Document ID: EPA-HQ-OPP-2009-0268-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-05-28T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  October 16, 2009

SUBJECT:	Boscalid; Petition for Establishing Permanent Tolerances on
Alfalfa and the Citrus Crop Group 10, and Amending the Established
Tolerance on the Stone Fruit Crop Group 12.  Summary of Analytical
Chemistry and Residue Data.

PC Code:  128008	DP Barcode:  364447

Decision No.:  405556	Registration No.:  7969-198, 7968-197, 7969-199

Petition Nos.:  9F7527, 9F7529	Regulatory Action:  Section 3
Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  188425-85-6

MRID No.:  see MRID Summary Table	40 CFR:  180.589

		              									Ver.Apr.08

FROM:		Amelia M. Acierto, Chemist

		Risk Assessment Branch III

Health Effects Division (7509P)  SEQ CHAPTER \h \r 1 

THROUGH:	Stephen Funk, Senior Science Advisor

		Risk Assessment Branch III

Health Effects Division (7509P

TO:		Tony Kish, Risk Manager Team #22

		Fungicide Branch

		Registration Division (7505P)	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h
\r 1 

		

MRID Summary Table

MRID No.	Study Type	Comments

45903601	860.1500/1520 Citrus	New DER; 45903601.der.doc

47470201	860.1500 Stone Fruit	New DER; 47470201.der.doc

47584401	860.1500 Alfalfa	New DER; 47584401.der.doc

47584402	860.1520 Citrus	New DER; 47584402.der.doc

47584403	860.1480 Cattle	New DER; 47584403.der.doc

  SEQ CHAPTER \h \r 1 This document was originally prepared under
contract by Dynamac Corporation (1910 Sedwick Road, Building 100, Suite
B; Durham, NC 27713).  

The document has been reviewed by the Health Effects Division (HED) and
revised to reflect current Office of Pesticide Programs for  (OPP)
policies.

Executive Summary

  SEQ CHAPTER \h \r 1 Boscalid,
2-chloro-N-(4´-chloro[1,1´-biphenyl]-2-yl)-3-pyridinecarboxamide, is a
carboxamide (anilide) class fungicide that inhibits mitochondrial
respiration, thereby inhibiting spore germination, germ tube elongation,
mycelial growth, and sporulation in all major stages of fungal
development and reproduction necessary for disease development in a
variety of vegetable, fruit and row crops.  There are currently two
water-dispersible granular (WDG) boscalid end-use products (EPs)
registered to BASF in the US for use on food/feed crops, one containing
only boscalid and one which is a mixture of two active ingredients.  The
single active ingredient formulation is a 70% WDG (Endura® Fungicide;
EPA Reg. No. 7969-197) and the mixture formulation is a WDG containing
25.2% boscalid and 12.8% pyraclostrobin (Pristine® Fungicide; EPA Reg.
No. 7969-199).  Only boscalid is addressed in this document;
pyraclostrobin is being evaluated separately. 

-(4′-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide and the glucuronic
acid conjugate of the 5-hydroxy metabolite at levels ranging from 0.02
ppm in eggs to 0.35 ppm in meat byproducts of cattle, goats, horses, and
sheep. 

BASF is proposing new uses for boscalid on alfalfa using the 25% and 70%
WDG formulations and on citrus fruits using the 25% WDG formulation. 
The proposed uses on alfalfa are for repeated broadcast foliar
applications at up to 0.28 lb ai/A for the 25% WDG and 0.48 lb ai/A for
the 70% WDG, with a minimum retreatment interval (RTI) of 14 days, for a
maximum of 0.85 or 1.44 lb ai/A/season for the 25% and 70% WDG,
respectively.  A maximum of 3 applications to alfalfa are allowed per
season with no more than 2 applications per cutting.  The proposed use
on citrus fruits is for up to four broadcast foliar applications during
fruit development at rates up to 0.29 lb ai/A with a minimum RTI of 10
days, for a maximum of 1.17 lb ai/A/season.  All applications can be
made using ground or aerial equipment, and the proposed PHIs are 14 days
for alfalfa and 0 days for citrus fruits.  In conjunction with these
uses, BASF is proposing the following permanent tolerances for boscalid:

Alfalfa forage	35 ppm

Alfalfa hay	85 ppm

Citrus Crop Group 10	2.0 ppm

Based on residue data from new stone fruit field trials conducted using
the maximum labeled use rate for boscalid (25% WDG) on stone fruits,
BASF is also requesting that the existing 1.7 ppm tolerance on the stone
fruits crop group be increased as follows:

Stone Fruit Crop Group 12	5.0 ppm

The registrant has also submitted FIFRA Section 3 registration requests
to add the uses for alfalfa forage and hay and citrus fruits, crop group
10 on the labels of BAS 510F (EPA Reg. No. 7969-198) and Pristine®
Fungicide (EPA Reg. No. 7969-199), and the uses for alfalfa forage and
hay on the label of Endura® Fungicide (EPA Reg. No. 7969-197).

In addition, based on the potential increase in dietary exposure of
livestock to boscalid due to the new use on alfalfa, BASF is proposing
new or amended boscalid tolerances on the following livestock
commodities:

  

Milk	0.2 ppm

Milk fat (cream)	1.5 ppm

Fat (cattle, goat, horse, and sheep)	1.5 ppm

Meat (cattle, goat, horse, and sheep)	0.2 ppm

Meat byproducts (cattle, goat, horse, and sheep)	1.5 ppm

Kidney (cattle, goat, horse, and sheep)	1.0 ppm

Liver (cattle, goat, horse, and sheep)	1.0 ppm

Liver (poultry) 	0.2 ppm

Fat (poultry)	0.2 ppm

Meat byproducts (poultry)	0.2 ppm

Fat (hogs)	0.2 ppm

Meat byproducts (hogs)	0.2 ppm

Kidney (hogs)	0.2 ppm

Liver (hogs)	0.2 ppm

  SEQ CHAPTER \h \r 1 The nature of boscalid residues in primary crops
and livestock is considered adequately understood, based on the
acceptable metabolism studies on lettuce, grapes, beans, goats and hens.
 For purposes of tolerances and dietary risk assessment, the HED,
through its Metabolism Assessment Review Committee (MARC), has concluded
that the residue of concern in plant commodities is boscalid, and the
residue of concern in livestock commodities include boscalid, its
5-hydroxy metabolite (M510F01) and the glucuronic acid conjugate of the
5-hydroxy metabolite (M510F02).

An adequate gas chromatograph/mass spectrometric (GC/MS)   SEQ CHAPTER
\h \r 1 method (Method D0008) is available for enforcing boscalid
tolerances in plant commodities, and an adequate GC/electron capture
detection method (Method DFG S19) is available for enforcing the current
tolerances in livestock commodities.  These methods have been found
adequate by the Analytical Chemistry Branch (ACB) of BEAD.

An adequate data collection method is available for plant commodities.  
Boscalid residues in plant commodities were determined using liquid
chromatography with tandem mass spectrometric detection (LC/MS/MS)
method (BASF Method D9908).  This method was adequately validated in
conjunction with the analysis of field trial and processing study
samples, and the validated limit of quantitation (LOQ) is 0.05 ppm for
boscalid in all plant commodities tested. 

For data collection in livestock, residues of boscalid and its hydroxy
metabolite M510F01 (including its glucuronide conjugate) were determined
using a LC/MS/MS method (BASF Method 471/0, modified), which was
adequately validated in conjunction with analysis of feeding study
samples.  The validated LOQ for each analyte is 0.01 ppm in milk and
0.025 ppm in tissues, for combined LOQs of 0.02 ppm in milk and 0.05 ppm
in tissues.  The combined residues are expressed in parent equivalents.

The data requirements for testing with the multiresidue methods in the
Pesticide Analytical Method (PAM I) have been fulfilled and were
discussed in the earlier petitions.  Residues of boscalid and its
metabolite M510F01 were not adequately recovered using multiresidue
method.  Protocol A was not applicable. Protocol B was not applicable
for boscalid and yielded inconsistent recoveries of M510F01.  Residues
of boscalid and M510F01 had good responses with GC/ECD on a DB-1 column
under Protocol C but neither analyte was recovered at ≥30% using
Protocol D, E, and F.  

Adequate cattle and poultry feeding studies are available covering the
potential levels of dietary exposure for livestock to boscalid residues.
 Considering the existing and recommended tolerances for all feedstuffs,
the dietary burden of livestock for boscalid residues in a reasonably
balanced diet are 10.8 ppm for beef cattle, 22.5 ppm for dairy cattle,
4.0 ppm for poultry and 5.3 ppm for swine.  Based on these levels of
dietary exposure and the residue data from the feeding studies, the
existing tolerances for milk, and fat, meat and meat byproducts of
cattle, goats, horses and sheep are adequate.  The existing tolerances
for eggs, poultry meat, and meat and meat byproducts of hogs are also
adequate; however, the tolerances for hog fat, poultry fat, and poultry
meat byproducts should each be increased to 0.20 ppm.

The data generated from alfalfa, orange, lemon, and grapefruit field
trials are adequate and support the proposed uses of the 25% WDG
formulation of boscalid on alfalfa and citrus fruits.  An adequate
number of tests were conducted on the representative crops in the
appropriate geographic regions, and the tests were conducted at ~1x the
proposed use rate.  Samples were collected around the proposed
preharvest interval (PHI) and analyzed for residues of boscalid.  The
available field trial data support tolerances of 30 ppm for alfalfa
forage, 65 ppm for alfalfa hay, and 1.6 ppm for the citrus fruit crop
group 10.

An adequate citrus processing study is available indicating that
boscalid residues are reduced in juice (<0.2x); therefore, a separate
tolerance is not required for citrus juice.  However, residues were
shown to concentrate in both dried pulp (3.1x) and oil (59x).  Based on
the processing factors for dried pulp and oil and the highest average
field trial (HAFT) residues for citrus fruits (1.39 ppm), the maximum
expected boscalid residues would be 4.31 ppm in dried pulp and 82 ppm in
oil, which would support tolerances of 4.5 ppm for dried citrus pulp and
85 ppm for citrus oil.

The new stone fruit field  data are adequate.  When residue data from
all the  stone fruit field trials at the 1x rate with 0-day PHI are
pooled together by crop, the data support a tolerance of 3.5 ppm for the
stone fruit crop group 12.

Adequate confined, limited and extensive field rotational crop studies
are available supporting the existing tolerances for indirect residues
of boscalid in rotational crops.  These data support the 14-day
plant-back interval currently specified for crops without boscalid uses.
 No additional rotational crop data are required for purposes of this
petition. 

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

HED has examined the residue chemistry database for boscalid and
concludes that pending submission of a revised Section B for alfalfa, a
revised Section F for alfalfa, citrus fruit, stone fruit and livestock
as noted below, and provided the forthcoming Human Health Risk
Assessment does not identify any risks of concern, there are no residue
chemistry deficiencies that would preclude establishing permanent
tolerances for boscalid on alfalfa forage and hay and on the citrus
fruits crop group 10, and for increasing the existing tolerance on the
stone fruit crop group 12, and the existing tolerances on hog fat,
poultry fat, and poultry meat byproducts. However, the deficiencies
noted below must be resolved as a condition of registration.  

Note to PM: HED recommends that the following tolerance definition
entries in 40 CFR 180.589 be revised and that tolerances for the listed
commodities be established, as follows:

 General. (1) Tolerances are established for residues of the fungicide
boscalid, including its metabolites and degradates, in or on the
commodities listed below.   Compliance with the tolerance levels
specified below is to be determined by measuring only
-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) in or
on the commodity. 

Alfalfa, forage …………………………………..    30.0  ppm

Alfalfa, hay ………………………………………   65.0  ppm

Citrus, dried pulp ………………………….. …….   4.5 ppm

Citrus, oil………………………………………...   85.0 ppm

Fruit, citrus, group 10 …………………….     	      1.6 ppm

Fruit, stone, group 12 ……………  ………...            3.5 ppm

(2) Tolerances are established for residues of the fungicide boscalid,
including its metabolites and degradates, in or on the food commodities
listed below.  Compliance with the tolerance levels specified below is
to be determined by measuring only the sum of 3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) and metabolites
2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide and
glucuronic acid conjugate of
2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide, calculated
as the stoichiometric equivalent of boscalid, in or on the commodity.

Hog, fat………………………………………….......0.20 ppm

Poultry, fat
.................................................................0.20
ppm

Poultry, meat byproducts……………………………0.20 ppm

The established tolerances of the following commodities remain
unchanged. 

