Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2017
Fourteenth Annual Report
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PRO^
March 1, 2018

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Pesticide Registration Service Fees
Accomplishments -- Progress in Meeting Decision Times
Number of PRIA Actions Completed in FY 2017
Because each pesticide application package can require more than one decision, the EPA counts
"decisions," rather than registration applications for tracking purposes. The number of decisions
that have to be made within an application depends on the number of product registrations and
tolerance petitions in the application. For instance, one conventional new non-food outdoor use
application package required five decisions, one for each product label being amended. One
decision is designated as a "primary" decision, while the others are "secondary" decisions within
the application package in the agency's tracking systems. Generally, each application
categorized as a Fast Track, Non-Fast Track New Product, identical/substantially similar new
product, new product, Non-Fast Track Amendment or label amendment submitted with data,
contains a single product and is a single decision.
EPA completed 2,026 decisions subject to PRIA during FY' 17. FY' 17 completions represent a
7% decrease over the 2,174 decisions completed in FY' 16. Among the FY' 17 completed
decisions, 338 (16.7% of total) were antimicrobial decisions, 163 (8.0%) biopesticide decisions,
937 (46.2%) conventional pesticide decisions, 42 (2.1%) inert clearances and 546 (26.9%)
miscellaneous decisions. Table III (in Appendix A) titled "Number of PRIA Actions Completed
in FY 2014, 2015, 2016 and 2017" summarizes the number of decisions completed by each
PRIA category and provides a comparison of the five years under PRIA 3 (FY' 13, FY' 14,
FY'15, FY'16, & FY'17).
An additional 144 applications were withdrawn - an increase from the numbers withdrawn
in FY'16 (142 applications) and FY'15 (114).
FIFRA Section 33(f)(4)(B), "Initial Content and Preliminary Technical Screenings," first directs
the agency, not later than 21 days after receiving an application and the required registration
service fee, to conduct an initial screening of the contents of the application, and if the
application fails the content screen and cannot be corrected by the applicant within the 21-day
period, the agency is to reject the application. During FY' 17, zero applications were
rejected/withdrawn for significant "content" deficiencies. In FY'16, FY'15, FY14, and FY'13
seventeen, twelve, nine and six applications, respectively, were rejected/withdrawn as a result of
the 21-day content screen.
The Preliminary Technical Screen then directs the agency to screen the application to determine
if the data are accurate, complete and consistent with the proposed labeling and/or tolerance.
The technical screen is to be completed not later than 45/90 days after the PRIA start date, and
if the application fails the technical screen and cannot be corrected within 10 business days, the
agency is to reject the application. During FY' 17, Preliminary Technical Screens were
completed for 1,639 PRIA 3 submissions. 149 10-day deficiency letters were sent out resulting
in 32 applications being rejected or withdrawn. Eleven conventional chemical applications were
withdrawn and six were rejected; eight antimicrobial packages were withdrawn, and one was
rejected. Six biopesticide applications were withdrawn.
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Reasons for applications being rejected or withdrawn as a result of the Preliminary Technical
Screen include:
Not substantially similar;
Data deficiencies/missing data
Inadequate efficacy data to support claims
Uncleared inerts/missing inert data
Inadequate acute toxicity data
Unacceptable bridging arguments
Data matrix/data comp issues
Revised CSF significantly different from accepted CSF
Rejected applications are not counted as completed decisions.
Number Decisions Completed in	Number Withdrawn in Fiscal Year
Fiscal Year
Type of Pesticide
2014
2015
2016
2017
2014
2015
2016
2017
Conventional
895
960
966
937
89
65
97
83
Antimicrobial
287
319
353
338
34
29
36
40
Biopesticide
129
154
152
163
30
17
7
15
Inert
45
56
49
42
0
1
0
4
Miscellaneous
575
622
654
546
0
2
2
2
Total
1,931
2,111
2,174
2,026
153
114
142
144
The EPA completed 99.1 percent of all decisions on or before their original or extended PRIA
due date. In FY'17, 18 decisions (out of 2,026 completed decisions) were late. Decisions were
typically delayed due to the need for additional time and data to address risk issues to ensure
adequate protection of human health and the environment.
