[Federal Register Volume 69, Number 12 (Tuesday, January 20, 2004)]
[Notices]
[Pages 2712-2715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1107]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-OW-7611-7]


Notice of Availability of Draft Revised Ambient Water Quality 
Criteria Document for Chloroform and Request for Scientific Views

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and request for scientific views.

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SUMMARY: This notice informs the public about the availability of and 
requests scientific views on a revised draft human health criteria 
document for chloroform. The Agency derived the revised criteria 
according to the procedures and methods in EPA's Methodology for 
Deriving Ambient Water Quality Criteria for the Protection of Human 
Health (2000) (2000 Human Health Methodology).
    The Clean Water Act (CWA) requires the Environmental Protection 
Agency (EPA) to develop and publish and, from time to time, revise 
criteria for water accurately reflecting the latest scientific 
knowledge. When final, these criteria will provide EPA's 
recommendations to States and authorized Tribes as they establish their 
water quality standards as State or Tribal law or regulation. At this 
time the Agency is not making final recommendations. Rather the Agency 
is requesting scientific views on the draft revised criteria because 
the criteria reflect changes in several of the values used to derive 
them, including the Reference Dose (RfD), the Relative Source 
Contribution (RSC) and Bioaccumulation Factors.

DATES: All scientific information must be submitted to the Agency on or 
before March 22, 2004.

ADDRESSES: Scientific views may be submitted electronically, by mail, 
or through hand-delivery/courier. Follow detailed instructions as 
provided in section I.C. of the SUPPLEMENTARY INFORMATION section. 
Copies of the criteria document entitled, Ambient Water Quality 
Criteria for the Protection of Human Health: Chloroform--Revised Draft 
(EPA-822-R-04-002) may be obtained from EPA's Water Resource Center by 
phone at (202) 566-1729, or by e-mail to [email protected] 
or by conventional mail to: EPA Water Resource Center, 4101T, 1200 
Pennsylvania Avenue NW., Washington, DC 20460. You can also download 
the document from EPA's Web site at http://www.epa.gov/waterscience/humanhealth/docs/.

FOR FURTHER INFORMATION CONTACT: Dr. Tala Henry, Health and Ecological 
Criteria Division (4304T), U.S. EPA, 1200 Pennsylvania Avenue NW., 
Washington, DC 20460; (202) 566-1323; [email protected]

SUPPLEMENTARY INFORMATION:

I. General Information

A. Interested Entities

    Entities potentially interested in today's notice are those that 
produce, use, or regulate chloroform. Categories and entities 
interested in today's notice include:

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                Category                 Examples of interested entities
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State/Local/Tribal Government..........  States and Tribes
Industries discharging pollutants to     Paper and pulp mills, steam
 surface waters.                          electric generators, organic
                                          chemicals/petroleum refining.
Publically-owned treatment works         Drinking water treatment
 discharging pollutants to surface        plants, wastewater treatment
 waters.                                  plants.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be interested in this 
notice. This table lists the types of entities that EPA is now aware 
could potentially be interested in this notice. Other types of entities 
not listed in the table could also be interested.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
notice under Docket ID No. OW-2003-0082. The official public docket 
consists of the documents specifically referenced in this notice, any 
scientific views received, and other information related to this 
notice. Although a part of the official docket, the public docket does 
not include Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. The official 
public docket is the collection of materials that is available for 
public viewing at the Water Docket in the EPA Docket Center, (EPA/DC) 
EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The 
EPA Docket Center 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 Office of Water Docket is (202) 566-2426. To view these 
materials, please call ahead to schedule an appointment. Every user is 
entitled to copy 266 pages per day before incurring a charge. The 
docket may charge 15 cents a page for each page

