Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Rules and Regulations 10381 

calculating annual gas consumption for 

each fluorinated GHG and N2O used at 

your facility and emissions from the use 

of each fluorinated heat transfer fluid. 

* * * * * 

(3) Ensure that the inventory at the 

beginning of one reporting year is 

identical to the inventory reported at the 

end of the previous reporting year. This 

requirement does not apply to the endof-the-year inventory of fluorinated heat 

transfer fluids in 2011 and the 

beginning-of-the-year inventory of the 

same in 2012. 

* * * * * 

■ 7. Section 98.95 is amended by 

revising paragraph (b) to read as follows: 

§ 98.95 Procedures for estimating missing 

data. 

* * * * * 

(b) If you use fluorinated heat transfer 

fluids at your facility and are missing 

data for one or more of the parameters 

in Equation I–16 of this subpart, you 

must estimate fluorinated heat transfer 

fluid emissions using the arithmetic 

average of the emission rates for the 

reporting year immediately preceding 

the period of missing data and the 

months immediately following the 

period of missing data. Alternatively, 

you may estimate missing information 

using records from the fluorinated heat 

transfer fluid supplier. You must 

document the method used and values 

used for all missing data values. 

■ 8. Section 98.96 is amended by: 

■ a. Revising paragraph (c)(4). 

■ b. Revising paragraph (r). 

■ c. Revising paragraph (s). 

■ d. Adding paragraph (u). 

■ e. Adding paragraph (v). 

§ 98.96 Data reporting requirements. 

* * * * * 

(c) * * * 

(4) Each fluorinated heat transfer fluid 

emitted as calculated in Equation 1–16 

of this subpart. 

* * * * * 

(r) For fluorinated heat transfer fluid 

emissions, inputs to the fluorinated heat 

transfer fluid mass balance equation, 

Equation I–16 of this subpart, for each 

fluorinated heat transfer fluid used. 

(s) Where missing data procedures 

were used to estimate inputs into the 

fluorinated heat transfer fluid mass 

balance equation under § 98.95(b), the 

number of times missing data 

procedures were followed in the 

reporting year, the method used to 

estimate the missing data, and the 

estimates of those data. 

* * * * * 

(u) For each fluorinated heat transfer 

fluid used, whether the emission 

estimate includes emissions from all 

applications or from only the 

applications specified in the definition 

of fluorinated heat transfer fluids in 

§ 98.98. 

(v) For reporting year 2012 only, the 

date on which you began monitoring 

emissions of fluorinated heat transfer 

fluids whose vapor pressure falls below 

1 mm Hg absolute at 25 °C. This is 

either January 1, 2012 or March 23, 

2012. 

■ 9. Section 98.98 is amended by 

removing the definition of ‘‘Heat 

transfer fluids’’ and adding the 

definition of ‘‘Fluorinated heat transfer 

fluids’’ in alphabetical order to read as 

follows: 

§ 98.98 Definitions. 

* * * * * 

Fluorinated heat transfer fluids means 

fluorinated GHGs used for temperature 

control, device testing, cleaning 

substrate surfaces and other parts, and 

soldering in certain types of electronics 

manufacturing production processes. 

Fluorinated heat transfer fluids do not 

include fluorinated GHGs used as 

lubricants or surfactants. For fluorinated 

heat transfer fluids under this subpart I, 

the lower vapor pressure limit of 1 mm 

Hg in absolute at 25 °C in the definition 

of Fluorinated greenhouse gas in § 98.6 

shall not apply. Fluorinated heat 

transfer fluids used in the electronics 

manufacturing sector include, but are 

not limited to, perfluoropolyethers, 

perfluoroalkanes, perfluoroethers, 

tertiary perfluoroamines, and 

perfluorocyclic ethers. 