Average Decision Times
The average decision time for each PRIA category, shown in Table III in the Appendix, is the
number of days it took the agency to complete a decision once the decision review time-period
had formally begun. Meaningful comparisons of average decision times can only be made for
those fee categories with a significant number of completed decisions, and such comparisons are
complicated by the fact that many individual submissions are broken down into multiple
component decisions for tracking purposes weighting different submissions unequally.
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Due Date Extensions (Negotiated Due Dates)
Among the FY' 17 completions, we extended due dates for 263 decisions (13.1%) by mutual
agreement with the applicant. The percentage of decisions completed with due date extensions
inFY'17 decreased from that in FY'16 (13.1% vs 15.7%). Extensions generally were needed
due to missing or deficient data; risk issues; late risk assessments; MRL harmonization issues;
and delays due to global/joint reviews, public participation process, public interest findings,
publication of notices in the Federal Register, and issues requiring additional review and
coordination with other agencies. In FY'17 we extended due dates for 8%, 13.5%, and 21.3%
of completed antimicrobial, biopesticide, and conventional decisions respectively, while in
FY'16, the percentages extended were 8.8%, 14.5% and 27.4% respectively.
Number of Completed Decisions with Due Date Extensions Compared to Total Completed

FY 2014
FY 2015
FY 2016
FY 2017
Fee Category
Number
due date
extensions
Total
Number
due date
extensions
Total
Number
due date
extensions
Total
Number
due date
extensions
Total
Antimicrobial (A)
41
287
44
319
31
353
27
338
Biopesticide (B)
30
129
29
154
22
152
22
163
Conventional (R)
259
895
230
960
265
966
200
937
Inerts
9
45
18
56
21
49
16
42
Miscellaneous
1
575
3
622
2
654
0
546
Total Decisions
340
1931
324
2111
341
2174
265
2026
As discussed above, an active ingredient or a new use application package can include a number
of decisions to account for the number of registrations and tolerances requested for the new
active ingredient or new use. All of the decisions associated with these applications are linked to
one decision that has been designated as the "primary" decision with the rest termed "secondary"
decisions. A new product or amendment application package will have only one decision in the
agency's tracking system; however, some new product and amendment applications are
dependent upon the data submitted with another application, the primary decision, as described
in the primary/secondary guidance. If there are data issues, the due dates for both the primary
and all of its secondary decisions will be extended. Consequently, an analysis of due date
extensions using all decisions can only indicate trends from one fiscal year to another. To
conduct a more detailed analysis, the agency focused on primary decisions.
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Number of Completed Primary Decisions with Due Date Extensions Compared to Total Completed

FY 2014
FY 2015
FY 2016
FY 2017
Fee Category
Due Date
Extensions
Total
Due Date
Extensions
Total
Due Date
Extensions
Total
Due Date
Extensions
Total
Antimicrobial (A)
41
256
38
281
23
272
26
282
Biopesticide (B)
19
106
17
127
12
126
16
145
Conventional (R)
159
678
128
732
118
691
100
745
Inerts
9
45
18
56
21
47
16
42
Miscellaneous
1
575
3
622
2
652
0
546
Total Decisions
229
1660
204
1818
176
1788
158
1760
If only primary decisions are considered, 9.0% had due date extensions in FY' 17 according to
the agency's tracking systems, a decrease from the 9.8% in FY'16. Of the primary decisions,
due dates for 9.2% of antimicrobial, 11.0% of biopesticide, and 13.4% of conventional
primary decisions were extended, in comparison to 8.4%, 9.5% and 17.1% respectively in
FY'16.
The following general types of decisions involved due date extensions in FY' 14 - FY' 17:
Number of Decisions with Due Date Extensions by Type of Decision (All Decisions)
Fiscal
Year
New
Active
Ingredient
New
Uses
New
Products
Amendments
Inerts
Misc
Other
(EUP,
tolerances,
protocols,
etc.)
Total with
Due Date
Extensions
2014
47
79
95
67
9
1
42
340
2015
60
70
85
51
18
3
37
324
2016
31
170
60
29
19
4
28
341
2017
34
108
62
26
16
0
19
265
In FY'17 64% of completed new active ingredient decisions required due date extensions;
53% of completed new use decisions required due date extensions; 9.3% of completed new
product decisions required due date extensions; 6.4% of completed amendment decisions
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required due date extensions; 38.1% of completed inert decisions required due date
extensions; 17.3% of completed other (EUP, tolerance, protocol review, cancer reassessment)
decisions required due date extensions, and 0% of completed miscellaneous decisions required
due date extensions.
