81878 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

G. Executive Order 13175—Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). In this action, EPA is not 

addressing any tribal implementation 

plans. This action is limited to states 

that do not meet their existing 

obligation for PSD SIP submittal. Thus, 

Executive Order 13175 does not apply 

to this action. 

Although Executive Order 13175 does 

not apply to this final rule, EPA 

specifically solicited additional 

comment on the proposal for this action 

from tribal officials and we received one 

comment from a tribal agency. 

Additionally, EPA participated in a 

conference call on July 29, 2010, with 

the National Tribal Air Association 

(NTAA). 

H. Executive Order 13045—Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets E.O. 13045 (62 FR 

19885, April 23, 1997) as applying only 

to those regulatory actions that concern 

health or safety risks, such that the 

analysis required under section 5–501 of 

the E.O. has the potential to influence 

the regulation. This action is not subject 

to E.O. 13045 because it merely 

prescribes EPA’s action for states that do 

not meet their existing obligation for 

PSD SIP submittal. 

I. Executive Order 13211—Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211 (66 FR 28355 (May 22, 2001)), 

because it is not a significant regulatory 

action under Executive Order 12866. 

This action merely prescribes EPA’s 

action for states that do not meet their 

existing obligation for PSD SIP 

submittal. 

J. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Public Law 

104–113, 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. NTTAA directs EPA to provide 

Congress, through OMB, explanations 

when the Agency decides not to use 

available and applicable voluntary 

consensus standards. 

This rulemaking does not involve 

technical standards. Therefore, EPA is 

not considering the use of any voluntary 

consensus standards. 

K. Executive Order 12898—Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 (59 FR 7629, 

February 16, 1994) establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the U.S. 

EPA has determined that this final 

rule will not have disproportionately 

high and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. This rule merely 

prescribes EPA’s action for states that do 

not meet their existing obligation for 

PSD SIP submittal. 

L. 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. Section 804 

exempts from section 801 the following 

types of rules: (1) Rules of particular 

applicability; (2) rules relating to agency 

management or personnel; and (3) rules 

of agency organization, procedure, or 

practice that do not substantially affect 

the rights or obligations of non-agency 

parties. 5 U.S. 804(3). EPA is not 

required to submit a rule report 

regarding this action under section 801 

because this is a rule of agency 

organization, procedure, or practice that 

does not substantially affect the rights or 

obligations of non-agency parties. 

V. Judicial Review 

Under section 307(b)(1) of the Act, 

judicial review of this final action is 

available by filing of a petition for 

review in the U.S. Court of Appeals for 

the District of Columbia Circuit by 

February 28, 2011. Any such judicial 

review is limited to only those 

objections that are raised with 

reasonable specificity in timely 

comments. Under section 307(b)(2) of 

the Act, the requirements of this final 

action may not be challenged later in 

civil or criminal proceedings brought by 

us to enforce these requirements. 

VI. Statutory Authority 

The statutory authority for this action 

is provided by sections 101, 111, 114, 

116, and 301 of the CAA as amended 

(42 U.S.C. 7401, 7411, 7414, 7416, and 

7601). 

List of Subjects in 40 CFR Part 52 

Air pollution control, Carbon dioxide, 

Carbon dioxide equivalents, Carbon 

monoxide, Environmental protection, 

Greenhouse gases, Hydrofluorocarbons, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Methane, Nitrogen dioxide, Nitrous 

oxide, Ozone, Particulate matter, 

Perfluorocarbons, Reporting and 

recordkeeping requirements, Sulfur 

hexafluoride, Sulfur oxides, Volatile 

organic compounds. 

Dated: December 23, 2010. 

Gina McCarthy, 

Assistant Administrator, Office of Air and 

Radiation. 

