UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:	04/02/09

SUBJECT:	Pyraclostrobin: Petitions for the Establishment of Permanent Tolerances on Grain, Sorghum Grain, Forage and Stover (PP#8F7385); Increase of Tolerance for the Stone Fruit Crop Group 12 to satisfy European Union (EU) import requirement (PP#8F7390); and Establishment of a Permanent import Tolerance for Coffee (PP#8E7394).  Summary of Analytical Chemistry and Residue Data.

PC Code:  099100, 125620 & 128008	DP Barcode: 359194

Decision No.: 397102	Registration No.: 7969-186, 7969-266

Petition Nos.: 8F7385, 8F7390, and 8E7394 	Regulatory Action:  Section 3 Registration

Risk Assessment Type: N/A	Case No.: N/A

TXR No.: N/A	CAS No.: 175013-18-0

MRID No.: 47470201 through 47470204	40 CFR: 180.582

		              									Ver.Apr.08

FROM:		Meheret Negussie, Chemist	  SEQ CHAPTER \h \r 1

			Risk Assessment Branch III

			Health Effects Division (7509P)

THROUGH:		Thurston Morton, Chemist	  SEQ CHAPTER \h \r 1

			Risk Assessment Branch IV

			Health Effects Division (7509P)

				and

			Leung Cheng, Senior Chemist	  SEQ CHAPTER \h \r 1

			Risk Assessment Branch III

			Health Effects Division (7509P)

TO:			Tony Kish, RM# 22

			Fungicide Branch		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

			Registration Division (7505P)

Executive Summary

  SEQ CHAPTER \h \r 1 Pyraclostrobin belongs to the strobilurin class of fungicides.  Strobilurins are synthetic analogs of a natural antifungal substance which inhibits spore germination, mycelial growth, and sporulation of the fungi causing diseases such as fruit rot in strawberry, early leaf rot in peanuts, late blight in pestachios, rust diseases in soybeans, pre- and post fruit rot of pome and stone fruits.  The fungicide is currently registered to BASF Corporation (BASF) for use on a variety of field, vegetable, fruit, and nut crops.  It is formulated as water-dispersible granules (WDG) or an emulsifiable concentrate (EC) and is typically applied as foliar applications using ground or aerial equipment at maximum seasonal rates of 0.3-3.0 lb ai/A.  The 20% WDG formulation is also registered for use as a seed treatment on some crops.

In PP#8F7385, BASF requests the establishment of new tolerances for the combined residues of the fungicide pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl)pyrazol-3-yl]oxy]-o-tolyl] carbamate), expressed as parent compound, in/on the following commodities:

Sorghum, grain	0.5 ppm

Sorghum, forage	5 ppm

Sorghum, stover	0.8 ppm

Concurrently, BASF wishes to amend the registration of Headline® Fungicide (EPA Reg. No. 7969-186) to add use on grain sorghum.  Headline® Fungicide is an EC formulation containing 23.6% ai (2.09 lb ai/gal) of pyraclostrobin.  The proposed use is one foliar application at the maximum seasonal rate of 0.2 lb ai/A. The application may be made using ground equipment.  The proposed preharvest intervals (PHI) range to the beginning of flowering stage (25%).  In addition, the petitioner is requesting to amend the registration of Stamina Fungicide Seed Treatment BAS 500 12 F (EPA Reg. No. 7969-266), containing 18.4% ai (1.67 lb/gal), to add seed treatment on grain sorghum.  BAS 500 12 F is proposed for seed treatment at maximum rates of 0.01-0.02 lb ai/100 lb seed (0.002 lb ai/A).

In PP#8F7390, BASF requests an increase in tolerance for the combined residues of the fungicide pyraclostrobin and its desmethoxy metabolite, expressed as parent compound, in/on stone fruit crop group 12.  The proposed tolerance is:

Fruit, stone, group	2.5 ppm

In PP#8E7394, BASF requests the establishment of tolerances for the combined residues of the fungicide pyraclostrobin and its desmethoxy metabolite, expressed as parent compound, in/on imported coffee.  The proposed tolerance is:

Coffee, bean, green	0.5 ppm

  SEQ CHAPTER \h \r 1 Pyraclostrobin tolerances have been established in 40 CFR §180.582.  Tolerances for plant commodities are listed in 40 CFR §180.582 (a)(1) and are expressed in terms of the combined residues of the fungicide pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), expressed as parent compound.  The established tolerances for plant commodities range from 0.02 ppm in/on wheat grain to 29 ppm in/on leafy vegetables, except Brassica.

Tolerances for livestock commodities are listed in 40 CFR §180.582 (a)(2) and are expressed in terms of the combined residues of the fungicide pyraclostrobin and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound.  The established tolerances for livestock commodities range from 0.1 to 1.5 ppm; no tolerances are established for poultry commodities.

The nature of the residue in plants, rotational crops, and livestock is adequately understood.   In plants,   SEQ CHAPTER \h \r 1 the results of metabolism studies conducted on grape, potato, and wheat indicate that pyraclostrobin and its desmethoxy metabolite (BF 500-3) are the major residues in crop matrices including livestock feeds; tryptophan was found to be the major residue in potato tuber and wheat grain when carbon-14 was introduced in the tolyl ring (via the shikimic acid pathway).  The major degradation reactions are the removal of the methoxy group from the carbamate nitrogen and breakage of the ether bond.  In rotational crops, it was   SEQ CHAPTER \h \r 1 shown that pyraclostrobin and its desmethoxy metabolite are the major residues taken up into the plants.  In the   SEQ CHAPTER \h \r 1 goat, the major residues are pyraclostrobin and BF 500-3 in muscle and fat; pyraclostrobin, BF 500-3, and BF 500-5 (1-(4-chlorophenyl)-1H-pyrazol-3-ol) and its sulfate conjugate in milk; pyraclostrobin, BF 500-3, and BF 500-5 and its sulfate conjugate, and hydroxylated desmethoxy metabolite (500M67) in kidney; and metabolites hydrolyzed to BF 500-5 and its hydroxylated compound (BF 500-8; 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol in liver.  In poultry, the major residues are pyraclostrobin and BF 500-3 in eggs; pyraclostrobin, BF 500-3, and hydroxylated BF 500-3 (500M64) in fat; and the glucuronic acid conjugate of hydroxylated BF 500-3 (500M32) in liver.  Radioactive residues were below detection in muscle.  The main degradation reactions in livestock consist of demethoxylation, hydroxylation, and conjugation, and breaking of the ether bond.

The HED Metabolism Assessment Review Committee (MARC memo 10/9/01, DP# 278044, L. Cheng) has determined that for purposes of tolerance and dietary risk assessments, the residues of concern in plant and rotational crop commodities include pyraclostrobin and metabolite BF 500-3.  The residues of concern in livestock commodities include pyraclostrobin and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol (BF 500-5) and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

There are adequate residue analytical methods for tolerance enforcement and data collection.    SEQ CHAPTER \h \r 1 The analytical methods (LC/MS/MS and HPLC/UV) for plant commodities measure pyraclostrobin and its desmethoxy metabolite.  The methods (GC/MS and LC/MS/MS) for livestock commodities convert pyraclostrobin and related metabolites to chlorophenylpyrazolol (BF 500-5) and hydroxylated chlorophenylpyrazolol (BF 500-8) in goats and chlorophenylpyrazolol (BF 500-5) and hydroxylated chlorophenylpyrazolol (BF 500-9) in poultry.  These methods were successfully validated by an independent laboratory and validated using radiolabeled samples from metabolism studies.  The proposed enforcement methods have been forwarded to ACB/BEAD for petition method validations.  HED concludes that these methods are suitable as enforcement methods.  Samples of raw agricultural and processed commodities from the current petitions were analyzed for pyraclostrobin residues of concern using an adequate LC/MS/MS method (BASF Method D9908), which is similar to the proposed enforcement method.  The method was adequately validated in conjunction with the field trial analyses.  For each analyte, the validated limit of quantitation (LOQ) is 0.02 ppm in plant commodities, 0.01 ppm in milk, and 0.05 ppm in eggs and tissues.

The requirements for multiresidue methods testing data are fulfilled.  Pyraclostrobin was successfully evaluated through several of the FDA protocols (complete recovery through protocols D and E), while recovery of metabolite BF 500-3 was unsuccessful in all protocols.

There are adequate storage stability data from previous pyraclostrobin petition submissions.  (DP# 269668, 11/28/01, L. Cheng (PP#0F6139).  These data may be translated in the current petition to validate sample storage conditions and durations.  There are no corrections which need to be applied since pyraclostrobin residues of concern were found to be reasonably stable over a wide range of commodities under frozen storage conditions for 19-25 months.

Adequate cattle and poultry feeding studies are available to support the livestock dietary burdens resulting from the proposed uses.  Previously the maximum theoretical dietary burden (MTDB) of pyraclostrobin to beef and dairy cattle were estimated (DP# 269668, 11/28/01, L. Cheng) to be 36.3 ppm and 35.4 ppm, respectively. Dietary burdens were calculated for beef (4.9 ppm), dairy (9.5 ppm), poultry (0.95 ppm), and swine (0.55 ppm).  The calculations reflect the most recent guidance from HED concerning revisions of feedstuff percentages in “Table 1 Feedstuffs” (June 2008) and construction of reasonably balanced livestock diets.  Based on these dietary exposure levels and the residue data from the ruminant feeding study, the existing pyraclostrobin tolerances for milk, meat, fat, meat byproducts except liver, and liver of cattle, goats, hogs, horses, and sheep are adequate, and no adjustments are needed.  Tolerances for eggs and poultry are not needed at this time based on data from the poultry feeding and metabolism studies [Category 180.6(a)(3)].  If in the future, the petitioner proposes a use which increases the dietary burdens of poultry, then the Category 3 situation will be re-evaluated.

