UNITED STATES OF AMERICA

FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

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TECHNICAL ELECTRONIC PRODUCT RADIATION SAFETY

STANDARDS COMMITTEE

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29th Meeting

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WEDNESDAY,

MAY 22, 2002

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This is a corrected version of the transcript. These edits were to
correct spelling errors or clarify terminology. In no cases were the
contents of recorded statements altered.

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The Committee met at 8:30 a.m. in Salon of the Hilton Washington, D.C.
North, 620 Perry Parkway, Gaithersburg, Maryland, Dr. Lawrence
Rothenberg, Chairman, presiding.

[PRESENT]{.underline}:

LAWRENCE ROTHENBERG, Ph.D., Chairman

JANE BENSON, M.D., Member

MICHAEL CASWELL, Ph.D., Member

ALICE FAHY-ELWOOD, M.S., Member

DAVID LAMBETH, Ph.D., Member

JILL LIPOTI, Ph.D., Member

MICHELE LOSCOCCO, M.S., Member

W. GREGORY LOTZ, Ph.D., Member

KIYOHIKO MABUCHI, M.D., Member

MAUREEN MURDOCH NELSON, M.D., Ph.D., Member

ROBERT PLEASURE, J.D., Member

JOHN SANDRIK, Ph.D., Member

ORHAN SULEIMAN, M.S., Ph.D., Executive Secretary

C-O-N-T-E-N-T-S

Page

Greeting and Introduction

by Dr. Orhan Suleiman 3

Chairperson\'s Opening Remarks

by Dr. Larry Rothenberg 6

Update of Informal Issues

by Ms. Lillian Gill 8

Computed Tomography

by Dr. Stanley Stern 19

Committee Discussion 53

Sunlamp Products

by Dr. Howard Cyr 99

Open Public Hearing 121

Personnel Security Screening Systems

by Mr. Frank Cerra and 181

Mr. Dan Kassaday 188

Open Public Hearing 196

Committee Discussion 241

P-R-O-C-E-E-D-I-N-G-S

(8:38 a.m.)

DR. SULEIMAN: On the record. Before we get started, I\'ll also advise
all the Committee Members that when you speak could you bring the
microphone closer so our electronic system can pick it up. I\'d like to
welcome everybody this morning. In the interest of time and efficient
management, let\'s get started.

I\'m Orhan Suleiman, the Executive Secretary for the Technical
Electronic Product Radiation Safety Standards Committee. I need to read
something to get us started officially. Let me do that. Then I\'ll pass
off to Dr. Rothenberg who is the Chair of the Committee.

\"In accordance with the Radiation Control for Health and Safety Act of
1968, Public Law 90-602, the Secretary of Health and Human Services has
established the Technical Electronic Product Radiation Safety Standards
Committee, TEPRSSC, for consultation on matters relating to technical,
electronic, product, radiation, safety. As specified by the law, the
Committee consists of 15 members including the Chairman who are
appointed by the Commissioner of Food and Drugs for overlapping terms of
four years or less. Five members are selected from Governmental Agencies
including State and Federal Governments, five members from the affected
industries, and five members from the general public of which at least
one shall be a representative for organized labor.

Members must be technically qualified by training and experience in one
of more fields of science or engineering applicable to electronic,
product, radiation, and safety standards. The primary function of
TEPRSSC is to provide advice and consultation to the Commissioner of
Food and Drugs on the technical feasibility and reasonableness of
performance standards for electronic products, to control the emission
of electronic product radiation from such products, and to review
amendments to such standards before being prescribed by the
Commissioner.

The Committee is not requested to review individual applications or
particular products of specific firms. Public Law 90-602 in its
legislative history clearly indicated that the TEPRSSC members are
expected to represent a wide range of interests with at least one-third
of the Committee nominated by the regulated industry itself and
appointed on the basis of their being able to represent industry wide
concerns.

Section 534 of the Federal Food, Drug and Cosmetic Act specifies that
TEPRSSC members are not to be considered officers or employees of the
United States for any purpose including conflict of interest
determinations. However, to be consistent with FDA\'s general policies
regarding advisory committees, the Agency believes a public disposer
memorandum should be made a part of the public record which identifies
each member and provides their employment affiliation. Approved on
August 30, 1999, June 9, 2000, April 24, 2002, by delegated authority of
the Commission of Food and Drugs.\"

The members of the Technical Electric Product Radiation Safety Standards
Committee are the general public members; Larry Rothenberg from Memorial
Sloan-Kettering, William Rice from American Radiology, Francis Gasparro
from Cheshire High School, Robert Pleasure from the Center for Working
Capital, actually as of July he\'s now with the AFL-CIO Center for
Working Capital, and Jane Benson from the Johns Hopkins University
School of Medicine.

Government representatives are Greg Lotz from the National Institute for
Occupational Safety and Health, Michele Loscocco from United States Navy
Joint Readiness Clinical Advisory Board, Kiyohiko Mabuchi from the
National Cancer Institute, Jill Lipoti from the Department of
Environmental Protection and Energy from New Jersey, and Maureen Murdoch
Nelson from the Veterans Administration Medical Center.

Representatives of industry when they were originally appointed are
Alice Fahy-Elwood represented Lucent Technologies, John Sandrik from
General Electric Medical Systems, David Lambeth from Lambeth Systems,
Michael Caswell from C.B. Fleet Company, and Quirino Balzano from
Motorola Florida Laboratories. At this point I\'d like to pass off to
Dr. Rothenberg.

CHAIRMAN ROTHENBERG: I\'d like to welcome everyone on behalf of the
Committee and thank the Committee Members for taking time out from their
busy schedules to participate. We have a rather extended schedule today.
In order to cover the materials which will be presented, we want to keep
everything moving along smoothly.

I\'d just like to remind you that we have several scheduled speakers.
The Committee Members of course are free to participate in all of the
discussions. We will certainly hope that they will participate
extensively. For those of you on the floor, we must remind you that you
have to be recognized by the Chair in order to speak. We\'ll try to
accommodate input as time permits.

I think with that you\'ve heard the names of the members but maybe just
to be sure everyone is clear who the Committee Members are if we could
just start with Ms. Fahy-Elwood on my right and just go around briefly.
Please introduce yourselves.

MS. FAHY-ELWOOD: I\'m Alice Fahy-Elwood. I\'m a health physics
consultant to industry.

DR. NELSON: I\'m Maureen Murdoch Nelson. I\'m a general internist at the
Minneapolis VA Medical Center.

DR. LIPOTI: I\'m Jill Lipoti. I work for the New Jersey Department of
Environmental Protection.

DR. BENSON: I\'m Jane Benson. I\'m a pediatric radiologist at Johns
Hopkins Hospital.

DR. MABUCHI: I\'m Kiyo Mabuchi. I\'m an epidemiologist from the National
Cancer Institute.

DR. LAMBETH: I\'m David Lambeth. I\'m at Carnegie-Mellon University.

DR. CASWELL: I\'m Mike Caswell. I\'m Director of Scientific Affairs at
C.B. Fleet Company, Incorporated.

DR. SULEIMAN: I\'m Orhan Suleiman with FDA.

CHAIRMAN ROTHENBERG: Larry Rothenberg with Memorial Sloan-Kettering
Cancer Center.

DR. SANDRIK: I\'m John Sandrik an imaging physicist in GE Medical
Systems.

MS. LOSCOCCO: Michele Loscocco, U.S. Navy. I executed a transfer this
week from the Joint Readiness Clinical Advisory Board to the National
Naval Medical Center.

DR. LOTZ: Greg Lotz. I\'m with the radiation research programs at NIOSH
in Cincinnati.

MR. PLEASURE: Robert Pleasure, AFL-CIO Center for Working Capital.

CHAIRMAN ROTHENBERG: Okay. We\'re missing two members of the Committee.
We\'re hoping they will show up. Dr. William Rice, a practicing
community radiologist and Francis Gasparro with research experience in
photobiology. I think at this point we\'d like to proceed with the
program so we\'d like to welcome Ms. Lillian Gill who will give us an
update of informal issues with the CDRH.

MS. GILL: Good morning, Committee. Good morning, audience. I\'d like to
add my welcome to Dr. Suleiman and Dr. Rothenberg. I welcome all of you
to this meeting of the TEPRSSC Advisory Committee. I really want to
extend a special welcome to those five new committee members that are
joining us for the first time.

We\'re pleased that you have made time in your crowded schedules to
consult with and to advise us on key issues that are on the agenda such
as the computed tomography, sunlamp products and personnel screening
systems. Before our experts begin their presentations, I want to provide
you with an update on some of the issues that have been discussed with
this Committee before particularly four.

First I\'d like to bring an update on the wireless cell phone CRADA.
CDRH continues to receive a number of inquiries about the safety of
wireless phones. In order to ensure that the needed research is
conducted to address the public concern, the CDRH has signed a
Cooperative Research and Development Agreement with the Cellular
Telecommunications and Internet Association or CTIA. Under this CRADA
agreement, CDRH provides research recommendations and research oversight
while CTIA funds the research into the health effect of radio frequency
emissions from wireless phones.

In fiscal year 2000, the CDRH made recommendations on the follow up
research needed to address reported structural changes in the genetic
material of lymphocytes after exposure to signals from a wireless phone.
The CDRH is currently providing scientific oversight to those proposals
that were funded in this area.

In fiscal year 2001, the CDRH convened two scientific meetings to define
the epidemiological research needs related to use of wireless phones.
Based on the input received at these meetings, CDRH submitted its
recommendations on the epidemiology research needs to CTIA.

Turning to the status of the laser amendments. At your last meeting, I
provided a progress report on the proposed amendments to the laser
standard. We are continuing to amend this standard because of some more
recent scientific knowledge received on laser bio-effects and because we
are harmonizing our requirements with those of the International
Electrotechnical Commission.

I also indicated at that meeting that the technical writing of the
standard and the preamble had been completed. Since then some additional
requirements have been made to both documents. Because the regulated
industry was so strongly in favor of our plan to amend, we provided
temporary relief to the industry last year while those documents
continued to move through the process.

A guidance document entitled \"Laser Nos. 50\" was issued stating that
we would not object to industry\'s compliance with those requirements of
the IEC standard of which we announced our intention to incorporate into
the standard changes. Those aspects involved the new designation of
hazard classification, radiometric measurements for classification,
reduced controls and indicators for power lasers, and some labelling
aspects.

Although the progress of this has moved a bit slower than we planned at
the present time we are working with the FDA economics staff to develop
an economic analysis of the impact of these amendments on the regulated
industry. This analysis is a necessary step in the process of paving
clearance by our Office of Management and Budget for publication of this
amendment. We found this analysis to be both lengthy and difficult
because of its diversity of products and the companies within the laser
product industries.

Regarding the fluoroscopy amendments, FDA\'s efforts to publish the
proposed amendments to the performance standard for diagnostic X-ray
systems also continues. These amendments primarily addressing
fluoroscopic X-ray systems have been discussed in detail at these
meetings. Since the May 2001 meeting, the review at FDA was completed
and the draft [Federal Register]{.underline} notice was forwarded to the
Department. We did receive feedback from the Department and a number of
suggestions that we place some additional emphasis in the Notice of
Proposed Rulemaking regarding the monetary costs and benefits of these
proposed amendments.

The cost of the amendments had previously been described in our draft
analysis. It was made available on our web site as we solicited some
comments. The benefit analysis which was summarized in more detail in
that Notice of Proposed Rulemaking was presented at our 2001 Science
Symposium last February and has also been posted on our web site for
review by interested parties.

The revise of the NPR has been reviewed again by FDA and has been
forwarded once again to the Department for review. Because they agreed
and concurred with the draft NPR that they initially reviewed given we
made changes to the impact assessment regarding cost and benefits, we
are hopeful that we get publication in the near future and I\'ll be able
to give you a positive report on that at the next meeting.

When published, this NPR will specify a 120 comment period during which
time the industry, the medical community and the interested public can
provide comment on the proposed amendments. The Agency then has the
responsibility for reviewing those comments and hopefully proceeding to
publication of the final rule.

Lastly I want to mention some of the activities that have been going on
for counter-terrorism and the response to radiological threats. Like
most Government Agencies, we\'ve been very much involved in a number of
counter-terrorism activities. For the past 30 years, the major
concentration of radiological expertise in FDA was in the Center for
Devices and Radiological Health and its predecessor, the Bureau of
Radiological Health.

During that period, they served as the Agency\'s focal point for
reacting to domestic radiological emergencies, routinely participating
in multi-Agency and FDA headquarter planning activities and exercises,
and responding to some real events such as Three Mile Island. Last fall,
it became very conceivable that terrorists would attempt to employ
nuclear or radiological weapons in the United States.

Consequently when the FDA Office of Regulatory Affairs who has the
responsibility for emergency planning for the Agency began the
modification of the FDA Radiological Emergency Response Plan, the Center
and other sister centers within FDA began the modification of our
individual response plans to incorporate counter-terrorist preparation.
All plans across FDA will ultimately be harmonized with the Response
Plan of the Department of Health and Human Services.

Among the other things, the CDRH plan recognized the need to manage two
categories of radiological hazards. The first category is the use of
abuse of electronic radiation-emitting devices. These are devices that
may be used by terrorists such as the aiming of lasers at aircraft to
blind airline pilots making night landings or those used inappropriately
by security personnel resulting in a potential over exposure to the
public. The second category is the use of radioactive material as
nuclear weapons, \"dirty bombs\" and \-- devices or high activity
sources clandestinely positioned to expose the public.

Separate emergency response teams under our plan were created to deal
with these two categories. CDRH working with the radiological response
cadre that was formed some years ago to respond to domestic accidents
established a larger cadre of personnel with skills appropriate to those
functions needed by the Emergency Operations Center. About two months
ago, this center offered a new cadre, a basic course in radiation
physics and information on the roles and responsibilities of Federal
Agencies that are participating in the Federal Emergency Response
Structure.

Personnel in other centers and members of our field staff who are
located around the U.S. were invited to attend and participated as
trainers in the course. Our training will continue on specific duties in
the Emergency Operations Centers as we go forward. The center does not
plan to send response teams to assist at an incident site, not
initially. Instead the Agency will utilize the regional and district
field personnel who have continuously participated in our exercises and
are there to respond to the scene of real events. Exceptions to this
will be center employees who are officers of the Public Health Service
Commissioned Corps.

The CDRH will have two functions; both a support and a communication
function. The first is support of the regional and district teams. The
second includes guidance to the public, technical consultations to
professionals and to the regulated industry. I\'ve given you a very
brief summary of four activities that are ongoing at CDRH. I think we
have experts and those who have been working specifically on those
amended standards in the audience if you should have additional
questions on those. Thank you.

CHAIRMAN ROTHENBERG: Okay. Thank you very much. Does anyone on the
Committee have any questions for Ms. Gill?

DR. NELSON: As I recall at the last meeting specifically talking about
cell phones, we had talked about encouraging these studies to look at a
wide variety of outcomes, not necessarily cancer as the only outcome.
Can you tell me what kinds of studies are ongoing in terms of what
outcomes they\'re looking at?

MS. GILL: I can\'t specifically tell you that. Unfortunately we did lose
our coordinator for that. I\'m not sure Howard Cyr is here. Howard
isn\'t available to give you some specifics on that, but he should be in
the afternoon able to provide you with some of those.

CHAIRMAN ROTHENBERG: Okay. Anyone else?

DR. LIPOTI: Is there any time frame for when the fluoroscopy amendments
might be published? How long does it take for the Department to review
things? Do they then have to leave the Department and go before the
Office of Management and Budget and so forth?

MS. GILL: That is the process. I really can\'t give you a specific on
when we expect it to be through. Certainly events that have occurred
since we submitted it have put these kinds of things on the backburner.
Because they have reviewed, I\'m certainly planning and hoping that they
will move this a little more quickly. Sometimes that happens if they\'ve
seen it before and they\'re aware of the issues involved. I\'d like to
be able to say we can get it out of there in the next four to six months
but I\'m not sure. I don\'t know if you have any additional information.

CHAIRMAN ROTHENBERG: Is Tom Shope here? Do you have anything to add?

MR. SHOPE: Away from microphone.

CHAIRMAN ROTHENBERG: Thank you. Okay. If there are no further questions,
thank you very much for your report. Our next presentation is going to
be by Dr. Stanley Stern on computed tomography and proposed amendments.

DR. STERN: It will be just a few moments while we get everything
coordinated with the computer and the projector.

DR. LIPOTI: Larry, while they\'re figuring out the computer, could I ask
one more question about the counter-terrorism issue?

CHAIRMAN ROTHENBERG: Sure.

DR. LIPOTI: There were two functions that headquarters would have. One
is the support of the regional and district personnel and the other one
was communication. Communication with the public was what I gathered.
What kinds of tools are you developing for communication with the
public? Is it on radiological hazard or is it on food?

MS. GILL: We\'re working with our sister centers. Our Center for Drugs
has responsibility for the potassium iodide distribution. Our Center for
Foods certainly has responsibility for any contaminant or any
radiological impact on food issues. So it would be communication about
red health issues specifically from CDRH, from both centers.

There is a larger plan that the Agency has developed. It speaks to
counter-terrorist issues across all devices so there\'s a specific
element for red health issues. All three centers are coordinating our
plan for that.

