Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Rules and Regulations 75389 

Nothing in this section shall affect the 

application of any Federal tax law. 

§ 1807.908 Fraud, waste and abuse. 

Any person who becomes aware of 

the existence or apparent existence of 

fraud, waste or abuse of assistance 

provided under this part should report 

such incidences to the Office of 

Inspector General of the U.S. 

Department of the Treasury. 

Dated: November 24, 2010. 

Donna J. Gambrell, 

Director, Community Development Financial 

Institutions Fund. 

[FR Doc. 2010–30303 Filed 12–2–10; 8:45 am] 

BILLING CODE 4810–70–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0732; FRL–8854–6] 

Metrafenone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of metrafenone 

(3-bromo-6-methoxy-2- 

methylphenyl)(2,3,4-trimethoxy-6- 

methylphenyl)methanone in or on 

grapes. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 3, 2010. Objections and 

requests for hearings must be received 

on or before February 1, 2011, 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–2008–0732. 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: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8050; e-mail 

address: maignan.tawanda@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://www.gpoaccess.gov/ecfr. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go 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–2008–0732 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 February 1, 2011. 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–2008–0732, 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 October 7, 

2009 (74 FR 51599) (FRL–8792–7), 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 8F7371) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.624 be amended by 

establishing tolerances for residues of 

the fungicide metrafenone, (3-bromo-6- 

methoxy-2-methylphenyl)(2,3,4- 

trimethoxy-6-methylphenyl) 

methanone, in or on table and wine 

grapes at 4.5 parts per million (ppm), 

juice grapes at 0.45 ppm, and raisin 

grapes at 17 ppm. That notice 


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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. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the proposed tolerances 

for wine and juice grapes are not 

needed. The reason for this change is 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with 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 metrafenone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with metrafenone 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. 

Metrafenone has low acute toxicity 

via oral, inhalation and dermal routes. 

It is not a dermal sensitizer, or a skin or 

eye irritant. Subchronic and chronic 

studies showed that the liver was the 

primary organ affected in toxicity 

studies with mice, rats and rabbits, 

along with impacts on body weights and 

body weight gains. After chronic 

durations, the liver and body weight 

effects were accompanied by kidney 

effects. In the subchronic and chronic 

toxicity studies in dogs, no effects were 

seen at any dose, up to 500 milligrams/ 

kilogram/day (mg/kg/day). In 

developmental toxicity studies in rats 

and rabbits, there were no effects 

observed in fetuses at any dose level up 

to 700 mg/kg/day in rabbits and 1,000 

mg/kg/day in rats. The maternal effects 

in the rabbit developmental study 

consisted of liver effects as well as 

decreased body weight gains and food 

consumption. In the rat developmental 

toxicity study, no effects were observed 

in the maternal animals. In the 2- 

generation reproduction study, there 

was no evidence of reproductive effects 

or any impacts on the endocrine system. 

Effects in parental animals and offspring 

consisted of decreased body weights 

and body weight gains, and these were 

observed at similar doses. In addition, 

in the parental animals liver effects and 

decreased thymus weights were 

observed at the same high doses that 

resulted in decreased body weight gains. 

Based on a battery of mutagenicity 

studies, metrafenone is not considered 

to be genotoxic. In accordance with the 

EPA’s Final Guidelines for Carcinogen 

Risk Assessment (March, 2005), 

metrafenone is classified as ‘‘Suggestive 

Evidence of Carcinogenicity,’’ and 

concluded that human risk to liver 

tumorgenesis would not be expected at 

exposure levels that do not cause 

tumors in mice. The no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) selected for the chronic 

reference dose (cRfD) are based on 

hepatotoxicity and nephrotoxicity 

observed at doses lower than the liver 

tumor response dose. Thus, the cRfD is 

protective of the cancer effects. The 

weight of evidence considerations can 

be found in the Federal Register of 

September 20, 2006 (71 FR 54915) 

(FRL–8093–7). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by metrafenone as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Metrafenone: Human Health Risk 

Assessment for Foliar Use on Grapes in 

docket ID number EPA–HQ–OPP–2008– 

0732. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL. Uncertainty/safety factors (U/ 

SF) are used in conjunction with the 

POD to calculate a safe exposure level— 

generally referred to as a populationadjusted dose (PAD) (a = acute c = 

chronic) 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 Metrafenone used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METRAFENONE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (All populations, 

including infants and children).

No appropriate endpoint attributable to a single dose identified. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METRAFENONE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Chronic dietary (All populations, NOAEL = 24.9 mg/kg/day ....... Chronic RfD = 0.249 mg/kg/day Combined Chronic/Carcinogenicity¥Rat 

including infants and children). UFA = 10x cPAD = 0.249 mg/kg/day LOAEL = 260 mg/kg/day based on 

UFH = 10x hepatotoxicity and nephrotoxicity in both 

FQPA SF = 1x sexes. 

Cancer (Oral, dermal, inhalation) Suggestive evidence of carcinogenicity. Quantification of cancer risk using a cancer potency factor is not 

required. The chronic reference dose is protective of potential cancer risk. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to metrafenone, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from metrafenone in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for Metrafenone; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCID, Version 2.03), which 

incorporates food consumption data as 

reported by respondents in the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). No Percent Crop 

Treated (PCT) information was 

incorporated into the dietary exposure 

and risk assessment; it was assumed 

that 100 PCT for grapes. As to residue 

levels, EPA assumed treated 

commodities would contain tolerance 

level residues 2X higher than the 

proposed tolerances to account for 

additional residues of potential concern 

with respect to toxicity which were not 

included in the proposed tolerance for 

enforcement purposes. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized and referenced in Unit 

III.A., EPA has concluded that 

metrafenone is classified as ‘‘Suggestive 

Evidence of Carcinogenicity.’’ Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for metrafenone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

metrafenone. 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 First Index Reservoir 

Screening Tool (FIRST), 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 metrafenone for chronic 

exposures for non-cancer assessments 

are estimated to be 22.82 parts per 

billion (ppb) for surface water and 0.097 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic (non-cancer) dietary risk 

assessment, the water concentration of 

value 22.82 ppb was used to assess the 

contribution to drinking water because 

the Tier II PRZM/EXAMS value was 

higher than the Tier I FIRST and 

groundwater values. 

