[Federal Register Volume 77, Number 184 (Friday, September 21, 2012)]
[Rules and Regulations]
[Pages 58493-58499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23352]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0593; FRL-9358-3]
Flumioxazin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
flumioxazin in or on multiple commodities which are identified and
discussed later in this document. Valent U.S.A. Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective September 21, 2012. Objections and
requests for hearings must be received on or before November 20, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0593, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPP Docket is (703) 305-5805. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Bethany Benbow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-8072; email address: benbow.bethany@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection
[[Page 58494]]
or request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2011-0593 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing, and must be received by the
Hearing Clerk on or before November 20, 2012. Addresses for mail and
hand delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0593, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2011, 76 FR 53374 (FRL-8884-
9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1F7886)
by Valent U.S.A. Corporation, 1600 Riviera Ave., Suite 200, Walnut
Creek, CA 94596. The petition requested that 40 CFR 180.568 be amended
by establishing tolerances for residues of the herbicide, flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on Pea and bean,
dried shelled (except soybean), crop subgroup 6C at 0.1 parts per
million (ppm); Rapeseed, crop subgroup 20A at 0.35 ppm for seed, 0.04
ppm for meal, and 0.02 ppm for refined oil; Sunflower, crop subgroup
20B at 0.5 ppm for seed, 0.03 for meal, 0.02 ppm for refined oil; and
Wheat at 0.35 ppm for grain, 5.0 ppm for straw, 0.02 ppm for forage,
0.02 ppm for hay, 0.35 ppm for bran, 0.05 ppm for flour, 0.35 ppm for
germ, 0.08 ppm for middlings, 0.11 ppm for shorts, 110 ppm for
aspirated grain fractions. In addition, the petition requested
revocation of the existing tolerance for residues of flumioxazin in or
on beans, dry seed, if a tolerance for Crop subgroup 6C (which includes
this commodity) is set as requested. That notice referenced a summary
of the petition prepared by Valent U.S.A. Corporation, the registrant,
which is available in the docket, EPA-HQ-OPP-2011-0593 at http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition and use of
the OECD tolerance calculation procedures, EPA has determined that a
single tolerance to cover all of the commodities within each of the
crop subgroups is appropriate versus individual tolerances for each of
the commodities within the crop subgroups. In addition, EPA has
determined that several of the proposed tolerances for wheat
commodities, including wheat bran, flour, germ, middlings, and shorts,
are not required. The reason for these changes are explained in Unit
IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flumioxazin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flumioxazin follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. A summary of the toxicological findings are as follows:
Flumioxazin has mild or low acute toxicity when administered
orally, dermally, or by inhalation. It is not an eye or skin irritant,
or a dermal sensitizer. In general, the subchronic and chronic toxicity
studies demonstrated that toxic effects associated with flumioxazin
include anemia as well as effects on the liver and the cardiovascular
system. Developmental effects were observed in developmental rat
studies but not in developmental rabbit studies. Hematologic
(hematopoietic) effects of anemia were noted in rats, consisting of
alterations in hemoglobin parameters. Increased renal toxicity in male
rats was also reported following chronic exposure. There is no evidence
of neurotoxicity or immunotoxicity in the recently submitted guideline
studies. Increased quantitative susceptibility was seen in the rat
developmental toxicity studies. Fetal effects were observed in the
absence of maternal toxicity. In addition, both increased qualitative
and quantitative susceptibility were observed in the rat reproduction
study. Severe fetal effects were observed at lower doses than milder
parental effects. In most of the available mutagenicity studies,
flumioxazin was negative for mutagenicity; however, aberrations were
seen in a chromosomal aberration assay (CHO cells). Based on the lack
of evidence of carcinogenicity in mice and rats, flumioxazin is
classified as ``not likely to be carcinogenic to humans.''
