Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Rules and Regulations 66795 

§ 300.13 Fee for obtaining a preparer tax 

identification number. 

* * * * * 

(b) Fee. [Reserved] 

* * * * * 

■ Par. 3. Section 300.13T is added to 

read as follows: 

§ 300.13T Fee for obtaining a preparer tax 

identification number. 

(a) [Reserved] 

(b) Fee. The fee to apply for or renew 

a preparer tax identification number is 

$33 per year, which is the cost to the 

government for processing the 

application for a preparer tax 

identification number and does not 

include any fees charged by the vendor. 

(c) [Reserved] 

(d) Effective/applicability date. This 

section will be applicable for all PTIN 

applications filed on or after November 

1, 2015. 

Karen M. Schiller, 

Acting Deputy Commissioner for Services and 

Enforcement. 

Approved: October 16, 2015. 

Mark J. Mazur, 

Assistant Secretary of the Treasury (Tax 

Policy). 

[FR Doc. 2015–27789 Filed 10–29–15; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0607; FRL–9934–88] 

Metaflumizone; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for the combined residues of 

the insecticide metaflumizone in or on 

the raw agricultural commodities citrus 

(crop group 10–10) at 0.04 parts per 

million (ppm); pome fruit (crop group 

11–10) at 0.04 ppm; stone fruit (crop 

group 12–12) at 0.04 ppm; and tree nut 

(crop group 14–12) at 0.04 ppm. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 30, 2015. Objections and 

requests for hearings must be received 

on or before December 29, 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–2014–0607, 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), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http://

www.ecfr.gov/cgi-bin/textidx?&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–2014–0607 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

received by the Hearing Clerk on or 

before December 29, 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– 

2014–0607, 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. Background and Statutory Findings 

In the Federal Register of December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

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 #4F8286) by 

BASF Corporation, P.O. Box 13528, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.657 

be amended by establishing a tolerance 

for the combined residues of the 


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66796 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Rules and Regulations 

insecticide metaflumizone (2-[2-(4- 

cyanophenyl)-1-[3- 

(trifluoromethyl)phenyl]ethylidene]-N- 

[4-(trifluoromethoxy)phenyl] 

hydrazinecarboxamide; E and Z 

isomers) and its metabolite 4-{2-oxo-2- 

[3-(trifluoromethyl)phenyl]ethyl}- 

benzonitrile, in or on the raw 

agricultural commodities citrus (crop 

group 10–10) at 0.04 ppm; pome fruit 

(crop group 11–10) at 0.04 ppm; stone 

fruit (crop group 12–12) at 0.04 ppm; 

and tree nut (crop group 14–12) at 0.04 

ppm. In addition, that petition 

requested removal of the existing 

tolerances for metaflumizone in or on 

fruit, citrus group 10 at 0.04 ppm and 

nut, tree, group 14 at 0.04 ppm upon 

establishment of the petitioned-for 

tolerances. That document included a 

summary of the petition prepared by 

BASF Corporation, the registrant. There 

were no substantive comments received 

in response to the notice of filing. 

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), 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, 

consistent with FFDCA section 

408(b)(2), for a tolerance for 

metaflumizone, including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

establishing the tolerance 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. 

Hematotoxicity (toxicity of the blood) 

was the primary toxic effect of concern 

following subchronic or chronic oral 

exposures to metaflumizone. Splenic 

extramedullary hematopoiesis, 

increased hemosiderin, and anemia 

were the most common hematotoxic 

effects reported after repeated oral 

dosing with metaflumizone. Chronic 

oral (gavage) exposures to dogs resulted 

in slight decreases in mean corpuscular 

hemoglobin concentration and total 

hemoglobin, leading to increased 

plasma bilirubin, increased urinary 

urobilinogen, and increased 

hemosiderin in the liver. In a chronic 

toxicity/carcinogenicity study in mice, 

anemia was observed in the form of 

increased hemosiderin in the spleen, 

increased mean absolute reticulocyte 

count, decreased mean corpuscular 

volume, and mean corpuscular 

hemoglobin. 

