/^Z^\ Status of Conditional
trfj	k f\
I 1 Registrations under FIFRA sec.
3(c)(7)(C) from 2000 to 2015
XJt PRO^^
May 2015

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received

Ammonium
Carbamate
AD
2/24/2014
Green Algae Toxicity Study
11/24/2014
49496201
In Review
10/24/2014

Bethoxazin
AD
6/6/2006
Fish Acute Toxicity Test, Freshwater and Marine
9/30/2006
46939003
Cancelled
9/20/2006
Cancelled July 2011
Daphnid Chronic Toxicity Test
9/30/2006
46969001
Cancelled
9/20/2006




90-Day Inhalation Toxicity
4/30/2007
Waiver Requested
Cancelled
N/A




Seedlinq Emerqence, Tier II
6/1/2008
47675201
Satisfied
2/13/2009




Veqetative Viqor, Tier II
6/1/2008
47675201
Satisfied
2/13/2009




Duckweed Study
6/1/2008
47675202
Satisfied
2/13/2009




Alqal Toxicity, Tiers I and II
6/1/2008
47675203
Satisfied
2/13/2009

Boric Acid
AD
9/27/2007
Fish Acute Toxicity Test, Freshwater and Marine
9/28/2008
47425202
Satisfied
5/15/2008

Mysid Acute Toxicity Test
9/28/2008
47425204
Satisfied
5/15/2008




Acute Embryo larvae
9/28/2008
47425201
Satisfied
5/15/2008




Green Alaqe Study
6/1/2008
47425203
Satisfied
5/15/2008




Whole Sediment Freshwater
9/28/2008
Waiver Requested
Waived
N/A




Whole Sediment Marine
9/28/2008
Waiver Requested
Waived
N/A




Leachinq Study
11/28/2008
Waiver Requested
Waived
N/A




Ready Biodeqradability
3/6/2010
48012102
Satisfied
3/5/2010




Sediment and Soil Adsorption/Desorption
Isotherm
3/6/2010
48012103
Satisfied
3/5/2010

Cetyi pyridinium
chloride
AD
3/5/2009
Activated Sludge Sorption Isotherm
3/6/2010
48012104
In Review
3/5/2010
2010 Studies Not Acceptable. New data
submitted in October 2013,under reivew
as of April 2014



Aerobic Deqradation
3/6/2010
48012105
Satisfied
3/5/2010




Alqal Toxicity, Tiers I and II
3/6/2010
48012106
Satisfied
3/5/2010




Activated Sludqe Sorption Isotherm
3/6/2010
48012107
Satisfied
3/5/2010




Bacterial Reverse Mutation Test
3/6/2010
48012108
Satisfied
3/5/2010




Mouse Carcinoqenicity Study
10/31/2009
47667001
Satisfied
2/9/2009




Skin Sensitization
10/31/2007
Waiver Requested
Waived
N/A




Hydrolysis
4/31/2007
47348101
Satisfied
2/15/2008

Copper
Carbonate, basic
(Polymeric
Betaine)


Aerobic Soil Metabolism
10/31/2007
47757601
Satisfied
5/22/2009



Avian Acute Oral
10/31/2007
46768502
Satisfied
2/24/2006

AD
10/31/2006
Fish Acute Toxicity Test, Freshwater and Marine
10/31/2007
Waiver Requested
Waived
N/A



Aquatic Invetebrate Acute Toxicity, Test,
Freshhwater Daphnids
10/31/2007
Waiver Requested
Waived
N/A




Other (fixation)
4/31/2007
47484102,47484101,
47497001
Satisfied
7/22/2008 and
8/5/2208




21/28-Day Dermal Toxicity
5/14/2004
47045101
Satisfied
2/1/2007




Surface residue wipe study
5/14/2004
46764002
Satisfied
2/21/2006




Fish Early-Life Staqe Toxicity Test
5/14/2004
46914401
Satisfied
8/18/2006




Fish BCF
5/14/2004
45834101
Satisfied
1/9/2003




Whole Sediment Acute Toxicity Invertebrates,
Freshwater
5/14/2004
45821701
Satisfied
12/20/2002

DDAC
AD
5/14/2003
Whole Sediment Acute Toxicity Invertebrates,
Marine
5/14/2004
45821702
Satisfied
12/20/2002

Honey bee toxicity study
5/14/2004
Waiver Requested
Waived
N/A




Seedlinq Emerqence, Tier II
5/14/2004
46375401
Satisfied
10/1/2004




Veqetative Viqor, Tier II
5/14/2004
46414501
Satisfied
12/1/2004




Aquatic Plant Toxicity Test using Lemna spp.
Tiers I and II
5/14/2004
46295804
Satisfied
6/16/2004




Anaerobic Aquatic Metabolism
5/14/2004
46124303
Satisfied
11/18/2003




Alqal Toxicity, Tiers I and II
5/14/2004
46295801
Satisfied
6/16/2004




Environmental monitorinq study
5/14/2004
46934201
Satisfied
9/14/2006




Seedling Emergence using rice (Oryza sativa),
TEP
6/1/2008
47675201
Satisfied
2/13/2009

6/1/2015
1 of 35

-------

Chemical
Divi&ion
Reg Notice Date
Conditional Data Reauirementfs)

MRID for Studv
Review Status
Date Data
Received
Comments



Tier II Vegative Vigor using rice (Oryza sativa)
TEO
6/1/2008
47675201
Satisfied
2/13/2009




Lemna qibba (duckweed) usinq TEP
6/1/2008
47675202
Satisfied
2/13/2009




Algal toxicity studies using TEP Anabaena flos-
aquae (blue-green cyanobacteria) Noavicula
pelliculosa (freshwater diatom) Skeletonema
cosatum (marine diatom)
6/1/2008
47675203, 47675204
Satisfied
2/13/2009

Fenpropimorph
AD
9/27/2007
Acute estuarine/marine fish
9/28/2008
47425202
Satisfied
5/15/2008




Acute Mvsid shrimp
9/28/2008
47425204
Satisfied
5/15/2008




Acute embryo larvae usinq E. oyster
9/28/2008
47425201
Satisfied
5/15/2008




Selenastrum capricornutum (green algae) using
TEP
6/1/2008
47425203
Satisfied
5/15/2008




Whole sediment acute freshwater invertabrates
usinq fenpropimorphic acid
9/28/2008
47425201
Satisfied
5/15/2008




Whole sediment acute marine invertabrates
usinq fenpropimorphic acid
9/28/2008
47425201
Satisfied
5/15/2008




Leachability of Wood Preservatives
11/28/2008
Waiver Requested
Waived
N/A

Glvcolic Acid
AD
71654-1
Registered conditionally but no data required
No Data Required
N/A
N/A
N/A

Listeria specific
bacteriophage
AD
6/18/2008
Additional efficacy data (Monitoring Plan)
Not specified
47242001
Satisfied
9/28/2007

Lonzabec
AD
5/20/2006
Storaqe Stability /Corrosion Characteristics
12/1/2006
46309707, 46309706
Satisfied
7/8/2004

Analytical Method
12/1/2006
46309707
Satisfied
7/8/2004

Potassium
Hypochlorite
AD
63838-10
Registered conditionally but no data required
No Data Required
N/A
N/A
N/A

Silver chloride
AD
3/28/2006
Enforcement Analytical Method
6/28/2006
46914401
Satisfied
8/18/2006




Phase 1 - Product Characterization








Particle Size Distribution
3/31/2012
48854401

6/6/2012




Surface Area
3/31/2012
48821601, 48957801
Satisfied
5/4/2012 and
10/25/2012




Phase 2 - Product Testing








Stability
3/31/2012
Waiver Request
4878801
Satisfied
4/2/2012




Storaqe Stability
3/31/2012
48788002
Satisfied
4/2/2012




Corrosion Characteristics
3/31/2012
48788002
Satisfied
4/2/2012




UV-Vis
3/31/2012
48878801
Satisfied
6/29/2012




Solubility
3/31/2012
48788003
Satisfied
4/2/2012




Phase 3 - Release Characteristics/Exposure








Dissolution Kinetics
6/28/2013
49141001
Satisfied
6/3/2013




Leachinq Test of Textile
5/31/2013
49165501
Satisfied
7/2/2013




Dermal Exposure-Indoor
3/31/2013

Waived
11/8/2012
Agency determined use of water-soluble



Inhalation Exposure-Indoor
3/31/2013

Waived
11/8/2012
packaging satisfied exposure testing



Attrition Test - Laundry Drying
3/31/2013

Waived

Agency determined Attrition Test no
longer needed based on water-soluble
packaging and the results of the
dissolution kinetics and textile leaching
studies (10/22/2013)



Phase 4 - Health Effects








90-Day Inhalation


Waived

No longer required based on water-
soluble packaging which greatly reduces
inhalation exposure.



90-Day Dermal Toxicity
6/30/2015

Pending

The textile leaching study indicated that
silver in the form of particulate (which
likely contains AGS-20 particles) was
released from surface coated textiles.



Reproduction/Developmental Toxicity Screening
Test


Pending

Required based on specific concerns for
sensitive organ targets including testes
and uterine lining
6/1/2015
2 of 35

-------
in vitro micronucleus (MN) assay
Phase 5 - Ecoloqic Effects
Avian Acute Oral Toxicity
Aquatic Invertebrate Acute Toxicity, Feshwater
Daphnids
Fish Acute Toxicity Test, Freshwater and Marine
Phase 6 - Characterization
UV-Vis
Particle Size Distribution
Surface Area
Solubility
Zeta-potential
Phase 7 - Health Effects
90-Day Oral Toxicity
90-Day Dermal Toxicity
Modified Reproduction/Developmental Toxicity
Screening Test
in vitro micronucleus (MN) assay
Phase 8 - Ecological Effects
Modified Aquatic Food Chain Transfer
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
t R. .ii 'li.itinn Statue

ID for S
Date Data
Chemical
Division
ReĢ Notice Date
Review Status
Pending
Pending
Pending
Pending
Pending
Pending
Pending
Pending
Pending
No longer reguired.
No longer reguired.
No longer required.
No longer reguired.
Pending
Required to define the potential
mutagenicity of the specific product
Waived for the purposes of hazard
labeling because of language on the label
but if nanosilver particles are found to be
attached or within aquatic plant cells in
the aquatic plant, Tier II study(ies), and/or
found within invertebrates in the chronic
whole sediment studies this study is
required for a waterfowl. Protocols are
required to be submitted prior to
conducting the study
The Agency determined a study with the
most acutely sensitive aquatic animal
species to silver, Daphnia magna, is
required to support risk assessment and
characterization based on results of the
textile leaching and dissolution kinetics
studies. Protocols are required to be
submitted prior to conducting the study.
Based on results of textile leaching study,
dissolution studies, and toxicity of other
nanosilvers, the Agency determined if the
acute freshwater invertebrate results with
AGS-20 and the nanosilver in AGS-20
demonstrate that their toxicity is
significantly more toxic than the other
nanosilvers used to support the risk
assessment data on an acutely sensitive
freshwater and an acutely sensitive
saltwater fish species are required to
confirm the risk assessment and
characterization findings. Protocols are
required to be submitted prior to
conducting the study.	
The textile leaching study indicated that
silver in the form of particulate (which
likely contains AGS-20 particles) was
released from surface coated textiles.
No longer required because the
dissolution kinetics and textile leaching
studies indicated that silver nanoparticles
were not released in sufficient amounts to
be of concern for human health.
If nanosilver particles are found to be
attached or within aquatic plant cells in
the aquatic plant, Tier II studies, and/or
found within invertebrates in the chronic
whole sediment studies this study is
required. Protocols are required to be
submitted prior to conducting the study.
6/1/2015
3 of 35

-------
Silver Nano
Particles
AD
12/1/2011
Terrestrial Plant Toxicity, Seedling Emergence
Aquatic Plant Toxicity, Tier II
Algal Toxicity, Tier II
Measuring the Chronic Effects of Freshwater
Sediment-Associated Contaminants on
Chironomus dilutes
Measuring the Chronic Effects of Freshwater
Sediment-Associated Contaminants on Hyalella
azteca
6/30/2015
6/30/2015
6/30/2015
6/30/2015
6/30/2015
\ Ļ 'i I'-'tinn Statue

ID for S
Cnemica
Conditional Data Reauirementlsl
Division
ReĢ Notice Date
Review Status
Pending
Pending
Pending
Pending
Pending
Based on results of the textile leaching
study, the dissolution studies, and toxicity
of other nanosilvers the Agency
determined if the nanosilver in AGS-20
with the green algae, Selenastrum
capricornutum, is significantly more toxic
than the other nanosilvers used to
support the risk assessment, a Tier II
(dose response) study with the rice, Oryza
sativa, with AGS-20 and the nanosilver in
AGS-20 is required to confirm the findings
of the risk assessment. Protocols are
required to be submitted prior to
conducting the study.	
Based on results of the textile leaching
study, the dissolution studies, and toxicity
of other nanosilvers the Agency
determined if the nanosilver in AGS-20
with the green algae, Selenastrum
capricornutum, is significantly more toxic
than the other nanosilvers used to
support the risk assessment, a Tier II
(dose response) study with the duckweed,
Lemna minor, is required to confirm the
findings of the risk assessment. Protocols
are required to be submitted prior to
conducting the study.	
Based on results of the textile leaching
study, the dissolution studies, and toxicity
of other nanosilvers the Agency
determined one Tier II (dose response)
study conducted with the green algae, S.
capricornutum, is required to confirm the
findings of the risk assessment. If the Tier
II S. capricornutum result is significantly
more toxic than value used in risk
assessment data on the freshwater and
saltwater diatoms (Navicula pelliculosa
and Skeletonema costatum) and the
cyanobacterium (Anabaena flos-aqua) is
also required.	
Based on results of the textile leaching
study and the dissolution studies the
Agency determined this study is required
to confirm the findings of the risk
assessment. The more toxic of the end
use product (AGS-20) or the nanosilver
from the Hyalella azteca study is the
required test substance. Protocols are
required to be submitted prior to
conducting the study.	
Based on results of the textile leaching
study and the dissolution studies Agency
determined study is required to confirm
the findings of the risk assessment.
Protocols are required to be submitted
prior to conducting the study.	
6/1/2015
4 of 35

-------
Chemical
Division
Ren Notice Date
Conditional Data Requirement(s)

MRID for Studv
Review Status
Date Data




Measuring the Chronic Effects of Marine and
Estuarine Sediment-Associated Contaminants
on Leptocheirus plumulosus
6/30/2015

Pending

Based on results of the textile leaching
study and the dissolution studies Agency
determined study is required to confirm
the findings of the risk assessment. The
more toxic of the end use product (AGS-
20) or the nanosilver from the Hyalella
azteca study is the required test
substance. Protocols are required to be
submitted prior to conducting the study.



Phase 9 - Environmental Fnte








Rate of Aggregation
6/30/2015

Pending

Required to determine the rate at which
the product aggregates or deaggregates
in the aqueous medium (when the
product dissolves in an aqueous medium)



Activated Sludge Sorption Isotherm
6/30/2015

Pending

Required to determine the effect of AGS-
20 and the nanosilver in AGS-20 on
microbes present in wastewater sludge



Adsorption/Desorption
6/30/2015

Pending

Required to determine the rate AGS-20
and the nanosilver contained in AGS-20
binds to sediment and soils. (If AGS-20 or
nanosilver in AGS-20 does not bind
strongly, it will migrate into ground water
with a possibly of ground water
contamination or if it binds strongly it will
result in benthic invertebrate exposure.)



Leaching Studies (Soil Column Tests)
6/30/2015

Pending

The Agency determined that the
Adsorption/ Desorption (Soil) study can
be conducted to provide information on
both partitioning to solids and mobility in
subsurface environment and therefore
waives this study.



