US Environmental Protection Agency Office of
Pesticide Programs
SePRO's Petition to Establish a New 10-Year
Exclusive Use Period for Data Supporting New
Minor Uses
September 26, 2018
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MRID #50679106
Report Title:
Petition to Establish a New 10-Year Exclusive Use Period for Data Supporting New Minor Uses
Active Ingredient:
Fluridone
EPA Guideline:
None
Author(s):
Laurent C. Mezin, Ph.D.
SePRO Corporation
11550 N. Meridian Street
Suite 600
Carmel, IN 46032
Completion Date:
September 26, 2018
Sponsor/Submitter:
Laurent C. Mezin, Ph.D.
SePRO Corporation
11550 N. Meridian Street
Suite 600
Carmel, IN 46032
EPA Company Number 67690
Document Number:
SEPR0092018
Page 1 of 12
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STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality, on any basis whatsoever, is made for any information contained in
this document. I acknowledge that information not designated as within the scope of FIFRA
Section (10) (d) (1) (A), (B) or (C) and which pertains to a registered or previously registered
pesticide is not entitled to confidential treatment and may be released to the public, subject to the
provisions regarding disclosure to multinational entities under FIFRA 10(g).
COMPANY: SePRO Corporation
COMPANY
REPRESENTATIVE:
26 September 2018
Laurent C. Mezin, Ph.D.
Regulatory and Government Affairs Leader
Date
Page 2 of 12
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STATEMENT OF COMPLIANCE WITH GOOD LABORATORY
PRACTICE STANDARDS
This study was not conducted in accordance with the requirements of 40 CFR Part 160
and differs in the following ways:
This document is not a study, does not rely upon a test material and/or experimentation
and does not meet the definition of a study under 40 CFR Part 160.3, as there is not any test
material or experimentation.
Study Director: as this document is not a study and does not meet the definition of a
study there is not a study director.
AUTHOR /SPONSOR/SUBMITTER:
' i i"
26 September 2018
Laurent C. Mezin, Ph.D. Date
Regulatory and Government Affairs Leader
Page 3 of 12
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Contents
Executive Summary 5
Introduction 5
EPA Certification Statement Error! Bookmark not defined.
Current EPA Fluridone Regulatory Status 6
Basis for Minor Use Classification Request 6
FIFRA Minor Use-Acreage 7
Conclusion 7
Table 1. SePRO Corporation Fluridone EPA Registrations 8
Table 2. Fluridone Tolerances Established Under 40 CFR Part 180.420 9
References 12
Page 4 of 12
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SePRO Corporation
Sonar Technical (EPA Registration Number 67690-6)
Fluridone Technical (EPA Registration Number 67690-31)
Fluridone Technical (EPA Registration Number 67690-63)
Petition to Establish a New 10-Year Exclusive Use Period for Data
Supporting New Minor Uses
Products: Brake
EPA Registration Number 67690-78
Executive Summary
SePRO Corporation (SePRO) is petitioning the EPA to establish a new 10-year exclusive use
period for all data being submitted to support the use of fluridone on the following minor use
crops: avocado, pomegranate, pistachio, mandarin, and cherries/peaches/plums (stone fruit crop
group). Pursuant to FIFRA Section 3(c)(l)(F)(VI) a new 10-year exclusive use period can be
obtained for the minor use-specific data generated by a registrant to register a minor use after the
initial exclusive use period expires.
Introduction
Fluridone (1-Methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(l//)-pyridinone) was registered
with the EPA in 1986 as a new active ingredient for aquatic weed control, which is classified as a
minor use. This was the only EPA registered use for the active ingredient until the Agency
approved the use on cotton in 2016. SePRO acquired the active ingredient (including
registrations and the supporting database) from Dow Elanco in 1993 and became the primary
registrant. SePRO currently has three technical grade active ingredient (TGAI) fluridone
registrations and 17 typical end-use product (TEP) fluridone registrations. Please refer to Table 1
for a listing of all current SePRO registrations for products containing fluridone.
