[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Rules and Regulations]
[Page 11519-11526]
[DOCID:fr08mr06-6]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0510; FRL-7758-2]

Spinosad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
Spinosad in/on the following commodities: Alfalfa seed; alfalfa seed
screenings; banana; food commodities; animal feed, nongrass, group 18,
forage; animal feed, nongrass, group 18, hay; peanut, hay; vegetable,
bulb, group 3, except green onion; onion, green; grass, forage, fodder
and hay, group 17, forage; grass, forage, fodder and hay, group 17,
hay; grain, cereal, group 16, stover, except rice; grain, cereal, group
16, forage, except rice; grain, cereal, group 16, hay, except rice;
grain, cereal, group 16, straw, except rice; peppermint, tops; and
spearment tops. The Interregional Research Project Number 4 (IR-4)] on
behalf of the registrant, Dow AgroScience, LLC requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA). In addition, EPA is
deleting certain spinosad tolerances that are no longer needed as a
result of this action. Also, the term ``Food commodities'' replaces the
commodity name ``all commodities in connection with the quarantine
eradication programs against exotic, non-indigenous, fruit fly species,
where a separate higher tolerance in not already established'' as
previously listed under Sec. 180.495(b).

DATES: This regulation is effective March 8, 2006. Objections and
requests for hearings must be received on or before May 8, 2006.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0510. All documents in the
docket are listed in the EDOCKET index at http://www.epa.gov/edocket.

Although listed in the index, some information is not publicly
available, i.e., 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 either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505C), 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:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
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 Access Electronic Copies of this Document and Other
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/, you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.

epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR
part 180 is available at E-CFR Beta Site Two at http://www.

gpoaccess.gov/ ecfr/. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at http://www.epa.
 gpo/opptsfrs/ home/guidelin. htm/

II. Background and Statutory Findings

    In the Federal Register of July 20, 2005 (70 FR 41730)(FRL-7721-6),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of several pesticide petitions (PP
3E6699, 3E6780, 3E6782, 3E6802, 3E6804, and 4E6811) by the
Interregional Research Project Number 4 (IR-4), 681 U. S. Highway
1 South, North Brunswick, NJ 08902-3390. The petitions
requested that 40 CFR 180.495 be amended by establishing a tolerance
for residues of the insecticide spinosad, in or on the following raw
agricultural commodities (RACs):
    PP 3E6699 proposes to establish tolerances for banana and plantain
at 0.25 parts per million (ppm).

    PP 3E6780 proposes to establish tolerances for food commodities at
0.02 ppm.
    PP 3E6782 proposes to establish tolerances for spearmint, tops at
5.0 ppm and peppermint, tops at 5.0 ppm.
    PP 3E6802 proposes to establish tolerances for animal feed,
nongrass, group 18, forage at 20 ppm; animal feed, nongrass, group 18
hay at 25 ppm; and peanut, hay at 25 ppm.
    PP 3E6804 proposes to establish tolerances for vegetable, bulb,
except green onion, group 3 at 0.1 ppm and onion, green at 2.0 ppm.
    PP 4E6811 proposes to establish tolerances for: grass, forage,
fodder and hay, group 17, forage at 1.5 ppm; grass, forage, fodder and
hay, group 17, hay at 5 ppm; corn, field, stover; corn, pop, stover;
and corn, sweet, stover at 5.0 ppm; corn, field, forage; corn, sweet,
forage; and corn, pop, forage at 1.5 ppm; teosinte, forage at 1.5 ppm;
millet, pearl, forage; and millet, proso, forage at 1.5 ppm; millet,
pearl, hay; millet, proso, hay; millet proso,straw at 5.0 ppm; sorghum,
forage, forage and sorghum, grain, forage at 1.5 ppm; sorghum, forage,
hay; and sorghum, grain, stover at 5.0 ppm; wheat, forage at 1.5 ppm;
wheat, hay and wheat, straw at 5.0 ppm; barley, straw and barley, hay
at 5.0 ppm; rye, forage at 1.5 ppm; rye, straw at 5 ppm; oat, forage at
1.5 ppm; oat, hay and oat, straw at 5.0 ppm; triticale, forage at 1.5
ppm; and triticale, hay at 5.0 ppm.
    That notice included a summary of the petition prepared by by Dow
AgroSciences, LLC, Indianapolis IN, 46268, the registrant. One comment
was received in response to the notice of filing. A discussion of the
commenter's concerns is presented in Unit IV. C. - Public Comments.
    Several of the proposed petitions described in Unit II. were
subsequently amended by the petitioner as follows:
    Tolerances for animal feed, nongrass, group 18, forage at 35 ppm;
animal feed, nongrass, group 18 hay at 30 ppm; and separate tolerances
for alfalfa seed at 0.15 ppm; and alfalfa, seed screenings at 2 ppm;
banana at 0.25 ppm; grass, forage, fodder and hay, group 17, forage at
10 ppm; grain, cereal, group 16, stover, except rice at 10 ppm; grain,
cereal, group 16, forage, except rice at 2.5 ppm; peppermint, tops at
3.5 ppm; and spearmint, tops at 3.5 ppm. In addition, tolerance for
grain, cereal, group 16, stover, except rice at 10 ppm replaces the
proposed 5.0 ppm tolerance for corn, field, stover; corn, pop, stover;
corn, sweet, stover, and sorghum, grain, stover and the tolerance for
grain, cereal, group 16, forage, except rice at 2.5 ppm replaces
proposed tolerance of 1.5 ppm for corn, field, forage; corn, pop,
forage; corn, sweet, forage; teosinte, forage; millet, pearl, forage;
millet, proso, forage; sorghum, forage, forage; sorghum, grain, forage;
wheat, forage; rye, forage; oat, forage; and triticale, forage.
Tolerance for grain, cereal, group 16, hay, except rice at 10 ppm
replaces proposed tolerance of 5.0 ppm for millet, pearl, hay; millet,
proso, hay; sorghum, forage, hay; wheat, hay; barley, hay; oat, hay;
and triticale, hay. Finally, tolerance for grain, cereal, group 16,
straw, except rice at 1.0 ppm replaces proposed tolerance of 5.0 ppm
for millet, proso, straw; wheat, straw; barley, straw; rye, straw; and
oat, straw.
    EPA is also deleting several established tolerances in
Sec. 180.495(a) and Sec. 180.495(b) that are no longer needed, as a
result of this action.
    The tolerance deletions under Sec. 180.495(a) are being replaced by
the establishment of the crop group tolerance for grain, cereal, group
16, stover, forage, hay, and straw. The tolerance deletions under
Sec. 180.495(b) are time-limited tolerances established under section
18 emergency exemptions that are superceded by the establishment of
general tolerances for spinosad under Sec. 180.495(a).
    The revisions to Sec. 180.495 are as follows:
    Delete the tolerances established under Sec. 180.495(a) for
residues of spinosad in or on corn, forage at 1.0 ppm; corn, hay at 1.0
ppm; corn stover at 1.0 ppm; corn straw at 1.0 ppm; sorghum, forage at
1.0 ppm; sorghum, forage, hay at 1.0 ppm; sorghum, grain, stover at 1.0
ppm; sorghum, straw at 1.0 ppm; wheat, forage at 1.0 ppm; wheat, hay at
1.0 ppm and wheat, straw at 1.0 ppm. Tolerances for grain, cereal,
group 16, stover, except rice at 10 ppm; grain, cereal, group 16,
forage, except rice at 2.5 ppm; grain, cereal, group 16, hay, except
rice at 10 ppm; and for grain, cereal, group 16, straw, except rice at
1.0 ppm replace these tolerances by this action under Sec. 180.495 (a).
    Delete the time-limited tolerance for all commodities in connection
with the quarantine eradication programs against exotic, non-
indigenous, fruit fly species, where a separate higher tolerance is not
already established at 0.02 ppm; alfalfa, forage at 4.0 ppm; alfalfa,
hay at 4.0 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm;
peanut, hay at 10 ppm and onion, dry bulb at 0.10 ppm. Permanent
tolerances for food commodities at 0.02 ppm; peanut, hay at 11 ppm;
grass, forage, fodder and hay, group 17, forage at 10 ppm; grass,
forage, fodder and hay, group 17, hay at 5 ppm; grain, cereal, group
16, stover, except rice at 10 ppm and vegetable, bulb, except green
onion, group 3 at 0.1 ppm are established by this action under
Sec. 180.495(a).
    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 define ``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. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, at http://www. epa.gov/

