E8-14796. 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.

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: [e-mail].
• 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 [phone], and the telephone number for the Office of Water is [phone].

FOR FURTHER INFORMATION CONTACT:

Heidi L. Bethel, Health and Ecological Criteria Division (4304T), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460; [phone]; [e-mail].

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.

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.