[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19355-19356]
[FR Doc No: 2011-8305]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Staff Attendance at Southwest Power Pool Markets
Operations Policy Committee Meeting

    The Federal Energy Regulatory Commission hereby gives notice that
members of its staff may attend the meeting of the Southwest Power
Pool, Inc. (SPP) Markets Operations Policy Committee (MOPC), as noted
below. Their attendance is part of the Commission's ongoing outreach
efforts.

SPP MOPC

    April 12, 2011 (8 a.m.-5 p.m.), April 13, 2011 (8 a.m.-3 p.m.),
Doubletree Hotel, 616 West 7th Street, Tulsa, OK 74127,<PHONE_NUMBER>.
    The discussions may address matters at issue in the following
proceedings:

Docket No. ER06-451, Southwest Power Pool, Inc.
Docket No. ER08-1419, Southwest Power Pool, Inc.
Docket No. ER09-659, Southwest Power Pool, Inc.
Docket No. ER09-1050, Southwest Power Pool, Inc.
Docket No. OA08-104, Southwest Power Pool, Inc.
Docket No. ER10-696, Southwest Power Pool, Inc.
Docket No. ER10-941, Southwest Power Pool, Inc.
Docket No. ER10-1069, Southwest Power Pool, Inc.
Docket No. ER10-1254, Southwest Power Pool, Inc.
Docket No. ER10-1269, Southwest Power Pool, Inc.
Docket No. ER10-1697, Southwest Power Pool, Inc.
Docket No. ER10-2244, Southwest Power Pool, Inc.
Docket No. ER11-13, Southwest Power Pool, Inc.
Docket No. ER11-2303, Southwest Power Pool, Inc.
Docket No. ER11-2428, Southwest Power Pool, Inc.
Docket No. ER11-2528, Southwest Power Pool, Inc.
Docket No. ER11-2711, Southwest Power Pool, Inc.
Docket No. ER11-2719, Southwest Power Pool, Inc.
Docket No. ER11-2725, Southwest Power Pool, Inc.
Docket No. ER11-2736, Southwest Power Pool, Inc.
Docket No. ER11-2758, Southwest Power Pool, Inc.
Docket No. ER11-2781, Southwest Power Pool, Inc.
Docket No. ER11-2783, Southwest Power Pool, Inc.
Docket No. ER11-2787, Southwest Power Pool, Inc.
Docket No. ER11-2828, Southwest Power Pool, Inc.
Docket No. ER11-2837, Southwest Power Pool, Inc.
Docket No. ER11-2861, Southwest Power Pool, Inc.
Docket No. ER11-2881, Southwest Power Pool, Inc.
Docket No. ER11-2916, Southwest Power Pool, Inc.

    These meetings are open to the public.
    For more information, contact Patrick Clarey, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or<EMAIL_ADDRESS>
    Dated: April 1, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-8305 Filed 4-6-11; 8:45 am]
BILLING CODE 6717-01-P


have for HCV and HIV-1 for looking at the specificity of
the assays.  We also need to take part, at least once or
twice a year, in proficiency studies to monitor the overall
performance of the laboratory.  So, these are the sort of
quality issues that a NAT lab faces, I think, to be able to
work well.
[Slide]
This is a list of the NAT working reagents, which
I am sure most of you have seen before, and these are the
reagents which were available from NIBSC for hepatitis C,
HIV-1 and 2.  I give these figures in international units
per milliliter if you divide this by about half.  B19,
hepatitis B, hepatitis A, we haven't got an international
standard yet, and a multiplex standard which has all five
viruses of these concentrations.
There are also other working reagents, C, HIV-1,
HBV and B19, available from other laboratories and I think
Mei-ying Yu will describe the CBER reagents, and these have
all be calibrated again to respective international
standards.
[Slide]

sgg
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Going on to proficiency studies, these are blind
panels which are tested once or twice a year, and what they
do is look at performance of a validated assay and show the
reproducibility of the assay, confirm the skill of the
laboratory and compare the results of one laboratory to
another.
[Slide]
In the U.K. I run a group called the U.K. NAT
testing laboratories.  We, so far, have sent out three
proficiency panels over the years.  The first two panels
have dilutions of genotypes 1 and 3, ranging from 50,000 IU
to 0.2 IU.  The third panel had dilutions of genotypes 1 to
6 and negative controls.  Over the years the participants
have increased from six to nine in these panels.
[Slide]
My final slide is really the results of the last
panel, which I hope you can see.  These are the six
genotypes of hepatitis C, ranging from 100 IU down to 5,
and 120 for the other four, and five diluent samples.  All
the labs to start with could pick up 100 IU/ml of all the
genotypes and this fulfills the European requirement which
Micha Nubling mentioned of a validated assay being able to
pick up 100 IU/ml.  There was only one lab that picked up
false positive, and the majority of laboratories could go
down to 20 IU/ml of all the genotypes.

sgg
MILLER REPORTING COMPANY, INC.
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So, in some ways this is a very good illustration
of how the laboratories in the U.K. are actually getting
closer together in terms of sensitivity and specificity of
the assays.
I will conclude by saying that for the
standardization and quality assurance of NAT we now have
available the standards which are calibrated in
international units, which can be used throughout the
world, and we have panels such as genotype panels and
proficiency panels for looking at the performance of
laboratories.  Thank you.
DR. YU:  Thank you, John Saldanha.  Let's have
some short questions and comments.  Later on in this
session we are going to have a discussion session.  Please?
DR. BIANCO:  Celso Bianco.  John, you were very
emphatic in trying to encourage the use of international
units.  However, all the regulatory agencies around the
world continue to use -- or most of them -- copies or
genome equivalence, at least in some of the regulations.
How are we going to agree on something like that?
DR. SALDANHA:  Well, actually the majority of
regulatory authorities use international units.  CPMP, as
Micha Nubling pointed out earlier, define HCV in terms of
international units per milliliter.  The German regulatory
authorities have 5000 IU/ml as well.  In the U.K. we use

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
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100 IU/ml.  With HIV the problem is slightly more difficult
because the HIV-1 assays have been well established and it
is only recently that we have had an international standard
and the calibration studies have only just been completed.
But what I hope is that once these materials are available
and have been calibrated most laboratories will switch over
to IU because it makes things so much easier.  Although
people talk about copies and genome equivalence, as far as
I can see, they are not strictly equivalent and you can't
compare one with the other.
DR. YU:  I would just like to comment that CBER
now is going to use IU versus copies.  Okay?
DR. BISWAS:  Thank you very much, John.  Our next
speaker is Dr. Micha Nubling, from the Paul Ehrlich
Institute, who will talk about the European standardization
and quality assurance program.
Europe
[Slide]
DR. NUBLING:  John already mentioned
standardization through common reference preparations.
[Slide]
I would like to focus on two related but,
nevertheless, similar topics, different topics.  This is
standardization of NAT tests and I would like to introduce
you to the European IVD directive, which is the regulatory

sgg
MILLER REPORTING COMPANY, INC.
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framework for future IVD regulation in all of Europe, and
especially come to the so-called common technical
specifications which have been defined for at least some of
the NAT assays.
The second part of my presentation will also
cover quality assurance in laboratory and here I would like
to come to the proficiency testing system as it is now
installed for official medicine products controlled
laboratories network, which is organized by EDQM in
Strasbourg.
[Slide]
First coming to the European IVD directive, just
a very short introduction, it is a regulation which defines
the conditions of placing IVDs on the European market.
Once these conditions are fulfilled the IVD can be CE
marked and this allows them free movement of IVDs in the
common market in all of Europe.  The IVD directive defines
quite generally so-called essential requirements which
cover mainly reliability of assays and protection of users
and third parties.
[Slide]
This is just a picture to make it a little bit
clearer.  In order for a product to become CE marked, the
manufacturer has to install so-called process specific
steps, for example, by showing conformity with certain

sgg
MILLER REPORTING COMPANY, INC.
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standards, like the ISO 9000 standard and EN 46001.  In
addition to this, product specific requirements have to be
fulfilled which are later on in so-called European
harmonized written standards and in the essential
requirements in the IV directive and, last but not least,
let's say the most important products, the so-called high
risk IVDs, which are laid down in the so-called common
technical specifications, CTS.
[Slide]
The IV directive is a very new regulation and
currently we are just in the middle of the first transition
phase, meaning that CE marking is already possible, CE
marking of IVDs is already possible since June, 2000 but,
nevertheless, also national approvals can be applied and
are still valid.  Then there comes the second transition
phase.  After the end of 2005 all IVDs in Europe have to be
CE marked and the national regulations, which are quite
different in different countries in Europe, will be
replaced totally by this IVD regulation.
[Slide]
I mentioned already the common technical
specifications.  These are product specific requirements,
and the question is why they have been defined.  With think
they are a flexible, fast and updatable process and this is
important for several reasons.  Flexible and fast and

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
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updatable because there is a working group, which is a
steady working group, which has defined now the first
version of the CTS but if there is a need, they can convene
again and improve or update the current version of the CTS.
This may be possible if, for example, test improvement
occur and there is a need for a new requirement.
Epidemiological changes have occurred in the past and the
respective requirements need to have all these changes.
Also, availability of samples, sample use and diagnostic
evaluations change.  For example, yesterday evening we
discussed HIV-2 seroconversion panels which are not
available at the moment but, for example, once these panels
will be available they would be included in the CTS.  Last,
not least, state-of-the-art of IVDs changes quite rapidly
with time and this also has to be reflected by a fast
process.
[Slide]
The CTS consists of general principles and of a
number of qualifications of standards to be used for
diagnostic evaluations.  I just want to briefly introduce
some of the general principles which lead, to a certain
extent, also to standardization of NAT assays which are
concepted for the European market in the future.
One example is that the detection limit of assays
has to be expressed as a 95 percent positive cut-off value

sgg
MILLER REPORTING COMPANY, INC.
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based on the international standard, as John already
introduced and as he made reference to the EPI validation
guideline and how this value for the different assays
should be established.
Genome and subtype detection efficiency has to be
investigated and the respective information has to be given
to the user.  Quantification limits should also be
expressed by reference to the national standards, and that
is also an approach for how the system failure rate should
be calculated.
[Slide]
An important statement in the common technical
specifications for NAT assays is that the so-called
functionality control or internal control is a check for
the whole procedure, including extraction/amplification
detection estimated as the current state-of-the-art.  So,
any test without such a control will have problems in
Europe.
[Slide]
There are also certain statements made about how
to investigate robustness, including pre-seroconversion
samples, high titer samples.  Carryover has to be
investigated and also the whole system failure rate has to
be established.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
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The number and qualification of samples have been
defined for the tests which could be used, at least for
blood banks.  So, certain numbers of subtypes and genome
types have been defined, and also how these numbers could
be achieved.  I already mentioned the detection limit.
This is just to give you an impression.  There are many
other tables.  Also, for specificity certain numbers have
been agreed to for the different NATs for different
viruses, how specificity should be expressed.
[Slide]
At the moment, we still have national approvals
and different manufacturers contacted PEI also in order to
get approval.  At the moment we have some problems or at
least discussions with tests, why the whole procedure is
controlled.  An NAT procedure may start with a
concentration of viruses, for example, by centrifugation,
then extraction, precipitation and capture of nucleic acid
amplification and detection of amplification products.
Assays which have internal controls or positive controls
which consist of in vitro transcripts cover only these
later steps of the whole procedure and, for example,
centrifugation and detection of viral genomes is, by
definition, not controlled.  For the time being, therefore,
at least it is discussed at the moment if a parallel run
control should be required for such tests, which contains

sgg
MILLER REPORTING COMPANY, INC.
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real virus and which should be performed once per run in
order to control at least once per run the whole process.
Of course, this run control should contain the targets in
suitable concentrations in order to make sense.
So far the so-called common technical
specifications are still in a draft version at the moment,
but they will be accepted by the European Commission in due
course very probably.
[Slide]
The second topic of quality assurance and
official medicine control laboratories, or MCLs, as already
mentioned several times, there is a requirement for pool
testing for HCV RNA and pools have to be non-reactive and
run controls have to be used and methods have to be
validated by internal controls to test for inhibitors.
This is the requirement as it is stated in Europe, and
there is also testing of plasma derivatives, the so-called
OMCLs have to retest the manufacturing pools, and a future
target is that there could also be a mutual recognition
between OMCLs in the future.
[Slide]
So OMCL retests these manufacturing pools and
there were efforts made by the European department for
quality of medicines, in Strasbourg, to implement and
maintain excellence among the different OMCLs in order to

sgg
MILLER REPORTING COMPANY, INC.
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allow potentially in the future mutual recognition.  This
consists of exchange of expertise and experience between
different OMCLs between, let's say, more experienced OMCLs
and OMCLs which just start with NAT testing.  In this
network, also a validation guideline has been defined and
testing modalities -- how many samples should be tested;
the algorithm for getting final results -- have been agreed
upon.
Also, EDQM also defined or prepared the so-called
biologic reference preparation which is estimated as a kind
of European standard for HCV RNA, and last but not least,
established a proficiency testing system for the different
OMCLs.
[Slide]
I would like to summarize shortly what has been
obtained in this field so far.  The whole proficiency
testing system started in 1998.  At this time, before the
respective regulation came into place, it was a kind of
trial phase and OMCLs exchanged materials and performed a
kind of self-assessment with common samples.  At this time
there were eight OMCLs through Europe which volunteered.
Since 1999, since this regulation has been in
place, there has been a certain system established for how
this proficiency testing has to be performed.  First of
all, there is an external scientific advisor who designs

sgg
MILLER REPORTING COMPANY, INC.
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the protocols.  Two studies are performed per year.  A set
of 20 coded samples is sent out to the different OMCLs
containing different dilutions of HCV RNA positive samples
and also different genotypes.  The main focus is not to
obtain maximal sensitivity but to focus on the consistent
detection of the 100 international units, which is the
sensitivity limit for this plasma pool requirement.
In the meantime, since 1999, six studies have
been performed.  The missing study is just being finished
at the moment.  The number of participants increased from
eight in the beginning to between 12 and 14, and these
OMCLs come from different European countries as well as
from Australia.
[Slide]
I would just like to summarize in very few words
the results.  In the first two years this was still a
start-up phase for new NAT labs for several of the OMCLs.
So, a first failures had to be recognized in some labs.
These 100 international units were not detected
consistently, but over the different studies there was a
steady overall improvement.  The last study where the
results have been obtained there was no failure at all, and
all the OMCLs which participated had 100 percent detection
of this concentration, which is important.
[Slide]

sgg
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This are just the results of the last study which
I just mentioned.  It is not very good to read but here are
the 100 international units in this sample.  Here are
higher concentrations, and they all got positive results.
It was 100 percent positive, and with 32 international
units still 86 percent of OMCLs get positive results.  What
is at least as important is that for negative samples there
were no false-positive results reported.
[Slide]
So, this was a short overview about the
proficiency testing system as it is performed for control
laboratories in Europe, and I have to mention EDQM who
provides the umbrella under which the studies are
performed, especially Guy Rautman and Jean Mark Spieser who
put much effort into this.  As I mentioned also, there are
external scientific advisors and two of them are present
here today.  Thanks a lot.
DR. BISWAS:  Thank you very much.  Are there any
questions for Dr. Nubling?  Yes?
DR. GALLARDA:  Jim Gallarda.  Dr. Nubling, can
you describe the relationship between the OMCL guidelines
for an external run control which specifies 100 IU/ml as
compared to the European Pharmacopeia supplement 2000,
which says a run control should be some multiple of the 95
percent limit of detection of the technology?  I am just

sgg
MILLER REPORTING COMPANY, INC.
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wondering if one supersedes the other, or if there is some
harmony between the European Pharmacopeia and OMCL.
DR. NUBLING:  From an acoustic point of view, I
didn't understand everything, but I think you asked for the
95 percent positive cut-off value in relation to the 100
international units?
DR. GALLARDA:  Right, the European Pharmacopeia
supplement 2000 specifies that an external run control for
NAT should run at some multiple of the 95 percent limit of
detection of the assay.
DR. NUBLING:  Yes.
DR. GALLARDA:  Whereas, the OMCL specifies 100
IU/ml for that external run control.  I was wondering about
the difference in the two organizations.
DR. NUBLING:  Maybe I do not understand your
question but I will try to answer to the extent that I
understood it.  This 95 percent cut-off value defines the
concentration, a method to detect in 95 percent of the
assays.  So, if I would have an assay which would detect
consistently this 100 international units, the 95 percent
sensitivity of this assay would be approximately 30
international units.  This is a prerequisite because a
factor of three gives you a certainty of nearly 100 percent
detection in three times higher concentration.  This is

sgg
MILLER REPORTING COMPANY, INC.
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what we need to achieve in order to take consistently these
100 international units.
DR. BISWAS:  Micha, I have a quick question for
you.  You had mentioned something about a whole system
failure rate.  What do you mean by that?  What would be a
partial system failure rate?  What does that mean?
DR. NUBLING:  A whole system failure rate is
defined for a complete system which is installed, for
example, by a manufacturer in a laboratory, including
extraction and everything.  And, one parameter which should
be investigated is the complete procedure to be, let's say,
challenged by low titer samples in order to get
independently which step makes the failure to get the whole
failure rate of the system.
DR. BISWAS:  Thank you very much, Micha.  Our
next speaker is my colleague, Mei-ying Yu, from CBER, FDA.
CBER/FDA
[Slide]
DR. YU:  In my talk I will cover standardization
for donor-screen NAT and in-process control NAT, and also I
will address the other quality assurance issues.
[Slide]
As you all know, standardization of NAT methods
is very essential because we have diverse NAT methods, and
they have varied sensitivity, specificity and

sgg
MILLER REPORTING COMPANY, INC.
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reproducibility.  We also have varied minipool size for
HIV, HCV NAT.  We have 96 to 1200 for source plasma, and
for whole blood we have from 16 to 24 pool size.
We also need analytical standards.  This is so
that we can have a standardized assay and also standardized
reporting so that we can report it either as copies or,
preferably, IU/ml.  Analytical standards will monitor
laboratory proficiency and will be used for lot release of
test kits.
[Slide]
Donor screen NAT, this is in BPAC, Blood Products
Advisory Committee, held in March, 1997 and it says the
pool test for HIV, HCV and HBV is a form of donor
screening, requiring IND and licensure.  Dr. Paul Mied
already mentioned that this morning.  So, we need a donor
identification notification deferral and follow-up.  We
need to identify and notify recipients of implicated
products.  We need to quarantine or destroy the positive
units and components, and we need to perform look-back to
retrieve, destroy and unpooled or untransfused units.
[Slide]
We do have CBER NAT standards for donor screened
NAT.  There are not standards available for HIV and HCV.
Currently, the NIS standard for HBV is under development.
The current required analytical sensitivity is 100 IU/ml

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[Federal Register: October 16, 2006 (Volume 71, Number 199)]
[Notices]
[Page 60704-60708]
[DOCID:fr16oc06-35]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2005-0039; FRL-8231-3]

Request for Nominations of Drinking Water Contaminants for the
Contaminant Candidate List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is requesting
nominations

of chemical and microbial contaminants for possible inclusion in the
third drinking water Contaminant Candidate List (CCL 3). EPA is also
requesting information that shows the nominated contaminant may have an
adverse health effect on people and the contaminant occurs or is likely
to occur in public water systems.

DATES: Nominations must be received on or before December 15, 2006.

ADDRESSES: Submit your nominations to the CCL3 Nominations Web site
http://www.epa.gov/safewater/ccl/ccl3.html by following the on-line

instructions for submitting nominations or mail to CCL Nominations,
Environmental Protection Agency, Mail Code: 4607M, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: For general information contact the
EPA Safe Drinking Water Hotline at<PHONE_NUMBER> or e-mail:
<EMAIL_ADDRESS>For technical questions about this notice contact Clifton

Townsend, Standards and Risk Management Division, Office of Ground
Water and Drinking Water, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-1576; e-mail address<EMAIL_ADDRESS>For technical
inquiries regarding EPA's CCL 3 Nominations Web site, please contact
Zeno Bain at<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION

I. General Information

A. Does This Action Apply to Me

    This action requests drinking water contaminant candidate
nominations and provides information on how the public can submit
nominations to the Agency.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
Docket ID No. EPA-HQ-OW-2005-0039. Publicly available docket materials
are available either electronically through http://www.regulations.gov

or in hard copy at the Water Docket in the EPA Docket Center.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to visit the Public Reading Room to
view documents. Consult EPA's Federal Register notice at 71 FR 54815
(September 19, 2006) or the EPA Web site at http://www.epa.gov/epahome/dockets.htm
 for current information on docket status,

locations and telephone numbers.

    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at http://www.epa.gov/fedrgstr/.

II. Background

A. What Is the CCL?

    There are thousands of naturally occurring and man-made
contaminants that have the potential to enter sources of drinking water
(e.g., pesticides, pharmaceuticals, personal care products, industrial
chemicals). Some of these contaminants may pose no risk to human
health, but others may cause cancer or have endocrine disrupting,
reproductive, or developmental effects. Naturally occurring microbial
contaminants may also cause acute illness. To ensure that public health
is protected, EPA must assess the universe of unregulated drinking
water contaminants to determine if they may require regulation under
the Safe Drinking Water Act (SDWA).
    The CCL is the primary vehicle used by EPA to target and prioritize
unregulated contaminants in drinking water for research and analysis to
determine which new contaminants should be regulated. SDWA requires
that EPA publish, every five years, a list of unregulated chemical and
microbial contaminants that are known or anticipated to occur in public
water systems and which may require regulation under the Safe Drinking
Water Act (SWDA Section 1412(b)(1)). EPA is also required to consult
with the scientific community and provide notice and opportunity for
public comment prior to publication of the CCL.
    SDWA also requires EPA to determine whether to regulate at least
five contaminants from the CCL every five years. In making regulatory
determinations, the Agency must consider the following three statutory
criteria:
    1. Is the contaminant likely to cause an adverse effect on the
health of persons?
    2. Is the contaminant known or likely to occur in public water
systems at a frequency and level of concern?
    3. Does regulation of the contaminant present a meaningful
opportunity for health risk reduction for persons served by public
water systems?

B. How Did EPA Develop Previous Contaminant Candidate Lists?

    The first CCL (CCL 1) was published on March 2, 1998 (63 FR 10273).
The contaminants were categorized based on four priority areas in
drinking water research: occurrence, health effects, treatment, and
analytical methods. CCL 1 was developed based on a review by technical
experts of readily available information and contained 50 chemicals and
10 microbial contaminants. EPA consulted with the scientific community
and the National Drinking Water Advisory Council (NDWAC) on a process
for developing the first CCL. Based on the NDWAC recommendations, the
Agency developed and used screening and evaluation criteria to develop
a list of chemical contaminants for CCL 1. For microbiological
contaminants, the Agency followed NDWAC recommendations and sought
external expertise to identify and select potential waterborne
pathogens. The Agency convened a workshop of microbiologists and public
health experts who developed criteria for screening and evaluation and
subsequently developed an initial list of potential microbiological
contaminants.
    On July 18, 2003 (68 FR 42897), EPA announced its final regulatory
determination for nine contaminants from CCL 1, which concluded that
sufficient data and information was available to make the determination
not to regulate nine contaminants (eight chemicals and one microbial).
    The second CCL (CCL2) was published on February 24, 2005 (70 FR
9071) and carried forward the remaining 51 chemical and microbial
contaminants listed on CCL 1. Currently, the Agency is evaluating data
and research on these chemicals and microbes to make regulatory
determinations as it continues work to develop the CCL 3.

C. How Is EPA Developing Future CCLs?

    After publication of CCL 1, the Agency recognized the need for a
more robust and transparent process for identifying and narrowing the
list of potential contaminants for future CCLs and sought advice from
the National Academies of Science (NAS) on how to improve the CCL
process. The 2001 NAS report, Classifying Drinking Water Contaminants
for Regulatory Consideration (NAS 2001), proposed a broader, more
comprehensive screening process to assist EPA in identifying those
contaminants for the CCL. The NAS recommended that EPA develop and use
a process for creating future

CCLs whereby a broadly defined ``universe'' of potential drinking water
contaminants is identified, assessed, and reduced to a preliminary CCL
(PCCL) using simple screening criteria that indicate public health risk
and the likelihood of occurrence in drinking water. All of the
contaminants on the PCCL would then be assessed in more detail using a
classification approach and tools along with expert judgment to
evaluate the likelihood that specific contaminants could occur in
drinking water at levels and at frequencies that pose a public health
risk. The outcome of the detailed classification approach results in
the draft CCL.
    The contaminants initially considered for the CCL (i.e. CCL
Universe) include naturally occurring substances, emerging waterborne
pathogens, chemical agents, byproducts and degradants of chemical
agents, and biological toxins. The PCCL will include contaminants that
occur, or have the potential to occur, in drinking water and cause, or
may cause adverse health effects.
    In 2002, EPA consulted with NDWAC and received advice for
implementing the 2001 NAS recommendations. NDWAC recommended that EPA
move forward with the NAS recommendations using an adaptive management
approach. This approach provides a framework to implement
recommendations in phases and refine and adjust the CCL process as more
information and experience are attained. NDWAC provided specific
recommendations on eliciting public participation and suggested that
EPA seek contaminant nominations from the public for inclusion on the
CCL. Implementing the nominations process provides a mechanism for
early public participation in the CCL process and allows the Agency to
obtain suggestions for contaminants that should be on the CCL (NDWAC
2004).

D. How Will EPA Use Data Sources To Identify Contaminants for the CCL
Universe?

    Based upon recommendations from NAS and NDWAC, the Agency is using
the following guiding principles to construct the CCL Universe: (1) The
universe should include those contaminants that have demonstrated or
have potential occurrence in drinking water, and (2) the universe
should include those contaminants that have demonstrated or have
potential adverse health effects. These inclusionary principles apply
to the selection of CCL contaminants for initial consideration in the
CCL Universe.
    EPA has evaluated over 280 resources (referred to as ``data
sources'') to determine whether they are appropriate for use in
identifying potential drinking water contaminants for the CCL. The data
sources vary widely in their development and use (e.g., research,
surveys, and compliance monitoring); type of data (e.g.,
concentrations, health effects, microbiological occurrence, and
environmental fate); data format; availability; and possible
applicability to the universe of contaminants for consideration.
    The Agency recognizes that there are significant differences in the
methods and information used to characterize chemical and
microbiological contaminants. Chemical contaminants tend to be
characterized by toxicological and occurrence data that can be modeled
or estimated if measurement is not possible. These discrete
characteristics are often captured in data sources.
    To identify chemical contaminants, consistent with recommendations
for developing the Universe, the Agency recognizes that the most
appropriate data sources for use in the CCL classification process will
provide information in a number of areas including concentrations,
health effects, occurrence, and environmental fate. EPA has identified
four factors that should be met for data sources to be considered
useable. Sources are screened for relevance, completeness, redundancy
(those sources with the most comprehensive sources are selected, while
less comprehensive sources with the same information are rejected), and
retrievability to determine use in the CCL classification process.
Table 1 provides a list of the data sources that EPA will use in
compiling the Chemical CCL Universe.

        Table 1.--Initial Classification of Chemical Data Sources
------------------------------------------------------------------------
               Data source name                      Organizations
------------------------------------------------------------------------
ATSDR CERCLA Priority List...................  Agency for Toxic
                                                Substances and Disease
                                                Registry.
ATSDR Minimal Risk Levels (MRLs).............  Agency for Toxic
                                                Substances and Disease
                                                Registry.
Chemical Toxicity Database--Ministry of        Ministry of Health and
 Health and Welfare, Japan.                     Welfare, Japan.
Chemical Update System/Inventory Update Rule   EPA.
 (CUS/IUR).
Cumulative Estimated Daily Intake/Acceptable   U.S. Food and Drug
 Daily Intake (CEDI/ADI) Database.              Administration (FDA).
Database of Sources of Environmental Releases  EPA.
 of Dioxin-Like Compounds in the United
 States.
Distributed Structure Searchable Toxicity      EPA.
 Public Database Network (DSSTox).
Everything Added to Food in the United States  FDA.
 (EAFUS) Database.
Federal Insecticide, Fungicide, and            EPA.
 Rodenticide Act (FIFRA) List.
Generally Regarded As Safe (GRAS) Substance    FDA.
 List.
Guidelines for Canadian Drinking Water         Health Canada.
 Quality (CADW): Summary of Guidelines.
World Health Organization (WHO) Guidelines     WHO.
 for Drinking Water Quality: Summary Tables.
Health Advisories (HA) Summary Tables........  EPA.
High Production Volume (HPV) Chemical List...  EPA.
Hazardous Substances Data Bank (HSDB)........  National Library of
                                                Medicine.
Indirect Additives Database..................  FDA.
International Agency for Research on Cancer    International Agency for
 (IARC) Monographs.                             Research on Cancer.
International Toxicity Estimates for Risk      Toxicology Excellence for
 (ITER) Database.                               Risk Assessment (TERA).
Integrated Risk Information System (IRIS)....  EPA.
Joint Meeting On Pesticide Residues (JMPR)--   World Health
 2001. Inventory of Pesticide Evaluations.      Organization, Food and
                                                Agriculture Organization
National Drinking Water Contaminant            EPA.
 Occurrence Database (NCOD)--Round 1 & 2.
National Drinking Water Contaminant            EPA.
 Occurrence Database (NCOD)--Unregulated
 Contaminant Monitoring Rule (UCMR).

National Inorganics and Radionuclides Survey   EPA.
 (NIRS).
National Pesticide Use Database..............  National Center for Food
                                                and Agricultural Policy.
National Reconnaissance of Emerging            U.S. Geological Survey
 Contaminants (NREC)--USGS Toxic Substances     (USGS).
 Hydrology Program.
National Toxicology Program (NTP) Studies....  National Cancer
                                                Institute.
National Water Quality Assessment (NAWQA)....  USGS.
OSHA 1988 Permissible Exposure Limits (PELs).  National Institute for
                                                Occupational Safety and
                                                Health (NIOSH).
Pesticide Data Program.......................  USDA.
Pesticides Pilot Monitoring Program..........  USGS/EPA.
Risk Assessment Information System (RAIS)--    U.S. Department of
 Department of Energy--Chemical Factors.        Energy.
Risk Assessment Information System (RAIS)--    Department of Energy.
 Health Effects Data.
State of California EPA Chemicals Known to     State of California.
 the State to Cause Cancer or Reproductive
 Toxicity.
Storage and Retrieval (STORET)...............  EPA.
Substance Registry System (SRS)..............  EPA.
Syracuse Research Corporation (SRC)--BIODEG..  Syracuse Research
                                                Corporation.
The Toxics Release Inventory (TRI)...........  EPA.
Toxic Substances Control Act (TSCA) List.....  EPA.
Toxicity Criteria Database--California Office  California Office of
 of Environmental Health Hazard Assessment      Environmental Health
 (OEHHA).                                       Hazard Assessment.
University of Maryland--Partial List of Acute  University of Maryland.
 Toxins/Partial List of Teratogens.
------------------------------------------------------------------------

    For microbes, the adverse health effects from exposure are
characterized by clinical or epidemiological data and there are few
analytical methods to estimate or model the occurrence of microbes.
Limited sources of tabular data for microbes may require evaluation of
primary literature, technical reports, monographs and reference books
to identify the universe of microbes for consideration. The Agency is
using human pathogens as the starting point for identifying
microorganisms considered for inclusion in the CCL Universe. The
primary source of information on human pathogens is Risk Factors for
Human Disease Emergence (Taylor et al. 2001), which provides a list of
1,415 human pathogens. In addition to the Taylor et al study, the
Agency will use the nominations process to ensure that the CCL universe
captures emerging pathogens.

E. Why Is EPA Soliciting Contaminant Nominations?

    EPA is requesting contaminant nominations from the public to ensure
that contaminants that may not be identified for consideration as part
of the recommended CCL process are considered. The Agency is making
significant progress in developing a contaminant classification
approach and continues to implement the NAS and NDWAC recommendations.
    While NAS and NDWAC recommended a data driven step-wise approach to
classifying contaminants, these experts also recognized the importance
of providing an additional pathway for the public to identify new and
emerging contaminants that may not be identified in an evaluation of
the data sources. A public nominations process allows the Agency to
consider new and emerging contaminants that might not otherwise be
considered because new information has not been widely reported or
recorded.
    Following the recommendations of NAS and NDWAC, the Agency has
compiled a universe of contaminants and will add nominated contaminants
from the public to the CCL Universe. The nominees will be considered as
EPA evaluates NAS and NDWAC recommendations to screen the CCL universe
and develops criteria to classify contaminants for the draft CCL.

III. EPA CCL Nominations Process

    This contaminant nominations process is the first opportunity to
make nominations to the new CCL (CCL 3). The Agency will also accept
nominations during the notice and comment period following EPA's
publication of the draft CCL 3.

A. How can Stakeholders, Agencies, Industry, and the Public Nominate
Contaminants for the CCL?

    EPA's preferred method for submission of contaminant nominations is
through the EPA CCL 3 Nomination Web site. Interested parties can
nominate chemicals, microbes, or other materials for consideration on
the new CCL by sending information electronically, or in hard copy to
EPA. Do not submit confidential business information (CBI) through e-
mail. If you wish to submit CBI, first contact EPA (see ADDRESSES
section) for instructions on how to submit CBI. When submitting a
nomination, it is preferred that the nominators include a name,
affiliation, phone number, mailing address, and e-mail address;
however, this information is not required and nominations can be
submitted anonymously. The nominator should also address the following
questions for each contaminant nominated to the CCL:
    1. What is the contaminant's name, CAS number, and/or common
synonym (if applicable)?
    2. What factors make this contaminant a priority for the CCL 3
process (e.g., widespread occurrence; anticipated toxicity to humans;
potentially harmful effects to susceptible populations (e.g., children,
elderly and immunocompromised); potentially contaminated source water
(surface or ground water), and/or finished water; released to air,
land, and/or water; contaminants manufactured in large quantities with
a potential to occur in source waters)?
    3. What are the significant health effects and occurrence data
available, which you believe supports the CCL requirement(s) that a
contaminant may have an adverse effect on the health of persons and is
known or anticipated to occur in public water systems? Please provide
complete citations, including author(s), title, journal and date.
Contact information for the primary investigator would also be helpful.

B. How Do I Submit Nominations Through EPA's Nominations Web Site?

    The Web site is designed to provide key information to the Agency,
as described in Section III. A of this notice, for each contaminant
nominated to the CCL process.
    The Web address to nominate a contaminant can be found at http://www.epa.gov/safewater/ccl/ccl3.html
.

C. How do I Submit Nominations in Hard Copy?

    You may submit nominations by mail. To allow full Agency
consideration of your nomination, please ensure that your nominations
are received or postmarked by midnight December 15, 2006. The addresses
for submittal of nominations by mail are listed in the ADDRESSES
section of this document.

D. What Will Happen to My Nominations After I Submit Them?

    The Agency will include nominated contaminants into the CCL
Universe. EPA will evaluate the information available for the nominated
contaminants to determine the appropriateness of inclusion on the PCCL
and finally the CCL. While EPA does not intend to respond to the
nominations directly or individually, the Agency will fully explain
nominated contaminants for the CCL3.

IV. References

    Copies of these documents are found at http://www.regulations.gov,

Docket ID No. EPA-OW-2005-0039.

    NAS 2001. National Academy of Sciences, National Research
Council. 2001. Classifying Drinking Water Contaminants for
Regulatory Consideration. National Academy Press. Washington, DC.
Available at http://books.nap.edu/books/0309074088/html/index.html

NDWAC 2004. National Drinking Water Advisory Council. National
Drinking Water Advisory Council Report on the CCL Classification
Process to the U.S. Environmental Protection Agency, May 18, 2004.
Available at http://www.epa.gov/safewater/ndwac/pdfs/report_ccl_ndwac_07-06-04.pdf
.

    Taylor, Latham, and Woolhouse. 2001. Risk factors for human
disease emergence (Appendix A). Philosophical Transactions of the
Royal Society of London Biology: 256:983-98.

    Dated: October 6, 2006.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
 [FR Doc. E6-17099 Filed 10-13-06; 8:45 am]

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