Pesticides; Revised Fee Schedule for Covered Applications Under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4), 52085-52104 [2019-21117]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52085-52104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21117]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2019-0543; FRL-10000-37]


Pesticides; Revised Fee Schedule for Covered Applications Under 
the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is publishing a revised list of pesticide registration 
service fees applicable to pesticide applications covered under the 
Pesticide Registration Improvement Extension Act of 2018 (PRIA 4), 
which was signed into law and became effective March 8, 2019. As 
specified in the law and effective October 1, 2019, the registration 
service fees for covered pesticide registration applications received 
on or after that date will be increased by 5%. The revised fees will 
remain in effect through September 30, 2021.

FOR FURTHER INFORMATION CONTACT: Stephen A. Schaible, PRIA Coordinator, 
Office of Pesticide Programs, U.S. Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703)308-9362; 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 are 
requesting registration of a new pesticide product or amendment to an 
existing pesticide product under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), petitioning to establish a

[[Page 52086]]

tolerance or tolerance exemption for an active ingredient or inert 
ingredient under the Federal Food, Drug, and Cosmetic Act (FFDCA), or 
otherwise seeking a regulatory determination under FIFRA or FFDCA for 
certain activities specified under PRIA. The following list of North 
American Industrial Classification System (NAICS) codes is not intended 
to be exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
may include:

 Agricultural pesticide manufacturers (NAICS code 325320)
 Antimicrobial pesticide manufacturers (NAICS code 325611, 
325612)
 Antifoulant pesticide manufacturers (NAICS code 325510)
 Wood preservative manufacturers (NAICS code 325194)

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-2019-0543, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton 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 information about the docket available at https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    The Pesticide Registration Improvement Act of 2003 (PRIA) 
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 March 8, 2019, the Pesticide Registration Improvement Extension 
Act of 2018 was signed into law by the President, revising, among other 
things, FIFRA section 33. The new law reauthorized the service fee 
system through fiscal year 2023 and established fees and review times 
for applications received during fiscal years 2019 (as of March 8, 
2019) through 2023. 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, 2019, increase by 5% 
(rounding up to the nearest dollar) from the fee amounts established by 
the law (Pub. L. 116-8).

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

    The increase in these registration service fees is required by 
section 33(b)(6)(A) of FIFRA. The publication of these revised 
registration service fee schedules is required by section 33(b)(6)(C) 
of FIFRA as amended (U.S.C. Title 7, Ch. 6, Subchapter II, Section 
136w-8).

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 of 2018 Fee 
Schedule

    The fee schedule provided in the Pesticide Registration Improvement 
Extension Act of 2018 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 this notice, EPA has retained the format of the tables included 
in the Pesticide Registration Improvement Extension Act of 2018. 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 212 categories spread across the 3 
Divisions. There are 70 RD categories, 36 AD categories, 79 BPPD 
categories, 16 inert categories, and 11 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 Review Time'' lists the 
decision times in months for each type of action.
     The column titled ``FY'20-FY'21 Fees ($)'' lists the 
registration service fee for the action for fiscal year 2020 (October 
1, 2019 through September 30, 2020) and fiscal year 2021 (October 1, 
2020 through September 30, 2021).
    2. The following acronyms are used in some of the tables:
     DART--Dose Adequacy Response Team.
     DNT--Developmental Neurotoxicity.
     DfE--Design for the Environment.
     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, 2019

A. Registration Division (RD)

    The Registration Division of OPP is responsible for the processing 
of pesticide applications and associated tolerance petitions for 
pesticides that

[[Page 52087]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                 New CR No.                Action               review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
R010.............................               1  New Active Ingredient, Food                24         790,737
                                                    use 2 3.
R020.............................               2  New Active Ingredient, Food                18         658,947
                                                    use; reduced risk 2 3.
R040.............................               3  New Active Ingredient, Food                18         485,628
                                                    use; Experimental Use Permit
                                                    application; establish
                                                    temporary tolerance;
                                                    submitted before application
                                                    for registration; credit 45%
                                                    of fee toward new active
                                                    ingredient application that
                                                    follows 3.
R060.............................               4  New Active Ingredient, Non-                21         549,366
                                                    food use; outdoor 2 3.
R070.............................               5  New Active Ingredient, Non-                16         457,805
                                                    food use; outdoor; reduced
                                                    risk 2 3.
R090.............................               6  New Active Ingredient, Non-                16         339,875
                                                    food use; outdoor;
                                                    Experimental Use Permit
                                                    application; submitted
                                                    before application for
                                                    registration; credit 45% of
                                                    fee toward new active
                                                    ingredient application that
                                                    follows 3.
R110.............................               7  New Active Ingredient, Non-                20         305,544
                                                    food use; indoor 2 3.
R120.............................               8  New Active Ingredient, Non-                14         254,620
                                                    food use; indoor; reduced
                                                    risk 2 3.
R121.............................               9  New Active Ingredient, Non-                18         191,444
                                                    food use; indoor;
                                                    Experimental Use Permit
                                                    application; submitted
                                                    before application for
                                                    registration; credit 45% of
                                                    fee toward new active
                                                    ingredient application that
                                                    follows 3.
R122.............................              10  Enriched isomer(s) of                      18         332,985
                                                    registered mixed-isomer
                                                    active ingredient 2 3.
R123.............................              11  New Active Ingredient, Seed                18         495,455
                                                    treatment only; includes
                                                    agricultural and non-
                                                    agricultural seeds; residues
                                                    not expected in raw
                                                    agricultural commodities 2 3.
R125.............................              12  New Active Ingredient, Seed                16         339,875
                                                    treatment; Experimental Use
                                                    Permit application;
                                                    submitted before application
                                                    for registration; credit 45%
                                                    of fee toward new active
                                                    ingredient application that
                                                    follows 3.
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant
  at the applicant's initiative to support the application after completion of the technical deficiency
  screening, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new active ingredient or first food use application.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                    Table 2--Registration Division--New Uses
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                 New CR No.                Action               review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
R130.............................              13  First food use; indoor; food/              21         201,017
                                                    food handling 2 3.
R140.............................              14  Additional food use; Indoor;               15          46,906
                                                    food/food handling 3 4.
R150.............................              15  First food use 2 3...........              21         332,960
R155.............................        16 (new)  First food use, Experimental               21         277,466
                                                    Use Permit application; a.i.
                                                    registered for non-food
                                                    outdoor use 3 4.
R160.............................              17  First food use; reduced risk               16         277,466
                                                    2 3.
R170.............................              18  Additional food use 3 4......              15          83,317
R175.............................              19  Additional food uses covered               10          69,431
                                                    within a crop group
                                                    resulting from the
                                                    conversion of existing
                                                    approved crop group(s) to
                                                    one or more revised crop
                                                    groups 3 4.
R180.............................              20  Additional food use; reduced               10          69,431
                                                    risk 3 4.
R190.............................              21  Additional food uses; 6 or                 15         499,895
                                                    more submitted in one
                                                    application 3 4.

