	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 		     WASHINGTON, D.C. 20460

 ADVANCE \d61 	OFF		ICE OF PREVENTION,

OFFICE OF PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM

DATE:		February 13, 2009

SUBJECT:	Preliminary Human Health Assessment for the Registration Review
of Capsaicin

				Registration Review Case #: 4018

				PC Code: 070701

				CAS #: 404-86-4

				Chemical Class: Biochemicals

FROM:		Sadaf Shaukat, Biologist

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

THROUGH:	Angela Gonzales, Biologist

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO:			Chris Pfeifer, Regulatory Action Leader

				Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

ACTION REQUESTED

The following is a preliminary human health assessment for the
biopesticide Capsaicin in support of the development of the Registration
Review Work Plan.

RECOMMENDATIONS AND CONCLUSIONS

Executive Summary

Based on the available data and information, the Agency, in general,
does not foresee the need for new data or for a new human health risk
assessment for capsaicin, with the exception that the Agency is aware of
information regarding the potential mutagenicity of the active
ingredient, of which it will investigate further.  It is important to
note that there is a reasonable certainty of no harm based on what is
known about capsaicin, and although this investigation is not likely to
entail a full risk assessment, the Agency intends on thoroughly
addressing this issue in the Final Report.  All data requirements per 40
CFR 158.2050 have been fulfilled for this active ingredient.  Hazard and
exposure data and information as well as Agency risk assessments on this
chemical were evaluated against current safety standards established by
the Agency’s scientific policies and regulations and it was determined
that there is no need to conduct an additional, full human health risk
assessment, again, with the exception of further research into
capsaicin’s potential for mutagenicity.  The active ingredient is a
naturally-occurring substance, has a non-toxic mode of action (it is a
repellent) and there is a significant history of exposure to humans and
the environment.  Excessive exposure may cause some slight eye and skin
irritation.  Personal protection equipment (PPE) requirements and
sufficient label warnings provide sufficient protection for these
exposures.  All registered end-use products have a low concentration of
capsaicin, ranging from 0.0001% to 4.94%. There is reasonable certainty
that no harm will result to the general population from the products
containing this active ingredient when they are used according to label
instructions.

I. Background

Capsaicin is the active component of chili peppers, plants that belong
to the Capsicum genus.  It is obtained by grinding chili peppers into a
fine powder.

According to some of the product labels containing capsaicin as the
active ingredient, it has the ability to repel certain insects
(including aphids, cabbage loopers, etc.) from plants such as citrus
fruits, and root, bulb, and leafy vegetables.  In addition, it can be
used to repel animals such as deer, elk, rabbits, dogs, cats, and
groundhogs.

Currently, there are thirty-three end-use products that are registered
with BPPD containing this biochemical.  Eighteen products have capsaicin
as the only active ingredient.  The remaining fifteen products are
combination products and the other active ingredients found in them
include allyl isothiocyanate, oil of black pepper, piperidine,
butanethiol, putrescent whole egg solids, and garlic oil.  One of the
registered end-use products (Capsyn Reg No. 43889-1) may be considered
an MP as it is cited as a source of active ingredient in other products.
 However, the label solely indicates that it is an EP.

II. Toxicity Profile

Capsaicin is a commonly consumed food commodity and has a significant
history of exposure to humans.  It has been determined that due to the
nature of this compound, it is unlikely that products containing
capsaicin will have adverse effects on human health.  All toxicology
data requirements have been satisfied and it is unlikely that any
additional data will required, pending the investigation on potential
mutagenicity.  Toxicology data and or rationale to fulfill or waive
these requirements are available on the currently registered EPs; all of
which indicate that these products are of low toxicity.

Available acute toxicity data on the EP’s indicates that all
thirty-three products fall into Toxicity Category III or IV for all
routes of exposure.  According to one study, capsaicin was considered
weakly mutagenic at the highest dose tested.  However, based on the
weight of evidence that capsaicin has a long history of being widely
available in the food supply and there have previously been no accounts
of deleterious mutagenic effects, the Agency has reason to believe that
exposure to capsaicin is not likely to cause mutagenic effects when the
products are used according to label instructions.  Nevertheless, the
Agency will investigate this matter further.