Fluridone (initially developed under the numbered compound code name of EL171) was initially
developed in the US as a potential cotton herbicide by Eli Lilly. This use was never submitted to
EPA due to economic reasons (i.e., it was too expensive to produce and sell in the cotton
market). Fluridone is a systemic herbicide used to manage aquatic weeds in ponds, lakes, and
other aquatic sites. It inhibits carotene synthesis, which causes the loss of chlorophyll. It is
typically applied to large-scale areas or the whole water body because it requires a contact time
of >45 days to be effective. It is highly regarded as having a very good safety profile and is one
of most widely used aquatic herbicides for large scale management of aquatic weeds in sensitive
environments. The EPA approved labeling allows for a single treatment of up to 90 ppb for a
whole pond and 150 ppb for lakes and other sites, with a maximum cumulative application of
150 ppb per growth cycle and up to 2 pounds per acre on dewatered aquatic sites. There are no
direct application food uses for fluridone; however, fluridone treated water can be used to
irrigate food crops and pastures and is approved for use in potable water up to 150 ppb. There are
Page 5 of 12
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a number of tolerances established under 40 CFR Part 180.420 (refer to Table 2 for a full listing
of the fluridone tolerances). The Agency reassessed the fluridone tolerances on September 20,
2004 (Tolerance Reassessment Document).
In 2016 the EPA approved the use of fluridone in cotton and granted the appropriate tolerances
under 40 CFR Part 180.420. Additionally, it granted a minor use determination and established a
new exclusive use period for this use under FIFRA 2(H)(2) (EPA, DP#423484).
The EPA is also in-process of completing Registration Review for fluridone. It is anticipated to
have a final decision in 2019.
Current EPA Fluridone Regulatory Status
Fluridone is currently registered with EPA as an aquatic and terrestrial herbicide.
Based upon the initial date of EPA registration for fluridone (1986), the initial data
(exclusive use and data compensation) for the original supporting data has expired,
above, the EPA established a new 10-year exclusive use period for data supporting
2016.
Basis for Minor Use Classification Request
FIFRA 2(11) defines "minor use" as follows:
"The term 'minor use' means the use of a pesticide on an animal, on a commercial
agricultural crop or site, or for the protection of public health where-
(1) The total United States acreage for the crop is less than 300,000 acres, as determined
by the Secretary of Agriculture; or
(2) The Administrator, in consultation with the Secretary of Agriculture, determines that,
based on information provided by an applicant for registration or a registrant, the use
does not provide sufficient economic incentive to support the initial registration or
continuing registration of a pesticide for such use and
A. There are insufficient efficacious alternative registered pesticides available for
the use;
B. The alternatives to the pesticide use pose greater risks to the environment or
human health;
C. The minor use pesticide plays or will play a significant part in managing pest
resistance; or
D. The minor use pesticide plays or will play a significant part in an integrated
pest management program."
The new proposed uses of fluridone on avocado, pomegranate, pistachio, mandarin, and
cherries/peaches/plums (stone fruit crop group) meets FIFRA 2(H)(1). All of the new crops meet
the definition of a minor use, based on US acreage less than 300,000 acres. The following
supports this conclusion.
protection
As noted
cotton in
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FIFRA Minor Use-Acreage
Based upon a review of USD A data each of the identified new uses meet the definition of a
minor use. Additionally, USDA data from the 2012 Census of Agriculture provides crop acreage
information for each of the crops of interest. The following table summarizes the 2012 crop
acreage in the USA. The data demonstrate that each of the crops of interest are well below the
minor use threshold of 300,000 acres:
Minor Use Crop
2012 Acreage1
Avocado
73,534
Pomegranate
32,887
Pistachio
232,653
Mandarin (also includes tangerine)
42,289
Cherries
155,029
Peaches
128,480
Plum
88,122
*USDA National Agricultural Statistics, 2012 Census of Agriculture, Crop Acreage
Based upon the above information, all new crops meet the definition of minor use.
Conclusion
Based upon FIFRA 2(H)(1) and the above information, SePRO confirms that use of fluridone on
avocado, pomegranate, pistachio, mandarin, and cherries/peaches/plums (stone fruit crop group)
meet the definition of a minor use. Pursuant to FIFRA Section 3(c)(l)(F)(VI) a new 10-year
exclusive use period can be granted for the data supporting the minor uses noted above. SePRO
requests that EPA issue a new 10-year exclusive use period for the submitted data to support
avocado, pomegranate, pistachio, mandarin, and cherries/peaches/plums (stone fruit crop group).
Page 7 of 12
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Table 1. SePRO Corporation Fluridone EPA Registrations
EPA Registration Number
Product Name
Percent Active Ingredient
67690-3
Sonar SRP/5P
5.0
67690-4
Sonar A.S.
