[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Rules and Regulations]
[Pages 57276-57280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22597]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0911; FRL-9398-9]


Quinoxyfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
quinoxyfen in or on multiple commodities which are identified and 
discussed later in this document. This regulation also deletes the 
established tolerances in or on grape; pepper, bell; pepper, nonbell; 
and strawberry as they will be superseded by crop group/subgroup 
tolerances established by this tolerance rule. The Interregional 
Research Project Number 4 (IR-4) Project Headquarters requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 18, 2013. Objections and 
requests for hearings must be received on or before November 18, 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-2012-0911, 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].

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://www.ecfr.gov/cgi-bin/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-2012-0911 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 18, 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-2012-0911, 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.html.

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 Wednesday, January 16, 2013 (78 FR 3377) 
(FRL-9375-4), 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 2E8117) by IR-4 Project Headquarters, 500 College Road 
East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.588 be amended by establishing tolerances for residues of the 
fungicide quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or 
on berry, low growing, subgroup 13-07G at 0.90 parts per million (ppm); 
fruiting, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F 
at 0.60 ppm and vegetable, fruiting, group 8-10 at 1.7 ppm. In 
addition, the petition requested removal of established tolerances in 
or on grape at 0.60 ppm; strawberry at 0.90 ppm; pepper, bell at 0.35 
ppm; and pepper, nonbell at 1.7 ppm, as these will be superseded upon 
approval of the proposed tolerances. That document referenced a summary 
of the petition prepared by Dow AgroSciences LLC, the registrant, which 
is available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    EPA has revised proposed tolerance levels for several commodities 
and revised the quinoxyfen tolerance expression for all established 
commodities. The reasons for these changes are 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

[[Page 57277]]

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 quinoxyfen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with quinoxyfen 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.
    The primary target organs affected by quinoxyfen are the liver and 
kidney. The most sensitive species was the rat. Liver effects were seen 
in the subchronic rat and mouse studies as well as the chronic dog 
study. Subchronic effects observed in rats and mice at high doses 
included increased liver weights, hepatocellular hypertrophy, and 
individual cell hepatocellular necrosis. Chronic effects observed in 
the dog included increased liver weights, increased alkaline 
phosphatase levels, and increased incidence of very slight to slight 
microscopic hepatic lesions. Kidney effects were noted in the rat 
combined chronic/carcinogenicity study that resulted in an increased 
severity of chronic progressive glomerulonephropathy in males. Body-
weight decrements were seen in the rat and/or mouse subchronic, chronic 
and carcinogenicity studies as well as the rabbit developmental and rat 
reproduction studies.
    Oral rat and rabbit developmental studies showed no increased 
qualitative or quantitative susceptibility of offspring to quinoxyfen 
in utero. In the rabbit developmental toxicity study, maternal and 
developmental toxicity were observed at the highest dose tested (HDT) 
(lowest-observed adverse-effect level; LOAEL = 200 mg/kg/day). Maternal 
effects included inanition (exhaustion due to lack of nourishment), 
clinical signs, decreased body weight and body-weight gains, decreased 
food consumption, and increased incidence of abortion late in 
pregnancy. Developmental toxicity was evidenced as increased incidence 
of abortion late in pregnancy. No maternal or developmental toxicity 
was observed in the rat developmental study up to the limit dose of 
1,000 mg/kg/day. In the 2-generation rat reproduction study, no 
parental effects were observed up to the HDT (100 mg/kg/day) while 
first-generation pup weights were reduced at the same dose. There is 
apparent quantitative susceptibility when looking at the 2-generation 
reproductive study in isolation, but when using a weight-of-evidence 
approach that puts the offspring findings in the 2-generation 
reproduction toxicity study in context with the full toxicological 
database there is no concern for susceptibility to offspring since it 
is anticipated that parental toxicity would have been observed at the 
same dose (see Unit III.D.2).
    No evidence of neurotoxicity or neuropathology was seen in any of 
the submitted studies.
    A 28-day immunotoxicity study showed no evidence that quinoxyfen 
elicits an immunotoxic response up to the HDT.
    The EPA has classified quinoxyfen as ``not likely to be 
carcinogenic to humans'' based on no evidence of carcinogenicity in rat 
or mice studies. Moreover, quinoxyfen did not show evidence of 
mutagenicity in in vitro or in vivo studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by quinoxyfen 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: ``Quinoxyfen. Human-Health Risk 
Assessment for the Proposed Uses on Vegetable, Fruiting, Group 8-10; 
Fruit, Small Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; 
and Berry, Low Growing Subgroup 13-07G,'' dated August 20, 2013, pp. 
27-30 in docket ID number EPA-HQ-OPP-2012-0911.

