 

<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007)>

<<<FOR FURTHER INFORMATION CONTACT:> <Samantha Hulkower, Registration
Division (7505P), Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: 703-603-0683; e-mail address: 
Hulkower.Samantha<@epa.gov>.>>>

 

<>

<ELANCO ANIMAL HEALTH>

<9F7543>

<	EPA has received a pesticide petition (9F7543) from ELANCO ANIMAL
HEALTH via Technology Sciences Group Inc., 4061 North 156th Drive,
Goodyear, AZ 85395, proposing, pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR
part 180.>

<>

<<	1. by establishing a tolerance for residues of>>

<	[the insecticide spinosad, a fermentation product of Saccharopolyspora
spinosa which consists of two related active ingredients: Spinosyn A
(Factor A: CAS # 131929–60–7) or 2-[(6-deoxy-2,3,4-tri- O
-methyl-α- L
-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyra
n-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahyd
ro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and
Spinosyn D (Factor D; CAS # 131929–63–0) or 2-[(6-deoxy-2,3,4-tri- O
-methyl-α- L
-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyr
an-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahy
dro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione] in or
on the raw agricultural commodities [“Milk”] at [5] parts per
million (ppm) [“Milk, fat”] at [40] parts per million (ppm)
[“Cattle, fat”, “Goat, fat” and “Sheep, fat”] at [30] parts
per million (ppm) [“Hog, meat” and “Poultry, meat byproducts”]
at [0.2] parts per million (ppm) [“Hog, meat byproducts”] at [0.6]
parts per million (ppm) [“Poultry, fat”] at [1.5] parts per million
(ppm) and [“Hog, fat”] at [2.0] parts per million (ppm).  [The
tolerances revisions are a reflection of changes in the ELANCO ANIMAL
HEALTH (EAH) product line which include an amendment to their premise
spray Elector PSP* [72642-2] allowing a direct spray on poultry and a
discontinuation (by voluntary cancellation) of the Elector* Insect
Control Product [72642-1].  Together these two product actions eliminate
pour-on and on animal spray uses for cattle, retain premise sprays for
general livestock and allow direct spray for poultry.  With the removal
of the pour-on cattle use, alternate data for a dermal use within a
previous Magnitude of Residue cattle study is revisited to
conservatively represent potential overspray from the general premise
use.  The new Table 1 Feedstuffs (June 2008) EPA guidance for Maximum
Reasonable Dietary Burdens (MRBD) has been employed to reconstruct and
revise the animal diets for poultry, swine and cattle.] EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data supports granting of the petition. Additional data may
be needed before EPA rules on the petition.

[The supporting assessment includes the Agency conclusion that spinosad
is considered toxicologically identical to another pesticide,
spinetoram. This conclusion is based on the following: (1) Spinetoram
and spinosad are large molecules with nearly identical structures; and
(2) the toxicological profiles for each are similar (generalized
systemic toxicity) with similar doses and endpoints chosen for
human-health risk assessment. Spinosad and spinetoram should be
considered toxicologically identical in the same manner that metabolites
are generally considered toxicologically identical to the parent.]>

<A. Residue Chemistry>

<	1. Plant metabolism. [Per the Federal Register: April 15, 1998 (Vol
63, No 72) OPP-300644; FRL-5785-7, the nature of the residue of spinosad
in plants has been studied in several plants (apple, cabbage, cotton,
tomato and turnip) and is adequately understood.  EPA determined the
rotational crop study showed no carryover of measurable spinosad related
residues in representative test crops (lettuce, radish, and wheat). 
Tolerances for enforcement are established for spinosad based on the
residue definition of Spinosyn A (Factor A) plus Spinosyn D (Factor
D).]>

<	2. Analytical method. [EPA has determined adequate analytical methods
are available for enforcement purposes for spinosad in plant and animal
matrices.  Methods include an immunoassay particle-based method 97.05
and an HPLC/UV method GRM 03.15 and a suite of specific crop methods:
GRM 94.02 (cottonseed and related commodities), GRM 95.17 (leafy
vegetables), GRM 96.09 (citrus), GRM 96.14 (tree nuts), GRM 95.04
(fruiting vegetables), GRM 94.02.S1 (cotton gin byproducts).  GRM 94.02
has a successful independent lab validation and was submitted for
inclusion in PAM II as Method I.  EPA recently concluded that for water,
residues should be estimated using total spinosad residue method (EPA,
D316077, August 2, 2006).  An updated Dow AgroSciences method GRM 06.13
for the determination of residues of spinosad and its metabolites in
poultry tissues and eggs by Liquid Chromatography with Tandem Mass
Spectrometry supports this petition.]>