fedrgstr/EPA-PEST/1997/ November/Day-26/ p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of spinosad on:
Alfalfa seed at 0.15 ppm; alfalfa seed screenings at 2.0 ppm; banana at
0.25 parts per million (ppm); food commodities at 0.02 ppm; spearmint,
tops at 3.5 ppm; peppermint, tops at 3.5 ppm; animal feed, nongrass,
group 18, forage at 35 ppm; animal feed, nongrass, group 18, hay at 30
ppm; alfalfa, seed at 0.15 ppm; alfalfa, seed screenings at 2.0 ppm;
peanut, hay at 11 ppm; vegetable, bulb, group 3, except green onion,
group 3 at 0.1 ppm; onion, green at 2.0 ppm; grass, forage, fodder and
hay, group 17, forage at 10 ppm; grass, forage, fodder and hay, group
17, hay at 5 ppm; grain, cereal, group 16, stover, except rice at 10
ppm; grain, cereal, group 16, forage, except rice at 2.5 ppm; grain,
cereal, group 16, hay, except rice at 10 ppm; grain, cereal, group 16,
straw, except rice at 1.0 ppm.

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 nature of the toxic 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 reviewed are
discussed in the Federal Register of September 27, 2002 (67 FR 60923)
(FRL-7199-5).

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the lowest dose at which
adverse effects of concern are identified the LOAEL is sometimes used
for risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for
intraspecies differences.
    Three other types of safety or UFs may be used: ``Traditional UF``
the ``special FQPA safety factor;'' and the ``default FQPA safety
factor.'' By the term ``traditional UF,'' EPA is referring to those
additional UF's used prior to FQPA passage to account for database
deficiencies. These traditional UFs have been incorporated by the FQPA
into the additional safety factor for the protection of infants and
children. The term ``pecial FQPA safety factor'' refers to those safety
factors that are deemed necessary for the protection of infants and
children primarily as a result of the FQPA. The ``default FQPA safety
factor'' is the additional 10X safety factor that is mandated by the
statute unless it is decided that there are reliable data to choose a
different additional factor (potentially a traditional UF or a special
FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by an UF of 100 to account for
interspecies and intraspecies differences and any traditional UFs
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor
or the default FQPA safety factor is used, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-5), one in a million (1 X 10-6), or one in ten
million (1 X 10-7). Under certain specific circumstances,
MOE calculations will be used for the carcinogenic risk assessment. In
this non-linear approach, a ``point of departure'' is identified below
which carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure (MOEcancer
= point of departure/exposures) is calculated.
    A summary of the toxicological endpoints for spinosad used for
human risk assessment is discussed in Unit III., B. of the Spinosad
Final Rule published in the Federal Register of September 27, 2002 (67
FR 60923) (FRL-199-5).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.495) for the residues of spinosad, in or on a
variety of RACs. Risk assessments were conducted by EPA to assess
dietary exposures from spinosad in food as follows:
    i. Acute exposure. Acute dietary 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. The Agency did not select a dose and endpoint for an
acute dietary risk assessment due to the lack of toxicological effects
of concern attributable to a single exposure (dose) in studies
available in the data base including oral developmental toxicity
studies in rats and rabbits. In the acute neurotoxicity study, the
NOAEL was 2,000 milligram/kilograms/day (mg/kg/day), highest dose
tested. An acute dietary risk assessment is not required.
    ii. Chronic exposure. Chronic dietary risk assessments were
conducted using the Dietary Exposure Evaluation Model - Food
Consumption Intake Database (DEEMTM/FCID), ver. 2.03; acute
and cancer endpoints were not identified which incorporates the food
consumption data from the U.S. Department of Agriculture Continuing
Surveys of Food Intakes by Individuals (CSFII; 1994-1996, and 1998).
The chronic dietary analyses assumed average/projected percent crop
treated estimates, projected percent head treated resulting from the
dermal and premise treatments to ruminants, average field trial
residues, experimentally determined processing factors, and anticipated
livestock residues. For drinking water, the chronic analyses assumed
the modeled tier 1 FIRST chronic surface water estimate resulting from
the application of spinosad to turf (highest registered/proposed rate).
The chronic analysis used average field trial residues for grape,
barley grain, corn grain, oat grain, rice grain, and wheat grain. The
chronic analysis also used processing factors from the grape, corn and
wheat processing studies. The resulting exposure estimates were 96% the
cPAD and are therefore, less than EPA's level of concern (children 1-2
years old were the most highly exposed subpopulation).
    iii. Cancer. Spinosad has been classified as not likely to be
carcinogenic in humans based on the results of a carcinogenicity study
in mice and the combined chronic toxicity and carcinogenicity study in
rats. Therefore, a quantitative cancer risk assessment was not
performed.
    iv. Anticipated residue and percent crop treated (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 chemicals that have been
measured in food. If EPA relies on such information, EPA must require
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. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. As
required by section 408(b)(2)(E) of FFDCA, EPA will issue a Data Call-
In for information relating to anticipated residues to be submitted no
later than 5 years from the date of issuance of this tolerance final
rule.
    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 the Agency can make the following findings: Condition 1,
that 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 such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if 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 section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
    The Agency used PCT information as follows:
    The chronic analysis assumed tolerance level residues for all crop,
poultry, and egg commodities, and anticipated residues for ruminant and
milk commodities. The Agency used PCT information as follows: Almond
5%; apple 30%; apricot 10%; avocado 5%; bean, green 10%; broccoli 40%;
cabbage 30%; cantaloupes 10%; cauliflower 45%; celery 50%; cherry 25%;
collards 25%; cotton 5%; cucumber 20%; eggplant 15%; green, mustard
15%; green, turnip 5%; kale 30%; citrus (5%; excluding lemon and
orange), lemon 10%; lettuce 50%; nectarine 30%; orange 10%; peach 5%;
pear 10%; pepper 35%; potato 5%; prune and plum 10%; spinach 30%;
squash 10%; strawberry 35%; corn, sweet < 1%; tangerine 10%; tomato 20%;
and watermelon 5%.
    Exposure analysis also incorporated projected percent ruminant head
treated resulting from the registered dermal and premise use (dairy
cattle 23%; beef cattle 31%; actual data are not available despite this
being a registered use); and projected PCT for alfalfa of 1%.
    EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five except for those situations in which the
average PCT is less than one. In those cases < 1% is used as the average
and < 2.5% is used the maximum. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the single maximum value
reported overall from available federal, state, and private market
survey data on the existing use, across all years, and rounded up to
the nearest multiple of five. In most cases, EPA uses available data
from United States Department of Agriculture/National Agricultural
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the
National Center for Food and Agriculture Policy (NCFAP) for the most
recent six years.
    EPA projects PCT for a new insecticide use by assuming that the PCT
for the insecticide's initial five years will not exceed the average
PCT of the dominant insecticide (the one with the largest PCT) within
all insecticides over three latest available years. The PCTs included
in the average may be each for the same insecticide or for different
insecticidessince the same or different insecticides may dominate for
each year selected. Typically, EPA uses USDA/NASS as the source for raw
PCT data because it is non-proprietary and directly available without
computation.
    This method of projecting PCT for a new insecticide use, with or
without regard to specific pest(s), produces an upper-end projection
that is unlikely, in most cases, to be exceeded in actuality because
the dominant insecticide is well-established and accepted by farmers.
Factors that bear on whether a projection based on the dominant
insecticide could be exceeded are whether the new insecticide is more
efficacious or controls a broader spectrum of pests than the dominant
insecticide, whether it is more cost-effective than the dominant
insecticide, and whether it is likely to be readily accepted by growers
and experts. These factors have been considered for this insecticide
new use, and they indicate that it is unlikely that actual PCT for this
new use will exceed the PCT for the dominant insecticide in the next
five years.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for spinosad in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
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 and Screening concentration in
Groundwater models, the EECs of spinosad for acute exposures are
estimated to be 25.2 parts per billion (ppb) for surface water and
0.037 ppb for ground water. The EECs for chronic exposures are
estimated to be 2.3 ppb for surface water and 0.037 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the DEEM-FCID. For chronic dietary risk assessment, the
surface water value (chronic; 56-day average) of 2.3 ppb was used for
all direct and indirect sources of water. The surface water estimate
was used for all direct and indirect sources of water. The surface
water estimate was used for direct and indirect sources of water as it
is greater than the ground water estimate.
    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 turf/lawn and ornamental/garden pest control (i.e.,
worms, moths, flies, beetles, midges, thrips, leafminers, fire ants,
etc.), indoor pest control, termiticides, and flea and tick control on
pets). A summary of the residential uses for spinosad is discussed in
Unit III.C. of the final rule published in the Federal Register of
September 27, 2002 (67 FR 60923) (FRL-7199-5).
    Spinosad is currently registered for use on the following
residential non-dietary sites: Turf and ornamentals. Granular
(homeowner) and emulsifiable concentrate (EC: commercial applicators)
formulations are registered. No dermal endpoints were identified and
based on the granular formulation and low vapor pressure for spinosad,
residential handler/applicator and post- application dermal/inhalation
exposure assessments were not conducted. The Agency concluded that
there is potential toddler short-term, non-dietary oral exposures
(hand-to-mouth, object-to-mouth, ingestion of granulars, and soil
ingestion). An endpoint attributable to a single exposure (acute
exposure) has not been identified; therefore, episodic ingestion of
granules was not assessed. The resulting combined short-term incidental
oral MOEs were 640 and are therefore, less than the Agency's level of

