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[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Rules and Regulations]
[Pages 23625-23630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9447]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-1018; FRL-9340-5]

Quizalofop Ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
quizalofop ethyl in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally removes 
established tolerances on canola seed and canola meal, as they will be 
superseded by new tolerances. Finally, this regulation removes several 
time-limited tolerances, as they have expired. Interregional Research 
Project Number 4 (IR-4) requested these tolerances, under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 20, 2012. Objections and 
requests for hearings must be received on or before June 19, 2012, 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-2010-1018. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; email address: nollen.laura@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
harmonized test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines,'' which is listed under ``Documents related to our 
mission.''

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-2010-1018 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

[[Page 23626]]

received by the Hearing Clerk on or before June 19, 2012. 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-2010-1018, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of February 25, 2011 (76 FR 10584) (FRL-
8863-3), 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 
0E7802, by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.441 be amended by 
establishing tolerances for residues of the herbicide quizalofop ethyl, 
ethyl-2-[4-(6-chloroquinoxalin-2-yl oxy)phenoxy]propanoate, including 
its metabolites and degradates, in or on rapeseed subgroup 20A, except 
flax, seed at 1.0 parts per million (ppm); gold of pleasure, meal at 
1.5 ppm; crambe, meal at 1.5 ppm; sorghum, grain at 0.2 ppm; sorghum, 
forage at 0.2 ppm; sorghum, stover at 0.35 ppm; and sorghum, aspirated 
grain at 1.0 ppm. The petition additionally requested that EPA amend 
tolerances in 40 CFR 180.441 by removing the established tolerance for 
canola, seed at 1.0 ppm from the table in paragraph (a)(3), as the 
individual tolerance will be superseded by inclusion in rapeseed 
subgroup 20A, except flax, seed. The petition also proposed to remove 
the tolerances in Sec.  180.441(a)(4), as these tolerances expired on 
June 14, 1999.
    The petition, PP 0E7802, also proposed to amend 40 CFR 180.441 by 
combining the tables for sections (a)(1) and (a)(3) into one table 
under section (a)(1), and by removing section (a)(3). It further 
proposed to revise the tolerance expression under section (a)(1). The 
petition, PP 0E7802, additionally proposed to revise the tolerance 
expression under section (a)(2).
    Finally, PP 0E7802 proposed to revise the tolerance expression 
under section (c). That notice referenced a summary of the petition 
prepared on behalf of IR-4 by E.I. du Pont de Nemours and Company, the 
registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petitions, EPA has 
revised the proposed tolerance level and/or commodity definition for 
several commodities. The Agency has also removed the established 
tolerance on canola, meal, as the data were used to establish a 
tolerance on rapeseed meal, the preferred commodity terminology. 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 
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 quizalofop ethyl 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
quizalofop ethyl 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.
    Quizalofop ethyl has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. It is not an eye or dermal irritant nor 
a skin sensitizer. The liver has been identified as the target organ, 
as evidenced by increased liver weights and histopathological changes 
in the liver. There were no effects observed in the oral toxicity 
studies that could be attributable to a single-dose exposure and no 
observed toxicity in a subchronic dermal toxicity study in rabbits. 
Following subchronic oral exposures, decreased body weight gains, 
increased liver weight and centrilobular liver cell enlargement were 
noted in rats, and an increased incidence of testicular atrophy was 
noted in dogs. A combined chronic toxicity/carcinogenicity study in 
rats noted an increased incidence of centrilobular enlargement of the 
liver in both sexes and mild anemia in males. No treatment-related 
effects on brain weight or histopathology of the nervous system were 
observed in studies that measured those endpoints.
    In developmental toxicity studies in rats and rabbits, maternal 
effects, including decreased body weight gains and food consumption, 
were noted at a level that did not result in developmental effects. In 
the 2-generation reproduction study in rats, maternal effects including 
decreased body weight and body weight gains were noted at the same dose 
level that resulted in prenatal and postnatal effects (decreased 
percentage of pups born alive and decreased pup weights).
    Carcinogenicity studies in rats and mice disclosed no more than 
very limited data suggestive of a potential for carcinogenic risk. No 
evidence of carcinogenicity was seen in female mice and in male or 
female rats. Liver tumors were found in male mice. However,