Modified Activated Sludge, Respiration Inhibition
Test for Sparingly Soluble Chemicals
6/30/2015

Pending

Required to determine if AGS-20 and the
nanosilver in AGS-20, which is not highly
water soluble, has adverse effects on the
microbes present in the activated sludge
Tolylfluanid
AD
12/30/2007
Monitoring Study
3/1/2008
48071901
Cancelled
4/22/2010
Voluntary cancellation requests for all
registered tolylfluanid products were
received and should post in the February
FR.
Trimethoxysilyl
quat
AD
11/22/2006
Developmental Toxicity Study (to remove
production cap of 10,000lbs)
1/31/2008
47449001
Satisfied
6/17/2008



Enforcement Analytical Method
6/21/2007
47148601
Satisfied
6/7/2007

Aspergillus
BPPD
6/24/2003
1. Efficacy (Texas)
6/24/2006
46859502
Satisfied
6/15/2006

flavus AF36


2. 5-batch analysis
6/24/2006
46859501
Satisfied
6/14/2006

Aspergillus
flavus NRRL
21882
BPPD
5/28/2004
1. Analysis and certified limits
11/28/2006
47008702
47189202 47349302
47364501
Satisfied
12/18/2006
7/26/2007
2/19/2008
3/6/2008




2. Product identity and composition
11/28/2006
47008702 47364501
Satisfied
12/18/2006
3/6/2008




3. Storage stability
11/28/2006
47364501 47349302
Satisfied
2/19/2008




4. Efficacy
Not specified
47008701 47189201
47299401
Satisfied
12/18/2006
7/26/2007
12/6/2007

6/1/2015
5 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)
6/20/2001
MRID for Studv
45206101
Review Status
Date Data
Comments
, > - r-
BPPD
6/20/2000
1. Manufacturing process (upgrade submitted
study; includes 5-batch analyses and quality
control to limit microbial impurities)


Bacillus subtilis
QST 713
Satisfied
9/11/2000

2. Freshwater fish toxicity/pathoqenicity
6/20/2001
45455202
Satisfied
7/17/2001
3. Freshwater aquatic invertebrate
toxicity/pathoqenicity
6/20/2001
45455203
Satisfied
7/17/2001
4. 30-day toxicity/pathoqenicity in qrass shrimp
6/20/2001
45455204
Satisfied
7/17/2001
5. Non-tarqet insect - parasitic Hymenoptera
6/20/2001
45455205
Satisfied
7/17/2001
6. Honeybee study
6/20/2001
46172901 46172902
Satisfied
1/14/2004
7. Storaqe stability
6/20/2002
45188101
Satisfied
9/11/2000
Beauveria
bassiana strain
447
BPPD
9/27/2002
5-batch analysis
6/30/2004
46480601
Satisfied
8/29/2005

Beauveria
bassiana strain
HF23
BPPD
12/27/06
1. 5-batch analysis
6/27/2008
47345701
Satisfied
2/14/2008

2. Certification of limits
6/27/2008
47345701
Satisfied
2/14/2008
3. Unintentional inqredients
6/27/2008
47345701
Satisfied
2/14/2008
4. Human pathoqens
6/27/2008
47345701
Satisfied
2/14/2008
5. Storaqe stability
6/27/2008
47779201
Satisfied
6/16/2009
6. Viability data
6/27/2008
47345701
Satisfied
2/14/2008
Calcium lactate
BPPD
2/15/2008
Efficacy
2/15/2009
N/A
Cancelled
N/A
Registration of product with this active
ingredient was cancelled on 9/3/2010.
Chenopodium
ambrosoides var.
BPPD
6/30/2010
1. Storaqe stability
6/30/2015

Pending

Due date for submission of storage
stability data extended to 6/30/2015.
2. 5-batch preliminary analysis
6/30/2011
49061001 49061002
In Review
2/21/2013
Chondrostereum
purpureum
BPPD
9/23/2004
5-batch analysis
Not specified
46702401
Satisfied
12/5/2005

Coat Protein Gene
of Plum Pox Virus
BPPD
5/7/2010
Independent laboratory validation of analytical
method
5/7/2011
4828401
Satisfied
11/3/2010

Coddling moth
virus
BPPD
6/20/2001
Cell culture study
6/30/2003
45650901
Satisfied
4/11/2002

Corn qluten meal
BPPD
9/4/2002
Storaqe stability
3/4/2003
45870101
Satisfied
3/4/2003

COT102 x
COT67B
(Vip3Aa19 x
FLCrylAb)
BPPD
6/26/2008
1. Independent laboratory validation of analytical
method
5/1/2009
47743201
Satisfied
5/1/2009

2. 7-14 day Daphnia or aquatic invertebrate
dietary study
5/1/2009
47779101 47779102
Satisfied
6/16/2009
3. Baseline susceptibility and diagnostic
concentration determinations for major cotton
pests
1/31/2009
47662801
Satisfied
2/2/2009
CrylF in corn
BPPD
5/18/2001
1. Soil degradation study (field)
Not specified
47120701
Satisfied
5/2/2007

2. Confirmatory Monarch butterfly data
Not specified
45759701
Satisfied
9/18/2002
CrylF (Event 281)
and CrylAc
(Event 3006) Bt in
cotton1
BPPD
9/30/2004
1. Data supporting natural refuge as alternate
host to Cotton Bollworm (CBW)
7/31/2005
46610301 46909901
47019301
Satisfied
8/1/2005
8/10/2006
12/29/2006

2. Baseline susceptibility data and discriminating
dose of toxins for Tobacco Budworm (TBW) and
CBW
9/1/2005
46938701 47223501
Satisfied
1/31/2005
9/21/2006
9/5/2007
3. Avian chronic exposure study
9/30/2008
Waiver requested
Waived
4/7/2006
4. Non-target insect study (minute pirate bug)
9/30/2008
47462301
Satisified
7/1/2008
5. Soil fate/terrestrial expression studies for long
range soil persistence
Not specified
47214501
Satisfied
8/27/2007
Cry2Ab2 in cotton
BPPD
6/14/2002
1. Heat stability study
6/30/2003
45086303
Satisfied
4/7/2000

2. Confirmatory soil degradation study
6/30/2003
45806601
Satisfied
11/25/2002
3. Avian oral toxicity
6/30/2003
45086316 45086317
Satisfied
4/7/2000
4. Ladvbeetle larval data
6/30/2003
45086311
Satisfied
4/7/2000
6/1/2015
6 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)
2/13/2005
MRID for Studv
Review Status
Date Data
Comments
45943801 46186501
46262701 46725901
46949101
Received
, > - r-
BPPD
2/24/2003
1. Insect resistance management/pest biology
research data
' .. i 1. . .

Cry3Bb1 (Event
MON 863)
Satisfied
5/29/2003
2/4/2004 5/4/2004
12/12/2005
10/4/2006

2. Expression data
2/24/2005
46479902
Satisfied
2/25/2005
3. Field deqradataion studies
2/24/2005
46510301
Satisfied
3/31/2005
4. Laboratory toxicity data for 2 species of non-
tarqet beetles
2/242005
46479904 46479905
Satisfied
2/25/2005
5. 3-year full-scale or semi-field studies - non-
tarqet invertebrates
Not specified
46262702 46262703
46394202
Satisfied
5/4/2004
11/1/2004
6. 6-week broiler dietary study
Not specified
45941501
Satisfied
5/23/2003
Cry3Bb1 (Event
MON 88017)
BPPD
12/13/2005
1. Insect resistance management/pest biology
research data
Not specified
45943801 46186501
46262701 46725901
46949101
Satisfied
5/29/2003
2/4/2004 5/4/2004
12/12/2005
10/4/2006
The registration of this active ingredient
required that the conditional data
requirements for Cry3Bb1 (Event MON
863) must be satisfied.
2. Expression data
Not specified
46479902
Satisfied
2/25/2005
3. Field deqradataion studies
Not specified
46510301
Satisfied
3/31/2005
4. Laboratory toxicity data for 2 species of non-
target beetles
Not specified
46479904 46479905
Satisfied
2/25/2005
5. 3-year full-scale or semi-field studies - non-
tarqet invertebrates
Not specified
46262702 46262703
Satisfied
5/4/2004
6. 6-week broiler dietary study
Not specified
45941501
Satisfied
5/23/2003
Cry34Ab1 and
Cry35Ab1
(Cry34/35Ab1)
BPPD
8/31/2005
1. Laboratory toxicity data for 2 species of non-
tarqet beetles
8/31/2007
46714101 47436701
Satisfied
12/20/2005
6/3/2008
This registration will expire 9/30/2015.
2. 3-year full-scale field or semi-field studies -
non-tarqet invertebrates
9/30/2009
47870301
Satisfied
9/28/2009
3. 3-year field degradation study
1/31/2010
47959501
Satisfied
1/21/2010
Cydia pomonella
Granulosis Virus
BPPD
7/17/2000
1. Manufacturing process
7/17/2002
N/A
Cancelled
N/A
Registrations of products with this active
ingredient were cancelled on 7/14/2010.
2. Analysis of Samples
7/17/2002
N/A
Cancelled
N/A
3. Product identity
7/17/2002
N/A
Cancelled
N/A
4. Certification of limits
7/17/2002
N/A
Cancelled
N/A
5. Acute Intraperitoneal toxicity/pathogenicity
study
7/17/2002
N/A
cancelled
N/A
eCry3.1Ab (Event
5307)
BPPD
7/31/2012
1. Plant-based diagnostic assay report
By 2014
49048901, 49049001
In Review
1/31/2013
Item 2 not submitted by due date.
Syngenta committed to 1/2015
submission. Item 3 extension requested
and granted to submission date.
2. Corn rootworm baseline susceptibility data
7/31/2014
49559102
In Review
1/30/2015
3. Data to address cross-resistance potential
with Cry3Bb1 and Cry34/35Ab1
7/31/2014
49492501
In Review
10/20/2014
German
Cockroach
Pheromone
BPPD
9/23/2004
5-batch analysis
8/1/2005
46469401 46539801
Satisfied
2/14/2005
5/4/2005

Harpin proteins
BPPD
4/19/2000
1. Freshwater invertebrate pathogenicity
4/19/2001
45380401
Satisfied
4/17/2001

2. 5-batch analysis for survival of Harpin-
producing E. coli in end-prodct and quatitation of
human pathoqens
4/19/2001
45380402
Satisfied
4/17/2001
3. Sample media without antibiotics to detect
bacterial contamination
4/19/2001
45380402
Satisfied
4/17/2001
4. PCR-based amplification to detect/estimate
residual plasmid in end-product
4/19/2001
45380403
Satisfied
4/17/2001
Metarhizium
anisoptiae F52
BPPD
6/6/2003
1. Manufacturinq process - upqrade
1/30/2011
48058801
Satisfied
4/12/2010

2. Formation of unintentional ingredients -
upqrade
1/30/2011
47880601 48177001
Satisfied
10/9/2009
8/6/2010
3. Freshwater Fish Testing - repeat
1/30/2011
Waiver requested
Waived
12/9/2004
1/14/2008
4. Product identity - upqrade
1/30/2011
47123901
Satisfied
5/4/2007
6/1/2015
7 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received

MIR162
BPPD
11/26/2008
1. Analytical method validation
11/1/2009
N/A
Satisfied
6/15/2009

(Vip3Aa20)


2. 7-14 day Daphnia study or aquatic
invertebrate dietary study
11/1/2009
47779102
Satisfied
5/1/2009

MIR 604 (mCry3A)
BPPD
10/3/2006
1. 3-year field degradation study
1/31/2011
Waiver requested
Waived
N/A




2. 3-year full-scale field or semi-field studies -
non-tarqet invertebrates
1/31/2011
48285801
In Review
11/4/2010

MOCrylF (Event
DAS-06275-8)
BPPD
5/27/2005
1. Independent laboratory validation of analytical
method
Not specified
46656101
Satisfied
10/3/2005
Registration of products containing this
active ingredient will expire 9/30/2015.


2. Confirm moCrylF protein levels in soil under
range of conditions typical for Bt corn cultivation.
3/15/2008
47120702
Satisfied
5/7/2007




3. Confirmatory non-tarqet insect field data
3/15/2008
46784601
Satisfied
3/15/2006

MON 89034
(Cry1A.105 and
BPPD
6/10/2008
1. 7-14 day daphnia study or aquatic
invertebrate dietary study
4/1/2009
47838801
Satisfied
8/27/2009

Cry2Ab2)


2. Info on cross-resistance of Cry1A.105, CrylF
and
CrylAc for target pests, and
impact on the durability of MON 89034
4/1/2009
47838801
Satisfied
8/27/2009












3. Sweet Corn: baseline susceptibility studies of
major pests
4/1/2009
47791201 47791202
47791203
Satisfied
7/14/2008
6/30/2009
6/30/2009




4. Sweet corn: baseline Fall Army Worm
susceptibility studies to the 2 proteins
4/1/2009
48588801 48588802
48588803
Satisfied
8/30/2011




5. Analytical method validation, including
reaqents/methodoloqy
4/1/2010
47731601
Satisfied
4/22/2009

Muscador albus
BPPD
9/22/2005
1. 5-batch analysis
Not specified
47526001
Cancelled
9/2/2008
Registrations of products with this active



2. Storaqe stability
9/1/2008
47526002
Cancelled
9/2/2008
ingredient were cancelled on 10/4/2010.



2. Acute inhalation toxicity
1/31/2007
47043801
Cancelled
1/31/2007

Nuclear
Polyhedrosis Virus
of Anagraphs
falcifera
BPPD
8/92002
Analysis of samples
1/8/2003
46228201
Satisfied
3/22/2004

Oil of Black Pepper
and Piperine
BPPD
3/18/2004
Storage stability
12/1/2005
46717901
Satisfied
12/27/2005

Paecilomyces
lilacinus strain
251
BPPD
3/30/2005
Acute intraperitoneal toxicity pathogenicity study
9/30/2006
46950401 47197501
Satisfied
8/6/2007




1. Analysis of Samples
5/1/2011
48453101
Satisfied
4/14/2011
Product identity requirement will be



2. Manufacturinq process
10/1/2009
47885301
Satisfied
10/16/2009
satisfied when the microorganism
Pasteuria usgae
BPPD
6/2/2009
3. Storaqe Stability
6/1/2010
48196201
Satisfied
8/17/2010
classification is determined by the



4. Product Identity
When organism is
classified
N/A
In review
N/A
International Committee for Systematic
Bacteriology.
Pseudomonas
chloroaphis
BPPD
9/28/2001
1. Data demonstrating production of
siderophores
6/28/2004
46615902 46766902
Cancelled
8/4/2005
2/23/2006
This registration containing this active
ingredient was cancelled on 7/22/2013.
strain 63-28


2. Growth and survival of microbe at 10-25°C
6/28/2004
46615901 46615901
Cancelled
8/4/2005
2/23/2006

Pseudozyma
flocculosa strain
PF-A22
BPPD
9/20/2002
1. Confirmatory pulmonary toxicity/pathogenicity
study
10/3/2003 7/1/2005
4/1/2006 9/20/2006
6/1/2007 10/31/2007
10/31/2008
N/A
Cancelled
N/A
Registrations of products with this active
ingredient were cancelled on 7/15/2011.