<	3. Magnitude of residues. [ELANCO ANIMAL HEALTH seeks an amendment to
the Elector* PSP Premise Insect Control Agent [72642-2] product
registration that will add direct application to poultry for control of
Northern Fowl Mite to the existing label which already allows premise
sprays for several types of livestock. An MOR study of sprayed chickens
in simulated commercial poultry facilities (Rosser and Shackelford 2008)
with analysis of spinosad residues in edible poultry tissues and eggs is
submitted in support of direct and premise spray use in poultry. 
Chickens were treated with a direct-body spray at a spinosad
concentration of 1000 ppm applied at an average volume of 1 gallon of
spray mixture per 100 chickens with five applications in 14-day
intervals.  The housing for these chickens was also treated with a
premise spray at a spinosad concentration of 800 ppm applied at a volume
of approximately 1 gallon of spray mixture per 500 square feet of
surface area to cover interior surfaces of the poultry house with nine
premise spray applications in 7-day intervals.  Test substance-related
adverse effects, including effects on egg production or body weight,
were not observed during the study and there were no abnormal necropsy
observations.

The limit of quantitation (LOQ) and limit of detection (LOD) were
validated at 0.01 μg/g and 0.003 μg/g, respectively, for each of the
analytes in each of the five matrices (eggs, fat, liver, muscle and
skin).

Residues were generally present at highest concentrations in fat and
skin relative to other matrices.  The resulting spinosad residues peaked
over the range of Day 0 to Day 7 (days after last treatment) depending
upon the tissue. The resulting spray residues are used in the
calculation of the revised tolerances for poultry and well as in the
anticipated residues for dietary assessment.  Because no acute endpoint
has been chosen for spinosad, it is appropriate to utilize the peak of
the average residues from the spray study for the calculation of the
poultry anticipated residues in the risk assessment.  For tolerance
assessment, it is proposed that the highest observed residues are used
to set an upper limit for commerce.

A proposed reduction of tolerances for milk, hog meat and various animal
fats is based in part on the voluntary cancellation of the Elector*
Insect Control Agent [72642-1] and in part on revised animal dietary
burden for MRBD (EPA Memorandum June 30 2008).  The pour-on use pattern
is no longer applicable.  The 2L- 400 ppm dermal spray use residues from
a previous Magnitude of Residue study (MRID 45080605) in cattle is used
to conservatively represent potential overspray of premise use with
livestock per recommendation of HED in 2006 (T. Bloem, EPA, D321764,
February 2, 2006.)  The cattle received 2L of 400 ppm spinosad spray for
5 treatments every 7 days.  In addition, the premises of dermal treated
animals were sprayed every seven days with an 800 ppm spinosad solution.
 The highest residues values for the various animal tissues (kidney,
liver, muscle, milk and fat) support the proposed tolerances and were
all less than 0.5 ppm.  Because no acute endpoint has been chosen for
spinosad, it is appropriate to utilize the peak of the average residues
from the spray study for the calculation of the poultry anticipated
residues in the risk assessment.  The mean values for the 2L- 400 ppm
dermal spray use were used for dietary assessment and were all less than
0.4 ppm.]

>

<B. Toxicological Profile [Per the Federal Register: April 15, 1998 (Vol
63, No 72) OPP-300644; FRL-5785-7, EPA determined the toxicological
profile and endpoints for spinosad are adequate for risk assessment
evaluations and determination of FQPA.  For recent spinosad decisions,
per Federal Register: December 5, 2007 (Volume 72, Number 233);
FRL-8339-8, EPA employed slightly revised endpoints based on their
decision that spinetoram is toxicologically identical to spinosad.  EPA
picked the lowest of the spinosad and spinetoram endpoints for each
exposure scenario.  A summary of the toxicological endpoints for
spinosad and spinetoram used for human risk assessment can be found at  
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov  in
docket EPA-HQ-OPP-2007-0310.  Relevant information is summarized
below.]>

<	1. Acute toxicity.  [No appropriate endpoint attributable to a single
dose was identified; the EPA has not established an acute RfD for
spinosad or spinetoram.]>