The postulated pesticidal mode of 

action of metaflumizone involves 

inhibition of sodium channels in target 

insect species; however, in mammals 

(rats), there were only clinical signs of 

neurotoxicity (i.e., piloerection and 

body temperature variations) with no 

neuropathology in the presence of 

systemic toxicity (e.g., recumbency and 

poor general state) following acute or 

repeated exposures. Similarly, several 

immune system organs seem to be 

affected following metaflumizone 

administration via the oral, dermal, and 

inhalation routes (e.g., the presence of 

macrophages in the thymus, lymphocyte 

necrosis in the mesenteric lymph nodes, 

and diffuse atrophy of the mandibular); 

however, there was no evidence of any 

functional deficits at the highest dose 

tested in a recently submitted and 

reviewed guideline immunotoxicity 

study. Therefore, the clinical 

neurotoxicity signs and the effects on 

the immune system organs following 

metaflumizone administration are likely 

to be secondary to the hematotoxic 

effects. 

Metaflumizone induced an increased 

incidence of a missing subclavian artery 

at a relatively high dose that also caused 

severe maternal toxicity (e.g., late term 

abortions) in the developmental toxicity 

study in rabbits. There was no evidence 

(quantitative or qualitative) of increased 

susceptibility following in utero 

exposures to rats or rabbit and following 

pre- and post natal exposures. There 

was no evidence that metaflumizone is 

genotoxic and carcinogenicity studies 

with mice and rabbits were negative. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by metaflumizone 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 the document 

entitled, ‘‘Metaflumizone: Human 

Health Risk Assessment in Support of 

Section 3 Registrations for Application 

of Metaflumizone to Pome Fruit (crop 

group (CG) 11–10) and Stone Fruit (CG 

12–12); Updating the CG Designation for 

Citrus to 10–10 and Tree Nuts to 14–12; 

and Permitting Aerial Application to 

Citrus Fruits, Grapes, Tree Nuts, and 

Nurseries Containing Field-/ContainerGrown Nonbearing Stone and Pome 

Fruit Trees’’ in docket ID number EPA– 

HQ–OPP–2014–0607. 

B. Toxicological Endpoints of 

Departure/Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOCs) 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 metaflumizone used for 

human risk assessment is provided 

below: 


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i. Acute Dietary Endpoint (General 

population including infants and 

children). An acute dietary endpoint 

was not established for this population 

group since an endpoint of concern 

(effect) attributable to a single dose was 

not identified in the database. Studies 

considered for this endpoint included 

the acute neurotoxicity study for which 

a LOAEL was not observed. 

ii. Acute Dietary Endpoint (Females 

13–49 years old). This endpoint was 

established based on a developmental 

effect observed in the rabbit 

developmental toxicity study that can 

be potentially due to a single dose of 

metaflumizone. This effect consisted of 

an increased incidence of an absent 

subclavian artery in the offspring at the 

LOAEL of 300 milligram/kilogram (mg/ 

kg) body weight/day (bw/day) 

metaflumizone (NOAEL = 100 mg/kg 

bw/day). The rat developmental toxicity 

study was also considered for this 

endpoint; however, no developmental 

effects were observed in this study at 

the highest dose tested of 120 mg/kg 

bw/day metaflumizone. A combined 

uncertainty factor (UF) of 300 was 

applied to account for interspecies (10x) 

and intraspecies (10x) extrapolation. A 

Food Quality Protection Act (FQPA) 

safety factor (SF) of 3x was retained 

because the rabbit developmental 

toxicity study was performed via oral 

gavage dosing. In an absorption study 

submitted by the petitioner, dietary 

exposures (which are more relevant for 

human exposures) exhibited an 

approximately 2-fold greater absorption 

into the systemic circulation than oral 

gavage dosing and, thus, can potentially 

lead to toxicity at 2-fold lower levels of 

exposure. Thus, aPAD for females 13–49 

years old is estimated to be 0.33 mg/kg 

bw/day. 

iii. Chronic Dietary Endpoint. This 

endpoint was established based on 

results of a chronic toxicity study with 

dogs via capsule administration. The 

effects at the LOAEL of 30 mg/kg bw/ 

day (NOAEL = 12 mg/kg bw/day), 

consisted of reduced general health 

condition, slight to severe ataxia, 

recumbency, and severe salivation, 

decreases in mean cell hemoglobin 

concentration (MCHC) and total 

hemoglobin (Hb) and increased 

bilirubin, increased urobilinogen, and 

increased hemosiderin in the liver. A 

combined UF of 300 was applied to 

account for interspecies (10x) and 

intraspecies (10x) extrapolation and an 

FQPA SF of 3x was retained for the 

higher absorption observed in dietary 

exposures to metaflumizone (see above). 

