Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices 9071

EPA West, U.S. EPA, 1200 Pennsylvania 

Avenue, NW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Mr. 

M. Ahmar Siddiqui, Document Control 

Officer, at (202) 566–1044, or via e-mail 

at siddiqui.ahmar@epa.gov.

SUPPLEMENTARY INFORMATION: EPA has 

previously transferred to its contractor, 

ERG (located in Chantilly, Virginia and 

Lexington, Massachusetts), information, 

including CBI, that was collected under 

the authority of section 308 of the CWA. 

Notice of the transfer was provided to 

the affected industries (see, for example, 

59 FR 58840, November 15, 1994). EPA 

determined that this transfer was 

necessary to enable the contractors and 

subcontractors to perform their work in 

supporting EPA in planning, 

developing, and reviewing effluent 

guidelines and standards for certain 

industries. 

Today, EPA is giving notice that it has 

entered into additional contracts, 

numbers 68–C–02–095 and 68–C–01–

073, with ERG. The reason for these 

contracts is to secure additional 

contractor support in engineering 

analysis, survey and database 

development, economic analyses, and 

ecological analyses. To obtain assistance 

in responding to these contracts, ERG 

has entered into contracts with their 

subcontractors. In particular, ERG has 

obtained the services of the following 

subcontractors: Abt Associates (located 

in Cambridge, Massachusetts); AH 

Environmental Consultants, Inc. 

(located in Newport News and 

Springfield, Virginia); AmDyne 

Corporation (located in Glen Burnie, 

Maryland); Amendola Engineering, Inc. 

(located in Westlake, Ohio); Analytica 

Alaska, Inc. (located in Juneau, Alaska); 

Applied Geographics, Inc. (located in 

Boston, Massachusetts); Avanti 

Corporation (located in Annandale, 

Virginia); CK Environmental (located in 

Atlanta, Georgia); DRPA, Inc. (located in 

Rosslyn, Virginia); GeoLogics 

Corporation (located in Alexandria, 

Virginia); Hydraulic and Water 

Resources Engineers, Inc. (located in 

Waltham, Massachusetts); N. McCubbin 

Consultants, Inc. (located in Foster, 

Quebec, Canada); Stratus Consulting, 

Inc. (located in Boulder, Colorado); 

Tetra Tech, Inc. (located in Fairfax, 

Virginia); Versar, Inc. (located in 

Springfield, Virginia); and independent 

consultant Danforth Bodien. 

All EPA contractor, subcontractor, 

and consultant personnel are bound by 

the requirements and sanctions 

contained in their contracts with EPA 

and in EPA’s confidentiality regulations 

found at 40 CFR Part 2, Subpart B. ERG 

and its subcontractors adhere to EPAapproved security plans which describe 

procedures to protect CBI. The 

procedures in these plans are applied to 

CBI previously gathered by EPA for the 

industries identified below and to CBI 

that may be gathered in the future for 

these industries. The security plans 

specify that contractor and 

subcontractor personnel are required to 

sign non-disclosure agreements and are 

briefed on appropriate security 

procedures before they are permitted 

access to CBI. No person is 

automatically granted access to CBI; a 

need to know must exist. 

The information that will be 

transferred to ERG and its 

subcontractors consists primarily of 

information previously collected by 

EPA to support the development and 

review of effluent limitations guidelines 

and standards under the CWA and the 

development of discharge standards 

under Title XIV. In particular, 

information, including CBI, collected for 

the planning, development, and review 

of effluent limitations guidelines and 

standards for the following industries 

may be transferred: Airport deicing; 

aquaculture; concentrated animal 

feeding operations; centralized waste 

treatment; coal mining; drinking water; 

industrial laundries; waste combustors; 

iron and steel manufacturing; landfills; 

meat and poultry products; metal 

finishing; metal products and 

manufacturing; nonferrous metals 

manufacturing; oil and gas extraction 

(including coalbed methane); ore 

mining and dressing; organic chemicals, 

plastics, and synthetic fibers; pesticide 

chemicals; pharmaceutical 

manufacturing; petroleum refining; 

pulp, paper, and paperboard 

manufacturing; steam electric power 

generation; textile mills; timber 

products processing; tobacco; and 

transportation equipment cleaning. In 

addition, for the development of 

standards under Title XIV, EPA may 

transfer information, including CBI, 

about large cruise ships that operate in 

the waters around Alaska. 

EPA also intends to transfer to ERG 

and its subcontractors all information 

listed in this notice, of the type 

described above (including CBI) that 

may be collected in the future under the 

authority of section 308 of the CWA or 

voluntarily submitted (e.g., in comments 

in response to a Federal Register

notice), as is necessary to enable ERG 

and its subcontractors to carry out the 

work required by their contracts to 

support EPA’s effluent guidelines 

planning process; development of 

effluent limitations guidelines and 

standards; and discharge standards from 

cruise ships.

Dated: February 15, 2005. 

Geoffrey H. Grubbs, 

Director, Office of Science and Technology.

[FR Doc. 05–3528 Filed 2–23–05; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY 

[OW–2003–0028; FRL–7876–9] 

RIN 2060–AD86 

Drinking Water Contaminant Candidate 

List 2; Final Notice

AGENCY: Environmental Protection 

Agency.

ACTION: Notice.

SUMMARY: The Safe Drinking Water Act 

(SDWA), as amended in 1996, requires 

the Environmental Protection Agency 

(EPA) to publish a list of contaminants 

that, at the time of publication, are not 

subject to any proposed or promulgated 

national primary drinking water 

regulations, that are known or 

anticipated to occur in public water 

systems, and that may require 

regulations under SDWA (section 1412 

(b)(1)). SDWA, as amended, specifies 

that EPA must publish the first list of 

drinking water contaminants no later 

than 18 months after the date of 

enactment, i.e., by February 1998, and 

every five years thereafter. 