41.7
67690-6
Sonar Technical
99.2
67690-12
Sonar X
5.0
67690-21
Sonar Q Quick Release
5.0
67690-30
Fluridone SC
41.7
67690-31
Fluridone Technical
99.2
67690-32
Fluridone SRP
5.0
67690-45
SonarOne
5.0
67690-48
Sonar Extra
3.79
67690-54
Sonar Genesis
6.3
67690-61
Sonar H4C
2.7
67690-63
Fluridone Technical
99.3
67690-64
WhiteCap SC
41.7
67690-65
WhiteCap RTU
3.79
67690-66
WhiteCap WDG
5.0
67690-73
Brake F2
17.26
67690-74
Brake FX Herbicide
6.3
67690-75
Brake F16 Herbicide
11.7
67690-78
Brake
13.76
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Table 2. Fluridone Tolerances Established Under 40 CFR Part 180.420
(a) General. (1) Tolerances are established for residues of the herbicide fluridone, including its
metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance
with the tolerance levels specified in this paragraph is to be determined by measuring only the
sum of fluridone, 1 -niethyl-3-phenyl-5-(3-(trifluoroniethyl )phenyl )~4( 1 //>-pyridinone, and its
bound residues, calculated as the stoichiometric equivalent of fluridone, in or on the commodity.
t
(Commodity
[Parts per million
Crayfish
Fish
0.5
(2) Tolerances are established for residues of the herbicide fluridone, including its metabolites
and degradates, in or on the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by measuring only fluridone, 1-
methyl-3-phenyl-5-(3-(tri 11 uorotnethyl )phenyl )-4( 1 //)-pyridinone, in or on the commodity.
(Commodity
'Parts per million
jCattle, fat
0.05
(Cattle, kidney
(Cattle, liver
Cattle, meat
[
0.05
i
JCattle, meat byproducts
j
0.05
|Cotton, gin byproducts
\
{Cotton, undelinted seed
|
Egg
0.05
Goat, fat
0.05
Goat, kidney
Goat, liver
!
Goat, meat
0.05
Goat, meat byproducts
0.05
Hog, fat
0.05
Hog, kidney
|
Hog, liver
|
Hog, meat
|
0.05
Hog, meat byproducts
|
0.05
Horse, fat
|
0.05
Horse, kidney
|
Horse, liver
iHorse, meat
0.05
jHorse, meat byproducts
|
0.05
Milk
|
0.05
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Poultry, fat
0.05
{Poultry, kidney
0.01
[Poultry, liver
0.01
{Poultry, me;
0.05
[Poultry, meat byproducts
0.05
[Sheep, fat
0.05
(Sheep, kidney
0.1
Sheep, liver
0.1
(Sheep, meat
0.05
jSheep, meat byproducts
0.05
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established for indirect or inadvertent
residues of the herbicide flu rid one, including its metabolites and degradates, in or on the irrigated
crop commodities and crop groupings in the table in this paragraph, resulting from use of
irrigation water containing residues of 0.15 parts per million following applications of fl undone
on or around aquatic sites. Where tolerances are established at higher levels from other uses of
fl undone on the crops in the table in this paragraph, the higher tolerance also applies to residues
in or on the irrigated commodity. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only fluridone, 1 -tnethyl-3-phenyl-5-(3-
(trifluoromethyl)phenyl)-4(li?)-pyridinone, in or on the commodity.
{Commodity
Parts per million
Animal feed, 11 on grass, group 18
0.15
[Avocado
0.1
(Berry, grou]
0.1
(Cranberry
0.1
Fruit, citrus, group 10
0.1
{Fruit, pome, groujT
0.1
Fruit, stone, group 12
0.1
Grain, cereal, forage, fodder and straw, group 16
0.1
Grain, cereal, group 15
0.1
Grape
0.1
Grass, forage
0.15
Hop, dried cones
0.1
Nut, tree, group 14
0.1
Okra
0.1
Stravvbeny
0.1
{Vegetable, brassica, leafy, group 5
0.1
[Vegetable, cucurbit, group 9
0.1
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(Vegetable, fruiting, group 8
I o.i
{Vegetable, leafy, except brassica, group 4
I
(Vegetable, leaves of root and tuber, group 2
1 0.1
[Vegetable, legume, group 6
I
[Vegetable, root and tuber, gro
o.i
[76 FR 23495, Apr. 27, 2011, as amended at 77 FR 66720, Nov. 7, 2012; 80 FR 18143, Apr. 3,
2015; 81 FR 7987, Feb. 17, 2016; 81 FR 72539, Oct. 20, 2016]
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References
USDA National Agricultural Statistics, 2012 Census of Agriculture, Crop Acreage.
Page 12 of 12
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