concern. EPA concludes that all other registered/proposed application
scenarios will not result in residential exposures.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to spinosad and any other
substances and spinosad does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that spinosad has 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
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www. epa.gov/ pesticides/ cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional UFs and/or special FQPA
safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rat and rabbit fetuses to in utero and/or
postnatal exposure to spinosad.
    3. Conclusion. There is a complete toxicity data base for spinosad
and exposure data are complete or are estimated based on data that
reasonably account for potential exposures. EPA determined that the 10X
SF to protect infants and children should be removed. The FQPA factor
is removed because:
    i. The toxicological database for spinosad is complete for FQPA
assessment.
    ii. There is no evidence of increased susceptibility of rat or
rabbit fetuses following in utero exposure in the developmental studies
with spinosad, and there is no evidence of increased susceptibility of
young rats in the reproduction study with spinosad.
    iii. There are no residual uncertainties identified in the exposure
databases; the dietary food exposure assessment (chronic only; no acute
endpoint was identified) is refined using Anticipated Residues
calculated from field trial data and available PCT information.
    iv. EPA has indicated that the dietary drinking water exposure is
based on conservative modeling estimates.
    v. EPA Residential SOPs were used to assess post-application
exposure to children as well as incidental oral exposure of toddlers,
so these assessments do not underestimate the exposure and risks posed
by spinosad.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated environmental concentrations
(EECs). The DWLOC values are not regulatory standards for drinking
water, but are theoretical upper limits on a pesticide's concentration
in drinking water in light of total aggregate exposure to a pesticide
in food and residential uses. In calculating a DWLOC, the Agency
determines how much of the acceptable exposure (i.e., the PAD) is
available for exposure through drinking water e.g., allowable chronic
water exposure (mg/kg/day) = CPAD - (average food + residential
exposure). This allowable exposure through drinking water is used to
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L) / 70 kg (adult male), 2L / 60 kg (adult female),
and 1L / 10 kg (child). Different populations will have different
DWLOCs. Generally, a DWLOC is calculated for each type of risk
assessment used: Acute, short-term, intermediate-term, chronic, and
cancer.
    When EECs for surface water and ground water are less than the
calculated DWOCs, EPA concluded with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposures for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses changes. When
new uses are added EPA reassesses the potential impacts of residues of
the pesticide in drinking water as a part of the aggregate assessment
process.
    More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EECs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs.
    1. Acute risk. Acute aggregate risk consists of the combined
dietary exposures from food and drinking water sources. The total
exposure is compared to the acute RfD. An acute RfD was not identified
since no effects were observed in oral toxicity studies that could be
attributable to a single dose. Therefore, the Agency concludes that
there is a reasonable certainty of no acute harm from aggregate
exposure to spinosad.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to spinosad
from food and water will utilize 30% of the cPAD for the U.S.
population, 36% of the cPAD for all infants, and 96% of the cPAD for
children 1-2 years old. Based on the use pattern, chronic residential
exposure to

residues of spinosad is not expected. In addition, there is potential
for chronic dietary exposure to spinosad in drinking water. Dietary
exposure analysis included drinking water, therefore, exposure
estimates represent aggregate chronic exposure. EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    In general, aggregate exposures are calculated by summing dietary
(food and water) and residential exposures (residential or other non-
occupational exposures). Based on the anticipated residential exposure
scenarios and since acute and cancer risk assessments are not required,
only short-term (residential, food and water) and chronic (food and
water) aggregate exposure assessments were conducted.
    Spinosad is currently registered for uses (turf and ornamental
application) that could result in short-term residential exposures
(incidental oral exposures to toddlers). This incidental oral exposure
is combined with chronic dietary (food and water) exposure for
determination of aggregate short-term exposure. The Agency uses chronic
dietary exposure when conducting short-term aggregate assessments as it
has been determined this will more accurately reflect exposure from
food than will acute exposure. Table 1 of this unit is a summary of the
short-term aggregate exposure and risk estimates. Since the resulting
aggregate MOEs are greater than or equal to 150, short-term aggregate
exposure to spinosad from food and residential uses is below the
Agency's level of concern.

