Document ID: EPA-HQ-OPP-2006-0889-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-08-22T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:		9/26/06

Subject:	Pyriproxyfen Use in/on Numerous Commodities. Summary of
Analytical Chemistry and Residue Data.  PP# 6E7033.

 

DP #:	327023	Decision:	3364813

PC Code:	129032	MRID#s.:	None

40 CFR 180.	510

From:	W. Cutchin, Acting Branch Senior Scientist 

ARIA Team/Technical Review Branch

Registration Division (RD) (7905P)

Through:	G. Kramer, Ph.D., Senior Chemist

Registration Action Branch 1 (RAB1)

Health Effects Division (HED) (7509P)

To:		S. Brothers/D. Rosenblatt, RM 05

		Risk Integration Minor Use and Emergency Response Branch 

		RIMIERB/RD (7505P)

Executive Summary 

The Interregional Research Project Number 4 (IR-4) has submitted a
petition for the establishment of permanent tolerances for residues of
the insecticide pyriproxyfen
[2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine] in conjunction with
requests for amended Section 3 registrations of formulations containing
pyriproxyfen for use on a variety of crops.  The petitioner is proposing
the establishment of the following permanent tolerances for residues of
pyriproxyfen per se:

Commodity

	Tolerance

Vegetable, root and tuber, Group 1	0.15 ppm

Vegetable, leaves of root and tuber, Group 2	2.0 ppm

Vegetable, bulb, Group 3, 

     except onion, dry bulb 	0.70 ppm

Vegetable, leafy, except Brassica, Group 4 	2.0 ppm

Vegetable, legume, Group 6 	0.20 ppm

Vegetable, foliage of legume, Group 7 	2.0 ppm

Caneberry Subgroup 13A 	1.0 ppm

Grain, cereal, group 15 	1.1 ppm

Rice, hulls	5.5 ppm

Grain, cereal, forage, fodder and straw, 

     Group 16 	1.1 ppm

Animal feed, nongrass, Group 18, forage 	0.70 ppm

Animal feed, nongrass, Group 18, hay	1.1 ppm

Animal feed, nongrass, Group 18, seed	2.0 ppm

Artichoke, globe	2.0 ppm

Asparagus 	2.0 ppm

Banana 	0.20 ppm

Cacao bean 	0.02 ppm

Canola, seed 	0.20 ppm

Coffee 	0.02 ppm

Cranberry 	1.0 ppm

Date 	0.30 ppm

Kiwifruit 	0.10 ppm

Pawpaw  	1.0 ppm

Peanut 	0.20 ppm

Pineapple 	0.30 ppm

Pomegranate 	0.20 ppm

Safflower, seed 	0.20 ppm

Sesame, seed 	0.20 ppm

Sugarcane 	1.1 ppm

Tea  	0.02 ppm

Watercress 	2.0 ppm

 

There are currently several end-use products of pyriproxyfen with
food/feed uses that are registered to Valent USA Corporation: three
emulsifiable concentrates (EC), a wettable powder (WP), and an ant bait
granular formulation.  These formulations are registered for use on
cotton, fruiting vegetables, citrus fruits, pome fruits, stone fruit,
bushberry, tree nuts, lychee, guava and related tropical fruits.  The
maximum seasonal use is 0.020-0.219 lb/ai/acre.  There is a maximum of
two applications (at least 2-16 weeks apart) per season.  The single
application rate is 0.01-0.109 lb ai/acre with 0- to 21-day preharvest
application intervals (PHIs).

The nature of the residue is understood in plants and livestock. 
Pyriproxyfen per se is the residue of concern in crops and ruminants for
purposes of tolerance enforcement and risk assessment (DP Num: 250953,
W. Donovan and W. Dykstra, 11/19/98).  An adequate enforcement gas
chromatography/nitrogen-phosphorous detector (GC/NPD) method is
available to enforce the proposed tolerances and has been forwarded to
the Food and Drug Administration (FDA) for inclusion in Pesticide
Analytical Method (PAM) Vol. II (DP Num: 258406, W. Donovan, 8/5/99).

No new residue field trial data were submitted with this petition. 
IR-4’s proposals for the new tolerances were presented to HED’s
Chemistry Science Advisory Council (ChemSAC) on June 22, 2006.  The SAC
agreed with the petitoner’s proposals.  ARIA recommends for all the
proposed tolerances except for those for which confirmatory data are
required since, as of the date of this review, the confirmatory data
have not been received.  The tolerance for the residues of pyriproxyfen
on vegetable leaves of root and tuber, Group 1; vegetable, leafy, except
Brassica, Group 4; vegetable, foliage of legume, Group 7; artichoke,
globe; asparagus; kiwifruit; and watercress cannot be established at
this time.  In addition, IR-4 has proposed a tolerance vegetable,
legume, Group 6.  The data have been reviewed and a tolerance of 0.20
ppm was recommended for the residues of vegetable, legume, Group 6 ( 
SEQ CHAPTER \h \r 1 PP#s 4F6847, 3E6596, 3E6596, 3E6750, 4E6866, 4E6865
& 3E6582, DP Num: 312387, 312389, 312391, 312460 and 312463, G. Kramer,
7/15/05).  The tolerance request is no longer required.  The commodity
definition, vegetable, bulb, Group 3, except onion dry bulb is
incorrect.  The correct definition is: vegetable, bulb, Group 3, except
onion bulb. The tolerance definition should be corrected in Section F.

Associated with the proposed tolerances are processed commodities of
regulatory interest.  Since no new processing data were submitted with
this petition, the theoretical processing factors or processing factors
from the Agency’s pyriproxyfen database are used to calculate a
tolerance value.  Tolerances are required for all the processed
commodities which have higher estimated tolerance levels than the
associated RAC.   Tolerances are required for beet, dry pulp at 3.0 ppm;
potato granules/flakes, chips, and wet peel, all at 0.75 ppm; rice,
hulls at 5.5 ppm; coffee, instant at 0.10 ppm; and pineapple, process
residue at 1.1 ppm.

Some of the raw agricultural commodities (RAC) for which tolerances are
requested and some of the associated processed commodities are livestock
feed items of regulatory interest. However, there are not sufficient
changes in dietary burdens to require increases in livestock tolerances
at this time. 

Residue Chemistry Deficiencies

860.1550 Proposed Tolerances

The petitioner is requested to submit a revised Section F as specified
below in the "Recommendations" section of this document.

