UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

DATE:	24 March 2009

SUBJECT:	Boscalid.  Petition   SEQ CHAPTER \h \r 1 Requesting the
Establishment of a Permanent Tolerance for Residues Associated with Food
Use of the Fungicide on Imported Coffee.  Summary of Analytical
Chemistry and Residue Data.

PC Code:  128008	DP Barcode:  355919

Decision Number:  394535	Registration Number:  NA

Petition Number:  8E7367	Regulatory Action:  Amended Section 3

Risk Assessment Type:  NA	Case Number:  NA

TXR Number:  NA	CAS Number:  188425-85-6

MRID Numbers:  47353903 to -06	40CFR §180.589

Chemical Class:  Carboxamide (Anilide) 			      Fungicide	Trade Name: 
Cantus®



FROM:	  SEQ CHAPTER \h \r 1 William T. Drew, Chemist

		Alternative Risk Integration and Assessment (ARIA) Team 

		Risk Integration, Minor Use and Emergency Response Branch (RIMUERB) 

		Registration Division (RD), 7505P

THROUGH:	William Cutchin, Acting Senior Scientist

		ARIA/RIMUERB/RD, 7505P

TO:		Tony Kish and Bryant Crowe, RM Team 22

		Fungicide Branch (FB)/RD, 7505P

  SEQ CHAPTER \h \r 1 This data evaluation record (DER) was originally
prepared under contract by Dynamac Corporation (2275 Research Boulevard,
Suite 300; Rockville, MD 20850).  The DER has been reviewed by the
Registration Division (RD), and revised to reflect current Office of
Pesticide Programs (OPP) policies.  

Executive Summary

	Boscalid is a carboxamide (anilide) fungicide that inhibits
mitochondrial respiration, thereby inhibiting spore germination, germ
tube elongation, mycelial growth, and sporulation of pathogenic fungi on
the leaf surface.  Boscalid is currently registered to BASF Corporation,
as water-dispersible granule (WDG) formulations, for use on a wide
variety of food/feed crops.  

	BASF Corporation has submitted four volumes of coffee field trial data
in support of a petition, PP#8E7367, to establish a tolerance for
residues of boscalid in imported coffee, arising from the proposed use
on coffee grown in Brazil.  It was noted that the current tolerance
action was submitted along with an application for an amended use
pattern on, and tolerance in, bananas (PP#8E7366; D355200; D. Dotson; 24
November 2008).  Section F of PP#8E7367 has proposed the establishment
of a tolerance (without registration) for residues of the fungicide
boscalid [3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl)] in or on imported coffee, at
the level listed below.  

Coffee	0.05 ppm

	The end-use product (EP) relevant to this tolerance action is Cantus, a
WDG formulation containing 50% of the active ingredient (ai), boscalid. 
Cantus is claimed to be effective for the control of Phoma (Phoma
costaricencis) and Ascochyta (Ascochyta coffeae) spots on coffee grown
in Brazil.  Cantus is proposed for one foliar spray treatment to coffee,
at a maximum rate of 0.075 kg ai/ha (0.067 lb ai/A), with a pre-harvest
interval (PHI) of 45 days.  

	Boscalid tolerances for plant commodities are listed in 40CFR
§180.589[a][1], and are currently expressed in terms of the parent
compound, boscalid.  Plant commodity tolerances range from 0.05 ppm in
peanuts, and tuberous and corm vegetables (subgroup 1C), to 60 ppm in
leafy greens (subgroup 4A), except head and leaf lettuce.  

	  SEQ CHAPTER \h \r 1 The nature of the residue in plants is adequately
understood.  HED has determined that, in target crops, boscalid per se
is the residue of concern (ROC) for purposes of risk assessment and
tolerance expression.  

	There are no significant livestock feedstuffs associated with the
proposed use pattern on coffee.  Therefore, no livestock metabolism
data, enforcement methods, storage stability data, or feeding studies
are required to support this petition.  The requirements for rotational
crop data are also not relevant to this petition request, because coffee
crops are typically not rotated, and data for Guidelines 860.1850 and
860.1900 are not required to establish tolerances in imported
commodities.  

