Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2018
Fifteenth Annual Report


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Table IV
Number of PRIA Decisions Pending at the End of the Fiscal Year
(FY 2015 through FY 2018)
Key to the table
	R - Conventional Pesticides
	A - Antimicrobial Pesticides
	B - Biopesticides
	EUP - Experimental Use Permit
	I - Inert Ingredient
	M - Miscellaneous
	PIP - Plant-Incorporated Protectants
	SAP - FIFRA Scientific Advisory Panel
	SCLP - Straight Chain Lepidopteran Pheromones
Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year
PRIA
Category
Description of Category
Number of PRIA Decisions
Pending at the End of Fiscal
Year
2015
2016
2017
2018
R010
New Active Ingredient, Food Use
20
27
36
65
R020
New Active Ingredient, Food use; reduced risk
26
20
20
6
R060
New Active Ingredient, Non-food use, outdoor

6
10
10
R090
New Active Ingredient, Non-food use, outdoor, EUP

1
1

R110
New Active Ingredient, Non-food use; indoor
3
2
2
2
R121
New Active Ingredient, Non-food use; indoor; EUP



1
R124
Conditional Ruling on Pre-application Study Waivers; applicant-
initiated
2
5
5
3
R140
Additional food use; Indoor; food/food handling
2


3
R150
New Use, First food use
10
6
3
6
R17
New Use, Each Additional New Food Use
5
5
5
5
R170
New Use, Additional Food Use
202
190
198
192
R175
Additional food uses covered within a crop grouping resulting from
the conversion of an existing approved crop grouping
76
56
85
101
R180
New Use, Additional food use; reduced risk
16
33
23
30
R190
New Use, Additional food uses; 6 or more submitted in one
application
73
50
49
57
R200
New Use, Additional food uses; 6 or more submitted in one
application; reduced risk
10
12

15
2

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Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year
PRIA
Category
Description of Category
Number of PRIA Decisions
Pending at the End of Fiscal
Year
2015
2016
2017
2018
R230
New Use, Additional use; non-food; outdoor
19
13
17
18
R240
New Use, Additional use; non-food; outdoor; reduced risk
3
4

2
R250
EUP, new use; no credit toward new use registration
1



R251
EUP which requires no changes to tolerance; non-crop destruct
1



R260
New use; non-food; indoor
8
2
5
6
R270
New use; non-food; indoor; reduced risk
2
1

2
R271
New use; non-food; indoor; EUP

1


R272
Review of Study Protocol; applicant-initiated; excludes DART, pre-
registration conferences, Rapid Response review, DNT protocol
review, protocols needing HSRB review
3
4
7
7
R273
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
12
7
4
1
R280
Establish import tolerance; new active ingredient or first food use
2
3
5
3
R29
Import tolerance, Additional new food use
1
1
1
1
R290
Establish import tolerance; additional food use
7
18
14
21
B291
Establish import tolerances; additional food uses; 6 or more crops
submitted in one petition
2
2


R292
Amend an established tolerance (e.g., decrease or increase); domestic
or import; applicant-initiated
18
9
10
11
R294
Establish tolerances for inadvertent residues; 6 or more
1
1
1
1
R295
Establish tolerance(s) for residues in one rotational crop in response
to a specific rotational crop application; applicant-initiated
1

1
7
R298
Amend established tolerance, submission of amended labels
28
22
21
7
R299
Amend 6 or more established tolerances; submission of amended
labels.


11
11
3

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Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year
PRIA
Category
Description of Category
Number of PRIA Decisions
Pending at the End of Fiscal
Year
2015
2016
2017
2018
R300
New product; identical or substantially similar in composition and use
to a registered product; no data review or only product chemistry data;
cite-all data citation, 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.
47
32
76
45
R301
New product; 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.
27
30
42
29
R310
New end-use or manufacturing-use product; requires review of data
package within RD; includes reviews and/or waivers of data for only:
	product chemistry and/or
	acute toxicity and/or
	public health pest efficacy
46
52
67
44
R314
New product with 2 or more registered AIs never before registered as
this combination
30
17
38
22
R315
New product, non-food, animal product with 2 animal safety studies
9
13
2
8
R320
New product; new physical form; requires data review in science
divisions
25
18
17
18
R331
New product, repack of identical end-use product as a MUP
2



R333
New product with unregistered source of AI, cite-all
29
21
37
20
R334
New product with unregistered source of AI, selective citation
22
48
43
35
R340
Amendment requiring data review within RD (e.g., changes to
precautionary label statements, or source changes to an unregistered
source of active ingredient)
38
28
49
35
R345
Amendment; non-food animal product with animal safety data