RECOMMENDATIONS

Pending the results of the upcoming human health risk assessment and
provided revised Section F is submitted, ARIA concludes there are no
residue chemistry data requirements that would preclude the
establishment of an unconditional registration and permanent tolerances
for residues of pyriproxyfen per se in/on the following:

Commodity

	Tolerance

Vegetable, root and tuber, Group 1	0.15 ppm

Beet, dry pulp	3.0 ppm

Potato, granules/flakes	0.75 ppm

Potato, chips	0.75 ppm

Potato peel, wet	0.75 ppm

Vegetable, bulb, Group 3, 

     except onion, bulb 	0.70 ppm

Caneberry Subgroup 13A 	1.0 ppm

Grain, cereal, group 15 	1.1 ppm

Rice, hulls	5.5 ppm

Grain, cereal, forage, fodder and straw, 

     Group 16 	1.1 ppm

Animal feed, nongrass, Group 18, forage	0.70 ppm

Animal feed, nongrass, Group 18, hay	1.1 ppm

Animal feed, nongrass, Group 18, seed	2.0 ppm

Banana 	0.20 ppm

Cacao bean 	0.02 ppm

Canola, seed 	0.20 ppm

Coffee 	0.02 ppm

Coffee, instant	0.10 ppm

Cranberry 	1.0 ppm

Date 	0.30 ppm

Pawpaw  	1.0 ppm

Peanut 	0.20 ppm

Pineapple 	0.30 ppm

Pineapple, process residue	1.1 ppm

Pomegranate 	0.20 ppm

Safflower, seed 	0.20 ppm

Sesame, seed 	0.20 ppm

Sugarcane 	1.1 ppm

Tea  	0.02 ppm

Background

Pyriproxyfen is an analogue of an insect juvenile hormone and interferes
with the hormonal control of insect growth and development, thereby
inhibiting egg hatch, larval embryogenesis, metamorphosis, and adult
emergence.  There are currently several end-use products of pyriproxyfen
with food/feed uses that are registered to Valent USA Corporation: three
ECs, a WP, and an ant bait granular formulation.  These formulations are
registered for use on cotton, fruiting vegetables, citrus fruits, pome
fruits, stone fruit, bushberry, tree nuts, lychee, guava and related
tropical fruits, and are marketed under the trade names Knack® IGR
[0.86 lb/gal EC; EPA Reg. No. 59639-95], Distance® IGR [0.86 lb/gal EC;
EPA Reg. No. 59639-96], Esteem® IGR [2.9 lb/gal EC; EPA Reg. No.
59639-104], Esteem® 35 WP IGR [35% WP; EPA Reg. No. 59639-115], and
Esteem® Ant Bait [0.5% w/w; EPA Reg. No. 59639-114].

Table 1.  Test Compound Nomenclature

Pyriproxyfen	

Common name	Pyriproxyfen

Company experimental name	S-71639, S-31183

IUPAC name	4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether

CAS name	2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine

CAS #	95737-68-1

End-use products/(EP)	Knack® IGR, Distance® IGR, Esteem® IGR,
Esteem® 35 WP IGR, and Esteem® Ant Bait

Table 2.  Physicochemical Properties of the Technical Grade Test
Compound

Parameter	Value

Melting point/range	45-47 °C

pH 	6.4 ( 20°C)

Density	1.24 (25 °C)

Water solubility ( 25°C)	0.367 ppm

Solvent solubility (mg/L at 20°C)	76700 (Hexane)

Solvent solubility (mg/L at 20°C)	60100 (Methanol)

Vapor pressure at 20°C	1.0 x 10-7 mm/Hg

Dissociation constant (pKa)	NA*

Octanol/water partition coefficient Log(KOW)	5.37

UV/visible absorption spectrum	288 and 330 nm

* Not Available.

Directions for Use 

Table 3.  Summary of Directions for Use of Pyriproxyfen

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

Artichoke, Globe

Foliar application ground equipment	Knack® IGR [59639-95]

Esteem® 35 WP IGR [59639-115]	0.0672	2	0.134	7	RTI = 14 days

By ground: 10-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Asparagus

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.0672	2	0.134	7	RTI = 14 days

By ground: 10-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Banana and Plantain

Foliar application ground or aerial equipment	Knack® IGR [59639-95]
Esteem® 35 WP IGR [59639-115]	0.109	3	0.327	14	RTI = 14 days

By air: 3-10 gpa

By ground: 10-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Berries

Foliar application ground or aerial equipment	Knack® IGR [59639-95]
Esteem® 35 WP IGR [59639-115]	0.109	2	0.218	7	RTI = 14 days

By air: min 5 gpa

By ground: min 50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.109	2	0.218	1	RTI = 12-16 weeks

Bulb Vegetables

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.0672	2	0.134	3	RTI = 14 days

By ground: 20-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Cacao Bean

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Canola (seed only)

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Cereal Grains

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Coffee

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Cranberry

Foliar application ground or aerial equipment	Knack® IGR [59639-95]
Esteem® 35 WP IGR [59639-115]	0.109	2	0.218	7	RTI = 14 days

By air: min 5 gpa

By ground: min 20 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.109	2	0.218	1	RTI = 12-16 weeks

Dates

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Kiwi Fruit

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.109	2	0.218	30	RTI = 14 days

By ground: min 45 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.109	2	0.218	1	RTI = 12-16 weeks

Leafy Vegetables (except Brassica) 

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.0672	2	0.134	14	RTI = 14 days

By ground: 10-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Legume Vegetable (Succulent or Dried)

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.0672	2	0.134	7	RTI = 14 days

By ground: 10-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Nongrass Animal Feed

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Pawpaw

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.109	3	0.327	14	RTI = 14 days

By ground: 100-400 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.109	3	0.327	1	RTI = 12-16 weeks

Peanuts

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Pineapple

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.0672	2	0.134	1	RTI = 21 days

By ground: 20-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Pomegranate

Foliar application ground or aerial equipment	Knack® IGR [59639-95]
Esteem® 35 WP IGR [59639-115]	0.109	3	0.327	14	RTI = 14 days

By air: 3-10 gpa

By ground: 10-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.109	3	0.327	1	RTI = 12-16 weeks

Root and Tuber Vegetables

Foliar application ground equipment	Knack® IGR [59639-95] Esteem® 35
WP IGR [59639-115]	0.0545	2	0.109	3	RTI = 14 days

By ground: 20-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0545	2	0.109	1	RTI = 12-16 weeks

Safflower

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Sesame

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Sugarcane

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Tea

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.02	2	0.04	1	RTI = 12-16 weeks

Watercress

Foliar application ground or aerial equipment	Knack® IGR [59639-95]
Esteem® 35 WP IGR [59639-115]	0.0672	2	0.134	7	RTI = 14 days

By air or ground: 10-50 gpa

Broadcast ground or aerial equipment	Esteem® Ant Bait IGR [59639-114]
0.0672	2	0.134	1	RTI = 12-16 weeks

Conclusions.  The use directions are adequate for the proposed uses.

860.1300 Nature of the Residue - Plants

DP Num: 238190, W. Donovan, 12/7/98

PP#6F4737, DP Num: 228556, J. Garbus, 5/6/97 

DP Num: 253836, W. Donovan, 3/25/99

DP Num: 250953, W. Donovan and W. Dykstra, 11/19/98

Adequate metabolism studies for pyriproxyfen are available on apples (DP
Num: 238190, W. Donovan, 12/7/98), cotton (DP Num: 228556, J. Garbus,
5/6/97), and tomatoes (DP Num: 253836, W. Donovan, 3/25/99).  Based on
these studies, the Metabolism Assessment Review Committee (MARC)
determined that the residue of concern in plants is pyriproxyfen per se
(DP Num: 250953, W. Donovan and W. Dykstra, 11/19/98). 