                     Table 1.--Aggregate Risk Assessment for Short-Term Exposure to spinosad
----------------------------------------------------------------------------------------------------------------
                                                                            Chronic
                                                                            Food and   Residential    Aggregate
              Population/Subgroup                NOAEL (mg/   Target MOE     Water         Oral     MOE2 (food +
                                                  kg/day)                   Exposure    Exposure1    water, and
                                                                          (mg/kg/day)  (mg/kg/day)  residential)
----------------------------------------------------------------------------------------------------------------
All infants (< (1 year old)                              4.9          100     0.009605       0.0076           280
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                4.9          100     0.025784       0.0076           150
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                                4.9          100     0.019729       0.0076           180
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                               4.9          100      0.01259       0.0076           240
----------------------------------------------------------------------------------------------------------------
1 residential exposure = sum of hand-to-mouth, object-to-mouth, and soil ingestion residue estimates.
2 Aggregate MOE = NOAEL divided by (Chronic Food Exposure + Residential Exposure)

    4. Aggregate cancer risk for U.S. population. Spinosad has been
classified as ``not likely to be carcinogenic in humans'' based on the
results of a carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in rats. Therefore, spinosad is not
expected to pose a cancer risk to humans.
    5. 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, and to infants and children from aggregate
exposure to spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Agency concludes that currently available enforcement methods
are sufficient to enforce tolerances associated with the petition under
consideration. Enforcement methodology using high pressure liquid
chromatography with ultraviolet detector (HPLC/UV) is available to
enforce the tolerances in plants. Adequate livestock methods are
available for tolerance enforcement. Method RES 94094 (GRM 95.03) is an
HPLC/UV method suitable for determination of spinosad residues in
ruminant commodities. Method GRM 95.03 has undergone successful
independent laboratory validation (ILV) and EPA laboratory validation,
and has been forwarded to FDA for inclusion in PAM Volume II. Method
GRM 95.15 is another HPLC/UV method suitable for determination of
spinosad residues in poultry commodities. This method has been
forwarded to FDA for inclusion in PAM Volume II. Method RES 95114, an
immunoassay method for determination of spinosad residues in ruminant
commodities, underwent a successful ILV and EPA laboratory validation.
It has been submitted to FDA for inclusion in PAM Volume II. The
methods may be requested from: Paul Golden, U.S EPA/OPP/BEAD/ACB,
Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-
5350; telephone number:<PHONE_NUMBER>; Fax<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Canadian or Mexican maximum residue limits in/on corn
forage (5 ppm), corn fodder (5 ppm), wheat fodder (1 ppm), and wheat
straw (1 ppm). The Agency concluded that the appropriate cereal grain
forage, stover, hay and straw tolerances for the United States are 2.5
ppm, 10 ppm, and 1.0 ppm, respectively. There are Codex MRLs for
spinosad in corn forage (5 ppm), corn fodder (5 ppm), wheat fodder (1
ppm) and wheat straw (1 ppm). Based on available data and applications
proposed for the United States, the Agency concluded that the
appropriate cereal grain forage, stover, hay and straw tolerances for
the United States are 2.5 ppm, 10 ppm, and 1.0 ppm, respectively. The
Codex MRLs for corn forage and fodder are based on field residue data
from the United States. The Codex tolerances for corn forage and fodder
are based on a dry weight basis whereas in the United States tolerances
for corn forage and fodder are based on an as-fed basis. When
evaluating data on an as-fed basis there is a high moisture content
that will substantially increase the tolerance level compared to
evaluating the same data on a dry weight basis. Therefore it is not
appropriate to harmonize the tolerance values for these commodities.
Therefore, harmonization is not an issue for these commodities.

C. Public Comments

    One comment was received from a private citizen who opposed the
authorization to sell to any pesticide that leaves a residue on food.
The Agency has received this same comment from this commenter on
numerous previous occasions and rejects it for the reasons previously
stated in the Federal

Register of January 7, 2005 (70 FR 1349) (FRL-7691-4).

V. Conclusion

    Therefore, the tolerance is established for residues of spinosad, a
naturally occurring product consisting of: Spinosyn A (2-[(6-deoxy-
2,3,4-tri-O-methyl-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 (2-[(6-deoxy-
2,3,4-tri-O-methyl-L-mannopyranosyl)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-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione) in/on the following
commodities: Alfalfa seed at 0.15 ppm; alfalfa seed screenings at 2.0
ppm; banana at 0.25 ppm; food commodities at 0.02 ppm; spearmint, tops
at 3.5 ppm; peppermint, tops at 3.5 ppm; animal feed, nongrass, group
18, forage at 35 ppm; animal feed, nongrass, group 18 hay at 30 ppm;
peanut, hay at 11 ppm; vegetable, bulb, group 3, except green onion,
group 3 at 0.1 ppm; onion, green at 2.0 ppm; grass, forage, fodder and
hay, group 17, forage at 10 ppm; grass, forage, fodder and hay, group
17, hay at 5 ppm; grain, cereal, group 16, stover, except rice at 10
ppm; grain, cereal, group 16, forage, except rice at 2.5 ppm; grain,
cereal, group 16, hay, except rice at 10 ppm; grain, cereal, group 16,
straw, except rice at 1.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2005-0510 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before May 8,
2006.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    2. Mail your written request to: Office of the Hearing Clerk
(1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is<PHONE_NUMBER>.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number, EPA-HQ-OPP-2005-0510 to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or 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). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: February 17, 2006.
Donald R. Stubbs,
Acting 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:
0
i. In paragragh (a), in the table, by removing: Corn, forage at 1.0
ppm; corn, hay at 1.0 ppm; corn stover at 1.0 ppm; corn straw at 1.0
ppm; grass, forage, fodder and hay, group 17 at 0.02 ppm; sorghum,
forage at 1.0 ppm; sorghum, forage, hay at 1.0 ppm; sorghum, grain,
stover at 1.0 ppm; sorghum, straw at 1.0 ppm; wheat, forage at 1.0 ppm;
wheat, hay at 1.0 ppm and wheat, straw at 1.0 ppm; and by
alphabetically adding the commodities as set forth below.
0
ii. In paragraph (b), in the table, by removing: All commodities in
connection with the quarantine eradication programs against exotic,
non-indigenous, fruit fly species, where a separate higher tolerance in
is not already established at 0.02 ppm; alfalfa, forage at 4.0 ppm;
alfalfa, hay at 4.0 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0
ppm; peanut, hay at 10 ppm and onion, dry bulb at 0.10 ppm.
    The additions read as follows:

Sec.  180.495  Spinosad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Alfalfa, seed..............................................         0.15
Alfalfa, seed screenings...................................          2.0
Animal feed, nongrass, group, 18, forage...................         35.0
Animal feed, nongrass, group, 18, hay......................         30.0
                                * * * * *
Banana.....................................................         0.25
Food commodities...........................................         0.02
Grain, cereal, group 16, forage, except rice...............          2.5
Grain, cereal, group 16, hay, except rice..................         10.0
Grain, cereal, group, 16, stover, except rice..............         10.0
Grain, cereal, group, 16, straw, except rice...............          1.0
                                * * * * *
Grass, forage, fodder and hay, group 17, forage............         10.0
Grass, forage, fodder and hay, group 17, hay...............          5.0
                                * * * * *
Onion, green...............................................          2.0
                                * * * * *
Peanut, hay................................................         11.0
Peppermint, tops...........................................          3.5
                                * * * * *
Spearmint, tops............................................          3.5
                                * * * * *
Vegetable, bulb, group 3, except green onion...............         0.10
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 06-1939 Filed 3-7-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17057-17058]
[FR Doc No: 2015-07266]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0868]