No studies were provided to fill the data requirements for 90-Day Oral
Toxicity/OPPTS 870.3100, Prenatal Development/OPPTS 870.3700, or
Mutagenicity: In vitro Mammalian Cell Assay (mouse lymphoma)/OPPTS
870.5300.  According to the RED, these studies have been waived due to
the long history of use by humans as food additive without any
indication of deleterious health effects.

Based on capsaicin’s physical and chemical properties, it is
considered to be non-persistent in the environment.  It degrades rapidly
in the environment and therefore, human exposure to pesticidal residues
is expected to be minimal.

Based on the information presented above, the Agency does not foresee
the need for new data or for a new human health risk assessment.   There
is reasonable certainty that no harm will result to the general
population from exposure to capsaicin in the products containing this
active ingredient when they are used according to label instructions.
The Agency will investigate the potential for mutagenicity from exposure
to the active ingredient, although there is a reasonable certainty of no
harm based on what the Agency knows about capsaicin.

III. Tolerances

§ 180.1165   Capsaicin; exemption from the requirement of a
tolerance.

Capsaicin is exempt from the requirement of a tolerance in or on all
food commodities when used in accordance with approved label rates and
good agricultural practice.

[63 FR 39521, July 23, 1998]

IV. Incidents

According to the Incident Data System, there have been nine reports of
human-related incidents from use of capsaicin products.

One incident was a human fatality due to the lack of efficacy of a
bear-deterrent product.  Four unspecified incidents were due to the lack
of efficacy of a dog repellent product.  One major incident occurred
with a red pepper spray, however no information was available to
determine the cause.  Two other incidents (one moderate and one minor)
were due to misuse/lack of following label directions.  The last
incident was considered minor and caused minor irritation to throat and
eyes.  Not enough information was provided to determine whether this was
due to misuse or not.  None of these incidents are attributable to
information unknown to the Agency regarding the nature of capsaicin.
Label language on capsaicin products is appropriate and sufficient to
protect users/handlers of these products.

V. References

U.S. EPA RED Fact Sheet for Capsaicin (070701).  Issued June, 1992.

U.S. EPA RED-Capsaicin (070701). Issued June, 1992.

 cc:  S. Shaukat, C. Pfeiffer, BPPD Science Review File

	 S. Shaukat, FT, PY-S: 2/12/09

 PAGE  3


[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Rules and Regulations]
[Pages 44440-44444]
[FR Doc No: 2013-17823]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0419; FRL-9390-2]

Imazosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
imazosulfuron in or on the melon subgroup 9A and the tuberous and corm
subgroup 1C. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective July 24, 2013. Objections and
requests for hearings must be received on or before September 23, 2013,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0419, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. 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 (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2012-0419 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
September 23, 2013. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0419, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8025) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201W., Princeton, NJ 08540. The petition requested
that 40 CFR 180.651 be amended by establishing tolerances for residues
of the herbicide imazosulfuron, (2-chloro-N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl] imidazo-[1,2-a]pyridine-3-sulfonamide), in
or on tuberous and corm vegetables, crop subgroup 1C at 0.02 parts per
million (ppm); and in melon, crop subgroup 9A at 0.02 ppm. That
document referenced a summary of the petition prepared by Valent USA
Corporation, 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
modified the commodity definitions to be consistent with Agency policy.
The reason for these changes is explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 imazosulfuron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with imazosulfuron
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.
    The toxicology data for imazosulfuron suggest that this herbicide
possesses relatively low toxicity. Many of the effects of single or
repeated dosing were observed near or beyond the respective limit
doses.
    The primary target organ of imazosulfuron in repeated-dose studies
was the liver in all species tested. Mild to moderate thyroid effects
were apparent only in the chronic toxicity study in dogs. Dramatic eye
effects (retinal degeneration, lens vascularization, cataracts and
corneal scarring) were observed in rats fed >1,000 mg/kg/day beginning
at 3 months in the chronic toxicity/carcinogenicity study. Ocular
effects (increased incidence of eye opacity, corneal edema,
inflammation and neovascularization) were also observed in the high-
dose males (4,577 mg/kg/day) in the 90-day feeding toxicity study in
rats. Decreased body weight and body weight gain compared to control
were frequent findings throughout the toxicology database for
imazosulfuron.
    Clinical signs (decreased motor activity, abnormal gait, upward
curvature of the spine and piloerection) were observed in males at the
limit dose of the acute neurotoxicity study; however, these effects can
be attributed to generalized toxicity and were resolved by day 2 of the
study. No neurotoxic effects were observed during the subchronic
screening battery or noted as clinical signs in any other repeated-dose
study.
    No developmental effects were observed at the highest dose tested
(HDT) (125 mg/kg/day) in the rabbit developmental toxicity study. No
developmental or reproductive toxicity was observed in the 1-generation
rat study. Decreased pup viability was observed in the rat 2-generation
reproduction study at a dose approaching the limit dose (LOAEL = 892
mg/kg/day) in both the F1 and F2 offspring generations. Mortality was
also observed in the parental generation at this dose. No increased
qualitative or quantitative offspring susceptibility was apparent in
any of the submitted studies for imazosulfuron.
    There was no evidence of carcinogenicity in rats and mice up to the
limit dose at 24 and 18 months, respectively. Imazosulfuron was
determined to be non-mutagenic in bacteria and negative in an in vivo
mammalian cytogenetics assay. Overall, there was no evidence that
imazosulfuron was either mutagenic or clastogenic in either in vivo or
in vitro assays. The cancer classification is ``not likely to be
carcinogenic to humans,'' based on the absence of significant tumor
increases in the carcinogenicity studies.
    Specific information on the studies received and the nature of the
adverse effects caused by imazosulfuron 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 the document titled ``Imazosulfuron: Human
Health Risk Assessment for Proposed Uses on Melon (Crop Subgroup 9A)
and Tuberous and Corm Vegetables (Crop Subgroup 1C),'' pp. 29-33 in
docket ID number EPA-HQ-OPP-2012-0419.