We\'ve developed and will be developing probably a command center that
mans the phone. We will be putting out on the web site names, contact
persons, things like that. As you might understand, we\'re a little bit
skeptical of putting out the full plan on the web site. I think enough
information for the public to make some contact and any other way that
they might get information. We\'re providing information and training to
the field, to anything that the states may need, and we can be available
to go if asked.

DR. LIPOTI: Thanks.

CHAIRMAN ROTHENBERG: Thank you again. I think our projector is now
functioning, so Dr. Stern.

DR. STERN: Thank you very much. This presentation grows out of the
collaborative efforts of an FDA group of science, regulation and
economics staff. We\'re working to facilitate radiation dose reduction
through consideration of amendments to the existing CT performance
standard. Our motivation is the proposition that the current Federal
regulations covering CT, in place since the mid-1980s, have not kept
pace with technological developments and with the need to assure the
lowest dose for the best image quality practically achievable.

The work group\'s current thinking and my own personal ideas and
analysis presented here do not necessarily reflect any official position
of the FDA or its components. Many items in the slides are annotated
with superscripted numbers that cite references and notes listed at the
end of the presentation. Reference to any products, manufacturers,
models of CT systems or external web sites does not imply FDA
endorsement.

The theme of the introductory part of this presentation is the interplay
of technology and clinical practice in CT, how the rapid technological
and clinical advances of the past few years have increased CT use and
have led to public-health concerns. This theme is a basis for background
discussion and for updates on the activities CDRH has undertaken to
address these concerns since I spoke about them last year.

Computed tomography is a vitally important, beneficial modality whose
radiation doses are relatively higher than those of most other X-ray
exams. The scope of CT applications is broad, and CT is used in many
different ways, from diagnosis, to cancer staging, to treatment
planning, and more recently for real-time visualization during
interventional operations.

This slide summarizes those physical, geometrical, and mechanical
aspects of currently predominant CT technology that bear on individual
radiation-dose delivery. Electron-beam CT is not covered here because
e-beam CT scanners make up perhaps only 1 to 2 percent of approximately
10,000 CT units in the U.S.

The essential feature of X-ray CT irradiation is a thin, fan-shaped
X-ray beam that rotates around a patient. In most systems, X-ray
detectors are located beyond the patient diametrically opposite the
X-ray source, and the beam and detectors rotate together while the
detectors register X-rays transmitted through the patient. In the
figure, the X-ray beam is indicated by the red shading, and the
detectors are indicated by green.

A single 360 degree rotation typically takes from one-half to one
second, a relatively brief period compared to rotation times of ten
years ago. An important point is that while some of the most recent
models of scanners now offer different options that enable a system to
automatically adjust radiation output higher or lower to account for a
patient\'s circumference, in most systems the radiological techniques,
such as the peak X-ray tube voltage (kVp), the X-ray tube current (mA),
the rotation time, need to be set manually by the CT technologist. In an
ideal workplace, these settings are based on a technique chart which a
facility would develop covering different examination protocols and
various sizes of patients.

What\'s referred to as a single "slice" corresponds to a thickness
usually between 1 and 10 millimeters along the length of a patient, and
it yields one cross-sectional image per single rotation. Single-slice
scanners are distinguished from CT systems that are capable of doing
multi-slice scanning.

Spiral multi-slice scanners were introduced only four years ago, and
when they operate in multi-slice mode, they produce two to four
cross-sectional images simultaneously per rotation. These images
correspond to adjacent slices along the length of the patient. Newer
spiral scanner models can provide eight and even 16 slices
simultaneously, and in the next few years they will probably replace
most of the axial-only models.

In axial CT, the table moves increment-by-increment following each
single rotation. Spiral scanning, also called "helical" scanning, refers
to table movement at a constant rate during continuous rotations. It\'s
called spiral or helical because the combination of smooth table
movement and X-ray source rotation leads to the X-ray field tracing out
a helical path around the patient.

The direction along the length of the patient is referred to as the
"z-axis", the axis about which the beam and detectors rotate. Typically
in a single phase of a CT examination the table movement spans a range
covering on the order of 10 to 50 slices along the length of a patient.

The features of fast, multi-slice spiral CT have enabled scanning of
large volumes of patient anatomy, three-dimensional rendering of images,
angiography, single-breath-hold imaging and visualization of small lung
nodules. The bottom line is that these advances in CT technology have
been rapidly adopted into clinical practice and have led to an explosive
growth in the number of applications, to a capability of examining
patients quickly, and to a high rate of use.

The items on the left-hand side of this slide underscore some
public-health concerns ensuing from the growth in use of CT. The
right-hand side lists the preliminary responses of CDRH in addressing
these concerns. First, we are faced with the problem of determining the
scope of radiological exposure from CT. How many CT examinations are
going on annually and just how large are the doses from what particular
exams?

CDRH provided the principal technical direction for a survey conducted
through the Nationwide Evaluation of X-ray Trends (N.E.X.T.) program
administered by the Conference of Radiation Control Program Directors.
Between April 2000 and July 2001 state inspectors surveyed examination
doses and workloads in 263 CT facilities randomly selected in 39 states
to provide the first national understanding of the magnitude of
collective dose from CT since the first CT survey in 1990 in the United
States.

A related project is the ongoing development of a handbook of patient
doses associated with approximately 50 of the most common CT
examinations. Such a handbook would foster risk communication between
medical staff and patients, and it would enable medical physicists and
radiologists to evaluate patient tissue doses and effective dose for
their facility\'s CT systems and adjust their protocols as needed to
reduce doses.

With respect to the second item, in February 2001 the [American Journal
of Roentgenology]{.underline} published a series of papers describing
the potential risk associated with inappropriate equipment settings and
scanning techniques in CT examinations of children. A great deal of
publicity resulted from these studies, and our concerns were voiced at
the last meeting of TEPRSSC. Following the advice of TEPRSSC, last
November CDRH issued a Public Health Notification to radiologists,
radiation health professionals, risk managers, and hospital
administrators alerting facilities to the problem and providing
practical advice on how to reduce risk associated with CT dose in
pediatric and small adult patients.

Since that time there has been burgeoning popularization of a group of
applications commonly referred to as CT "screening" of self-referred
individuals who are asymptomatic of any particular disease. Among these
applications are included "whole-body" examinations, examinations of the
lungs for cancer, and "calcium-scoring" of the heart as a purported
indicator of potential heart disease. Right now CT screening makes up
only a tiny fraction of the number of CT procedures performed annually
in the U.S.

Our main concerns are the risks associated with false positive results
and with radiation dose. False positive results could needlessly lead to
follow up tests or procedures that might be invasive - associated with
surgical risks of anesthesia, bleeding, infection, scarring - or entail
additional radiological exams. Radiation doses in diagnostic CT are
among the highest of those of all X-ray modalities, and screening CT
doses are significantly large even when "low-dose" protocols might be
applied.

There are no scientific studies demonstrating that whole-body CT
screening of asymptomatic people is efficacious. Were it a useful
screening test, it would be able to detect particular diseases early
enough to be managed, treated, or cured and advantageously spare a
person at least some of the detriment associated with serious illness or
premature death. At this time such presumed benefit of whole-body CT
screening is in fact uncertain, and the benefit may not be great enough
to offset the potential harms such screening could cause.

FDA has recently posted a web page about CT screening. The page provides
information about our concerns, contains brief explanations of computed
tomography, radiation risks, radiation quantities and units, the
regulatory status of CT, and includes links to related resources. It is
hoped that an objective presentation from a Government institution whose
fundamental mission is to protect public health will clarify the natures
of the risks and presumed benefits in a way that persuades people to
carefully consider these aspects of CT screening before deciding whether
or not to have such exams.

With respect to the last item in the slide, we are aware of the small
but growing use of what\'s called \"CT fluoroscopy\" or \"dynamic CT\"
to visually guide interventional procedures involving biopsy, drainage,
and device placement. \"CT fluoroscopy\" refers to the capability of a
CT system to update images in nearly real time as the X-ray field and
detectors rotate multiple times around a patient at a fixed z position,
that is, without table movement.

Recent reports cite mean values of entrance skin dose of approximately
100 to 400 mGy, below the threshold for skin injury. Several years ago a
small CDRH group drafted guidance for reviewers and manufacturers of CT
systems capable of CT fluoroscopy, but the move to formal adoption of
final guidance has been on hold in view of the relatively small
probability for skin injury in the most common procedures and also since
preliminary findings of the 2000 CT survey indicated that only 5 percent
of the most frequently used CT units in facilities have the capability
of doing CT fluoroscopy.

The baseline of radiation protection with respect to CT equipment is
prescribed by the Federal Government through performance standards
established under the Radiation Control for Health and Safety Act. The
regulations in place now date back approximately 20 years. These rules
apply to manufacturers of CT equipment, not to the facilities that use
the equipment. The basic mandate is documentary: Manufacturers must
provide users with specified documentation of dose values for CT systems
under typical operating conditions. Because this mandate predates
special or new modalities such as electron-beam, multi-slice, spiral,
fluoroscopic, or cone-beam CT, the doses manufacturers report don\'t
necessarily pertain to those modes of operation. There is no regulatory
ceiling on patient dose, and there are few major equipment requirements
particular to CT per se.

The current FDA standard for CT dose documentation is represented by the
computed tomography dose index, abbreviated "CTDI". CTDI incorporates a
number of the physical aspects associated with the geometry and
irradiation conditions of computed tomography. These aspects include a
rotating fan-shaped beam, collimation of the primary radiation to a thin
slice along the z axis, the axis of rotation, broad scattering of the
primary radiation by the material it passes through, and
scattered-radiation contributions to the dose that are cumulative with
multiple rotations.

CTDI is an index of dose, a descriptor or indicator of the magnitude of
dose associated with the radiation output of a specific CT model. It is
not a measure of patient dose on a person-by-person basis. CTDI is a
representation of dose which is standardized for specific reference
materials and reference-procedure conditions. It\'s measured in a
cylindrical phantom made of nearly solid acrylic, with diameter either
16 centimeters to correspond to the adult head or 32 centimeters to the
adult body.

The figure in the center of the slide depicts a cylindrical phantom, and
to the left is a face view of the phantom within the fan beam indicated
by the red shading. The X-ray source is at the apex on the bottom, and
the X-ray detectors are indicated by the green shading at the top. In a
single scan, the fan beam and detectors rotate as an ensemble once
around the central axis represented in the figure on the left by the
origin of the x-y coordinate system. This central axis of rotation is
the z axis.

Even though the CT radiation intended for image formation is collimated
within a relatively thin section along the z axis, much radiation
actually scatters throughout the phantom or patient. In the center
figure, the red shading corresponds to the primary radiation passing
through the phantom to the detectors, and the dark blue-green shading
represents the scattered radiation. So the dose is actually distributed,
not localized exclusively to the narrow region collimated.

The figure on the right is called the dose \"profile,\" and it
represents the distribution of dose along the z axis for a single slice.
The abscissa corresponds to position along the z axis, where 0
millimeters is at the center, and the ordinate is the dose in units of
mGy. In your notes perhaps a previous version of the slide has units of
rad. It\'s an older version of dose units. For single-slice scanners,
the z-axis collimation of the system defines the slice thickness,
designated by the letter "T" here, and in this example T is 13
millimeters. One sees that although most of the primary radiation is
contained within the 13 millimeter wide central zone of the phantom, the
scattered radiation extends far beyond the central zone, to more than
100 millimeters on either side. Furthermore, when there are multiple
scans extending over a range along the patient length, as there are in
most CT exams, at any one location along the z axis the scattered
radiation from these other scans cumulatively adds to the dose.

FDA therefore defined the dose index CTDI to be proportional to an
integral which include the dose contributions from scattered as well as
primary radiation over a range of the dose profile extending from
negative seven to positive seven times the slice thickness T. In the
example depicted, for a slice thickness of 13 millimeters, the range of
integration is from -91 millimeters to +91 millimeters, covering
practically all of the dose contributions, and the CTDI here is 8.2 mGy,
or 0.82 rad. An advantage of defining a dose index this way is that
mathematically CTDI is identical to the average dose in the central
plane of 14 contiguous axial scans. In other words, the integral
appropriately accounts for the dose contributions of adjacent, nearby
slices, each with its own single-slice profile. So one can think of CTDI
as the dose associated with a reference procedure: It is the average
central-plane dose for a 14 slice exam, a reasonable representation of
how exams were done 20 years ago.

From today\'s perspective, there are several problems with the
regulatory definition of CTDI. CTDI is simply not defined for spiral CT
scanning, which is how most body exams are done currently. For spiral
scanning the irradiation geometry and dose profile are different than
these figures depict. Also, spiral scanning or no, the regulatory
definition of CTDI does not account for CT procedures where the slices
are not adjacent, that is, where slices may be separated by gaps or
where they may overlap.

Over the years medical physicists have introduced a number of
non-regulatory variants of CTDI that have been adopted into practice and
to some extent by manufacturers. For example, it is much easier to
measure CTDI with a fixed-length, 100 millimeter long ionization chamber
rather than integrate a dose profile determined through
thermoluminescence dosimetry. "CTDI~100~" refers to the practice of
using a 100 millimeter long ionization chamber either in the center hole
of a phantom or in any of its peripheral holes to measure a value of
CTDI integrated from -50 millimeters to +50 millimeters irrespective of
the slice thickness T. Although the ionization chamber is contained
entirely within the acrylic phantom, CTDI~100~ usually refers to dose to
air, not dose to acrylic as in the FDA definition.

A variant of CTDI~100~ is what is called the \"weighted\" CTDI,
abbreviated "CTDI~W~," and it is based on a combination of values of
CTDI~100~ measured in the center hole and in the peripheral holes. This
combination approximates the CTDI~100~ averaged over the entire central
plane of the phantom. Another variant, the \"volume\" CTDI is being
introduced in an amendment to the current international manufacturers\'
consensus standard covering the radiation safety of CT equipment.

I\'m going into such details because I want to point out the bottom line
really. The bottom line here can be broken into two parts. First,
variant quantities of CTDI that are either more easily determined, or of
broader generality, or of more utility, have by and large replaced the
FDA definition of CTDI for most practical purposes. Second, as a result
of this proliferation of non-standardized terms, there is confusion
amongst CT system users about precise definitions of CTDI values,
especially for values displayed by some CT systems.

Possible amendments to the current radiation-safety performance standard
would require particular technical features for CT equipment. Although
requiring such features through a mandatory standard applicable to all
new CT systems conceivably guarantees the largest and most systematic
dose reduction on a population-wide basis, there are a number of
associated issues that demand careful thought before we undertake such
change. We seek your comments, ideas, and questions on any aspect of
what is being suggested. The initial focus of the work group effort is
on three possible features - display and recording of standardized dose
indices, automatic control of X-ray exposure according to individual
patient thickness, and X-ray field-size limitation for multi-slice
systems.

This amendment would require each new CT system to provide users with
options to display and record one or more dose indices for every
patient\'s examination. The dose indices and related terminology would
be standardized through formal definition in the regulations.

This amendment would enable an aspect of facility quality assurance that
today is feasible only with extra effort or through features available
on just some newer scanner models. The basis of this quality assurance
is the use of what are called "reference dose values" as norms to which
individual examination doses could be compared. If reference values are
exceeded, facilities could follow up anomalies by looking at possible
problems to see if exposures could be reduced without compromising image
quality. A reference dose value corresponds to the 75th percentile of
the distribution of measured dose values for particular radiological
procedures. Reference values may be generated based on a facility\'s own
records of dose distributions for various CT exams or based on regional
or national dose distributions.

The concept of reference dose values, also called "reference levels",
was introduced in the United Kingdom about ten years ago and is being
adopted throughout Western Europe. It is being introduced into the U.S.
by the American College of Radiology with the aid of a task group of the
American Association of Physicists in Medicine. For example, the ACR
requires facility audits of dose values for comparison to reference
levels in its new CT accreditation program. There is no question about
the technical feasibility of simpler versions of such displays because
they already are available on some of the newer CT models, albeit with
ambiguous definitions.

We assume that the systematic use of dose-index display or recording in
a facility audit program could reduce patient CT dose on average on the
order of 15 percent. This projection is based on the range of dose
reduction observed between 1985 and 1995 in the United Kingdom for
modalities other than CT, in a period before particular indices of
patient CT dose were introduced.

There are several prospective indices of patient dose that could be
displayed and recorded for the purpose of dose audits. For the two
indices described in this slide, equivalent quantities are recommended
in quality criteria guidelines published by the European Commission,
although not quite with the same nomenclature as used here.

In the first amendment to the second edition of the International
Electrotechnical Commission safety standard for CT equipment, the
"volume" computed tomography dose index is introduced. It is based
essentially on the weighted CTDI, which is a weighted sum of CTDI~100~
measured in the central and peripheral holes of an acrylic phantom. For
axial scanning the denominator in the expression for volume CTDI is
z/nT, the ratio of the table increment per rotation to the total
thickness of tomographic sections imaged. In axial scanning the volume
CTDI is essentially what\'s known as the "multiple scan average dose",
abbreviated "MSAD". "Pitch" is the analogous denominator for spiral
scanning. The important point here is that these denominators in the
expressions listed account for modifications to the weighted dose index
arising from possible gaps between multiple scans or their possible
overlap for examination protocols that may differ according to the
particular exam being performed. This accounting makes the volume CTDI
more sensitive to differing examination protocols than either CTDI~W~
alone, or CTDI~100~ alone, or the FDA regulatory CTDI.

