[Federal Register Volume 73, Number 126 (Monday, June 30, 2008)]
[Notices]
[Pages 36866-36867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14796]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8686-6]


Methodology for Deriving Ambient Water Quality Criteria for the 
Protection of Human Health; Draft Technical Support Document, Volume 3: 
Development of Site-Specific Bioaccumulation Factors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability of draft for scientific views.

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SUMMARY: In 2000, EPA announced the availability of final revisions to 
the Methodology for Deriving Ambient Water Quality Criteria for the 
Protection of Human Health (2000) (hereafter ``2000 Human Health 
Methodology'') published pursuant to section 304(a)(1) of the Clean 
Water Act (CWA). Along with the 2000 Human Health Methodology, EPA 
committed to publishing several technical support documents to provide 
additional detail to the Methodology document, including two documents 
that describe the development of bioaccumulation factors for use in 
ambient water quality criteria calculations. In 2003, EPA announced the 
release of the Technical Support Document Volume 2: Development of 
National Bioaccumulation Factors (hereafter ``National BAF TSD''). 
Today, the Agency is soliciting scientific views on the Draft Technical 
Support Document, Volume 3: Development of Site-Specific 
Bioaccumulation Factors (hereafter ``Draft Site-Specific BAF TSD'') 
that accompanies the Methodology and the National BAF TSD. The National 
BAF TSD contains technical details on how EPA develops national 
bioaccumulation factors for use in deriving national recommended 
ambient water quality criteria for protecting human health. The Draft 
Site-Specific BAF TSD contains technical details on how States and 
Tribes may develop site-specific bioaccumulation factors for use in 
deriving site-specific ambient water quality criteria for protecting 
human health. The goal in deriving site-specific BAFs is to determine 
the most accurate estimates of bioaccumulation feasible for each site.

DATES: Scientific views must be received on or before August 14, 2008. 
Scientific views postmarked after this date may not receive the same 
consideration.

ADDRESSES: Submit your scientific views, identified by Docket ID No. 
EPA-HQ-OW-2008-0494, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting scientific views.
     E-mail: [email protected].
     Mail: U.S. Environmental Protection Agency; EPA Docket 
Center (EPA/DC) Water Docket, MC 2822T; 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460.
     Hand Delivery: EPA Docket Center, 1301 Constitution Ave, 
NW., EPA West, Room 3334, Washington DC. Such deliveries are only 
accepted during the Docket's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your scientific views to Docket ID No. EPA-HQ-
OW-2008-0494. EPA's policy is that all scientific views received will 
be included in the public docket without change and may be made 
available online at http://www.regulations.gov, including any personal 
information provided, unless the comment includes information claimed 
to be Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through http://www.regulations.gov your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the Office of Water 
Docket/EPA/DC, 1301 Constitution Ave, NW., EPA West, Room 3334, 
Washington, DC. This Docket Facility is open from 8:30 a.m. until 4:30 
p.m., EST, 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 is (202) 566-2426.

FOR FURTHER INFORMATION CONTACT: Heidi L. Bethel, Health and Ecological 
Criteria Division (4304T), U.S. EPA, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; (202) 566-2054; [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does This Action Apply to Me?

    The intended audience for the Draft Site-Specific BAF TSD includes 
State and Tribal water quality staff scientists or risk assessors 
(``investigators'') who are responsible for deriving State or Tribal 
water quality standards, stakeholders interested in developing site-
specific BAFs, and other users interested in site-specific 
bioaccumulation issues for other applications.

[[Page 36867]]

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

    EPA requests scientific views on all aspects of the Draft Site-
Specific BAF TSD, including the soundness of the technical approaches 
described in the document, the usefulness of the document for States 
and Tribes in calculating BAFs, and the guidance's clarity of 
presentation.
    1. Submitting CBI. Do not submit this information to EPA through 
http://www.regulations.gov or e-mail. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM 
as CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Scientific views. When submitting 
scientific views, remember to:
     Identify the notice by docket number and other identifying 
information (subject heading, Federal Register date and page number).
     Follow directions--The agency may ask you to respond to 
specific questions or organize scientific views by referencing a Code 
of Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your scientific views by the deadline 
identified.