Specific information on the studies received and the nature of the
adverse effects caused by flumioxazin as well as the no-observed-
adverse-effect-level
[[Page 58495]]
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies can be found at http://www.regulations.gov in the
document, Flumioxazin. Human Health Risk Assessment for the Proposed
Uses on Wheat, Sunflower, Safflower, Flax, Lentils and Field Peas on
page 20 in docket ID number EPA-HQ-OPP-2011-0593.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction
with the POD to calculate a safe exposure level--generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for flumioxazin used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Flumioxazin for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Females 13-50 NOAEL = 3 mg/kg/day Acute RfD = aPAD = Oral Developmental and
years of age). UFA = 10x. 0.03 mg/kg/day. Supplemental Pre-natal Studies
UFH = 10x........... (Rat) LOAEL = 10 mg/kg/day, based
FQPA SF = 1x........ on cardiovascular effects in
fetuses.
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Acute dietary (General population No appropriate toxicological effects attributable to a single exposure (dose)
including infants and children). were observed in oral toxicity studies including maternal effects in
developmental studies in rats and rabbits. Therefore, a dose and endpoint
were not identified for this risk assessment.
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Chronic dietary (All populations) NOAEL= 2.0 mg/kg/day Chronic RfD= cPAD = 2-Year Chronic/Carcinogenicity
UFA = 10x........... 0.02 mg/kg/day. Study (Rat) LOAEL = 18 mg/kg/day,
UFH = 10x........... based on increased chronic
FQPA SF = 1x........ nephropathy in males and
decreased hematological
parameters in females.
Incidental oral short-term (1 to NOAEL= 6.3 mg/kg/day LOC for MOE = 100.. 2-Generation Reproduction Study
30 days) and intermediate-term UFA = 10x........... (Rat) LOAEL = 12.7 mg/kg/day,
(1 to 6 months). UFH = 10x........... based on decreased pup body
FQPA SF = 1x........ weight and testicular atrophy in
F1 males.
Dermal-Children short-term (1 to NOAEL = 6.3 mg/kg/ LOC for MOE = 100.. 2-Generation Reproduction Study
30 days) and intermediate-term day (dermal (Rat) LOAEL = 12.7 mg/kg/day,
(1 to 6 months). absorption factor = based on decreased pup body
8%). weight and testicular atrophy in
UFA = 10x........... F1 males.
UFH = 10x...........
FQPA SF = 1x........
Dermal-Adults All Durations...... NOAEL= 30 mg/kg/day. LOC for MOE = 100.. Dermal Developmental Study (Rat)
UFA = 10x........... LOAEL = 100 mg/kg/day, based on
UFH = 10x........... cardiovascular effects in
FQPA SF = 1x........ fetuses.
Inhalation short-term (1 to 30 oral study NOAEL= 3 LOC for MOE = 1000. Oral Developmental Study (Rat)
days) and Intermediate term (1 mg/kg/day LOAEL = 10 mg/kg/day, based on
to 6 months). (inhalation cardiovascular effects in
absorption rate = fetuses.
100%).
UFA = 10x...........
UFH = 10x...........
FQPA SF = 10x.......
UFDB................
Inhalation Long-term (> 6 months) NOAEL = 2 mg/kg/day LOC for MOE = 1000. 2-Year Chronic/Carcinogenicity
(inhalation Study (Rat) LOAEL = 18 mg/kg/day,
absorption rate = based on increased chronic
100%). nephropathy in males and
UFA = 10x........... decreased hematological
UFH = 10x........... parameters in females.
FQPA SF = 10x.......
UFDB................
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[[Page 58496]]
Cancer (Oral, dermal, inhalation) ``Not likely to be a carcinogenic to humans,'' based on the lack of
carcinogenicity in a 2-year rat study, an 18-month mouse study, and a
battery of mutagenic studies.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
risk assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in 40 CFR
180.568. EPA assessed dietary exposures from flumioxazin in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for flumioxazin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed residues are present in all commodities at
the tolerance level and that 100% of commodities with tolerances are
treated with flumioxazin. In addition, EPA used default concentration
factors to estimate residues of flumioxazin in processed commodities.
Acute dietary exposure was only estimated for females 13-49 years old
based on cardiovascular effects in fetuses observed in the oral
developmental and supplemental pre-natal rat studies. An endpoint of
concern was not established for acute dietary assessment of the general
population.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed residues are
present in all commodities at the tolerance level and that 100% of
commodities with tolerances are treated with flumioxazin. In addition,
EPA used default concentration factors to estimate residues of
flumioxazin in processed commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flumioxazin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk was not conducted.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flumioxazin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flumioxazin. 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.
