[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Rules and Regulations]
[Page 60321-60327]
[DOCID:fr30se10-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0616; FRL-8844-1]

Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises tolerances for residues of spinosad in
or on hog, fat; hog, meat; hog, meat byproducts; poultry meat
byproducts. Elanco Animal Health (A Division of Eli Lilly & Company)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective September 30, 2010. Objections and
requests for hearings must be received on or before November 29, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0616. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

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:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0616 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 29, 2010. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2

may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0616, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 26, 2009 (74 FR 55003) (FRL-
8794-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9F7543) by Elanco Animal Health (A Division of Eli Lilly & Company),
2001 West Main Street, Greenfield, IN 46140. The petition requested
that 40 CFR 180.495 be amended by reducing established tolerances for
residues of the insecticide spinosad, a fermentation product of
Saccharopolyspora spinosa, which consists of two related active
ingredients: Spinosyn A (Factor A: CAS No. 131929-60-7) or 2-[(6-deoxy-
2,3,4-tri-O-methyl-a-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-a-L-manno-
pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-
yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-
4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on
milk from 7 parts per million (ppm) to 5 ppm; milk, fat from 80 ppm to
40 ppm; cattle, goat, and sheep, fat from 50 ppm to 30 ppm; hog, meat
from 1.5 ppm to 0.2 ppm; hog, meat byproducts from 8 ppm to 0.6 ppm;
and hog, fat from 33 ppm to 2.0 ppm. The petition additionally
requested increases in the existing tolerances for residues of spinosad
in or on poultry meat byproducts from 0.1 ppm to 0.2 ppm and poultry,
fat from 1.3 ppm to 1.5 ppm. That notice referenced a summary of the
petition prepared by Elanco Animal Health, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
concluded that revision of the proposed tolerances in or on hog, fat
from 2.0 ppm to 5.0 ppm; hog, meat from 0.2 ppm to 0.50 ppm; hog, meat
byproducts from 0.6 ppm to 2.0 ppm; poultry, meat byproducts from 0.10
ppm to 0.20 ppm is necessary and revision of the currently-established
ruminant fat (i.e., cattle, goat, and sheep) and poultry, fat
tolerances, as proposed by Elanco Animal Health in the petition, is
unnecessary. The reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for spinosad including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spinosad
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Spinosad has low acute toxicity via the oral and dermal
routes of exposure. It is not a dermal sensitizer, nor inhalation,
primary eye, or primary skin irritant. In subchronic toxicity studies
conducted in mice treatment-related findings included vacuolation of
cells of the lymphoid organs, liver, kidney, stomach, female
reproductive tract, and epididymis, and less severely in the heart,
lung, pancreas, adrenal cortex, bone marrow, tongue, pituitary gland,
and anemia. In rats, thyroid follicle epithelial cell vacuolation,
anemia, multifocal hepatocellular granuloma, cardiomyopathy, and
splenic histiocytosis were observed following subchronic exposure, in
dogs microscopic changes in a variety of tissues, anemia, and possible
liver damage were seen with short-term repeated dosing. In a chronic
feeding study in dogs, increases in serum alanine aminotransferase,
aspartate aminotransferase, and triglycerides levels, and the presence
of tissue abnormalities, including vacuolated cell aggregations,
arteritis, and glandular cell vacuolation (parathyroid) were seen.
Vacuolation of thyroid follicular cells, increased absolute and
relative thyroid weights were observed in a chronic oral toxicity study
in rats. Spinosad is classified as ``not likely to be carcinogenic to
humans'' based on lack of evidence for carcinogenicity of spinosad in
mice and rats. No neurotoxic effects were seen in the acute or
subchronic neurotoxicity study in rats. In developmental toxicity
studies, there is no evidence of increased susceptibility following in
utero exposures in rats and rabbits. In the 2-generation reproduction
study, no adverse effects were observed on the offspring at dose levels
that produced parental toxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by spinosad as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Spinosad and Spinetoram. Human-Health
Risk Assessment for Direct-Spray