[[Page 52088]]

 
R200.............................              22  Additional Food Use; 6 or                  10         416,580
                                                    more submitted in one
                                                    application; Reduced Risk 3
                                                    4.
R210.............................              23  Additional food use;                       12          51,436
                                                    Experimental Use Permit
                                                    application; establish
                                                    temporary tolerance; no
                                                    credit toward new use
                                                    registration 3 4.
R220.............................              24  Additional food use;                        6          20,830
                                                    Experimental Use Permit
                                                    application; crop destruct
                                                    basis; no credit toward new
                                                    use registration 3 4.
R230.............................              25  Additional use; non-food;                  15          33,299
                                                    outdoor 3 4.
R240.............................              26  Additional use; non-food;                  10          27,749
                                                    outdoor; reduced risk 3 4.
R250.............................              27  Additional use; non-food;                   6          20,830
                                                    outdoor; Experimental Use
                                                    Permit application; no
                                                    credit toward new use
                                                    registration 3 4.
R251.............................              28  Experimental Use Permit                     8          20,830
                                                    application which requires
                                                    no changes to the
                                                    tolerance(s); non-crop
                                                    destruct basis 3.
R260.............................              29  New use; non-food; indoor 3 4              12          16,083
R270.............................              30  New use; non-food; indoor;                  9          13,403
                                                    reduced risk 3 4.
R271.............................              31  New use; non-food; indoor;                  6          10,212
                                                    Experimental Use Permit
                                                    application; no credit
                                                    toward new use registration
                                                    3 4.
R273.............................              32  Additional use; seed                       12          52,968
                                                    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 3 4.
R274.............................              33  Additional uses; seed                      12         317,797
                                                    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 3 4.
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant
  at the applicant's initiative to support the application after completion of the technical deficiency
  screening, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new active ingredient or first food use application.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
\4\ Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
  the new use(s). All items in the covered application must be submitted together in one package. Each
  application for an additional new product registration and new inert approval(s) that is submitted in the new
  use application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant
  at the applicant's initiative to support the application after completion of the technical deficiency screen,
  and (c) is not itself a covered registration application, must be assessed 25% of the full registration
  service fee for the new use application.


                           Table 3--Registration Division--Import and Other Tolerances
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                 New CR No.                Action               review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
R280.............................              34  Establish import tolerance;                21         335,026
                                                    new active ingredient or
                                                    first food use 2.
R290.............................              35  Establish Import tolerance;                15          67,007
                                                    Additional new food use.
R291.............................              36  Establish import tolerances;               15         402,031
                                                    additional food uses; 6 or
                                                    more crops submitted in one
                                                    petition.

[[Page 52089]]

 
R292.............................              37  Amend an established                       11          47,609
                                                    tolerance (e.g., decrease or
                                                    increase) and/or harmonize
                                                    established tolerances with
                                                    Codex MRLs; domestic or
                                                    import; applicant-initiated.
R293.............................              38  Establish tolerance(s) for                 12          56,158
                                                    inadvertent residues in one
                                                    crop; applicant-initiated.
R294.............................              39  Establish tolerances for                   12         336,939
                                                    inadvertent residues; 6 or
                                                    more crops submitted in one
                                                    application; applicant-
                                                    initiated.
R295.............................              40  Establish tolerance(s) for                 15          69,431
                                                    residues in one rotational
                                                    crop in response to a
                                                    specific rotational crop
                                                    application; submission of
                                                    corresponding label
                                                    amendments which specify the
                                                    necessary plant-back
                                                    restrictions; applicant-
                                                    initiated 3 4.
R296.............................              41  Establish tolerances for                   15         416,580
                                                    residues in rotational crops
                                                    in response to a specific
                                                    rotational crop petition; 6
                                                    or more crops submitted in
                                                    one application; submission
                                                    of corresponding label
                                                    amendments which specify the
                                                    necessary plant-back
                                                    restrictions; applicant-
                                                    initiated 3 4.
R297.............................              42  Amend 6 or more established                11         285,639
                                                    tolerances (e.g., decrease
                                                    or increase) in one
                                                    petition; domestic or
                                                    import; applicant-initiated.
R298.............................              43  Amend an established                       13          61,494
                                                    tolerance (e.g., decrease or
                                                    increase); domestic or
                                                    import; submission of
                                                    corresponding amended labels
                                                    (requiring science review)3
                                                    4.
R299.............................              44  Amend 6 or more established                13         299,525
                                                    tolerances (e.g., decrease
                                                    or increase); domestic or
                                                    import; submission of
                                                    corresponding amended labels
                                                    (requiring science review)3
                                                    4.
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant
  at the applicant's initiative to support the application after completion of the technical deficiency
  screening, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new active ingredient or first food use application.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the applicant's written or electronic
  confirmation of agreement to the Agency.
\4\ Amendment applications to add the revised use pattern(s) to registered product labels are covered by the
  base fee for the category. All items in the covered application must be submitted together in one package.
  Each application for an additional new product registration and new inert approval(s) that is submitted in the
  amendment application package is subject to the registration service fee for a new product or a new inert
  approval. However, if an amendment application only proposes to register the amendment for a new product and
  there are no amendments in the application, then review of one new product application is covered by the base
  fee. All such associated applications that are submitted together will be subject to the category decision
  review time.