Another possible index for dose-display and recording is called the
"dose-length product", and it may hold more promise than the volume
CTDI. Dose-length product is simply the product of the volume CTDI and
the length of the irradiated volume. Here is its chief advantage:
Because the length of the irradiated volume depends on the region of the
body being studied, different examinations will be associated more
uniquely with characteristic values of dose-length product than with
values of volume CTDI.

This result is evident from the table on the left which compares values
of volume CTDI to those of dose-length product. The dose-length product
values are relatively sensitive to differences in exams, whereas for the
kinds of exams listed here, volume CTDI is practically constant between
30 and 35 mGy. The implication is that facility audits of dose-length
product could be exquisitely sensitive to anomalously large doses for
each different kind of examination. Each kind of examination could be
associated with its own unique distribution of dose-length product
values.

Another point in favor of the use of dose-length product is that it is
approximately proportional to the total energy imparted and is therefore
a better indicator of radiation risk than is the volume CTDI. Using
anatomy-specific coefficients derived from computer simulations, one can
estimate effective dose from the dose-length product, and effective dose
is the closest indicator we have for overall radiation detriment. It is
my understanding that one manufacturer already displays values for
effective dose on newer CT models in Europe.

Of the three technical areas that we are considering, probably the
largest dose reduction, at least for thinner patients, would be brought
about by requiring every newly manufactured CT system to provide the
capability of automatically adjusting the amounts of X-ray emissions to
those needed to image particular patient anatomy. In other words, as the
X-ray beam probes a thinner portion of the anatomy which would not
require as much radiation as a thicker portion would in order to reach
the detectors, the CT system would automatically reduce the average tube
current, or voltage, or some combination of radiological variables to
spare that thinner part unnecessary dose.

And conversely, when the beam encounters thicker anatomy, the CT system
would automatically increase the tube output to levels needed for
adequate visualization. An automatic exposure control system offers a
technical answer to facilities where for practical or clinical reasons
it is not the practice to change manual techniques on a
patient-by-patient basis let alone re-adjust techniques within a single
patient exam. With an AEC system in place, the presumption is that
pediatric and thinner adult patients would receive lower doses than
thicker patients.

A number of different approaches for modulating X-ray tube output are
available on newer scanner models, and these approaches span a range of
technical complexity. For example, at one end of the range are systems
that offer recommendations of specified technique settings for tube
current-time product and tube potential that the user may choose to
apply. Such recommendations are not automatic adjustments per se, but
they are based on anterior-posterior and lateral scan projection
radiograph data.

Scan projection radiographs are the scout views obtained prior to
regular CT scanning. At the other end of the range of approaches to AEC
is truly automated, continuously updated tube-current modulation in
three dimensions based on measurements of X-ray attenuation at the
corresponding angles of the previous rotation. In between these two
extremes are several other algorithms offering, for example, automated
tube-current modulation axially only for various image qualities that
may be selected by a user.

The figures in the slide depict how emissions would vary according to
patient sizes in three dimensions. On the left is a cross section of the
torso in the x-y plane, and the thickness or thinness of each red arrow
corresponds to the relatively greater or lesser amount of radiation
needed for reconstructing an image as the X-ray tube rotates around the
z axis. Not only is there tube-current modulation for the x and y
dimensions, there is also modulation corresponding to changes in average
anatomical thickness along the z axis as the table moves. The graph on
the right shows how the tube current is reduced or increased by this
additional current-normalization factor that accounts for the average
anatomical thickness which the fan-beam slice encounters along the
length of the patient. For example, the X-ray tube output would be
relatively small when the patient\'s neck is passing through the fan
beam, but increases rapidly when the shoulders are in the beam and
decreases as the beam probes the lungs. Calculations and measurements
suggest that use of a sophisticated automatic exposure control system
could reduce patient dose by approximately 30 percent compared to
systems where the techniques are set manually.

We are concerned that a number of different multi-slice CT models
produce images with a technologically inefficient application of
radiation. This inefficient technology has been dubbed "over-beaming".

The two figures represent a comparison of the spatial distributions of
radiation incident along the length of a patient. The figure on the left
depicts the distribution for a single-slice CT scanner, whereas the one
on the right corresponds to that of a multi-slice CT scanner. The CT
system represented on the left produces one image associated with a
single slice, while the model on the right can produce four images
simultaneously, each associated with a thinner slice. In each figure the
gradient in area and intensity of shading from dark red to light pink is
a schematic representation of the falloff in radiation exposure from the
central umbra of the collimated X-ray field to the peripheral penumbra.
On the left, a single detector, indicated by the green rectangle,
captures essentially the entire radiation distribution. On the right,
however, the system of four detectors captures only the radiation of the
umbra region.

The total width of the tomographic section imaged - 5 millimeters in
this example - for the slice associated with the one image produced on
the left is equal to the sum of the widths of the four 1.25-millimeter
wide slices respectively associated with the four images produced on the
right. In other words, in either figure the amount of visual information
that can be used for image reconstruction is approximately the same, and
in fact in the case of the multi-slice CT system, a user could elect to
trade off the resolution offered by four adjacent 1.25-millimeter wide
slices for a single 5-millimeter wide slice with relatively less image
noise than in each of the thinner-slice images.

Here\'s the important point in this comparison: Although the amount of
radiation applied to construct one image with the single-slice scanner
or to construct a set of images with the multi-slice system is the same
for each configuration, for the multi-slice CT system the radiation
distribution is much wider than that of the single-slice system.

Why? Multi-slice CT imaging requires that radiation incident on the
patient be consistently distributed across each of the separate areas
subtended by the detectors. Such consistency can be achieved by opening
up the z-collimation of the source radiation so that only the most
spatially uniform region of the X-ray field, the umbra, is subtended by
the detectors. I should point out that when that occurs, the spatially
varying penumbral regions are excluded from the detectors. Furthermore,
since the X-ray focal spot tends to wander around spatially, multi-slice
models broaden the umbra by opening the collimation even more to
compensate for X-ray source excursions. In the example depicted by these
figures, the width of the z-collimation for the multi-slice system is 15
millimeters versus 5 millimeters for the single-slice system.

The problem of consistent spatial irradiation is not encountered in
single-slice systems because the single detector is longer than the
extent of the incident radiation, and it simply integrates the whole
distribution incident. However, multi-slice systems are not efficient
users of radiation in this sense: All of the radiation that falls beyond
the spatial extent of the detectors is not used by the detectors for
image construction, but it is nevertheless incident on the patient, and
it contributes to the dose.

To mitigate the inefficient use of radiation in multi-slice computed
tomography, we suggest consideration of an X-ray-field-size limitation.
Such an amendment would require that all new CT systems be capable of
automatically limiting field sizes to those no larger than needed to
construct multi-slice images.

Several technical approaches to enable such limitation have been
patented, and one in fact has been implemented. The approach implemented
uses some of the X-ray detectors lying beyond those capturing the
clinically useful signal to track the wandering of the penumbral regions
of the X-ray field and feed back instructions to motor-driven collimator
cams to readjust their positions. Tracking and updated instructions are
done in real time to maintain the narrowest needed umbra incident on the
detectors. This system is represented by the figure on the left. The
X-ray field borders demarcated by dashed lines are set by the collimator
cams - also indicated with dashes - for an initial position of the X-ray
source so that the umbra is subtended by the clinical-signal detectors.

As the X-ray source wanders to the right, other detectors which are not
depicted here pick up the movement of the penumbra and instruct the
collimator cams to re-adjust their positions to those indicated by the
solid lines. The result is that the umbra remains subtended by the
clinical-signal detectors. Had the collimation position remained
unchanged, there would have been an inconsistent spatial distribution of
the X-ray radiation across the clinical-signal detectors.

The chart on the right represents two multi-slice dose profiles measured
in a head phantom on the same CT system. For the same 5-millimeter wide
imaging-sensitivity profile, the dose profile in black is obtained when
there is no tracking and collimation-update system, whereas the dose
profile in fuchsia is obtained when the tracking-update system is
activated.

It is evident that the non-tracking dose profile is approximately 50
percent wider than the tracking profile. All of the radiation
represented by the difference between the two profiles would correspond
to radiation which is incident on a patient, contributes to the dose but
is not used to construct images. Data suggest that the kind of
X-ray-field size limitation enabled by tracking and collimation
adjustment could reduce dose in multi-slice CT systems on the order of
30 percent.

I will present quantitative projections of benefits that could result
from the relative amounts of dose reduction associated with the possible
implementation of amendments to the Federal radiation-safety standard in
each of the technical areas just described. The principal benefit would
be a population-wide reduction in morbidity and mortality associated
with avoidance of cancers produced by CT radiation.

Projections are based on preliminary estimates of the current annual CT
dose in the United States derived from the 2000-2001 N.E.X.T. survey.
The survey results indicate that the total number of CT exams annually
is approximately 58 million, where 79 percent of all exams are comprised
of scanning in six anatomical regions or combinations of regions -
brain, abdomen-pelvis, chest, abdomen, chest-abdomen-pelvis, and pelvis
alone. Approximately 29 percent of all CT units in the U.S. can do
multi-slice spiral scanning, a remarkably large percentage since this
technology was introduced to the market in 1998. The effective dose
average for the six exam regions is approximately 6.2 millisievert, and
the product of this average and the number of exams corresponds to a
collective annual dose of approximately 360,000 person-sieverts per
year.

If all CT equipment were to include the technical features just proposed
for consideration as mandatory standards, then based on the relative
dose reductions and the collective dose attributable to CT, one can
estimate an annual collective dose savings of 193,000 person-sieverts
per year; 54,000 for dose-index display and recording in a
quality-assurance program, 108,000 for automatic exposure control, and
31,000 for X-ray-field size limitation in multi-slice systems. All of
these values are uncertain, and they\'re based on a number of
assumptions detailed in the slides, references, and notes.

For an annual collective dose savings of 193,000 person-sieverts, on the
order of 8,700 radiation-induced cancer mortalities are projected to be
avoided per year beginning 20 years after each annual collective
exposure. The yellow shading is intended to highlight the uncertainty in
this projection which is based on an extrapolation to the CT-dose region
of a mortality risk estimate derived from larger-dose epidemiological
data. Other methods of extrapolation could yield higher or lower
estimates of the number of radiation-induced cancer deaths, and it is
even possible that the estimated dose savings would not result in any
avoidance of cancer death at all. In the United States in the year 2000,
the annual number of deaths linked to cancer from all causes not
specifically associated with radiation is approximately 550,000.

There would also be a significant benefit in the pecuniary savings
associated with societal willingness to pay to cover mortality risk.
Economists have estimated that society pays on the order of \$5 million
per year per premature mortality that might otherwise be avoided.

Will there be amendments to the CT radiation-safety standard? Here are
the initial steps in this process. We\'ve come up with a framework for
analysis that will lead to what is called a "concept paper" for
amendments which will be the basis for CDRH decisions on how to proceed.

This slide represents a framework for analyzing prospective technical
areas with respect to issues that need to be addressed in decisions on
how to proceed. In the block on the right, the region shaded in green
lists the technical areas summarized in this presentation, and the
region shaded in pink lists areas where we have an interest that is
deferred for the time being. The yellow-shaded block on the lift lists
some general categories of issues - technical feasibility, impact on
clinical aspects such as efficacy and frequency of utilization,
harmonization with international consensus standards, CDRH resources
required to develop test methods and to incorporate the administration
of new rules in a compliance program. The arrows indicate that in
principle each of these issues can be applied as a basis of assessment
to each technical area under consideration.

We would like to hear your thoughts about any of these issues. Although
the equipment features that I\'ve discussed today may all be technically
feasible, there remain a number of particular questions outstanding.
Here are a few examples: First, for the purpose of display or recording
in a quality-assurance program, not only would we have to select a
representative index of patient dose, we would need to specify whether
the dose index could be based on average values for a system determined
by manufacturers for all models of scanners or whether it must be
specific to the particular unit actually used in a facility. Should the
dose index displayed or recorded be based on real-time measurements made
during actual patient examinations? How would the index represent values
in an automatic exposure control mode? Parameters based on CTDI may not
be good candidates to represent skin dose, particularly for CT
fluoroscopy. What is a good index for skin dose? What impact might a
dose-index recording capability have on practice and use? Would there be
any inhibitions fostered by the possibility of associating recorded
values with patient medical records?

Second, with respect to automatic exposure control, in addition to
specifying what kind of technological approach is best, perhaps the key
question is how to define the optimal amounts of radiation needed by the
detectors for particular imaging tasks. These amounts would effectively
set the points of detection equilibrium driving the modulation of
emissions from the X-ray source according to patient anatomy thickness.
Should standards be set to optimize detection? Who should set the
equilibrium points and how would that be done? By manufacturers? By
radiologists? By FDA? Philip Judy, a prominent medical physicist, has
posed a related question: If automatic exposure control reduces dose to
thinner patients on average, would it on average increase dose to
thicker patients? The answer is not obvious.

Third, a primary challenge in developing an amendment for
X-ray-field-size limitation or for automatic exposure control and most
likely other areas as well would be how to prescribe performance
standards-not design standards-forward-looking enough to transcend
limitations that might be present in current technological approaches.

In conclusion, an FDA work group has identified several areas for
possible development of mandatory CT-equipment radiation-safety
performance standards. The initial focus is on technically feasible
features that would reduce patient dose - dose-index standardization,
display, and recording, automatic exposure control, and X-ray-field size
limitation. Were these features implemented on all CT systems, the
projected collective dose savings in the United States would be
approximately 193,000 person-sieverts yearly.

The work group has established a framework of issues for analysis that
would be detailed in a regulatory concept paper for decisions on how to
proceed. In the development process we need input from industry,
professional and other stakeholder groups, the Conference of Radiation
Control Program Directors and States, as well as TEPRSSC. Our time line
for the initial stage of this process is the completion of a concept
paper by the end of this year for CDRH review and decision making and a
follow-up briefing for TEPRSSC next year. Thank you for your attention.

CHAIRMAN ROTHENBERG: Thank you. I think we can proceed with questions
and comments from the Committee at this point. There are a number of
concerns and questions I had. First of all, when are the results of the
N.E.X.T. survey going to be published and where will they be available?

DR. STERN: The \"when\" is problematic. There are preliminary results
available right now on-line. The FDA CT web site contains the reference
as a URL link. The definitive results of the survey might not be
available for another year. We would publish those in the journal
[Radiology]{.underline}.

CHAIRMAN ROTHENBERG: Okay. Also with regard to the automatic exposure
control, this would be potentially a device which would vary the
exposure rate depending upon the thickness of the patient and the
particular projections. But each of the manufacturers has a standard
technique which they present with their devices. With automatic exposure
devises in radiography, at least in screen-film radiography, the main
technique about which the variations are made is determined by the
optical density produced on the film.

In CT and other digital devices, we don\'t have that type of limit to
guide us. Has there been any effort to determine how the manufacturers
arrive at their techniques because each manufacturer for each type of
machine may actually have for their standard technique a different dose
which they present in their literature?

DR. STERN: Well, that is the key question that you\'ve raised about
where to put the "set point," as it were, about which the radiation
emissions are modulated. I think there\'s work going on generally in the
community. I can\'t point to specific papers about it. It\'s a question
that we have to think about in developing such a performance standard.

CHAIRMAN ROTHENBERG: Yes, John.

DR. SANDRIK: Way back on the first page of your presentation you
mentioned balancing lowest dose and best image quality or something
related to image quality, yes, lowest dose for the best image quality
practically achievable. Then the bulk of the rest of the paper I think
maybe until you got to the part about equilibrium points or something
concentrated on the dose aspect with very little regarding the image
quality.

I think particularly as Dr. Rothenberg brought up, when you get to the
AEC performance some measure of image quality is going to be very
critical in deciding how this system operates and what are its limits. I
think that ought to be brought into some of this concept, at least in a
concept paper, for the the limits. What we see right now is just
low-dose to no-dose CT is the only way to go because the only benefit is
reducing cancer mortality. We don\'t see any sort of lower limit at
which point the image becomes unusable. I think more effort would need
to be put in towards that kind of work.

DR. STERN: Certainly we\'re very sensitive to the image quality. Image
quality should I think have a primary role. These are issues that I\'ve
mentioned in the presentation. We would certainly consider the
importance of image quality and how to adjust those accordingly for any
kind of concept paper. That\'s our intent.

CHAIRMAN ROTHENBERG: Yes, Michele.

MS. LOSCOCCO: You indicated that the survey results were preliminary and
on the web and will eventually get published. Does that include the work
you\'re doing on the handbook? When would those doses be out?

DR. STERN: With respect to the handbook, there\'s no information on the
web and there aren\'t preliminary results. The handbook project has been
going on for a while. It\'s been deferred for a while for other
priorities. There\'s always a hope to get it done within a year. I
can\'t give a definitive date for that. We want to work on it. We\'re
working on it. We\'ve done a lot of work on it. We\'ll get it out when
we can.

MS. LOSCOCCO: Because I guess my thought process is I\'m not sure where
we stand with axial versus multi-slice. If we had that handbook that
identified some of that, we might be able to get a handle on what kind
of dose limits we wanted to set.

DR. STERN: It\'s not our intent to set regulatory dose limits per se.
None of the technical features that we talk about for the amendments
would set a limit on dose.

CHAIRMAN ROTHENBERG: Yes, Rob.