When only primary decisions are considered, the breakdown of decision types looks like this:
Number of Primary Decisions with Due Date Extensions by Type of Primary Decision
Fiscal
Year
New
Active
Ingredient
New
Uses
New
Products
Amendments
Inerts
Misc
Other (EUP,
tolerances,
protocols,
etc.)
Total with
Due Date
Extensions
2014
14
28
87
53
9
1
37
229
2015
14
26
78
40
18
3
25
204
2016
15
48
53
21
20
3
16
176
2017
13
33
60
22
16
0
14
158
In FY' 17 59% of completed, new active ingredient, primary decisions required due date
extensions; 49% of completed, new use, primary decisions required due date extensions; 10% of
completed, new product, primary decisions required due date extensions; 5.9% of completed,
amendment, primary decisions required due date extensions; 38.1% of completed, inert, primary
decisions required due date extensions; 14% of completed, other (EUP, tolerance, protocol
review, cancer reassessment), primary decisions required due date extensions and 0% of
completed miscellaneous primary decisions required due date extensions.
Antimicrobials
Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary
Decisions - Antimicrobials
Fiscal Year
FY 2014
FY 2015
FY 2016
FY 2017
Type
Number
with
Extensions
Total
Number
with
Extensions
Total
Number
with
Extensions
Total
Number
with
Extensions
Total
New Active
Ingredient
0
1
1
1
5
6
1
1
New Uses
4
10
2
7
0
3
0
1
New Products
18
131
19
151
1
143
17
151
Amendments
9
95
14
115
5
108
7
117
Other (tolerances,
EUP protocols, etc.)
10
19
2
7
3
12
1
11
Total with
Extensions
41
256
38
281
2
3
272
26
282
In FY' 17 the percentage of antimicrobial primary decisions with a due date extension (9.2%)
was up from FY' 16 (8.4%).
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Biopesticides
Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of
Primary Decisions - Biopesticides
Fiscal Year
FY 2014
FY 2015
FY 2016
FY 2017

Number

Number

Number

Number

Type
with
Extensions
Total
with
Extensions
Total
with
Extensions
Total
with
Extensions
Total
New Active
Ingredient
8
12
7
12
8
19
6
19
New Uses
1
14
1
4
1
4
1
7
New Products
7
51
4
66
2
75
6
67
Amendments
1
15
3
26
0
13
3
31
Other (tolerances,
EUP, protocols, etc.)
2
14
2
19
1
15
0
21
Total with Due Date
Extensions
19
106
17
127
12
126
16
145
In FY'17 the percentage of biopesticide primary decisions with due date extensions (11%) was
up from FY' 16 (9.5%).
Conventional
Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary
Decisions - Conventional Pesticides
Fiscal Year
FY 2014
FY 2015
FY 2016
FY 2017
Type
Number
with
Extensions
Total
Number
with
Extensions
Total
Number
with
Extensions
Total
Number with
Extensions
Total
New Active Ingredient
6
7
6
8
2
3
6
6
New Uses
23
56
23
60
54
82
32
58
New Products
62
323
55
367
41
354
37
391
Amendments
43
229
23
238
17
193
12
222
Other (EUP, tolerances,
protocols, etc.)
25
63
21
59
12
59
13
68
Total with Due Date
Extensions
159
678
12
8
732
12
6
691
100
745
In FY'17 the percentage of conventional primary decisions with a due date extension (13.4%)
was down from FY' 16 (18.5%).
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Note: Table V in Appendix A lists all applications subject to PRIA completed during FY' 17
with the decision time for each decision.
Public Participation Process
Federal pesticide law includes only limited requirements for public participation in the pesticide
registration process. In response to the President's directive on transparency and open
government, the EPA explored opportunities for expanding the openness of the process, and in
October 2009, began implementing a public participation process for certain registration actions.
This process increased the public's opportunities to comment on risk assessments and proposed
registration actions. Both the EPA and the public benefit from a public participation process
because the public can aid in understanding potential risks and benefits, contribute to meaningful
protective measures, and improve the public dialogue on pesticide registration decisions. The
public participation process is used for the following types of applications:
	new active ingredients,
	first food use,
	first outdoor use,
	first residential use, and
	other actions of significant interest.
