Status of Conditional
Registrations under FIFRA
sec. 3(c)(7)(C) from 2000
through 2017
(July 2018)

-------
New Active Ingredient Registration Status
2000-2017
Ammonium
Carbamate
Division
AD
2/24/2014


49496201
Satisfied
Date Data


1. Green Algae Toxicity Study
11/24/2014
10/24/2014

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

3. 90-Day Inhalation Toxicity
4/30/2007
Waiver requested
Cancelled
N/A

Boric Acid
AD
9/27/2007
1. Seedlinq Emerqence, Tier II
6/1/2008
47675201
Satisfied
2/13/2009

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


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


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


5. Fish Acute Toxicity Test, Freshwater and
Marine
9/28/2008
47425202
Satisfied
5/15/2008


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


7. Acute Embryo laivae
9/28/2008
47425201
Satisfied
5/15/2008


8. Green Alqae Study
6/1/2008
47425203
Satisfied
5/15/2008


9. Whole Sediment Freshwater
9/28/2008
Waiver requested
Waived
N/A


10. Whole Sediment Marine
9/28/2008
Waiver requested
Waived
N/A


11. Leachinq Study
11/28/2008
Waiver requested
Waived
N/A


Cetyl pyridinium
chloride
AD
3/5/2009
1. Ready Biodeqradability
3/6/2010
49233702
Satisfied
9/26/2013

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


3. Activated Sludqe Sorption Isotherm
3/6/2010
49233701
Satisfied
9/26/2013


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


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


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


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


Copper
Carbonate, basic
(Polymeric
Betaine)
AD
10/31/2006
1. Mouse Carcinoqenicity Study
10/31/2009
47667001
Satisfied
2/9/2009

Chem Satisfied
2. Skin Sensitization
10/31/2007
Waiver requested
Waived
N/A


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


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


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


6. Fish Acute Toxicity Test, Freshwater and
Marine
10/31/2007
Waiver requested
Waived
N/A


7. Aquatic Invetebrate Acute Toxicity, Test,
Freshwater Daphnids
10/31/2007
Waiver requested
Waived
N/A


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


DDAC
AD
5/14/2003
1. 21/28-Day Dermal Toxicity
5/14/2004
47045101
Satisfied
2/1/2007

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

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

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

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

6. Whole Sediment Acute Toxicity Invertebrates,
Marine
5/14/2004
45821702
Satisfied
12/20/2002

7. Honey bee toxicity study
5/14/2004
Waiver requested
Waived
N/A

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

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

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

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

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

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

Fenpropimorph
AD
9/27/2007
1. Seedling Emergence using rice (Oryza sativa),
TEP
6/1/2008
47675201
Satisfied
2/13/2009

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


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


4. 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


5. Acute estuarine/marine fish
9/28/2008
47425202
Satisfied
5/15/2008


6. Acute Mysid shrimp
9/28/2008
47425204
Satisfied
5/15/2008


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


8. Selenastrum capricornutum (green algae)
usinq TEP
6/1/2008
47425203
Satisfied
5/15/2008


7/31/2018
1 of 18

-------
New Active Ingredient Registration Status
2000-2017
Chemic.il
	
Division



47425201
Satisfied
Date Data



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


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


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


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

No Data Required
Listeria specific
bacteriophage
AD
6/18/2008
1. Additional efficacy data (Monitoring Plan)
Not specified
47242001
Satisfied
9/28/2007

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

Chem Satisfied
2. Analytical Method
12/1/2006
46309707
Satisfied
7/8/2004


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

No Data Required
Silver chloride
AD
3/28/2006
1. Enforcement Analytical Method
6/28/2006
46914401
Satisfied
8/18/2006

Chem Satisfied
Tolylfluanid
AD
12/30/2007
1. Monitoring Study
3/1/2008
48071901
Study not acceptable but
requirement later waived
4/22/2010
Voluntary cancellation (03/17/2015)
Chem Cancelled
Trimethoxysilyl
quat
AD
11/22/2006
1. Developmental Toxicity Study (to remove
production cap of 10,000lbs)
1/31/2008
47449001
Satisfied
6/17/2008

Chem Satisfied
2. Enforcement Analytical Method
6/21/2007
47148601
Satisfied
6/7/2007

Aspergillus flavus
AF36
BPPD
6/24/2003
1. Efficacy (Texas)
6/24/2006
46859502
Satisfied
6/15/2006