The submitted field trial data on grain sorghum forage, grain sorghum grain, and grain sorghum stover are adequate.  Based on the available data, HED recommends tolerances of 5.0 ppm on grain sorghum, forage, 0.60 ppm on grain sorghum, grain, and 0.80 ppm on grain sorghum, stover.

The submitted field trial data on stone fruits submitted in PP#8F7390 are adequate.  There are already existing residue data at 0-day PHI for stone fruits generated using the Headline 20%WDG formulation (containing pyraclostrobin as the only active ingredient).  The new stone fruit field trials were conducted using the Pristine 12.8% WG formulation (containing pyraclostrobin and boscalid as the active ingredients).  Combined residues of pyraclostrobin in stone fruits resulting from applications of Pristine WG formulation (5 x 0.12 lb ai/A) ranged from 0.04 – 1.88 ppm at 0-day PHI and from 0.04 – 1.90 ppm at 1-day PHI.  The new 0-day residue data are higher than those submitted using the Headline that ranged from 0.04 - 0.67 ppm.  The current EPA established tolerance for total residues of pyraclostrobin in the fruit stone, group 12 is 0.9 ppm.  Based on the available data, HED recommends for the increased tolerance of 2.5 ppm on fruit stone, group 12.

The submitted field trial data on coffee are adequate.  Adequate processing studies were also available on coffee.  The coffee processing study indicates that residues of pyraclostrobin do not concentrate in coffee processed fractions.  Based on the available data, HED recommends a 0.30 ppm tolerance on coffee, green bean.

Analytical reference standards for pyraclostrobin and its regulated metabolites are available at the EPA National Pesticide Standards Repository.

Regulatory Recommendations and Residue Chemistry Deficiencies

Provided a revised Section F is submitted, there are no residue chemistry issues that would preclude granting registration for the requested use of pyraclostrobin as stated below.

Provided the forthcoming Human Health Risk Assessment does not identify any risks concerns, HED recommends establishment of tolerances as follows:

	Appropriate 	Tolerances For Revised Section F:

Sorghum, grain, forage	5.0 ppm

Sorghum, grain, grain	0.60 ppm

Sorghum, grain, stover	0.80 ppm

Fruit, stone, group 12	2.5 ppm

Coffee	0.30 ppm

HED also recommends in favor of the registrant’s requests to amend Headline® Fungicide (EPA Reg. No. 7969-186) to add uses on grain sorghum and coffee, and Stamina Fungicide Seed Treatment (EPA Reg. No. 7969-266) to add new uses on grain sorghum.

	Background

Pyraclostrobin belongs to the strobilurin class of fungicides.  Strobilurins are synthetic analogs of a natural antifungal substance which inhibits spore germination and mycelial growth and sporulation of the fungus on the leaf surface.  The fungicide is currently registered to BASF for use on a variety of field, vegetable, fruit, and nut crops.  Permanent tolerances are established [40 CFR §180.582(a)(1)] for the combined residues of pyraclostrobin and its desmethoxy metabolite (BF 500-3), expressed as parent, in/on numerous plant commodities at levels ranging from 0.02 ppm in/on wheat grain to 29 ppm in/on leafy vegetables, except Brassica.  The chemical structure and nomenclature of pyraclostrobin are presented in Table  1.  The physicochemical properties of the technical grade of pyraclostrobin are presented in Table 2.

TABLE 1.	Test Compound Nomenclature.

Compound

Common name	Pyraclostrobin

Company experimental name	BAS 500 F

IUPAC name	methyl N-{2-[1-(4-chlorophenyl)-1H-pyrazol-3-yloxymethyl]phenyl}(N-methoxy) carbamate

CAS name	methyl [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxycarbam ate

CAS registry number	175013-18-0

End-use products (EP)	2.0 lb/gal EC-formulation (Headline® Fungicide, EPA Reg. No. 7969-186), 1.67 lb/gal Stamina Fungicide Seed Treatment BAS 500 12 F (EPA Reg. No. 7969-266), BAS 516 04F -12.8% WG (Pristine® Fungicide;  EPA Reg. No. 7969-199, which also contains 25.2% of boscalid)

TABLE 2.	Physicochemical Properties of Technical Grade Pyraclostrobin.

Parameter	Value	References1  (MRID)

Melting point/range	63.7-65.2º C	45118213

pH	Not applicable

	Density	1.367 g/cm3 	45118214

Water solubility at 20º C	1.9 ± 0.17 mg/L (deionized water, pH 5.8)

	45118233

Solvent solubility	n-heptane: (0.37 g/100mL);  2-propanol (3.0 g/100mL); 1-octanol (2.42 g/100mL);  olive oil (2.80 g/100m/L);  methanol  (10.08 g/100mL); >50 g/100mL in acetone, ethyl acetate , acetonitrile, DCM and toluene.	45118228

Vapor pressure	2.6 x 10-10 hPa  at 20º C

	45118214

Dissociation constant, pKa	None (no dissociable moieties)

	Octanol/water partition coefficient, Log(KOW) at room temperature	3.990 mean log Pow;  (Pow is 9772)

	45118215

UV/visible absorption spectrum	The structural identity of BAS 500 F was confirmed by NMR and MS spectra. UV molecular extinction (e [1 mol-1 cm-1]): 2.5x104 at 205 nm; 2.4x104 at 275 nm.	1996/109552

1	Product Chemistry data were reviewed by the Registration Division (DP# 269848 and DP# 274191, 5/3/01, 5/15/01, and 6/7/01, S. Malak).

2	BASF  Document Number.

Directions for Use

A summary of the pyraclostrobin end-use products proposed for use on the crops discussed in this document is listed in Table 3. Table 4 presents the summary of proposed crop use patterns.

TABLE 3.   Summary of Proposed Pyraclostrobin End-Use Products.

Trade Name	EPA Reg. No.	% ai of Formulation	Formulation Type	Target Crops	Label Date

Headline® Fungicide	7969-186	23.6%,

(2.09 lb ai/gal)	EC	Sorghum	Supplemental label attached in Section B. (June 30, 2008)

Stamina BAS 500 12 F	7969-266	18.4%

(1.67 lb ai/gal)	Seed Treatment	Sorghum	Supplemental label attached in Section B. (June 30, 2008)

Pristine® Fungicide

BAS 516 04F (Mix with Boscalid)	7969-199	12.8%

(1.1 lb ai/gal)

	WG	Stone Fruits Group-Apricot, Cherry (sweet and sour), Nectarine, Peach, Plum and Prune.	Label March 27, 2008

Headline® Fungicide (COMET® in Brazil)	7969-186	23.6%

(2.09 lb ai/gal)	EC	Coffee	Supplemental label attached in Section B. (June 30, 2008).

TABLE 4.  Summary of Proposed/Registered Use Patterns of Pyraclostrobin on Various Crops.

Applic. Timing, Type, and Equip.	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

Grain Sorghum

 Ground sprayer, aerial, or sprinkler irrigation systems.	[7969-186]

23.6% EC	(0.1-0.2)

6 to 12 fl ozs/A	1	(0.2)

12 fl ozs/A	 No later than 25% flowering	 Begin applications prior to disease development. Use higher rate (0.15-0.2 lb ai/A) when disease pressure is high (Northern leaf blight and Southern leaf blight).

Do not use in greenhouse or transplant production systems. For resistance management, if additional fungicide application is needed use a labeled non-group 11 fungicide with a different mode of action. No aerial application in NY state except as permitted under FIFRA section 24(c).

Grain Sorghum

Apply as a water-based mixture using standard slurry or mist-type seed treatment application equipment. 	[7969-266]

18.4%	(0.001-0.002)

0.01-0.02 lb/100 lbs seed

	N/S

	N/S

	Seed treatment	Use at commercial treatment facilities. Not for use on a farm. Use higher rate when disease pressure is expected to be high.

Mechanical agitation is required for proper mixing.

Coffee

Ground sprayer, aerial, or sprinkler irrigation systems.	[7969-186]

25% EC	(0.1-0.2)

150-200

g/ha	2	N/S

	45	Apply when leaf infection indexes up to 5% are observed. Re-apply in dose of  0.1 lb ai/A whenever the infection index by rust reaches up to 5% again. Maximum of two applications.

Stone Fruits Crop Group 12

 Ground application, aerial, or sprinkler irrigation equipment.  [7969-199]

12.8% WG	(0.084-0.117)

10.5-14.5 ozs of product1	5	(0.585)

72.5 ozs of product1	0	 Begin application at pink bud or prior to onset of disease development and continue on a 7-14 day interval. Do not make more than 5 applications of Pristine or other group 7 or 11 fungicides per season.  Do not make more than 2 sequential applications before alternating to a labeled fungicide with a different mode of action. For aerial application, use no less than 10 gal of spray solution per acre.

Do not apply when wind speed favors drift. Do not use in grrenhouse or transplant production. No aerial application in NY state except as permitted under FIFRA section 24(c).

N/S= not specified

1 0.128 oz (0.008lb) of pyraclostrobin in 1 oz of product.

Conclusions.  The submitted use directions are sufficient to allow evaluation of the available residue data relative to the proposed use.  The field trial data for grain sorghum, the stone fruit crop group 12, and coffee reflect the proposed use pattern.