Modeled estimates of drinking water concentrations, based on the
estimated environmental concentrations (EECs) for flumioxazin and its
major degradates (482-HA and APF) under the use as an aquatic
herbicide, were directly entered into the dietary exposure model. For
acute dietary risk assessment, the water concentration value of 400
parts per billion (ppb) was used to assess the contribution to drinking
water. For chronic dietary risk assessment, the water concentration of
value 142 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Flumioxazin is
currently registered for the following uses that could result in
residential exposures: Aquatic areas, ornamental gardens, ornamental
trees, and turf in residential lawns, athletic fields, parks, and golf
courses. EPA assessed residential exposure with the assumption that
homeowner handlers wear shorts, short-sleeved shirts, socks, and shoes,
and that they complete all tasks associated with the use of a pesticide
product including mixing/loading, if needed, as well as the
application. Residential handler exposure scenarios for both dermal and
inhalation are considered to be short-term only, due to the infrequent
use patterns associated with homeowner products. EPA uses the term
``post-application'' to describe exposure to individuals that occur as
a result of being in an environment that has been previously treated
with a pesticide. Flumioxazin can be used in many areas that can be
frequented by the general population including residential areas, golf
courses, lakes, and ponds. As a result, individuals can be exposed by
entering these areas if they have been previously treated. Therefore,
short-term and intermediate dermal post-application exposures and risks
were assessed for adults and children. In addition, oral post-
application exposures and risks were assessed for children to be
protective of possible hand-to-mouth, object-to-mouth, and soil
ingestion activities that may occur on treated turf areas. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
flumioxazin to share a common mechanism of toxicity with any other
substances, and flumioxazin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that flumioxazin does not
have a common mechanism of toxicity with other
[[Page 58497]]
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Evidence of increased
susceptibility to fetuses was observed in the oral and dermal
developmental rat studies [i.e. cardiovascular anomalies (ventricular
septal defect)] that occurred in the absence of maternal toxicity.
Additionally, the rat reproduction study demonstrated evidence of
qualitative and quantitative post-natal susceptibility because
reproductive effects in offspring were observed at doses lower than
those that caused parental/systemic toxicity, and because the
reproductive effects in offspring were considered to be more severe
than the parental/systemic effects.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for oral and dermal exposures, but be
retained at 10X for inhalation exposures. That decision is based on the
following findings:
i. The toxicity database for flumioxazin is largely complete with
the exception of an inhalation developmental study, which was recently
determined necessary, in order to better assess route-specific
inhalation risks. In the absence of this study, a 10x FQPA safety
factor to account for database uncertainty is needed to protect the
safety of infants and children to assess risks for all inhalation
exposure scenarios. The toxicity profile can be characterized for all
effects, including potential developmental and reproductive toxicity,
immunotoxicity and neurotoxicity with the current database.
ii. There is no indication that flumioxazin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. Although increased susceptibility was seen in the rat
developmental and reproductive studies, EPA's concern for these effects
is low, and there are no residual uncertainties for pre- and/or
postnatal toxicity because: The developmental toxicity NOAELs/LOAELs
are well characterized after oral and dermal exposure; the offspring
toxicity NOAEL and LOAEL are well characterized in the reproduction
study and; the Points of Departure (POD) for assessing risk to
developing fetuses, infants, and children have been selected either
from the developmental and reproductive toxicity studies from the
chronic study which established a lower POD for chronic effects than
the studies in pre- and postnatal animals. Thus, the regulatory
endpoints for flumioxazin are protective of the increased
susceptibility seen in the developmental and reproduction studies, and
there are no residual concerns for these effects.