Chem Satisfied
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

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

3. Storaqe 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

Bacillus subtilis
QST713
BPPD
6/20/2000
1. Manufacturing process (upgrade submitted
study; includes 5-batch analyses and quality
control to limit microbial impurities)
6/20/2001
45206101
Satisfied
9/11/2000

Chem Satisfied
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

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

Chem Satisfied
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
1. Efficacy
2/15/2009
N/A
Cancelled
N/A
Registration of product with this active
ingredient was cancelled on 9/3/2010.
Chem Cancelled
Chondrostereum
purpureum
BPPD
9/23/2004
5-batch analysis
Not specified
46702401
Satisfied
12/5/2005

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

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

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

Chem Satisfied
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

Chem Satisfied
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




1. Soil degradation study (field)
Not specified
47120701
Satisfied
5/2/2007

Chem Satisfied
7/31/2018
2 of 18

-------
New Active Ingredient Registration Status
2000-2017
Chemical
Division
Re.: Notice Date
Condition.il Data Reciuirementlsl
2. Confirmatory Monarch butterfly data
Not specified
MRID tor Studv Submitted
45759701
Review Status
Satisfied
Date Data
9/18/2002
Comments

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

Chem Satisfied
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-tarqet insect study (minute pirate buq)
9/30/2008
47462301
Satis ified
7/1/2008

5. Soil fate/terrestrial expression studies for long
ranqe 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

Chem Satisfied
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. Ladybeetle larval data
6/30/2003
45086311
Satisfied
4/7/2000

Cry3Bb1 (Event
MON 863)
BPPD
2/24/2003
1. Insect resistance management/pest biology
research data
2/13/2005
45943801 46186501 46262701
46725901 46949101
Satisfied
5/29/2003
2/4/2004 5/4/2004
12/12/2005
10/4/2006

Chem Satisfied
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
2/24/2005
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.
Chem 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-
tarqet 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 expired 9/30/2015.
Chem Satisfied
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.
Chem Cancelled
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

German
Cockroach
Pheromone
BPPD
9/23/2004
1. 5-batch analysis
8/1/2005
46469401 46539801
Satisfied
2/14/2005
5/4/2005

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

Chem Satisfied
2. 5-batch analysis for suivival 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
anisopliae F52
BPPD
6/6/2003
1. Manufacturinq process - upqrade
1/30/2011
48058801
Satisfied
4/12/2010

Chem Satisfied
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

7/31/2018
3 of 18

-------
New Active Ingredient Registration Status
2000-2017
Chemical
Division
Re.: Notice Date
Condition.il Data Reciuirementlsl
4. Product identity - upgrade
1/30/2011
MRID tor Studv Submitted
47123901
Review Status
Satisfied
Date Data
5/4/2007
Comments

MIR162
(Vip3Aa20)
BPPD
11/26/2008
1. Analytical method validation
11/1/2009
N/A
Satisfied
6/15/2009

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

MOCrylF (Event
DAS-06275-8)
BPPD
5/27/2005
1. I ndependent laboratory validation of analytical
method
Not specified
46656101
Satisfied
10/3/2005
Registration of products containing this
active ingredient expired 9/30/2015.
Chem Satisfied
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
Cry2Ab2)
BPPD
6/10/2008
1. 7-14 day daphnia study or aquatic invertebrate
dietary study
4/1/2009
47838801
Satisfied
8/27/2009

Chem Satisfied
2. Info on cross-resistance of Cry1 A. 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
U
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
ingredient were cancelled on 10/4/2010.
Chem Cancelled
2. Storaqe stability
9/1/2008
47526002
Cancelled
9/2/2008

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

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

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

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

Chem Satisfied
Pseudomonas
chloroaphis
strain 63-28
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.
Chem Cancelled
2. Growth and suivival 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.
Chem Cancelled
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

Trypsin
modulating
oostatic factor
(TMOF)
BPPD
5/24/2004
1. Storage Stability
5/24/2006
N/A
Cancelled
N/A
Registrations of products with this active
ingredient were cancelled on 7/21/2005.
Chem Cancelled
Xanthomonas
campestris pv
vesicatoria and
Pseuodomonas
syringae pv
tomato (2 active
inqredients)
BPPD
12/9/2005
1. 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.
Chem Satisfied
Quillaja saponaria
extract
BPPD
7/14/2007
1. Product performance (efficacy)
7/15/2010
47645201 to 47645212
48151401 to 48151413
Satisfied
1/15/2009
7/15/2012

