80 FR 30625 - Mesotrione; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 103 (May 29, 2015)

This regulation establishes tolerances for residues of mesotrione in or on almond, hulls, fruit, citrus, group 10-10; fruit, pome, group 11-10; fruit, stone, group 12-12; and nut, tree, group 14- 12. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Rules and Regulations]
[Pages 30625-30630]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12938]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0303; FRL-9927-75]


Mesotrione; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mesotrione in or on almond, hulls, fruit, citrus, group 10-10; fruit, 
pome, group 11-10; fruit, stone, group 12-12; and nut, tree, group 14-
12. Syngenta Crop Protection, LLC requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 29, 2015. Objections and 
requests for hearings must be received on or before July 28, 2015, 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-2014-0303, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0303 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 
July 28, 2015. 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-2014-0303, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online

[[Page 30626]]

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 September 2, 2014 (79 FR 44729) (FRL-
9911-67), 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 
4F8240) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR part 180.571 be amended by 
establishing tolerances for residues of the herbicide, mesotrione, in 
or on citrus fruit, crop group 10-10 at 0.01 parts per million (ppm); 
pome fruit, crop group 11-10 at 0.01 ppm; stone fruit, crop group 12-12 
at 0.01 ppm; tree nuts, crop group 14-12 at 0.01 ppm; and almond hulls 
at 0.015 ppm. That document referenced a summary of the petition 
prepared by Syngenta Crop Protection, LLC the registrant, which is 
available in the docket, http://www.regulations.gov. Comments were 
received in response to the notice of filing. EPA's response to these 
comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance for residues of mesotrione in or on fruit, 
citrus, group 10-10 at 0.01 ppm; fruit, pome, group 11-10 at 0.01 ppm; 
fruit, stone, group 12-12 at 0.01 ppm; nut, tree, group 14-12 at 0.01 
ppm; and almond, hulls at 0.02 ppm. The reason for these changes are 
explained in Unit IV.D.

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 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 mesotrione including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with mesotrione 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.
    In subchronic and chronic oral studies in the rat, mouse, and dog, 
mesotrione produced ocular (ocular discharge and corneal abnormalities 
and lesions), kidney (increased organ weights), and liver effects 
(increased organ weights and hepatocyte fat vacuolation), which are 
consistent with the mammalian toxicity profile for 
hydroxyphenylpyruvate dioxygenase (HPPD) inhibitors caused by high 
tyrosine levels in the blood. Body-weight decrements and decreased food 
consumption were also noted in mice and rats in multiple studies. Even 
though the rat was found to be the most sensitive species for these 
effects, the mouse was identified as a more appropriate model for 
assessing human risk due to similar activity in mice and humans of an 
enzyme involved in tyrosine catabolism. There was evidence of increased 
quantitative susceptibility of rats and mice in the developmental and 
reproduction toxicity studies. Offspring effects in the developmental 
toxicity studies were evidenced by delayed ossification and ancillary 
ribs and vertebrae at doses below or in the absence of maternal 
toxicity in both species. In the reproduction toxicity studies, 
tyrosinemia and ocular discharge were observed in offspring at doses 
below those for parental toxicity, which was evidenced by increased 
organ weights (liver in the rat and kidney in the mouse) and 
tyrosinemia.
    Mesotrione was classified as having low acute toxicity via the 
oral, dermal, and inhalation routes (Toxicity Categories III or IV). It 
is classified as a mild eye irritant, but it is not a dermal sensitizer 
or dermal irritant.
    There was no evidence of neurotoxicity, mutagenicity, carcinogenic 
potential, or immunotoxicity in relevant studies. Specific information 
on the studies received and the nature of the adverse effects caused by 
mesotrione 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 titled, 
``Mesotrione. Human Health Risk Assessment in Support of the Section 3 
Request for Use of Mesotrione on Pome Fruit, Stone Fruit, Citrus, and 
Tree Nuts'', on page 26-29 in docket ID number EPA-HQ-OPP-2014-0303.