Development and Submission of Near Infrared Analytical
Procedures; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Development
and Submission of Near Infrared Analytical Procedures.'' This draft
guidance provides recommendations to applicants of new drug
applications (NDAs) and abbreviated new drug applications (ANDAs)
regarding the development and submission of near infrared (NIR)
analytical procedures used during the manufacture and analysis of
pharmaceuticals. This draft guidance only pertains to the development
and validation of NIR analytical procedures and does not provide
recommendations concerning the set up and qualification of NIR
instruments or their maintenance and calibration.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 1, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John L. Smith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Development and Submission of Near Infrared Analytical
Procedures.'' This draft guidance provides recommendations to
applicants of NDAs and ANDAs regarding the development and submission
of NIR analytical procedures used during the manufacture and analysis
of pharmaceuticals (including raw materials, in-process materials and
intermediates, and finished products). It also provides recommendations
regarding how the concepts described in the International Conference on
Harmonisation (ICH) guidance for industry, ``Q2(R1) Validation of
Analytical Procedures: Text and Methodology'' (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm265700.htm)
and ``PAT--A Framework for Innovative Pharmaceutical Development,
Manufacturing, and Quality Assurance'' (http://www.fda.gov/downloads/Drugs/Guidances/ucm070305.pdf) can be applied to the development,
validation,

and submission of NIR analytical procedures.
    This draft guidance only pertains to the development and validation
of NIR analytical procedures and does not provide recommendations
concerning the set up and qualification of NIR instruments or their
maintenance and calibration.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the submission
and development of NIR analytical procedures. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314 for NDAs,
ANDAs, supplements to applications, and annual reports have been
approved under OMB control number 0910-0001.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07266 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P


                                                                PC Code: 125619
                                                           DP Barcode:  D418674
                                                                PC Code: 125619
                                                           DP Barcode:  D418674
              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
 --------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------
MEMORANDUM

DATE:	September 30, 2014

SUBJECT:	Drinking Water Exposure Assessment for the Section 3 New Use of Metconazole on Pea and Bean (Dried Shelled, Subgroup 6C), and Sunflower (Subgroup 20B)

TO:		Laura Nollen, Risk Manager Reviewer
		Barbara Madden, Minor Use Team Leader
		Marion Johnson, Branch Chief
		Risk Integration Minor Use, and Emergency Response Branch
      Registration Division (7505P)

      Erin Malone, Risk Manager Reviewer
      Hope Johnson, Product Manager Team 21
      Cynthia Giles-Parker, Branch Chief
      Fungicide Branch
      Registration Division (7505P)

FROM:	Faruque Khan, Ph.D. Senior Fate Scientist
		Environmental Risk Branch I
		Environmental Fate and Effects Division (7507P)

APPROVED
BY:		Sujatha Sankula, Ph.D. Branch Chief
		Meghan Radtke, Ph.D., Acting RAPL
		Environmental Risk Branch I
		Environmental Fate and Effects Division (7507P)

Executive Summary

This memo summarizes the estimated drinking water concentrations (EDWCs) of metconazole (5-[(4-Chlorophenyl) methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol]) in surface water and groundwater in support of the proposed Section 3 new uses. The Interregional Research Project Number 4 (IR-4) submitted a tolerance petition for metconazole new uses on pea/bean (dried shelled) and sunflower. Foliar spray applications (aerial and ground boom) are being proposed for the new uses. The IR-4 also revised existing crop groupings by converting stone fruit Group 12 to stone fruit Group 12-12, nut tree Group 12 to nut tree Group 14-12 and the expansion from canola seed to rapeseed Subgroup 20A. Since there are no changes in application rates and methods for the revised crop groupings, previous drinking water assessments (DWAs) fulfill the requirement for refining EDWCs for these crops (stone fruit and nut tree nut   -  USEPA 2007, D340378; canola  -  USEPA 2008, D350276).
Metconazole parent is the only residue of concern considered in the drinking water assessment.  No degradates of metconazole were included based on the recommendation from the Residues of Concern Knowledgebase Subcommittee (ROCKS) of the Health Effects Division (HED) (USEPA, 2008, D348234).

For surface water, the modeled EDWCs for pea/bean (dried shelled) and sunflower for this assessment did not exceed the previously recommended concentrations of 45.5 ug/L (peak) and 22.8 ug/L (30 year annual average concentration) based on the turf scenario (USEPA 2007, D340378) as well as 38.7 ug/L (annual mean concentration) based on the cranberry scenario (USEPA 2010, D380513). However, the previously estimated EDWCs for cranberry use were based on a 0.87 PCA (Percent Cropped Area) factor. Recently, EFED implemented a revised guidance for PCA (USEPA 2014). Since metconazole can be used in agricultural and non-agricultural settings, a PCA factor of 1.0 was used to revise the previously estimated surface water EDWCs based on cranberry use. Revised peak EDWC of 49.5 ug/L from cranberry use exceeded previously recommended EDWC of 45.5 ug/L for turf use. Therefore, the revised recommended EDWCs are 49.5 ug/L for peak and 43.9 ug/L for annual mean concentrations derived from cranberry scenario. The recommended annual average concentration of 22.8 ug/L has not been revised because the PCA factor of 1.0 remains unchanged for turf.
This is the first time the PRZM-GW model has been used in estimating metconazole EDWCs for groundwater since the inception of the model in 2012. The highest application rate of 0.60 lbs a.i./A for turf was modeled in estimating metconazole EDWCs for groundwater. Since application rates for proposed uses are lower than turf, no additional modeling for PRZM-GW modeling is warranted at this time. The estimated PRZM-GW groundwater acute concentration of 51.8 ug/L and chronic concentration of 20.0 ug/L are higher than the previously recommended concentration of 0.38 ug/L for turf (USEPA 2007, D340378). Therefore, the current EDWCs supersede the previously recommended EDWCs for groundwater. The revised recommended EDWCs for both surface water and groundwater for use in HED's human health dietary risk assessment are summarized in Table 1.

Table 1.  Recommended EDWCs for the Proposed Uses of Metconazole for Drinking Water Sources
Drinking Water Source
Crop Scenario (Model)
                                 Peak Exposure
                                    (Acute)
                                    (ug/L)
                             Annual Mean Exposure
                             (Non-Cancer Chronic)
                                    (μg/L)
                            30-year Mean Exposure
                               (Cancer Chronic)
                                   (ug/L)
Surface Water
Turf
                                     45.5
                                     31.3
                                    22.8[1]

Cranberry
                                    49.6[1]
                                43.9[,][1,][2]
                                     NA[3]
Groundwater
WI Central Sand Scenario
                                 51.8[,1,][4]
                                     NA[3]
                                 20.0[,1,][4]
[1] Bolded values are the recommended EDWCs for surface water and groundwater for metconazole uses
2 The provisional cranberry scenario is applicable for a year simulation only.
[3] Not applicable [4] PRZM-GW model was used to reassess groundwater EDWCs for turf use, which has the highest the highest application rate of 0.6 lbs a.i/A for metconazole; groundwater EDWCs are based on a PRZM-GW 100 years simulation

Proposed Use
Metconazole is a broad-spectrum systemic triazole fungicide that can be applied as a foliar spray via ground and aerial application methods. The IR-4 and Valent Corporation are seeking registration of two new uses and tolerances for revised crop groups (Table 2). According to the proposed label (Metconazole 50WDG Fungicide), metconazole can be applied at a maximum application rate/year of 0.125-0.44 lb a.i./A via ground and aerial application methods. Two of the proposed uses have not been considered previously in drinking water assessments. These include uses on pea/bean (dried shelled) and sunflower. Since there are no changes in application rates and methods for the revised crop groupings, previous DWAs conducted for various crops including stone fruit and tree nut (USEPA 2007, D340378) and canola (USEPA 2008, D350276) fulfill the requirement for refining EDWCs for these crops.