860.1300 Nature of the Residue - Plants

HED Metabolism Assessment Review Committee Decision Memo, DP# 278044, 10/9/01, L. Cheng;  Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

The nature of the residue in plants is adequately understood based on acceptable metabolism studies conducted on grape, potato, and wheat.  The metabolism of pyraclostrobin is similar in the three crops investigated.  Pyraclostrobin and its desmethoxy metabolite (BF 500-3) are the major residues in crop matrices including livestock feeds; tryptophan was found to be the major residue in potato tuber and wheat grain when carbon-14 was introduced in the tolyl ring (via the shikimic acid pathway).  The major degradation reactions are the removal of the methoxy group from the carbamate nitrogen and breakage of the ether bond.

The HED MARC has determined that for the tolerance and risk assessment, the terminal residues of concern in plants consist of pyraclostrobin and its metabolite BF 500-3.

860.1300 Nature of the Residue – Livestock

HED Metabolism Assessment Review Committee Decision Memo, DP# 278044, 10/9/01, L. Cheng;  Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

The nature of the residue in livestock is adequately understood based on acceptable ruminant and poultry metabolism studies.  In the   SEQ CHAPTER \h \r 1 goat, the major residues are pyraclostrobin and BF 500-3 in muscle and fat; pyraclostrobin, BF 500-3, and BF 500-5 and its sulfate conjugate in milk; pyraclostrobin, BF 500-3, and BF 500-5 and its sulfate conjugate, and hydroxylated desmethoxy metabolite (500M67) in kidney; and metabolites hydrolyzed to BF 500-5 and its hydroxylated compound (BF 500-8) in liver.  In poultry, the major residues are pyraclostrobin and BF 500-3 in eggs; pyraclostrobin, BF 500-3, and hydroxylated BF 500-3 (500M64) in fat; and the glucuronic acid conjugate of hydroxylated BF 500-3 (500M32) in liver.  Radioactive residues were below detection in muscle.  The main degradation reactions in livestock consist of demethoxylation, hydroxylation, and conjugation, and breaking of the ether bond.

The HED MARC has determined that for the tolerance and risk assessment, the residues of concern in livestock commodities consist of pyraclostrobin and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol (BF 500-5) and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

860.1340 Residue Analytical Methods

Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

Chemistry Memo DP# 269850, 11/8/00, L. Cheng (PP#0F6139)

There are adequate residue analytical methods for tolerance enforcement and data collection.

  SEQ CHAPTER \h \r 1

Plant commodities:  Two adequate methods were proposed in PP#0F6139 for enforcing tolerances for residues of pyraclostrobin and the metabolite BF 500-3 in/on plant commodities:  an LC/MS/MS method (BASF Method D9908) and an HPLC/UV method (Method D9904).  The validated method LOQ for both pyraclostrobin and BF 500-3 is 0.02 ppm in all tested plant matrices, for a combined LOQ of 0.04 ppm.  Adequate independent method validation and radiovalidation data were submitted for both methods and forwarded to ACB/BEAD for a petition method validation.

Except for green coffee beans, samples of raw agricultural and processed commodities PP#8F7385, PP#8F7390 and PP#8E7394 were analyzed for residues of pyraclostrobin and its desmethoxy metabolite BF 500-3 using BASF Analytical Method D9908 (version II for sorghum).  Briefly, residues were extracted by shaking with methanol:water:2 N HCl (70:25:5; v:v:v); methanol:water (70:30, v:v) and centrifuged.  Residues were then partitioned with cyclohexane and 1N HCL saturated with NaCl, concentrated to dryness, and re-dissolved in buffered methanol:water (80:20, v:v).  The final chromatographic analysis of residues was determined by LC/MS/MS.  Total residues of pyraclostrobin and BF 500-3 are expressed as pyraclostrobin equivalents.  For each analyte, the validated method LOQ is 0.02 ppm. The method is adequate for data collection based on acceptable concurrent method recovery data.

Samples of coffee (green beans) (PP#8E7394) in Brazil were analyzed for residues of pyraclostrobin and its metabolite BF 500-3 using an LC/MS/MS method according to SOP-PA.0243 based on BASF method 445/0.  Sample extraction is similar to Method D9908 described above, except the final extract is re-dissolved in buffered methanol:water (50:50, v:v).  For each analyte, the validated method LOQ is 0.02 ppm, and the calculated LODs are 0.003 ppm for pyraclostrobin and 0.001 ppm for BF-500-3.  The method is adequate for data collection based on acceptable concurrent method recovery data.

Livestock commodities:    SEQ CHAPTER \h \r 1 In the previous petition, PP#0F06139, two tolerance enforcement methods were proposed for ruminant commodities:  HPLC/UV method 439/0 and Method 446, consisting of GC/MS method 446/0 and LC/MS/MS method 446/1.  The HPLC/UV method determines residues of pyraclostrobin per se.  Method 446 has a hydrolysis step, and determines residues of pyraclostrobin and its metabolites as BF 500-5 and BF 500-8.  The validated method LOQs for BF 500-5 type residues, in parent equivalents, are 0.01 ppm for milk and 0.05 ppm for tissues, and the validated LOQs for BF 500-8 type residues, in parent equivalents, are 0.01 ppm for milk, and 0.05 ppm for tissues.  Independent method validation data for the HPLC/UV and LC/MS/MS methods are acceptable.  Radiovalidation data submitted for the GC/MS and LC/MS/MS methods are adequate for liver and milk, and marginal for muscle.  Method 446 has been forwarded to ACB/BEAD for petition method validation.  HED concludes that Method 446 is suitable as an enforcement method.  The petitioner had been requested to modify the proposed enforcement method to include any modifications made by the EPA laboratory during the Agency laboratory validation.  An enforcement method for poultry was reviewed in PP#0F06139.  However, tolerances for poultry egg and tissues have not been established and are not required for the purpose of these petitions.

860.1360 Multiresidue Methods

Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

A cursory summary of the multiresidue methods testing data for pyraclostrobin and its metabolite BF500-3 was reported in PP#0F6139.  Pyraclostrobin was successfully evaluated through several of the FDA protocols, while recovery of BF 500-3 was unsuccessful in all protocols.  Pyraclostrobin was completely recovered through Protocol D (in grape) and E (in grape), and partially recovered through Protocol F (in peanut).  Metabolite BF 500-3 had poor peak shape and inadequate sensitivity with Protocol C columns, and therefore, was not further analyzed under Protocol D, E, and F.  The results of the multiresidue testing for pyraclostrobin were forwarded to FDA on 1/4/02 for the purpose of updating PAM, Volume I.

860.1380 Storage Stability

Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

hat pyraclostrobin and metabolite BF 500-3 are reasonably stable at ≤-10 ºC in fortified samples of grape juice (juices), sugar beet tops (leafy vegetables), sugar beet roots (root crop), tomatoes (fruit/fruiting vegetable), wheat grain (non-oily grain), and wheat straw (dry feed) for up to 25 months, and in fortified samples of peanut nutmeats (oilseed) and peanut oil for up to 19 months.

The storage intervals and conditions for samples collected from the magnitude of the residue and processing studies discussed in this document are presented below in Table 5.

TABLE 5.   Summary of Storage Conditions and Intervals of Samples from Crop Field Trials.

Matrix 	MRID	Storage Temperature (°C)	Actual Storage Duration (Months) Interval of Demonstrated Storage Stability (months)

Sweet/Sour Cherry	47470201

	-10

	5.7	19-25

Peach

	4.9

	Plum

	3.8

	Sorghum Forage	47470203

	-5

	5.3	19-25

Sorghum Grain

	8.2

	Sorghum Stover

	5.3

	Coffee	47470204

	≤-20	4.1	19-25

Coffee (Green bean, Caleaned green bean, Roasted beans, Dried spent grounds, Liquor extract, and Instant coffee).	47470202

	<-5	<1 month	19-25

Conclusions.  The storage conditions and durations of samples are supported by adequate storage stability data available indicating that pyraclostrobin and BF 500-3 are stable in frozen representative plant matrices for at least 25 months (DP# 269668, L. Cheng, 11/28/01).

860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the current petitions as there are no aquatic uses being proposed for pyraclostrobin.

860.1460 Food Handling

This guideline requirement is not relevant to the current petitions as there are no food-handling uses being proposed for pyraclostrobin.

860.1480 Meat, Milk, Poultry, and Eggs

Livestock dietary burdens

No new livestock feeding studies were submitted with these petitions. The potential for transfer of pyraclostrobin residues of concern to meat, milk, poultry, and eggs exists because there are several livestock feedstuffs (sorghum forage, sorghum grain, and sorghum forage) that are associated with the proposed use in the current petition (PP#8F7385).  The livestock dietary burdens of pyraclostrobin are presented in Table 6, and reflect the most recent guidance from HED concerning revisions of feedstuff percentages in OPPTS 860.1000 Table 1 and construction of reasonably balanced livestock diets (RBLDs).  The new livestock feedstuffs included in the current petition are sorghum grain, sorghum forage, and sorghum stover. The calculated dietary burdens of pyraclostrobin are estimated at 4.9 ppm (beef), 9.5 ppm (dairy), 0.95 ppm (poultry), and 0.55 ppm (swine).  The current dietary burdens for cattle and poultry differ very slightly from the previous estimates (D343754, J. Stokes, 2/12/2008).