The EPA published the first 

Candidate Contaminant List (CCL) in 

March of 1998 (63 FR 10273). The 

second draft CCL (CCL 2) was published 

on April 2, 2004 (69 FR 17406) and 

announced EPA’s preliminary decision 

to carry forward the remaining 51 

contaminants on the 1998 CCL as the 

draft CCL 2, provided information on 

EPA’s efforts to expand and strengthen 

the underlying CCL listing process to be 

used for future CCL listings, and sought 

comment on the draft list as well as 

EPA’s efforts to improve the 

contaminant selection process for future 

CCLs. Today’s final CCL 2 carries 

forward the remaining 51 contaminants 

proposed on April 2, 2004.

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. OW–2003–0028. All documents in 

the docket are listed in the EDOCKET 

index at http://www.epa.gov/edocket.

Although listed in the index, some 

information is not publically available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publically 

available only in hard copy form. 

Publically available docket materials are 

9072 Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices 

available either electronically in 

EDOCKET or in hard copy at the Water 

Docket, EPA/DC, EPA West, Room 

B102, 1301 Constitution Avenue, 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 Water Docket is (202) 566–2426. For 

access to docket material, please call 

(202) 566–2426 to schedule an 

appointment.

FOR FURTHER INFORMATION CONTACT: For 

questions about this notice contact Dan 

Olson, Standards and Risk Management 

Division, Office of Ground Water and 

Drinking Water (MC–4607M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460; telephone number: 202–564–

5239; fax number: 202–564–3752; e-mail 

address: olson.daniel@epa.gov. For 

general information contact the EPA 

Safe Drinking Water Hotline at (800) 

426–4791 or e-mail: hotlinesdwa@epa.gov. The Safe Drinking Water 

Hotline is open Monday through Friday, 

excluding legal holidays, from 9 a.m. to 

5 p.m.

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Impose Any 

Requirements on My Public Water 

System? 

Today’s action does not impose any 

requirements on anyone. Instead, it 

notifies interested parties of EPA’s final 

CCL 2 as well as EPA’s efforts to 

improve the contaminant selection 

process for future CCLs. Contaminants 

on the list will be considered under the 

regulatory determination provision of 

SDWA (see section 1412(b)(1)(B)(ii)), 

which directs EPA to select at least five 

contaminants from the CCL every five 

years to determine if regulating the 

contaminants through National Primary 

Drinking Water Regulations would 

present a meaningful opportunity to 

reduce health risk. 

II. Background and Summary of 

Today’s Action 

A. What Is the Purpose of Today’s 

Action?

The CCL is the primary source of 

priority contaminants for evaluation by 

EPA’s drinking water program. 

Contaminants on the CCL are currently 

not subject to any proposed or 

promulgated national primary drinking 

water regulation, but are known or 

anticipated to occur in public water 

systems, and may require regulation 

under SDWA. The EPA conducts 

research on health effects, analytical 

methods, contaminant occurrence, 

treatment technologies, and treatment 

effectiveness for priority drinking water 

contaminants on the CCL. The Agency 

also develops drinking water guidance 

and health advisories, and makes 

regulatory determinations for priority 

contaminants on the CCL. 

Today’s action informs interested 

parties of EPA’s final CCL 2 as well as 

EPA’s efforts to improve the 

contaminant selection process for future 

CCLs. 

B. The Background of the CCL 

The SDWA is the core statute 

protecting drinking water at the Federal 

level. Under SDWA, EPA sets public 

health goals and enforceable standards 

for drinking water quality. In 1996, 

Congress amended SDWA to emphasize 

sound science and risk-based prioritysetting. Congress also changed the way 

drinking water regulatory priorities are 

set by establishing the CCL 

requirements. The 1996 SDWA 

amendments require EPA to (1) publish 

every five years a list of currently 

unregulated contaminants in drinking 

water that may pose risks (the CCL), and 

(2) make determinations on whether or 

not to regulate at least five of these 

contaminants on a five year cycle, or 

three and a half years after each CCL is 

published (SDWA section (b)(1)). 

Today’s action is being published 

pursuant to the requirements in section 

1412(b)(1). The contaminants included 

are not subject to any proposed or 

promulgated national primary drinking 

water regulation, are known or 

anticipated to occur in public water 

systems, and may require regulation 

under the SDWA. A draft CCL 2 was 

published in the April 2, 2004 edition 

of the Federal Register (69 FR 17406) to 

announce EPA’s preliminary decision to 

carry forward the remaining 51 

contaminants on the 1998 CCL as the 

CCL 2, to provide information on EPA’s 

efforts to expand and strengthen the 

underlying CCL listing process to be 

used for future CCL listings, and to seek 

comment on the draft list as well as 

EPA’s efforts to improve the 

contaminant selection process for future 

CCLs. 

Today’s action establishes the final 

CCL 2 which includes 42 chemicals or 

chemical groups and nine 

microbiological contaminants. This list 

continues to be an important tool under 

the SDWA to help prioritize research 

and serves as the central focus of the 

regulatory determination process noted 

previously. It is important to note, 

however, that under the SDWA, the EPA 

may also make regulatory 

determinations for any unregulated 

contaminant not on today’s CCL (see 

SDWA section 1412(b)(1)(B)(ii)(III)). 

Thus, the Agency has the authority to 

act as necessary to protect public health 

as new information becomes available. 