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

[[Page 30627]]

complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for mesotrione used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Mesotrione for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)..  Not applicable......  Not applicable.....  No adverse effects attributable to
                                                                               a single dose were observed. As a
                                                                               result, no hazard was identified
                                                                               and an endpoint was not selected.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)  LOAEL = 2.1 mg/kg/    Chronic RfD = 0.007  Reproduction study (mouse)
                                    day.                  mg/kg/day.          LOAEL = 2.1/2.4 mg/kg/day (M/F)
                                   UFA = 10x...........  cPAD = 0.007 mg/kg/   based on tyrosinemia and ocular
                                   UFH = 10x...........   day..                discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   LOAEL = 2.1 mg/kg/    LOC for MOE = 300..  Reproduction study (mouse)
 30 days) and intermediate-term     day.                                      LOAEL = 2.1/2.4 mg/kg/day (M/F)
 (1 to 6 months).                  UFA = 10x...........                        based on tyrosinemia and ocular
                                   UFH = 10x...........                        discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days),  LOAEL = 2.1 mg/kg/    LOC for MOE = 300..  Reproduction study (mouse)
 intermediate-term (1 to six        day.                                      LOAEL = 2.1/2.4 mg/kg/day (M/F)
 months), and long-term (>6        UFA = 10x...........                        based on tyrosinemia and ocular
 months).                          UFH = 10x...........                        discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     LOAEL = 2.1 mg/kg/    LOC for MOE = 300..  Reproduction study (mouse)
 days), intermediate-term (1 to 6   day.                                      LOAEL = 2.1/2.4 mg/kg/day (M/F)
 months), and long-term (>6        UFA = 10x...........                        based on tyrosinemia and ocular
 months).                          UFH = 10x...........                        discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)   Classified as ``not likely to be carcinogenic to humans'' based upon lack of
                                                    evidence of carcinogenicity in rats and mice.
----------------------------------------------------------------------------------------------------------------
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). UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mesotrione, EPA considered exposure under the petitioned-
for tolerances as well as all existing mesotrione tolerances in 40 CFR 
180.571. EPA assessed dietary exposures from mesotrione 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 
mesotrione; 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 National 
Health and Nutrition Examination Survey, What We Eat in America 2003-
2008. The chronic analysis assumed 100% crop treated (CT), Dietary 
Exposure Evaluation Model (DEEM 7.81) default processing factors, and 
tolerance-level residues for all foods. Drinking water was incorporated 
directly into the dietary assessment using the groundwater 
concentration and the PRZM-GW model. The chronic dietary risk 
assessment shows that the chronic dietary risk estimates are not of 
concern (i.e., <100% chronic population-adjusted dose (cPAD)). The 
chronic dietary risk estimate for the highest exposed population 
subgroup, all infants (<1 year old), is 17% of the cPAD.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that mesotrione does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for mesotrione. Tolerance level residues and/or 100% 
CT 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 mesotrione in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of mesotrione. 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) for surface

[[Page 30628]]

