From: [log in to unmask] [mailto:[log in to unmask]]
Sent: Tuesday, January 20, 2004 11:25 AM
Subject: [epa-water] Notice of Availability of Draft Revised Ambient Water
[Federal Register: January 20, 2004 (Volume 69, Number 12)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
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.
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 <A
HREF="mailto:[log in to unmask]">[log in to unmask]</A
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 <A
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; <A
HREF="mailto:[log in to unmask]">[log in to unmask]</A>
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:
Category Examples of interested entities
State/Local/Tribal Government.......... States and Tribes
Industries discharging pollutants to Paper and pulp mills, steam
surface waters. electric generators, organic
Publically-owned treatment works Drinking water treatment
discharging pollutants to surface plants, wastewater treatment
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
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 <A
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 <A
HREF="http://www.epa.gov/edocket/">http://www.epa.gov/edocket/</A> 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
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 <A
www.epa.gov/edocket/</A> 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
ii. E-mail. Scientific views may be sent by electronic mail (e-
mail) to: <A HREF="mailto:[log in to unmask]">[log in to unmask]</A>,
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
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.
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
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
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.
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
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
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:
* Fish Consumption Rate
* Dose Response Parameter
* Relative Source Contribution (RSC)
* 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
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 (<A
HREF="http://www.epa.gov/iris/">http://www.epa.gov/iris/</A>). 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
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
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
(K<SUB>ow</SUB>) (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
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
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
* The determination of Relative Source Contribution and the
value as estimated.
* 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
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
Dated: December 23, 2003.
Geoffrey H. Grubbs,
Director, Office of Science and Technology.
[FR Doc. 04-1107 Filed 1-16-04; 8:45 am]
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