Cattle, fat………………………………………… . 0.30 ppm

Cattle, meat………………………………………... 0.10 ppm

Cattle, meat byproducts ……………………………0.35 ppm

Egg …………………………………………………0.02 ppm

Goat, fat……………………………………………. 0.30 ppm

Goat, meat…………………………………………. 0.10 ppm

Goat, meat byproducts .……………………………. 0.35 ppm

Hog, meat...………………………………………....0.05 ppm

Hog, meat byproducts……………………………....0.10 ppm

Horse, fat…………………………………………....0.30 ppm

Horse, meat………………………………………….0.10 ppm

Horse, meat byproducts  ……………………………0.35 ppm

Milk…………………………………………………0.10 ppm

Poultry,
meat..............................................................0.05
ppm

Sheep, fat ………………………………………….. 0.30 ppm

Sheep, meat………………………………………. .  0.10 ppm

Sheep, meat byproducts ………………………… . . 0.35 ppm

The recommended tolerances in/on alfalfa, citrus and stone fruits are
based on the crop field trial data.  The appropriate tolerance levels
were determined using the Agency’s Standard Operating Proceedure (SOP)
“Guidelines for Setting Pesticide Tolerances Based on Field Trial
Data”.   

The adequacy of the existing livestock tolerances were assessed using
the available cattle and poultry feeding studies that cover the
potential levels of dietary exposure of livestock to boscalid residues. 
The data indicate that the existing tolerances for meat (0.05 ppm) and
meat byproducts (0.10 ppm) of hogs are adequate; however, the tolerance
for hog fat should be increased to 0.20 ppm.  The adequacy of the
existing tolerances for poultry were assessed using residue data from
the 5.31 ppm dose group in the poultry feeding studies; this group
represents 1.3x the calculated dietary burden for poultry.  Maximum
combined residues for this dose group were <0.02 ppm in eggs, <0.175 ppm
in liver, <0.05 ppm in muscle, and <0.124 ppm in fat.  Average combined
residues were 0.02 ppm in eggs, 0.136 ppm in liver, 0.05 ppm in muscle,
and 0.081 ppm in fat.  These data indicate that the existing tolerances
for eggs (0.02 ppm) and poultry meat (0.05 ppm) are adequate; however,
the tolerances for poultry fat and meat byproducts should each be
increased to 0.20 ppm.  

Note to PM: HED recommends that the tolerance definition entry in 40 CFR
180.589 (d) Indirect or inadvertent residues should be revised to read
as follows:

 (d)  Indirect or inadvertent residues.  Tolerances are established for
residues of the fungicide boscalid, including its metabolites and
degradates, in or on the commodities listed below.   Compliance with the
tolerance levels specified below is to be determined by measuring only
-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) in or
on the commodity. 

Commodity	Parts per million

Animal feed, nongrass, group 18, forage, excluding alfalfa	1.0

Animal feed, nongrass, group 18, hay, excluding alfalfa	2.0

Animal feed, nongrass, group 18, seed, excluding alfalfa

	

860.1200  Direction for Use

	●	A revised Section B for alfalfa is required to amend the label
direction for the 70% WDG formulation since it could not be supported by
the field trial data generated with a maximum seasonal use rate of 0.9
lb ai/A.   The proposed label rate for the 70% formulation is 1.7x
higher; the label should be revised to match the field trial rate.

Proposed Tolerances

	●	Boscalid residues concentrate in citrus dried pulp (3.1x) and
citrus oil (59x).  A revised Section F is required to propose separate
tolerances for citrus, dried pulp at 4.5 ppm, citrus, oil at 85 ppm, and
Fruit, citrus, group 10 at 1.6 ppm. 

  	●	The available data for stone fruits will not support a tolerance
level of 5.0 ppm.  A revised Section F should be submitted with a
tolerance for Fruit, stone, group 12 at 3.5 ppm..

	●	The available data will not support the proposed tolerances for
meat, meat byproducts, and fat of cattle goat, horse, and sheep at 0.2,
1.5, and 1.5 ppm , respectively.  The existing tolerances will be
maintained  for meat, meat byproducts and fat of cattle, goat, horse and
sheep at 0.10 ppm, 0.35 ppm, and 0.30 ppm, respectively.  The available
data will not support the proposed tolerance of 0.2 ppm for milk and the
proposed tolerance of  1.5 for milk fat.  The existing tolerance of 0.10
ppm will be maintained for milk, and it is adequate to cover milk fat.  
For all remaining livestock commodities, the proposed tolerances must be
revised to reflect the recommended tolerance levels as specified in
Table 11.

Note to PM:   Revisions of the livestock commodities data collection
methods have been included in the registrant’s submissions.  However,
BASF have not indicated whether any of the changes were made in their
attempt to resolve any of the deficiencies noted by the Agency in their
2003 petition (DP# 278385, M. Nelson, 8/15/2003).   If the methods have
been revised and finalized, this should be clarified and the entire
final versions of the enforcement and the data collection methods should
be submitted to the Agency.  Otherwise, registration for the new or
amended use patterns for the boscalid products should be made
conditional until the deficiencies noted above are fully resolved. 

Background

The chemical structure and nomenclature of boscalid and its hydroxyl
metabolite and physicochemical properties of the technical grade of
boscalid are presented in Tables 1 and 2.

Table 1.	Nomenclature of Boscalid and its Hydroxy Metabolite.

Compound	

Common name	Boscalid; Nicobifen

Company experimental name	BAS 510 F

IUPAC name	2-chloro-N-(4'-chlorobiphenyl-2-yl)-nicotinamide

CAS name	3-pyridinecorboxamide,2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl

Molecular weight	343.2

CAS registry number	188425-85-6

End-use product (EPs)	25.2% WDG (Pristine® Fungicide; EPA Reg. No.
7969-199, also contains 12.8% pyraclostrobin)

70% WDG (Endura® Fungicide; EPA Reg. No. 7969-197)

Hydroxy-metabolite	

Common name	Boscalid hydroxy metabolite

Company experimental name	M510F01 (glucuronide conjugate – M510F02)

CAS name	2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide

Molecular weight	359.2

Table 2.	Physicochemical Properties of Boscalid.

Parameter	Value	References

Melting point/range	142.8-143.8 C	MRIDs 45404802 and
45404804-45404809

pH	NA (does not dissociate in water) 

	Relative Density (20ºC)	1.381g/cm3

	Water solubility (20ºC)	4.64 mg/L at pH 6

	Solvent solubility (g/100 mL at 20ºC)	acetone	16-20	ethyl acetate
6.7-8.0 methanol	4-5	2-propanol	<0.01 acetonitrile	4-5	dichloromethane
20-25 toluene 	2-5	n-heptane 	<0.01

1-octanol	<0.01	olive oil	2.9

N,N-DMF >25

	Vapor pressure	7 x 10-9 hPa 

	Dissociation constant, pKa	None (does not dissociate in water)

	Octanol/water partition coefficient, Log(KOW)	2.96 

	UV/visible absorption spectrum	UV molecular extinction (e[lmol-1cm-1]):
 3.15 x104 at 228 nm; 1.53 x103 at 290 nm

	

860.1200  Directions for Use

BASF is proposing new uses for the 25% WDG on alfalfa and citrus fruits
and for the 70% WDG formulation on alfalfa.  Supplemental labels were
provided. The use directions for alfalfa and citrus, including the
directions for stone fruits are summarized below in Table 3.  

Table 3.	Summary of Directions for Use of Boscalid.

Applic. Timing, Type, and Equip.1	Formulation

[EPA Reg. No.]	Applic. Rate 

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations 2

Alfalfa 3

Broadcast foliar applications when conditions are favorable to disease
development; ground or aerial equipment. 	70% WDG

[7969-197]	0.09-0.48	3 

(2 per cutting)

	1.44	14	The minimum RTI is 14 days.  For aerial applications, use a
minimum of 10 gal/A

Do not make more than 2 applications per cutting or 3 applications per
season.

	25.2% WDG

[7969-199]	0.19-0.28

	3 

(2 per cutting)

	0.85	14

	Citrus Fruits

Broadcast foliar applications prior to infection; ground or aerial
equipment	25.2% WDG

[7969-199]	0.25-0.29	4	1.17	0	The minimum RTI is 10 days.  For aerial
applications, use a minimum of 10 gal/A

Stone Fruits

Broadcast foliar applications from pink bud through fruit development;
ground or aerial equipment	25.2% WDG

[7969-199]	0.17-0.23	5	1.14	0	The minimum RTI is 7 days.

For aerial applications, use a minimum of 10 gal/A

1	Ground application may be made through the following types of
irrigation systems:  center pivot, lateral move, end tow, side wheel
roll, traveler, big gun, solid set, or hand move. 

2	Use directions allow for the use of spray adjuvants, and specify a
14-day plant-back interval for rotational crops without registered uses
for boscalid.

3	For stand establishment of fall seeded alfalfa, begin applications in
fall through early winter prior to first snowfall or extended cool, wet
conditions.  For seed pod protection, begin applications at 10% to 30%
bloom.

Conclusions.  The submitted use directions are sufficient to allow for
evaluation of the submitted residue data relative to the proposed use
pattern.  The available field trial data support the proposed use
directions for the 25% WDG formulation on alfalfa and citrus fruits, and
the supplemental field trail data on stone fruits support the current
use on stone fruits.  However, a revised Section B for alfalfa is
required to amend the label direction for the 70% WDG formulation since
it could not be supported by the field trial data generated with a
maximum seasonal use rate of 0.9 lb ai/A.   The proposed label rate for
the 70% formulation is 1.7x higher; the label should be revised to match
the field trial rate.

860.1300 Nature of the Residue - Plants

PP#1F6313; DP# 278385; M. Nelson; 8/15/2003

HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003

The nature of boscalid residues in primary crops is adequately
understood, based upon acceptable grape, lettuce and bean metabolism
studies; these studies were reviewed in the initial boscalid petition,
PP#1F6313.  No significant metabolism of boscalid occurred in grapes or
lettuce; unchanged parent was the only component identified, accounting
for 92-98% and 99% total radioactive residues (TRR), respectively.  In
bean plants, boscalid metabolized slowly; unchanged parent was the major
component identified, accounting for up to 72% TRR in dry bean seeds,
and 99% TRR in bean plants.  Cleavage products,
1-(chlorophenyl)-2-aminobenzene and 2-chloronicotinic acid, were present
in small amounts, accounting for <1% and <10% TRR, respectively.

HED has concluded that the parent compound, boscalid, is the sole
residue of concern in primary crop for purposes of risk assessment and
the tolerance expression.  The cleavage products were not included,
based on the limited cleavage which occurred, and the low levels of
their ingestion expected from dietary and environmental sources. 

 

860.1300 Nature of the Residue - Livestock

PP#1F6313; DP# 278385; M. Nelson; 8/15/2003

HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003

≥10% TRR.  No amide bridge cleavage products were identified. 
Based on the structural similarity of boscalid and M510F 01, and the
fact that the enzymatic hydrolysis step in the proposed enforcement
method will release M510F 02 back to free M510F 01, HED concluded that
the combined residues of parent boscalid, M510F 01 and M510F02 are the
residues of concern in livestock matrices for purposes of risk
assessment and the tolerance expression.  

860.1340 Residue Analytical Methods - Plants

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

DP# 284510; D. Swineford and E. Kolbe; 8/12/2003 (PMV memo)

An adequate GC/MS method (Method D0008) is available for enforcing
boscalid tolerances in plant commodities.  The Analytical Chemistry
Branch of the Biological and Economic Analysis Division (ACB/BEAD)
concluded that the method is acceptable for enforcement purposes in
plants without the need for an EPA validation (DP# 284510; D. Swineford
and E. Kolbe, 8/12/2003, PMV memo).

  

An adequate LC/MS/MS method (BASF Method D9908, Version II) is also
available for collecting residue data on plant commodities.  Boscalid
residues in all of the plant commodities associated with the current
field trials and the citrus processing study were determined using this
LC/MS/MS method.  Briefly,  the residues were extracted from plant
commodities, except citrus oil, with methanol (MeOH):water:2 N HCl
(70:25:5; v/v/v) and centrifuged.  For oil, samples were initially
dissolved in hexane, and residues were partitioned into acetonitrile,
concentrated to dryness and the re-dissolved in MeOH:water:2 N HCl
(70:25:5; v/v/v).  Residues from each commodity were then diluted with
1N HCl saturated with NaCl, and partitioned into cyclohexane.  Residues
were concentrated to dryness, re-dissolved in MeOH:water:4 mM ammonium
formate (80:20:0.1, v/v/v), and analyzed by LC/MS/MS using the m/z
343→307 transition to detect and quantify boscalid.  Residues are
quantified using an external calibration curve of boscalid standards. 
The validated LOQ was 0.05 ppm for each plant commodity and the LOD was
reported to be 0.01 ppm for alfalfa forage and hay, citrus fruits and
citrus fruit processed fractions.  

The method was adequately validated in conjunction with each field
trial, using control samples of each plant matrix fortified with
boscalid at levels ranging from 0.05 to 50 ppm.

860.1340 Residue Analytical Methods - Livestock

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

DER Reference 47584403

An enforcement method is available for determining the residues of
concern in livestock.  Method DFG S19 is a GC/electron capture detection
method that was successfully validated by ACB/BEAD. 