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 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 imazosulfuron used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of December 29, 2010 (75 FR 81878)
(FRL-8857-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to imazosulfuron, EPA considered exposure under the
petitioned-for tolerances as well as all existing imazosulfuron
tolerances in 40 CFR 180.651. EPA assessed dietary exposures from
imazosulfuron 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.
    Such effects were identified for imazosulfuron. In estimating acute
dietary exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA assumed 100 percent crop treated (PCT)
and tolerance-level residues for all registered and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and
tolerance-level residues for all registered and proposed uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that imazosulfuron does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT

information in the dietary assessment for imazosulfuron. Tolerance
level residues and/or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for imazosulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of imazosulfuron. 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 Tier 1 Rice Model and Screening Concentration in
Ground Water (SCI-GROW) models, the estimated drinking water
concentrations (EDWCs) of imazosulfuron for acute exposures are
estimated to be 278.9 parts per billion (ppb) for surface water and 4.8
ppb for ground water and for chronic exposures are estimated to be
278.9 ppb for surface water and 4.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 278.9 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 278.9 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). Imazosulfuron is
currently registered for the following uses that could result in
residential exposures: Residential turfgrass and recreational areas.
EPA assessed residential exposure using the following assumptions:
    Residential handlers may receive short-term dermal and inhalation
exposure to imazosulfuron when mixing, loading, and applying the
pesticide on home lawns. Since a dermal endpoint of concern was not
identified for imazosulfuron, only short-term inhalation exposure of
residential handlers was assessed.
    Post-application inhalation exposure is not expected due to the
nature of pesticide applications to residential lawns. Based on climate
effects (such as rain) and post-application activities (such as lawn
mowing), inhalation exposure to imazosulfuron is expected to be
negligible. Furthermore, imazosulfuron has low acute inhalation
toxicity, low vapor pressure (<3.5 x 10-6 Pa) and a low
proposed use rate (0.3 lb ai/A). Therefore, EPA assessed only short-
term post-application incidental oral exposure of children (toddlers)
based on the following scenarios: Incidental oral exposure from treated
turf via hand-to-mouth activities; incidental oral exposure from
treated turf via object-to-mouth activities; and incidental oral
exposure from treated turf via soil ingestion.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 imazosulfuron to share a common mechanism of
toxicity with any other substances, and imazosulfuron does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
imazosulfuron 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 Web site 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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor 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 following in utero and/or postnatal exposure
in the developmental toxicity studies in rats or rabbits, or in the 2-
generation rat reproduction study. Neither the rat nor rabbit
developmental studies identified developmental effects. The parental
NOAEL is clearly defined, less than or equal to the offspring NOAEL and
based on general systemic toxicity. At near-limit dose, 20%-30%
decreases in numbers of implants/dam, total pups/dam and live pups/dam
on post-natal day (PND) 0, and viability index were observed in
F1 pups of the 2-generation reproductive study in rats.
Similarly, decreased live pups/dam and live births and viability and
lactation indices were noted for F2 pups at doses that
induced parental mortality. The points of departure are protective of
these effects.
    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 imazosulfuron is complete.
    ii. There is no indication that imazosulfuron is a neurotoxic
chemical based on clinical observations of neurotoxicity during the
conduct of developmental or chronic studies. No adverse neurobehavioral
signs were observed at doses approaching the limit dose in any of the
short-term studies (subchronic oral, 21-day dermal). No neurotoxic
effects were observed during the subchronic neurotoxicity screen in
which adverse effects of decreased body weight, body weight gain and
food efficiency were observed at 575 mg/kg/day (LOAEL). The acute
neurotoxicity screen (ACN) yielded a LOAEL at the limit dose for
clinical signs, abnormal gait, decreased activity, piloerection and
upward curvature of the spine and decreased motor activity in males,
all of which were resolved by day 2. No treatment-related effects were
observed in Functional Observational Battery (FOB) parameters, gross
and neurohistopathology, motor activity or brain morphometrics of the
ACN. The weight of evidence demonstrates that imazosulfuron is not a
neurotoxic compound because the clinical findings in the ACN study
occurred only at the limit dose and may be attributed to generalized
toxicity. A developmental neurotoxicity study is not required at this
time.
    iii. As discussed in Unit III.D.2., there is no concern for
increased susceptibility to offspring following pre- and postnatal
exposure to rats or in utero exposure in rabbits.
    iv. There are no residual uncertainties identified in the exposure
databases.