860.1300 Nature of the Residue - Livestock

PP#6F4737, DP Num: 228556, J. Garbus, 5/6/97 

DP Num: 250953, W. Donovan and W. Dykstra, 11/19/98

Ruminant and poultry metabolism studies have previously been submitted
and reviewed (PP#6F4737, DP Num: 228556, J. Garbus, 5/6/97) in
conjunction with a petition for cotton.  The HED MARC determined that
should future crop uses increase the maximum theoretical dietary burden
(MTDB) to the point that tolerances are needed in livestock commodities,
the residue of concern will be pyriproxyfen and the free and sulfate
forms of 4'-OH-PYR.

860.1340 Residue Analytical Methods

DP Num: 257337, W. Donovan, 7/1/99 

DP Num: 258406, W. Donovan, 8/5/99

In conjunction with previously submitted crop field trial studies, the
registrant submitted adequate concurrent recovery data for a GC/NPD
method (RM-33P-1-3a or 9.66 V 1) used to determine residues of
pyriproxyfen in/on the subject crops.  The method has undergone an
adequate radiovalidation, independent laboratory validation (ILV) trial,
petition method validation (PMV) trial (DP Num: 257337, W. Donovan,
7/1/99), and has been forwarded to the FDA for inclusion in PAM Vol. II
(DP Num: 258406, W. Donovan, 8/5/99).  The limits of detection and
quantitation (LOD and LOQ) are 0.01 and 0.02 ppm, respectively.  The
GC/NPD method RM-33P-1-3a is adequate for enforcement of the recommended
tolerance levels for residues of pyriproxyfen per se in/on the subject
crops.  As tolerances for residues of pyriproxyfen in livestock
commodities are not required at this time, enforcement methodology for
determining residues in livestock are not required.

60.1360 Multiresidue Methods

PP#6F4737, DP Num: 228556, J. Garbus, 5/6/97

Multiresidue testing data have previously been provided (PP#6F4737, DP
Num: 228556, J. Garbus, 5/6/97) for pyriproxyfen.  Pyriproxyfen was
recovered from fortified apple and cotton samples through protocols A,
C, D, E, and F.

860.1380 Storage Stability

45556003.der.wpd, 45647301.der.wpd, 45616101.der.wpd, W. Donovan,
10/10/02

The stability of pyriproxyfen residues in frozen cabbage samples was
demonstrated for 35 days (45556003.der.wpd), in frozen okra samples for
33 days (45647301.der.wpd), and in frozen sugar apple samples for 300
days (45616101.der.wpd).  These data are adequate to support the
tolerances for the proposed uses.

860.1480 Meat, Milk, Poultry, and Eggs

DP Num: 238190, W. Donovan, 12/7/98

PP#s 4F6847, 3E6596, 3E6596, 3E6750, 4E6866, 4E6865 & 3E6582, DP Num:
310072, 316784, 316788, 316800, 316798, 316802 & 314308, G. Kramer,
6/30/05 

PP#6F4737, DP Num: 228556, 228925, & 228926, J. Garbus, 5/6/97

The requested tolerances have associated livestock feed items.  The feed
items result in theoretical dietary burdens to beef and dairy cattle,
poultry and swine calculated in Table 4. 



Table 4.  Calculation of Livestock Theoretical Dietary Burdens from Feed
Items Associated with Proposed Tolerances.

RAC

    Feed	Proposed

ppm	RAC

Data	%DM1	Percent of Diet	MTDB

ppm

Beef	Dairy	Poultry	Breed Pig	Finish Pig	Beef2	Dairy2	Poultry3	Breed Pig3
Finish Pig3