Thus, the chronic population adjusted 

dose (cPAD) is estimated to be 0.040 

mg/kg bw/day. 

iv. Incidental Oral (Short- and 

Intermediate-Term). This endpoint was 

selected on the basis of the maternal 

effects observed in the rat twogeneration reproductive toxicity study 

at the LOAEL of 50 mg/kg bw/day 

metaflumizone (NOAEL = 20 mg/kg bw/ 

day). Maternal toxicity consisted of poor 

general health and body weight deficits 

which were also associated with 

improper nursing behavior. Similar 

effects were also noted in a 

developmental neurotoxicity study 

(gavage, range finding) also considered 

for this endpoint. In this study, poor 

maternal health was also observed at the 

LOAEL of 120 mg/kg bw/day 

metaflumizone (NOAEL = 80 mg/kg bw/ 

day). Both studies considered for this 

endpoint achieved a clear maternal 

NOAEL for the offspring effects, but the 

NOAEL of 20 mg/kg bw/day for the 2- 

generation reproductive toxicity study is 

considered more protective. A 

combined UF of 300 was applied to 

account for interspecies (10x) and 

intraspecies (10x) extrapolation, and an 

FQPA SF of 3x to account for the 2-fold 

greater absorption observed in dietary 

versus oral gavage exposures (see 

above). The LOC is 300. 

v. Dermal (Short- and IntermediateTerm). This endpoint was based on a rat 

90-day dermal toxicity study in which 

deficits in body weight, body-weight 

gain, and food consumption (in males 

and females); anogenital smearing; 

increased macrophages in the thymus; 

lymphocyte necrosis in the mesenteric 

lymph nodes; diffuse atrophy of the 

mandibular lymph node; and increased 

hemosiderin in the liver (females only) 

were observed at the LOAEL of 300 mg/ 

kg bw/day (NOAEL = 100 mg/kg bw/

day). The LOC, for both occupational 

and residential exposure is 100, based 

on a combined UF of 100 for 

interspecies (10x) and in intraspecies 

(10x) extrapolation. The FQPA SF is 

reduced to 1x for this exposure scenario 

because there is no residual uncertainty 

concerning potential effects on infants 

and children. 

vi. Inhalation (Short- and 

Intermediate-Term). There is a 28-day 

inhalation study that is adequate for 

both exposure durations. There was no 

NOAEL identified for female rats. At the 

LOAEL of 0.10 milligrams per Liter (mg/ 

L) metaflumizone (NOAEL = 0.03 mg/L), 

histopathology of the nasal tissues, 

lungs, thymus, prostate, and adrenal 

cortex was observed in males. The 

LOAEL of 0.03 mg/L identified in 

females resulted in lymphocyte necrosis 

in the mesenteric lymph node. 

The methods and dosimetry equations 

described in EPA’s reference 

concentration (RfC) guidance (1994) are 

suited for calculating human-equivalent 

concentrations (HECs) based on the 

inhalation toxicity point of departure 

(NOAEL, LOAEL, or Benchmark Dose 

Lower Confidence Limit (BMDL)) for 

use in MOE calculations. The regionaldeposited-dose ratio (RDDR), which 

accounts for the particulate diameter 

(mass median aerodynamic diameter 

(MMAD) and geometric standard 

deviation (sg) of aerosols), can be used 

to estimate the different dose fractions 

deposited along the respiratory tract. 

The RDDR accounts for interspecies 

differences in ventilation and 

respiratory-tract surface areas. Thus, the 

RDDR can be used to adjust an observed 

inhalation particulate exposure of an 

animal to the predicted inhalation 

exposure for a human. For the 

subchronic inhalation toxicity study 

with metaflumizone, an RDDR was 

estimated at 2.81 based on systemic 

effects (lymphocyte necrosis in the 

mesenteric lymph node) in females at 

the LOAEL of 0.03 mg/L (no NOAEL 

established), and a MMAD of 1.7 

micrometer (mm) and sg of 2.7. 

For this action with metaflumizone, 

residential and occupational handler 

scenarios are being assessed. For 

residential handler scenarios, 2-hr/day 

inhalation exposures are assumed. 