Use on Poultry and Discontinuation by Voluntary Cancellation of the
Cattle Pour-On and Direct Cattle Spray Registrations,'' p. 12 in docket
ID number EPA-HQ-OPP-2009-0616.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction
with the POD to calculate a safe exposure level - generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD) - and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://
www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spinosad used for
human risk assessment can be found at http://www.regulations.gov in
document ``Spinosad and Spinetoram. Human-Health Risk Assessment for
Direct-Spray Use on Poultry and Discontinuation by Voluntary
Cancellation of the Cattle Pour-On and Direct Cattle Spray
Registrations,'' p. 5 in docket ID number EPA-HQ-OPP-2009-0616.
    The Agency has concluded that spinosad should be considered
toxicologically identical to another pesticide, spinetoram. This
conclusion is based on the following: Spinetoram and spinosad are large
molecules with nearly identical structures; and 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. Although, as just stated, the
doses and endpoints for spinosad and spinetoram are similar, they are
not identical due to variations in dosing levels used in the spinetoram
and spinosad toxicological studies. EPA compared the spinosad and
spinetoram doses and endpoints for each exposure scenario and selected
the lower of the two doses for use in human risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spinosad/spinetoram, EPA considered exposure under the
petitioned-for tolerances as well as all existing spinosad/spinetoram
tolerances in 40 CFR 180.495 and 180.635. EPA assessed dietary
exposures from spinosad in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
spinosad; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey
of Food Intake by Individuals (CSFII). As to residue levels in food,
the chronic analysis assumed 100 percent crop treated (PCT) for all
food crop commodities excluding those listed below where PCT estimates
were incorporated to refine the livestock dietary burden estimates;
used average field-trial residues for apple, Brassica leafy vegetables,
citrus, fruiting vegetables, herbs, banana, grape, several cereal
grains, and strawberry; used tolerance-level residues for the remaining
food crop commodities; and used Dietary Exposure Evaluation Model
DEEM(\TM\) (ver. 7.81) default processing factors for all commodities
excluding orange juice, field corn (meal, starch, flour, and oil),
grape juice, and wheat (flour and germ) where the results from
processing factors were assumed; and modeled drinking water estimates.
Tolerance level hog and poultry residues were assumed while the
ruminant residue estimates were refined through the incorporation of
average residues from the feeding/dermal magnitude of the residue
studies and incorporation of the following projected combined spinosad/
spinetoram PCT estimates to refine the ruminant dietary burden: Leaves
of root and tuber vegetables - 50%; grain sorghum grain - 5%; soybean
seed - 5%; and sweet corn forage - 39%.
    Spinosad is registered for application to all of the same crops as
spinetoram, with similar pre-harvest and retreatment intervals, and
application rates greater than or equal to spinetoram. Further, both
products control the same pest species. For this reason, EPA concluded
it would overstate exposure to assume that residues of both spinosad
and spinetoram would appear on the same food. Rather, EPA aggregated
exposure by either assuming that all commodities contain spinosad
residues (because side-by-side spinetoram and spinosad 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.
    iii. Cancer. Based on the lack of evidence of carcinogenicity in
rats and mice, EPA has classified spinosad as ``not likely to be
carcinogenic to humans;'' therefore a quantitative exposure assessment
to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate

does not understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    Tolerance level hog and poultry residues were assumed while the
ruminant residue estimates were refined through the incorporation of
average residues from the feeding/dermal magnitude of the residue
studies and incorporation of the following projected combined spinosad/
spinetoram PCT estimates to refine the ruminant dietary burden uses as
follows: 39% sweet corn forage; 50% leaves of root and tuber
vegetables; 5% sorghum grain; and 5% soybean seed meal.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (USDA/NASS), proprietary market
surveys, and the National Pesticide Use Database for the chemical/crop
combination for the most recent 6-7 years. EPA uses an average PCT for
chronic dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than one. In those cases, 1% is used as the average PCT and 2.5%
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the highest observed maximum
value reported within the recent 6 years of available public and
private market survey data for the existing use and rounded up to the
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which spinosad may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spinosad in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of spinosad. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of spinosad/spinetoram
for acute exposures are estimated to be 14.419 parts per billion (ppb)
for surface water and 0.072 ppb for ground water. For chronic exposures
for non-cancer assessments are estimated to be 6.171 ppb for surface
water and 0.072 ppb for ground water. EDWCs for spinosad for acute
exposures are estimated to be 34.5 parts per billion (ppb) for surface
water and 1.1 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 10.5 ppb for surface water and
1.1 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 10.5 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Spinosad is currently registered for the following uses that could
result in residential exposures: Application to turfgrass and
ornamentals. EPA assessed residential exposure using the following
assumptions: The Agency has concluded that spinosad and spinetoram are
toxicologically equivalent; therefore, residential exposure to both
spinosad and spinetoram was evaluated. Spinosad is currently registered
for homeowner application to turf grass and ornamentals. Spinetoram is
registered for homeowner applications to gardens, lawns/ornamentals and
turf grass. Since spinosad and spinetoram control the same pests, EPA
concludes that these products will not be used for the same uses in
combination with each other and thus combining spinosad and spinetoram
residential exposures would overstate exposure.
    There is potential for residential handler and post-application
exposures to both spinosad and spinetoram. However, since no dermal
endpoints for either spinetoram or spinosad were identified, only
short-term incidental oral exposures to toddlers are anticipated from
the registered turf and ornamental application scenarios for spinosad
and spinetoram and short-term inhalation exposure to handler/
applicators is anticipated for the registered home garden, turf, and
ornamental application scenarios.
    Based on the low application rates, granular formulation, and/or
low vapor pressure, quantitative residential inhalation post-
application exposure assessments were not performed for spinosad or
spinetoram. The Agency notes that the spinetoram residential-handler
inhalation MOEs were >=4,300,000 for house garden, home lawns and
ornamental use; based on this and the low vapor pressure for spinosad,
the Agency anticipates the post-application residential inhalation
risks to be negligible.
     EPA notes that for spinosad the registered fruit fly bait
application scenario permits application to non-crop vegetation and
this use may result in residential exposures. Based on the application
rates (fruit fly bait - 0.0003 pounds active ingredients/acre (lb ai/
acre); turf/ornamental - 0.41 lbs ai/acre), EPA concludes that
residential exposure resulting from the fruit fly application will be
insignificant when compared to the exposure resulting from homeowner
uses on the turf/ornamentals. Therefore, quantitative analysis of the
residential exposure resulting from the fruit fly bait application was
not performed. Further information regarding EPA standard assumptions
and generic inputs for residential exposures may be found at http://
www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular

pesticide's residues and ``other substances that have a common
mechanism of toxicity.''
     EPA has not found spinosad/spinetoram to share a common mechanism
of toxicity with any other substances, and spinosad/spinetoram does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
spinosad/spinetoram does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) SF. In applying this provision, EPA either
retains the default value of 10X, or uses a different additional SF
when reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat and rabbit fetuses to in-utero exposure
to spinosad or spinetoram. In the spinosad and spinetoram rat and
rabbit developmental toxicity studies, no developmental toxicity was
observed at dose levels that did not induce maternal toxicity. In the
spinosad 2-generation reproduction studies, maternal and offspring
toxicity were equally severe, indicating no evidence of increased
susceptibility. In the spinetoram 2-generation reproduction study, no
adverse effects were observed on the offspring at dose levels that
produced parental toxicity. Therefore, there is no evidence of
increased susceptibility and there are no concerns or residual
uncertainties for pre-natal and/or post-natal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for spinetoram is complete, except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Harmonized Test Guideline 870.7800)
required for pesticide registration; however, the existing data are
sufficient for endpoint selection for exposure/risk assessment
scenarios, and for valuation of the requirements under the FQPA.
    There was some evidence of adverse effects on the organs of the
immune system at the LOAEL in three short-term studies with spinosad or
spinetoram. In these studies, anemia was observed in multiple species
(rats, mice and dogs) with the presence of histiocytic aggregates of
macrophages in various organs and tissues (lymph nodes, spleen, thymus,
and bone marrow). Aggregation of macrophages was indicative of immune
stimulation in response to insults of the chemical exposure and was
considered secondary effects of the toxic effect to the hematopoetic
system. Therefore, these effects are not considered to be indicative of
frank immunotoxicity. In the chronic study with dogs, areteritis and
necrosis of the areterial walls of the thymus was seen in one female
dog at the highest dose tested (HDT). This finding is attributed to the
exacerbation of the spontaneous arteritis present in genetically
predisposed Beagle dogs (``Beagle Pain Syndrome''), not immunotoxicity.
Further, a clear NOAEL was attained in each of these studies, and the
observed histopathologies were generally observed in the presence of
other organ toxicity. In addition, spinosad and spinetoram do not
belong to a class of chemicals (e.g., the organotins, heavy metals, or
halogenated aromatic hydrocarbons) that would be expected to be
immunotoxic.
    Based on the considerations in this Unit, EPA does not believe that
conducting a special series 870.7800 immunotoxicity study will result
in a POD less than the NOAEL of 2.49 mg/kg/day already set for spinosad
and spinetoram. Consequently, an additional database UF does not need
to be applied.
    ii. There is no indication that spinosad is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that spinosad results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments utilized 100 PCT and
tolerance-level residues, and DEEM\TM\ default processing factors for
all registered and proposed crop commodities and all food commodities
from livestock except commodities from ruminants. EPA used PCT
information when calculating livestock dietary burdens for ruminants
from sweet corn forage, leaves of root and tuber vegetables, sorghum
grain, and soybean seed meal. EPA believes that the PCT estimates used
are conservative estimates. EPA made conservative (protective)
assumptions in the ground water and surface water modeling used to
assess exposure to spinosad/spinetoram in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
spinosad/spinetoram.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spinosad is not expected to pose an acute risk.
    2. Chronic risk. Since there are no registered/proposed uses which
result in chronic residential exposures, the chronic aggregate exposure
assessment consists of exposure from food and water. Using the exposure
assumptions described in this unit for chronic exposure, EPA has
concluded that chronic exposure to spinosad and spinetoram from food
and water will utilize 94% of the cPAD for children 1-2 years old the
population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water