                                  Table 4--Registration Division--New Products
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months)(1)      fees ($)
----------------------------------------------------------------------------------------------------------------
R300............................              45  New product; or similar                      4           1,662
                                                   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 2
                                                   3

[[Page 52090]]

 
R301............................              46  New product; or similar                      4           1,992
                                                   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
                                                   (identical data citation and
                                                   claims to cited product(s)),
                                                   where applicant does not own
                                                   all required data and does
                                                   not have a specific
                                                   authorization letter from
                                                   data owner2 3
R310............................              47  New end-use or manufacturing-                7           7,667
                                                   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; excludes products
                                                   requiring or citing an animal
                                                   safety study; 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
                                                   child resistant
                                                   packaging and/or
                                                   pest(s) requiring
                                                   efficacy--for up to 3 target
                                                   pests2 3 4.
R314............................              48  New end use product containing               8           9,058
                                                   up to three 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; excludes
                                                   products requiring or citing
                                                   an animal safety study;
                                                   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
                                                   child resistant
                                                   packaging and/or
                                                   pest(s) requiring
                                                   efficacy (4) for up to 3
                                                   target pests2 3.
R319............................        49 (new)  New end use product containing              10          13,258
                                                   up to three 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; excludes
                                                   products requiring or citing
                                                   an animal safety study;
                                                   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
                                                   child resistant
                                                   packaging and/or
                                                   pest(s) requiring
                                                   efficacy 4--for 4 to 7 target
                                                   pests2 3.
R318............................        50 (new)  New end-use product containing               9          13,915
                                                   four 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; excludes
                                                   products requiring or citing
                                                   an animal safety study;
                                                   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
                                                   child resistant
                                                   packaging and/or
                                                   pest(s) requiring
                                                   efficacy--for up to 3 target
                                                   pests2 3 4.
R321............................        51 (new)  New end use product containing              11          18,115
                                                   four 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; excludes
                                                   products requiring or citing
                                                   an animal safety study;
                                                   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
                                                   child resistant
                                                   packaging and/or
                                                   pest(s) requiring
                                                   efficacy 4--for 4 to 7 target
                                                   pests2 3.
R315............................              52  New end-use on-animal product,               9          10,311
                                                   registered source of active
                                                   ingredient(s) with submission
                                                   of data and/or waivers for
                                                   only:
                                                   Animal safety and
                                                   pest(s) requiring
                                                   efficacy and/or
                                                   product chemistry and/
                                                   or
                                                   acute toxicity and/or
                                                   child resistant
                                                   packaging2 3 4.

[[Page 52091]]

 
R316............................        53 (new)  New end-use or manufacturing                 9          11,867
                                                   product with registered
                                                   source(s) of active
                                                   ingredient(s) including
                                                   products containing two or
                                                   more registered active
                                                   ingredients previously
                                                   combined in other registered
                                                   products; excludes products
                                                   requiring or citing an animal
                                                   safety study; and requires
                                                   review of data and/or waivers
                                                   for only:
                                                   Product chemistry and/
                                                   or
                                                   acute toxicity and/or
                                                   child resistant
                                                   packaging and/or
                                                   pest(s) requiring
                                                   efficacy--for greater than 3
                                                   and up to 7 target pests2 3
                                                   4.
R317............................        54 (new)  New end-use or manufacturing                10          16,067
                                                   product with registered
                                                   source(s) of active
                                                   ingredient(s) including
                                                   products containing two or
                                                   more registered active
                                                   ingredients previously
                                                   combined in other registered
                                                   products; excludes products
                                                   requiring or citing an animal
                                                   safety study; and requires
                                                   review of data and/or waivers
                                                   for only:
                                                   Product chemistry and/
                                                   or
                                                   acute toxicity and/or
                                                   child resistant
                                                   packaging and/or
                                                   pest(s) requiring
                                                   efficacy--for greater than 7
                                                   target pests2 3 4.
R320............................              55  New product; new physical                   12          13,888
                                                   form; requires data review in
                                                   science divisions2 3
R331............................              56  New product; repack of                       3           2,657
                                                   identical registered end-use
                                                   product as a manufacturing-
                                                   use product, or identical
                                                   registered manufacturing-use
                                                   product as an end-use
                                                   product; same registered uses
                                                   only2 3
R332............................              57  New manufacturing-use product;              24         297,376
                                                   registered active ingredient;
                                                   unregistered source of active
                                                   ingredient; submission of
                                                   completely new generic data
                                                   package; registered uses
                                                   only; requires review in RD
                                                   and science divisions2 3
R333............................              58  New product; MUP or end use                 10          20,830
                                                   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 data2 3
R334............................              59  New product; MUP or end use                 11          24,255
                                                   product with unregistered
                                                   source of the active
                                                   ingredient; requires science
                                                   data review; new physical
                                                   form; etc. Selective data
                                                   citation 2 3
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
\4\ For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: Public health pests listed in PR Notice 2002-1, livestock pests (e.g., Horn flies, Stable
  flies), wood-destroying pests (e.g., termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g., Asian Longhorned beetle, Emerald Ash Borer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: Mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.


                                   Table 5--Registration Division--Amendments
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                  (months) \(1)\     fees ($)
----------------------------------------------------------------------------------------------------------------
R340............................              60  Amendment requiring data                     4           5,238
                                                   review within RD (e.g.,
                                                   changes to precautionary
                                                   label statements); includes
                                                   adding/modifying pest(s)
                                                   claims for up to 2 target
                                                   pests; excludes products
                                                   requiring or citing an animal
                                                   safety study.\2\ \3\

[[Page 52092]]

 
R341............................        61 (new)  Amendment requiring data                     6           6,288
                                                   review within RD (e.g.,
                                                   changes to precautionary
                                                   label statements), includes
                                                   adding/modifying pest(s)
                                                   claims for greater than 2
                                                   target pests; excludes
                                                   products requiring or citing
                                                   an animal safety study.\2\
                                                   \3\
R345............................              62  Amending on-animal products
                                                   previously registered, with
                                                   the submission of data and/or
                                                   waivers for only:
                                                     Animal safety and
                                                     pest(s) requiring
                                                  efficacy and/or
                                                     product chemistry
                                                  and/or
                                                     acute toxicity and/
                                                  or
                                                     child resistant                   7           9,261
                                                  packaging.\2\ \3\ \4\
R350............................              63  Amendment requiring data                     9          13,888
                                                   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) \2\ \3\
R351............................              64  Amendment adding a new                       8          13,888
                                                   unregistered source of active
                                                   ingredient.\2\ \3\
R352............................              65  Amendment adding already                     8          13,888
                                                   approved uses; selective
                                                   method of support; does not
                                                   apply if the applicant owns
                                                   all cited data.\2\ \3\
R371............................              66  Amendment to Experimental Use                6          10,595
                                                   Permit; (does not include
                                                   extending a permit's time
                                                   period).\2\ \3\
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.
\4\For the purposes of classifying proposed registration actions into PRIA categories, ``pest(s) requiring
  efficacy'' are: Public health pests listed in PR Notice 2002-1, livestock pests (e.g., Horn flies, Stable
  flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive
  species (e.g., Asian Longhorned beetle, Emerald Ash Borer). This list may be updated/refined as invasive pest
  needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups
  (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against
  a pest group (general), use the group listing below and each group will count as 1. The general pests groups
  are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes,
  lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies,
  mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true
  bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and
  harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites,
  arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without
  a general claim then each specific pest will count as 1.