The dietary food exposure assessments were performed based on 100 PCT
and tolerance-level residues. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to imazosulfuron 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 imazosulfuron.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to imazosulfuron will occupy 1.2% of the aPAD for all infants less than
one year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
imazosulfuron from food and water will utilize 2% of the cPAD for all
infants less than one year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
imazosulfuron is not expected.
    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).
    Imazosulfuron is 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 imazosulfuron.
    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 33,000 for adults
and 8,700 for children. Because EPA's level of concern for
imazosulfuron is a MOE of 100 or below, these MOEs are not of concern.
    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).
    An intermediate-term adverse effect was identified; however,
imazosulfuron is not registered for any use patterns that would result
in intermediate-term residential exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for imazosulfuron.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, imazosulfuron is 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 imazosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography method with tandem mass spectroscopy detection (LC/MS/
MS)) is available to enforce the tolerance expression.
    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>; email 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 United Nations
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.
    The Codex has not established any MRLs for imazosulfuron.

C. Revisions to Petitioned-For Tolerances

    The proposed commodity definitions are being modified from ``Melon
crop subgroup 9A'' to ``Melon subgroup 9A'' and ``Tuberous and corm
vegetables crop subgroup 1C'' to ``Vegetable, tuberous and corm,
subgroup 1C'' to be in line with Agency terminology.

V. Conclusion

    Therefore, tolerances are established for residues of
imazosulfuron, (2-chloro-N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl] imidazo-[1,2-a]pyridine-3-sulfonamide), in
or on melon subgroup 9A at 0.02 ppm and vegetable, tuberous and corm,
subgroup 1C at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: July 17, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.651, in paragraph (a), add alphabetically the following
commodities to the table to read as follows:

Sec.  180.651  Imazosulfuron; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Melon subgroup 9A............................................       0.02

                                * * * * *
Vegetable, tuberous and corm, subgroup 1C....................       0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-17823 Filed 7-23-13; 8:45 am]
BILLING CODE 6560-50-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER
(1/1/2007)

EPA Biopesticides and Pollution Prevention Division contact: [insert
name and telephone number with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green and brackets, i.e., “[insert
company name],” with the information specific to your action.

SUBMISSION: E-mail the completed template to<EMAIL_ADDRESS>
TEMPLATE:

AgriVir, LLC

To Be Assigned by EPA

	EPA has received a pesticide petition (To Be Assigned by EPA) from
AgriVir, LLC, 7700 Leesburg Pike, Suite 208, Falls Church, VA 22043
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.