	An adequate gas chromatograph with mass spectrometer detection (GC/MS) 
 SEQ CHAPTER \h \r 1 method (Method D0008) is available for enforcing
tolerances in plant commodities.  The method has been approved by the
Analytical Chemistry Branch (ACB) of the Biological and Economic
Analysis Division (BEAD).  Residues in samples from the coffee field
trials associated with this petition were determined using a
high-performance liquid chromatograph with ultraviolet detection
(HPLC/UV) method (BASF Method 441/0).  This method was adequately
validated prior to, and in conjunction with, the field trial analyses;
the validated limit of quantitation (LOQ) was 0.05 ppm for boscalid in
coffee green beans.  

	The requirements for multiresidue methods (MRM) testing data have been
fulfilled.  Residues of boscalid and its hydroxy metabolite were not
adequately recovered using the MRMs.  The MRM data have been forwarded
to FDA for a future updating of PAM, Volume I.  

	Adequate storage stability data are available from previous boscalid
petitions.  These data indicate that boscalid is reasonably stable under
frozen conditions in diverse crop matrices for intervals of at least 24
months.  Samples from the coffee trials were stored for a maximum
duration of approximately 16 months prior to residue analysis.  There
are no storage stability issues or corrections that need to be applied
to the results of the coffee field trials.  

	Adequate magnitude of the residue data were submitted for coffee.  The
results indicate that residues of boscalid were below the method LOQ
(<0.05 ppm) in all samples of coffee green beans harvested 45 days
following foliar broadcast treatment of coffee plants with the 50% WDG
formulation at 0.134 lb ai/A (2X the proposed maximum use rate). 
Residues were also <0.05 ppm in samples treated at the same rate, and
collected at PHIs of 0, 15, 30, and 60 days.  Although the available
coffee field trial data represent 2X the proposed maximum seasonal use
rate specified on the Cantus label, the data will support the proposed
use on coffee grown in Brazil, as well as the proposed raw agricultural
commodity (RAC) tolerance of 0.05 ppm.  However, a revised Section F
should be submitted to correct the commodity definition, (which is
“coffee, green bean”).  The Agency reserves the right to require
additional field trial data, as well as use pattern information, in the
event that boscalid use on coffee grown in countries other than Brazil
is proposed in the future.  

	A coffee processing study was not submitted with this petition.  Data
investigating the potential of boscalid residues to concentrate in
roasted coffee beans, and instant coffee are required.  

	The Codex Alimentarius Commission has established a maximum residue
limit (MRL) for residues of boscalid in/on coffee beans at 0.05 ppm,
which is in harmony with the tolerance recommended by HED and ARIA/RD.  

	Analytical reference standards for boscalid are available at the EPA
National Pesticide Standards Repository.  

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

	Pending submission of a coffee processing study, and a revised Section
F, there are no residue chemistry issues that would preclude the
establishment of a tolerance for boscalid residues in imported coffee,
arising from the requested use of boscalid on coffee in Brazil. 
Provided that the forthcoming human health risk assessment does not
identify any issues of concern, the submitted data support a tolerance
for residues of boscalid in/on imported coffee, at the level listed
below.  

Coffee, green bean	0.05 ppm

	860.1520 Processed Food and Feed

	A study investigating the potential of boscalid residues to concentrate
in roasted coffee beans, and instant coffee, is required.  The study
should be conducted at an exaggerated application rate (5X), in order to
obtain sufficient residue levels for the calculation of processing
factors.  

	860.1550 Proposed Tolerances

	The petitioner should submit a revised Section F to correct the
commodity definition, as recommended in Table 7, on page 11.  

Other Considerations

	HED and ARIA/RD note that there are still outstanding deficiencies
and/or issues (listed below) from an early boscalid petition (PP#1F6313;
D278385; M.J. Nelson; 15 August 2003), which should also be addressed by
the petitioner.  These data gaps do not affect the subject petition.  

	1. The petitioner should submit radiovalidation data, demonstrating the
efficiency of the hydrolysis step in the proposed tolerance enforcement
method (DFG S19) for livestock matrices.  These radiovalidation data
will also be used in support of the data collection method (BASF Method
471/0) for livestock matrices.  

	2. The petitioner should submit radiovalidation data demonstrating the
efficiency of the microwave hydrolysis step in BASF Method 476/0, which
determines bound residues of boscalid in milk and liver.  

	3. Data are required, demonstrating the frozen storage stability of
boscalid residues in processed grape juice over an interval of at least
2 months.  

