67910 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 

established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemptions 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of FFDCA section 408(n)(4). 

For these same reasons, the Agency has 

determined that this rule does not have 

any ‘‘tribal implications’’ as described 

in Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: October 28, 2005. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910 the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

Inert Ingredient Limits Uses 

* * * * * * * 

2-Bromo-2-nitro1,3- 

propanediol 

(CAS Reg. 

No. 52–51–7) 

0.04% or 

less by 

weight of 

the total 

pesticide 

formulation 

In-can preservative 

* * * * * * * 

* * * * * 

■ 3. In § 180.930 the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

Inert Ingredient Limits Uses 

* * * * * * * 

2-Bromo-2-nitro1,3- 

propanediol 

(CAS Reg. 

No. 52–51–7) 

0.04% or 

less by 

weight of 

the total 

pesticide 

formulation 

In-can preservative 

* * * * * * * 

* * * * * 

[FR Doc. 05–22255 Filed 11–8–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0254; FRL–7740–8] 

Flucarbazone-sodium; Time-Limited 

Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for combined 

residues of flucarbazone-sodium, 4,5- 

dihydro-3-methoxy-4-methyl-5-oxo-N- 

[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, 

sodium salt and its N-desmethyl 

metabolite in or on wheat, forage at 0.30 

parts per million (ppm); wheat, grain at 

0.01 ppm; wheat, hay at 0.10 ppm; and 

wheat, straw at 0.05 ppm; and combined 

residues of flucarbazone-sodium and its 

metabolites converted to 2- 

(trifluoromethoxy) benzene sulfonamide 

and calculated as flucarbazone-sodium 

in or on milk at 0.005 ppm; meat and 

meat byproducts (excluding liver) of 

cattle, goats, hogs, horses, and sheep at 

0.01 ppm; and liver of cattle, goats, 

hogs, horses, and sheep at 1.5 ppm. 

Arysta LifeScience North America 

Corporation requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). The tolerance will expire on 

November 30, 2006. 

DATES: This regulation is effective 

November 9, 2005. Objections and 

requests for hearings must be received 

on or before January 9, 2006. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 67911 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0254. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

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

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Jim 

Tompkins, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5697; e-mail 

address:Tompkins.Jim@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: 

• 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 provides 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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

http://docket.epa.gov/edkpub/index.jsp. 

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 Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of September 

29, 2000 (65 FR 58364) (FRL–6745–9), 

EPA issued a time-limited tolerance for 

combined residues of the herbicide, 

flucarbazone-sodium, 4,5-dihydro-3- 

methoxy-4-methyl-5-oxo-N- 

[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, 

sodium salt and its N-desmethyl 

metabolite in or on wheat, forage at 0.30 

ppm; wheat, grain at 0.01 ppm; wheat, 

hay at 0.10 ppm; and wheat, straw at 

0.05 ppm; and combined residues of 

flucarbazone-sodium and its metabolites 

converted to 2-(trifluoromethoxy) 

benzene sulfonamide and calculated as 

flucarbazone-sodium in or on milk at 

0.005 ppm; meat and meat byproducts 

(excluding liver) of cattle, goats, hogs, 

horses, and sheep at 0.01 ppm; and liver 

of cattle, goats, hogs, horses, and sheep 

at 1.5 ppm. The tolerance will expire on 

November 1, 2005. 