water and with Screening Concentration in Ground Water (SCI-GROW) and 
Pesticide Root Zone Model Ground Water (PRZM GW) for ground water, the 
estimated drinking water concentrations (EDWCs) of mesiotrione for 
chronic exposures for non-cancer assessments are estimated to be 5.1 
ppb (1--10 year average) and 2.2 (30-year average) for surface water 
and 18.4 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of 
value 18.4 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).
    Mesotrione is currently registered for the following uses that 
could result in residential exposures: Golf course turf, home lawns, 
and recreational turf. Both liquid and granular formulations are 
registered, resulting in potential residential handler (dermal and 
inhalation) and post-application (dermal and incidental oral) 
exposures. Residential handler (dermal plus inhalation) exposures were 
assessed for adults using various handheld equipment. Post-application 
dermal exposure was assessed for adults, as well as children 11 to <16 
years old, children 6 to <11 years old, and children 1 to <2 years old 
performing various activities on turf. For children 1 to <2 years old, 
incidental oral (hand-to-mouth) post-application exposure was also 
assessed. These uses were assessed using the revised 2012 Residential 
Standard Operating Procedures. 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.''
    There are marked differences among species in the ocular toxicity 
associated with inhibition of HPPD. Ocular effects following treatment 
with HPPD inhibitor herbicides are seen in the rat but not in the 
mouse. Monkeys also seem to be recalcitrant to the ocular toxicity 
induced by HPPD inhibition. One explanation for this species-specific 
response in ocular opacity may be related to species differences in the 
clearance of tyrosine. A metabolic pathway exists to remove tyrosine 
from the blood that involves the liver enzyme TAT. In contrast to rats 
where ocular toxicity is observed following exposure to HPPD-inhibiting 
herbicides, mice and humans are unlikely to achieve the levels of 
plasma tyrosine necessary to produce ocular opacities because the 
activity of TAT in these species is much greater compared to rats.
    HPPD inhibitors (e.g., nitisinone) are used as an effective 
therapeutic agent to treat patients suffering from rare genetic 
diseases of tyrosine catabolism. Treatment starts in childhood but is 
often sustained throughout patient's lifetime. The human experience 
indicates that a therapeutic dose (1 mg/kg/day dose) of nitisinone has 
an excellent safety record in infants, children, and adults and that 
serious adverse health outcomes have not been observed in a population 
followed for approximately a decade. Rarely, ocular effects are seen in 
patients with high plasma tyrosine levels; however, these effects are 
transient and can be readily reversed upon adherence to a restricted 
protein diet. This observation indicates that an HPPD inhibitor in it 
and of itself cannot easily overwhelm the tyrosine-clearance mechanism 
in humans.
    Therefore, exposures to environmental residues of HPPD-inhibiting 
herbicides are unlikely to result in the high blood levels of tyrosine 
and ocular toxicity in humans due to an efficient metabolic process to 
handle excess tyrosine. The Agency continues to study the complex 
relationships between elevated tyrosine levels and biological effects 
in various species. In the future, assessments of HPPD-inhibiting 
herbicides may consider more appropriate models and cross species 
extrapolation methods. Therefore, EPA has not conducted cumulative risk 
assessment with other HPPD inhibitors.

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. There was evidence of 
increased quantitative susceptibility of rats and mice in the 
developmental and reproduction toxicity studies. Offspring effects in 
the developmental toxicity studies were evidenced by delayed 
ossification and ancillary ribs and vertebrae at doses below or in the 
absence of maternal toxicity in both species. In the reproduction 
toxicity studies, tyrosinemia and ocular discharge were observed in 
offspring at doses below those for parental toxicity, which was 
evidenced by increased organ weights (liver in the rat and kidney in 
the mouse) and tyrosinemia.
    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 3x for use of a LOAEL from the reproduction 
toxicity study. That decision is based on the following findings:
    i. The toxicity database for mesotrione is adequate for FQPA 
assessment.
    ii. There is no indication that mesotrione is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. The ocular discharge seen in the reproduction toxicity study 
in mice provided a highly conservative endpoint. The LOAEL for this 
study is currently the lowest dose tested. The incidence of ocular 
discharge lacked a clear dose response, but an effect was evident at 
the highest dose tested indicating that the choice of LOAEL in this 
study may also be conservative.
    iv. There is low concern for susceptibility seen in the 
developmental and reproduction toxicity studies because the doses and 
endpoints selected are protective of effects seen in these studies. The 
doses and endpoints are also protective of developmental effects 
observed in the rat and rabbit developmental toxicity studies.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to mesotrione in drinking water. The residential 
exposure assessments are based upon