[[Page 2713]]

over the 266-page limit plus an administrative fee of $25.00.
    2. Electronic Access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or read the 
scientific views, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once in the system, select 
``search,'' then key in the appropriate docket identification number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute is not included in the official public docket. 
EPA's policy is that copyrighted material will not be placed in EPA's 
electronic public docket but will be available only in printed, paper 
form in the official public docket. To the extent feasible, publicly 
available docket materials will be made available in EPA's electronic 
public docket. When a document is selected from the index list in EPA 
Dockets, the system will identify whether the document is available for 
viewing in EPA's electronic public docket. Although not all docket 
materials may be available electronically, you may still access any of 
the publicly available docket materials through the docket facility 
identified in Section I.B.1.
    It is important to note that EPA's policy is that scientific views, 
whether submitted electronically or in paper, will be made available 
for public viewing in EPA's electronic public docket as EPA receives 
them and without change, unless your views and information contain 
copyrighted material, CBI, or other information whose disclosure is 
restricted by statute. When EPA identifies a scientific view containing 
copyrighted material, EPA will provide a reference to that material in 
the version of the view that is placed in EPA's electronic public 
docket. The entire printed scientific view, including the copyrighted 
material, will be available in the public docket.
    Scientific views submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Scientific views that are mailed or delivered to the Docket 
will be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit My Scientific Views?

    You may submit scientific views electronically, by mail, or through 
hand delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket identification number in the subject line on the 
first page of your scientific views. Please ensure that your scientific 
views are submitted within the specified time period. Scientific views 
received after the close of the stated time period will be marked 
``late.'' EPA is not required to consider these late scientific views.
    1. Electronically. If you submit electronic information as 
prescribed below, EPA recommends that you include your name, mailing 
address, and an e-mail address or other contact information in the body 
of your scientific views. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the scientific information and allows 
EPA to contact you in case EPA cannot read your scientific views due to 
technical difficulties or needs further information on the substance of 
your scientific views. EPA's policy is that EPA will not edit your 
scientific views, and any identifying or contact information provided 
in the body of the scientific views will be included as part of the 
scientific views that are placed in the official public docket, and 
made available in EPA's electronic public docket. If EPA cannot read 
your scientific views due to technical difficulties and cannot contact 
you for clarification, EPA may not be able to consider your scientific 
views.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit scientific views to EPA electronically is EPA's preferred method 
for receiving scientific views. Go directly to EPA Dockets at http://www.epa.gov/edocket/ and follow the online instructions for submitting 
scientific views. To access EPA's electronic public docket from the EPA 
Internet Home page, select ``Information Sources,'' ``Dockets,'' and 
``EPA Dockets.'' Once in the system, select ``search,'' and then key in 
Docket ID No. OW-2003-0082. The system is an ``anonymous access'' 
system, which means EPA will not know your identity, e-mail address, or 
other contact information unless you provide it in the body of your 
input.
    ii. E-mail. Scientific views may be sent by electronic mail (e-
mail) to: [email protected], Attention Docket ID No. OW-2003-0082. In 
contrast to EPA's electronic public docket, EPA's e-mail system is not 
an ``anonymous access'' system. If you send an e-mail with scientific 
views directly to the Docket without going through EPA's electronic 
public docket, EPA's e-mail system automatically captures your e-mail 
address. E-mail addresses that are automatically captured by EPA's e-
mail system are included as part of the information that is placed in 
the official public docket, and made available in EPA's electronic 
public docket.
    iii. Disk or CD ROM. You may submit scientific views on a disk or 
CD ROM that you mail to the mailing address identified in Section 
I.C.2. These electronic submissions will be accepted in WordPerfect 9, 
or higher, or ASCII file format. Avoid the use of special characters 
and any form of encryption.
    2. By Mail. Send your scientific views to: Water Docket in the EPA 
Docket Center, Environmental Protection Agency, Mailcode 4101T, 1200 
Pennsylvania Ave., NW., Washington, DC, 20460, Attention Docket ID No. 
OW-2003-0082.
    3. By Hand Delivery or Courier. Deliver your scientific views to: 
Water Docket, EPA Docket Center, EPA West, Room B102, 1301 Constitution 
Ave., NW., Washington, DC, Attention Docket ID No. OW-2003-0082. Such 
deliveries are only accepted during the Docket's normal hours of 
operation as identified in section I.B.1.