Table 5.   Calculation of Reasonably Balanced Dietary Burdens (RBDBs) of Pyraclostrobin Residues for  Livestock. 1

Feedstuff	Type	% Dry Matter 	% Diet 	Tolerance (ppm)	Dietary Contribution (ppm)

Beef Cattle R 15%, CC 80%, PC 5%

Barley, hay	R	88	10	25	2.84

Cotton, gin byproducts	R	90	5	30	1.67

Barley, grain	CC	88	20	0.4	0.091

Corn, field, grain/milled byproducts	CC	88	20	0.1	0.023

Canola/sunflower, meal	PC	92	5	0.3	0.016

Sorghum, grain, forage/silage	R	35	--	5.0	--

Sorghum, grain, grain	CC	86	40	0.6	0.27

Sorghum, grain, stover	R	88	--	0.8	--

TOTAL BURDEN	--	--	100

4.9

Dairy Cattle R 45%, CC 45%, PC 10%

Almond, hulls	R	90	5	1.6	0.09

Legume, hay (cowpea)	R	30	5	25	4.16

Barley, grain	CC	88	20	0.4	0.091

Cotton, undelinted seed	PC	90	10	0.3	0.033

Sorghum, grain, forage/silage	R	35	35	5.0	5

Sorghum, grain, grain	CC	86	25	0.6	0.15

Sorghum, grain, stover	R	88	--	0.8	--

TOTAL BURDEN	--	--	100	--	9.5

Poultry CC 75%, PC 25%

Oat, grain	CC	88	70	1.2	0.84

Canola/sunflower, meal	PC	92	25	0.3	0.075

Sorghum, grain, grain	CC	86	5	0.6	0.03

TOTAL BURDEN	--	--	100	--	0.945

Swine CC  85%, PC 15%

Barley, grain	CC	88	5	0.4	0.02

Canola/sunflower, meal	PC	92	15	0.3	0.045

Sorghum, grain, grain	CC	86	80	0.6	0.48

TOTAL BURDEN	--	--	100	--	0.545

1   All data are based on Table 1 Feedstuffs (June 2008), a revision of feedstuffs data found in Table 1 (180.1000 OPPTS Test Guidelines).  Residue levels for beef and dairy are corrected for moisture content and are determined by formula: tolerance / %DM  x  % in diet.  Residue levels for poultry and swine are considered “as-is” and are determined by formula: tolerance  x   % in diet.  R: roughage; CC: carbohydrate concentrate;  PC:  protein concentrate.

Typical compositions of daily rations for the animals of choice for Table 1 data  follow:

Feedlot beef  are fed higher amounts of CC (up to 80 %), and lower amounts of  R (15-20 %) and PC (5-10 %) as the slaughter time (last 3 months) gets closer.  High volume milk-producing lactating dairy cows have a daily ration of 45 % R, 40-45 % CC, and 10-15 % PC.

A laying hen that will give a steady egg production is fed 75-80 % CC and 20-25 % PC.   A marketable hog diet that will give steady growth would have 80-85 % CC and 15-20 % PC.

Livestock feeding studies: Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

Adequate feeding studies were reviewed in PP#0F6139.  The current pyraclostrobin tolerances

for livestock commodities were established based on results from these studies and the Agency’s

estimated dietary burdens for pyraclostrobin residues, which were originally calculated to be 36.3

 ppm for beef cattle, 35.4 ppm for dairy cattle, and 0.35 ppm for poultry.  The more recent dietary

burden for pyraclostrobin residues are estimated at 4.9 ppm (beef ), 9.5 ppm (dairy), 0.95 ppm

(poultry), and 0.55 ppm (swine).  In the poultry feeding study, l  SEQ CHAPTER \h \r 1 aying hens were orally dosed once

daily for 30 consecutive days with pyraclostrobin at dose levels equivalent to 0.28 ppm (0.3x),

0.88 ppm (0.9x), and 3.01 ppm (3.0x).  At the highest feeding level of 3.01 ppm, residues of

pyraclostrobin and its metabolites hydrolyzable to BF 500-5 were less than the method LOQ

(0.05 ppm) in all egg and tissue samples, except for one egg sample (Day 17) where residues of

 pyraclostrobin were detected at 0.064 ppm and <0.05 ppm upon re-analysis.  Residue analysis of

BF 500-8 was not conducted (the metabolism data show all metabolites hydrolyzable to BF 500-

8 would be less than 10% TRR), but instead an isomeric compound (BF 500-9) was measured.

Levels of BF 500-9 also were all <0.05 ppm.

Conclusions:  Based on these dietary exposure levels and the residue data from the ruminant feeding study, the existing pyraclostrobin tolerances for milk (0.1 ppm), meat (0.1 ppm), fat (0.1 ppm), meat byproducts except liver (0.2 ppm), and liver (1.5 ppm) of cattle, goats, hogs, horses, and sheep are adequate to support the proposed uses.  Tolerances for eggs and poultry are not needed based on data from the poultry feeding and metabolism studies [Category 180.6(a)(3)].  If, in the future, the petitioner proposes a use which increases the dietary burdens of poultry, then the Category 3 situation will be re-evaluated.

860.1500 Crop Field Trials

BASF has submitted grain sorghum field trials supporting a new use of pyraclostrobin (EC) and seed treatment on grain sorghum, along with an increased tolerance petition on stone fruits.  In addition, BASF has submitted coffee field trials plus a processing study on coffee to support a tolerance on imported coffee.    SEQ CHAPTER \h \r 1 The results from these studies are summarized and discussed below.

Field Trial Data Submitted Under 8F7390

DER Reference List	47470201.der.doc

Adequate field trial data are available supporting the use of pyraclostrobin on cherries (sweet and sour), peaches, and plums.  A total of eighteen field trials were conducted in the United States and Canada during the 2007 growing season in EPA Regions 1, 2, 5, 6, 10 and 11.  Seven trials were conducted on cherries (sweet and sour) grown in MI (2), CA (3), WA (1), and ON (1), six trials were conducted on peaches grown in  NY (1), GA (2), MI (1),  OK (1), and CA (1), and five trials were conducted on  plums grown in CA (4) and MI (1).  At each field trial location, an untreated plot and a treated plot were established.  The treated plots received five foliar applications of a WG formulation of boscalid (BAS 510 F) and pyraclostrobin (BAS 500 F) at 258 g ai/ha (0.230 lb ai/A) and 131 g ai/ha (0.117 lb ai/A), respectively. (Only the residue data from treatments with pyraclostrobin are reported in this Data Evaluation Record).  All applications were made as foliar sprays using commercial ground equipment or equipment which simulated commercial applications.  The target application timing was 28, 21, 14, 7, and 0 days before harvest.  The applications were made between crop growth stages BBCH 85 and 89, using 1.02 kg of product/ha (0.91 lb of product/A) in spray volumes targeting 187 L/ha (19.99 gal/A).  Samples of cherries, peaches, and plums were harvested 0 days after last application (DALA) as well as 1-DALA.  At three sites, additional samples were harvested 5 and 10 days after treatment to generate residue decline data.   An adjuvant was not added to the spray mixture for all applications.  The storage interval of treated samples from harvest to analysis was 259 days (8.6 months). Storage stability data are supported by a previous study.

The residues of pyraclostrobin and its N-desmethoxy metabolite (BF 500-3) were quantitated by HPLC/MS/MS according to BASF Method No. D9908.  The LOQ was 0.02 mg/kg each for pyraclostrobin and BF 500-3.   Acceptable concurrent method validation data were obtained.  Samples were fortified with pyraclostrobin and its metabolite at 0.02 mg/kg and 50 mg/kg with average recoveries of 89%, 89%, 103%, and 104% in sweet cherries, sour cherries, peaches and plums, respectively.  For BF 500-3, the average procedural recoveries were 78%, 85%, 95%, and 111% in sweet cherries, sour cherries, peaches, and plums, respectively. Recoveries were within the acceptable range (70-120%).

A summary of residue data from the stone fruit field trials is presented in Table 7.  The results from these trials indicate that following five applications of the 2.0 lb/gal EC formulation of pyraclostrobin reflecting a PHI of 0-days, combined residues (BAS 500 F and BF-500-3, in parent equivalents) ranged from 0.04 - 1.88 mg/kg in sweet cherries, 0.52 - 1.33 mg/kg in sour cherries, 0.31 - 1.75 mg/kg in peaches, and 0.04 - 0.45 mg/kg in plums.  At 1-DALA, total pyaclostrobin residues ranged from 0.04 - 1.38 mg/kg in sweet cherries, 0.44 - 1.17 mg/kg in sour cherries, 0.24 - 1.90 mg/kg in peaches, and 0.04 - 0.36 mg/kg in plums.  The average combined residues were 0.764 in sweet cherries, 0.955 in sour cherries, 0.602 in peaches, and 0.198 in plums.  Residue decline data show that residues of pyraclostrobin decrease in sweet cherries, sour cherries, peaches, and plums with increasing pre-harvest intervals.

TABLE 7.  Summary of Residues from the Crop Field Trials with Pyraclostrobin.

Crop Matrix

 	Total Applic. Rate

(lb ai/A)

 	PHI (days)

 	Residues (mg/kg)

	Mean	Std. Dev.	HAFT	Min.	Max.

