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Status of Actual/Anticipated Residue Tolerance Review Process

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As of December 31, 2007, EPA has screened dietary assessments for 192 pesticides with tolerance decisions made between August 1996 and the end of 2004.  The Agency has determined that 185 continue to meet the FQPA safety standard and the next scheduled review for these chemicals will be conducted as part of the Registration Review process. For the remaining seven chemicals, avermectin, chlorpropham, esfenvalerate, imazalil, iprodione, thiabendazole, and thiophanate-methyl, further review is necessary.  For most of the seven chemicals, new risk assessments are currently being conducted or have been recently conducted for other purposes.  Consequently, the Agency decided to defer its final determination for these chemicals until the risk assessments are completed and any new risk management decisions are made.  All assessments are conducted using the most recent monitoring data and risk assessment methodologies. 

The tables below summarize, by year, the 192 reviewed chemicals.  EPA’s goal is to complete its screening review approximately three years after the initial tolerance decisions.  For example, by the end of 2008, all of the 2005 initial assessments will be screened and review determinations will be completed for most of the chemicals.

List of Acronyms in Tables:

aRAD:
Acute Population Adjusted Dose
LOQ:
Level of Quantification
AR:
Anticipated or Actual Residue
MBS:
Market Basket Survey
cPAD:
Chronic Population Adjusted Dose
PCT:
Percent Crop Treated
FDA:
Food and Drug Administration
PDP:
Pesticide Data Program
FQPA:
Food Quality Protection Act
RA:
Risk Assessment
FRN:
Federal Register Notice
RAC:
Raw Agricultural Commodity
FT:
Field Trial
RED:
Reregistration Eligibility Decision
LOD:
Level of Detection    

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Summary of Tolerance Decisions

2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

2004 (28 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
Ethyl Naphthalene Acetate
056008
Tolerance Level - Review Complete RED 05/26/04 D295168
Avermectin
122804
Field Trail, MBS, & PDP (milk)
MBS for apples, celery, oranges, orange juice, pears, potatoes & tomatoes
70FR7876
02/16/05
65FR80353
12/21/00
D297225
Further Review Needed1
Oryzalin
104201
Tolerance Level - Review Complete TRED 05/26/04 D288403
Benfluralin
084301
Tolerance Level - Review Complete RED 07/31/04 D294493
Desmedipham
104801
Tolerance Level - Review Complete TRED 07/31/04 D301539
Trifluralin
036101
Field Trial – Review Complete TRED 08/31/04  
Thifensulfuron Methyl
128845
Tolerance Level - Review Complete 69FR55975
09/17/04
D332697
12/12/06
Dimethenamid
129051
Tolerance Level - Review Complete 69FR57197
09/14/04
D304790
Flumetsulam
129016
Tolerance Level - Review Complete TRED 09/16/04 D306239
Fluridone
112900
Tolerance Level - Review Complete TRED 09/20/04 D306456
Chlorimuron
128901
Tolerance Level - Review Complete TRED 09/24/04 D301317
Ethoxyquin
055501
Tolerance Level - Review Complete RED 09/27/04 D310459

Cycloate
004130
Tolerance Level - Review Complete RED 09/30/04  
MCPA
030501
Tolerance Level - Review Complete RED 09/30/04 D307892
Naptalam Sodium Salts
030703
Field Trial – Review Complete RED 09/30/04  
Thiram
079801
Field Trial - Review Complete RED 09/30/04 D293295
Pyraclostrobin
099100
Field Trial – Review Complete 69FR63083
10/29/04
D323632
11/30/05
Mepanipyrim
288203
Field Trial – Review Complete 69FR60820
9/30/04
D305695
Deltamethrin
097805
Field Trial – Review Complete 69FR60602
9/30/04
D303463
Fenamidone
046679
Field Trial – Review Complete 69FR58058
9/29/04
D284460
D314116
Lactofen
128888
Field Trial – Review Complete FR6957207
9/24/04
D269621
D339011
Pyrimethanil
288201
Field Trial – Review Complete 69FR52434
8/26/04
D284866
DCPA
078701
FDA monitoring for lettuce only – Review Complete2 69FR51571
8/20/04
D283580
Spiroxamine
120759
Field Trial  - Review Complete 69FR42560
7/16/04
D284789
Novaluron
124002
Field Trial - Review Complete 69FR31013
6/2/04
D295824
Imidacloprid
129099
Tolerance Level – Review Complete 69FR30076
5/26/04
D337873
Fosthiazate
129022
Field Trial - Review Complete 69FR18263
4/7/04
D291003
Sulfuryl fluoride
078003
Magnitude of Residue – Review Complete 69FR3240
1/23/04
D312659