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.
    Following is a summary of the ``Dose-Response Assessment'' with the 
appropriate toxicological endpoints used if available from the human 
health risk assessment.
    1. Acute dietary endpoint (all populations). There were no adverse 
effects observed attributable to a single dose for the general 
population (including infants and children) or females 13-49 years of 
age; therefore, an acute RfD and PAD were not calculated for this 
exposure scenario.
    2. Chronic dietary endpoint (all populations). The chronic RfD 
(cRfD) was established based on the NOAEL (20 mg/kg/day) from the rat 
combined chronic toxicity/carcinogenicity study. The LOAEL of 80 mg/kg/
day in this study is based on increases in severity of chronic 
progressive glomerulonephropathy in the males and minimal decreases in 
body weight and body-weight gain in both sexes. The NOAEL of 20 mg/kg 
was chosen because the study and endpoint are appropriate for the route 
and duration of exposure. The cPAD of 0.2 mg/kg/day is derived from the 
NOAEL of 20 mg/kg/day and a 100-fold uncertainty factor (10X for 
interspecies extrapolation, 10X for

[[Page 57278]]

intraspecies variation, and 1X for FQPA SF).
    3. Cancer classification. The Agency classified quinoxyfen as ``not 
likely to be carcinogenic to humans'' by all routes of exposure based 
upon lack of evidence of carcinogenicity in rats and mice.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to quinoxyfen, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinoxyfen tolerances in 40 CFR 
180.588. EPA assessed dietary exposures from quinoxyfen 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 one-day or single exposure. No such effects were 
identified in the toxicological studies for quinoxyfen; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used Dietary Exposure Evaluation Model--Food Consumption 
Intake Database (DEEM-FCID), ver. 3.16 which incorporates consumption 
data from the United States Department of Agriculture (USDA) 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEA). The unrefined chronic analysis assumed 100 
percent crop treated (PCT), DEEM 7.81 default concentration factors, 
and tolerance-level residues for all existing and proposed crop uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that quinoxyfen 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 or PCT information in the dietary assessment for 
quinoxyfen. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for quinoxyfen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of quinoxyfen. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) for 
surface water, and the Screening Concentration in Ground Water (SCI-
GROW) models for ground water, the estimated drinking water 
concentrations (EDWCs) of quinoxyfen for chronic exposure, assessments 
are estimated to be 0.66 ppb for surface water and for ground water, 
the estimated drinking water concentration is 0.0034 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.66 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Quinoxyfen is not 
registered for any specific use patterns 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.''
    EPA has not found quinoxyfen to share a common mechanism of 
toxicity with any other substances, and quinoxyfen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
quinoxyfen 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. Oral rat and rabbit 
developmental studies showed no increased qualitative or quantitative 
susceptibility of offspring to quinoxyfen in utero. In isolation, there 
is evidence of increased quantitative susceptibility in the 2-
generation reproduction toxicity study. No parental effects were 
observed up to the HDT (100 mg/kg/day) while first-generation pup 
weights were reduced at the same dose. Concern is low since:
    i. The effects in pups are well characterized with a clear NOAEL of 
20 mg/kg/day.
    ii. The pup effects are minimal at the LOAEL and only noted in the 
first-generation offspring.
    iii. The doses and endpoints selected for regulatory purposes would 
address concerns for the pup effects noted in the rat reproduction 
study.

Additionally, taking into consideration the full toxicological 
database, there would be no susceptibility to offspring since 
assessments to parental animals are intentionally limited in the 2-
generation reproduction study to avoid stressing dams and affecting the 
rearing and care of offspring. If additional evaluations had been 
performed on parental animals in the 2-generation reproduction study, 
including histopathology and organ weight assessments, then it is 
expected that the kidney and liver effects observed in the rat 
subchronic oral study and in the interim (12 months) and final 
sacrifices of the rat chronic toxicity/carcinogenicity study would have 
been seen at the 100 mg/kg/day dose in the reproduction study. 
Therefore, when using a weight-of-evidence approach that puts the 
offspring findings in the 2-generation reproduction toxicity study in 
context with the full toxicological database there is no concern for 
susceptibility to offspring since it is anticipated that parental 
toxicity would have been observed at the same dose.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF is reduced to 1X. That decision is based on the following 
findings:

[[Page 57279]]

    i. The toxicity database for quinoxyfen is complete.
    ii. There is no indication that quinoxyfen is a neurotoxic chemical 
based on available acute and subchronic neurotoxicity studies. EPA 
determined that there is no need to require a developmental 
neurotoxicity study or apply additional uncertainty factors to account 
for neurotoxicity.
    iii. Using the full toxicological database, there is no indication 
that quinoxyfen will result in increased susceptibility to offspring 
(see Unit III.D.2).
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT, tolerance-level residues, and DEEM 7.81 default processing 
factors. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to quinoxyfen in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by quinoxyfen.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
and no acute dietary endpoint was identified for any segment of the 
United States (U.S.) population. Therefore, quinoxyfen is not expected 
to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
quinoxyfen from food and water will utilize 8.5% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. There are no residential uses for quinoxyfen.
    3. Short-term and intermediate-term risks. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Quinoxyfen is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term and intermediate-term aggregate 
risk is the sum of the risk from exposure to quinoxyfen through food 
and water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, quinoxyfen is not expected to pose a cancer risk to humans.
    5. 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 quinoxyfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate gas chromatography/mass-selective detector (GC/MSD) 
method is available for enforcing quinoxyfen tolerances (DowElanco 
Procedure ERC95.26); a successful petition method validation (PMV) has 
been completed. The lowest level of method validation (LLMV) was 0.01 
ppm. Samples from the submitted field and processing studies were 
analyzed using a high-performance liquid chromatography/mass 
spectrometry (HPLC/MS) method derived from Dow AgroSciences Report RF 
98-200 dated May 31, 1999; method entitled ``Determination of Residues 
of Quinoxyfen Applied as EF-1295 in Hops.'' The LLMV was 0.01 ppm for 
quinoxyfen in all tomato matrices.
    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: 
[email protected].

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.
    Codex MRLs are established for residues of quinoxyfen per se in/on 
grapes, strawberries, and peppers. EPA is raising the level of the 
requested U.S. tolerances for residues of quinoxyfen in/on the berry, 
low growing subgroup 13-07G and the fruit, small, vine climbing, except 
fuzzy kiwifruit, subgroup 13-07F in order to harmonize with the Codex 
MRLs. Harmonization of the requested U.S. tolerance for residues of 
quinoxyfen in/on the vegetable, fruiting, group 8-10 (1.7 ppm) with the 
Codex MRL for peppers (1 ppm) is not possible because residue data from 
field trials conducted in the U.S. with quinoxyfen show that residues 
levels resulting from use of quinoxyfen under the existing U.S. 
registration on peppers may exceed the Codex MRL.

C. Revisions to Petitioned-for Tolerances

    EPA increased the proposed tolerance levels for fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F and berry, low 
growing, subgroup 13-07G to 2.0 ppm and 1.0 ppm, respectively, in order 
to harmonize with international Codex maximum residue limits (MRLs). 
EPA relied on Organization for Economic Co-operation and Development 
(OECD) tolerance-calculation procedures and the submitted residue data 
sets in establishing these tolerances.
    In addition, EPA revised the quinoxyfen tolerance expression to 
clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of quinoxyfen not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

[[Page 57280]]

V. Conclusion

    Therefore, tolerances are established for residues of quinoxyfen 
(5,7-dichloro-4-(4-fluorophen oxy)quinoline) in or on berry, low 
growing, subgroup 13-07G at 1.0 ppm; fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; and vegetable, 
fruiting, group 8-10 at 1.7 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 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: September 9, 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.  180.588 amend paragraph (a) as follows:
0
i. Revise the introductory text,
0
ii. Remove entries for commodities: ``Grape''; ``Pepper, bell''; 
``Pepper, nonbell''; and ``Strawberry'', and
0
iii. Alphabetically add the following commodities to the table.
    The additions read as follows:


Sec.  180.588  Quinoxyfen; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
fungicide quinoxyfen, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only quinoxyfen (5,7-dichloro-4-(4-
fluorophenoxy)quinoline).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, subgroup 13-07G........................          1.0
Fruit, small vine climbing, except fuzzy kiwifruit,                  2.0
 subgroup 13-07F...........................................
 
                                * * * * *
Vegetable, fruiting, group 8-10............................          1.7
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-22597 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P