<	2. Genotoxicty. [Assays for genotoxicity consisting of a bacterial
reverse mutation assay (Ames test), and in vitro assay for cytogenetic
damage using the Chinese hamster ovary cells, an in vitro mammalian gene
mutation assay using lymphoma cells, an in vitro assay for DNA damage
and repair in rat hepatocytes, and an in vivo cytogenetic assay in the
mouse bone marrow (micronucleus test) have been conducted with spinosad.
 These studies show a lack of genotoxicity.]>

<	3. Reproductive and developmental toxicity. [>Spinosad caused
decreased body weights in maternal rats given 200 mg/kg/day by gavage in
a developmental study (highest dose tested).  This was not accompanied
by either embryotoxicity, fetal toxicity, or teratogenicity.  The
no-observed-effect levels (NOELs) for maternal and fetal toxicity in
rats were 50 and 200 mg/kg/day, respectively.  A developmental study in
rabbits showed that spinosad caused decreased body weight gain and two
abortions attributed to inanition in maternal rabbits at 50 mg/kg/day
(highest dose tested).  Maternal toxicity was not accompanied by either
embryo toxicity, fetal toxicity, or teratogenicity.  The NOELs for
maternal and developmental effects in rabbits were 10 and 50 mg/kg/day,
respectively.  In a two-generation reproduction study in rats, parental
toxicity was observed in both males and females given 100 mg/kg/day
(highest dose tested).  Effects in the offspring (decreased litter size
and pup weight) at 100 mg/kg/day were attributed to maternal toxicity. 
The systemic and reproductive NOELs were both 10 mg/kg/day.  EPA has
determined that reliable data show that it would be safe for infants and
children to reduce the 10X FQPA safety factor to 1X.]

<	4. Subchronic toxicity. [Both Short-term endpoints (inhalation and
incidental oral) were established based on the Oral NOAEL of 4.9
mg/kg/day from the subchronic feeding study in dogs with spinosad and a
LOC for MOEs of 100.]>

<	5. Chronic toxicity. [EPA used the lowest NOAEL of 0.249 mg/kg/day
from the chronic toxicity study in dogs for spinetoram and a 100X UF to
establish a cRfD of 0.0249 mg/kg/day for both spinosad and spinetoram. 
Spinosad is considered ``Not likely to be Carcinogenic to Humans''.]>

<	6. Animal metabolism. [The nature of spinosad residue in animals is
understood based on livestock studies in ruminants (oral and dermal) and
poultry (oral) (D316077, August 2, 2006).  ADME studies in rats indicate
spinosad is rapidly absorbed and extensively metabolized.  Also the rat
metabolism studies showed no major differences between the
bioavailability, routes or rates of excretion, or metabolism of Factor A
or Factor D.  Urine and fecal excretions were almost completed in
48-hours post-dosing.  In addition, the routes and rates of excretion
were not affected by repeated administration.  EPA recently indicated
that for fish/shellfish within the risk assessment estimates of the
total residue within edible tissues is applicable (EPA, D316077, August
2, 2006).  Total edible residues in fish have been extensively
characterized within BCF studies (MRID 43557601, 44557734, 47355801].>

<	7. Metabolite toxicology. [Results of the plant and animal metabolism
studies and toxicity testing have been assessed.  Per Federal Register:
April 15, 1998 (Vol 63, No 72)  FRL-5785-7,  EPA concluded that the
spinosad metabolites/fermentation impurities (Factor B, Factor B of D,
Factor K, and other related Factors) were no more toxicological concern
than the two parent compounds.  Metabolite toxicity has been addressed
by establishment of the residue for tolerance purposes as the parent
materials.  In addition, for risk assessment purposes, the total residue
in water and edible fish is now conservatively considered.]

>

<	8. Endocrine disruption. [There is no evidence to suggest that
spinosad has an effect on any endocrine system.]>

<C. Aggregate Exposure [The agency conducted an assessment of the
aggregate exposure for spinosad and spinetoram in conjunction with the
establishment of the initial spinetoram tolerances reported in the
Federal Register of October 10, 2007 (  HYPERLINK
"http://www.epa.gov/EPA-PEST/2007/October/Day-10/p19947.htm"  72 FR
57492 ) (FRL-8149-9).  The EPA assumed toxicological equivalency of
spinosad and spinetoram in their aggregate exposure assessment. 
Anticipated exposure to spinosad was deemed acceptable.  The proposed
changes in use pattern lower the overall dietary exposure from animal
commodities in the human diet.  No new aggregate assessments are
warranted.]>

<	1. Dietary exposure. [i. Acute exposure. No quantitative acute dietary
exposure assessment has been required for spinosad.

ii. Chronic exposure.  Spinosad and spinetoram are deemed
toxicologically equivalent by EPA.  Based on the similarity of the
insecticides and the anticipated markets for each, it is unlikely that
spinosad and spinetoram will be applied to the same crop.  Hence, EPA
aggregated exposure by either assuming that all commodities contain
spinosad (because side-by-side spinosad and spinetoram residue data
indicated that spinetoram residues were less than or equal to spinosad
residues) or summing the percentage of a crop that would be treated with
spinosad and the percentage that would be treated with spinetoram.