[[Page 23627]]

these tumors were seen only at an excessive dose, occurred at low 
incidence, showed marginal statistical significance at the high dose 
(no dose response), and were not accompanied with corroborative pre-
neoplastic lesions. Further, liver tumors are common and occur with a 
high degree of variability in male mice. In addition, mutagenicity 
studies conducted on quizalofop ethyl did not demonstrate evidence of 
mutagenic potential. Consequently, there is no concern for the 
carcinogenicity following exposure to quizalofop ethyl.
    Specific information on the studies received and the nature of the 
adverse effects caused by quizalofop ethyl 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: ``Quizalofop-P-ethyl: Human Health 
Risk Assessment for New Uses on Sorghum, Rapeseed Crop Group 20 A, and 
Field Corn,'' at pp. 33-34 in docket ID number EPA-HQ-OPP-2010-1018.

B. Toxicological Points of Departure/Levels of Concern

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

     Table --Summary of Toxicological Doses and Endpoints for Quizalofop Ethyl for Use in Human Health Risk
                                                   Assessment
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                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)....   No appropriate endpoint was identified. There were no effects observed in
                                       oral toxicity studies that could be attributed to a single-dose exposure.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL = 0.9 mg/kg/day.  Chronic RfD = 0.009 mg/ Chronic toxicity/
                                     UFA = 10x.............   kg/day.                 Carcinogenicity study in
                                     UFH = 10x.............  cPAD = 0.009 mg/kg/      rats. LOAEL = 3.7 mg/kg/
                                     FQPA SF = 1x..........   day..                   day based on increased
                                                                                      incidence of centrilobular
                                                                                      enlargement of the liver
                                                                                      in both sexes and mild
                                                                                      anemia in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..                    No concern as to human carcinogenicity.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. Mg/kg/day= milligrams/kilograms/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to quizalofop ethyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing quizalofop ethyl 
tolerances in 40 CFR 180.441. EPA assessed dietary exposures from 
quizalofop ethyl 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 effects were 
identified in the toxicological studies for quizalofop ethyl; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As 
to residue levels in food, EPA incorporated tolerance-level residues 
and 100 percent crop treated (PCT) for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that there is no concern with regard to carcinogenicity. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is not needed.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for quizalofop ethyl. Tolerance level residues and/or 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 quizalofop ethyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of quizalofop ethyl. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
quizalofop ethyl for chronic exposures for non-cancer assessments are 
estimated to be 2 parts per billion (ppb) for surface water and 1.29 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the

[[Page 23628]]