D. What Should I Consider as I Prepare My Scientific Views for EPA?

    You may find these suggestions helpful for preparing your 
scientific views:
    1. Explain your scientific views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide any technical information and/or data you used that 
support your scientific views.
    4. Provide specific examples to illustrate your concerns.
    5. Offer alternatives.
    6. Make sure to submit your scientific views by the time period 
deadline identified.
    7. To ensure proper receipt by EPA, identify the appropriate docket 
identification number in the subject line on the first page of your 
response. It would also be helpful if you provided the name, date, and 
Federal Register citation related to your views.

[[Page 2714]]

II. Background and Today's Notice

A. What are Recommended Water Quality Criteria?

    Recommended water quality criteria represent the concentrations of 
a chemical in water at or below which human health is protected from 
adverse effects of the chemical. Section 304(a)(1) of the Clean Water 
Act (CWA) requires EPA to develop and publish, and, from time to time, 
revise criteria for water accurately reflecting the latest scientific 
knowledge. Water quality criteria developed under section 304(a) are 
based solely on data and scientific judgments. They do not consider 
economic impacts or the technological feasibility of meeting the 
criteria in ambient water. Section 304(a) criteria provide guidance to 
States and Tribes in adopting water quality standards. The criteria 
also provide a scientific basis for EPA to develop Federally 
promulgated water quality standards under section 303(c) of the CWA.

B. What Is Chloroform and Why Are We Concerned About it?

    Chloroform (trichloromethane) is nonflammable and slightly soluble 
in water. Chloroform is a volatile organic liquid that has a number of 
industrial and chemical uses. It is manufactured and used as a solvent 
and as an intermediate in the production of refrigerants, plastics, and 
other solvents. Because of its volatility, chloroform has the potential 
to evaporate from water and escape from contaminated environmental 
media (e.g., water or soil) into air, and may also be released in vapor 
from some types of industrial or chemical operations. The chief reason 
for chloroform-related health concerns is that it is generated as a by-
product during the chlorination of drinking water. Chloroform has also 
been detected in a wide variety of foods and beverages. Because 
chloroform is thought to be ubiquitous in the environment and exposure 
may occur from several routes of exposure, concerns have been raised 
over the potential risks posed by exposure of humans to it. For these 
reasons, EPA has developed ambient water quality criteria for 
chloroform.

C. Why Did EPA Revise the Chloroform Criteria?

    EPA originally published Human Health AWQC for chloroform in 1980 
(45 FR 79318, October 1980). These criteria were updated by 
incorporating newer toxicity values from EPA's Integrated Risk 
Information System (IRIS) data base and published in the 1992 National 
Toxics Rule (57 FR 60848). The criteria values promulgated in the 
National Toxics Rule are the same values included in EPA's most recent 
compilation of national recommended water quality criteria, published 
in 2002 (67 FR 79091). The chloroform criteria currently recommended by 
EPA are: 5.7 [mu]g/L for consumption of water + organisms and 470 
[mu]g/L for consumption of organisms only. The 2002 compilation did not 
include updates to the chloroform criteria based on the 2000 Human 
Health Methodology. Rather, EPA indicated in the 2002 compilation that 
updates for chemicals undergoing major reassessments, including 
chloroform, would be published in the future. The draft revised 
criteria document announced in this notice is the result of that 
reassessment.

D. What's New in the Revised Criteria?

    The draft revised criteria reflect the Agency's consideration of 
the recent advances in scientific information available since the 2002 
criteria were recommend. We have revised the criteria by implementing 
EPA's Methodology for Deriving Ambient Water Quality Criteria for the 
Protection of Human Health (2002) (EPA-822-B-00-004; 2000 Human Health 
Methodology). Specifically, we used new:

    [sbull] Fish Consumption Rate
    [sbull] Dose Response Parameter
    [sbull] Relative Source Contribution (RSC)
    [sbull] Bioaccumulation Factors

