
[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Rules and Regulations]               
[Page 8261-8266]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe10-10]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0885; FRL-8810-3]

 
Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
flumioxazin in or on vegetable, cucurbit, group 9; leaf petioles 
subgroup 4B; and hop, dried cones. This regulation additionally deletes 
the existing tolerances on almond and melon, subgroup 9A, as they will 
be superseded by inclusion in tree nut group 14 and cucurbit vegetable 
group 9, respectively. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 24, 2010. Objections and 
requests for hearings must be received on or before April 26, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0885. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: nollen.laura@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 cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/oppts and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0885 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 as required by 40 CFR part 178 
on or before April 26, 2010.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0885, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 13, 2009 (74 FR 16866) (FRL-8396-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E7462) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ 
08540. 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)-2 H -1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H )-dione, in or on vegetable, 
cucurbit, group 9 at 0.03 parts per million (ppm); leaf petioles, 
subgroup 4B at 0.02 ppm; and hop, dried cones at 0.07 ppm. The petition 
additionally requested that EPA revoke the existing tolerance on 
almonds, as a tolerance on nut, tree, group 14 has been established; 
and requested that EPA delete the existing tolerance for melon subgroup 
9A,

[[Page 8262]]

because it will be replaced by the proposed tolerance for vegetable, 
cucurbit, group 9. That notice referenced a summary of the petition 
prepared on behalf of IR-4 by Valent U.S.A. Corporation, the 
registrant, which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance on hop, dried cones. The reason for this 
change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of flumioxazin on vegetable, cucurbit, group 9 
at 0.03 ppm; leaf petioles subgroup 4B at 0.02 ppm; and hop, dried 
cones at 0.05 ppm. EPA's assessment of exposures and risks associated 
with establishing tolerances 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.
    Flumioxazin has mild or no acute toxicity when administered via the 
oral, dermal and inhalation routes of exposure. It has little or no 
toxicity with respect to eye or skin irritation and is not a dermal 
sensitizer. Subchronic and chronic toxicity studies demonstrated that 
the key toxic effects associated with flumioxazin include anemia and 
impacts on the liver and the cardiovascular system. Hematologic 
(hematopoietic) effects of anemia were noted in rats, including 
alterations in hemoglobin parameters. Increased absolute and relative 
liver weights and/or increased alkaline phosphatase values were 
observed in dogs.
    There was no evidence (quantitative or qualitative) of 
susceptibility following in-utero oral exposure in rabbits. 
Developmental studies in the rat resulted in cardiovascular anomalies, 
including ventricular septal defects. In the two-generation 
reproduction study, systemic effects (clinical signs and mortality as 
well as a decrease in body weight/gain and food consumption) were noted 
in males and females; more severe offspring effects (decrease in the 
number of live born and decreased pup body weights) were noted at lower 
doses than that which resulted in parental effects.
    None of the acute, subchronic, chronic, developmental or 
reproduction studies indicated an effect on the nervous systems. Based 
on the lack of evidence of carcinogenicity in mice and rats, 
flumioxazin is classified as ``not likely to be carcinogenic to 
humans.'' Flumioxazin did not induce significant increases in any tumor 
type in either rats or mice under the conditions of the studies, and it 
did not induce any mutagenic activity in the required battery of 
mutgenicity studies.
    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 (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 Aquatic Use and Proposed Food Uses on 
Cucurbit Vegetables, Leaf Petioles, and Hops,'' at pages 58-62 in 
docket ID number EPA-HQ-OPP-2008-0885.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in the 
document ``Flumioxazin. Human Health Risk Assessment for the Proposed 
Aquatic Use and Proposed Food Uses on Cucurbit Vegetables, Leaf 
Petioles, and Hops,'' at pages 26-28 in docket ID number EPA-HQ-OPP-
2008-0885.

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

[[Page 8263]]

