
[Federal Register Volume 79, Number 172 (Friday, September 5, 2014)]
[Rules and Regulations]
[Pages 52985-52989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21068]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0445; FRL-9915-32]


Flazasulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
flazasulfuron in or on tree nut group 14-12. ISK Biosciences 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 5, 2014. Objections and 
requests for hearings must be received on or before November 4, 2014, 
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-2013-0445, 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), West William Jefferson Clinton 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, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 305-7090; email address: RDFRNotices@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. 
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/Title40/40tab02.tpl. To access the 
OCSPP 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-2013-0445 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 4, 2014. 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-2013-0445, 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 December 30, 2013 (78 FR 79361) (FRL-
9903-69), 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 
3F8173) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, 
Concord, Ohio 44077. The petition requested that 40 CFR 180.655 be 
amended by establishing tolerances for residues of the herbicide 
flazasulfuron, N-[[4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide, in or on tree nut group 14-12 
at 0.01 parts per million (ppm). That document 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.
    Based upon review of the data supporting the petition, EPA has 
added a tolerance for almond, hulls. The reason 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

[[Page 52986]]

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 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 since there was no corroborating indication of 
neurotoxicity in the subchronic neurotoxicity study. There are no 
indications of immunotoxicity potential from the repeated dose studies 
in the toxicity database. In addition, preliminary assessment of the 
available immunotoxicity study (currently under detailed review) shows 
no immunotoxicity in female mice when tested up to levels near the 
limit dose. Therefore, there are no concerns for immunotoxicity.
    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 Tree Nuts,'' at p. 28 in docket ID 
number EPA-HQ-OPP-2013-0445.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
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
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      NOAEL = 50 mg/kg/day...  Acute RfD = 0.5 mg/kg/   Acute neurotoxicity
 including females, 13-49 years of     UFA = 10x..............   day.                     (rat) LOAEL = 1,000 mg/
 age).                                 UFH = 10x..............  aPAD = 0.5 mg/kg/day...   kg/day based on
                                       FQPA SF = 1x...........                            transient decrease in
                                                                                          motor activity
                                                                                          observed at Day 0 (5
                                                                                          hours post-dosing).

[[Page 52987]]

 
Chronic dietary......................  NOAEL= 1.3 mg/kg/day...  Chronic RfD = 0.013 mg/  Combined Chronic
(All populations)....................  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).
Incidental oral short-term...........  NOAEL= 2 mg/kg/day.....  LOC for MOE = 100......  90-Day Oral Toxicity
(1 to 30 days) and Intermediate Term   UFA = 10x..............                            (dog) LOAEL = 10 mg/kg/
 (1 to 6 months).                      UFH = 10x..............                            day based on changes
                                       FQPA SF = 1x...........                            in liver (increase in:
                                                                                          Deposition of brown
                                                                                          pigments, glutamic
                                                                                          pyruvic transaminase,
                                                                                          creatine
                                                                                          phosphokinase,
                                                                                          inflammatory cell
                                                                                          infiltration,
                                                                                          microgranulomas).
                                      --------------------------------------------------------------------------
Dermal short-term....................    No hazard was identified at the limit dose following dermal exposure.
(1 to 30 days) and Intermediate-Term
 (1 to 6 months).
                                      --------------------------------------------------------------------------
Inhalation short-term................  NOAEL= 2 mg/kg/day.....  LOC for MOE = 100......  90-Day oral toxicity
(1 to 30 days) and Intermediate-Term   UFA = 10x..............                            (dog) LOAEL = 10 mg/kg/
 (1 to 6 months).                      UFH = 10x..............                            day based on changes
                                       FQPA SF =1x............                            in liver (increase in:
                                                                                          Deposition of brown
                                                                                          pigments, glutamic
                                                                                          pyruvic transaminase,
                                                                                          creatine
                                                                                          phosphokinase,
                                                                                          inflammatory cell
                                                                                          infiltration,
                                                                                          microgranulomas).
                                      --------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day= milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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 as well as all existing flazasulfuron 
tolerances in 40 CFR 180.655. 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 U.S. Department of Agriculture's 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 
tolerance level residues and 100% of the crop was treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture's National Health and Nutrition Examination Survey, What 
We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA 
made the same assumptions (tolerance level residues and 100 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 Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for flazasulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flazasulfuron. 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 Tier II PRZM-EXAMS--Index Reservoir model and PRZM-GW 
model, the estimated drinking water concentrations (EDWCs) of 
flazasulfuron for acute exposures are estimated to be 26.9 parts per 
billion (ppb) for surface water and 90.8 ppb for ground water and for 
chronic exposures for non-cancer assessments are estimated to be 4.67 
ppb for surface water and 55.6 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 90.8 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 55.6 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). There are no 
residential uses being requested at this time. Therefore, residential 
handler and post-application scenarios were not assessed for the 
proposed tree nut use. However, there are existing residential uses 
that have been previously assessed and are used in the aggregate 
assessment presented in this document. Flazasulfuron is currently 
registered for the following uses that could result in residential 
exposures: Golf courses, sod farms, professionally managed athletic