                                  Table 6--Registration Division--Other Actions
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time    FY'20--FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
R124............................              67  Conditional Ruling on Pre-                   6           2,657
                                                   application Study Waivers;
                                                   applicant-initiated.
R272............................              68  Review of Study Protocol                     3           2,657
                                                   applicant- initiated;
                                                   excludes DART, pre-
                                                   registration conference,
                                                   Rapid Response review, DNT
                                                   protocol review, protocol
                                                   needing HSRB review.
R275............................              69  Rebuttal of agency reviewed                  3           2,657
                                                   protocol, applicant
                                                   initiated.
R370............................              70  Cancer reassessment; applicant-             18         208,163
                                                   initiated.
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.

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.

[[Page 52093]]



                            Table 7--Antimicrobials Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                Review Time    FY'20--FY'21
                                                                                     (Months)1       Fees ($)
----------------------------------------------------------------------------------------------------------------
A380............................              71  New Active Ingredient;                      24         144,734
                                                   Indirect Food use; establish
                                                   tolerance or tolerance
                                                   exemption if required.2 3
A390............................              72  New Active Ingredient; Direct               24         241,220
                                                   Food use; establish tolerance
                                                   or tolerance exemption if
                                                   required.2 3
A410............................              73  New Active Ingredient Non-food              21         241,262
                                                   use.2 3
A431............................              74  New Active Ingredient, Non-                 12          84,237
                                                   food use; low-risk.2 3
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                   Table 8--Antimicrobials Division--New Uses
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                Review Time    FY'20--FY'21
                                                                                    (Months) 1       Fees ($)
----------------------------------------------------------------------------------------------------------------
A440............................              75  New Use, Indirect Food Use,                 21          33,506
                                                   establish tolerance or
                                                   tolerance exemption.2 3 4
A441............................        76 (new)  Additional Indirect food uses;              21         120,614
                                                   establish tolerances or
                                                   tolerance exemptions if
                                                   required; 6 or more submitted
                                                   in one application.3 4 5
A450............................              77  New use, Direct food use,                   21         100,511
                                                   establish tolerance or
                                                   tolerance exemption.2 3 4
A451............................        78 (new)  Additional Direct food uses;                21         191,452
                                                   establish tolerances or
                                                   tolerance exemptions if
                                                   required; 6 or more submitted
                                                   in one application.3 4 5
A500............................              79  New use, non-food4 5                        12          33,506
A501............................              80  New use, non-food; 6 or more                15          80,413
                                                   submitted in one
                                                   application.4 5
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.
\3\ If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.

[[Page 52094]]

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


                          Table 9--Antimicrobials Division--New Products and Amendments
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time    FY'20--FY'21
                                                                                     (months)1       fees ($)
----------------------------------------------------------------------------------------------------------------
A530............................              81  New product, identical or                    4           1,342
                                                   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.2
                                                   3
A531............................              82  New product; identical or                    4           1,916
                                                   substantially similar in
                                                   composition and use to a
                                                   registered product;
                                                   registered source of active
                                                   ingredient: selective data
                                                   citation only for data on
                                                   product chemistry and/or
                                                   acute toxicity and/or public
                                                   health pest efficacy, where
                                                   applicant does not own all
                                                   required data and does not
                                                   have a specific authorization
                                                   letter from data owner.2 3
A532............................              83  New product; identical or                    5           5,363
                                                   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.2 3
A540............................              84  New end use product; FIFRA                   5           5,363
                                                   Sec.   2(mm) uses only; up to
                                                   25 public health organisms.2
                                                   3 5 6
A541............................        85 (new)  New end use product; FIFRA                   7           8,925
                                                   Sec.   2(mm) uses only; 26-50
                                                   public health organisms.2 3 5
                                                   6
A542............................        86 (new)  New end use product; FIFRA                  10          15,750
                                                   Sec.   2(mm) uses only; >= 51
                                                   public health organisms.2 3 5
A550............................              87  New end-use product; uses                    9          13,888
                                                   other than FIFRA Sec.
                                                   2(mm); non-FQPA product.2 3 5
A560............................              88  New manufacturing use product;               6          13,226
                                                   registered active ingredient;
                                                   selective data citation.2 3
A565............................        89 (new)  New manufacturing-use product;              12          19,146
                                                   registered active ingredient;
                                                   unregistered source of active
                                                   ingredient; submission of new
                                                   generic data package;
                                                   registered uses only;
                                                   requires science review.2 3
A570............................              90  Label amendment requiring data               4           4,023
                                                   review; up to 25 public
                                                   health organisms.3 4 5 6
A573............................        91 (new)  Label amendment requiring data               6           6,668
                                                   review; 26-50 public health
                                                   organisms.2 3 5 7
A574............................        92 (new)  Label amendment requiring data               9          11,550
                                                   review; >= 51 public health
                                                   organisms.2 3 5 7
A572............................              93  New Product or amendment                     9          13,888
                                                   requiring data review for
                                                   risk assessment by Science
                                                   Branch (e.g., changes to REI,
                                                   or PPE, or use rate).2 3 4
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

[[Page 52095]]

 
\4\ (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
\5\ The applicant must identify the substantially similar product if opting to use cite-all or the selective
  method to support acute toxicity data requirements.
\6\ Once a submission for a new product with public health organisms has been submitted and classified in either
  A540 or A541, additional organisms submitted for the same product before expiration of the first submission's
  original decision review time period will result in reclassification of both the original and subsequent
  submission into the appropriate new category based on the sum of the number or organisms in both submissions.
  A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the
  new category.
\7\ Once a submission for a label amendment with public health organisms has been submitted and classified in
  either A570 or A573, additional organisms submitted for the same product before expiration of the first
  submission's original decision review time period will result in reclassification of both the original and
  subsequent submission into the appropriate new category based on the sum of the number or organisms in both
  submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the
  fee of the new category.