* * * * * 

■ 10. Table I–2 to Subpart I is revised 

to read as follows: 

TABLE I–2 TO SUBPART I OF PART 98—EXAMPLES OF FLUORINATED GHGS AND FLUORINATED HEAT TRANSFER FLUIDS

USED BY THE ELECTRONICS INDUSTRY

Product type Fluorinated GHGs and fluorinated heat transfer fluids used during manufacture 

Electronics .......................... CF4, C2F6, C3F8, c-C4F8, c-C4F8O, C4F6, C5F8, CHF3, CH2F2, NF3, SF6, and fluorinated HTFs (CF3-(O-CF(CF3)- 

CF2)n-(O-CF2)m-O-CF3, CnF2n∂2, CnF2n∂1(O)CmF2m∂1, CnF2nO, (CnF2n∂1)3N). 

[FR Doc. 2012–3769 Filed 2–21–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0168; FRL–9333–4] 

Metaflumizone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of metaflumizone 

in or on citrus fruit, tree nuts, almond 

hulls; and grape. BASF Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 22, 2012. Objections and 

requests for hearings must be received 

on or before April 23, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0168. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in 

Rm. S–4400, One Potomac Yard (South 

Bldg.), 2777 S. Crystal Dr., Arlington, 

VA. The Docket Facility is open from 

8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays. The 

Docket Facility telephone number is 

(703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Julie 

Chao, Registration Division (7505P), 

Office of Pesticide Programs, 


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Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8735; email address: 

chao.julie@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2008–0168 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 23, 2012. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2008–0168, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of August 10, 

2011 (76 FR 49396) (FRL–8882–8), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 7F7260) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the insecticide 

metaflumizone, in or on: Fruit, citrus, 

group 10 at 0.04 ppm; nut, tree, group 

14 at 0.04 ppm; almond, hulls at 0.04 

ppm; and grape at 0.04 ppm. That notice 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for metaflumizone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with metaflumizone 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. 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, 


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and diffuse atrophy of the mandibular); 

however, there was no evidence of any 

functional deficits at the highest dose 

tested (HDT) 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-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

entitled ‘‘Metaflumizone. Revised 

Human-Health Risk Assessment 

Associated with a Section 3 Registration 

for a Fire Ant Bait for Application to 

Citrus, Tree Nuts, and Grape, and a new 

Section 3 Registration for a Fly Bait for 

Application around Industrial, 

Commercial, Agricultural, and 

Recreational Facilities/Structures and 

Premises’’ in docket ID number EPA– 

HQ–OPP–2008–0168. 

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 

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 in 

this unit: 

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 in which 

no toxicity was observed at any dose 

including the HDT, which is the limit 

dose (1,000 milligrams/kilograms/day 

(mg/kg/day)). 

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 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 HDT of 120 mg/kg bw/ 

day metaflumizone. A combined 

uncertainty factor of 300 was applied to 

account for interspecies (10X) and 

intraspecies (10X) extrapolation and a 

Food Quality Protection Act (FQPA) 

safety factor of 3X. Thus, the acute 

population adjusted dose (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 the 

systemic toxicity observed in the 

chronic toxicity study with dogs. At the 

LOAEL of 30 mg/kg bw/day (NOAEL = 

12 mg/kg bw/day), the effects consisted 

of reduced general health condition, 

slight to severe ataxia, recumbency, and 

severe salivation, slight decreases in 

mean corpuscular hemoglobin 

concentration and total hemoglobin, 

leading to increased plasma bilirubin, 

increased urinary urobilinogen, and 

increased hemosiderin in the liver. A 

combined uncertainty factor of 300 was 

applied to account for interspecies (10X) 

and intraspecies (10X) extrapolation and 

an FQPA safety factor of 3X. 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 2-generation 

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 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. The 

Agency’s level of concern for this 

scenario is 300 based on a 10X 

intraspecies factor, a 10X interspecies 

factor, and an FQPA safety factor of 3X. 