In FY' 17, the agency issued 21 PRIA actions for public comment. Of those, 2 were for
antimicrobial pesticides, 9 were for biopesticides, and 10 were for conventional chemicals. For
additional information, please see https://www.epa.gov/pesticide-registration/public-
participation-process-registration-actions.
Antimicrobial Time Frames
Section 33(k)(2)(E) directs the EPA to review its progress in meeting the timeline requirements
for the review of antimicrobial pesticide products under section 3(h). The timeline requirement
under section 3(h) for substantially similar or identical products is 90 days. Under PRIA 3,
antimicrobial substantially similar or identical products fall under one of three fee categories,
A530, A531 and A532. PRIA 3 time frames were 4 months for an A530 and an A531 and 5
months for an A532. Of the 42 decisions in fee category A530 completed in FY' 17, 13 (31%)
were completed within 90 days and 29 (69%) were completed within the four month PRIA time
frame. There were zero decisions requiring negotiation of the due date or completed late. Of the
19 other substantially similar or identical products in fee categories A531 and A532, 18 (95%)
were completed within their PRIA time frames, 1 (5%) met its extended (renegotiated) due date,
and zero were late.
For new product decisions in fee category A540, the section 3(h) time frame is 180 days with a
goal of reducing the review time to 120 days. The PRIA 3 time frame for this category is 150
days. Of the 85 FY'17 decisions in this category, two (2.4%) were completed within 120 days
(met the reduced 3(h) time frame); 34 (40%) were completed between 121 days and 150 days
(met their original PRIA due date), 33 (38.8%) were completed between 151 days and 180 days
(met the section 3(h) time frame), and 16 (18.8%) were completed after 181 days but within
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their extended PRIA due date.
For new product decisions in fee category A550, the section 3(h) timeframe is 180 days with a
goal of reducing the review time to 120 days. The PRIA 3 timeframe is 210 days. Of the 3
FY'16 decisions in this category, zero were completed within 120 days; zero were completed
within 180 days (met the section 3(h) time frame), and 3 (100%) met their PRIA due date (<210
days).
Pesticide Incident Data System
Section 33(k)(2)(I) requires the EPA to report on progress in updating the Incident Data System
(IDS) and making the data available to the public. The EPA has made improvements in the
collection of and electronic recording of incident data received through FIFRA 6(a)(2) data as
well as from consumer reporting. The Office of Pesticide Program's (OPP) incident website
continues to be revised on an annual basis to better educate stakeholders on pesticide incidents
and to make it easier to report incident data to the EPA. The EPA is working with a variety of
organizations to improve incident data sharing (e.g., through EPA's continued cooperative
agreement with the National Pesticide Information Center at Oregon State University; via
quarterly incident meetings with Canada's Pest Management Regulatory Agency; via a
Memorandum of Understanding being developed with the US Fish and Wildlife Service; and
through FIFRA cooperative agreements with states). The EPA uses incident information when
developing risk mitigation options during the risk assessment process to ensure the continued
safe use of pesticide products. Also, trends in incident data can be used at any time to mitigate
potential emerging concerns. To help improve the timeliness of responses that may be needed
quickly, the EPA is implementing a process that will screen incidents as they come into the
Agency to identify those that may need immediate attention. Currently, the EPA provides
incident information to other federal agencies, states and EPA regions on a regular basis and
provides information to public inquiries through the FOIA process.
Sources of Pesticide Usage Data
Section 33(k)(2)(J) requires the EPA to summarize the sources of publicly available pesticide
usage data.
FEDERAL SOURCES
USDA Pesticide Usage Data Sources
 USDA National Agricultural Statistics Service (NASS): NASS conducts farmer
surveys to collect pesticide-usage data on major field (e.g., corn, cotton, and soybean),
vegetable, and fruit crops in states that account for the bulk of production of these crops.
These data are collected based on surveys and updated at various frequencies determined
by USDA.
https://www.nass.usda.gov/Survevs/Guide to NASS Survevs/Chemical Use/
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	Pest Management Strategic Plans: USDA produces Pest Management Strategic Plans
(PMSP) that focuses on pest-by-pest management practices for a crop in a state or region.