Beet 	 

    tops 	0.15

23	20	10	NU4	NU	NU	0.13	0.07	0	0	0

    molasses 	1.9

25	10	10	NU	NU	NU	0.76	0.76	0	0	0

    dry pulp	3.0

88	20	25	NU	15	NU	0.68	0.85	0	0.45	0

Carrot

	    culls	0.15

12	40	25	NU	20	10	0.5	0.31	0	0.03	0.02

Potato 

	    culls	0.15

20	75	50	NU	25	50	0.56	0.38	0	0.04	0.08

    waste	0.15

12	75	50	NU	25	NU	0.94	0.63	0	0.04	0

Sweet potato 

	    roots	0.15

32	60	25	NU	60	25	0.28	0.12	0	0.09	0.04

Turnip 

	    root	0.15

15	85	20	NU	40	40	0.85	0.20	0	0.06	0.06

    tops	0.15

30	50	30	NU	10	NU	0.25	0.15	0	0.02	0

Cereal grain

	    grain 	1.1	wheat	89	60	50	82	80	80	0.74	0.62	0.90	0.88	0.88

    bran	1.1	barley	88	50	20	10	25	15	0.63	0.25	0.11	0.28	0.17

    forage 	1.1	wheat	25	60	65	NU	15	NU	2.64	2.86	0	0.17	0

    hay 	1.1	wheat	88	25	60	NU	NU	NU	0.31	0.75	0	0	0

    straw 	1.1	wheat	88	15	10	NU	NU	NU	0.19	0.13	0	0	0

    flour	1.1	barley	88	20	20	20	20	20	0.25	0.25	0.22	0.22	0.22

    milled byp 	1.1	wheat	88	63	50	50	70	50	0.77	0.63	0.55	0.77	0.55

    AGF	1.1	wheat	88	20	20	NU	20	20	0.25	0.25	0	0.22	0.22

Alfalfa 

	    forage 	0.7

35	50	70	NU	60	NU	1	1.4	0	0.42	0

    seed	2.0

88	25	25	20	35	30	0.57	0.57	0.40	0.70	0.60

    screenings	1.1

88	25	30	NU	NU	NU	0	0	0	0	0

    hay 	1.1

89	25	70	NU	20	NU	0.31	0.87	0	0.22	0

    meal	1.1

89	25	50	10	20	10	0	0	0.11	0.22	0.11

    silage	0.7

40	60	75	NU	50	NU	1.05	1.31	0	0.35	0

Clover 

	    forage 	0.7

30	30	70	NU	10	NU	0.70	1.63	0	0.07	0

    hay 	1.1

89	20	60	NU	NU	NU	0.25	0.74	0	0	0

    silage	0.7

30	30	60	NU	10	NU	0.7	1.4	0	0.20	0

Vetch 

	    forage 	0.7

30	65	60	NU	15	NU	1.52	1.40	0	0.11	0

    hay	1.1

85	20	60	NU	NU	NU	0.26	0.78	0	0	0

Canola 

	    meal	0.2

88	NU	15	25	15	15	0	0.03	0.05	0.03	0.03

Peanut 

	    meal 	0.2

85	15	20	25	20	15	0.04	0.05	0.05	0.04	0.03

    hay 	0.2

85	25	60	NU	10	NU	0.06	0.14	0	0.02	0

    hulls	0.2

95	15	NU	NU	NU	NU	0.03	0	0	0	0

Pineapple 

	    process res. 	0.2

20	30	20	NU	20	NU	0.30	0.20	0	0.04	0

Safflower 

	    seed 	0.2

94	10	25	NU	20	20	0.02	0.05	0	0.04	0.04

    forage 	0.2

23	25	33	NU	NU	NU	0.22	0.29	0	0	0

    meal	0.2

91	10	15	25	25	25	0.02	0.03	0.05	0.05	0.05

Sugarcane 

	    molasses	1.1

75	10	10	NU	NU	NU	0.15	0.15	0	0	0

Largest Dietary Burden from a single feed item:	2.93	2.86	0.90	0.88	0.88

     	1 Percent Dry Matter

	2 MTDB = [%DM/Percent of Diet] x Proposed Tolerance

	3 MTDB = Percent of Diet x Proposed Tolerance

	4 NU = not used

	Table 1, OPPTS GLN 860.1000Ruminants

An adequate cattle feeding study has been previously reviewed (DP Num:
238190, W. Donovan, 12/7/98).  In lactating cows which were dosed at 3,
9, and 30 ppm for 28 consecutive days, nondetectable (<0.01 ppm)
residues of pyriproxyfen and its metabolites 4'-OH-PYR, POP, and
2,5-OH-pyridine were observed in whole milk (3, 9, and 30 ppm dose
levels), and liver (30 ppm dose level).  Detectable pyriproxyfen
residues (0.01-0.02 ppm) and nondetectable residues (<0.01 or <0.02 ppm)
of  4'-OH-PYR, POP, and 2,5-OH-pyridine were present in cream at the 30
ppm dose level.  Dectectable 2,5-OH-pyridine residue levels were also
found in liver samples collected on day 28 at the 30 ppm dose level. 
Fat and muscle were only analyzed for pyriproxyfen and 4'-OH-PYR. 
Nondetectable residues (<0.01 ppm) of pyriproxyfen and 4'-OH-PYR were
observed in muscle at the 30 ppm dosing level; detectable pyriproxyfen
residues (0.05-0.07 ppm) and residues of 4'-OH-PYR below the LOD (<0.01
ppm) were present in fat at the 30 ppm dosing level.  Residues of
pyriproxyfen were nondetectable (<0.01 ppm) in fat at the 3 ppm dosing
level and detectable (0.01-0.03 ppm) at the 9 ppm dosing level;
4'-OH-PYR was not analyzed for in these samples.  The highest residue
levels of pyriproxyfen (0.05-0.07 ppm) were observed in fat at the
highest dose level (30 ppm).

The last calculated maximum theoretical dietary burden (MTDB) for beef
and dairy cattle included soybean, seed at 0.20 ppm and grass forage at
0.70 ppm.  The MTDB for beef and dairy cattle were determined to be 1.91
and 1.51 ppm, respectively.  HED concluded that tolerances would not be
required for residues of pyriproxyfen in ruminant commodities provided
that no additional uses on livestock feed items are proposed (PP#s
4F6847, 3E6596, 3E6596, 3E6750, 4E6866, 4E6865 & 3E6582, DP Num: 310072,
316784, 316788, 316800, 316798, 316802 & 314308, G. Kramer, 6/30/05). 
Reasonable cattle diets were constructed using existing feed items and
proposed feed items in Table 4 (personal communication, J. Stokes and B.
Schnieder, 9/19/06).  The revised dietary calculation changes the
dietary burden to 1.06 ppm for beef cattle and 1.81 ppm for dairy
cattle.  Extrapolation from the feeding study indicates that residues of
pyriproxyfen can be expected to be <0.01 ppm on all cattle commodities
including milk and cream.  No detectable pyriproxyfen residues are
expected on ruminant commodities from the proposed uses; therefore,
tolerances are not required for residues of pyriproxyfen in ruminant
commodities at this time. 

Table 5.  Calculation of the MTDB of Pyriproxyfen in Beef Cattle

Feed Commodity	Estimated

Tolerance 

(ppm)	% Dry 

Matter a	Beef Cattle

	% of Diet	Burden, ppm

Soybean, meal	0.20	89	15	0.03

Wheat, milled by products	1.1	88	20	0.25

Beet, molasses	0.15	25	5	0.03

Wheat, hay	1.1	88	35	0.44

Corn, grain	1.1	89	25	0.31

TOTAL	100	1.06

a  Table 1, OPPTS GLN 860.1000.

Table 6.  Calculation of the MTDB of Pyriproxyfen in Dairy Cattle

Feed Commodity	Estimated

Tolerance 

(ppm)	% Dry 

Matter a	Dairy Cattle

	% of Diet	Burden, ppm

Soybean, meal	0.20	89	15	0.03

Wheat, milled by products	1.1	88	20	0.25

Beet, molasses	0.15	25	5	0.03

Wheat, hay	1.1	88	20	0.25

Corn, grain	1.1	89	20	0.25

Alfalfa, silage	2.00	40	20	1.00

TOTAL	100	1.81

a  Table 1, OPPTS GLN 860.1000.

Poultry

In conjunction with the petition for use on cotton (PP#6F4737, DP Num:
228556, 228925, & 228926, J. Garbus, 5/6/97), HED concluded that
secondary residues in poultry and eggs are unlikely in light of the
poultry metabolism study results.  In the poultry metabolism study,
conducted at a feeding level of 10 ppm (200X), the maximum total
radioactive residues (TRR) were 0.926 ppm in fat, 0.095 ppm in meat,
0.75 ppm in liver, 0.861 ppm in kidney, and 0.29 ppm in egg.  The
conclusion was based on an MTDB of 0.004 ppm. 

The last calculated MTDB for poultry included soybean, seed at 0.20 ppm
and cottonseed meal at 0.05 ppm was determined to be 0.05 ppm.  HED
concluded that tolerances would not be required for residues of
pyriproxyfen in livestock commodities provided that no additional uses
on livestock feed items are proposed (PP#s 4F6847, 3E6596, 3E6596,
3E6750, 4E6866, 4E6865 & 3E6582, DP Num: 310072, 316784, 316788, 316800,
316798, 316802 & 314308, G. Kramer, 6/30/05).  A reasonable poultry diet
was constructed using existing feed items and proposed feed items in
Table 4 (personal communication, J. Stokes and B. Schnieder, 9/19/06). 
The revised dietary calculation changes the poultry dietary burden to
0.92 ppm.  Extrapolation from the metabolism study indicates that
residues of pyriproxyfen can be expected on poultry commodities. 
However, the expected residues are less than the previously established
0.10 ppm tolerance as a result of the food handling establishment use;
therefore, an increase in the tolerances on poultry commodities is not
required at this time.  

Table 7.  Calculation of the MTDB of Pyriproxyfen in Poultry

Feed Commodity	Estimated

Tolerance (ppm)	Poultry

% of Diet a	Burden, ppm

Alfalfa, meal	1.1	10	0.11

Cereal, grain	1.1	70	0.77

Soybean, meal	0.2	20	0.04

TOTAL	100	0.92

a  Table 1, OPPTS GLN 860.1000.

Swine

A reasonable swine diet was constructed using the existing and proposed
feed items in Table 4 (personal communication, J. Stokes and B.
Schnieder, 9/19/06).  The revised dietary calculation changes the swine
dietary burden to 0.97 ppm.  Since the residues on swine commodities
would be calculated using the cattle feeding study, the highest dietary
burden calculated for swine is less than that of cattle, and no
detectable cattle residues are expected, it is unlikely any detectable
residues would be found in swine commodities from the proposed uses. 
Therefore, at this time no pyriproxyfen tolerances are required for
swine commodities. 