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). 

Metrafenone is not registered for any 

specific use patterns that would result 

in residential exposure. 

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 metrafenone to 

share a common mechanism of toxicity 

with any other substances, and 

metrafenone does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that metrafenone does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 


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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 SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

susceptibility following in utero and/or 

postnatal exposure in the 

developmental toxicity studies in rats or 

rabbits, and in the 2-generation rat 

reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

metrafenone is complete with the 

exception of an immunotoxicity study. 

In accordance with the updated 40 CFR 

part 158 toxicity data requirements for 

conventional pesticides, an 

immunotoxicity study is required for 

metrafenone. EPA has evaluated the 

available metrafenone toxicity data to 

determine whether an additional UFDB

is needed to account for the lack of the 

study. Decreased thymus weight, a 

potential immunotoxic effect, was 

observed only in adults and solely in a 

2-generation reproduction study in rats. 

Because this effect was observed in only 

one species (rats) in one study, at the 

highest dose tested, and the NOAEL for 

this effect is 3X higher than the NOAEL 

for liver toxicity on which the cPAD is 

based, EPA believes the NOAEL for liver 

toxicity is protective of this effect, and 

an additional UFDB is not needed to 

account for potential immunotoxicity. 

ii. There is no indication that 

metrafenone is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

metrafenone 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 food exposure assessments 

were based on assuming 100 PCT and 

residues 2X higher than the proposed 

tolerance residue levels. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to metrafenone 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by metrafenone. 

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. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, metrafenone is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to metrafenone 

from food and water will utilize 1% of 

the cPAD for the general U.S. 

population and 5% of the cPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

There are no residential uses for 

metrafenone. 

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). Because there is no 

residential exposure, metrafenone is not 

expected to pose a short-term risk. 

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). 

Because there is no residential 

exposure, metrafenone is not expected 

to pose an intermediate-term risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized and referenced in Unit 

III.A., EPA has concluded that the cRfD/ 

cPAD for metrafenone is protective of 

the cancer effects. As noted above, the 

chronic exposure for the general U.S. 

population utilizes only 1% of the 

cPAD. 

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 metrafenone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography (GC) 

method with electron capture (ECD) and 

mass spectrometry (MS) detection, 

Method FAMS 105–01, is available to 

enforce the tolerance expression for 

grapes. However, EPA requires 

radiovalidation data for any future 

tolerances on other commodities. Such 

data were being generated at the time 

EPA was reviewing the grape 

submission. 

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 metrafenone. Although there has 

been an agreement to harmonize the 

proposed grape MRL with Canada, the 

MRL has yet to be harmonized between 

member states. 

C. Revisions to Petitioned-for Tolerances 

EPA is not establishing the proposed 

tolerances for wine and juice grapes. 

Tolerances on raw agricultural 

commodities (such as grapes) are 

applicable to food processed from those 

commodities (such as grape juice and 

wine). Because the processing data 

indicate that residues of metrafenone do 

not concentrate in grape juice or wine, 

a tolerance on the raw agricultural 

commodity is all that is necessary. 

EPA is revising the requested 

tolerance expression to clarify the 

chemical moieties that are covered by 


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the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 

tolerances cover residues of the 

fungicide metrafenone, including its 

metabolites and degradates, but that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only metrafenone (3-bromo-6-methoxy2-methylphenyl)(2,3,4-trimethoxy-6- 

methylphenyl)methanone in or on the 

commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of metrafenone, (3-bromo-6- 

methoxy-2-methylphenyl)(2,3,4- 

trimethoxy-6-methylphenyl)methanone, 

in or on grape at 4.5 ppm and grape, 

raisin at 17 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: November 24, 2010. 

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 180.624 paragraph (a) is 

revised to read as follows: 

§ 180.624 Metrafenone; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

metrafenone, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

metrafenone (3-bromo-6-methoxy-2- 

methylphenyl)(2,3,4-trimethoxy-6- 

methylphenyl)methanone in or on the 

following commodities: 

Commodity Parts per million 

Grape .............................. 4 .5 

Grape, raisin ................... 17 

* * * * * 

[FR Doc. 2010–30363 Filed 12–2–10; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 54 

[CC Docket No. 02–6, GN Docket No. 09– 

51; FCC 10–175] 

Schools and Libraries Universal 

Service Support Mechanism and A 

National Broadband Plan for Our 

Future 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) takes another step toward 

realizing the National Broadband Plan’s 

vision of improving connectivity to 

schools and libraries by upgrading and 

modernizing the successful E-rate 

program. In particular, the Commission 

takes action on upgrades that can be 

implemented in funding year 2011 (July 

1, 2011–June 30, 2012); enables schools 

and libraries to better serve students, 

teachers, librarians, and their 

communities by providing more 

flexibility to select and make available 

the most cost-effective broadband and 

other communications services; 

simplifies and streamlines the program; 

and improves safeguards against waste, 

fraud and abuse. In addition, the 

Commission adopts the eligible services 

list for funding year 2011. 

DATES: Effective January 3, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Regina Brown, Wireline Competition 


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