water concentration of value 2 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). Quizalofop ethyl 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 quizalofop ethyl to share a common mechanism of 
toxicity with any other substances, and quizalofop ethyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
quizalofop ethyl 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 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 quizalofop ethyl 
toxicity database is adequate to evaluate potential increased 
susceptibility of infants and children, and includes developmental 
toxicity studies in rats and rabbits and a 2-generation reproduction 
study in rats. In developmental toxicity studies in rats and rabbits, 
maternal effects, including decreased body weight gains and food 
consumption, were noted (100 mg/kg/day for rats and 60 mg/kg/day for 
rabbits) in the absence of developmental effects. In the 2-generation 
reproduction study in rats, maternal effects (decreased body weight and 
body weight gains) were noted at 20 mg/kg/day, the same dose level that 
resulted in prenatal and postnatal effects (decreased percentage of 
pups born alive and decreased pup weights).
    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 quizalofop ethyl is complete except 
for acute and subchronic neurotoxicity testing. Recent changes to 40 
CFR part 158 imposed new data requirements for acute and subchronic 
neurotoxicity testing (OPPTS Guideline 870.6200) for pesticide 
registration. HED has determined from available studies in the 
quizalofop ethyl toxicity database that quizalofop does not have 
specific neurotoxicity. More specifically, there were no treatment-
related effects on brain weight or histopathology of the nervous system 
seen in studies that measured these endpoints. There was no evidence of 
effects on functional development observed in a postnatal segment of 
the reproduction study in rats. In addition, quizalofop ethyl does not 
belong to a chemical class that is considered neurotoxic. Although 
clinical signs possibly indicative of neurotoxicity were seen, they 
were only observed at high doses and, even then, were rare. The 
requested acute and subchronic neurotoxicity studies are expected to 
confirm that there are no indications of neurotoxicity. Therefore, EPA 
does not believe that conducting acute and subchronic neurotoxicity 
studies will result in a NOAEL less than the chronic NOAEL of 0.9 mg/
kg/day already set for quizalofop ethyl. Based on the information in 
this unit, EPA has also determined that there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    ii. There is no evidence that quizalofop ethyl results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iii. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary exposure assessments were performed 
based on 100 PCT and tolerance-level residues, and EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to quizalofop ethyl in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by quizalofop ethyl.

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-, 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 
was identified and no acute dietary endpoint was selected. Therefore, 
quizalofop ethyl 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 
quizalofop ethyl from food and water will utilize 29% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for quizalofop ethyl.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because no short- or 
intermediate-term adverse effect was identified, quizalofop ethyl is 
not expected to pose a short- or intermediate-term risk.
    4. Aggregate cancer risk for U.S. population. Based on the 
information described in Unit III.A., there is no concern for human 
carcinogenicity.
    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 quizalofop ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Morse Method Meth-147, a high

[[Page 23629]]

performance liquid chromatography method) is available to enforce the 
tolerance expression for plant commodities. The method may be requested 
from: Chief, Analytical Chemistry Branch, Environmental Science Center, 
701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-
2905; email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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. The Codex has not 
established a MRL for quizalofop ethyl.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the residue field trial data supporting the 
petitions, EPA revised the proposed tolerances on rapeseed subgroup 
20A, except flax, seed from 1.0 ppm to 1.5 ppm; sorghum, grain, stover 
from 0.35 ppm to 0.30 ppm; crambe, meal from 1.5 ppm to 2.0 ppm; and 
gold of pleasure, meal from 1.5 ppm to 2.0 ppm. The Agency revised 
these tolerance levels based on analysis of the residue field trial 
data using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data.
    Based on available canola processing data, a tolerance for canola, 
meal was previously established at 1.5 ppm. Using the available canola 
processing data, EPA has recommended a tolerance for gold of pleasure, 
meal; and crambe, meal at 2.0 ppm, by adjusting for the proposed 
application rate. As such, the previously established tolerance on 
canola, meal at 1.5 ppm was also revised to 2.0 ppm, and EPA is 
revising the commodity definition for canola, meal to rapeseed, meal in 
order to reflect the correct commodity terminology. Therefore, EPA 
determined that a tolerance should be established on rapeseed, meal at 
2.0 ppm, and the established tolerance on canola, meal at 1.5 ppm 
should be removed.
    The Agency also revised several other proposed and established 
commodity definitions to reflect the correct terminology, as follows: 
Bean, dry to bean, dry seed; sorghum, grain to sorghum, grain, grain; 
sorghum, forage to sorghum, grain, forage; sorghum, stover to sorghum, 
grain, stover; sorghum, aspirated grain to sorghum, grain, aspirated 
grain fractions; and soybean to soybean, seed.

