Document ID: EPA-HQ-ORD-2010-0395-0001
Agency: epa
Document Type: Notice
Title: Draft EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and Response to National Academy of Sciences (NAS) Comments
Posted Date: 2010-05-21T04:00Z

[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Notices]               
[Page 28610-28612]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my10-78]                         

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9154-2; Docket ID No. EPA-HQ-ORD-2010-0395]

 
Draft EPA's Reanalysis of Key Issues Related to Dioxin Toxicity 
and Response to NAS Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Public Comment Period.

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SUMMARY: EPA is announcing a 90-day public comment period for the 
external review draft entitled, ``EPA's Reanalysis of Key Issues 
Related to Dioxin Toxicity and Response to NAS Comments'' (EPA/600/R-
10/038A). This draft report responds to the key recommendations and 
comments included in the National Academy of Sciences (NAS) 2006 
report. In addition, it includes new analyses on potential human 
effects that may result from exposure to 2,3,7,8-tetrachlorodibenzo-p-
dioxin (TCDD). These analyses have not been in previous versions of 
draft reports related to EPA's dioxin reassessment activity. This draft 
report is now considered to be under EPA's Integrated Risk Information 
System (IRIS) program, and thus, the new IRIS process announced in May 
2009 (http://www.epa.gov/iris/process/) is being followed. Per the May 
2009 process, this draft report is beginning Step 4--independent 
external peer review and public review and comment. This draft dioxin 
report was prepared by the National Center for Environmental Assessment 
(NCEA) within the EPA Office of Research and Development (ORD).
    The draft document, ``EPA's Reanalysis of Key Issues Related to 
Dioxin Toxicity and Response to NAS Comments,'' is also being provided 
to EPA's Science Advisory Board (SAB), a body established under the 
Federal Advisory Committee Act, for independent external peer review. 
The SAB will convene an expert panel composed of scientists 
knowledgeable about technical issues related to dioxins and risk 
assessment. The SAB is expected to hold a public teleconference on or 
about June 24, 2010, and a public panel meeting on July 13-15, 2010. 
The SAB peer review meetings will be announced by the SAB staff office 
in a separate Federal Register Notice. EPA intends to forward all 
public comments submitted before July 7, 2010, in response to this 
notice to the SAB peer review panel for their consideration. Members of 
the public who wish to ensure that their technical comments are 
provided to the SAB expert panel before each meeting should also e-mail 
their comments separately to Thomas Armitage, the SAB Designated 
Federal Officer at armitage.thomas@epa.gov, following the procedures in 
the Federal Register Notice announcing the SAB public meetings. When 
completing this draft dioxin report, EPA will consider any written 
public comments that EPA receives in accordance with the detailed 
instructions provided below under SUPPLEMENTARY INFORMATION. The public 
comment period and SAB external peer review are independent processes 
that provide separate opportunities for all interested parties to 
comment on the draft report.
    EPA is releasing this draft report solely for the purpose of pre-
dissemination peer review under applicable information quality 
guidelines. This draft report has not been formally disseminated by 
EPA. It does not represent and should not be construed to represent any 
Agency policy or determination.

DATES: The public comment period begins May 21, 2010, and ends August 
19, 2010. Comments should be in writing and must be received by EPA by 
August 19, 2010.
    Due to the timing of the SAB's peer review meeting, EPA can only 
guarantee that those comments received by July 7, 2010, in response to 
this Federal Register notice will be provided to the SAB panel prior to 
the SAB meeting. Comments received after July 7, will still be provided 
to the SAB panel and will also inform the Agency's revision of the 
draft report.

ADDRESSES: The external review draft titled, ``EPA's Reanalysis of Key 
Issues Related to Dioxin Toxicity and Response to NAS Comments'' (EPA/
600/R-10/038A) is available primarily via the Internet on the NCEA home 
page under the Recent Additions and Publications menus at http://
www.epa.gov/ncea. A limited number of paper copies are available from 
the Information Management Team (Address: Information Management Team, 
National Center for Environmental Assessment (Mail Code: 8601P), U.S. 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone: 703-347-8561; facsimile: 703-347-
8691). If you request a paper copy,

[[Page 28611]]

please provide your name, mailing address, and the assessment title.
    Comments may be submitted electronically via http://
www.regulations.gov, by e-mail, by mail, by facsimile, or by hand 
delivery/courier. Please follow the detailed instructions provided in 
the SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the docket, 
regulations.gov or public comment period, please contact the Office of 
Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone: 202-566-1752; facsimile: 202-566-1753; 
or e-mail: ORD.Docket@epa.gov.
    For information on the draft report, please contact Linda C. Tuxen, 
National Center for Environmental Assessment (8601P), U.S. 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone: 703-347-8609; facsimile: 703-347-8699; 
or e-mail: tuxen.linda@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Draft Report, ``EPA's Reanalysis of Key Issues 
Related to Dioxin Toxicity and Response to NAS Comments''