III. Drinking Water Contaminant 

Candidate List 2 

Table III–1 lists the contaminants on 

the final CCL 2. These contaminants are 

identified by name and, where 

available, the Chemical Abstracts 

Service Registry Number (CASRN). The 

final CCL 2 consists of nine 

microbiological contaminants and 42 

chemical contaminants or contaminant 

groups.

TABLE III–1.—FINAL DRINKING WATER

CONTAMINANT CANDIDATE LIST 2

Microbiological contaminant candidates 

Adenoviruses Aeromonas hydrophila 

Caliciviruses 

Coxsackieviruses 

Cyanobacteria (blue-green algae), other 

freshwater algae, and their toxins 

Echoviruses 

Helicobacter pylori 

Microsporidia (Enterocytozoon and Septata) 

Mycobacterium avium intracellulare (MAC) 

Chemical contaminant candidates 

CASRN 

1,1,2,2-

tetrachloroethane.

79–34–5 

1,2,4-

trimethylbenzene.

95–63–6 

1,1-dichloroethane .... 75–34–3 

1,1-dichloropropene .. 563–58–6 

1,2-diphenylhydrazine 122–66–7 

1,3-dichloropropane .. 142–28–9 

1,3-dichloropropene .. 542–75–6 

2,4,6-trichlorophenol 88–06–2 

2,2-dichloropropane .. 594–20–7 

2,4-dichlorophenol ..... 120–83–2 

2,4-dinitrophenol ....... 51–28–5 

2,4-dinitrotoluene ...... 121–14–2 

2,6-dinitrotoluene ...... 606–20–2 

2-methyl-Phenol (ocresol).95–48–7 

Acetochlor ................. 34256–82–1 

Alachlor ESA & other 

acetanilide pesticide degradation 

products.

N/A 

Aluminum .................. 7429–90–5 

Boron ......................... 7440–42–8 

Bromobenzene .......... 108–86–1 

DCPA mono-acid 

degradate.

887–54–7 

DCPA di-acid 

degradate.

2136–79–0 

DDE ........................... 72–55–9 

Diazinon .................... 333–41–5 

Disulfoton .................. 298–04–4 

Diuron ........................ 330–54–1 

EPTC (s-ethyldipropylthiocarbamate).759–94–4 

Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices 9073

Fonofos ..................... 944–22–9 

p-Isopropyltoluene (pcymene).99–87–6 

Linuron ...................... 330–55–2 

Methyl bromide ......... 74–83–9 

Methyl-t-butyl ether 

(MTBE).

1634–04–4 

Metolachlor ................ 51218–45–2 

Molinate ..................... 2212–67–1 

Nitrobenzene ............. 98–95–3 

Organotins ................. N/A 

Perchlorate ................ 14797–73–0 

Prometon ................... 1610–18–0 

RDX ........................... 121–82–4 

Terbacil ..................... 5902–51–2 

Terbufos .................... 13071–79–9 

Triazines and degradation products of 

triazines.

including, but not limited to Cyanazine 

21725–46–2 and 

atrazine-desethyl 

6190–65–4 

Vanadium .................. 7440–62–2 

IV. Summary of Comments 

The comment period on the April 2, 

2004, Federal Register notice, ‘‘Drinking 

Water Contaminant Candidate List 2; 

Notice’’ (69 FR 17406) ended on June 1, 

2004. EPA received a total of seven 

comments that focused on EPA’s draft 

CCL 2 and EPA’s efforts to improve the 

contaminant selection process for future 

CCLs. EPA received two comments from 

associations representing water utilities, 

one comment from a State-related 

association, one comment from a water 

utility, one comment from a State 

agency, one comment from an 

individual, and one anonymous 

comment. A summary of these 

comments and EPA’s response to these 

comments follow. A complete copy of 

the public comments and the Agency’s 

responses are included in the Docket for 

today’s action and can be obtained at 

http://www.epa.gov/edocket/. 

The majority of comments were 

supportive of the CCL process. The 

comments on development of the draft 

CCL 2 focused on two key topic areas: 

(1) Reassembling the CCL taking new 

available information into account; 

suggestions on information that should 

be considered, and contaminants that 

should be included or deleted from the 

CCL; and (2) requests for information on 

the status of CCL-related research. 

Comments on the development of future 

CCLs focused on four key topic areas: 

(1) Expert judgement and transparency, 

(2) the role of data quality, (3) a 

simplified approach with adaptive 

management for future CCLs, and (4) the 

role of virulence factor activity 

relationships (VFARs). The remainder of 

this section discusses these key areas in 

turn.

A. Developing the draft CCL 2 

1. Suggestions on new information 

and contaminants that should be 

included or deleted from the CCL. 

Comment Summary: Two 

commenters believe that EPA should 

create a new CCL taking new available 

information into account. One 

commenter recommended that EPA not 

carry forward five chemicals (1,1,2,2-

tetrachloroethane, 1,1-dichloropropene, 

1,3-dichloropropane, 1,3-

dichloropropene, and 2,2, 

dichloropropane) currently on CCL 1 to 

CCL 2, two commenters recommended 

that N-nitrosodimethylamine (NDMA) 

should be added to the CCL, and one 

commenter recommended that 

enterotoxigenic Escherichia coli (E. coli) 

be included on the final CCL 2. 