[[Page 52988]]

fields, commercial lawns, Christmas trees, and industrial vegetation 
management areas. EPA assessed residential exposure using the following 
assumptions:
    i. Residential Handler Exposures. Residential short-term (1-30 
days) dermal and inhalation exposures are expected from flazasulfuron 
handler activities associated with the residential spot treatment use. 
Since no hazard was identified for the dermal route of exposure, dermal 
risks were not assessed. A MOE greater than 100 for the inhalation 
route is deemed adequate to protect residential flazasulfuron handlers. 
Handler scenarios resulted in MOEs ranging from 27,000 to 6,800,000 for 
inhalation exposures and, therefore are not of concern.
    ii. Residential Post-application Exposures. Since the use sites 
include recreational parks, there is a potential for short-term dermal 
and incidental oral exposures to occur for children from the broadcast 
use of flazasulfuron. When determining the potential for residential 
exposure, the Agency considers residues, leaf to skin/hand residue 
transfer, children's hand-to-mouth transfer, and exposure time. Since 
no hazard was identified for the dermal route of exposure, dermal risks 
were not assessed. All children post-application scenarios resulted in 
MOEs ranging from 2,900 to 1,300,000 for incidental oral exposures and, 
therefore are not of concern.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 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 Food Quality 
Protection Act Safety Factor (FQPA 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, this effect was not seen in the developmental 
study in Sprague-Dawley rats tested up to the limit dose, and this 
concern is further addressed by the presence of clear NOAELs and 
LOAELs, and by the selection of regulatory endpoints that are 
protective of this effect. Therefore, EPA has no concerns for increased 
qualitative susceptibility.
    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.
    ii. There is no concern for increased quantitative or qualitative 
susceptibility in offspring.
    iii. There are no neurotoxicity concerns.
    iv. There are no residual uncertainties regarding exposure.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to flazasulfuron will occupy 3% 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 23% 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). The short-
term aggregate exposure for adults, which accounts for inhalation 
exposure while treating turf and dietary exposure from food and water, 
resulted in an MOE of 1,600 and is not of concern. The short-term 
aggregate exposure for children ages 1<2, which accounts for incidental 
oral exposure from hand-to-mouth activities on treated turf and dietary 
exposure from food and water, resulted in an MOE of 810 and is not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Since intermediate-term residential exposures are not likely to 
occur, intermediate-term aggregate risks were not assessed.
    5. Aggregate cancer risk for U.S. population. Because there was no 
evidence of carcinogenicity in the rat and mouse carcinogenicity 
studies,

[[Page 52989]]

flazasulfuron is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to 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.

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. The Codex has not 
established a MRL for flazasulfuron.

C. Revisions to Petitioned-For Tolerances

    EPA has added a tolerance for almond, hulls. Almond hulls are 
listed separately as a raw agricultural commodity for almonds in Table 
1 of OCSPP 860.1000, and are included in Table 1 Feedstuffs (June 
2008); therefore, a tolerance is required for almond hulls.

V. Conclusion

    Therefore, tolerances are established for residues of 
flazasulfuron, N-[[4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide, in or on tree nut group 14-12 
at 0.01 ppm and on almond hulls at 0.01 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: August 27, 2014.
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.  180.655, add alphabetically the following commodities to 
the table in paragraph (a), to read as follows:


Sec.  180.655  Flazasulfuron; tolerance for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         0.01
 
                                * * * * *
Nut, tree, group 14-12.....................................         0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-21068 Filed 9-4-14; 8:45 am]
BILLING CODE 6560-50-P