[FR Doc. 2010–32762 Filed 12–28–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0205; FRL–8857–4] 

Imazosulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of imazosulfuron 

in or on pepper, bell; pepper, non-bell; 

rice, grain; and tomato. Valent USA 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 29, 2010. Objections and 

requests for hearings must be received 

on or before February 28, 2011, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 


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ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0205. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0205 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 28, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0205, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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 May 6, 2009 

(74 FR 20947) (FRL–8412–7), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 9F7535) by Valent 

USA Corporation, 1600 Riviera Ave., 

Suite 200, Walnut Creek, CA 94596. The 

petition requested that 40 CFR part 180 

be amended by adding a section for the 

herbicide imazosulfuron and 

establishing tolerances therein for 

residues of imazosulfuron, 2-chloro-N- 

[[(4,6-dimethoxy-2- 

pyrimidinyl)amino]carbonyl] imidazo- 

[1,2-a]pyridine-3-sulfonamide, in or on 

pepper, bell, fruit; pepper, non-bell, 

fruit; rice, grain; and tomato, fruit; each 

at 0.02 parts per million (ppm). That 

notice referenced a summary of the 

petition prepared by Valent USA 

Corporation, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

EPA has modified the proposed 

commodity terms for pepper and tomato 

commodities and revised the requested 

tolerance expression in accordance with 

current policy. The reasons for these 

changes are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

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 


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sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for imazosulfuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with imazosulfuron 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. 

The toxicology data for imazosulfuron 

suggest that this herbicide possesses 

relatively low toxicity. Many of the 

effects of single or repeated dosing were 

observed near or beyond the respective 

limit doses. 

Imazosulfuron is of low acute toxicity 

by the oral, dermal, and inhalation 

routes of exposure; it is not a skin or eye 

irritant or a dermal sensitizer. The 

primary target organ of imazosulfuron in 

repeated-dose studies was the liver in 

all species tested. Mild to moderate 

thyroid effects were apparent only in 

the chronic toxicity study in dogs. 

Dramatic eye effects (retinal 

degeneration, lens vascularization, 

cataracts and corneal scarring) were 

observed in rats fed > 1,000 mg/kg/day 

beginning at 3 months in the chronic 

toxicity/carcinogenicity study. Ocular 

effects (increased incidence of eye 

opacity, corneal edema, inflammation 

and neovascularization) were also 

observed in the high-dose males (4,577 

mg/kg/day) in the 90-day feeding 

toxicity study in rats. Decreased body 

weight and body weight gain compared 

to control were frequent findings 

throughout the toxicology database for 

imazosulfuron. 

Clinical signs (decreased motor 

activity, abnormal gait, upward 

curvature of the spine and piloerection) 

were observed in males at the limit dose 

of the acute neurotoxicity study; 

however, these effects can be attributed 

to generalized toxicity and were 

resolved by Day 2 of the study. No 

neurotoxic effects were observed during 

the subchronic screening battery or 

noted as clinical signs in any other 

repeated-dose study. 

No developmental effects were 

observed at the highest dose tested 

(HDT) (125 mg/kg/day) in the rabbit 

developmental toxicity study. No 

developmental or reproductive toxicity 

was observed in the 1-generation rat 

study. Decreased pup viability was 

observed in the rat 2-generation 

reproduction study at a dose 

approaching the limit dose (LOAEL = 

892 mg/kg/day) in both the F1 and F2 

offspring generations. Mortality was also 

observed in the parental generation at 

this dose. No increased qualitative or 

quantitative offspring susceptibility was 

apparent in any of the submitted studies 

for imazosulfuron. 

There was no evidence of 

carcinogenicity in rats and mice up to 

the limit dose at 24 and 18 months, 

respectively. Imazosulfuron was 

determined to be non-mutagenic in 

bacteria and negative in an in vivo 

mammalian cytogenetics assay. Overall, 

there was no evidence that 

imazosulfuron was either mutagenic or 

clastogenic in either in vivo or in vitro 

assays. The cancer classification is ‘‘not 

likely to be carcinogenic to humans,’’ 

based on the absence of significant 

tumor increases in the carcinogenicity 

studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by imazosulfuron as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Imazosulfuron: Human Health Risk 

Assessment for Proposed Uses on Rice, 

Peppers and Tomatoes,’’ p. 45 in docket 

ID number EPA–HQ–OPP–2009–0205. 