1 Because both aPAD and cPAD are close to the Agency's level of concern, further review considering newer data is needed.

2 Many uses were dropped during the Reregistration process including the lettuce use which was the only use that relied upon monitoring data.

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2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

2003 (16 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
4-chlorophenoxy -acetic acid
019401
Tolerance Level - Review Complete TRED 04/02/03 D288835
Dinocap
036001
Field Trial - Review Complete RED 05/29/03 D278615
Lactofen
128888
Field Trial - Review Complete TRED 09/24/03 D269621
Sodium Acifluorfen Field Trial - Review Complete RED 09/26/03 D279497
Ziram
034805
Field Trial - Review Complete TRED 09/29/03 D280356
Famoxadone
113202
Field Trial - Review Complete 68FR39462
7/2/03
D276070
Thiacloprid
014019
Field Trial - Review Complete 68FR55503
9/26/03
D278485
Thiamethoxam
060109
Field Trial - Review Complete 67FR66561
11/1/02
68FR51471
8/27/03
D285545
Cyromazine
121301
ARs for ruminants - Review Complete 68FR72585
12/6/02
D284528
Folpet
081601
Field Trial - Review Complete 68FR10377
3/5/03
D285511
Hexythiazox
128849
Field Trial - Review Complete 68FR10370
3/5/03
D286278
Bifenthrin
128825
PDP and Field Trial Review Complete3 68FR23056
4/30/03
D283796
Emamectin benzoate
122806
Field Trial - Review Complete 68FR40791
7/9/03
D291065
Bifenazate
000586
Field Trial (tomatoes only) - Review Complete 68FR55494
9/26/03
D286170
Glufosinate ammonium
128850
Field Trial - Review Complete 68FR55833
9/29/03
D290086
Sethoxydim
121001
Field Trial - Review Complete 68FR55858
9/29/03
D278440

3 Because the highest dietary risk < 22% of the cPAD and all other PADs are below 10%, it is unlikely that residues detected in monitoring studies would increase to the extent that the dietary risks would increase to near the level of concern, even if use increased significantly. Therefore, the next scheduled review will be during the Registration Review Process.

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2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