Stone Fruit  (proposed use = 0.585 lb ai/A total application rate, 0-day PHI)

Sweet Cherry	0.585	0	0.764	0.624	1.605	0.04	1.88

Sour Cherry	0.585	0	0.955	0.320	1.165	0.52	1.33

Peach	0.585	0	0.602	0.493	1.645	0.31	1.75

Plum	0.585	0	0.198	0.159	0.395	0.04	0.45

Conclusions: The petitioner has provided adequate residue data reflecting the maximum proposed use pattern of pyraclostrobin in/on stone fruits.  The combined residues of pyraclostrobin and its metabolite BF 500-3 did not exceed the proposed tolerance level of 2.5 ppm in/on stone fruits following five applications of the 2.0 lb/gal EC formulation of pyraclostrobin reflecting a PHI of 0-days.  The combined residues ranged from 0.04 - 1.88 mg/kg in sweet cherries, 0.52 - 1.33 mg/kg in sour cherries, 0.31 - 1.75 mg/kg in peaches and 0.04 - 0.45 mg/kg in plums.  At 1-DALA, total pyaclostrobin residues ranged from 0.04 - 1.38 mg/kg in sweet cherries, 0.44 - 1.17 mg/kg in sour cherries, 0.24 - 1.90 mg/kg in peaches and 0.04 - 0.36 mg/kg in plums.  The average combined residues were 0.764 in sweet cherries, 0.955 in sour cherries, 0.602 in peaches, and 0.198 in plums.  Samples were analyzed using an adequate analytical method, and are supported by the available storage stability data.  The number and locations of field trials are in accordance with OPPTS Guideline 860.1500, and the conducted field trials reflect the maximum proposed foliar use pattern.

The field trial data for all stone fruits (cherry, peach, and plum) reflecting the 0.585 lb ai/A were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine an appropriate tolerance level; see Appendix II.  The tolerance spreadsheet recommends a tolerance of 2.5 ppm for stone fruits crop group 12.

Field Trial Data Submitted Under 8F7385

DER Reference List	47470203.der.doc

BASF Corporation (BASF) has submitted field trial data for pyraclostrobin (BAS 500 F) on grain sorghum.  A total of twelve field trials were conducted in the United States in Regions 2 (GA, 1 trial), 4 (AR, 1 trial), 5 (IA, IL, KS, MN, 1 trial each), 6 (OK, TX 1 trial each), 7 (NE, 1 trial) and 8 (TX, 3 trials) during the 2006 - 2007 growing season.  At each test location, an untreated plot and a treated plot were established.  At the trials on grain sorghum, the crops were grown from seed treated with both triticonazole (4.2 lb/gal flowable) at 50 g ai/100 kg seed (0.005 lb ai/A) and pyraclostrobin (1.7 lb/gal flowable) at 20 g ai/100kg seed (0.002 lb ai/A).  The sorghum plants were later treated once foliarly with pyraclostrobin (2 lb/gal EC) at 0.19 -0.22 lb ai/A (0.22 - 0.23 kg ai/ha) targeting the growth stage 25% flowering (BBCH code 61 -63).  The foliar applications were made in 20 - 34 gal/A of water (189 - 318 L/ha) using ground equipment. An adjuvant was added to the spray mixture for all foliar applications except one site (R060574).

The residues of pyraclostrobin and its N-desmethoxy metabolite (BF 500-3) in/on grain sorghum raw agricultural commodity (RAC) samples (forage, grain, and stover) were quantitated by LC/MS/MS using BASF analytical method D9908 (version II).  The validated LOQ was 0.02 ppm for each analyte, for a combined LOQ of 0.04 ppm.  The method was adequate for data collection based on acceptable concurrent method recoveries.

A summary of residue data from sorghum field trials is presented in Table 8.  The results from these trials indicate that after a single broadcast foliar application of pyaclostrobin at ~ 0.2 lb ai/A to sorghum grown from seed treated with pyraclostrobin at 20 g ai/100 kg seed (0.002 lb ai/A), combined residues of pyraclostrobin (BAS 500 F and BF-500-3) ranged from <0.04 - 1.96,  <0.04 - 0.47, and <0.04 - 0.85 ppm, in/on sorghum forage, grain, and stover, respectively, each harvested at commercial maturity.  The storage interval from collection to extraction ranged from 109 - 247 days (3.6 - 8.1 months) for sorghum RAC samples.  Adequate storage stability data are available to support the storage interval.

TABLE 8.  Summary of Residues from the Crop Field Trials with Pyraclostrobin.

Crop Matrix

 	Total Applic. Rate

(lb ai/A)

 	PHI (days)

 	Residues (ppm)

	Mean	Std. Dev.	HAFT 	Min.	Max.

Sorghum Grain (proposed use = 0.20 lb ai/A total application rate, 13-122-day PHI)

Sorghum forage	0.20	13-43	0.61	0.52	1.72	<0.04	1.96

Sorghum grain	0.20	46-122	0.09	0.11	0.41	<0.04	0.47

Sorghum stover	0.20	46-122	0.17	0.21	0.75	<0.04	0.85

Conclusions: The petitioner has provided adequate residue data reflecting the maximum proposed use pattern of pyraclostrobin (seed treatment and foliar) in/on sorghum.  The combined residues of pyraclostrobin and its metabolite BF 500-3 did not exceed the proposed tolerance level of 5.0 ppm and 0.5 ppm in sorghum forage and grain, respectively; however, in sorghum stover, the combined residue value was slightly higher (0.85) than the proposed value of 0.80 ppm.  The combined residues ranged from <0.04 - 1.96, <0.04 - 0.47, and <0.04 - 0.85 ppm, in/on sorghum forage, grain, and stover, respectively, each harvested at commercial maturity.  Samples were analyzed using adequate methods and are supported by the available storage stability data.

The field trial data for grain sorghum (forage, grain, and stover) reflecting the 0.19 - 0.22 lb ai/A were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine an appropriate tolerance level; see Appendix II.  The tolerance spreadsheet recommends a tolerance of 5.0 ppm for sorghum forage, 0.60 ppm for sorghum grain, and 0.80 ppm for sorghum stover.  The tolerance spreadsheet recommends a tolerance of 0.60 ppm for sorghum grain which is slightly higher than the level (0.50 ppm) proposed by the petitioner.

Field Trial Data Submitted Under 8E7394

DER Reference List	47470204.der.doc

BASF has submitted five field trial data for pyraclostrobin on coffee, conducted in Brazil during the 2007 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 two foliar broadcast applications of the EC formulation of pyraclostrobin at 200 g ai/ha (0.178 lb ai/A) and 150 g ai/ha (0.134 lb ai/A).  Samples of mature green coffee beans were harvested 45 days after treatment.  At two sites, additional samples were harvested 0, 15, 30, and 60 days after treatment to generate residue decline data.  Only one sample was collected from all the field trials.  An adjuvant was not added to the spray mixture for all applications.

The residues of pyraclostrobin and its N-desmethoxy metabolite (BF 500-3) in coffee samples were quantitated by HPLC/MS/MS according to SOP-PA.0243 based on BASF method 445/0, entitled “Method for the determination of BAS 480 F, BAS 490 F, BAS 500 F, BAS 505 F and BAS 510 F in plant matrices.” The LOQ was 0.02 mg/kg for each analyte, and the LODs were 0.003 mg/kg for pyraclostrobin and 0.001 mg/kg for its metabolite.  The analytical method was validated at the LOQ and 100X LOQ for pyraclostrobin and its metabolite.  Acceptable recovery data was obtained for each analyte.  Recoveries ranged from 84 - 114%.

A summary of residue data from the coffee field trials is presented in Table 9.  The results from these trials indicate that combined residues (parent and metabolite) ranged from 0.04 to 0.15 mg/kg in/on all samples of green coffee beans harvested 45 days following two foliar treatments of coffee crops with EC formulation.  Combined residues ranged from 0.04 - 0.31 mg/kg in/on samples treated at the same rate and collected at PHIs of 0, 15, 30, and 60.  Residue decline data show that pyraclostrobin decreases in coffee beans with increasing pre-harvest intervals.  The maximum storage interval of treated coffee samples from harvest to analysis was 123 days (4 months).  Storage stability data were not submitted with this study.  Adequate storage stability data are available to support the storage interval.

TABLE 9.  Summary of Residues from the Crop Field Trials with Pyraclostrobin.

Crop Matrix

 	Total Applic. Rate

(lb ai/A)

 	PHI (days)

 	Residues (ppm)

	Mean	Std. Dev.	HAFT1	Min.	Max.

Coffee (total application rate-not specified, 45-day PHI)

Coffee	0.312	45	0.064	0.048	--	0.04	0.15

1 = Only one sample collected per field trial.

Conclusions:  The petitioner has provided adequate residue data reflecting the maximum proposed use pattern of pyraclostrobin in/on coffee bean.  The combined residues of pyraclostrobin and its metabolite BF 500-3 did not exceed the proposed tolerance level of 0.5 ppm harvested 44-DALA, following two foliar applications of an EC formulation at ~0.178 lb ai/A/application and 0.134 lb ai/A for a total seasonal application rate of ~0.312 lb ai/A.  The combined residues were 0.04 - 0.15 mg/kg.  Samples were analyzed using adequate methods and are supported by the available storage stability data.

The field trial data for coffee reflecting 0.312 lb ai/A were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine an appropriate tolerance level; see Appendix II.  The tolerance spreadsheet recommends a tolerance of 0.30 ppm for coffee, which is slightly lower than the level (0.5 ppm) proposed by the petitioner.