MR. PLEASURE: You begin the paper by saying that your concerns emerged
as a result of the interplay of clinical practice and the technical
aspects of CT. Then you identify as one of the major problems in the
beginning the asymptomatic self-referrals.

I\'m just speaking as a citizen. We watch television and see ads for CT
with tombstones and all sorts of promotion of this. Working people go in
and they get this perhaps without any referral as you suggest in perhaps
very large numbers. My sense is that your recommendations for change
relate to recording and technical requirements of the equipment and
don\'t touch this major problem of asymptomatic self-referral.

I know there are limitations as to the scope of this Committee. I am
troubled that a central issue that you\'ve identified may be only
indirectly dealt with by your recommended changes. Isn\'t there
authority under some of the enabling acts to do something about what may
appear to be a defect because of its usage in this particular device? In
other words, it\'s being used for a purpose that has no value in
creating significant risk. No value at least in the reported literature.
Why have you been so conservative in your recommendations?

DR. STERN: The approach that we take stems from our understanding of our
authority under the Federal law, the Radiation Control of Health and
Safety Act. One aspect of that act is to promulgate standards for
equipment really. It\'s an equipment-based approach. It doesn\'t really
give us authority on the use of the equipment.

We can\'t direct facilities on how to use the equipment or not. Such
authority is vested in the states. The states have that authority
really. So our approach has been to do what we can with respect to
equipment features or suggest that we might do with respect to equipment
features to reduce dose. For the issue of asymptomatic referrals for
whole-body scanning, we take an approach of providing information
through our web site to alert people to the issues involved and to the
problems involved with it.

MR. PLEASURE: Well, there is this reference in our manual and in the
regulations to defects in an electronic product. One that does use
radiation as an intended purpose has a defect if it creates an
unnecessary risk of injury or fails to accomplish its intended purpose.
In this particular case, I would for purposes of this discussion say
that without any warning on the product itself that says that this
product is not to be used for whole-body scanning in asymptomatic
situations.

It\'s like when I was a child going into the shoe store and having my
feet exposed to a fluoroscope just to fit my feet to the shoes. Here you
have a product that\'s put out, advertised aggressively and there\'s no
warning label on the product itself that it is not to be used as you say
for general screening and asymptomatic situations. So I would assert
that under 21 CFR 1003.2 why is this not a defect in the electronic
product? This is creating an unnecessary risk of injury in terms of your
own report.

DR. STERN: I would have to pass on the definition of "defect" to people
more familiar with how it\'s been used traditionally by CDRH, perhaps in
the Office of Compliance who know about that. I can\'t specifically say
how defect is defined.

Another point I do want to make though is that FDA or CDRH haven\'t
taken a position that the practice of whole-body CT screening for
asymptomatic individuals is bad and you should not do that. I think such
decisions on efficacy are made by more expert groups, for example, the
U.S. Preventative Services Task Force. What we\'re doing is we\'re
trying to provide information about our concerns and about the possible
risks and leave it up to individuals to make the decision for
themselves.

MR. PLEASURE: Well, as a Committee Member I think it would be useful for
us to have more information about the application of the particular
regulation that I referred to and whether or not with other enabling
legislation we can make recommendations that connect the technical
aspects of the piece of equipment to actual utilization, the interplay
as you say of clinical practice and the equipment itself. If we can\'t
touch that, then it seems that the scope is far narrower than I thought
it was now after two plus years on the Committee.

CHAIRMAN ROTHENBERG: I think Dr. Suleiman would like to make a comment
on this also. I would like to congratulate the Center on the web site
that they did put up because I do think it provides a lot of very
valuable, basic and advanced information for both members of the public
and also experts in the field. So if people get to that web site I think
they will be very heavily aware of the risks as opposed to what the
minimal benefits might be from some type of situation. Of course that
doesn\'t address your question, but it\'s there. The question is how to
make people aware to read it.

DR. SULEIMAN: Okay. Before I hand off to Tom Shope as well, we look on
this law as a regulatory tool. I think we\'ve been focusing on it
because I think it\'s something that maybe we and we only can do, the
FDA, and there are things to do to facilitate the process.

X-ray systems are medical devices and prescription devices. We allow
them to be used only under the prescription of a healing arts
practitioner unlike the foot fluoroscopes, unlike the people scanner
that will come up this afternoon. Physicians are allowed to use not only
drugs but other products off-line other than its intended use. There\'s
a strong medical practice issue here that evades this specific
regulatory law. I think we\'ve looked at some of the other options.

We came up with the pediatric advisory. This Committee recommended that
last year. We came out with an advisory alert to that effect. The web
page which is extremely extensive hit the streets several weeks ago.
There was an awful lot of thought and discussion and whatever. We took a
very educational approach with that.

I\'m throwing some of those factors out. We\'ve weighed them and argued
and developed some strategy. I think Tom you can probably discuss it in
a little bit more detail.

DR. SHOPE: Tom Shope from the Office of Science and Technology. Actually
I was going to stand up and address this issue of the "defect." The
"defect" there has to do with a defect in the performance of the
equipment. Our CT systems that are doing whole-body scanning are working
as designed. I don\'t know what defect we would address there to get at
from that standpoint. It\'s really a defect related to the emission of
X-rays that the part of the regulation and law addresses. I don\'t think
we see a way there to address this issue of use of a device being a
defect in the device itself. So that was the comment I was going to
make.

I\'m a little bit out of my field in terms of getting into the legal
issues. I think though our General Counsel and other people in
compliance would agree that that\'s talking about a defect with regard
to how the equipment actually operates, performs - emits or doesn\'t
emit radiation when it should or shouldn\'t, as opposed to how the
equipment functioning as designed is being used.

CHAIRMAN ROTHENBERG: Thank you. Yes, Maureen.

DR. NELSON: I want to make a comment and then I have a question. My
comment is that I agree that right now there isn\'t any evidence to
support the use of screening CT to cardiac disease or cancer or that
sort of thing, but that isn\'t to say that at some point that it
doesn\'t. I think we have to be careful to not slam the door completely
on this use, although I would argue that this sort of use should only be
done in controlled clinical trials at this point in time.

The question that I have follows on Mr. Pleasure\'s question. That is
that we did put out an advisory last year for pediatric use of CT. It
seems to me could we not extend that advisory to this not only putting
up a web site, but my understanding is that you actually sent letters
out or something like that. Could somebody tell me what we did with that
pediatric advisory and what that consisted of?

DR. STERN: It was a public health notification. It was sent out to
people physically. It\'s on the web site as well.

DR. NELSON: Who are the people you sent it to?

DR. STERN: Radiologists, hospital administrators, radiation risk
managers at hospitals.

DR. NELSON: Couldn\'t we do the same with this?

DR. STERN: What I\'m suggesting is it might be premature to do the same.
You\'d have to describe the nature of the advisory. Is it that there
might be a problem? There is a problem? It might be premature. Just as
you\'ve said right now that you don\'t want to close the door
completely. It might take a while to evaluate the efficacy of screening
exams.

DR. NELSON: It seems to me right now you could say that there is no good
evidence that shows that these screens are beneficial and that
physicians and these people you mentioned should be very cautious in
recommending them or prescribing them.

CHAIRMAN ROTHENBERG: Yes. Basically what you are saying is to
essentially put out some amended version of what\'s on the web site
itself since it\'s already out there publicly making those statements.
Why would this change anything?

DR. NELSON: Right.

CHAIRMAN ROTHENBERG: It would just put it into very targeted hands.

DR. NELSON: Right. I\'m not sure everybody reads the web site.

DR. SANDRIK: On another area of the dose indices, about 25 percent of
your dose savings deals with the users making some notice of the dose
indices, doing audits, setting up reference dose levels, but as you also
pointed out the performance standards apply to manufacturers and not to
facilities. What methods would you expect that you\'d be applying to try
to capture this 25 percent of dose savings when you really don\'t have a
regulatory control over this group or I think you\'d need to have that?

DR. STERN: We can only make recommendations to users on how to use such
systems. The starting point, getting out the gate, is having a
requirement that all CT systems provide the users with an option for a
display and recording facility. Right now there is no such requirement.
Most CT systems don\'t have any display capability right now. We\'re
just looking at getting it off the ground. With respect to how the users
actually implement it, that has to do with education and information and
persuasion.

CHAIRMAN ROTHENBERG: Yes, Dr. Benson.

DR. BENSON: To address something along those lines, you\'ve been
mentioning that the CT dose display would be something that you\'d want
in new machines as they\'re manufactured. Is there any way we can
encourage manufacturers to make a device that could be an add-on to
existing machines? Only because the generation time for replacement of
machines is eight to ten years, whereas the add-on generation can be
anywhere from one to three years. Our dose savings could kick in perhaps
sooner than might otherwise be.

DR. STERN: Well, what you\'re saying is true. It\'s just that our
regulations are prospective. They\'re not retro-fitted to older
equipment. If one believes that dose display is useful and one wants to
promulgate a new rule or standard for dose display, then it\'s possible
to encourage add-ons to existing systems as well. My impression is that
CT equipment is replaced rather rapidly, at least recently.

CHAIRMAN ROTHENBERG: I\'d just like to make another point. In terms of
the dose display, it seems to me that in most cases since everything is
already in a computer on a CT scanner, this involves more of software
development as opposed to hardware changes on the equipment itself, so
it might possibly be easier to implement that then it would be on
certain other types of X-ray equipment.

I have a related question to that. In terms of proposing the dose
display on the machine, again because it\'s a computer, I would also
like to suggest that there be a method for somehow recording and putting
in some type of database this information because currently we have a
situation with some of the fluoroscopy equipment where we have built
into a number of newer pieces of equipment a dose display device which
may come up at the end of the exam. However, on many of these pieces of
equipment, and I\'m not familiar with all of them, when the next patient
is entered that information disappears.

There\'s no logging of that. That then means that it\'s incumbent upon
the technologist or somebody else in the facility to record that
information usually in some log book. The question is how do you deal
with this information. It\'s all handwritten in a log book as opposed to
being on a computer where it would be amenable to some type of analysis
for arriving at reference levels and just keeping track of certain
patients that are getting many exams. So if there\'s a recommendation to
have a display which is already present, as you mentioned, on many of
the new scanners, that it also possibly be a recommendation to be able
to keep the data.

DR. STERN: Thank you. That\'s an important comment. A recording feature
is one of the aspects we would consider.

CHAIRMAN ROTHENBERG: Yes.

DR. BENSON: Another feature you might consider. We had talked about
setting dose limitations and how that might not be a good idea. On the
other hand, if you come out with recommendations that companies set them
at a low level and make those default settings so that a patient who is
put through willy-nilly, which unfortunately quite often the case in
these high-throughput CT establishments, those people would not be
unintentionally over-dosed. If anything, they would be unintentionally
under-dosed.

And make it a conscious act to increase the dose to a level that would
make an image that, say, the individual radiologist would want. Make
that a conscious act so that it is perhaps one way our Committee can be
a little more effective in terms of reducing overall dose in making
intentionally low recommendations so that image quality can be more
carefully controlled on a patient-to-patient basis.

DR. STERN: Thank you for your comment.

CHAIRMAN ROTHENBERG: Yes.

MS. LOSCOCCO: Well, I guess along those lines I think there\'s some
hesitation probably on the part of industry, on the part of the physics
community that helps set up these dose recommendations and protocols
that the radiologist is the one that eventually has to read that image
and is the one that is held responsible for finding the data. That\'s
kind of where I was going with my first question. You have to tie image
quality to your limit or recommendation. How are you going to come up
with that kind of range?

DR. STERN: I can\'t answer the question of how one would determine a
set-point for an automatic exposure control system to modulate the
emissions of that with respect to optimal image quality and minimal
dose. It\'s something that\'s a research problem that has to be worked
out, I think, over time.

CHAIRMAN ROTHENBERG: Certainly there is already in each manufacturer\'s
specifications some index point of low contrast performance at a certain
standard dose level. So there\'s certainly on the way to that position
because clearly the low contrast performances are going to be most
heavily affected by the dose setting.

DR. BENSON: Well, I would say that the Society for Pediatric Radiology
has spent the last year on this subject and has a publication currently
out of the summary of their efforts. They have come up with a dose
schedule that seems to produce good radiologic images at much lower
doses then have previously been used. If those could be adopted and
adapted by the individual manufacturers as a baseline then in effect it
will bring the radiologists back into the process of producing images
where up until now they\'ve been if not excluded at least ignored.

CHAIRMAN ROTHENBERG: Yes, Jill.

DR. LIPOTI: There are a couple of pieces of background information that
are not in our packets that I think would assist this Committee in
making recommendations. One is a copy of the FDA web site having to do
with whole-body scanning. Another one is a copy of the preliminary
results of the N.E.X.T. survey which are on the web but which were not
part of our background materials. A third one is some information from
the American College of Radiology on their accreditation process which
is not yet in place as I understand it but is anticipated for CT.

DR. STERN: Sorry. I believe it is in place, yes.

DR. LIPOTI: Well, people have applied but I\'m not sure that people have
been approved yet. But I think that we have to look at this whole
approach to CT as a partnership. It\'s a partnership where the FDA has a
significant leadership role particularly in providing for changes to the
equipment so that the user can then be more intelligent in their use of
this particular modality.

I would look to states as being the ones who would deal with medical
practice issues and the prevention of unnecessary radiation exposures
and could perhaps provide a requirement for a quality assurance program
which is the thing that you need to make sure that all users then use
the features that the manufacturers have built into the system. It
can\'t be approached as only FDA requirements. It has to be looked at as
the total regulatory spectrum.

I guess as part of that though I would also look to FDA leadership to
help identify the costs perhaps of some of the retro-fit that would be
needed for a current CT to provide some information about dose indices
for the user. Yes, states can write a regulation that would require
retro-fit, but then each state is going to have to do a cost benefit
analysis individually whereas perhaps in the course of collecting data
from the manufacturers on providing these options on new machines you
could also collect data on providing that as a retro-fit.

CHAIRMAN ROTHENBERG: I would like to just raise one other point in terms
of at least the educational activities of the center. That is when I
speak to radiologists they seem to be particularly in the recent years
much more aware of the fact that the dose from the CT exams is higher in
many cases than from certain other routine exams that are being
performed.

However, I also hear that although many of the machines are in the
radiology department and they are performing the diagnosis and the
radiologic technologist performing the exams, they don\'t necessarily
control how often the exams are performed and on whom they\'re
performed. They are often required to proceed with exams ordered by
other physicians. I think this is an area where the other physicians may
be routinely ordering exams, as with any other radiology exam, that may
not always be necessary. I think it\'s important to make the rest of the
medical community aware of the dose levels in CT exams.

Again I know there is web site information but in terms of getting to
others, maybe targeted mailings to other medical societies for
distribution to their members would also be a good idea to follow up on.
This could lead to a significant reduction in dose just by preventing
unnecessary exams being performed.

MR. PLEASURE: You\'ve identified, Dr. Stern, through automatic exposure
control and X-ray-field-size limitations and dose index standardization,
display and recording, ways of reducing unnecessary exposure. Right now
it\'s feasible as I understand it. The new models have this capacity in
these three areas.

What I\'m trying to understand is the interplay of this responsibility
to identify a defect in old equipment let\'s say that does now, if I
were to infer from this, it does have too large a field-size, too wide a
field-size right now on the old equipment and it\'s possible to narrow
it. There\'s no automatic exposure control so that we\'re creating
unnecessary exposures right now with the older equipment. The
professionals have limited capacity to identify the exposure.

So I have a piece of old equipment. I would just as a person on the
street say the old equipment has a defect given the state-of-the-art.
Why not use those remedies available to FDA for defective equipment to
move toward reducing all these unnecessary exposures?

DR. STERN: Well, this is really a legal question. It\'s beyond my
expertise to address how FDA could answer that question.

MR. PLEASURE: But I would argue part of the responsibility of this
Committee is to look at the legislation that creates the Committee, the
remedies that are available that are actually referred to in our manual,
and to make recommendations as to not only the narrow issues that are
brought before us but also as to ways of dealing with it that are within
the scope of FDA\'s authority, and this Committee\'s purview if I read
the manual correctly.

CHAIRMAN ROTHENBERG: I just want to raise one point with regard to this
specific issue that Dr. Stern hopefully can reply to. If I were to go
right now and buy a CT scanner, could I buy one with automatic exposure
control? I know there have been many papers and they are under
development.

DR. STERN: Yes. I think you can. I think there are some systems that
offer that feature.

CHAIRMAN ROTHENBERG: With an actual feedback type system as opposed to
based on \-- view.

DR. STERN: I believe so, yes.

MS. LOSCOCCO: They exist.

CHAIRMAN ROTHENBERG: I haven\'t seen one in operation yet, but I know
they\'re coming. They\'re very limited at this point, but this is
certainly something we should keep in mind for the future. Maybe we want
to make a recommendation that they should evaluate again cost benefit
for this type of modification of older equipment.

MR. PLEASURE: Well, there is a cost benefit analysis at least in terms
of on the benefit side the numbers of people who are currently being
exposed and the costs associated with those unnecessary cancers that are
caused. It\'s \$5 million per person.

CHAIRMAN ROTHENBERG: But I think also in terms of cost, what would be
the actual cost to the person using the machine to have the machine
upgraded?