Agency Response: In response to 

commenters who recommended that 

EPA create a new CCL to take new 

available information into account, and 

the suggestion that EPA remove five 

chemicals (1,1,2,2-tetrachloroethane, 

1,1-dichloropropene, 1,3-

dichloropropane, 1,3-dichloropropene, 

and 2,2, dichloropropane) from the CCL, 

EPA does not believe that it is 

appropriate to create a new CCL, or 

remove any contaminants from the CCL, 

at this time. Where there is adequate 

information about a particular 

contaminant, EPA plans to make a 

regulatory determination which will 

either remove that contaminant from the 

CCL or start a national rule making 

process to set a national primary 

drinking water regulation. With regard 

to future CCLs, EPA is developing an 

expanded comprehensive system for 

evaluating a wider range of existing 

information, identifying new data, and 

applying revised screening criteria to 

generate the CCL 3 in response to 

extensive recommendations from the 

National Academy of Sciences National 

Research Council (NRC) and National 

Drinking Water Advisory Council 

(NDWAC). 

With specific regard to NDMA, there 

is already a substantive body of health 

effects research that the Agency has 

relied upon to classify it as a ‘‘probable 

human carcinogen’’ (USEPA, 1993). The 

key information gap for this 

contaminant relates to occurrence in 

public water system distribution 

systems. Some initial research has been 

conducted in this area and the Agency 

plans to collect more comprehensive 

occurrence information as part of the 

upcoming national survey of key 

unregulated contaminants under section 

1445(a)(2). 

Regarding enterotoxigenic E. coli, EPA 

will be considering this microbe as part 

of the revised and expanded CCL 3 

review process. The Agency believes 

that this will be a more appropriate and 

effective approach for evaluating this 

bacteria in comparison to a wide range 

of other microbes that will be 

considered under the broader analytical 

approach recommended by the NRC and 

NDWAC. 

2. Provide the status of CCL-related 

research, data collection, and pending 

initiatives that have been undertaken 

since CCL 1. 

Comment Summary: Commenters 

identified several CCL-related research 

activities that have been undertaken 

since CCL 1 and requested that EPA 

provide the status of CCL-related 

research, data collection, and pending 

initiatives that have been undertaken 

since CCL 1. 

Two commenters also requested 

information about the Agency’s progress 

to date and the intended future path for 

integrating the 35 deferred pesticides 

and 21 contaminants (suspected of 

having adverse effects on endocrine 

function) into the CCL process. 

Agency Response: EPA agrees that the 

status of CCL-related research should be 

publically available. The Agency has 

taken a number of steps to provide this 

information through its Web sites and in 

documents it has published. 

EPA Web sites addressing CCL-related 

research information include the 

following: 

• EPA’s Office of Ground Water and 

Drinking Water Drinking Water 

Research Information Network (DRINK), 

found at http://www.epa.gov/safewater/

drink/intro.html, is a publicly 

accessible, Web based system that tracks 

over 1,000 ongoing research projects 

conducted by EPA and other research 

partners from national, regional, and 

international research agencies and 

organizations. The DRINK system stores, 

manages, and delivers descriptive 

summary data on drinking water-related 

projects, including abstracts, status of 

projects, uniform resource locators to 

datasets and reports, and contact 

information on projects. 

• EPA’s Office of Ground Water and 

Drinking Water Web site at http://

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

has information on the NDWAC (e.g., 

reports, meeting announcements, and 

meeting summaries which includes 

meetings of the NDWAC CCL Work 

Group), monitoring of unregulated 

contaminants from public water 

systems, the National Contaminant 

Occurrence Database, analytical 

methods for compliance monitoring, 

and treatment technologies.

• EPA’s Office of Research and 

Development (ORD) environmental 

9074 Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices 

information management system Web 

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

maintains information on EPA research 

projects, including project title, abstract, 

start and end dates, principal 

investigator, funding, results and 

publications, and related technical 

documents. 

• EPA’s Office of Science and 

Technology Web site at http://

www.epa.gov/waterscience/

humanhealth/ has information on EPA’s 

drinking water standards, health and 

consumer advisories, criteria 

documents, and related technical 

documents. 

A key document addressing CCLrelated research and information is 

EPA’s Draft Multi-Year Plan (MYP) for 

the drinking water research program. 

The Draft MYP describes the Agency’s 

drinking water research program 

activities and plans for fiscal years 

2003—2010 (see http://www.epa.gov/

osp/myp/dw.pdf). As a tool for planning 

and communication, the MYP provides: 

(1) A context for annual planning 

decisions and a basis for describing the 

impacts of these decisions; (2) a 

framework for integrating research on 

common issues across the EPA’s ORD 

laboratories and centers, as well as 

across the various Agency Goals 

established under the Government 

Performance and Results Act; and (3) a 

resource for communicating research 

plans and products within ORD and 

with EPA programs, the regions and 

interested parties outside of EPA. MYPs 

are updated on a biennial basis to 

provide opportunities for making the 

necessary adjustments to the research 

program. 

As discussed in the draft CCL 2 notice 

(69 FR 17406), EPA plans to consider 

the deferred pesticides in the context of 

an improved approach for selecting 

contaminants for future CCLs (CCL 3). 

This will enable the Agency to consider 

these contaminants in a consistent, 

reproducible manner with a wide range 

of other contaminants. In this regard, it 

is important to note that EPA may 

conduct research, and make regulatory 

determinations for any unregulated 

contaminant not on today’s CCL (see 

SDWA section 1412(b)(1)(B)(ii)(III)). 

Thus, the Agency has the authority to 

act as necessary to protect public health 

as new information becomes available. 

As with pesticides, EPA believes that 

suspected endocrine disruptors should 

be considered when the next CCL is 

developed. This enables the Agency to 

use a more refined and improved 

approach in evaluating these 

contaminants. As previously stated, 

EPA is not restricted to the 

contaminants on this CCL for making 

regulatory determinations. 

B. Developing a Process for Future CCLs 

There were four key issues identified 

by commenters on developing a process 

for future CCLs. They are: 

1. Expert judgement and transparency 

2. The Role of Data Quality. 

3. Simplified approach with adaptive 

management applied for future CCLs. 