860.1520 Processed Food and Feed

DER Reference	47470202.der.doc

In conjunction with the coffee field trials,   SEQ CHAPTER \h \r 1 BASF Corporation (BASF) has submitted a processing study for pyraclostrobin on coffee.  Two field trials were conducted in Costa Rica during the 2007 growing season.  The treated plots received two broadcast foliar applications of the EC at 0.82 - 0.89 lb ai/A (918 - 996 g ai/ha) (~5X the proposed rate) and 0.68 lb ai/A (758 - 760 g ai/ha) (~5X the proposed rate) for a total rate of 1.50 - 1.57 lb ai/A (1.678 - 1.754 kg ai/ha/season).  There was a 61-day retreatment interval between the applications, which were made 105 and 44 days before harvest.  The applications were made in 27 - 30 gal/A of water (459 - 507 L/ha) using ground equipment, with an adjuvant.  Single control and duplicate treated samples of mature coffee were harvested 44 days after the last application.  Green coffee beans were processed to cleaned green bean, roasted bean, coffee extract, dried spent grounds, liquor extract and freeze-dried instant coffee using simulated commercial procedures.  Storage stability data are not required since the samples were stored less than 30 days from collection to analysis.  However, adequate storage stability data are available to support storage conditions and durations of samples.

The coffee RAC (green bean) and processed commodity samples were analyzed for residues of pyraclostrobin and its N-desmethoxy metabolite (BF 500-3) using an LC/MS/MS method D9908, Version II.  Acceptable concurrent method validation data were obtained.  The LOD and LOQ of residues of pyraclostrobin and its metabolite (BF 500-3) in/on coffee RAC and processed commodity samples were 0.005 and 0.02 ppm, respectively, for each analyte.  The results from the processing study on coffee indicated that combined residues of pyraclostrobin and its metabolite BF 500-3 in four green bean RAC samples were 0.05 - 0.12 ppm.  Combined residues in cleaned green bean samples were 0.05 - 0.11 ppm.  Combined residues were non-quantifiable in all other coffee processed fractions with the exception of two treated dried spent grounds samples from one of the trials (RCN R070040) that contained combined residues at 0.04 ppm.

A summary of residue data from the coffee processing study is presented in Table 10.  A comparison of the residues in the RAC with those in each processed fraction indicated that residues of pyraclostrobin do not concentrate in coffee processed fractions.

TABLE 10.   Residue Data from Coffee Processing Study with Pyraclostrobin.

RAC; Trial ID	Processed Commodity	Total Rate

(lb ai/A) 	PHI

(days)	Combined Residues of Pyraclostrobin and its BF 500-3 Metabolite (ppm)	Processing Factor

Pyraclostrobin	BF-500-3	Combined

	Green beans (RAC); RCN R070040	Green beans (RAC)	1.57	44	0.0984; 0.0997 <0.0259; 0.0237	<0.12; <0.12 	N/A; N/A

	Cleaned green bean

	0.0881; 0.0868	<0.02; <0.02	<0.11; <0.11	0.9; 0.9

	Roasted beans

	<0.02; <0.02	<0.02; <0.02	<0.04; <0.04	0.2; 0.2

Green beans (RAC); RCN R070040	Dried spent grounds

	<0.02; <0.02	0.0238; 0.0204	<0.04; <0.04	0.2; 0.2

	Liquor extract

	<0.02; <0.02	<0.02; <0.02	<0.04; <0.04 	0.2; 0.2

	Instant coffee

	<0.02; <0.02	<0.02; <0.02	<0.04; <0.04	0.2; 0.2

Green beans

(RAC); RCN R070041  	Green beans (RAC)	1.50	44	0.0333; 0.0368 <0.02<0.02;	<0.05; <0.06	N/A; N/A

	Cleaned green bean

	0.0350; 0.0343	<0.02<0.02;	<0.06; <0.05	1.1X; 0.9

	Roasted beans

	<0.02; <0.02	<0.02<0.02;	<0.04; <0.04 	0.6; 0.5

Green beans (RAC); RCN R070041	Dried spent grounds

	<0.02; <0.02	<0.02<0.02;	<0.04; <0.04 	0.6; 0.5

	Liquor extract

	<0.02; <0.02	<0.02<0.02;	<0.04; <0.04 	0.6; 0.5

	Instant coffee

	<0.02; <0.02	<0.02<0.02;	<0.04; <0.04 	0.6; 0.5

Conclusions.  The coffee processing study is adequate.  Residues of pyraclostrobin were detected in the green bean RAC and cleaned green bean from a field trial treated at an exaggerated 5x rate. Combined residues were non-quantifiable in all other coffee processed fractions, with the exception of two treated dried spent grounds samples from one of the trials (RCN R070040) that contained combined residues at 0.04 ppm.  The data indicate that residues of pyraclostrobin and its metabolite do not concentrate in cleaned green bean, coffee roasted beans, dried spent grounds, liquor extract, and instant coffee samples.

Plums/Prunes

Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

Field trial data was submitted (PP#0F6139) depicting the potential for concentration of residues of pyraclostrobin in prunes, the only processed commodity of plums.  The submitted plum processing data were adequate.  The data indicate that the combined residues of pyraclostrobin and its metabolite BF 500-3 concentrated slightly in prunes at 1.2x and 1.3x.

Conclusions.  The HAFT residue of plums treated at 1x the maximum seasonal rate (0.6 lb ai/A/season; 0-day PHI) from the submitted plum field trial studies was 0.19 ppm  for pyraclostrobin and <0.02 ppm for BF 500-3 (<0.21 ppm combined residues).  Based on the HAFT (<0.21 ppm) and an average concentration factor of 1.3x, the maximum expected pyraclostrobin and BF 500-3 residues in prunes would be 0.273 ppm, which is lower than the proposed RAC tolerance of 2.5 ppm for the stone fruits crop group.  Based on these data, a tolerance for pyraclostrobin residues in prunes is not warranted.

860.1650 Submittal of Analytical Reference Standards

Analytical standards for pyraclostrobin and its regulated metabolites (BF 500-3) are currently available in the EPA National Pesticide Standards Repository (e-mail correspondence with T. Cole, 2/17/09).

860.1850 Confined Accumulation in Rotational Crops

HED Metabolism Assessment Review Committee Decision Memo, DP# 278044, 10/9/01, L. Cheng

Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

An adequate confined rotational crop study was reviewed in PP#0F6139.  The study showed that the metabolism of pyraclostrobin in rotated crops is similar but more extensive than that in primary crops.  Pyraclostrobin undergoes demethoxylation to yield BF 500-3, followed by further degradation to medium polar and polar metabolites, and subsequent conjugation reactions and incorporation into natural products.  The HED MARC has determined that the residues of concern in rotational crops consist of pyraclostrobin and metabolite BF 500-3.

860.1900 Field Accumulation in Rotational Crops

Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

A limited field rotational crop study was reviewed in PP#0F6139.  The results indicate that r  SEQ CHAPTER \h \r 1 esidues of pyraclostrobin and its metabolite BF 500-3 were each less than the method LOQ (<0.02 ppm) in/on rotational crop matrices (radish, roots and tops; cabbage, with and without wrapper leaves; and wheat forage, hay, and grain) planted 14 days following the last of six sequential foliar applications to the primary crop, cucumbers, of the 2 lb/gal EC formulation at 0.19 - 0.20 lb ai/A/application.  Residues of pyraclostrobin in/on one sample of wheat straw from the CA test site were at the LOQ (0.02 ppm), but residues of pyraclostrobin in/on a replicate sample from the same plot were below the LOQ (0.012 ppm) for an average residue of <0.02 ppm.  Residues of metabolite BF 500-3 were nondetectable (<0.02 ppm) in/on all samples of wheat straw.

The registered pyraclostrobin end-use product labels presently specify a 14-day plantback interval restriction for all crops that are not registered.

860.1550 Proposed Tolerances

The HED Metabolism Assessment Review Committee (MARC memo of 10/9/01, DP# 278044, L. Cheng) has determined that for purposes of tolerance and dietary risk assessments, the residues of concern in plant and rotational crop commodities include pyraclostrobin and its desmethoxy metabolite, BF 500-3.  The residues of concern in livestock commodities include pyraclostrobin and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol (BF 500-5) and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

  SEQ CHAPTER \h \r 1 Pyraclostrobin tolerances for plant commodities are listed in 40 CFR §180.582 (a)(1) and are expressed in terms of the combined residues of the fungicide pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), expressed as parent compound.

Pyraclostrobin tolerances for livestock commodities are listed in 40 CFR §180.582 (a)(2) and are expressed in terms of the combined residues of the fungicide pyraclostrobin and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound.

For petition (PP#8F7385), BASF has proposed a tolerance for the combined residues of pyraclostrobin and its desmethoxy metabolite in/on sorghum forage, grain, and stover at 5.0 ppm, 0.5 ppm, and 0.8 ppm, respectively.  The submitted field trial data for sorghum forage, grain, and stover are adequate.  The field trial data for these crops were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix II.  The tolerance spreadsheet recommends tolerances of 5.0 ppm for sorghum forage, 0.60 ppm for sorghum grain, and 0.80 ppm for sorghum stover.

For petition (PP#8F7390), BASF has proposed a tolerance for the combined residues of pyraclostrobin and its desmethoxy metabolite in/on stone fruit crop group at 2.5 ppm.  The submitted field trial data for stone fruits are acceptable.  The field trial data for stone fruits were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix II.  The tolerance spreadsheet recommends a tolerance of 2.5 ppm for stone fruits.

For petition (PP#8F7394), BASF has proposed a tolerance for the combined residues of pyraclostrobin and its desmethoxy metabolite in/on coffee green bean at 0.5 ppm.  The submitted field trial data for coffee is adequate.  The field trial data for coffee were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix II.  The tolerance spreadsheet recommends tolerances of 0.30 ppm for coffee.

An acceptable coffee processing study has been submitted and the results suggest that no tolerances are required for the processed commodities of coffee.

There are no Codex MRLs for pyraclostrobin for the crop commodities discussed in this document.