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 

imazosulfuron used for human risk 

assessment is shown in the Table of this 

unit. 

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

ASSESSMENT

Exposure/Scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–49 years of 

age).

An acute reference dose specific to females age 13–49 was not identified, because there was no 

prenatal or fetal toxicity observed in developmental or reproductive animal studies following a single oral dose. 

Acute dietary (General population including 

females 13–49 years of age and infants 

and children).

NOAEL = 400 mg/kg/day UFA = 

10x.

Acute RfD = 4 mg/ 

kg/day.

Acute neurotoxicity screening battery. 

LOAEL = 2,000 mg/kg/day based on the 

following clinical signs: Abnormal gait, 

decreased activity, piloerection and upward curvature of the spine; and incidents of irregular breathing, reduced 

righting reflex, tremors, decreased visual placement response in males and 

increased response to sound in one 

female. 


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

ASSESSMENT—Continued 

Exposure/Scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

UFH = 10x ...................................

FQPA SF = 1x ............................

aPAD = 4 mg/kg/ 

day 

Chronic dietary (All populations) ................ NOAEL= 75 mg/kg/day UFA = 

10x.

Chronic RfD = 0.75 

mg/kg/day.

Chronic toxicity in the dog. 

LOAEL = 150 mg/kg/day based on moderate thyroid hypertrophy (males at 

mid- and high-dose; mild hypertrophy 

in females at high-dose). 

UFH = 10x ...................................

FQPA SF = 1x ............................

cPAD = 0.75 mg/kg/ 

day.

Incidental oral short-term (1 to 30 days) 

and intermediate-term (1 to 6 months).

NOAEL= 235 mg/kg/day UFA = 

10x.

LOC for MOE = 100 Reproduction, 2-generation (rat). 

LOAEL = 892 mg/kg/day based on mortality, clinical signs, decreased body 

weights, body weight gains and food 

consumption in parents. 

90-day oral toxicity (rat). 

LOAEL = 956 mg/kg/day based on decreased body weight gains and food 

efficiency. 

UFH = 10x.

FQPA SF = 1x.

Dermal short-term (1 to 30 days) and intermediate-term (1 to 6 months).No systemic toxicity occurred at the limit dose and the primary toxic effects of concern (liver, eye) 

were adequately assessed in a 21-day dermal toxicity study. It is concluded that this compound 

is not or is poorly absorbed through the skin and, therefore, a quantitative risk assessment for 

this route and duration of exposure is not necessary. 

Inhalation short-term (1 to 30 days) and intermediate-term (1 to 6 months).Inhalation (or oral) study NOAEL 

= 235 mg/kg/day (inhalation 

absorption rate = 100%).

LOC for MOE = 100 Reproduction, 2-generation (rat). 

LOAEL = 892 mg/kg/day based on mortality, clinical signs, decreased body 

weights, body weight gains and food 

consumption in parents. 

UFA = 10x.

UFH = 10x.

FQPA SF = 1x ............................ ................................. 90-day oral toxicity (rat). LOAEL = 956 

mg/kg/day based on decreased body 

weight gains and food efficiency. 

Cancer (Oral, dermal, inhalation) ............... Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of significant tumor 

increases in two adequate rodent carcinogenicity studies. 

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

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account 

for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = 

acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to imazosulfuron, EPA 

considered exposure under the 

petitioned-for tolerances. There are no 

tolerances currently established for 

imazosulfuron. EPA assessed dietary 

exposures from imazosulfuron 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 imazosulfuron. 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 

Intakes by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

that residues are present in all 

commodities at the tolerance level and 

that 100% of commodities are treated 

with imazosulfuron. DEEMTM 7.81 

default concentration factors were used 

to estimate residues of imazosulfuron in 

processed commodities. 