Table 2. Proposed New Uses and Conversion of Old Crop Groups to New Crop Groups for Metconazole
                                   Use Site
                               Single App. Rate
                                 (lbs a.i./A)
                                   # of App
                               Annual App. Rate
                                 (lbs a.i./A)
                          Retreatment Interval (days)
                                      PHI
                               Application Type

                                  EPA Reg #
                             Comments/restrictions
                              Proposed New Uses
                   Dried Shelled Pea and bean except soybean
                                 (Subgroup 6C)
                                  0.08-0.125
                                       2
                                     0.25
                                     7-10
                                      21
                            Aerial and Ground boom
                                   59639-147

                           Sunflower (Subgroup 20B)
0.078-0.125
                                       2
                                     0.25
                                     7-14
                                      21
                            Aerial and Ground boom
                                   59639-147

                             Crop Group Expansion
                       Canola [Rapeseed (Subgroup 20A)]
                                 0.0625-0.125
                                       1
                                     0.125
                                      --
                                      35
                                    Aerial

                                   59639-147
                           One application per year

                Conversion of old crop group to new crop group
                          Stone Fruit  (Group 12-12)
                                  0.11-0.125
                                       3
                                     0.375
                                     7-14
                                      14
                                    Aerial
                                   59639-147
                      Maximum two sequential applications
                                   Tree Nut
                                 (Group 14-12
                                  0.078-0.11
                                       4
                                     0.44
                                     7-14
                                      25
                                    Aerial

                                   59639-147
                      Maximum two sequential applications

Residues of Concern

Three degradates were observed at greater than 10% of the applied dose in laboratory fate studies:  M30, hydroxymetconazole, and M13. However, the Residues of Concern Knowledgebase Subcommittee (ROCKS) reported that the residue of concern for metconazole in drinking water is the parent only (USEPA 2008, D348234). Degradates were excluded in the DWA. A detailed rationale for excluding several metconazole metabolites is included in the previous DWA (USEPA 2010, D375778+).

Modeling Approach and Input Parameters

Models

	Surface Water

The Surface Water Concentration Calculator (SWCC v 1.106) model was used to generate EDWCs for the Tier II aquatic exposure assessment. The SWCC is a graphical user interface that runs the Pesticide Root Zone Model (PRZM, v 5, November 15, 2006) and the Variable Volume Water Body Model (VVWM, 3/6/2014) (USEPA, 2006b). Simulations are run for multiple (usually 30) years and the EDWCs represent peak values that are expected once every ten years based on the thirty years of daily values generated during the simulation. The default PCA of 1.0 was used for the proposed uses because metconazole can be used in both agricultural and non-agricultural settings (USEPA 2012).

      Groundwater

The Screening Concentration in Ground Water (SCI-GROW v2.3, Jul. 29, 2003) model[1] is a regression model used as a screening tool to estimate pesticide concentrations found in groundwater that is used for drinking water. SCI-GROW was developed by fitting a linear model to ground water concentrations with the Relative Index of Leaching Potential (RILP) as the independent variable.  Ground water concentrations were taken from 90-day average high concentrations from Prospective Ground Water studies. The SCI-GROW model and user's manual may also be downloaded from the EPA Water Models web-page (http://www.epa.gov/oppefed1/models/water/#scigrow). PCAs are not applicable for the SCI-GROW model.

In addition, Tier 1 groundwater EDWCs for metconazole, resulting from its use on turf for the highest  application rate of 0.60 lbs a.i./A for metconazole was also estimated using the PRZM-GW model (USEPA, 2012c), with the GW-GUI (Graphical User Interface, version 1.0, August 31, 2012).  PRZM-GW is a one-dimensional, finite-difference model that estimates the concentrations of pesticides in groundwater.  It accounts for pesticide fate in the crop root zone by simulating pesticide transport and degradation through the soil profile after a pesticide is applied to an agricultural field. PRZM-GW permits the assessment of multiple years of pesticide application (up to 100 years) on a single site. Six standard scenarios, each representing a different region known to be vulnerable to groundwater contamination, are available for use with PRZM-GW for risk assessment purposes. In PRZM-GW simulations, each of these standard scenarios was used.  PRZM-GW output values represent pesticide concentrations in a vulnerable groundwater supply that is located directly beneath a rural agricultural field following many years of pesticide application. Since there is no breakthrough (i.e., the number of days that it takes for the applied chemical to reach the aquifer) observed for 30 years of simulations, extended weather files for 100 years were used to determine EDWCs for modeled scenarios. PCAs are not applicable for the PRZM-GW model.

Input Parameters

A summary of the model input parameter values used in SWCC, SCI-GROW, and PRZM-GW models are in Table 3, Table 4, and Table 5, respectively. Input parameters were selected in accordance with EFED's "Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides," Version 2.1 (USEPA 2009). Sample model output files are located in Appendix B.

Table 3. SWCC Input Parameters for Metconazole Proposed Uses
Parameter
Input Value and Unit
 Source
Comment
Scenarios for proposed Uses
Pea and Bean (Crop subgroup 6C)
Sunflower (Crop subgroup 20B)

MIbeanSTD
NDCanolaSTD1

N/A[2]

All available scenarios for each use
Maximum Single
Application Rate lbs a.i./A
(Number of Application/year)
Pea and Beans: 0.125 (2)
Sunflower: 0.125 (2)

Proposed labels
EPA Reg. No. 59639-147

Label directions
Initial Application Date

Pea and Beans: August 24
Pea and Beans: July 20

Based on crop scenarios and label directions
Application Interval (days)
Pea and Beans: 7
Sunflower: 7

Intervals were selected to reflect labeled application patterns.
Application Method
Aerial and Ground Bean/Peas, Sunflower
Proposed labels
Label directions
Hydrolysis (t1/2)
0
MRID 46902201
Stable
Application efficiency and Spray Drift (fraction)
Aerial: 0.95 and 0.135
Ground: 0.99 and 0.066
 Input Guidance[3]

Default
Molecular weight
319.8
MRID 447215-05

Solubility in water
(pH 7, 20 °C)
18.7 mg/L

Solubility of cis isomer[4]
Vapor pressure
7.8 x10[-][8] Torr  (mmHg)

Vapor Pressure of Cis-isomer[4]
Hydrolysis (t1/2)
0
MRID 46902201

Stable
Aquatic photolysis (t1/2)
72 days
MRID 46902202
                                      ---
Aerobic soil metabolism (t1/2)
 470.7 days
MRID 46970901
MRID 46902204
MRID 46808408
Upper 90[th] %-ile confidence bound on the mean of  six DT50s
Aerobic aquatic metabolism (t1/2)
Stable
MRID 46902205

Pond water-sediment system from Germany
Anaerobic aquatic metabolism (t1/2)
Stable
MRID 46808410

Greater than 1 year
Partition coefficient Koc
1544 mL/g
MRID 46808411

Average of four Koc
[1] In absence of sunflower standard scenario, NDCanola STD was used as a surrogate
[2] Not Applicable
3 USEPA 2010  http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm
4 Since the cis-isomer is the major constituent (85%) of metconazole, physical properties of the cis-isomer were used in modeling

Table 4. SCI-GROW (v2.3) Input Parameter Values for Metconazole
                                   Parameter
                                     Value
                                    Source
                                   Comments
Application Rate (lbs a.i./acre)
                                     0.125
                            EPA Reg. No. 59639-147
                                Proposed label
Number of applications
                                       2
                            EPA Reg. No. 59639-147

Koc (mL/g)
                                    1213.5
                                 MRID 46808411
                         Median of four Koc values.
Aerobic soil metabolism t (1/2) (days)
                                     261.7
MRID 46970901
MRID 46902204
                                 MRID 46808408
                            Median of six values.

