Document ID: EPA-HQ-OPP-2007-0308-0003
Agency: epa
Document Type: Rule
Title: Flumioxazin; Pesticide Tolerance
Posted Date: 2008-03-05T05:00Z

[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Rules and Regulations]               
[Page 11826-11831]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr08-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0308; FRL-8352-5]

 
Flumioxazin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This regulation establishes a tolerance for residues of 
flumioxazin in or on alfalfa, forage; alfalfa, hay; asparagus; bean, 
dry seed; bushberry subgroup 13-07B; melon, subgroup 9A;

[[Page 11827]]

nut, tree, group 14; okra; and vegetable, fruiting, group 8. The 
Interregional Research Project 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This 
regulation also modifies 40 CFR 180.568(b) by deleting existing time-
limited tolerances in/on alfalfa, forage and alfalfa, hay at 0.13 and 
0.45 ppm, respectively, made redundant by the newly-established 
tolerances.

DATES: This regulation is effective March 5, 2008. Objections and 
requests for hearings must be received on or before May 5, 2008, 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-2007-0308. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0308 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 May 5, 2008.
    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-2007-0308, 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'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 Registers of June 27, 2007, (72 FR 35237; FRL-8133-
4) and September 28, 2007; (72 FR 55204; FRL-8147-1), EPA issued 
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 6E7151 and PP 6F7092, 
respectively,) by the IR-4 Project Headquarters, 500 College Road East, 
Suite 201 W, Princeton, NJ 08540 and the registrant, Valent U.S.A. 
Corporation. The petitions 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, commodities 
alfalfa, forage at 1.0 parts per million (ppm), alfalfa, hay at 2.0 ppm 
(PP 6F7092), asparagus, aronia berry, buffalo currant, Chilean guava, 
European barberry, highbush cranberry, honeysuckle, jostaberry, 
juneberry, lingonberry, native currant, salal, sea

[[Page 11828]]

buckthorn, and okra at 0.02 ppm, bushberry subgroup 13B at 0.02 ppm, 
melon subgroup 9A at 0.02 parts per million (ppm), dry bean at 0.10 
ppm, vegetable, fruiting, crop group 8 at 0.02 ppm, and nut, tree, crop 
group 14, at 0.02 ppm (PP 6E7151). These notices referenced a summary 
of the petition prepared 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 notices of 
filing.
    Based upon review of the data supporting the petitions, EPA has 
revised certain proposed tolerance levels and corrected commodity 
definitions as follow:
    1. The Agency determined that adequate data are available to 
support establishing a tolerance for the bushberry subgroup 13-07B. IR-
4 petitioned for a tolerance for bushberry subgroup 13B as well as 
individual tolerances on aronia berry, buffalo currant, Chilean guava, 
European barberry, highbush cranberry, honeysuckle, jostaberry, 
juneberry, lingonberry, native currant, salal, and sea buckthorn (PP 
6E7151). In the Federal Register of December 7, 2007 (72 FR 69150-
69158) (FRL-8340-6), EPA issued a final rule that revised the crop 
grouping regulations. As part of this action, EPA expanded and revised 
berries group 13. Changes to crop group 13 (berries) included adding 
new commodities, revising existing subgroups and creating new subgroups 
(including a bushberry subgroup 13-07B consisting of the commodities 
requested in PP 6E7151 and cultivars, varieties, and/or hybrids of 
these).
    EPA indicated in the December 7, 2007 final rule as well as the 
earlier May 23, 2007 proposed rule (72 FR 28920-28930) that, for 
existing petitions for which a Notice of Filing had been published, the 
Agency would attempt to conform these petitions to the rule. Therefore, 
consistent with this rule, EPA is establishing tolerances on Bushberry 
subgroup 13-07B. Bushberry subgroup 13-07B consists of the berries for 
which tolerances were requested in PP 6E7151.
    EPA concludes it is reasonable to revise the petitioned-for 
tolerances so that they agree with the recent crop grouping revisions 
because:
    i. Although the subgroup includes several new commodities, these 
commodities were proposed as individual tolerances and are closely 
related minor crops which contribute little to overall dietary or 
aggregate exposure and risk;
    ii. Flumixoazin exposure from these added commodities was 
considered when EPA conducted the dietary and aggregate risk 
assessments supporting this action; and
    iii. The representative commodities for the revised subgroup has 
not changed.
    2. The proposed tolerance for bean, dry, was revised to bean, dry, 
seed and the tolerance level revised from 0.06 ppm to 0.05 ppm.