Adjustment to shorter exposure 

scenarios relative to the animal toxicity 

study duration (e.g., 2 hr. residential 

exposures) should only be made if there 

is time-course information that would 

support a shorter time-frame. Since 

there is no such information available 

for metaflumizone, the unadjusted 

animal POD was used to assess the 

shorter duration residential handler 

exposures. Thus, the HEC equals the 

LOAEL from the study, and was 

calculated to be 0.084 mg/L. The FQPA 

SF of 10x is being retained for lack of 

a NOAEL for females in the study. The 

standard interspecies extrapolation UF 

can be reduced from 10x to 3x due to 

the HEC calculation accounting for 

pharmacokinetic (not 

pharmacodynamic) interspecies 

differences. The intraspecies UF 

remains at 10x. Therefore, the LOC for 

this scenario is 300, which includes the 

FQPA SF of 10x, interspecies (3x), and 

intraspecies (10x) extrapolation. 

C. Exposure Assessment 

1. Dietary Exposure from Food and 

Feed Uses. Tolerances have been 

established in (40 CFR 180.657) for the 

residues of metaflumizone, in or on a 

variety of raw agricultural commodities. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

metaflumizone in food as follows: 


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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 metaflumizone. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. As to residue levels in food, 

EPA assumed tolerance-level residues. It 

was further assumed that 100% of crops 

with the requested uses of 

metaflumizone were treated. 

ii. Chronic Exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 

NHANES/WWEIA. As to residue levels 

in food, EPA assumed tolerance-level 

residues. It was further assumed that 

100% of crops with the requested uses 

of metaflumizone were treated. 

iii. Cancer. EPA has concluded that 

metaflumizone 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 or PCT 

information in the dietary assessment 

for metaflumizone. Tolerance-level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary Exposure from Drinking 

Water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for metaflumizone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

metaflumizone. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

metaflumizone for acute exposures are 

estimated to be 1.03 parts per billion 

(ppb) for surface water and 1.09 x 10¥12

ppb for ground water. The EDWCs of 

metaflumizone for chronic exposures for 

non-cancer chronic assessments are 

estimated to be 0.487 ppb for surface 

water and 1.09 x 10¥12 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 1.03 ppb was 

used to assess the contribution of 

drinking water. For chronic dietary risk 

assessment, the water concentration 

value of 0.487 ppb was used to assess 

the contribution of 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). 

Metaflumizone is currently registered 

for the following uses that could result 

in residential exposures: As a fire ant 

bait for application to lawns, 

landscapes, golf courses, and other noncropland area; and as a fly bait for use 

around industrial buildings, commercial 

facilities, agricultural structures/

premises, and recreational facilities/

areas. 

EPA assessed residential exposure 

using the following assumptions: Fire 

ant bait applications to home lawns are 

expected to result in short-term, 

residential handler exposure to adults. 

Fire ant bait applications to lawns and 

golf-courses are expected to result in 

short-term, post-application dermal 

exposure to adults, children 11 to <16 

years old, and children 1 to <2 years 

old, and incident oral exposure for 

children 1 to <2 years old. For the fly 

bait product, residential handler 

exposure is not expected, because the 

product is applied by commercial 

handlers. The fly bait product is 

expected to result in short-term, postapplication dermal exposure to adults, 

children 11 to <16 years old, and 

children 1 to <2 years old, and incident 

oral exposure for children 1 to <2 years 

old. 

For residential handlers, dermal and 

inhalation exposures are combined 

since the endpoints are similar for these 

routes. For children (1- to <2-year-olds), 

post-application hand-to-mouth and 

dermal exposures are combined. Since 

the LOCs for the dermal, inhalation and 

incidental oral routes are not the same 

(dermal LOC = 100, inhalation LOC = 

300, and incidental oral LOC = 300), 

these routes were combined using the 

aggregate risk index approach. 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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

metaflumizone and any other 

substances and metaflumizone does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action; 

therefore, EPA has not assumed that 

metaflumizone has 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 the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s Web site at http://www.epa.gov/

pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional ten-fold 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 data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA SFs, as appropriate. 

