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51850 Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 

environmental results; highlighting 

strengths and challenges in program 

management; demonstrating continued 

stakeholder commitment; assessing the 

progress of the NEP as a national 

program; and transferring lessons 

learned within EPA, among NEPs, and 

with other watershed programs. For this 

ICR cycle, program evaluations will be 

required for nine programs in FY2010, 

nine programs in FY2011, and ten 

programs in 2012. 

Government Performance Results Act: 

EPA requests that each of the 28 NEPs 

receiving § 320 funds report information 

that can be used in the GPRA reporting 

process. This reporting is done on an 

annual basis and is used to show 

environmental results that are being 

achieved within the overall NEP 

Program. This information is ultimately 

submitted to Congress along with GPRA 

information from other EPA programs. 

Burden Statement: The annual public 

reporting and recordkeeping burden for 

this collection of information is 

estimated to average 218 hours per 

response. Burden means the total time, 

effort, or financial resources expended 

by persons to generate, maintain, retain, 

or disclose or provide information to or 

for a Federal agency. This includes the 

time needed to review instructions; 

develop, acquire, install, and utilize 

technology and systems for the purposes 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements which have subsequently 

changed; train personnel to be able to 

respond to a collection of information; 

search data sources; complete and 

review the collection of information; 

and transmit or otherwise disclose the 

information. 

The ICR provides a detailed 

explanation of the Agency’s estimate, 

which is only briefly summarized here: 

Estimated total number of potential 

respondents: 28. 

Frequency of response: Annual. 

Estimated total average number of 

responses for each respondent: 2.3. 

Estimated total annual burden hours: 

5,833. 

Estimated total annual costs: 

$409,349, includes $0 annualized 

capital or O&M costs. 

Are There Changes in the Estimates 

from the Last Approval? 

There are no changes in burden from 

the last approval. 

What is the Next Step in the Process for 

this ICR? 

EPA will consider the comments 

received and amend the ICR as 

appropriate. The final ICR package will 

then be submitted to OMB for review 

and approval pursuant to 5 CFR 

1320.12. At that time, EPA will issue 

another Federal Register notice 

pursuant to 5 CFR 1320.5(a)(1)(iv) to 

announce the submission of the ICR to 

OMB and the opportunity to submit 

additional comments to OMB. If you 

have any questions about this ICR or the 

approval process, please contact the 

technical person listed under FOR 

FURTHER INFORMATION CONTACT. 

Dated: October 1, 2009. 

Suzanne Schwartz, 

Director, Office of Wetlands, Oceans, and 

Watersheds. 

[FR Doc. E9–24341 Filed 10–7–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OW–2007–1189 FRL–8963–6] 

RIN 2040–AD99 

Drinking Water Contaminant Candidate 

List 3—Final 

AGENCY: Environmental Protection 


Agency (EPA). 


ACTION: Notice. 


SUMMARY: The Environmental Protection 

Agency is publishing the third 

Contaminant Candidate List (CCL 3) 

since the Safe Drinking Water Act 

(SDWA) amendments of 1996. The CCL 

3 is a list of contaminants that are 

currently not subject to any proposed or 

promulgated national primary drinking 

water regulations, that are known or 

anticipated to occur in public water 

systems, and which may require 

regulation under SDWA. Today’s final 

CCL 3 includes 104 chemicals or 

chemical groups and 12 microbiological 

contaminants. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OW–2007–1189. All 

documents in the docket are listed on 

http://www.regulations.gov. Although 

listed in the index, some information is 

not publicly available. For example, 

confidential business information or 

other information whose disclosure is 

restricted by statute is not publicly 

available. Certain other material, such as 

copyrighted material, is not placed on 

the Internet and is only in hard copy 

form. Publicly available docket 

materials are available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the Water Docket, EPA/DC, EPA West, 

Room 3334, 1301 Constitution Ave., 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the EPA Docket Center is 

(202) 566–2426. 

FOR FURTHER INFORMATION CONTACT: For 

information on chemical contaminants 

contact Thomas Carpenter, Office of 

Ground Water and Drinking Water, 

Standards and Risk Management 

Division, at (202) 564–4885 or e-mail 

carpenter.thomas@epa.gov. For 

information on microbial contaminants 

contact Tracy Bone, Office of Ground 

Water and Drinking Water, at (202) 564– 

5257 or e-mail bone.tracy@epa.gov. For 

general information contact the EPA 

Safe Drinking Water Hotline at (800) 

426–4791 or e-mail: hotlinesdwa@epa.gov. 

Abbreviations and Acronyms 

CASRN—Chemical Abstract Services 

Registry Number 

CDC—Centers for Disease Control and 

Prevention 

CCL—Contaminant Candidate List 

CCL 1—EPA’s First Contaminant Candidate 

List 

CCL 2—EPA’s Second Contaminant 

Candidate List 

CCL 3—EPA’s Third Contaminant Candidate 

List 

CERCLA—Comprehensive Environmental 

Response, Compensation, and Liability Act 

CFR—Code of Federal Regulations 

CSF—Cancer Slope Factor 

DBP—disinfection byproduct 

EPA—United States Environmental 

Protection Agency 

ESA—ethanesulfonic acid 

FDA—United States Food and Drug 

Administration 

FIFRA—Federal Insecticide, Fungicide, and 

Rodenticide Act 

FR—Federal Register 

HRL—Health Reference Level 

ICR—Information Collection Request 

IUR—Inventory Update Rule 

MCL—maximum contaminant level 

MCLG—maximum contaminant level goal 

NCFAP—National Center for Food and 

Agricultural Policy 

NDWAC—National Drinking Water Advisory 

Council 

NDMA—N-nitrosodimethylamine 

NIRS—National Inorganic Radiological 

Survey 

NRC—National Academies of Science’s 

National Research Council 

NPDWR—national primary drinking water 

regulation 

OPP—Office of Pesticide Programs 

PCCL—Preliminary CCL 

PFOA—perfluorooctanoic acid 

PFOS—perfluorooctane sulfonic acid 
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Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 51851 

PWS—public water system 

RAISHE—Risk Assessment Information 

System, Health Effects 

RDX– Cyclotrimethylenetrinitramine 

RfD—reference dose 

RTECS—Registry of Toxic Effects for 

Chemical Substances 

SAB—EPA Science Advisory Board 

SDWA—Safe Drinking Water Act 

TRI—Toxics Release Inventory 

TNT—2, 4, 6-trinitrotoluene 

UCMR—Unregulated Contaminant 

Monitoring Regulation 

UCMR 1—First Unregulated Contaminant 

Monitoring Regulation 

UCMR 2—Second Unregulated Contaminant 

Monitoring Regulation 

UCM R1/2—Unregulated Contaminant 

Monitoring Round 1⁄2 

U.S.—United States of America 

USGS—United States Geological Survey 

WBDO—waterborne disease outbreak 

WHO—World Health Organization 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Impose Any 


Requirements on My Public Water 


System? 


B. What Is the Purpose of this Action? 

C. SDWA Risk Management Provisions 

1. Contaminant Candidate List 3 

2. Regulatory Determinations 

3. Unregulated Contaminant Monitoring 

II. What is on EPA’s Drinking Water 

Contaminant Candidate List 3? 

III. What Comments did EPA Receive on the 

Draft CCL 3 and How did the Agency 

Respond? 

A. Advisory from the EPA Science 


Advisory Board (SAB) 


B. Chemical Contaminants 

1. Pesticides and Degradates 

2. Cancelled Pesticides 

3. Perfluorinated Compounds 

4. Pharmaceuticals 

5. Perchlorate 

6. Disinfection Byproducts 

C. Microbial Contaminants 

1. Using the CDC WBDO’s as a Scoring 


Criteria 


2. Mycobacterium avium 

3. Vibrio cholerae and Entamoeba 


hystolitica 


D. Other comments 

1. Data Sources for the Contaminant 


Candidate Lists 


2. Contaminant Candidate List and 

Unregulated Contaminants Monitoring 

Regulation 

IV. Data Needs for CCL 3 Contaminants 

A. Chemical Contaminants 

1. Health Effects 

2. Occurrence 

3. Analytical Methods 

B. Microbial Contaminants 

V. Next Steps/Future Contaminant Candidate 

Lists 

VI. References 

I. General Information 

A. Does This Action Impose Any 

Requirements on My Public Water 

System? 

The final Contaminant Candidate List 

3 (CCL 3) will not impose any 

requirements on anyone. Instead, this 

action notifies interested parties of the 

availability of U.S. EPA’s final CCL 3, 

and provides information on the 

Agency’s next steps to evaluate these 

contaminants. 

B. What Is the Purpose of This Action? 

The purpose of this action is to 

present the final CCL 3, a summary of 

the comments received on the draft CCL 

3, and a description of the Agency’s 

process for identifying contaminants to 

be placed on the list. Pursuant to section 

1412(b)(1)(B)(i) of SDWA, as amended 

in 1996, EPA is required to publish a list 

of contaminants (1) that are currently 

unregulated, (2) that are known or 

anticipated to occur in public water 

systems, and (3) which may require 

regulations under the Safe Drinking 

Water Act (SDWA). This section briefly 

summarizes the statutory requirements 

for CCL 3, and related activities 

surrounding the contaminants included 

on the final CCL 3. 

C. SDWA Risk Management Provisions 

1. Contaminant Candidate List 3 

SDWA section 1412(b)(1) requires that 

in the development of the CCL, EPA 

consider specific data sources and 

include the scientific community. EPA 

must evaluate substances identified in 

section 101(14) of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980 and substances 

registered as pesticides under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). SDWA also 

requires the Agency to consider the 

National Contaminant Occurrence 

Database established under section 

1445(g) of SDWA. SDWA directs the 

Agency to consult with the scientific 

community, including the Science 

Advisory Board (SAB). In addition it 

directs the Agency to consider the 

health effects and occurrence 

information for unregulated 

contaminants to identify those 

contaminants that present the greatest 

public health concern related to 

exposure from drinking water. 

EPA interprets the criterion that 

contaminants are known or anticipated 

to occur in public water systems 

broadly. In evaluating this criterion, 

EPA considers not only public water 

system monitoring data, but also data on 

ambient concentrations in surface and 

ground waters, and releases to the 

environment (e.g., Toxics Release 

Inventory). While such data may not 

establish conclusively that 

contaminants are known to occur in 

public water systems, EPA believes 

these data are sufficient to anticipate 

that contaminants may occur in public 

water systems and to place them on the 

CCL. Once contaminants have been 

placed on the CCL, EPA identifies if 

there are any additional data needs, 

including gaps in occurrence data. 

In selecting contaminants for the CCL 

3, each of the above requirements was 

met. The Agency considered adverse 

health effects that may pose a greater 

risk to life stages and other sensitive 

groups which represent a meaningful 

portion of the population. Adverse 

health effects associated with infants, 

children, pregnant women, the elderly, 

and individuals with a history of serious 

illness were evaluated for both 

chemicals and microbes. 