(3)

	1. by establishing a tolerance for residues of

	2. to establish an exemption from the requirement of a tolerance for

	3. to establish an amendment/expansion of an existing tolerance
exemption for the

(1)

	1. microbial pesticide  Indian meal moth granulosis virus

	2. biochemical pesticide [insert name of active ingredient]

	3. plant-pesticide [insert name of active ingredient] in or on [insert
commodity].

	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, AgriVir, LLC
has submitted the following summary of information, data, and arguments
in support of their pesticide petition. This summary was prepared by
AgriVir, LLC and EPA has not fully evaluated the merits of the pesticide
petition. The summary may have been edited by EPA if the terminology
used was unclear, the summary contained extraneous material, or the
summary unintentionally made the reader conclude that the findings
reflected EPA’s position and not the position of the petitioner.

I. AgriVir, LLC  Petition Summary

	[To Be Assigned by EPA]

A. Product Name and Proposed Use Practices

	Indian Meal Moth Granulosis Virus (trade names: BioGuard-V, NutGuard-V,
FruitGuard-V) used for control of Indian meal moth on shelled and
inshell nuts, dried fruits, cereal grains, and other agricultural
commodities susceptible to infestation by Indian meal moth. The U.S.
Environmental Protection Agency has previously registered AgriVir's
microbial pest control product under EPA Reg. No. 733176-1. This is a
biological insecticide intended to control Indian meal moth, a serious
pest of various stored commodities.

The Indian meal moth (or "IMM"), is a serious cosmopolitan pest of many
stored agricultural commodities and processed fractions. Infestation can
occur at any time from harvest to eventual consumption of the commodity.
 IMM is estimated to be responsible, for example, for approximately 90%
of the damage done to dried fruits and nuts in storage.  In facilities
where susceptible commodities are handled, fragments and other debris
from the commodities gets into cracks, crevices, and other places and
IMM propagates on this material. This establishes a general infestation
and reservoir for the Indian meal moth in such facilities.

Control of Indian meal moth by this MPCA is by means of producing an
infection of the insect larvae with Indian meal moth granulosis virus
(IMMGV) such that the larvae stop eating and expire and do not progress
into mature, breeding adults Indian meal moths. The effect of the MPCA
occurs at a point soon after the hatch of Indian meal moth eggs on an
infested commodity such that damage to the commodity (by larvae feeding
on the commodity) is substantially reduced and the larvae generally do
not progress to a point of development where they are readily visible to
the untrained observer.  The IMMGV component of this MPCA is a naturally
occurring isolate of the Indian Meal Moth Granulosis Virus.  It has not
been genetically modified.

IMMGV has no hosts other than larvae of the Indian meal moth and acts by
making the Indian meal moth larvae sick, rather than by a toxic
mechanism (i.e., IMMGV does not produce any specific toxin which kills
the larvae).  Indian meal moth larvae succumb to granulosis disease due
to serious damage to one of their major organs for storage of nutrients.

The MPCA is prepared without isolation of IMMGV and, as such, the MPCA
which is the subject of the present petition consists, therefore, of a
homogenate of IMMGV occlusion bodies ("viral particles"), infected
Indian meal moth larval parts, heat sterilized wheat bran, brewer's
yeast, and vitamins and antioxidants (these latter two less than 0.6%
total of the product).

The maximum label rate for the MPCA is 5 ozs. / ton of commodity (142 g
MPCA / 1087 Kg commodity).

The purpose of the present petition is to clarify the nature of the MPCA
under the existing Tolerance Exemption at 40 CFR 180.1218.  This
currently reads:

An exemption from the requirement of a tolerance is established for
residues of the microbial pesticide Indian Meal Moth Granulosis Virus
when used in or on all food commodities.

The present petition seeks to amend the above, existing Tolerance
Exemption so as to read as follows:

An exemption from the requirement of a tolerance is established for
residues of the microbial pesticide Indian Meal Moth Granulosis Virus
(Indian meal moth Granulosis virus infected Indian meal moth larval
parts homogenized with heat treated wheat bran and brewer’s yeast
by-products) when used in or on all food commodities.

This proposed amended description of the MPCA is believed to be more
accurate as it correctly represents all significant components of the
residues which may result from use of Indian meal moth granulosis virus
product on food commodities.

