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[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Rules and Regulations]
[Pages 10962-10968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4332]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0494; FRL-8883-1]

Flazasulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

[[Page 10963]]

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flazasulfuron in or on citrus fruit, grape, and sugarcane. ISK 
Biosciences Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 24, 2012. Objections and 
requests for hearings must be received on or before April 24, 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-2010-0494. 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; email address: stanton.susan@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.''

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-2010-0494 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 
April 24, 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-2010-0494, 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 Tolerance

    In the Federal Register of August 4, 2010 (75 FR 46926) (FRL-8834-
9), 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 
0F7666) by ISK Biosciences Corporation, 7470 Auburn Rd., Suite A, 
Concord, OH 44077. The petition requested that 40 CFR part 180 be 
amended by adding a section for the herbicide flazasulfuron and 
establishing tolerances therein for residues of flazasulfuron, N-
[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(trifluoromethyl)-2-
pyridinesulfonamide, in or on fruit, citrus, group 10 at 0.01 parts per 
million (ppm); grapes at 0.01 ppm; and sugarcane at 0.01 ppm. That 
notice referenced a summary of the petition prepared by ISK Biosciences 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    EPA has made minor changes to the citrus and grape commodity terms. 
The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include

[[Page 10964]]

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 flazasulfuron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with flazasulfuron 
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.
    Flazasulfuron exhibits low acute toxicity via oral, dermal and 
inhalation routes of exposure. It is not irritating to the skin or eyes 
and is not a dermal sensitizer. Subchronic studies in animals indicated 
decreased body weight gain, slight anemia in rats, and liver 
abnormalities in dogs. Dermal or systemic toxicity was not seen in a 
subchronic dermal study in rabbits at dose levels up to the limit dose.
    In the longer-term mammalian toxicity studies, the kidney and liver 
were the primary target organs of flazasulfuron toxicity. Observed 
effects included adverse changes in kidney function (chronic 
nephropathy) and kidney physiology (enlargement, dark color of kidney), 
increases in liver weight and hepatocellular hypertrophy, increases in 
inflammatory cell infiltration, hepatocellular necrosis, hepatocellular 
swelling, and bile duct proliferation.
    Developmental toxicity was observed in both rats and rabbits. 
Reduced fetal weights and delays in ossification were seen in a 
developmental toxicity study with Sprague-Dawley rats; an increased 
incidence of visceral malformations (intraventricular septal defect) 
was seen in a developmental study with Wistar rats. The developmental 
study in rabbits showed high incidences of abortion at the highest dose 
tested. Decreases in body weight and chronic nephropathy were observed 
in offspring in a 2-generation rat reproduction toxicity study. The 
effects on offspring in these studies occurred at dose levels which 
were also toxic to the parents.
    A transient decrease in motor activity 5 hours post-dosing on Day 0 
was observed at the mid-dose in an acute neurotoxicity study. This 
observation may be associated with a systemic effect and not with 
neurotoxicity. The effect was reversed by the next scheduled 
observation (Day 7), and neurohistopathologic evaluation of tissues 
from the central and peripheral nervous systems of high dose and 
control animals did not demonstrate any test material-related 
neurotoxic lesions.
    There was no evidence of carcinogenicity in the mouse oncogenicity 
study or the combined chronic toxicity/carcinogenicity study in the rat 
and no evidence of genotoxic potential in in vitro and in vivo 
mutagenicity studies. Based on the results of these studies, EPA has 
classified flazasulfuron as ``No evidence of carcinogenicity to 
humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by flazasulfuron 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 ``Flazasulfuron: Human Health Risk 
Assessment for Proposed Uses on Citrus, Grapes, Sugarcane, Christmas 
Trees, and Industrial Vegetation,'' at p. 36 in docket ID number EPA-
HQ-OPP-2010-0494.

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-observed-adverse-effect-level (NOAEL) 
and the lowest-observed-adverse-effect-level (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 flazasulfuron used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Flazasulfuron 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
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Acute dietary (General population      NOAEL = 50 mg/kg/day...  Acute RfD = 0.5 mg/kg/   Acute neurotoxicity
 including females, 13-49 years old,   UFA = 10x..............   day.                     study in rats.
 infants and children).                UFH = 10x..............  aPAD = 0.5 mg/kg/day...  LOAEL = 1,000 mg/kg/day
                                       FQPA SF = 1x...........                            based on transient
                                                                                          decrease in motor
                                                                                          activity at Day 0 (5
                                                                                          hours post-dosing).
Chronic dietary (All populations)....  NOAEL= 1.3 mg/kg/day...  Chronic RfD = 0.013 mg/  Combined Chronic
                                       UFA = 10x..............   kg/day.                  Toxicity/
                                       UFH = 10x..............  cPAD = 0.013 mg/kg/day.   Carcinogenicity in
                                       FQPA SF = 1x...........                            rats.
                                                                                         LOAEL = 13.3 mg/kg/day
                                                                                          based on adverse
                                                                                          change in kidney
                                                                                          function (chronic
                                                                                          nephropathy).
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[[Page 10965]]