2. Storage stability
10/3/2003 7/1/2005
4/1/2006 9/20/2006
6/1/2007 10/31/2007
10/31/2008
N/A
Cancelled
N/A




3. Certificates of Analysis
Not specified
N/A
Cancelled
N/A

6/1/2015
8 of 35

-------
Chemical
Division
Ren Notice Date
Conditional Data Requirement(s)

MRID for Studv
Review Status
Date Data
Comments
Trypsin
modulating
oostatic factor
(TMOR
BPPD
5/24/2004
Storage Stability
5/24/2006
N/A
Cancelled
N/A
Registrations of products with this active
ingredient were cancelled on 7/21/2005.
Xanthomonas
campestris pv
vesicatoria and
Pseuodomonas
syringae pv
tomato (2 active
innrpHipntc)
BPPD
12/9/2005
PCR-based screen maintain/report QA/QC
6/9/2006
46887301
Satisfied
6/12/2006
Registrationsof products with this active
ingredients requires ongoing QA/QC data
to be submitted to EPA whenever
requested. All other conditions of
registration are satisfied.
Quillaja
saoonaria extract
BPPD
7/14/2007
Product performance (efficacy)
7/15/2010
47645201 to
47645212 48151401
Satisfied
1/15/2009
7/15/2012

Trichoderma
harzianum strain
BPPD
5/25/2000
1. Efficacy of PCR-RAPD protocol for strain
identity
8/25/2000
N/A
Cancelled
Not submitted
Registrations of products with this active
ingredient were cancelled on 7/21/2005.
T-39


2. 5-batch analysis
5/25/2001
N/A
Cancelled
Not submitted




3. Freshwater invertebrate study verification
Not specified
44890101
Cancelled
8/23/2000




4. Plant-pathoqenicity
Not specified
N/A
Cancelled
Not submitted




5. Non-tarqet insect (Ladybird beetle)
Not specified
N/A
cancelled
Not submitted




6. Upgrade honeybee study
5/25/2001
45244001
Cancelled
9/22/2000

(Z,E)-9,12
Tetradecadien-1-
vl acetate
BPPD
3/13/2006
Storage stability
9/13/2007
48830401
Satisfied
5/17/2012
The conditions of registration are
satisfied.
Z,Z-3,13-
BPPD
4/20/2006
Storage stability
10/20/2007 2/28/2014
49313401
Satisfied
2/6/2014
New registration notice mailed to
Octadecadien-1 -ol


Corrosion characteristics
10/20/2007 2/28/2014
49313401
Satisfied
2/6/2014
registrant 9/25/2014



1 .Freshwater invertebrate (Daphnia) study
9/26/2004
46372101
Satisfied
9/29/2004

Acequinocyl
RD
9/26/2003
2. Acute sediment toxicity test for freshwater
invertebrates for the major metabolite,
deacetylated acequinocyl; pending results on
freshwater invertebrates, the test for sediment
dwelling estaurine/marine invertebrates may be
required. If required, it is to be submitted within 1
year of the date of the Agency's notification to
company
9/26/2004
46372101
Satisfied
9/24/2004




3. Acute toxicity study for the deacetylated
acequinocyl using fish (rainbow trout; or bluegill
sunfish)
9/26/2004
46370502
Satisfied
9/24/2004




4. Acute toxicity study for the deacetylated
acequinocyl using an aquatic invertebrate using
daphnids or mysids as the test species
9/26/2004
46372101
Satisfied
9/24/2004




Storage stability and corrosion characteristics
9/26/2005
46372101
Satisfied
8/5/2005

Acetaminophen
RD
3/21/2003
Conditionally registered but no data
requirements
N/A
N/A
N/A
N/A




Storaqe Stability Data for Rotational Crops
3/5/2004
46729102
Satisfied
1/12/2006

Acetamiprid
RD
3/5/2002
Radio validation data for IM-2_1 amide in
ruminant muscle
8/5/2002
Waiver Rquested
Waived
12/17/2002
Waiver requested on 12/17/02. Data
indicate that residues of IM-2-1 amide in
ruminant muscle can be estimated by
applying a 10-fold factor to residues of IM-
2-1 in muscle. Submission of these data
would result in the use of empirical data in
risk assessments and removal of the 10-
fold factor used to estimate residues of IM
2-1.



Avian Reproduction
3/5/2003
46369201 46555601
Satisfied
6/16/2003




Acute Aquatic Invertebrate
3/5/2003
45932501 45916201
49034202
Satisfied
5/14/2003;01/09/2
013

6/1/2015
9 of 35

-------
Chemical
Division
Reg Notice Date
Conditional Data Reauirementfs)

MRID for Studv
Review Status
Date Data
Comments m,



Freshwater Fish Early Life-Stage
8/5/2002
n/a
Satisfied
n/a
Decision made that no further data are
required.



Toxicity of Foliar Residue to the Honey Bee
3/5/2003
45932505 45932504
Satisfied
5/14/2003




Tier II Phototoxicity, Veqetative Viqor - Lettuce
3/5/2003
46229602 46229601
Satisfied
2/10/2004




1. Developmental neurotoxicity study in rats
8/11/2002
46046401
Satisfied
7/3/2003




2. Subchronic neurotoxicity study in rats
8/11/2002
45713601
Satisfied
7/11/2002

Acibenzolar-s-
methyl
RD
8/11/2000
3. Mutagenicity study (Ames assay) with
technical-grade acibenzolar-s-methyl (prepared
by a new "thiazole" production process)
8/11/2002
48490001 48490002
48490003
Satisfied
5/24/2011



4. Soil photolysis study
8/11/2001
45434103 45434104
In Review
6/20/2001
Upqrade



5. Aerobic soil metabolism study
8/11/2001
45434103 45434104
In Review
6/20/2001
Upqrade



6. Aerobic aquatic metabolism study
8/11/2001
45434103 45434104
In Review
6/20/2001
Upqrade



7. One of two Batch equilibrium study
8/11/2001
45434103 45434104
In Review
6/20/2001
Upqrade
Alpha-Chlorhydrin
RD
12/7/2006
Registered conditionally but no data required
N/A
N/A
N/A
N/A




1. Storaqe Stability
8/30/2011
48372401
Satisfied
2/1/2011




2. Corrosion Characteristics
8/30/2011
48372401
Satisfied
2/1/2011




3. 5-batch analysis from commercial-scale
production of product,
8/30/2011
48720201;48720202
Satisfied
1/18/2012

Aminocyclopyrac
hlor
RD
8/30/2010
4. Repeated dose in sensitive species to
address chronic exposure
8/30/2012
48830801
In Review
5/17/2012
90 Day Oral Gavage Study in Rats with
Deqradate IN-V097.



5. Avian Reproduction
8/30/2012 10/1/2016
48333632;48333633
In Review
1/25/2011
new waterfowl study needed



6. Freshwater Invertebrate Life Cycle Toxicity
Study
8/30/2012
48576201
In Review
8/11/2011




1. Nature of the residue-Plants
no date specified
49133501
Satisfied
5/23/2013




2. Nature of the residue-Livestock
no date specified
48237521
In Review
10/5/2010




3. Residue Analytical Methods
no date specified
48237521
In Review
10/5/2010




4. Storaqe stability
no date specified
48612001
Satisfied
9/29/2011




5. Meat, poultry and eggs - poultry feeding study
no date specified
49135508
In Review
5/23/2013
Waiver submitted



6. Crop field trials
no date specified
49133502 49133503
In Review
5/23/2013




7. Field accumulation in rotational crops
no date specified
49135504-07
In Review
5/23/2013




8. Acute Avian Dietary (Quail)
no date specified
48237511
Satisfied
10/5/2010




9. Avian reproduction
no date specified
48237512,48237513,
48237514,48237515
Not Satisfied
10/5/2010
48237512, 48237514,48237515 satisfied;
48237513 needs to be repeated.



10. Aquatic Invertebrate Life Cycle - Saltwater
no date specified
48407503
Satisfied
3/8/2011




11. Aquatic invertebrate life cycle
no date specified
48071501
Satisfied
4/22/2010

Amicarbazone
RD
10/4/2005
12. Tier II vegetative vigor
no date specified
48237518,48237519,
48237520
Satsified
10/5/2010




13. Tier II seedling emergence and vegetative
viqor
no date specified
48237516,48237517
Satisfied
10/5/2010




14. Aerobic soil metabolism
no date specified
48237507
Satisfied
10/5/2010




15. Aerobic water/sediment metabolism
no date specified
48237508
Not Satisfied
10/5/2010
Study needs to be repeated



16. Hydrolysis for degradates
no date specified
48073601 48237506
Satisfied
4/26/2010,
10/5/2010




17. Aerobic soil metabolism fro Des-amino, N-
methyl des-amino.
no date specified
48407501 48407502
Satisified
3/8/2011




18. Analytical reference standards to the EPA
National Pesticide Standards Repository: DA
amicarbazone, iPr-2-OH DA Amicarbazone,
aminocarbazone-d9, iPr-2-OH DA amicarbazone-
d6.
no date specified

Not Satisfied





19. Fish early life staqe
no date specified
48237510
Satisfied
10/5/2010




1. Completed enforcement method of analysis to
show that the analytical method differentiates
between aminoyralid, picloram and clopyralid
no date specified
46729001
Satisfied
1/12/2006

nn Status
6/1/2015
10 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




2. The completed enforcement method to EPA
Fort Meade Laboratory for validation
no date specified
46729000
Satisfied
1/12/2006

Aminopyralid
RD
8/10/2005
3. Storage stability data for grass forage and hay
reflecting up to approximately 15 months of
frozen storaqe
no date specified
46661301
Satisfied
10/11/2005




4. Repeated Aerobic Soil Metabolism Study
no date specified
47911201
Satisfied
11/13/2009




5. Repeated Avian Reproduction study in
bobwhite quail
no date specified
47109901
Satisfied
4/20/2007




6. Repeated Tier II Aquatic Plant Growth: Blue-
qreen alqae, Anabaena flos aquae
no date specified
47109902
Satisfied
4/20/2007

Indaziflam
RD
7/26/2010
1. Estuarine/Marine Invertebrate Life Cycle
7/26/2012
49073301
In Review
70/1/2013

2. Avian reproduction study on Mallard duck
7/26/2012
48892801
In Review
7/30/2012




1. Storage stability data for the benzene-labeled
rate rice metabolism study
9/24/2003
46076600
Satisfied
9/22/2003




2. Poultry feeding study
9/24/2003
48060601 waiver
requested
Waived
4/13/2010
waiver; DP 377208; acceptable
Bispyribac-
RD
9/24/2001
3.28-day inhalation
9/24/2003
48578001 waiver
requested
Waived
8/22/2011
waiver; DP 394228; under review4/2014
Sodium
4. In vitro mammalian cell qene mutation assay
9/24/2003
46076601
Satisfied
9/22/2003




5. Residue data generated for the vegetative
viqor of terrestrial plants
9/24/2003
waiver requested
Waived
9/30/2002
waiver; DP 287947; acceptable



6. Residue data generated for the seedling
emerqence of terrestrial plants
9/24/2003
waiver requested
Waived
9/30/2002
waiver; DP 287947; acceptable



7. Toxicity study to qreen alqae
9/24/2003
46076602
Satisfied
9/22/2003




1. Radiovalidation study to support the adequacy
of the proposed tolerance
12/31/2002
46220001
Satisfied
3/11/2004




2. Radiovalidation data demonstrating the
efficiency of the microwave hydrolysis step in
Method 476/0
12/31/2003
46220002
Satisfied
3/11/2004




3. All proposed data collection and tolerance
methods, revised to state that solutions of
analytical standards should not be stored longer
than 2 months before replacement
8/30/2004
46351401,46351402,
46351403
In Review
8/31/2004




4. Final Report of the storage stability study in
plant matrices with description of the fortification
solutions (solvent) used in the study and a full
description of the analytical method (445/0)
8/30/2004
46351404,46351405
In Review
8/31/2004




5. Data demonstrating the frozen storage
stability of BAS 510 F residues in processed
grape juice (2 months) and tomato paste (5
months)
12/31/2003
46160103;45405126;
45405109;47584402.
Satisfied
12/23/2003;
4/3/2001;4/3/2001
; 2/3/2009.




6. Additional field trials, conducted per their
8/31/2004
46655106
Satisfied
10/11/2005




respective proposed use pattern by 8/31/2004




3 for mustard greens (one each from Regions
2,3, and 10)
8/31/2004
46512001
Satisfied
3/31/2005




2 for cucumber (one each from Regions 2 and
10)
8/31/2004
46512002
Satisfied
3/31/2005




1 for sunflower seed (from Reqion 5)
8/31/2004
46512003
Satisfied
3/31/2005

Boscalid
RD
7/21/2003
7. Limited field accumulation study which
provides data on beet tops (sugar or garden) and
turnip tops, from beets and turnips planted as
rotational crops into treated soil 14 days
following the last of 3 applications of BAS 510 F
totalinq -1.8 lbs ai/A
8/31/2004
46210606
Satisfied
3/2/2004

6/1/2015
11 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




8. Limited field accumulation study which








provides residue data on spinach and celery,
planted as rotational crops into treated soil 14
days following the last of 3 applications of BAS
510 F totaling -1.8 lbs ai/A (alternatively, the
petitioner may submit a full set of crop field trials
data for spinach (6) and celery (6), via a use
pattern similar/identical to that for lettuce, and
8/31/2004
46145101,46145102
Satisfied
12/1/2003




request a direct use tolerance on all of crop








qroup 4








9.Demonstration that pH, water hardness, and








the use of dechlorinated tap water do not affect








the toxicity of Boscalid and if it can be








demonstrated that mean measured
8/31/2004
waiver requested
Waived
11/18/2004




concentrations accurately reflect the amount of




chemical in solution, so aquatic toxicity tests
using fish and invertebrates may be upgraded to
core studies.








10. Provide data on growth (length and weight)
of Daphnia magna in the freshwater invertebrate
8/31/2004
46351406,45405005
Satisfied
8/31/2004




life cyle study.








11. Provide data for freshwater mollusc such as








Corbicula spp., given the persisitence of
Boscalid and its tendency to partition onto
8/31/2004
waiver requested
Waived





sediments,








12. 21/28 day inhalation study
8/31/2004
waiver requested
In Review
n/a




13. Dermal sensitization
8/31/2004
46270102
Satisfied
5/13/2004




1. Developmental neurotoxicity study in rats
12/31/2003
45819101
Satisfied
12/10/2002




2. Storage stability data validating the following
intervals for buprofezin, BF 9, and BF 12:








cucumber (26 months); summer squash (12
months); lettuce (31 months); wheat forage, hay
and straw (29 months); wheat grain (21 months);
sugar beet top and root (24 months); mustard
greens (28 months); turnip tops and roots (29
months); carrot (26 months).
12/31/2003
44576916;46804701
Satisfied
1/30/2001;
4/6/2006


RD
8/31/2000
3. Frozen storage intervals for cantaloupe (10
months); summer squash (12 months);
cucumber (26 months) are to be validated.
12/31/2003
48488201;48488202;
48488203
Satisfied
5/20/2011;
6/13/2011

Buprofezin


4. Cantaloupe field trials in Regions 2 and 10.
12/31/2003
48488202
Satisfied
6/13/2011




5. Frozen sample interval for lettuce samples (28
months) to be validated.
12/31/2003
46804701
Satisfied
4/6/2006




6. Leaf lettuce field trials in Regions 1 and 10.
12/31/2003
47112003
Satisfied
4/20/2007




7. Data needed to upgrade the terrestrial field








trial storage stability from upgradable to
12/31/2003
44576915
Satisfied
6/5/1998




acceptable.








8. Freshwater Fish Full Life Cycle Life
12/31/2003
48083904
Pending
4/1/2015
repeat study due 4/2015



1. Ruminant feeding study
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07



2. Repeat of the 21-day chronic toxicity test with
freshwater invertebrates
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07



3. Repeat of the acute toxicity study on plants
with a plant species that can provide a better
representation of the toxicity of parent
butafenacil to vascular plants
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07
Butafenacil
RD
9/29/2003
4. Chronic toxicity test with an estuarine/marine
invertebrate species.
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07
6/1/2015
12 of 35

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Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




5. Repeat of the tier II seedling emergence 123-
1(a)
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07



6. Repeat of the veqetative viqor 123-1 Cb)
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07



7. Acute fish study with parent butafenacil in the
presence of natural sunlight or an equivalent
source
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07



8. Frozen storaqe stability data
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07



9. Ruminant validation method
9/29/2006
N/A
Cancelled
N/A
all products cancelled on 7/16/07



1. Acute neurotoxicity study in rats
6/1/2003
46012992,46012947
Satisfied





2. Subchronic neurotoxicity study in rats
6/1/2003
46012921,46012946
Satisfied
6/3/2003




3. Developmental neurotoxicity study in rats
6/1/2003
46012925
Satisfied
6/3/2003




4. In vitro cytoqenetic assay
6/1/2003
46012919
Satisfied
6/3/2003




5. Nature of the residue in plants
6/1/2003
46012908,46012909
Satisfied
6/3/2003




6. Residue analytical methods
6/1/2003
46012912,46012914
Satisfied
6/3/2003




7. Storaqe stability data
6/1/2003
46012916,46012917
Satisfied
6/3/2003

Ciodinafop-
propargyl


8. Maqnitude of the residue in plants
6/1/2003
46012918
Satisfied
6/3/2003

RD
6/6/2000
9. Hydrolysis
6/1/2003
46012926
Satisfied
6/3/2003



10. Photolysis in water
6/1/2003
46012927,46012928
Satisfied
6/3/2003




11. Anaerobic soil metabolism on deqradate
6/1/2003
Not Submitted
Waived
6/3/2003
Reqirement withdrawn



12. Adsorption/desorption
6/1/2003
46012934,46012935,
46012936,46012937
Satisfied
6/3/2003




13. Field dissipation
6/1/2003
46012939
Satisfied
6/3/2003




14. Aerobic soil metabolism
6/1/2003
46012930,46012931
Satisfied
6/3/2003




15. Avian reproduction
6/1/2003
46012945
Satisfied
6/3/2003




16. Seedlinq emerqence/veqetative viqor
6/1/2003
46012902,46012901
Satisfied
6/3/2003




1. Developmental immunotoxicity study
5/30/2006
46536502,46536501
Satisfied
4/29/2005, 2008




2. Additional analysis of test materials used in
mutaqenicity studies
5/30/2006
46339001,46339002,
46339003, 46339004
Satisified
8/10/2004