MR. PLEASURE: Well, one of the remedies available if you identify it as
a defect if it rises to that level is to require notification to go out
to everybody that\'s purchased this and tell them there are problems
with the equipment that you\'re using. You could do much better. I mean,
before you actually pull it off the market at least you could get the
word out. Manufacturer notifies purchasers, dealers and distributors of
a hazard and appropriate use until corrected is one of the identified
remedies in the regulation.

CHAIRMAN ROTHENBERG: Certainly again \--

MR. PLEASURE: That doesn\'t cost much.

CHAIRMAN ROTHENBERG: Based on Dr. Shope\'s previous statement, the
definition of defect that you are raising is certainly different from
the one that the Center uses.

MR. PLEASURE: No. I think I was speaking in broader terms before. Now
I\'ve focused on defects or limitations that have been identified in
this paper on unnecessary exposures because of the width and
possibilities of limiting that, and there were two other areas that I
identified that the paper has identified that are limitations that are
not present with the newest equipment.

So this relates directly to the unnecessary exposures by the equipment
because technically it doesn\'t have the capacity of the newer
equipment. These are meaningful distinctions because as identified by
Dr. Stern, they\'re producing unnecessary exposures. Unnecessary because
we have the equipment to avoid it.

I think this defect relates not only to manufacturer\'s failures in the
manufacturing process but producing something specifically that\'s
causing unnecessary risks and exposures that we can avoid. We should be
using the best available and safest technology.

DR. NELSON: I was wondering if you wanted to make a motion. The other
thing I was wondering if it wouldn\'t be helpful to maybe have some
legal people from FDA speak to this Committee about the issues you\'ve
raised.

MR. PLEASURE: Well, that\'s an interesting invitation.

CHAIRMAN ROTHENBERG: Why don\'t we just have a formal recommendation for
the FDA to look at the law again and see whether this interpretation
which is different from their previous interpretation is supported by
the current \--

MR. PLEASURE: Well, I would differ with you as to whether it\'s
different from their previous interpretation. I earlier had raised a
question as to whether the scanning, that is the practice of scanning in
asymptomatic self-referred cases was in itself a defect. I\'m not
talking about that now. It was indicated that it was not the way
technical staff understood the regulations. I\'m now talking about a
performance standard, that the older devices are producing unnecessary
exposures that the newer devices that have been identified don\'t
produce.

CHAIRMAN ROTHENBERG: But it\'s not clear to me. The older machines are
potentially going to produce the same doses when proper account is taken
by the operator for the size of the patient. This could be potentially
addressed. At least a major aspect of it, not 100 percent of it could be
addressed by the proper education of the user.

MR. PLEASURE: I don\'t understand that to be the case.

CHAIRMAN ROTHENBERG: Certainly for different size patients we could \--

MS. LOSCOCCO: I think you\'re actually talking about two different
things. You\'re talking about the collimation, the fact that the
detectors in the multi-slice, the profile of the beam is extending past
the detectors. You\'re talking about particular patient doses. Am I
following you correctly?

MR. PLEASURE: Well, if you take a look at pages 11 and 12 which is the
concern and 13 of the report that relate to automatic exposure control,
inefficient use of radiation and field size with a patient, it ends with
feasibility of using newer models that give this capacity. I don\'t
think people have the capacity when they\'re using it to get to this
point. As I understand it, the equipment doesn\'t allow for limiting
this unnecessary exposure in ordinary use. What I think a first level
would be is at least the manufacturers to notify users and others to
whom they\'ve distributed equipment that the equipment is producing
unnecessary exposures.

I would agree with you, Chair, that it would be useful to have some
discussion as to the ways in which FDA uses this defect in electronic
products to deal with uses of products that are no longer
state-of-the-art. Why do we have to wait five or six years for the
change to occur? Shouldn\'t there be some assessment of the damage
that\'s being done right now that\'s feasible to avoid? Shouldn\'t there
be a cost- benefit analysis of that as you suggest?

CHAIRMAN ROTHENBERG: Do you want to make a motion to that effect?

DR. LAMBETH: Perhaps I\'m a little naive about certain aspects of
implementation in this whole process, but there were several things I
picked up out of your discussion that I would like to touch on just a
second. One was your specific recommendation was that the automatic
exposure control would be an option, not a requirement.

DR. STERN: The automatic exposure control would be an option for the
user to use. The user could use automatic exposure control or a manual
technique at the user's discretion, but the requirement would be that
the CT unit have the capability of doing automatic exposure control.

DR. LAMBETH: And that would be for future machines.

DR. STERN: Yes.

DR. LAMBETH: Not retroactively.

DR. STERN: Correct.

DR. LAMBETH: Which is what we\'re now discussing here. I tend to
hesitate to use the word "defect" because I tend to think of the word
"defect" as meaning something that has gone wrong as opposed to a
deficiency in old equipment which was designed that way to start with.

The other aspect of that is the display index. Having that is only an
educational aspect. It\'s not something that suddenly changes the amount
of exposure that a patient gets unless the operator chooses to use it in
some intelligent way.

DR. STERN: That\'s right.

DR. LAMBETH: So implementing that actually seems, I agree, more like a
software issue than a hardware issue. But I don\'t know many of these
machines so I couldn\'t really say that for sure, but I know how some of
the machines are probably built. In terms of the automatic exposure
control, there\'s an assumption being made in point of fact the
operators are over-exposing the patients either because they\'re in a
hurry, they want to guarantee a good image every time or they\'re not
well educated about the benefits and trade-offs.

So I\'m sure the study was done conscientiously that predicts the
savings and exposure, but there are guidelines the manufacturers have
that says this is what the exposure should be, I assume. They would put
that with their products when they were selling their product. So I was
curious about this summary number about the savings, not so much about
how to operate the machine as opposed to how the machine is being
misused to get this number.

DR. STERN: The savings in dose, you\'re talking about the percentage
dose reductions.

DR. LAMBETH: Right. You\'re final summary.

DR. STERN: The final summary is based on the percentage dose reductions
that are based on a number of assumptions detailed in the notes. The
current number of exposures as determined or as inferred from
preliminary data of the N.E.X.T. survey, that\'s where those numbers
come from. Am I not answering your question?

DR. LAMBETH: I guess it\'s just an unknown on my part. I\'m just
questioning it and probing you. Forgive me if I do that a little bit. In
actual operation, we\'re making an assumption that the operator
over-exposed the patients compared to what an automatic exposure process
would do.

DR. STERN: Those numbers for automatic exposure are based I believe on a
couple of papers detailed there for measurements really. You could be
right in the sense that on average if operators were using their current
systems ideally now, they would be based on technique charts where they
would set their technique settings for the examination and for the size
of the patient that they are examining. We don\'t know how all operators
are doing with respect to that. So there is some assumption that it
could be better through an automated exposure control system.

DR. LAMBETH: Any system that would have automatic exposure control I
would assume the operator would have some adjustments on that or some
ability to adjust it or as you said turn it off entirely.

DR. STERN: Yes. The operator could use the manual techniques that an
operator uses currently. They\'re not obligated to use the automated
exposure controls.

DR. LAMBETH: I would think there would be a high propensity to always
over-dose the patient to make sure I got a good image.

DR. STERN: Well, part of the problem raised by Larry Rothenberg and John
Sandrik had to do with how does one set an automatic exposure control
system to give very good images and at the same time reduce the dose.
That is a problem that has to be worked out.

CHAIRMAN ROTHENBERG: We have to cover several issues today, so I\'d like
to try to wrap this up. What I was hearing were at least three
recommendations that maybe the Committee would like to proceed with
motions on. One was just first of all dealing with the current CT
screening web site information to have that as a more targeted mailing
similar to what was done with the pediatric and small adult information
a year ago. I think that one would be able to deal with quickly. Can we
have someone make a motion?

DR. NELSON: I\'ll make a motion.

CHAIRMAN ROTHENBERG: Okay. So basically the motion will be to take the
information that\'s on the web site and distribute it to a more targeted
audience similar to what was done with the pediatrics.

MR. PLEASURE: I\'ll second that.

CHAIRMAN ROTHENBERG: A second. Any further discussion of that?

MS. LOSCOCCO: Would that be to include beyond the radiology community I
think was the intent?

CHAIRMAN ROTHENBERG: Yes. Any other? All in favor on the Committee of
that motion?

(Chorus of ayes.)

CHAIRMAN ROTHENBERG: It looks like pretty much unanimous with that.
That\'s certainly one recommendation. The other was just to follow
through on Dr. Stern\'s request or point out that they want to proceed
with the regulatory concept paper with more complete analysis of the
issues raised in his presentation. It sounded like we certainly want to
proceed with all these issues. Is there a motion?

DR. LAMBETH: Well, adding to it that image quality be made a significant
part of that concept paper which I don\'t think it was quite as
significant in the presentation as you just mentioned.

CHAIRMAN ROTHENBERG: So do you want to make that motion?

DR. LAMBETH: I move that the concept paper go forth with the dose and
image quality measures in terms of limiting dose to CT.

CHAIRMAN ROTHENBERG: Is there a second?

DR. LIPOTI: I\'ll second it, but I\'m concerned about the time line
which was given in the last page, page 19. The concept paper is to be
completed somewhere around December 2002. Then there\'s to be an update
for TEPRSSC.

At that point, I would assume we would be asked if we want to proceed to
a Notice of Proposed Rulemaking. That could take if we follow the
fluoroscopy example three to four years before a Notice of Proposed
Rulemaking gets out of the Agency. Then they\'ll be a 120 day comment
period, response to comments received another two years to respond to
comments. We\'re looking at maybe 2009 before we have final standards
for the manufacturers. I\'m very concerned about a time line that\'s
that long. I would like to add to this motion a compressed time line
which moves to the Notice of Proposed Rulemaking in 2003.

CHAIRMAN ROTHENBERG: Okay. Are you willing to accept that? Do you want
to comment on that?

DR. LAMBETH: I guess I would like to see what the concept paper produces
before we talk about producing rules from that and at least have the
opportunity for the Committee to review the concept paper before that
would go into a proposed rulemaking.

DR. BENSON: Well, certainly some kind of compressed time line might be
in order just simply to keep up with the pace at which technology
changes. We don\'t want to perpetually chase our own tails.

DR. LOTZ: I was also going to say that it seems like encouraging a
faster time line does not necessarily hasten questionable decisions or
whatever because even in an NPRM there is all the comment time and so
forth. FDA is not going to throw one out on the street without a great
deal of internal and probably even some stakeholder deliberations and so
forth. It would seem to me that there are safeguards built in the
process even in working with it and trying to move it along quicker.

DR. LIPOTI: I\'d like to speak to one more point about the need for that
compressed time line. We\'re basing a lot of this on the N.E.X.T. survey
data which I have seen. That survey data was collected in 2000 and 2001.
It has been since 2001 into 2002 that we\'ve seen the advent of these
screening clinics. This N.E.X.T. data does not capture the number of
people that are receiving these whole-body scans, asymptomatic
individuals with self-referral.

We need to do something about the equipment. We need to do something
about how the equipment is used. We need to do something to retro-fit
previously purchased equipment. We need to do something to educate
individuals about the use of equipment. But the first step and the need
for the FDA leadership is in setting something for the manufacturers to
shoot for.

It\'s true that there are CT machines available that already have an
automatic exposure control and some of these other features. But
there\'s no economic incentive for an institution to purchase these
unless there\'s a regulation requiring that they be purchased. So
despite all of the best intentions of the radiology community and the
medical physicists in recommending that these new features be purchased
on the machines, it really comes down to bottom line. It costs more to
buy something with an AEC or to have a dose-index readout which can then
lead to better use of the equipment. So I think we really need to move
forward on these three concepts.

CHAIRMAN ROTHENBERG: Well, is it possible for us to do more than
recommend that the time scale be compressed? We\'re already at May.
They\'re talking about having something in December.

DR. LIPOTI: They\'re talking about a concept paper. I want a Notice of
Proposed Rulemaking commitment.

DR. SULEIMAN: Let me clarify. The concept paper is an internal process.
We don\'t even go forward unless the center decides that the concept is
sound. I\'m not 100 percent certain of this but I don\'t think it\'s
necessary or essential to share it and therefore delay the process.
That\'s our own internal safeguards.

We\'re running these proposals by you now. You could argue that we
don\'t necessarily have to come in front of TEPRSSC again for this issue
because when we go with the proposed rulemaking, everything is out there
for everybody to comment on. So requiring another review by the
Committee, we have people who probably enjoy doing that but I think
it\'s not going to speed the process up. So I think we\'re trying to
weigh that internally.

The other thing is if you want to get work done, you have to keep the
task simple. I just beg you to try to keep the task clearly defined, the
recommendations clearly defined and then we can probably act on them one
by one. If you give us a run-on sentence, we\'re going to spend a lot of
time arguing about what you really meant. I think we want a clear
message from the Committee. If it means breaking up into three or four
very simple recommendations, we\'ll address them one by one.

MR. PLEASURE: Well, I would like to invite Dr. Lipoti to make a motion.
She expressed my concerns better than I did.

CHAIRMAN ROTHENBERG: Okay. We have a motion to proceed with the
schedule. It seems like there may be concern that maybe that\'s not the
way to go at this point, that we should give more specific targeted time
lines to actual proposed rulemaking as opposed to proceeding with the
concept paper.

DR. LAMBETH: Is the motion written? Can you read me the motion?

CHAIRMAN ROTHENBERG: Well, I believe it was to go ahead with the concept
paper as proposed by Dr. Stern with the addition of addressing the image
quality issue.

DR. LAMBETH: And so you want to put a time line on that concept paper
and then you want to add the other time lines.

DR. LIPOTI: No. Actually now that I know what the concept paper is I
could ignore the concept paper. I want to go right to the Notice of
Proposed Rulemaking. The internal workings of FDA really don\'t involve
me.

CHAIRMAN ROTHENBERG: Okay. But do we want to encourage them to go ahead
with the concept paper and address the image quality in addition to
anything else we\'re going to propose?

DR. LIPOTI: Maybe we should say we strongly endorse the framework which
has been provided by Dr. Stern. We urge the inclusion of an image
quality component. We strongly endorse FDA moving forward to proposed
rulemaking in 2003.

MR. PLEASURE: I\'ll second that.

CHAIRMAN ROTHENBERG: I\'m not a parliamentarian, so where do we stand
with regard to our previous motion?

DR. SANDRIK: Withdraw the first motion.

CHAIRMAN ROTHENBERG: Okay. So given that second motion, is there further
discussion on that?

(No response.)

CHAIRMAN ROTHENBERG: Okay. All in favor of proceeding according to the
motion made by Dr. Lipoti and seconded?

(Chorus of ayes.)

CHAIRMAN ROTHENBERG: Do we need to do more specific things with regard
to that motion?

COURT REPORTER: You need to announce the results for the record.

CHAIRMAN ROTHENBERG: Okay. Can we have the vote one more time?

COURT REPORTER: Just say the result.

CHAIRMAN ROTHENBERG: Okay. It appears to be unanimous. It is unanimous.
Okay. There was a further discussion about asking someone from the FDA
to come back to us and tell us about the capability to proceed with
recommending that older equipment which would be considered to have a
defect or whatever the appropriate word is to also be addressed in the
rulemaking. Did you want to propose?

MR. PLEASURE: I would propose that the issue be addressed in the
proposed rulemaking, and that the proposed rulemaking explain the
implications of this particular proposed rule to retro-fitting,
replacing, repurchasing older equipment applies, how labeling is
affected, that it is compliant with existing regulations would be
affected. In other words, I would like to see the proposed rule embedded
or framed in an explanation as to how this rule would be implemented.

CHAIRMAN ROTHENBERG: Are you talking about this rule in particular or in
general?

MR. PLEASURE: Well, right now I\'m just talking about this rule. I had
expressed myself before that it would be useful when we took up these
issues as Dr. Lipoti indicated before it would be good to see these in a
broad regulatory framework so that we understand both state, Federal,
and the various acts that affect our deliberations, how this all comes
together and changes practice in the field.

CHAIRMAN ROTHENBERG: Could we just ask then for a reply on what is the
authority to require retro-fitting of existing equipment to be in
compliance with new regulations?

MR. PLEASURE: Yes. I think the proposed rules should deal with that
issue. So that\'s as far as this motion goes. I\'m not now saying that
it must require retro-fitting. After you consider that issue, I may go
beyond that and suggest that we also may want to recommend what we think
the implications of this is for enforcement purposes.

CHAIRMAN ROTHENBERG: Okay. So for the moment we\'re asking for the
proposed rules with regard to CT that retro-fitting be considered.

MR. PLEASURE: Yes.

CHAIRMAN ROTHENBERG: Okay. Do we have a second for that?

DR. NELSON: I\'ll second.

CHAIRMAN ROTHENBERG: Okay. Any further discussion?

DR. SANDRIK: Just a couple comments. One point I think Dr. Stern brought
up was that probably the oldest systems are mainly single-slice systems
for which the collimation issue probably doesn\'t apply. The dose
savings regarding collimation is mainly probably on the most recent two
or three year old systems. I think some of those are probably being
addressed retro-actively anyway.

The issue of AEC is probably not going to be easily implemented back on
these systems, but in any case there is manual control. It\'s largely a
matter of user education to take advantage of those controls. Even if
AEC was retro-fitted on those systems, it\'s not required that they use
it in any case.

What\'s the other one? It\'s the reference levels. It\'s largely a
matter of user education. I\'m just not convinced that there is a lot of
benefit in trying to retro-fit particularly the old systems where some
of these things just don\'t apply to what the issues are raised in some
particular cases, like the multi-slice.