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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    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 the petitioned-for tolerance 
for residues of flumioxazin on alfalfa, forage at 3.0 ppm; alfalfa, hay 
at 8.0 ppm; asparagus at 0.02 ppm; bushberry subgroup 13-07B at 0.02 
ppm; melon, subgroup 9A at 0.02 ppm; bean, dry seed at 0.05 ppm; 
vegetable, fruiting, group 8 at 0.02 ppm; okra at 0.02 ppm; and nut, 
tree, group 14, at 0.02 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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 orally, 
dermally, or by inhalation. It has little or no toxicity with regard to 
eye irritation or skin irritation. The chemical, flumioxazin, was not a 
dermal sensitizer. Subchronic and chronic toxicity studies demonstrated 
that the target organs of flumioxazin are the liver, spleen and 
cardiovascular system. Developmental effects were observed in 
developmental rat studies. These effects were fetal cardiovascular 
anomalies (especially ventricular septal defects).
    Flumioxazin has been classified as a ``Not Likely Human 
Carcinogen,'' based on the lack of carcinogenicity in a 2-year rat 
study, an 18-month mouse study, and a battery of mutagenic 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 Food Use of the Herbicide Flumioxazin on 
Alfalfa, Asparagus, Dry Beans, Fruiting Vegetables (Group 8, Including 
Okra), Melons (Subgroup 9A), Bushberries (Subgroup 13B), and Tree Nuts 
(Group 14), and a Request for an Amended Use on Garlic,'' dated 28 Nov. 
2007. The referenced document is available in the docket established by 
this action, which is described under ADDRESSES, and is identified as 
EPA-HQ-OPP-2007-0308-0003 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the NOAEL in the toxicology study identified as appropriate for 
use in risk assessment. However, if a NOAEL cannot be determined, LOAEL 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC 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 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose

[[Page 11829]]

(aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD 
are calculated by dividing the LOC by all applicable UFs. Short-term, 
intermediate-term, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.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 the Proposed 
Food Use of the Herbicide Flumioxazin on Alfalfa, Asparagus, Dry Beans, 
Fruiting Vegetables (Group 8, Including Okra), Melons (Subgroup 9A), 
Bushberries (Subgroup 13B), and Tree Nuts (Group 14), and a Request for 
an Amended Use on Garlic,'' dated 28 Nov. 2007 in docket ID number EPA-
HQ-OPP-2007-0308-0003.

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, e.g., cardiovascular effects in offspring, for 
the population subgroup, females 13 to 49 years.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As 
to residue levels in food, EPA assumed all foods for which there are 
tolerances (current and proposed) were treated (100% crop treated (%CT 
or PCT) assumption) and contain tolerance-level residues. Percent crop 
treated (PCT) and/or anticipated residues were not used in the acute 
risk assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996, 
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances (existing and proposed) were treated (100% 
crop treated assumption) and contain tolerance-level residues. PCT and/
or anticipated residues were not used in the chronic risk assessment.
    iii. Cancer. The Agency has determined that flumioxazin is ``not 
likely to be a human carcinogen'' based on the lack of carcinogenicity 
in a 2-rat study, an 18 month mouse study, and a battery of mutagenic 
studies. Therefore, a quantitative exposure assessment to evaluate 
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for flumioxazin and its degradates, 482-HA 
and APF, in drinking water. Because the Agency does not have 
comprehensive monitoring data, drinking water concentration estimates 
are made by reliance on simulation or modeling taking into account data 
on the environmental fate characteristics of flumioxazin. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/
water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of flumioxazin for 
acute exposures are estimated to be 34 parts per billion (ppb) for 
surface water and 48 ppb for groundwater. The EECs for chronic 
exposures are estimated to be 18 ppb for surface water and 48 ppb for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 48 ppb was used to access 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 48 ppb was used to access 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Flumioxazin is not registered for use on any sites that would 
result in residential exposure.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to flumioxazin and 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 not assumed that flumioxazin has 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 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for pre-natal and 
post-natal 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. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional FQPA safety factor value based on the use of 
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Pre-natal and post-natal sensitivity. The pre-natal and post-
natal toxicity database for flumioxazin include the rat and rabbit 
developmental toxicity studies and the 2-generation reproduction 
toxicity study in rats. There is evidence of quantitative 
susceptibility following oral and dermal exposures to rats. Following 
in-utero