Clothianidin
RD
5/30/2003
3. Rotational crop residue field trials with mature
soybeans
5/30/2006
46826901
Satisfied
5/15/2006

4. Aerobic aquatic metabolism
5/30/2006
46826903
Satisfied
5/15/2006




5. Seed leachinq study
5/30/2006
46826904
Satisfied
5/15/2006




6. Whole sediment acute toxicity to freshwater
invertebrates
5/30/2006
46826902
Satisfied
5/15/2006




7. Field test for pollinators
5/30/2006
46907801,46907802
Satisfied
8/9/2006




1. All the submitted fate and transport studies
were classified either supplemental or
unacceptable. Therefore, the registrant is
required to respond to notes present in all of the
EFED DERs. The identified data gaps must be
resolved by submitting additional details about
the methods or results. If the studies cannot be
upgraded, new studies may be required
3/31/2005
446537701 46537702
46537703 46537704
46537705 46537706
46537707 46537709
46537710 46537711
46537712 46537713
46537714 46537715
46537716 46537717
46537719 46537720
46537722 46537723
46537724 46784201
46784202
Satisfied
5/2/05, 3/15/06
(last 2)




2. Hydrolysis/aerobic soil on the degradate
CCTS to look into the fate of this degradate and
to confirm that the degradates HTID, CDTS and
p-Toluamide were only photolytic degradates
resultinq from lonq exposure to liqht
11/30/2006
46537725 (waiver
requested)
Waived
5/2/2005




3. Replacement avian reproduction study using
bobwhite quail to establish valid NOAECs for
parent cyazofamid and the CCIM deqradate
11/30/2006
45638515,47716308
Satisfied
3/28/02, 3/31/09




4. Freshwater Invertebrate Life Cycle Test using
the parent
11/30/2006
46702708,47716307
Satisfied
12/5/05, 3/31/09

6/1/2015
13 of 35

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Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received

Cyazofamid
RD
11/9/2004
5. Photodeqradation on Soil
11/30/2005
46702704
Satisfied
12/5/2005

6. Aerobic Soil Metabolism (Two relevant U.S.
soils)
11/30/2005
47716301 (waiver
request)
Waived
3/31/2009




7. Aerobic Aquatic Metabolism (One water
sediment system)
11/30/2005
47716303
Satisfied
3/31/2009




8. Anaerobic Aquatic Metabolism (One water
sediment system)
11/30/2005
47716302
Satisfied
3/31/2009




9. Bio-accumulation in Fish Study
11/30/2005
47716305
Satisfied
3/31/2009




10. Nature of Residue: Information pertaining to
dates of sample collection, extraction, final
analysis. Representative chromatograms of the
radiolabeled residues taken before and after
storaqe under frozen conditions
3/31/2005
46537726, 46537727,
46537728
Satisfied
5/2/2005




11. Storage Stability data for 18 months on the
representative commodities of the cucurbit
required to support the storage intervals and
conditions of the crop field trials
11/30/2006
46989701
In Review
11/21/2006




12. Confined Accumulation in Rotational Crops:
Data to confirm the actual sample storage
interval storage stability data indicate that the
parent and its metabolites CCIM and CCBA are
stable in fortified samples of carrot roots, lettuce,
and wheat forage stored frozen for at least 4
months
11/30/2006
46537726, 46537727,
46537728
Not Satisfied
5/2/2005




1. Acute neurotoxicity study
6/27/2013
49128101
In Review
5/16/2013

Cyflufenamid
RD
6/27/2012
2.Sample storage stability associated with the
apple metabolism study must be submitted for a
period than covers 17 months.
6/27/2014

In Review

Waiver submitted 12/2012



1. 28-day inhalation toxicity study
6/1/2006
46471101
Satisfied
2/15/2005

Cyhalofop-butyl
RD
5/23/2002
2. Carcinogenicity study in rats
6/1/2006
46471101,46471102,
46471103
Satisfied
2/15/2005




3. Carcinogenicity study in mice
6/1/2006
46471101,46471102,
46471103
Satisfied
2/15/2005




1. New ames mutagenicity test conducted at
adequate dose levels
2/28/2001
45225501
In Review
10/2/2000
Will be reviewed in registration review



2. Additional information concerning the
metabolism study for poultry and eggs and the
rotational crop study. The storage time between
sampling and analysis for poultry, eggs, and
rotational crops must be reported. If the storage
time was longer than 6 months, adequate data
concerning the stability of residues during the
storage period between collection and final
analysis.
2/28/2001
45225500
In Review
10/2/2000
Will be reviewed in registration review
Diclosulam
RD
3/8/2000
3. Analysis of plant metabolism or field trial
samples of peanut and soybean for 2,6-DCA
using a validated method at the parts per billion
level. The storage time b/t sampling and analysis
for 2,6-DCA must be reported. If the storage time
was longer than 6 mo., adequate data
concerning the stability of residues during the
storage period b/t collection and final analysis
must be provided
2/28/2001
45225500
In Review
10/2/2000
Will be reviewed in registration review



4. Additional positive control data and
untransformed motor activity data for the acute
neurotoxicity study and the 1-year neurotoxicity
study
2/28/2001
45225502,45225503,
45225504, 45225505,
45225506
In Review
10/2/2000
Will be reviewed in registration review
6/1/2015
14 of 35

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Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received

Difenacoum
RD
9/28/2007
Reqistered conditionally but no data required
no data req.
N/A
N/A
N/A




1. Field Volatility from Soil study
6/30/2012 4/1/2014
9/1/14


7/13/2012
Protocol received 7/13/2012; approved
with comments 3/8/2013. Due date
extended to 4/01/2014.



2. Estimation of inhalation Exposure, outdoor
Sites
12/31/2013 4/1/2014
9/1/14


7/13/2012
Protocol received 7/13/2012 an approved
with comments 3/8/2013. Due date
extended to 4/01/2014.



3. Environmental Chemistry Methods and
Independent Laboratory Validations for Soil,
Water, and Air
6/30/2011
48128201,48535303,
48575201
Air- Satisfied; Soil and Water In
review
6/21/10 and
8/15/11




4. Aerobic Aquatic Metabolism study
9/30/2011
48662501
Satisfied
3/5/2012

Dimethyl disulfide
RD
7/9/2010
5. Anaerobic Aquatic Metabolism study
9/30/2011
48662502
Satisfied
3/5/2012




6. Vegetative Vigor study
9/30/2011
Response submitted
but no Mrid assiqned
In review
5/29/2014
Partially satisfied. Registrant submitted
additional raw data.



7. Aquatic Freshwater Invertebrate Life-Cycle
Toxicity study
9/30/2011
48662504
In Review
3/5/2012




8. Aquatic Saltwater invertebrate Life-Cycle
Toxicity study
9/30/2011
48662506
In Review
3/5/2012




9. Freshwater Fish Early Life-Stage Toxicity
study
9/30/2011
48662503
In Review
3/5/2012




10. Saltwater Fish Early Life-Stage Toxicity study
9/30/2011
48662505
In Review
3/5/2012




1. Stability to metals and metal ions
no date specified
46403801
Satisfied
11/12/2004




2. Confirm sample extraction and analysis dates
for MRID 45639822.
12/17/2004
No MRID assigned
Satisfied
2/3/2005
Information submitted in conjunction with
a new use application. 120 Day plant
back interbal retained.



3. Confirmatory dermal absorption study in the
rat
9/17/2005
47013401
Satisfied
12/22/2006




4. Developmental neurotoxicity study in the rat
9/17/2006
47677502 48291601
Satisfied
2/17/2009




5. Developmental immunotoxicity study in the rat
with comparative measures between pups and
the parents.
9/17/2006
47677501
Satisfied
2/17/2009




6. Photodegradation in soil
9/17/2005
45640109
Satisfied
8/24/2010
Referred to study reed 3/19/2002.
Satisfied
Dinotefuran
RD
9/17/2004
7. New aerobic soil metabolism or upgrade 2nd
study (MRID 45640112) by addressing the
characterization of the major degradates at
various samplinq intervals.
9/17/2005
46711201,46711202
Satisfied
12/16/2005




8. Anaerobic Aquatic/soil metabolism study
needs to be upgraded if direct application to
water is proposed.
not specified
48680002
Satisfied
12/6/2011
submitted with rice application. Satisfied



9. Aerobic aquatic metabolism study needed for
any future aquatic uses.
not specified
48680002
Satisfied
12/6/2011
submitted with rice application. Satisfied



10. Repeated fish early life stage toxicity test
9/17/2005
45639719
Satisfied
8/24/2010
Referred to study reed 3/19/2002.
Satisfied.



11. Avian acute oral test using bobwhite quail or
mallard duck
9/17/2005
47353601
Satisfied
2/25/2008
Satisfied



12. Aquatic invertebrate life cycle test is needed
for any future aquatic uses.
not specified
45639718
Satisfied
8/24/2010
Referred to study reed 3/19/2002.
Satisfied.
Eco2Fume
RD
12/20/1999
Conditionally registered under 3(c )(7)(c) but no
data requirements
no data req.
N/A

N/A

6/1/2015
15 of 35

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Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




1. Product chem. Data that is partially satisfied
and needed: product identity and discussion of
ingredients, beginning materials and
manufacturing process, formation of impurities,
prelim analysis, analytical methods to verify cert
limits, and stability. NOT satisfied: oxidizing or
reducing action, explodability, storage stability,
corrosion characteristics.
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



2. hydrolysis study needs the % of phenyl-ring
transformation products that are present after 30
days
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



3. Photodegradation in water: electronic
absorption spectra of ethametsulfuron methyl at
ph5 and 9.
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13
Ethametsulfuron
RD
4/23/2001
4. Aerobic soil metabolism: triazine radiolabeled
study to address comments in study review.
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13
Methyl
5. Terrestrial field dissipation study: Analytical
method for identifying and quantifying residues
of "cold" ethametsulfuron methyl must be
evaluated
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



6. Freshwater fish full life-cycle
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



7. Tier II seed germination/seed emergence
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



8. Tier II vegetative vigor
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



9. Tier II Lemma gibba, Skeletonma costatum,
blue green algae
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



10. Batch equilibrium adsorption/desorption
study were conducted with acidic soils taken
from eastern states. At least 2 alkaline soils
should be included. Soil TLC studies only
provide ancillary data.
4/23/2005
N/A
Cancelled
N/A
all products cancelled on 2/20/13



11. Additional information required for acute
inhalation and dermal sensitization studies.
Refer to review.
4/23/2005
N/A
N/A
N/A
all products cancelled on 2/20/13



1. Acute and subchronic neurotoxicity
3/1/2003
45932301,45925701
Satisfied
4/22/2003




2. Development neurotoxicity
9/1/2003
46062301
Satisfied
8/28/2003

Etofenprox
RD
9/14/2001
3. Residential "Indoor Surface Residue
Dissipation Study following Total Release
Product Use"
9/1/2003
46075002
Satisfied
9/3/2006

4. Residential "Indoor Air Concentration
Measurements following Total Release Product
Use"
9/1/2003
46075003
Satisfied
9/3/2006




5. Product Performance Data for cockroaches,
fleas, ticks, and mosquitoes
9/1/2002
46066506
Satisfied
9/5/2003




1. Core freshwater fish acute toxicity studies
not specified
46059001,46059002
Satisfied
8/25/2003

Etoxazole
RD
8/22/2002
2. 90-day subchronic inhalation study on rats
not specified
48134301 waiver
requested
Waived
6/28/2010




1. Leaching/Adsorption/Desorption study (one
additional soil type which should be finer-grained
than those previously tested-which were sand,
sandy/loam, and sandy/clay/loam)
8/31/2004
46350401
Satisfied
8/30/2004
Study Supplemental, requirement
satisfied
Famoxadone
RD
7/17/2003
2. Acute freshwater fish (Rainbow trout)
quideline study usinq the end-use product
8/31/2004
46144801
Satisfied
12/4/2003

3. Whole sediment acute toxicity invertebrates,
freshwater chironomids, the 28-day test
8/31/2004 10/01/2014
12/31/14 6/30/15
44946308
Not Satisfied
12/31/2014
Registrant submitted rebuttal. Rebuttal
denied. Study due date 12/31/14



4. Honey-bee acute contact with the end-use
product bv
8/31/2004
46350402
Satisfied
8/30/2004

6/1/2015
16 of 35

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Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




5. Honey-bee toxicity of residues on foliage with
the end-use product
8/31/2004
46350403
Satisfied
8/30/2004




1. Honey bee acute contact LD50
Dec-03
45802901
Satisfied
11/19/2002




2. Mallard duck reproduction
Dec-04
46418601
Satisfied
12/6/2004




3. Freshwater fish early life-stage or fish full life
cycle
Dec-04
47332201 waiver
request; 48389201
study
Satisfied
12/6/2004;
02/16/2011
Waiver denied; study satisfied
requirement.



4. Aerobic soil metabolism
Dec-04
45385819
Satisfied
11/21/2002




5. Residue analytical methods-plants any
modification or revisions recommended by the
Aqency
Jun-03
no modifications
requested
Satisfied
11/21/2002

Fenamidone
RD
9/30/2002
6. Confined accumulation in rotational crops-
fenamidone labeled in the N-phenyl ring (aniline
and substituted aniline standards should be
included)
Dec-03
waiver requested
Waived
11/21/2002




7. Confined accumulation in rotational crop study
Dec-03
46440805,
47514101,
47514102,
47514103
Satisfied
1/2/2005
8/12/2008
8/12/2008
8/12/2008




8. Storage stability data for the confined
accumulation in rotational crop study
Dec-03
47817002
Satisfied
7/30/2009




10. Developmental neurotoxicity study
Dec-03
46501102,46590001
Satisfied
3/18/04, 7/12/05




11. 28-day inhalation toxicity study
Dec-03
47465801 wiver
requested
Waived
7/2/2008




12. Storage Stability
Mar-04
47120801

5/2/2007




13. Corrosion Characteristics
Mar-04
46152101
Satisfied
12/15/2003

Fenpyroximate
RD
9/29/2000
1. Confirmatory data must be submitted for the
existing rat developmental study including
additional historical control data.
9/27/2003
45323301
Satisfied
2/6/2001

2. 28 day inhalation study
9/27/2003
45323302
Satisfied
2/6/2001




3. Aerobic soil metabolism and
9/27/2003
45649708
Satisfied
4/1/2002




adsorption/desorption (batch equilibrium) study.




1. One-year storage stability and corrosion
characteristics
11/14/2008
46220905
Satisfied
3/2/2004
Agency letter, dated 11/20/08, states that
the study submitted with the application
satisfies the requirement.



2. Acute neurotoxicity study including historical
positive control data, analytical data verifying
homogeneity, and stability of formulated test
materials for this study.
6/30/2009
47785301
Satisfied
6/23/2009
DP366699, acceptable DP404895, under
review DP408778, under review



3. Aerobic aquatic metabolism
6/30/2009
47785302
Satisfied
6/23/2009
DP366710; supplemental, satisfies
requirement



4. Aerobic soil metabolism
6/30/2009
47785303
Satisfied
6/23/2009
DP366710, acceptable
Flazasulfuron
RD
5/14/2007
5. Anaerobic aquatic metabolism
6/30/2009
47785304
Satisfied
6/23/2009
DP366710; supplemental, satisfies
requirement



6. Soil Mobility: Adsorption/desorption (parent)
6/30/2009
47030002
Satisfied
1/2/2013




7. Freshwater fish early life-staqe
6/30/2009
47785305
Satisfied
6/23/2009
DP366710, acceptable



8. Aquatic invertebrate life-cycle (freshwater)
6/30/2009
47785306
Satisfied
6/23/2009
DP366710; supplemental, satisfies
requirement



10. Aquatic vascular plant (duckweed) study
6/30/2009
47785307
Satisfied
6/23/2009
DP366710; supplemental, satisfies
requirement



11. Seedling emergence (Tier II)
6/30/2009
47785308
Satisfied
6/23/2009
DP366710, DP372895 acceptable



12. Studies need to be conducted on the
hydrolysis degradates DTPU and DTPP at the
pH(s) at which they are most stable to hydrolysis
no date specified
47785309
Satisfied
6/23/2009
DP366710, acceptable
6/1/2015
17 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received

Flonicamid
RD
9/25/2003
1. 90-day inhalation study to address concerns
for repeated exposure via the inhalation route as
a result of qreenhouse use
9/25/2005
waiver requested
Waived

waiver granted 5/9/2005
2. Storage stability/corrosion characteristics and
UV/Visible absorption data
9/25/2005
46370701
Satisfied
10/26/2007




3. UV/Visible absorption data
9/25/2005
45911601
In Review
4/17/2003




1. Seedlinq emerqence study
9/28/2008
48651302
Satisfied
11/8/2011

Florasulam
RD
9/28/2007
2. Independent laboratory validation study for the
Florasulam method in soil and the 5-Hydroxy
Florasulam Degradate in Soil by Capillary Gas
chromatoqraphy with mass Selective Detector
9/28/2008
48651303
In Review
11/21/2008

3. 5-batch analysis on the samples produced on
commercial scale and based on the analytical
results, a revised CSF
9/28/2008
47595601
Satisfied
11/13/2008




4. One-year storage stability and corrosion
characteristics studies
9/28/2008
48902101
Satisfied
4/3/2009




1. 28-day inhalation toxicity study in rats
Dec-03
48571410
Satisfied
9/8/2011
Waiver request submitted in 2002 was
deemed acceptable due to label
mitigation (inclusion of respirator). Full
study was submitted in 2011 as part of
reqistration review



2. Developmental neurotoxicity study in rats
(Submit protocol for Agency approval and submit
the study 2 years after approval
3/13/2003 (protocol
due)
4654401,47018301,
47037001
Satisfied
4/28/2005

Fluazinam
RD
3/5/2003
3. Subchronic neurotoxicity screening battery in
rats, required based on results of the
developmental neurotoxicity study (must by
submitted 2 years after notification by the
Aqency
N/A
N/A
Waived
N/A
Data not requested based on results of
developmental neurotoxicity studies.



