[Federal Register Volume 77, Number 184 (Friday, September 21, 2012)]
[Rules and Regulations]
[Pages 58493-58499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23352]



40 CFR Part 180

[EPA-HQ-OPP-2011-0593; FRL-9358-3]

Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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 

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.


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 

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 
    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, 
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 

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-

[[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
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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
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.
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.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 10x.......
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.......

[[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.
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 
    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 
    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 
    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 
    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 

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:


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

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. Section 180.568 is amended by:
a. Alphabetically adding the following commodities to the table in 
paragraph (a);
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]