2002 (39 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
Pymetrozine
101103
Field Trial - Review Complete 66FR66786
12/27/01
D279321
Ethalfluralin
113101
Tolerance Level - Review Complete 67FR2333
01/17/02
D273508
Bentazon
275200
Field Trial - Review Complete 67FR5740
02/07/02
D273508
Diflubenzuron
108201
Field Trial - Review Complete 67FR7085
02/15/02
67FR59006
09/19/02
D277608
Difenzoquat
106401
Tolerance Level - Review Complete TRED 04/25/02 D279988
Diquat Dibromide
032201
Tolerance Level - Review Complete TRED 04/25/02 D281200
Thiabendazole
060101
PDP and Field Trial – crops not specified for PDP RED 5/01/02 Further Review Needed4
Propiconazole
122101
Study data - Review Complete RED 07/18/06  
Propanil
028201
Field Trial - Review Complete TRED 05/20/02 D281147
Cyhalofop-butyl
082583
Field Trial (rice) - Review Complete 67FR38407
06/4/02
D277695
Carboxin
090201
Tolerance Level - Review Complete 67FR40211
06/12/02
D288406
Linuron
035506
Field Trial - Review Complete TRED 05/31/02 D271950
Norflurazon
105801
Tolerance Level - Review Complete TRED 05/31/02 D279777
Triflumizole
128879
Field Trial - Review Complete 67FR40219
06/12/02
D280864
Sodium Acifluorfen
114402
Tolerance Level - Review Complete Other 06/03/02 D274255
Metolachlor
108801
Tolerance Level - Review Complete TRED 06/17/02 D282964
Propyzamide
101701
PDP & FDA Monitoring - Review Complete5 TRED 07/05/02 D275194
Tebuthiuron
105501
Magnitude of Residue - Review Complete TRED 07/05/02 D274580
Imazalil
111901
PDP data used TRED 07/12/02 D280708
Further Review Needed6
Butylate
041405
Tolerance Level - Review Complete TRED 07/19/02 D284229
Chlorpropham
018301
Acute – tolerances & 100% CT Chronic & Cancer – PDP data used for potatoes 2 X 10-6 TRED 07/19/02 D284229
Further Review Needed7
Indoxacarb
067710
Field Trial - Review Complete 67FR47299
07/18/02
D298137
Primisulfuron
128973
Tolerance Level - Review Complete TRED 07/23/02 D283729
Metsulfuronmethyl
122010
Tolerance Level - Review Complete RD 07/24/02 D281907
Chlorsulfuron
118601
Tolerance Level - Review Complete RD 07/30/02 D266070
Diuron
035505
Field Trial - Review Complete TRED 07/30/02 D291567
Endosulfan
079401
Field Trial and PDP & FDA Monitoring – Review Complete8 RED 07/31/02 D250471
Hexazinone
107201
Tolerance Level - Review Complete TRED 08/01/02 D275621
Methoprene
105401
Exemption from tolerances - Review Complete    
Asulum
106901
Field Trial - Review Complete TRED 08/01/02 D276505
Fenarimol
206600
FDA monitoring for apples, bananas, cherries, grapes, and pears  – Review Complete9 TRED 08/01/02 D283429
Oxyfluorfen
111601
Field Trial - Review Complete RED 08/02/02 D279694
Thiophanate-methyl
102001
MBC residues from benomyl derived from PDP data, Field Trial data used for TM 67FR55137
08/28/02
D275774
Further Review Needed10
Triclopyr
116001
ARs (chronic, acute) for rice, fish, shellfish, livestock commodities 67FR58712
09/18/02
This information provide by RD
Clopyralid
117403
Tolerance, PCT plus Processing Factors - Review Complete 67FR60152
09/25/02
D265925
Tolylfluanid
309200
Field Trial - Review Complete 67FR60130
09/25/02
D275570
Fenamidone
046679
Field Trial - Review Complete 67FR60966
09/27/02
D297216
Cyfluthrin
128831
Field Trial - Review Complete 67FR60976
09/27/02
D284804
lambda-Cyhalothrin
128897
Field Trial - Review Complete 67FR60902
09/27/02
D301595

4 Because the aPAD from the RED is close to the Agency's level of concern, further review is needed.

5 Because the highest dietary risk, < 1% of the cPAD, and cancer risk is about 1 X 10-7, it is unlikely that residues detected in monitoring studies would increase to the extent that the dietary risks would increase to near the level of concern, even if use increased significantly. Therefore, the next scheduled review will be during the Registration Review Process.

6 Because cancer risk is close to the Agency's level of concern, further review is needed.

7 Because cancer risk is close to the Agency's level of concern, further review is needed.

8 Because the highest dietary risk < 6% of the aPAD and cPAD, it is unlikely that residues detected in monitoring studies would increase to the extent that the dietary risks would increase to near the level of concern, even if use increased significantly. Therefore, the next scheduled review will be during the Registration Review Process.

9 Because the highest dietary risk < 1% of the cPAD, it is unlikely that residues detected in monitoring studies would increase to the extent that the dietary risks would increase to near the level of concern, even if use increased significantly. Therefore, the next scheduled review will be during the Registration Review Process.