CHAIRMAN ROTHENBERG: Well, we\'re asking them to consider this. After
consideration they may decide how to proceed with that which may address
the issues you\'ve raised.

DR. LAMBETH: I tend to agree with the last comments a little bit because
on page 16, the uncertainty statements that are delivered with respect
to the projected benefits. If you can\'t be certain that there\'s any
benefits, then it seems like you\'re creating a situation. If it\'s a
requirement on old machines to retro-fit them, you\'re injecting a lot
of cost and time and difficulties without any real understanding of the
benefits. So if we\'re going to do a study on whether or not we should
do that, I think we should really tighten up on these benefits that are
going to be attained out of it so that you make a logical decision at
the end.

CHAIRMAN ROTHENBERG: Isn\'t that normally a requirement?

DR. LAMBETH: But I\'m saying tighten up on it. This is highly uncertain.
You go through this and it could be that the numbers are way off.

DR. SULEIMAN: Well, I think the uncertainty error margin is basically
just because of a lot of the atomic bomb data. That\'s just the best
science there is. I think this is just your discussion on your motion.

DR. LAMBETH: But there must be a lot of uncertainty in the aspect of how
much abuse there is to the machine in terms of just negligence of the
user as opposed to yes I always over-expose the patient because I want
to get a really good image and I\'m not going to back that off even if I
have automatic exposure control. I don\'t know how you get your hands on
that, but it\'s a crucial aspect of the process.

MS. FAHY-ELWOOD: I would just have a comment with all due respect, that
is separate of the motion that was made. The motion is that as part of
the process of proposed rulemaking that FDA consider that all old
machines be brought into compliance with the new rule. So that could all
be included in the discussion certainly within the rulemaking discussion
but as far as the motion goes, I don\'t know. The motion itself, are we
voting on the motion, I don\'t know if it applies.

DR. LAMBETH: Well, I don\'t know what it means to consider retrospect.
It seems to me part of the consideration process should be is it really
worthwhile because I think it probably represents a lot of trouble for
people to implement something retro-actively and to older machines.

DR. SULEIMAN: Again, I\'m trying to clarify here. The way I see it is
we\'re going to go back and we\'re going to look at the legal authority.
If in fact forget historically, traditionally, we grandfather in the old
equipment, do we in fact have the authority to retro-fit and make this
applicable to existing older equipment? I think that\'s a yes or no
answer by our legal staff.

I think the second issue of whether we go ahead or not on that is an FDA
decision. I guess once we find out we can do that then we\'ll make a
separate decision. If we don\'t have the authority, the decision has
been made for us. If we do have the authority, then I think we\'ll have
to do a more detailed economic analysis and benefit and find out we do
have quite a bit of information. There\'s no other such information out
there, but there\'s clearly a lot of information we don\'t have access
to.

How much more science? How much more data? That\'s why you\'re here, to
help balance and give us your opinion. Clearly we\'re not coming in out
of the blue on this thing because if you look at our CT web site and you
look at all the other organizations, professional societies, they have
all weighed in. They\'ve all stuck their neck out and expressed similar
concerns. We\'re clearly not doing this by ourselves. We\'re clearly
part of a large concern about this issue.

CHAIRMAN ROTHENBERG: Okay. I think we do have to move along. So can we
now take a vote on this most recent proposal? All in favor?

(Chorus of ayes.)

CHAIRMAN ROTHENBERG: Opposed?

(No response.)

CHAIRMAN ROTHENBERG: Okay. It\'s one opposed and the rest in favor.

DR. SANDRIK: Two opposed.

CHAIRMAN ROTHENBERG: I\'m sorry, two opposed. Okay. So we had how many
in favor? Let\'s just get the count again. Ten in favor and two opposed.
Okay. I think we then should take a short break at this point. Then we
would like to consider the next issue before our lunch break. Let\'s
make this short. About a ten minute break and then we\'ll reconvene at
11:10 a.m. Off the record.

(Whereupon, the foregoing matter went off the record at 11:00 a.m. and
went back on the record at 11:14 a.m.)

CHAIRMAN ROTHENBERG: On the record. Our next item of business is
generally labelled Sunlamp Products. We\'re going to have a presentation
by Dr. Howard Cyr, but we\'re also going to have several speakers in the
Open Public Hearing part in this. Dr. Suleiman is just going to read the
list. We\'ll start with Dr. Cyr\'s presentation.

DR. SULEIMAN: All right, yes. The four public speakers, I just want to
make sure we didn\'t leave anybody out. This is the order of their
appearance. It will be Don Smith, Joe Schuster, Steve Mackin, and Bob
Levin. When the public speakers speak for the record not only say your
name but also your affiliation.

CHAIRMAN ROTHENBERG: Okay. So now, Dr. Cyr, please proceed.

DR. CYR: Good morning. My name is Howard Cyr. I\'m with the Office of
Science and Technology in the Center. I guess I have to speak really
close to this.

CHAIRMAN ROTHENBERG: Are we okay on that microphone?

(No response.)

DR. CYR: I\'m going to speak about possible amendments to our Sunlamp
performance standards. I want to give you just a very brief background.
This started about four years ago. Several things happened. Number one,
it\'s been some 15 or 16 years since we looked at the performance
standard. Science has changed and we wanted to look at our standard in
terms of the changes.

The other significant event was a petition, actually two petitions, but
the main one from the Academy of Dermatology asking us either to ban
sunlamps or if that couldn\'t be done to strengthen our warnings and
educational efforts. We replied to them that we were not having any
intentions of banning sunlamps but we would work toward the second
request on stronger warnings.

I spoke to TEPRSSC two years ago. In that time, we presented five
possible amendments to our performance standard. We had looked at this
in some detail, and our assessment in the year 2000 was what we were
presenting to you at that time was a non-controversial. In reality of
course, things erupted rather quickly, and there were major concerns
from the affected industry. This became a matter of controversy in a
quick period of time.

I\'m going to highlight here two of those controversial proposals. At
the time, we thought it would be a good idea to incorporate a
recommended exposure schedule. That\'s how much dosage somebody should
get to produce and maintain a tan, how to build up to the tan and then
how to maintain the tan, putting that recommended exposure schedule into
the standard per se.

As an interim measure, we proposed putting the existing performance
standard in realizing full well that it was one of the items that needed
revision based on new science. You TEPRSSC people wisely told us why
incorporate something you already know is outdated into a standard. So
that was one of the items that turned out to be controversial and told
us not to go forward with.

The second one was to incorporate a non-melanoma action spectrum in
addition to what we were using at the time, an erythemal action
spectrum. The non-melanoma action spectrum is used internationally to
classify lamps. We were thinking along those same lines. At the TEPRSSC
meeting two years ago, you told us our use of this new action spectrum
seemed to be rather premature and that we really hadn\'t gone through
all of the various steps as to how we were going to use it, and why
don\'t we go back and study this a little more before we come back to
you with that particular proposal.

What you did instruct us to do was to go and talk with the stakeholders
and to try and iron out some of these controversial issues and then come
back at a later date with either revised or new issues after you have
met with the various groups. We met on September 13, 2000, with
industry; the medical and scientific community and went over quite a few
of these issues. I think we resolved quite a few of them at that time.

We planned for additional meetings. We were going to meet to discuss
lamp compatibility. That\'s if your lamp burns out and you need to
replace it, what qualifies as a replacement lamp. We were originally
going to do this in September, but that meeting got postponed until
February 7th and 8th of this year. So it\'s a relatively recent meeting.

Item number two there. We did meet with Health Canada in September. We
had to postpone the meeting because of the events of September 11th, but
the people from Canada had already purchased their tickets and said can
we come down and talk to you anyway. It would be beneficial for both of
us to talk about mutual standards between the two countries. So they did
come down, and we spent a good day talking with Health Canada in
September of last year.

With regards to education, you asked us to strengthen our educational
efforts. We have started some collaboration with the Conference of
Radiation Control Program Directors. They have suggested state
regulations on how states should regulate sunlamps in their particular
jurisdictions. We had a meeting with them.

We also discussed educational efforts at that particular meeting. I
would note that the industry itself since our deliberations a couple of
years ago have started quite a few programs on their own in terms of
education. There seems to be quite an effort on the part of the industry
in this particular area.

Also in the meantime, CDRH, our group is convinced that more research
was necessary particularly on the issue of recommended exposure
schedules. We want to know how different people with different skin
types tan and how long do they maintain that tan. I want to talk to you
about two studies.

We have one which is more than halfway done, almost towards completion.
That is to look at the various measurement techniques, instruments,
biopsies, and studying thymidine dimers and things like that to try to
get a better feel for skin sensitivity to UV. We\'ve had more than 100
human subjects in this study. I think about 70 have partaken right now.
We\'re trying to finish the study off.

The second part of this is a new study. That is to actually do the job.
That is to come up with a recommended exposure schedule for producing
and maintaining tans. This will be using lamps that are more similar to
those that are used in the salon. For purposes of science in the first
part and to get the job done quickly, we use lamps which have more UVB
then is currently used in salons and are not typical of those used in
the salon.

Today we\'re back here and we think we\'re ready to go forward with four
proposed revisions. These are revised warning labels, the inclusion of
these labels or statements into catalogues, specification sheets and
descriptive brochures. We also want to visit the question of who is a
manufacturer. That is someone who makes significant modifications that
affects the performance as specified in the standard. There are certain
performance requirements spelled out per se in the performance
standards. If you do something that dramatically changes those
requirements, you assume the responsibilities of becoming a
manufacturer.

This requirement is already per se in the device laws. It\'s
incorporated in the laser standard. We wanted to put it per se into the
performance standard for sunlamps. The last of the four is revised
specifications for protective eyewear.

Rationale for these revised proposals. We wanted a clearer,
user-friendly warning label. What we have now is a rather long
paragraph. We wanted something that is easily read. We wanted the
warnings to appear in home-use products and in advertisements. The part
about advertisements is new. The appearance in home-use products, there
are labels on the products, but the customer who buys it doesn\'t
actually see the label until such time as they have purchased the
product. So that\'s one of the rationales for including it in the
advertisement. You can see the warning labels before you\'ve actually
made a purchase.

CHAIRMAN ROTHENBERG: Could you just put it back on the slide show mode
so it\'ll be bigger for the audience?

DR. CYR: Requirements for a manufacturer is something that we wanted to
include in the performance standard per se. I\'ve already covered that.
It\'s part of medical device regulations, and it\'s in the laser
standard. We wanted to put it into the sunlamp performance standard.

We also wanted to incorporate new requirements for protective eyewears
that are more quantitated and consistent. You notice I put the word
goggles in parenthesis here. This is because the international community
prefers that word. That\'s a word that they like.

We use the word eyewear. I think of goggles as most Americans do as
something big and bulky whereas eyewear can be rather simple that just
covers the eyeball. If we were to go toward an international standard,
the decision between eyewear and goggles would have to be ironed out.
Maybe we would leave it this way, eyewear (goggles).

Here\'s the existing warning statement. Danger, ultraviolet radiation.
Follow instructions. Avoid overexposure. As with natural sunlight,
overexposure can cause eye and skin injury and allergic reactions.
Repeated exposure may cause premature aging of the skin and skin cancer.
This goes on for three slides.

Wear protective eyewear. Failure to may result in severe burns or
long-term injury to the eyes. Medications or cosmetics may increase your
sensitivity to the ultraviolet radiation. Consult physician before using
sunlamp if you are using medications or if you have a history of skin
problems or believe yourself especially sensitive to sunlight. If you do
not tan in the sun, you are unlikely to tan from use of this product.
Having gone through three slides and read that you can understand maybe
why we would want something in bullet form and a little easier to read
and understand.

This is what the international community has come up with. Warning.
Ultraviolet radiation may cause injury to the eyes and skin such as skin
aging and eventually skin cancer. Read instructions carefully. Wear
protective goggles provided. Certain medications and cosmetics may
increase sensitivity.

I put this up here because we presented this earlier at one of our
meetings and there was considerable concern about the word
\"eventually\" and that\'s why I have it in italics. That almost implies
that it\'s inevitable. That\'s certainly not the case. Not everybody who
goes to the beach or who goes to a tanning salon will get skin cancer.
So we certainly took that under consideration and have dropped that word
from what we\'re proposing on the next slide.

The other change that we\'ll make between this slide and the next one is
the very last line. Certain medications and cosmetics may increase
sensitivity. People told us that they wanted the words sensitivity to UV
radiation. I did make that change.

Here is the revised warning statement that we are suggesting today.
Warning. Ultraviolet radiation may cause injury to the eyes and skin.
Skin aging, skin cancer. Read instructions carefully. Wear protective
eyewear (goggles) provided. Certain medications and cosmetics may
increase sensitivity to ultraviolet radiation.

We also propose that these warning statements be included in all
catalogs, specification sheets and descriptive brochures and any other
purchasing information pertaining to each Sunlamp Product and
ultraviolet lamp. A legible reproduction of the warning statement
required by the Code of Federal Regulations Chapter 21 and Part 1040.20.
That\'s the performance standard.

It also says that the modification of a Sunlamp Product previously
certified under this chapter by any person engaged in the business of
manufacturing, assembling, or modifying Sunlamp Products shall be
construed as manufacturing under the act if the modification affects any
aspect of the product\'s performance or intended functions for which
this section has an applicable requirement. The manufacturer who
performs such modifications shall re-certify and re-identify the product
in accordance with Chapter 21 of the Code of Federal Regulations.

Examples of some of the modifications are if you change the warning
labels on your product, if you go beyond the maximum exposure timer
limit that\'s part of the standard. They\'re spelled out into the
performance standard. You can easily see what those are.

I know that the industry has some major concerns about this. Some of the
speakers will be addressing that. They\'ll want more detail than that. I
sympathize with them on the detail. I think it\'s something we can work
on. I\'m not objecting at all to what they\'re going to present since
I\'ve seen it. It looks reasonable that we negotiate with them to try to
iron out the details.

Protective eyewear. I want to tell you what\'s there right now.
Currently it says the spectral transmittance shall not exceed a value of
0.001 over the wavelength region 200 to 320 nanometers, that\'s a UVB
region, and a value of 0.01 for a 320 to 400 nanometers, the UVA region,
and shall be sufficient over the wavelength region above 400 nanometers,
the visible, to enable user to see clearly enough to reset the timer.

We\'re going to make some changes regarding some levels and wavelengths.
We also certainly want to change the last one because nobody right now
goes and resets the timer. That\'s not done. We don\'t want people to do
that. You should be able to see the stop button to shut the emissions
off, but once you set it, that\'s it. It\'s usually done out at the
desk, not inside of the room. That\'s my understanding.

Here\'s the proposal. This one is wrong. Obviously since I messed up my
slides, I have the wrong one here. For a visible region, a more
quantitative definition, the luminous transmittance shall not be less
than one percent and the unweighted transmittance between 400 and 550
shall not exceed five percent. The measurements are over a five
nanometer interval, not a two. These are last minute changes that we
messed up on. So it\'s a five nanometer interval and the wavelength
region applies to the unweighted transmission.

Some other issues that we\'ve been discussing. I told you that we had a
meeting on February 7th and 8th about replacement lamps. We want to
determine an absolute method of compatibility. We think we should be
ready for a presentation of this issue at the next TEPRSSC meeting.
It\'s going to take us that long to prepare a proposed rule. There are
lots of steps in the writing of a proposed rule. We\'ll be doing that in
the next year but also preparing this extra issue to present next year,
and only then would we go forward with a proposed rule.

We have been discussing other issues which we think are more long-term.
That\'s being brought about because of our interest in coming up with
international standards that are harmonized between the various
countries. Again this goes back to some of the things which were
controversial; the non-melanoma skin cancer action spectrum which is
used in the classification of lamps into categories and also some caps
on irradiance, how strong a delivery of dose can be given from these
particular products. I\'m not going to say much more about these. These
are still from our concern from the Center as being in development and
being discussed.

In summary, I\'ve presented four proposed amendments at today\'s meeting
of TEPRSSC. We think we\'ll be ready with a fifth one at the next
meeting involving a lamp rating system. We will obviously continue on
with our evaluation and laboratory studies that are ongoing. We will
work toward international harmonization efforts that are coming down the
road. Thank you.

CHAIRMAN ROTHENBERG: Okay. Thank you. Are there questions from the
Committee?

DR. LAMBETH: I have a very brief question on your eyewear (goggles)
proposed statement. Why did you limit it to 550 nanometers, the
transmittance? Should not be less than one percent over the 400 to 550.
I assume this is the region where you\'re trying to make sure the person
can see.

DR. CYR: Right. I\'d like to introduce Sharon Miller our engineer from
the Office of Science and Technology who is the expert on the eyewear
part.

MS. MILLER: So you\'re wondering why we\'re limiting the transmittance
over the 400 to 550 nanometers?

DR. LAMBETH: No. You\'ve made sure people can see. You have at least one
percent transmittance over the blue and up to the green. But what was
the one with the red?

MS. MILLER: Okay. No, that was the error in the slide. The one percent
lower limit on luminous transmittance by definition that actually covers
up to 780 nanometers.

DR. LAMBETH: Okay.

MS. MILLER: But the 400 to 550 is for the five percent cap just on
unweighted transmittance. We need to correct that in the handout.
That\'s to protect the eye from too much visible light.

DR. LAMBETH: I was looking at the handout. So the slide was different.
Is that what you\'re saying?

