[Federal Register Volume 67, Number 1 (Wednesday, January 2, 2002)]
[Notices]
[Pages 75-76]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-32088]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7124-1]
Peer Review of EPA Draft Human Health and Ecological Risk
Assessment of Perchlorate
AGENCY: Environmental Protection Agency.
ACTION: Notice of Peer Review Workshop and public comment period.
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SUMMARY: The U.S. Environmental Protection Agency (EPA) Office of
Research and Development is announcing an external peer review workshop
to review the revised draft document entitled, ``Perchlorate
Environmental Contamination: Toxicological Review and Risk
Characterization'' (NCEA-I-0503). The EPA is also announcing a public
comment period for this draft document. The workshop is being organized
and convened by the Eastern Research Group, Inc. (ERG), an EPA
contractor.
DATES: The two-day peer review workshop will begin on Tuesday, March 5,
2002, at 9 a.m. and will end on Wednesday, March 6, 2002, at 4:30 p.m.
The 30-day public review and comment period will begin January 9, 2002,
and will end February 11, 2002.
ADDRESSES: The external peer review meeting will be held at a facility
in Sacramento, California. To attend the meeting as an observer, please
register with ERG via the Internet by visiting [email protected].
You may also register by calling ERG's conference registration line at
781-674-7374 or by faxing a registration request to 781-674-2906. Upon
registering, you will be sent an agenda and a logistical fact sheet
containing information on the meeting site, overnight accommodations,
and ground transportation. The deadline for pre-registration is
February 25, 2002. Space is limited, and reservations will be accepted
on a first-come, first-served basis. There will be a limited time for
oral comments on the revised draft document during the meeting. When
registering, please let ERG know if you
[[Page 76]]
wish to make a brief statement not to exceed five minutes.
Document Availability: The external review draft of the perchlorate
document will be available by January 9, 2002, on EPA's National Center
for Environmental Assessment (NCEA) Web site at http://www.epa.gov/ncea. In addition, a compact disk (CD) containing documents cited in
the ``Perchlorate Environmental Contamination: Toxicological Review and
Risk Characterization'' report that cannot be readily obtained from the
open literature will be available by request as of January 9, 2002. To
obtain a copy of the CD, you may contact the EPA Superfund Records
Center in San Francisco, California. A shipping and handling fee may
apply. The circulation desk phone number for the Superfund Records
Center is 415-536-2000. Copies of the perchlorate document and CD are
not available from ERG.
Comment Submission: Written comments should be submitted to ERG,
Inc., 110 Hartwell Avenue, Lexington, Massachusetts 02421. Comments
under 50 pages may be sent via e-mail attachment (in Word, Word
Perfect, or PDF) to [email protected]. Written comments must be
postmarked by the end of the public comment period (February 11, 2002).
Please note that all technical comments received in response to this
notice will be placed in a public record. For that reason, commentors
should not submit personal information (such as medical data or home
address), Confidential Business Information, or information protected
by copyright. Due to limited resources, acknowledgments will not be
sent.
FOR FURTHER INFORMATION CONTACT: Questions regarding registration and
logistics should be directed to EPA's contractor, ERG, Inc., at 781-
674-7374. For technical inquiries, please contact: Annie Jarabek, U.S.
Environmental Protection Agency (MD 52), USEPA Mailroom, Research
Triangle Park, NC 27711; telephone 919-541-4847; facsimile 919-541-
1818; e-mail [email protected].
SUPPLEMENTARY INFORMATION: Perchlorate (ClO4) is an anion
that originates as a contaminant in groundwater and surface waters from
the dissolution of ammonium, potassium, magnesium, or sodium salts.
Perchlorate is exceedingly mobile in aqueous systems and can persist
for many decades under typical groundwater and surface water
conditions. A major source of perchlorate contamination is the
manufacture of ammonium perchlorate for use as the oxidizer component
and primary ingredient in solid propellant for rockets, missiles, and
fireworks.
EPA's Superfund Technical Support Center issued a provisional
reference dose (RfD) for perchlorate in 1992 and a revised provisional
RfD in 1995 based on the effects of potassium perchlorate in patients
with Graves' disease (an autoimmune disease that results in
hyperthyroidism). (An RfD is an estimate of a daily oral human exposure
that is anticipated to be without adverse noncancer health effects over
a lifetime.) In March 1997, the existing toxicologic database on
perchlorate was determined to be inadequate for quantitative human
health risk assessment by an external peer review panel. A lack of data
on the ecotoxicological effects was also noted. In May 1997, a testing
strategy was developed based on the known mode-of-action for
perchlorate toxicity (the inhibition of iodide uptake in the thyroid
and subsequent perturbations of thyroid hormone homeostasis), and an
accelerated research program was initiated to gain a better
understanding of the human health effects of perchlorate, examine
possible ecological impacts, refine analytical methods, develop
treatment technologies, and better characterize the occurrence of
perchlorate in groundwater and surface waters.
In December 1998, the National Center for Environmental Assessment
(NCEA) developed an external peer review draft document that assessed
the human health and ecological risk of perchlorate (``Perchlorate
Environmental Contamination: Toxicology Review and Risk
Characterization Based on Emerging Information,'' NCEA-I-0503). This
document presented an updated human health risk assessment that
incorporated results of the newly performed health effects studies
available as of November 1998 and a screening-level ecological
assessment. The human health risk assessment model utilized a mode-of-
action approach that harmonized noncancer and cancer approaches to
derive a single oral risk benchmark based on precursor effects for both
neurodevelopmental and thyroid neoplasia. A workshop was convened in
February 1999 in San Bernardino, California, to provide external peer
review of that document. Peer reviewers endorsed the conceptual
approach proposed by NCEA, but recommended that new analyses be
conducted and that several additional studies be planned and performed.
NCEA has prepared a revised perchlorate assessment that addresses
comments from the 1999 external peer review workshop and incorporates
data from additional studies that were either nearing completion at the
time of the 1999 review or were recommended at that time. This revised
draft document is the subject of the external peer review workshop
announced in today's Federal Register notice.
The external peer review panel will consist of a panel of
independent scientists selected by EPA's contractor, ERG, from the
fields of developmental toxicology, reproductive toxicology,
neurotoxicology, immunotoxicology, pharmacokinetics, genetic
toxicology, endocrinology, pathology, epidemiology, statistics,
ecotoxicology, and environmental transport and biotransformation. Peer
reviewers will review the revised human health and ecological risk
assessment for perchlorate as well as new studies performed since the
1999 external peer review. Following the external peer review workshop,
ERG will prepare a report summarizing the workshop. EPA will address
the comments of the external peer reviewers in finalizing the
perchlorate risk assessment document and in developing revised toxicity
values. The human health and ecological risk assessment may be used in
the future to support development of a health advisory or possible
drinking water regulations and cleanup decisions at hazardous waste
sites. However, any such future decisions would be subject to all
applicable statutory and regulatory requirements and policy
considerations for use of the assessments under those programs.
Dated: December 20, 2001.
George W. Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 01-32088 Filed 12-31-01; 8:45 am]
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