Chem Satisfied

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

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

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2000-2017
4. Plant-pathogenicity
5. Non-target insect (Ladybird beetle)
6. Upgrade honeybee study
Not specified
Not specified
5/25/2001
Datp Data
Not submitted
Not submitted
(Z,E)-9, 12
Tetradecadien-1-yl
acetate
1. Storage stability
The conditions of registration are satisfied.
Z,Z-3, 13-
Octadecadien-1 -ol
1. Storage stability
10/20/2007 2/28/2014
2. Corrosion characteristics
10/20/2007 2/28/2014
New registration notice mailed to registrant
9/25/2014
Chem Satisfied
1.Freshwater invertebrate (Daphnia) study
Acequinocyl
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
3. Acute toxicity study for the deacetylated
acequinocyl using fish (rainbow trout; or bluegill
sunfish)
4. Acute toxicity study for the deacetylated
acequinocyl using an aquatic invertebrate using
daphnids or mysids as the test species
Storage stability and corrosion characteristics
Chem Satisfied
Acetaminophen
1. Conditionally registered but no data
requirements
No Data Required
1. Storage Stability Data for Rotational Crops
2. Radio validation data for IM-2_1 amide in
ruminant muscle
Waiver requested
Acetamiprid
3. Avian Reproduction
4. Acute Aquatic Invertebrate
46369201 46555601
45932501 45916201 49034202
Freshwater Fish Early Life-Stage
Toxicity of Foliar Residue to the Honey Bee
45932505 45932504
Tier II Phytotoxicity, Vegetative Vigor - Lettuce
46229602 46229601
Chem Satisfied
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.
5/14/2003;
1/09/2013
Decision made that no further data are
required.	
Alpha-Chlorhydrin
Registered conditionally but no data required
No Data Required
1. Storage stability data for the benzene-labeled
rate rice metabolism study	
2. Poultry feeding study
48060601
requested
Bispyribac-
Sodium
3. 28-day inhalation
48578001
requested
4. In vitro mammalian cell gene mutation assay
46076601
5. Residue data generated for the vegetative
vigor of terrestrial plants
Waiver requested
6. Residue data generated for the seedling
emergence of terrestrial plants
Waiver requested
7. Toxicity study to green algae
46076602
Chem Satisfied
Waiver; DP 377208; acceptable
Waiver; DP 394228; waived
Waiver; DP 287947; acceptable
Waiver; DP 287947; acceptable
1. Ruminant feeding study
2. Repeat of the 21-day chronic toxicity test with
freshwater invertebrates
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
4. Chronic toxicity test with an estuarine/marine
invertebrate species.	
All products cancelled on 7/16/07
Chem Cancelled
All products cancelled on 7/16/07
All products cancelled on 7/16/07
All products cancelled on 7/16/07
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2000-2017
Chemical
Division





Date Data





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(b)
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
6/3/2003

Chem 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


Clodinafop-
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
Requirement 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,
4/292008

Chem Satisfied



2. Additional analysis of test materials used in
mutaqenicity studies
5/30/2006
46339001, 46339002,
46339003, 46339004
Satis ified
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. 28-day inhalation toxicity study
6/1/2006
46471101
Satisfied
2/15/2005

Chem Satisfied
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


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

Chem Satisfied



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

Chem Satisfied



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 received 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 internals.
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 received 3/19/2002.
Satisfied.




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

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2000-2017
Chemical

Re,; Notice Date


MRID tor Study Submitted

Date Data
Comments




12. Aquatic invertebrate life cycle test is needed
for any future aquatic uses.
Not specified
45639718
Satisfied
8/24/2010
Referred to study received 3/19/2002.
Satisfied.