    In 2003, EPA, along with other federal agencies, asked the NAS to 
review aspects of the science in EPA's draft dioxin reassessment 
entitled, ``Exposure and Human Health Reassessment of 2,3,7,8-
Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds,'' and, in 
2004, EPA sent a 2003 external review draft dioxin reassessment to the 
NAS for their peer review. The NAS held several public meetings during 
their review of the draft reassessment and on July 11, 2006, released 
the final report of their review entitled, ``Health Risks from Dioxin 
and Related Compounds: Evaluation of the EPA Reassessment.''
    The NAS identified three key areas in the 2003 draft reassessment 
that required substantial improvement to support a more scientifically 
robust risk characterization. These three areas were: (1) Justification 
of approaches to dose-response modeling for cancer and non-cancer 
endpoints; (2) transparency and clarity in selection of key data sets 
for analysis; and (3) transparency, thoroughness, and clarity in 
quantitative uncertainty analysis. The NAS provided EPA with 
recommendations to address their key concerns.
    EPA's draft dioxin report, which is being provided for public 
review and comment, includes significant new analyses on both the 
potential cancer and noncancer human health effects that may result 
from exposures to TCDD. For instance, this draft report addresses the 
explicit recommendation of the NAS to develop a quantitative risk 
estimate for noncancer effects that may result from long-term (chronic) 
oral exposure to dioxins. Thus, this draft dioxin report includes an 
oral reference dose (RfD) for TCDD--the most well-studied and 
considered to be among the most toxic of the dioxin-like compounds. An 
RfD was not in the 2003 draft dioxin reassessment.
    In addition, in 2003, EPA and other federal agencies developed a 
set of questions and answers related to dioxins, which have been 
updated about every year and a half. These materials have again been 
updated to include more recent information. These questions and answers 
provide general information on dioxins such as what they are, where 
they can be found, and major sources of dioxins. They also discuss 
possible effects of dioxin exposure in humans, include advice about 
consumption of food that might contain dioxins, and explain the review 
process for the dioxin reassessment. For additional information on 
dioxins and on EPA's overall dioxin assessment activity, these 
questions and answers may be accessed at: http://www.fda.gov/Food/
FoodSafety/FoodContaminantsAdulteration/ChemicalContaminants/
DioxinsPCBs/ucm077524.htm.

II. How To Submit Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2010-
0395, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Facsimile: 202-566-1753.
     Mail: Office of Environmental Information (OEI) Docket 
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460. The telephone number is 
202-566-1752. If you provide comments by mail, please submit one 
unbound original with pages numbered consecutively, and three copies of 
the comments. For attachments, provide an index, number pages 
consecutively with the comments, and submit an unbound original and 
three copies.
     Hand Delivery: The OEI Docket is located in the EPA 
Headquarters Docket Center, EPA West Building, Room 3334, 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. Deliveries are only accepted during the 
docket's normal hours of operation, and special arrangements should be 
made for deliveries of boxed information. If you provide comments by 
hand delivery, please submit one unbound original with pages numbered 
consecutively, and three copies of the comments. For attachments, 
provide an index, number pages consecutively with the comments, and 
submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2010-0395. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the closing date will 
be marked ``late,'' and may only be considered if time permits. It is 
EPA's policy to include all comments it receives in the public docket 
without change and to make the comments available online at http://
www.regulations.gov, including any personal information provided, 
unless comments include 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 comments. If you send e-mail 
comments directly to EPA without going through http://
www.regulations.gov, your e-mail address will be automatically captured 
and included as part of the comments that are placed in the public 
docket and made available on the Internet. If you submit electronic 
comments, EPA recommends that you include your name and other contact 
information in the body of your comments and with any disk or CD-ROM 
you submit. If EPA cannot read your comments due to technical 
difficulties and cannot contact you for clarification, EPA may not be 
able to consider your comments. Electronic files should avoid the use 
of special characters and 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

[[Page 28612]]

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 at http://www.regulations.gov or in 
hard copy at the OEI Docket in the EPA Headquarters Docket Center.

    Dated: May 17, 2010.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2010-12280 Filed 5-20-10; 8:45 am]
BILLING CODE 6560-50-P