The proposed revision of the meat and milk animal commodity tolerances
for spinosad are based on part on revised animal dietary burdens
according to the  Table 1 Feedstuffs (June 2008) EPA guidance for
Maximum Reasonable Dietary Burdens (EPA Memorandum June 30 2008).  The
revised procedures reflect the EPA updated understanding of feedlot
production procedures and nutritional requirements allotted as Roughage
(R), Protein (PC) and Carbohydrate (CC) categories.  Revised MRBD
dietary burdens are supported for dairy cattle at 44.34 ppm, beef cattle
at 18.34 ppm, swine at 2.78 ppm and poultry at 2.63 ppm for tolerance
calculations.  For the calculation of cattle tolerances, a regression
equation for transfer of spinosad to animal tissues and milk was built
using the dose levels of 23.17 ppm, 97.87 ppm from a recent feeding
study (MRID 47296401) and the 10 ppm value from the previous work (MRID
44058826) because these doses bracket the revised animal dietary burden
in cattle.  The proposed tolerances include residue contributions for
the feed-through use in cattle and premise spray for general livestock.

For the calculation of swine tolerances and the revised dietary
anticipated residues for cattle, the regression equation for transfer of
spinosad to animal tissues and milk was built using the 1, 3, and 10 ppm
values from the older feeding (MRID 44058826) because these doses
bracket the germane burdens.]>

<	i. Food. [The chronic dietary exposure assessment (EPA, D337531,
September 12, 2007) was recreated in Dietary Exposure Evaluation Model -
Food Consumption Intake Database (DEEM-FCID) (version 2.16) which
incorporates the United States Department of Agriculture (USDA)
1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals
(CSFII).  The residues of livestock were refined through the
incorporation of a refined dietary burden (average field crop residues
and projected PCT) with average milk residues for spinosad from the
ruminant MOR study.  Specifically the revised MRBD Diets have been
refined by input of average residues for feedstuffs (46159801), previous
EPA assumptions regarding residues (Bloem, EPA Assessment, DP337531,
September 12, 2007; Bloem, EPA Assessment, DP339485, May 14, 2007;
Sproat, EPA, Memorandum D341762, October 13, 2004; Dougherty, EPA
Memorandum, D269680, November 14, 2000) and PCT information (Bloem, EPA
Assessment, DP337531; Federal Register of March 21, 2007 Vol 72. No 54,
FRL–8114–4; Halvorson, US EPA, DP334157, December 13, 2006).

The dietary analysis assumed DEEM (ver 7.81) default processing factors
for many food commodities, EPA specified processing factors for corn,
grape, and wheat, 100% crop treated for food commodities and used
average field trial residues for several commodities: apple, leafy
vegetables, Brassica vegetables, citrus, fruiting vegetables, herbs,
banana and strawberry and tolerances values for all others, except
fish/shellfish which were conservatively represented as 12.5 ppm (3X
fold of the 4 ppm tolerance for spinosad.)]>

<	ii. Drinking water. [Drinking water estimates were determined based on
EPA screening models and concentrations were directly entered into the
dietary exposure model. For spinetoram, estimated environmental
concentrations (EECs) for chronic exposures are calculated to be 6.17
ppb for surface water using the First Index Reservoir Screening Tool
(FIRST) and 0.072 ppb for ground water using the Screening Concentration
in Ground Water (SCI-GROW) model.  For spinosad, average values of 10.5
ppb for surface water and 1.1 ppb for ground water were conservatively
estimated based on additional uses.  Thus, for the joint chronic dietary
risk assessment, EPA has used the water concentration value of 10.5 ppb
to assess the contribution to drinking water.]>