For the current livestock feeding study, residues of boscalid and its
hydroxy metabolite M510F01 (including the glucuronide conjugate M510F02)
were determined using a LC/MS/MS  method (BASF Method 471/0, modified)
which was previously reviewed in conjunction with earlier feeding
studies.

For this method, residues in milk and tissue matrices were extracted
with MeOH, filtered and concentrated.  To convert the glucuronide
conjugate (M501F02) to the free hydroxy metabolite (M501F01), residues
were re-dissolved in 0.1M sodium acetate buffer and incubated with
β-glucuronidase/arylsulphatase for 1 hour at 37°C.  The resulting
hydrolysate was diluted with water, salinized, and acidified with 1M
HCl.  Residues were then partitioned into ethyl acetate and concentrated
to dryness.  Residues were re-dissolved in water:MeOH (7:3, v/v) and
cleaned up by elution through a C-18 SPE cartridge using water:MeOH
(3:7, v/v).  Residue samples from muscle also underwent an additional
cleanup step using a silica gel SPE cartridge eluted with
dichloromethane:acetone (8:2, v/v).  Residues in the final eluates were
concentrated to dryness and re-dissolved in acetonitrile:water (1:1,
v/v) for analysis.  Residues of boscalid and M510F01 were determined by
LC/MS/MS using the m/z 343→140 transition for boscalid and the
359→140 transition for M501F01, with external standardization. 
Residues are expressed in terms of the individual analytes, and the
validated LOQs for each analyte are 0.01 ppm in milk matrices and 0.025
ppm in tissues.  The reported LODs for each analyte were 0.0067 ppm in
milk and 0.0167 ppm in tissues.   For calculating combined residues,
Metabolite M510F01 residues are converted to parent equivalents using a
conversion factor of 0.96.

The above method was adequately validated prior to and in conjunction
with the analysis of feeding study samples, using control samples
fortified with boscalid and M510F01 at 0.01-2.5 ppm for milk, skim milk
and cream, and 0.025-2.5 ppm for liver, kidney, muscle and fat samples.

860.1360 Multiresidue Methods

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

  SEQ CHAPTER \h \r 1 Residues of boscalid and its metabolite M510F01
were not adequately recovered using the multiresidue methods.  Protocol
A was not applicable.  Protocol B was not applicable for boscalid and
yielded inconsistent recoveries of M510F01.  Residues of boscalid and
its hydroxy metabolite M510F01 had good responses with GC/ECD on a DB-1
column under Protocol C.  Neither analyte was recovered at ≥30% using
Protocols D, E, and F.  The study has been forwarded to FDA for a future
updating of PAM, Vol. I.

860.1380 Storage Stability

DP# 322235, D. Dotson, 11/03/2005

MRID 47584402.der

Adequate storage stability studies are available indicating that
boscalid is relatively stable at ≤-20ºC in fortified samples of
cabbage (leafy vegetables), canola seed (oil seed), peach
(fruit/fruiting vegetable), sugar beet roots (root crop), peas (legume
vegetable), wheat grain (non-oily grain), wheat forage (foliage), and
wheat straw (dry feed) for up to 24 months.

 and placed in storage at ≤-5°C.  No zero-day analysis was conducted
on the fortified samples prior to storage.  The stored samples were
analyzed in duplicate along with control samples freshly fortified with
boscalid at 0.05 ppm and 2.0 ppm.  The average recovery from the stored
orange fruit, dried pulp, juice and oil samples (corrected for
concurrent recoveries) were 117%, 109%, 119%, and 126%, respectively. 
These data indicate that boscalid is stable at -5°C for up to 109 days
(3.6 months) in orange fruit, dried pulp, juice and oil.

The storage durations and conditions of samples from the crop field
trials submitted to support this petition are presented in Table 4.  

Table 4.	Summary of Storage Conditions and Durations of Samples from
Crop Field Trial and Processing Studies.  

Matrix 	Storage Temperature

 (°C)	Actual Storage Duration	Interval of Demonstrated Storage
Stability

(months)

Alfalfa Forage	<-5	5-13	24 – wheat forage

Alfalfa Hay	<-5	5-13	24 – wheat straw

Orange	<-10	1.0-6.2	24 – peach

Orange Peel	<-10	1.0-5.3	24 – peach 

Orange Pulp	<-10	1.0-6.0	24 – peach 

Orange Dried Pulp	<-5	3.4	3.6

Orange Juice	<-5	3.4-3.5	3.6

Orange Oil	<-5	3.4	3.6

Grapefruit	<-10	2.8-4.9	24 – peach 

Lemon	<-10	0.8-4.5	24 – peach 

Cherry (Sweet and Tart)	<-5	3.3-8.6 	24 – peach 

Peach	<-5	4.9-8.0 	24 – peach 

Plum	<-5	4.5-6.3 	24 – peach 

Conclusions.  The available storage stability data are adequate and
support the storage conditions and durations for samples of alfalfa,
citrus fruits, and stone fruits from the current field trials and the
acceptable citrus processing study.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed/registered uses that are relevant to this
guideline topic.

860.1460 Food Handling

There are no proposed/registered uses that are relevant to this
guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003		

DP# 322235; D. Dotson, 11/03/2005

45405110.der (cattle feeding study)

45643801.der (poultry feeding study)

47584403.der (cattle feeding study)

Adequate cattle and poultry feeding studies are available.  The current
tolerances for livestock commodities are based on the residue data from
the earlier cattle and poultry feeding studies and the previously
calculated dietary burdens of livestock for boscalid.  The maximum
dietary burden for poultry was originally calculated to be 1.85 ppm (DP#
278385, M. Nelson, 8/15/2003), and the maximum dietary burdens for other
livestock were most recently calculated to be 16.4 ppm for beef  cattle,
13.2 ppm for dairy cattle, and 1.79 ppm for swine (DP# 322235, D.
Dotson, 11/03/2005).

 

Cattle Feeding Studies.  BASF Corporation submitted a new cattle feeding
study conducted in 2008 in which two groups of lactating dairy cows were
administered with encapsulated boscalid via balling gun for 29
consecutive days at the target doses of 35 ppm (Group 2; 3 cows) or 105
ppm (Group 3; 7 cows).  Based on the average feed consumption, these
dose levels are equivalent to 35.8 and 116.3 mg ai/kg feed (dry feed
weight basis) or 1.22 and 3.56 mg ai/kg body weight/day for the low and
high dose groups, respectively.  These dose levels are intended to
represent 1x and 3x the anticipated EU dietary burden of 35 ppm in the
feed on a dry weight basis.   The four additional cows in the high dose
group were used to assess residue decline (depuration) following the
final dosing.  However, one of the four cows developed John’s disease
and was euthanized. 

The cows were milked twice a day, and samples composited daily for each
cow from the 1x and 3x dose groups on day -1, 1, 4, 7, 10, 13, 16, 19,
22, 25 and 28.  Three cows each from the 1x and 3x groups were
sacrificed 24 hours after the final dose period.  One cow in the
high-dose group was sacrificed at days 36, 39 and 43 (i.e., 7, 10 and 14
days after the final dose).  Samples of liver (representative samples
from each lobe), both kidneys, muscle (composite of round, flank, and
loin), omental fat, perirenal fat, and subcutaneous fat were collected. 

The LC/MS/MS method (BASF No. 471/0, modified) was used for determining
the residues of boscalid and its hydroxy metabolite M510F01 (including
glucoronide conjugate M519F02) in milk and tissues.  The modified method
was adequately validated based on acceptable method validation and
concurrent method recovery data.  The limit of quantitation (LOQ) for
each analyte in milk was 0.01 ppm (0.02 ppm combined) and 0.025 ppm
(0.05 ppm combined) for each analyte in tissues.  

All milk and tissue samples were stored frozen  from collection to
analysis.  Milk, skim milk, and cream were analyzed within 4.76 days;
liver, kidney and muscle, within 35-48 days; and fat within 48-70 days. 
The available storage stability data from earlier studies (DER for MRID
45405108) demonstrate that residues of boscalid and M510F01 are stable
for up to 5.5 months in cow milk, liver, and muscle, and are adequate to
support the storage intervals and conditions of milk, skim milk, muscle,
liver, fat and kidney samples from this study.  

For the low dose group, the combined residues of boscalid in milk
samples collected over the course of the dosing period were <0.02-0.03
ppm (parent, <0.01-0.023 ppm; M510F01, <0.01 ppm).  For the high dose
group, the combined residues were 0.03-0.12 ppm (parent, <0.021-0.112
ppm; M510F01, <0.01-0.017 ppm).   Milk samples from day 22 and 28 of the
study, and from the depuration cow remaining at day 42 of the study,
were separated into skim milk and cream.  Residues of  boscalid and
M510F01 in skim milk from all dosed groups were each <LOQ (<0.01 ppm) or
at LOQ (0.012 ppm for parent boscalid in one high dose sample). 
Combined residues for boscalid and M510F01 in cream were 0.06-0.08 ppm 
for the low dose group and 0.14-0.50 ppm for the high dose group. 
Residues appeared to peak on day 7 and then plateau at a lower level for
the remainder of the dosing period.   

For the residue decline study in the high dose cows, boscalid and
M510F01 residues were each <LOQ (<0.01 ppm) in milk samples collected at
days 2,7,10 after the dosing period with excepton of a sample from day
31 where the residues of boscalid were 0.037 ppm 2 days after dosing
ceased.   The residue declined to below the LOQ in milk 7,10 and 14 days
after dosing.   In skim milk and cream samples collected during the
depuration phase 14 days after dosing, the residues of boscalid and
M510F01 were each <LOQ (<0.01 ppm).  In all tissue samples collected
7,10, and 14 days after dosing  of the high dose group, the residues of
boscalid and M510F01 were each <LOQ (<0.025 ppm) except in omental and
perirenal fat in samples collected 7 days after dosing, where parent
boscalid residues were 0.033 and 0.037 ppm, respectively.  The residues
declined to <LOQ in these matrices 10 and 14 days after dosing. 

 

Residues of boscalid and M510F01 in tissue samples collected immediately
after 29 days of dosing at 1x and 3x the EU anticipated dietary burden
were determined..  Combined residues of boscalid and M510F01in liver
samples from the low and high dose groups were 0.08-0.11 ppm and
0.15-0.24  ppm, respectively.   In kidney samples, combined residues
were 0.10-0.11 and 0.11-0.24 ppm from the low and high dose groups,
respectively.  In muscle samples from both dosing groups, residues of
boscalid and M510F01 were below the LOQ (<0.025 ppm each).  In omental
fat samples, combined residues were 0.08-0.23 ppm and 0.18-0.23 ppm from
the low and high dose groups, respectively.   In perirenal fat samples,
combined residues of boscalid and M501F01 were 0.12-0.24 ppm and
0.199-0.28 ppm from the low and high dose groups, respectively.  In
subcutaneous fat samples, the combined residues were 0.10-0.20 ppm and
0.08-0,18 ppm from the low and high dose groups, respectively.

The combined residue data from the 2008 dairy cattle feeding study are
summarized in Table 5.  

The potential for secondary transfer of boscalid residue of concern in
meat, milk, poultry, swine, and eggs exists since livestock feedstuffs
that are associated with the proposed uses.  Grain, aspirated fractions
are no longer used and was replaced with cotton, gin byproducts as the
latter yields higher contributions to the diet (beef cattle only).   The
calculated dietary burdens of boscalid to livestock are 10.8 ppm for
beef cattle, 22.5 ppm for dairy cattle, 4.0 ppm for poultry, and 5.3 ppm
for swine (Table 8).

Table  5.	Summary of Combined Residue Data from Recent Dairy Cattle
Feeding Study with Boscalid.

Matrix	Feeding Level (ppm)	Residue Levels (ppm) 1

n	Min.	Max.	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Milk	35.8

(1.0x) 3	30	<0.02	<0.03	0.02	0.02	0.008

Skim Milk

6	<0.02	<0.02	0.02	0.02	NA2 

Cream

6	<0.06	<0.08	0.07	0.07	0.006

Liver

3	0.08	0.11	0.09	0.10	0.015

Kidney

3	<0.10	<0.11	0.11	0.11	0.009

Muscle 

3	<0.05	<0.05	0.05	0.05	 NA

Fat (omental, perirenal, subcutaneous)

9	<0.08	<0.24	0.20	0.18	0.059

Milk	116.3

(3.3x) 3	60	<0.03	<0.12	0.06	0.06	0.018

Skim Milk

12	<0.02	<0.02	0.02	0.02	NA

Cream

12	<0.14	<0.50	0.25	0.26	0.111

Liver

3	0.15	0.24	0.21	0.20	0.043

Kidney

3	<0.11	0.24	0.19	0.18	0.065

Muscle 

3	<0.05	<0.05	0.05	0.05	 NA

Fat (omental, perirenal, subcutaneous)

9	<0.08	<0.28	0.19	0.20	0.057

1 	The combined LOQ (0.02 ppm for milk matrices and 0.05 ppm for
tissues) was used for values <LOQ when calculating the median, mean and
standard deviation.  Residue are expressed in parent equivalents.