2. Regulatory Determinations 

SDWA section 1412(b)(1) requires 

EPA to determine whether to regulate at 

least five contaminants from the CCL 

every five years. SDWA specifies that 

EPA shall regulate a contaminant if the 

Administrator determines that: 

• The contaminant may have an 

adverse effect on the health of persons; 

• The contaminant is known to occur, 

or there is a substantial likelihood that 

the contaminant will occur in public 

water systems with a frequency and at 

levels of public health concern; and 

• In the sole judgment of the 

Administrator, regulation of such 

contaminant presents a meaningful 

opportunity for health risk reduction for 

persons served by public water systems. 

EPA interprets these criteria as more 

rigorous than what is used to place 

contaminants on the CCL. Section IV of 

this notice presents the current data 

needs for regulatory determination for 

the CCL 3 contaminants. 

If EPA makes a determination that a 

national primary drinking water 

regulation is needed, then the Agency 

has 24 months to publish a proposed 

Maximum Contaminant Level Goal 

(MCLG) 1 and a proposed National 

Primary Drinking Water Rule 

(NPDWR).2 After the proposal, the 

Agency has 18 months to publish a final 

1 An MCLG is the ‘‘maximum level of a 

contaminant in drinking water at which no known 

or anticipated adverse effect on the health of 

persons would occur, and which allows an 

adequate margin of safety. Maximum contaminant 

level goals are non-enforceable health goals’’ (40 

CFR 141.2). 

2 An NPDWR is a legally enforceable standard 

that applies to public water systems. An NPDWR 

sets a legal limit (called a maximum contaminant 

level or MCL) or specifies a certain treatment 

technique (TT) for public water systems for a 

specific contaminant or group of contaminants. 
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51852 Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 

MCLG and promulgate a final NPDWR contaminants on the list; and (3) on CHEMICAL CONTAMINANTS—Continued 

(SDWA 1412(b)(1)(E)).3 

3. Unregulated Contaminant Monitoring 

SDWA provides EPA with the 

authority to require all large and a 

subset of small systems to monitor for 

up to 30 unregulated contaminants 

every five years under the Unregulated 

Contaminant Monitoring Regulation 

(UCMR). The second unregulated 

contaminant monitoring rule (UCMR 2), 

which was promulgated on January 4, 

2007 (72 FR 367; USEPA, 2007a), 

requires monitoring for several 

pesticides and pesticide degradates, five 

polybrominated diphenyl ether (PBDE) 

flame retardants, a group of 

nitrosamines, and two munitions (TNT 

and RDX). All of the chemicals on 

UCMR 2 were included among the 

contaminants evaluated for CCL 3. 

Data collected under the UCMR are an 

important source of occurrence 

information for both the CCL and 

Regulatory Determination processes. 

There is an additional discussion of the 

relationship between CCL and UCMR in 

Section III. D of this Federal Register 

(FR) notice. 

II. What Is on EPA’s Drinking Water 

Contaminant Candidate List 3? 

The draft CCL 3 was published on 

February 21, 2008 (73 FR 9628; USEPA 

2008a), and included 93 chemicals or 

chemical groups and 11 microbiological 

contaminants. EPA provided 

information and sought comment on its 

efforts to expand and strengthen the 

underlying CCL listing process, the draft 

list, and EPA’s efforts to improve the 

contaminant selection process for future 

CCLs. 

In developing the draft CCL 3, EPA 

implemented a new process from that 

used for CCL 1 and CCL 2. This new 

process builds on evaluations from 

previous CCLs, and was based on 

substantial expert input and 

recommendations from various groups, 

including the National Academy of 

Science’s National Research Council 

(NRC) and the National Drinking Water 

Advisory Council (NDWAC). This 

process is summarized in the draft CCL 

3 FR notice. 

In general, the criteria for including a 

contaminant on the CCL consisted of 

determining whether the occurrence or 

anticipated occurrence of a contaminant 

was likely at levels of concern to human 

health. The draft CCL 3 notice solicited 

input from the public, and specifically 

requested comments on (1) the approach 

EPA used to create the list; (2) 

3 The statute authorizes a nine month extension 

of this promulgation date. 

CASRN 

114078 ...............
 

50282 .................
 

50271 .................
 

53167 .................
 

57636 .................
 

13194484 ...........
 

107211 ...............
 

75218 .................
 

96457 .................
 

22224926 ...........
 

50000 .................
 

7440564 .............
 

74975 .................
 

75456 .................
 

110543 ...............
 

302012 ...............
 

72333 .................
 

10265926 ...........
 

67561 .................
 

74839 .................
 

1634044 .............
 

51218452 ...........
 

171118095 .........
 

152019733 .........
 

2212671 .............
 

7439987 .............
 

98953 .................
 

55630 .................
 

872504 ...............
 

55185 .................
 

62759 .................
 

621647 ...............
 

86306 .................
 

930552 ...............
 

68224 .................
 

103651 ...............
 

95534 .................
 

75569 .................
 

301122 ...............
 

42874033 ...........
 

14797730 ...........
 

1763231 .............
 

335671 ...............
 

52645531 ...........
 

41198087 ...........
 

91225 .................
 

121824 ...............
 

135988 ...............
 

7440246 .............
 

107534963 .........
 

112410238 .........
 

13494809 ...........
 

13071799 ...........
 

56070167 ...........
 

59669260 ...........
 

23564058 ...........
 

26471625 ...........
 

Common name—registry 

name 

Erythromycin. 


Estradiol (17-beta estradiol). 

Estriol. 

Estrone. 

Ethinyl Estradiol (17-alpha 

Ethynyl Estradiol). 

Ethoprop. 

Ethylene glycol. 

Ethylene oxide. 

Ethylene thiourea. 

Fenamiphos. 

Formaldehyde. 

Germanium. 

Halon 1011 

(bromochloromethane). 

HCFC-22. 

Hexane. 

Hydrazine. 

Mestranol. 

Methamidophos. 

Methanol. 

Methyl bromide 

(Bromomethane). 

Methyl tert-butyl ether. 

Metolachlor. 

Metolachlor 

ethanesulfonic acid 

(ESA). 

Metolachlor oxanilic acid 

(OA). 

Molinate. 

Molybdenum. 

Nitrobenzene. 

Nitroglycerin. 

N-Methyl-2-pyrrolidone. 

N-Nitrosodiethylamine 

(NDEA). 

N-nitrosodimethylamine 

(NDMA). 

N-Nitroso-di-n-propylamine (NDPA). 

N-Nitrosodiphenylamine. 

N-nitrosopyrrolidine 

(NPYR). 

Norethindrone (19-

Norethisterone). 

N-Propylbenzene. 

O-Toluidine. 

Oxirane, methyl-. 

Oxydemeton-methyl. 

Oxyfluorfen. 

Perchlorate. 

Perfluorooctane sulfonic 

acid (PFOS). 

Perfluorooctanoic acid 

(PFOA). 

Permethrin. 

Profenofos. 

Quinoline. 

RDX. 

Sec-Butylbenzene. 

Strontium. 

Tebuconazole. 

Tebufenozide. 

Tellurium. 

Terbufos. 

Terbufos sulfone. 

Thiodicarb. 

Thiophanate-methyl. 

Toluene diisocyanate. 

CASRN 

630206 ...............
 

75343 .................
 

96184 .................
 

106990 ...............
 

99650 .................
 

123911 ...............
 

57910 .................
 

71363 .................
 

109864 ...............
 

107186 ...............
 

16655826 ...........
 

101779 ...............
 

30560191 ...........
 

75070 .................
 

60355 .................
 

34256821 ...........
 

187022113 .........
 

184992444 .........
 

107028 ...............
 

142363539 .........
 

171262172 .........
 

319846 ...............
 

62533 .................
 

741582 ...............
 

100447 ...............
 

25013165 ...........
 

133062 ...............
 

14866683 ...........
 

74873 .................
 

110429624 .........
 

7440484 .............
 

80159 .................
 

NA ......................
 

141662 ...............
 

55290647 ...........
 

60515 .................
 

298044 ...............
 

330541 ...............
 

517099 ...............
 

474862 ...............
 

specific contaminants such as 

pharmaceuticals, perfluorinated 

compounds, and microbes. 

The final CCL 3 includes 104 

chemicals or chemical groups and 12 

microbiological contaminants (Exhibit 

1). The list includes, among others, 

pesticides, biological toxins, 

disinfection byproducts, chemicals used 

in commerce, and waterborne 

pathogens. The Agency considered the 

best available data and information on 

health effects and occurrence to 

evaluate 7,500 unregulated 

contaminants and selected 116 

candidates for the final CCL 3, which 

have the potential to present health 

risks through drinking water exposure. 

Exhibit 1. Final Contaminant 

Candidate List 3: 

CHEMICAL CONTAMINANTS 

Common name—registry 

name 

1,1,1,2-Tetrachloroethane. 


1,1-Dichloroethane. 


1,2,3-Trichloropropane. 


1,3-Butadiene. 


1,3-Dinitrobenzene. 


1,4-Dioxane. 


17 alpha-Estradiol. 


1-Butanol. 


2-Methoxyethanol. 


2-Propen-1-ol. 


3-Hydroxycarbofuran. 


4,4′-Methylenedianiline. 


Acephate. 


Acetaldehyde. 


Acetamide. 


Acetochlor. 


Acetochlor ethanesulfonic 


acid (ESA). 

Acetochlor oxanilic acid 

(OA). 

Acrolein. 

Alachlor ethanesulfonic 

acid (ESA). 

Alachlor oxanilic acid 

(OA). 

AlphaHexachlorocyclohexane. 

Aniline. 

Bensulide. 

Benzyl chloride. 

Butylated hydroxyanisole. 

Captan. 

Chlorate. 

Chloromethane (Methyl 

chloride). 

Clethodim. 

Cobalt. 

Cumene hydroperoxide. 

Cyanotoxins. 

Dicrotophos. 

Dimethipin. 

Dimethoate. 

Disulfoton. 

Diuron. 

Equilenin. 

Equilin. 
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Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 51853 

CHEMICAL CONTAMINANTS—Continued 

Common name—registry CASRN name 

78488 .................
 Tribufos. 

121448 ............... Triethylamine. 

76879 ................. Triphenyltin hydroxide 

(TPTH). 

51796 ................. Urethane. 

7440622 ............. Vanadium. 

50471448 ........... Vinclozolin. 

137304 ............... Ziram. 

MICROBIAL CONTAMINANTS 

Adenovirus 

Caliciviruses 

Campylobacter jejuni 

Enterovirus 

Escherichia coli (0157) 

Helicobacter pylori 

Hepatitis A virus 

Legionella pneumophila 

Mycobacterium avium 

Naegleria fowleri 

Salmonella enterica 

Shigella sonnei 

III. What Comments Did EPA Receive 

on the Draft CCL 3 and How Did the 

Agency Respond? 

EPA received comments from 177 

individuals or organizations on the draft 

CCL 3. Commenters identified several 

issues on the draft CCL 3 and the 

process used to select contaminants for 

the list. Many commenters noted the 

substantial effort, overall improvement, 

improved scientific rigor, and increased 

stakeholder involvement employed by 

EPA to develop the draft CCL 3. 

Commenters also provided information 

and recommendations for the Agency to 

consider as it finalized the CCL 3. The 

Agency has provided responses to 

individual comments in the ‘‘Final 

Comment Response Document for the 

Third Drinking Water Contaminant 

Candidate List 3 (Categorized Public 

Comments)’’ document that is available 

in the docket (USEPA 2009c). 