4. The role of virulence factor activity 

relationships. 

Each of these issues is discussed in 

turn below. 

1. Expert Judgement and Transparency

Comment Summary: Two 

commenters stated that there is a need 

for the CCL process to be a transparent 

process. The commenters stated that 

they view the transparency of the CCL 

process as being critical to its success so 

that both the regulated community and 

the public can understand it. One 

commenter also recommended that the 

Agency combine expert judgement and 

classification algorithms (a formula or 

set of steps for solving a particular 

problem) in developing the CCL. 

Classification algorithms or automated 

processes should serve as mechanisms 

for screening down the number of 

contaminants that the experts must then 

evaluate in greater depth. 

Both commenters believe that the use 

of expert judgement can be transparent 

and is an essential component to any 

future CCL process. They urged EPA to 

clearly define the role of expert 

judgement including the specific parts 

of the listing process where it would be 

used. 

One commenter also suggested that 

the CCL process should be an ongoing 

process within the Office of Water and 

that the Agency should actively monitor 

appropriate peer-reviewed literature for 

new contaminants, new methods, and 

new health effects data. In addition, the 

Agency should also increase its 

involvement in ongoing symposia, 

professional meetings, and workshops 

on topics relevant to the CCL. 

Agency’s Response: The Agency 

agrees with the commenters that 

transparency and use of expert 

judgement should be important 

components of the CCL process. These 

recommendations were included in both 

the NRC report (NRC, 2001) and in the 

NDWAC Report on the CCL 

Classification Process to the U.S. 

Environmental Protection Agency 

(NDWAC, 2004). The Agency received 

the NDWAC report in May of 2004 and 

is currently evaluating the 

recommendations. 

The NRC and NDWAC reports 

recommend that the EPA conduct the 

CCL process so that interested 

stakeholders have an opportunity to 

participate at key steps in developing 

the CCL. Additionally the reports 

recommend greater use of expert 

judgment and critical review of the CCL 

classification process. While the reports 

did not provide specific advice on how 

to accomplish these recommendations 

they did identify key milestones, such 

as selecting sources of data and 

developing criteria to select 

contaminants. Structuring the process 

around such milestones should enhance 

transparency and facilitate expert 

review. 

The Agency continues to evaluate the 

NDWAC recommendation on how to 

include expert judgment and conduct 

the CCL process in a transparent manner 

and will consider these comments as 

future CCLs are developed. 

2. The Role of Data Quality 

Comment Summary: Two 

commenters stressed the importance of 

data quality in the CCL process. Both 

commenters support the use of high 

quality data and sound science in the 

CCL process. 

The commenters expressed some 

concern about the current quality of 

data used for the CCL process. The 

commenters suggested that EPA should 

focus on using high quality data that are 

appropriate to support valid 

characterization of a contaminant and 

that EPA maintains a focus on data 

quality at each stage of the CCL process. 

One commenter expressed an interest 

in participating in the ongoing 

development and application of a viable 

data quality assurance system that 

would support the data objectives for 

each step in the CCL process. 

Agency’s Response: The NDWAC 

recommendations also discussed the 

nature and type of data and information 

used in the CCL process. In discussing 

information quality considerations, the 

Council noted that data and information 

on contaminants considered in the CCL 

process will consist of different types of 

data and that some contaminants will 

not be robustly characterized. The 

report also recommends that while the 

Agency should be explicit about how it 

selects data for the CCL process, the 

process must have some flexibility to 

adequately consider emerging 

contaminants. As the Agency develops 

the CCL process and evaluates the 

NDWAC recommendations, it will 

consider the commenters’

recommendations as well as the SDWA 

data quality requirements.

Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices 9075

3. Simplified Approach 

Comment Summary: One commenter 

expressed concern over the NAS and 

NDWAC recommendations, 

characterizing them as ‘‘a theoretical 

and esoteric process and not a pragmatic 

process.’’ The commenter believes that 

there is a need for the Agency to 

develop a simpler, more streamlined 

approach that uses only the attributes of 

occurrence and health effects and that 

potentially eliminates some of the major 

complications associated with the NRC 

three-step, five-attribute CCL process, 

thereby making the process more 

effective in the near term. The NRC 

approach can serve as a useful guide for 

the Agency’s long-term CCL 

development effort; however, the details 

and logistics of the approach require 

additional work. 

One commenter was concerned about 

the resources and time needed to 

develop the CCL using a new approach. 

The commenter suggested that 

convening a series of workshops with 

external experts would be an efficient 

way of addressing issues related to data 

quality, contaminant attributes, training 

sets, process performance, and protocols 

for classification algorithms. 

Agency’s Response: The NDWAC 

report provides a series of 

recommendations for the Agency to 

consider as it develops the CCL process. 

The NDWAC report also noted that the 

NRC three-step approach using five 

attributes has merit, but identified 

practical limitations or difficulties the 

Agency would need to address. For 

example, the NDWAC report 

recommends that the Agency should 

consider classification approaches but 

‘‘should use another approach for 

selecting contaminants for the near term 

(i.e., for CCL 3) if there are difficulties 

that cannot be overcome.’’ The NDWAC 

report also identifies issues that the 

Agency should consider in the NRC’s 

recommendation on classification 

approaches and emphasizes that the 

Agency should consider practical 

constraints. The NDWAC report 

specifically recommended that the 

screening step be as simple as possible, 

which would require fewer resources 

and less time while adequately 

identifying those contaminants of 

greatest significance. The report further 

encouraged the Agency to consider 

whether fewer than the five attributes 

used in the NRC example of a 

classification approach are adequate for 

a new CCL process. The NDWAC report 

recognizes that the Agency will learn 

more about the CCL process in each 

iterative step and recommended an 

adaptive management approach to 

develop the CCL process. As the Agency 

evaluates the NDWAC 

recommendations, it will consider the 

need for a pragmatic approach using 

available resources for development of 

the next CCL and the most efficient 

ways to incorporate expert involvement 

in the CCL process.

