Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Rules and Regulations 30625 

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 19, 2015. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.617: 

■ a. Remove the entries in the table in 

paragraph (a) for ‘‘Canola seed,’’ ‘‘Fruit, 

stone, group 12,’’ ‘‘Nut, tree, group 14,’’ 

and ‘‘Pistachio;’’ 

■ b. Add alphabetically the entries for 

‘‘Fruit, stone, group 12–12’’, ‘‘Nut, tree, 

group 14–12’’, ‘‘Pea and bean, dried 

shelled, except soybean, subgroup 6C’’, 

‘‘Rapeseed subgroup 20A’’, and 

‘‘Sunflower subgroup 20B’’ to the table 

in paragraph (a). 

■ c. Revise paragraph (b). 

The additions and revision read as 

follows: 

§ 180.617 Metconazole; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Fruit, stone, group 12–12 ....... 0 .2 

* * * * * 

Nut, tree, group 14–12 ........... 0 .04 

* * * * * 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C ........................................ 0 .15 

* * * * * 

Rapeseed subgroup 20A ........ 0 .08 

* * * * * 

Sunflower subgroup 20B ........ 0 .7 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2015–12936 Filed 5–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: 

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 Publishing Office’s eCFR 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 


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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. Bodyweight 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-observedadverse-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 


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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

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

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/

day.

UFA = 10x 

UFH = 10x 

FQPA SF/UFL = 3x 

Chronic RfD = 0.007 

mg/kg/day.

cPAD = 0.007 mg/

kg/day. 

Reproduction study (mouse) 

LOAEL = 2.1/2.4 mg/kg/day (M/F) based on tyrosinemia and 

ocular discharge. NOAEL not established. 

Incidental oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

LOAEL = 2.1 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF/UFL = 3x 

LOC for MOE = 300 Reproduction study (mouse) 

LOAEL = 2.1/2.4 mg/kg/day (M/F) based on tyrosinemia and 

ocular discharge. NOAEL not established. 

Dermal short-term (1 to 30 

days), intermediate-term (1 to 

six months), and long-term 

(>6 months).

LOAEL = 2.1 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF/UFL = 3x 

LOC for MOE = 300 Reproduction study (mouse) 

LOAEL = 2.1/2.4 mg/kg/day (M/F) based on tyrosinemia and 

ocular discharge. NOAEL not established. 

Inhalation short-term (1 to 30 

days), intermediate-term (1 to 

6 months), and long-term (>6 

months).

LOAEL = 2.1 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF/UFL = 3x 

LOC for MOE = 300 Reproduction study (mouse) 

LOAEL = 2.1/2.4 mg/kg/day (M/F) based on tyrosinemia and 

ocular discharge. NOAEL not established. 

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 populationadjusted 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 


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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 nonoccupational, 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-tomouth) 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 tyrosineclearance mechanism in humans. 

Therefore, exposures to 

environmental residues of HPPDinhibiting 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 


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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 postapplication 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 postapplication 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 shortand intermediate-term aggregate risk 

calculations as incidental oral exposure 

is possible for this population. All shortand 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 


Lhorne on DSK2VPTVN1PROD with RULES
30630 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 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: 

§ 180.571 Mesotrione; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Part 56 

Piping Systems and Appurtenances 

CFR Correction 

■ In Title 46 of the Code of Federal 

Regulations, Parts 41 to 69, revised as of 

October 1, 2014, on page 229, in 

§ 56.70–15, the heading for paragraph 

(b) is reinstated before paragraph (1) to 

read: ‘‘(b) Girth butt welds.’’ 

[FR Doc. 2015–13052 Filed 5–28–15; 8:45 am] 

BILLING CODE 1505–01–D 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 15–98; RM–11748; DA 15– 

621] 

Television Broadcasting Services; 

Providence, Rhode Island 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Commission has before it 

a Notice of Proposed Rulemaking issued 

in response to a petition for rulemaking 

filed by WJAR Licensee, LLC (the 

Licensee), the licensee of WJAR(TV), 

channel 51, Providence, Rhode Island, 

requesting the substitution of channel 

50 for channel 51 at Providence. The 

licensee filed comments reaffirming its 

interest in the proposed channel 

substitution and stated that if the 

proposal is granted, it will promptly file 

an application for the facilities specified 

in its rulemaking petition and construct 

the station. The licensee asserts that 

adopting the proposed channel 

substitution would serve the public 

interest because it would remove any 

potential interference with a wireless 

licensee in the Lower 700 MHz A Block 

located adjacent to channel 51 in 

Providence, Rhode Island-New Bedford, 

Massachusetts and Boston, 

Massachusetts television markets. 

DATES: This rule is effective May 29, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Jeremy Miller, Jeremy.Miller@fcc.gov, 

Media Bureau, (202) 418–1507. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 15–98, 

adopted May 22, 2015, and released 

May 22, 2015. The full text of this 

document is available for public 

inspection and copying during normal 

business hours in the FCC’s Reference 

Information Center at Portals II, CY– 

A257, 445 12th Street SW., Washington, 

DC 20554. This document will also be 

available via ECFS (http://

fjallfoss.fcc.gov/ecfs/). To request 

materials in accessible formats for 

people with disabilities (braille, large 

print, electronic files, audio format), 

send an email to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice), 202– 

418–0432 (tty). 

This document does not contain 

information collection requirements 

subject to the Paperwork Reduction Act 

of 1995, Public Law 104–13. In addition, 

therefore, it does not contain any 


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