Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2014
Eleventh Annual Report
March 1, 2015

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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
Pesticide Registration Service Fees
Ś. " '	i ' " He grass in Meeting Decision Times
Number of PP : 'Śn Hons Completed ii h
The EPA counts "decisions," rather than registration applications, and each application package can require
more than one decision. 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 1,919 decisions subject to PRIA during FY' 14. In addition, 12 non-PRIA inert clearances,
which were submitted before inert clearances became a covered pesticide activity under PRIA 3, were also
completed during FY' 14 making the total number of completed decisions equal to 1,931. FY' 14 completions
represent a 7% decrease over the 2,084 decisions completed in FY' 13. This decrease is likely due to the
government shutdown in October 2013. Among the FY' 14 completed decisions, 287 (15% of total) were
antimicrobial decisions, 129 (7%) biopesticide decisions, 895 (46%) conventional pesticide decisions, 45 (2%)
inert clearances and 575 (30%) miscellaneous decisions. Table III titled "Number of PRIA Actions Completed
in FY 2011, 2012, 2013 and 2014" summarizes the number of decisions completed by each PRIA category
and compares the first two years under PRIA 3 (FY' 13 & FY' 14) with the last two fiscal years under PRIA 2
(FY'11 & FY' 12).
An additional 153 applications were withdrawn - a slight increase from the number withdrawn in FY' 13 (138
applications) but fewer than in FY' 11.
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' 14 nine
applications were rejected/withdrawn for significant "content" deficiencies. In FY' 13, FY12, and FY' 11, six,
four and eight applications, respectively, were rejected/withdrawn as a result of the 21-day content screen.
Second, the Preliminary Technical Screen 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' 14,
Preliminary Technical Screens were completed for 1,600 PRIA 3 submissions. 149 10-day deficiency letters
were sent out resulting in 49 applications being rejected or withdrawn. Nineteen conventional chemical
applications were withdrawn, and two applications were formally rejected. Ten antimicrobial packages were withdrawn,
and five were rejected. Twelve BPPD applications were withdrawn, and one was rejected.
Reasons for applications being rejected or withdrawn as a result of the Preliminary Technical Screen include:
- Not substantially similar;
Missing data;
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
Data deficiencies;
Inadequate acute toxicity data;
Uncleared inerts;
Waiver request for post-application exposure study denied;
Unacceptable bridging arguments;
Data matrix/data comp issues
- New AI rejected for inadequate characterization of the strain;
Rejected applications are not counted as completed decisions.
Number Decisions Completed in	Number Withdrawn in Fiscal Year
Fiscal Year
Type of Pesticide
2011
2012
2013
2014
2011
2012
2013
2014
Conventional
1074
1068
1039
895
121
95
87
89
Antimicrobial
346
333
329
287
24
18
43
34
Biopesticide
134
173
111
129
20
10
8
30
Inert


43
45


0
0
Miscellaneous


562
575


0
0
Total
1554
1574
2084
1931
165
123
138
153
The EPA completed 85 percent of all decisions on or before their original or extended PRIA due date. In
FY' 14, 292 decisions (out of 1,931 completed decisions) were late due to the government shutdown in October
2013 and the "short term strategy" implemented by EPA to reduce the backlog created by the shutdown.
Average Decision Times
The average decision time for each PRIA category, shown in Table III, is the number of days it took the agency
to complete a decision once the application was received and payment was made or a fee waiver or an
exemption was granted. The mandated time frame or decision review time-period changed from one fiscal year
to another as prescribed by statute and depends on the fiscal year in which an application was
received. Meaningful comparisons in average decision times can only be made for those fee categories with a
significant number of completed decisions. In comparison to FY' 13, average decision review times in FY' 14
seemed to increase across the board for new product submissions, most new active ingredient submissions,
tolerances and most amendment submissions. Exceptions to this across the board increase in average decision
review times would include several conventional new use category submissions, and an AD amendment
category submission where the average decision review times decreased. BPPD's major new active ingredient
category submissions remained almost the same (i.e., increased on average by only one day).
Due Date Extensions (Negotiated Due Dates)
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
Among the FY' 14 completions, we extended due dates for 340 decisions (17.6%) by mutual agreement with the
applicant. The percentage of decisions completed with due date extensions increased slightly in FY' 14 from
FY' 13 (17.6% vs 15%). Due to the government shutdown, FY' 14 renegotiation percentages are somewhat of a
special case. To deal with the backlog of PRIA actions which resulted from the two-week shutdown, OPP
eschewed renegotiating PRIA due dates in favor of utilizing that time and resource to reduce the backlog. This
was referred to as "the short term strategy". This strategy was in place from the middle of October 2013 to the
middle of January 2014. In addition to the cascading effects of the shutdown, extensions generally were
needed because of missing or deficient data or risk issues. In FY' 14 we extended due dates for 14.3%, 23.2%,
and 28.9% of completed antimicrobial, biopesticide, and conventional decisions respectively, while in FY' 13,
the percentages we extended were 22.2%, 30.6% and 19.7% respectively.
Number of Completed Decisions with Due Date Extensions Compared to Total Completed