MS. MILLER: No, the slide was the same. It was also an error. Both the
handout and the slide were done before we \--

DR. LAMBETH: Okay. So you\'re limiting it to five percent total
transmittance in the \--

MS. MILLER: 400 to 550.

DR. LAMBETH: That\'s an integrated transmittance.

MS. MILLER: No, the transmittance would be measured at five nanometer
intervals, and we don\'t want that value to go above five percent
anywhere in that wavelength region.

DR. LAMBETH: Okay. Then above that wavelength?

MS. MILLER: Above that wavelength region it could as high as they want
because that\'s not a hazardous region for the retina.

DR. LAMBETH: Okay. So the 550 is hazardous?

MS. MILLER: Well, we know that the blue light hazard function starts
dropping off between 500 and 600. The reason we chose 550 was because
that\'s the wavelength region that\'s been in the IEC standard for
several years. I can\'t say that 550 is a cut-off point between
hazardous and not hazardous. That\'s just a practical region to use.

DR. LAMBETH: Okay. Thank you.

CHAIRMAN ROTHENBERG: John.

DR. SANDRIK: Yes. Just to pursue that a little further. I guess I
sympathize with your intent to have a more quantitative standard there.
As Dr. Cyr indicated, the purpose has changed from resetting the timer
to just shutting off a button or something. But I guess there\'s the
value in the indication of why it is you want to have a certain level of
transmittance and I guess it\'s to be able to see something.

I guess at these levels it would probably assume that this shut off
button is illuminated at some particular level of luminance so that when
it comes through this eye-goggle you can see the shut off buttons. Is
there some sort of typical standard level that this thing is illuminated
at or it\'s self-luminous or something, so that you can always assure
that you can see this thing at this level of transmittance?

MS. MILLER: No. Currently I don\'t believe they are luminated in
general, and there\'s no requirement for them to by illuminated. But the
one percent luminous transmittance we\'ve worked out with other
engineers on the IEC Committee, just based on qualitative tests of
eyewear, holding them up in sunbeds and saying can we see what we need
to see and then measuring the luminous transmittance, that value seemed
to be a reasonable value to allow people to see well enough to push the
stop button or get out of the bed if they need to and just see well
enough to be able to function.

DR. SANDRIK: Okay. So essentially the stop button is probably being
illuminated by the \--

MS. MILLER: By the light from the bed.

DR. SANDRIK: From the bed. You can probably assume that there\'s some
level of luminance or illuminance that gives you enough to see by. Okay.
Thank you.

MS. MILLER: Right.

DR. LAMBETH: I\'m still a little confused. Could you just read me the
proposed proposal? What we have isn\'t right.

MS. MILLER: Okay. Right. I don\'t have it in front of me. The
requirement is that the luminous transmittance which is a calculated
value based on the spectral response of the eye, that is a function that
goes from 380 to 780 nanometers. So you\'d have to calculate the
transmittance of the eyewear, multiply it by that function, in addition
multiply that by a standard light source spectrum, integrate that, and
then divide that by \--

It\'s a complicated formula. So that\'s a value that\'s based on the
integrated transmittance of the eyewear over the 380 to 780 nanometer
region. That should not go below one percent. Really this is a
quantitative way that you can measure that will meet the same
requirement that we have now that says you should be able to see clearly
enough through the eyewear to be able to reset something or push a stop
button.

Then the other requirement is a cap on how much transmittance you can
have in the visible region. That is that the spectral transmittance of
the eyewear between 400 and 550 nanometers measured at five nanometer
intervals shall not go above five percent.

DR. LAMBETH: Okay. Thank you.

CHAIRMAN ROTHENBERG: What are the UV numbers?

MS. MILLER: We haven\'t discussed UV limits because those are going to
remain exactly the same as they have been.

CHAIRMAN ROTHENBERG: Just for reference, what are they?

MS. MILLER: That\'s 0.1 percent in the UVB and one percent in the UVA.

DR. BENSON: Is the revised warning statement also going to be on the
boxes of sunlamps purchased for home use as well? Would it be the same
statement or a different statement?

DR. CYR: Our intention was that it would be the same statement.

DR. BENSON: Okay. Because it says \"wear protective eyewear (goggles)
provided.\" Are they going to be in the same box or is it encumbant upon
the purchaser to buy their own eyewear?

DR. CYR: I know that some people from the industry are going to address
that issue. There\'s a debate as to what that means in the standard as
being provided. The custom right now is that most customers going to the
salon purchase their eyewear. If the customers apparently don\'t want to
do that for some reason, they will be provided with eyewear as required
in the standard. But the custom and tradition is that people buy their
protective eyewears. There\'s a wide range of different colors and sizes
and shapes. That gives them a choice as to what kind they want.

DR. BENSON: But there\'s nowhere in here about that. For someone buying
a sunlamp to use at home, there\'s nothing to indicate that there is a
certain kind of approved eyewear that they need to look out for.

DR. CYR: Good point.

DR. BENSON: And that it\'s not simply sunglasses.

DR. CYR: Thank you. I had not thought of that. The change on eyewear
came to me last evening. I will incorporate it into the slides and mail
the new slides to you by E-mail to all those who sign up on the sheet
here. So be sure to sign up on the sheet and I\'ll get copies of the new
slides to you.

AUDIENCE MEMBER: All units come with eyewear.

DR. CYR: All home units come with eyewear.

DR. BENSON: And this eyewear would conform to these standards.

DR. CYR: They would conform to the standards, right.

DR. BENSON: Okay. And there\'s something on the box that says wear the
eyewear that is given to you and none other.

DR. CYR: Yes.

DR. BENSON: Okay.

DR. CASWELL: A couple of brief questions. First, in your warning
statement, why skin aging rather than a more generic photo aging? Any
reason for that? Is it to conform with IEC?

DR. CYR: That came out of IEC I suspect because photo aging may be a
term that many clients wouldn\'t understand. It\'s a good scientific
term. I understand it and you do and others, but it may well be that
they thought an average person might not understand the term photo
aging.

DR. CASWELL: Okay. The second question, Dr. Cyr, is in terms of the
manufacturing issue, who is defined as a manufacturer? It\'s my
understanding that tanning beds are Class I medical devices.

DR. CYR: Right.

DR. CASWELL: Do manufacturers of Class I medical devices need to be
licensed?

DR. CYR: No.

DR. CASWELL: No. They\'re exempt from that. So that would not be a
requirement for someone who wanted to modify a tanning bed.

DR. CYR: I\'m not following the question.

DR. CASWELL: If a salon operator wanted to retro-fit a tanning bed to
modify the specifications, the performance characteristics of that
tanning bed, they could do so as long as it met the current performance
specifications.

DR. CYR: Right.

DR. CASWELL: Okay. Thank you.

DR. CYR: The discussion was can you change an acrylic shield or
something like that.

DR. CASWELL: Right.

DR. CYR: You can put in lamps that are compatible. We have a policy
letter on compatibility. You can make those kinds of changes.

CHAIRMAN ROTHENBERG: Yes.

DR. MABUCHI: Just one minor question. In the warning, you say injury to
the eyes and the skin. The skin aging and skin cancer. Are you implying
there is some other type of injuries to the skin other than skin cancer
and aging?

DR. CYR: Other kinds?

DR. MABUCHI: You\'re saying injuries to the eyes and skin and also the
skin aging and skin cancer. Does it imply that there are other skin
lesions besides skin cancer and aging?

DR. CYR: There are talk about immune effects but we didn\'t include
anything like that in there. Oh, burns, yes. Sunburns, sure.

DR. CASWELL: But those are acute effects.

DR. MABUCHI: Acute effects, yes.

DR. CASWELL: These are really addressing chronic effects.

DR. CYR: We meant to include acute effects in there too. That\'s what is
meant by injury to the eye and skin were burns.

DR. CASWELL: That covers it.

DR. CYR: I know that one of the comments will be to put sunburn per se
into that warning statement.

CHAIRMAN ROTHENBERG: Yes. I think what I\'d like to do is have some
public comments and we\'re still going to continue discussion after
that. So why don\'t we go ahead with the speakers? The first speaker
will be Don Smith. Would you please just identify your organization, *et
cetera*?

MR. SMITH: Can you hear me? Is this on? Two years ago when I left this
meeting and was flying back to Tucson, Arizona I realized that we were
going to need scientific information to present to this Committee on a
number of subjects on down the line.

CHAIRMAN ROTHENBERG: Can you just identify \--

MR. SMITH: So we formed the UVR Research Institute which is a division
of the North American Alliance of Tanning Salon Owners. The UVR Research
Institute occupies 1,950 square feet. We have sophisticated
spectroradiometric and other testing gear. We have set out to try to
identify those things we need to know about the testing of sunlamps,
sunbeds, eyewear, *et cetera*. So that\'s been our basic purpose.

I would like to mention that Dr. Cyr has been very good about removing a
lot of the offensive words. We could argue about the warning label
forever. But the only comments that I would like to make are from our
side of the point we are concerned about when we get this global
harmonization that comes to us.

\(1\) The culture is different. The language is different. So we have
problems with that. (2) In the European system as best we can identify
it there is no opportunity to have sessions like this where you can make
comments. Some of the things that come over to us we\'re a little
concerned about what we\'re getting that anybody\'s had any input on.

Regarding the warning label, the only changes I still was arguing with
Dr. Cyr last week is I believe that instead of saying \"may cause\" that
it\'s more scientifically correct to say \"may contribute to these
things.\" I\'d asked him to put sunburning in there because that\'s the
most leading cause.

Let me just tell you that my remarks are made from the point of view of
all of us that are out there actually tanning the people in the field.
No one will ever look at these warning labels on the beds. That just
doesn\'t happen. They\'re in there to get their clothes off and get
ready.

So it may be helpful for you to know that there is a form that is
generally in use that\'s a client release and informed consent form that
will be changed to conform with whatever language. It goes into much
more detail that the client signs and fills out at the time that they do
it. So that the label that\'s on the bed is just a small part of what
we\'re doing to properly inform the client as to the risks involved in
the tanning procedure.

That may help you to see that we do this. This is accompanied with just
for your information a complete skin typing, sub-typing form so that you
can\'t set up exposure schedules as you know unless you know the skin
type, sub-type of the individual. These are on the front and back and
the client signs those things and they\'re kept for permanent record.
That\'s all the comments I had to make on the warning label, just to
thank Dr. Cyr for being so kind to address all these.

I\'d like next to discuss the issue of the definition of a manufacturer
because that\'s the one that causes the most concern. We had a meeting
on the 7th. We submitted that on the testing of a single lamp and a test
stand are standard procedure. We went a long way. I\'d recommend that we
meet again in September or October and again next year in February
because I believe we have the capability of coming to this Committee
next year and recommending a standard protocol for both the testing of a
single lamp and a test stand and which is more complicated testing the
array, *i.e.*, the complete sunbed.

My concern with this is we talk about any aspect of the products
performance or intended function. We know what the intended function is.
That\'s not a problem. If we do not have a standard protocol for testing
the array, *i.e.*, the sunbed, how are we going to determine
performance? We can\'t. That\'s the problem that we have with it, not
that there isn\'t a valid reason on this.

I\'ve asked the question and the material you have is how can FDA
recommend that TEPRSSC approve this if it\'s based on the standardized
measurement at performance and yet we have no standard protocol for
measuring performance. So it seems like we got the cart before the
horse.

Therefore, our recommendations to this Committee is to reject this
approval of Amendment 3 once again and challenge us all to meet again
this fall and meet again next spring and come to you with two documents.
One is a standard protocol for testing a single lamp and a test stand
which will resolve the lamp compatibility issue. Two is a standard
testing protocol for the array, *i.e.*, the sunbed so that we can
resolve all the other issues that stem from that which is exposure
schedules, *et cetera*.

Now we\'re ready to present this in September. We\'ve come up with a new
spectroradiometric technique where we can measure the change over time.
We read the entire spectrum. We can follow it. So there\'s performance
degradation in both the lamps and the bed. We\'ve also developed a new
eight-point technique to where we measure the radiation around the whole
body. What those two things allow us to do is to calculate the dose
delivered during that session. We think these are interesting to note.

So I believe that we can\'t do this now unless and until we do these
things. If we do it now, it\'s going to be left up to the manufacturers
to decide. They\'re going to say you have to buy our parts. It\'s going
to put the tanning salon owner at a distinct disadvantage. Let me tell
you how important these are.

If a salon owner is considered to be the manufacturer or record on a
product, the manufacturer\'s warranty and product liability insurance
will be null and void. That avenue of coverage for the public is gone.
I\'ve checked with all five of the insurers who insure tanning salons.
They assure me if a salon owner is named the manufacturer of record,
that coverage is gone.

So what we do here if we\'re not careful is we now have the public
dealing with a situation that has no insurance coverage. That\'s how
important it is. My recommendation is let\'s define performance first.
Let\'s come back to you next year and do that.

The next area is to get into the issue of eyewear. We have tested all of
the leading eyewear that are sold. Based on the old 0.1 and one percent
standards, we believe that all of it is in compliance. We\'ll get
differences between lenses. We do not believe that the products sold
including the disposables that we\'re providing to the customers present
any risk to the industry.

I\'d like to bring you to Dr. David Sliney of the Army that a lot of you
know is the expert in it. He says in a 2001 paper that we don\'t really
know how much is safe and we don\'t have any answers to these questions.

I\'d also like to point out to you that in doing this research to talk
to you about this I began to look at it in light boxes where we set 13
inches away for 20 minutes have 10,000 lux. If you can\'t handle that,
you can go 5,000 lux for 60 minutes. We decided to measure in a standard
sunlamp that has a 20 minute time to 4.0 MED. We measured 1,743 lux.

So we\'re dealing with a different phenomenon here that we have to keep
in mind. I then took this and said if this was this five percent T thing
if we applied that to the box, you can see what that would mean. Going
beyond that, we said there\'s a lot of evidence and then there\'s the
citations, studies done for the military and they found that it took 23
percent transmission in the visible range in order to have the proper
visual acuity to see the cockpit dials.

Let me tell you the problem we\'re facing from my side. Right now the
new beds that are coming out have all the controls all around the
canopy. There\'s fan controls, aromatherapy controls, up and down
controls. So what happens today with the old generation of eyewear that
restricted to this under five percent is those people must take off
those goggles to see the controls. That isn\'t productive. All of us
agree that it shouldn\'t happen.

The new generation of eyewear that\'s come out allow enough additional
vision to where they can see these controls with them. Now while some of
those products out here today would be grandfathered if we\'re not
careful about this five percent, we\'ll create a situation where we\'re
going to mandate that these people have to keep taking their eyeglasses
off to see them.

Just one more slide to show you this is some work that we\'ve done where
we\'ve compared sunlight with an Optronic 754 spectroradiometer. The
sunlight data was determined on August 28th at 11:30 p.m. As you know if
you\'re going to talk about sunlight and make comparisons, you have to
precisely define the terms under which you measured that sunlight.

As you can see here, we have sunlight. If we\'re worried about the
retinal burns from the visible range, we have a lot of problem in the
sunlight. Yet the military specs are 25 to 50 percent for visible light
transmission for sunglasses. So that\'s the problem that we have if you
begin to look at these things. Plus there\'s some concern as Sharon
Miller raised about is there a problem with high pressure lamps.

Remember the typical sunlamp is a three to four percent UVB which is why
Dr. Sliney is concerned. That\'s the most dangerous ranges we\'re
working with for the eye. High pressure is about 0.4 percent. We\'re
dealing with a different issue.

Here\'s the recommendations. You have a copy with you that we have made.
We\'d like to present for your proposal. I\'m not sure Sharon if I have
those numbers right, but it\'s now as I understand it 380 to 780 which
is what we thought it was Monday. Then down here it is now 400 to 550.

We\'re trying to solve the problem of having enough light to see these
off switches and the controls. That\'s what we want to do. If we\'re not
careful in the older products, it forces them to remove it. The new
generation of eyewear allows more visible through. But they typically
will range in the ones that we\'ve tested in the 15 to 35 percent range.
That\'s still within the 25 to 35 percent range of sunglasses for
military aviators. Clearly the existing products would be grandfathered,
but it would prohibit the development of new eyewear that people can see
these controls. If you\'ve ever had a chance to look at these beds, they
have stuff all over them that you have to see.

So what measurement device will we use? Are we going to use a
spectrophotometer with a Tungsten bulb? We believe that we should use
both tube-type and high pressure lamps because that\'s what we\'re in
the cabin. That\'s what we\'re using. So our testing has been done on
real, live tanning lamps.

Today out of the Institute they\'re testing high pressure lamps with the
various eyewear. We set up a field. We know the irradiants. We put the
eyewear device in the middle. We read it just like the eye would see it.
We have some concern about this.

If you want to look at light boxes, the light boxes I mentioned to you
have 10,000 lux that you set 13 inches away. If we have a problem here,
FDA ought to jump on these light boxes really quick because we have
1,700 lux and they have 10,000. We need to put these things into
perspective.

What we would recommend is that we need to decide what we\'re going to
do; spectrophotometer, spectroradiometer. Our thoughts as of a meeting
we had Monday is we probably ought to do both. We\'re testing today also
a high UVB percentage. We have lamps that approach eight percent UVB.
That\'s probably the worst case, and we think we ought to test it there.

