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71083

Proposed Rules Federal Register


Vol. 72, No. 240

Friday, December 14, 2007

This section of the FEDERAL REGISTER documents for a fee. Publicly available females, by cancer type.’’ According to
contains notices to the public of the proposed documents created or received at the the petitioner, BEIR VII shows that the
issuance of rules and regulations. The NRC after November 1, 1999, are cancer mortality risks for women and
purpose of these notices is to give interested available electronically at the NRC’s children are much higher than for men.
persons an opportunity to participate in the Electronic Reading Room at http:// Further, the petitioner asserts that the
rule making prior to the adoption of the final
www.nrc.gov/reading-rm/adams.html. GEIS’s radiological impact analysis is
rules.
From this site, the public can gain entry calculated based on an ‘‘arbitrary and
into the NRC’s Agencywide Document false’’ threshold dose model, implying
NUCLEAR REGULATORY Access and Management System that a dose received below the threshold
COMMISSION (ADAMS), which provides text and would not be of ‘‘regulatory concern.’’
image files of NRC’s public documents. In this regard, the petitioner refers to
10 CFR Part 51 If you do not have access to ADAMS or BEIR VII, which concludes that there is
if there are problems in accessing the no evidence of a ‘‘threshold dose
[Docket No. PRM–51–11] documents located in ADAMS, contact phenomenon.’’
Sally Shaw; Denial of Petition for the PDR reference staff at (800) 387– The petitioner also asserts that the
Rulemaking 4209, (301) 415–4737 or by e-mail to GEIS reports radiation risks to nuclear
pdr@nrc.gov. workers of one rem per year based on
AGENCY: Nuclear Regulatory FOR FURTHER INFORMATION CONTACT: BEIR V. The petitioner requests that
Commission. David T. Diec, telephone (301) 415– these radiation risks be recalculated
ACTION: Denial of petition for 2834, e-mail dtd@nrc.gov, or Andrew using BEIR VII and the latest science in
rulemaking. Luu, telephone (301) 415–1078, e-mail medical journals, which include
anl@nrc.gov, Office of Nuclear Reactor exposure to internal radiation sources
SUMMARY: The Nuclear Regulatory Regulation, Nuclear Regulatory (alpha and beta emitters, via inhalation
Commission (NRC) is denying a petition Commission, Washington, DC 20555– or ingestion). Finally, the petitioner
for rulemaking (PRM) submitted by 0001. asserts that the radiological impact
Sally Shaw on June 23, 2006. The analysis contained in the GEIS assumes
SUPPLEMENTARY INFORMATION:
petition, docketed as PRM–51–11, that non-stochastic effects will not occur
requests that the NRC prepare a The Petition if the dose equivalent from internal and
rulemaking to reconcile NUREG–1437, On November 20, 2006 (71 FR 67072), external sources combined is less than
‘‘Generic Environmental Impact the NRC published a notice of receipt of 50 rem per year and, as such, must be
Statement for License Renewal of a petition for rulemaking filed by Sally recalculated in light of BEIR VII.
Nuclear Plants’’ (May 1996) (GEIS), for Shaw (the petitioner). The petitioner
nuclear power plant operating license NRC Evaluation
requested that the NRC reconcile the
renewal applications with the National GEIS with the NAS BEIR VII report, The petitioner’s request is that the
Academy of Sciences’ (NAS), ‘‘Health which was released in 2005. The GEIS NRC reconcile the GEIS with the NAS
Risks From Exposure to Low Levels of incorporates data from BEIR V, an BEIR VII, 2005 report. The NRC’s
Ionizing Radiation: Biological Effects of earlier NAS report that was released in regulations for implementing its
Ionizing Radiation (BEIR) VII, Phase 2,’’ 1990. The NRC regulation, Part 10 of the responsibilities under the National
Seventh Ed., 2005 report. The petitioner Code of Federal Regulations Section Environmental Policy Act (NEPA) are
believes that this action is necessary 51.95(c), requires that the NRC prepare contained in 10 CFR part 51,
because the BEIR VII report represents a supplemental environmental impact ‘‘Environmental Protection Regulations
new and significant information on statement (SEIS) to the GEIS. The for Domestic Licensing and Related
radiation standards and risk factors that findings of the GEIS are set forth in Regulatory Functions.’’ The renewal of
must be reflected in NRC’s GEIS. Table B–1 of Appendix B to subpart A a nuclear power plant operating license
Although the NRC recognizes that the of 10 CFR part 51 (Table B–1). A copy is identified as a major Federal action
petition highlighted that BEIR VII of the petition can be found in ADAMS significantly affecting the quality of the
contains a more refined risk assessment under accession number ML061770056. human environment, and thus an SEIS
based on additional medical data and a Specifically, the petitioner requests (in conjunction with the GEIS) is
better dosimetry system, the NRC is that the NRC consider the NAS BEIR VII required before the NRC determines
denying PRM–51–11 because it does not report as new and significant whether to approve or disapprove the
provide significant information or information and update the radiological license renewal application. The NRC’s
arguments that were not previously impacts and conclusions set forth in the requirements for renewal of operating
considered by the Commission. GEIS, including early fatalities, latent licenses for nuclear power plants are
ADDRESSES: Publicly available fatalities, and any injury projections contained in 10 CFR part 54. The GEIS
documents related to these petitions and based on this information. The assesses environmental impacts that
the NRC’s letter of denial to the petitioner asserts that BEIR VII could be associated with nuclear power
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petitioner may be viewed electronically represents the ‘‘current science,’’ and plant license renewal and establishes
on public computers in the NRC’s states that BEIR VII, unlike BEIR V, generic findings for each type of
PublicDocument Room (PDR), 01 F21, ‘‘estimates risks for cancer incidence environmental impact covering as many
One White Flint North, 11555 Rockville rates as well as mortality and also plants as possible. The GEIS reflects the
Pike, Rockville, Maryland. The PDR provides detailed risk figures according NRC’s findings regarding those
reproduction contractor will copy to age of exposure for males and environmental impacts associated with