4. Processed commodity study on potatoes at a
hiqher treatment level, 5x
Dec-03
waiver requested and
qranted
Satisfied
1/17/2002




5. Photodegration in soil
Dec-03
45584205 waiver
requested
Waived
10/28/2008




6. Terrestrial Field Dissipation and concurrent
storaqe stability study
Dec-04
48631521,48631522,
48631523
Satisfied
10/28/2008




7. Tier I or Tier II Terrestrial Plant Growth,
seedling emergence and vegetative vigor by
12/2003
Dec-03
46172801,46172802
Satisified
1/15/2004

Flubendiamide
RD
8/1/2008
Reqistered conditionally but no data required
no additional data
N/A
N/A
N/A




1. Refined analytical methods for the
quantification of flucarbazone-sodium and its
degradates in both soil and water (analytes of
concern: flucarbazone-sodium, its sulfonamide
and sulfonic acid degradates, O-desmethyl
flucarbazone, N, O-dimethyltriazolinone, and N-
methyltriazolinone
10/1/2001
46926101,46926102,
46926103
In Review
9/5/2006




2. 28-day rat inhalation study
10/1/2001
46168501
Satisfied
1/12/2004




3. A revised plant enforcement method which
measures all residues of toxicological concern:
flucarbazone-sodium; its N-desmethyl
metabolite; and flucarbazone sulfonamide and
its conjugates. Also submit an independent
laboratory validation and radiovalidation of the
method
10/1/2001
46223700
Waived
3/18/2004

6/1/2015
18 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received

Flucarbazone
RD
9/29/2000
4. Additional residue field trial data on the
sulfonamide metabolite and its conjugates. If the
company can provide adequate storage stability
data from the previously conducted field trials,
the samples from these field trials may be
analyzed for sulfonamide and its conjuqates
10/1/2001
46223700
Waived
3/18/2004




5. Additional data on the sulfonamide metabolite
and its conjugates in grain samples from the
submitted processed food/feed study, should re-
analyze grain samples from this study for
flucarbazone sulfonamide and its conjugates. If
quantifiable residues are found in the grain, then
you must conduct a processinq study
10/1/2001
46223700
Waived
3/18/2004




6. Additional storage stability data from the
submitted rotational crop studies for turnip tops
and kale
10/1/2001
46103702
Satisfied
10/1/2003




7. Field rotational crop studies supporting the 11-
month plant back interval for canola, barley and
field peas
10/1/2001
46083802
In Review
10/1/2003




8. Seedling emergence and vegetative vigor
data for sulfonamide degradate (test plant
species should include lentil, canola, oat, onion,
suqarbeet and buckwheat)
10/1/2001
46103701
Satisfied
10/27/2003




9. Three field dissipation studies conducted on
bare qround
10/1/2001
46223703, 46223704
Satisfied
3/18/2004




1. Additional storage stability data for the
metabolite S-3153 acid-4-OH in field corn and
stover
9/30/2004
46028601
Satisfied
7/10/2003

Flufenpyr-ethyl
RD
9/30/2003
2. Confirmatory method for residues of flufenpyr-
ethyl in/or on corn, soybeans, sugarcane raw
agricultural commoditities (RACs) by 9/30/2004.
If the confirmatory method does not utilize a
mass-selective detector (MSD), then an
interference study will be required.
9/30/2004
46028602
Satisfied
7/10/2003




1. Confirmatory residue analytical method for
plants
4/12/2003
45914603
Satisfied
4/22/2003

Flumioxazin
RD
4/12/2001
2. Aqueous photolysis
4/12/2003
45914601
Satisfied
4/22/2003




3. Anaerobic soil/aqueous soil metabolism
4/12/2003
45914602
Satisfied
4/22/2003




4. Field dissipation
4/12/2003
46163701
Satisfied
4/22/2003




1. Additional storage stability data are needed for
celery and spinach relfecting a storage interval of
38 months. One study should be conducted on
any representative leafy vegetable.
1/31/2009
49054401,49054402,
49054403, 49054404
Satisfied
2/6/2013




2. Provide sample history of cow metabolism
study (46708514).
1/31/2009
47689304
Satisfied
2/24/2009

Fluopicolide
RD
1/28/2008
3. Provide storage stability, clarify identification
of peaks, correct flowchart for fat, recalculate the
radioactivity levels for the cow metabolism study
(46708518).
1/31/2009
47689305
Satisified
2/24/2009




4. Provide sample history of the hen metabolism
study (46708515).
1/31/2009
47689303
Satisfied
2/24/2009




5. Provide stability data for the duration of the
storage period for the hen metabolism study
(46708519).
1/31/2009
47689306
Satisfied
2/24/2009

6/1/2015
19 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




1. Field accumulation in rotational crops;cotton,
canola, cereal grains (except rice), and soybean
12/1/2015
49006009	49006008
49006010
In review

due date extended to 12/1/2015
Fluopyram
RD
2/2/2012






2. 90 day inhalation
4/30/2012
48828300 waiver
requested
Waived
6/19/2012




3. Seedling emergence, tier II for buckwheat.
12/1/2012
48934301
In review
9/13/2012




1. Additional information (definitive identification
of the test substance, spleen weights at
necropsy, and competence of the laboratory to
perform this type of assay) that will potentially
allow upgrade of the assessment of the mouse
subacute immunotoxicity study
6/30/2006
48692105
Satisfied
12/14/2011




2. Additional data concerning the
chromatograms and chromatography from the
qoat metabolism study
6/30/2006
46925801
Satisfied
9/1/2006




3. Proposed enforcement method, including
instructions for the analysis of all crops and their
associated processed commodities for which the
petitioner is requesting tolerances
6/30/2006
46486101,46925803,
46486102
Satisfied
9/1/2006




4. Residue enforcement method livestock
6/30/2006
46486101 46486102
46925803
Satisfied
3/3/2005;09/01/20
06




5. Additional information and confirmatory raw
data for the residue storage stability study
6/30/2006
46925801
Satisfied
9/1/2006




6. Summary information concerning the weather
conditions for the growing season for each crop
field residue trial
6/30/2006
46925801
Satisfied
9/1/2006




7. New peanut processing study
9/20/2007
47588901
Satisfied
11/6/2008




8. Analytical reference standards for
Fluoxastrobin, itsZ-isomer, a metabolite, several
deuterated molecules
6/30/2006
analytical reference
standards are
available
Satisfied
n/a

Fluoxastrobin
RD
9/20/2005
9. Summary information concerning the weather
conditions for the growing season for each field
rotational crop residue study
6/30/2006
46925801
Satisfied
9/1/2006




10. Soil characteristics data for each field
rotational crop trial from which samples were
analyzed
6/30/2006
46925801
Satisfied
9/1/2006




11. Explanation of why samples from one of the
grass forage and hay rotational crop field trials
appears to have been harvested more than one
year after planting of the grass corp
6/30/2006
46925801
Satisfied
9/1/2006




12. One acute (10-day) sediment toxicity test
6/30/2006
45865506
(unacceptable),
46925805 (waiver
request)
In review
2/4/2003,
9/1/2006
Waiver request



13. One chronic (28-day) sediment toxicity test
6/30/2006
45865505
(unacceptable),
46404901
(supplemental),
46925805 (waiver
request)
In review
2/4/2003,11/16/20
04, 9/1/2006
Waiver request



14. Upgrade for anaerobic aquatic metabolism
and one of the aerobic aquatic metabolism
studies
6/30/2006
46925806
Satisfied
not found




15. Upgrade for the 96-hour rainbow trout acute
toxicity study of deqradate HEC 7180
9/30/2006
46925805
Satisfied
9/1/2006




16. Upgrade for the 96-hour sheepshead
minnow acute toxicity studv
9/30/2006
45865417,46925805
Not Satisifed
2/4/2003,
9/1/2006

6/1/2015
20 of 35

-------
Chemical
Division
Reft Notice Date
Conditional Data Requirement(s)

MRID for Studv
Review Status
Date Data
I
Due Date
- . ....




1. immunotoxicity study
4/29/2015
48360301;48360302;
48360303
Satisfied
1/21/2011
Conditional Data requirement satisfied:
Aqency accepted study- 3/29/2011



2. Storage stability data for flutriafol and/or its
metabolites in/on livestock and soybean
commoditites
4/29/2015
47959201,47606601,
46568301
Satisfied
9/4/2012,
7/17/2013

Flutriafol
RD
4/29/2010
3. A confined rotation crop study conducted with
[triazole-3,5-14C] flutriafol and [carbinol14C]
flutriafol
4/29/2015
47732601
47675601
47659101
Satisfied
4/22/2009
2/13/2009
1/30/2009




4. small scale prospective ground water
monitoring study
4/29/2015
48735801,48769301,
48838501
Pending
2/2/2012,
3/13/2012,
4/4/2012
Protocol review completed



5. Avian acute oral LD50 study with passerine
birds
4/29/2015
48586401 waiver
denied
Pending
8/26/2011
Protocol review completed; new study
expected 4/29/15



1. Fish early life staqe study
3/27/2004
46241301
Satisfied
4/5/2004




2. Seed germination/seedling emergence study
conducted using the end-use product
3/27/2004
45483801
Satisfied
8/24/2001




3. Vegetative vigar study conducted using the
end-use product
3/27/2004
45483802
Satisfied
8/24/2001

Foramsulfuron
RD
3/27/2002
4. Tier II aquatic plant growth study conducted
using the end-use product
3/27/2004
45109911
Satisfied
4/3/2000




5. Submit an acceptable study to complete the
data requirement as specified in the Confidential
Attachment to the Registration Notice.
3/27/2004
45554701;
45562501;45562501;
45562502
Satisfied
4/8/2002




1. Aquatic Algal Species
12/31/2006
46753501,46753502,
46753503, 46753504
Satisfied
2/8/2006

Forchlorfenuron
RD
9/30/2004 but
reg notice dated
2/2/2005
2. Vegetative Vigor Study
12/31/2006
46753505
Overdue
2/8/2006
Study Supplemental; waiver denied,
Requirement partially satisfied; Company
notified that a new study is needed.
3. Field Dissipation Study
1/15/2007
waiver requested
Waived
4/5/2005



4. Avian Chronic Study
1/15/2007
Waiver requested.
In Review
N/A
EFED Review expected 4/2015 Waiver
requested and denied; rebuttal submitted
and in review. Avian reproduction study
in review



1. The final report of the 3 year storage stability
data for tomato
12/30/2008
45866701
Satisfied
8/24/2009




2. Tobacco storage stability study (data depicting
frozen storage stability of foshiazate and ASC-
67131 in a representative foliage commodity
12/30/2008
45866701 (tomato) and
45866705 (tobacco)
Satisfied
2/27/2003
Registrant submitted the studies prior to
registration in response to the Agency's
residue chemistry review of 8/27/2002.



3. Analytical grade reference standards for the
foshiazate metabolite ASC-67131 must be
submitted to the EPA standards repository
12/30/2008
No MRID No.
Satisified
N/A
Sample shipped to EPA's standards
repository on 12/6/2004
Fosthiazate
RD
3/30/2004
4. Additional data to characterize insoluble
residues in 30 days after treatment (DAT) rotated
wheat commodities
12/30/2008

Waived
8/24/2010
Required only for a pending use that was
not registered.



5. Storage stability data to support the additional
analyses required on the 30-DAT wheat forage,
straw, and grain
12/30/2008

Waived
8/24/2010
Required only forpending use that was
not registered.



6. 28-day inhalation study in rats with foshiazate
12/30/2008
46744901
Satisfied
1/30/2006




7. Developmental neurotoxicity (DNT) study in
rats with comparative ChE measurements in
adults and pups
12/30/2008
46784301 waiver
requested and granted
Waived
5/15/2006




8. A worker study for activities involving contact
ith treated soil conducted concurrently with a soil
residue dissipation studv.
12/30/2008
47098901 waiver
request
Waived
4/2/2007
Agency did additional risk assessments
and concluded MOEs are adequate.
Requirement withdrawn.
6/1/2015	21 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




1. 28-dav dermal toxicity study
no date specified
46917201
Satisfied
8/21/2006

Furfural
RD
10/5/2006
2. Guideline 28- or 90-day inhalation study
no date specified
46917202,47419101,
46426505
Satisfied
8/21/2006,
5/19/2008

3. Field/greenhouse volatility study for each
major application method
no date specified
47253701
Satisfied
10/11/2007




4. Dislodqeable foliar residue study
no date specified
47146202
Satisfied
6/19/2007




1. immunotoxicity study
12/14/2012
48691003
Satisfied
12/12/2011




2. Multiresidue Methods
12/14/2012
49019000
In Review
12/17/2012




3. Storage stability for rice, grain, peppers,
tomatoes.
12/14/2012; extended
to 4/30/2013
49114902
In Review
4/30/2013




4. Confined Accumulation in Rotational Crops
12/14/2012
48691001
Satisfied
12/12/2011

Imazosulfuron
RD
12/14/2010
5. Field Accumulation in Rotational Crops
12/14/2012 6/30/2014
extension granted until
6/30/2014

12/17/2012




6. Acute toxicity study addressing effects of
degradate, ISPN, to fish, quatic invertebrates,
and aquatic non-vascular plants.
12/14/2012
49019001,49019002,
49019003,49019004,
49019005,49019006
All studies accepable except
4901003 (new study required)
12/17/2012




7. Acute Avian Oral Toxicity Study
12/14/2012
48691002
In Review
12/12/2011




1. Product identity and composition
1/30/2002
45591501
Satisfied
1/30/2002




2. Description of materials used to produce the
product
1/30/2002
45591501
Satisfied
1/30/2002




3. Description of production process
1/30/2002
45591501
Satisfied
1/30/2002




4. Description of formulation process
1/30/2002
45591501
Satisfied
1/30/2002




5. Discussion of formation of impurities
1/30/2002
45591501
Satisfied
1/30/2002




6. Developmental neurotoxicity study in the rat
10/30/2002
46749001,46749002,
46749003
Satisfied
2/2/2006




7. 90-day inhalation toxicity study in the rat
10/30/2002
45354001
Satisfied
2/2/2006




8. Poultry feedinq study
10/30/2002
46114302
Satisfied
11/6/2003




9. Confirmatory method for plants
10/30/2002
45795818
Satisfied
11/4/2002

Indoxacarb
RD
9/29/2000
10. Specificity testing for analytical methods for
plants
10/30/2002
45795818
Satisfied
11/4/2002

11. Storage stabiliry data reflecting the maximum
frozen storage intervals of cotton processed
samples
10/30/2002
45795819
Satisfied
11/4/2002