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. The pesticide
which is the subject of this petition is Indian meal moth granulosis
virus which is prepared as below summarized:

Indian meal moth eggs are seeded onto a solid diet mixture composed of
heat treated (sterilized) wheat bran, brewers yeast, and trace amounts
of vitamins required for proper larval growth.

The eggs are allowed to hatch and develop into Indian meal moth larva.

These larvae are infected with Indian meal moth Granulosis virus
(sourced from a prior batch) and the infection is allowed to propagate
to fullness.

Water to form a slurry and this is homogenized.

The homogenized slurry is dried to yield dry solids.

The dried solids are cold milled to produce a final MPCA product which
is a fine, wettable powder.

As can be understood from the production process the final MPCA is an
inseparable homogenate of infected insect larval parts, heat treated
wheat bran, and broken yeast cells and yeast byproducts. There are no
intentionally added inert ingredients in the MPCA.   The residues
present on treated food commodities will be residues of this homogenized
powdered MPCA.

	2. Magnitude of residues at the time of harvest and method used to
determine the residue.

The maximum label rate for the MPCA is 5 ozs. / ton of commodity (142 g
MPCA / 1087 Kg commodity).  If no residues of the MPCA are lost by
further processing or handling of the treated commodity the worst case
theoretical residues of MPCA are:

0.142 Kg / 1087 Kg  =   0.00013 Kg/Kg   =   0.013 %  =  130 ppm

Because the maximum theoretical residues are very low and the MPCA has
no significant toxicological effects potential (see below for mammalian
toxicology profile) no method for residue analysis is used or proposed.
This is consistent with use of this MPCA under a Tolerance Exemption.

	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. This product already
has an existing Tolerance Exemption (at 40 CFR 180.1218) for use on all
food commodities. Because the maximum theoretical residues are very low
and the MPCA has no significant toxicological effects potential (see
below for mammalian toxicology profile) no method for residue analysis
is used or proposed. This is consistent with use of this MPCA under a
Tolerance Exemption.

C. Mammalian Toxicological Profile

	The mode of action for IMMGV in its host, the larval stage of P.
interpunctella, is pathogenic in nature.  IMMGV produces granulosis
disease in the larvae of P. interpunctella.  "Granulosis" disease is so
named because cells in infected tissue sections, when observed under
light microscopy, are full of minute, refractile bodies termed
"granules".  The initial signs of granulosis disease occur several days
after larval ingestion of the viral occlusion bodies and consist of
sluggishness and loss of appetite.  These initial signs are followed by
a change in the appearance of the larvae.  They are normally light brown
and semilucent but when infected become opaque and white. This change is
the result of the massive accumulation of viral occlusion bodies in the
fat body of the infected larva. The fat body is the site of intermediary
metabolism in these larvae and it is in the fat body that fat, protein,
and glycogen are primarily stored. The pathogenicity of IMMGV to the
larva results from the mode of viral release from cells of the fat body.
 As discussed above, this occurs by rupture of the cells of the fat
body, thereby leading to degeneration and necrosis of the fat body and,
ultimately, death of the infected larva.

The above-cited mode of action is distinct from a toxicity based mode of
action. That is, unlike some microbial pest control agents which produce
endo- or exo-toxins which act to kill the target pest, IMMGV produces no
toxins as part of its mode of action.

Hazard Potential to Mammals:

IMMGV poses no hazard potential to mammals via ingestion, dermal
contact, or inhalation. There is no baculovirus (the type of virus which
IMMGV is) known to infect or replicate in any vertebrate host. Among
invertebrates, IMMGV itself has no known host other than larvae of P.
interpunctella and has been shown not to cross-infect lepidopteran or
other insects other than P. interpunctella.

A number of studies on the toxicity of baculoviruses, inclusive of
granulosis viruses, to animals have shown that these agents are
non-toxic by the oral, dermal, inhalation and injection routes of
exposure and that no effects on overall health, gross or micro
pathology, hematology, clinical chemistry, and antibody stimulation
occur in test animals. These studies have been published in the open
literature and were submitted as part of AgriVir, LLC's original
application for registration of this MPCA.

Cell culture studies (submitted by AgriVir as part of its original
registration submission) have shown that IMMGV which is actively
infective and pathogenic to IMM larva does not produce cytotoxicity nor
does it replicate in or produce pathogenicity in the following mammalian
cell lines:

WI-38 (ATTC CCL 75: human lung [embryonic])

WS1 (ATTC CRL 1502: human endothelium [embryonic skin])

CV-1 (ATTC CCL 70: African green monkey,  renal)

These cell culture studies further support the already established fact
that IMMGV poses no hazard to mammals.