<

	2. Non-dietary exposure. [EPA has determined there is potential for
residential handler and post-application exposures to
spinosad/spinetoram.  Because spinosad and spinetoram control the
similar pests, EPA concluded these products will not be used in
combination with each other and combining the residential exposures is
unnecessary.  Per Federal Register of October 10, 2007 (  HYPERLINK
"http://www.epa.gov/EPA-PEST/2007/October/Day-10/p19947.htm"  72 FR
57492 ) (FRL-8149-9), short-term residential inhalation risks were
estimated for adult residential handlers, as well as short-term
post-application incidental oral risks for toddlers, based on
applications to home lawns, home gardens and ornamentals.>

<D. Cumulative Effects>

<	[EPA has not made a common mechanism of toxicity finding as to
spinosad and any other substances and spinosad does not appear to
produce a toxic metabolite produced by other substances.  HED’s Hazard
Assessment and Policy Committee noted that toxicologically equivalent
does not imply a cumulative assessment which involves the concepts of
mechanism of toxicity and potency.  For the purposes of tolerance
action, it is not assumed that spinosad has a common mechanism of
toxicity with other substances.]>

<E. Safety Determination [The proposed actions of this petition have
been added via DEEM to EPA’s initial assessment for
spinetoram/spinosad (EPA, D337531, September 12, 2007).  With the
cancellation of the ELANCO cattle product (72642-1), the overall dietary
exposure is lower than that predicted in the previous assessment.  There
is a reasonable certainty that no harm will result to the general
population or infants and children from the aggregate exposure to
spinosad/spinetoram residues from these uses.]>

<	1. U.S. population. [The resulting dietary exposure for the general
population is estimated to be lowered to 27.8% of the cPAD relative to
the previous EPA assessment of <35%.  When the food and water exposure
is summed with the estimated residential inhalation exposure for youth
(over 12 years old) and adults, the resulting short term aggregate MOE
values previously ranged from 650 to 710 (Federal Register: Dec 5, 2007
(Vol 72, No 233); FRL-8339-8) and the MOEs values of not of concern to
HED.]>

<	2. Infants and children. [EPA has determined that reliable data allow
a reduction of the FQPA safety factor to 1X for infants and children. 
The revised dietary exposure for the most exposed subpopulation
(children 1 to 2 years) is estimated to be lowered to 57.3% of the cPAD
relative to the previous estimation of 81%.  Previously short term
post-application risks were estimated for toddlers, based on application
to home lawn, home gardens and ornamentals and risks were not of concern
given resulting MOEs were >1200.  The resulting short term aggregate MOE
values were >180 and are, therefore, not of concern to HED.]>

<F. International Tolerances>

<	[A variety of international and CODEX MRLs are in place for spinosad,
but MRLs established for animal commodities such as meat and milk have
been disharmonized (in part due to interpretations of the cattle pour-on
use).  The proposed changes serve to shrink the gap between the US
tolerances and several international MRLs.  Several MRL websites were
used to compile the list of MRLs, however no claim is made regarding the
verification of these values relative to the national authorities.

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Swine Kidney	0.3	PPM

EU MRL	Bovine Meat	0.3	PPM

EU MRL	Bovine Fat 	3	PPM

EU MRL	Bovine Liver	2	PPM

EU MRL	Bovine Kidney	1	PPM

EU MRL	Bovine Edible Offal	0.5	PPM

EU MRL	Sheep, Goat and Horse Meat	0.05	PPM

EU MRL	Sheep, Goat and Horse Fat 	2	PPM

EU MRL	Sheep, Goat and Horse Liver, Kidney  and Edible Offal	0.5	PPM

EU MRL	Poultry Meat	0.2	PPM

EU MRL	Poultry Fat 	1	PPM

EU MRL	Poultry Liver, Kidney, and Edible Offal	0.2	PPM

EU MRL	Other farm animals (rabbit, kangaroo)	0.02	PPM

EU MRL	Milk and Cream	0.5	PPM

EU MRL	Bird Eggs	0.2	PPM

Australia	Edible Offal	T0.2	PPM

Australia	Eggs	T0.05	PPM

Australia	Meat	T0.2	PPM

Australia	Milk	T0.1	PPM

Australia	Poultry Edible Offal	T0.05	PPM

Australia	Poultry fat	T0.2	PPM

Australia	Poultry meat	0.01	PPM

Canada	Fat of Cattle, Goats, Hogs, Horses and Sheep	5.0	PPM

Canada	Meat byproducts of Cattle, Goats, Hogs, Horses and Sheep	1.0	PPM

Canada	Meat of Cattle, Goats, Hogs, Horses and Sheep	0.2	PPM

Canada	Milk	0.5	PPM

Canada	Milk fat	17	PPM

]>

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