4. The Role of Virulence Factor Activity 

Relationship. 

Comment Summary: A variety of 

comments were received on the 

proposed role of genomic data and the 

VFAR concept for the CCL process. 

Most of the commenters acknowledged 

that VFAR appears to be a powerful and 

useful tool that shows great promise for 

future CCL development, but felt that 

the Agency had not made clear how it 

proposes to use VFAR technology. 

The commenters suggested that the 

Agency is placing too much emphasis 

on VFAR. One commenter stated that 

the Agency appears to be relying too 

heavily on an advanced genomic 

technology. The commenter expressed 

concerns that the technology’s 

applications to environmental samples 

are unproven and recommended that it 

not be used in the next CCL process. 

One commenter suggested that there 

are many unknown variables associated 

with the VFAR concept and it should 

therefore be treated with extreme 

caution. Two commenters are concerned 

that VFAR may not offer practical 

solutions to immediate concerns 

regarding waterborne disease and would 

require a multi-year commitment and 

collaboration by EPA and other 

participating organizations before it 

would be useful. 

Agency Response: The NRC (NRC, 

2001) recommendations provided a 

detailed discussion of the potential and 

proposed role of VFARs in the CCL 

process. The VFAR principle can be 

described as comparing the gene 

structure of newly identified waterborne 

pathogens to pathogens with known 

genetic structures that have been 

associated with human disease. 

Virulence factors are defined broadly 

by the NRC as the ability of a pathogen 

to persist in the environment, gain entry 

into a host (e.g., humans), reproduce, 

and cause disease or other health 

problems either because of its 

architecture or because of its 

biochemical compounds. A number of 

virulence factors are known, including 

the ability of a microbe to move within 

a host under its own power, the ability 

of mechanisms to protect the microbe 

against the body’s defenses (e.g., antiphagocytosis mechanisms), the ability of 

a microbe to adhere or attach to the 

surface of a host cell, and the ability of 

microbes to produce toxins that injure 

host cells. The NDWAC was specifically 

charged to provide an evaluation of the 

VFAR approach and to identify studies 

that explore the feasibility of the 

approach. While the Agency recognizes 

VFAR as a potential tool for future 

CCLs, EPA is not planning to solely rely 

on the approach in the near term for 

CCLs. In its deliberation, the NDWAC 

conducted several explorations and 

literature reviews on the nature and 

type of genomic data available to 

characterize genes that may be 

associated with virulence factors and an 

organism’s potential to cause harm. The 

reviews and analyses showed that the 

technology, although powerful, still has 

serious limitations for near term CCLs. 

The NDWAC provided a series of 

pragmatic recommendations for 

considering pathogens for near term 

CCLs and several recommendations for 

improving this process as genomic 

technology and reporting improve. As 

the Agency develops the CCL process 

for microbes it will take these comments 

under consideration. 

V. Developing Future CCLs—NDWAC 

Recommendations and Next Steps 

A. NDWAC Recommendations

In the Federal Register notice of April 

2, 2004 (69 FR 17406), EPA discussed 

the activities of the NRC and the 

NDWAC related to the CCL. The EPA 

sought the advice of the NRC in 

response to comments received during 

the development of the 1998 CCL, 

which advocated a broader, more 

comprehensive approach for selecting 

contaminants. 

The Agency asked the NRC to address 

three key topics related to drinking 

water contaminant selection and 

prioritization: 

1. What approach should be used to 

develop future CCLs? 

2. How best should EPA assess 

emerging drinking water contaminants 

and related databases to support future 

CCL efforts? 

3. What approach should EPA use to 

set priorities for contaminants on the 

CCL? 

The NRC’s findings and 

recommendations on these topics were 

published in three reports: Setting 

Priorities for Drinking Water 

Contaminants (NRC, 1999a), Identifying 

Future Drinking Water Contaminants 

(NRC, 1999b), and Classifying Drinking 

Water Contaminants for Regulatory 

Consideration (NRC, 2001). 

The NRC recommendations provided 

a framework for evaluating a larger 

number of contaminants and making 

decisions about contaminants for which 

9076 Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices 

data are limited through the use of 

innovative technologies and expert 

advice. The EPA requested the 

assistance of NDWAC to evaluate and 

provide advice on implementing the 

NRC’s recommended classification 

process. 

The NDWAC formed the CCL 

Classification Process Work Group (the 

Work Group) and charged it with 

reviewing the NRC 2001 report. The 

Work Group was asked to advise the 

NDWAC on development and 

application of the classification 

approach suggested by the NRC, 

including evaluating proposed and 

alternative methodologies. The Work 

Group met 10 times from September of 

2002 to March of 2004. All Work Group 

meetings were open to the public and 

announced in the Federal Register. In 

conducting its review, the Work Group 

considered the large and growing 

number of agents that might become 

candidates for scrutiny in the CCL 

process, and the rapid expansion of 

information on these agents. Based on 

this review, the Work Group provided 

the following recommendations: 

1. There is merit in the three-step 

selection process proposed by NRC for 

classifying chemical and microbial 

contaminants. The NDWAC believes the 

three-step process should involve 

identification of the CCL universe, 

screening the universe to a preliminary 

CCL, and selecting the CCL from the 

Preliminary CCL. 

