify the applicant and require payment of any additional amount 
due. A refund will be provided in case of an overpayment. EPA will not 
process the application further until the proper fee has been paid for 
the category of application or a request for a fee waiver accompanies 
the application and the appropriate portion of the fee has been paid.
    EPA will assign a unique identification number to each covered 
application for which payment has been made. EPA notifies the applicant 
of the unique identification number. This information is sent by email 
if EPA has either an email address on file or an email address is 
provided on the application.

VII. Addresses for Applications

    New covered applications should be identified in the title line 
with the mail code REGFEE.
     By U.S. Postal Service mail. Document Processing Desk 
(REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460-
0001.

[[Page 57178]]

     By courier. Document Processing Desk (REGFEE), Office of 
Pesticide Programs, U.S. Environmental Protection Agency, Room S-4400, 
One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA 
22202-4501.
    Couriers and delivery personnel must present a valid picture 
identification card to gain access to the building. Hours of operation 
for the Document Processing Desk are 8 a.m. to 4:30 p.m., Monday 
through Friday, excluding Federal holidays.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Pesticides.

    Dated: September 15, 2015.
Marty Monell,
Acting Director, Office of Pesticide Programs.
[FR Doc. 2015-24064 Filed 9-21-15; 8:45 am]
BILLING CODE 6560-50-P