	Due to the physical properties of the final product (a fine, dry
powder) the technical MPCA does have a mild to moderate, reversible eye
irritation potential.

Hazard Potential to the Environment:

The only potential environmental effect of IMMGV is on the population of
Indian meal moths. This is because, as discussed above, IMMGV has no
hosts other than larvae of the Indian meal moth and acts by a
pathogenicity mechanism rather than a toxicity mechanism (i.e., IMMGV
does produce any specific toxin).  Since IMMGV is a naturally occurring
virus which has naturally infected Indian meal moth larvae for at least
decades and probably longer, its use on Indian meal moth larvae which
may infest dried fruits and nuts and other stored commodities cannot
reasonably be expected to endanger the Indian meal moth population as a
whole.

Therefore, there are no reasonably anticipated or likely environmental
effects of use of IMMGV for protection of agricultural commodities from
Indian meal moth damage.

Hazard Potential to Non-Target Species:

There is no hazard potential to non-target species. As above-noted,
there is no baculovirus known to infect or replicate in any vertebrate
host. Among invertebrates, IMMGV itself has no known host other than
larvae of P. interpunctella and has been shown not to cross-infect
lepidopteran or other insects other than P. interpunctella.

D. Aggregate Exposure

	1. Dietary exposure. [Insert text.]

	i. Food. -- The levels of residues in treated commodities will be very
low. The application rates for this MPCA are from 1 to 5 ounces of  MPCA
per ton of commodity to be treated.  The theoretical maximum residue
would be 130 ppm. Therefore, dietary exposure is insignificant.

	ii. Drinking water. The proposed use patterns for this MPCA are for
Indoor Food and Non-Food uses. Therefore, there is no potential for
drinking water exposure associated with the approval of this petition.

	2. Non-dietary exposure. This MPCA  only has any pest control utility
in the treatment of various commodities for control of Indian meal moth.
Therefore, the only potential for non-dietary exposure is to applicators
and to mixer/loaders who will use this MPCA. These non-dietary exposures
are not covered within FQPA and they are expected to be low. Information
already in EPA's data bases which has been previously cited by AgriVir,
LLC indicates that workers involved with baculovirus production and use
do not experience adverse effects as a result of these exposures.

E. Cumulative Effects

	Due to its mechanism of action and extremely limited host specificity,
it can be reliably stated that this MPCA does not share a common
mechanism of action with any other conventional, biochemical, or
microbial pesticide.

F. Safety Determination

	1. U.S. population. Available information reliably supports that the
IMMGV in this MPCA will not produce adverse effects in humans of any age
as a result of exposure by ingestion, dermal contact, or inhalation and
– indeed – that IMMGV appears to be biologically inactive in other
than its natural host. This MPCA does contain heat treated wheat bran
which is derived from its use as a component of the larval diet for
preparing the MPCA. Wheat bran may contain wheat gluten and some
individuals are intolerant to wheat gluten (a condition known as
“celiac disease”). In such individuals the consumption of sufficient
amounts of gluten causes gastro-intestinal symptoms which are
uncomfortable and may be intensely so. Persons with celiac disease are
normally advised to avoid foods containing gluten in any significant
quantity.  Food labeling regulations in most of the world provide for a
standard as to what constitutes foods which can be labeled “gluten
free” such that persons with gluten intolerance can identify and
select such foods. Consumption of “gluten free” foods prevents onset
of the symptoms of gluten intolerance in persons who are gluten
intolerant.  In the United States, the Food and Drug Administration has
proposed that “gluten free” foods contain less than 20 ppm gluten
derived from components in such foods which may originally carry some
gluten and have been treated / processed to reduce or remove gluten. The
wheat bran used in preparation of the this IMMGV-containing MPCA is heat
sterilized prior to its use in MPCA production.  This destroys
micro-organisms which might otherwise contaminate the larval culture and
also denatures gluten which may be present in the wheat bran (wheat bran
being a fraction of wheat which is normally quite low in gluten anyway).
 Tests for gluten in the heat sterilized wheat bran show no detectable
gluten by method IS-1009-1979 (LOD 40 ppm) and the test report is
provided in the present petition to amend this tolerance exemption.  As
calculated in the present petition the theoretical maximum level of
gluten possible present in treated commodities and foods would be 0.005
ppm (5 ppb). This is calculated on the assumption that gluten is present
in the heat sterilized wheat bran at the 40 ppm limit of detection and
that the MPCA is applied at the maximum label rate.  This theoretical
maximum gluten residue is 4,000-times lower than the Food and Drug
Administration’s limit for gluten free foods of 20 ppm.  AgriVir, LLC
concludes therefore, that there is a reasonable certainty that no harm
to sensitive persons, including persons intolerant to gluten, will
result from dietary exposure to residues which could occur as a result
of approval of this petition.