A. Advisory From the EPA Science 

Advisory Board 

The EPA SAB and its Drinking Water 

Committee reviewed the draft CCL 3 

during 2008, and provided an advisory 

to the Administrator on January 29, 

2009. EPA staff met with the SAB to 

provide an overview of the draft CCL 3, 

to answer questions from the Drinking 

Water Committee, and to clarify 

questions from the full SAB. The 

Agency also participated in 

teleconferences with SAB during the 

development of the ‘‘SAB Advisory on 

EPA’s Draft Third Drinking Water 

Contaminant Candidate List (CCL 3)’’ 

(USEPA 2009d). SAB comments on the 

overall CCL 3 process and 

documentation are summarized in the 

following paragraphs. 

The SAB noted that the process used 

to develop the draft CCL 3 represents a 

major improvement over the previous 

CCL processes and recognized the 

adaptive management strategies 

employed by EPA as an appropriate 

approach that should continue to be 

used in future CCLs. However, the SAB 

also believes the documentation of the 

process used to develop the draft CCL 

3 lacks transparency. For example, one 

suggestion stated that EPA should 

document and justify why each of the 

contaminants from previous CCL lists 

were excluded from the draft CCL 3. 

The SAB also stated that the current 

list may be too large for chemicals; and 

it may include too few pathogens. The 

SAB acknowledged that the CCL 3 has 

dual goals of developing regulatory 

determinations and identifying longerterm research needs. They also 

recommended that EPA prioritize the 

list to better identify regulatory 

priorities, research needs, and longer 

term needs for the next CCL. 

EPA Response to SAB 

Recommendations 

The Agency has updated the technical 

support documents for the CCL 3 to 

increase the transparency of the process 

that was used to determine which 

contaminants to include on the final 

CCL 3. Several specific suggestions to 

improve the transparency of the process 

are addressed in the supporting 

documents and identified in Section III 

of this notice. Documents describing the 

process and tables that identify the data 

used to select contaminants can be 

found on EPA’s Web site at: http:// 

www.epa.gov/safewater/ccl/index.html. 

More detailed information on the 

contaminants, such as the ‘‘Final CCL 3 

Contaminant Information Sheets.’’, 

(USEPA, 2009e) and the ‘‘Final 

Contaminant Candidate List 3 Microbes: 

PCCL to CCL Process’’ can be found in 

the docket (USEPA, 2009g) and on 

EPA’s Web site. 

In Section IV of this FR notice, the 

Agency has also identified which 

contaminants will need additional data 

and information on their occurrence, 

health effects, and analytical methods. 

As the Agency continues to evaluate 

contaminants on the CCL 3, we will 

work with EPA and non-EPA scientists 

to develop and collect the best available 

science to support decision making for 

future regulatory determinations. 

B. Chemical Contaminants 

EPA evaluated data and information 

on chemical contaminants provided by 

commenters and collected by the 

Agency after the draft CCL 3 was 

published. EPA used the same process 

described in the draft CCL 3 FR notice 

(73 FR 9628, USEPA 2008a) to evaluate 

contaminants for which data became 

available after the publication of the 

draft CCL 3. Based on these analyses, 

EPA is taking the following actions on 

chemical contaminants: EPA is 

removing two pesticides from the CCL 

3 that are no longer used in the United 

States, and the Agency is adding 13 

chemical contaminants to the final CCL 

3. EPA concluded that one antibiotic 

(erythromycin), nine hormones (17 

alpha-estradiol, 17 beta-estradiol, 

equilenin, equilin, estriol, estrone, 

ethinyl estradiol, mestranol, and 

norethindrone), two potential 

disinfection byproducts (DBP) (Halon 

1011 (bromochloeromethane) and 

chlorate), and one perfluorinated 

compound (Perfluorooctanoic sulfonic 

acid (PFOS)) should be included on the 

CCL 3 based on their potential adverse 

health effects and potential for 

occurrence in public water systems. The 

Agency has summarized the comments 

and information used to evaluate these 

contaminants in this section of the FR 

notice. The specific data used to 

evaluate these contaminants can be 

found in the response to comment 

document (USEPA, 2009c) and the 

‘‘Final CCL 3 Contaminant Information 

Sheets’’ in the docket (USEPA, 2009e). 

1. Pesticides and Degradates 

EPA received more than 65 public 

comments on pesticides and their 

related degradates. Some commenters 

were concerned about the number of 

pesticides listed on the draft CCL 3. One 

commenter states, ‘‘* * * in the process 

of narrowing the universe of 7,500 

unregulated chemicals down to 93 

* * * EPA selected nearly half (42 out 

of 93) to be pesticides or pesticide 

degradates.’’ This and other commenters 

viewed the listing of pesticides as a 

selection bias and noted that EPA has 

not clearly demonstrated, in the process 

used to derive the draft CCL 3, that 

these 42 pesticides and degradates pose 

the greatest public health concern. In 

addition, this commenter believed that 

the inclusion and proportional share of 

pesticides and their degradates on the 

draft CCL 3 should take into account the 

Agency’s regulatory determination 

findings where none of the pesticides or 

degradates evaluated were ultimately 

determined to provide a meaningful 

opportunity to provide public health 

protection. In contrast, some 

commenters were in agreement with the 

pesticides included on the draft CCL 3, 

and in some cases, commenters 
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suggested placing additional pesticides 

on the final CCL 3. 

EPA Response: EPA does not agree 

with the commenter’s statement that 

there is a selection bias for pesticides. 

The CCL 3 process was developed to 

evaluate contaminants from a broad 

universe of chemicals in accordance 

with the NRC and NDWAC 

recommendations. The chemicals are 

subject to consistent screening and 

evaluation based on chemical specific 

factors such as physical properties, 

health effects data, and their potential to 

occur in public water systems. SDWA 

requires EPA to evaluate substances 

registered as pesticides under FIFRA. 

All pesticides identified in the universe 

of chemicals were evaluated by EPA 

using the same process as other 

chemicals. Previous regulatory 

determinations not to develop a NPDWR 

for 10 pesticides or degradates in 

Regulatory Determinations 1 and 2 are 

irrelevant to other pesticides on the CCL 

3. The regulatory determination process, 

like the CCL process, is data driven. To 

make a regulatory determination, EPA 

evaluates the available occurrence and 

health effects data for that contaminant 

against the criteria in SDWA Section 

1412 (b)(1)(a). The Agency has 

responded to comments on specific 

pesticides in the response to comment 

document (USEPA, 2009c). 

2. Cancelled Pesticides Registrations 

SAB and other public commenters 

suggested that specific pesticide active 

ingredients (Nitrofen and Ethion) 

should be removed from the CCL 3 

because they are no longer used in 

registered pesticides. The SAB also 

commented that EPA should consider 

removing pesticides from the CCL 3 that 

are no longer registered products or are 

in the process of being phased out of 

use. The pesticides identified by the 

commenters, Nitrofen and Ethion, are 

not included on the final CCL 3. The 

evaluation of these two pesticides is 

summarized in the following 

paragraphs. 

a. Nitrofen 

EPA received comment from the 

public and the SAB that Nitrofen should 

not be included on the final CCL 3. 

Commenters noted that the available 

information on use, release, and 

potential environmental occurrence of 

Nitrofen indicate that it should not be 

anticipated to occur in public water 

systems (PWS). 

EPA Response: EPA agrees with the 

commenters that Nitrofen should be 

removed from the CCL 3. It is no longer 

manufactured or sold in the United 

States. Its inclusion on the draft list was 

based on a reported TRI release which, 

when investigated, indicated that 

Nitrofen stocks were recently found in 

a warehouse and properly disposed of 

in accordance with the Resource 

Conservation and Recovery Act Subtitle 

C landfill regulations. TRI requires that 

information on landfill releases, even 

releases in compliance with regulations, 

be reported; therefore, the Nitrofen 

release was incorporated in the total TRI 

data used in the CCL process. Based on 

this information, Nitrofen is not 

anticipated to occur in PWSs, and the 

Agency has not included Nitrofen on 

the final CCL 3. 

b. Ethion 

Commenters noted that the 

registration for Ethion was cancelled 

and therefore EPA should not include 

Ethion on the final CCL 3. 

EPA Response: EPA agrees with the 

commenters and has not included 

Ethion on the final CCL 3. On March 22, 

2002, EPA published a cancellation 

order discontinuing the manufacture of 

Ethion containing products as of 

October 1, 2003, and prohibiting the use 

of existing stocks after December 31, 

2004 (67 FR 13328; USEPA, 2002). A 

July 23, 2004 action revoked the 

remaining Ethion tolerances, as of 

October 1, 2008 (69 FR 43918; USEPA, 

2004). EPA notes that SDWA criteria 

consider whether a contaminant is 

known or anticipated to occur in PWSs 

and may have an adverse effect. It is 

possible for a contaminant to occur in 

a PWS even after its uses are canceled 

if it is very persistent in the 

environment. Ethion is moderately 

persistent in the environment, but is not 

likely to contaminate surface water 

through dissolved runoff. Based on 

laboratory and field data, including 

monitoring data compiled in EPA’s 

Pesticides in Ground Water Database, 

EPA does not expect that Ethion will 

contaminate ground water (USEPA, 

2001). Based on Ethion’s discontinued 

registration status, prohibited use of 

stocks, and moderate persistence, the 

Agency does not anticipate that it will 

occur in PWSs; therefore, it is not 

included on the final CCL 3. 

3. Perfluorinated Compounds 

In the draft CCL 3 FR notice, EPA 

sought comments on its proposed 

decisions to include perfluorooctanoic 

acid (PFOA) and not to include PFOS 

on the draft CCL 3 (73 FR 9652, USEPA 

2008a). The majority of commenters 

agreed with the inclusion of PFOA on 

the CCL 3. Commenters pointed out that 

PFOA warrants inclusion on the CCL 

due to its known occurrence in drinking 

water supplies and systems and its 

potential adverse health effects. A 

number of these commenters also wrote 

in support of regulating PFOA under 

SDWA. The SAB also stated that PFOA 

should be a high priority for 

consideration by the Agency for the CCL 

3. One commenter argued that EPA did 

not use the most relevant information in 

the CCL 3 process to characterize 

PFOA’s health effects and occurrence. 

Some of the commenters who were in 

support of including PFOA on the CCL 

also recommended adding PFOS and 

other perfluorinated compounds to the 

list. The SAB noted that 

perfluorochemicals may be a class of 

contaminants that the Agency should 

consider as a group based on their 

similar structures and chemical 

makeup. 

EPA Response: The Agency agrees 

with commenters that potential health 

effects based on animal studies and the 

occurrence of PFOA in drinking water 

supplies warrant its inclusion on the 

CCL 3. The Agency used the best 

available science and information to 

evaluate and list drinking water 

contaminant candidates. PFOA has been 

detected in a number of drinking water 

supplies and ambient waters. It is also 

highly persistent in the environment 

and has been shown to be toxic in 

animal studies. Based on these potential 

adverse health effects and occurrence 

information, EPA concludes that PFOA 

is known or anticipated to occur in 

public water systems and may require 

regulation. Therefore EPA has included 

PFOA on the final CCL 3. 