are performed for a food-use pesticide, if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. No such effect was identified for the 
general population. However, EPA identified potential acute effects 
(cardiovascular effects in offspring) for the population subgroup, 
females 13 to 49 years old.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA used tolerance-level 
residues, Dietary Exposure Evaluation Model (DEEM) default processing 
factors for all processed commodities (with the exception of tomato, 
which used the empirical processing factor of 1x), and assumed 100 
percent crop treated (PCT) for all proposed commodities.
    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 used tolerance-level 
residues, DEEM default processing factors for all processed commodities 
(with the exception of tomato, which used the empirical processing 
factor of 1x), and assumed 100 PCT for all proposed commodities.
    iii. Cancer. Based on the lack of evidence of carcinogenicity in 
two adequate rodent carcinogenicity studies, EPA has classified 
flumioxazin as ``not likely to be carcinogenic to humans.'' Therefore, 
a quantitative exposure assessment to evaluate cancer risk is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for flumioxazin. Tolerance level residues or 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. A hydrolysis study for 
flumioxazin indicates that flumioxazin forms the metabolite 482-HA, 
which can further hydrolyze into the metabolites APF and THPA. The 
rates of the two hydrolytic reactions are very pH dependent, but 
flumioxaxin is not very stable at any likely environmental pH. Data 
also indicates that THPA and APF are likely to be very mobile. Although 
THPA can comprise a major portion of the total residue in water, it 
does not possess a phenyl ring and is thus considered significantly 
less toxic than flumioxazin, APF, and 482-HA. For this reason, THPA has 
not been included as a residue of concern in drinking water. Therefore, 
the residues of concern in drinking water are flumioxazin and its 482-
HA and APF degradates. The Agency used screening level water exposure 
models in the dietary exposure analysis and risk assessment for 
flumioxazin and its degradates of concern in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of flumioxazin and its degradates of 
concern. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at http://www.epa.gov/
oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) model, 
the estimated drinking water concentrations (EDWCs) of flumioxazin, 
482-HA and APF for acute exposures are estimated to be 1.03 parts per 
billion (ppb), 6.87 ppb, and 26.46 ppb, respectively, for surface 
water. For chronic exposures for non-cancer assessments, the EDWCs of 
482-HA and APF are estimated to be 4.84 ppb and 12.85 ppb, 
respectively, for surface water. Based on the Screening Concentration 
in Ground Water (SCI-GROW) model, for both acute and chronic (non-
cancer) exposures, the EDWCs of 482-HA and APF are estimated to be 
45.27 ppb and 2.66 ppb, respectively, for ground water. EDWCs of 
flumioxazin are estimated to be negligible in ground water for acute 
exposures and in both surface and ground water for chronic exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The EDWC of 48 ppb (0.048 
ppm), the total EDWC for flumioxazin residues in groundwater (including 
flumioxazin, 482-HA, and APF), was used to assess the contribution to 
drinking water for both the acute and chronic dietary risk assessments.
    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 use in the following areas 
that could result in residential exposures: Walkways, parking lots and 
non-grassy areas around residential dwellings. EPA assessed residential 
exposure using the following assumptions: Short-term dermal and 
inhalation exposure to adult handlers resulting from the use of 
flumioxazin within residential settings. For the above use sites, no 
postapplication exposure to adults or children from flumioxazin is 
expected.
    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 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA 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. The prenatal and postnatal 
toxicology database for flumioxazin includes rat and rabbit prenatal 
developmental toxicity studies and a two-generation reproduction 
toxicity study in rats. There is no evidence of increased 
susceptibility following in-utero oral exposure in rabbits; however, 
there is evidence of increased quantitative susceptibility of rat 
fetuses to in utero exposure to flumioxazin in the oral and dermal 
developmental studies. In both studies, there was an increased 
incidence in fetal cardiovascular anomalies (including ventricular 
septal defects) in the absence of maternal toxicity. Additionally, 
quantitative susceptibility was observed in the two-

[[Page 8264]]