(considered to be a background exposure level).
    Spinosad and spinetoram are currently registered for uses that
could result in short-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to spinosad and
spinetoram.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of >=160 for all
population subgroups. As the aggregate MOEs are greater than 100 for
all population subgroups, including infants and children, short-term
aggregate exposure to spinosad and spinetoram is not of concern to EPA.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Spinosad and spinetoram are not registered for any use patterns
that would result in intermediate-term residential exposure. Therefore,
the intermediate-term aggregate risk is the sum of the risk from the
exposure to spinosad and spinetoram through food and water, which has
already been addressed, and will not be greater than the chronic
aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in rats and mice at doses that were judged
to be adequate to assess the carcinogenic potential, spinosad and
spinetoram were classified as ``not likely to be carcinogenic to
humans,'' and are not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spinosad and spinetoram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for enforcement of the ruminant and
hog tolerances. Method RES 94094 (GRM 95.03; ruminant and hog); Method
RES 95114 (ruminant and hog); GRM 95.15 (poultry). Data pertaining to
Multiresidue Methods (MRMs) testing of spinosyns A, D, B, and K and N-
demethyl spinosyn D were forwarded to the Food and Drug Administration
(FDA) for review.
     The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    Codex does have a MRLs for combined residues of spinosyn A and D
in/on fat from mammals other than marine at 2 ppm and edible offal at
0.5 ppm and Canada does have MRLs for residues of spinosyn A and D in/
on hog fat at 5.0 ppm, hog meat byproducts at 1.0 ppm, and hog meat at
0.2 ppm. For the most part, these international tolerances are lower
than the level of the hog tolerances being established today. The Codex
values were set in 2004. At that time only the diets of cattle (beef
and dairy) were considered in establishing the MRLs, which were then
considered adequate for all mammals, including hogs. However, the
United States calculates hog exposure based on specific diets for
finishing and breeder hogs. These diets are high in grains and grain
byproducts and would not have included forages and other commodities
present in the cattle diet. The diets considered were different,
leading to different calculated exposures, leading to different MRL/
tolerance estimates for the hog commodities. Accordingly, given the
manner in which the Codex values were chosen, EPA does not believe it
is appropriate to harmonize with the Codex levels.

C. Revisions to Petitioned-For Tolerances

    Elanco Animal Health requested registration for direct spray of
Elector PSP (EPA Reg. No. 72642-2) to poultry and discontinuation by
voluntary cancellation of the cattle pour-on and direct cattle spray
registrations for Elector Insect Control Product (EPA Reg. No. 72642-
1). The petitioner also requested an increase in the currently-
established poultry fat (1.3 ppm to 1.5 ppm), poultry meat (0.10 ppm to
0.2 ppm), and poultry meat byproducts (0.10 ppm to 0.2 ppm) tolerances
and a decrease in the currently-established milk (7.0 ppm to 5 ppm),
milk fat (85 ppm to 40 ppm), hog fat (33 ppm to 2.0 ppm), hog meat (1.5
ppm to 0.2 ppm), hog meat byproducts (8.0 ppm to 0.6 ppm), and ruminant
fat (cattle, goat, and sheep - 50 ppm to 30 ppm) tolerances (tolerances
for combined residues of spinosyns A and D).
    With the elimination of cattle pour-on and direct cattle spray
uses, ruminants may be exposed to spinosad via consumption of treated
feed, premise application, and through the feed-through (cattle only)
and ear tag uses (cattle only). Based on the elimination of the cattle
dermal application scenario and a recalculation of spinosad residues in
ruminant commodities from the consumption of treated feed, the
petitioner requested a reduction in the milk, milk fat, and ruminant
(cattle, goat, and sheep) fat tolerances. Based on a comparison of the
estimated total residue without the dermal/premise application and the
currently-established tolerances, the EPA concludes that revision of
the currently-established ruminant tolerances is unnecessary. Since
elimination of the dermal uses does not necessitate a change in the
current ruminant tolerances, the EPA concludes that residues resulting
from premise treated are insignificant when compared to the residue
estimates from the other routes of exposure.
    The petitioner requested a reduction in the hog fat, meat, and meat
byproducts tolerances. The current hog tolerances were established as
part of the registration for application of spinosad to stored grains
where a hog dietary burden of 41.2 ppm was calculated. As a
conservative surrogate for residues following premise treatment, the
results from the cattle dermal magnitude of the residue study were used
(residue data following only premise treatment are not available). EPA
notes that hogs have a significantly lower maximum reasonably balanced
dietary burden (MRDB) than ruminants and the residues resulting from
the premise treatment were therefore considered when establishing a
tolerance (this is on contrast to ruminants where residues resulting
from premise treatment were not