V. Conclusion

    Therefore, tolerances are established for residues of quizalofop 
ethyl, ethyl-2-[4-(6-chloroquinoxalin-2-yl oxy)phenoxy]propanoate, in 
or on crambe, meal at 2.0 ppm; gold of pleasure, meal at 2.0 ppm; 
rapeseed, meal at 2.0 ppm; rapeseed, subgroup 20A, except flax, seed at 
1.5 ppm; sorghum, grain, grain at 0.20 ppm; sorghum, grain, forage at 
0.20 ppm; sorghum, grain, stover at 0.30 ppm; and sorghum, grain, 
aspirated grain fractions at 1.0 ppm. This final rule additionally 
removes the established tolerances for canola, seed at 1.0 ppm; and 
canola, meal at 1.5 ppm. This regulation also deletes time-limited 
tolerances for quizalofop ethyl on beet, sugar, molasses at 0.2 ppm; 
beet, sugar, roots at 0.1 ppm; beet, sugar, tops at 0.5 ppm; vegetable, 
foliage of legume, except soybean, subgroup 7A at 3.0 ppm; and 
vegetable, legume, group 6 at 0.25 ppm, as the tolerances expired on 
June 14, 1999. Finally, this final rule revises the tolerance 
expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of quizalofop ethyl 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.

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

[[Page 23630]]

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: April 11, 2012.
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. Section 180.441 is amended as follows:
0
i. Revise paragraph (a)(1);
0
ii. Revise paragraph (a)(2) introductory text;
0
iii. Remove paragraphs (a)(3) and (a)(4); and
0
iv. Revise paragraph (c) introductory text.
    The revisions read as follows:

Sec.  180.441  Quizalofop ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide quizalofop ethyl, 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 those quizalofop ethyl residues convertible to 2-
methoxy-6-chloroquinoxaline, expressed as the stoichiometric equivalent 
of quizalofop ethyl, in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Barley, grain...........................................            0.05
Barley, hay.............................................            0.05
Barley, straw...........................................            0.05
Bean, dry, seed.........................................            0.4
Bean, succulent.........................................            0.25
Beet, sugar, molasses...................................            0.2
Beet, sugar, roots......................................            0.1
Beet, sugar, tops.......................................            0.5
Cotton, undelinted seed.................................            0.1
Cowpea, forage..........................................            3.0
Cowpea, hay.............................................            3.0
Crambe, meal............................................            2.0
Flax, seed..............................................            0.05
Gold of pleasure, meal..................................            2.0
Lentil, seed............................................            0.05
Pea, dry................................................            0.25
Pea, field, hay.........................................            3.0
Pea, field, vines.......................................            3.0
Pea, succulent..........................................            0.3
Peppermint, tops........................................            2.0
Rapeseed, meal..........................................            2.0
Rapeseed subgroup 20A, except flax, seed................            1.5
Sorghum, grain, aspirated grain fractions...............            1.0
Sorghum, grain, forage..................................            0.20
Sorghum, grain, grain...................................            0.20
Sorghum, grain, stover..................................            0.30
Soybean, flour..........................................            0.5
Soybean, hulls..........................................            0.02
Soybean, meal...........................................            0.5
Soybean, seed...........................................            0.05
Soybean, soapstock......................................            1.0
Spearmint, tops.........................................            2.0
Sunflower, seed.........................................            1.9
Wheat, forage...........................................            0.05
Wheat, grain............................................            0.05
Wheat, hay..............................................            0.05
Wheat, straw............................................            0.05
------------------------------------------------------------------------

     (2) Tolerances are established for residues of the herbicide 
quizalofop ethyl, 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 those quizalofop ethyl residues convertible to 
quizalofop (2-[4-(6-chloroquinoxalin-2-yl-oxy)phenoxy]propanoic acid), 
expressed as quizalofop, in or on the commodity.
* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registration are established for residues of the herbicide 
quizalofop ethyl, 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 those quizalofop ethyl residues convertible to 2-
methoxy-6-chloroquinoxaline, expressed as the stoichiometric equivalent 
of quizalofop ethyl, in or on the commodity.
* * * * *
[FR Doc. 2012-9447 Filed 4-19-12; 8:45 am]
BILLING CODE 6560-50-P
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