Background

	The chemical structure and nomenclature of boscalid are presented in
Table 1, below.  The physicochemical properties of the technical grade
of boscalid are presented in Table 2, below.  

TABLE 1	Boscalid Nomenclature.  

Compound structure	

Empirical formula	C18H12Cl2N2O

Molecular weight	343.2

Common name	Boscalid

Company experimental name	BAS 510F

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

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

CAS registry number	188425-85-6

End-use product (EP)	Cantus (50% WDG)



TABLE 2	Physicochemical Properties of Boscalid (Technical Grade).  

Parameter	Value	References

Melting point/range (ºC)	142.8-143.8	MRIDs #45404802 and #45404804 to
-09

pH	Does not dissociate in water.

	Relative density (g/cm3 at 20ºC)	1.381

	Water solubility (mg/L at 20ºC)	4.64 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 (hPa)	7 x 10-9

	Dissociation constant, pKa	None

	Octanol/water partition coefficient, Log (KOW)	2.96

	UV/visible absorption spectrum	UV molecular extinction(e[lmol-1cm-1]) =


3.15 x 104 at 228 nm; 1.53 x 103 at 290 nm.

	

860.1200 Directions for Use

	The petitioner has submitted a specimen label for Cantus, a WDG
formulation containing 50% boscalid.  The label was affixed with an
approval stamp from Brazil’s Ministry of Agriculture, dated 21
February 2005.  Section B of the petition specifies that the proposed
use is on coffee grown in Brazil only.  Cantus is proposed for the
control of Phoma (Phoma costaricencis) and Ascochyta (Ascochyta coffeae)
spots on coffee.  A summary of the proposed use pattern is summarized in
Table 3, below.  

Table 3	Summary of Use Directions for Boscalid.

Use Timing; Type; and Equipment	Formulated Product	Use Rate

(lb ai/A)

[kg ai/ha]	Maximum # of Uses per Season	Max Seasonal Use Rate

(lb ai/A)

[kg ai/ha]	PHI

(Days)	Use Directions and Limitations

Coffee Grown in Brazil

First sign of disease; foliar broadcast;

ground	50% WDG	0.067

[0.075]	1	0.067

[0.075]	45	Application should be made evenly, using a spray volume of
500-1,000 L/ha. 



	Conclusions:  The proposed use directions for application on coffee are
adequately described, and sufficient to allow evaluation of the residue
data relative to the proposed use.  Although the available coffee field
trial data represent 2X the maximum use rate specified on the Cantus
label, the data will support the proposed use on coffee grown in Brazil,
because residues were nonquantifiable in all samples.  

860.1300 Nature of the Residue - Plants

	PP#1F6313 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 2003

	HED MARC Decision Memo; D286786; M.J. Nelson; 9 January 2003

	  SEQ CHAPTER \h \r 1 The nature of boscalid residues in target
(primary) crops is adequately understood, based upon acceptable 14C
metabolism studies conducted on grapes, lettuce and beans; 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 ROC
for risk assessment, and the tolerance expression, for primary (target)
crops.  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 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 2003

	HED MARC Decision Memo; D286786; M.J. Nelson; 9 January 2003

	There are no significant livestock feedstuffs associated with the
proposed use on coffee.  Nonetheless, it has been determined that the  
SEQ CHAPTER \h \r 1 nature of boscalid residues in livestock is
adequately understood, based upon acceptable 14C metabolism studies
conducted on lactating goats, and laying hens.  In both the goat and the
hen, parent boscalid, M510F 01 (hydroxy metabolite), and M510F 02
(M510F01 glucuronide) were identified as the major residues, with 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 BAS 510 F, M510F 01, and M510F02 are the ROCs for
risk assessment, and the tolerance expression, in livestock matrices.  

860.1340 Residue Analytical Methods

	DER Reference List (Reviewed for PP#1F6313):  

		46351405; Data Collection, BASF Method 445/0

		45405027; Data Collection, BASF Method D9908

		45405028; Tolerance Enforcement, BASF Method D0008

	PP#1F6313 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 2003

	PMV Results Memo D284510; D. Swineford and E. Kolbe; 12 August 2003

	An adequate GC/MS method (Method D0008) is available for enforcing
boscalid tolerances in plant commodities.  BEAD/ACB concluded that the
method is acceptable for enforcement purposes in plants without the need
for an EPA validation.  