iv. There are no residual uncertainties identified in the exposure
databases. Because the acute and chronic dietary exposure estimates
were based on several conservative assumptions (100% of crops treated
with residues present at tolerance levels, default processing factors
and screening level drinking water estimates), EPA is confident that
the dietary exposure assessments do not underestimate risk to the
general U.S. population and various population subgroups. Similarly,
EPA does not believe that the non-dietary residential exposures are
underestimated because they are based on the conservative assumptions
of EPA's Draft Standard Operating Procedures (SOPs) for Residential
Exposure Assessments (December 1997), and updates contained in the
Science Advisory Council Policy 12 (February 2001) as well as the uses
specified in the proposed labels.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
1. Acute risk. Acute aggregate risk takes into account exposure to
residues in food and drinking water alone. Therefore, acute aggregate
risk is equivalent to the acute dietary risk as discussed in Unit
III.C.1.i. The acute dietary exposure estimate for females 13-49 years
old will utilize 68% of the aPAD, which is below the Agency's LOC (100%
of the aPAD).
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flumioxazin from food and water will utilize 54% of the cPAD for all
infants (< 1 year old) the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
flumioxazin is not expected.
3. Short-term risk. Flumioxazin is currently registered for uses
that could result in short-term residential exposure, and the Agency
has determined that it is appropriate to aggregate chronic exposure
through food and water with short-term residential exposures to
flumioxazin.
Different methodologies were used for the presentation of short-
term aggregate risk for adults and children. An aggregate risk estimate
(ARI) approach was required to estimate short-term adult aggregate risk
because there are different LOCs for adult dermal and inhalation
exposures, 100 and 1,000, respectively. For short-term child aggregate
risk, the combined MOE approach was used because the endpoint of
concern (decreased pup weight) and the LOC are the same. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate ARI of 1.15 for adults and aggregate MOE
of 150 for children. Because EPA's LOC for flumioxazin is an ARI of 1
or below and a MOE of 100 or below, these aggregate risk estimates are
not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Since the short- and intermediate-term toxicological endpoints
for flumioxazin are the same for each route of exposure, only short-
term exposures were assessed.
[[Page 58498]]
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flumioxazin is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flumioxazin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) method, Valent Method RM30-A-1) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. There are no MRLs
established by Codex, Canada, or Mexico for any of the proposed
commodities in the current registration actions.
C. Revisions to Petitioned-For Tolerances
EPA has revised the requested tolerances by adjusting the tolerance
values, substituting crop group tolerances for individual tolerances,
and dropping unnecessary tolerances. The tolerance levels were revised
based on analysis of the field trial data using the Organization for
Economic Cooperation and Development (OECD) tolerance calculation
procedures. EPA believes they differ from the petitioner's proposed
tolerances for dried pea, rapeseed subgroup 20A, and wheat grain and
straw due to the petitioner having possibly used the National
Technology Transfer and Advancement Act of 1995 (NAFTA) tolerance
calculation procedures as opposed to the OECD procedure. In addition,
EPA is setting single tolerances for the crop subgroups (6C, 20A and
20B) versus individual tolerances for each commodity within the
subgroups since maximum residues of the commodities within the crop
subgroups differ by less than 5X. The proposed tolerances for wheat
commodities (bran, flour, germ, middlings, and shorts) are also not
necessary since they are covered by the tolerance being set for wheat
grain.
V. Conclusion
Therefore, tolerances are established for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 H -1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H)-dione, including its
metabolites and degradates, in or on the commodities as set forth in
the regulatory text. Compliance with the tolerance levels specified
below is to be determined by measuring only flumioxazin.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of NTTAA, Public Law 104-113, section 12(d) (15 U.S.C.
272 note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 58499]]
Dated: September 10, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.568 is amended by:
0
a. Alphabetically adding the following commodities to the table in
paragraph (a);
0
b. Removing the commodity, ``bean, dry seed'' from the table in
paragraph (a).
The amendments read as follows:
Sec. 180.568 Flumioxazin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Grain, aspirated fractions................................ 100
* * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C.. 0.07
* * * * *
Rapeseed subgroup 20A..................................... 0.40
* * * * *
Sunflower subgroup 20B.................................... 0.50
* * * * *
Wheat, forage............................................. 0.02
Wheat, grain.............................................. 0.40
Wheat, hay................................................ 0.02
Wheat, straw.............................................. 6.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-23352 Filed 9-20-12; 8:45 am]
BILLING CODE 6560-50-P