Attachment B: Registration Service Fees

7 USC 136w-8: Pesticide registration service fees
Text contains those laws in effect on May 4, 2015
From Title 7-AGRICULTURE
CHAPTER 6-INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II-ENVIRONMENTAL PESTICIDE CONTROL
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§136w–8. Pesticide registration service fees
(a) Definition of costs
In this section, the term "costs", when used with respect to review and decisionmaking pertaining to an
application for which registration service fees are paid under this section, means(1) costs to the extent that(A) officers and employees provide direct support for the review and decisionmaking for covered pesticide
applications, associated tolerances, and corresponding risk and benefits information and analyses;
(B) persons and organizations under contract with the Administrator engage in the review of the
applications, and corresponding risk and benefits information and assessments; and
(C) advisory committees and other accredited persons or organizations, on the request of the
Administrator, engage in the peer review of risk or benefits information associated with covered pesticide
applications;
(2) costs of management of information, and the acquisition, maintenance, and repair of computer and
telecommunication resources (including software), used to support review of pesticide applications, associated
tolerances, and corresponding risk and benefits information and analyses; and
(3) costs of collecting registration service fees under subsections (b) and (c) and reporting, auditing, and
accounting under this section.
(b) Fees
(1) In general
Effective beginning on the effective date of the Pesticide Registration Improvement Act of 2003, the
Administrator shall assess and collect covered pesticide registration service fees in accordance with this
section.
(2) Covered pesticide registration applications
(A) In general
An application for the registration of a pesticide covered by this subchapter that is received by the
Administrator on or after the effective date of the Pesticide Registration Improvement Act of 2003 shall be
subject to a registration service fee under this section.
(B) Existing applications
(i) In general
Subject to clause (ii), an application for the registration of a pesticide that was submitted to the
Administrator before the effective date of the Pesticide Registration Improvement Act of 2003 and is
pending on that effective date shall be subject to a service fee under this section if the application is for the
registration of a new active ingredient that is not listed in the Registration Division 2003 Work Plan of the
Office of Pesticide Programs of the Environmental Protection Agency.
(ii) Tolerance or exemption fees
The amount of any fee otherwise payable for an application described in clause (i) under this section
shall be reduced by the amount of any fees paid to support the related petition for a pesticide tolerance or
exemption under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(C) Documentation
An application subject to a registration service fee under this section shall be submitted with documentation
certifying(i) payment of the registration service fee; or
(ii) payment of at least 25 percent of the registration service fee and a request for a waiver from or
reduction of the remaining amount of the registration service fee.
(D) Payment
The registration service fee required under this subsection shall be due upon submission of the application.
(E) Applications subject to additional fees
An application may be subject to additional fees if(i) the applicant identified the incorrect registration service fee and decision review period;
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(ii) after review of a waiver request, the Administrator denies the waiver request; or
(iii) after review of the application, the Administrator determines that a different registration service fee
and decision review period apply to the application.
(F) Effect of failure to pay fees
The Administrator shall reject any application submitted without the required registration service fee.
(G) Non-refundable portion of fees
(i) In general
The Administrator shall retain 25 percent of the applicable registration service fee.
(ii) Limitation
Any waiver, refund, credit or other reduction in the registration service fee shall not exceed 75 percent of
the registration service fee.
(H) Collection of unpaid fees
In any case in which the Administrator does not receive payment of a registration service fee (or applicable
portion of the registration service fee) by the date that is 30 days after the fee is due, the fee shall be treated
as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.
(3) Schedule of covered applications and registration service fees
Subject to paragraph (6), the schedule of covered pesticide registration applications and corresponding
registration service fees shall be as follows:

EPA
No.
R010
R020
R040

R060
R070
R090

R110
R120
R121

R122
R123

R125
New

TABLE 1. - REGISTRATION DIVISION - NEW ACTIVE INGREDIENTS
Decision
Registration
New
Review
Service
Action
CR
Time
Fee
No.
(Months)
($)
(1)
1
New Active Ingredient, Food use (2) (3)
24
569,221
2
New Active Ingredient, Food use; reduced risk (2) (3)
18
569,221
3
New Active Ingredient, Food use; Experimental Use Permit application;
18
419,502
establish temporary tolerance; submitted before application for
registration; credit 45% of fee toward new active ingredient application
that follows (3)
4
New Active Ingredient, Non-food use; outdoor (2) (3)
21
395,467
5
New Active Ingredient, Non-food use; outdoor; reduced risk (2) (3)
16
395,467
6 New Active Ingredient, Non-food use; outdoor; Experimental Use Permit
16
293,596
application; submitted before application for registration; credit 45% of
fee toward new active ingredient (3)
7
New Active Ingredient, Non-food use; indoor (2) (3)
20
219,949
8
New Active Ingredient, Non-food use; indoor; reduced risk (2) (3)
14
219,949
9
New Active Ingredient, Non-food use; indoor; Experimental Use Permit
18
165,375
application; submitted before application for registration; credit 45% of
fee toward new active ingredient application that follows (3)
10
Enriched isomer(s) of registered mixed-isomer active ingredient (2) (3)
18
287,643
11 ew Active Ingredient, Seed treatment only; includes agricultural and non18
427,991
agricultural seeds; residues not expected in raw agricultural
commodities (2) (3)
12
New Active Ingredient, Seed treatment; Experimental Use Permit
16
293,596
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
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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 Agencyaccepted 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
New
EPA
CR
No.
No.
R130
R140
R150
R160
R170
R175
New

13
14
15
16
17
18

R180
R190
R200

19
20
21

R210

22

R220

23

R230
R240
R250

24
25
26

R251
New
R260
R270
R271

27
28
29
30

R273

31

R274

32

Action

First food use; indoor; food/food handling (2) (3)
Additional food use; Indoor; food/food handling (3) (4)
First food use (2) (3)
First food use; reduced risk (2) (3)
Additional food use (3) (4)
Additional food uses covered within a crop group resulting from the
conversion of existing approved crop group(s) to one or more revised
crop groups. (3) (4)
Additional food use; reduced risk (3) (4)
Additional food uses; 6 or more submitted in one application (3) (4)
Additional food uses; 6 or more submitted in one application; reduced risk
(3) (4)
Additional food use; Experimental Use Permit application; establish
temporary tolerance; no credit toward new use registration (3) (4)
Additional food use; Experimental Use Permit application; crop destruct
basis; no credit toward new use registration (3) (4)
Additional use; non-food; outdoor (3) (4)
Additional use; non-food; outdoor; reduced risk (3) (4)
dditional use; non-food; outdoor; Experimental Use Permit application; no
credit toward new use registration (3) (4)
Experimental Use Permit application which requires no changes to the
tolerance(s); non-crop destruct basis (3)
New use; non-food; indoor (3) (4)
New use; non-food; indoor; reduced risk (3) (4)
New use; non-food; indoor; Experimental Use Permit application; no credit
toward new use registration (3) (4)
Additional use; seed treatment; limited uptake into raw agricultural
commodities; includes crops with established tolerances (e.g., for soil or
foliar application); includes food or non-food uses (3) (4)
Additional uses; seed 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)

Decision
Registration
Review
Service
Time
Fee
(Months)
($)
(1)
21
173,644
15
40,518
21
239,684
16
239,684
15
59,976
10
59,976

10
15
10

59,976
359,856
359,856

12

44,431

6

17,993

15
10
6

23,969
23,969
17,993

8

17,993

12
9
6

11,577
11,577
8,820

12

45,754

12

274,523

(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
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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 Agencyaccepted 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.

EPA
No.
R280
R290
R291
R292
R293
R294
R295
R296

R297
New
R298
New

R299
New

TABLE 3. - REGISTRATION DIVISION - IMPORT AND OTHER TOLERANCES
Decision
Registration
New
Review
Service
Action
CR
Time
Fee
No.
(Months)
($)
(1)
33
Establish import tolerance; new active ingredient or first food use (2)
21
289,407
34
Establish import tolerance; additional food use
15
57,882
35
Establish import tolerances; additional food uses; 6 or more crops
15
347,288
submitted in one petition
36 Amend an established tolerance (e.g., decrease or increase); domestic or
11
41,124
import; applicant-initiated
37
Establish tolerance(s) for inadvertent residues in one crop; applicant12
48,510
initiated
38 stablish tolerances for inadvertent residues; 6 or more crops submitted in
12
291,060
one application; applicant-initiated
39 Establish tolerance(s) for residues in one rotational crop in response to a
15
59,976
specific rotational crop application; applicant-initiated
40
Establish tolerances for residues in rotational crops in response to a
15
359,856
specific rotational crop petition; 6 or more crops submitted in one
application; applicant-initiated
41
Amend 6 or more established tolerances (e.g., decrease or increase) in
11
246,744
one petition; domestic or import; applicant-initiated
42 Amend an established tolerance (e.g., decrease or increase); domestic or
13
53,120
import; submission of amended labels (requiring science review) in
addition to those associated with the amended tolerance; applicantinitiated (3)
43
Amend 6 or more established tolerances (e.g., decrease or increase);
13
258,740
domestic or import; submission of amended labels (requiring science
review) in addition to those associated with the amended tolerance;
applicant-initiated (3)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
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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 Agencyaccepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution
of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2
business days following the registrant's written or electronic confirmation of agreement to the Agency.
TABLE 4. - REGISTRATION DIVISION - NEW PRODUCTS
New
EPA
CR
No.
No.
R300