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 that residues are present in all 

commodities at the tolerance level and 

that 100% of commodities are treated 

with imazosulfuron. DEEMTM 7.81 

default concentration factors were used 

to estimate residues of imazosulfuron in 

processed commodities. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified imazosulfuron as ‘‘Not 

likely to be Carcinogenic to Humans’’; 

therefore, a dietary exposure assessment 

for the purpose of assessing cancer risk 

is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for imazosulfuron. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The residues of concern in 

drinking water include imazosulfuron 

and its degradates HMS, IPSN, UDPM, 

ADPM, and SDPM. The Agency used 

screening level water exposure models 

in the dietary exposure analysis and risk 

assessment for imazosulfuron and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 

imazosulfuron and its degradates. 

Further information regarding EPA 


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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), Tier 1 Rice 

Model, and Screening Concentration in 

Ground Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of imazosulfuron and its 

degradates for both acute exposures and 

chronic exposures for non-cancer 

assessments are estimated to be 278.9 

parts per billion (ppb) for surface water 

(based on the Tier 1 Rice Model results) 

and 4.8 ppb for ground water (based on 

the SCI–GROW model results). 

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 278.9 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). 

Imazosulfuron is currently registered for 

the following uses that could result in 

residential exposures: Residential 

turfgrass and recreational areas. EPA 

assessed residential exposure using the 

following assumptions: There is a 

potential for exposure of homeowners 

applying products containing 

imazosulfuron on home lawns. There is 

also a potential for post-application 

exposure of adults and children entering 

turf areas that have been treated with 

imazosulfuron and for bystander 

exposure of adults and children in areas 

adjacent to pesticide applications. 

Residential handlers may receive 

short-term dermal and inhalation 

exposure to imazosulfuron when 

mixing, loading and applying the 

pesticide on home lawns. Since a 

dermal endpoint of concern was not 

identified for imazosulfuron, only shortterm inhalation exposure of residential 

handlers was assessed. 

Adults and children may receive 

short-term inhalation and dermal 

exposures from entering turf areas 

treated with imazosulfuron. 

Volatilization of imazosulfuron may 

also be a source of short-term postapplication inhalation exposure of 

bystanders nearby application sites. 

Finally, children may receive short-term 

incidental oral exposure (i.e., hand-tomouth, object-to-mouth and soil 

ingestion exposure) during postapplication activities on treated turf. 

EPA did not identify any dermal 

endpoints of concern for imazosulfuron; 

and a quantitative post-application 

inhalation exposure assessment was not 

performed for imazosulfuron due to its 

low acute inhalation toxicity, low vapor 

pressure (< 3.5 × 10¥6 Pa), low proposed 

use rate (0.3 lb ai/A), and the soildirected application method (i.e., it is 

not applied using equipment, such as 

air blast sprayers, that would result in 

higher post-application inhalation 

exposures). Therefore, EPA assessed 

only short-term post-application 

incidental oral exposure of children 

(toddlers). 

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 imazosulfuron to 

share a common mechanism of toxicity 

with any other substances, and 

imazosulfuron does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that imazosulfuron does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

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 pre- and postnatal toxicity database 

for imazosulfuron includes guideline rat 

and rabbit developmental toxicity 

studies and a 2-generation reproduction 

toxicity study in rats. No developmental 

effects were observed at the HDT in the 

rabbit developmental toxicity study, and 

no developmental or reproductive 

toxicity was observed in the 

developmental (1-generation) rat study. 

In the 2-generation rat reproduction 

study, both decreased pup viability and 

parental mortality were observed, but 

only at a dose approaching the limit 

dose. 

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 

imazosulfuron is largely complete, 

lacking only an immunotoxicity study. 

EPA has evaluated the available toxicity 

data for imazosulfuron and determined 

that an additional database uncertainty 

factor is not needed to account for 

potential immunotoxicity. The most 

sensitive endpoint in the database is 

moderate thyroid hypertrophy. Liver 

toxicity accompanied by body weight 

and food consumption effects is seen 

throughout the toxicology database. No 

treatment-related changes indicative of 

potential immunotoxicity were seen in 

hematology parameters, organ weights 

(thymus, spleen), gross necropsy 

(enlarged lymph nodes) or 

histopathology (spleen, thymus, lymph 

nodes) when tested up to the limit dose 

in mice and rats. Therefore, EPA does 

not believe that conducting a special 

series 870.7800 immunotoxicity study 

will result in a NOAEL less than 75 mg/ 

kg/day, which is presently used as the 

point of departure for chronic risk 

assessment. 

ii. No neurotoxic effects were 

observed during the subchronic 

screening battery or noted as clinical 

signs in any other repeated-dose study. 