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 Agency’s level of concern for 

this scenario is 100 based on a 10X 

interspecies factor, and a 10X 

intraspecies factor. 

vi. Inhalation (short- and 

intermediate-term). There is a 28-day 

inhalation study for this exposure 

scenario. There was no NOAEL 

identified for female rats. At the LOAEL 

of 0.10 mg/Liter (L) metaflumizone 

(NOAEL = 0.03 mg/L), histopathology of 

the nasal tissues, lungs, thymus, 

prostate, and adrenal cortex was 

observed in males. The LOAEL 

identified in females resulted in 

lymphocyte necrosis in the mesenteric 

lymph node. The Agency’s level of 

concern for this scenario is 1,000 based 

on a 10X interspecies factor, a 10X 

intraspecies factor, and an FQPA safety 

factor of 10X. Route-specific toxicity 

studies were selected for assessment of 


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short-intermediate-term dermal, 

inhalation, and oral exposures. Shortintermediate-term dermal and 

inhalation exposures can be aggregated 

based on the immunotoxic effects seen 

at the LOAEL in the selected studies. 

Short/intermediate-term oral, dermal, 

and inhalation exposures can be 

aggregated based on the decreased body 

weight or decreased body-weight gain 

effects seen at the LOAEL in the 

selected oral and dermal studies and at 

doses above the LOAEL in the selected 

inhalation study. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to metaflumizone, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from metaflumizone 

in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for metaflumizone. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

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 1994–1996 and 1998 

CSFII. 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. Based on the data 

summarized in Unit III.A., 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/or 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 1.14 parts per billion 

(ppb) for surface water and 0.00214 ppb 

for ground water. The EDWCs of 

metaflumizone for chronic exposures for 

non-cancer chronic assessments are 

estimated to be 0.597 ppb for surface 

water and 0.00214 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 1.14 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 0.597 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). 

Metaflumizone is currently registered 

for the following uses that could result 

in residential exposures: Pet spot-on 

products to control fleas on dogs and 

cats; fire ant bait products for 

application to lawns, landscapes, golf 

courses, and other non-cropland area. In 

addition, a pending fly bait product is 

proposed for use in areas where people 

may be present; therefore, a residential 

exposure assessment was performed for 

this use. 

EPA assessed residential exposure 

using the following assumptions: For 

the pet spot-on products, residential 

handler exposure is not expected, 

because the product is applied directly 

from a tube to the pet. Pet spot-on 

applications are expected to result in 

short- and intermediate-term postapplication dermal exposure to all 

populations, and incident oral exposure 

(i.e., hand-to-mouth) for children 3 to <6 

years of age. For the 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, 

landscapes, golf-courses, and other noncropland areas are expected to result in 

short-term, post-application dermal 

exposure to adults, adolescents, and 

children 3 to <6 years old, and incident 

oral exposure for children 3 to <6 years 

old. For the pending fly bait product, 

residential handler exposure is not 

expected, because the product is 

applied by commercial handlers. The 

pending fly bait product is expected to 

result in short-term, post-application 

dermal exposure to adults and children 

3 to <6 years old, and incident oral 

exposure to children 3 to <6 years old. 

For residential handlers, dermal and 

inhalation exposures are combined 

since the endpoints are similar for these 

routes. For children (3 to <6 year olds), 

post-application hand-to-mouth and 

dermal exposures are combined. Since 

the levels of concern (LOCs) for the 

dermal, inhalation and incidental oral 

routes are not the same (dermal LOC = 

100, inhalation LOC = 1,000, 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.’’ 

EPA has not found metaflumizone to 

share a common mechanism of toxicity 

with 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 

assumed that metaflumizone does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 


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Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Rules and Regulations 10385 

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. 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 is no evidence for increased 

qualitative or quantitative sensitivity/ 

susceptibility resulting from prenatal 

and/or postnatal exposures. In the rat 

prenatal development toxicity study, 

there was no offspring toxicity reported 

at any 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 safety 

factor 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 toxicity database for 

metaflumizone is complete. 

ii. There is no indication that 

metaflumizone directly affects the 

nervous system. Clinical signs 

consisting of piloerection and body 

temperature variations were observed 

only in the absence of neuropathology 

and in the presence of a poor general 

state. There is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors to account 

for neurotoxicity. 

iii. There is no evidence that 

metaflumizone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

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

drinking water estimates. Therefore, 

HED concludes that while the 

submission of data/information by the 

petitioner addressing the residue 

chemistry deficiencies may conceivably 

result in adjustment of the maximum 

theoretical residue estimate, actual 

metaflumizone dietary exposure 

estimates will not be greater than those 

generated in the current risk assessment. 