Table 8.  Calculation of the MTDB of Pyriproxyfen in Swine

Feed Commodity	Estimated

Tolerance (ppm)	Poultry

% of Diet a	Burden, ppm

Corn, grain	1.1	85	0.94

Canola, meal	0.2	15	0.03

TOTAL	100	0.97

a  Table 1, OPPTS GLN 860.1000.

860.1500 Crop Field Trials

No new data were submitted with this petition.  IR-4’s proposals for
the new tolerances were presented to HED’s ChemSAC on June 22, 2006. 
The SAC’s determinations as well as the current status of each
proposed tolerance is discussed below.

Vegetable, root and tuber, Group 1

IR-4 has proposed a tolerance of 0.15 ppm on vegetable, root and tuber,
Group 1 using the supporting data from dry bulb onion (PP# 3E6750). 
Considering the supporting data, the ChemSAC agreed with the proposed
tolerance.  A tolerance for the residues of pyriproxyfen on vegetable,
root and tuber, Group 1 at 0.15 ppm should be established.  

Vegetable, leaves of root and tuber, Group 2

IR-4 has proposed a tolerance of 2.0 ppm on vegetable, leaves of root
and tuber, Group 2

using the tolerance established at 2.0 ppm on Brassica, leafy greens,
subgroup 5B and a future residue study on celery with 8 trials in 2005
to provide confirmatory data.  Considering the supporting data, the
ChemSAC agreed with the proposed tolerance.  However, as of the date of
this review, the confirmatory data have not been received.  A tolerance
for the residues of pyriproxyfen on vegetable, leaves of root and tuber,
Group 1 cannot be established at this time.  The tolerance request
should be removed from Section F.  The issue should be revisited when
the data are submitted. 

Vegetable, bulb, Group 3, except onion dry bulb

IR-4 proposed a tolerance of 0.70 ppm on vegetable, bulb, Group 3,
except onion dry bulb

using the tolerance established on 0.70 ppm for onion, green which in
turn was based on grass, forage (PP# 4F6847).  Considering the
supporting data, the ChemSAC agreed with the proposed tolerance. 
However, the commodity definition is incorrect.  The correct definition
is: vegetable, bulb, Group 3, except onion bulb. A tolerance for the
residues of pyriproxyfen on vegetable, bulb, Group 3, except onion bulb
at 0.70 ppm should be established.  The tolerance definition should be
corrected in Section F.

Vegetable, leafy, except Brassica, Group 4

IR-4 has proposed a tolerance of 2.0 ppm on vegetable, leafy, except
Brassica, Group 4

using the tolerance established at 2.0 ppm on Brassica, leafy greens,
subgroup 5B and a future residue study on celery with 8 trials in 2005
to provide confirmatory data.  Considering the supporting data, the
ChemSAC agreed with the proposed tolerance.  However, as of the date of
this review, the confirmatory data have not been received.  A tolerance
for the residues of pyriproxyfen on vegetable, leafy, except Brassica,
Group 4 cannot be established at this time.  The tolerance request
should be removed from Section F.  The issue should be revisited when
the data are submitted. 

Vegetable, legume, Group 6

IR-4 has proposed a tolerance of 0.20 ppm based on the residue data
developed on the representative crops for Subgroup 6A.  A petition
proposing a tolerance for pyriproxyfen on vegetable, legume, edible
podded, Subgroup 6A; pea and bean, succulent shelled, Subgroup 6B; and
pea and bean, dried shelled, except soybean, Subgroup 6C, PP# 3E6596. 
This petition was accompanied by two data volumes, MRID# 45940001
(pyriproxyfen on edible-podded peas) and MRID# 45940002 (pyriproxyfen on
snap beans).  The data has been reviewed and a tolerance of 0.20 ppm was
recommended for the residues of vegetable, legume, Group 6 (  SEQ
CHAPTER \h \r 1 PP#s 4F6847, 3E6596, 3E6596, 3E6750, 4E6866, 4E6865 &
3E6582, DP Num: 312387, 312389, 312391, 312460 and 312463, G. Kramer,
7/15/05).  Since the requested tolerance has already been established,
the tolerance request should be removed from Section F.

Vegetable, foliage of legume, Group 7

IR-4 has proposed a tolerance of 2.0 ppm on vegetable, foliage of
legume, Group 7 using the tolerance established at 2.0 ppm Brassica,
leafy greens, subgroup 5B and a future residue study on celery with 8
trials in 2005 to provide confirmatory data.  Considering the supporting
data, the ChemSAC agreed with the proposed tolerance.  However, as of
the date of this review, the confirmatory data have not been received. 
A tolerance for the residues of pyriproxyfen on vegetable, foliage of
legume, Group 7 cannot be established at this time.  The tolerance
request should be removed from Section F.  The issue should be revisited
when the data are submitted. 

Caneberry subgroup 13A

IR-4 has proposed a tolerance of 1.0 ppm using the tolerance established
on 1.0 ppm for caneberry Subgroup 13A based on the tolerance for
bushberry subgroup 13B  (PP# 2E6353).  Considering the supporting data,
the ChemSAC agreed with the proposed tolerance.  A tolerance for the
residues of pyriproxyfen on caneberry Subgroup 13A at 1.0 ppm should be
established.

Grain, cereal, Group 15

IR-4 has proposed a tolerance of 1.1 ppm on grain, cereal, Group 15
using the tolerance established at 1.1 ppm on grass, forage (PP#
4F6847).  Considering the supporting data and the proposed use as an ant
bait only, the ChemSAC agreed with the proposed tolerance.  A tolerance
for the residues of pyriproxyfen on grain, cereal, Group 15 at 1.1 ppm
should be established.

Grain, cereal, forage, fodder and straw, Group 16

IR-4 proposed a tolerance of 1.1 ppm on grain, cereal, forage, fodder
and straw, Group 16 using the tolerance established at 1.1 ppm on grass,
forage (PP# 4F6847).  Considering the supporting data and the proposed
use only as an ant bait, the ChemSAC agreed with the proposed tolerance.
 

A tolerance for the residues of pyriproxyfen on grain, cereal, forage,
fodder and straw, Group 16 at 1.1 ppm should be established.

Animal feed, nongrass, Group 18

IR-4 proposed a tolerance of 0.70, 1.1, and 2.0 ppm on animal feed,
nongrass, Group 18, forage, hay, and seed, respectively, using the
tolerance established at 0.70, 1.1, and 2.0 ppm on Grass, forage, hay,
and seed (PP# 4F6847).  Considering the supporting data, the ChemSAC
agreed with the proposed tolerance.  A tolerance for the residues of
pyriproxyfen on animal feed, nongrass, Group 18, forage, hay, and seed
at 0.70, 1.1, 2.0 ppm respectively should be established.  