	Samples of coffee green beans were analyzed for residues of boscalid
using an HPLC/UV method (BASF Method 441/0), entitled Determination of
BAS 510 F Residues in Potato, Tomato, Garlic, Onion, Carrot, Melon,
Cucumber, Grape and Coffee.  Briefly, samples were extracted with
methanol, and then vacuum filtered through a sintered funnel.  The
filter cake was washed with water/methanol (20:80, v:v).  The filtrate
was then diluted with water, and cleaned up using two C18 cartridges. 
Residues were eluted with isooctane/ethyl acetate (90:10, v:v).  The
eluate was put through a silica cartridge, and the residues were eluted
with ethyl acetate.  The silica cartridge eluate was evaporated to
dryness, the residues were dissolved in water/acetonitrile
(ACN)/tetrahydrofuran (THF) (90:5:5, v:v:v), and further cleaned up
using a chromatography pre-column system.  The fraction corresponding to
the interval between 6.0 and 10.3 minutes was collected and diluted with
water/ACN/THF (90:5:5, v:v:v) for HPLC/UV determination of boscalid. 
The method LOQ, determined as the lowest level of method validation
(LLMV) was 0.05 ppm for residues of boscalid in coffee green beans.  The
limit of detection (LOD) was not reported.  To verify the adequacy of
the method for data collection, untreated samples of coffee green beans
were fortified with boscalid at levels of 0.05 and 0.50 ppm.  Method
recoveries ranged from 84 to 108%.  

860.1360 Multiresidue Methods

	PP#1F6313 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 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, Volume I.  

860.1380 Storage Stability

	DER Reference List (Reviewed for PP#s   SEQ CHAPTER \h \r 1 1F6313,
3E6791, 4F6875 & 5E6933):  

		  SEQ CHAPTER \h \r 1 46351404; Plant Matrices

		46160103; Tomato Paste

	PPs#1F6313, 3E6791, 4F6875 & 5E6933 Residue Chemistry Memo; D322235; D.
Dotson; 3 				November 2005

ively stable at ≤-20ºC in fortified samples of cabbage (leafy
vegetable), 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
intervals of up to 24 months.  Data are also available indicating that
boscalid is stable for up to 45 days in peanut oil, and for up to 38.4
months in tomato paste stored at ≤-20ºC.  It was noted that the
initial boscalid petition, PP#1F6313, requested storage stability data
on grape processed commodities; this data requirement remains
outstanding.  The storage conditions and durations for coffee green bean
samples are summarized in Table 4, below.  

TABLE 4	Summary of Storage Conditions and Durations for Samples from the
Coffee Field Trials.  

Crop [Matrix]	Storage Temperature (°C)	Actual Storage Duration (Days)
[Months] 1	Interval of Demonstrated Storage Stability (Months) 2

Coffee

[green bean]	-20 ± 2	409-474

[13.4-15.6]	24

  SEQ CHAPTER \h \r 1 1. Actual storage duration from harvest to
analysis.  Extraction dates were not reported.  

2. Based on data from diverse crop matrices (D322235; D. Dotson; 3
November 2005).  

	Conclusions:  Adequate storage stability data are available,
demonstrating that residues of boscalid are stable under frozen
conditions in diverse crop matrices for intervals of at least 24 months.
 Samples from the coffee trials were stored for a maximum of about 16
months prior to residue analysis.  There are no storage stability issues
or corrections that need to be applied to the results of residue studies
relevant to the coffee petition.  

860.1400 Water, Fish, and Irrigated Crops

	This guideline requirement is not relevant to the current petition, as
there are no aquatic uses being proposed for boscalid.  

860.1460 Food Handling

	This guideline requirement is not relevant to the current petition, as
there are no food handling uses being proposed for boscalid.  

860.1480 Meat, Milk, Poultry, and Eggs

	There are no significant livestock feedstuffs associated with the
proposed use on coffee.  Therefore, data requirements pertaining to
meat, milk, poultry and eggs are not relevant to this tolerance
petition.  

