Document ID: EPA-HQ-OPP-2012-0139-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flumioxazin
Posted Date: 2013-04-05T04:00Z

[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Rules and Regulations]
[Pages 20461-20466]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07980]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0139; FRL-9381-7]

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. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

[[Page 20462]]

DATES: This regulation is effective April 5, 2013. Objections and 
requests for hearings must be received on or before June 4, 2013, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0139, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; email address: ertman.andrew@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://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 or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0139 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 
June 4, 2013. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0139, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 2E7982) 
by IR-4, 500 College Road 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)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-
tetrahydro-1H-isoindole-1,3(2H)-dione, in or on artichoke at 0.02 parts 
per million (ppm); cabbage and Chinese cabbage (tight-headed varieties 
only) at 0.02 ppm; olives, and olive oil at 0.02 ppm; pomegranate at 
0.02 ppm; cactus fruit at 0.1 ppm, and cactus pads at 0.05 ppm. That 
document referenced a summary of the petition prepared by Valent U.S.A. 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being established for some 
commodities. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.* * 
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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,

[[Page 20463]]

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.
    In general, flumioxazin has mild or low acute toxicity. Also, 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 (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0139 on pages 
43-48 of the document titled ``Flumioxazin. Human Health Risk 
Assessment for the Proposed Uses on Artichoke, Cabbage, Olive, 
Pomegranate, and Prickly Pear Cactus''.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flumioxazin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 21, 2012 (77 FR 58493) 
(FRL-9358-3).

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 U.S. 
Department of Agriculture's National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA) from 2003-2008. As to 
residue levels in food, EPA assumed tolerance level residues and 100 
percent crop treated (PCT) for all proposed and registered commodities. 
In addition, EPA used default concentration factors to estimate 
residues of flumioxazin in processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA from 2003-2008. As to residue levels in food, EPA assumed 
tolerance level residues and 100 PCT for all proposed and registered 
commodities. 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 is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for flumioxazin. Tolerance level residues and 100 PCT were assumed for 
all food commodities.
    2. Dietary exposure from drinking water. In the environment 
flumioxazin photodegrades very rapidly in water and on soil. 
Concentrations of flumioxazin and its major degradates (482-HA, APF, 
and THPA) are expected to be found in water; however, flumioxazin and 
the metabolites 482-HA and APF have been identified as the residues of 
concern in drinking water.
    To estimate concentrations of flumioxazin including its major 
degradates of concern (482-HA and APF) in ground water, the Agency used 
a screening level water exposure model in the dietary exposure analysis 
and risk assessment. This simulation model took into account data on 
the physical, chemical, and fate/transport characteristics of 
flumioxazin. Since this chemical is currently registered for direct 
applications to water, surface water estimates are based on the use of 
flumioxazin as an aquatic herbicide where a maximum 400 parts per 
billion (ppb) concentration is maintained. Hydrolysis is considered the 
major route of dissipation for flumioxazin in the environment and the 
levels of degradates (482-HA and APF) increase continuously with time.
    Based on the Screening Concentration in Ground Water (SCI-GROW) 
model the estimated drinking water concentrations (EDWCs) for both 
acute and chronic exposures of 482-HA and APF are estimated to be 45.27 
ppb and 2.66 ppb, respectively, in ground water. EDWCs of parent 
flumioxazin are estimated to be negligible in ground water for both 
acute and chronic exposures. For surface water, the EDWCs for 
flumioxazin are estimated to be 400 ppb for acute exposures and no 482-
HA and APF is expected to be present. For chronic exposures, EDWCs of 
flumioxazin and its major degradates

[[Page 20464]]

(482-HA and APF) are estimated to be 9.4, 21.6, and 110.1 ppb, 
respectively, for surface water resulting in an EDWC of 142 ppb 
(total).
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 400 ppb was used to assess 
the contribution to drinking water of flumioxazin. For chronic dietary 
risk assessment, the water concentration of value 142 ppb (the total 
EDWC for flumioxazin, 482-HA and APF in surface water) was used to 
assess the contribution to drinking water of flumioxazin and its major 
degradates (482-HA and APF).
    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.
    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 uses that could result in 
residential exposures, including aquatic areas, ornamental gardens, 
ornamental trees, turf, 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 ``postapplication'' to describe exposure to 
individuals that occur as a result of being in an environment that has 
been previously treated with a pesticide. Flumioxazin is registered for 
use 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 
postapplication 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 
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:
    a. The developmental toxicity NOAELs/LOAELs are well characterized 
after oral and dermal exposure;
    b. The offspring toxicity NOAEL and LOAEL are well characterized in 
the reproduction study and
    c. The points of departure 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 point of departure 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. The acute and chronic dietary analyses were based on 
tolerance-level residues and 100 PCT assumptions for all commodities. 
The dietary drinking water assessment utilized water concentration 
values generated by model and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water

[[Page 20465]]

concentrations. The residential exposure assessment incorporates 
similarly conservative assumptions in the assessment of post-
application exposure to children and in the incidental oral exposure 
assessment for children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to flumioxazin will occupy 75% of the aPAD for females 13-49 years old, 
the only population group of concern for acute risk.
    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 44% of the cPAD for all 
infants less than 1 year old, the population subgroup 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.
    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 levels of concern (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 1.12 for adults and 
aggregate MOE of 182 for children. Because EPA's level of concern 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.
    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.
    The Codex has not established MRLs for flumioxazin for any of the 
commodities covered by this document.

C. Revisions to Petitioned-For Tolerances

    The Agency has revised the levels for prickly pear cactus fruit and 
pads from 0.1 and 0.05 to 0.07 and 0.06, respectively. The 
modifications were due to the Agency's use of the Organization for 
Economic Co-operation and Development (OECD) calculation procedures to 
determine the appropriate tolerance levels.
    Additionally, the petition proposed a tolerance for olive oil at 
0.02 ppm. The Agency reviewed an olive oil processing study and found 
that the residue levels found in olive oil were the same as those found 
in olives. As such, the Agency has determined that a tolerance for 
olive is appropriate, and a separate tolerance on olive oil is not 
necessary.

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 artichoke, 
globe at 0.02 ppm; cabbage at 0.02 ppm; cabbage, Chinese, napa at 0.02 
ppm; olive at 0.02 ppm; pomegranate at 0.02 ppm; prickly pear, fruit at 
0.07 ppm; and prickly pear, pads at 0.06 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections

[[Page 20466]]

subject to OMB approval under the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), nor does it require any special considerations 
under Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 28, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.568, add alphabetically the following commodities to 
the table in paragraph (a) to read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Artichoke, globe...........................................         0.02
 
                                * * * * *
Cabbage....................................................         0.02
Cabbage, Chinese, napa.....................................         0.02
 
                                * * * * *
Olive......................................................         0.02
 
                                * * * * *
Pomegranate................................................         0.02
Prickly pear, fruit........................................         0.07
Prickly pear, pads.........................................         0.06
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-07980 Filed 4-4-13; 8:45 am]
BILLING CODE 6560-50-P