FY 2011
FY 2012
FY 2013
FY 2014
Fee Category
Number
due date
extensions
Total
Number
due date
extensions
Total
Number
due date
extensions
Total
Number
due date
extensions
Total
Antimicrobial (A)
85
346
86
333
73
329
41
287
Biopesticide (B)
48
134
74
173
34
111
30
129
Conventional (R)
236
1074
235
1068
205
1039
259
895
Inerts
-
-
-
-
1
43
9
45
Miscellaneous
-
-
-
-
-
562
1
575
Total Decisions
369
1554
395
1574
313
2084
340
1931
As discussed previously, 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 decisions can only indicate trends from one fiscal year to another. To conduct a more detailed analysis,
the agency focused on primary decisions.
Number of Completed Primary Decisions with Due Date Extensions Compared to Total Completed

FY 2011
FY 2012
FY 2013
FY 2014
Fee Category
Due Date
Extensions
Total
Due Date
Extensions
Total
Due Date
Extensions
Total
Due Date
Extensions
Total
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
Antimicrobial (A)
70
292
71
304
64
285
41
256
Biopesticide (B)
31
112
43
136
16
88
19
106
Conventional (R)
153
880
127
800
109
797
159
678
Inerts
_
_
_
_
1
43
9
45
Miscellaneous
_
_
_
_
0
562
1
575
Total Decisions
254
1284
241
1240
190
1775
229
1660
If only primary decisions are considered, 13.8% had due date extensions in FY' 14 according to the agency's
tracking systems, an increase from the 10.7% in FY' 13. Of the primary decisions, due dates for 16% of
antimicrobial, 17.9% of Biopesticide, and 23.4% of conventional primary decisions were extended, in
comparison to 22.4%, 18.2% and 13.7% respectively in FY'13.
The following general types of decisions involved due date extensions in FY' 11 - FY' 14:
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
2011
21
111
154
64
-
-
19
369
2012
113
86
119
56
-
-
21
395
2013
40
103
92
49
1
0
28
313
2014
47
79
95
67
9
1
42
340
In FY' 14 80% of completed new active ingredient decisions required due date extensions; 40% of completed
new use decisions required due date extensions; 18% of completed new product decisions required due date
extensions; 16% of completed amendment decisions required due date extensions; 20% of completed inert
decisions required due date extensions; 38% of completed other (EUP, tolerance, protocol review, cancer
reassessment) decisions required due date extensions, and <1% 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
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
Fiscal
Year
New
Active
Ingredient
New
Uses
New
Products
Amendments
Inerts
Misc
Other (EUP,
tolerances,
protocols,
etc.)
Total with
Due Date
Extensions
2011
11
39
142
45
-
-
17
254
2012
36
30
115
43
-
-
17
241
2013
18
35
77
37
1
0
22
190
2014
14
28
87
53
9
1
37
229
In FY' 14 70% of completed, new active ingredient, primary decisions required due date extensions; 35% of
completed, new use, primary decisions required due date extensions; 17% of completed, new product, primary
decisions required due date extensions; 16% of completed, amendment, primary decisions required due date
extensions; 20% of completed, inert, primary decisions required due date extensions; 38.5% of completed,
other (EUP, tolerance, protocol review, cancer reassessment), primary decisions required due date extensions
and < 1% 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 2011
FY 2012
FY 2013
FY 2014
Type
Number
with
Extensions
Total
Number
with
Extensions
Total
Number
with
Extensions
Total
Number
with
Extensions
Total
New Active
Ingredient
1
3
3
4
4
4
0
1
New Uses
2
6
2
8
6
14
4
10
New Products
47
162
46
200
35
173
18
131
Amendments
15
106
11
81
11
80
9
95
Other (tolerances,
EUP protocols, etc.)
5
15
9
11
8
14
10
19
Total with
Extensions
70
292
71
304
64
285
41
256
In FY' 14 the percentage of antimicrobial primary decisions with a due date extension (16%) was down from
FY'13 (22.4%).
Biopesticides
Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of
Primary Decisions - Biopesticides
Fiscal Year	FY 2011	FY 2012	FY 2013	FY 2014
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014