Since the available information reliably supports that the IMMGV in this
MPCA will not produce adverse effects in humans of any age as a result
of exposure by ingestion, dermal contact, or inhalation and that the
other major components of this MPCA are themselves food substances and
dietary supplements, AgriVir, LLC concludes that there is a reasonable
certainty that no harm to the general adult population will result from
dietary exposure to residues which could occur as a result of approval
of this petition.

	2. Infants and children. The available information reliably supports
that this MPCA will not produce adverse effects in humans of any age,
including infants and children and that the other major components of
this MPCA are themselves food substances and dietary supplements. The
potential for adverse effects on persons, including infants and
children, who are sensitive to gluten was discussed above and it is
clear that use of Indian meal moth granulosis product on food
commodities will meet presently proposed FDA standards for gluten free
foods.  These conclusions apply for exposure to this product by
ingestion, dermal contact, or inhalation,  Accordingly, AgriVir, LLC
concludes that there is a reasonable certainty that no harm to infants
and children will result from dietary exposure to residues which could
occur as a result of approval of this petition.

G. Effects on the Immune and Endocrine Systems

	There is no reliable information to indicate that IMMGV has a potential
to produce endocrine effects.  The available studies suggest that IMMGV
is essentially biologically inactive in any organism other than its
natural host, the larva of the Indian meal moth.

H. Existing Tolerances

§ 180.1218 Indian Meal Moth Granulosis Virus; exemption from

the requirement of a tolerance.

An exemption from the requirement of a tolerance is established for
residues of the microbial pesticide Indian Meal Moth Granulosis Virus
when used in or on all food commodities.

I. International Tolerances

	There are no Codex maximum residue levels [MRLsl established for
residues of IMMGV or of this whole MPCA. IMMGV containing products are
presently not registered for pest control outside of the U.S..

 PAGE

 PAGE   9


[Federal Register Volume 76, Number 114 (Tuesday, June 14, 2011)]
[Notices]
[Pages 34691-34692]
[FR Doc No: 2011-14632]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-43-000]

Edison Mission Energy v. Midwest Independent Transmission System
Operator, Inc.; Notice of Complaint

    Take notice that on June 3, 2011, pursuant to section 206 of the
Federal Power Act, 16 U.S.C. 824e (2006) and Rule 206 of the Rules of
Practice and Procedure of the Federal Energy Regulatory Commission
(Commission), 18 CFR 385.206 (2011), Edison Mission Energy, on behalf
of NorthStar and Pheasant Ridge wind projects (Edison Wind Projects)
(collectively Complainants), filed a complaint against the Midwest
Independent Transmission System Operator, Inc. (Midwest ISO or
Respondent), alleging that Midwest ISO is requiring the Edison Wind
Projects to satisfy the M3 milestone in contravention of the Midwest
ISO's Tariff and the Commission's Order issued on August 25, 2008 in
Docket ER08-1169-000.\1\
---------------------------------------------------------------------------

    \1\ Midwest Independent Transmission System Operator, Inc., 124
FERC ] 61,183 (2008).
---------------------------------------------------------------------------

    Complainant certifies that copies of the complaint were served on
the contacts for the Midwest ISO as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for

review in the Commission's Public Reference Room in Washington, DC.
There is an ``eSubscription'' link on the Web site that enables
subscribers to receive e-mail notification when a document is added to
a subscribed docket(s). For assistance with any FERC Online service,
please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll
free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 17, 2011.

    Dated: June 7, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-14632 Filed 6-13-11; 8:45 am]
BILLING CODE 6717-01-P