10 Because cPAD is close to the Agency's level of concern, further review is needed.

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2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

2001 (10 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
Clopyralid
117403
Review Complete 66FR2308
1/11/01
D270885
Clomazone
125401
Review Complete 66FR68908
02/14/01
D280762
Flutolanil
128975
Review Complete 66FR10196
02/20/01
D268880
Chlorothalonil
081901
PDP for most uses and FDA for blueberries, cabbage, cranberries, mangoes, onions, papaya, peanuts, and soybeans
Review Complete11
66FR14330
3/12/01
72FR41224
7/27/07
D337925
D305987
Imazethapyr
128922 & 23
Review Complete 66FR14846
03/14/01
D232428
Hexythiazox
128849
PCT and study data for chronic analysis - Review Complete 66FR19879
4/18/01
D269766
Thiamethoxam
060109
PCT and study data for chronic analysis - Review Complete 65FR80343
12/21/00;
66FR28386
5/23/01
D285545
Buprofezin
275100
Field Trial data for chronic - Review Complete 66FR46381
9/5/01
D244349
Metalaxyl
113501 & 02
Review Complete 66FR47994
09/17/01
 
Propargite
097601
Field Trial and PDP for grapes, citrus, potatoes, nectarines
Review Complete12
RED 09/28/01  

11 A new assessment was completed in support of tolerance decision for snow peas in 2007. Because the highest dietary risk is 8% of the cPAD, it is unlikely that residues detected in monitoring studies would increase to the extent that the dietary risks would increase to above the level of concern, even if use increased significantly. Therefore, the next scheduled review will be during the Registration Review Process.

12 Because the highest dietary risk is low, it is unlikely that residues detected in monitoring studies would increase to the extent that the dietary risks would increase above the level of concern, even if use increased significantly. Therefore, the next scheduled review will be during the Registration Review Process.

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2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

2000 (6 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
Diclofop-methyl Field Trial - Review Complete 08/10/00-RA
RED 09/00
Some monitoring data - not used
Terrazole
(Etridiazole)
Field Trial - Review Complete 06/06/00-RA
RED 09/00
No AR chronic and acute, and ½ LOQ for cancer
Triallate Field Trial - Review Complete 04/18/00-RA
RED 03/01
Some monitoring data - not used
Bentazon Field Trial - Review Complete 11/15/99-RA
FRN 03/08/00
Only AR is  for succulent beans
Cyromazine Only ARs for meat and milk - Review Complete 07/22/99 - Exposure memo  
Indoxacarb Field Trial - Review Complete 08/22/00-RA
FRN 09/29/00
 

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2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

1999 (36 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
Captan Field Trial and monitoring data RED 11/99 Review Complete13
3-Carbamyl-2,4,
5-trichorobenzoic acid
Exemption from tolerance - Review Complete    
Dichlorbenil Tolerance Level - Review Complete    
Dicofol Field Trial and monitoring data RED 11/98 Review Complete14
EPTC Field Trial - Review Complete RED 12/99 citrus processing study needed
Folpet Field Trial - Review Complete RED 11/99 hops (imported) added in 2002
hops and avocado added in 2004
Magnesium Phosphide Field Trial - Review Complete RED 12/98
FRN 06/09/99
LOD used
Methomyl Field Trial - Review Complete RED 12/98 Aggregate with thiodicarb
Pebulate Field Trial - Review Complete RED 11/98 ½ LOD for all RAC
Propachlor Tolerance Level - Review Complete RED 11/99  
TPTH Field Trial - Review Complete RED 9/99 ½ LOQ for metabolites & cooking study
Azoxystrobin Primarily Field Trial - Review Complete FRN 3/17/99 AR for raisins and grapes only
Clofentezine Tolerance Level - Review Complete    
Dicamba Tolerance Level - Review Complete    
Difenconazole Field Trial - Review Complete FRN 06/02/99 No AR for acute
Emamectin benzoate Field Trial - Review Complete FRN 05/19/99 Acute - ½ LOD Chronic - no AR
Hexaconazole Field Trial - Review Complete FRN 06/30/99 RA 4/20/99
Kresoxim-methyl Field Trial - Review Complete FRN 06/10/99 Concentration factors
Picloram Tolerance Level - Review Complete    
Pyridate Tolerance Level - Review Complete    
Hexythiazox Tolerance Level - Review Complete    
Aluminum tisoethylphos Tolerance Level - Review Complete    
Red pepper Exemption from tolerances - Review Complete    
Coppers Exemption from tolerances - Review Complete    
Tebuconazole Field Trial - Review Complete FRN 01/08/99 Acute-AR Chronic-Tolerance
Cinnamaldehyde Exemption from tolerances - Review Complete    
Beauvaria bassiana Exemption from tolerances - Review Complete    
Trichoderma viride Exemption from tolerances - Review Complete    
Dichloroquinoline-carboxlic acid Tolerance Level - Review Complete    
Tebufenozide Tolerance Level - Review Complete FRN 04/07/99  
Halosulfuron Tolerance Level - Review Complete    
Aqueous ext of seaweed meal 25(b) - Review Complete    
Ethylene Exemption from tolerances - Review Complete    
Gibberellic acid Exemption from tolerances - Review Complete    
Indolebutyric acid 25(b) - Review Complete    
Pelargonic acid Exemption from tolerances - Review Complete    