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 postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by metaflumizone. 

v. Dietary exposures (which are more 

relevant for human exposures) exhibited 

an approximately 2-fold greater 

absorption into the systemic circulation 

and, thus, can potentially lead to 

toxicity at 2-fold lower levels of 

exposure. Applying a FQPA safety 

factor 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). 

vi. The FQPA safety factor 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 safety factor of 

10X is adequate due to the severity of 

lymphocyte necrosis being minimal to 

slight and not exhibiting a strong dose 

dependence. 

vii. The FQPA safety factor for dermal 

exposure scenarios is being reduced 

from 10X to 1X since there is a routespecific study with a clear NOAEL. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

metaflumizone will occupy <1% of the 

aPAD for females 13–49 years old. An 

acute dietary exposure estimate was 

generated for females 13–49 years old, 

but not for the remaining population 

subgroups since an endpoint attributed 

to a single dose was not identified for 

those populations. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to metaflumizone 

from food and water will utilize <1% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of metaflumizone is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 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 

level of concern (LOC) is different for 

dermal and oral exposures (100 and 300, 

respectively), 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 3 for the general 

population, and 2 for children 1–2 years 

old. Since the LOCs for the dermal, 

inhalation and incidental oral routes are 

not the same (dermal LOC = 100, 

inhalation LOC = 1,000, and incidental 

oral LOC = 300), these routes were 

combined using the aggregate risk index 

approach. Because EPA’s LOC for 

metaflumizone is an aggregate risk 

index less than 1, the aggregate risks are 

not of concern. These aggregate risk 

indices utilize residential exposure 

estimates from the pet spot-on products, 

which represent the worst-case 

exposure scenario. However, it should 

be noted that all registered pet spot-on 

products containing metaflumizone are 

pending voluntary cancellation; 

therefore, these aggregate risk indices 

can be considered conservative. 

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 currently registered 

for uses that could result in 

intermediate-term residential exposure; 


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

same for metaflumizone, the short-term 

aggregate assessment is protective of 

longer-term exposures. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

metaflumizone is not expected to pose 

a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

metaflumizone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatograph/mass 

spectrometer/mass spectrometer (LC/ 

MS/MS) Method 531/0) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for metaflumizone. 

V. Conclusion 

Therefore, tolerances are established 

for residues of metaflumizone, (E and Z 

isomers; 2-[2-(4-cyanophenyl)-1-[3- 

(trifluoromethyl) phenyl]ethylidene]-N- 

[4-(trifluoromethoxy)phenyl] 

hydrazinecarboxamide) and its 

metabolite 4-{2-oxo-2-[3- 

(trifluoromethyl) phenyl]ethyl}- 

benzonitrile, in or on: Fruit, citrus, 

group 10 at 0.04 ppm; nut, tree, group 

14 at 0.04 ppm; almond, hulls at 0.04 

ppm; and grape at 0.04 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 3, 2012. 