2	NA = Not applicable.

3	Dose level compared to the calculated maximum dietary burden of 35.18
ppm for diary cattle. 

In the earlier cattle feeding study, three groups of dairy cows (3-4
cows/dose group) were dosed orally with boscalid for 29-30 consecutive
days at levels equivalent to 1.8, 5.9, and 20.2 ppm in the diet.  These
dose levels are respectively equivalent to 0.05x, 0.17x, and 0.57x the
current maximum dietary burden for dairy cattle.  Cows were milked twice
daily, and the pooled daily milk samples for each cow from Study Days 1,
3, 6, 9, 12, 15, 18, 21, 24 and 28 were sampled for analysis.  Whole
milk samples from Day 21 were also separated into skim milk and cream. 
Animals were sacrificed within 24 hours of receiving the final dose and
samples of muscle, fat, liver, and kidney were collected.

Samples of milk and tissues were analyzed for residues of boscalid and
M510F01 (free and conjugated) using an LC/MS/MS method (BASF Method
471/0), which was adequately validated in conjugation with the analysis
of feeding study samples.  The method LOQ for each analyte is 0.01 ppm
in milk and 0.025 ppm in tissues, for combined LOQs of 0.02 ppm in milk
and 0.05 ppm in tissues.  Samples of milk and liver were also analyzed
for non-extractable conjugated residues, determined as M510F53, using a
GC/MS method (BASF Method 476/0), which was also adequately validated. 
The method LOQ for M510F53 is 0.01 ppm in milk and 0.05 ppm in tissues. 
The sample storage durations and conditions for the feeding study were
adequately supported by the available storage stability data.

The data on residues of M510F53 in milk and liver will not be summarized
in this report as M510F53 is not a residue of concern.  For the low-dose
group (1.8 ppm), the combined residues of boscalid and M510F01 (free and
conjugated) were <0.02 ppm in all milk samples and skim milk, and <0.05
ppm in all samples of muscle, liver and kidneys.  However, quantifiable
residues of the parent, boscalid were detected at 0.023-0.045 ppm in the
low-dose cream samples and at 0.053 ppm in one of three fat samples. 
Residues of boscalid were generally <LOQ in kidneys, and residues of
M510F01 were <LOQ in milk, cream, fat and muscle.  In liver, residues
consisted primarily of M510F01, with only liver from the high-dose group
having residues of boscalid above the LOQ.  A summary of the residue
data from the 5.9 and 20.2 ppm dose groups are presented in Table 6.

Table 6.	Summary of Combined Residue Data from Earlier Dairy Cattle
Feeding Study with Boscalid.

Matrix	Feeding Level (ppm)	Residue Levels (ppm) 1

n	Min.	Max.	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Milk	5.9

(0.2x) 4	33	<0.02	0.023	0.02	0.02	<0.001

Skim Milk

3	<0.02	<0.02	0.02	0.02	NA 

Cream

3	<0.110	<0.125	0.123	0.119	0.008

Liver

3	<0.051	<0.064	0.055	0.057	0.007

Kidney

3	<0.063	<0.090	0.071	0.075	0.014

Muscle 

3	<0.05	<0.05	0.05	0.05	 NA

Fat

3	<0.082	<0.12	0.11	0.104	0.020

Milk (Days 15-28) 3	20.2

(0.6x) 4	22	<0.021	<0.096	0.040	0.042	0.015

Skim Milk

4	<0.02	<0.021	0.02	0.02	<0.001

Cream

4	<0.25	<0.38	0.37	0.34	0.062

Liver

3	0.17	0.18	0.18	0.18	0.006

Kidney

3	<0.17	<0.32	0.22	0.24	0.076

Muscle 

3	<0.05	<0.058	0.05	0.053	0.005

Fat

3	<0.24	<0.29	0.28	0.27	0.026

1 	The combined LOQ (0.02 ppm for milk matrices and 0.05 ppm for
tissues) was used for values <LOQ when calculating the median, mean and
standard deviation.  Residues are expressed in parent equivalents.

2	NA = Not applicable.

3	Residues in milk plateaued by Day 15.

4	Dose level compared to calculated maximum dietary burden of 35.18 ppm
for diary cattle. 

Poultry feeding study.  In the poultry feeding study, three groups of
laying hens were dosed orally once a day for 29 consecutive days with
boscalid at levels equivalent to of 1.02, 5.31, and 19.6 ppm in the
diet, which are respectively equivalent to 0.25x, 1.3x, and 4.8x of the
maximum dietary burden of poultry to boscalid.  Each group consisted of
3 or 5 subgroups with 4 hens per subgroup.  During the dosing period,
eggs were collected twice each day and pooled by day and subgroup.  Hens
were sacrificed within 5 hours of the final dose, with the exception of
hens in two subgroups from the high-dose that were sacrificed at 3 and
10 days post-dose to study depuration.  Samples of muscle, fat and liver
were collected at sacrifice and pooled by subgroup.

 

Residues of boscalid and M510F01 (free + conjugated) in eggs and tissues
were determined using an LC/MS/MS method (BASF No. 471/0, modified),
which was adequately validated in conjunction with the analysis of
feeding study samples.  The validated LOQ for each analyte is 0.01 ppm
in eggs and 0.025 ppm in tissues, for combined LOQs of 0.02 ppm in eggs
and 0.05 ppm in tissues.  The sample storage durations and conditions
for the feeding study were adequately supported by the available storage
stability data.

For the low-dose group (1.02 ppm), the combined residues of boscalid and
M510F01 (free and conjugated) were <0.02 ppm in all samples of eggs, and
<0.05 ppm in all muscle and fat samples.  In liver, boscalid residues
were <LOQ in all samples, and residues of M510F01 were quantifiable in
only one sample at 0.026 ppm, for combined residues of <0.051 ppm.  In
the mid- and high-dose groups, residues of boscalid were <LOQ in liver
and muscle, and residues of M510F01 were generally <LOQ in muscle and
fat.  Residues in eggs from the high-dose group were comprised of
approximately equal amounts of boscalid and M510F01.  A summary of the
residue data from the 5.31 and 19.6 ppm dose groups are presented in
Table 7.  

Table 7.	Summary of Combined Residue Data from Poultry Feeding Study
with Boscalid.

Matrix	Feeding Level (ppm)	Residue Levels (ppm) 1

n	Min.	Max.	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Eggs (Days 1-28)	5.31

(1.3x) 3	30	<0.02	<0.02	0.02	0.02	NA

Liver

3	<0.106	<0.175	0.126	0.136	0.036

Muscle 

3	<0.05	<0.05	0.05	0.05	NA

Fat

3	<0.052	<0.124	0.066	0.081	0.038

Eggs (Days 7-28) 4	19.6

(4.8x) 3	34	0.027	0.065	0.049	0.047	0.012

Liver

3	<0.316	<0.466	0.429	0.404	0.078

Muscle 

3	<0.05	<0.05	0.05	0.05	NA

Fat

3	<0.135	<0.196	0.186	0.172	0.033

1 	The combined LOQ (0.02 ppm for eggs and 0.05 ppm for tissues) was
used for values <LOQ when calculating the median, mean and standard
deviation.  Residue are expressed in parent equivalents.

2	NA = Not applicable.

3	Dose level compared to the calculated maximum dietary burden of 4.10
ppm for poultry. 

4	Residues in eggs plateaued by Day 7.

Livestock Dietary Burdens.  As alfalfa forage and hay are major
livestock feedstuffs, the dietary burdens for livestock were
recalculated for this petition.  Based on the recent changes in
calculating residues in reasonably balanced livestock diets (Table 1,
Feedstuffs, June 2008), the dietary burden for livestock from boscalid
residues was recalculated to be 10.8 ppm for beef cattle, 22.5 ppm for
dairy cattle, 4.0 ppm for poultry and 5.3 ppm for swine (Table 8).    

Table 8.	Calculation of Dietary Burdens of Boscalid Residues to
Livestock.

Feedstuff	Type 1	% Dry Matter2	% Diet 2	Recommended Tolerance (ppm)
Dietary Contribution (ppm) 3

Beef Cattle

Alfalfa, hay	R	89	10	65	7.3

Cotton, gin byproducts	R	90	5	55	3.06

Field corn, grain	CC	88	80	0.2	0.18

Canola, meal	PC	88	5	3.5 4	0.2

TOTAL BURDEN	--	--	100	--	10.8

Dairy Cattle

Alfalfa, forage	R	35	20	30	17.2

Grass, hay	R	88	25	8.0	2.27

Apple, wet pomace	CC	40	10	10	2.50

Field corn, grain	CC	88	35	0.2	0.08

Canola, meal	P	88	10	3.5 4	0.4

TOTAL BURDEN	--	--	100	--	22.5

Poultry

Field corn, grain	CC	88	75	0.2	0.15

Alfalfa, meal	PC	90	5	65 4	3.25

Canola, meal	PC	89	15	3.5 4	0.53

Peanut, meal	PC	85	5	0.15	0.0075

TOTAL BURDEN	--	--	100	--	4.0

Swine

Field corn, grain	CC	88	85	0.2	1.70

Alfalfa, meal	PC	90	5	65 4	3.25

Canola, meal	PC	89	10	3.5 4	0.35

TOTAL BURDEN	--	--	100	--	5.3

1	R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein concentrate.

2	OPPTS 860.1000 Table 1 Feedstuffs (June 2008).  

3	Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle;
contribution = ([tolerance] X % diet) for poultry and swine.

4	The tolerance for canola seed (3.5 ppm) was used for meal, and the
tolerance for alfalfa hay (65 ppm) was used for alfalfa meal.

Conclusions.  The available cattle and poultry feeding studies are
adequate and cover the potential levels of dietary exposure of livestock
to boscalid residues. 

The magnitude of the residues of boscalid and M510F01 was adequately
determined in the new (2008) feeding study with lactating diary cows
dosed orally for 29 consecutive with boscalid at levels equivalent to
35.8 ppm (low dose, 1x the anticipated dietary burden) and 116.3 ppm
(high dose, 3x the anticipated dietary burden) in the diet (dry feed
weight basis).  Over the entire dosing period, the maximum combined
residues in milk samples were 0.03 and 0.12 ppm for the low and high
dose group, respectively.   Following 29 days of dosing, the combined
residues in tissues from the low and high dose groups were,
respectively, 0.11 and 0.24 in liver and kidney samples; less than the
combined LOQ (<0.05 ppm) in muscle samples; 0.23 ppm in omental fat;
0.24 and 0.28 ppm in perirenal fat; and 0.20 and 0.18 ppm in
subcutaneous fat.  

For hogs, the adequacy of the existing tolerances were assessed using
residue data from the 5.9 ppm dose group in the cattle feeding studies;
this group represents 1.1x the calculated dietary burden for swine. 
Maximum combined residues for this dose group were <0.064 ppm in liver,
<0.090 ppm in kidney, <0.05 ppm in muscle, and <0.12 ppm in fat. 
Average combined residues were 0.057 ppm in liver, 0.075 ppm in kidneys,
0.05 ppm in muscle, and 0.104 ppm in fat.  

The data indicate that the existing tolerances for meat (0.05 ppm) and
meat byproducts (0.10 ppm) of hogs are adequate; however, the tolerance
for hog fat should be increased to 0.20 ppm.

For poultry, the adequacy of the existing tolerances were assessed using
residue data from the 5.31 ppm dose group in the poultry feeding
studies; this group represents 1.3x the calculated dietary burden for
poultry.  Maximum combined residues for this dose group were <0.02 ppm
in eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in
fat.  Average combined residues were 0.02 ppm in eggs, 0.136 ppm in
liver, 0.05 ppm in muscle, and 0.081 ppm in fat.  These data indicate
that the existing tolerances for eggs (0.02 ppm) and poultry meat (0.05
ppm) are adequate; however, the tolerances for poultry fat and meat
byproducts should each be increased to 0.20 ppm.  

860.1500 Crop Field Trials

DP# 278385, M. Nelson, 8/15/2003

DP# 323288, D. Soderberg, 6/14/2007

47584401.der (alfalfa)

45903601.de1 (citrus fruits)

47470201.de2 (stone fruits)

BASF submitted field trial data on alfalfa, oranges, lemons and
grapefruits in support of new uses for boscalid (WDG) on alfalfa and the
citrus fruits crop group.  BASF also submitted new stone fruit field
trial data supporting an amended tolerance for stone fruits.  The
results from the new field trials and the previously submitted stone
fruit field trails are summarized in Table 9 and discussed below.

Table 9.	Summary of Residue Data from Crop Field Trials with Boscalid
(WDG).

Crop matrix

(DER)	Treatment Info.	Total Applic. Rate (lb ai/A)	PHI (days) 1	Residue
Levels (ppm) 2

n	Min.	Max.	HAFT 3	Median	Mean	Std. Dev.