12. Photodeqradation in water
10/30/2002
45795802
Satisfied
11/4/2002




13. Hydrolysis
10/30/2002
45795801
Satisfied
11/4/2002




14. Aerobic soil metabolism
10/30/2002
45795803, 45906701
Satisfied
11/4/02, 4/11/03




15. Anaerobic aquatic metabolism
10/30/2002
45795804
Satisfied
11/4/2002




16. Aerobic aquatic metabolism
10/30/2002
45793301
Satisfied
10/31/2002




17. Leaching-adsorption/desorption
10/30/2002
45795805, 45795806,
45795807, 45795808,
45906702
Satisfied
11/4/02,
4/11/03(..702)




18. Terrestrial field dissipation
10/30/2002
45795810,45795811
Satisfied
11/4/2002




19. Accumulation in fish
10/30/2002
45805301
Satisfied
11/22/2002

lodomethane
RD
10/5/2007
Agency does not request any additional
conditional data in req. notice
no additional data
required
N/A
N/A
N/A




1. Avian reproduction studies
12/31/2004
46431803
Satisfied
12/27/2004




2. Freshwater fish early-life staqe studies
12/31/2004
46431804
Satisfied
12/27/2004




3. Estuarine invertebrate life-staqe studies
12/31/2004
48288301
Satisfied
11/5/2010




4. Carcinogenicity study in mice
12/31/2004
Waiver requested
Waived
1/4/2008
waivers found acceptable within HED risk
assessment (D350046)



5. Developmental toxicity study in rabbits
12/31/2004
Waiver Requested
Waived
1/4/2008
waivers found acceptable within HED risk
assessment (D350046)
iodosuifuron-
methyl-sodium


6. 28-day inhalation study
12/31/2003
Waiver requested
Waived
1/4/2008
waivers found acceptable within HED risk
assessment (D350046)
RD
10/26/2002
7. 21-day dermal study
12/31/2003
Waiver requested
Waived
1/4/2008
waivers found acceptable within HED risk
assessment (D350046)
6/1/2015
22 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)
12/31/2004
MRID for Studv
Review Status
Date Data
Comments
N/A
Received
, > - r-


8. Analytical methods in plants, soil, and water.


N/A
N/A
For this requirement, the regsitrant
understood in a meeting with the Agency
on 4/9/2003 that the requirement was
placed in reserve pending consultation
with industry working groups on ways to
address the requirement. This chemical
is currently in registration review and this
required is included in the DCI.
Ipconazole
RD
9/10/2004
1. 28-dav dermal toxicity study in rats
4/30/2006
47048916
Satisfied
5/15/2006

2. 90-day inhalation toxicity study in rats
4/30/2006
47048915
Satisfied
4/19/2005

3. Additional soil adsorption/desorption study
conducted in a low orqanic matter (OM) soil
4/30/2006
46827503
Satisfied
5/15/2006

4. In vivo cytoqenic assay
4/30/2006
46827502
Satisfied
5/15/2006

Macleaya Extract
RD
9/19/2002
1. 90-day dermal study in the rabbit
3/31/2004
46273804
Waived
5/18/2004
Study called in under Registration Review
Data Call-in Notice issued 6/12/2012.
HAZPOC waived
2. 90-day inhalation in rats
3/31/2004
46273806
Waived
5/18/2004
Study called in under Registration Review
Data Call-in Notice issued 6/12/2012.
HAZPOC waived
3. Developmental study in the rabbit
3/31/2004
46273807
Waived
5/18/2004
Study called in under Registration Review
Data Call-In Notice issued 6/12/2012.
HAZPOC waived
4. Mutagenicity battery (gene mutation in
bacteria) and mammamalian cells, and an in
vivo cytogenetics assay
3/31/2004
46273814, 46273811,
46273812
Satisfied
5/18/2004
Study called in under Registration Review
Data Call-in Notice issued 6/12/2012.
Mammalian
Gonadotropin
Releasing
Hormone
RD
9/29/2009
1. Guideline 830.1700 Preliminary analysis and
validation of the method of analysis of the
formulation
9/29/2010
48623801
Satisfied
9/29/2011

2. Guideline 830.1750 Certified Limits (basic and
alternate CSFs)
9/29/2010
48959701
Satisfied
10/1/2012

Mandipropamid
RD
1/9/2008
1. New chronic daphnia study
1/9/2009
47802601
Satisfied
7/14/2009

2. Storage stability data for SYN 500003 which
covers the entire 32 months of storage (interim
storage stability data for six months were
submitted)
1/9/2009
47642303
In Review
1/12/2009

Mesosulfuron-
methyl
RD
3/31/2004
1. One year storage stability and corrosion
characteristics
10/1/2005
46647101
Satisfied
9/19/2005

2. Independent laboratory validation of the
livestock enforcement method for mesosulfuron-
methyl in ruminant liver
10/1/2004
48080501
Satisfied
4/30/2010

3. Storage stability data to demonstrate the
stability of mesosulfuron-methyl residues in/on
wheat forage stored frozen for up to 26 months
and in/on wheat grain and straw stored frozen for
up to 25 months
10/1/2005
46229001, 46229002,
46229003, 46229004
In Review
5/22/2004

4. Tier II vegetative vigor study with Osprey
herbicide
10/1/2005
46688201
In Review
11/14/2005

5. Terrestrial field dissipation study with
Silverado Wild Oat herbicide in a spring wheat
area such as North Dakota.
10/1/2006
46948901
In Review
10/3/2006

6. Avian-reproduction study (mallard duck)
4/2/2006
Waiver requested
Waived
3/30/01, 10/28/04

6/1/2015
23 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-






Received




7. Independently validated analytical chemistry
methods to identify and quantify residues of
mesosulfuron-methyl and its degradates in water
(must be sufficiently sensitive to adequately
determine and characterize mesosulfuron-methyl
residues in water resources down to levels of
ecotoxicological importance)
4/2/2005
46451701, 46451702
Supplemental
1/24/2005
Addressed in Reg Review DCI



1. Developmental neurotoxicity study in the
mouse.
6/4/2005
45651812
Waived
3/28/2002




2. Adequate storage stability data in the plant
and livestock metabolism studies
6/4/2005
45651814
Waived
3/28/2002




3. Revised interference study
6/4/2005
45651816
Waived
3/28/2002

Mesotrione
RD
6/4/2001
4. 28-day Inhalation study
6/4/2005
46562908 waiver
requested
Waived
6/27/2005




5. Phytotoxicity studies
6/4/2005
47093501
Satisfied
3/20/2007




6. Improvement in the extraction method in the
soil analytical method
6/4/2005
45651815
Satisfied





7. A prospective groundwater monitoring study at
a vulnerable site in the southern US.
6/4/2005
47418901
Satisfied
5/7/2008

Metaflumizone
RD
4/30/2007
1. Storage and corrosion characteristics
10/30/2008
47267901
Satisfied
10/30/2007




1. Bi-valve mussel bioaccumulation study
6/30/2002
45702704
Satisfied





2. Frog embryo teratogenesis assay using
Xenopus laevis
6/30/2002
48661701
In review





3. Sub-acute sediment study usinq Hexaqenia
6/30/2002
45702703
In Review


Methoxyfenozide
RD
7/5/2000
4. Chronic Sediment Study using Chinonomus
riparius
6/30/2002
45032801
In review





5. Honey Bee Brood Studies
6/30/2002
45065501; 48350501;
48962201; 48962202;
48962203
In review


Metofluthrin
RD
9/29/2006
1. Fish toxicity bluegill study
9/29/2008
47414002
Satisfied
4/30/2008

2. Honey bee acute contact
9/29/2008
47046301, 47414001
Satisfied
2/2/07, 4/30/08




1. Immunotoxicity study needed for future uses
11/30/2012
48981302
Satisfied
11/13/2012




2. Method validation data must be submitted for
Method FAMS 105-01 reflecting fortifications at
4.5 ppm for grapes, and at both the LOQ (0.05
ppm) and 17 ppm for raisins.
11/30/2012
48981303, 48981304
Satisfied
11/13/2012




3. Radiovalidation for method FAMS 105-01 to
demonstrate recovery of weathered residues of
metrafenone from grapes. Cucumber data may
be submitted in lieu of grapes if the data show
adequate extractibility by 9:2 n-heptane/acetone.
11/30/2012
48981305-8
Satisfied
11/13/2012

Metrafenone
RD
11/24/2010
4. Radiovalidation data are required to support
the data collection method, BASF Method 535/0.
Samples from the cucumber metabolism study
currently in progress may also be used to
generate these data.
11/30/2012
48981305-8
Satisfied
11/13/2012




5. Avian acute oral with passerine birds
11/30/2012
48981309
Satisfied
11/13/2012




6. Acute tox freshwater fish
11/30/2012
48981310
Satisfied
11/13/2012




7. Chronic freshwater fish early-life stage
11/30/2012
48981311
Satisfied
11/13/2012




8. Chronic aquatic freshwater invertebrate life-
cycle
11/30/2012
48981312
Satisfied
11/13/2012




9. Acute marine/estuarine invertebrate
11/30/2012
48981313
Satisfied
11/13/2012




10. Aquatic vascular plant growth Tier II
11/30/2012
48981314
Satisfied
11/13/2012




11. Aquatic non-vascular Tier II
11/30/2012
48981315-21
Satisfied
11/13/2012

6/1/2015
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Comments



, > - r-





' .. i >. . .
Received




12. Chronic freshwater invertebrate whole
sediment on TGAI for Chironomus dilutus
11/30/2012
48981320-22
Satisfied
11/13/2012




13. Storage stability and corrosion
characteristics
11/30/2012
48981301
Satisfied
11/14/2012




1. Acute inhalation toxicity (technical)- rat (not
upqradable-must be repeated)
5/29/2004
N/A
Cancelled
N/A
Voluntarily cancelled.



2. 28-day dermal toxicity-rabbit (not upgradable-
must be repeated)
9/29/2005
N/A
Cancelled
N/A
Voluntarily cancelled.



3. Prenatal developmental toxicity-rabbit
(possibly upqradable)
9/29/2005
N/A
Cancelled
N/A
Voluntarily cancelled.



4. Prenatal development toxicity- rat (possibly
upqradable)
9/29/2005
N/A
Cancelled
N/A
Voluntarily cancelled.
Milbemectin
RD
9/29/2003
5. Multigeneration reproductive toxicity-rat
(possibly upqradable)
9/29/2007
N/A
Cancelled
N/A
Voluntarily cancelled.



6. Estuarine fish early life-stage- sheepshead
minnow
9/29/2004
N/A
Cancelled
N/A
Voluntarily cancelled.



7. Estuarine invertebrate life-staqe- mysid
9/29/2004
N/A
Cancelled
N/A
Voluntarily cancelled.



8. Aquatic acute sediment toxicity testinq
9/29/2004
N/A
Cancelled
N/A
Voluntarily cancelled.



9. Anaerobic aquatic metabolism (possibly
upqradable)
9/29/2005
N/A
Cancelled
N/A
Voluntarily cancelled.



10. Bioconcentration in fish (possibly
upqradable)
9/29/2005
N/A
Cancelled
N/A
Voluntarily cancelled.
Nicarbazin
RD
11/23/2005
1. Storage stability and corrosion characteristics
studies
11/23/2006
46416408
Satisfied
1/12/2005




1. 90-day inhalation toxicity study in rats
9/25/2003
Waiver requested
Waived
N/A

Novaluron
RD
9/25/2001
2. Two mutagenicity studies: In vitro mammalian
cell gene mutation and in vivo cytogenetrics
assay
9/25/2003
45638321,45638222
Satisfied
3/22/2002




1. Results of one year storage stability and
corrosion characteristics
no date specified
46712101
In Review
12/16/2005




2. Analytical reference standard to the National
Pesticide Standards Repository
no date specified
sample(s) received on
6/25/08
Satisfied
sample(s)
received on
6/25/08
Sample expires on 4/1/17
Orthosulfamuron
RD
2/22/2007
3. Dates of sample extraction, initial TLC
analysis, and metabolite identification analyses
in order to determine sample storage intervals
for the submitted goat metabolism study. (If the
initial quantitative TLC analyses were conducted
within 6 months of sample collection, then
supporting storage stability data will not be
required)
no date specified
information provided in
letter dated 9/27/07
Satisfied
information
provided in letter
dated 9/27/07




4. Radiovalidation data (using samples from the
rice metabolism study) for the method chosen for
tolerance enforcement purposes
no date specified
47030001
In Review
1/16/2007




5. Recovery data using specific directions for
each multiresidue method used by FDA
no date specified
47674201
In Review
2/12/2009

Penoxsulam
RD
9/27/2004
1. Seed germination/seeding emergence
studies, vegetative vigor studies, and an aquatic
plant growth study using Duckweed with the
degradates, BSA, 2-amino-TP, TPSA, BSTCA
methyl, BSTCA, 2-amino-TCA, 5-OH-
penoxsulam, SFA, sulfonamide, 5, 8-di-OH and
5-OH 2 amino TP
no date specified
46758301, Exhibit A in
46758300
Satisfied
2/13/2006

2. Test terrestrial plants using the liquid and end-
use products of penoxsulam.
no date specified
46930301,46930302
Satisfied
2/13/2003

6/1/2015
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Comments



, > - r-





' .. i >. . .
Received




3. Enforcement method revised as
recommended in the Analytical Chemistry
laboratory memo dated 9/17/2004
no date specified
46389701
Satisfied
10/26/2004




4. One year storage stability and corrosion
characteristics
no date specified
46433901,46433902,
46449901
Satisfied
12/28/04,
12/28/04, 1/24/05

Picaridin

12/7/2000
1. 5 week oral toxicity study in rats
4/15/2001
45387901
Satisfied
12/1/2002




2. 14 week oral toxicity study in rats.
4/15/2001
45387902
Satisfied
12/1/2002


RD

3. Submit the protocol and locations for conduct
of the 2001 market test for 2000 human
subjects.
3/1/2001
Correspondence - no
MRID assigned
Satisfied
2/28/2001




4. Submit the results of the marketing test with
up to 2000 subjects.
12/1/2001
Correspondence - no
MRID assiqned
Satisfied
9/27/2001




Additional validation data for pinoxaden and M2
residues in livestock commodities
not specified
47293207
Satisfied
11/30/2007




Storage Stability Data for Rotational Crops in
barley for 15 months and wheat for 6 months.
not specified
47293208
Satisfied
11/30/2007




Fish acute toxicity tests required for parent
pinoxaden to replace supplemental studies
not specified
47293202
In Review
11/30/2007




Freshwater invertebrate acute toxicity study for
parent pinoxaden to replace an unacceptable
study
not specified
47293210
In Review
11/30/2007




Estuarine/marine fish acute toxicity test using
parent pinoxaden to replace a supplemental
study
not specified
47293210
In Review
11/30/2007




Estuarine/marine shrimp acute toxicity test is
required using parent pinoxaden to replace a
supplemental study.
not specified
47293201
In Review
11/30/2007




Freshwater fish early life-stage study using
parent pinoxaden
not specified
47293210
In Review
11/30/2007




Freshwater invertebrate life-stage study required
using pinoxaden
not specified
47293210
In Review
11/30/2007




Avian dietary studies in mallard duck and
bobwhite quail for the formulated product with
adjuvant
not specified
47293210
In Review
11/30/2007

Pinoxaden
RD
7/27/2005
Acute fish toxicity for the degradate NOA-407854
on warm water species only, for the degradate
NOA-447204 on warm water and cold water
species, and for the formulated product with
adjuvant on warm water and cold water species
not specified
47293210
In Review
11/30/2007




Freshwater invertebrate life-cycle studies for the
degradate NOA-447204 and formulated product
with adjuvant
not specified
47293210
In Review
11/30/2007




Marine-estuarine shell deposition studies for the
degradates NOA-407854 and NOA-447204.
not specified
47293210
In Review
11/30/2007




Freshwater fish early life-stage studies for the
degradate NOA-407854, and the degradate NOA
447204
not specified
47293210
In Review
11/30/2007




Freshwater invertebrate life-cycle studies for the
degradate NOA-447204, and for the degradate
NOA -407854 to replace a supplemental study.
not specified
47293210
In Review
11/30/2007




Seedling emergence and vegetative vigor
studies for each of the two main degradates
NOA-407854 and NOA-447204
not specified
47293204,47293205,
47293206
In Review
11/30/2007

6/1/2015
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Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




Tier II Aquatic plant growth studies for the parent
pinoxaden, degradates NOA-407854 and NOA-
447204, and for the formulation with adjuvant
not specified
47293210
In Review
11/30/2007




830 Series subgroup A required for the
pinoxaden technical produced on a commerical
scale.
not specified
46701301
Satisfied
11/30/2007