                  Table 10--Antimicrobials Division--Experimental Use Permits and Other Actions
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time    FY'20--FY'21
                                                                                     (months)1       fees ($)
----------------------------------------------------------------------------------------------------------------
A520............................              94  Experimental Use Permit                      9           6,703
                                                   application, non-food use.2
A521............................              95  Review of public health                      4           4,963
                                                   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............................              96  Review of public health                     12          12,764
                                                   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
A537............................        97 (new)  New Active Ingredient/New Use,              18         160,814
                                                   Experimental Use Permit
                                                   application; Direct food use;
                                                   Establish tolerance or
                                                   tolerance exemption if
                                                   required. Credit 45% of fee
                                                   toward new active ingredient/
                                                   new use application that
                                                   follows.
A538............................        98 (new)  New Active Ingredient/New Use,              18         100,511
                                                   Experimental Use Permit
                                                   application; Indirect food
                                                   use; Establish tolerance or
                                                   tolerance exemption if
                                                   required Credit 45% of fee
                                                   toward new active ingredient/
                                                   new use application that
                                                   follows.
A539............................        99 (new)  New Active Ingredient/New Use,              15          96,772
                                                   Experimental Use Permit
                                                   application; Nonfood use.
                                                   Credit 45% of fee toward new
                                                   active ingredient/new use
                                                   application that follows.
A529............................             100  Amendment to Experimental Use                9          12,001
                                                   Permit; requires data review
                                                   or risk assessment.2
A523............................             101  Review of protocol other than                9          12,764
                                                   a public health efficacy
                                                   study (i.e., Toxicology or
                                                   Exposure Protocols)
A571............................             102  Science reassessment: Cancer                18         100,511
                                                   risk, refined ecological
                                                   risk, and/or endangered
                                                   species; applicant-initiated.
A533............................       103 (new)  Exemption from the requirement               4           2,607
                                                   of an Experimental Use
                                                   Permit.2
A534............................       104 (new)  Rebuttal of agency reviewed                  4           4,963
                                                   protocol, applicant initiated
A535............................       105 (new)  Conditional Ruling on Pre-                   6           2,530
                                                   application Study Waiver or
                                                   Data Bridging Argument;
                                                   applicant-initiated
A536............................       106 (new)  Conditional Ruling on Pre-                   4           2,607
                                                   application Direct Food,
                                                   Indirect Food, Nonfood use
                                                   determination; applicant-
                                                   initiated
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

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.

[[Page 52096]]



                            Table 11--Biopesticides Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months).1       fees ($)
----------------------------------------------------------------------------------------------------------------
B580............................             107  New active ingredient; food                 20          53,606
                                                   use; petition to establish a
                                                   tolerance.2 3
B590............................             108  New active ingredient; food                 18          33,506
                                                   use; petition to establish a
                                                   tolerance exemption.2 3
B600............................             109  New active ingredient; non-                 13          20,104
                                                   food use.2 3
B610............................             110  New active ingredient;                      10          13,403
                                                   Experimental Use Permit
                                                   application; petition to
                                                   establish a temporary
                                                   tolerance or temporary
                                                   tolerance exemption.3
B611............................             111  New active ingredient;                      12          13,403
                                                   Experimental Use Permit
                                                   application; petition to
                                                   establish permanent tolerance
                                                   exemption.3
B612............................             112  New active ingredient; no                   10          18,428
                                                   change to a permanent
                                                   tolerance exemption.2 3
B613............................             113  New active ingredient;                      11          18,428
                                                   petition to convert a
                                                   temporary tolerance or a
                                                   temporary tolerance exemption
                                                   to a permanent tolerance or
                                                   tolerance exemption.2 3
B620............................             114  New active ingredient;                       7           6,703
                                                   Experimental Use Permit
                                                   application; non-food use
                                                   including crop destruct.3
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant
  at the applicant's initiative to support the application after completion of the technical deficiency
  screening, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new active ingredient or first food use application.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                   Table 12--Biopesticides Division--New Uses
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B630............................             115  First food use; petition to                 13          13,403
                                                   establish a tolerance
                                                   exemption.2 4
B631............................             116  New food use; petition to                   12          13,403
                                                   amend an established
                                                   tolerance.3 4
B640............................             117  First food use; petition to                 19          20,104
                                                   establish a tolerance.2 4
B643............................             118  New Food use; petition to                   10          13,403
                                                   amend tolerance exemption.3 4
B642............................             119  First food use; indoor; food/               12          33,506
                                                   food handling.2 4
B644............................             120  New use, no change to an                     8          13,403
                                                   established tolerance or
                                                   tolerance exemption.3 4
B650............................             121  New use; non-food.3 4                        7           6,703
B645............................       122 (new)  New food use; Experimental Use              12          13,403
                                                   Permit application; petition
                                                   to amend or add a tolerance
                                                   exemption.4
B646............................       123 (new)  New use; non-food use                        7           6,703
                                                   including crop destruct;
                                                   Experimental Use Permit
                                                   application.4
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
  a first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use. Any information that (a) was
  neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
  initiative to support the application after completion of the technical deficiency screening, and (c) is not
  itself a covered registration application, must be assessed 25% of the full registration service fee for the
  new active ingredient or first food use application.