Citrus Fruits (proposed use = 1.17 lb ai/A total application rate, 0-day
PHI) 4

Orange

(45903601.de1)	Concentrated 	1.19-1.22	0	12	0.179	1.425	1.393	0.388
0.610	0.467

	Dilute	1.20-1.21	0	14	0.238	0.676	0.588	0.353	0.418	0.146

Grapefruit

(45903601.de1)	Concentrated 	1.20	0	6	0.115	0.847	0.836	0.143	0.365
0.364

	Dilute	1.20	0	6	0.064	0.272	0.261	0.125	0.155	0.086

Lemon

(45903601.de1)	Concentrated 	1.18-1.23	0	6	0.522	1.51	1.239	0.671	0.822
0.370

	Dilute	1.18-1.20	0	4	0.600	0.936	0.872	0.775	0.771	0.140

Stone Fruits (proposed use = 1.15 lb ai/A total application rate, 0-day
PHI) 5

Cherry  

(47470201.de2)	NA	1.15	0	14	<0.05	2.98	1.63	1.47	1.57	0.89

	1	14	<0.05	2.69	1.95	1.09	1.28	0.81

Peach

(47470201.de2)

1.15	0	12	0.56	3.79	1.94	0.76	1.15	1.03

	1	12	0.46	3.87	2.74	0.75	1.19	1.15

Plum

(47470201.de2)

1.15	0	10	<0.05	0.79	0.67	0.14	0.34	0.31

	1	10	<0.05	0.57	0.71	0.11	0.26	0.24

Cherry

(45405121.der)	NA	1.35	0	2	1.28	1.70	1.49	1.49	1.49	NA

Peach

(45405121.der)

1.14-1.17

8	0.47	1.20	1.19	0.74	0.77	0.29

Plum

(45405121.der)

1.15-1.17

8	0.09	0.85	0.70	0.50	0.47	0.23

Cherry

(46665505.der)	Concentrated 	1.15-1.16	0	6	0.641	1.635	1.635	0.999	1.056
0.370

	Dilute	1.15	0	6	0.736	1.505	1.505	1.313	1.229	0.309

Peach

(46665505.der)	Concentrated 	1.14-1.16	0	9	0.157	0.663	0.663	0.479	0.450
0.157

	Dilute	1.14-1.17	0	9	0.193	0.746	0.746	0.422	0.434	0.203

Plum

(46665505.der)	Concentrated 	1.14-1.15	0	6	0.081	0.566	0.566	0.154	0.214
0.182

	Dilute	1.14-1.15	0	6	0.103	0.344	0.344	0.198	0.211	0.105

Alfalfa (proposed use = 0.85 lb ai/A total application rate, 14-day PHI)
6

Alfalfa Forage

(47584401.der) 	 Trt #2 7	0.88-0.92	12-15	24	1.10	20.30	17.67	5.04	7.05
5.20

	12-16	24	0.81	19.40	17.23	4.98	6.25	5.09

	43-73	22	<0.05	0.53	0.37	0.12	0.17	0.14

	 Trt #3	0.86-0.93	19-23	24	0.11	6.16	6.10	1.94	2.05	1.66

	20-23	24	0.32	5.59	5.06	2.12	2.29	1.62

	49-76	22	<0.05	0.50	0.50	0.11	0.16	0.13

	 Trt #4	0.59-0.62	12-15	24	0.97	15.68	14.47	3.95	4.94	3.78

	12-16	24	0.85	15.32	15.07	3.59	5.56	4.51

	43-70	22	<0.05	0.38	0.32	0.08	0.12	0.09

	 Trt #5	0.57-0.62	19-23	24	0.05	5.44	5.38	1.21	1.75	1.58

	20-23	24	0.29	3.64	3.46	2.12	2.03	1.07

	49-76	22	<0.05	0.44	0.44	0.07	0.14	0.14

Alfalfa Hay

(47584401.der)	Trt #2 7	0.88-0.92	12-15	24	3.36	43.02	42.62	14.00	17.37
11.19

	12-16	24	5.22	51.12	48.91	16.10	20.93	13.64

	43-73	22	0.07	3.63	2.38	0.37	0.62	0.78

	 (Trt #3	0.86-0.93	19-23	24	0.14	20.84	19.84	6.37	6.97	5.93

	20-23	24	1.52	15.26	14.72	6.72	7.24	4.44

	49-76	22	<0.05	1.36	1.17	0.24	0.49	0.45

	Trt #4	0.59-0.62	12-15	24	3.11	33.78	31.34	10.80	15.30	9.21

	12-16	24	4.48	40.06	39.33	16.89	18.23	11.40

	43-70	22	<0.05	0.72	0.70	0.27	0.31	0.19

	Trt #5	0.57-0.62	19-23	24	0.42	12.46	12.23	3.80	5.29	4.45

	20-23	24	1.88	21.60	18.31	7.44	7.50	4.76

	49-76	22	<0.05	1.12	1.10	0.25	0.45	0.40

1	For the alfalfa field trials, the three separate harvest intervals are
the PHIs for the 1st, 2nd and 3rd cuttings.

2	The validated LOQ for boscalid is 0.05 ppm in plant commodities.  For
all calculations, the LOQ (0.05 ppm) was used for all values reported as
<LOQ.

3	HAFT = Highest average field trial result.

4	The citrus field trails were conducted using either concentrate or
dilute spray volumes.

5	For stone fruits, the data are reported separately for the three MRIDs
(47470201, 46665505, and 45405121).  In MRID 45405121, applications to
stone fruits were made using either concentrate or dilute spray volumes.

6	For the alfalfa field trials, Treatments #2 and #3 included three
boscalid applications at ~0.3 lb ai/A/application with the first and
second applications made prior to the 1st cutting and the final
application made prior to the 2nd cutting.  Treatments #4 and #5
included two applications at ~0.3 lb ai/A/application, with the first
application made prior to the 1st cutting and the second application
made prior to the 2nd cutting.

7	Treatment #2 represents the worse case use on alfalfa and reflects the
proposed use pattern.  As residues (bolded) from the 1st and 2nd cutting
were similar in magnitude and both reflected the proposed 14-day PHI,
all values from these two cutting were used to access tolerances for
forage and hay.

Citrus Fruits, Crop Group 10.  BASF submitted field trial data for
boscalid on citrus fruits.  Twenty four field trials conducted in the US
in Zones 3, 6, and 10 during the 2001-2002 growing season on oranges (13
trials), grapefruit (6 trails), and lemons (5 trials).  In each test,
boscalid (70% WDG) was applied to citrus trees as four broadcast foliar
applications during fruit development and maturation at rates of
0.294-0.320 lb ai/A/application and RTIs of 7-11 days, for total rates
of 1.18-1.23 lb ai/A/season (1x proposed use rate).  Applications were
made with ground equipment using either concentrate spray volumes of
74-93 gal/A (12 trials) or dilute spray volumes of 149-362 gal/A (12
trials).  All applications included the use of adjuvants (rates not
reported).  Single control and duplicate treated samples of citrus
fruits were harvested at maturity on the day of the final application
(0-day after treatment [DAT], proposed PHI).  Samples were stored frozen
for up to 6.2 months prior to analysis, an interval supported by
available storage stability data.

Citrus fruit samples were analyzed for residues of boscalid using an
LC/MS/MS method (BASF Method D9908), which was adequately validated in
conjunction with the analysis of field trial samples.  The method limit
of quantitation (LOQ) for boscalid is 0.05 ppm in citrus fruits.

 

Following four concentrated spray applications of boscalid (WDG) at
rates totaling 1.18-1.23 lb ai/A (1x rate), boscalid residues at 0 DAT
were 0.179-1.43 ppm in/on 12 orange samples, 0.115-0.847 ppm in/on 6
grapefruit samples, and 0.522-1.51 ppm in/on 6 lemon samples.  Following
four dilute spray applications of boscalid (WDG) at rates totaling
1.18-1.20 lb ai/A (1x rate), boscalid residues at 0 DAT were 0.238-0.676
ppm in/on 14 orange samples, 0.064-0.272 ppm in/on 6 grapefruit samples,
and 0.936-0.872 ppm in/on 4 lemon samples.  No residue decline data were
provided.

Average boscalid residues for the concentrated sprays were 0.610 ppm for
oranges, 0.365 ppm for grapefruit, and 0.822 ppm for lemons, and average
boscalid residues for the dilute sprays were 0.418 ppm for oranges,
0.155 ppm for grapefruit, and 0.771 ppm for lemons.  Based on the
average residues, the concentrated sprays resulted in higher residue
levels on all three types of citrus fruits, although the difference was
marginal for lemons which had the highest residues of any of the citrus
fruits.  Compared to the dilute sprays, average residues from the
concentrated sprays were 1.45x higher for oranges, 2.35x higher for
grapefruit and 1.07x higher in lemons. .

Some of the oranges were separated  into wet peel and pulp.  Following
four foliar applications of boscalid (WDG) to orange trees at rates
totaling 1.19-1.22 lb ai/A, average boscalid residues at 0 DAT from each
field trial were 0.206-1.39 ppm for whole orange fruit (RAC), 0.661-5.40
ppm for peel, and <0.05-0.151 ppm for wet pulp.  As compared to the
whole fruit, Boscalid residues were lower in orange pulp and higher in
peel.  

When the residue data are pooled for both spray volume types, the
average boscalid residues were 0.507 ppm for oranges, 0.260 ppm for
grapefruit, and 0.802 ppm for lemons, and HAFT residues were 1.39 ppm
for oranges, 0.836 ppm for grapefruit, and 0.710 ppm for lemons.  The
pooled residue data for each commodity will be used to assess separate
possible tolerances on oranges, lemons and grapefruits.

Conclusion.  The submitted field trial data are adequate and support the
use of boscalid (WDG) on citrus fruits as either dilute or concentrated
broadcast foliar applications during fruit development and maturation at
rates of up to 0.29 lb ai/A.   The highest residues which were found
were 1.43 ppm in oranges,  0.85 ppm in grapefruit, and 1.51 ppm in
lemons  The data support a maximum of 4 applications per season and a
maximum seasonal use rate of 1.16 lb ai/A, a minimum RTI of 10 days, and
a minimum PHI of 0 days. 

Some of the oranges were separated  into wet peel and pulp.  As compared
to the whole fruit, boscalid residues were lower in orange pulp and
higher in peel.

  

Stone Fruits, Crop Group 12.  Adequate field trial data supporting the
use of boscalid (WDG) on stone fruits were previously submitted (DP#
278385, M. Nelson, 8/15/2003; and DP# 323288, D. Soderberg, 6/14/2007). 
These earlier studies supported the use of boscalid on stone fruits as
up to 5 broadcast foliar applications during fruit development at rates
of up to 0.23 lb ai/A, at a minimum RTI of 7 days, for a total of 1.15
lb ai/A/season.  The label specified PHI for stone fruits is 0 days. 
The previously submitted residue data on stone fruits (Table 9) support
the current 1.7 ppm tolerance on stone fruits.

BASF has submitted additional field trial data for boscalid on stone
fruits from eighteen field trials conducted in the U.S. and Canada
during 2007 on representative stone fruit species, including 5 trials on
sweet cherries in Zones 5 and 10; 2 trials on tart cherries in Zone 5; 6
trials on peaches in Zones 1, 2, 5, 6 and 10; and 5 trials on plums in
Zones 5 and 10.  The end-use product, Pristine, EPA Reg. No. 7969-199, a
water-dispersible granular (WDG) formulation containing 25.2% boscalid
and 12.8% pyraclostrobin, was applied to the stone fruits as five
broadcast foliar applications during fruit development at a target rate
of 0.23 lb ai/A and at retreatment intervals (RTIs) of 7 days between
crop growth stages BBCH 75 and 89 (i.e., 28, 21, 14, 7, and 0 days
before harvest), for a total rate of 1.15 lb ai/A/season.  All
applications were made using ground equipment in volumes of 20-150 gal/A
(187-1403 L/ha).  No adjuvants were used.  

Single control and duplicate treated samples of each type of stone fruit
were harvested from each test on the day of the last application (0 DAT)
and at 1 DAT.  To evaluate residue decline, additional duplicate treated
samples were harvested at 5 and 10 DAT from one test each on cherry,
peach and plum.  Samples were stored frozen (≤-5°C) for up to 8.6
months prior to analysis, an interval supported by available storage
stability data.

Stone fruit samples were analyzed for residues of boscalid using an
adequate LC/MS/MS method (BASF Method D9908, Ver. II).  The method was
validated for data collection based on acceptable concurrent method
recoveries.  The limit of quantitation (LOQ) is 0.05 ppm for boscalid
in/on stone fruits, and the limit of detection (LOD) was not reported.