A summary of the recommended tolerances for the crop commodities discussed in this document is presented in Table 11.

The current EPA established tolerance for total residues of pyraclostrobin in the stone fruit crop group is 0.9 ppm in 40 CFR §180.582.

TABLE 11.	Tolerance Summary for Pyraclostrobin.

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

Tolerances Proposed Under PP#8F7385

Sorghum grain, forage	5.0	5.0	Sorghum, grain, forage.

Sorghum, grain, grain.

Sorghum, grain, stover.

Adequate field trial data are available.

Sorghum grain, grain	0.5	0.60

	Sorghum grain, stover	0.8	0.80

	Tolerances Proposed Under PP#8F7390

Fruit, stone, group 12	2.5	6.0	Fruit, stone group 12. Adequate field trial data are available.

Tolerances Proposed Under PP#8E7394

Coffee	0.5	0.30	Coffee, green bean. Adequate field trial data are available.

References

DP#s:	269668, 272771, 272789, 274095, 274192, 274471, 274957, 275843, and 278429

Subject:	PP#0F06139.  Pyraclostrobin on Various Crops:  Bananas (import), Barley, Berries, Bulb Vegetables, Citrus Fruits, Cucurbit Vegetables, Dried Shelled Pea & Bean (except Soybean), Fruiting Vegetables, Grapes, Grass, Peanut, Pistachio, Root Vegetables (except Sugar Beet), Rye, Snap Beans, Stone Fruits, Strawberry, Sugar Beet, Tree Nuts, Tuberous and Corm Vegetables, and Wheat.  Review of Analytical Methods and Residue Data.  EPA File Symbols:

From:	L. Cheng

To:	C. Giles-Parker/J. Bazuin

Dated:	11/28/01

MRIDs:	45118428-451184-37, 45118501-45118512, 45118514-45118537, 45118601-45118625, 45160501, 45272801, 45274901, 45321101, 45367501, 45399401, and 45429901

DP#:	278044

Subject:	PP# 0F06139.  PC Code 099100.  Pyraclostrobin.  Outcome of the HED Metabolism Assessment Review Committee (MARC) Meeting Held on September 20, 2001.

From:	L. Cheng

To:	Y. Donovan

Dated:	10/09/01

MRIDs:	None

DP#:	269850

Subject:	PP# 0F06139.  Pyraclostrobin (BAS 500F) in or on Various Crops. Request for Tolerance Method Validation (TMV) Trial.

From:	L. Cheng

To:	F. D. Griffith, Jr.

Dated:	11/8/00

MRIDs:	45118505, 45118504, 45118509, 45118510, 45118501, 45118503, 45118507, 45118514

  SEQ CHAPTER \h \r 1 Attachments:

Appendix I - International Residue Limit Status sheet

Appendix II - Tolerance Assessment Calculations

Template Version November 2003

Appendix I – International Residue Limits

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  methyl [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy carbamate	Common Name:

Pyraclostrobin	(   Proposed tolerances

(  Reevaluated tolerance

(  Other	Date: 03/19/2009

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#8F7385, PP#8F7390, PP#8E7394

DP#359194

Other Identifier:

Residue definition (step 8/CXL):  pyraclostrobin	Reviewers/Branch: M. Negussie, T. Morton, L. Cheng

	Residue definition in PP#8F7385, PP#8F7390, and PP#8E7394:  Combined residues of pyraclostrobin and BF 500-3, expressed as pyraclostrobin.

Crop (s)	MRL (mg/kg)	Crop (s)	Recommended Tolerance (ppm)

PP#8F7385

   Sorghum, grain,  forage	5.0

Sorghum, grain, grain	0.6

Sorghum,  grain, stover	0.8

PP#8F7390

	Stone Fruits	1.	Fruits, Stone,  group 12 	2.5

PP#8F7394

Coffee beans	0.3	   Coffee, bean, green 	0.3

Limits for Canada	Limits for Mexico

(No Limits

(No Limits for the crops requested	xNo Limits

(No Limits for the crops requested

Residue definition:

plant: methyl [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxycarbam ate, including the metabolite [2-[[[1(4-chlorophenyl)-1H-pyrazol -3-yl]oxy]methyl]phenyl]carbamate

livestock: methyl [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxycarbam ate, including the metabolites

convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol

	Residue definition: N/A

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

Apricot	0.7

Nectarines	0.7

Peaches	0.7

Plumcots	0.7

Plums	0.7

Prune plums	0.7

Sweet cherries	0.7

Tart cherries	0.7

S.Funk, 03/31/2009.

Appendix I – International Residue Limits

Appendix I.  Tolerance Assessment Calculations

hat 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.  For Coffee field trial data ~60% (3 of 5 samples), plum ~20% (2 of 10 samples), and sorghum grain field trial data ~46% (11 of 24 samples) were below LOQ.  Maximum likelihood estimation (MLE) procedures were needed to impute censored values.  The residue data for coffee, plum, and sorghum grain were first entered into the MLE spreadsheet to obtain the censored values and the pyraclostrobin-coffee, plum, and sorghum grain dataset was then entered into the tolerance spreadsheet.

The dataset used to establish tolerances for pyraclostrobin residues in/on coffee reflect two broadcast foliar applications totaling 0.312 lb ai/A and a PHI of 45 day (Table II-1).  The dataset used for cherry (sweet & sour), peach, and plum reflect five foliar applications totaling 0.585 lb ai/A and a PHI of 0 days (Table II-2-4), respectively.  The dataset used for sorghum forage, grain, and stover reflect seed treatment at 0.002 lb ai/A and one broadcast foliar application totaling 0.19-0.22 lb ai/A (Table II-5-7), respectively.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data, the field trial application rates were within 25% of each other, and the PHIs are consistent with the proposed label.

The values for combined pyraclostrobin residues were used to calculate the appropriate tolerances for cherry (sweet & sour) (Table II-2), peach (Table II-3), sorghum-forage (Table II-5), and sorghum-stover (Table II-7).  MLE spreadsheet was used to obtain the censored values for coffee (Table II-1), plum (Table II-4), and sorghum-grain (Table II-6).  The residue datasets for each commodity were entered into the tolerance spreadsheet and visual inspection of the lognormal probability plots for coffee, plum, sorghum forage and sorghum grain (Figures II-1, 7, 9 and 11) indicate that the data sets are reasonably lognormal; however, the data sets for cherry (sweet & sour), peach and sorghum stover (Figures II-3, 5 and 13) do not appear to be lognormal.  The results from the Shapiro-Francia test statistic (Figures II-2, 8,10 and 12) indicate that the assumption of lognormality is correct for coffee, plum, sorghum forage and sorghum grain; however, the assumption of lognormality is not correct for cherry (sweet & sour), peach and sorghum stover (Figures II-4, 6 and 14).

The tolerance spreadsheet calculates and recommends 0.30 ppm for Coffee, 2.5 ppm for stone fruits, 5.0 ppm for sorghum forage, 0.60 ppm for sorghum grain, and 0.80 ppm for sorghum stover. (Figures II-2, 4, 10, 12 and 14), respectively.

Table II-1:  Residue Data Used to Calculate Tolerance of Pyraclostrobin in/on Coffee.

Regulator:	EPA

Chemical:	Pyraclostrobin

Crop:	Coffee

PHI:	45 days

Application Rate:	0.312 lb ai/A/season

Submitter:	BASF

MRID Citation:	MRID 47470204

	Combined Residues/MLE

	0.012

	0.020

	0.05

	0.15

	0.029

Figure II-  SEQ Figure_II \* ARABIC  1 :  Lognormal Probability Plot of Pyraclostrobin on Coffee.

Figure II-2:  Data Summary for Residues of Pyraclostrobin in/on Coffee.

Table II-2:  Residue Data Used to Calculate Tolerance of Pyraclostrobin in/on Cherry (Sweet and Sour).

Regulator:	EPA

Chemical:	Pyraclostrobin

Crop:	Sweet Cherry

PHI:	0 days

Application Rate:	5 x 0.117 lb ai/A/application

Submitter:	BASF

MRID Citation:	MRID 47470201

	Combined Residues

	0.890

	0.870

	1.360

	1.850

	0.05

	0.04

	0.6

	0.45

	1.00

	1.33

	0.52

	0.65

	1.25

	0.98

Figure II-3:  Lognormal Probability Plot of Pyraclostrobin on Cherry (sweet & sour).

Figure II-4. Data Summary for Residues of Pyraclostrobin on Cherry (sweet &sour).

Table II-3:  Residue Data Used to Calculate Tolerance of Pyraclostrobin in/on Peach.

Regulator:	EPA

Chemical:	Pyraclostrobin

Crop:	Peach

PHI:	0 days

Application Rate:	5 x 0.117 lb ai/A/application

Submitter:	BASF

MRID Citation:	MRID 47470201

	Combined Residues

	1.54

	1.75

	0.51

	0.51

	0.31

	0.35

	0.4

	0.4

	0.4

	0.32

	0.38

	0.35

Figure II-5:  Lognormal Probability Plot of Pyraclostrobin on Peach.

Figure II-6. Data Summary for Residues of Pyraclostrobin on Peach.

Table II-4:  Residue Data Used to Calculate Tolerance of Pyraclostrobin in/on Plum.

Regulator:	EPA

Chemical:	Pyraclostrobin

Crop:	Plum

PHI:	0 days

Application Rate:	5 x 0.117 lb ai/A/application

Submitter:	BASF

MRID Citation:	MRID 47470201

	Combined Residues/MLE

	0.14

	0.08

	0.35

	0.44

	0.014

	0.026

	0.08

	0.09

	0.36

	0.36

Figure II-7:  Lognormal Probability Plot of Pyraclostrobin on Plum.