In the Federal Register of July 27, 

2005 (70 FR 43412) (FRL–7727–2), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 5F6949) by Arysta 

LifeScience North America Corporation, 

100 First Street, Suite 1700, San 

Francisco, CA 94105. The petition 

requested that 40 CFR 180.562 be 

amended by establishing a tolerance for 

combined residues of the herbicide, 

flucarbazone-sodium, 4,5-dihydro-3- 

methoxy-4-methyl-5-oxo-N- 

[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, 

sodium salt and its N-desmethyl 

metabolite in or on wheat, forage at 0.30 

ppm; wheat, grain at 0.01 ppm; wheat, 

hay at 0.10 ppm; and wheat, straw at 

0.05 ppm; and combined residues of 

flucarbazone-sodium and its metabolites 

converted to 2-(trifluoromethoxy) 

benzene sulfonamide and calculated as 

flucarbazone-sodium in or on milk at 

0.005 ppm; meat and meat byproducts 

(excluding liver) of cattle, goats, hogs, 

horses, and sheep at 0.01 ppm; and liver 

of cattle, goats, hogs, horses, and sheep 

at 1.5 ppm. This notice included a 

summary of the petition prepared by 

Arysta LifeScience North America 

Corporation, the registrant. Comments 

were received on the notice of filing. 

EPA response to those comments is 

discussed in Unit IV.D. 

The time limited-tolerance previously 

issued September 29, 2000 (65 FR 

58364) (FRL–6745–9), will be extended 

for 13 months and will expire on 

November 30, 2006. A time-limited 

tolerance will be issued due to 

outstanding studies (independent 

laboratory validations of: Analytical 

Method for the Determination ODesmethyl MKH 6562 (Metabolite of 

MKH 6562 in Soil by High Performance 

Liquid Chromatography Tandem Mass 

Spectrometry), Analytical Method for 

the Determination of MKH 6562 and 

Metabolites NODT (N,Odimethyltriazolinone), Sulfonic Acid 

and Sulfonamide in Soil by High 

Performance Liquid Chromatography 

Tandem Mass Spectrometry, and 

Analytical Method for the 

Determination of MKH 6562 and Three 

Metabolites in Groundwater by High 

Performance Liquid Chromatography 

Tandem Mass Spectrometry) will be 

submitted to the Agency by the 

registrant in January 2006. 

Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

67912 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 

the risk assessment process, see http:// 

docket.epa.gov/edkpub/index.jsp. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of the 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, 

consistent with section 408(b)(2) of the 

FFDCA, for a tolerance for combined 

residues of flucarbazone-sodium, 4,5- 

dihydro-3-methoxy-4-methyl-5-oxo-N- 

[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, 

sodium salt and its N-desmethyl 

metabolite in or on wheat, forage at 0.30 

ppm; wheat, grain at 0.01 ppm; wheat, 

hay at 0.10 ppm; and wheat, straw at 

0.05 ppm; and combined residues of 

flucarbazone-sodium and its metabolites 

converted to 2-(trifluoromethoxy) 

benzene sulfonamide and calculated as 

flucarbazone-sodium in or on milk at 

0.005 ppm; meat and meat byproducts 

(excluding liver) of cattle, goats, hogs, 

horses, and sheep at 0.01 ppm; and liver 

of cattle, goats, hogs, horses, and sheep 

at 1.5 ppm. 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

flucarbazone-sodium 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://docket.epa.gov/ 

edkpub/index.jsp. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http:// 

docket.epa.gov/edkpub/index.jsp. 

A summary of the toxicological 

endpoints for flucarbazone-sodium used 

for human risk assessment is discussed 

in Unit III.B. of the final rule published 

in the Federal Register of September 29, 

2000 (65 FR 58363) (FRL–6745–9). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established 40 CFR 180.562 for the 

combined residues of flucarbazonesodium, in or on wheat, forage at 0.30 

ppm; wheat, grain at 0.01 ppm; wheat, 

hay at 0.10 ppm; and wheat, straw at 

0.05 ppm; and combined residues of 

flucarbazone-sodium and its metabolites 

converted to 2-(trifluoromethoxy) 

benzene sulfonamide and calculated as 

flucarbazone-sodium in or on milk at 

0.005 ppm; meat and meat byproducts 

(excluding liver) of cattle, goats, hogs, 

horses, and sheep at 0.01 ppm; and liver 

of cattle, goats, hogs, horses, and sheep 

at 1.5 ppm. Risk assessments were 

conducted by EPA to assess dietary 

exposures from flucarbazone-sodium 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 one day or 

single exposure. The Dietary Exposure 

Evaluation Model (DEEMTM) analysis 

evaluated the individual food 

consumption as reported by 

respondents in the United States 

Department of Agriculture (USDA) 

1989–1992 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. 

A summary of the acute dietary 

exposure assessment is discussed in 

Unit III.C. of the final rule published in 

the Federal Register of September 29, 

2000 (65 FR 58363). 

ii. Chronic exposure. In conducting 

this chronic dietary exposure and risk 

assessment the DEEMTM analysis 

evaluated the individual food 

consumption as reported by 

respondents in the USDA 1989–1992 

Nationwide CSFII and accumulated 

exposure to the chemical for each 

commodity. 

A summary of the chronic dietary 

exposure assessment is discussed in 

Unit III.C. of the final rule published in 

the Federal Register of September 29, 

2000 (65 FR 58363). 

iii. Cancer. A summary of the dietary 

exposure assessment is discussed in 

Unit III.C. of the final rule published in 

the Federal Register of September 29, 

2000 (65 FR 58363). 

Section 408(b)(2)(E) of the FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide chemicals 

that have been measured in food. If EPA 

relies on such information, EPA must 

require that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. Following the initial 

data submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. As required by 

section 408(b)(2)(E) of the FFDCA, EPA 

will issue a Data Call-In for information 

relating to anticipated residues to be 

submitted no later than 5 years from the 

date of issuance of this tolerance. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

flucarbazone-sodium in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

flucarbazone-sodium. Further 

information regarding EPA drinking 

water models used in pesticide 

exposure assessment can be found at 

http://docket.epa.gov/edkpub/index.jsp. 

A summary of the dietary exposure 

from drinking water assessment is 

discussed in Unit III. C. of the final rule 

published in the Federal Register of 

September 29, 2000 (65 FR 58363). 

Based on the generic expected 

environmental concentration (GENEEC) 

and screening concentration in ground 

water (SCI-GROW) models, the 

estimated environmental concentrations 

(EECs) of flucarbazone-sodium for acute 

exposures are estimated to be 1.42 parts 

per billion (ppb) for surface water and 

Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 67913 

0.2 ppb for ground water. The EECs for 

chronic exposures are estimated to be 

1.25 ppb for surface water and 0.2 ppb 

for ground 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). 

Flucarbazone-sodium is not registered 

for use on any sites that would result in 

residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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 

flucarbazone-sodium and any other 

substances and flucarbazone-sodium 

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 flucarbazone-sodium 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 website at http:// 

www.epa.gov/pesticides/cumulative/. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of the 

FFDCA provides that EPA shall apply 

an additional tenfold 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 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 margin 

of exposure (MOE) analysis or through 

using uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. 

2. Prenatal and postnatal sensitivity. 

A summary of the prenatal and 

postnatal sensitivity assessment is 

discussed in Unit III.D. of the final rule 

published in the Federal Register of 

September 29, 2000 (65 FR 58363). 

3. Conclusion. There is a complete 

toxicity data base for flucarbazonesodium and exposure data are complete 

or are estimated based on data that 

reasonably accounts for potential 

exposures. A summary of the safety 

factor is discussed in Unit III.D. of the 

final rule published in the Federal 

Register of September 29, 2000 (65 FR 

58363). 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. A summary of the acute 

risk assessment is discussed in Unit 

III.E. of the final rule published in the 

Federal Register of September 29, 2000 

(65 FR 58363). 

2. Chronic risk. A summary of the 

chronic risk assessment is discussed in 

Unit III.E. of the final rule published in 

the Federal Register of September 29, 

2000 (65 FR 58363). 

3. Short-term risk. A summary of the 

short-term risk assessment is discussed 

in Unit III.E. of the final rule published 

in the Federal Register of September 29, 

2000 (65 FR 58363). 

4. Intermediate-term risk. A summary 

of the intermediate-term risk assessment 

is discussed in Unit III.E. of the final 

rule published in the Federal Register 

of September 29, 2000 (65 FR 58363). 

5. Aggregate cancer risk for U.S. 

population. A summary of the aggregate 

cancer risk for U.S. population 

assessment is discussed in Unit III.E. of 

the final rule published in the Federal 

Register of September 29, 2000 (65 FR 

58363). 

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 

flucarbazone-sodium residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The petitioner has proposed residue 

analytical methods for tolerance 

enforcement in wheat and livestock 

commodities. The analytical 

enforcement method for wheat employs 

accelerated solvent extraction, clean-up 

using solid phase extraction columns 

followed by detection and quantitation 

by liquid chromatography/tandem mass 

spectroscopy (LC/MS/MS). The 

analytical method for livestock 

commodities is a common moiety 

method which measures residues of 

flucarbazone-sodium (MKH6562) in 

animal tissues and milk by extracting 

and hydrolyzing MKH 6562 and MKH 

6562-related residues to MKH 6562 

sulfonamide. Detection is achieved 

using negative ion electrospray mass 

spectrometry using deuterated MKH 

6562 sulfonamide as an internal 

standard. Both methods have undergone 

successful validations by independent 

laboratories and have been accepted by 

the Agency. The analytical standards for 

these methods are available 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 

A default Maximum Residue Limit 

(MRL) of 0.01 ppm has been established 

in Canada for residues of flucarbazonesodium and its N-desmethyl metabolite 

on wheat grain. This value is consistent 

with the tolerance being established in 

the United States on wheat grain. There 

are no Codex MRLs for this compound 

on wheat. Therefore, no compatibility 

issues exist with Codex in regard to the 

U.S. tolerances discussed in this review. 

C. Conditions 

None. 

D. Comments 

Public comments were received from 

B. Sachau who objected to the proposed 

tolerances because of the supposed 

harmful effects to the human genes. B. 

Sachau’s comments contained no 

scientific data or evidence to rebut the 

Agency’s conclusion that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

flucarbazone-sodium including all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. EPA has responded 

to B. Sachau’s generalized comments on 

numerous previous occasions. 70 FR 

1349, 1354 (January 7, 2005); 69 FR 

63083, 63096 (October 29, 2004). 

V. Conclusion 

Therefore, the time-limited tolerance 

(expires November 30, 2006) is 

established for combined residues of 

flucarbazone-sodium, 4,5-dihydro-3- 

methoxy-4-methyl-5-oxo-N- 

[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, 

sodium salt and its N-desmethyl 

metabolite, in or on wheat, forage at 

0.30 ppm; wheat, grain at 0.01 ppm; 

wheat, hay at 0.10 ppm; and wheat, 

67914 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 

straw at 0.05 ppm; and combined 

residues of flucarbazone-sodium and its 

metabolites converted to 2- 

(trifluoromethoxy) benzene sulfonamide 

and calculated as flucarbazone-sodium 

in or on milk at 0.005 ppm; meat and 

meat byproducts (excluding liver) of 

cattle, goats, hogs, horses, and sheep at 

0.01 ppm; and liver of cattle, goats, 

hogs, horses, and sheep at 1.5ppm. 

VI. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d), as was provided in the 

old sections 408 and 409 of the FFDCA. 

However, the period for filing objections 

is now 60 days, rather than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2005–0254 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before January 9, 2006. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2005–0254, to: Public Information 

and Records Integrity Branch, 

Information Technology and Resources 

Management Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001. In person or by courier, bring a 

copy to the location of the PIRIB 

described in ADDRESSES. You may also 

send an electronic copy of your request 

via e-mail to: opp-docket@epa.gov. 

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of the 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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the 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. The 

Agency hereby certifies that this rule 

will not have significant negative 

economic impact on a substantial 

number of small entities. In addition, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999). Executive Order 

13132 requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 67915 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ This 

final rule directly regulates growers, 

food processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: October 28, 2005. 

Lois Rossi, 

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 180.562 is revised to read 

as follows: 

§ 180.562 Flucarbazone-sodium; 

tolerances for residues. 

(a) General. (1) Time-limited 

tolerances are established for combined 

residues of the herbicide flucarbazonesodium, 4,5-dihydro-3-methoxy-4- 

methyl-5-oxo-N- 

[[2(trifluoromethoxy)phenyl] sulfonyl]- 

1H-1,2,4-triazole 1-carboxamide, 

sodium salt) and its N-desmethyl 

metabolite in or on the following food 

commodities: 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Wheat, forage ..... 0.30 ........... 11/30/06 

Wheat, grain ........ 0.01 ........... 11/30/06 

Wheat, hay .......... 0.10 ........... 11/30/06 

Wheat, straw ....... 0.05 ........... 11/30/06 

(2) Time-limited tolerances are 

established for combined residues of the 

herbicide flucarbazone-sodium, 4,5- 

dihydro-3-methoxy-4-methyl-5-oxo-N- 

[[2(trifluoromethoxy)phenyl] sulfonyl]- 

1H-1,2,4-triazole 1-carboxamide, 

sodium salt) and its metabolites 

converted to 2- 

(trifluoromethoxy)benzene sulfonamide 

and calculated as flucarbazone-sodium 

in or on the following food 

commodities: 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Cattle, liver .......... 1.50 ........... 11/30/06 

Cattle, meat ......... 0.01 ........... 11/30/06 

Cattle, meat byproducts except 

liver.

0.01 ........... 11/30/06 

Goat, liver ............ 1.50 ........... 11/30/06 

Goat, meat .......... 0.01 ........... 11/30/06 

Goat, meat byproducts except 

liver.

0.01 ........... 11/30/06 

Hog, liver ............. 1.50 ........... 11/30/06 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Hog, meat ........... 0.01 ........... 11/30/06 

Hog, meat byproducts except 

liver.

0.01 ........... 11/30/06 

Horse, liver .......... 1.50 ........... 11/30/06 

Horse, meat ........ 0.01 ........... 11/30/06 

Horse, meat byproducts except 

liver.

0.01 ........... 11/30/06 

Milk ...................... 0.005 ......... 11/30/06 

Sheep, liver ......... 1.50 ........... 11/30/06 

Sheep, meat ........ 0.01 ........... 11/30/06 

Sheep, meat byproducts except 

liver.

0.01 ........... 11/30/06 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertant residues. 

[Reserved] 

[FR Doc. 05–22254 Filed 11–8–05; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 20 and 68 

[WT Docket 01–309, FCC 05–166] 

Hearing Aid Compatibility 

Requirements for Wireless Carriers 

Offering Dual-Band GSM Handsets; 

Request for Waiver of Hearing Aid 

Compatibility Requirements for 

Cingular Wireless LLC 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; petitions for waiver. 

SUMMARY: The Federal Communications 

Commission (FCC or Commission) ruled 

that, until August 1, 2006, it will base 

the hearing aid compatibility 

compliance rating of dual-band GSM 

handsets on their operation in the 1900 

MHz band only. Given its broad 

applicability, the Commission clarified 

that its action applies to all handset 

manufacturers, carriers and service 

providers that offer dual-band GSM 

wireless handsets that operate in both 

the 850 MHz and 1900 MHz bands. 

Consistent with this action, the 

Commission granted in part a request 

from Cingular Wireless LLC (Cingular). 

Finally, the Commission imposed 

conditions on Cingular and all other 

entities that elect to avail themselves of 

the temporary relief granted by the 

Memorandum Opinion and Order 

(MO&O). 

DATES: Effective September 8, 2005.