generation rat reproduction study, in which offspring effects (decrease 
in the number of live born and decreased pup body weights) were 
observed at lower doses than those which caused parental/systemic 
toxicity (red substance in vagina and increased mortality in females as 
well as decreases in male and female body weights, body weight gains 
and food consumption).
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for flumioxazin is complete except for 
immunotoxicity, acute neurotoxicity, and subchronic neurotoxicity 
testing. Recent changes to 40 CFR part 158 make acute and subchronic 
neurotoxicity testing (OPPTS Guideline 870.6200), and immunotoxicity 
testing (OPPTS Guideline 870.7800) required for pesticide registration; 
however, the existing data are sufficient for endpoint selection for 
exposure/risk assessment scenarios, and for evaluation of the 
requirements under the FQPA.
    The available data for flumioxazin do not show the potential for 
neurotoxic effects. In the subchronic and chronic toxicity studies, 
signs of anemia (a potential immunotoxic effect) were observed. In the 
rat, hematologic (hematopoietic) effects of anemia were noted, 
including alterations in hemoglobin parameters. Flumioxazin is a 
protporphyrinogen oxidase (PPO) inhibitor, which inhibits the 
biosynthesis of chlorophyll in plants (giving flumioxazin its weed-
control properties). In animals, PPO is responsible for one of the 
later steps in heme synthesis; therefore, the inhibition of PPO results 
in anemia. Although anemia can potentially be considered an immunotoxic 
effect, in this case it's likely the anemia is due to the inhibited 
heme formation (which can interfere with the porphyrin component of 
heme, a hematopoietic effect resulting in anemia), and the blood 
effects are not considered to be the result of potential immunotoxicity 
in this case. Thus, EPA has concluded that flumioxazin does not 
directly impact the nervous system or directly target the immune 
system. The Agency does not believe that conducting a functional 
immunotoxicity study will result in a NOAEL lower than the regulatory 
dose for risk assessment; therefore, an additional database uncertainty 
factor is not needed to account for potential immunotoxicity or 
neurotoxicity.
    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. There is evidence of increased quantitative susceptibility of 
the young following exposure to flumioxazin in the oral and dermal 
developmental toxicity studies in the rat and in the two-generation rat 
reproduction study; therefore, a degree of concern analysis was 
performed to determine the level of concern for the effects observed 
when considered in the context of all available toxicity data and to 
identify any residual concerns after establishing toxicity endpoints 
and traditional UFs to be used in the flumioxazin risk assessment. In 
considering the overall toxicity profile and the endpoints and doses 
selected for the flumioxazin risk assessment, EPA characterized the 
degree of concern for the susceptibility observed in the rat 
developmental and two-generation reproductive studies as low and 
determined that there are no residual uncertainties for prenatal and/or 
postnatal toxicity because:
    a. The only missing toxicity data for flumioxazin are the newly 
required neurotoxicity and immunotoxicity studies; however, no 
additional UF is needed in the absence of these studies because there 
is no evidence to indicate that flumioxazin targets the nervous system 
or the immune system. Further, EPA has concluded that a developmental 
neurotoxicity study is not required.
    b. There are clear NOAELs and LOAELs for the developmental and 
offspring effects noted in the rat developmental toxicity and two-
generation reproductive toxicity studies, and the doses and endpoints 
have been selected from these studies for risk assessment for the 
relevant exposed populations, i.e., pregnant females and children (with 
the exception of the chronic dietary endpoint, for which a chronic 
study was chosen for endpoint selection).
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on conservative assumptions, including 100 PCT data and tolerance-level 
residues. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to flumioxazin in 
drinking water. Postapplication exposure to children is not expected. 
These assessments will not underestimate the exposure and risks posed 
by flumioxazin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to flumioxazin will occupy 9% of the aPAD for females 13 to 49 years 
old, the population subgroup where a potential acute risk was 
identified.
    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 19% of the cPAD for 
children less than 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. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    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. Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded that the combined short-term food, water, and 
residential exposures aggregated result in aggregate MOEs of 2,400 or 
greater. As the aggregate MOEs for short-term exposure are greater than 
100 (the LOC) for all exposure scenarios, short-term aggregate 
exposures to flumioxazin are not of concern to EPA.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic

[[Page 8265]]

exposure to food and water (considered to be a background exposure 
level). Flumioxazin is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to flumioxazin through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in 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

    The following adequate enforcement methodology is available to 
enforce the tolerance expression: A gas chromatography/nitrogen-
phosphorus detection (GC/NPD) method. 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; 
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for residues of flumioxazin on commodities associated with 
this petition.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the residue field trial data supporting the 
petition, EPA revised the proposed tolerance on hop, dried cones from 
0.07 ppm to 0.05 ppm. EPA revised this tolerance level based on 
analysis of the residue field trial data using the Agency's Tolerance 
Spreadsheet in accordance with the Agency's Guidance for Setting 
Pesticide Tolerances Based on Field Trial Data. EPA has also revised 
the introductory text in Sec.  180.568 to clarify in the tolerance 
expression: (1) That, as provided in FFDCA section 408(a)(3), the 
tolerance covers metabolites and degradates of flumioxazin not 
specifically mentioned; and (2) that compliance with the specified 
tolerance levels is to be determined by measuring only the specific 
compounds mentioned in the tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of 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 vegetable, 
cucurbit, group 9 at 0.03 ppm; leaf petioles subgroup 4B at 0.02 ppm; 
and hop, dried cones at 0.05 ppm.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: February 1, 2010.
Daniel J. Rosenblatt,
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 180.568 is amended in paragraph (a) by revising the 
introductory text, removing the entries for ``Almond'' and ``Melon, 
subgroup 9A'' from the table; and by alphabetically adding ``Hop, dried 
cones''; ``Leaf petioles subgroup 4B''; and ``Vegetable, cucurbit, 
group 9'' to the table to read as follows:

[[Page 8266]]

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * * Tolerances are established for residues of 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, including its 
metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only flumioxazin.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Hop, dried cones........................................            0.05
Leaf petioles subgroup 4B...............................            0.02
                                * * * * *
Vegetable, cucurbit, group 9............................            0.03
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-3166 Filed 2-23-10; 8:45 am]
BILLING CODE 6560-50-S