Following five foliar applications of boscalid (WDG) at rates totaling
1.15 lb ai/A, boscalid residues at 0 DAT were <0.05-2.84 ppm in sweet
cherries,  1.22-2.98 ppm in sour cherries,                              
                                                                        
                                                                        
                                                                        
                                                                        
                             0.56-3.79 ppm in peaches, and <0.05-0.79
ppm in plums harvested at 0 DAT.  Residues at 1 DAT were <0.05-2.69 ppm
in 14 samples of sweet cherries, 0.96-2.62 ppm in sour cherries,
0.46-3.87 ppm in 12 samples of peaches, and <0.05-0.57 ppm in 10 samples
of plums.  Average boscalid residues at 0 and 1 DAT were respectively
1.57 and 1.28 ppm in sweet cherries, 1.15 and 1.19 ppm in peaches, and
0.34 and 0.26 ppm in plums.  The highest average field trial (HAFT)
residues at 0 and 1 DAT were respectively 1.63 and 1.95 ppm for
cherries, 1.94 and 2.74 ppm for peaches, and 0.67 and 0.71 ppm for
plums.

Data from the residue decline tests indicated that average boscalid
residues in/on cherries, peaches, and plums decreased over time.

Conclusion. The available stone fruit field trial data are adequate to
support a tolerance increase from 1.7 ppm to 3.5 ppm for the stone
fruits crop group 12.   The recommended tolerance is based on the
tolerance spreadsheet using the pooled data from field trials for
representative crops of cherries, peaches, and plum treated at 1x rate
with the PHI of 0 day. When residue data from all the adequate stone
fruit field trials (1x rate with 0-day PHI) are pooled by crop, the data
support 

The data support the use of boscalid (WDG) on stone fruits up to five
broadcast foliar applications during fruit development at 0.23 lb
ai/A/application, for a total application rate of 1.15 lb ai/A.  The
data support a minimum RTI of 7 days and a minimum PHI of 0 days.  

Alfalfa.  BASF submitted field trial data for boscalid from 12 alfalfa
field trials conducted in the United States in Zones 1, 2, 5, 7, 9, 10,
and 11 and Canada in Zones 5 and 5B during the 2007 growing season. 
Each test site included one control plot (Treatment #1) and four treated
plots (Treatments #2-5). The treated plots received 2 or 3 broadcast
foliar applications of boscalid during vegetative development using
ground equipment at volumes of 20-34 gal/A.  All applications included
the use of adjuvants.  The application rates and timing of applications
were as follows:

Treatment #2 received a total of 3 applications at the rate of 0.28 –
0.32 lbs ai/A/application or a total of 0.88-0.92 lb ai/A with
retreatment intervals (RTI) of 12-15 and 28-53 days.  Applications 1, 2,
and 3 were made approximately 28 days before the 1st cutting, 14 days
before the 1st cutting, and 14 days before the 2nd cutting.             

Treatment #3 received a total of 3 applications as in treatment #2 with
RTI of 13-14 and 29-53 days.  Applications 1, 2 and 3 were made
approximately 35 days before the 1st cutting, 21 days before the 1st
cutting, and 21 days before 2nd cutting.

Treatment #4 received a total of 2 applications at the rate of 0.29-0.31
lbs ai/A/application or a total of 0.59 – 0.62 lb ai/A with RTI of
28-53 days.  Applications were made 14 days before the 1st cutting and
14 days before the 2nd cutting.

Treatment #5 received a total of 2 applications at the rate of 0.28-0.32
lbs ai/A/application or a total of 0.57– 0.62 lb ai/A with RTI of
29-53 days.  Applications were made 21 days before the 1st cutting and
21 days before the 2nd cutting.

With the exception of one test site, three cuttings of alfalfa were
harvested from each plot according to typical agricultural practices,
with the 3rd cutting being made at normal maturity (beginning bloom
stage).  The exact treatment-to-harvest intervals for each cutting are
presented below along with the residue levels in forage and hay.  At
each cutting, single control and duplicate treated samples of alfalfa
forage and hay were collected from each test, with hay samples being
field-dried to a moisture content of ~10-20% prior to sampling.  After
sampling, forage and hay samples were held in frozen (<-5°C) storage
for up to 13 months prior to extraction for analysis.  This duration is
supported by the available storage stability data.

Samples of alfalfa forage and hay were analyzed for residues of boscalid
using an LC/MS/MS method (BASF Method D9908), which was adequately
validated for data collection based on acceptable concurrent method
recoveries.  The limit of quantitation (LOQ) was 0.05 ppm for boscalid
in alfalfa forage and hay, and the reported limit of detection (LOD) was
0.004 ppm.

For Treatment #2 (3 applications each at ~0.3 lb ai/A with an ~14-day
PHI), residues of boscalid in/on forage were 1.10-20.3 ppm at 12-15 days
after the second application (1st cutting), 0.81-19.4 ppm at 12-16 days
after the third application (2nd cutting), and <0.05-0.53 ppm at 43-73
days after the third application (3rd cutting).  Residues of boscalid
in/on hay were 3.36-43.02 ppm at 12-15 days after the second application
(1st cutting), 5.22-51.12 ppm at 12-16 days after the third application
(2nd cutting), and 0.07-3.63 ppm at 43-73 days after the third
application (3rd cutting).  For the 1st, 2nd, and 3rd cuttings, boscalid
residues averaged, respectively, 7.05, 6.25 and 0.17 ppm in/on forage
and 17.37, 20.93 and 0.62 ppm in/on hay.

For Treatment #3 (3 applications each at ~0.3 lb ai/A with an ~21-day
PHI), residues of boscalid in/on forage were 0.11-6.16 ppm at 19-23 days
after the second application (1st cutting), 0.32-5.59 ppm at 20-23 days
after the third application (2nd cutting), and <0.05-0.50 ppm at 49-76
days after the third application (3rd cutting).  Residues of boscalid
in/on hay were 0.14-20.84 ppm at 19-23 days after the second application
(1st cutting), 1.52-15.26 ppm at 20-23 days after the third application
(2nd cutting), and <0.05-1.36 ppm at 49-76 days after the third
application (3rd cutting).  For the 1st, 2nd, and 3rd cuttings, boscalid
residues  averaged, respectively, 2.05, 2.29 and 0.16 ppm in/on forage
and 6.97, 7.24 and 0.49 ppm in/on hay. 

For Treatment #4 (2 applications each at ~0.3 lb ai/A with an ~14-day
PHI), residues of boscalid in/on forage were 0.97-15.68 ppm at 12-15
days after the first application (1st cutting), 0.85-15.32 ppm at 12-16
days after the second application (2nd cutting), and <0.05-0.38 ppm at
43-70 days after the second application (3rd cutting).  Residues of
boscalid in/on hay were 3.11-33.78 ppm at 12-15 days after the first
application (1st cutting), 4.48-40.06 ppm at 12-16 days after the second
application (2nd cutting), and <0.05-0.72 ppm at 43-70 days after the
second application (3rd cutting).  For the 1st, 2nd, and 3rd cuttings,
boscalid residues averaged, respectively, 4.94, 5.56 and 0.12 ppm in/on
forage and 15.30, 18.23 and 0.31 ppm in/on hay. 

For Treatment #5 (2 applications each at ~0.3 lb ai/A with an ~21-day
PHI), residues of boscalid in/on forage were <0.05-5.44 ppm at 19-23
days after the first application (1st cutting), 0.29-3.64 ppm at 20-23
days after the second application (2nd cutting), and <0.05-0.44 ppm at
49-76 days after the second application (3rd cutting).  Residues of
boscalid in/on hay were 0.42-12.46 ppm at 19-23 days after the first
application (1st cutting), 1.88-21.60 ppm at 20-23 days after the second
application (2nd cutting), and <0.05-1.12 ppm at 46-76 days after the
second application (3rd cutting).  For the 1st, 2nd, and 3rd cuttings,
boscalid residues averaged, respectively, 1.75, 2.03 and 0.14 ppm in/on
forage and 5.29, 7.50 and 0.45 ppm in/on hay. 

Overall, boscalid residues were higher in/on forage and hay from the
treatments using 3 applications rather than 2 applications, and the
residues were higher in forage and hay from treatments having the
~14-day PHI rather than the ~21-day PHI.  The worst-case treatment for
residues was Treatment #2, and the highest residues were found in forage
and hay from 1st and 2nd cuttings.  For Treatment #2, average boscalid
residues from the 1st and 2nd cuttings were 7.05 and 6.25 ppm for forage
and 17.37 and 20.93 ppm for hay.

Conclusion.  The maximum residues of boscalid were found in the
treatment (Treatment 2) after 2 or 3 foliar applications of boscalid at
~0.3 lb ai/A/application.  The residues collected at 12-16 days DALA
after the 1st and 2nd cutting were 20.30 and 19.40 ppm, respectively
in/on forage and 43.02 and 51.12 ppm in/on hay.  In general, boscalid
residue decline occurred after the 3rd cutting of forage and hay.

The submitted alfalfa field trial data are adequate and would support
the use of two or three broadcast foliar applications of  boscalid 
(25.2% ,WDG formulation) to alfalfa at up to ~0.30 lb ai/A/application,
with no more than two applications per cutting, for maximum seasonal use
rates 0.6 or 0.9 lb ai/A.  The data also support a minimum RTI of 14
days and minimum PHIs of either 14 or 21 days.    However, the alfalfa
field trial data will not support the proposed use rates of the 70% WDG
as the proposed maximum single (0.48 lb ai/A) and seasonal (1.44 lb
ai/A) application rates for the 70% WDG are approximately 1.6x higher
than the rates used in the alfalfa field. 

860.1520 Processed Food and Feed

47584402.der (citrus)

BASF submitted residue data from an orange processing study conducted in
FL (Zone 3) during 2008.  A 70% water dispersible granule (WDG)
formulation of boscalid was applied to Valencia orange trees during
fruit maturation as two broadcast foliar applications at rates of 0.30
lb ai/A/application at a retreatment interval (RTI) of 10 days, for a
total rate of 0.60 lb ai/A.  Applications were made using airblast
ground equipment in volumes of ~100 gal/A of water and included the use
of Crossfire® adjuvant (0.5% v/v).  Single control and treated bulk
samples of oranges were harvested one day after the second application
(1 DAT), and were processed within 4 days into dried pulp, juice, and
oil using commercial processing procedures.  

The data collection LC/MS/MS method (BASF Method D9908, Version II) used
to analyze boscalid residues in/on orange fruit and processed
commodities was adequately validated prior to and in conjunction with
the analysis of processing samples.  The limit of quantitation (LOQ) was
0.05 ppm in citrus fruits, and the limit of detection (LOD) was 0.01
ppm.

Following two broadcast foliar applications of boscalid (WDG) at rates
totaling ~0.60 lb ai/A, boscalid residues averaged 0.22 ppm in/on whole
fruit.  The average boscalid residues in the processed commodities were
0.694 ppm in dried pulp, <0.05 ppm in juice, and 13.1 ppm in oil.  These
data indicate that boscalid residues were reduced in juice by 0.23x, but
concentrated 3.2x in dried pulp and 59x in oil. The theoretical
processing factors for citrus are 2x for juice, 3.3x for dried pulp and
1000x for oil (OPPTS 860.1520, Table 3).

For the storage stability study, whole orange fruits, dried pulp and oil
were stored at <-5°C for up to 3.6 months prior to analysis.  The
conditions and duration for sample storage are supported by a concurrent
storage stability study in which control samples of each matrix were
fortified with boscalid at 0.5 ppm and stored under the same conditions
as the RAC and processing study samples.  After 3.6 months of frozen
storage, the corrected recoveries of boscalid were 109-126% from all
four citrus matrices. 

Table 10.	Residue Data from Orange Processing Study with Boscalid (WDG)

RAC	Processed

Commodity	Total Rate

(lb ai/A)	PHI

(days)	Residues (ppm) 1	Processing Factor3

Orange	Fruit (RAC)	0.602	1	0.2210, 0.2209  (0.2210)	--

	Dried Pulp

	0.5884, 0.8002  (0.694) 2	2.7x,  3.6x  (3.2x)

	Juice

	<0.05, <0.05  (<0.05)	<0.23x, <0.23x  (<0.23x)

	Oil

	13.6, 12.49  (13.05) 2	6.1x 5.7x   (59x)

1	The LOQ is 0.05 ppm for all commodities.  

2	Residues are average of 3 replicates each.  Mean of multiple analyses
are in parenthesis.  

2	The processing factor was calculated by dividing the residue in the
processed commodity by the residue in the associated RAC sample.  The
LOQ was used to calculate the processing factor for the value below the
LOQ.  Mean processing factors are in parenthesis..  

Conclusions.  The orange processing study is adequate.  As boscalid
residues were reduced in juice (<0.2x), a separate tolerance is not
required for citrus juice.  However, separate tolerances are required
for citrus dried pulp and oil.  Based on the processing factors for
dried pulp (3.1x) and oil (59x) and the HAFT residues (see Table 9) for
citrus fruits (orange – 1.39 ppm), the maximum expected boscalid
residues would be 4.31 ppm in dried pulp and 82 ppm in oil.  These data
support tolerances of 4.5 ppm for dried citrus pulp and 85 ppm for
citrus oil.

 

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

Analytical reference standards for boscalid and its hydroxy metabolite
(with an expiration dates of 4/1/2014) are currently available in the
EPA National Pesticide Standards Repository (personal communication with
Dallas Wright; ACB/BEAD; 7/22/09). 