Table 5. PRZM-GW Input Parameters[1] for Metconazloe Uses

                                 Variable Name

                                  Data Value
                                  Data Source
                                    MRID(s)
                                    Comment
Application Method
Foliar Application

EPA Reg. No. 59639-147
                                Proposed label
Application Rate
(lbs a.i./A) [kg/ha]
0.125 [0.140] (Pea/Bean and Sunflower 0.12 [0.135]
 Turf:: 0.12 [0.134]
EPA Reg. No. 59639-147

Application Frequency
Dried bean/peas: 2 time per year
Sunflower: 2 time per year
Turf: 5 times/year
EPA Reg. No. 59639-

US EPA, 2007
Proposed label

                                 Previous DWA
Application Interval (days)
7 (Pea/Bean)
7 Sunflower:
14 (Turf)
EPA Reg. No. 59639-147
Proposed label
                                Proposed Label
Hydrolysis, DT50 (Days)
Stable
MRID 46902201
                                      ---
Aerobic Soil Metabolism  DT50 (Days)
 470.7 days
MRID 46970901
MRID 46902204
MRID 46808408
      Upper 90[th] %-ile confidence bound on the mean of  six half-lives
Koc (mL/goc)
1544 mL/g
MRID 46808411

Average of four Koc
[1]EFED input parameter guidance: http://www.epa.gov/oppefed1/models/water/przm_gw/wqtt_przm_gw_input_guidance.htm

Modeling Results

The estimated metconazole concentrations in surface water used for drinking water are summarized in Table 6. The estimated concentrations in surface water for use on sunflower resulted in the highest EDWCs at 8.25 ug/L for acute, 6.45 ug/L for annual mean and 5.08 ug/L for a 30-year annual average. Acute and chronic estimated metconazole concentrations in surface water used for drinking water ranged from 2.89 to 8.25 ug/L. The estimated metconazole concentrations in groundwater used for drinking water are summarized in Table 7. The estimated concentrations in groundwater for use on turf resulted in the highest EDWCs at 51.8 ug/L for acute and 20.0 ug/L for a 100-year annual average. The PRZM-GW EDWCs are higher than the SCI-GROW EDWCs for the proposed uses and previously recommended EDWC of 0.38 ug/L for turf uses. Therefore, the current EDWCs supersede the previously recommended EDWCs for groundwater.

Table 6.  EDWCs for Metconazole Applications to Various Crops
Drinking Water Source
Crop
Crop Scenario
1-in-10-year Peak Exposure
1-in-10-year Annual Mean Exposure
                            30-year Mean Exposure

                             Concentration (ug/L)
Surface water[1]
Bean and Pea (dried Shelled)
MI Bean STD
                                  7.57(A)[2]
                                  6.65(G)[3]
                                    4.45(A)
                                    3.97(G)
                                    3.33(A)
                                    2.89(G)

Sunflower
ND Canola  STD

                                   8.25 (A)
                                   6.60 (G)

                                   6.45 (A)
                                   5.04 (G)

                                   5.08 (A)
                                    3.92(G)
1 Surface Water Concentration Calculator was used to determine EDWCs in surface water
[2] Aerial application
[3] Ground boom application
Table 7. Results from PRZM-GW and SCI-GROW Modeling Based on Metconazole Uses on Turf and Proposed New Uses

                                     Crop
                                   Scenario
                                    Highest
                                     Daily
                                 Value (ug/L)
                                Average (ug/L)
                  Average Simulation Breakthrough Time (days)
Turf[1]
(0.12 lbs a.i./A x 5 applications)
FL citrus
                                     29.1
                                     20.2
                                     16195

FL potato
                                     0.04
                                     0.02
                                     34338

GA peanut
                                     6.11
                                      1.8
                                     26738

NC cotton
                                     14.1
                                      9.1
                                     16492

DELMARVA sweet corn
                                     20.0
                                      9.1
                                     19640

WI corn
                                    51.8[2]
                                    20.0[2]
                                     23037
Pea/Bean (Dried Shelled) and Sunflower
(0.125 lbs a.i./A x 2 applications)
Generic Scenario[3]
                                     0.032
                                     0.032
                                     NA[4]
[1] PRZM-GW modeled the highest metconazole application rate of 0.6 lbs a.i/A for metconazole uses
[2] Bolded concentrations are the highest EDWCs determined for groundwater
[3] EDWCs are based on SCI-GROW model
[4] Not Applicable

Monitoring Data

Monitoring data for metconazole were available from the United States Geological Survey (USGS) National Water-Quality Assessment (NAWQA) Program Data Warehouse (http://infotrek.er.usgs.gov/nawqa_queries/jsp/swmaster.jsp), searched on September 08, 2014.  Metconazole was not detected in 75 surface water samples collected from multiple states (CA, GA, IA, IN, MO, NE, TX, and WI) at the limit of quantitation (LOQ) of 5.2 ng/L. However, the study design of NAWQA is not targeted to account for all metconazole use areas, timing of application and other factors which may more accurately represent spatially and temporally dependent variables influencing runoff vulnerability. No groundwater and sediment data are available at this time.

Drinking Water Treatment

There is no available information on the effects of drinking water treatment on metconazole.  The EDWCs in this assessment are representative of concentrations in drinking water source water (pre-treatment). For surface water, the conceptual model assumes that a pesticide reaches surface water via spray drift or surface runoff, it is instantaneously mixed, and concentrations are observed in the water body. Metconazole is stable to hydrolysis. Therefore, metconazole will not degrade by hydrolysis during the time that elapses from drinking water intake through distribution to the first tap. Metconazole is also not sensitive to aqueous photolysis. Therefore, if ultraviolet light were used as a means of disinfection, degradation of metconazole would not be expected to be significant. Metconazole has a low degradation rate in aerobic aquatic environments, therefore, there is not expected to be significant degradation during water treatment. The most successful treatment process for removing pesticides from drinking water is thought to be treatment with granular activated carbon (GAC), which is only used in larger drinking water treatment facilities. The ability of GAC to remove pesticides will vary with the properties of the chemical, the viability of the biofilm on the GAC, and whether the sorption sites on GAC have reached capacity (Badriyha et al., 2003; Zhao et al., 1999). Data on the sorption of metconazole to GAC are not available; however, the average Koc (1544 mL/g) value of metconazole suggests that there is a potential for removal of metconazole through GAC treatment because of its high adsorption coefficient.

Literature Cited

Badriyha, B. N., Ravindran, V., Den, W., & Pirbazari, M. 2003.  Bioadsorber efficiency, design, and performance forecasting for alachlor removal. Water Research, 37.

USEPA, 2007.  Revised Drinking Water Exposure Assessment for Metconazole Based on The Proposed Labels of BAS 556 01F, Caramba(TM), V-10116 VPP, Metconazole 50 WDG, and Metconazole Technical. Environmental Fate and Effects Division.  Office of Pesticide Programs. United States Environmental Protection Agency (D D340378).

USEPA, 2008. Updated Drinking Water Exposure Assessment for the use of metconazole in/on canola seed. Environmental Fate and Effects Division.  Office of Pesticide Programs. United States Environmental Protection Agency (D D350276).

USEPA. 2009. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version 2.1.  Environmental Fate and Effects Division.  Office of Pesticide Programs. United States Environmental Protection Agency. Available at http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm (Accessed February 10, 2013).

USEPA, 2010. Drinking Water Exposure Assessment to Establish Tolerances of Parent Metconazole for Tuberous/Corm (Subgroup IC) and Bushberry (Subgroup 13-07C) crops as well as Seed Treatments. Environmental Fate and Effects Division.  Office of Pesticide Programs. United States Environmental Protection Agency (D375778+).