Although untoward clinical signs were 

observed in the acute neurotoxicity 

study, these effects can be attributed to 

generalized toxicity and were resolved 

by Day 2 of the study. Based on these 

considerations, there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

imazosulfuron results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 


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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 81883 

iv. There are no significant residual 

uncertainties in the exposure databases. 

Data have been requested to confirm the 

stability of imazosulfuron during frozen 

storage and the metabolic profile of 

pyrimidine-labeled imazosulfuron in 

rice grain in the confined rotational crop 

trial. A field rotational crop study is also 

required for grain (wheat); however, as 

explained in Unit III.D.3.iv.c., EPA does 

not expect these studies to have a 

measurable impact on exposure 

estimates for imazosulfuron. 

a. Storage stability. The final reports 

of the storage stability studies must be 

submitted, reflecting frozen storage 

intervals of up to 11.8 months for 

peppers, up to 34.5 months for rice 

grain, and up to 17.3 months for 

tomatoes. Interim data suggest that 

imazosulfuron is stable in frozen 

storage, and similar sulfonylurea 

chemicals are known to be stable. 

Therefore, EPA expects imazosulfuron 

to be stable in frozen storage but is 

requiring the final study reports as 

confirmation. 

b. Metabolic profile. The HPLC profile 

for the pyrimidinyl (Py)-label grain 

storage stability analysis must be 

submitted to confirm that the metabolite 

profile was stable in Py-label grain. 

Grain samples from the confined 

rotational crop study were stored for a 

relatively long interval (9 months) prior 

to completion of the analyses. Analysis 

of an imidozolyl (Im)-label sample after 

the 9-month period yielded a metabolic 

profile similar to that of a sample 

analyzed at the start of the period. A 

similar comparison must be made for 

the Py-label sample of grain. This is of 

no practical consequence for risk 

assessment because total residue levels 

on grain were small (<0.01 ppm at a 

365-day plantback interval), 

imazosulfuron was not present, and no 

metabolites/degradates were considered 

toxicologically significant. 

c. Field accumulation in rotational 

crops (grain). The grain (wheat) 

rotational crop study is needed to 

identify maximum levels of residues in 

grain and livestock feed items (forage, 

straw) as a function of the plantback 

interval. On an interim basis, a 

plantback interval of 12 months is being 

required for grains and soybeans. The 

results of the rotational crop study may 

allow a shorter plantback interval. The 

confined rotational crop study showed 

that imazosulfuron and metabolites will 

be negligible (<0.01 ppm) on forage, 

hay, straw, stover, and grain at a 365- 

day plantback interval and will, 

therefore, make no contribution to 

dietary exposure. 

The dietary food exposure 

assessments were performed assuming 

tolerance-level residues and 100 PCT for 

all commodities. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

imazosulfuron in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by imazosulfuron. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to imazosulfuron 

will occupy 1.4% of the aPAD for 

infants less than 1 year old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to imazosulfuron 

from food and water will utilize 2.7% of 

the cPAD for 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 

imazosulfuron 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). Imazosulfuron 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 imazosulfuron. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 40,000 for adults and 7,000 for 

children. For adults, the aggregate MOE 

includes short-term residential handler 

inhalation exposure plus chronic 

dietary exposure to imazosulfuron from 

food and water. For children, the 

aggregate MOE includes short-term 

incidental oral residential exposure plus 

chronic dietary exposure to 

imazosulfuron from food and water. 