Prohexadione
Calcium
RD
4/26/2000
1. Storage stability on the processed
commodities of peanuts
4/30/2001
45190501 waiver
requested
Waived
8/16/2000



2. 21-dav dermal toxicity study in rabbits
10/31/2001
45430301
Satisfied
6/18/2001

Propoxycarbazon
e-sodium


1. Additional storage stability data for mustard
greens and turnips to validate the submitted field
rotational crop study
6/30/2006
46874601
Satisfied
6/30/2006

RD
6/30/2004
2. Study monitoring of "carboxylic acid"
degradate to determine if it is accumulating in
ponds, lakes and reservoirs near
propoxycarbazone use areas
6/30/2006
46365701 waiver
request
Waived
9/20/2004
waiver granted 4/26/2005



1. Developmental neurotoxicity study, brain
morphometric measurements from the mid and
low dose animals, also addressing the other
deficiencies listed in the DER to allow the
reconsideration of the FQPA database
uncertainty factor
12/1/2007
47293901
Satisfied
12/3/2007




2. Final report of the ongoing storage stability
study with prothioconazole and
desthioprothioconazole in plant commodities
3/31/2008
47408201
Satisfied
4/21/2008




3. Poultry feeding study with prothioconazole
6/30/2008
47492801
Satisfied
7/30/2008




4.Data to confirm the degree of stability of the
prothioconazole-4-hydroxy in ruminant fat for a
duration of 45 days.
12/1/2007
47107801
Satisfied
4/17/2007




5. Analytical reference standards for the
following compounds: prothioconazole-desthio,
prothioconazole sulfonic acid potassium salt,
prothioconazole
7/1/2007
N/A
Satisfied
4/4/2007

Prothioconazole
RD
3/27/2007
6. Raw data from field fortifications in MRID
46246447 (in addition to the percent conversions
reported in the study)
12/1/2007
47337401
Satisfied
2/15/2008




7. Proposed data collection and enforcement
methods for livestock commodities must be be
validated for poultry commodities. The EPA labs
validated the livestock method for liver and milk.
If the poultry method is the same or essentially
the same, then the registrant at a minimum must
present an argument and confirm (in writing) that
the cow liver LOQ covers chicken liver. At a
max, the registrant must validate the method for
poultry commodities, including a demonstration
of the LOQs.
6/30/2008
47492801
Satisfied
7/30/2008




8. Repeat sediment toxicity study using
chironomids following Agency guidelines in
which the chemical is first added to the sediment
12/1/2007
47626901
Satisfied
12/17/2008




1. Anaerobic Soil Metabolism
12/30/2000
N/A
Cancelled
N/A
There are no active registrations. All
reqistrations cancelled



2. Anaerobic Aquatic Metabolism
12/30/2000
N/A
Cancelled
N/A
There are no active registrations. All
reqistrations cancelled
6/1/2015
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PT807-HCI
12/30/1999
3. Aged Leaching
4. Terrestrial Field Dissipation
5. Developmental Rat Neurotoxicity study
10/30/2001
6/30/2001
12/30/2000
t R. .ii 'li.itinn Statue

ID for S
Date Data
Chemical
Division
ReĢ Notice Date
Review Status
Comments
N/A
N/A
N/A
Cancelled
Cancelled
Cancelled
N/A
N/A
N/A
There are no active registrations. All
registrations cancelled
There are no active registrations. All
registrations cancelled
There are no active registrations. All
registrations cancelled	
Pyraclostrobin
RD
9/30/2007
1. Annually by December 31 of each year and
beginning in 2003, report percent crop treated
data for pyraclostrobin for each crop
pyraclostrobin is sold for use on.	
annually
BASF submitted PCT
data in December of
each year, beginning
in 2003 through 2010
Satisfied
2. 2 year chronic toxicology study in rats must be
submitted for female rats. The primary
deficiency in the results for female rats in the
study previously submitted is that the highest
dose was well below the sub-chronic maximum
dose and there were no significant treatment-
related toxicological effects.
9/30/2006
3. 18-month carcinogenicity study in mice must
be submitted for female rats. The primary
deficiency in the results for female mice in the
study previously submitted is that the highest
administered dose was well below the
subchronic maximum tolerated does and there
were no significant systemic treatment-related
toxicological effects of the dosing.
BASF submitted
additional supporting
data in 2/1/2002 in
advance of the
registration decision.
45596201 and
45596202-45596206
(supplemental
information)	
Satisfied
9/30/2006
46678201
Satisfied
4. 2 generation repro study in rats; primary
deficiencies in the study previously submitted are
that there were no adverse, treatment-related
maternal, reproductive, or offspring effexts at the
highest dose tested, and the limit dose was not
approached.	
9/30/2005
45596210 submitted in
advance of the
registration decision
Satisfied
5. 28 day dermal toxicity study in rats
9/30/2004
6. 28 day inhalation study in rats
9/30/2004
45596201 submitted in
advance of the
registration decision
Satisfied
46638801
Satisfied
7. Aerobic aquatic metabolism study
9/30/2005
rebuttal submitted
45826701
Satisfied
8. Acute aquatic toxicity of pyraclostrobin
degradates BF 500-3 and BF 500-6 to
freshwater fish
9/30/2005
46164001,46164002,
46164003
Satisfied
9. Acute aquatic toxicity of pyraclostrobin
degradates BF 500-3 and BF 500-6 to freshwate
invertebrates
9/30/2005
46164001,46164002,
46164003
Satisfied
10. Acute aquatic toxicity of pyraclostrobin
degradates of BF 500-3 and BF 500-6 to
freshwater green '<
9/30/2005
46164001,46164002,
46164003
Satisfied
11. Acute toxicity of pyraclostrobin to sediment-
dwelling organisms
9/30/2005
49080401,49080402
(45826705,46164003)
Satisfied
12. Mysid life-cycle study
9/30/2005 1/31/2014
46227601
(supplemental);
49302901
Satisfied
13. Avian acute toxicity study using the
formulated product Headline EC
9/30/2005
45826702
Satisfied
EPA informed BASF on March 23,2011
(via email) that PCT data is no longer
required
2/1/2002
EPA upgraded study to acceptable for
both male and female rats 9/10/2003
10/27/2005
EPA report from CARC of 2/15/2007
indicates data requirement has been
satisfied
2/1/2002
Original study upgraded to acceptable in
HIARC memo of 2/10/2003
2/1/2002
Original study upgraded to acceptable in
HIARC memo of 2/10/2003
9/6/2005
12/18/2002
12/29/2003
waiver request requested and reviewed
12/29/2003
waiver request requested and reviewed
12/29/2003
waiver request requested and reviewed
3/11/13
(12/29/2003)
EPA classified the studies that were
received in 2003 as supplemental; new
studies were received on 3/11/2013
01/23/2014;
3/17/2004
Satisfied - 49302901 Supplemental
(46227601)	
12/18/2002
6/1/2015
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MRID for Studv
Review Status
Date Data
I
Que Date


MmmmimmMmmMimkmmmmaMMM
, > - r-



^ 1 ģ i, , i
Submitted
, ! ' , ' 1 1
Received




14. Fish acute toxicity study using the formulated
product Headline EC
9/30/2005 4/1/2015
45826703, 45826704
Not Satisfied
12/18/2002
Study was conducted according to OECD
guidelines ut classified as invalid in a
review dated 2/10/2005. A waiver request
was submitted on 8/29/2013. The waiver
request was denied for the studies on the
formulation but studies were submitted on
the technical and are under review.
Letter sent denying waiver and requesting
a new study be submitted. New study due
4/1/2015.



15.Modify tolerance enforcement methods for
determination of pyraclostrobin and it
desmethoxy metabolite in or on plant
commodities - the LC/MS/MS method D9808
and the HPLC/UV method D9904 to include any
modifications made by the EPA laboratory during
the Agency laboratory validation.
within 3 months of
BASF's receipt of the
methods from the
Agency
46710001
Satisfied
12/7/2005




16.Modify tolerance enforcement methods for
determination of residues of pyraclostrobin in or
on ruminant commodities - the HPLC/UV metho
439/0 and the HPLC/UV method 446 to include
any modifications made by the EPA laboratory
during the Agency laboratory validation.
within 3 months of
BASF's receipt of the
methods from the
Agency
46710001
Sstisfied
12/7/2005




17.Data to support storage conditions of milk
and fat tissue samples from ruminant study
9/30/2004
45765401
Satisfied
9/25/2002
Supported HED memo - 7/26/2004



18. Study confirming that rotational crop samples
were analyzed within the interval represented by
the storage stability study must be submitted.
9/30/2004
46469501
Satisified
2/9/2005




1. Photolysis in water using pyraflufen-ethyl and
all possible transformation products
12/31/2003
46162701, 46162702
Satisfied
12/31/2003




2. Avian reproduction studies
12/31/2003
46447901
Satisfied
1/18/2005

Pyraflufen-ethyl
RD
9/27/2002
3. Phototoxicity fish early life stage study using
transformation product E-1 and transformation
product E2.
12/31/2003
48409701
Satisfied
3/2/2011




4. 28-day Inhalation study
12/31/2003
48381204
Satisfied
2/10/2011




5. Preliminary analysis (830.1700) conducted in
compliance with the GLP requirements of
40CFR160.
12/31/2003
46162701
Satisfied
12/31/2003




1. Storage stability and corrosion characteristics
studies
8/9/2008
47309101
Satisfied
12/27/2007




2. In vivo dermal penetration study
8/9/2009
47860001
Satisfied
9/18/109




3. Revisions to the analytical methods
8/9/2009
47806401
Satisfied
7/17/2009

Pyrasulfotole
RD
8/9/2007
4. Analytical reference standard for pyrasulfotole,
pyrosulfotole-desmethyl and labeled internal
standards to the EPA National Pesticide
Standards Repository
8/9/2009
47806401
Satisfied
7/17/2009




5. Toxicity of residues in sediment to benthic
organisms (freshwater and marine)
8/9/2009
47552401
Satisfied
9/29/2008

Pvridalvl
RD
4/24/2008
1. Dissociation Constant
no date specified
47664701
Satisfied
2/3/2009

Pyroxsulam
RD
2/27/2008
1. One year storage stability and corrosion
characteristics studies
2/27/2009
47711901
Satisfied
3/25/2009




1. Dermal penetration
10/1/2004
47830401 47476901
Satisfied
3/2/2010 and
3/11/2009




2. 28-dav inhalation (rat)
1/1/2005
waiver requested
Waived
4/1/2004

6/1/2015
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Review Status
Date Data
Comments
, > - r-





' .. i >. . .
Received

Quinoxyfen
RD
9/30/2003
3. Avian reproduction study with the mallard
duck for parent and metabolite
10/1/2005
45360412 waiver
requested for parent;
48991801 study for
metabolite.
waiver granted for parent;
requirement satisfied for
metabolite.
3/25/2004;11/12/2
012
Waiver granted for parent; study held in
reserve for the metabolie until a method
was developed.



4. Chronic Toxicity (Marine/Estuarine Fish and
Invertebrates)
1/2005;6/2015
48102301,48102302
Not Satisfied
5/21/2010
new study due 6/2015



5. Acute Avian Reproduction
7/1/2004
47783301 waiver
requested
Requirement withdrawn
4/28/2005




6. Acute Oral (rat)
7/1/2004
46360401
Satisfied


Saflufenacil
RD
9/3/2009
1. Fish early life-stage toxicity with modified
lighting for LDPH chemicals
no date specified
N/A
Requirement withdrawn
N/A
This is no longer a requirement for this
chemical. Three ai's were chosen to
submit the study, and this was not in that
group. The data received supported
EFED's earlier conclusions regarding
LDPH phototoxicity, so no further
information is needed on this topic for
saflufenacil at this time.



2. Immunotoxicity study
no date specified
48233701
Satisfied
10/14/2010
Acceptable; review completed 3/30/11



3. One year storage stability and corrosion
characteristics
no date specified
47913803
In Review
4/27/2010
Still in review with RD/TRB under DP
378571



4. 830 series group A data (including a revised
basic CSF) for the BAS 800H TGAI/MUP when
the product is produced on commercial scale
no date specified
47913802 48445701
Satisfied
4/27/2010
Still in review with RD/TRB under DP
378571



1. Successful PMV of plant and livestock
enforcement methods
3/28/2008
48875802
Satisfied
29-Jun-12




2. Poultry feeding study
3/28/2009
47396302 waiver
requested
waiver granted
4/9/2008




3. Processing studies
9/28/2009
47453501
Satisfied
20-Jun-08




4. Analytical reference standards
3/28/2008
48875802
Satisified
29-Jun-12




5. Acute freshwater invertebrate
6/28/2008
47359202,47359203
Satisfied
2/29/2008

Spinetoram
RD
9/28/2007
6. Oyster acute toxicity test (shell deposition) raw
data or new study
6/28/2008
47359201
Satisfied
2/29/2008

7. Acute estaurine/marine fish
9/28/2009
47767601
Satisfied
6/3/2009




8. Acute freshwater fish
9/28/2008
47902003, 47902004
Satisfied
11/3/2009




9. Mysid chronic toxicity test
2/28/2009
47790501
Satisfied
6/30/2009




10. Whole sediment acute toxicity invertebrates,
estuarine and freshwater
2/28/2009
47689701
Satisfied
2/27/2009




11. Honey bee toxicity of residues on foliage
2/28/2009
47689702
Satisfied
2/27/2009




12. 5-batch preliminary analysis data on this
technical product produced on large or
commercial scale, along with a revised CSF
12/31/2007
47306602,47306603,
48085901
Satisfied
12/18/17, 5/5/10-
(901)




1. Details of the commercial scale production
process for the TGAI/MUP for the facility located
in Germany
6/30/2007
47024301
Satisfied
1/8/2007




2. 5-batch analysis for the TGAI/MUP batches
produced on a commercial scale, also submit a
revised basic formulation based on the 5-
batches produced on a commercial scale
6/30/2007
47024301
Satisfied
1/8/2007




3. Apple (juice) and grape (juice) processing
studies which monitor for residue of spirodiclofen
6/30/2007
47168602,47168601
Satisfied
7/2/2007

Spirodiclofen
RD
6/30/2005
4. Additional morphometric analyses of the
caudate putamen, parietal cortex, hippocampal
gyrus, and dentate gyrus at the mid and low
doses are required for both sexes in the
developmental neurotoxicity studv
6/30/2007
47166501
Satisfied
6/28/2007

6/1/2015
30 of 35

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Rep. Notice Date
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MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




5. Repeated freshwater fish acute toxicity study
usinq blueqill sunfish
6/30/2007
Waiver requested
waiver granted
N/A




6. Repeated freshwater fish acute toxicity study
usinq rainbow trout
6/30/2007
Waiver requested
waiver granted
N/A




7. Repeated freshwater invertebrate toxicity
study usinq daphnia maqna
6/30/2007
Waiver requested
waiver granted
N/A




8. Repeated estuarine/marine acute toxicity -
sheepshead minnow
6/30/2007
Waiver requested
waiver granted
N/A




9. Repeated estuarine/marine acute toxicity -
mysid shrimp
6/30/2007
Waiver requested
waiver granted
N/A




1. Additional storage stability data for rotational
crops
11/3/2007
47293301
Satisfied
5/18/2007

Spiromesifen
RD
5/3/2005
2. Avian reproduction study using bobwhite quail
and mallard duck
5/3/2007
47133101,47142201
Satisfied
11/30/07, 5/31/07

3. Chironomid sediment toxicity test
5/3/2007
47133102,47133103
Satisfied
5/18/2007




4. Chronic field test for pollinators
5/3/2007
47344401
Supplemental
2/12/2008
Requirement put on hold pending the
development of a protocol.