PFOS was not included on the draft 

CCL 3, but has been included on the 

final CCL 3. A major factor in EPA’s 

decision to not include PFOS on the 

draft CCL 3 was the voluntary phase-out 

of production of PFOS in the U.S. 

between 2000 and 2002 (FR 73 9652; 

USEPA 2008a). However, EPA has 

evaluated new information from the 

October 9, 2007, significant new use 

rule (SNUR) that shows there are 

ongoing uses of PFOS that could lead to 

its occurrence in water (FR 72 57222– 

57235; USEPA 2007b). The Agency 

concluded, based upon this potential to 

occur in PWSs, existing data on 

environmental persistence, and toxicity 

in animal studies, that PFOS is known 

or anticipated to occur in public water 

systems and may require regulation. 

Therefore, EPA has included this 

compound on the final CCL 3. 

The Agency continues to analyze the 

data and information related to the 

possible adverse health effects 

associated with PFOA and PFOS. As 

noted in the draft CCL 3 FR notice, the 

SAB completed a review of a draft 

PFOA risk assessment in 2006 and made 
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recommendations for the further 

development of the risk assessment 

(USEPA, 2006a). A number of important 

studies are underway, and the Agency 

continues to participate in research 

regarding the toxicity of related 

perfluorochemicals, as well as research 

to help identify routes of human 

exposure. EPA is evaluating additional 

research and has not made any 

definitive conclusions on the risk 

assessment at this time. The Agency 

also issued ‘‘Provisional Health 

Advisories for PFOA and PFOS’’ 

(USEPA 2009f) to provide technical 

information to State and local officials, 

and PWSs for consideration in 

addressing local contamination of 

drinking water to protect public health. 

This information has been included in 

the docket and the ‘‘Final CCL 3 

Contaminant Information Sheets’’ for 

PFOA and PFOS (USEPA, 2009e). 

While the Agency did not specifically 

seek comment on other perfluorinated 

compounds in the draft CCL 3 FR 

notice, some of these compounds were 

included in the CCL 3 Universe. 

However, the Agency had only limited 

data on the potential occurrence of these 

compounds and potential adverse 

health effects. Commenters did not 

provide additional occurrence or health 

effects data than those already evaluated 

by the Agency; therefore, they are not 

listed on the CCL at this time. The 

Agency will continue to evaluate 

perfluorinated compounds to ascertain 

whether they possess similar 

toxicological properties and if they are 

anticipated or known to occur in public 

water systems. 

4. Pharmaceuticals 

In the draft CCL 3 FR notice (73 FR 

9652; USEPA, 2008a), EPA explained 

how pharmaceuticals were evaluated in 

the CCL 3 process, and sought 

additional data and information on the 

concentrations of pharmaceuticals in 

finished or ambient water. EPA also 

requested comment on how 

pharmaceuticals have been considered 

in the CCL 3 process. In addition, EPA 

sent a letter to State public health and 

environmental departments requesting 

information on the States’ activities and 

initiatives involving pharmaceuticals. 

The Agency specifically requested 

information on pharmaceuticals in the 

areas of occurrence, human health 

effects research, analytical methods 

development, and stewardship. EPA 

received a number of comments on 

pharmaceuticals and the CCL 3. 

Commenters pointed out that additional 

research is needed to address the health 

effects and occurrence of 

pharmaceuticals in drinking water. 

Commenters also noted that the 

contaminants were detected at low 

levels. Commenters differed on whether 

pharmaceuticals should be included on 

the CCL 3. Some commenters provided 

references from the published literature 

on the occurrence of pharmaceuticals in 

water and on the health effects of 

pharmaceuticals. In its comments, the 

SAB noted that pharmaceuticals may be 

a class of contaminants that need 

special attention when considering 

them for CCL 3 or future CCLs, and 

recommended that EPA use additional 

data on occurrence of pharmaceuticals 

in water from the United States 

Geological Survey (USGS), or studies in 

the peer-reviewed literature (USEPA, 

2009d). 

EPA Response: EPA is actively 

working to evaluate the potential risks 

to human health and aquatic life posed 

by trace amounts of pharmaceuticals 

and personal care products in water, 

and to identify measures to minimize 

their occurrence. The Agency has a 

number of activities underway and will 

continue to add activities as 

appropriate. All of these activities are 

described in further detail on our Web 

site located at http://www.epa.gov/ 

waterscience/ppcp. Additional 

information on the Agency’s research 

related to pharmaceuticals can be found 

at http://www.epa.gov/ppcp. 

In the CCL 3 process, EPA evaluated 

the potential adverse health effects of 

pharmaceuticals and their occurrence in 

public drinking water systems to 

determine if pharmaceuticals should be 

added to the list. Since the draft CCL 3 

was published, several publications 

have focused on the occurrence of 

pharmaceuticals in ambient water and 

drinking water. In response to 

comments, EPA has conducted 

additional data collection efforts to 

comprehensively review recent 

published information from USGS and 

other sources, including those cited by 

commenters, to identify the best 

available occurrence information for 

pharmaceuticals. EPA identified new 

occurrence data for 81 contaminants 

from 22 sources. The Agency also 

conducted additional literature reviews 

to identify the best available health 

effects information and identified data 

from sources including: EPA Office of 

Pesticide Programs, the Food and Drug 

Administration (FDA) Center for 

Veterinary Medicine, the Joint Food and 

Agriculture Organization/World Health 

Organization (WHO) Expert Committee 

on Food Additives, and the European 

Medicines Agency, and the FDA Center 

for Drug Evaluation and Research. EPA 

used the new data in the same process 

that was described in the draft CCL 3 FR 

notice to further evaluate 

pharmaceutical contaminants. 

Based upon this re-evaluation with 

new data, EPA concluded that one 

antibiotic (erythromycin) and nine 

hormones (17 alpha-estradiol, 17 betaestradiol, equilenin, equilin, estriol, 

estrone, ethinyl estradiol, mestranol, 

and norethindrone), should be included 

on the CCL 3 because these 

contaminants are known or anticipated 

to occur in public water systems and 

may require regulation. The specific 

data used to evaluate these 

contaminants can be found in the ‘‘Final 

CCL 3 Contaminant Information Sheets’’ 

(USEPA, 2009e). 

5. Perchlorate 

EPA received several comments on 

perchlorate in response to the draft CCL 

3. Commenters noted that perchlorate 

should be included on the final CCL 3 

and provided occurrence and health 

effects data. Commenters also identified 

potential sources of perchlorate in the 

environment. 

EPA Response: EPA included 

perchlorate on the first CCL in 1998 and 

on the second CCL in 2005. EPA is 

including perchlorate on CCL 3 while 

the Agency continues to evaluate 

scientific information related to a 

regulatory determination. 

EPA published a preliminary 

regulatory determination for perchlorate 

in the FR on October 10, 2008 (73 FR 

60262; USEPA, 2008b). In this notice, 

EPA solicited public comment on its 

preliminary determination not to 

regulate perchlorate. The Agency issued 

an interim health advisory for 

perchlorate to provide technical 

information to State and local officials 

and PWSs for consideration in 

addressing local contamination of 

drinking water (USEPA, 2008c). 

EPA received more than 32,000 

comments on the preliminary regulatory 

determination (73 FR 60262; USEPA 

2008b). The majority of comments were 

submitted by individuals opposed to the 

decision. There were also unique 

comments that recommended further 

scientific evaluation of the information 

EPA used to make the preliminary 

determination. These commenters 

included EPA’s NDWAC, SAB, and 

Children’s Health Protection Advisory 

Committee. All of the comments 

received on the preliminary regulatory 

determination FR notice can be 

reviewed on www.regulations.gov. Refer 

to docket number EPA–HQ–OW–2008– 

0692. 

6. Disinfection Byproducts (DBP) 

EPA received several comments on 

unregulated disinfection byproducts. 
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Most comments supported the inclusion 

of N-nitrosodimethylamine (NDMA) and 

the other N-nitrosamines (Nnitrosodiethylamine, N-nitroso-di-npropylamine, N-nitrosodiphenylamine, 

N-nitrosopyrrolidine) on CCL 3, citing 

the evidence for their carcinogenicity 

and the overarching need to evaluate 

this risk. The SAB advised EPA to 

consider N-nitrosamines as a group 

because of their similar toxicities and 

likelihood to occur together. One 

commenter expressed concern that two 

N-nitrosamines: N-nitroso-di-nbutylamine and N-nitrosomethylethylamine (which are included 

in UCMR 2) are not listed on the draft 

CCL 3. Several commenters expressed 

concern about the overall lack of DBPs 

on the draft CCL 3, citing their assumed 

presence as a result of drinking water 

disinfection. One commenter requested 

that the remaining halo-acetic acids not 

covered under the current DBP 

regulation (bromochloroacetic acid, 

dibromochloroacetic acid, 

bromodichloroacetic acid, and 

tribromoacetic acid) be added to the 

CCL 3. Several commenters mentioned 

groups of chemicals, such as halonitriles, halo-aldehydes, halonitromethanes, and other nitrogenous 

DBPs that they believed should be 

included on the CCL 3. 

EPA Response: The CCL 3 process 

took into consideration the potential 

formation of DBPs in disinfected and 

treated drinking water. Potential DBPs 

with available health information were 

added to the CCL Chemical Universe 

even if they did not have measured 

occurrence data. This is because DBPs 

were considered to have ‘‘default’’ 

occurrence for the Universe since they 

are potentially formed in treated 

drinking water supplies (USEPA 2009a). 

In screening chemicals from the 

Universe to the Preliminary CCL 

(PCCL), EPA added DBPs to the PCCL 

that lacked quantitative occurrence data 

but were in the Toxicity Category 1 or 

Toxicity Category 2 groupings because 

of their potential presence in disinfected 

and treated drinking water (USEPA 

2009b). EPA attempted to identify 

additional health effects and occurrence 

data for these DBPs to determine 

whether to include them on the CCL 3. 

Quantitative occurrence data were 

needed in order for DBPs to be 

evaluated for inclusion on the CCL 3. 

The Agency sought comment on the 

approach and the data used to select 

contaminants in the draft CCL 3. 

EPA evaluated 85 chemicals in the 

groups of potential DBPs mentioned by 

the commenters, but the available data 

showed that most DBPs had limited or 

low levels of occurrence, or lacked 

health effects data. For example, the two 

UCMR 2 nitrosamines that are not on 

CCL 3 lacked sufficient occurrence 

information for inclusion on the list. 

There is additional discussion of the 

interrelationship between the CCL and 

UCMR in Section III.D of this FR notice. 

Several commenters mentioned 

chemicals that were not included in the 

Universe data compilation, but they did 

not submit the health effects and/or 

occurrence information that would be 

necessary to support their inclusion on 

the final CCL 3. 