Eco2Fume
RD
12/20/1999
Conditionally registered under 3(c )(7)(c ) but no
data requirements
No data required
N/A
N/A
N/A

No Data Required



1. Product chem. Data 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
Chem Cancelled



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
Methyl
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



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 qermination/seed emerqence
4/23/2005
N/A
Cancelled
N/A
All products cancelled on 2/20/13




8. Tier II veqetative viqor
4/23/2005
N/A
Cancelled
N/A
All products cancelled on 2/20/13




9. Tier II Lemma gibba, Skeletonma costatum,
blue qreen alqae
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
Cancelled
N/A
All products cancelled on 2/20/13




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

Chem Satisfied



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


Etofenprox
RD
9/14/2001
3. ResidentiaT'lndoor 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


Etoxazole
RD
8/22/2002
1. Core freshwater fish acute toxicity studies
Not specified
46059001, 46059002
Satisfied
8/25/2003

Chem Satisfied
2. 90-day subchronic inhalation study on rats
Not specified
48134301 Waiver requested
Waived
6/28/2010





1. Honey bee acute contact LD50
12/1/2003
45802901
Satisfied
11/19/2002

Chem Satisfied



2. Mallard duck reproduction
12/1/2004
46418601
Satisfied
12/6/2004





3. Freshwater fish early life-stage or fish full life
cycle
12/1/2004
47332201 Waiver requested;
48389201 study
Satisfied
12/6/2004;
2/16/2011
Waiver denied; study satisfied
requirement.




4. Aerobic soil metabolism
12/1/2004
45385819
Satisfied
11/21/2002





5. Residue analytical methods-plants any
modification or revisions recommended by the
Aqency
6/1/2003
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)
12/1/2003
Waiver requested
Waived
11/21/2002





7. Confined accumulation in rotational crop study
12/1/2003
46440805,
47514101,
47514102,
47514103
Satisfied
1/2/2005
8/12/2008
8/12/2008
8/12/2008


7/31/2018
7 of 18

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New Active Ingredient Registration Status
2000-2017
Chemical
Division
Re.: Notice Date
Condition.il Data Reciuirement(s)

MRID tor Studv Submitted
Review Status
Date Data
Comments










8. Storage stability data for the confined
accumulation in rotational crop study
12/1/2003
47817002
Satisfied
7/30/2009


9. Developmental neurotoxicity study
12/1/2003
46501102, 46590001
Satisfied
3/18/04, 7/12/05


10. 28-day inhalation toxicity study
12/1/2003
47465801 Waiver requested
Waived
7/2/2008


11. Storaqe Stability
3/1/2004
47817002
Satisfied
7/30/2009


12. Corrosion Characteristics
3/1/2004
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

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


3. Aerobic soil metabolism and
adsorption/desorption (batch equilibrium) study.
9/27/2003
45649708
Satisfied
4/1/2002


Flazasulfuron
RD
5/14/2007
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.
Chem Satisfied
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 acceptable, DP408778
acceptable

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

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

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

10. Seedlinq emerqence (Tier II)
6/30/2009
47785308
Satisfied
6/23/2009
DP366710, DP372895 acceptable

11. 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

Fluazinam
RD
3/5/2003
1. 28-day inhalation toxicity study in rats
12/1/2003
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 registration
review
Chem Satisfied
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


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 Agency
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
12/3/2003
Waiver requested and granted
Satisfied
1/17/2002


5. Photodeqration in soil
12/1/2003
45584205 Waiver requested
Waived
10/28/2008


6. Terrestrial Field Dissipation and concurrent
storaqe stability study
12/1/2004
48631521, 48631522, 48631523
Satisfied
10/28/2008


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


Flubendiamide
RD
8/1/2008
1. Vegetative Filter Strip Study
7/31/2010
48175602, 48175604, 48175606
Satisfied
11/8/2010

Chem Satisfied
2. Protocol for Farm Pond Watering Program
Study
8/3/2010
48535201
48535201 (approval of NC
monitoring site)
48644901 (approval of GA
monitorinq site
Satisfied
11/8/2010


3. Farm Pond Water Monitoring Program Study
1/31/2012
49415301, 49415302,
49415303
Satisfied
2/20/2015





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

Chem Satisfied
7/31/2018
8 of 18

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New Active Ingredient Registration Status
2000-2017
Chemical
Division





Date Data


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

Chem Satisfied
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

Chem Satisfied



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
Satis ified
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





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

Chem Satisfied



2. Seed germination/seedling emergence study
conducted usinq 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
usinq 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. The final report of the 3 year storage stability
data for tomato
12/30/2008
45866701
Satisfied
8/24/2009

Chem Satisfied



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 number.
Satis ified
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 qrain
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 study.
12/30/2008
47098901 waiver request
Waived
4/2/2007
Agency did additional risk assessments
and concluded MOEs are adequate.
Requirement withdrawn.