2. The NDWAC recommends that the 

Agency should move forward with the 

NRC recommendation to develop and 

evaluate some form of prototype 

classification approach. (A prototype 

classification uses computer-based 

computational tools to weigh selected 

contaminant characteristics against the 

characteristics of various classes of 

drinking water contaminants whose 

occurrence and health effects are 

relatively well understood.) 

3. The NDWAC believes that expert 

judgment plays an important role 

throughout the three-step selection 

process, particularly in reviewing the 

prototype model and the output of the 

new classification approach. 

4. The NDWAC recommended 

enhancing the surveillance for emerging 

chemical and microbial contaminants 

and also soliciting information from the 

public via a nomination process to 

assure a full consideration of potential 

contaminants.

The NDWAC also identified a number 

of practical limitations or difficulties in 

developing and applying the 

recommended approach and provided 

advice on how these might be 

addressed. 

The NDWAC presented the final 

report to the Administrator on May 19, 

2004. The report, entitled National 

Drinking Water Advisory Council 

Report on the CCL Classification Process 

to the U.S. Environmental Protection 

Agency provides a detailed summary of 

the questions considered by the 

NDWAC, the analyses conducted to 

explore the questions, key points 

discussed, and the NDWAC’s 

recommendations and rationale for the 

recommendations. The report is 

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

safewater/ndwac/council.html.

B. Next Steps 

The Agency is working to evaluate the 

NDWAC recommendations and to meet 

the statutory deadline to issue the next 

CCL. The NDWAC recommendations 

encourage the Agency to consider the 

practical limitations identified in their 

report and to use an adaptive 

management approach to develop CCLs. 

This adaptive management approach 

will enable the Agency to identify 

which recommendations can be 

implemented for the next CCL while 

learning from and improving upon each 

successive listing process and at the 

same time protecting public health. In 

its development of a new CCL process, 

the Agency will focus on several areas 

in the near future and continue to seek 

input and advice from experts and 

interested stakeholders. Some of the key 

areas to be explored in developing the 

new CCL process are discussed below. 

The NDWAC recommended that 

microbial and chemical contaminants be 

evaluated by parallel processes that 

meet in the formation of a single CCL. 

The Agency is developing parallel 

processes for microbial and chemical 

contaminants that take into account the 

systematic differences in how these 

contaminants are characterized and take 

the best advantage of the information 

available for microbial and chemical 

contaminants. 

The Agency is also considering 

approaches and opportunities to seek 

out and incorporate input from experts 

and interested stakeholders as the CCL 

process is developed. EPA held a public 

meeting on September 15, 2004, to 

provide an update on its efforts to 

improve upon the CCL process. The 

Agency is also consulting with 

interested stakeholders on how to 

increase expert involvement in the 

process and on opportunities to gather 

information on new and emerging 

contaminants through professional 

conferences, focused workshops, and 

coordination with other Federal and 

State agencies. The Agency will provide 

additional opportunities for the 

exchange of information with the public 

before the next CCL is proposed in the 

Federal Register. 

The Agency is evaluating data sources 

that characterize a contaminant’s 

potential to occur in drinking water and 

produce adverse health effect. The 

evaluation will consider the NRC and 

NDWAC recommendations as well as 

SDWA requirements in selecting 

information and data to consider for the 

next CCL. This evaluation will identify 

the best available data that for use in the 

CCL process and result in a process to 

compile information for a significantly 

larger group of chemical and microbial 

contaminants than initially considered 

for CCL 1. 

The Agency anticipates conducting 

analyses to identify specific criteria 

related to occurrence and health effects 

associated with contaminants that could 

be used to select contaminants for the 

CCL. The Agency is evaluating the 

NDWAC recommendation to develop a 

series of screening criteria that would 

identify contaminants for additional 

scrutiny and prioritization. The 

NDWAC recommendations provide 

insight on the occurrence and health 

effects data that the Agency could use 

to identify a smaller set of contaminants 

for additional evaluation but does not 

recommend specific levels or criteria to 

implement the screening process. 

The NDWAC also recommended that 

the Agency explore the use of 

classification approaches to identify 

contaminants for consideration for the 

CCL. The Agency is evaluating the 

requirements for a classification 

approach for the next CCL and 

anticipates seeking additional advice 

from experts and stakeholders. EPA will 

need to evaluate various classification 

approaches, consider the range of 

potential performance indicators, 

conduct calibration and validation 

analyses, and engage experts in the 

evaluation of the selected approach(es) 

and associated validation results. 

As a new CCL process is developed 

and implemented for the next list, the 

Agency will provide updates and 

information on the process. The CCL 

process is a critical input to shaping the 

future direction of the drinking water 

program. The Agency anticipates that 

improvements to the process will result 

in a more comprehensive approach to 

developing the CCL. 

VI. References

Federal Register, Vol. 63, No. 40. 

Announcement of the Drinking Water 

Contaminant Candidate List; Notice. 

March 2, 1998. 10273. (63 FR 10273). 

Federal Register, Vol. 69, No. 64. Drinking 

Water Contaminant Candidate List 2; 

Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices 9077

Notice. April 2, 2004. 17406. (69 FR 

17406).

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. 

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

safewater/ndwac/council.html.

National Research Council (NRC). 1999a. 

Setting Priorities for Drinking Water 

Contaminants. National Academy Press, 

Washington, DC http://www.nap.edu/

catalog/6294.html.

National Research Council (NRC). 1999b. 

Identifying Future Drinking Water 

Contaminants. National Academy Press, 

Washington, DC http://www.nap.edu/

catalog/9595.html.

NRC. 2001. Classifying Drinking Water 

Contaminants for Regulatory 

Considerations. National Academy Press, 

Washington, DC http://books.nap.edu/

books/0309074088/html/index.html.