13 The Captan RED that was approved in November 1999 included the initial tolerance decision.  Over the period from 1994-2003, total use has declined, particularly for high consumption foods such as apples.  PDP monitoring data indicate similar or lower residue levels than those used for the initial assessment.  Also, the highest acute risk is 36% of the PAD, the highest cPAD is <2%, and cancer risk is 1.3 X 10-7.   Based on the stable use, stable or declining residues in available monitoring data and the portion of the risk cup available, the Agency believes that that residue levels used in its initial assessment would not increase in a way that would alter its initial safety finding.  Therefore, the review is complete.  Next scheduled anticipated residue review will be completed during Registration Review.

14 The Dicofol RED that was approved in December 1999 included the initial tolerance decision.  For acute risks, EPA only used study data and as such, the review is complete.  However, extensive monitoring data were used for the chronic risk assessment used in making the safety determinations for existing tolerances.  Over the period from 1994-2003, total use has remained stable, particularly for high consumption foods.  PDP monitoring data indicate similar or lower residue levels than those used for the initial assessment.  Also, the highest chronic risk is 38% of the PAD for children 1-6 years old.  Commodities (apples and grapes) commonly consumed for this age group have stable use.  Based on the stable use, stable or declining residues in available monitoring data and the portion of the risk cup available, the Agency believes that that residue levels used in its initial assessment would not increase in a way that would alter its initial safety finding.  Therefore, the review is complete.  Next scheduled anticipated residue review will be completed during Registration Review.

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2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

1998 (31 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
Alachlor Field Trial - Review Complete RED 12/98  
Aluminum phosphide Field Trial - Review Complete RA 6/22/98  
Chlorothalonil Field Trial  and monitoring data (PDP & FDA)
Review Completed15
RED 04/99 See 2001 table
Hydramethylnon Tolerance Level - Review Complete    
Iprodione Field Trial  and monitoring data (PDP & FDA) RED 11/98 Further Review Needed16
Thiodicarb Field Trial - Review Complete RED 12/98  
Bacillus thuringgiensis Exemption from tolerances - Review Complete    
Bifenthrin Tolerance Level - Review Complete FRN 06/30/99 Updated with new data
08/21/02
Clethodim Tolerance Level - Review Complete FRN 04/08/98  
Cyfluthrin Field Trial - Review Complete FRN 06/30/99  
Cymoxanil Tolerance Level - Review Complete FRN 06/30/99  
Cypermethrin Field Trial - Review Complete FRN 09/11/98  
Deltamethrin Field Trial - Review Complete FRN 08/26/98 All Field Trial - 07/17/03
Fenoxaprop-ethyl Tolerance Level - Review Complete 02/02/98 D242374
Fludioxonil Tolerance Level - Review Complete    
Flufenacet Tolerance Level - Review Complete    
Isoxaflutole Field Trial - Review Complete FRN 09/23/98  
Myclobutanil Tolerance Level - Review Complete FRN 05/12/98  
Prometryn Tolerance Level - Review Complete    
Sulfosate Tolerance Level - Review Complete
Tefluthrin Tolerance Level - Review Complete    
Tralomethrin Field Trial - Review Complete FRN 11/26/97  
Zeta-cypermethrin Tolerance Level - Review Complete    
Hydroprene Exemption from tolerances - Review Complete    
Fenvalerate Field Trial  and monitoring data (PDP & FDA) FRN 11/26/97 Voluntary Cancellation
Esfenvalerate Field Trial  and monitoring data (PDP & FDA) FR 09/11/98
& 04/29/98
D274838
Further Review Needed17
Cryolite Field Trial - Review Complete   D279010
Bensulfuron methyl Tolerance Level - Review Complete    
Dimethoxyprimidinylaminocarb Tolerance Level - Review Complete    
Quizalofop-ethyl Tolerance Level - Review Complete    
Triasulfuron Tolerance Level - Review Complete    