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

Chem Satisfied
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


7/31/2018
9 of 18

-------
New Active Ingredient Registration Status
2000-2017

Division
Re.: Notice Date
Condition.il Data Reciuirementlsl

MRID tor Studv Submitted

Date Data





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

Chem Satisfied



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





5. Discussion of formation of impurities
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 internals 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





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

No Data Required



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

Chemical Satisfied



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)

lodosulfuron-
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)




8. Analytical methods in plants, soil, and water.
12/31/2004
N/A
N/A
N/A
For this requirement, the registrant
understood in a meeting with the Agency
on 4/9/2003 that the requirement was
placed in reseive 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.




1. 28-day dermal toxicity study in rats
4/30/2006
47048916
Satisfied
5/15/2006

Chem Satisfied



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


Ipconazole
RD
9/10/2004
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





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
Chem Satisfied
Macleaya Extract
RD
9/19/2002
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
cytoqenetics 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
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

Chem Satisfied
7/31/2018
10 of 18

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New Active Ingredient Registration Status
2000-2017
2. Guideline 830.1750 Certified Limits (basic and
alternate CSFs)
1. Developmental neurotoxicity study in the
mouse.
2. Adequate storage stability data in the plant and
livestock metabolism studies
3. Revised interference study
45651816
4. 28-day Inhalation study
5. Phytotoxicity studies
46562908 Waiver requested
47093501
6. Improvement in the extraction method in the
soil analytical method
7. A prospective groundwater monitoring study at
a vulnerable site in the southern US.
Chem Satisfied
Metaflumizone
1. Storage and corrosion characteristics
Chem Satisfied
1. Fish toxicity bluegill study
2. Honey bee acute contact
47046301, 47414001
2/2/2007,
4/30/2008
Chem Satisfied
1. Immunotoxicity study needed for future uses
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.	
48981303, 48981304
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.
48981305-48981308
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.	
48981305-48981308
5. Avian acute oral with passerine birds
6. Acute tox freshwater fish
7. Chronic freshwater fish early-life stage
8. Chronic aquatic freshwater invertebrate life-
cycle	
9. Acute marine/estuarine invertebrate
10. Aquatic vascular plant growth Tier II
11. Aquatic non-vascular Tier I
48981315-48981321
12. Chronic freshwater invertebrate whole
sediment on TGAI for Chironomus dilutus
48981320-48981322
13. Storage stability and corrosion characteristics
Chem Satisfied
1. Acute inhalation toxicity (technical)- rat (not
upgradable-must be repeated)
2. 28-day dermal toxicity-rabbit (not upgradable-
must be repeated)
3. Prenatal developmental toxicity-rabbit (possibly
upgradable)
4. Prenatal development toxicity- rat (possibly
upgradable)
5. Multigeneration reproductive toxicity-rat
(possibly upgradable)
6. Estuarine fish early life-stage- sheepshead
minnow
7. Estuarine invertebrate life-stage- mysid
8. Aquatic acute sediment toxicity testing
9. Anaerobic aquatic metabolism (possibly
upgradable)	
10. Bioconcentration in fish (possibly upgradable)
Voluntarily cancelled.
Chem Cancelled
Voluntarily cancelled.
Voluntarily cancelled.
Voluntarily cancelled.
Voluntarily cancelled.
Voluntarily cancelled.
Voluntarily cancelled.
Voluntarily cancelled.
Voluntarily cancelled.
Voluntarily cancelled.
1. Storage stability and corrosion characteristics
studies
46416408
Chem Satisfied
1. 90-day inhalation toxicity study in rats
Waiver requested
Chem Satisfied
7/31/2018
11 of 18

-------
New Active Ingredient Registration Status
2000-2017
Chemical
Jlyisi&n
Uga jtfgtics ©site


MRID tor Studv Submitted
Review Status
Date Data
Comments










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





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

Chem Satisfied
Penoxsulam
RD
9/27/2004
2. Test terrestrial plants using the liquid and end-
use products of penoxsulam.
No date specified
46930301, 46930302
Satisfied
2/13/2003





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
12/28/2004,
12/28/2004,
1/24/2005





