Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health; Technical Support Document, Volume 3: Development of Site-Specific Bioaccumulation Factors, 50182-50183 [E9-23631]

Download as PDF 50182 Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices DATES: The National and Governmental Advisory Committees will hold an open meeting on Wednesday, October 14, from 8:30 a.m. to 5:30 p.m., and Thursday, October 15, from 8:30 a.m. until 1:15 p.m. ADDRESSES: The meeting will be held, tentatively, at either of these hotels: (1) Stowe Mountain Center, 5781 Mountain Road, Stowe, Vermont 05672. Telephone: 802–253–3558; or, (2) The Essex, 70 Essex Way, Essex Junction, VT 05452. Telephone: 802–878–1100. The meeting is open to the public, with limited seating on a first-come, firstserved basis. The exact location will be posted, at https://www.epa.gov/ocem/ nacgac-page.htm, prior to the meeting. However, interested parties should contact Oscar Carrillo (see below). FOR FURTHER INFORMATION CONTACT: Oscar Carrillo, Designated Federal Officer, carrillo.oscar@epa.gov, 202– 564–0347, U.S. EPA, Office of Cooperative Environmental Management (1601–M), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. SUPPLEMENTARY INFORMATION: Requests to make oral comments or provide written comments to the Committees should be sent to Oscar Carrillo, Designated Federal Officer, at the contact information above. Meeting Access: For information on access or services for individuals with disabilities, please contact Oscar Carrillo at 202–564–0347 or carrillo.oscar@epa.gov. To request accommodation of a disability, please contact Oscar Carrillo, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. Dated: September 25, 2009. Cynthia Jones-Jackson, Acting Designated Federal Officer. [FR Doc. E9–23573 Filed 9–29–09; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY I. General Information CPrice-Sewell on DSKGBLS3C1PROD with NOTICES [FRL–8964–1] Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health; Technical Support Document, Volume 3: Development of Site-Specific Bioaccumulation Factors AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability of final document. VerDate Nov<24>2008 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 releasing the Technical Support Document, Volume 3: Development of Site-Specific Bioaccumulation Factors (hereafter ‘‘Site-Specific BAF TSD’’) that accompanies the Methodology and the National BAF TSD. EPA accepted scientific views on the draft document in two separate Federal Register Notices. 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 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. 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; bethel.heidi@epa.gov. SUPPLEMENTARY INFORMATION: 14:56 Sep 29, 2009 Jkt 217001 A. Where can I find additional information on this document? EPA solicited scientific views on the draft document in two separate Federal Register Notices (73 FR 36866 and 73 FR 46624). Scientific views were accepted at https://www.regulations.gov at Docket ID No. EPA–HQ–OW–2008– 0494. Publicly available docket materials are available either electronically in https:// www.regulations.gov or in hard copy at PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 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., EDT, 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. Scientific views received by EPA and a document indicating EPA’s response to scientific views can also be found at the docket locations listed above. A range of scientific views were received on the document. Views received did result in some minor changes to the document including some changes to table and figure captions; an example calculation correction and clarification of chemical types for which the document applies. A comprehensive list of changes to the document can be found in the response document. Other comments were addressed in the comment document, but did not result in changes to the document. A. Does This Action Apply to Me? The intended audience for the SiteSpecific 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 sitespecific bioaccumulation issues for other applications. II. What Are Water Quality Criteria? Water quality criteria are scientifically derived numeric and/or narrative values that protect applicable designated uses, e.g., 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 E:\FR\FM\30SEN1.SGM 30SEN1 Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices CPrice-Sewell on DSKGBLS3C1PROD with NOTICES 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 with guidance to adjust water quality criteria developed by EPA 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. The SiteSpecific BAF TSD, released 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 Bioaccumulation Factors Technical Support Document Volume III (SiteSpecific BAF TSD) In order to prevent harmful exposures to chemicals in water through eating contaminated fish and shellfish, national section 304(a) water quality criteria for protecting human health 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 (e.g., 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 Site-Specific BAF VerDate Nov<24>2008 14:56 Sep 29, 2009 Jkt 217001 TSD expands on the information presented in the National BAF TSD by providing users with specific information on how to calculate sitespecific BAFs for use in modifying the national section 304(a) criteria, and is available on EPA’s Web site at https:// www.epa.gov/waterscience/criteria/ humanhealth/method/. 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 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. Dated: September 21, 2009. Michael H. Shapiro, Acting Assistant Administrator, Office of Water. [FR Doc. E9–23631 Filed 9–29–09; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2009–0608; FRL–8433–1] Pesticide Experimental Use Permit; Receipt of Application; Comment Request AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces EPA’s receipt of an application 67979–EUP–I from Syngenta Seeds Inc. requesting an experimental use permit (EUP) for the plant-incorporated protectant (PIP) [Event 5307] Bacillus thuringiensis eCry3.1Ab protein and the genetic material necessary for its production (vector pSYN12274) in event 5307 corn (SYN–;53;7–1) and combined trait hybrids with one or more of the following additional PIPs: 1) [Bt11] Bacillus thuringiensis Cry1Ab deltaendotoxin and the genetic material (as contained in plasmid vector pZO1502) necessary for its production in corn, 2) [DAS–59122–7] Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material (vector PHP 17662) necessary for their production in Event DAS–59122–7 corn, 3) [MIR162] Bacillus thuringiensis Vip3Aa20 and the genetic material necessary for its production (vector pNOV1300) in event MIR162 maize (SYN–IR162–4), 4) [MIR604] Modified Cry3A protein and the genetic material necessary for its PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 50183 production (via elements of pZM26) in corn (SYN–IR604–8), and 5) [TC1507] Bacillus thuringiensis Cry1F protein and the genetic material (vector PHP8999) for its production in Event TC1507 corn. The Agency has determined that the permit may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11(a), the Agency is soliciting comments on this application. DATES: Comments must be received on or before October 30, 2009. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2009–0608, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2009– 0608. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// 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 regulations.gov or email. The regulations.gov website 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 regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the 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 E:\FR\FM\30SEN1.SGM 30SEN1