In addition to the data used by the 

Agency in the draft CCL 3, such as the 

May 14, 1996, DBP Information 

Collection Rule (ICR) (61 FR 24354, 

USEPA 1996), EPA used drinking water 

occurrence data from the State of 

California Department of Health 

Services ICR and studies cited by 

commenters (Krasner et al., 2006) to 

evaluate the occurrence of DBPs. The 

Agency also sought and identified new 

health effects information. A study EPA 

requested during the development of the 

Stage 2 Rule on chlorate was completed 

(NTP 2008) and occurrence information 

on bromochloromethane (Halon 1011) 

was also identified. EPA concluded that 

chlorate and bromochloromethane are 

known or anticipated to occur in PWSs 

and may require regulation. Therefore 

the Agency added these two 

contaminants to the CCL 3. 

EPA continues to participate in 

research concerning the toxicity, 

occurrence, exposure, and treatment of 

unregulated disinfection byproducts. 

This research will inform the 

development of future CCLs and the 

regulatory determination process, as 

well as future reviews of existing 

drinking water regulations. 

C. Microbial Contaminants 

EPA is including twelve pathogens on 

the final CCL 3, one more than the 

eleven pathogens on the draft CCL 3. 

The Agency is adding Adenovirus, 

Enterovirus, and Mycobacterium avium 

to the final CCL 3, and is removing 

Vibrio cholerae and Entamoeba 

histolytica from the final CCL 3. 

The protocol EPA used to select the 

microbial contaminants for the CCL 3 is 

described in detail in the draft CCL 3, 

notice (73 FR 9631, 9644; USEPA, 

2008a). Except for a minor change 

discussed in Section III.C.1, the protocol 

for selecting pathogens for the final CCL 

3 remains the same as the protocol for 

the draft CCL 3; EPA selected the 

pathogens based on their health effects 

and occurrence in drinking water. 

Based on public comment, EPA 

modified the waterborne disease 

outbreak (WBDO) protocol. The Agency 

removed older, Centers for Disease 

Control (CDC) reported WBDOs (prior to 

1990) from the occurrence analysis to 

account for the impact of drinking water 

regulations that have been implemented 

since 1990. This change in the WBDO 

protocol resulted in the exclusion of 

Vibrio cholerae and Entamoeba 

hystolitica from the final CCL 3 and the 

inclusion of Adenovirus and 

Enterovirus to the final CCL 3. 

Based on public comment, EPA 

reviewed the health score for 

Mycobacterium avium. After reevaluating the health effects 

information, EPA determined that a 

higher health effects score was 

appropriate for this pathogen. 

1. Using the CDC WBDO’s as a Scoring 

Criterion 

A commenter recommended the use 

of outbreak data tied to the 

implementation of the SDWA and its 

amendments (i.e., after 1990). The 

commenter, as well as SAB, also 

encouraged EPA to develop its own 

occurrence database instead of relying 

on CDC reported WBDOs. A few 

commenters noted that, in general, the 

information on occurrence of pathogens 

in drinking water is limited, and that 

EPA should develop more occurrence 

information. 

EPA Response: EPA agrees in part 

with this recommendation, and 

recognizes that after implementation of 

SDWA and its amendments, PWSs 

should have changed their practices 

resulting in fewer outbreaks. Therefore, 

early outbreaks (i.e., before 1990) may 

not represent the current situation and 

controls at PWSs operating under these 

regulations. EPA removed CDC WBDOs 

prior to 1990 from the occurrence 

analysis. This change resulted in the 

exclusion of Vibrio cholerae and 

Entamoeba hystolitica from the final 

CCL 3 because their WBDO scores were 

reduced due to the removal of older 

documented WBDOs from consideration 

(USEPA, 2009e). 

EPA disagrees with abandoning the 

CDC database and continues to use the 

CDC documented WBDOs in the CCL 3 

pathogen scoring process. CDC collects 

statistical data on WBDOs every year 

(since 1920). CDC has consistently 

applied a definition for WBDO as well 

as consistently investigated and verified 

epidemiological information related to 

illnesses. This consistency in 

definitions and methods allows EPA to 

consistently compare the WBDO data. In 

contrast, individual research studies on 

isolated outbreaks may have different 

methods and goals, and therefore 

disparate study designs, making 

evaluation of the results difficult from a 
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national perspective. No other national 

database on drinking-water related 

illnesses exists. 

EPA contributes and collaborates with 

CDC on the Morbidity and Mortality 

Weekly Report’s annual surveillance 

summary, and is confident of the quality 

of the information in the report. EPA 

agrees with the commenter that there is 

a need for more information on 

occurrence of pathogens in drinking 

water; however, EPA believes that the 

CDC WBDO data is the best available 

information at this time. 

2. Mycobacterium Avium 

EPA received more than a dozen 

comments requesting that EPA reexamine the health effects score for 

Mycobacterium avium and to include 

the pathogen on the final CCL 3. 

Commenters pointed to the long 

treatment duration and the severity of 

the disease particularly for the elderly 

population. Commenters also cited the 

increased incidence of disease, 

particularly amongst the elderly. 

EPA Response: EPA re-evaluated 

Mycobacterium avium’s health effects 

information and increased the health 

effects score for one of the sensitive life 

stages, or populations; specifically, the 

elderly. The Agency agrees with 

commenters that the potential health 

effects on the elderly and the occurrence 

of Mycobacterium avium in drinking 

water supplies warrant its inclusion on 

the CCL 3. The health effects score was 

increased based on the severity and 

treatment duration on the elderly as 

described in Murray 2007 (USEPA, 

2009g). Based on this information, EPA 

anticipates that Mycobacterium avium 

may occur in PWSs and require 

regulation. Therefore the Agency has 

included Mycobacterium avium on the 

final CCL 3. 

3. Vibrio cholerae and Entamoeba 

hystolitica 

EPA received a few comments 

recommending the exclusion of both 

Vibrio cholerae and Entamoeba 

hystolitica from the final CCL 3. 

Commenters recommended that EPA 

not include these pathogens because 

cholera and amebiasis are currently rare 

in the United States, even though they 

are still common in other countries. 

Also, commenters felt that current 

treatment practices (i.e., disinfection) 

will provide sufficient protection 

against Vibrio cholerae. However, one 

commenter supported keeping Vibrio 

cholerae because its occurrence is likely 

to increase and expand as climate 

change continues. 

EPA Response: Based on public 

comment discussed earlier, EPA 

changed the WBDO protocol. The 

Agency removed older, CDC reported 

WBDOs (prior to 1990) from the 

occurrence analysis to account for 

recently implemented regulations (e.g., 

Surface Water Treatment Rule, Total 

Coliform Rule). This change in the 

WBDO protocol resulted in the 

reduction of the WBDO score for both 

Vibrio cholerae and Entamoeba 

hystolitica, and their exclusion from the 

final CCL 3. However, EPA did not 

consider treatment as one of the 

parameters for inclusion or exclusion of 

a pathogen onto the CCL 3 because 

many public water systems are not 

required to treat, as discussed in the 

draft CCL 3 FR notice (73 FR 9648; 

USEPA, 2008a). Further, EPA 

acknowledges the potential impact 

climate change may have on water 

quality; however, at this time EPA does 

not have enough information to assess 

the risk. 

D. Other Comments 

1. Data Sources for Contaminant 

Candidate Lists 

Several commenters noted that EPA 

used occurrence data sources that could 

only identify a contaminant’s potential 

to occur in PWSs. These included data 

from the TRI, National Center for Food 

and Agricultural Policy (NCFAP), 

modeled occurrence data for pesticides, 

and chemical production data. While 

some commenters urged EPA to rely on 

this type of data, other commenters 

suggested that production data should 

only be used to identify chemicals for 

initial consideration (i.e., inclusion on 

the CCL 3 Universe) and more rigorous 

data should be used to screen or include 

chemicals on the CCL. 

EPA response: The Agency used data 

from the TRI and modeled occurrence 

data for pesticides developed by the 

Office of Pesticide Programs (OPP) to 

support the inclusion of contaminants 

on the CCL 3, but EPA did not rely on 

the Chemical Update System (CUS) and 

the Inventory Update Rule (IUR) data 

(i.e., production volume). 

In developing the CCL, SDWA 

requires that EPA consider unregulated 

contaminants that are known or 

anticipated to occur in PWSs and may 

require regulation. EPA believes that the 

TRI and the OPP data are sufficient for 

it to anticipate that a contaminant that 

is released into the environment may 

occur in a PWS. The Agency coupled 

these data with health effects 

information to evaluate contaminants. 

The NRC (2001) and NDWAC (2004) 

reports included specific 

recommendations on data and 

information that the Agency could use 

to anticipate the occurrence of 

contaminants in PWSs. Both of these 

panels cited the importance of 

identifying contaminants that did not 

yet have occurrence information 

indicating detections in source waters or 

drinking water. NDWAC recognized that 

the Agency could apply a hierarchy to 

the use of detected occurrence over 

potential occurrence, but also noted that 

the use of these types of data enables the 

Agency to be proactive in protecting 

public health. 

EPA also conducted several reviews 

of the data sources and information 

used to develop the CCL 3. EPA sought 

contaminants for the Agency to consider 

in its FR notice, seeking nominations 

(71 FR 65573, USEPA 2006b). The 

Agency published a list of data sources 

including the TRI, CUSIUR, and 

NCFAP. Many of the nominated 

contaminants are chemicals included 

solely on those lists. The Agency also 

conducted several expert panels to 

review the types of data and information 

it used to evaluate contaminants. While 

these panels provided recommendation 

to qualify these types of data, which the 

Agency implemented, the panels did 

not recommend excluding these data 

sources. Based on this input from 

stakeholders and expert reviews, the 

Agency included 51 contaminants with 

TRI and/or modeled occurrence data for 

pesticides to support inclusion on the 

CCL 3 because EPA anticipates that 

these contaminants may occur in PWSs 

and may require regulation. 

2. Contaminant Candidate List and 

Unregulated Contaminant Monitoring 

Regulation 

Several commenters requested 

clarification on the interrelationship 

between the UCMR and the CCL. 

Commenters wanted to know whether 

the CCL draws from chemicals on the 

UCMR, or the UCMR draws from 

chemicals on the CCL to develop the 

respective lists. One commenter 

encouraged EPA to ‘‘improve correlation 

between the CCL and the UCMR.’’ 

EPA response: The 1996 amendments 

to SDWA instituted the CCL and UCMR 

programs to provide information EPA 

needs to determine which drinking 

water contaminants have the greatest 

potential to present a meaningful 

opportunity to reduce health risk 

through a NPWDR. The CCL is the 

primary mechanism for the 

identification of contaminants that may 

require regulation, while UCMR 

provides EPA with the data necessary to 

determine if a contaminant occurs at a 

frequency and at levels of public health 

concern. The CCL and UCMR are parts 
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51858 Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 

of the risk management process, and 

they support and inform each other. 

The UCMR sampling program was 

designed to consider the technical 

difficulty and expense of analyzing up 

to 30 contaminants as well as their 

potential to occur in treated drinking 

water at levels of public health concern. 

The UCMR approach includes three 

different sampling design options, with 

the determination of the appropriate 

option for each contaminant based 

primarily on the difficulty and expense 

of the analytical methods used, and the 

associated issue of laboratory capacity. 

The sampling designs described below 

are discussed in detail in the proposed 

UCMR 2 (70 FR 49094; USEPA 2005). 