USEPA. 2014. Guidance on Development and Use of Community Water System Drinking Water IntakePercent Cropped Area Adjustment Factors for Use in Drinking Water Exposure Assessments:2014 Update. Environmental Fate and Effects Division, Office of Chemical Safety and Pollution Prevention, United States Environmental Protection Agency.

Zhao, X., Hickey, R. F., & Voice, T. C. 1999.  Long-term evaluation of adsorption capacity in a biological activated carbon fluidized bed reactor system. Water Research, 33(13).

                           Appendix A: Model Outputs

Model: SWCC

Variable Volume Water Model, SWCC Compatible Version

 *******************************************
Performed on:  9/ 9/2014  at  9:33

Peak 1-in-10       =   8.25     ppb
Chronic 1-in-10    =   6.45     ppb
Simulation Avg     =   5.08     ppb

YEAR    Peak      4-day      21-day     60-day     90-day   Yearly Avg Benthic Pk  Benthic 21-day
  1    1.26E+00   1.20E+00   9.95E-01   7.73E-01   7.09E-01   2.81E-01   5.22E-01   5.22E-01
  2    1.97E+00   1.90E+00   1.68E+00   1.45E+00   1.36E+00   8.75E-01   1.15E+00   1.15E+00
  3    3.32E+00   3.22E+00   2.91E+00   2.69E+00   2.57E+00   1.75E+00   2.28E+00   2.28E+00
  4    6.15E+00   5.97E+00   5.40E+00   4.81E+00   4.57E+00   3.08E+00   4.09E+00   4.08E+00
  5    5.13E+00   5.05E+00   4.78E+00   4.53E+00   4.48E+00   4.00E+00   4.30E+00   4.30E+00
  6    5.11E+00   5.04E+00   4.83E+00   4.66E+00   4.56E+00   4.08E+00   4.40E+00   4.40E+00
  7    5.33E+00   5.26E+00   5.03E+00   4.78E+00   4.67E+00   4.31E+00   4.56E+00   4.56E+00
  8    6.38E+00   6.27E+00   5.91E+00   5.45E+00   5.26E+00   4.52E+00   5.02E+00   5.02E+00
  9    5.55E+00   5.47E+00   5.24E+00   4.98E+00   4.86E+00   4.56E+00   4.84E+00   4.87E+00
 10    7.04E+00   6.96E+00   6.60E+00   6.11E+00   5.90E+00   5.06E+00   5.61E+00   5.61E+00
 11    1.07E+01   1.04E+01   9.48E+00   8.66E+00   8.29E+00   6.06E+00   7.51E+00   7.51E+00
 12    7.50E+00   7.43E+00   7.21E+00   7.39E+00   7.64E+00   6.63E+00   7.39E+00   7.43E+00
 13    7.24E+00   7.16E+00   6.88E+00   6.63E+00   6.55E+00   6.02E+00   6.40E+00   6.39E+00
 14    6.67E+00   6.60E+00   6.36E+00   6.13E+00   6.18E+00   5.72E+00   6.17E+00   6.21E+00
 15    7.18E+00   7.12E+00   6.90E+00   6.75E+00   6.63E+00   5.96E+00   6.53E+00   6.53E+00
 16    6.82E+00   6.75E+00   6.51E+00   6.40E+00   6.54E+00   5.90E+00   6.42E+00   6.46E+00
 17    7.11E+00   7.02E+00   6.74E+00   6.42E+00   6.27E+00   5.74E+00   6.19E+00   6.18E+00
 18    7.15E+00   7.08E+00   6.86E+00   6.56E+00   6.55E+00   6.05E+00   6.44E+00   6.43E+00
 19    7.29E+00   7.21E+00   6.94E+00   6.65E+00   6.51E+00   6.10E+00   6.43E+00   6.43E+00
 20    7.98E+00   7.84E+00   7.42E+00   7.12E+00   7.02E+00   6.08E+00   6.70E+00   6.69E+00
 21    7.14E+00   7.05E+00   6.77E+00   6.53E+00   6.63E+00   6.01E+00   6.56E+00   6.60E+00
 22    7.72E+00   7.65E+00   7.39E+00   7.04E+00   6.84E+00   5.92E+00   6.57E+00   6.57E+00
 23    7.53E+00   7.44E+00   7.22E+00   6.91E+00   6.79E+00   6.19E+00   6.60E+00   6.59E+00
 24    7.16E+00   7.09E+00   6.85E+00   6.58E+00   6.52E+00   6.21E+00   6.43E+00   6.47E+00
 25    7.37E+00   7.27E+00   6.97E+00   6.67E+00   6.57E+00   6.03E+00   6.37E+00   6.37E+00
 26    6.72E+00   6.64E+00   6.40E+00   6.13E+00   6.20E+00   5.78E+00   6.18E+00   6.22E+00
 27    1.24E+01   1.20E+01   1.08E+01   9.38E+00   8.85E+00   6.43E+00   7.85E+00   7.84E+00
 28    7.74E+00   7.66E+00   7.42E+00   7.48E+00   7.62E+00   6.82E+00   7.59E+00   7.63E+00
*******************************************************************************

Model SCIGROW

                           SCIGROW
                          VERSION 2.3
            ENVIRONMENTAL FATE AND EFFECTS DIVISION
                 OFFICE OF PESTICIDE PROGRAMS
             U.S. ENVIRONMENTAL PROTECTION AGENCY
                        SCREENING MODEL
                FOR AQUATIC PESTICIDE EXPOSURE

 SciGrow version 2.3
 chemical:Metconazole
 time is  9/22/2014  15:14:15
 ------------------------------------------------------------------------
  Application      Number of       Total Use    Koc      Soil Aerobic
  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)
 ------------------------------------------------------------------------
      0.125           2.0           0.250      1.21E+03      261.7
 ------------------------------------------------------------------------
 groundwater screening cond (ppb) =   3.17E-02
 ************************************************************************

                                 MODEL PRZM-GW

Groundwater Analysis for Metconazole and the Wisconsin Corn - WI Central Sands Scenario
Estimated groundwater concentrations and breakthrough times for metconazole are presented in Table 1 for the Wisconsin Corn - WI Central Sands groundwater scenario. A graphical presentation of the daily concentrations in the aquifer is presented in Figure 1. These values were generated with the PRZM-GW (Version 1.07). Critical input values for the model are summarized in Tables 2 and 3.

Table 1. Groundwater Results for Metconazole and the Wisconsin Corn - WI Central Sands Scenario.
Peak Concentration (ppb)
    51.8
Post-Breakthrough Mean Concentration (ppb)
      46
Entire Simulation Mean Concentration (ppb)
      20
Average Breakthrough Time (days)
23037.51
Throughputs
1.569701

Table 2. Chemical Properties for Groundwater Modeling of Metconazole.
Koc (ml/g)
1544
Surface Soil Half Life (days)
470.7
Hydrolysis Half Life (days)
0
Diffusion Coefficint Air (cm2/day)
0.0
Henry's Constant
0.0
Enthalpy (kcal/mol)
0.0

Table 3. Pesticide Application Scheme Used for Metconazole (applied every year of the simulation)
Application Days Relative to Emergence Date (05/01)
Application Method
Application Rate
(kg/ha)
30
Ground application with mass distribution increasing proportionally with depth to 4 cm
0.134
44
Ground application with mass distribution increasing proportionally with depth to 4 cm
0.134
58
Ground application with mass distribution increasing proportionally with depth to 4 cm
0.134
72
Ground application with mass distribution increasing proportionally with depth to 4 cm
0.134
86
Ground application with mass distribution increasing proportionally with depth to 4 cm
0.134

Figure 1. Aquifer Breakthrough Curve for Metconazole and the Wisconsin Corn - WI Central Sands Scenario