Figure II-8. Data Summary for Residues of Pyraclostrobin on Plum.

Table II-5:  Residue Data Used to Calculate Tolerance of Pyraclostrobin in/on Sorghum Forage.

Regulator:	EPA

Chemical:	Pyraclostrobin

Crop:	Sorghum-Forage

PHI:	Applied no later than 25% flowering

Application Rate:	0.19-0.22 lb ai/A/application

Submitter:	BASF

MRID Citation:	MRID 47470203

	Combined Residues

	0.69

	0.65

	0.2

	0.14

	0.44

	0.26

	1.42

	1.26

	0.85

	1.31

	0.23

	0.17

	0.52

	0.59

	0.47

	0.37

	0.04

	0.04

	0.49

	0.49

	1.96

	1.49

	0.12

	0.57

Figure II-9:  Lognormal Probability Plot of Pyraclostrobin on Sorghum-Forage

Figure II-10. Data Summary for Residues of Pyraclostrobin in/on Sorghum-Forage.

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Figure II-12. Data Summary for Residues of Pyraclostrobin in/on Sorghum-Grain.

Table II-7: Residue Data Used to Calculate Tolerance of Pyraclostrobin in/on Sorghum Stover.

Regulator:	EPA

Chemical:	Pyraclostrobin

Crop:	Sorghum-stover

PHI:	Applied no later than 25% flowering

Application Rate:	0.19-0.22 lb ai/A/application

Submitter:	BASF

MRID Citation:	MRID 47470203

	Combined Residues

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	0.09

Figure II-13.  Lognormal probability plot of Pyraclostrobin for Sorghum-Stover

Figure II-14. Data Summary for Residues of Pyraclostrobin in/on Sorghum-Stover.

Pyraclostrobin	Summary of Analytical Chemistry and Residue Data	DP#:  359194

	Page   PAGE  1  of   NUMPAGES  39


[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Page 57970]
[FR Doc No: 2022-20509]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2010-0036]

Southeastern Pennsylvania Transportation Authority's Request To
Amend Its Positive Train Control Implementation Plan, Including a
Request for Approval of a Discontinuance or Modification of a Railroad
Signal System

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document provides the public with notice that, on July
27, 2022, and supplemented on August 4, 2022, the Southeastern
Pennsylvania Transportation Authority (SEPTA) submitted a request for
amendment (RFA) to its FRA-approved Positive Train Control
Implementation Plan (PTCIP). The RFA includes a petition seeking
approval to discontinue or modify a signal system. On August 17, 2022,
FRA approved, in part, SEPTA's RFA to its PTCIP; however, FRA did not
provide a decision on SEPTA's request to discontinue or modify a
portion of its signal system at that time, as FRA must seek public
comment on that aspect before issuing a decision.

DATES: FRA will consider comments received by November 7, 2022. FRA may
consider comments received after that date to the extent practicable
and without delaying implementation of valuable or necessary
modifications to a signal system.

ADDRESSES:
    Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name and the
applicable docket number. The relevant PTC docket number for the host
railroad that filed this RFA to its PTCIP is Docket No. FRA-2010-0036.
For convenience, all active PTC dockets are hyperlinked on FRA's
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FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
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SUPPLEMENTARY INFORMATION: In general, title 49 United States Code
(U.S.C.) section 20157(h) requires FRA to certify that a host
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Advanced Civil Speed Enforcement System II (ACSES II) and that RFA is
available in Docket No. FRA-2010-0036.
    Specifically, under 49 CFR 236.1021(c), SEPTA requested approval to
discontinue the MB and 6N signals at Control Point (CP) South Elwyn
located at milepost (MP) 15.9 and the 1660 automatic signal located at
MP 16.6 in approach to CP South Elwyn on its West Chester Line. SEPTA
also proposed to make the method of operation between CP Elwyn (MP
15.3) and CP Wawa (MP 18.07) by signal indication of a traffic control
system, without fixed automatic block signals, supplemented by a cab
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Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
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    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
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[FR Doc. 2022-20509 Filed 9-21-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: June 21, 2006 (Volume 71, Number 119)]
[Notices]
[Page 35640-35641]
[DOCID:fr21jn06-80]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-382-000]

Northwest Pipeline Corporation; Notice of Request Under Blanket
Authorization

June 14, 2006.

    Take notice that on June 5, 2006, Northwest Pipeline Corporation
(Northwest), 295 Chipeta Way, Salt Lake City, Utah 84158, filed in
Docket No. CP06-382-000 a request pursuant to sections 157.205(b) and
157.216(b)(2) of the Commission's Regulations under the Natural Gas Act
(18 CFR 157.205 and 157.216) for authorization to abandon, by removal,
its Thomas Bullock Tap facilities for deliveries to Intermountain Gas
Company in Bannock County, Idaho, under the authorization issued in
Docket No. CP82-433-000 pursuant to section 7 of the Natural Gas Act,
all as more fully described in the request.
    This filing is available for review at the Commission in the Public
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 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
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<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,

contact<PHONE_NUMBER>.
    Any questions concerning this request may be directed to Gary K.
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Corporation, P.O. Box 58900, Salt Lake City, Utah 84158, at (801) 584-
7117.
    Northwest states that the Thomas Bullock Tap facilities originally
were installed to deliver natural gas to Intermountain for distribution
to the Thomas Bullock service station, caf[eacute] and motel in the
vicinity of McCammon, Idaho. Northwest indicates that it currently has
no contractual obligation to make deliveries at this point, and made
its last deliveries to this point on May 9, 2006. Northwest avers that
Intermountain has reconfigured its distribution facilities to serve the
subject end-users from Northwest's nearby McCammon Meter Station
delivery point in order to accommodate landowner plans to develop the
land where the Thomas Bullock Tap facilities are located.
    Northwest contends that Intermountain, the only customer served by
the Thomas Bullock Tap during the past twelve months, has provided its
written consent to the abandonment.
    Any person or the Commission's Staff may, within 45 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR
157.205) a protest to the request. If no protest is filed within the
time allowed therefore, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request shall be treated as
an application for authorization pursuant to section 7 of the NGA.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the

``e-filing'' link. The Commission strongly encourages electronic
filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9788 Filed 6-20-06; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM

DATE:  7/29/15

FROM:  Ken Mitchell/EPA Region 4

TO:   Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

SUBJECT:  Discussion of the Clean Power Plan with R4 State and Local Air Directors

SUMMARY:         REGION 4 PROVIDED INFORMATION ON THE CLEAN POWER PLAN to participants at Metro4 SESARM Spring meeting in Atlanta, GA, on May 20, 2015.  The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.   ATTENDEES:

EPA Ken Mitchell/EPA R4 Beverly Banister/EPA R4 Other Region 4 Air Program Management and Staff

External Stakeholders John Hornback/Metro4 SESARM Approximately 50 Region 4 State and Local Air Directors and Staff

ATTACHMENT


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on December 19, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-16657

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AIR CANADA
                                    Date Filed:  December 5, 2003

Relief requested:  Statement of Authorization under 14 CFR Part 212 to
permit Air Canada and its subsidiary Jazz Air to carry the code of
Singapore Airlines, for an indefinite duration, on scheduled flights
operated by Air Canada and/or Jazz Air, between any point or points in
Canada and any point or points in the United States (in conjunction with
Singapore Airlines’ services between Singapore and the United States).

If renewal, date and citation of last action:  New authority.

Applicant representative:  Anita Mosner,<PHONE_NUMBER>            DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
                                               Action date:  December
19, 2003

Effective dates of authority granted:  indefinite duration (see below).

Basis for approval:  For Canada, the United States-Canada Air Transport
Services Agreement; and, for Singapore, The Multilateral Agreement on
the Liberalization of International Air Transportation.

Remarks/Conditions:  The code-share authority that we granted is subject
to the following conditions:  1) The Statement of Authorization will
remain in effect only as long as (i) Air Canada, Jazz Air and Singapore
Airlines continue to hold the necessary underlying authority to operate
the code-share services at issue, and (ii) the code-share agreement
providing for the code-share operations remains in effect.  2) Air
Canada, Jazz Air and Singapore Airlines must promptly notify the
Department (Office of International Aviation) if the subject agreement
providing for these code-share operations is no longer effective or the
carriers decide to cease operating any or all of the approved services.
(We expect this notice to be received within ten days of such
noneffectiveness or of such decision and filed in Docket OST
2003-16657).  3) Air Canada, Jazz Air and Singapore Airlines must notify
the Department no later than 30 days before they begin any new
code-share service under the code-share services authorized here.  Such
notice shall identify the market(s) to be served, and the date on which
the service will begin.  Such notice should be filed in Docket OST
2003-16657.  4) The code-share operations conducted under this authority
must comply with 14 CFR Part 257 and with any amendments to the
Department’s regulations concerning code-share arrangements that may
be adopted.  5) Notwithstanding any provisions in the contract between
the subject carriers, our approval here is expressly conditioned upon
the requirements that the subject foreign air transportation be sold in
the name of the carrier holding out the service in computer reservation
systems and elsewhere; that the carrier selling such transportation
(that is, the carrier shown on the ticket) accept responsibility for the
entirety of the code-share journey for all obligations established in
its contract of carriage with the passenger; and that the passenger
liability of the operating carrier be unaffected.  6) The code-share
authority granted here is specifically conditioned so that neither
carrier shall give any force or effect to any contractual provisions
between themselves that are contrary to these conditions.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
_______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.

To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp