Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 46847 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, these rules do not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

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 action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by October 4, 2010. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the Proposed Rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements. 

Dated: July 6, 2010. 

Keith Takata, 

Acting Regional Administrator, Region IX. 

■ Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220, is amended by 

adding paragraphs (c)(379) 

(i)(A)(3)and(4) to read as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(379) * * * 

(i) * * * 

(A) * * * 

(3) Rule 1111, ‘‘Reduction of NOX

Emissions from Natural Gas-Fired, FanType Central Furnaces,’’ amended on 

November 6, 2009. 

(4) Rule 1147, ‘‘NOX Reductions from 

Miscellaneous Sources,’’ adopted on 

December 5, 2008. 

* * * * * 

[FR Doc. 2010–19057 Filed 8–3–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0797; FRL–8835–8] 

Halosulfuron-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of halosulfuronmethyl in or on multiple commodities 

which are identified and discussed later 

in this document. Additionally, this 

regulation removes the existing 

tolerance on bean, snap, succulent at 

0.05 parts per million (ppm) in that it 

is superseded by this action establishing 

a tolerance at 0.05 ppm on pea and 

bean, succulent shelled, subgroup 6B. 

The Interregional Research Project 

Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 4, 2010. Objections and requests 

for hearings must be received on or 

before October 4, 2010, 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–2009–0797. 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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 


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46848 Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 

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. 

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–2009–0797 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 October 4, 2010. 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–2009–0797, 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 Wednesday, 

January 6, 2010 (75 FR 864) (FRL–8801– 

5), 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 9E7577) by IR-4 

Project Headquarters, 500 College Road 

East, Suite 201 W, Princeton, NJ 08549. 

The petition requested that 40 CFR 

180.479 be amended by establishing 

tolerances for residues of the herbicide 

halosulfuron-methyl, methyl 3-chloro-5- 

[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]

carbonyl]amino]sulfonyl]-1-methyl-1 Hpyrazole-4-carboxylate, and its 

metabolites and degradates (compliance 

with the tolerance level specified is to 

be determined by measuring only those 

halosulfuron-methyl residues 

convertible to 3-chloro-1-methyl-5- 

sulfamoylpyrazole-4-carboxylic acid, 

expressed as the stoichiometric 

equivalent of halosulfuron-methyl) in or 

on pea and bean, succulent shelled, 

subgroup 6B; pea and bean, dried 

shelled, except soybean, subgroup 6C; 

vegetables, tuberous and corm, 

subgroup 1C; bushberry, subgroup 13- 

07B; apple; rhubarb; and okra at 0.05 

ppm That notice referenced a summary 

of the petition prepared by Gowan 

Company, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA is not 

taking action at this time on the 

petitioned-for tolerance for pea and 

bean, dried shelled, except soybean, 

subgroup 6C due to insufficient field 

trial data to support this use. 

Additionally, the Agency is revoking the 

existing tolerance on bean, snap, 

succulent at 0.05 ppm in order to 

eliminate redundancy with the 0.05 

ppm tolerance on pea and bean, 

succulent shelled, subgroup 6B 

established by this action. EPA is also 

revising the tolerance expressions for 

halosurfuron-methyl for new uses in 

this regulation and for existing plant 

and livestock commodities to clarify the 

chemical moieties that are covered by 

the tolerances and specify how 

compliance with the tolerances is to be 

measured. The reasons for these changes 

are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information’’. This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with 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 halosulfuronmethyl including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with halosulfuronmethyl follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 


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Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 46849 

Halosulfuron-methyl has low acute 

toxicity by oral, dermal, and inhalation 

routes of exposure. It is not a dermal 

sensitizer nor is it an eye or skin irritant. 

The toxicity mode of action in mammals 

is undetermined. However, available 

data show that the dog is the most 

sensitive animal species. In the dog, 

decreased body weight was seen in the 

chronic oral toxicity study and 

decreased body weight gain was 

observed in females in the subchronic 

oral toxicity study. In the rat and mouse, 

there was a decrease in body weight 

gains at high dose levels in short-term 

and long-term oral and dermal studies. 

Both acute and subchronic 

neurotoxicity studies showed no 

neurotoxic effects. There was no 

quantitative evidence for increased 

susceptibility following pre- and/or 

post-natal exposure. However, there was 

qualitative evidence for increased 

susceptibility. In the rat developmental 

toxicity study, increases in resorptions, 

soft tissue (dilation of the lateral 

ventricles) and skeletal variations, and 

decreases in body weights were seen in 

the fetuses compared to clinical signs 

and decreases in body weights and food 

consumption in the maternal animals. 

In the rabbit study, increases in 

resorptions and post-implantation losses 

and a decrease in mean litter size were 

seen in the presence of decreases in 

body weight and food consumption in 

maternal animals. Thus, in both species, 

the developmental effect was 

considered to be qualitatively more 

severe than maternal effects. 

Halosulfuron-methyl is classified as 

‘‘not likely to be carcinogenic to 

humans’’ based on a lack of evidence for 

carcinogenicity in mice and rats 

following long-term dietary 

administration. Halosulfuron-methyl is 

negative for mutagenicity in a battery of 

genotoxicity studies. There is no 

evidence of immunotoxicity in the 

available studies for halosulfuronmethyl. Acute and subchronic 

neurotoxicity studies showed no 

evidence of neurotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by halosulfuron-methyl 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document: ‘‘Halosulfuron-Methyl: 

Human Health Risk Assessment for IR4 Proposed Uses on Crop Group 6B 

Succulent Shelled Pea and Bean 

Subgroup, Crop Group 1C Tuberous and 

Corm Vegetables Subgroup, Crop Group 

6C Dried Shelled Pea and Bean (Except 

Soybean), Subgroup 13-07B Bushberry, 

Okra, Apples, and Rhubarb, dated April 

5, 2010,’’ p. 13 in docket ID number 

EPA–HQ–OPP–2009–0797–0005. 

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 halosulfuron-methyl used 

for human risk assessment is shown in 

the Table of this unit. 

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

Exposure/Scenario 

Point of Departure and Uncertainty/FQPA Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary 

(Females 13–49 years of 

age) 

NOAEL = 50 milligrams/kilograms/day (mg/kg/day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.5 mg/kg/day 

aPAD = 0.5 mg/kg/day 

Developmental Toxicity - Rabbit 

LOAEL = 150 mg/kg/day based on decreased 

mean litter size, increased number of resorptions and increased post-implantations loss. 

Acute dietary 

(General population including 

infants and children) 

N/A N/A No adverse effect attributable to a single dose 

was identified and no dose/endpoint was selected. 

Chronic dietary 

(All populations) 

NOAEL= 10 mg/kg/day UFA

= 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.1 mg/kg/ 

day 

cPAD = 0.1 mg/kg/day 

Chronic Toxicity - Dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gains in females. 

Incidental oral short-term 

(1 to 30 days) 

NOAEL= 50 mg/kg/day UFA

= 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100.

Developmental Toxicity - Rabbit 

LOAEL = 150 mg/kg/day based on decreased 

body weight gain, food consumption, and 

food efficiency (maternal toxicity). 

Incidental oral intermediateterm 

(1 to 6 months) 

NOAEL= 10 mg/kg/day 

UFA= 10x 

UFH= 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100 

13 week Subchronic toxicity - Dog 

LOAEL = 40 mg/kg/day based on on decreased 

body weight gains and food efficiency along 

with hematological and clinical chemistry 

changes. 


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46850 Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 

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

Continued 

Exposure/Scenario 

Point of Departure and Uncertainty/FQPA Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Dermal short-term 

(1 to 30 days) 

Dermal study NOAEL = 

100mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100 

21-Day Dermal Toxicity Study - Rat 

LOAEL = 1,000 mg/kg/day based on decreased 

body weight gain in males. 

Dermal intermediate-term 

(1 to 6 months) 

Dermal study NOAEL= 10 

mg/kg/day (dermal absorption rate = 75%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100 

13 Week Subchronic Toxicity - Dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gains and food efficiency along 

with hematological and clinical chemistry 

changes. 

Inhalation short-term 

(1 to 30 days) 

Inhalation study NOAEL = 

50 mg/kg/day (inhalation 

absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100 

Developmental Toxicity - Rabbit 

LOAEL = 150 mg/kg/day based on decreased 

body weight gain, food consumption, and 

food efficiency (maternal toxicity). 

Inhalation Intermediate-term 

(1 to 6 months) 

Inhalation (or oral) study 

NOAEL = 10 mg/kg/day 

(inhalation absorption rate 

= 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100 

13 week Subchronic Toxicity - Dog 

LOAEL = 40 mg/kg/day based on based on decreased body weight gains and food efficiency along with hematological and clinical 

chemistry changes. 

Cancer 

(Oral, dermal, inhalation) 

Classification: ≥not likely to be carcinogenic to humans≥ by the oral route, based on no evidence of carcinogenicity from studies in rats and mice. 

A 75% dermal absorption factor should be used in route-to-route extrapolation for the intermediate term dermal exposure risk. Absorption via 

the inhalation route is presumed to be equivalent to oral absorption.NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (inter-species). UFH = potential variation in sensitivity 

among members of the human population (intra-species). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to halosulfuron-methyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing halosulfuron-methyl tolerances 

in 40 CFR 180.479. EPA assessed dietary 

exposures from halosulfuron-methyl 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 

halosulfuron-methyl including 

decreased mean litter size, increased 

number of resorptions (total and per 

dam) and increased post-implantation 

loss (developmental toxicity) were 

identified for the population subgroup 

females 13 to 49 years old (the only 

population subgroup with a 

toxicological endpoint attributable to a 

single dose of halosulfuron-methyl). 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 and 100 percent 

crop treated (PCT) for all existing and 

recommended new uses of 

halosulfuron-methyl. 

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 and 

100 PCT for all existing and 

recommended new uses of 

halosulfuron-methyl 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that halosulfuron-methyl 

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 PCT 

information EPA did not use anticipated 

residue and/or PCT information in the 

dietary assessment for halosulfuronmethyl. Tolerance level residues and 

100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for halosulfuron-methyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of halosulfuron-methyl. 

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 


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Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 46851 

(EDWCs) of halosulfuron-methyl are 

Tier I EDWCs based on a maximum 

annual application rate of 0.125 lb 

active ingredient (ai)/acre(A) for rice. 

Acute exposures and chronic 

exposures for non-cancer assessments 

are estimated to be 59.2 parts per billion 

(ppb) based on FIRST model for surface 

water and 0.065 ppb bases on SCIGROW model results for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute and chronic dietary risk 

assessment, the water concentration 

value of 59.2 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). 

Halosulfuron-methyl is currently 

registered for the following uses that 

could result in residential exposures: 

Ornamentals, and commercial and 

residential turfgrass. EPA assessed 

residential exposure using the following 

assumptions: Residential handlers may 

receive short-term dermal and 

inhalation exposures to halosulfuronmethyl when mixing, loading and 

applying halosulfuron-methyl products. 

Adults and children may be exposed to 

halosulfuron-methyl residues through 

dermal contact with turf during 

postapplication activities. In addition, 

toddlers may receive short- and 

intermediate-term oral exposure from 

incidental ingestion during 

postapplication activities. 

Halosulfuron-methyl exposure data 

for handler activities were not 

submitted to EPA in support of 

registered lawn uses. EPA’s Draft 

Standard Operating Procedures (SOPs) 

for Residential Exposure Assessments, 

and Recommended Revisions were used 

as the basis for the residential handler 

exposure calculations. The handler 

exposure data used in this assessment 

are from the Outdoor Residential 

Exposure Task Force (ORETF). 

For residential exposure from lawn 

use, the Agency evaluated the combined 

exposure and risk estimates to adults 

from halsulfuron-methyl under 

scenarios including: 

i. Mix/load and broadcast application 

of liquid formulation (garden hose-end 

sprayer) for both dermal and inhalation 

routes, and 

ii. Post-application exposure by 

dermal route. 

For residential postapplication 

exposure, the following scenarios 

resulting from lawn treatment were 

assessed: 

a. Adult and children 3 to <6 years 

old post-application dermal exposure, 

b. Child 3 to <6 years old incidental 

ingestion of pesticide residues on lawns 

from hand-to-mouth transfer, 

c. Toddlers’ object-to-mouth transfer 

from mouthing of pesticide-treated turf 

grass, and 

d. Children 3 to <6 years old 

incidental ingestion of soil from 

pesticide-treated residential areas. Postapplication exposures from various 

activities following lawn treatment are 

considered to be the most common and 

significant in residential settings. 

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 halosulfuronmethyl to share a common mechanism 

of toxicity with any other substances, 

and halosulfuron-methyl does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

halosulfuron-methyl 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 website 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 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for halosulfuron-methyl 

includes rat and rabbit developmental 

toxicity studies and a 2-generation 

reproduction toxicity study in rats. As 

discussed in Unit III.A., there was no 

quantitative evidence for increased 

susceptibility following pre-natal and/or 

post-natal exposure. However, there was 

qualitative evidence for increased 

susceptibility of fetuses in the rat and 

rabbit developmental studies. In the rat 

study, increases in resorptions, soft 

tissue (dilation of the lateral ventricles) 

and skeletal variations, and decreases in 

body weights were seen in the fetuses 

compared to clinical signs and 

decreases in body weights and food 

consumption in the maternal animals. 

In the rabbit study, increases in 

resorptions and post-implantation losses 

and decrease in mean litter size was 

seen in the presence of decreases in 

body weight and food consumption in 

maternal animals. Thus, in both species, 

the developmental effect was 

considered to be qualitatively more 

severe than maternal effects (i.e., 

qualitative evidence for susceptibility). 

In both studies, there are clear NOAELs/ 

LOAELs for developmental and 

maternal toxicities, developmental 

effects were seen in the presence of 

maternal toxicity, and the effects were 

only seen at the high dose. Additionally, 

in rats, developmental effects were seen 

at a dose which is approaching the 

limit-dose. The degree of concern is low 

and there are no residual uncertainties 

for prenatal toxicity in both rats and 

rabbits. 

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 

halosulfuron-methyl is complete except 

for an immunotoxicity study as required 

by the latest amendment to 40 CFR part 

158. After analysis of the database, an 

additional factor (UFDB) for database 

uncertainty is not needed to account for 

the lack of this study because the 

available data do not suggest that this 

chemical affects the immune system. 

ii. There is no indication that 

halosulfuron-methyl is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is qualitative 

evidence of increased susceptibility in 

the prenatal developmental studies in 


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46852 Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 

rats and rabbits, as discussed in this 

unit, there are no residual uncertainties 

after establishing toxicity endpoints and 

the degree of concern for pre-and/or 

post-natal toxicity is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues, and 

conservative (protective) assumptions in 

the ground water and surface water 

modeling were used to assess exposure 

to halosulfuron-methyl in drinking 

water. Similarly conservative 

assumptions were also used to assess 

post-application exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by halosulfuron-methyl. 

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 

halosulfuron-methyl will occupy less 

than 1% of the aPAD for the population 

subgroup of concern, females 13-49 

years old, the only population group 

where there are acute toxicology 

concerns. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to halosulfuronmethyl from food and water will utilize 

5% of the cPAD for all infants less than 

1 year 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 halosulfuron-methyl 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). Halosulfuron-methyl 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 halosulfuron-methyl. 

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 shortterm aggregate MOEs ranging from 2,800 

to 4,800. The MOE for the U.S. 

population is 4,700. The most highly 

exposed subgroup is all infants (< 1 year 

old), with a MOE of 2,800. Because 

these estimates of short-term aggregate 

risk for halosulfuron-methyl are above a 

MOE of 100, these MOEs are not of 

concern to EPA. 

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). 

Halosulfuron-methyl is currently 

registered for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to halosulfuron-methyl. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs ranging from 500 to 

680. The MOE for the U.S. population 

is 500. The most highly exposed 

children’s subgroup was all infants (< 1 

year old), with a MOE of 680. These 

estimates of aggregate risk do not exceed 

the Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

halosulfuron-methyl 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 

halosulfuron-methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate analytical method is 

available for the enforcement of 

tolerances for residues of halosulfuronmethyl in plants. Monsanto Analytical 

Method RES-109-97-4 (gas 

chromatography, using thermionicspecific detection, TSD, nitrogen 

specific) has been validated by EPA. 

The method’s limit of quantitation 

(LOQ) determined across a variety of 

tested crops is 0.05 ppm. 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. 

There are no Codex, Canadian or 

Mexican maximum residue limits 

(MRLs) established for residues of 

halosulfuron-methyl in crop or livestock 

commodities. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is not taking action on the 

petitioned-for tolerance for pea and 

bean, dried shelled (except soybean) 

due to inadequate data available to 

support these uses. Generally, EPA 

recommends that five field trials be 

submitted for peas but none have been 

submitted with this petition. 

EPA is revising the tolerance 

expressions for halosurfuron-methyl for 

new uses in this regulation and for 

existing plant and livestock 

commodities to clarify the chemical 

moieties that are covered by the 

tolerances and specify how compliance 

with the tolerances is to be measured. 

The revised tolerance expression for 

livestock commodities makes clear that 

the tolerances cover residues of 

halosulfuron-methyl and its metabolites 

and degradates and that compliance 

with the tolerance levels will be 

determined by measuring only those 

halosulfuron-methyl residues 

containing the 3-chlorosulfonamide 

(3CSA) moiety, expressed as the 

stoichiometric equivalent of 

halosulfuron-methyl. 


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Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 46853 

EPA believes that it is reasonable to 

make these changes in the tolerance 

expressions final without prior proposal 

and opportunity for comment, because 

public comment is not necessary, in that 

the changes have no substantive effect 

on the tolerance, but rather are merely 

intended to clarify the tolerance 

expression compliance component(s) 

measurement. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide 

halosulfuron-methyl, methyl 5-[(4,6- 

dimethoxy-2-pyrimidiny)amino]

carbonylaminosulfonyl]-3-chloro-1- 

methyl-1H-pyrazole-4-carboxylate, 

including its metabolites and 

degradates, in or on pea and bean, 

succulent shelled, subgroup 6B; 

vegetable, tuberous and corm, subgroup 

1C; bushberry, subgroup 13-07B; apple; 

rhubarb; and okra at 0.05 ppm. 

Compliance with the tolerance level 

specified below is to be determined by 

measuring only halosulfuron-methyl. 

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) (Public Law 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: July 26, 2010. 

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 180.479 is amended as 

follows: 

■ i. Revise the introductory text in 

paragraphs (a)(1) and (a)(2); 

■ ii. In paragraph (a)(2), in the table, 

revise the commodity Bean, snap, 

succulent to read Pea and bean, 

succulent shelled, subgroup 6; and 

■ iii. Alphabetically add the following 

commodities to the table in paragraph 

(a)(2) to read as follows: 

§ 180.479 Halosulfuron-methyl; tolerances 

for residues. 

(a) * * * (1) Tolerances are established 

for residues of the herbicide 

halosulfuron-methyl, methyl 5-[(4,6- 

dimethoxy-2-pyrimidiny)amino] 

carbonylaminosulfonyl]-3-chloro-1- 

methyl-1H-pyrazole-4-carboxylate, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only those halosulfuronmethyl residues containing the 3- 

chlorosulfonamide (3-CSA) moiety, 

expressed as the stoichiometric 

equivalent of halosulfuron-methyl, in or 

on the commodity. 

* * * * * 

(2) Tolerances are established for 

residues of the herbicide halosulfuronmethyl, methyl 5-[(4,6-dimethoxy-2- 

pyrimidiny)amino]

carbonylaminosulfonyl]-3-chloro-1- 

methyl-1H-pyrazole-4-carboxylate, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only halosulfuron-methyl. 

Commodity Parts per million 

* * * * * 

Apple ............................... 0.05 

* * * * * 

Bushberry, subgroup 13- 

07B .............................. 0.05 

* * * * * 

Okra ................................ 0.05 


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46854 Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Rules and Regulations 

Commodity Parts per million 

* * * * * 

Pea and bean, succulent 

shelled, subgroup 6B .. 0.05 

* * * * * 

Rhubarb .......................... 0.05 

* * * * * 

Vegetable, tuberous and 

corm, subgroup 1C ..... 0.05 

* * * * * 

[FR Doc. 2010–19053 Filed 8–3–10; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 97 

[WP Docket No. 10–72, WP Docket No. 10– 

54; FCC 10–124] 

Amendment of the Commission’s 

Rules Regarding Amateur Radio 

Service Communications During 

Government Disaster Drills 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) amends its rules to permit 

amateur radio operators to transmit 

messages, under certain limited 

circumstances, during either 

government-sponsored or nongovernment sponsored emergency and 

disaster preparedness drills, regardless 

of whether the operators are employees 

of entities participating in the drill. 

DATES: Effective September 3, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Beers, Policy Division, Public 

Safety and Homeland Security Bureau, 

(202) 418–1170, or TTY (202) 418–7233. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order (R&O) in WP Docket No. 

10–72; WP Docket No. 10–54; FCC 10– 

124, adopted July 14, 2010, and released 

July 14, 2010. The complete text of this 

document is available for inspection 

and copying during normal business 

hours in the FCC Reference Information 

Center, Room CY–A257, 445 12th Street, 

SW., Washington, DC 20554. This 

document may also be obtained from 

the Commission’s duplicating 

contractor, Best Copy and Printing, Inc., 

in person at 445 12th Street, SW., Room 

CY–B402, Washington, DC 20554, via 

telephone at (202) 488–5300, via 

facsimile at (202) 488–5563, or via 

e-mail at FCC@BCPIWEB.COM. 

Alternative formats (computer diskette, 

large print, audio cassette, and Braille) 

are available to persons with disabilities 

by sending an e-mail to FCC504@fcc.gov 

or calling the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530, TTY (202) 418–0432. This 

document is also available on the 

Commission’s Web site at http:// 

www.fcc.gov. 

Summary of the Report and Order 

1. Current rules provide for amateur 

radio use during emergencies. At the 

same time, the rules prohibit 

communications in which the station 

licensee or control operator has a 

pecuniary interest, including 

communications on behalf of an 

employer. While there are some 

exceptions to this prohibition, there is 

none that would permit amateur station 

control operators who are employees of 

public safety agencies and other entities, 

such as hospitals, to participate in 

drills, tests and exercises in preparation 

for such emergency situations and 

transmit messages on behalf of their 

employers during such drills and tests. 

Accordingly, the Commission amends 

its rules to provide that, under certain 

limited conditions, amateur radio 

operators may transmit messages during 

emergency and disaster preparedness 

drills and exercises, limited to the 

duration of such drills and exercises, 

regardless of whether the operators are 

employees of entities participating in 

the drills or exercises. 

2. One of the fundamental principles 

underlying the amateur radio service is 

the ‘‘[r]ecognition and enhancement of 

the value of the amateur service to the 

public as a voluntary noncommercial 

communication service, particularly 

with respect to providing emergency 

communications.’’ Further, the rules 

state that ‘‘[n]o provision of these rules 

prevents the use by an amateur station 

of any means of radio communication at 

its disposal to provide essential 

communication needs in connection 

with the immediate safety of human life 

and immediate protection of property 

when normal communication systems 

are not available.’’ Indeed, amateur radio 

operators provide essential 

communications links and facilitate 

relief actions in disaster situations. 

While land mobile radio services are the 

primary means of conducting 

emergency communications, amateur 

radio plays a unique and critical role 

when these primary facilities are 

damaged, overloaded, or destroyed. For 

example, during Hurricane Katrina, 

amateur radio operators volunteered to 

support many agencies, such as the 

Federal Emergency Management 

Agency, the National Weather Service, 

and the American Red Cross. Amateur 

radio stations provided urgently needed 

wireless communications in many 

locations where there were no other 

means of communicating and also 

provided other technical aid to the 

communities affected by Hurricane 

Katrina. 

3. Since amateur radio is often an 

essential element of emergency 

preparedness and response, many state 

and local governments, public safety 

agencies, and hospitals incorporate 

amateur radio operators and the 

communication capabilities of the 

amateur service into their emergency 

planning. In this regard, some entities, 

such as hospitals, emergency operations 

centers, and police, fire, and emergency 

medical service stations, have 

emphasized the participation of their 

employees who are amateur station 

operators in emergency and disaster 

drills and tests. For example, a 

representative of the New Orleans 

Urban Area Security Initiative recently 

emphasized the importance of 

conducting emergency drills and the 

need for amateur participation. 

4. The Commission’s rules expressly 

permit operation of amateur stations for 

public service communications during 

emergencies, and on a voluntary basis 

during drills and exercises in 

preparation for such emergencies. 

Given, however, that the Amateur Radio 

Service is primarily designated for 

‘‘amateurs, that is, duly authorized 

persons interested in radio technique 

solely with a personal aim and without 

pecuniary interest,’’ the rules expressly 

prohibit amateur stations from 

transmitting communications ‘‘in which 

the station licensee or control operator 

has a pecuniary interest, including 

communications on behalf of an 

employer.’’ Accordingly, public safety 

and public health entities seeking to 

have employees operate amateur 

stations during government-sponsored 

emergency preparedness and disaster 

drills presently must request a waiver. 

In this connection, Commission staff has 

granted several waivers on a case-by 

case basis. 

5. On February 17, 2010, the 

American Hospital Association (AHA) 

filed a request for a blanket waiver of 

Section 97.113(a)(3) of the 

Commission’s rules to permit hospitals 

seeking accreditation to use amateur 

radio operators who are hospital 

employees to transmit communications 

on behalf of the hospital as part of 

emergency preparedness drills. On 

March 3, 2010, the Wireless 

Telecommunications and Public Safety 


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