USEPA. 1993. N-nitrosodimethylamine; 

CASRN 62–75–9, Integrated Risk 

Information Service (IRIS). 

Carcinogenicity assessment last updated 

July 1, 1993.

Dated: February 17, 2005. 

Benjamin H. Grumbles, 

Assistant Administrator, Office of Water.

[FR Doc. 05–3527 Filed 2–23–05; 8:45 am] 

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS 

COMMISSION 

Notice of Public Information 

Collection(s) Being Reviewed by the 

Federal Communications Commission 

February 15, 2005.

SUMMARY: The Federal Communications 

Commission, as part of its continuing 

effort to reduce paperwork burden 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on the 

following information collection(s), as 

required by the Paperwork Reduction 

Act (PRA) of 1995, Public Law 104–13. 

An agency may not conduct or sponsor 

a collection of information unless it 

displays a currently valid control 

number. No person shall be subject to 

any penalty for failing to comply with 

a collection of information subject to the 

Paperwork Reduction Act (PRA) that 

does not display a valid control number. 

Comments are requested concerning (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Commission, including whether the 

information shall have practical utility; 

(b) the accuracy of the Commission’s 

burden estimate; (c) ways to enhance 

the quality, utility, and clarity of the 

information collected; and (d) ways to 

minimize the burden of the collection of 

information on the respondents, 

including the use of automated 

collection techniques or other forms of 

information technology.

DATES: Written Paperwork Reduction 

Act (PRA) comments should be 

submitted on or before March 28, 2005. 

If you anticipate that you will be 

submitting PRA comments, but find it 

difficult to do so within the period of 

time allowed by this notice, you should 

advise the contact listed below as soon 

as possible.

ADDRESSES: Direct all Paperwork 

Reduction Act (PRA) comments to 

Judith B. Herman, Federal 

Communications Commission, Room 1–

C804, 445 12th Street, SW., Washington, 

DC 20554 or via the Internet to JudithB.Herman@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For 

additional information or copies of the 

information collection(s), contact Judith 

B. Herman at 202–418–0214 or via the 

Internet at Judith-B.Herman@fcc.gov.

SUPPLEMENTARY INFORMATION: 

OMB Control No.: 3060–0823. 

Title: Pay Telephone Reclassification, 

Memorandum Opinion and Order, CC 

Docket No. 96–128. 

Form No.: N/A. 

Type of Review: Extension of a 

currently approved collection. 

Respondents: Business or other forprofit. 

Number of Respondents: 400. 

Estimated Time Per Response: 2–35 

hours. 

Frequency of Response:

Recordkeeping requirement, third party 

disclosure requirement, and on 

occasion, monthly, and quarterly 

reporting requirements. 

Total Annual Burden: 44,700 hours. 

Total Annual Cost: $480,000. 

Privacy Act Impact Assessment: No.

Needs and Uses: The Commission is 

seeking extension (no change in 

requirements) for this information 

collection. The Commission is 

submitting this information collection to 

the OMB in order to obtain the full 

three-year clearance from them. For 

background, the Commission adopted 

and released a Memorandum Opinion 

and Order in March 1998, which 

clarified the requirements established in 

the Payphones Orders for the provision 

of payphone-specific coding digits and 

for tariffs that local exchange carriers 

(LECs) must file pursuant to the 

Payphone Orders. The Commission also 

granted a waiver of Part 69 of the 

Commission’s rules so that LECs can 

establish rate elements to recover the 

costs of implementing FLEX–ANI (a 

type of switch software) to provide 

payphone specific coding digits for percall compensation. The Commission is 

required in the Payphone Orders to 

implement section 276 of the Act.

OMB Control No.: 3060–0986. 

Title: Competitive Carrier Line Count 

Report. 

Form No.: FCC Form 525. 

Type of Review: Revision of a 

currently approved collection. 

Respondents: Business or other forprofit. 

Number of Respondents: 1,300 

respondents; 4,753 responses. 

Estimated Time Per Response: .5–6 

hours. 

Frequency of Response: On occasion, 

quarterly and annual reporting 

requirements and third party disclosure 

requirement. 

Total Annual Burden: 3,707 hours. 

Total Annual Cost: N/A. 

Privacy Act Impact Assessment: N/A. 

Needs and Uses: The Commission has 

revised this information collection. The 

information collection has been revised 

as a result of: (1) Certain collections 

associated with the election of a 

disaggregation path were one-time in 

nature and have been eliminated and 

removed from this burden estimate; and 

(2) the Commission has created a new 

FCC Form 525 to collect line count data 

required by Competitive Eligible 

Telecommunications Carriers (CETCs) 

pursuant to this and other OMB control 

numbers, as well as line count data 

related to lines provided by CETCs 

using unbundled network elements 

(UNEs). The UNE data are necessary for 

Universal Service Administrative 

Company (USAC) to implement section 

54.307 of the Commission’s rules. It is 

anticipated that the implementation of 

FCC Form 525 will reduce burdens in 

several collections by standardizing the 

information submission format. As 

collections 3060–0972, 3060–0774 and 

3060–0942 are renewed, the information 

provided in FCC Form 525 will be 

eliminated from the burden estimates 

for these collections. The Commission 

will use the information requirements to 

determine whether and to what extent 

rural telecommunications carriers 

providing the data are eligible to receive 

universal service support.

OMB Control No.: 3060–0298. 

Title: Competitive Carrier Line Count 

Report. 

Form No.: FCC Form 525. 

Type of Review: Revision of a 

currently approved collection.

Respondents: Business or other forprofit. 

Number of Respondents: 1,300 

respondents; 4,753 responses. 

Estimated Time Per Response: 57 

hours.