5. Preliminary commercial scale

46825601
Satisfied
9/8/2006




1. New photodegradation on soil study,
conducted on sterile soil
6/30/2009
47576501,47576502
Satisfied
10/22/2008




2. Soil taxonomy for the Saskatoon loam soil
from Sasketchwan, Canada
12/30/2009
Letter
Satisfied
1/09




3. Avian reproduction study with the mallard
duck
6/30/2010
47757401,48968801
Satisfied
5/11/2009,
10/11/2012



6/30/2008
10/15/2010
4. Field testing for pollinators
6/30/2010
47576401,47563302,
47563303, 47563304,
47563305, 47563306,
47563307, 47563308,
47563309,47563310,
47563311,47563312
Satisifed
10/22/08 (first 2),
10/7/08 (the rest)
Further testing may be required pending
protocol development.
Spirotetramat
RD
5. Freshwater fish toxicity with fathead minnows
6/30/2009
47774301
Satisfied
6/10/2009



6. Avian oral toxicity study with passerine
species
6/30/2009
47774302
Satisfied
6/10/2009




7. One year storage stability and corrosion
characteristic studies
6/30/2009
48002901
Satisfied
3/3/2010




8. Full scale five-batch preliminary analysis of
the technical material
6/30/2009
48525902,4852903,
48525904
Satisfied
7/1/2011




9. Avian Reproduction with Mallard Duck
(required in 10/15/2010 decision)
10/15/2011
48958801
In Review
10/11/2012




lO.lmmunotoxicity (required in 10/15/2010
decision)
10/15/2011
48525901
Satisfied
7/1/2001




11. Subchronic neurotoxicity (required in
10/15/2010 decision)
10/15/2011
48958802
Satisfied
10/11/2012




1. Modify the confirmatory method to use more
than single-ion monitoring or conduct an
interference study
7/31/2005
N/A
N/A
N/A
Products cancelled 5/23/2012.



2. Storage and stability data for the hops trials
which were conducted in Germany
12/31/2004
N/A
N/A
N/A
Products cancelled 5/23/2012.



Storage stability for bananas frozen for 6 months
12/31/2004
N/A
N/A
N/A
Products cancelled 5/23/2012.
Spiroxamine
RD
7/16/2004
3. Two-Generation Reproduction Study-Rat
(Additional data to clarify lactation indices and
clinical signs of toxicity in the second generation
in the submitted study (if data is insufficient to
upgrade study, a new two-generation
reproduction study must be submitted with any
future new uses)
12/30/2004
N/A
N/A
N/A
Products cancelled 5/23/2012.
6/1/2015
31 of 35

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Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-





' .. i >. . .
Received




4. Adsorption/Desorption study with soils from
hop-qrowinq areas
9/30/2005
N/A
N/A
N/A
Products cancelled 5/23/2012.



5. Freshwater fish (Blueqill sunfish)-Acute
9/30/2005
N/A
N/A
N/A
Products cancelled 5/23/2012.



6. Freshwater fish rainbow trout-Acute
9/30/2005
N/A
N/A
N/A
Products cancelled 5/23/2012.



7. Aquatic plant growth (conducted at maximum
seasonal use rate)
9/30/2005
N/A
N/A
N/A
Products cancelled 5/23/2012.
Tebufenpyrad
RD
8/26/2002
1. 90-day inhalation study
no date specified



This was registered under 3c5 and data
was confirmatory. Data not submitted to
date. Registrant notified 2/3/2014.
Company intends to conduct study nd
submit by 9/2014.



1. Analytical reference standard for tembotrione
and its M5 metabolite to the EPA National
Pesticide Standards Repository
3/28/2008
N/A
Satisfied
7/23/2008
Confirmed receipt of standard by Ft.
Meade Laboratory (National Pesticide
Standards Repository)
Tembotrione
RD
9/28/2007
2. Revision of enforcement methods LC/MS/Ms
Methods AE/03/01 for plant commodities and
00967 for livestock commodities to include a
calculation for the conversion of residues of the
metabolite(s) to parent equivalents for
quantitation
9/28/2008
47552801,47552802
Satisified
9/29/2008




3. Life cycle study of estaurine/marine
invertebrates
9/8/2009
47623501
In Review
12/15/2008




4. Chemical-specific dislodgeable foliar residue
study
9/28/2009
47305501 waiver
requested
waiver granted
12/19/2007
waiver granted 10/10/2008



1. 28-day Inhalation Study
8/8/2005
N/A
N/A
N/A
Voluntarily cancelled.



2. Developmental neurotoxicity study
8/8/2005
N/A
N/A
N/A
Voluntarily cancelled.



3. Residue data on soybean aspirated grain
fractions (qrain dust)
8/8/2005
N/A
N/A
N/A
Voluntarily cancelled.
Tepraloxydim
RD
8/8/2001
4. Aerobic aquatic metabolism study
8/8/2005
N/A
N/A
N/A
Voluntarily cancelled.



5. Leaching adsorption/desorption-mobility of
aqed residues
8/8/2005
N/A
N/A
N/A
Voluntarily cancelled.



6. Photolysis in water
8/8/2005
N/A
N/A
N/A
Voluntarily cancelled.



7. Terrestrial field dissipation studies
8/8/2005
N/A
N/A
N/A
Voluntarily cancelled.
Tetraconazole
RD
4/14/2005
1. Single side-by-side sugar beet field trial
comparing two and six applications of Eminent
125SI at 0.10 lb ai/acre/application. The
retreatment intervals for the plot receiving six
applications should be 14 days and the RTI for
the plot receiving two applications should be 21
days (the final application and harvest dates for
each should be identical; preharvest interval
(PHI) of 14 days; 4 samples from each plot
should be collected
5/1/2007
47111401
Satisfied
4/23/2007




2. 28-day inhalation study based on the current
use pattern
2/1/2007
46990301
Satisfied
11/21/2006




3. Study determining toxicity to benthic
orqanisms (includinq chronomid)
1/1/2006
46614304
Satisfied
8/2/2005




4. Study determininq the toxicity to earthworms
12/1/2006
46614305,46614306
Satisfied
8/2/2005




5. New quideline adsorption/desorption study
11/1/2006
47023201
Satisfied
1/8/2007




1. Confirmatory procedure for the livestock
tissue analytical enforcement method
3/26/2004
waiver requested
waiver granted
1/14/2004
Waiver granted 12/16/04



2. Photodeqration in soil
9/26/2004
44927933
Satisfied
4/28/2004
Found to be acceptable 6/16/04



3. One year storaqe stability
9/26/2005
46462301
Satisfied
2/4/2005
Found to be acceptable 9/23/05



4. Corrosion characteristics
9/26/2005
46462301
Satisfied
2/4/2005
Found to be acceptable 9/23/05
Thiacloprid
RD
9/26/2003
5. Bioaccumulation in fish
9/26/2005
44927602 waiver
requested
waiver granted
6/8/2004
MRID submitted supported waiver request
which was qranted on 8/3/04
6/1/2015
32 of 35

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Chemical
Division
Reft Notice Date
Conditional Data Requirement(s)

MRID for Studv
Review Status
Date Data
I
Due Date
- . ....




6. Limited field accumulation studies in rotational
crops for wheat and soybeans
9/26/2007
46677901,46677902
N/A
10/28/2005
A waiver request was submitted along
with data on wheat and soybeans. Data
not reviewed since 12 month plant back
interbal was retained.



7. Five batch analysis
when commercial
batches available/
46677905
Satisfied
10/28/2005




1. Modification of Method AG-675 to add
microwave extraction of liver or a new
enforcement method for liver, additional
radiovalidation data for beef liver
3/4/2002
45659202,45659203
Satisfied
4/23/2002




2. Storage stability data continued to cover the
conditions and intervals that plant and animal
commodity samples were stored (up to 30
months)
3/4/2002
45659204, 45659205
Satisfied
4/23/2002

Thiamethoxam
RD
12/4/2000
3. Reanalysis of the cow liver samples from the
feeding study using a microwave extraction step
3/4/2002
45659206
Satisfied
4/23/2002




4. Reanalysis of field rotational crop samples for
metabolite CGA-265307 and description of
storage conditions for future uses
3/4/2002
45659201
Satisfied
4/23/2002




5. Plant metabolism study on a leafy vegetable
(Crop group 4 or 5)
3/4/2002
45093714
Satisfied
3/31/2000




6. Poultry metabolism study
3/4/2002
44703526,44715115
Satisfied
11/19/98,
12/10/98




7. Developmental neurotoxicity study
12/4/2002
46028201,46028202
Satisfied
7/3/2003




8. Repeated daphnia chronic study
12/4/2002
45500001
Satisfied
9/19/2001




1. Analytical reference standards:
Thiencarbazone-methyl and its metabolites BYH
18636-MMT-glucoside, BYH 18636-MMT and
isotopically labeled standards provided to the
EPA National Pesticide Standards Repository
9/30/2009
sample(s) received
Satisfied
sample(s)
received




2. Additional storage stability data (sample
extraction and analysis dates for all samples) for
the wheat crop field trial study
9/30/2010
47715301 49428301
Satisfied
3/27/2009
7/14/14




3. Immunotoxicity study
9/30/2010
48263001
Satisfied
10/15/2010




4. Terrestrial field dissipation guideline currently
classified as supplemental-upgradable pending
review of recently submitted additional soil
storage stability data
no date specified
47525801
Satisfied
9/2/2008

Thiencarbazone-
methyl
RD
9/30/2008
5. Additional data for the analytical method for
the determination of residues of BYH18636 and
its metabolites BYH18636-carboxylic acid,
BYH18636-sulfonamide, BYH18636 sulfonamide'
carboxylic acid, BYH18636-MMT, and
BYH18636-triazolinone carboxamide in soil and
sediment using LC/MS/MS
9/30/2010
47070114,47070043,
47070118,47070044
rebuttal submitted
reguesing original
methods and
validations be
accepted.
In Review
10/4/2010




6. Independent laboratory validation of method
GS-004-W06-01 for the determination of
BYH 18636 and its metabolites BYH18636-
carboxylic acid, BYH18636-sulfonamide,
BYH18636-sulfonamide carboxylic acid,
BYH 18636-MMT and BYH18636-
dicarboxysulfonamide in water using LC-MS/MS
9/30/2010
rebuttal submitted
In Review
10/4/2010




7. Storage stability study conducted for a
minimum of one year ambient warehouse
conditions must be repeated and submitted
9/30/2010
47069902 waiver
reguested
waiver granted
9/29/2010

6/1/2015
33 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)
9/30/2009
MRID for Studv
47070114; 47070043;
47070118; 47070044
Review Status
Date Data
Comments
, > - r-


8. Copy of analytical methods and samples


In Review
10/4/2010
Samples received in Ft. Meade Lab.
Expiration date for technical is 6/29/2022;
expiration dates for metabolite samples
are 8/30/2027, 11/8/2014, 2/20/2017.
9. 5-batch analysis reflecting commercial scale
production
9/30/2009
47918601
Satisfied
11/25/2009

Tolfenpyrad
RD
7/28/2010
1. 90-day dermal toxicity study in rat, storage
stability, corrosion characteristics
7/28/2011
482334021,
482334022
Satisfied
9/20/2010

2. for prod. Chem. Review, submit analytical
method as described in MRIDs 47447704 and
47447705, and samples to EPA lab for validation
7/28/2011
48660301
Satisfied
9/20/2010

Topramezone
(BAS 670H)
RD
8/10/2005
1 .Aerobic aquatic metabolism
7/31/2008
47496702
In Review
8/1/2008

2. Anaerobic Aquatic Metabolism
7/31/2008
47496703
In Review
8/1/2008

3. Mobility in Soils
7/31/2008
45902425, 46242703
Satisfied
3/28/03, 4/6/04

4. Frozen Storage Stability
7/31/2008
47496704, 47496705,
47496708
In Review
8/1/2008

5. Avian Subacute Dietary
7/31/2008
47496708, 47496707
Satisfied
8/1/2008

6. Avian Reproduction
7/31/2008
47496708, 47496707
Satisfied
8/1/2008

7. Aquatic Invertebrate Life-cycle
7/31/2008
47496707
In Review
8/1/2008

8. Aquatic Plant Growth (Tier II) (Navicula)
7/31/2008
48600403
Satisfied
3/2/2012

9. Seedlinq Emerqence (Tier II)
7/31/2008
45902327
Satisfied
3/28/2003

10. Veqetative Viqor (Tier II)
7/31/2008
45902328
Satisfied
3/28/2003

11. Adequate storage stability data in the plant
and livestock metabolism studies by 7/31/2008
7/31/2008
45902410

3/28/2003

12. 5 batch analysis





Trifloxysulfuron
RD
9/29/2003
1. Independently validated analytical chemistry
methods to identify and quantify residues in
water. These methods must be sufficiently
sensitive to adequately determine NOAEC,
EC05, and characterize residues in water
resources
9/29/2008
47534701, 47534702
In Review
9/9/2008

2. Repeat of the Tier II aquatic vascular plant
test on Lemma gibba with the technical in the
acidic pH range
9/29/2008
47168201
Satisfied
7/2/2007

3. Repeat of the Tier II aquatic plant test on the
blue-green algae Anabaena flos-algae with the
technical
9/29/2008
47168202
Satisfied
7/2/2007

4. Product chemistry deficiencies
9/29/2008
47157600, 47157601
Satisfied
6/12/2007




1. Dermal sensitization study (870.2600)-submit
positive control data conducted within 6 months
of the study date for either MRID nos. 448020-34
or -35 or submit a new dermal sensitization study
Oct-03
46817301
Satisfied
4/17/2006

2. 28-day (nose only) inhalation toxicity study in
rats
Oct-03
Waiver requested
waiver granted
3/15/2005

3. Developmental neurotoxicity study
Oct-04
waiver requested
waiver granted
5/20/2005

4. Rat metabolism study
Oct-04
46503401
Satisfied
October, 2004

5. Mechanistic study (to be discussed and
designed in collaboration with the registrant)
no date specified
n/a
Reguirement withdrawn


6. Parital carcinogenicity study in the male rat at
hiqher dose levels
Dec-06
46552101 waiver
requested
waiver granted
5/23/2005

7. Additional storaqe and stability data
Oct-04
47091801
Satisfied
3/29/2007

8. Avian Reproduction study in Bobwhite Quail
Oct-04
48733902
Satisfied
2/1/2012

9. Acute Freshwater Fish Toxicity Study in
Blueqill sunfish and rainbow trout
Oct-03
46021001
Satisfied
6/30/2003

6/1/2015
34 of 35

-------
Chemical
Division
Rep. Notice Date
Conditional Data Reauirement(s)

MRID for Studv
Review Status
Date Data
Comments



, > - r-






Received

Triticonazole
RD
9/30/2002
10. Freshwater Fish Early Life-Stage Toxicity
Study
Oct-04
46876702
Satisfied
7/3/2006




11. Freshwater Fish Chronic Life Cycle Toxicity
Study
Dec-04
46876703
Satisfied
7/3/2006




12. Acute Aquatic Invertebrate Freshwater
Toxicity Study
Oct-03

Satisfied





13. Daphnia maqna Life-Cycle Toxicity Study
Dec-04
46876701
Satisfied
7/3/2006




14. Acute Estuarine/Marine Aquatic Animal
Toxicity Studies
Oct-03

Satisfied





15. Fish Early Life-Stage Estuarine/Marine
Toxicity Study
Oct-03
46876702
Satisfied
October, 2003




16. Estuarine/Marine Invertebrate Life-Cycle
Toxicity Study
Oct-03
48842801
Satisfied
Oct-03




17. Additional aerobic metabolism study
Oct-03
47296303
(unacceptable)
49017701 in review
In Review
12/5/2007,
12/2012




18. Aerobic aquatic metabolism study
Dec-04
47296301
Satisfied
12/5/2007




19. Additional aqueous photolysis data
Oct-03
47296302
Satisfied
12/5/2007




20. Corrected CSF and description of production
process
no date specified
46608801
Satisfied
7/27/2005




1. TLC scans for initial qrape extracts
Dec-01
454614402 45461403
Satisified
7/25/2001




2. Substitution of derivatizing agent in the
residue analytical method
Dec-01
45437801;45437802
Satisfied
6/25/2001




3. Incorporate changes resulting from method
review
Dec-01
rebuttal to review
sumbitted
Satisfied





4. Protocol first then pulmonary sensitization
study
Dec-01
45568300 waiver
requested
No longer required





5. Storage stability data for the grape processing
study
Dec-01
45461402,45461403
Satisfied
7/25/2001

Zoxamide
RD
4/11/2001
6. Product stewardship plan for monitoring and
recording incidents related to inhalation and
dermal sensitization. Biannual reports required,
Dec-01
N/A
Satisfied
N/A
Report received; no inicidents reported;
no longer required.



7. Full scale production data including 5 batch
analysis
Dec-01
45568301;45568302
Satisfied
12/20/2001




8. Resistance monitoring data for potatoes
Dec-01
45568303; 45568304;
45568305
Satisfied
12/20/2001
Submitted as part of harmonization effort
with PMRA. BEAD determined data no
lonqer needed.



9. Proximity information of endangered,
threatened freshwater fish and estuaring/marine
invertebrates to use sites
Dec-01
waiver requested
waiver granted
12/20/2001
Registrant is member of Endangered
Species Task Force
6/1/2015
35 of 35

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