860.1500 Crop Field Trials

	DER Reference List:  

		47353903 to -06; Coffee Green Beans

	Four coffee field trials were conducted in Brazil during the 2000
growing season.  At each test location, an untreated plot, and a treated
plot were established, with each plot containing mature coffee trees. 
The treated plots received a single foliar broadcast application of the
50% WDG formulation of boscalid at a rate of either 0.134 lb ai/A (0.15
kg ai/ha) or 0.268 lb ai/A (0.30 kg ai/ha).  All applications were made
using ground equipment, in spray volumes of approximately 53 gal/A (500
L/ha), without an adjuvant.  Samples of mature coffee cherries were
harvested 45 days after treatment (BBCH 79-89).  At one site, additional
samples were harvested 0, 15, 30 and 60 days after treatment, in order
to generate residue decline data.  The harvested coffee cherries were
then dried for 10 days, and processed into coffee green beans using a
manual pulper.  The coffee green beans were stored frozen (at roughly
-20°C) for a maximum of 474 days (15.6 months) prior to residue
analysis.  There are adequate storage stability data from previous
boscalid submissions to support the storage conditions and durations of
the coffee bean samples.  

	Samples of coffee green beans were analyzed for residues of boscalid
using an HPLC/UV method (BASF Method 441/0).  The validated LOQ was 0.05
ppm for boscalid in coffee green beans.  To verify the adequacy of the
method for data collection, untreated samples of coffee green beans were
fortified with boscalid at levels of 0.05 and 0.50 ppm.  Method
recoveries ranged from 84 to 108%.  

	The results (see Table 5, below) indicate that residues of boscalid
were below the method LOQ (<0.05 ppm) in all samples of coffee green
beans harvested 45 days following foliar treatment of coffee crops with
the 50% WDG at 0.134 lb ai/A (2X the maximum proposed rate).  Residues
were also <0.05 ppm in samples treated at the same rate, and collected
at PHIs of 0, 15, 30 and 60 days.  Samples treated at the higher rate of
0.268 lb ai/A contained residues of <0.05-0.08 ppm.  

TABLE 5	Summary of Residue Data from Coffee Field Trials with Boscalid. 


Crop [Matrix]	Total Use Rate

(lb ai/A) [kg ai/ha]	PHI (Days)	Residue Levels (ppm) 1



	n	Min.	Max.	HAFT 2	Median	Mean	Std. Dev.

Coffee

[green bean]	0.134 [0.150]	45	4	<0.05	<0.05	<0.05	0.05	0.05	0

	0.268 [0.300]	45	3	<0.05	0.08	0.08	0.05	0.06	0.02

1. For calculation of the median, mean, and standard deviation, the LOQ
(0.05 ppm) was used for residues reported 	as <LOQ.  

2. HAFT = Highest Average Field Trial.  

	Conclusions:  The submitted residue data for coffee are adequate, and
the number of trials performed is consistent with OPPTS Guideline
860.1500 (Crop Field Trials).  Based on the NAFTA Guidance Document on
Data Requirements for Tolerances on Imported Commodities in the United
States and Canada (dated December 2005), 3 trials would be required to
establish a tolerance in imported coffee beans (see Table 6, below). 
The amount of coffee available for consumption that is imported is more
than 75%, while the maximum percent of the diet for coffee is less than
0.05%.  

	Although the coffee field trial data represent 2X the maximum use rate
specified on the Cantus label, the data will support the proposed use
because residues were nonquantifiable in all samples.  The submitted
data support the proposed RAC tolerance of 0.05 ppm.  However, a revised
Section F should be submitted to correct the commodity definition from
“coffee” to “coffee, green bean.”  The Agency reserves the right
to require additional field trial data, as well as use pattern
information, in the event that boscalid use on coffee grown in countries
other than Brazil is proposed in the future.  

Table 6	Coffee Imported to the United States (Five-Year Average,
2003-2007)*

Country	Coffee (1,000 Metric Tons)	% Total Imported	Estimated Number of
Trials

Brazil	288,265	21.6%	0.6

Colombia	235,872	17.6%	0.5

Vietnam	165,010	12.3%	0.4

Guatemala	106,408	8.0%	0.2

Mexico	87,544	6.5%	0.2

Indonesia	83,996	6.3%	0.2

Costa Rica	52,395	3.9%	0.1

Germany	47,711	3.6%	0.1

Peru	47,431	3.5%	0.1

Others	222,286	16.6%	0.5

World 	1,336,916	100.0%	3

* USDA/Economic Research Service Data (last updated 15 March 2008).  