44

R301

45

R310

46

Action

New product; or similar 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)
New product; or similar combination product (already registered) to an
identical or substantially similar in composition and use to a registered
product; registered source of active ingredient; selective data citation
only for data on product chemistry and/or acute toxicity and/or public
health pest efficacy, where applicant does not own all required data and
does not have a specific authorization letter from data owner. (2) (3)
New end-use or manufacturing-use product with registered source(s) of
active ingredient(s); includes products containing two or more registered
active ingredients previously combined in other registered products;
requires review of data package within RD only; includes data and/or
waivers of data for only:

Decision
Registration
Review
Service
Time
Fee
(Months)
($)
(1)
4
1,434

4

1,720

7

4,807

8

6,009

product chemistry and/or
acute toxicity and/or
public health pest efficacy and/or

R314
New

47

child resistant packaging. (2) (3)
New end use product containing two or more registered active ingredients
never before registered as this combination in a formulated product; new
product label is identical or substantially similar to the labels of currently
registered products which separately contain the respective component
active ingredients; requires review of data package within RD only;
includes data and/or waivers of data for only:

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product chemistry and/or
acute toxicity and/or
public health pest efficacy and/or

R315
New

48

child resistant packaging. (2) (3)
New end-use non-food animal product with submission of two or more
target animal safety studies; includes data and/or waivers of data for
only:

9

8,000

12

11,996

3

2,294

24

256,883

10

17,993

11

17,993

product chemistry and/or
acute toxicity and/or
public health pest efficacy and/or
animal safety studies and/or

R320

49

R331

50

R332

51

R333
New

52

R334
New

53

child resistant packaging (2) (3)
New product; new physical form; requires data review in science divisions
(2) (3)
New product; repack of identical registered end-use product as a
manufacturing-use product; same registered uses only (2) (3)
New manufacturing-use product; registered active ingredient; unregistered
source of active ingredient; submission of completely new generic data
package; registered uses only; requires review in RD and science
divisions (2) (3)
New product; MUP or End use product with unregistered source of active
ingredient; requires science data review; new physical form; etc. Cite-all
or selective data citation where applicant owns all required data. (2) (3)
New product; MUP or End use 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 Agencyaccepted 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.

EPA
No.
R340
R345
New
R350

R351
New

TABLE 5. - REGISTRATION DIVISION - AMENDMENTS TO REGISTRATION
Decision
Registration
New
Review
Service
Action
CR
Time
Fee
No.
(Months)
($)
(1)
54
Amendment requiring data review within RD (e.g., changes to
4
3,617
precautionary label statements) (2) (3)
55
Amending non-food animal product that includes submission of target
7
8,000
animal safety data; previously registered (2) (3)
56
Amendment requiring data review in science divisions (e.g., changes to
9
11,996
REI, or PPE, or PHI, or use rate, or number of applications; or add
aerial application; or modify GW/SW advisory statement) (2) (3)
57 Amendment adding a new unregistered source of active ingredient. (2) (3)
8
11,996

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R352
New
R371

58 Amendment adding already approved uses; selective method of support;
does not apply if the applicant owns all cited data (2) (3)
59
Amendment to Experimental Use Permit; (does not include extending a
permit's time period) (3)

8

11,996

6

9,151

(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 fasttrack 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 Agencyaccepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution
of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2
business days following the registrant's written or electronic confirmation of agreement to the Agency.
TABLE 6. - REGISTRATION DIVISION - OTHER ACTIONS
New
EPA
CR
No.
No.

Action

R124
R272

60
61

R275
New
R370

62

Conditional Ruling on Preapplication Study Waivers; applicant-initiated
Review of Study Protocol applicant-initiated; excludes DART, preregistration conference, Rapid Response review, DNT protocol review,
protocol needing HSRB review
Rebuttal of agency reviewed protocol, applicant initiated

63

Cancer reassessment; applicant-initiated

Decision
Registration
Review
Service
Time
Fee
(Months)
($)
(1)
6
2,294
3
2,294

3

2,294

18

179,818

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.

EPA
No.
A380
A390
A400
A410
A420
A430
A431

TABLE 7. - ANTIMICROBIALS DIVISION - NEW ACTIVE INGREDIENTS
Decision
Registration
New
Review
Service
Action
CR
Time
Fee
No.
(Months)
($)
(1)
64
Food use; establish tolerance exemption (2) (3)
24
104,187
65
Food use; establish tolerance (2) (3)
24
173,644
66
Non-food use; outdoor; FIFRA §2(mm) uses (2) (3)
18
86,823
67
Non-food use; outdoor; uses other than FIFRA §2(mm) (2) (3)
21
173,644
68
Non-food use; indoor; FIFRA §2(mm) uses (2) (3)
18
57,882
69
Non-food use; indoor; uses other than FIFRA §2(mm) (2) (3)
20
86,823
70 on-food use; indoor; low-risk, low-toxicity food-grade active ingredient(s);
12
60,638
efficacy testing for public health claims required under GLP and
following DIS/TSS or AD-approved study protocol (2) (3)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a
first food use are covered by the base fee for that new active ingredient or first food use application and retain the
same decision time review period as the new active ingredient or first food use application. The application must
be received by the agency in one package. The base fee for the category covers a maximum of five new products.
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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 Agencyaccepted 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
New
EPA
CR
No.
No.
A440
A450
A460
A470
A471
New
A480
A481
New
A490

71
72
73
74
75

A491
New
A500
A501
New
A510
A511
New

79

76
77
78

80
81
82
83

Action

First food use; establish tolerance exemption (2) (3) (4)
First food use; establish tolerance (2) (3) (4)
Additional food use; establish tolerance exemption (3) (4) (5)
Additional food use; establish tolerance (3) (4) (5)
Additional food uses; establish tolerances; 6 or more submitted in one
application (3) (4) (5)
Additional use; non-food; outdoor; FIFRA §2(mm) uses (4) (5)
Additional non-food outdoor uses; FIFRA §2(mm) uses; 6 or more
submitted in one application (4) (5)
Additional use; non-food; outdoor; uses other than FIFRA §2(mm) (4)
(5)
Additional non-food; outdoor; uses other than FIFRA §2(mm); 6 or more
submitted in one application (4) (5)
Additional use; non-food, indoor, FIFRA §2(mm) uses (4) (5)
dditional non-food; indoor; FIFRA §2(mm) uses; 6 or more submitted in
one application (4) (5)
Additional use; non-food; indoor; uses other than FIFRA §2(mm) (4) (5)
Additional non-food; indoor; uses other than FIFRA §2(mm); 6 or more
submitted in one application (4) (5)

Decision
Review
Time
(Months)
(1)
21
21
15
15
15

Registration
Service
Fee
($)
28,942
86,823
11,577
28,942
173,652

9
9

17,365
104,190

15

28,942

15

173,652

9
9

11,577
69,462

12
12

11,577
69,462

(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
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screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration
service fee for the new active ingredient or first food use application.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient
of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
the data for such clearance of such product is not subject to a registration service fee for the tolerance action for
two years from the effective date of the rule.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft
accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped
label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and
requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for
subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the
applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agencyaccepted 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.