Assessment monitoring is the most 

extensive, and is used when the 

technology of the analytical methods is 

in common use in drinking water 

laboratories. Screening monitoring relies 

more on identifying a statistically valid 

representation of the universe of PWSs 

in order to reduce the number of 

utilities impacted by the monitoring. It 

is designed to assure the necessary 

laboratory capacity in those cases where 

the analytical technology is more 

complex and/or expensive. The prescreening monitoring option detailed in 

the UCMR program is based on 

assessing the vulnerability of selected 

PWSs and may be used when the 

analytical techniques are so complex 

that commercial laboratory capacity is 

severely limited; this option has not 

been exercised to date. 

EPA promulgated UCMR 2 on January 

4, 2007 (72 FR 367; USEPA 2007a). The 

UCMR program was developed in 

coordination with the development of 

the CCL. Both programs consider the 

adverse health effects a contaminant 

may pose through drinking water 

exposures. 

Sixteen contaminants on the UCMR 2 

monitoring list are also on the final CCL 

3. The final CCL 3 includes acetochlor 

and its degradates, alachlor degradates, 

dimethoate, 1,3-dinitrobenzene, 

metolachlor and its degradates, RDX, 

terbufos sulfone, and four of the 

nitrosamines that are a part of UCMR 2. 

In addition to the health effects data and 

potential occurrence, the UCMR 2 also 

considers analytical method availability 

and cost, availability of analytical 

standards, and laboratory capacity to 

support a nationwide monitoring 

program in selecting contaminants. 

The UCMR 2 includes nine 

contaminants that are not on the final 

CCL 3. The five polybrominated flame 

retardants can be measured by the same 

analytical method used for terbufos 

sulfone. The polybrominated flame 

retardants are listed on UCMR 2 because 

of concern that these have become more 

widespread environmental 

contaminants (Darnerud et al., 2001). 

The polybrominated flame retardants 

lacked sufficient occurrence information 

to be listed on final CCL 3 (73 FR 9628; 

USEPA 2008a). This UCMR 2 

monitoring data will provide 

information for future CCLs. Similarly, 

2,4,6-trinitrotoluene (TNT) and two of 

the nitrosamines not on CCL 3 are also 

measured by an analytical method in 

the UCMR 2. Alachor was listed on 

UCMR 2 for monitoring along with its 

degradates to allow for the measurement 

of co-concurrence between the parent 

compound and its degradates. It was 

removed from consideration for CCL 3 

because it is currently regulated. The 

Agency will use the results from UCMR 

2 as a source of occurrence information 

during the development of CCL 4, as 

well as for CCL 3 regulatory 

determinations. 

IV. Data Needs for CCL 3 Contaminants 

After the listing process, the CCL 3 

contaminants are evaluated further to 

determine if a contaminant has 

sufficient data to meet the regulatory 

determination criteria set forth in 

SDWA section 1412(b)(1) and 

previously outlined in Section I.C of 

this notice. If the data are sufficient, a 

regulatory determination may be made. 

EPA must make regulatory 

determinations on at least five CCL 3 

contaminants every five years. 

The SAB and other commenters have 

indicated that the CCL 3 may be too 

large and recommended additional 

priority ranking of contaminants to 

focus resources. EPA acknowledges that 

many contaminants on the CCL 3 have 

substantial data and information needs 

that will have to be met before the 

Agency can make a regulatory 

determination in accordance with 

SDWA 1412 (b)(1)(A). Currently, several 

of the CCL 3 contaminants have data or 

information needs. These are described 

in the following section. 

A. Chemical Contaminants 

EPA assessed the data and 

information gathered on the CCL 3 

chemical contaminants and generated a 

table (Exhibit 2) to help identify data/ 

information needs for further regulatory 

determination evaluations. In general, 

EPA characterized each chemical 

contaminant included on the final CCL 

3 for their data needs in three categories; 

health effects, occurrence, and 

analytical methods. The data needs 

were characterized as no data needs, 

specific data needs, or substantial data 

needs. The health effects, occurrence, 

and analytical methods data/ 

information used to classify data needs 

are featured in the supporting 

documentation and in the ‘‘Final CCL 3 

Contaminant Information Sheets’’ in the 

docket (USEPA, 2009e). Blank cells in 

Exhibit 2 generally indicate that there is 

no data need for that contaminant in 

that category. Cells with a ‘‘2’’ indicate 

that the data are under evaluation by 

EPA and the contaminant has a specific 

need. Cells with a ‘‘1’’ indicate that 

there is a data need for that 

contaminant, and that need may be 

substantial. The following sections 

describe the types of data or information 

gaps outlined in Exhibit 2 and provide 

examples. 

1. Health Effects 

EPA categorized the health effects 

data needs for Exhibit 2 using the 

following set of assumptions. Any 

chemical that had an existing EPA 

quantitative assessment (Reference Dose 

(RfD) or Cancer Slope Factor (CSF)) for 

the oral route of exposure is identified 

on the table as not having a health effect 

data need based on the assumption that 

EPA will be able to use the existing data 

along with more recent studies to 

develop a quantitative health effects 

assessment. These chemicals are 

designated with a blank cell in the 

health effects column. There may well 

be opportunities to further elucidate 

mode of action or to reduce uncertainty 

for the analyses associated with these 

contaminants, but such data would not 

be necessary to develop an assessment. 

Similarly, any chemical that has an 

assessment being developed by EPA is 

not identified on the table as having a 

data need, and is represented by a blank 

cell because that work is currently 

ongoing. 

The next category of chemicals with 

health effects data needs have 

quantitative assessments conducted by 

other government agencies such as 

WHO, and Agency for Toxic Substances 

and Disease Registry. These chemicals 

are designated with a ‘‘2’’ in the health 

effects column on the table, signifying 

that an EPA assessment is needed and 

sufficient information may be available 

to initiate the assessment. These data 

apply to oral exposures that can be used 

to support a quantitative assessment of 

risk; however, EPA has not yet 

thoroughly evaluated the existing risk 

assessment to determine if it and the 

supporting data meet EPA data quality 

guidelines and is compatible with EPA 

risk assessment policies. For example, at 

times there may be an RfD-equivalent 

for oral exposures based on inhalation 

data (i.e., California EPA), which is an 

approach EPA does not typically use 

unless there is a physiologically-based 
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Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 51859 

pharmacokinetic model that supports 

the cross route extrapolation. The 

Agency is currently evaluating whether 

this type of model information and 

results are available. For a few 

chemicals marked with the ‘‘2’’ 

designation in the health effects 

column, there is no assessment by 

another agency, but EPA identified a 

critical study suitable for quantification 

of likely cancer risk during the 

development of the CCL 3 process. In 

these cases, an assessment is needed 

based on the data identified. 

The final group of chemicals on 

Exhibit 2 is designated with a ‘‘1’’ in the 

health effects column of the table. For 

these chemicals, the CCL process used 

data from a small group of studies 

identified through the Registry of Toxic 

Effects for Chemical Substances 

(RTECS), a provisional Risk Assessment 

Information System Health Effects 

assessment, and/or a limited literature 

search for the health effects component 

of the CCL 3 evaluation. These 

chemicals have the most substantial 

health effects data gaps and information 

collection needs. 

2. Occurrence 

EPA categorized the occurrence data 

needs for Exhibit 2, after evaluating data 

availability from UCMR 1 and 2, 

Unregulated Contaminant Monitoring 

Round 1 and 2 (UCM R1/2), National 

Inorganic Radiological Survey (NIRS), 

NAWQA, TRI, NCFAP, and other 

supplemental data sources. 

Chemicals with finished water 

occurrence data from UCMR 1, UCMR 2, 

or UCM R1/2 were generally 

characterized as not having an 

occurrence data gap because these data 

are considered nationally 

representative; therefore, they have 

sufficient occurrence data to be further 

evaluated if it is consistent with the 

health effects information. These 

chemicals are designated with a blank 

cell in the occurrence column of Exhibit 

2. 

Contaminants from data sources with 

limited PWS monitoring data (i.e., 

ground water systems only), spatial or 

geographical data limitations, and/or a 

small sample size were identified as 

having a data gap because additional 

monitoring data may be needed for 

further evaluation as part of the 

regulatory determinations process. 

These were given a ‘‘2’’ in the 

occurrence column of Exhibit 2, and 

examples of data sources with this type 

of data include the UCMR screening 

survey, NIRS, DBP ICR data, and others. 

Chemicals from occurrence data 

sources with ambient monitoring data, 

environmental release data, or modeled 

data were given a ‘‘1’’ in the occurrence 

column because there are substantial 

additional data needs to be considered 

and evaluated as part of the regulatory 

determinations process. Examples of 

data sources with this type of data 

include USGS’s NAWQA, National 

Reconnaissance of Emerging 

Contaminants, TRI, and others with 

similar data. 

3. Analytical Methods 

To conduct nationally representative 

drinking water occurrence studies, and 

support a regulatory determination, EPA 

must have an analytical method that is 

suitable for the drinking water matrix 

and is robust enough to be used by 

many laboratories to conduct national 

studies and/or compliance monitoring. 

The analytical method should be 

sensitive enough to allow for 

quantitation of the chemical at a 

concentration below the HRL, or as 

close to the HRL as practically feasible. 

EPA categorized available analytical 

methods for the CCL chemicals to define 

the data needs presented in Exhibit 2. 

EPA reviewed the methods to assess if 

they had been developed for drinking 

water and then evaluated estimated 

reporting levels for the chemical by that 

method. When available, methodspecific reporting levels, lowest 

concentration minimum reporting 

levels, and promulgated minimum 

reporting levels were also used to 

measure method sensitivity. When this 

was not possible, EPA used a value of 

five times the method detection limit or 

detection limit; this approach has been 

used in the past. 

Chemicals with blanks in the 

analytical methods column of Exhibit 2 

are generally those chemicals for which 

EPA has an established drinking water 

method, with estimated reporting levels 

that are adequate for analysis relative to 

the HRL. However, in some cases, a 

blank may also signify that EPA is 

currently in the process of developing a 

method that it believes will have 

adequate reporting levels. Chemicals 

with a ‘‘2’’ in the analytical method 

column of Exhibit 2 have a drinking 

water method that is under 

development by EPA. EPA has 

evaluated the available methods for 

each of these chemicals and determined 

that the reporting level does not allow 

for quantitation of the chemical at a 

concentration below the HRL or as close 

to the HRL as practical. Therefore, EPA 

has designated that these methods 

require further development to increase 

their sensitivity and lower the estimated 

method reporting level or method 

detection level. Those chemicals listed 

as a ‘‘1’’ in the methods column do not 

have an established method for drinking 

water or a method that is suitable for a 

national drinking water occurrence 

study. 

Key to Exhibit 2 

The following key is a reference guide 

to reading Exhibit 2 and interpreting the 

data presented in the table. 

Note: Categories are based on the extent of 

available data for each contaminant. 

