[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Rules and Regulations]
[Pages 69005-69009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28132]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0781; FRL-8850-3]


Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flumioxazin in or on the commodity fish, freshwater. Valent U.S.A. 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 10, 2010. Objections and 
requests for hearings must be received on or before January 10, 2011, 
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-2008-0781. 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: Kathryn V. Montague, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; e-mail address: 
<a href="/cdn-cgi/l/email-protection#e38e8c8d9782849686cd8882978b919a8da3869382cd848c95"><span class="__cf_email__" data-cfemail="3b5654554f5a5c4e5e15505a4f534942557b5e4b5a155c544d">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

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-2008-0781 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 
January 10, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2008-0781, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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. Summary of Petitioned-for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), 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 
8F7438) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, 
Walnut Creek, CA 94596. The petition requested that 40 CFR part 180 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 and its 
metabolites APF (3-oxo-4-prop-2-ynyl-6-amino-7-fluoro-3,4-dihydro-1,4-
benzoxazin) and 482-HA (N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-
1,4-benzoxazin-6-yl)cyclohex-1-ene-1-carboxamide-2-carboxylic acid) in 
or on commodity fish, freshwater at 1.5 parts per million (ppm). That 
notice 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.

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

[[Page 69006]]

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 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.
    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. Sub-chronic 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 2-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, sub-chronic, 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 
mutagenicity 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 document ``Flumioxazin. Human Health Risk 
Assessment for a Proposed Aquatic Use,'' pp. 49 to 56 in docket ID 
number EPA-HQ-OPP-2008-0781.

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 the NOAEL and LOAEL of concern are 
identified. Uncertainty/safety factors (UFS) 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 can be found at http://www.regulations.gov in 
document ``Flumioxazin. Human Health Risk Assessment for a Proposed 
Aquatic Use,'' pp. 25 to 26 in docket ID number EPA-HQ-OPP-2008-0781.

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. 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 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 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 PCT information. EPA did not use

[[Page 69007]]

anticipated residue and/or PCT information in the dietary assessment 
for flumioxazin. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The estimated drinking 
water concentrations (EDWCs) of flumioxazin, 482-HA, APF and THPA 
degradates for acute exposures are 400 parts per billion (ppb) 
flumioxazin, at day zero and estimated to be 10.4 ppb, 1.6 ppb, and 
110.1 ppb for flumioxazin, 482-HA and APF degradates, respectively, at 
day 30 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 both surface and 
ground water for chronic exposures.
    The estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The peak day zero of 0.40 ppm 
for flumioxazin was used to assess the contribution to drinking water 
for the acute dietary risk assessment, and the day 30 total of 0.142 
ppm for flumioxazin, 482-HA and APF degradates was used to assess the 
contribution to drinking water for the chronic dietary risk assessment.
    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 post-application 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 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. The prenatal and postnatal 
toxicology database for flumioxazin includes rat and rabbit prenatal 
developmental toxicity studies and a 2-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 2-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 sub-chronic neurotoxicity 
testing. Recent changes to 40 CFR part 158 make acute and sub-chronic 
neurotoxicity testing (OPPTS Test Guideline 870.6200), and 
immunotoxicity testing (OPPTS Test 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 sub-chronic 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 
protoporphyrinogen 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 is 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. 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 uncertainty factors (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 2-generation rat 
reproduction study;

[[Page 69008]]

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 
uncertainty/safety factor 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 2-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 uncertainty/safety factor 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 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 2-
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. EPA used similarly conservative assumptions to assess 
post-application exposure of children as well as incidental oral 
exposure of toddlers. Post-application 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 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-term intermediate-term, 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 66% of the aPAD for females 13-49 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 51% of the cPAD for all 
infants 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 at http://www.regulations.gov in document ``Flumioxazin. Human Health Risk 
Assessment for a Proposed Aquatic Use,'' pp. 33 to 46 in docket ID 
number EPA-HQ-OPP-2008-0781 for short-term exposures from adult 
application of flumioxazin to residential walkways, parking lots and 
non-grassy areas and children and adults swimming in treated water, EPA 
has concluded the combined short-term food, water, and residential 
exposures results in aggregate MOEs of 690 for adults and 470 for 
children. Because EPA's level of concern for flumioxazin is a MOE of 
100 or below, these MOEs 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).
    Intermediate-term aggregate risks are identical to the short-term 
aggregate risks, since endpoints for short-term and intermediate-term 
risk assessments are the same, and since residential exposure durations 
are expected to be short-term in nature.
    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: <a href="/cdn-cgi/l/email-protection#e29087918b8697878f87968a8d8691a2879283cc858d94"><span class="__cf_email__" data-cfemail="f0829583999485959d9584989f9483b0958091de979f86">[email protected]</span></a>.

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 U.N. 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 Codex, Canadian or Mexican maximum residue limits 
(MRLs) established for residues of flumioxazin on commodities 
associated with this petition.

V. Conclusion

    Therefore, tolerances are established for residues of 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 and its 
metabolites APF (3-oxo-4-prop-2-ynyl-6-amino-7-fluoro-3,4-dihydro-1,4-
benzoxazin) and 482-HA

[[Page 69009]]

(N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-
yl)cyclohex-1-ene-1-carboxamide-2-carboxylic acid), in or on fish, 
freshwater at 1.5 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 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 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) (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 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: October 28, 2010.
Lois Rossi,
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 by alphabetically adding the following 
commodity to the table in paragraph (a) to read as follows:


Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fish, freshwater........................................             1.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-28132 Filed 11-9-10; 8:45 am]
BILLING CODE 6560-50-P


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