860.1850 Confined Accumulation in Rotational Crops

PP#1F6313; DP# 278385, M. Nelson, 8/15/03

HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003

The nature of the residue in rotational crops is adequately understood
and was summarized in a previous residue chemistry summary document. 
The MARC has concluded that the residue of concern in rotated crops for
purposes of risk assessment and the tolerance expression is parent
compound.

860.1900 Field Accumulation in Rotational Crops

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

DP# 322235, D. Dotson, 11/03/2005

DP# 323288, D. Soderberg, 6/14/2007 

Adequate limited and extensive field rotational crop studies are
available supporting the existing tolerances for indirect residues in
rotational crops.  These data support the label-specific plant back
interval of 14 days for crops without boscalid uses.  No additional
rotational crop data are required for purposes of this petition. 

860.1550 Proposed Tolerances

For purposes of both the tolerance expression and dietary risk
assessment, HED has concluded that the residues of concern in plant
commodities include only boscalid, and the residues of concern in
livestock commodities include boscalid, its 5-hydroxy metabolite, and
the glucuronide conjugate of the 5-hydroxy metabolite.

Permanent tolerances are established for residues of boscalid in/on
various plant commodities at levels ranging from 0.05 to 60 ppm [40 CFR
§180.589(a)(1)].  Separate tolerances are also established for indirect
or inadvertent residues of boscalid in rotational crops at levels
ranging from 0.05 to 8.0 ppm [40 CFR §180.589(d)].  Tolerances are also
established for the combined residues of boscalid, its 5-hydroxy
metabolite and the glucuronic acid conjugate of the 5-hydroxy
metabolite, at levels ranging from 0.02 ppm to 0.35 ppm [40 CFR
§180.589(a)(2)].  The proposed and recommended tolerances for boscalid
are presented in Table 11.

An adequate number of field trials conducted at ~1x the existing or
proposed use rates are available on alfalfa, citrus fruits (orange,
lemon, grapefruit) and stone fruits (cherry, peach and plum) to support
permanent tolerances.  The Agency’s SOP “Guidelines for Setting
Pesticide Tolerances Based on Field Trial Data” was utilized for
determining the appropriate tolerance level for each commodity (Appendix
II).  For alfalfa forage and hay, residue data from both the 1st and 2nd
cuttings of Treatment #2 (1x rate) were used to assess tolerances as
both cuttings were collected around the proposed 14-day PHI, and residue
levels were similar for the two cuttings.  The recommended tolerances
for alfalfa forage and hay are 30 and 65 ppm, respectively.

For the citrus fruits, the residue data were pooled by crop, and
separate possible tolerances were calculated for oranges (1.6 ppm),
lemons (1.6 ppm), and grapefruits (1.1 ppm) using the tolerance
spreadsheet.  As the minimum and maximum recommended tolerances differ
by less than 5x, a crop group tolerance is appropriate for citrus, and
the recommended tolerance is 1.6 ppm.

For stone fruits, all the adequate residue data were pooled by crop
(including previously reviewed studies), and separate possible
tolerances were calculated for cherry (3.5 ppm), peach (3.0 ppm) and
plum (1.6 ppm) using the tolerance spreadsheet.  As the minimum and
maximum recommended tolerances differ by less than 5x, a crop group
tolerance is appropriate for stone fruits, and the recommended tolerance
is 3.5 ppm.

As boscalid residues were reduced in orange juice (<0.2x), a separate
tolerance is not required for citrus juice.  However, boscalid residues
were shown to concentrate in dried pulp (3.1x) and oil (59x).  Based on
these processing factors and the HAFT residues for citrus fruits (1.39
ppm), the maximum expected boscalid residues would be 4.31 ppm in dried
pulp and 82 ppm in oil.  These data support tolerances of 4.5 ppm for
dried citrus pulp and 85 ppm for citrus oil.

were <0.03 ppm in milk, <0.08 ppm in cream, ≤0.11 ppm in liver and
kidneys, <0.05 ppm in muscle and <0.24 ppm in fat.  These data indicate
that the existing tolerances for milk and fat, meat and meat byproducts
of cattle, goats, horses and sheep are more than adequate.  Separate
tolerances for liver and kidney are not required.

For hogs, the adequacy of the existing tolerances were assessed using
residue data from the 5.9 ppm dose group (1.1x dietary burden for swine)
in the cattle feeding studies.  Maximum combined residues for this dose
group were <0.064 ppm in liver, <0.090 ppm in kidney, <0.05 ppm in
muscle, and <0.12 ppm in fat.  These data indicate that the existing
tolerances for meat (0.05 ppm) and meat byproducts (0.10 ppm) of hogs
are adequate; however, the tolerance for hog fat should be increased to
0.20 ppm. Separate tolerances of hog liver and kidney are not necessary.

For poultry, the adequacy of the existing tolerances were assessed using
residue data from the 5.31 ppm dose group in the poultry feeding
studies; this group represents 1.3x the calculated dietary burden for
poultry.  Maximum combined residues for this dose group were <0.02 ppm
in eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in
fat.  These data indicate that the existing tolerances for eggs (0.02
ppm) and poultry meat (0.05 ppm) are adequate; however, the tolerances
for poultry fat and meat byproducts should each be increased to 0.20
ppm.  A separate tolerance for liver is not necessary.

 

The Codex Alimentarius Commission, Canada and Mexico have not
established any maximum residue limits (MRLs) for residues of boscalid
in/on alfalfa forage and hay or citrus fruits (Appendix I).  However,
there is an existing Codex MRL for stone fruits at 3 mg/kg, and Canada
has established MRLs at 1.7 mg/kg for the various member of the stone
fruits crop group.  Canada also has also established MRLs for various
livestock commodities.  The Canadian MRLs for stone fruits and livestock
commodities are currently harmonized with the respective US tolerances;
however, once the recommended increases are made to US tolerances, the
US tolerances on stone fruits, poultry fat and meat byproducts and hog
fat will no longer be harmonized with the Canadian MRLs. 

Table 11. 	Tolerance Summary for Boscalid.

Commodity	Proposed  Tolerance (ppm	Existing Tolerance (ppm)	Recommended
Tolerance (ppm)	Comments; Correct Commodity Definition

40 CFR 180.589(a)(1)

Alfalfa, forage	35	--	30	Adequate alfalfa forage and hay residue data
are available.

Alfalfa, hay	85	--	65

	Citrus, dried pulp	None	--	4.5	An adequate orange processing study is
available indicating that boscalid residues can concentrate in dried
pulp (3.1x) and oil (59x)

Citrus, oil	None	--	85

	Fruit, citrus, group 10	2.0	--	1.6	Adequate orange, grapefruit, and
lemon residue data are available.

Fruit, stone, group 12	5.0	1.7	3.5	An increase in the established
tolerance is required based on adequate cherry, peach and plum residue
data.

40 CFR 180.589(a)(2)

Cattle, fat	1.5	0.30	0.30	Based on the residue data from the 35.8 ppm
dose group in the cattle feeding studies and the calculated dietary
burden for dairy cattle (35.2 ppm), the existing tolerances are
adequate.  Separate tolerances for liver and kidney are not necessary.

Cattle, kidney	1.0	--	None

	Cattle, liver	1.0	--	None

	Cattle, meat	0.2	0.10	0.10

	Cattle, meat byproducts	1.5	0.35	0.35

	Egg	0.02	0.02	0.02	The existing tolerance on eggs is adequate.

Goat, fat	1.5	0.30	0.30	See Cattle above.

Goat, kidney	1.0	--	None

	Goat, liver	1.0	--	None

	Goat, meat	0.2	0.10	0.10

	Goat, meat byproducts	1.5	0.35	0.35

	Hog, fat	0.2	0.10	0.20	Based on the residue data from the 5.9 ppm dose
group in the cattle feeding studies and the calculated dietary burden
for swine (5.30 ppm), the existing tolerances on hog meat and meat
byproducts are adequate.  However, the tolerance for hog fat should be
increased to 0.20 ppm.

Hog, meat	0.05	0.05	0.05

	Hog, meat byproducts	0.2	0.10	0.10

	Hog, kidney	0.2	--	None

	Hog, liver	0.2	--	None

	Horse, fat	1.5	0.30	0.30	See Cattle above.

Horse, kidney	1.0	--	None

	Horse, liver	1.0	--	None

	Horse, meat	0.2	0.10	0.10

	Horse, meat byproducts	1.5	0.35	0.35

	Milk	0.2	0.10	0.10	The existing tolerance for milk will adequately
cover residues in both whole milk and milk fat

Milk, fat (cream)	1.5	--	None

	Poultry, liver	0.2	--	None	Based on the residue data from the 5.31 ppm
dose group in the poultry feeding study and the calculated dietary
burden for poultry (4.10 ppm), the existing tolerance for meat is
adequate and the tolerances of fat and meat byproducts should be
increased to 0.20 ppm.  A separate tolerance for liver is not necessary.

Poultry, fat	0.2	0.05	0.20

	Poultry, meat	0.05	0.05	0.05

	Poultry, meat byproducts	0.2	0.10	0.20

	Sheep, fat	1.5	0.30	0.30	See Cattle above.

Sheep, kidney	1.0	--	None

	Sheep, liver	1.0	--	None

	Sheep, meat	0.2	0.10	0.10

	Sheep, meat byproducts	1.5	0.35	0.35

	

References

DP Numbers:	278385, 282532, 286787, 287829

Subject:	PP#1F06313.  BAS 510 F (Common Name: Boscalid), New Fungicide
Active Ingredient.  Residue Chemistry Summary Document.  SEQ CHAPTER \h
\r 1 

From:	M. Nelson

To:	M. Rodriquez/C. Giles-Parker

Dated:	08/15/2003

MRIDs:	45405021-45405028, 45405101-45405128, 45405202-45405204,
45623401-45623413, and 45643801

DP Number:	322235

Subject:	  SEQ CHAPTER \h \r 1 PP#s 1F6313, 3E6791, 4F6875, and 5E6933: 
Boscalid, Registrant’s Response to Deficiencies Cited in Tolerance
Petition 1F6313.  Summary of Analytical Chemistry and Residue Data for
Rotational Root Crops, Direct Uses on Celery, Spinach, Bananas,
Strawberries, Almonds, and Potatoes, and Seed Treatment Uses on Bulb
Vegetables, Brassica Leafy Vegetables, Legume Vegetables, Peanuts, and
Sunflowers.

From:	D. Dotson

To:	J. Bazuin/T. Kish

Dated:	11/3/2005

MRIDs:	46145101, 46145102, 46160103, 46210606, and 46351401-46351405

DP Number:	323288

Subject:	  SEQ CHAPTER \h \r 1 Boscalid.  Petition for a Tolerance for
Belgian Endive; Petition for Increased Tolerances on Strawberry and the
Berries Crop Group; Submission of Requested Field Trial Data on
Cucumber, Mustard Greens and Sunflower; and Supplemental Field Trial
Data on Fruiting Vegetables, Radishes, Spearmint, Peppermint, Grapes,
and Stone Fruits; and Submission of Field Trials and a Processing Study
for Cotton.  Summary of Analytical Chemistry and Residue Data.

From:	D. Soderberg

To:	C. Swartz

Dated:	6/04/2007

MRIDs:	46512002, 46512003, 46637701, 46665501, 46665502, 46665503,
46665504, 46665505, 46665506, 46713801, 46685902, 46685901

  SEQ CHAPTER \h \r 1 Attachments:  

Appendix I -  International Residue Limits 

Appendix II - Tolerance Assessment Calculations

Template Version April 2008

Appendix I – International Residue Limits

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  

3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl	Common
Name:

Boscalid	X  Proposed tolerances

X  Reevaluated tolerance

  Other	Date: 8/05/09

Codex Status (Maximum Residue Limits)	U. S. Tolerances

□No Codex proposal step 6 or above

□No Codex proposal step 6 or above for the crops requested 
Petition Numbers:  PP#9F7527 and PP#9F9529

DP#: 364447 

□ No Limits

□  No Limits for the crops requested	X  No Limits

□  No Limits for the crops requested

Residue definition:  boscalid for plant commodities; and combined
residues of boscalid and M510F01 (free and conjugates) for animal
commodities	Residue definition: NA.  Mexico defers to US tolerances or
Codex MRLs for its export purposes.

Crops/Commodities	MRL (mg/kg)	Crops/Commodities	MRL (ppm)

apricot, plumcot, plum, peach, sweet cherry, and tart cherry	1.7

Eggs	0.02

Fat of cattle, goats, hogs, horses, and sheep	0.3

Fat of poultry	0.05

Meat of cattle, goats, hogs, horses, and sheep	0.1

Meat of poultry 	0.05

Meat byproducts of cattle, goats, hogs, horses, and sheep	0.35

Meat byproducts of poultry	0.1

Milk	0.1

	Notes/Special Instructions: S.Funk, 10/14/2009.