Agencies

[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Notices]
[Pages 50182-50183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23631]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8964-1]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability of final document.

-----------------------------------------------------------------------

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 releasing the Technical Support Document, Volume 
3: Development of Site-Specific Bioaccumulation Factors (hereafter 
``Site-Specific BAF TSD'') that accompanies the Methodology and the 
National BAF TSD. EPA accepted scientific views on the draft document 
in two separate Federal Register Notices. 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 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.

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; bethel.heidi@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Where can I find additional information on this document?

    EPA solicited scientific views on the draft document in two 
separate Federal Register Notices (73 FR 36866 and 73 FR 46624). 
Scientific views were accepted at https://www.regulations.gov at Docket 
ID No. EPA-HQ-OW-2008-0494. Publicly available docket materials are 
available either electronically in https://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., EDT, 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.
    Scientific views received by EPA and a document indicating EPA's 
response to scientific views can also be found at the docket locations 
listed above. A range of scientific views were received on the 
document. Views received did result in some minor changes to the 
document including some changes to table and figure captions; an 
example calculation correction and clarification of chemical types for 
which the document applies. A comprehensive list of changes to the 
document can be found in the response document. Other comments were 
addressed in the comment document, but did not result in changes to the 
document.

A. Does This Action Apply to Me?

    The intended audience for the 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.

II. What Are Water Quality Criteria?

    Water quality criteria are scientifically derived numeric and/or 
narrative values that protect applicable designated uses, e.g., 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

[[Page 50183]]

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 with guidance to 
adjust water quality criteria developed by EPA 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. The Site-Specific BAF TSD, released 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 Bioaccumulation Factors Technical 
Support Document Volume III (Site-Specific BAF TSD)

    In order to prevent harmful exposures to chemicals in water through 
eating contaminated fish and shellfish, national section 304(a) water 
quality criteria for protecting human health 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 (e.g., 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 Site-Specific BAF TSD expands on 
the information presented in the National BAF TSD by providing users 
with specific information on how to calculate site-specific BAFs for 
use in modifying the national section 304(a) criteria, and is available 
on EPA's Web site at https://www.epa.gov/waterscience/criteria/humanhealth/method/. 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 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.

    Dated: September 21, 2009.
Michael H. Shapiro,
Acting Assistant Administrator, Office of Water.
[FR Doc. E9-23631 Filed 9-29-09; 8:45 am]
BILLING CODE 6560-50-P
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