2. Prenatal and Postnatal Sensitivity. 

There is no evidence for increased 

qualitative or quantitative sensitivity/

susceptibility resulting from pre- and/or 

postnatal exposures. In the rat prenatal 

development toxicity study, there was 

no offspring toxicity reported at any 


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dose tested whereas in the rabbit study 

a maltransformation based on an absent 

subclavian artery was noted to occur 

only in the presence of severe maternal 

toxicity. Similarly, offspring mortality 

in the 2-generation reproductive toxicity 

occurred only in the presence of a poor 

maternal health state. Thus, there is no 

evidence for increased 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 from 10x to 3x for all oral 

exposure scenarios; retained at 10x for 

inhalation exposure scenarios; and 

reduced to 1x for dermal exposures. 

That decision is based on the following 

findings: 

i. The toxicological database for 

metaflumizone is adequate for risk 

assessment and FQPA SF evaluation. 

Several studies are available for 

evaluating the safety of metaflumizone, 

although differences in dose 

administration and a missing NOAEL 

warrant retention of various FQPA 

safety factors in this instance. 

Dietary exposures exhibited an 

approximately 2-fold greater absorption 

into the systemic circulation as 

compared to oral gavage and, thus, can 

potentially lead to toxicity at 2-fold 

lower levels of exposure. Applying an 

FQPA SF of 3x for all oral exposure 

scenarios is adequate to protect against 

any greater toxicity that might occur in 

dietary exposures (absorption was noted 

to be 2-fold greater in dietary versus oral 

gavage studies). 

The FQPA SF of 10x is being retained 

for inhalation exposure scenarios for the 

use of a LOAEL instead of a NOAEL (no 

NOAEL achieved) for histopathological 

lesions consisting of lymphocyte 

necrosis in the mesenteric lymph node. 

The FQPA SF of 10x is adequate 

because the effect (lymphocyte necrosis) 

is considered minimal to slight and does 

not exhibit a strong dose dependence. 

The FQPA SF for dermal exposure 

scenarios is being reduced from 10x to 

1x since there is a route-specific study 

with a clear NOAEL. 

ii. There is no indication that 

metaflumizone directly affects the 

nervous system. Clinical signs 

indicative of neurotoxicity were 

observed in several studies; however, 

these signs were generally observed in 

the presence of poor animal health (e.g., 

reduced general health condition, loss 

of body weight, or death). In addition, 

no neuropathology was observed in any 

study with metaflumizone. There is no 

need for a developmental neurotoxicity 

study or additional uncertainty factors 

to account for neurotoxicity. 

iii. There are no residual concerns or 

uncertainties for increased sensitivity/

susceptibility in developing animals 

resulting from pre- and/or postnatal 

exposure. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary analyses assumed tolerancelevel residues, 100 PCT, and modeled 

drinking water estimates. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

metaflumizone in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by metaflumizone. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and cPAD. For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-, intermediate-, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. Based on the proposed/registered 

uses and since inhalation, dermal, and 

incidental oral exposures can be 

combined, aggregate acute (dietary), 

short-term (dietary, incidental oral, and/ 

or dermal), and chronic (dietary) 

assessments were conducted. 

1. Acute Risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute aggregate 

exposure assessment consists of 

exposure from only food and water. The 

acute dietary exposure assessment for 

females 13–49 years old was 1.6% of the 

aPAD and therefore, does not exceed 

EPA’s LOC. 

2. Chronic Risk. Since there are no 

registered/proposed uses that result in 

chronic residential exposure, the 

chronic aggregate exposure assessment 

consists of exposure from only food and 

water. The chronic dietary exposure 

estimate was ≤7.2% the cPAD and 

therefore, does not exceed EPA’s LOC. 

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). Metaflumizone is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to metaflumizone. Since the 

LOC and toxicological points of 

departure for the short-term dermal and 

oral routes of exposure differ, the 

aggregate risk index method was used to 

determine aggregate risk (aggregate risk 

indices >1 are not a risk of concern). 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

risk indices of 42 for the general 

population, and 22 for children 1–2 

years old. Because EPA’s LOC for 

metaflumizone is an aggregate risk 

index less than 1, the aggregate risks are 

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). 

Metaflumizone is not currently 

registered for uses that could result in 

intermediate-term residential exposure; 

however, since the PODs for the shortand intermediate-term durations are the 

same for metaflumizone, the short-term 

aggregate assessment is protective of 

intermediate-term exposures. 