Appendix II.  Tolerance Assessment Calculations.

For each of the crops listed below, the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data (SOP), along with the tolerance
spreadsheet, was used for calculating recommended tolerances.  As
specified in the SOP, the minimum of the 95% upper confidence limit
(UCL) on the 95th percentile and the point estimate of the 99th
percentile was selected as the tolerance value in cases when the dataset
was large (greater than 15 samples) and reasonably lognormal.  For
datasets that were small (≤15 samples) and reasonably lognormal, the
upper bound estimate of the 95th percentile based on the median residue
value was compared to the minimum of the 95% UCL on the 95th percentile
and the point estimate of the 99th percentile, and the minimum value was
selected as the tolerance value.  For datasets that were not lognormal,
the upper bound on the 89th percentile was selected as the tolerance
value (distribution-free method).  The rounding procedures specified in
the SOP were also used.

Citrus, Crop Group 10

The dataset used to assess a tolerance for boscalid residues in/on
citrus fruit consisted of field trial data for the representative crops
of orange, grapefruit, and lemon, and represented application rates of
1.18-1.23 lb ai/A (4 applications at ~0.29-0.32 lb ai/A/application)
with a  PHI of 0 day.  As specified by the SOP, the field trial
application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values used to calculate the tolerance are provided in Table II-1.  

All field trial sample results for orange, grapefruit, and lemon were
above the LOQ (0.05 ppm).  The datasets for orange was large (26
samples) and the datasets for grapefruits and lemons were relatively
small (10-12 samples).  The dataset for each crop was entered into the
tolerance spreadsheet.  Visual inspection of the lognormal probability
plots for each crop (Figures II-1, II-3, and II-5) indicates that the
datasets for all three crops are reasonably lognormal.  The results from
the approximate Shapiro-Francia test statistic (Figures II-2, II-4, and
II-6) confirmed that the assumption of lognormality should not be
rejected.  

Using the tolerance spreadsheet, the recommended tolerances are 1.6 ppm
for orange and lemon, and 1.1 ppm for grapefruit.  Because the minimum
and maximum recommended tolerances differ by less than 5x, a crop group
tolerance is appropriate for citrus.  The recommended value is 1.6 ppm,
the maximum of the recommended individual tolerances.

Table II-1.	Boscalid Residues in/on Citrus Fruits following Four Foliar
Applications of Boscalid (WDG) at Rates Totaling ~1.20 lb ai/A/season.

Regulator:	EPA	EPA	EPA

Chemical:	Boscalid	Boscalid	Boscalid

Crop:	Orange	Grapefruit 	Lemon

PHI:	0 day	0 day	0 day

App. Rate:	4 at 0.29-0.31 lb ai/A	4 at 0.30-0.31 lb ai/A	4 at 0.29-0.32
lb ai/A

Submitter:	BASF	BASF	BASF

MRID Citation:	MRID 45903601	MRID 45903601	MRID 45903601

	Residues	Residues	Residues

	0.179	0.064	0.522

	0.233	0.097	0.590

	0.237	0.102	0.664

	0.238	0.115	0.677

	0.241	0.120	0.742

	0.260	0.135	0.807

	0.271	0.147	0.936

	0.300	0.151	0.968

	0.306	0.249	1.510

	0.316	0.272

0.326	0.824

0.332	0.847

0.352

	0.354

	0.469

	0.471

	0.499

	0.544

	0.561

	0.644

	0.676

	0.676

	0.714

	1.190

	1.360

	1.425

Figure II-1.	Lognormal Probability Plot of Boscalid Residues in/on
Oranges Following Four Foliar Applications Totaling ~1.20 lb ai/A.

Figure II-2.	Data Summary Sheet for Residues of Boscalid in/on Oranges
Following Four Foliar Applications Totaling ~1.20 lb ai/A.

Figure II-3.	Lognormal Probability Plot of Boscalid Residues in/on
Grapefruit Following Four Foliar Applications Totaling ~1.20 lb ai/A.

Figure II-4.	Data Summary Sheet for Residues of Boscalid in/on
Grapefruit Following Four Foliar Applications Totaling ~1.20 lb ai/A.

Figure II-5.	Lognormal Probability Plot of Boscalid Residues in/on Lemon
Following Four Foliar Applications Totaling ~1.20 lb ai/A.

Figure II-6.	Data Summary Sheet for Residues of Boscalid in/on Lemon
Following Four Foliar Applications Totaling ~1.20 lb ai/A.

Stone Fruits, Crop Group 12

The datasets used to assess a tolerance for boscalid residues on stone
fruits consisted of field trial data for the representative crops of
cherries, peaches and plums, and represented application rates of 1.15
lb ai/A (5 applications at ~0.230 lb ai/A/application) with a PHI of 0
day.  As specified by the SOP, the field trial application rates and
PHIs are within 25% of the maximum label application rate and minimum
label PHI, respectively.  The residue values used to calculate the
tolerance are provided in Table II-2.  HED notes that the dataset
includes values from all adequate cherry, peach and plum field trials,
including the previously reviewed stone fruit data.  (DP# 278385, M.
Nelson, 8/15/03; and DP# 323288, D. Soderberg, 6/14/2007).

h	

h2

	

%

'

(

A

a

b

v

w

x

y

‚

¦

§

©

ª

Ã

â

ã

ä

é

$

%

B

x

y

§

Ä

ã

ä



,

F

`

z

”

¨

©

®

¯

°

±

Å

Æ

,

F

㐀ۖĀ̊l攃昀ĴЀF

G

P

`

z

㐀ۖĀ̊l攃昀ĴЀz

{

„

”

®

h

h

 hH

$

h

h

h

h

h

h

h

h

h

$

Æ

$

$

$

$

$

?

$

$

?

$

?

$

$

?

h 

 h

攃昀Ĵ

H*

\

H*

	š

	š

H*

\

\

H*

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

hy

kd

FfŽ

z

(

d

t

E

x

y

z

¯

Á

á

ê

õ

h2

$

$

$

$

$

$

Ô

$

$

$

$

Ô

$

ਁ氃愀϶lԀ

lognormal probability plots for each crop (Figures II-7, II-9, and
II-11) indicates that the datasets for cherry and peach are not
lognormal; whereas, the dataset for plum is reasonably lognormal.  The
results from the approximate Shapiro-Francia test statistic (Figures
II-8, II-10, and II-12) confirmed that the assumptions of lognormality. 

Using the tolerance spreadsheet, the recommended tolerances are 3.5 ppm
for cherry, 3.0 ppm for peaches, and 1.6 ppm for plums.  Because the
minimum and maximum recommended tolerances differ by less than 5x, a
crop group tolerance is appropriate for stone fruits.  The recommended
value is 3.5 ppm, the maximum of the recommended individual tolerances.

Table II-2.	Boscalid Residues in/on Stone Fruits following Five Foliar
Applications of Boscalid (WDG) at Rates Totaling ~1.15 lb ai/A/season.

Regulator:	EPA	EPA	EPA

Chemical:	Boscalid	Boscalid	Boscalid

Crop:	Cherry	Peach	Plum

PHI:	0 day	0 day	0 day

App. Rate:	5 at 0.23 lb ai/A	5 at 0.23 lb ai/A	5 at 0.23 lb ai/A

Submitter:	BASF	BASF	BASF

MRID Citation:	MRIDs 45405121, 46665505, 47470201	MRIDs 45405121,
46665505, 47470201	MRIDs 45405121, 46665505, 47470201

	Residues	Residues	Residues

	0.050	1.360	0.157	0.590	0.050	0.245

	0.060	1.415	0.193	0.636	0.050	0.246

	0.641	1.460	0.194	0.640	0.081	0.315

	0.736	1.470	0.315	0.663	0.088	0.344

	0.756	1.500	0.315	0.700	0.090	0.455

	0.906	1.505	0.334	0.723	0.100	0.461

	1.004	1.580	0.395	0.730	0.103	0.537

	1.030	1.635	0.400	0.730	0.109	0.549

	1.092	1.700	0.422	0.746	0.130	0.553

	1.211	1.760	0.472	0.751	0.130	0.566

	1.220	2.300	0.476	0.780	0.135	0.590

	1.270	2.530	0.479	0.800	0.149	0.620

	1.280	2.840	0.486	0.819	0.150	0.740

	1.307	2.980	0.492	0.900	0.172	0.790

	0.512	0.920	0.240	0.851

	0.514	1.170

	0.518	1.200

	0.560	2.820

	0.580	3.790

1	Residue values <LOQ are listed in bold.

Figure II-7.	Lognormal Probability Plot of Boscalid Residues in/on
Cherries (Sweet and Tart) Following Five Foliar Applications Totaling
~1.15 lb ai/A.

Figure II-8.	Data Summary Sheet for Residues of Boscalid in/on Cherries
(Sweet and Tart) Following Five Foliar Applications Totaling ~1.15 lb
ai/A.

Figure II-9.	Lognormal Probability Plot of Boscalid Residues in/on
Peaches Following Five Foliar Applications Totaling ~1.15 lb ai/A.

Figure II-10.	Data Summary Sheet for Residues of Boscalid in/on Peaches
Following Five Foliar Applications Totaling ~1.15 lb ai/A.

Figure II-11.	Lognormal Probability Plot of Boscalid Residues in/on
Plums Following Five Foliar Applications Totaling ~1.15 lb ai/A.

Figure II-12.	Data Summary Sheet for Residues of Boscalid in/on Plums
Following Five Foliar Applications Totaling ~1.15 lb ai/A.

Alfalfa Forage and Hay

The dataset used to establish tolerances for boscalid on alfalfa forage
and hay consisted of field trial data representing the three
applications of boscalid (WDG) at rates of 0.28-0.32 lb ai/A (~0.85 lb
ai/A/season) and a 14-day PHI.  The residues from the 1st and 2nd
cuttings of Treatment #2 had similar levels of residues; therefore,
values from both cuttings were used in the tolerance calculations.  As
specified by the SOP, the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI,
respectively.  The residue values used to calculate the tolerance are
provided in Table II-3.  

The forage and hay datasets (48 samples each) were entered into the
tolerance spreadsheet.  Visual inspection of the lognormal probability
plots (Figures II-13 and II-15) provided in the spreadsheet indicate
that the datasets are reasonably lognormal.  The result from the
approximate Shapiro-Francia test statistic (Figures II-14 and II-16)
confirmed that the assumption of lognormality should not be rejected. 

Using the tolerance spreadsheet, the recommended tolerances are 30 ppm
for alfalfa forage and 65 ppm for alfalfa hay.

Table II-3.	Boscalid Residues in/on Alfalfa Forage and Hay following
Three Foliar Applications of Boscalid (WDG) at Rates Totaling ~0.85 lb
ai/A/season.

Regulator:	EPA	EPA

Chemical:	Boscalid	Boscalid

Crop:	Alfalfa Forage	Alfalfa Hay

PHI:	12-16 days (Cuttings 1+2)	12-16 days (Cuttings 1+2)

App. Rate:	3 at 0.28-0.32 lb ai/A	3 at 0.28-0.32 lb ai/A

Submitter:	BASF	BASF

MRID Citation:	MRID 47584401	MRID 47584401

	Residues	Residues

	0.81	5.07	3.36	15.00

	1.04	5.10	3.92	16.64

	1.10	5.39	5.22	16.72

	1.32	5.42	5.33	17.35

	1.35	5.48	5.65	18.07

	1.49	5.98	7.66	19.11

	1.69	6.06	7.72	19.53

	2.42	6.39	7.91	19.99

	2.47	7.96	8.08	20.31

	2.51	8.06	9.47	21.64

	2.73	8.56	9.74	21.96

	2.82	8.79	11.41	23.00

	2.93	8.79	11.45	24.22

	2.97	11.11	11.54	25.22

	3.09	11.82	11.59	31.13

	3.42	12.98	11.82	31.23

	3.45	13.17	12.39	32.64

	3.78	14.06	12.90	35.77

	4.21	15.04	12.99	42.22

	4.39	15.05	13.01	42.38

	4.41	15.12	13.22	43.02

	4.57	15.21	13.83	45.77

	4.93	19.40	14.13	46.69

	5.00	20.30	14.13	51.12

Figure II-13.	Lognormal Probability Plot of Boscalid Residues in/on
Alfalfa Forage Following Three Foliar Applications Totaling ~0.85 lb
ai/A.

Figure II-14.	Data Summary Sheet for Residues of Boscalid in/on Alfalfa
Forage Following Three Foliar Applications Totaling ~0.85 lb ai/A.

Figure II-15.	Lognormal Probability Plot of Boscalid Residues in/on
Alfalfa Hay Following Three Foliar Applications Totaling ~0.85 lb ai/A.

Figure II-16.	Data Summary Sheet for Residues of Boscalid in/on Alfalfa
Hay Following Three Foliar Applications Totaling ~0.85 lb ai/A.

Boscalid	Summary of Analytical Chemistry and Residue Data	DP#:  364447

 PAGE   

Page   PAGE  8  of   NUMPAGES  48