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

Chem Satisfied



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


Picaridin
RD
12/7/2000
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





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

Chem Satisfied



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





3. Fish acute toxicity tests required for parent
pinoxaden to replace supplemental studies
Not specified
47293202
Satisfied
11/30/2007





4. Freshwater invertebrate acute toxicity study for
parent pinoxaden to replace an unacceptable
study
Not specified
47293210
Satisfied
11/30/2007





5. Estuarine/marine fish acute toxicity test using
parent pinoxaden to replace a supplemental study
Not specified
47293210
Satisfied
11/30/2007





6. Estuarine/marine shrimp acute toxicity test is
required using parent pinoxaden to replace a
supplemental study.
Not specified
47293201
Satisfied
11/30/2007





7. Freshwater fish early life-stage study using
parent pinoxaden
Not specified
47293210
Satisfied
11/30/2007





8. Freshwater invertebrate life-stage study
required usinq pinoxaden
not specified
47293210
Satisfied
11/30/2007





9. Avian dietary studies in mallard duck and
bobwhite quail for the formulated product with
adjuvant
Not specified
47293210
Satisfied
11/30/2007


Pinoxaden
RD
7/27/2005
10. 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
Satisfied
11/30/2007





11. Freshwater invertebrate life-cycle studies for
the degradate NOA-447204 and formulated
product with adjuvant
Not specified
47293210
Satisfied
11/30/2007





12. Marine-estuarine shell deposition studies for
the deqradates NOA-407854 and NOA-447204.
Not specified
47293210
Satisfied
11/30/2007





13. Freshwater fish early life-stage studies for the
degradate NOA-407854, and the degradate NOA-
447204
Not specified
47293210
Satisfied
11/30/2007





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


7/31/2018
12 of 18

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New Active Ingredient Registration Status
2000-2017
Chemical
Division
Re.: Notice Date


MRID tor Studv Submitted
Review Status
Date Data
Comments













15. Seedling emergence and vegetative vigor
studies for each of the two main degradates NOA-
407854 and NOA-447204
Not specified
47293204, 47293205, 47293206
Satisfied
11/30/2007





16. 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
Satisfied
11/30/2007





17. 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

Chem Satisfied


2. 21-day 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

Chem Satisfied
RD
6/30/2004
2. Study monitoring of "carboxylic acid" degradate
to determine if it is accumulating in ponds, lakes
and reseivoirs 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

Chem Satisfied



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 feedinq 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
registrations cancelled
Chem Cancelled



2. Anaerobic Aquatic Metabolism
12/30/2000
N/A
Cancelled
N/A
There are no active registrations. All
registrations cancelled

PT807-HCI
RD
12/30/1999
3. Aged Leaching
10/30/2001
N/A
Cancelled
N/A
There are no active registrations. All
registrations cancelled




4. Terrestrial Field Dissipation
6/30/2001
N/A
Cancelled
N/A
There are no active registrations. All
registrations cancelled




5. Developmental Rat Neurotoxicity study
12/30/2000
N/A
Cancelled
N/A
There are no active registrations. All
registrations cancelled

7/31/2018
13 of 18

-------
New Active Ingredient Registration Status
2000-2017
Chemical
Division
Re,; Notice Date


MRIDfor Studv Submitted
Review Status
Date Data
Comments
Q/A notes 1




Received





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

EPA informed BASF on March 23,2011
(via email) that PCT data is no longer
required
Chemical Pending or
overdue



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
toxicoloqical effects.
9/30/2006
BASF submitted additional
supporting data in 2/1/2002 in
advance of the registration
decision. 45596201 and
45596202-45596206
(supplemental information)
Satisfied
2/1/2002
EPA upgraded study to acceptable for
both male and female rats 9/10/2003




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 dose and there were no
significant systemic treatment-related toxicological
effects of the dosing.
9/30/2006
46678201
Satisfied
10/27/2005
EPA report from CARC of 2/15/2007
indicates data requirement has been
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
2/1/2002
Original study upgraded to acceptable in
HIARC memo of 2/10/2003




5. 28-day dermal toxicity study in rats
9/30/2004
45596201 submitted in advance
of the registration decision
Satisfied
2/1/2002
Original study upgraded to acceptable in
HIARC memo of 2/10/2003