Artichoke, globe

IR-4 has proposed a tolerance of 2.0 ppm on artichoke, globe using the
tolerance established at 2.0 ppm on Brassica, leafy greens, subgroup 5B
and a future residue study on celery with 8 trials in 2005 to provide
confirmatory data.  Considering the supporting data, the ChemSAC agreed
with the proposed tolerance.  However, as of the date of this review,
the confirmatory data have not been received.  A tolerance for the
residues of pyriproxyfen on artichoke, globe cannot be established at
this time.  The tolerance request should be removed from Section F.  The
issue should be revisited when the data are submitted.

Asparagus

IR-4 has proposed a tolerance of 2.0 ppm on asparagus using the
tolerance established at 2.0 ppm on Brassica, leafy greens, subgroup 5B
and a future residue study on celery with 8 trials in 2005 to provide
confirmatory data.  Considering the supporting data, the ChemSAC agreed
with the proposed tolerance.  However, as of the date of this review,
the confirmatory data have not been received.  A tolerance for the
residues of pyriproxyfen on asparagus cannot be established at this
time.  The tolerance request should be removed from Section F.  The
issue should be revisited when the data are submitted.

 

Banana

IR-4 has proposed a tolerance of 0.20 ppm on banana using the tolerance
established at 0.20 ppm on vegetable, fruiting, Group 8.  Considering
the supporting data, the ChemSAC agreed with the proposed tolerance.  A
tolerance for the residues of pyriproxyfen on banana at 0.20 ppm
respectively should be established.

Cacao bean

IR-4 has proposed a tolerance of 0.02 ppm on cacao bean using the
tolerance established at 0.02 ppm on nut, tree, Group 14.  Considering
the supporting data and the proposed use only as an ant bait, the
ChemSAC agreed with the proposed tolerance.  A tolerance for the
residues of pyriproxyfen on cacao bean at 0.02 ppm should be
established.

Canola, seed

IR-4 has proposed a tolerance of 0.20 ppm on canola using the tolerance
established at 0.20 ppm on bean, succulent.  Considering the supporting
data and the proposed use only as an ant bait, the ChemSAC agreed with
the proposed tolerance.  A tolerance for the residues of pyriproxyfen on
canola at 0.20 ppm should be established.

Coffee

 IR-4 has proposed a tolerance of 0.02 ppm on coffee using the tolerance
established at 0.02 ppm on nut, tree, Group 14.  Considering the
supporting data and the proposed use only as an ant bait, the ChemSAC
agreed with the proposed tolerance.  A tolerance for the residues of
pyriproxyfen on coffee at 0.02 ppm should be established.

Cranberry

IR-4 has proposed a tolerance of 1.0 ppm on cranberry using the
tolerance established at 1.0 ppm on bushberry, Subgroup 13B. 
Considering the supporting data the ChemSAC agreed with the proposed
tolerance.  A tolerance for the residues of pyriproxyfen on cranberry at
1.0 ppm should be established.

Date

IR-4 has proposed a tolerance of 0.30 ppm on date using the tolerance
established at 0.30 ppm on fig.  Considering the supporting data the
ChemSAC agreed with the proposed tolerance.  A tolerance for the
residues of pyriproxyfen on date at 0.30 ppm should be established. 

Kiwifruit

IR-4 has proposed a tolerance of 0.10 ppm on kiwifruit using the
tolerance established on starfruit and a future residue study on
kiwifruit with 3 trials in 2005 to provide confirmatory data. 
Considering the supporting data, the ChemSAC agreed with the proposed
tolerance.  However, as of the date of this review, the confirmatory
data have not been received.  A tolerance for the residues of
pyriproxyfen on kiwifruits cannot be established at this time.  The
tolerance request should be removed from Section F.  The issue should be
revisited when the data are submitted.

Pawpaw

IR-4 has proposed a tolerance of 1.0 ppm on pawpaw using the tolerance
established at 1.0 ppm on fruit, stone, Group 12.  Considering the
supporting data the ChemSAC agreed with the proposed tolerance.  A
tolerance for the residues of pyriproxyfen on pawpaw at 1.0 ppm should
be established. 

Peanut

IR-4 has proposed a tolerance of 0.20 ppm on peanut using the tolerance
established at 0.20 ppm on vegetable, legume, Group 6.  Considering the
supporting data and the proposed use only as an ant bait, the ChemSAC
agreed with the proposed tolerance.  A tolerance for the residues of
pyriproxyfen on peanut at 0.20 ppm should be established. 

Pineapple

IR-4 has proposed a tolerance of 0.30 ppm on pineapple using the
tolerance established at 0.30 ppm on fruit, citrus, Group 10. 
Considering the supporting data the ChemSAC agreed with the proposed
tolerance.  A tolerance for the residues of pyriproxyfen on pineapple at
0.30 ppm should be established. 

Pomegranate

IR-4 has proposed a tolerance of 0.20 ppm on pomegranate using the
tolerance established at 0.20 ppm on vegetable, fruiting, Group 8. 
Considering the supporting data the ChemSAC agreed with the proposed
tolerance.  A tolerance for the residues of pyriproxyfen on pomegranate
at 0.20 ppm should be established.

Safflower, seed

IR-4 has proposed a tolerance of 0.20 ppm on safflower, seed using the
tolerance established at 0.20 ppm on bean, succulent.  Considering the
supporting data and the proposed use only as an ant bait, the ChemSAC
agreed with the proposed tolerance.  A tolerance for the residues of
pyriproxyfen on safflower, seed at 0.20 ppm should be established. 

Sesame, seed

IR-4 has proposed a tolerance of 0.20 ppm on sesame, seed using the
tolerance established at 0.20 ppm on bean, succulent.  Considering the
supporting data and the proposed use only as an ant bait, the ChemSAC
agreed with the proposed tolerance.  A tolerance for the residues of
pyriproxyfen on sesame, seed at 0.20 ppm should be established.

Sugarcane

IR-4 has proposed a tolerance of 1.1 ppm on sugarcane using the
tolerance established at 1.1 ppm on grass.  Considering the supporting
data and the proposed use only as an ant bait, the ChemSAC agreed with
the proposed tolerance.  A tolerance for the residues of pyriproxyfen on
sugarcane at 1.1 ppm should be established.

Tea

IR-4 has proposed a tolerance of 0.02 ppm on tea using the tolerance
established at 0.02 ppm on nut, tree, Group 14.  Considering the
supporting data and the proposed use only as an ant bait, the ChemSAC
agreed with the proposed tolerance.  A tolerance for the residues of
pyriproxyfen on tea at 0.02 ppm should be established. 

Watercress

IR-4 has proposed a tolerance of 2.0 ppm on watercress using the
tolerance established at 2.0 ppm on Brassica, leafy greens, subgroup 5B
and a future residue study on celery with 8 trials in 2005 to provide
confirmatory data.  Considering the supporting data, the ChemSAC agreed
with the proposed tolerance.  However, as of the date of this review,
the confirmatory data have not been received.  A tolerance for the
residues of pyriproxyfen on watercress cannot be established at this
time.  The tolerance request should be removed from Section F.  The
issue should be revisited when the data are submitted.