1. Health Effects: 

1 = Substantial data needs (RTECS, 

RAISHE, and other small study data); 2 = 

Assessments exist from other government 

agencies. Sufficient information may exist to 

conduct an EPA assessment; Blank = Existing 

or ongoing EPA quantitative assessment (e.g., 

IRIS) 

2. Occurrence: 

1 = No comprehensive drinking water 

occurrence data (e.g., often only 

environmental release data such as TRI, or 

ambient water data), 2 = Limited available 

drinking water monitoring data; however, 

data may be limited by scope and sample size 

(e.g., UCMR 1 Screening Survey, NIRS); 

Blank = EPA has more extensive national 

drinking water monitoring data (e.g., UCMR, 

UCM R1/2) 

3. Analytical Method: 

1 = No analytical method suitable for 

national drinking water occurrence studies; 2 

= Drinking water method in development or 

being re-evaluated for comparison with new 

health effects information; Blank = EPA has 

a method or is in the process of developing 

a method that could be used for national 

drinking water monitoring. 

EXHIBIT 2. REGULATORY DETERMINATION DATA/INFORMATION NEEDS FOR CCL 3 CHEMICALS 

CASRN Common name Health 

effects Occurrence Analytical methods 

630206 ............................... 

75343 ................................. 

96184 ................................. 

106990 ............................... 

99650 ................................. 

1,1,1,2-Tetrachloroethane ................................................................... 

1,1-Dichloroethane .............................................................................. 

1,2,3-Trichloropropane ........................................................................ 

1,3-Butadiene ...................................................................................... 

1,3-Dinitrobenzene .............................................................................. 

................ 

1 

................ 

1 

................ 

........................ 

........................ 

........................ 

1 

........................ 

.....................

.....................

.....................

... 

2 

... 

2 

... 
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EXHIBIT 2. REGULATORY DETERMINATION DATA/INFORMATION NEEDS FOR CCL 3 CHEMICALS—Continued 

CASRN Common name Health 

effects Occurrence Analytical methods 

123911 ............................... 1,4-Dioxane ......................................................................................... ................ 1 ........................ 

71363 ................................. 1-Butanol ............................................................................................. ................ 1 1 

109864 ............................... 2-Methoxyethanol ................................................................................ 2 1 1 

107186 ............................... 2-Propen-1-ol ....................................................................................... ................ 1 1 

16655826 ........................... 3-Hydroxycarbofuran ........................................................................... 2 ........................ ........................ 

101779 ............................... 4,4’-Methylenedianiline ........................................................................ 2 1 1 

30560191 ........................... Acephate ............................................................................................. ................ 1 2 

75070 ................................. Acetaldehyde ....................................................................................... ................ 2 ........................ 

60355 ................................. Acetamide ............................................................................................ 2 1 1 

34256821 ........................... Acetochlor ............................................................................................ ................ ........................ ........................ 

187022113 ......................... Acetochlor ethanesulfonic acid (ESA) ................................................. 2 ........................ ........................ 

184992444 ......................... Acetochlor oxanilic acid (OA) .............................................................. 2 ........................ ........................ 

107028 ............................... Acrolein ................................................................................................ ................ 1 1 

142363539 ......................... Alachlor ethanesulfonic acid (ESA) ..................................................... 2 ........................ ........................ 

171262172 ......................... Alachlor oxanilic acid (OA) .................................................................. 2 ........................ ........................ 

319846 ............................... alpha-Hexachlorocyclohexane ............................................................ ................ 1 2 

64285069 ........................... Anatoxin-a ........................................................................................... ................ 1 2 

62533 ................................. Aniline .................................................................................................. 2 1 1 

741582 ............................... Bensulide ............................................................................................. ................ 1 1 

100447 ............................... Benzyl chloride .................................................................................... ................ 1 1 

25013165 ........................... Butylated hydroxyanisole .................................................................... 2 1 2 

133062 ............................... Captan ................................................................................................. ................ 1 2 

14866683 ........................... Chlorate ............................................................................................... ................ 2 ........................ 

74873 ................................. Chloromethane (Methyl chloride) ........................................................ 2 ........................ ........................ 

110429624 ......................... Clethodim ............................................................................................ ................ 1 2 

7440484 ............................. Cobalt .................................................................................................. ................ 2 ........................ 

80159 ................................. Cumene hydroperoxide ....................................................................... 1 1 1 

143545908 ......................... Cylindrospermopsin ............................................................................. ................ 1 2 

141662 ............................... Dicrotophos ......................................................................................... ................ 1 2 

55290647 ........................... Dimethipin ............................................................................................ ................ 1 2 

60515 ................................. Dimethoate .......................................................................................... ................ ........................ ........................ 

298044 ............................... Disulfoton ............................................................................................. ................ 2 ........................ 

330541 ............................... Diuron .................................................................................................. ................ 2 ........................ 

114078 ............................... Erythromycin ........................................................................................ 2 1 1 

13194484 ........................... Ethoprop .............................................................................................. ................ 1 2 

107211 ............................... Ethylene glycol .................................................................................... ................ 1 1 

75218 ................................. Ethylene oxide ..................................................................................... 1 1 1 

96457 ................................. Ethylene thiourea ................................................................................ ................ 1 2 

22224926 ........................... Fenamiphos ......................................................................................... ................ 1 2 

50000 ................................. Formaldehyde ...................................................................................... ................ 2 ........................ 

7440564 ............................. Germanium .......................................................................................... 1 2 2 

74975 ................................. Halon 1011 (bromochloromethane) ..................................................... 1 ........................ 2 

75456 ................................. HCFC–22 ............................................................................................. 1 1 2 

110543 ............................... Hexane ................................................................................................ 1 1 1 

302012 ............................... Hydrazine ............................................................................................ ................ 1 1 

10265926 ........................... Methamidophos ................................................................................... ................ 1 2 

67561 ................................. Methanol .............................................................................................. ................ 1 1 

74839 ................................. Methyl bromide (Bromomethane) ........................................................ ................ ........................ ........................ 

1634044 ............................. Methyl tert-butyl ether ......................................................................... ................ ........................ ........................ 

51218452 ........................... Metolachlor .......................................................................................... ................ ........................ ........................ 

171118095 ......................... Metolachlor ethanesulfonic acid (ESA) ............................................... 2 ........................ ........................ 

152019733 ......................... Metolachlor oxanilic acid (OA) ............................................................ 2 ........................ ........................ 

101043372 ......................... Microcystin-LR ..................................................................................... ................ 1 2 

2212671 ............................. Molinate ............................................................................................... ................ ........................ ........................ 

7439987 ............................. Molybdenum ........................................................................................ ................ 2 ........................ 

98953 ................................. Nitrobenzene ....................................................................................... ................ ........................ ........................ 

55630 ................................. Nitroglycerin ......................................................................................... 2 1 1 

872504 ............................... N-Methyl-2-pyrrolidone ........................................................................ 2 1 1 

55185 ................................. N-Nitrosodiethylamine (NDEA) ............................................................ ................ ........................ ........................ 

62759 ................................. N-nitrosodimethylamine (NDMA) ......................................................... ................ ........................ ........................ 

621647 ............................... N-Nitroso-di-n-propylamine (NDPA) .................................................... ................ ........................ ........................ 

86306 ................................. N-Nitrosodiphenylamine ...................................................................... ................ 1 1 

930552 ............................... N-nitrosopyrrolidine (NPYR) ................................................................ ................ ........................ ........................ 

103651 ............................... n-Propylbenzene ................................................................................. 1 ........................ 2 

95534 ................................. o-Toluidine ........................................................................................... 2 1 2 

75569 ................................. Oxirane, methyl­ ................................................................................. ................ 1 1 

301122 ............................... Oxydemeton-methyl ............................................................................ ................ 1 2 

42874033 ........................... Oxyfluorfen .......................................................................................... ................ 1 2 

14797730 ........................... Perchlorate .......................................................................................... ................ ........................ ........................ 

1763231 ............................. Perfluorooctane sulfonic acid (PFOS) ................................................. 2 1 ........................ 

335671 ............................... Perfluorooctanoic acid (PFOA) ............................................................ 2 1 ........................ 
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EXHIBIT 2. REGULATORY DETERMINATION DATA/INFORMATION NEEDS FOR CCL 3 CHEMICALS—Continued 

CASRN Common name Health 

effects Occurrence Analytical methods 

52645531 ........................... Permethrin ........................................................................................... ................ 1 2 

41198087 ........................... Profenofos ........................................................................................... ................ 1 2 

91225 ................................. Quinoline ............................................................................................. ................ 1 2 

121824 ............................... RDX ..................................................................................................... ................ ........................ ........................ 

135988 ............................... sec-Butylbenzene ................................................................................ 1 ........................ 2 

7440246 ............................. Strontium ............................................................................................. ................ 2 ........................ 

107534963 ......................... Tebuconazole ...................................................................................... ................ 1 2 

112410238 ......................... Tebufenozide ....................................................................................... ................ 1 1 

13494809 ........................... Tellurium .............................................................................................. 1 2 2 

13071799 ........................... Terbufos .............................................................................................. ................ 2 ........................ 

56070167 ........................... Terbufos sulfone .................................................................................. 2 ........................ ........................ 

59669260 ........................... Thiodicarb ............................................................................................ ................ 1 2 

23564058 ........................... Thiophanate-methyl ............................................................................. ................ 1 2 

26471625 ........................... Toluene diisocyanate .......................................................................... 2 1 1 

78488 ................................. Tribufos ................................................................................................ ................ 1 2 

121448 ............................... Triethylamine ....................................................................................... 1 1 1 

76879 ................................. Triphenyltin hydroxide (TPTH) ............................................................ ................ 1 1 

51796 ................................. Urethane .............................................................................................. 2 1 1 

7440622 ............................. Vanadium ............................................................................................ 2 2 ........................ 

50471448 ........................... Vinclozolin ........................................................................................... ................ 1 2 

137304 ............................... Ziram ................................................................................................... ................ 1 1 

57910 ................................. 17alpha-estradiol ................................................................................. 1 1 1 

517099 ............................... Equilenin .............................................................................................. 1 1 1 

474862 ............................... Equilin .................................................................................................. 1 1 1 

50282 ................................. Estradiol (17-beta estradiol) ................................................................ 2 1 ........................ 

50271 ................................. Estriol ................................................................................................... 1 1 2 

53167 ................................. Estrone ................................................................................................ 1 1 2 

57636 ................................. Ethinyl Estradiol (17-alpha ethynyl estradiol) ...................................... 1 1 2 

72333 ................................. Mestranol ............................................................................................. 1 1 1 

68224 ................................. Norethindrone (19-Norethisterone) ...................................................... 1 1 1 

B. Microbial Contaminants 

EPA intends to look at the over-arching 

risk posed by pathogens in drinking water. 

To this end, EPA is planning to evaluate the 

CCL 3 pathogens in the context of the 

existing drinking water regulatory program to 

determine the sufficiency of the barriers that 

help to prevent exposure. 

Commenters noted a need for information 

on the national occurrence of pathogens in 

drinking water. Development of such data 

would aid EPA in determining the likelihood 

that pathogens will occur in public water 

systems and thus clarify the extent to which 

they represent a significant public health 

threat. One aspect of determining the 

occurrence of any contaminant is the 

availability of a method to monitor for that 

contaminant. While there are many methods 

for monitoring the CCL 3 pathogens available 

from scientific papers and consensus 

organizations, not all of them may be 

appropriate for use in drinking water or for 

a national monitoring effort. Of the CCL 3 

pathogens, only enterovirus has an EPAapproved method for drinking water. EPA is 

working on developing and approving 

drinking water methods for some of the 

pathogens, and is considering the need for 

additional occurrence information. In 

addition, EPA is evaluating the suitability of 

current microbial indicators as well as the 

reliability of other indicators for CCL 

pathogens. 