6. 28-day inhalation study in rats
9/30/2004
46638801
Satisfied
9/6/2005





7. Aerobic aquatic metabolism study
9/30/2005
rebuttal submitted 45826701
Satisfied
12/18/2002





8. Acute aquatic toxicity of pyraclostrobin
degradates BF 500-3 and BF 500-6 to freshwater
fish
9/30/2005
46164001, 46164002, 46164003
Satisfied
12/29/2003
Waiver request requested and reviewed
U



9. Acute aquatic toxicity of pyraclostrobin
degradates BF 500-3 and BF 500-6 to freshwate
invertebrates
9/30/2005
46164001, 46164002, 46164003
Satisfied
12/29/2003
Waiver request requested and reviewed
U
Pyraclostrobin
RD
9/30/2007
10. Acute aquatic toxicity of pyraclostrobin
degradates of BF 500-3 and BF 500-6 to
freshwater qreen alqae
9/30/2005
46164001, 46164002, 46164003
Satisfied
12/29/2003
Waiver request requested and reviewed
U



11. Acute toxicity of pyraclostrobin to sediment-
dwelling organisms
9/30/2005
49080401, 49080402
(45826705, 46164003)
Satisfied
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




12. Mysid life-cycle study
9/30/2005 1/31/2014
46227601 (supplemental);
49302901
Satisfied
1/23/2014;
3/17/2004
Satisfied - 49302901 Supplemental
(46227601)




13. Avian acute toxicity study using the
formulated product Headline EC
9/30/2005
45826702
Satisfied
12/18/2002





14. Fish acute toxicity study using the formulated
product Headline EC
9/30/2005 4/1/2015
45826703, 45826704,
46164001/2/3
Satisfied
12/18/2002
Study was conducted according to OECD
guidelines but 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.
??? Update received.
Match received date to
received date in
comment?



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

?? Due date
7/31/2018
14 of 18

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New Active Ingredient Registration Status
2000-2017

Division
Re.: Notice Date
Condition.il Data Reciuirementlsl
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
durinq the Aqency laboratory validation.
within 3 months of
BASF's receipt of the
methods from the
Agency
MRID tor Studv Submitted
46710001
Review Status
Sstisfied
Date Data
12/7/2005
Comments
?? Due date



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 inteival represented by
the storage stability study must be submitted.
9/30/2004
46469501
Satis ified
2/9/2005





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

Chem Satisfied



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

Chem Satisfied



2. In vivo dermal penetration study
8/9/2009
47860001
Satisfied
9/27/2009





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
orqanisms (freshwater and marine)
8/9/2009
47552401
Satisfied
9/29/2008


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

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

Chem Satisfied
Saflufenacil
RD
9/3/2009
1. Fish early life-stage toxicity with modified
lighting for LDPH chemicals
No date specified
N/A
Satisfied/ Waived
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.
Chem In Review



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
48212601
Satisfied
9/29/2010





4. 830 series group A data (including a revised
basic CSF) for the BAS 800H TGAI/M UP when
the product is produced on commercial scale
No date specified
47913802 48445701
Satisfied
4/27/2010





1. Successful PMV of plant and livestock
enforcement methods
3/28/2008
48875802
Satisfied
6/29/2012

Chem Satisfied



2. Poultry feedinq study
3/28/2009
47396302 Waiver requested
Waived
4/9/2008





3. Processinq studies
9/28/2009
47453501
Satisfied
6/20/2008





4. Analytical reference standards
3/28/2008
48875802
Satis ified
6/29/2012





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





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


Spinetoram
RD
9/28/2007
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 foliaqe
2/28/2009
47689702
Satisfied
2/27/2009





12. 5-batch preliminary analysis data on this
technical product produced on large or
commercial scale, alonq with a revised CSF
12/31/2007
47306602, 47306603, 48085901
Satisfied
12/18/2017,
5/5/2010


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Chemical
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Date Data





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

Chem Satisfied



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





revised basic formulation based on the 5-batches
produced on a commercial scale





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 study
6/30/2007
47166501
Satisfied
6/28/2007





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





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





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





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





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





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

Chem Pending or
Overdue



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


Spiromesifen
RD
5/3/2005
3. Chironomid sediment toxicity test
5/3/2007
47133102, 47133103
Satisfied
5/18/2007


4. Chronic field test for pollinators
5/3/2007
47344401
Satisfied
2/12/2008
Requirement satisfied with the
supplemental study and polinator issue
has been forwarded to the active Reg
Review case for resolution.