The usage information included in a PMSP is generally a qualitative narrative of current
and potential pest management practices, including the use of pesticides.
http://www.northeastipm.org/ipm-planning/pest-management-strategic-plans/
	Census of Agriculture: NASS also produces the USDA Census of Agriculture, which
consists of uniform, comprehensive data on agricultural production and operator
characteristics in each county and state, as well as the U.S. as a whole.
https://agcensus.usda.gov/Publications/2012/
	Crop Profiles: USDA produces Crop Profiles that provide information in narrative
format about crop production, cultural practices, and pesticide usage. Each Crop Profile
describes how a commodity is produced, with emphasis on critical pest management
needs - including the role of pesticides in integrated pest management (IPM) and
resistance management programs, http://www.northeastipm.org/ipm-planning/crop-
profiles/
United States Geological Survey (USGS) - http://water.usgs.gov/nawqa/pnsp/usage/maps/: USGS
provides pesticide-use maps showing the geographic distribution of estimated use on agricultural
land in the conterminous United States for numerous pesticides.
STATE SOURCES
California Department of Pesticide Regulation http://www.cdpr.ca.gov/docs/pur/purmain.htm:
California Department of Pesticide Regulation collects usage information by conducting a
pesticide-usage census in the state. Pesticide usage reports are published annually for all
agricultural uses and some non-agricultural uses.
New Jersey - http://www.ni.gov/dep/enforcement/pcp/pcp-pubs.htm Through collaboration
with Rutgers University, the New Jersey Department of Environmental Protection Pesticide
Control Program (NJDEP) collects pesticide use information from private applicators in New
Jersey. These surveys are typically conducted every three years.
New York - http://ai.psur.cornel!.edu/: In collaboration with Cornell University, the State of
New York collects Pesticide Use data from commercial applicators, who are required to report
each pesticide application, at least annually.
Oregon -
http://www.oregon.gov/ODA/shared/Documents/Publications/PesticidesPARC/Pesticideuserepor
tingsvstemAnnualreport2008.pdf: Due to state budget constraints, Oregon discontinued its
pesticide use surveys. However, pesticide usage statistics from 2006-2008 are available on the
website.
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PROPRIETARY SOURCES
Kynetec - https://www.kynetec.com/ Kynetec is a primary source of proprietary data for
agricultural crops. The data are widely used by government entities as well as industry. These
data are collected for a large range of row, vegetable, and fruit crops in the continental U.S.
and include insecticides, fungicides, herbicides, nematicides, and growth regulators used by
producers. Data are collected annually.
SIGMA-: SIGMA, a subsidiary of GfK, is the primary source for international pesticide usage
data for fruits and vegetables. SIGMA provides an annual global study that quantifies the
pesticide usage crop-by-crop and by target pest in more than 65 countries, http://www.iov-
consulting.com/sigmaCP Prospectus HY2014v2 10Qctober2014 Word.pdf
Kline and Company - http://www.klinegroup.com/: Kline provides non-agricultural pesticide
usage data profiles of various market segments including but not limited to consumers,
professional pest management, turf and ornamental, biopesticides, mosquito control and
industrial vegetation management by chemical type. Reports cover sales and use of pesticides in
these markets.
Number of PRIA Applications Pending at the End of FY 2017
Table IV summarizes the pending registration applications (counted as decisions) in each of the
PRIA categories as required by FIFRA Section 33(k)(2)(v). As of September 30, 2017, 1,613
decisions subject to PRIA were pending in the agency's registration queue. Numbers pending at
the end of FY' 15 and FY' 16 are shown for comparison and were, 1,330 and 1,173, respectively.
The number of antimicrobial decisions pending at the end of FY' 17 (171) was greater than
that at the end of FY'16 (152).
The number of biopesticide decisions pending at the end of FY' 17 (217) was greater than that at
the end of FY'16 (140).
The number of conventional pesticide decisions pending at the end of FY' 17 (1,019) was greater
than that at the end of FY' 16 (841).
The number of PRIA inert decisions pending at the end of FY' 17 (37) was greater than that at the
end of FY'16 (35).
The number of miscellaneous decisions pending at the end of FY' 17 (169) was more than that at
the end of FY' 16 (5).
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