[[Page 30629]]

the Residential SOPs, which are based upon reasonable worst-case 
assumptions. These assessments will not underestimate the exposure and 
risks posed by mesotrione.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
mesotrione 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 
mesotrione from food and water will utilize 17% of the cPAD for infants 
(<1 year old) the population group receiving the greatest exposure. 
Chronic aggregate risk consists only of food and water and does not 
include residential post-application exposure. Chronic residential 
exposure is not expected based on the residential use pattern of 
mesotrione.
    3. Short- and intermediate-term risk. The short- and intermediate-
term toxicological PODs for mesotrione are the same for each route of 
exposure. Therefore, for residential exposure scenarios, only short-
term exposures were assessed, and are considered to be protective of 
intermediate-term exposure and risk.
    Short- and intermediate-term aggregate risk is made up of dietary 
and non-dietary sources of exposure. Since mesotrione has residential 
uses on turf, including golf courses, commercial, and residential 
sites, handler and post-application residential exposure is expected. 
Short- and intermediate-term aggregate risk is made up of average 
dietary exposures from food and drinking water sources, dermal, 
inhalation and oral (children only) residential exposures.
    Dietary (food + drinking water) exposure estimates are based on a 
conservative, unrefined chronic dietary exposure assessment. 
Residential exposure estimates are conservative estimates due to the 
standard assumptions that were built into the calculations. For adults, 
dermal plus inhalation exposures from handler activities were factored 
into the aggregate risk calculations. For children (6 to <11 years old) 
and children (11 to <16 years old, post-application dermal exposure 
from activities on treated turf were factored into the aggregate risk 
calculations. For children (1 to <2 years old), both dermal and 
incidental oral exposures were factored into the short-and 
intermediate-term aggregate risk calculations as incidental oral 
exposure is possible for this population. All short-and intermediate-
term aggregate MOEs are not of concern (children 1 to <2 years, MOE = 
1,400; children 6 to <11 years, MOE = 4,500; children 11 to <16 years, 
MOE = 5,800; and adults, MOE = 3,200).
    4. Aggregate cancer risk for U.S. population. An aggregate cancer 
risk was not calculated because mesotrione was classified as ``not 
likely to be carcinogenic to humans''.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to mesotrione residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography method with fluorescence detection) 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 mesotrione.

C. Response to Comments

    On September 2, 2014, EPA published a notice of filing in the 
Federal Register and two comments were received. The commenters noted 
that pesticides and mesotrione pose a risk to pollinators and human 
health. The Agency has determined that mesotrione poses no acute 
contact risk to adult honey bees and there are no risk estimates of 
concern for human health.

D. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance commodity definition for citrus, pome 
fruit, stone fruit, and tree nuts are being revised to conform with EPA 
preferred terms. In addition, based on the method LOQ of 0.01 ppm, EPA 
is revising the petitioned-for tolerance in/on almond hull of 0.02 ppm 
rather than 0.015 ppm.

V. Conclusion

    Therefore, tolerances are established for residues mesotrione in or 
on almond, hulls at 0.02 ppm; fruit, citrus, group 10-10 at 0.01 ppm; 
fruit, pome, group 11-10 at 0.01 ppm; fruit, stone, group 12-12 at 0.01 
ppm; and nut, tree, group 14-12 at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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

[[Page 30630]]

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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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: May 18, 2015.
Daniel J. Rosenblatt,
Acting 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.  180.571, add in alphabetical order entries for ``Almond, 
hulls'', ``Fruit, citrus, group 10-10'', ``Fruit, pome, group 11-10'', 
``Fruit, stone, group 12-12'', and ``Nut, tree, group 14-12'' to the 
table in paragraph (a) to read as follows:


Sec.  180.571  Mesotrione; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         0.02
 
                                * * * * *
Fruit, citrus, group 10-10.................................         0.01
Fruit, pome, group 11-10...................................         0.01
Fruit, stone, group 12-12..................................         0.01
 
                                * * * * *
Nut, tree, group 14-12.....................................         0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-12938 Filed 5-28-15; 8:45 am]
 BILLING CODE 6560-50-P