Number

Number

Number

Number

Type
with
Extensions
Total
with
Extensions
Total
with
Extensions
Total
with
Extensions
Total
New Active
Ingredient
8
10
22
28
8
13
8
12
New Uses
5
7
2
2
0
0
1
14
New Products
11
48
14
65
6
41
7
51
Amendments
4
32
3
21
0
20
1
15
Other (tolerances,
EUP,protocols, etc.)
3
15
2
20
2
14
2
14
Total with Due Date
Extensions
31
112
43
136
16
88
19
106
In FY' 14 the percentage of biopesticide primary decisions with due date extensions (18%) was almost the same
as in FY'13 (18.2%).
Conventional
Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary
Decisions - Conventional Pesticides
Fiscal Year
FY 2011
FY 2012
FY 2013
FY 2014
Type
Number
with
Extensions
Total
Number
with
Extensions
Total
Number
with
Extensions
Total
Number with
Extensions
Total
New Active Ingredient
2
4
11
12
6
9
6
7
New Uses
32
60
26
69
29
75
23
56
New Products
84
524
55
449
36
443
62
323
Amendments
26
235
29
236
26
221
43
229
Other (EUP, tolerances,
protocols, etc.)
9
57
6
34
12
49
25
63
Total with Due Date
Extensions
153
880
127
800
109
797
159
678
In FY' 14 the percentage of conventional primary decisions with a due date extension (23%) increased
substantially from FY'13 (13.7%).
Note: Appendix A lists all applications subject to PRIA completed during FY' 14_with the decision time for
each decision.
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
Pubi ticipation 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' 14 the agency issued 20 PRIA actions for public comment, of those, 1 was an antimicrobial pesticide, 12
were biopesticides, and 7 were conventional chemicals. For additional information, please see
http://www.epa.gov/pesticides/regulating/registration-public~involvement.html.
Antimicrobial Tit irnes
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 39 decisions in fee category A530
completed in FY' 14, 10 (26%) were completed within 90 days and 20 (51%) were completed within the four
month PRIA time frame, and 9 (23%) were completed late. In comparison, of the 64 decisions in fee category
A530 completed in FY' 13, 20 (31%) were completed within 90 days, and 40 (63%) were completed within the
PRIA time frame and 4 (6%) met their extended (renegotiated) due dates. Of the 34 other substantially similar
or identical products in fee categories A531 and A532, 28 were completed within their PRIA time frames, one
met its extended (renegotiated) due date, and 5 were late.
For other new product decisions in fee categories A540, and A550, the section 3(h) time frame is 180 days with
a goal of reducing the review time to 120 days. Of the 58 FY' 14 decisions in these fee categories, 0 were
completed within 120 days; 38 (66%) were completed within 180 days; 10 (17%) were completed within their
extended PRIA due date, and 10 (17%) were late.
In response to the government shutdown in October 2013, the Agency eschewed renegotiating PRIA due dates
in favor of utilizing that time and resources to reduce the backlog created by the shutdown. This has been
referred to as the "short term strategy" which was in place from the middle of October 2013 to the middle of
January 2014. Consequently, the late completions described above should probably be considered in view of
this "short term strategy".
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
ticide Incident Data System
Section 33(k)(2)(I) requires the EPA to report on the progress in updating the Incident Data System and making
the data available to the public. The EPA has made improvements in the electronic recording of incident data
received through FIFRA 6(a)(2) data as well as from consumer reporting. Through the EPA's cooperative
agreement with the National Pesticide Information Center at Oregon State University, the more recently
established ecological and pet reporting portals have been successful in providing more detailed information
regarding incidents related to companion animals as well as bee kills from sources such as states, veterinarians,
bee keepers and wildlife rehabilitation facilities. The EPA uses this 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. EPA provides
this 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
USD A Pesticide Usage Data Sources http://www.nass.usda.gov/About NASS indcx.asp
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.
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.
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.
USGS - http://water.usgs.gov/nawaa/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/label/labelque.htm: California Department
of Pesticide Regulation collects usage information by conducting a pesticide-usage census in the state. Data collection is
annual for all agricultural uses and offers site-specific information.
New Jersey - http://www.pestmanagement.rutgers.edu/niinpas/pesticidesurvevs.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 conducted every three years.
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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014
New York - http://ai.psur.comell.edii/: 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/PesticideiisereportingsvstemAnmialreport
2006.pdf: Due to state budget constraints. Oregon discontinued its pesticide use surveys. However, pesticide usage
statistics from 2006-2008 are available on the website.
PROPRIETARY SOURCES
GfK Kynetec - http://www. gfk .com Pages/default.aspx: GfK 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- http://www.gfk.com/us/Pages/default.aspx: SIGMA, a subsidiary of GfK Kynetec, 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.
Kline and Company - http://www.klinegroup.com/: Kline usage data provides non-agricultural pesticide data profiles of
home/garden and professional usage by class/market segment and chemical. Reports cover professional pesticides and
fertilizers in the turf and ornamental markets.
Number of Ph.. ~ ^plications Pending at the End Ś '>
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, 2014 1,330 decisions subject to
PRIA were pending in the agency's registration queue. Numbers pending at the end of FY' 13 and FY' 12 are
shown for comparison and were, 1,102 and 1,143, respectively.
The number of antimicrobial decisions pending at the end of FY' 14 (159) was greater than that at the end of
FY'13 (136) but less than that at the end of FY'12 (184).
The number of biopesticide decisions pending at the end of FY' 14 (145) was greater than that at the end of
FY'13 (135) and FY'12 (110).
The number of conventional pesticide decisions pending at the end of FY' 14 (962) was greater than that at the
end of FY'13 (794) and FY'12 (875).
The number of PRIA inert decisions pending at the end of FY' 14 (51) was greater than that at the end of FY' 13
(22).
The number of miscellaneous decisions pending at the end of FY' 14 (13) was about the same as those pending
at the end of FY'13 (15).
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