1


R35
Amendment, Non-fast track (changes to REI, PPE, PHI, rate and
number of applications, add aerial application, modify GW/SW
advisory statement)
2
2
2
2
R350
Amendment requiring data review in science divisions (e.g., changes
to REI, or PPE, or PHI, or use rate, or number of applications; or add
aerial application; or modify GW/SW advisory statement)
50
31
39
54
4

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Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year
PRIA
Category
Description of Category
Number of PRIA Decisions
Pending at the End of Fiscal
Year
2015
2016
2017
2018
R351
Amendment adding new unregistered source of AI
51
47
65
76
R352
Amendment adding already approved uses,
5
2
3
2
R370
Cancer reassessment; applicant-initiated
1
4
5
2
A380
New a.i., food use, establish tolerance exemption



2
A420
New a.i., non-food use; indoor; FIFRA section 2(mm) uses
17
5
2
4
A440
New use, First food use; establish tolerance exemption
4
1
1

A460
New use, Additional food use; establish tolerance exemption
5
5
3
3
A470
New use, Additional food use; establish tolerance



2
A480
New use, Additional use; non-food; outdoor; FIFRA 2(mm) uses


2

A490
New use, Additional use; non-food; outdoor; uses other than FIFRA
2(mm)
1



A500
New use, Additional use; non-food; indoor; FIFRA 2(mm) uses
2

2
9
A510
Additional use; non-food; indoor; uses other than FIFRA section
2(mm)
4



A521
Review of public health efficacy study protocol within AD; per AD
Internal Guidance for the Efficacy Protocol Review Process;
applicant-initiated; Tier 1
1
3
4
1
A522
Review of public health efficacy study protocol outside AD by
members of AD Efficacy Protocol Review Expert Panel; applicant-
initiated; Tier 2
3
3


A523
Review of protocol other than public health efficacy study
1

1

A530
New product; identical or substantially similar in composition anduse
to a registered product; no data review or only product chemistry
data; cite-all data citation, or selective data citation where applicant
owns all required data, or applicant submits specific authorization
letter from data owner. Category also includes 100% re-package of
registered end-use or manufacturing-use product that requires no data
submission nor data matrix.
11
10
9
10
A531
New product; 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.
11
4
7
2
A532
New product; identical or substantially similar in composition and use
to a registered product; registered active ingredient; unregistered
source of active ingredient; cite-all data citation except for product
chemistry; product chemistry data submitted
5
5
1
5
A540
New end use product; FIFRA 2(mm) uses only
41
47
41
45
5

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Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year
PRIA
Category
Description of Category
Number of PRIA Decisions
Pending at the End of Fiscal
Year
2015
2016
2017
2018
A550
New end-use product; uses other than FIFRA 2(mm); non-FQPA
product
1
3
3
3
A560
New manufacturing-use product; registered active ingredient;
selective data citation
16
9
9
3
A570
Label amendment requiring data submission
62
54
82
48
A571
Science reassessment: cancer; eco; ESA

1
1
1
A572
New product or amendment requiring data review
3
2
1
2
B590
New active ingredient; food use; establish tolerance exemption,
Mi crobi al/B i ochemi cal,
29
46
136
49
B600
New active ingredient; non-food use, Microbial/Biochemical,
5
4
6
12
B610
Food use; EUP; establish temporary tolerance exemption,
Mi crobi al/B i ochemi cal
2


2
B612
New active ingredient; no change to permanent tolerance exemption.
10
1
1

B614
Conditional ruling pre-application study waiver
1
1
1
3
B620
Non-food use; Experimental Use Permit application,
Mi crobi al/B i ochemi cal
1


1
B621
Extend or amend Experimental Use Permit, Microbial/Biochemical
2

1

B630
First food use; establish tolerance exemption, Microbial/Biochemical,
9

2
13
B640
New food use; petition to amend an established tolerance


4
4
B641
Amend established tolerance (e.g., decrease or increase)
1



B643
New food use; petition to amend tolerance exemption
5
4


B644
New use, no change to existing tolerance or tolerance exemption
1
1

8
B650
New use; non-food

4
1

B660
New product; identical or substantially similar in composition anduse
to a registered product; no data review or only product chemistry
data; cite-all data citation, or selective data citation where applicant
owns all required data, or applicant submits specific authorization
letter from data owner. Category also includes 100% re-package of
registered end-use or manufacturing-use product that requires no data
submission nor data matrix. Microbial/biochemical
3
6
4
1
B670
New product; registered source of active ingredient; all Tier I data for
product chemistry, toxicology, non-target organisms, and product
performance must be addressed with product specific data or with
request for data waivers supported by scientific rationales,
Mi crobi al/B i ochemi cal
9
15
13
16
6