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

Chem In Review



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





3. Avian reproduction study with the mallard duck
6/30/2010
48958801
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
Satis ifed
10/22/2008 (first
2), 10/7/2008 (the
rest)


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)
5/15/2011
48958801
Satisfied
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
Cancelled
N/A
Products cancelled 5/23/2012.
Chem Cancelled



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




2a. Storage stability for bananas frozen for 6
months
12/31/2004
N/A
Cancelled
N/A
Products cancelled 5/23/2012.

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2000-2017
Chemical
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Date Data


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
Cancelled
N/A
Products cancelled 5/23/2012.




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




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




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




7. Aquatic plant growth (conducted at maximum
seasonal use rate)
9/30/2005
N/A
Cancelled
N/A
Products cancelled 5/23/2012.

Tebufenpyrad
RD
8/26/2002
1. 90-day inhalation study
Cancelled

Cancelled






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



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




3. Residue data on soybean aspirated grain
fractions (qrain dust)
8/8/2005
N/A
Cancelled
N/A
Voluntarily cancelled.

Tepraloxydim
RD
8/8/2001
4. Aerobic aquatic metabolism study
8/8/2005
N/A
Cancelled
N/A
Voluntarily cancelled.




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




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




7. Terrestrial field dissipation studies
8/8/2005
N/A
Cancelled
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 internals 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 haivest dates for
each should be identical; preharvest inteival (PHI)
of 14 days; 4 samples from each plot should be
collected
5/1/2007
47111401
Satisfied
4/23/2007

Chem Satisfied



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 organisms
(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
Waived
1/14/2004
Waiver granted 12/16/04
Chem Satisfied



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
Waived
6/8/2004
MRID submitted supported waiver request
which was qranted on 8/3/04




6. Limited field accumulation studies in rotational
crops for wheat and soybeans
9/26/2007
46677901, 46677902
Waived
10/28/2005





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

Chem Satisfied



2. Storage stability data continued to cover the
conditions and internals 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
feedinq study usinq 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
storaqe conditions for future uses
3/4/2002
45659201
Satisfied
4/23/2002





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





6. Poultry metabolism study
3/4/2002
44703526, 44715115
Satisfied
11/19/1998,
12/10/1998


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Chemic.il
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fie.: Notice D»itc










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

Chem Satisfied
Tolfenpyrad
RD
7/28/2010
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





1.Aerobic aquatic metabolism
7/31/2008
47496702
Satisfied
8/1/2008

Status?



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





3. Mobility in Soils
7/31/2008
45902425, 46242703
Satisfied
3/28/2003,
4/6/2004





4. Frozen Storage Stability
7/31/2008
47496704, 47496705, 47496708
Satisfied
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
Satisfied
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


Topramezone
RD
8/10/2005
10. Veqetative Viqor (Tier II)
7/31/2008
45902328
Satisfied
3/28/2003


(BAS 670H)
11. Adequate storage stability data in the plant
and livestock metabolism studies by 7/31/2008
7/31/2008
45902410
Satisfied
3/28/2003

submitted as part of the
original registration
application and included
in HED's residue
chemistry chapter. Study
acceptable 5/27/05
(DP310772). Should not
have been included in
the conditional
requirements. Per Kay



12. 5-batch analysis
7/31/2008
47496701
Satisfied
8/1/2008





1. TLC scans for initial qrape extracts
12/1/2001
454614402 45461403
Satis ified
7/25/2001

Chemical Satisfied



2. Substitution of derivatizing agent in the residue
analytical method
12/1/2001
45437801; 45437802
Satisfied
6/25/2001





3. Incorporate changes resulting from method
review
12/1/2001
Rebuttal to review sumbitted
Satisfied






4. Protocol first then pulmonary sensitization
study
12/1/2001
45568300 Waiver requested
Waived






5. Storage stability data for the grape processing
study
12/1/2001
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,
12/1/2001
N/A
Satisfied
N/A
Report received; no inicidents reported; no
longer required.




7. Full scale production data including 5 batch
analysis
12/1/2001
45568301; 45568302
Satisfied
12/20/2001





8. Resistance monitoring data for potatoes
12/1/2001
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
12/1/2001
Waiver requested
Waived
12/20/2001
Registrant is member of Endangered
Species Task Force











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