860.1520 Processed Food and Feed

	A coffee processing study was not submitted with this petition.  Data
investigating the potential of boscalid residues to concentrate in
roasted coffee beans, and instant coffee, are required.  The study
should be conducted at an exaggerated application rate (5X), in order to
obtain sufficient residue levels for the calculation of processing
factors.  

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

	Analytical reference standards for boscalid (with an expiration date of
1 April 2014) are currently available in the EPA National Pesticide
Standards Repository (personal communication with Dallas Wright;
ACB/BEAD; 27 August 2008).  Upon expiration, reference standards for
boscalid should be replenished as requested by the Repository.  The
reference standards should be sent to ACB, located at Fort Meade, to the
attention of either Theresa Cole or Frederic Siegelman, at the address
listed below.  

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD   20755-5350

(Please note that the shipment will be returned if the extended zip code
is not used.)  

860.1850 and 860.1900 Confined and Field Accumulation in Rotational
Crops

	The requirements for rotational crop data are not relevant to the
current petition because coffee is typically not a rotated crop.  Also,
data for Guidelines 860.1850 and 860.1900 are not required to establish
tolerances in imported commodities.  

860.1550 Proposed Tolerances

	HED has determined that the ROC in plants is boscalid per se for the
purposes of risk assessment and tolerance expression (MARC Decision
Memo; D286786; M.J. Nelson; 9 January 2003).  Boscalid tolerances in
plant commodities are listed in 40CFR §180.589[a][1], and are expressed
in terms of residues of the fungicide, boscalid [3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl)].  The tolerance expression
proposed by BASF in the current petition is consistent with the
tolerance definition for plant commodities listed in 40CFR
§180.589[a][1].  

	The field trial data indicate that residues of boscalid were below the
method LOQ (<0.05 ppm) in all samples of coffee green beans harvested 45
days following foliar treatment of coffee trees with the 50% WDG
formulation, at a rate of 0.134 lb ai/A (2X the proposed maximum
seasonal use rate).  Residues were also <0.05 ppm in samples treated at
the same rate, and collected at PHIs of 0, 15, 30 and 60 days.  Based on
these data, ARIA/RD recommends in favor of establishing the proposed
tolerance for residues of boscalid in the RAC (coffee, green bean) at
0.05 ppm.  However, a revised Section F is required to correct the
commodity definition.  A tolerance summary is presented below, in Table
7.  

	The Codex Alimentarius Commission has established an MRL for residues
of boscalid in/on coffee beans at 0.05 ppm, which is in harmony with the
recommended tolerance in imported coffee.  An International Residue
Limit Status Form is appended to this document.  

Table 7	Tolerance Summary for Boscalid.  

Commodity	Proposed 

Tolerance (ppm)	Recommended 

Tolerance (ppm)	Comments;

Correct Commodity Definition

Coffee	0.05	0.05	Adequate field trial data are available; Coffee, green
bean



References

	PP#1F06313.  BAS 510 F (Common Name: Boscalid), New Fungicide Active
Ingredient.  Residue Chemistry Summary Document.; D278385, D282532,
D286787, D287829;  SEQ CHAPTER \h \r 1  M.J. Nelson; 15 August 2003.  

	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.; D322235;   SEQ CHAPTER \h
\r 1 D. Dotson; 3 November 2005.  

	PP# 1F06313.  BAS 510 F in/on Various Plant and Animal Commodities. 
HED Metabolism Assessment Review Committee (MARC) Decision Memo.;
D286786; M.J. Nelson; 9 January 2003.  

  SEQ CHAPTER \h \r 1 Attachment:  International Residue Limit Status
sheet



INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl	Common Name:  Boscalid	X
Recommended tolerance

 Re-evaluated tolerance

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dex Status (Maximum Residue Limits)	US Tolerances (Recommended)

 No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#8E7367

DP Number:  355919

 No Limits

X No Limits for the crops requested	X No Limits

 No Limits for the crops requested

Residue definition:  2-chloro-N-(4'-chloro[1,1'-

biphenyl]-2-yl)-3-pyridinecarboxamide

	Residue definition:  NA 2

Crop	MRL (mg/kg)	Crop	MRL (mg/kg)

























	Notes:  	1. Per Steve Funk, 26 August 2008.  

	2. NA = Not Applicable.  



Boscalid	Summary of Analytical Chemistry and Residue Data	D355919

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