considered). Based on these calculations, the EPA concludes that hog
tolerance should be lowered as follows: Hog, meat - 0.50 ppm; hog, fat
- 5.0 ppm; and hog, meat byproducts - 2.0 ppm.
    As part of the current request, the petitioner submitted a poultry
magnitude of the residue study monitoring spinosad residues following
both the proposed dermal application scenario (0.9x) and the currently-
registered premise treatment (1x). Based on these data and the current
poultry MRDB, the EPA concludes that the poultry meat byproducts
tolerance should be increased to 0.20 ppm (tolerance for the combined
residues of spinosyns A and D). All other poultry tolerances remain
adequate.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad in
or on poultry at 0.20 ppm poultry, meat byproducts; and tolerances are
increased as indicated for the following established commodities: Hog,
fat 5.0 ppm; hog, meat 0.50 ppm; hog, meat byproducts 2.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 24, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.495 is amended by revising the following entries in the
table in paragraph (a) to read as follows:

Sec.  180.495  Spinosad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Hog, fat.............................................                5.0
Hog, meat byproducts.................................                2.0
Hog, meat............................................               0.50
                                * * * * *
Poultry, meat byproducts.............................               0.20
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-24573 Filed 9-29-10; 8:45 am]
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[Federal Register: February 22, 2010 (Volume 75, Number 34)]
[Notices]
[Page 7591-7592]
[DOCID:fr22fe10-49]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-SFUND-2009-0907; FRL-9114-6]
RIN 2050-ZA05

Guidance on Recommended Interim Preliminary Remediation Goals for
Dioxin in Soil at CERCLA and RCRA Sites; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: In response to requests from the public, the Environmental
Protection Agency (EPA) is providing an additional 35 days for the
public to provide its comments on the draft recommended interim
preliminary remediation goals (PRGs) developed in the draft Guidance on
Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) and Resource Conservation and Recovery Act (RCRA) Sites. In
EPA's initial notice, which was published in the Federal Register on
January 7, 2010 (75 FR 984), the deadline for the public to provide its
comments was February 26, 2010. The purpose of this notice is to
provide additional time until April 2, 2010.

DATES: Comments must be received on or before April 2, 2010.

ADDRESSES: Provide your comments, identified by Docket ID No. EPA-HQ-
SFUND-2009-0907, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting your views.
     E-mail<EMAIL_ADDRESS>In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the

Docket without going through EPA's electronic public docket, EPA's e-
mail system automatically captures your e-mail address. E-mail
addresses that are automatically captured by EPA's e-mail system are
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.
     Fax:<PHONE_NUMBER>.
     Mail: EPA Docket Center, Environmental Protection Agency,
Mail Code: 5305T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
Please include a total of two copies.
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA
West Building, 1301 Constitution Avenue, NW., Washington, DC 20460,
Attention Docket ID No. EPA-HQ-SFUND-2009-0907. Deliveries are only
accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. Special arrangements should be made for deliveries of
boxed information. Please include a total of two copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
2009-0907. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected by statute through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA, without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: This Federal Register notice and supporting documentation
are available in a docket EPA has established under Docket ID No. EPA-
HQ-SFUND-2009-0907. All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OSWER Docket, EPA
West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OSWER
docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Marlene Berg, Office of Superfund
Remediation and Technology Innovation, 1200 Pennsylvania Avenue, NW.,
Mail Code: 5204P, Washington, DC 20460; by telephone/voicemail at (703)
603-8701; Fax:<PHONE_NUMBER>; or via e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA is extending the deadline for interested
parties to submit their comments by 35 days in response to a request
from the American Chemistry Council's Chlorine Council for more time to
submit comments on the draft recommended interim PRGs. The initial
deadline published in the Federal Register on January 7, 2010 (75 FR
984), was for 50 days. Therefore, the new deadline will now be April 2,
2010.

    Dated: February 12, 2010.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.
[FR Doc. 2010-3368 Filed 2-19-10; 8:45 am]
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