[[Page 52097]]

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


                                 Table 13--Biopesticides Division--New Products
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B652............................             124  New product; registered source              13          13,403
                                                   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.2 3
B660............................             125  New product; registered source               4           1,342
                                                   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.2 3
B670............................             126  New product; registered source               7           5,363
                                                   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.2 3
B671............................             127  New product; unregistered                   17          13,403
                                                   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.2 3
B672............................             128  New product; unregistered                   13           9,574
                                                   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.2 3

[[Page 52098]]

 
B673............................             129  New product MUP/EP;                         10           5,363
                                                   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.2 3
B674............................             130  New product MUP; Repack of                   4           1,342
                                                   identical registered end-use
                                                   product as a manufacturing-
                                                   use product; same registered
                                                   uses only.2 3
B675............................             131  New Product MUP; registered                 10           9,574
                                                   source of active ingredient;
                                                   submission of completely new
                                                   generic data package;
                                                   registered uses only.2 3
B676............................             132  New product; more than one                  13           9,574
                                                   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.2 3
B677............................             133  New end-use non-food animal                 10           9,261
                                                   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.2 3
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                  Table 14--Biopesticides Division--Amendments
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B621............................             134  Amendment; Experimental Use                  7           5,363
                                                   Permit; no change to an
                                                   established temporary
                                                   tolerance or tolerance
                                                   exemption.3
B622............................             135  Amendment; Experimental Use                 11          13,403
                                                   Permit; petition to amend an
                                                   established or temporary
                                                   tolerance or tolerance
                                                   exemption.3
B641............................             136  Amendment of an established                 13          13,403
                                                   tolerance or tolerance
                                                   exemption.
B680............................             137  Amendment; registered sources                5           5,363
                                                   of active ingredient(s); no
                                                   new use(s); no changes to an
                                                   established tolerance or
                                                   tolerance exemption. Requires
                                                   data submission.2 3
B681............................             138  Amendment; unregistered source               7           6,383
                                                   of active ingredient(s).
                                                   Requires data submission.2 3
B683............................             139  Label amendment; requires                    6           5,363
                                                   review/update of previous
                                                   risk assessment(s) without
                                                   data submission (e.g.,
                                                   labeling changes to REI, PPE,
                                                   PHI).2 3
B684............................             140  Amending non-food animal                     8           9,261
                                                   product that includes
                                                   submission of target animal
                                                   safety data; previously
                                                   registered.2 3
B685............................       141 (new)  Amendment; add a new                         5           5,363
                                                   biochemical unregistered
                                                   source of active ingredient
                                                   or a new microbial production
                                                   site. Requires submission of
                                                   analysis of samples data and
                                                   source/production site-
                                                   specific manufacturing
                                                   process description.3
----------------------------------------------------------------------------------------------------------------
1A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.

[[Page 52099]]

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


                                     Table 15--Biopesticides Division--SCLP
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B690............................             142  New active ingredient; food or               7           2,682
                                                   non-food use.2 6
B700............................             143  Experimental Use Permit                      7           1,342
                                                   application; new active
                                                   ingredient or new use.6
B701............................             144  Extend or amend Experimental                 4           1,342
                                                   Use Permit.6
B710............................             145  New product; registered source               4           1,342
                                                   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.3 6
B720............................             146  New product; registered source               5           1,342
                                                   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.3 6
B721............................             147  New product; unregistered                    7           2,810
                                                   source of active ingredient.3
                                                   6
B722............................             148  New use and/or amendment;                    7           2,601
                                                   petition to establish a
                                                   tolerance or tolerance
                                                   exemption.4 5 6
B730............................             149  Label amendment requiring data               5           1,342
                                                   submission.4 6
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a
  first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant
  at the applicant's initiative to support the application after completion of the technical deficiency
  screening, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new active ingredient or first food use application.
3 An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
4 (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

[[Page 52100]]

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


                                 Table 16--Biopesticides Division--Other Actions
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                 New CR No.                Action               review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B614.............................             150  Pre-application; Conditional                3           2,657
                                                    Ruling on rationales for
                                                    addressing a data
                                                    requirement in lieu of data;
                                                    applicant-initiated; applies
                                                    to one (1) rationale at a
                                                    time.
B615.............................             151  Rebuttal of agency reviewed                 3           2,657
                                                    protocol, applicant
                                                    initiated.
B682.............................             152  Protocol review; applicant                  3           2,554
                                                    initiated; excludes time for
                                                    HSRB review.
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to
  end on the next business day.


                                      Table 17--Biopesticides Division--PIP
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B740............................             153  Experimental Use Permit                      6         100,511
                                                   application; no petition for
                                                   tolerance/tolerance
                                                   exemption. Includes:
                                                  1. Non-food/feed use(s) for a
                                                   new 2 or registered 3 PIP 12;
                                                  2. food/feed use(s) for a new
                                                   or registered PIP with crop
                                                   destruct 12;
                                                  3. food/feed use(s) for a new
                                                   or registered PIP in which an
                                                   established tolerance/
                                                   tolerance exemption exists
                                                   for the intended use(s).4 12
B741............................       154 (new)  Experimental Use Permit                     12         167,515
                                                   application; no petition for
                                                   tolerance/tolerance
                                                   exemption. Includes:
                                                  1. Non-food/feed use(s) for a
                                                   new 2 or registered 3 PIP;
                                                  2. food/feed use(s) for a new
                                                   or registered PIP with crop
                                                   destruct;
                                                  3. food/feed use(s) for a new
                                                   or registered PIP in which an
                                                   established tolerance/
                                                   tolerance exemption exists
                                                   for the intended use(s);
                                                  SAP Review.12
B750............................             155  Experimental Use Permit                      9         134,012
                                                   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 3
                                                   PIP.4 12
B770............................             156  Experimental Use Permit                     15         201,017
                                                   application; new 2 PIP; with
                                                   petition to establish a
                                                   temporary tolerance/tolerance
                                                   exemption for the active
                                                   ingredient; credit 75% of
                                                   B771 fee toward registration
                                                   application for a new active
                                                   ingredient that follows; SAP
                                                   review.5 12
B771............................             157  Experimental Use Permit                     10         134,012
                                                   application; new 2 PIP; with
                                                   petition to establish a
                                                   temporary tolerance/tolerance
                                                   exemption for the active
                                                   ingredient; credit 75% of
                                                   B771 fee toward registration
                                                   application for a new active
                                                   ingredient that follows.12
B772............................             158  Application to amend or extend               3          13,403
                                                   an Experimental Use Permit;
                                                   no petition since the
                                                   established tolerance/
                                                   tolerance exemption for the
                                                   active ingredient is
                                                   unaffected.12
B773............................             159  Application to amend or extend               5          33,506
                                                   an Experimental Use Permit;
                                                   with petition to extend a
                                                   temporary tolerance/tolerance
                                                   exemption for the active
                                                   ingredient.12
B780............................             160  Registration application; new               12         167,514
                                                   2 PIP; non-food/feed.12
B790............................             161  Registration application; new               18         234,519
                                                   2 PIP; non-food/feed; SAP
                                                   review.5 12

[[Page 52101]]

 
B800............................             162  Registration application; new               13         180,915
                                                   2 PIP; with petition to
                                                   establish permanent tolerance/
                                                   tolerance exemption for the
                                                   active ingredient based on an
                                                   existing temporary tolerance/
                                                   tolerance exemption.12
B810............................             163  Registration application; new               19         247,920
                                                   2 PIP; with petition to
                                                   establish permanent tolerance/
                                                   tolerance exemption for the
                                                   active ingredient based on an
                                                   existing temporary tolerance/
                                                   tolerance exemption. SAP
                                                   review.5 12
B820............................             164  Registration application; new               15         214,419
                                                   2 PIP; with petition to
                                                   establish or amend a
                                                   permanent tolerance/tolerance
                                                   exemption of an active
                                                   ingredient.12
B840............................             165  Registration application; new               21         281,424
                                                   2 PIP; with petition to
                                                   establish or amend a
                                                   permanent tolerance/tolerance
                                                   exemption of an active
                                                   ingredient. SAP review.5 12
B851............................             166  Registration application; new                9         134,012
                                                   event of a previously
                                                   registered PIP active
                                                   ingredient(s); no petition
                                                   since permanent tolerance/
                                                   tolerance exemption is
                                                   already established for the
                                                   active ingredient(s).12
B870............................             167  Registration application;                    9          40,205
                                                   registered 3 PIP; new
                                                   product; new use; no petition
                                                   since a permanent tolerance/
                                                   tolerance exemption is
                                                   already established for the
                                                   active ingredient(s).4 12
B880............................             168  Registration application;                    9          33,506
                                                   registered 3 PIP; new product
                                                   or new terms of registration;
                                                   additional data submitted; no
                                                   petition since a permanent
                                                   tolerance/tolerance exemption
                                                   is already established for
                                                   the active ingredient(s).6 7
                                                   12
B881............................             169  Registration application;                   15         100,511
                                                   registered 3 PIP; new product
                                                   or new terms of registration;
                                                   additional data submitted; no
                                                   petition since a permanent
                                                   tolerance/tolerance exemption
                                                   is already established for
                                                   the active ingredient(s). SAP
                                                   review.5 6 7 12
B882............................       170 (new)  Registration application; new               15         201,017
                                                   2 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; SAP
                                                   Review.8 12
B883............................             171  Registration application; new                9         134,012
                                                   2 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.8 12
B884............................             172  Registration application; new               12         167,514
                                                   2 PIP, seed increase with
                                                   negotiated acreage cap and
                                                   time-limited registration;
                                                   with petition to establish a
                                                   permanent tolerance/tolerance
                                                   exemption for the active
                                                   ingredient.8 12
B885............................             173  Registration application;                    6          33,506
                                                   registered 2 PIP, seed
                                                   increase; breeding stack of
                                                   previously approved PIPs,
                                                   same crop; no petition since
                                                   a permanent tolerance/
                                                   tolerance exemption is
                                                   already established for the
                                                   active ingredient(s).9 12
B886............................       174 (new)  Registration application; new               18         234,519
                                                   2 PIP seed increase with
                                                   negotiated acreage cap and
                                                   time-limited registration;
                                                   with petition to establish a
                                                   permanent tolerance/tolerance
                                                   exemption for the active
                                                   ingredient. SAP Review.8 12
B890............................             175  Application to amend a seed                  9          67,007
                                                   increase registration;
                                                   converts registration to
                                                   commercial registration; no
                                                   petition since permanent
                                                   tolerance/tolerance exemption
                                                   is already established for
                                                   the active ingredient(s).12
B891............................             176  Application to amend a seed                 15         134,012
                                                   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.5 12
B900............................             177  Application to amend a                       6          13,403
                                                   registration, including
                                                   actions such as extending an
                                                   expiration date, modifying an
                                                   IRM plan, or adding an insect
                                                   to be controlled.10 11 12
B901............................             178  Application to amend a                      12          80,407
                                                   registration, including
                                                   actions such as extending an
                                                   expiration date, modifying an
                                                   IRM plan, or adding an insect
                                                   to be controlled. SAP
                                                   review.10 11 12
B902............................             179  PIP Protocol review                          3           6,703
B903............................             180  Inert ingredient tolerance                   6          67,007
                                                   exemption; e.g., a marker
                                                   such as NPT II; reviewed in
                                                   BPPD.
B904............................             181  Import tolerance or tolerance                9         134,012
                                                   exemption; processed
                                                   commodities/food only (inert
                                                   or active ingredient).
B905............................       182 (new)  SAP Review                                   6          67,007
B906............................       183 (new)  Petition to establish a                      3          33,503
                                                   temporary tolerance/tolerance
                                                   exemption for one or more
                                                   active ingredients.
B907............................       184 (new)  Petition to establish a                      3          13,403
                                                   temporary tolerance/tolerance
                                                   exemption for one or more
                                                   active ingredients based on
                                                   an existing temporary
                                                   tolerance/tolerance
                                                   exemption.

[[Page 52102]]

 
B908............................       185 (new)  Petition to establish a                      3          46,905
                                                   temporary tolerance/tolerance
                                                   exemption for one or more
                                                   active ingredients or inert
                                                   ingredients
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 New PIP = a PIP with an active ingredient that has not been registered.
3 Registered PIP = a PIP with an active ingredient that is currently registered.
4 Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet
  corn.
5 The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel (SAP) on risks that pesticides pose to wildlife, farm workers, pesticide
  applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new
  technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on
  the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect
  humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare
  for meetings with the SAP, additional time and costs are needed.
6 Registered PIPs stacked through conventional breeding.
7 Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
8 The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
9 Application can be submitted prior to or concurrently with an application for commercial registration.
10 For example, IRM plan modifications that are applicant-initiated.
11 EPA-initiated amendments shall not be charged fees.
12 Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.


                                           Table 18--Inert Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
I001............................             186  Approval of new food use inert              13          28,350
                                                   ingredient 2 3
I002............................             187  Amend currently approved inert              11           7,875
                                                   ingredient tolerance or
                                                   exemption from tolerance; new
                                                   data.2
I003............................             188  Amend currently approved inert               9           3,474
                                                   ingredient tolerance or
                                                   exemption from tolerance; no
                                                   new data.2
I004............................             189  Approval of new non-food use                 6          11,577
                                                   inert ingredient.2
I005............................             190  Amend currently approved non-                6           5,789
                                                   food use inert ingredient
                                                   with new use pattern; new
                                                   data.2
I006............................             191  Amend currently approved non-                3           3,474
                                                   food use inert ingredient
                                                   with new use pattern; no new
                                                   data.2
I007............................             192  Approval of substantially                    4           1,737
                                                   similar non-food use inert
                                                   ingredients when original
                                                   inert is compositionally
                                                   similar with similar use
                                                   pattern.2
I008............................             193  Approval of new or amended                   5           3,937
                                                   polymer inert ingredient,
                                                   food use.2
I009............................             194  Approval of new or amended                   4           3,242
                                                   polymer inert ingredient, non-
                                                   food use.2
I010............................             195  Petition to amend a single                   6           1,737
                                                   tolerance exemption
                                                   descriptor, or single non-
                                                   food use descriptor, to add
                                                   <=10 CASRNs; no new data.2
I011............................       196 (new)  Approval of new food use                    24         627,568
                                                   safener with tolerance or
                                                   exemption from tolerance.2 8
I012............................       197 (new)  Approval of new non-food use                21         436,004
                                                   safener.2 8
I013............................       198 (new)  Approval of additional food                 15          66,124
                                                   use for previously approved
                                                   safener with tolerance or
                                                   exemption from tolerance.2
I014............................       199 (new)  Approval of additional non-                 15          26,427
                                                   food use for previously
                                                   approved safener.2
I015............................       200 (new)  Approval of new generic data                24         283,215
                                                   for previously approved food
                                                   use safener.2
I016............................       201 (new)  Approval of amendment(s) to                 13          58,565
                                                   tolerance and label for
                                                   previously approved safener.2
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
3 If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.

[[Page 52103]]

 
4 Any other covered application that is associated with and dependent on the HSRB review will be subject to its
  separate registration service fee. The decision review times for the associated actions run concurrently but
  will end at the date of the latest review time.
5 Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
6 An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
7 Where the action involves approval of a new or amended label, on or before the end date of the decision review
  time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
  Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
  applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the
  draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the applicant's written or electronic
  confirmation of agreement to the Agency.
8 If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient
  is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active
  ingredient.


                               Table 19--External Review and Miscellaneous Actions
----------------------------------------------------------------------------------------------------------------
                                                                                     Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                    (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
M001............................             202  Study protocol requiring Human               9           8,335
                                                   Studies Review Board review
                                                   as defined in 40 CFR Part 26
                                                   in support of an active
                                                   ingredient.4
M002............................             203  Completed study requiring                    9           8,335
                                                   Human Studies Review Board
                                                   review as defined in 40 CFR
                                                   Part 26 in support of an
                                                   active ingredient.4
M003............................             204  External technical peer review              12          67,143
                                                   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.5
M004............................             205  External technical peer review              18          67,143
                                                   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.5
M005............................             206  New Product: Combination,                    9          23,153
                                                   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.6 7
M006............................             207  Request for up to 5 letters of               1             291
                                                   certification (Gold Seal) for
                                                   one actively registered
                                                   product (excludes distributor
                                                   products).8
M007............................             208  Request to extend Exclusive                 12           5,789
                                                   Use of data as provided by
                                                   FIFRA section 3(c)(1)(F)(ii).
M008............................             209  Request to grant Exclusive Use              15           1,737
                                                   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.
M009............................       210 (new)  Non-FIFRA Regulated                          4           2,482
                                                   Determination: Applicant
                                                   initiated, per product.
M010............................       211 (new)  Conditional ruling on pre-                   4           2,482
                                                   application, product
                                                   substantial similarity.
M011............................       212 (new)  Label amendment to add the DfE               4           3,831
                                                   logo; requires data review;
                                                   no other label changes.9
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
3 If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
4 Any other covered application that is associated with and dependent on the HSRB review will be subject to its
  separate registration service fee. The decision review times for the associated actions run concurrently but
  will end at the date of the latest review time.
5 Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
6 An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.

[[Page 52104]]

 
7 Where the action involves approval of a new or amended label, on or before the end date of the decision review
  time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
  Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
  applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the
  draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the applicant's written or electronic
  confirmation of agreement to the Agency.
8 Due to low fee and short time frame this category is not eligible for small business waivers. Gold seal
  applies to one registered product
9 This category includes amendments the sole purpose of which are to add DfE (or equivalent terms that do not
  use ``safe'' or derivatives of ``safe'') logos to a label. DfE is a voluntary program. A label bearing a DfE
  logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet
  objective, scientific criteria established and widely publicized by EPA.

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 website at https://www.epa.gov/pria-fees/pria-4-fee-determination-decision-tree 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 $24,999. All payments equal to or above 
$25,000 can be made by electronic funds transfer via the government 
payment website, https://www.pay.gov/.
    More detailed instructions on how to make an application payment in 
association with a PRIA application are provided at the following 
website, https://www.epa.gov/pria-fees/paying-pria-application-fees.

VI. How To Submit Applications

    Applicants are able to make PRIA submissions electronically via the 
Pesticide Submission Portal. The Portal is accessed through EPA's 
Central Data Exchange (CDX) network and requires user registration. 
Registrants currently submitting CDs or DVDs using the e-Dossier 
downloadable tool or their own builder tools using EPA's XML guidance 
can use the portal and forego courier delivery costs. Information on 
how to submit applications electronically via the Pesticide Submission 
Portal are provided at https://www.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications.
    Paper 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 https://www.epa.gov/pria-fees/pria-fee-waivers-small-businesses. 
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.
     By courier. Document Processing Desk (REGFEE), Office of 
Pesticide Programs, U.S. Environmental Protection Agency, Room S-4900, 
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 4:00 p.m., Monday 
through Friday, excluding Federal holidays.
    List of Subjects: Environmental protection, Administrative practice 
and procedure, Pesticides.

    Dated: September 24, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2019-21117 Filed 9-30-19; 8:45 am]
BILLING CODE 6560-50-P