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Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year
PRIA
Category
Description of Category
Number of PRIA Decisions
Pending at the End of Fiscal
Year
2015
2016
2017
2018
B671
New product; food use; unregistered source of active ingredient;
requires amendment of established tolerance or tolerance
exemption; all Tier I data requirements for product chemistry,
toxicology, non- target organisms, and product performance must
be addressed with product-specific data or with request for data
waivers supported by scientific rationales, Microbial/Biochemical


2
2
B672
New product; non-food use or food use having established tolerance
or tolerance exemption; unregistered source of active ingredient; no
data compensation issues; all Tier I data requirements for product
chemistry, toxicology, non-target organisms, and product
performance must be addressed with product-specific data or with
request for data waivers supported by scientific rationales,
Mi crobi al/B i ochemi cal
8
6
12
13
B673
New product, unregistered source of AI; citation of TGAI previously
approved
7
2
5
13
B674
New product; MUP; repack of identical end-use product as MUP
1



B676
New product, more than 1 active ingredient where one is an
unregistered source

1


B680
Label amendment requiring data submission, Microbial/Biochemical
6
8
8
3
B681
Label amendment; unregistered source of active ingredient;
supporting data require scientific review, Microbial/Biochemical
3
12
4
8
B682
Protocol review; applicant-initiated; excludes time for HSRB review


1

B683
Label amendment; update of previous risk assessment; no new data

1
2
1
B690
SCLP, New active ingredient; food or non-food use



4
B710
SCLP, New product; identical or substantially similar in composition
and use to a registered product; no data review or only product
chemistry data; cite-all data citation, or selective data citation where
applicant owns all required data, or applicant submits specific
authorization letter from data owner. Category also includes 100%
re-package of registered end-use or manufacturing-use product that
requires no data submission nor data matrix.

1


B720
SCLP, New product; registered source of active ingredient; all Tier I
data for product chemistry, toxicology, non-target organisms, and
product performance must be addressed with product specific data or
with request for data waivers supported by scientific rationales
5

2
1
B721
SCLP, New product; unregistered source of active ingredient

2
3
4
B730
SCLP, Label amendment requiring data submission
1



7

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Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year


Number of PRIA Decisions
PRIA
Category
Description of Category
Pending at the End of Fiscal
Year

2015
2016
2017
2018
B771
PIP, Experimental Use Permit application; new active ingredient;
establish temporary tolerance or tolerance exemption; no SAP review
required;

2
2

B772
Amend or extend EUP
1


1
B773
Amend or extend EUP with temporary tol exemption extension
2



B780
New PIP; non-food/feed
1



B790
New PIP; non-food/feed; SAP review
1



B800
New PIP; establish tol or exemption based on temporary tol

4


B851
PIP, New active ingredient; different genetic event of a previously
approved active ingredient; same crop; no tolerance action required;
no SAP review required
1



B880
PIP, New product; no SAP review required
2
7
2
1
B881
New PIP product; new terms of registration; additional data; SAP
review

2


B883
New 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


2

B885
PIP, seed increase, breeding stack of previously approved PIPs, same
crop
2
9
1
3
B900
PIP, Amendment (except #B890); No SAP review required; (e.g.,
new IRM requirements that are applicant initiated; or amending a
conditional registration to extend the registration expiration date with
additional data submitted)

1
1
10
B903
Inert tolerance exemption, reviewed in BPPD


1

B904
Import tolerance or tolerance exemption; processed commodities/
food use only (inert or active ingredient)



1
1001
New food-use inert
26
18
18
28
1002
Amend existing inert tolerance or exemption, new data
2
5
2
1
1003
Amend existing inert tolerance or exemption, no new data
1
1
4
5
1004
New non-food use inert
3
6
4
2
8

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Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year
PRIA
Category
Description of Category
Number of PRIA Decisions
Pending at the End of Fiscal
Year
2015
2016
2017
2018
1005
Amend currently approved non-food use inert with new use
pattern, no new data


1

1006
Amend existing non-food use inert with new use pattern, no new
data
1



1008
New polymer inert, food use
8
4
4
6
1009
New polymer inert, non-food use
3
1
4
5
M001
Protocol review by HSRB
1
2
4
1
M002
Completed study requiring HSRB review
1



M005
New product, combination of AIs from AD, BPPD, RD
3
2
1

M006
Gold seal letters
36

160

M007
Extension of Exclusive use of data 3(c)(l)(F)(ii)
2
1
4
3
M008
Exclusive use of data for a minor use 3(c)(l)(F)(vi)
4



9

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