 
Cancer (Oral, dermal, inhalation)....  Classification: ``No evidence of carcinogenicity to humans'' based on
                                        lack of carcinogenic effects in the rat and mouse carcinogenicity
                                        studies and lack of a mutagenicity concern.
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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. MOE = margin of exposure. LOC = level of
  concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flazasulfuron, EPA considered exposure under the 
petitioned-for tolerances. No other tolerances have been established 
for flazasulfuron. EPA assessed dietary exposures from flazasulfuron in 
food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for flazasulfuron. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed that 100% of citrus fruit, grape, and sugarcane commodities are 
treated with flazasulfuron and that residues on these commodities are 
present at the tolerance levels.
    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 made the same 
assumptions (tolerance-level residues and 100 percent crop treated 
(PCT)) as in the acute dietary exposure assessment.
    iii.  Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that flazasulfuron does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water include flazasulfuron and its identified degradates DTPU 
(N-(4,6-dimethoxy-2-pyrimidinyl)-N-[3-(trifluoromethyl)-2-
pyridinyl]urea), DTPP (4,6-dimethoxy-N-[3-(trifluoromethyl)-2-
pyridinyl]-2-pyrimidinamine), TPSA (3-(trifluoromethyl)-2-
pyridinesulfonamide), ADMP (2-amino-4,6-dimethoxypyrimidine), HTPP (6-
methoxy-2-[[3-(trifluoromethyl)-2-pyridinyl]amino]-4-pyrimidinol), and 
2,3-GTP (3-trifluoromethyl-2-pyridylguanidine). The Agency used 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for flazasulfuron and its degradates in drinking 
water. These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of flazasulfuron and its 
degradates. 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 Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of 
flazasulfuron and its degradates for acute exposures are estimated to 
be 26.9 parts per billion (ppb) for surface water and 102 ppb for 
ground water. EDWCs of flazasulfuron and its degradates for chronic 
exposures for non-cancer assessments are estimated to be 4.67 ppb for 
surface water and 102 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic dietary 
risk assessment, the water concentration value of 102 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). Flazasulfuron is 
currently registered for use on non-residential turf, including 
recreation areas (golf courses and professionally managed sports 
fields). There is a potential for post-application short-term dermal 
exposure of adults and children entering recreation areas which have 
been treated with flazasulfuron. However, since no hazard associated 
with dermal exposure was identified in the toxicity database for 
flazasulfuron, flazasulfuron is not expected to pose a risk from post-
application dermal exposure.
    In accordance with current policy, EPA did not conduct a 
quantitative assessment of post-application inhalation exposure to 
flazasulfuron; however, volatilization of pesticides may be a source of 
post-application inhalation exposure of individuals nearby pesticide 
applications. The Agency sought expert advice and input on issues 
related to volatilization of pesticides from its Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in 
December 2009, and received the SAP's final report on March 2, 2010 
http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html. EPA is 
currently in the process of evaluating the SAP report and may, as 
appropriate, develop policies and procedures to identify the need for 
and, subsequently, the way to incorporate post-application inhalation 
exposure into the Agency's risk assessments. In the case of 
flazasulfuron, although EPA has not conducted a quantitative assessment 
of post-application inhalation exposure, the Agency's concern for such 
exposures is low due to flazasulfuron's low vapor pressure (-7 torr) and low acute toxicity.
    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 
flazasulfuron to share a common mechanism of toxicity with any other 
substances, and flazasulfuron does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that flazasulfuron does 
not have a common mechanism of toxicity with other substances. For 
information regarding

[[Page 10966]]

EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The pre- and postnatal 
toxicity database for flazasulfuron includes developmental toxicity 
studies in rats (Sprague-Dawley and Wistar) and rabbits and a 2-
generation reproduction toxicity study in rats.
    There was no evidence of increased quantitative susceptibility of 
fetuses or offspring to flazasulfuron in any of the developmental or 
reproductive toxicity studies, since the effects on offspring occurred 
at dose levels which were also toxic to the parents. There is a 
potential concern for increased qualitative susceptibility of offspring 
based on the intraventricular septal defect seen in offspring at 
minimally toxic maternal dose levels in the Wistar rat developmental 
toxicity study; however, the concern for the increased susceptibility 
is low, and EPA did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional uncertainty factors 
(UFs) to be used in the risk assessment for flazasulfuron. There was a 
clear NOAEL and LOAEL in the Wistar rat study, and thus the dose 
response for the observed effect is well defined. In addition, since 
the Agency is using PODs for risk assessment that are lower than the 
NOAEL in the Wistar rat study, the PODs are protective of the adverse 
developmental effect.
    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 flazasulfuron is complete, except for 
an immunotoxicity study (OPPTS Guideline 870.7800) and a subchronic 
neurotoxicity study (OPPTS Guideline 870.6200b). These studies are now 
requirements under 40 CFR 158.500 for pesticide registration. In the 
absence of specific immunotoxicity and subchronic neurotoxicity 
studies, EPA has evaluated the available flazasulfuron toxicity 
database to determine whether an additional database uncertainty factor 
is needed to account for potential immunotoxicity or neurotoxicity.
    With the exception of a transient decrease in motor activity at a 
high dose level (1,000 mg/kg/day) in the acute neurotoxicity study, 
which may be associated with a systemic effect, there is no evidence of 
neurotoxicity in the flazasulfuron toxicity database. There is no 
evidence of immunotoxicity in the database, as indicated by hematology, 
lymphoid organ weights and histopathology in standard studies. 
Consequently, EPA believes the existing data are sufficient for 
endpoint selection for exposure/risk assessment and for evaluation of 
the requirements under FQPA, and an additional database uncertainty 
factor is not needed to account for the lack of these studies.
    ii. Although there was evidence of potential increased qualitative 
susceptibility of fetuses in the developmental toxicity study in Wistar 
rats, EPA's concern for increased qualitative susceptibility is low and 
the Agency did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment for flazasulfuron.
    iii. There are no residual uncertainties identified in the exposure 
databases.
    The dietary food exposure assessments were performed based on 100 
PCT and tolerance-level residues. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to flazasulfuron in drinking water. These assessments will not 
underestimate the exposure and risks posed by flazasulfuron.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to flazasulfuron will occupy 4% of the aPAD for infants less than one 
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
flazasulfuron from food and water will utilize 54% of the cPAD for 
infants less than one year old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
flazasulfuron is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Although 
there is potential for short-term residential dermal and inhalation 
post-application exposure to flazasulfuron, no short-term dermal hazard 
was identified for flazasulfuron and inhalation exposure is expected to 
be negligible; therefore, EPA relies on the chronic dietary risk 
assessment for evaluating short-term aggregate exposure to 
flazasulfuron.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
flazasulfuron is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
flazasulfuron.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flazasulfuron is not expected to pose a cancer risk to humans.

[[Page 10967]]

    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to flazasulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography/tandem mass spectrometry with multiple reaction 
monitoring (HPLC/MS-MS/MRM)) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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 flazasulfuron.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the citrus fruit crop group and grape commodity 
terms. ``Grapes'' has been changed to ``grape'' to agree with the 
Agency's Food and Feed Vocabulary. ISK Biosciences Corporation 
petitioned for a tolerance on the crop group ``fruit, citrus, group 
10.'' In the Federal Register of December 8, 2010 (75 FR 76284) (FRL-
8853-8), EPA issued a final rule that revised the crop grouping 
regulations. As part of this action, EPA expanded and revised the 
citrus fruit crop group. Changes to crop group 10 included adding 
Australian desert lime, Australian finger lime, Australian round lime, 
Brown River finger lime, Japanese summer grapefruit, Mediterranean 
mandarin, Mount White lime, New Guinea wild lime, Russell River lime, 
sweet lime, Tachibana orange, Tahiti lime, tangelo, tangor, trifoliate 
orange, and uniq fruit; creating subgroups; revising the representative 
commodities; and naming the new crop group citrus fruit group 10-10. 
EPA indicated in the December 8, 2010 final rule as well as the earlier 
January 6, 2010 proposed rule (75 FR 807) (FRL-8801-2) that, for 
existing petitions for which a Notice of Filing had been published, the 
Agency would attempt to conform these petitions to the rule. That is 
possible here because, despite the revisions to the representative 
commodities for the crop group, the petitioner's residue data 
submission pertaining to the representative commodities for the earlier 
version of the crop group meets the residue data requirements for the 
revised representative commodities. Additionally, EPA assessed the risk 
taking into account the additional crops included in the revised crop 
group. Therefore, consistent with this December 8, 2010 rule, EPA is 
establishing a tolerance on the revised subgroup ``fruit, citrus, group 
10-10.''

V. Conclusion

    Therefore, tolerances are established for residues of 
flazasulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide, including its metabolites and 
degrades, as set forth in the regulatory text.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination With Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not

[[Page 10968]]

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 9, 2012.
Steven Bradbury,
Director, 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 180.655 is added to read as follows:

Sec.  180.655  Flazasulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of 
flazasulfuron, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only flazasulfuron (N-
[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(trifluoromethyl)-2-
pyridinesulfonamide).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Fruit, citrus, group 10-10..................................        0.01
Grape.......................................................        0.01
Sugarcane...................................................        0.01
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-4332 Filed 2-23-12; 8:45 am]
BILLING CODE 6560-50-P
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