[[Page 11830]]

exposures, developmental effects (cardiovascular anomalies) were seen 
in the absence of maternal toxicity. There is no evidence (quantitative 
or qualitative) of susceptibility following in-utero oral exposure in 
rabbits. No developmental toxicity was seen at the highest dose tested 
(3x the Limit-Dose). There is quantitative evidence of susceptibility 
in the multi-generation reproduction study where effects in offspring 
were seen at doses lower than those which induced effects in parental 
animals.
     Although increased pre-natal and post-natal quantitative 
susceptibility was seen in rats, the Agency concluded that there is a 
low concern and no residual uncertainties for pre-natal and/or post-
natal toxicity effects of flumioxazin because:
    i. Developmental toxicity (including cardiovascular abnormalities) 
NOAELs and LOAELs from pre-natal exposure are well characterized after 
oral and dermal exposure,
    ii. The off-spring toxicity NOAEL and LOAEL from post-natal 
exposure are well characterized,
    iii. The dose selected for risk assessment is protective of all 
potential effects.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for flumioxazin is complete.
    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 there is quantitative evidence of increased 
susceptibility in the prenatal developmental studies and post-natal 
multi-generation study in rats, EPA did not identify any residual 
uncertainties after establishing toxicity endpoints and traditional UFs 
to be used in the risk assessment of flumioxazin. The degree of concern 
for pre-natal and/or post-natal toxicity is low.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100%CT and tolerance-level residues for all commodities. By using 
these screening-level assumptions, chronic exposures/risks will not be 
underestimated. The dietary drinking water assessment utilizes values 
generated by models and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water concentrations. These assessments will not underestimate the 
exposure and risks posed by flumioxazin.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC 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 8.0% of the aPAD at the 95th percentile of 
exposure for the population group, females 13 to 49 years old (the only 
subpopulation for which an acute endpoint was selected).
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flumixazim by the general U.S. population and all population subgroups 
have risk estimates below LOC. Exposure to flumioxazin from food and 
water will utilize 18% of the cPAD for infants less than 1 year old, 
the population group with greatest exposure. The general U.S. 
population utilize 6% of the cPAD. There are no residential uses for 
flumioxazin that result in chronic residential exposure to flumioxazin.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Flumioxazin is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
LOC.
    4. 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) 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; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no established or proposed Canadian, Mexican or Codex 
maximum residue levels (MRLs) for residues of flumioxazin in plant 
commodities subject to this action.

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, commodities 
alfalfa, forage at 3.0 ppm; alfalfa, hay at 8.0 ppm; asparagus at 0.02 
ppm; bushberry subgroup 13-07B at 0.02 ppm; melon subgroup 9A at 0.02 
ppm; bean, dry seed at 0.05 ppm; vegetable, fruiting, except cucurbits 
group 8 at 0.02 ppm; okra at 0.02 ppm; and nut, tree, group 14, at 0.02 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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).

[[Page 11831]]

    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 6, 2000) do not apply to this rule. In addition, This 
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 22, 2008.
Lois Rossi,
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 
commodities to the table in paragraph (a), and by removing the text and 
reserving paragraph (b) to read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage......................................                3.0
Alfalfa, hay.........................................                8.0
                                * * * * *
Asparagus............................................               0.02
Bean, dry seed.......................................               0.05
Bushberry subgroup 13-07B............................               0.02
                                * * * * *
Melon, subgroup 9A...................................               0.02
Nut, tree, group 14..................................               0.02
Okra.................................................               0.02
                                * * * * *
Vegetable, fruiting, group 8.........................               0.02
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E8-4102 Filed 3-4-08; 8:45 am]

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