860.1520 Processed Food and Feed

PP#s 4F6847, 3E6596, 3E6596, 3E6750, 4E6866, 4E6865 & 3E6582, DP Num:
310072, 316784, 316788, 316800, 316798, 316802 & 314308, G. Kramer,
6/30/05

PP#7F4882, DP Num: 238190, W. Donovan, 12/7/  SEQ CHAPTER \h \r 1 98 

PP#8F5022, DP Num: 253836, W. Donovan, 3/25/99

PP#8F5022, DP Num: 253836, W. Donovan, 3/25/99

  SEQ CHAPTER \h \r 1 PP#s 0F6220, 1E6285, 1E6272 & 2E6353, DP Num:
270048, 274378, 274383, & 278780, W. Donovan, 11/30/01 PP#s 2E6416,
2E6436 & 2F6385, DP Num: 284744, 284745, & 284805, W. Donovan, 10/10/02 

PP#6F4737, DP Num: 228556, 228925 & 228926, J. Garbus, 5/1/97

Many of the proposed tolerances are for RACs  which have associated
processed food/feed items of regulatory interest.  The following
information is available in the Agency’s database for pyriproxyfen
residues in processed commodities.

A grape processing study was submitted and found adequate.  Pyriproxyfen
residues were 0.55 ppm in the RAC, 0.65 ppm in raisins, and <0.01 ppm in
juice. A comparison of the residues of pyriproxyfen in the RAC with
those in each processed fraction resulted in concentration factors of
1.18 for raisins and <0.04 for juice.  These processing factors conform
with the theoretical maximum concentration factors.  As there was no
significant concentration, separate tolerances for grape juice and
raisins are not required. (PP#s 4F6847, 3E6596, 3E6596, 3E6750, 4E6866,
4E6865 & 3E6582, DP Num: 310072, 316784, 316788, 316800, 316798, 316802
& 314308, G. Kramer, 6/30/05). The grape juice processing data were used
for pineapple juice.

An apple processing study was submitted and found adequate.    SEQ
CHAPTER \h \r 1 Pyriproxyfen residues concentrated 4.9x in wet apple
pomace processed from treated apples (PP#7F4882, DP Num: 238190, W.
Donovan, 12/7/  SEQ CHAPTER \h \r 1 98).  The apple processing data were
used for potato, wet peel.

An orange processing study was  SEQ CHAPTER \h \r 1  submitted and found
adequate.  The study indicates that residues of pyriproxyfen do not
concentrate in juice, but concentrate by 74.6x in citrus oil and 6.4x in
dried pulp.  Based upon these concentration factors and the HAFT
residues in/on oranges of 0.22 ppm, the proposed tolerances for
pyriproxyfen residues in citrus oil and in dried pulp were established
at 20.0 and 2.0 ppm, respectively (PP#8F5022, DP Num: 253836, W.
Donovan, 3/25/99).  The orange juice processing data were used for
pineapple juice.

A tomato processing study was  SEQ CHAPTER \h \r 1  submitted and found
adequate.  Pyriproxyfen residues were 0.04 ppm in whole tomatoes, 0.02
ppm in paste, and <0.01 ppm in puree.    SEQ CHAPTER \h \r 1 As there
was no concentration, separate tolerances for tomato paste and puree are
not required (PP#8F5022, DP Num: 253836, W. Donovan, 3/25/99).

  SEQ CHAPTER \h \r 1 In a processed food/feed study, plums were
processed into prunes using simulated commercial procedures.  A
comparison of the residues in the plum RAC with those in processed
prunes resulted in a processing factor of 2.9x, which is similar to the
theoretical factor of 3.5x.  A separate tolerance was not be required
for prunes because the maximum expected residues in prunes (0.58 ppm)
processed from plums treated at the maximum application rate is lower
than the proposed 1.0 ppm tolerance for stone fruits.  Residues of
pyriproxyfen in prunes will be covered by the tolerance for stone fruits
when such a tolerance is established (  SEQ CHAPTER \h \r 1 PP#s 0F6220,
1E6285, 1E6272 & 2E6353, DP Num: 270048, 274378, 274383, & 278780, W.
Donovan, 11/30/01).

  SEQ CHAPTER \h \r 1 In a processed food/feed study, olives were
processed into olive oil using simulated commercial procedures.  A
comparison of the residues in the pitted olive raw agricultural
commodity (RAC) with those in the processed oil resulted in a processing
factor of 2.6x, which is less than the maximum theoretical factor of
10x.  The maximum pyriproxyfen residue in olive oil may be estimated as
the product of the processing factor and the HAFT from the field trial
studies, i.e., 2.6 x 0.73 ppm = 1.9 ppm.  Thus, a separate tolerance
level of 2.0 ppm was appropriate for “Olive, oil” (PP#s 2E6416,
2E6436 & 2F6385, DP Num: 284744, 284745, & 284805, W. Donovan,
10/10/02).

A cotton processing study was  SEQ CHAPTER \h \r 1  submitted and found
adequate.  There was no concentration of residues in processed
cottonseed commodities: meal at <0.1x, oil at 0.2x, and hulls at <0.1x
(PP#6F4737, DP Num: 228556, 228925 & 228926, J. Garbus, 5/1/97).  The
cotton processing data were used for all oil, meal, hulls, and grain
processed commodities.

The following table lists the commodities with proposed tolerances,
which have processed commodities of regulatory interest.  Since no new
processing data were submitted with this petition, the theoretical
processing factors (OPPTS GLN 860.1520) are listed.  Where possible,
processing factors from the Agency’s pyriproxyfen database are also
listed for similar commodities.  Where both theoretical and translated
processing factors are listed, the lowest of the factors is used to
calculate a tolerance value.  

Table 8.  Processed Food and Feed

RAC

 Processed                                                  Commodity
Processing Factor	Recommended Tolerancea

(ppm)

	Theoretical	Translated

	beets

     sugar, refined

     molasses 

     dry pulp	

20x

12.5x

20x	

<0.1c

<0.1 c

	0.15

NA

NA

3.0

potato

     granules/ flakes

     chips

     peel, wet	

5x

4.7x

5x	

4.9b	0.15

0.75

0.75

0.75

barley

     bran

     flour

     pearled barley	

8x

8x

1.2x	

<0.1c

<0.1c

<0.1c	1.1

NA

NA

NA

buckwheat

     flour	

1.4x	

<0.1c	1.1

NA

corn

     starch

     oil, refined

     grits

     meal

     flour	

9x

25x

9x

9x

1.5x	

<0.1c

0.2c

<0.1c

<0.1c

<0.1c	1.1

NA

NA

NA

NA

NA

millet

     flour	

1.4x	

<0.1c	1.1

NA

oats

     flour

     rolled oats	

1.4x

9x	

<0.1c

<0.1c	1.1

NA

NA

rice

     polished rice

     hull

     bran	

8x

5x

7.7	

<0.1c

 