5. Aggregate Cancer Risk for U.S. 

Population. As discussed in Unit III.A., 

EPA does not expect metaflumizone 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, and to infants and children 

from aggregate exposure to 

metaflumizone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

EPA previously reviewed method 

validation and independent laboratory 

validation (ILV) studies for the BASF 

high-performance liquid 

chromatography (HPLC)/mass 

spectrometry (MS)/MS analytical 

method 531/0 and forwarded the 

method to FDA for tolerance 

enforcement (46264221.der; D308394, T. 

Bloem, 30-Nov-2005; D328915, T. 

Bloem, 17-May-2006). It is noted that 

following method validation, BASF 

incorporated several minor 

modifications to method 531/0 with this 

revised method specified as 531/1 

(method 531/1 is the current 

enforcement method). Based on the 

similarities of the proposed crops to that 

currently registered and since the grape, 

citrus, and tree nut residue samples 


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were analyzed using a method very 

similar to the current enforcement 

method and since adequate validation 

data were submitted, EPA concludes 

that the current enforcement method is 

suitable for enforcement of the 

tolerances recommended herein. The 

limit of quantitation (LOQ) is 0.01 ppm 

for metaflumizone (E and Z isomers) 

and 0.018 ppm for M320I04 (expressed 

in parent equivalents). 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

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. 

Codex MRLs are not established in/on 

the relevant crops for metaflumizone; 

therefore, harmonization is not an issue 

for this petition. 

V. Conclusion 

Therefore, the tolerance is established 

for the combined residues of the 

insecticide metaflumizone (2-[2-(4- 

cyanophenyl)-1-[3- 

(trifluoromethyl)phenyl]ethylidene]-N- 

[4-(trifluoromethoxy)phenyl] 

hydrazinecarboxamide; E and Z 

isomers), in or on the following raw 

agricultural commodities: Fruit, citrus, 

group 10–10 at 0.04 ppm; fruit, pome, 

group 11–10 at 0.04 ppm; fruit, stone, 

group 12–12 at 0.04 ppm; and nut, tree, 

group 14–12 at 0.04 ppm. The existing 

tolerances for fruit, citrus, group 10 at 

0.04 ppm and for nut, tree, group 14 at 

0.04 ppm are removed because they are 

superseded by the tolerances being 

established in this action. 

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 

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 tolerances 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: October 21, 2015. 

G. Jeffrey Herndon, 

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. Section 180.657 is amended as 

follows: 

■ a. Remove the entries for ‘‘Fruit, 

citrus, group 10’’ and ‘‘Nut, tree, group 

14’’ from the table in paragraph (a). 

■ b. Add alphabetically the following 

list of commodities to the table in 

paragraph (a). 

The additions read as follows: 

§ 180.657 Metaflumizone; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Fruit, citrus, group 10–10 ......... 0.04 

Fruit, pome, group 11–10 ......... 0.04 

Fruit, stone, group 12–12 ......... 0.04 

* * * * * 

Nut, tree, group 14–12 ............. 0.04 

* * * * * 


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* * * * * 

[FR Doc. 2015–27788 Filed 10–29–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0035; FRL–9912–31] 

Rimsulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of rimsulfuron in 

or on sorghum, grain, forage; sorghum, 

grain, grain; and sorghum, grain, stover. 

E.I. du Pont de Nemours and Company 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 30, 2015. Objections and 

requests for hearings must be received 

on or before December 29, 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–2013–0035, 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 Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the Office of 

Chemical Safety and Pollution 

Prevention (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–2013–0035 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 December 29, 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– 

2013–0035, 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 July 19, 

2013 (78 FR 43115) (FRL–9392–9), 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 2F8131) by E.I. du Pont de 

Nemours and Company, 1007 Market 

Street, Wilmington, DE 19898. The 

petition requested that 40 CFR 180.478 

be amended by establishing tolerances 

for residues of the herbicide 

rimsulfuron, N-((4,6- 

dimethoxypyrimidin-2- 

yl)aminocarbonyl)-3-(ethylsulfonyl)-2- 

pyridinesulfonamide, in or on sorghum, 

forage; sorghum, grain; and sorghum, 

stover at 0.01 parts per million (ppm). 

That document referenced a summary of 

the petition prepared by E.I. du Pont de 

Nemours and Company, 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 revised 

the proposed commodity definitions. 

EPA has also revised the chemical name 

nomenclature for rimsulfuron in the 

tolerance expression. The reasons for 

these changes are explained in Unit 

IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 


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