    1. Fish Consumption Rate. The fish consumption rate used in 
revising the chloroform criteria is 17.5 grams per day. The value 
represents the 95th percentile rate for the general U.S. population. 
The data from which this value was derived and the scientific basis for 
applying this value in deriving national recommended ambient water 
quality criteria is described in EPA's 2000 Human Health Methodology. 
EPA has previously received peer review and scientific views on this 
value as part of developing the 2000 Human Health Methodology, and 
therefore, is not requesting scientific views on the fish consumption 
rate.
    2. Dose Response Parameter. The dose response parameter used in 
revising the chloroform criteria is the Reference Dose (RfD) that was 
revised by EPA's Integrated Risk Information System (IRIS) program in 
October 2001 (http://www.epa.gov/iris/). The IRIS program performed a 
detailed review of toxicological information on chloroform during the 
process of revising the RfD (EPA-635-R-01-001). The RfD published in 
IRIS is 1 x 10\-\\2\ mg/kg-day. EPA has previously received peer review 
and scientific views on this value as part of developing the IRIS 
profile and RfD, and therefore, is not requesting scientific views on 
the RfD.
    3. Relative Source Contribution (RSC). The RSC is taken into 
account in deriving AWQC for non-carcinogens, and for carcinogens for 
which a nonlinear approach is used for low-dose extrapolation. In light 
of the data supporting a nonlinear low-dose extrapolation for 
chloroform, a RSC is needed for this chemical. EPA recently published a 
report, Relative Source Contribution for Chloroform (EPA-822-R-01-006, 
March 2001), in support of the Stage 2 Disinfectants and Disinfection 
Byproducts--Proposed Rule (68 FR49548). This document examines the RSC 
to dose through all routes of exposure. The RSC value used in revising 
the chloroform criteria was derived using exposure data and analysis 
from that document. From our exposure analysis, it was found that data 
were insufficient to adequately quantify the exposures from ambient 
water and freshwater/estuarine fish consumption. Therefore, therefore 
the default RSC value of 20% was used for the calculation of the AWQC. 
EPA is particularly interested in receiving scientific views on the 
data used to derive the RSC and on the value used to calculate the AWQC 
for chloroform.
    4. Bioaccumulation Factors (BAFs). In the 2000 Human Health 
Methodology EPA recognized that to prevent harmful exposures to 
chemicals in water by eating contaminated fish and shellfish, national 
304(a) water quality criteria for the protection of human health must 
address the process of chemical bioaccumulation in aquatic organisms. 
EPA also developed detailed procedures and methods for developing BAFs 
to derive or revise ambient water quality criteria in the 2000 Human 
Health Methodology. In deriving the revised chloroform criteria, we 
have implemented these procedures and methods to develop national 
trophic-level specific bioaccumulation factors for trophic level 2, 3 
and 4 aquatic organisms. The bioaccumulation factors we derived are: 
2.8 L/kg for trophic level 2, 3.4 L/kg for trophic level 3, and 3.8 L/
kg for trophic level 4. The trophic level 3 and 4 BAF values were 
derived from laboratory-measured BCFs (Method 3) and the trophic level 
2 BAF was derived from the n-octanol-water partition coefficient 
(Kow) (Method 4), as described in the 2000 Human Health 
Methodology. EPA is particularly interested in receiving scientific 
views on the data used to derive the BAFs and

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on the value used to calculate the AWQC for chloroform.

E. What Are the Draft Revised National Recommended Water Quality 
Criteria for Chloroform?

    The draft revised criteria for chloroform are: 68 [mu]g/L for 
consumption of water + organisms and 2,400 [mu]g/L for consumption of 
organisms only.

F. What Specific Scientific Issues Does EPA Want Views On?

    Though the public is welcome to submit scientific views on any 
component of the chloroform ambient water quality criteria document, 
EPA is specifically interested in scientific views on the following 
scientific issues:
    [sbull] The determination of Relative Source Contribution and the 
value as estimated.
    [sbull] The data from which the bioaccumulation factors (BAFs) were 
derived and the values as estimated.

G. What Is the Status of Existing Recommended Criteria While They Are 
Being Revised?

    Water quality criteria published by EPA are the Agency's 
recommended water quality criteria until EPA revises or withdraws the 
criteria. EPA supports using the current section 304(a) criteria for 
those chemicals for which criteria are being updated and considers them 
to be scientifically sound until the Agency publishes final revised 
304(a) criteria.

    Dated: December 23, 2003.
Geoffrey H. Grubbs,
Director, Office of Science and Technology.
[FR Doc. 04-1107 Filed 1-16-04; 8:45 am]
BILLING CODE 6560-50-P