Because EPA’s level of concern for 

imazosulfuron is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified; however, imazosulfuron is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

imazosulfuron. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

imazosulfuron 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 

imazosulfuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry (LC/ 

MS/MS) Method RM–42C–3) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 


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81884 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for imazosulfuron. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is revising the proposed 

commodity terms for ‘‘pepper, bell, 

fruit’’; ‘‘pepper, non-bell, fruit’’; and 

‘‘tomato, fruit’’; to read ‘‘pepper, bell’’; 

‘‘pepper, non-bell’’; and ‘‘tomato’’. The 

commodity terms have been changed in 

accordance with the guidance in the 

Agency’s Food and Feed Commodity 

Vocabulary. 

EPA is also revising the requested 

tolerance expression 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 makes clear that the 

tolerances cover residues of the 

herbicide imazosulfuron, including its 

metabolites and degradates, but that 

compliance with the tolerance levels is 

to be determined by measuring only 

imazosulfuron, 2-chloro-N-[[(4,6- 

dimethoxy-2- 

pyrimidinyl)amino]carbonyl]imidazo- 

[1,2-a]pyridine-3-sulfonamide, in or on 

the commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of imazosulfuron, including 

its metabolites and degradates, in or on 

pepper, bell at 0.02 ppm; pepper, nonbell at 0.02 ppm; rice, grain at 0.02 ppm; 

and tomato at 0.02 ppm. Compliance 

with the tolerance levels is to be 

determined by measuring only 

imazosulfuron, 2-chloro-N-[[(4,6- 

dimethoxy-2- 

pyrimidinyl)amino]carbonyl]imidazo- 

[1,2-a]pyridine-3-sulfonamide, in or on 

the commodities. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 13, 2010. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.651 is added to read as 

follows: 

§ 180.651 Imazosulfuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

imazosulfuron, including its metabolites 

and degradates, in or on the following 

commodities. Compliance with the 

tolerance levels specified in the 

following table below is to be 

determined by measuring only 

imazosulfuron, 2-chloro-N-[[(4,6- 

dimethoxy-2- 

pyrimidinyl)amino]carbonyl]imidazo- 

[1,2-a]pyridine-3-sulfonamide, in or on 

the commodity. 


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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 81885 

Commodity Parts per 

million 

Pepper, bell .............................. 0.02 

Pepper, non-bell ....................... 0.02 

Rice, grain ................................ 0.02 

Tomato ...................................... 0.02 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2010–32451 Filed 12–28–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 413, 422, and 495 

[CMS–0033–F2] 

RIN 0938–AP78 

Medicare and Medicaid Programs; 

Electronic Health Record Incentive 

Program; Correcting Amendment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correcting 

amendment. 

SUMMARY: This document corrects 

typographical and technical errors 

identified in the final rule entitled 

‘‘Medicare and Medicaid Programs; 

Electronic Health Record Incentive 

Program’’ that appeared in the July 28, 

2010 Federal Register. 

DATES: Effective Date: This correcting 

amendment is effective December 29, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Maisler, (410) 786–5754. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2010–17207 (75 FR 44314) 

the final rule entitled ‘‘Medicare and 

Medicaid Programs; Electronic Health 

Record Incentive Program’’ (hereinafter 

referred to as the Medicare and 

Medicaid EHR Incentive Program), there 

were several technical and 

typographical errors that are identified 

in the Summary of Errors section and 

corrected in the Correction of Errors 

section and in the regulations text of 

this correcting amendment. 

II. Summary of Errors 

A. Errors in the Preamble 

In the preamble to this final rule, we 

made the following technical and 

typographical errors. 

On page 44314, in the FOR FURTHER

INFORMATION CONTACT, we are correcting 

the contact information for Medicaid 

incentive payment issues for better 

accuracy. 

On page 44337, in our response to a 

comment on the objective generate and 

transmit permissible prescriptions 

electronically, we inadvertently 

referenced only the restrictions 

established by the Department of Justice 

(DOJ) on electronic prescribing for 

controlled substances in Schedule II, 

when in fact we meant to include 

Schedule II–V. We intended to 

encompass all prescriptions where eprescribing is not permitted, so we are 

including Schedules III–V. At the time 

of the publication of the our January 13, 

2010 proposed rule, the Drug 

Enforcement Agency (DEA) had not 

published its March 31, 2010 final rule 

(75 FR 16236) on the electronic 

prescribing of controlled substances. We 

are aligning our regulation with the DEA 

regulations regarding electronic 

prescribing of controlled substances by 

adding schedules II–V so that we are in 

line with DEA regulation. 