II. What are Water Quality Criteria?

    Water quality criteria are scientifically derived numeric values 
that protect aquatic life or human health from the deleterious effects 
of pollutants in ambient water. Section 304(a)(1) of the Clean Water 
Act requires EPA to develop and publish and, from time to time, revise 
water quality criteria to accurately reflect the latest scientific 
knowledge. Water quality criteria developed under section 304(a) are 
based solely on data and scientific judgments on the relationship 
between pollutant concentrations and environmental and human health 
effects. Section 304(a) criteria do not reflect consideration of 
economic impacts or the technological feasibility of meeting the 
chemical concentrations in ambient water. Section 304(a) criteria 
provide guidance to States and authorized Tribes in adopting water 
quality standards that ultimately provide a basis for controlling 
discharges or releases of pollutants. The criteria also provide 
guidance to EPA when promulgating federal regulations under section 
303(c) when such action is necessary.
    The 2000 Human Health Methodology, along with the Technical Support 
Documents, provides States and authorized Tribes the necessary guidance 
to adjust water quality criteria developed under Section 304 to reflect 
local conditions or to develop their own water quality criteria using 
scientifically defensible methods. EPA believes that ambient water 
quality criteria inherently require several risk management decisions 
that are, in many cases, better made at the State, Tribal, or regional 
level. EPA encourages States and authorized Tribes to use the final 
Methodology and Technical Support Documents to develop site-specific 
water quality criteria to appropriately reflect local conditions. When 
final, the Draft Site-Specific BAF TSD, released for scientific views 
with today's announcement, will assist States and authorized Tribes in 
development of site-specific BAFs for use in site-specific ambient 
water quality criteria calculations.

III. Background Information on the Draft Bioaccumulation Factors 
Technical Support Document Volume III (Draft Site-Specific BAF TSD)

    In order to prevent harmful exposures to chemicals in water through 
eating contaminated fish and shellfish, national 304(a) water quality 
criteria for protecting human health must address chemical 
bioaccumulation in aquatic organisms. Bioaccumulation occurs when 
aquatic organisms accumulate chemicals in their bodies when they are 
exposed to these chemicals through the surrounding media (water, food, 
sediment). The extent of bioaccumulation by aquatic organisms varies 
widely depending on the chemical and the species, but it can be 
extremely high for some highly persistent and lipid-soluble chemicals. 
For such highly bioaccumulative chemicals, concentrations in aquatic 
organisms may pose unacceptable human health risks from eating fish and 
shellfish even when concentrations in water are too low to cause 
unacceptable health risks from drinking the water.
    EPA developed detailed procedures and guidelines described in the 
2000 Human Health Methodology for estimating bioaccumulation factor 
(BAF) values for use in deriving or revising ambient water quality 
criteria. The National BAF TSD discusses the technical basis for 
developing national BAFs, the underlying assumptions and uncertainties 
inherent to the approach, and applying the bioaccumulation component of 
the 2000 Human Health Methodology. The Draft Site-Specific BAF TSD 
expands on the information presented in the National BAF TSD by 
providing users specific information on how to calculate site-specific 
BAFs for use in modifying the national 304(a) criteria and is available 
from EPA's Web site at http://www.epa.gov/waterscience/criteria/humanhealth/method/index.html. Both documents rely on a framework for 
selecting the appropriate procedure for deriving BAFs that is based on 
chemical properties, biological activity and scientific information. 
The Draft Site-Specific BAF TSD presents methods for States, Tribes and 
other interested parties to calculate BAFs that are specific to their 
site. The goal in deriving site-specific BAFs is to determine the most 
accurate estimates of bioaccumulation feasible for each site.
    EPA requests scientific views on all aspects of the Draft Site-
Specific BAF TSD, including the soundness of the technical approaches 
described in the document, the usefulness of the document for States 
and Tribes in calculating BAFs, and the guidance's clarity of 
presentation.

    Dated: June 24, 2008.
Ephraim King,
Office Director, Office of Science and Technology.
[FR Doc. E8-14796 Filed 6-27-08; 8:45 am]
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