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71084 Federal Register / Vol. 72, No. 240 / Friday, December 14, 2007 / Proposed Rules

license renewal that are well and 51.93. The final SEIS and the GEIS Three major changes have occurred
understood. serve as the requisite NEPA analysis for after the BEIR V report was published.
any given license renewal application. First, an additional 12 years of follow-
GEIS The GEIS analysis, as shown in Table up medical data are available. Second,
The GEIS assesses the various B–1, concluded that both public and cancer incidence data for the cohort are
environmental impacts associated with occupational radiation exposures during available (for BEIR V, only mortality
license renewal in terms of significance any plant refurbishment or plant data were available). The impact of
and assigns one of three significance operation through the license renewal these two developments has reduced the
levels to a given impact—small, term are of a small significance level uncertainty in the assessment of cancer
moderate, or large. A small impact and meet all Category 1 criteria. This risk among the atomic bomb survivors.
means that the environmental effects are conclusion is based on a given Third, the dosimetry system used to
not detectable or are so minor that they licensee’s adherence to, and if assign radiation exposure to the atomic
will neither destabilize nor noticeably necessary, NRC enforcement of, the dose bomb survivors was replaced with an
alter any important attribute of the limits as required in 10 CFR part 20, improved dosimetry system. These
resource. For the purpose of assessing ‘‘Standards for Protection Against changes have improved our
radiological impacts, the NRC has Radiation’’ and in Appendix I to 10 CFR understanding of the health risks
concluded that those impacts that do part 50, ‘‘Numerical Guides for Design associated with radiation exposure. The
not exceed permissible levels in the Objectives and Limiting Conditions for overall risk estimates of the BEIR V and
NRC’s regulations are considered small. Operation to Meet the Criterion ‘As Low BEIR VII reports, however, remain
A moderate impact means that the As Is Reasonably Achievable’ (ALARA) statistically insignificant. In this regard,
environmental effects are sufficient to for Radioactive Material in Light-Water- the BEIR VII report states: ‘‘in general
alter noticeably but not to destabilize Cooled Nuclear Power Reactor the magnitude of estimated risks for
important attributes of the resource. A Effluents.’’ Regulations at 10 CFR part total cancer mortality or leukemia has
large impact means that the 20 require that a licensee limit the not changed greatly from estimates in
environmental effects are clearly annual dose to a member of the public past reports such as BEIR V and recent
noticeable and are sufficient to to no more than 0.1 rem (1mSv) total reports of the United Nations Scientific
destabilize important attributes of the effective dose equivalent (TEDE). In Committee on the Effects of Atomic
resource. addition, 40 CFR part 190, Radiation (UNSCEAR) and the
In addition to determining the ‘‘Environmental Radiation Protection International Commission on
significance of environmental impacts Standards For Nuclear Power Radiological Protection (ICRP). New
associated with license renewal, the Operations,’’ further restricts the data and analyses have reduced
NRC determines if its analysis can be allowable annual dose to a member of
applied to all plants and whether sampling uncertainty, but uncertainties
the public to a lower value of 0.025 rem related to estimating risk for exposure at
additional mitigation measures would (0.25 mSv) and to maintain doses to
be warranted. The GEIS sets forth two low doses and dose rates and
members of the public that are ALARA. transporting risks from Japanese
categories: Category 1 and Category 2. Finally, 10 CFR 50.34a requires a
Category 1 means that the GEIS analysis A-bomb survivors to the U.S. population
nuclear power plant to maintain control remain large. Uncertainties in
has shown that the environmental over radioactive gaseous and liquid
impacts associated with the issue have estimating risks of site-specific cancers
effluents produced during normal are especially large.’’
been determined to apply either to all operations to dose levels contained in
plants or, for some environmental Appendix I to 10 CFR Part 50, which are The NRC staff completed a review of
issues, to plants having a specific type in the range of 0.003 rem (0.03 mSv) to the BEIR VII report and documented its
of cooling system or other specified 0.005 rem (0.05 mSv). findings in the Commission paper
plant or site characteristics; a single SECY–05–0202, ‘‘Staff Review of the
significance level (i.e., small, moderate, BEIR Reports National Academies Study of the Health
or large) has been assigned to the The risk estimates of human health Risks from Exposure to Low Levels of
impacts; mitigation of adverse impacts effects from radiation were first Ionizing Radiation (BEIR VII),’’ dated
associated with the issue has been evaluated by scientific committees October 29, 2005 (ADAMS accession
considered in the analysis; and it has starting in the 1950s. Since 1972, the number ML052640532). In this paper,
been determined that additional plant- National Academy of Sciences has the NRC staff concluded that the
specific mitigation measures are not published a series of reports on the findings presented in the BEIR VII
likely to be sufficiently beneficial to biological effects of ionizing radiation report agree with the NRC’s current
warrant implementation. Category 2 (the BEIR reports), including the BEIR V understanding of the health risks from
means that the GEIS analysis does not report in 1990 and the BEIR VII report exposure to ionizing radiation. The
meet the criteria of Category 1, and thus, in 2005. The BEIR V and BEIR VII BEIR VII report’s major conclusion is
on that particular environmental issue, reports concentrated primarily on that current scientific evidence is
additional plant-specific review is providing a comprehensive review of all consistent with the hypothesis that
required. The GEIS findings are set forth biological and biophysical data there is a linear, no-threshold dose
in Table B–1 of Appendix B to subpart regarding the health effects attributable response relationship between exposure
A of 10 CFR part 51. to exposures to low doses of ionizing to ionizing radiation and the
For each license renewal application, radiation, ranging between 0 to 10 rem development of cancer in humans. This
the NRC will prepare a draft SEIS to (0–100 mSv). Although the BEIR VII conclusion is consistent with the system
analyze those plant-specific (Category 2) committee examined several sources of of radiological protection that the NRC
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issues. The SEIS is not required to cover epidemiological data (i.e., medical and used to develop its regulations and the
any Category 1 issues. The draft SEIS is occupational exposures), the single most GEIS. Therefore, the NRC’s regulations
made available for public comment. important source of epidemiological and the GEIS continue to be adequately
After consideration of any public data is the cohort of 120,000 Japanese protective of public health and safety
comments, the NRC will prepare and atomic bomb survivors from the cities of and the environment. Consequently,
issue a final SEIS under 10 CFR 51.91 Hiroshima and Nagasaki. none of the findings in the BEIR VII

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Federal Register / Vol. 72, No. 240 / Friday, December 14, 2007 / Proposed Rules 71085

report represent new and significant individual plant radiation protection more sensitive than males to radiation
information when compared to the programs and operating procedures. The exposure at 10 rem, a level that is 100
findings of the BEIR V report and thus, NRC has concluded that the current times the NRC’s radiation protection
there is no need to amend NRC NRC radiation protection standards standards specified in 10 CFR Part 20.
regulations or the GEIS. The NRC has continue to ensure adequate protection The BEIR VII committee’s preferred
determined that a specific rulemaking to of the public. This position is further estimate of lifetime attributable risk for
amend 10 CFR Part 51 and by extension, reiterated in the Commission Paper leukemia cancer incidence and
the GEIS, is not warranted. SECY–05–0202. In this paper, the NRC mortality (Tables 12–13), moreover,
staff reviewed and evaluated NRC’s suggest that males are more sensitive
Public Comments radiation safety regulations and than females. The BEIR VII committee
The NRC received a total of 74 public standards against the findings of the uses the 95 percent confidence intervals
comments relating to this petition. Of BEIR VII report. The NRC staff associated with estimated lifetime
the 74 comments, 69 supported granting concluded ‘‘that the findings presented cancer risk for males and females that
the petition. No comments opposed the in the National Academies BEIR VII suggest that the apparent gender
petition and five comments were not report contribute to our understanding difference may not be statistically
applicable to this petition. The letters in of the heath risks from exposure to significant. Consequently, the BEIR VII
support of the petition were essentially ionizing radiation. The major report combined the two risk estimates
identical and contained one or more of conclusion is that current scientific and cited an average value which was
the following four assertions: evidence is consistent with the also done by the BEIR V committee. A
A. Protect the most vulnerable hypothesis that there is a linear, no- potential gender difference was not
populations in the regulatory standards. threshold dose response relationship discussed in the BEIR VII report.
B. Recognize that ‘‘allowable’’ levels between exposure to ionizing radiation The NRC radiation protection
are not safe. and the development of cancer in regulation, 10 CFR 20.1208, requires
C. Consider radiation damage from humans.’’ The BEIR VII report’s each licensee to ensure that the dose
inhaling or ingesting radionuclides; and conclusion is consistent with the system equivalent to the embryo/fetus during
D. Recognize that there is no safe of radiological protection that the NRC the entire pregnancy, due to the
dose. used to develop its regulations and the occupational exposure of a declared
A. Protect the Most Vulnerable GEIS. Therefore, the NRC concludes that pregnant woman, does not exceed 0.5
Populations in the Regulatory Standards the current regulations continue to be rem (5 mSv). These radiation protection
adequately protective of the public standards continue to ensure adequate
Although some epidemiological health and safety and the environment. protection of the public health and
studies have shown that children, Consequently, none of the findings in safety and the environment.
individuals in poor health, and the the BEIR VII report warrant initiating The petitioner has also requested that
elderly are more radiosensitive to any immediate change to NRC the NRC review an article entitled
radiation at high doses and high dose regulations or the GEIS. ‘‘Healthy from the Start: Building a
rates, no adverse health effects have Better Basis for Environmental Health
been observed in these populations at B. Recognize That ‘‘Allowable’’ Levels Standards—Starting with Radiation,’’
the doses associated with NRC’s Are Not Safe published by the Institute for Energy
radiation protection regulations and Commenter states that these levels are and Environmental Research (IEER),
standards. The NRC, in NUREG 1850, based on obsolete ‘‘standard man,’’ February 2007. This article was not
‘‘Frequently Asked Questions on concept that applies to a healthy, white published in a scientific peer-reviewed
License Renewal of Nuclear Power male in the prime of his life, and ignore journal and the article’s conclusions do
Reactors,’’ provides information on a the more vulnerable fetus, growing not appear to have been subjected to an
number of studies that have been infant, children, and women who, independent peer review process. The
performed to examine the health effects according to the BEIR VII report, are 37– authors of this article have stated that
around nuclear power facilities. These 50 percent more vulnerable than men to there are cause-and-effect relationships
studies report that there is no the harmful effects of ionizing radiation. in the statistical associations between
conclusive evidence which shows a Although some epidemiological studies cancer rates and nuclear power reactor
statistical correlation between the low have shown that children, individuals operations. Although it is true that
level radiation dose received by in poor health, and the elderly are more cancer rates vary among locations, it is
members of the public living near a radiosensitive to radiation at high doses difficult to ascribe the cause of a cluster
nuclear power plant and their cancer and high dose rates, no adverse health of cancers to a specific environmental
incidence. effects have been observed in these agent, such as radiation from a nuclear
The dose from radioactive gaseous populations at the doses associated with power plant. Statistical association
and liquid effluents is based on the NRC’s radiation protection regulations alone does not demonstrate causation.
‘‘maximum exposed individual’’ and and standards. The amount of Also, well-established scientific
calculated to each of the four age groups radioactive material released from methods must be used to demonstrate
(0–1, 1–11, 11–17, and 17 years and nuclear power facilities is well that these causal effects are appeared to
older). The methodology and guidance measured, closely monitored, and be associated over time. Discussions
for calculating these doses and the known to be very small. As shown by regarding infants, children, and women
associated dose conversion factors for the studies referenced in NUREG–1850, are addressed in section A of this
each age group, are contained in the radiation dose received by members document.
Regulatory Guide 1.109, ‘‘Calculation of of the public from the normal operation
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Annual Doses to Man from Routine of a nuclear power plant are so low that C. Consider Radiation Damage From
Releases of Reactor Effluents for the no cancers have been observed. Inhaling or Ingesting Radionuclides
Purpose of Evaluating Compliance with The BEIR VII committee’s preferred The issue of radiation risks, as
10 CFR Part 50, Appendix I.’’ Nuclear estimate of lifetime attributable risk for discussed in the GEIS (i.e., Appendix E,
power reactors implement this solid cancer incidence and mortality section E 4.1.1), used a reference value
methodology and guidance in (Tables 12–13) suggest that females are of 1 rem to calculate the estimated

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71086 Federal Register / Vol. 72, No. 240 / Friday, December 14, 2007 / Proposed Rules

number of excess cancer fatalities, based ingesting of radioactive material which revision and will consider recent
on the BEIR V report. As discussed in includes alpha, beta, gamma, and radiological studies, including the BEIR
the section titled, ‘‘BEIR Reports,’’ while neutron emitters). The current dose VII, 2005 report. The summary of
the changes between the reports has regulations and standards contain findings as a result of the planned
increased our understanding of adequate radiation safety limits based update will be codified through an
radiation risk, none of the findings of on radiation exposures from all types of ongoing and routine rulemaking to 10
the BEIR VII report represent new and radioactive material and therefore, CFR Part 51, Subpart A, Appendix B,
significant information when compared continue to ensure adequate protection Table B1—Summary of Findings on
to the findings of the BEIR V report. of the public and occupational workers. NEPA Issues for License Renewal of
Thus, there is no need to amend NRC Further, Appendix I to 10 CFR Part 50 Nuclear Power Plants.
regulations or the GEIS. provides numerical ALARA dose The Commission has concluded that
Human health effects associated with criteria for the discharge of radioactive nuclear plants that are in compliance
ionizing radiation, which the GEIS gaseous and liquid effluents from with NRC radiation protection
classifies as a Category 1 issue, are nuclear power plants. These dose regulations and standards remain
divided into two broad categories, non- objectives are incorporated into each protective of public health and safety
stochastic and stochastic. The non- nuclear power plant’s license and the environment. The radiological
stochastic health effects are those in conditions. The NRC collects and health and environmental impacts
which the severity varies in direct assesses data regarding licensees’ contained in the GEIS, which are based
relationship with the radiation dose and adherence to regulations based on site on regulatory compliance, remain valid.
for which, according to scientific reports visits, audits and inspection records, For these reasons, the Commission
from ICRP, UNSCEAR, as well as the and the annual radiological effluent denies PRM–51–11.
BEIR committee, a dose threshold is release reports required to be submitted Dated at Rockville, Maryland, this 10th day
known to exist. Radiation-induced to the NRC and concludes that nuclear of December 2007.
cataract formation is an example of a power plants continue to maintain their For the Nuclear Regulatory Commission.
non-stochastic effect. The stochastic radioactive effluents to the ALARA dose
Annette L. Vietti-Cook,
health effects are those that occur criteria.
randomly and for which the probability Secretary of the Commission.
D. Recognize That There Is No Safe [FR Doc. E7–24291 Filed 12–13–07; 8:45 am]
of the effect occurring, rather than its
Dose
severity, is assumed to be a linear BILLING CODE 7590–01–P
function of dose without threshold. The BEIR VII report’s major
Hereditary effects and cancer incidences conclusion is that current scientific
are examples of stochastic effects. For evidence is consistent with the DEPARTMENT OF TRANSPORTATION
the mitigation of stochastic health hypothesis that there is a linear, no-
effects, the NRC endorses the linear, no- threshold dose response relationship Federal Aviation Administration
threshold dose response model as a between exposure to ionizing radiation
basis for its radiation protection and the development of cancer in 14 CFR Part 39
standards. This model indicates that any humans. The BEIR VII committee did [Docket No. FAA–2007–0258; Directorate
increase in radiation dose, no matter not attempt to equate radiation exposure Identifier 2007–CE–090–AD]
how small, results in an incremental and safety, nor did it offer any judgment
or opinion on what constitutes a safe RIN 2120–AA64
increase in the risk of adverse health
effects. level of radiation exposure. It concludes Airworthiness Directives; Air Tractor,
NRC regulations and standards, such that establishing limits on public Inc. AT–400, AT–500, AT–600, and AT–
as the annual dose limits contained in exposure to ionizing radiation is the 800 Series Airplanes
10 CFR Part 20 for members of the responsibility of Federal agencies like
public and for occupational workers, the U.S. Environmental Protection AGENCY: Federal Aviation
account for stochastic and non- Agency and the NRC. The linear, no- Administration (FAA), DOT.
stochastic health effects of radioactive threshold dose response relationship ACTION: Supplemental notice of
material inhaled or ingested into the between exposure to ionizing radiation proposed rulemaking (NPRM);
human body. For members of the and the development of cancer in Extension of the comment period.
public, the annual dose limit from humans is consistent with the system of
exposure to radiation from an NRC radiological protection that the NRC SUMMARY: We are revising an earlier
licensed facility is 0.1 rem. For uses as a basis to develop its proposed airworthiness directive (AD)
occupational workers, there are specific regulations. Therefore, the NRC’s that applies to certain Air Tractor, Inc.
dose limits to address the stochastic and regulations continue to ensure adequate (Air Tractor) AT–400, AT–500, AT–600,
non-stochastic health effects. The total protection of the public health and and AT–800 series airplanes. The earlier
effective dose equivalent limit which safety and the environment. NPRM proposed to supersede
addresses the stochastic health effects is Airworthiness Directive (AD) 2007–13–
limited to an annual dose of 5 rem. To Reasons for Denial 17, which applies to certain Air Tractor
address the non-stochastic health The Commission is denying the Models AT–602, AT–802, and AT–802A
effects, the annual dose limit to any petition for rulemaking submitted by airplanes. AD 2007–13–17 currently
individual organ or tissue and the skin, Sally Shaw. The specific issues requires you to repetitively inspect the
other than the lens of the eye, is 50 rem; contained in the petition are already engine mount for any cracks, repair or
the annual dose limit to the lens of the adequately addressed in the NRC’s replace any cracked engine mount, and
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eye is 15 rem. The dose unit is specified radiation protection regulations and report any cracks found to the FAA. The
as TEDE in rem. The TEDE dose is the standards. earlier NPRM proposed to retain the
sum of the deep-dose equivalent (i.e., Although this petition is being inspection actions of AD 2007–13–17
external exposures) and the committed denied, the Commission notes that the for Models AT–602, AT–802, and AT–
effective dose equivalent (i.e., internal current GEIS that referenced the BEIR V, 802A airplanes, including the
exposures received from inhaling or 1999 report, is undergoing planned compliance times and effective dates;

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