On page 44351, in our discussion of 

the proposed rule EP/Eligible Hospital 

Measure, we erroneously referred to 

‘‘five rules’’ related to clinical decision 

support although we reduced that 

requirement to one rule. 

On page 44359, in our response to a 

comment regarding charging fees, we 

inadvertently omitted a word. Also, in 

our discussion of the numerator and 

denominator for the clinical summary 

objective, we inadvertently referred to 

unique patients, rather than to office 

visits. As the measure for this objective 

relies on office visits (see 

§ 495.6(d)(13)), we are correcting the 

preamble to also refer to office visits. 

We have also eliminated a reference in 

the preamble to eligible hospitals and 

CAHs in the threshold for this objective, 

as the objective applies only to EPs. 

On pages 44440 and 44442, we are 

revising our discussions of hospitalbased EPs, so that they correctly refer to 

EPs that furnish ‘‘90 percent or more,’’ 

(rather than ‘‘more than 90 percent’’) of 

their covered professional services in an 

inpatient or emergency department 

setting. This is in keeping with the 

definition in § 495.4. 

On page 44487, we are correcting the 

preamble to more precisely state that the 

90-day period for deriving hospitals’ 

patient volume is based on the 

preceding fiscal year. This is in keeping 

with § 495.306, which specifically 

references the fiscal year. 

Also, on page 44487 and page 44488 

we inadvertently referred to hospitals 

when discussing the patient panel 

methodology for estimating Medicaid 

patient volume. As the patient panel 

methodology will be used only by EPs 

(and as our regulation cites only to EPs 

when discussing the patient panel 

methodology—see § 495.306(d)), we are 

eliminating the references to hospitals. 

On page 44488, we incorrectly 

included ‘‘unduplicated Medicaid 

encounters’’ in the last sentence, instead 

of ‘‘unduplicated encounters.’’ This 

correction allows for us to keep the 

numerator and denominator consistent 

when determining the Medicaid patient 

volume. 

On pages 44499, 44518, 44549, and 

44562, we made typographical errors 

which include errors in mathematical 

symbols, column headings, and the 

numbering and referencing of tables. 

B. Errors in the Regulation Text 

On page 44568, in § 495.6(d)(14)(i), 

we erroneously omitted medication 

allergies in the list of examples. 

Therefore, we are including this 

reference to be consistent with the 

preamble of the July 28, 2010 final rule. 

On page 44568, in § 495.6(e)(1), we 

inadvertently omitted a reference to the 

exclusion for any EP who writes fewer 

than 100 prescriptions during the EHR 

reporting period (as discussed in the 

preamble of the final rule (see page 

44336)). Therefore, we are correcting 

§ 495.6(e)(1) by referencing this 

exclusion in accordance with 

§ 495.6(a)(2) ‘‘Implement drug-formulary 

checks.’’ 

On page 44587, in § 495.366(b)(3), we 

made inadvertent errors by citing to 

inpatient and outpatient settings, rather 

than the inpatient or emergency room 

settings in a discussion of ‘‘hospitalbased.’’ 

On page 44588, in § 495.368(c) 

regarding overpayments, we are 

correcting the period of consideration 

for overpayments. We note that section 

1903(d)(2) of the Act was amended by 

section 6506 of the Patient Protection 

and Affordable Care Act (known as the 

Affordable Care Act (ACA)). This 

amendment changed the mandatory 

time period for collection of 

overpayments from 60 days to 1 year. 

Therefore, we are correcting § 495.368(c) 

to implement this statutory change. 

III. Correction of Errors in the Preamble 

In FR Doc. 2010–17207 of July 28, 

2010, we make the following 

corrections: 


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