<0.1c	1.1

NA

5.5

NA

rye

     flour

     milled by products

     bran	

1.4x

9x

7.7x	

<0.1c

<0.1c

<0.1c	1.1

NA

NA

NA

sorghum

     flour

     syrup	

1.4x

9x	

<0.1c

<0.1c	1.1

NA

NA

wheat

     bran

     flour

     middlings

     shorts

     germ	

7.7x

1.4

9

8.3

9	

<0.1c

<0.1c

<0.1c

<0.1c

<0.1c	1.1

NA

NA

NA

NA

NA

Canola, seed 

     meal

     oil refined	

1.9

3	

<0.1c

0.2c	0.20

NA

NA

Coffee 

     bean roasted

     instant	

1.2

4.4

0.02

NA

0.1

Peanut 

     meal

     oil refined	

2.2

2.8	

<0.1c

0.2c	0.20

NA

NA

Pineapple 

     process residue

     juice	

3.8

4	

4.9b 

0.04d	0.30

1.1

NA

Safflower, seed 

     meal

     oil refined	

9.1

3.3	

<0.1c

0.2c	0.20

NA

NA

Sesame, seed 

     oil	

3.3	

0.2c	0.20

NA

Sugarcane 

     molasses

     sugar, refined	

20

11.8	

<0.1c

<0.1c	1.1

NA

NA

a   Calculations are based on the lower of theoretical or translated
processing factor.

b  Based on wet apple pomace, 4.9x.

c  Based on cottonseed meal at <0.1x, oil at 0.2x, and hulls at <0.1x.

d  Based on grape and orange juice, 0.04.

Tolerances are required for all the processed commodities which have
higher estimated tolerance levels that the associated RAC.  A revised
Section F is required for beet, dry pulp at 3.0 ppm; potato granules/
flakes, chips, and wet peel at 0.75 ppm; rice, hulls at 5.5 ppm; coffee,
instant at 0.10 ppm; and pineapple, process residue at 1.1 ppm. 

860.1850 and 860.1900:  Confined/Field Accumulation in Rotational Crops

An adequate confined rotational crop study (MRID 44036918) was conducted
in support of the cotton petition (PP#6F4737, DP Num: 228556, 228925 &
228926, J. Garbus, 5/6/97).  Based on a 30-day PBI and a treatment rate
of 0.18 lb ai/A, no pyriproxyfen residues above 0.01 ppm were found in
any of the following crop matrices:  lettuce leaf; radish tops and
roots; and wheat grain, forage, straw and chaff.  Accordingly, HED
concludes that a 30-day PBI for non-labeled crops is appropriate.

860.1550 Proposed Tolerances

Permanent tolerances for pyriproxyfen have been established for a
variety of commodities under 40 CFR §180.510.  There are currently no
established Codex, Canadian, or Mexican maximum residue limits (MRLs)
for pyriproxyfen.  An International Residue Limit Status sheet is
attached to this review.  Since no new data were included with this
submission, the methodology formulated by the NAFTA MRL/Tolerance
Harmonization Workgroup for calculating statistically-based pesticide
tolerances was not used.

Table 9.  Tolerance Summary for Pyriproxyfen

Commodity	Established/Proposed Tolerance (ppm)	Recommended Tolerance
(ppm)	Comments (correct commodity definition)

Vegetable, root and tuber, Group 1	0.15	0.15

	Potato, granules/flakes	None	0.75

	Potato, chips	None	0.75

	Potato peel, wet	None	0.75

	Potato peel, dried	None	0.75

	Vegetable, leaves of root and tuber, Group 2	2.0	None

	Vegetable, bulb, Group 3, 

     except onion, bulb 	0.70	0.70	Vegetable, bulb, Group 3, except
Onion, dry bulb

Vegetable, leafy, except Brassica, Group 4 	2.0	None

	Vegetable, legume, Group 6 	0.20	None

	Vegetable, foliage of legume, Group 7 	2.0	None

	Caneberry Subgroup 13A 	1.0	1.0

	Grain, cereal, group 15 	1.1	1.1

	Grain, cereal, forage, fodder and straw, 

     Group 16 	1.1	1.1

	Rice, hulls	None	5.5

	Animal feed, nongrass, Group 18, forage 	0.70	0.70

	Animal feed, nongrass, Group 18, hay	1.1	1.1

	Animal feed, nongrass, Group 18, seed	2.0	2.0

	Artichoke, globe	2.0	None

	Asparagus 	2.0	None

	Banana 	0.20	0.20

	Cacao bean 	0.02	0.02

	Canola, seed 	0.20	0.2

	Coffee 	0.02	0.02

	Coffee, instant	None	0.10

	Cranberry 	1.0	1.0

	Date 	0.30	0.30

	Kiwifruit 	0.10	None

	Pawpaw  	1.0	1.0

	Peanut 	0.20	0.20

	Pineapple 	0.30	0.30

	Pineapple, process residue	None	1.1

	Pomegranate 	0.20	0.02

	Safflower, seed 	0.20	0.20

	Sesame, seed 	0.20	0.02

	Sugarcane 	1.1	1.1

	Tea  	0.02
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牡档㈠〰ളഌ䤍呎剅䅎䥔乏䱁删卅䑉䕕䰠䵉呉匠䅔啔ݓ
ഇ桃浥捩污丠浡㩥ܠ䌍浯潭⁮慎敭›倠特灩潲祸敦ݮ

   Proposed tolerance

(   Reevaluated tolerance

(   Other	

Date: 8/11/06

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:  6E7033

DP Barcodes:  327023

Other Identifier:  129032

Residue definition (step 8/CXL): N/A	

Reviewer/Branch: W. Cutchin

	

Proposed Residue definition

Crop (s)	

MRL (mg/kg)	

Crop(s) 	

Tolerance (ppm)

None	

	Vegetable, root and tuber, Group 1	0.15 

	

	Vegetable, bulb, Group 3, 

     except Onion, dry bulb 	0.70 

	

	Caneberry Subgroup 13A 	1.0 

	

	Grain, cereal, group 15 	1.1 

	

	Grain, cereal, forage, fodder and straw, Group 16 	1.1 

	

	Animal feed, nongrass, Group 18, forage 	0.70 

Animal feed, nongrass, Group 18, hay	1.1 

Animal feed, nongrass, Group 18, seed	2.0 

Artichoke, globe	2.0 

Banana 	0.20 

Cacao bean 	0.02 

Canola, seed 	0.20 

Coffee 	0.02 

Cranberry 	1.0 

Date 	0.30 

Kiwifruit 	0.10 

Pawpaw  	1.0 

P慥畮⁴〇㈮‰܇܇楐敮灡汰⁥〇㌮‰܇܇潐敭牧湡瑡⁥〇
㈮‰܇܇慓晦潬敷Ⱳ猠敥⁤〇㈮‰܇܇敓慳敭‬敳摥ܠ⸰
〲ܠ܇匇杵牡慣敮ܠ⸱‱܇܇敔⁡ܠ⸰㈰ܠഇ楌業獴映牯䌠
湡摡ݡ䰍浩瑩⁳潦⁲敍楸潣܇

√  No Limits 

□  No Limits for the crops requested	

□  No Limits 

 √ No Limits for the crops requested 

Residue definition: N/A.

Registered as a pet treatment (flea).	

Residue definition: pyriproxifen

Crop(s)	

MRL (mg/kg)	

Crop(s)	

MRL (mg/kg)

	

	

	

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Notes/Special Instructions: S.Funk, Aug 11, 2006

	

Pyriproxyfen	Summary of Analytical Chemistry and Residue Data	DP Num:
327023

	  PAGE  1  of   NUMPAGES  31