EPA
No.
A530

A531

A532

A540
A550
A560
A570
A572
New

TABLE 9. - ANTIMICROBIALS DIVISION - NEW PRODUCTS AND AMENDMENTS
Decision
Registration
New
Review
Service
Action
CR
Time
Fee
No.
(Months)
($)
(1)
84 New product; identical or substantially similar in composition and use to a
4
1,159
registered product; no data review or only product chemistry data; citeall data citation, or selective data citation when applicant owns all
required data, or applicant submits specific authorization letter for data
owner. Category also includes 100% re-package of registered end-use
or manufacturing-use product that requires no data submission nor data
matrix. (2) (3)
85 New product; identical or substantially similar in composition and use to a
4
1,654
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)
86 New product; identical or substantially similar in composition and use to a
5
4,631
registered product; registered active ingredient; unregistered source of
active ingredient; cite-all data citation except for product chemistry;
product chemistry data submitted (2) (3)
87
New end use product; FIFRA §2(mm) uses only (2) (3)
5
4,631
88 New end-use product; uses other than FIFRA §2(mm); non-FQPA product
7
4,631
(2) (3)
89 ew manufacturing-use product; registered active ingredient; selective data
12
17,365
citation (2) (3)
90
Label amendment requiring data review (3) (4)
4
3,474
91 New Product or amendment requiring data review for risk assessment by
9
11,996
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
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(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 Agencyaccepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution
of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2
business days following the registrant's written or electronic confirmation of agreement to the Agency.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fasttrack amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials
Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to
registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as
PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e)
Submissions with data and requiring data review are subject to registration service fees.
TABLE 10. - ANTIMICROBIALS DIVISION - EXPERIMENTAL USE PERMITS AND OTHER TYPE OF
ACTIONS
Decision
Registration
New
Review
EPA
Service
Action
CR
Time
No.
Fee
No.
(Months)
($)
(1)
A520 92
Experimental Use Permit application, Non-Food Use (2)
9
5,789
A521 93 Review of public health efficacy study protocol within AD, per AD Internal
3
2,250
Guidance for the Efficacy Protocol Review Process; Code will also
include review of public health efficacy study protocol and data review
for devices making pesticidal claims; applicant-initiated; Tier 1
A522 94 Review of public health efficacy study protocol outside AD by members of
12
11,025
AD Efficacy Protocol Review Expert Panel; Code will also include
review of public health efficacy study protocol and data review for
devices making pesticidal claims; applicant-initiated; Tier 2
A524 95
New Active Ingredient, Experimental Use Permit application; Food Use
18
138,916
New
Requires Tolerance. Credit 45% of fee toward new active ingredient
application that follows. (2)
A525 96
New Active Ingredient, Experimental Use Permit application; Food Use
18
83,594
New
Requires Tolerance Exemption. Credit 45% of fee toward new active
ingredient application that follows. (2)
A526 97
New Active Ingredient, Experimental Use Permit application; Non-Food,
15
86,823
New
Outdoor Use. Credit 45% of fee toward new active ingredient
application that follows. (2)
A527 98
New Active Ingredient, Experimental Use Permit application; Non-Food,
15
58,000
New
Indoor Use. Credit 45% of fee toward new active ingredient application
that follows. (2)
A528 99
Experimental Use Permit application, Food Use; Requires Tolerance or
15
20,260
New
Tolerance Exemption (2)
A529 100
Amendment to Experimental Use Permit; requires data review or risk
9
10,365
New
assessment (2)
A523 101
Review of protocol other than a public health efficacy study (i.e.,
9
11,025
New
Toxicology or Exposure Protocols)
A571 102
Science reassessment: Cancer risk, refined ecological risk, and/or
18
86,823
New
endangered species; applicant-initiated
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft
accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped
label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and
requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for
subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the
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applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the
Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon
resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant
within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency.
TABLE 11. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - MICROBIAL AND BIOCHEMICAL
PESTICIDES; NEW ACTIVE INGREDIENTS
Decision
Registration
New
Review
EPA
Service
Action
CR
Time
No.
Fee
No.
(Months)
($)
(1)
B580 103
New active ingredient; food use; petition to establish a tolerance (2)
19
46,305
B590 104
New active ingredient; food use; petition to establish a tolerance
17
28,942
exemption (2)
B600 105
New active ingredient; non-food use (2)
13
17,365
B610 106
New active ingredient; Experimental Use Permit application; petition to
10
11,577
establish a temporary tolerance or temporary tolerance exemption
B611 107
New active ingredient; Experimental Use Permit application; petition to
12
11,577
New
establish permanent tolerance exemption
B612 108 ew active ingredient; no change to a permanent tolerance exemption (2)
10
15,918
New
B613 109
New active ingredient; petition to convert a temporary tolerance or a
11
15,918
New
temporary tolerance exemption to a permanent tolerance or tolerance
exemption (2)
B620 110
New active ingredient; Experimental Use Permit application; non-food
7
5,789
use including crop destruct
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a
first food use are covered by the base fee for that new active ingredient or first food use application and retain the
same decision time review period as the new active ingredient or first food use application. The application must
be received by the agency in one package. The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is submitted in the new
active ingredient application package or first food use application package is subject to the registration service fee
for a new product or a new inert approval. All such associated applications that are submitted together will be
subject to the new active ingredient or first food use decision review time, except where the new inert approval
decision review time is greater than that for the new active ingredient, in which case the associated new active
ingredient will be subject to the new inert approval decision review time. In the case of a new active ingredient
application, until that new active ingredient is approved, any subsequent application for another new product
containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active
ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an
additional new food use or uses will be subject to the registration service fee and decision review time for a first
food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
applicant at the applicant's initiative to support the application after completion of the technical deficiency
screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration
service fee for the new active ingredient or first food use application.
TABLE 12. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - MICROBIAL AND BIOCHEMICAL
PESTICIDES; NEW USES
Decision
Registration
New
EPA
Review
Service
Action
CR
No.
Time
Fee
No.
(Months) (1)
($)
B630 111
First food use; petition to establish a tolerance exemption (2)
13
11,577
B631 112
New food use; petition to amend an established tolerance (3)
12
11,577
B640 113
First food use; petition to establish a tolerance (2)
19
17,365
B643 114
New Food use; petition to amend tolerance exemption (3)
10
11,577
New
B642 115
First food use; indoor; food/food handling (2)
12
28,942
New
B644 116
New use, no change to an established tolerance or tolerance
8
11,577
New
exemption (3)
B650 117
New use; non-food (3)
7
5,789
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
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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) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
the new use(s). All items in the covered application must be submitted together in one package. Each application
for an additional new product registration and new inert approval(s) that is submitted in the new use application
package is subject to the registration service fee for a new product or a new inert approval. However, if a new use
application only proposes to register the new use for a new product and there are no amendments in the
application, then review of one new product application is covered by the new use fee. All such associated
applications that are submitted together will be subject to the new use decision review time. Any application for a
new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use
application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be
deemed a separate new-use application, subject to a separate registration service fee and new decision review
time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or
indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to
all of the new uses requested in the application. Any information that (a) was neither requested nor required by
the Agency, and (b) is submitted by the applicant at the applicant's initiative to support the application after
completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be
assessed 25% of the full registration service fee for the new use application.
TABLE 13. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - MICROBIAL AND BIOCHEMICAL
PESTICIDES; NEW PRODUCTS
Decision
Registration
New
Review
EPA
Service
Action
CR
Time
No.
Fee
No.
(Months)
($)
(1)
B652 118
New product; registered source of active ingredient; requires petition to
13
11,577
New
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 scientificallysound rationale explaining why the data requirement does not apply (2)
B660 119
New product; registered source of active ingredient(s); identical or
4
1,159
substantially similar in composition and use to a registered product; no
change in an established tolerance or tolerance exemption. No data
review, or only product chemistry data; cite-all data citation, or selective
data citation where applicant owns all required data or authorization from
data owner is demonstrated. Category includes 100% re-package of
registered end-use or manufacturing-use product that requires no data
submission or data matrix. For microbial pesticides, the active ingredient
(s) must not be re-isolated. (2)
B670 120
New product; registered source of active ingredient(s); no change in an
7
4,631
established tolerance or tolerance exemption; requires: 1) submission of
product specific data; or 2) citation of previously reviewed and accepted
data; or 3) submission or citation of data generated at government
expense; or 4) submission or citation of a scientifically-sound rationale
based on publicly available literature or other relevant information that
addresses the data requirement; or 5) submission of a request for a data
requirement to be waived supported by a scientifically-sound rationale
explaining why the data requirement does not apply. (2)
B671 121 New product; unregistered source of active ingredient(s); requires a petition
17
11,577
to amend an established tolerance or tolerance exemption; requires: 1)
submission of product specific data; or 2) citation of previously reviewed
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B672 122

B673 123
New

B674 124
New
B675 125
New
B676 126
New

B677 127
New

and accepted data; or 3) submission or citation of data generated at
government expense; or 4) submission or citation of a scientificallysound 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 scientificallysound rationale explaining why the data requirement does not apply. (2)
New product; unregistered 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)
New product MUP/EP; 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)
New product MUP; Repack of identical registered end-use product as a
manufacturing-use product; same registered uses only (2)
New Product MUP; registered source of active ingredient; submission of
completely new generic data package; registered uses only. (2)
New product; more than one 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)
New end-use non-food animal product with submission of two or more
target animal safety studies; includes data and/or waivers of data for
only:

13

8,269

10

4,631

4

1,159

10

8,269

13

8,269

10

8,000

product chemistry and/or
acute toxicity and/or
public health pest efficacy and/or
animal safety studies and/or
child resistant packaging (2)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but
(b) has an application pending with the Agency for review, will be considered an application for a new product with
an unregistered source of active ingredient.
TABLE 14. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - MICROBIAL AND BIOCHEMICAL
PESTICIDES; AMENDMENTS
Decision
Registration
New
Review
EPA
Service
Action
CR
Time
No.
Fee
No.
(Months)
($)
(1)
B621 128
Amendment; Experimental Use Permit; no change to an established
7
4,631
temporary tolerance or tolerance exemption.
B622 129 Amendment; Experimental Use Permit; petition to amend an established
11
11,577
New
or temporary tolerance or tolerance exemption.
B641 130
Amendment of an established tolerance or tolerance exemption.
13
11,577
B680 131 Amendment; registered source of active ingredient(s); no new use(s); no
5
4,631
changes to an established tolerance or tolerance exemption. Requires
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data submission. (2)
Amendment; unregistered source of active ingredient(s). Requires data
submission. (2)
B683 133 abel amendment; requires review/update of previous risk assessment(s)
New
without data submission (e.g., labeling changes to REI, PPE, PHI). (2)
B684 134
Amending non-food animal product that includes submission of target
New
animal safety data; previously registered (2)
B681 132

7

5,513

6

4,631

8

8,000

(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 fasttrack amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials
Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to
registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as
PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e)
Submissions with data and requiring data review are subject to registration service fees.
TABLE 15. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - STRAIGHT CHAIN
LEPIDOPTERAN PHEROMONES(SCLPS)
Decision
Registration
New
Review
EPA
Service
Action
CR
Time
No.
Fee
No.
(Months)
($)
(1)
B690 135
New active ingredient; food or non-food use. (2)
7
2,316
B700 136
Experimental Use Permit application; new active ingredient or new use.
7
1,159
B701 137
Extend or amend Experimental Use Permit.
4
1,159
B710 138
New product; registered source of active ingredient(s); identical or
4
1,159
substantially similar in composition and use to a registered product; no
change in an established tolerance or tolerance exemption. No data
review, or only product chemistry data; cite-all data citation, or selective
data citation where applicant owns all required data or authorization from
data owner is demonstrated. Category includes 100% re-package of
registered end-use or manufacturing-use product that requires no data
submission or data matrix. (3)
B720 139
New product; registered source of active ingredient(s); requires: 1)
5
1,159
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 scientificallysound 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 scientificallysound rationale explaining why the data requirement does not apply. (3)
B721 140
New product; unregistered source of active ingredient. (3)
7
2,426
B722 141 New use and/or amendment; petition to establish a tolerance or tolerance
7
2,246
exemption. (4) (5)
B730 142
Label amendment requiring data submission. (4)
5
1,159
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a
first food use are covered by the base fee for that new active ingredient or first food use application and retain the
same decision time review period as the new active ingredient or first food use application. The application must
be received by the agency in one package. The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is submitted in the new
active ingredient application package or first food use application package is subject to the registration service fee
for a new product or a new inert approval. All such associated applications that are submitted together will be
subject to the new active ingredient or first food use decision review time, except where the new inert approval
decision review time is greater than that for the new active ingredient, in which case the associated new active
ingredient will be subject to the new inert approval decision review time. In the case of a new active ingredient
application, until that new active ingredient is approved, any subsequent application for another new product
containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active
ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an
additional new food use or uses will be subject to the registration service fee and decision review time for a first
food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
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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 fasttrack amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials
Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to
registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as
PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e)
Submissions with data and requiring data review are subject to registration service fees.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
the new use(s). All items in the covered application must be submitted together in one package. Each application
for an additional new product registration and new inert approval(s) that is submitted in the new use application
package is subject to the registration service fee for a new product or a new inert approval. However, if a new use
application only proposes to register the new use for a new product and there are no amendments in the
application, then review of one new product application is covered by the new use fee. All such associated
applications that are submitted together will be subject to the new use decision review time. Any application for a
new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use
application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be
deemed a separate new-use application, subject to a separate registration service fee and new decision review
time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or
indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to
all of the new uses requested in the application. Any information that (a) was neither requested nor required by
the Agency, and (b) is submitted by the applicant at the applicant's initiative to support the application after
completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be
assessed 25% of the full registration service fee for the new use application.
TABLE 16. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - OTHER ACT
Decision
Registration
New
EPA
Review
Service
Action
CR
No.
Time
Fee
No.
(Months) (1)
($)
B614 143
Conditional Ruling on Preapplication Study Waivers; applicant3
2,294
New
initiated
B615 144
Rebuttal of agency reviewed protocol, applicant initiated
3
2,294
New
B682 145
Protocol review; applicant initiated; excludes time for HSRB review
3
2,205
(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 AND POLLUTION PREVENTION DIVISION - PLANT INCORPORATED
PROTECTANTS (PIPS)
Decision
Registration
New
Review
EPA
Service
Action
CR
Time
No.
Fee
No.
(Months)
($)
(1)
B740 146
Experimental Use Permit application; no petition for tolerance/tolerance
6
86,823
exemption. Includes:
) non-food/feed use(s) for a new (2) or registered (3) PIP;
) food/feed use(s) for a new or registered PIP with crop destruct;
) food/feed use(s) for a new or registered PIP in which an established
tolerance/tolerance exemption exists for the intended use(s). (4)
B750 147
Experimental Use Permit application; with a petition to establish a
9
115,763
temporary or permanent tolerance/tolerance exemption for the active
ingredient. Includes new food/feed use for a registered (3) PIP. (4)
B770 148 xperimental Use Permit application; new (2) PIP; with petition to establish
15
173,644
a temporary tolerance/tolerance exemption for the active ingredient;
credit 75% of B771 fee toward registration application for a new active
ingredient that follows; SAP review. (5)
B771 149 xperimental Use Permit application; new (2) PIP; with petition to establish
10
115,763
a temporary tolerance/tolerance exemption for the active ingredient;
credit 75% of B771 fee toward registration application for a new active
ingredient that follows.
B772 150
Application to amend or extend an Experimental Use Permit; no petition
3
11,577
since the established tolerance/tolerance exemption for the active
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B773 151

B780 152
B790 153
B800 154

B810 155

B820 156
B840 157

B851 158

B870 159

B880 160

B881 161

B883 162
New

B884 163
New
B885 164
New

B890 165

B891 166

B900 167

B901 168

B902 169
B903 170
B904 171

ingredient is unaffected.
Application to amend or extend an Experimental Use Permit; with petition
to extend a temporary tolerance/tolerance exemption for the active
ingredient.
Registration application; new (2) PIP; non-food/feed.
Registration application; new (2) PIP; non-food/feed; SAP review. (5)
Registration application; new (2) PIP; with petition to establish permanent
tolerance/tolerance exemption for the active ingredient based on an
existing temporary tolerance/tolerance exemption.
Registration application; new (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)
Registration application; new (2) PIP; with petition to establish or amend a
permanent tolerance/tolerance exemption of an active ingredient.
Registration application; new (2) PIP; with petition to establish or amend a
permanent tolerance/tolerance exemption of an active ingredient. SAP
review. (5)
Registration application; new event of a previously registered PIP active
ingredient(s); no petition since permanent tolerance/tolerance
exemption is already established for the active ingredient(s).
Registration application; registered (3) PIP; new product; new use; no
petition since a permanent tolerance/tolerance exemption is already
established for the active ingredient(s). (4)
Registration application; 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)
Registration application; 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)
Registration application; new (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)
Registration application; new (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)
Registration application; registered (3) 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)
Application to amend a seed increase registration; converts registration to
commercial registration; no petition since permanent tolerance/tolerance
exemption is already established for the active ingredient(s).
Application to amend a seed 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)
pplication to amend a registration, including actions such as extending an
expiration date, modifying an IRM plan, or adding an insect to be
controlled. (10) (11)
pplication to amend a registration, including actions such as extending an
expiration date, modifying an IRM plan, or adding an insect to be
controlled. SAP review. (10) (11)
PIP protocol review
Inert ingredient tolerance exemption; e.g., a marker such as NPT II;
reviewed in BPPD.
mport tolerance or tolerance exemption; processed commodities/food only
(inert or active ingredient).

5

28,942

12
18
12

144,704
202,585
231,585

18

289,407

15

289,407

21

347,288

9

115,763

9

34,729

9

28,942

15

86,823

9

115,763

12

144,704

9

86,823

9

57,882

15

115,763

6

11,577

12

69,458

3
6

5,789
57,882

9

115,763

(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
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sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target
species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of
the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these
decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks
posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time
and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance.
The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target
organism data submitted and the lack of insect resistance management data, which is usually not required for
seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration
application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.
TABLE 18. - INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
Decision
Registration
New
Review
EPA
Service
Action
CR
Time
No.
Fee
No.
(Months)
($)
(1)
Approval of new food use inert ingredient (2) (3)
12
18,000
001 172
002 173
Amend currently approved inert ingredient tolerance or exemption from
10
5,000
New
tolerance; new data (2)
003 174
Amend currently approved inert ingredient tolerance or exemption from
8
3,000
New
tolerance; no new data (2)
004 175
Approval of new non-food use inert ingredient (2)
8
10,000
New
005 176
Amend currently approved non-food use inert ingredient with new use
8
5,000
New
pattern; new data (2)
006 177
Amend currently approved non-food use inert ingredient with new use
6
3,000
New
pattern; no new data (2)
007 178
Approval of substantially similar non-food use inert ingredients when
4
1,500
New
original inert is compositionally similar with similar use pattern (2)
008 179
Approval of new polymer inert ingredient, food use (2)
5
3,400
New
009 180
Approval of new polymer inert ingredient, non food use (2)
4
2,800
New
010 181
Petition to amend a tolerance exemption descriptor to add one or more
6
1,500
New
CASRNs; no new data (2)
M001 182 tudy protocol requiring Human Studies Review Board review as defined in
9
7,200
New
40 CFR 26 in support of an active ingredient (4)
M002 183 ompleted study requiring Human Studies Review Board review as defined
9
7,200
New
in 40 CFR 26 in support of an active ingredient (4)
M003 184
External technical peer review of new active ingredient, product, or
12
58,000
New
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 §25(d), in support of a novel active ingredient, or unique use
pattern or application technology. Excludes PIP active ingredients. (5)
M004 185
External technical peer review of new active ingredient, product, or
18
58,000
New
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 §25(d), in support of a novel active ingredient, or unique use
pattern or application technology. Excludes PIP active ingredients. (5)
M005 186
New Product: Combination, Contains a combination of active ingredients
9
20,000
New
from a registered and/or unregistered source; conventional, antimicrobial
and/or biopesticide. Requires coordination with other regulatory divisions
to conduct review of data, label and/or verify the validity of existing data
as cited. Only existing uses for each active ingredient in the combination
product. (6) (7)
M006 187
Request for up to 5 letters of certification (Gold Seal) for one actively
1
250
New
registered product.
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M007 188 Request to extend Exclusive Use of data as provided by FIFRA Section 3
New
(c)(1)(F)(ii)
M008 189 Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)
New
(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is
required

12

5,000

10

1,500

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
to end on the next business day.
(2) If another covered application is associated with and dependent upon a pending application for an inert
ingredient action, each application will be subject to its respective registration service fee. The decision review
time for the other associated covered application will be extended to match the PRIA due date of the pending inert
ingredient action, unless the PRIA due date for the other associated covered action is further out, in which case it
will be subject to its own decision review time. If the application covers multiple ingredients grouped by EPA into
one chemical class, a single registration service fee will be assessed for approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient
of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
the data for such clearance of such product is not subject to a registration service fee for the tolerance action for
two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
its separate registration service fee. The decision review times for the associated actions run concurrently, but will
end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
separate registration service fee. The decision review time for the associated action will be extended by the
decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but
(b) has an application pending with the Agency for review, will be considered an application for a new product with
an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft
accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped
label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and
requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for
subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the
applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agencyaccepted 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) Pending pesticide registration applications
(A) In general
An applicant that submitted a registration application to the Administrator before the effective date of the
Pesticide Registration Improvement Act of 2003, but that is not required to pay a registration service fee
under paragraph (2)(B), may, on a voluntary basis, pay a registration service fee in accordance with
paragraph (2)(B).
(B) Voluntary fee
The Administrator may not compel payment of a registration service fee for an application described in
subparagraph (A).
(C) Documentation
An application for which a voluntary registration service fee is paid under this paragraph shall be submitted
with documentation certifying(i) payment of the registration service fee; or
(ii) a request for a waiver from or reduction of the registration service fee.
(5) Resubmission of pesticide registration applications
If a pesticide registration application is submitted by a person that paid the fee for the application under
paragraph (2), is determined by the Administrator to be complete, and is not approved or is withdrawn (without
a waiver or refund), the submission of the same pesticide registration application by the same person (or a
licensee, assignee, or successor of the person) shall not be subject to a fee under paragraph (2).
(6) Fee adjustment
(A) In general
Effective for a covered pesticide registration application received during the period beginning on October 1,
2013, and ending on September 30, 2015, the Administrator shall increase by 5 percent the registration
service fee payable for the application under paragraph (3).
(B) Additional adjustment
Effective for a covered pesticide registration application received on or after October 1, 2015, the
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Administrator shall increase by an additional 5 percent the registration service fee in effect as of September
30, 2015.
(C) Publication
The Administrator shall publish in the Federal Register the revised registration service fee schedules.
(7) Waivers and reductions
(A) In general
An applicant for a covered pesticide registration may request the Administrator to waive or reduce the
amount of a registration service fee payable under this section under the circumstances described in
subparagraphs (D) through (G).
(B) Documentation
(i) In general
A request for a waiver from or reduction of the registration service fee shall be accompanied by
appropriate documentation demonstrating the basis for the waiver or reduction.
(ii) Certification
The applicant shall provide to the Administrator a written certification, signed by a responsible officer,
that the documentation submitted to support the waiver or reduction request is accurate.
(iii) Inaccurate documentation
An application shall be subject to the applicable registration service fee payable under paragraph (3) if, at
any time, the Administrator determines that(I) the documentation supporting the waiver or reduction request is not accurate; or
(II) based on the documentation or any other information, the waiver or reduction should not have been
granted or should not be granted.
(C) Determination to grant or deny request
As soon as practicable, but not later than 60 days, after the date on which the Administrator receives a
request for a waiver or reduction of a registration service fee under this paragraph, the Administrator shall(i) determine whether to grant or deny the request; and
(ii) notify the applicant of the determination.
(D) Minor uses
(i) In general
The Administrator may exempt from, or waive a portion of, the registration service fee for an application
for minor uses for a pesticide.
(ii) Supporting documentation
An applicant requesting a waiver or exemption under this subparagraph shall provide supporting
documentation that demonstrates, to the satisfaction of the Administrator, that anticipated revenues from
the uses that are the subject of the application would be insufficient to justify imposition of the full
application fee.
(E) IR–4 exemption
The Administrator shall exempt an application from the registration service fee if the Administrator
determines that(i) the application is solely associated with a tolerance petition submitted in connection with the InterRegional Project Number 4 (IR–4) as described in section 2 of Public Law 89–106 (7 U.S.C. 450i(e)); and
(ii) the exemption is in the public interest.
(F) Small businesses
(i) In general
The Administrator shall waive 50 percent of the registration service fees payable by an entity for a
covered pesticide registration application under this section if the entity is a small business (as defined in
section 136a–1(i)(1)(E)(ii) of this title) at the time of application.
(ii) Waiver of fees
The Administrator shall waive 75 percent of the registration service fees payable by an entity under this
section if the entity(I) is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application;
and
(II) has average annual global gross revenues described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title
that does not exceed $10,000,000, at the time of application.
(iii) Formation for waiver
The Administrator shall not grant a waiver under this subparagraph if the Administrator determines that
the entity submitting the application has been formed or manipulated primarily for the purpose of qualifying
for the waiver.
(iv) Documentation
An entity requesting a waiver under this subparagraph shall provide to the Administrator(I) documentation demonstrating that the entity is a small business (as defined in section 136a–1(i)(1)
(E)(ii) of this title) at the time of application; and
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(II) if the entity is requesting a waiver of 75 percent of the applicable registration service fees payable
under this section, documentation demonstrating that the entity has an average annual global gross
revenue described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at
the time of application.
(G) Federal and State agency exemptions
An agency of the Federal Government or a State government shall be exempt from covered registration
service fees under this section.
(8) Refunds
(A) Early withdrawals
If, during the first 60 days after the beginning of the applicable decision time review period under
subsection (f)(3), a covered pesticide registration application is withdrawn by the applicant, the Administrator
shall refund all but 25 percent.1 of the total registration service fee payable under paragraph (3) for the
application.
(B) Withdrawals after the first 60 days of decision review time period
(i) In general
If a covered pesticide registration application is withdrawn after the first 60 days of the applicable
decision time review period, the Administrator shall determine what portion, if any, of the total registration
service fee payable under paragraph (3) for the application may be refunded based on the proportion of the
work completed at the time of withdrawal.
(ii) Timing
The Administrator shall(I) make the determination described in clause (i) not later than 90 days after the date the application is
withdrawn; and
(II) provide any refund as soon as practicable after the determination.
(C) Discretionary refunds
(i) In general
In the case of a pesticide registration application that has been filed with the Administrator and has not
been withdrawn by the applicant, but for which the Administrator has not yet made a final determination,
the Administrator may refund a portion of a covered registration service fee if the Administrator determines
that the refund is justified.
(ii) Basis
The Administrator may provide a refund for an application under this subparagraph(I) on the basis that, in reviewing the application, the Administrator has considered data submitted in
support of another pesticide registration application;
(II) on the basis that the Administrator completed portions of the review of the application before the
effective date of this section; or
(III) on the basis that the Administrator rejected the application under subsection (f)(4)(B).
(D) Credited fees
In determining whether to grant a refund under this paragraph, the Administrator shall take into account any
portion of the registration service fees credited under paragraph (2) or (4).
(c) Pesticide Registration Fund
(1) Establishment
There is established in the Treasury of the United States a Pesticide Registration Fund to be used in carrying
out this section (referred to in this section as the "Fund"), consisting of(A) such amounts as are deposited in the Fund under paragraph (2);
(B) any interest earned on investment of amounts in the Fund under paragraph (5); and
(C) any proceeds from the sale or redemption of investments held in the Fund.
(2) Deposits in Fund
Subject to paragraph (4), the Administrator shall deposit fees collected under this section in the Fund.
(3) Expenditures from Fund
(A) In general
Subject to subparagraphs (B) and (C) and paragraph (4), the Administrator may make expenditures from
the Fund(i) to cover the costs associated with the review and decisionmaking pertaining to all applications for
which registration service fees have been paid under this section; and
(ii) to otherwise carry out this section.
(B) Worker protection
(i) In general
For each of fiscal years 2013 through 2017, the Administrator shall use approximately 1/17 of the amount
in the Fund (but not less than $1,000,000) to enhance scientific and regulatory activities relating to worker
protection.
(ii) Partnership grants
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Of the amounts in the Fund, the Administrator shall use for partnership grants, for each of fiscal years
2013 through 2017, $500,000.
(iii) Pesticide safety education program
Of the amounts in the Fund, the Administrator shall use $500,000 for each of fiscal years 2013 through
2017 to carry out the pesticide safety education program.
(4) Collections and appropriations Acts
The fees authorized by this section and amounts deposited in the Fund(A) shall be collected and made available for obligation only to the extent provided in advance in
appropriations Acts; and
(B) shall be available without fiscal year limitation.
(5) Unused funds
(A) In general
Amounts in the Fund not currently needed to carry out this section shall be(i) maintained readily available or on deposit;
(ii) invested in obligations of the United States or guaranteed by the United States; or
(iii) invested in obligations, participations, or other instruments that are lawful investments for fiduciary,
trust, or public funds.
(B) Use of investment income
After consultation with the Secretary of the Treasury, the Administrator may use income from investments
described in clauses (ii) and (iii) of subparagraph (A) to carry out this section.
(d) Assessment of fees
(1) Definition of covered functions
In this subsection, the term "covered functions" means functions of the Office of Pesticide Programs of the
Environmental Protection Agency, as identified in key programs and projects of the final operating plan for the
Environmental Protection Agency submitted as part of the budget process for fiscal year 2002, regardless of
any subsequent transfer of 1 or more of the functions to another office or agency or the subsequent transfer of a
new function to the Office of Pesticide Programs.
(2) Minimum amount of appropriations
Registration service fees may not be assessed for a fiscal year under this section unless the amount of
appropriations for salaries, contracts, and expenses for the functions (as in existence in fiscal year 2012) of the
Office of Pesticide Programs of the Environmental Protection Agency for the fiscal year (excluding the amount
of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for
covered functions for fiscal year 2012 (excluding the amount of any fees appropriated for the fiscal year).
(3) Use of fees
Registration service fees authorized by this section shall be available, in the aggregate, only to defray
increases in the costs associated with the review and decisionmaking for the review of pesticide registration
applications and associated tolerances (including increases in the number of full-time equivalent positions in the
Environmental Protection Agency engaged in those activities) over the costs for fiscal year 2002, excluding
costs paid from fees appropriated for the fiscal year.
(4) Subsequent authority
If the Administrator does not assess registration service fees under subsection (b) during any portion of a
fiscal year as the result of paragraph (2) and is subsequently permitted to assess the fees under subsection (b)
during the fiscal year, the Administrator shall assess and collect the fees, without any modification in rate, at
any time during the fiscal year, notwithstanding any provisions of subsection (b) relating to the date fees are to
be paid.
(e) Reforms to reduce decision time review periods
To the maximum extent practicable consistent with the degrees of risk presented by pesticides and the type of
review appropriate to evaluate risks, the Administrator shall identify and evaluate reforms to the pesticide
registration process under this subchapter with the goal of reducing decision review periods in effect on the
effective date of the Pesticide Registration Improvement Extension Act of 2012 for pesticide registration actions
for covered pesticide registration applications (including reduced risk applications).
(f) Decision time review periods
(1) In general
Not later than 30 days after the effective date of the Pesticide Registration Improvement Extension Act of
2012, the Administrator shall make publicly available a schedule of decision review periods for covered
pesticide registration actions and corresponding registration service fees under this subchapter.
(2) Report
The schedule shall be the same as the applicable schedule provided under subsection (b)(3).
(3) Applications subject to decision time review periods
The decision time review periods specified in paragraph (1) shall apply to(A) covered pesticide registration applications subject to registration service fees under subsection (b)(2);
(B) covered pesticide registration applications for which an applicant has voluntarily paid registration
service fees under subsection (b)(4); and
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(C) covered pesticide registration applications listed in the Registration Division 2003 Work Plan of the
Office of Pesticide Programs of the Environmental Protection Agency.
(4) Start of decision time review period
(A) In general
Except as provided in subparagraphs (C), (D), and (E), in the case of a pesticide registration application
accompanied by the registration service fee required under this section, the decision time review period
begins 21 days after the date on which the Administrator receives the covered pesticide registration
application and fee.
(B) Initial content and preliminary technical screenings
(i) Screenings
(I) Initial content
Not later than 21 days after receiving an application and the required registration service fee, the
Administrator shall conduct an initial screening of the contents of the application in accordance with
clause (iii).
(II) Preliminary technical screening
After conducting the initial content screening described in subclause (I) and in accordance with clause
(iv), the Administrator shall conduct a preliminary technical screening(aa) not later than 45 days after the date on which the decision time review period begins (for
applications with decision time review periods of not more than 180 days); and
(bb) not later than 90 days after the date on which the decision time review period begins (for
applications with decision time review periods greater than 180 days).
(ii) Rejection
(I) In general
If the Administrator determines at any time before the Administrator completes the preliminary
technical screening under clause (i)(II) that the application failed the initial content or preliminary
technical screening and the applicant does not correct the failure before the date that is 10 business
days after the applicant receives a notification of the failure, the Administrator shall reject the application.
(II) Written notification
The Administrator shall make every effort to provide a written notification of a rejection under
subclause (I) during the 10-day period that begins on the date the Administrator completes the
preliminary technical screening.
(iii) Requirements of initial content screening
In conducting an initial content screening of an application, the Administrator shall determine whether(I)(aa) the applicable registration service fee has been paid; or
(bb) at least 25 percent of the applicable registration service fee has been paid and the application
contains a waiver or refund request for the outstanding amount and documentation establishing the basis
for the waiver request; and
(II) the application appears to contain all the necessary forms, data, and draft labeling, formatted in
accordance with guidance published by the Administrator.
(iv) Requirements of preliminary technical screening
In conducting a preliminary technical screening of an application, the Administrator shall determine if(I) the application and the data and information submitted with the application are accurate and
complete; and
(II) the application, data, and information are consistent with the proposed labeling and any proposal
for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of
this subchapter, could result in the granting of the application.
(C) Applications with waiver or reduction requests
(i) In general
In the case of an application submitted with a request for a waiver or reduction of registration service
fees under subsection (b)(7), the decision time review period shall be determined in accordance with this
subparagraph.
(ii) Request granted with no additional fees required
If the Administrator grants the waiver or reduction request and no additional fee is required, the decision
time review period begins on the earlier of(I) the date on which the Administrator grants the request; or
(II) the date that is 60 days after the date of receipt of the application.
(iii) Request granted with additional fees required
If the Administrator grants the waiver or reduction request, in whole or in part, but an additional
registration service fee is required, the decision time review period begins on the date on which the
Administrator receives certification of payment of the applicable registration service fee.
(iv) Request denied
If the Administrator denies the waiver or reduction request, the decision time review period begins on the
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date on which the Administrator receives certification of payment of the applicable registration service
fee.
(D) Pending applications
(i) In general
The start of the decision time review period for applications described in clause (ii) shall be the date on
which the Administrator receives certification of payment of the applicable registration service fee.
(ii) Applications
Clause (i) applies to(I) covered pesticide registration applications for which voluntary fees have been paid under
subsection (b)(4); and
(II) covered pesticide registration applications received on or after the effective date of the Pesticide
Registration Improvement Act of 2003 but submitted without the applicable registration service fee
required under this section due to the inability of the Administrator to assess fees under subsection (d)
(1).
(E) 2003 work plan
In the case of a covered pesticide registration application listed in the Registration Division 2003 Work Plan
of the Office of Pesticide Programs of the Environmental Protection Agency, the decision time review period
begins on the date that is 30 days after the effective date of the Pesticide Registration Improvement Act of
2003.
(5) Extension of decision time review period
The Administrator and the applicant may mutually agree in writing to extend a decision time review period
under this subsection.
(g) Judicial review
(1) In general
Any applicant adversely affected by the failure of the Administrator to make a determination on the application
of the applicant for registration of a new active ingredient or new use for which a registration service fee is paid
under this section may obtain judicial review of the failure solely under this section.
(2) Scope
(A) In general
In an action brought under this subsection, the only issue on review is whether the Administrator failed to
make a determination on the application specified in paragraph (1) by the end of the applicable decision time
review period required under subsection (f) for the application.
(B) Other actions
No other action authorized or required under this section shall be judicially reviewable by a Federal or State
court.
(3) Timing
(A) In general
A person may not obtain judicial review of the failure of the Administrator to make a determination on the
application specified in paragraph (1) before the expiration of the 2-year period that begins on the date on
which the decision time review period for the application ends.
(B) Meeting with Administrator
To be eligible to seek judicial review under this subsection, a person seeking the review shall first request
in writing, at least 120 days before filing the complaint for judicial review, a decision review meeting with the
Administrator.
(4) Remedies
The Administrator may not be required or permitted to refund any portion of a registration service fee paid in
response to a complaint that the Administrator has failed to make a determination on the covered pesticide
registration application specified in paragraph (1) by the end of the applicable decision review period.
(h) Accounting
The Administrator shall(1) provide an annual accounting of the registration service fees paid to the Administrator and disbursed from
the Fund, by providing financial statements in accordance with(A) the Chief Financial Officers Act of 1990 (Public Law 101–576; 104 Stat. 2838) and amendments made
by that Act; and
(B) the Government Management Reform Act of 1994 (Public Law 103–356; 108 Stat. 3410) and
amendments made by that Act;
(2) provide an accounting describing expenditures from the Fund authorized under subsection (c); and
(3) provide an annual accounting describing collections and expenditures authorized under subsection (d).
(i) Auditing
(1) Financial statements of agencies
For the purpose of section 3515(c) of title 31, the Fund shall be considered a component of an executive
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agency.
(2) Components
The annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities
under this section shall include an analysis of(A) the fees collected under subsection (b) and disbursed;
(B) compliance with subsection (f);
(C) the amount appropriated to meet the requirements of subsection (d)(1); and
(D) the reasonableness of the allocation of the overhead allocation of costs associated with the review and
decisionmaking pertaining to applications under this section.
(3) Inspector General
The Inspector General of the Environmental Protection Agency shall(A) conduct the annual audit required under this subsection; and
(B) report the findings and recommendations of the audit to the Administrator and to the appropriate
committees of Congress.
(j) Personnel levels
All full-time equivalent positions supported by fees authorized and collected under this section shall not be
counted against the agency-wide personnel level goals of the Environmental Protection Agency.
(k) Reports
(1) In general
Not later than March 1, 2005, and each March 1 thereafter through March 1, 2017, the Administrator shall
publish an annual report describing actions taken under this section.
(2) Contents
The report shall include(A) a review of the progress made in carrying out each requirement of subsections (e) and (f), including(i) the number of applications reviewed, including the decision times for each application specified in
subsection (f);
(ii) the number of label amendments that have been reviewed using electronic means;
(iii) the amount of money from the Reregistration and Expedited Processing Fund used to carry out inert
ingredient review and review of similar applications under section 136a–1(k)(3) of this title;
(iv) the number of applications completed for identical or substantially similar applications under section
136a(c)(3)(B) of this title, including the number of such applications completed within 90 days pursuant to
that section;
(v) the number of actions pending in each category of actions described in subsection (f)(3), as well as
the number of inert ingredients;
(vi) to the extent determined appropriate by the Administrator and consistent with the authorities of the
Administrator and limitations on delegation of functions by the Administrator, recommendations for(I) expanding the use of self-certification in all appropriate areas of the registration process;
(II) providing for accreditation of outside reviewers and the use of outside reviewers to conduct the
review of major portions of applications;
(III) reviewing the scope of use of the notification process to cover broader categories of registration
actions;
(IV) providing for electronic submission and review of labels, including process improvements to further
enhance the procedures used in electronic label review; and
(V) the allowance and use of summaries of acute toxicity studies;
(vii) the use of performance-based contracts, other contracts, and procurement to ensure that(I) the goals of this subchapter for the timely review of applications for registration are met; and
(II) the registration program is administered in the most productive and cost effective manner
practicable; and
(viii) the number of extensions of decision time review periods agreed to under subsection (f)(5) along
with a description of the reason that the Administrator was unable to make a decision within the initial
decision time review period;
(B) a description of the staffing and resources relating to the costs associated with the review and
decisionmaking pertaining to applications;
(C) a review of the progress in meeting the timeline requirements of section 136a–1(g) of this title;
(D) a review of the progress in carrying out section 136a(g) of this title, including(i) the number of pesticides or pesticide cases reviewed;
(ii) a description of the staffing and resources relating to the costs associated with the review and
decision making relating to reregistration and registration review for compliance with the deadlines
specified in this subchapter;
(iii) to the extent determined appropriate by the Administrator and consistent with the authorities of the
Administrator and limitations on delegation of functions by the Administrator, recommendations for(I) process improvements in the handling of registration review under section 136a(g) of this title;
(II) providing for accreditation of outside reviewers and the use of outside reviewers in the registration
review process; and
(III) streamlining the registration review process, consistent with section 136a(g) of this title;
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(E) a review of the progress in meeting the timeline requirements for the review of antimicrobial pesticide
products under section 136a(h) of this title;
(F) a review of the progress in carrying out the review of inert ingredients, including the number of
applications pending, the number of new applications, the number of applications reviewed, staffing, and
resources devoted to the review of inert ingredients and recommendations to improve the timeliness of review
of inert ingredients;
(G) a review of the progress made toward(i) carrying out section 136a–1(k)(4) of this title and the amounts from the Reregistration and Expedited
Processing Fund used for the purposes described in that section;
(ii) implementing systems for the electronic tracking of registration submissions by December 31, 2013;
(iii) implementing a system for tracking the status of conditional registrations, including making
nonconfidential information related to the conditional registrations publicly available by December 31, 2013;
(iv) implementing enhancements to the endangered species knowledge database, including making
nonconfidential information related to the database publicly available;
(v) implementing the capability to electronically submit and review labels submitted with registration
actions;
(vi) acquiring and implementing the capability to electronically assess and evaluate confidential
statements of formula submitted with registration actions by December 31, 2014; and
(vii) facilitating public participation in certain registration actions and the registration review process by
providing electronic notification to interested parties of additions to the public docket;
(H) the number of applications rejected by the Administrator under the initial content and preliminary
technical screening conducted under subsection (f)(4);
(I) a review of the progress made in updating the Pesticide Incident Data System, including progress
toward making the information contained in the System available to the public (as the Administrator
determines is appropriate); and
(J) an assessment of the public availability of summary pesticide usage data.
(3) Method
The Administrator shall publish a report required by this subsection by such method as the Administrator
determines to be the most effective for efficiently disseminating the report, including publication of the report on
the Internet site of the Environmental Protection Agency.
(4) Other report
(A) Scope
In addition to the annual report described in paragraph (1), not later than October 1, 2016, the
Administrator shall submit to the Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an analysis of the
impact of maintenance fees on small businesses that have(i) 10 or fewer employees; and
(ii) annual global gross revenue that does not exceed $2,000,000.
(B) Information required
In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the
report under that subparagraph, information on(i) the number of small businesses described in subparagraph (A) that are paying maintenance fees; and
(ii) the number of registrations each company holds.
(l) Savings clause
Nothing in this section affects any other duties, obligations, or authorities established by any other section of
this subchapter, including the right to judicial review of duties, obligations, or authorities established by any other
section of this subchapter.
(m) Termination of effectiveness
(1) In general
Except as provided in paragraph (2), the authority provided by this section terminates on September 30,
2017.
(2) Phase out
(A) Fiscal year 2018
During fiscal year 2018, the requirement to pay and collect registration service fees applies, except that the
level of registration service fees payable under this section shall be reduced 40 percent below the level in
effect on September 30, 2017.
(B) Fiscal year 2019
During fiscal year 2019, the requirement to pay and collect registration service fees applies, except that the
level of registration service fees payable under this section shall be reduced 70 percent below the level in
effect on September 30, 2017.
(C) September 30, 2019
Effective September 30, 2019, the requirement to pay and collect registration service fees terminates.
(D) Decision review periods
(i) Pending applications
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In the case of an application received under this section before September 30, 2017, the application shall
be reviewed in accordance with subsection (f).
(ii) New applications
In the case of an application received under this section on or after September 30, 2017, subsection (f)
shall not apply to the application.
(June 25, 1947, ch. 125, §33, as added Pub. L. 108–199, div. G, title V, §501(f)(2), Jan. 23, 2004, 118 Stat. 422 ;
amended Pub. L. 110–94, §5, Oct. 9, 2007, 121 Stat. 1002 ; Pub. L. 110–193, §1(a), Mar. 6, 2008, 122 Stat. 649 ;
Pub. L. 112–177, §2(a)(2)(B), (b), Sept. 28, 2012, 126 Stat. 1328, 1330.)

REFERENCES IN TEXT
The effective date of the Pesticide Registration Improvement Act of 2003, and the effective date of
this section, referred to in text, is the effective date of section 501 of Pub. L. 108–199, which is the
date that is 60 days after Jan. 23, 2004, unless otherwise provided, see section 501(h) of Pub. L.
108–199, set out as an Effective Date of 2004 Amendment note under section 136a of this title.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(2)(B)(ii), is act June 25,
1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§301 et seq.) of
Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21
and Tables.
The effective date of the Pesticide Registration Improvement Extension Act of 2012, referred to in
subsecs. (e) and (f)(1), probably means the effective date of section 2 of Pub. L. 112–177, which is
Oct. 1, 2012, see section 2(c) of Pub. L. 112–177, set out as a note under section 136a–1 of this title.
The Chief Financial Officers Act of 1990, referred to in subsec. (h)(1)(A), is Pub. L. 101–576, Nov.
15, 1990, 104 Stat. 2838 . For complete classification of this Act to the Code, see Short Title of 1990
Amendment note set out under section 501 of Title 31, Money and Finance, and Tables.
The Government Management Reform Act of 1994, referred to in subsec. (h)(1)(B), is Pub. L. 103–
356, Oct. 13, 1994, 108 Stat. 3410 , as amended. For complete classification of this Act to the Code,
see Short Title of 1994 Amendment note set out under section 3301 of Title 31, Money and Finance,
and Tables.

PRIOR PROVISIONS
A prior section 33 of act June 25, 1947, ch. 125, was renumbered section 34 and is classified to
section 136x of this title.

AMENDMENTS
2012-Subsec. (b)(3). Pub. L. 112–177, §2(b)(1)(A), added par. (3) and struck out former par. (3)

which related to schedule of covered applications and registration service fees.
Subsec. (b)(6)(A). Pub. L. 112–177, §2(b)(1)(B)(i), substituted "October 1, 2013" for "October 1,
2008" and "September 30, 2015" for "September 30, 2010".
Subsec. (b)(6)(B). Pub. L. 112–177, §2(b)(1)(B)(ii), substituted "October 1, 2015" for "October 1,
2010" and "September 30, 2015" for "September 30, 2010".
Subsec. (b)(7)(F)(i). Pub. L. 112–177, §2(a)(2)(B)(i), substituted "section 136a–1 (i)(1)(E)(ii)" for
"section 136a–1(i)(5)(E)(ii)".
Subsec. (b)(7)(F)(ii). Pub. L. 112–177, §2(a)(2)(B)(i), (ii), substituted "section 136a–1 (i)(1)(E)(ii)"
for "section 136a–1(i)(5)(E)(ii)" in subcl. (I) and "section 136a–1(i)(1)(E)(ii)(I)(bb)" for "136a–1(i)(5)(E)
(ii)(I)(bb)" in subcl. (II).
Subsec. (b)(7)(F)(iv)(I). Pub. L. 112–177, §2(a)(2)(B)(i), substituted "section 136a–1 (i)(1)(E)(ii)" for
"section 136a–1(i)(5)(E)(ii)".
Subsec. (b)(7)(F)(iv)(II). Pub. L. 112–177, §2(a)(2)(B)(ii), (iii), substituted "applicable" for
"applicable.", "revenue" for "revenues", and "section 136a–1(i)(1)(E)(ii)(I)(bb)" for "section 136a–1(i)
(5)(E)(ii)(I)(bb)".
Subsec. (b)(8)(C)(ii)(III). Pub. L. 112–177, §2(b)(1)(C), added subcl. (III).
Subsec. (c)(3)(B)(i). Pub. L. 112–177, §2(b)(2)(A), substituted "2013 through 2017" for "2008
through 2012".
Subsec. (c)(3)(B)(ii). Pub. L. 112–177, §2(b)(2)(B), substituted "grants, for each of fiscal years
2013 through 2017, $500,000." for "grants"(I) for each of fiscal years 2008 and 2009, $750,000; and
"(II) for each of fiscal years 2010 through 2012, $500,000."
Subsec. (c)(3)(B)(iii). Pub. L. 112–177, §2(b)(2)(C), substituted "2013 through 2017" for "2008
through 2012".
Subsec. (d)(2). Pub. L. 112–177, §2(b)(3)(A), substituted "2012" for "2002" in two places.
Subsec. (d)(4), (5). Pub. L. 112–177, §2(b)(3)(B), (C), redesignated par. (5) as (4) and struck out
former par. (4). Prior to amendment, text of par. (4) read as follows: "The requirements of paragraph
(2) shall have been considered to have been met for any fiscal year if the amount of appropriations
for salaries, contracts, and expenses for the functions (as in existence in fiscal year 2002) of the
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Office of Pesticide Programs of the Environmental Protection Agency for the fiscal year (excluding
the amount of any fees appropriated for the fiscal year) is not more than 3 percent below the amount
of appropriations for covered functions for fiscal year 2002 (excluding the amount of any fees
appropriated for the fiscal year)."
Subsec. (e). Pub. L. 112–177, §2(b)(4), substituted "Pesticide Registration Improvement Extension
Act of 2012" for "Pesticide Registration Improvement Act of 2003".
Subsec. (f)(1). Pub. L. 112–177, §2(b)(5)(A), substituted "Pesticide Registration Improvement
Extension Act of 2012, the Administrator shall make publicly available" for "Pesticide Registration
Improvement Renewal Act, the Administrator shall publish in the Federal Register".
Subsec. (f)(2). Pub. L. 112–177, §2(b)(5)(B), substituted "provided under subsection (b)(3)." for
"appearing in the Congressional Record on pages S10409 through S10411, dated July 31, 2007."
Subsec. (f)(4)(A). Pub. L. 112–177, §2(b)(5)(C)(i), inserted "and fee" before period at end.
Subsec. (f)(4)(B). Pub. L. 112–177, §2(b)(5)(C)(ii)(I), substituted "Initial content and preliminary
technical screenings" for "Completeness of application" in heading.
Subsec. (f)(4)(B)(i). Pub. L. 112–177, §2(b)(5)(C)(ii)(I), (II), substituted "Screenings" for "In
general" in cl. heading, designated existing provisions as subcl. (I) and inserted subcl. heading, and
added subcl. (II).
Subsec. (f)(4)(B)(ii). Pub. L. 112–177, §2(b)(5)(C)(ii)(III), added cl. (ii) and struck out former cl. (ii).
Prior to amendment, text read as follows: "If the Administrator determines under clause (i) that the
application does not pass the initial screening and cannot be corrected within the 21-day period, the
Administrator shall reject the application not later than 10 days after making the determination."
Subsec. (f)(4)(B)(iii). Pub. L. 112–177, §2(b)(5)(C)(ii)(IV), inserted "initial content" before
"screening" in heading, "content" before "screening" in introductory provisions, and substituted
"appears to contain" for "contains" in subcl. (II).
Subsec. (f)(4)(B)(iv). Pub. L. 112–177, §2(b)(5)(C)(ii)(V), added cl. (iv).
Subsec. (k)(1). Pub. L. 112–177, §2(b)(6)(A), substituted "March 1, 2017" for "March 1, 2014".
Subsec. (k)(2)(A)(viii). Pub. L. 112–177, §2(b)(6)(B)(i), added cl. (viii).
Subsec. (k)(2)(G) to (J). Pub. L. 112–177, §2(b)(6)(B)(ii)–(iv), added subpars. (G) to (J).
Subsec. (k)(4). Pub. L. 112–177, §2(b)(6)(C), added par. (4).
Subsec. (m)(1). Pub. L. 112–177, §2(b)(7)(A), substituted "2017" for "2012".
Subsec. (m)(2)(A). Pub. L. 112–177, §2(b)(7)(B)(i), substituted "2018" for "2013" in heading and
"2018," for "2013," and "September 30, 2017" for "September 30, 2012" in text.
Subsec. (m)(2)(B). Pub. L. 112–177, §2(b)(7)(B)(ii), substituted "2019" for "2014" in heading and
"2019," for "2014," and "September 30, 2017" for "September 30, 2012" in text.
Subsec. (m)(2)(C). Pub. L. 112–177, §2(b)(7)(B)(iii), substituted "2019" for "2014" in heading and
"September 30, 2019" for "September 30, 2014" in text.
Subsec. (m)(2)(D). Pub. L. 112–177, §2(b)(7)(B)(iv), substituted "2017" for "2012" in cls. (i) and (ii).
2008-Subsec. (b)(7)(D)(i). Pub. L. 110–193, §1(a)(1)(A)(i), added cl. (i) and struck out former cl. (i).
Prior to amendment, text read as follows: "The Administrator may waive or reduce a registration
service fee for an application for minor uses for a pesticide."
Subsec. (b)(7)(D)(ii). Pub. L. 110–193, §1(a)(1)(A)(ii), inserted "or exemption" after "waiver".
Subsec. (b)(7)(E). Pub. L. 110–193, §1(a)(1)(B)(ii), substituted "exempt an application from the
registration service fee" for "waive the registration service fee for an application" in introductory
provisions.
Pub. L. 110–193, §1(a)(1)(B)(i), substituted "exemption" for "waiver" in heading.
Subsec. (b)(7)(E)(ii). Pub. L. 110–193, §1(a)(1)(B)(iii), substituted "exemption" for "waiver".
Subsec. (m)(2)(A), (B). Pub. L. 110–193, §1(a)(2), substituted "2012" for "2008".
2007-Subsec. (b)(2)(C)(ii). Pub. L. 110–94, §5(a)(1), added cl. (ii) and struck out former cl. (ii)
which read as follows: "a request for a waiver from or reduction of the registration service fee."
Subsec. (b)(2)(D) to (H). Pub. L. 110–94, §5(a)(2), added subpars. (D) to (H).
Subsec. (b)(3)(A). Pub. L. 110–94, §5(b)(1)(A), substituted "Pesticide Registration Improvement
Renewal Act" for "Pesticide Registration Improvement Act of 2003".
Subsec. (b)(3)(B). Pub. L. 110–94, §5(b)(1)(B), substituted "S10409 through S10411, dated July
31, 2007." for "S11631 through S11633, dated September 17, 2003."
Subsec. (b)(6). Pub. L. 110–94, §5(b)(2), added par. (6) and struck out former par. (6). Prior to
amendment, text of par. (6) read as follows: "Effective for a covered pesticide registration application
received on or after October 1, 2005, the Administrator shall"(A) increase by 5 percent the service fee payable for the application under paragraph (3); and
"(B) publish in the Federal Register the revised registration service fee schedule."
Subsec. (b)(7)(F)(ii). Pub. L. 110–94, §5(c)(1), substituted "75 percent" for "all" in introductory
provisions.
Subsec. (b)(7)(F)(iv)(II). Pub. L. 110–94, §5(c)(2), substituted "75 percent of the applicable." for
"all".
Subsec. (b)(8)(A). Pub. L. 110–94, §5(d), substituted "25 percent." for "10 percent".
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Subsec. (c)(1)(B). Pub. L. 110–94, §5(e)(1), substituted "paragraph (5)" for "paragraph (4)".
Subsec. (c)(3)(B). Pub. L. 110–94, §5(e)(2)(A), added subpar. (B) and struck out former subpar.
(B). Prior to amendment, text of subpar. (B) read as follows: "For each of fiscal years 2004 through
2008, the Administrator shall use approximately 1/17 of the amount in the Fund (but not more than
$1,000,000, and not less than $750,000, for any fiscal year) to enhance current scientific and
regulatory activities related to worker protection."
Subsec. (c)(3)(C). Pub. L. 110–94, §5(e)(2)(B), struck out subpar. (C). Text read as follows: "For
each of fiscal years 2004 and 2005, the Administrator shall use approximately 1/34 of the amount in
the Fund (but not to exceed $500,000 for any fiscal year) for the review and evaluation of new inert
ingredients."
Subsec. (c)(5). Pub. L. 110–94, §5(e)(3), designated existing provisions as subpar. (A), inserted
heading, redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A) and
added subpar. (B).
Subsec. (d)(2). Pub. L. 110–94, §5(f), which directed substitution of "Registration" for "For fiscal
years 2004, 2005 and 2006 only, registration", was executed by making the substitution for text
which contained a comma after "2005" to reflect the probable intent of Congress.
Subsec. (f)(1). Pub. L. 110–94, §5(g)(1), substituted "Pesticide Registration Improvement Renewal
Act" for "Pesticide Registration Improvement Act of 2003".
Subsec. (f)(2). Pub. L. 110–94, §5(g)(2), substituted "S10409 through S10411, dated July 31,
2007." for "S11631 through S11633, dated September 17, 2003."
Subsec. (f)(4)(B). Pub. L. 110–94, §5(g)(3), added subpar. (B) and struck out former subpar. (B)
which provided criteria for determining completeness of pesticide registration applications.
Subsec. (k)(1). Pub. L. 110–94, §5(h)(1), substituted "March 1, 2014" for "March 1, 2009".
Subsec. (k)(2)(A)(ii) to (v). Pub. L. 110–94, §5(h)(2)(A)(i), (ii), added cls. (ii) to (iv) and
redesignated former cl. (ii) as (v). Former cls. (iii) and (iv) redesignated (vi) and (vii), respectively.
Subsec. (k)(2)(A)(vi). Pub. L. 110–94, §5(h)(2)(A)(i), (iii), redesignated cl. (iii) as (vi) and added
subcls. (IV) and (V).
Subsec. (k)(2)(A)(vii). Pub. L. 110–94, §5(h)(2)(A)(i), redesignated cl. (iv) as (vii).
Subsec. (k)(2)(D) to (F). Pub. L. 110–94, §5(h)(2)(B)–(D), added subpars. (D) to (F).
Subsec. (m)(1). Pub. L. 110–94, §5(i)(1), substituted "2012" for "2008".
Subsec. (m)(2)(A). Pub. L. 110–94, §5(i)(2)(A), substituted "2013" for "2009" in heading and text.
Subsec. (m)(2)(B), (C). Pub. L. 110–94, §5(i)(2)(B), substituted "2014" for "2010" in headings and
text.
Subsec. (m)(2)(D). Pub. L. 110–94, §5(i)(2)(C), substituted "2012" for "2008" in two places.

EFFECTIVE DATE OF 2012 AMENDMENT
Amendment by Pub. L. 112–177 effective Oct. 1, 2012, see section 2(c) of Pub. L. 112–177, set
out as a note under section 136a–1 of this title.
EFFECTIVE DATE OF 2008 AMENDMENT
Pub. L. 110–193, §1(b), Mar. 6, 2008, 122 Stat. 650 , provided that: "The amendments made by
subsection (a) [amending this section] take effect on October 1, 2007."

EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 110–94 effective Oct. 1, 2007, see section 6 of Pub. L. 110–94, set out as
a note under section 136a of this title.
EFFECTIVE DATE
Section effective on the date that is 60 days after Jan. 23, 2004, except as otherwise provided, see
section 501(h) of Pub. L. 108–199, set out as an Effective Date of 2004 Amendment note under
section 136a of this title.
1 So in original. The period probably should not appear.

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