Steven Bradbury, 

Director, 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 added to subpart 

C to read as follows: 

§ 180.657 Metaflumizone; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide metaflumizone, including its 

metabolites and degradates, in or on the 

commodities listed in the following 

table. Compliance with the tolerance 

levels specified in the following table is 

to be determined by measuring only the 

sum of metaflumizone (E and Z isomers; 

2-[2-(4-cyanophenyl)-1-[3- 

(trifluoromethyl) phenyl]ethylidene]-N- 

[4-(trifluoromethoxy)phenyl] 


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Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Rules and Regulations 10387 

hydrazinecarboxamide) and its 

metabolite 4-{2-oxo-2-[3- 

(trifluoromethyl) phenyl]ethyl}- 

benzonitrile, calculated as the 

stoichiometric equivalent of 

metaflumizone, in or on the following 

commodities: 

Commodity Parts per 

million 

Almond, hulls ................................ 0.04 

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

Grape ............................................ 0.04 

Nut, tree, group 14 ....................... 0.04 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–3795 Filed 2–21–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 302 

[EPA–HQ–SFUND–2011–0965; FRL–9635–9] 

Designation of Hazardous Substances; 

Designation, Reportable Quantities, 

and Notification 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to reinstate the maximum 

observed constituent concentrations for 

several listed hazardous wastes that 

were inadvertently removed from the 

regulations by a November 8, 2000 final 

rule. 

DATES: This rule is effective on April 23, 

2012 without further notice, unless EPA 

receives adverse comment by March 23, 

2012. If EPA receives adverse comment, 

we will publish a timely withdrawal in 

the Federal Register informing the 

public that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

SFUND–2011–0965, by one of the 

following methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• Email: superfund.docket@epa.gov. 

• Fax: 202–566–9744. 

• Mail: Environmental Protection 

Agency, EPA Docket Center (EPA/DC), 

Superfund Docket, Mailcode: 28221T, 

1200 Pennsylvania Ave. NW., 

Washington, DC 20460. 

• Hand Delivery: EPA Docket Center 

(EPA/DC), EPA West, Room 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460. Attention Docket ID No. EPA– 

HQ–SFUND–2011–0965. Such deliveries 

are only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–SFUND–2011– 

0965. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through www.regulations.gov, your 

email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the EPA–HQ–SFUND–2011–0965 

docket. This Docket Facility is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The Superfund Docket 

telephone number is (202) 566–0276. 

EPA Docket Center (EPA/DC), EPA 

West, Room 3334, 1301 Constitution 

Ave. NW., Washington, DC. 

FOR FURTHER INFORMATION CONTACT: For 

general information, contact the 

Superfund, TRI, EPCRA, RMP and Oil 

Information Center at (800) 424–9346 or 

TDD (800) 553–7672 (hearing impaired). 

In the Washington, DC metropolitan 

area, call (703) 412–9810 or TDD (703) 

412–3323. For more detailed 

information on specific aspects of this 

direct final rule, contact Lynn Beasley at 

(202) 564–1965 (beasley.lynn@epa.gov), 

U.S. Environmental Protection Agency, 

1200 Pennsylvania Avenue NW., 

Washington, DC 20460–0002, Mail Code 

5104A. 

SUPPLEMENTARY INFORMATION: 

I. Why is EPA using a direct final rule? 

EPA is publishing this rule without a 

prior proposed rule because we view 

this as a noncontroversial action and 

anticipate no adverse comment. This 

action merely reinstates the maximum 

observed constituent concentrations for 

several listed hazardous wastes that 

were inadvertently removed from 

regulations by a November 8, 2000 final 

rule. However, in the ‘‘Proposed Rules’’ 

section of today’s Federal Register, we 

are also publishing a separate proposed 

rule to reinstate these same maximum 

observed constituent concentrations for 

several listed hazardous wastes that 

were inadvertently removed from the 

regulations if adverse comments are 

received on this direct final rule. We 

will not institute a second comment 

period on this action. Any parties 

interested in commenting must do so at 

this time. For further information about 

commenting on this rule, see the 

ADDRESSES section of this document. 

If EPA receives adverse comment, we 

will publish a timely withdrawal in the 

Federal Register informing the public 

that this direct final rule will not take 

effect until EPA addresses all public 

comments in any subsequent final rule 

based on the proposed rule. 

II. Does this action apply to me? 

Type of entity Examples of affected entities 

Federal Agencies ............................ National Response Center and any Federal agency that may release or respond to releases of hazardous 

substances. 


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