15 New assessment completed in support of tolerance decision for snow peas in 2007.  Because the highest dietary risk is 8% of the cPAD, it is unlikely that residues detected in monitoring studies would increase to the extent that the dietary risks would increase to the level of concern, even if use increased significantly.  Therefore, the next scheduled review will be during the Registration Review Process.

16 New assessment is being conducted.  Final decision regarding the anticipated residue review will be made after the current action is completed.

17 The initial tolerance decision for esfenvalerate was in 1998. In 2004, a new assessment was completed indicating that dietary risks are below EPA's level of concern. However, both the aPAD and cPAD are close enough to the Agency's level of concern that changes in use patterns have the potential to increase residue to levels that could be of concern. A new risk assessment will be conducted in 2008 using the most recent data. A final decision regarding the anticipated residue review will be completed after the current action is completed.

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2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1996-97 | Acronyms List

1996-97 (26 chemicals reviewed)
Chemical
Type of Data Used for Estimating Residue Levels
Citation
Comments
 
Collectotrichum Gleosporioides Exemption from tolerances - No further action required    
Mepiquat Chloride Tolerance Level - Review Complete    
Bromacil Tolerance Level - Review Complete    
Butralin All tolerances revoked    
Diflubenzuron Field Trial - Review Complete RED 8/97 New assessment 4/30/04
Diphenylamine Tolerance Level - Review Complete RED 4/98 No acute endpoint
Metribuzin Tolerance Level - Review Complete    
Paraquat Tolerance Level - Review Complete    
Pendemethalin Tolerance Level - Review Complete    
Terbacil Tolerance Level - Review Complete    
Thiobencarb Tolerance Level - Review Complete    
Triclopyr Tolerance Level - Review Complete    
Zinc Phosphide Dietary risk not assessed in RED - Review Complete    
Abamectin Field Trial - Review Complete FRN 03/24/97 Monitoring used in 2004
Bromoxynil Field Trial - Review Complete FRN 05/13/98  
Fenpropathrin Field Trial - Review Complete FRN 11/26/97  
Fipronil Field Trial - Review Complete FRN 11/26/97  
Glufosinate-ammonium Tolerance Level - Review Complete    
Lamba-cyhatothrin Field Trial - Review Complete FRN 11/26/97  
Vinclozolin Field Trial - Review Complete FRN 07/18/97 D261993
Phosphinothrin acelyltransterase Exemption from tolerances - Review Complete    
Bt Cryac Exemption from tolerances - Review Complete    
Glyphosate Tolerance Level - Review Complete    
Sethoxyolim Tolerance Level - Review Complete    
Clopyralid No ARs used except for 10x reduction factor for sugar beets (FRN 09/25/02).
First FQPA action (FRN 05/16/97) was a section 18 temporary tolerance
   
Carbon Disulfide Field Trial - Review Complete FRN 05/16/97  

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