Furthermore, the Agency is actively 

working with stakeholders on additional 

information on distribution system issues 

needed to inform national risk management 

actions such as regulations and guidance. 

Based on currently available information, 

EPA and other stakeholders have identified 

the following issues as being the most 

relevant to protecting public health and 

maintaining the integrity of drinking water 

distribution systems for future consideration: 

cross connections and backflow of 

contaminated water; storage facility design, 

operation, or maintenance; main installation, 

repair or rehabilitation practices; intrusion 

due to pressure conditions; significance and 

control of biofilm and microbial growth; 

nitrification issues; and accumulation and 

release of contaminants from distribution 

system scales and sediments. These issues 

may be applicable to chemicals as well as 

microbial contaminants. 

V. Next Steps/Future Candidate Contaminant 

Lists 

The CCL process is a critical input to 

shaping the future direction of the drinking 

water program. The Agency will continue to 

gather information and evaluate 

contaminants on the CCL 3 to make a 

regulatory determination for at least five 

contaminants by 2013. The Agency will also 

continue to refine the CCL process and gather 

more data to identify contaminants for the 

fourth CCL by 2014. EPA will also continue 

to work to prioritize contaminants on the 

CCL 3, both for regulatory determination and 

for additional research and data collection. 

VI. References 

Darnerud, P.O., G.S. Erickson, T. 

Johannesson, P.B. Larson, and M. Viluksela. 

2001. Polybrominated Diphenyl Ethers: 

Occurrence, Dietary Exposure, and 

Toxicology. Environmental Health 

Perspectives Supplements. Vol. 109, No. S1. 

Available on the Internet at: http:// 

ehp.niehs.nih.gov/members/2001/suppl-1/ 

49–68darnerud/darnerud-full.html. 

National Drinking Water Advisory Council 

(NDWAC). 2004. National Drinking Water 

Advisory Council Report on the CCL 

Classification Process to the U. S. 

Environmental Protection Agency, May 19, 

2004. 

National Research Council (NRC). 2001. 

Classifying Drinking Water Contaminants for 

Regulatory Consideration. National Academy 

Press, Washington DC. 

National Toxicology Program (NTP). 2008. 

Toxicology and carcinogenesis studies of 

sodium chlorate (CAS No. 7775–09–9) in 

F344/N rats and B6C3F1 mice (drinking water 

studies). TR–517. U.S. Department of Health 

and Human Services. http:// 

ntp.niehs.nih.gov/?objectid=00132319–F1F6– 

975E–778A4E6504EB9191. 

Krasner, S. W., H. S. Weinberg, et al. 

(2006). ‘‘Occurrence of a new generation of 

disinfection byproducts.’’ Environ. Sci. 

Technol 40(23): 7175–7185. 

USEPA. 1996. National Primary Drinking 

Water Regulations: Monitoring Requirements 

for Public Drinking Water Supplies: 

Cryptosporitium, Giardia, Viruses, 

Disinfection Byproducts, Water Treatment 

Plant Data and Other Information 

Requirements; Final Rule. Federal Register. 

Vol. 61, No. 94. p. 24354. May 14, 1996. 

USEPA. 2001. Reregistration Eligibility 

Decision for Ethion. Available at: http:// 
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51862 Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 

www.epa.gov/pesticides/reregistration/REDs/ 

ethion_letter.htm (Section III. Summary of 

Ethion Risk Assessment, B. Environmental 

Risk Assessment 1. Environmental Fate and 

Transport) or in hard copy form from the 

EPA’s Office of Pesticide Program’s Special 

Docket (Docket ID: EPA–HQ–OPP–2007– 

0151–0007 on http://www.regulations.gov). 

USEPA. 2002. Ethion; Cancellation Order. 

Federal Register. Vol 67, No. 56. p. 13328, 

March 22, 2002. 

USEPA. 2004. Bitertanol, Chlorpropham, 

Cloprop, Combustion Product Gas, 

Cyanazine, et al.; Tolerance Actions. Federal 

Register. Vol. 69, No. 141. p. 43918, July 23, 

2004. 

USEPA. 2005. Unregulated Contaminant 

Monitoring Regulation (UCMR) for Public 

Water Systems Revisions; Proposed Rule. 

Federal Register. Vol. 70, No. 161. p. 49094. 

August 22, 2005. 

USEPA. 2006a. SAB Review of EPA’s Draft 

Risk Assessment of Potential Human Health 

Effects Associated with PFOA and Its Salts. 

EPA–SAB–06–006. 

USEPA. 2006b. National Primary Drinking 

Water Regulations: Ground Water Rule; Final 

Rule. Federal Register. Vol. 71, No. 216. p. 

65573, November 8, 2006. 

USEPA. 2007a. Unregulated Contaminant 

Monitoring Regulation (UCMR) for Public 

Water Systems Revisions; Final Rule. Federal 

Register. Vol. 72, No. 2. p. 367, January 4, 

2007. 

USEPA. 2007b. Perfluoroalkyl Sulfonates; 

Significant New Use Rule. Federal Register. 

Vol. 72, No. 194, p. 57222–57235, October 9, 

2007. 

USEPA. 2008a. Drinking Water 

Contaminant Candidate List 3—Draft Notice. 

Federal Register. Vol, 73. No 35. p. 9628. 

February 21, 2008. 

USEPA. 2008b. Drinking Water: 

Preliminary Regulatory Determination on 

Perchlorate. Federal Register. Vol. 73. No 

198. p. 60262. October 10, 2008. 

USEPA. 2008c. Interim Drinking Water 

Health Advisory for Perchlorate. EPA 822–R– 

08–025. December 2008. 

USEPA. 2009a. Final Contaminant 

Candidate List 3 Chemicals: Identifying the 

Universe. EPA. 815–R–09–006. August, 2009. 

USEPA. 2009b. Final Contaminant 

Candidate List 3 Chemicals: Screening to a 

PCCL. EPA 815–R–09–007. August, 2009. 

USEPA. 2009c. Final Comment Response 

Document for the Third Drinking Water 

Contaminant Candidate List 3 (Categorized 

Public Comments). EPA 815–R–09–010. 

August, 2009. 

USEPA. 2009d. SAB Advisory on EPA’s 

Draft Third Drinking Water Contaminant List 

(CCL 3). EPA–SAB–09–011. January 2009. 

http://yosemite.epa.gov/sab/sabproduct.nsf/ 

WebProjectsbyNameBOARD!OpenView. 

USEPA. 2009e. Final CCL 3 Contaminant 

Information Sheets. EPA 815–R–09–012. 

August, 2009. 

USEPA. 2009f. Provisional Health 

Advisories for Perfluorooctanoic Acid 

(PFOA) and Perfluorooctane Sulfonate 

(PFOS). January 2009. 

USEPA. 2009g. Final Contaminant 

Candidate List 3 Microbes: PCCL to CCL 

Process. EPA 815–R–09–009. August, 2009. 

Dated: September 21, 2009. 

Michael H. Shapiro, 

Acting Assistant Administrator, Office of 

Water. 

[FR Doc. E9–24287 Filed 10–7–09; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL ELECTION COMMISSION 

Sunshine Act Notices 

AGENCY: Federal Election Commission. 

DATE AND TIME: Tuesday, October 6, 

2009, at 10 a.m. 

PLACE: 999 E Street, NW., Washington, 

DC (Ninth Floor). 

STATUS: This meeting will be closed to 

the public. 

ITEMS TO BE DISCUSSED: 

Compliance matters pursuant to 2 

U.S.C. 437g. 

Audits conducted pursuant to 2 

U.S.C. 437g, § 438(b), and Title 26, 

U.S.C. 

Matters concerning participation in 

civil actions or proceedings or 

arbitration. 

Internal personnel rules and 

procedures or matters affecting a 

particular employee. 

DATE AND TIME: Thursday, October 8, 

2009, at 10 a.m. 

PLACE: 999 E Street, NW., Washington, 

DC (Ninth Floor). 

STATUS: This meeting will be open to 

the public. 

ITEMS TO BE DISCUSSED: 

Correction and Approval of Minutes. 

Notices of Proposed Rulemaking 

Implementing DC Court of Appeals 

Opinion in Shays v. FEC. 

Draft Advisory Opinion 2009–22: 

Democratic Senatorial Campaign 

Committee, by Marc Elias, Esquire. 

Draft Advisory Opinion 2009–23: 

Virginia Chapter of Sierra Club, by B. 

Holly Schadler and Michael B. Trister, 

Esqs. 

Draft Advisory Opinion 2009–24: 

Illinois Green Party, by John Ailey, 

Treasurer. 

Management and Administrative 

Matters. 

Individuals who plan to attend and 

require special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

contact Mary Dove, Commission 

Secretary, at (202) 694–1040, at least 72 

hours prior to the hearing date. 

PERSON TO CONTACT FOR INFORMATION: 

Judith Ingram, Press Officer, Telephone: 

(202) 694–1220. 

Mary W. Dove, 

Secretary of the Commission. 

[FR Doc. E9–24141 Filed 10–6–09; 11:15 am] 

BILLING CODE 6715–01–M 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisition of Shares of Bank or Bank 

Holding Companies 

The notificants listed below have 

applied under the Change in Bank 

Control Act (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire a bank or bank 

holding company. The factors that are 

considered in acting on the notices are 

set forth in paragraph 7 of the Act (12 

U.S.C. 1817(j)(7)). 

The notices are available for 

immediate inspection at the Federal 

Reserve Bank indicated. The notices 

also will be available for inspection at 

the office of the Board of Governors. 

Interested persons may express their 

views in writing to the Reserve Bank 

indicated for that notice or to the offices 

of the Board of Governors. Comments 

must be received not later than October 

24, 2009. 

A. Federal Reserve Bank of 

Minneapolis (Jacqueline G. King, 

Community Affairs Officer) 90 

Hennepin Avenue, Minneapolis, 

Minnesota 55480-0291: 

1. Darin J. Latterall, Kelliher, 

Minnesota, to acquire 25 percent or 

more of the voting shares of Kelliher 

Bancshares, Inc., Kelliher, Minnesota, 

and thereby indirectly gain control of 

Citizens State Bank of Kelliher, Kelliher, 

Minnesota 

Board of Governors of the Federal Reserve 

System, October 5, 2009. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E9–24276 Filed 10–7–09; 8:45 am] 

BILLING CODE 6210–01–S 

FEDERAL RESERVE SYSTEM 

Sunshine Act Meeting 

AGENCY HOLDING THE MEETING: Board of 

Governors of the Federal Reserve 

System. 

TIME AND DATE: 11:30 a.m., Tuesday, 

October 13, 2009. 


PLACE: Marriner S. Eccles Federal 


Reserve Board Building, 20th and C 


Streets, N.W., Washington, D.C. 20551. 


STATUS: Closed.