You need the filters. What device and the distance of the eyewear? So we
need to set up parameters on how we\'re all going to test these eyewear.
Then set up an ad hoc committee is what I recommend. There\'s six
companies that make eyewear. There are some of us that are interested.
Dr. David Sliney would be an excellent additions and there are some
experts at the FDA.

Let\'s study this. Let\'s find out what more than percentage makes good.
Is five percent right just because somebody from Europe put this in
something that we can\'t find the documentation on? What we recommend is
this Committee consider giving conditional approval but write the five
percent in with a pencil until we can study this. It shouldn\'t take us
but a month or two to do so. I also recommend as I mentioned a meeting
in September or October and one again next February or March so that
next year we can come in and present a lot more information to you.
Thank you.

CHAIRMAN ROTHENBERG: Thank you. Could you just tell us how many people
are involved in the Institute, the staff?

MR. SMITH: Well, we have three of us that are in there most of the time.
Barbara Grant is in there full time running the spectroradiometer. She
has a Master\'s Degree from the University of Arizona. We\'re poorly
funded and small, but I think as Sharon Miller and the people can tell
you we\'ve presented I think some pretty valuable information. We\'ve
gone in and tried to look at the basic things of how the sunlamps and
sunbeds work.

CHAIRMAN ROTHENBERG: Okay. Thank you. We must move on to our next
presenter who is Joe Schuster.

MR. SCHUSTER: Good morning, ladies and gentlemen, TEPRSSC Committee. My
name is Joe Schuster. I\'m the Vice President of tanning products for
the sunlamp manufacturer Light Sources, Incorporated. Today I\'m
speaking on behalf of the Indoor Tanning Association. My comment will
mainly focus on the labelling issue that you see in front of us.

As Dr. Cyr pointed out in previous meetings we\'ve not had significant
changes to the standard since 1986. With that in mind, we\'d like to
make sure that the labelling is very clear to the end user so that
there\'s not an undo public health risk. With the way it\'s set up right
now if you take a look at it, we think that it may be confusing that
regardless whether or not you wear eye protection, you still may have
eye damage. What we\'d like to see is with the first bullet point.
Ultraviolet radiation may cause injury to the skin. Skin aging, skin
cancer. Read instructions carefully.

When it comes down to protective eyewear, you\'ll see and I think one of
you noted earlier there\'s really no definition as to what type of eye
protection is necessary. The way it\'s looked at now, you could wear
sunglasses if that\'s the case. We think it should be clearer defined.

With that in mind, we feel that this bullet point should read wear
federally compliant eyewear. Unprotected exposure to UV radiation may
cause eye injury. We feel that\'s a little bit clearer in the
definition. That certainly will keep people away from an undo health
risk. Any questions?

CHAIRMAN ROTHENBERG: Any questions?

(No response.)

CHAIRMAN ROTHENBERG: We will have a more extended discussion session.

MR. SCHUSTER: Thank you for your time.

CHAIRMAN ROTHENBERG: Thank you. We\'ll move onto the next speaker who is
Steve Mackin.

MR. MACKIN: Good afternoon. I\'m Steve Mackin. I\'m from Solartech
Incorporated. We\'re one of the several companies that make handheld UV
meters to measure either outdoor UV index which the EPA is using some
right now for the Sunwise School Program. We also make meters for
measuring indoor ultraviolet, total UV, UVB, and MED per hour.

This is hard to read but it\'s a one pager trying to emphasize the
importance of eventually standardizing on outdoor versus indoor MED
definition. The FDA has proposed to define type II skin MED as 200
Joules per meter squared effective Diffey for sunlamps. That actually
brings it very close to the 200 Joules per meter squared that the WMO
and the EPA is currently using for the UV index. We support that, and we
think it\'s a very good idea. As you know, today it\'s 156 Joules per
meter squared.

If that does come true, this has some bearing to the definition of a
manufacturer amendment that you\'ve just been considering in the sense
that it will give everybody a uniform way to determine the effectiveness
of the sunbed and relate it to the outdoor index as well. They\'ll be
basically one and the same since the erythemal irradiance is the same
for both.

Accordingly if NWS and WMO decided to adopt 200, they could actually
change the UV index by taking a dividing factor from 25 that it is now,
the WMO, down to 24. They\'d have something totally compatible. Or if
the FDA decided they wanted to go to 210, then it would be identical to
the UV index.

At the previous meeting in February, Don Smith presented some
information about possibly using 180 Joules per meter squared. That
would give one MED and one SED, one SED being one-half of one MED, it
would give it an exact relationship to one UV index. So that\'s another
thing that could be considered.

It\'s our opinion that having different MED definitions and EAS
weightings between sun and tanning lamp measurements leads to confusion
and lack of common understanding. Since modern sunlamps are very close
to what we call the standard sun spectral irradiance, there doesn\'t
seem to be any reason why we should keep them separate anymore. They
should be identical.

Just a note here. The standard sun is 9.3 on the UV index or four MED
per hour which just happens to be the same as a tanning bed max timer
schedule of T~e~. That\'s at 210 Joules per meter squared. Using 200 as
an MED, the standard sun would be 8.9. If you round that off to nine,
you can see that a tanning bed reading 27 on a UV index would be three
times stronger than a standard sun. Hence the 20 minute T~e~ or maximum
timer to form that would be understandable.

The last half of this has to do with potentially in the future
considering the non-melanoma skin cancer action spectrum as part of the
equation for measuring sunlamps. Our position is that would confuse
things even further because it\'s very similar to the Diffey curve but
it starts out lower at 280 and it rises up toward 297 then it pretty
much follows the Diffey erythemal curve beyond that. It has two specific
wavelengths that it cuts off at for UVB and UVA and would be difficult
to measure.

That\'s about it. Basically asking that we consider sunlight and tanning
lamps as similar as far as erythemal effectiveness goes and taking them
together. There\'s one more slide here.

DR. LIPOTI: Larry, while he\'s putting up the other slide could you ask
Steve Mackin to please define NWS, WMO, MED?

MR. MACKIN: Sure. National Weather Service, World Meteorological
Organization. What was the other one?

DR. LIPOTI: MED.

MR. MACKIN: Minimal Erythemal Dose.

CHAIRMAN ROTHENBERG: And EAS.

MR. MACKIN: Erythemal Action Spectrum.

CHAIRMAN ROTHENBERG: Anything else?

MR. MACKIN: Sorry. I\'m so used to those abbreviations.

CHAIRMAN ROTHENBERG: Yes. Most of us are not necessarily familiar with
those.

MR. MACKIN: It\'s a Word Document.

CHAIRMAN ROTHENBERG: It\'s a Word? Okay. We\'re in Power Point and we
want to be in Word.

MR. MACKIN: All files.

CHAIRMAN ROTHENBERG: Any other brief questions?

MR. MACKIN: Well, rather than show that slide, in your handout there\'s
a graph basically that shows the Diffey erythemal action spectrum which
is the black line. It is basically weighted at one all through the UVB
range up until about 297. Then it heads down to about 330. Then it goes
out at a lesser slope towards 400. The idea of measuring either UV index
or MED per hour is to try and replicate as exactly as you can that
particular weighting function. This particular meter follows the blue
line there.

The other action spectrums that people have considered, I believe
there\'s an FDA specific one and there is the potential and non-melanoma
skin cancer one, the slope are almost identical. The reason I brought it
up in the one pager there is that if we settle on one action spectrum
for outdoor sun which is that one for the UV index and the National
Weather Service, let\'s at least stick with that for indoor lamps. I
believe that\'s pretty much the way they\'re heading. That\'s it.

CHAIRMAN ROTHENBERG: Thank you. We have one more speaker, Bob Levin.

DR. LEVIN: I\'m Bob Levin. I\'m with Osram Sylvania. I\'m here to
discuss one particular aspect of tanning lamps. That is a problem of
lamp compatibility that may compromise exposure safety.

There are new regulations under consideration now which may resolve
this. They come in the future development as opposed to the immediate
proposals. Lamps are identified in terms of two functions now. One is in
erythemal weighting. Another is melanogenic weighting. They\'re very
highly correlated. So in my discussion, I will just use the term
erythemal at the moment. There\'s no reason to make a distinction.

The method of identifying lamps at the moment is to take a spectral
power distribution at a fixed specified point with respect to the lamp
and from this calculate the time for a prescribed erythemal dose. This
is refered to as T~e~, the permitted exposure time. Note this a
benchmark value for a lamp that has nothing to do with actual exposure
in a tanning system. It\'s a historical artifact because in an actual
tanning system there are multiple lamps and the system will also affect
the exposure.

However, the systems are certified for a particular manufacturer\'s lamp
type. It is important that other manufacturer\'s lamps be substituted,
for example, matter of availability at times. The existing rule for the
compatibility of lamps is that the T~e~s for the original lamp used to
certify the bed and for the equivalent lamp that is substituted may not
differ by more than ten percent.

However, at the present T~e~ is not an absolute value. It\'s not
possible to determine a value unique to a lamp because it depends upon
the test factors, how hard the lamp is driven, and even such things as
ambient temperature can have significant effects. So one cannot look at
the original manufacturer\'s published value T~e~ in the FDA submittal
and use that to make an equivalent lamp.

However, it is very possible to compare two lamps because the effect of
the ballast, the effect of air temperature, and the other testing
conditions generally produce second-order changes in the lamp. Both
lamps would be affected by the same amount if you tested one of the
original lamps and one of the supposedly compatible lamps. If you
examine the ratio of the T~e~s calculated by this method, you can
determine whether or not lamps are compatible.

Our manufacturing group has been benchmarking lamps in the industry.
Then we have had comments and test data from our various customers
suggesting that lamps that are incompatible are often being substituted
today. We brought some lamps into our standardizing laboratory that
confirmed this. We decided to run an independent test to illustrate what
this effect is.

We picked one of our popular lamp types for this test. We identified
four other lamps that were claimed to be equivalent. We obtained samples
of all lamps that were new but had already been distributed to the
industry including ours. These were randomly chosen. We located two
production codes for four of the five groups, meaning we were not going
to have biased results due to an outlier manufacturing group.

We randomly selected lamps from the various cases of lamps we obtained
and sent them to an independent testing laboratory. They were tested in
a consistent manner. The manner we used were the ANSI specifications for
safety testing of lamps. Would you please put the overhead on? I will
show you the results. This is also in your handout. Thank you.

The average T~e~ value of the original reference lamps was 74 minutes.
Those are the two groups at the left of the screen. We used three lamps
in each group for our initial survey, and the differences were
significant enough that we did not extend statistically. The T~e~ ratios
of the other lamps to the standard lamps ranged from 0.5 to 0.63, far
from compatibility which would require somewhere between 0.9 and 1.1.

It was also interesting in all cases of non-compatibility that we found
in these in other lamps. The differences were in a direction to
increased exposure and increased potential risk of both acute and
chronic effects. Tanning systems have schedules based upon the certified
lamp, the original lamp for which the bed or chamber was tested. Since
reciprocity holds here, you can change equivalent time to exposure. You
have 60 to 100 percent higher irradiance exposure than intended with
non-complying lamps from this test.

Consequently the clients can be subjected to as much as twice the
intended exposure. This constitutes unnecessary exposure. Our concern is
that there are adverse chronic effects of tanning that correlate with
cumulative exposure dose. This increase for a single exposure may cause
minor acute effects but the cumulative exposure could cause significant
chronic effects.

We feel that this is a problem that can be addressed now. It does not
have to wait for additional regulations. We believe that the FDA should
look into this and remove non-compatible lamps from the market. Thank
you.

CHAIRMAN ROTHENBERG: Okay. We\'ve heard a lot of things from a number of
different people. What questions or comments do we have from the
Committee?

DR. CASWELL: I have a question for both for Bob and Don Smith. If a lamp
is incompatible now, who\'s responsible for that incompatibility? Is the
manufacturer responsible for that or is the tanning salon owner for that
under current guidelines?

DR. LEVIN: It\'s the responsibility of the manufacturer of the \--
compatible lamp because they publish in the literature and package
inserts that the lamps are compatible. The tanning parlors rely upon
this as proof of equivalence.

DR. CASWELL: Bob, could I follow up on that just a second? So you have
documentation on the compatibility of these lamps that you tested.

DR. LEVIN: Yes.

DR. CASWELL: It\'s not just verbiage.

DR. LEVIN: No, we have reports from independent labs in addition to our
own. These reports have been turned over already to the CDRH.

DR. CASWELL: Thank you.

MR. SMITH: The answer to your question is and checking with the five
leading insurance companies, it\'s the salon owner\'s responsibility.
That doesn\'t mean other people wouldn\'t be sued, but we\'re ultimately
responsible. If a state regulator is going to close down a salon, they
don\'t hold the manufacturer or distributor responsible. They hold the
salon owner responsible.

DR. CASWELL: Dr. Cyr, under your proposal for establishing an individual
who modifies a tanning bed as being responsible being the new
manufacturer, do you see that much would change in terms of the way the
operation is now? Are we just codifying what in fact exists right now? I
guess that\'s my question.

DR. CYR: My understanding is that we\'re codifying what already exists.
We\'re not making any dramatic changes to the present day requirements.

DR. CASWELL: Thank you.

MS. FAHY-ELWOOD: I just had a follow up question about the eyewear
issue. I was wondering what your position is on the adequacy of that
visible light transmittance cap for people in the bed being able to see
what\'s going on.

DR. CYR: The issue of the five percent being the tops?

MS. FAHY-ELWOOD: Yes.

DR. CYR: Sharon, do you want to address that?

MS. MILLER: So you\'re wondering if five percent is possibly not
adequate?

MS. FAHY-ELWOOD: Is inadequate, right.

MS. MILLER: The five percent value was basically chosen based on an
analysis for possible retinal damage from a situation that we would
consider worst case which is a sunbed that has what\'s called a
high-pressure lamp. The arc of the lamp is very small. When you have a
lot of radiation and a small area on the retina, that\'s a more
hazardous situation than a case of typical tanning beds when you have
many fluorescent lamps and it\'s a large field.

In fact, when Don presented the data of the SAD units that are used for
depression, he\'s right. Those are much brighter. They probably aren\'t
posing a retinal hazard. What we were trying to accomplish by putting
the five percent cap was to cover the worst case scenario of a bed that
has either a facial high pressure lamp or some beds have nothing but
high pressure lamps.

MS. FAHY-ELWOOD: And what about the one percent? Is that adequate for
people to actually see what\'s going on in the bed?

MS. MILLER: Well, we think it\'s kind of based on \--

MS. FAHY-ELWOOD: Or should it be less than one percent?

MS. MILLER: No, it should not be less. That\'s the floor, so it should
be above one percent.

MS. FAHY-ELWOOD: Okay. I see.

MS. MILLER: If it\'s right at one percent, some things may not be able
to be seen. This phenomenom of putting many controls and displays in the
bed is fairly new. We have test data probably from the year 2000 and
back that shows that the five percent cap would not eliminate any
eyewear from the market. Now there are newer beds with more controls
inside and newer eyewear that\'s more transmissive that would not meet
this requirement.

I\'ve spoken to the person that we consult with who\'s an expert on eye
safety, Dr. David Sliney, that Don Smith referred to. He believes based
on his years of experience that five percent is a safe cap. We could
possibly go back and do some further analysis and see if maybe we can
raise it a little bit since as Don pointed out eyewear for the military
is allowed to have much higher percent transmittance. So that\'s
something we could do some further work with and look at data that
we\'ve generated and possibly also data that Don Smith has generated and
speak to some of our other colleagues and see if we can come to
agreement.

MS. FAHY-ELWOOD: Okay. And the controls that people would need to see in
the bed would be in that blue-green region.

MS. MILLER: Well, that\'s a good point. Since that cap only applies to
the blue-green wavelength region, the controls could be designed so that
they were yellow and red. Then they wouldn\'t be affected. The cap
wouldn\'t affect that.

MS. FAHY-ELWOOD: Right. How about the labelling of eyewear? Is there any
requirement for labelling so that people know what they pick up is
appropriate for tanning beds?

MS. MILLER: No there isn\'t. It\'s so small. The eyewear is sometimes
only this big. (Indicating.) There\'s no room for labelling.

MS. FAHY-ELWOOD: Okay.

MR. SMITH: Well, the Institute is small in answer to your question. We
go off the expertise of the Optical Sciences Department at the
University of Arizona. That\'s one of the things they brought to our
attention. They\'re doing a lot of work with cock pit dials. We need to
focus some attention on what are the right colors in these buttons so
that we can read them easily. Right now we\'re depending on the light
from the tanning bed to see these things. Certainly some creative
thought could go in and make them a lot easier.

CHAIRMAN ROTHENBERG: Yes.

DR. BENSON: Something also might be done with voice-activated controls.
Certainly that technology has improved a great deal in the last couple
of years.

CHAIRMAN ROTHENBERG: Yes, John.

DR. SANDRIK: A question for Dr. Cyr on the definition of the
manufacturer. You had indicated I think in part of your discussion about
there are performance requirements specified in the standard and it
would be a matter of seeing that those performance requirements are
still met. In your definition, you do explicitly mention performance
requirements as stated in the standard. You also include intended
functions. Perhaps that gets into a bit vague area.

As I say there is actually a section in the 1040.2 called performance
requirements. There are five things identified. It must do these things.
There\'s nothing really identified as intended functions. I guess maybe
that leaves a vagueness here in terms of just where are you going with
that. How would you define those? Do you intend to define those, put
some limits around what you mean by those? I guess there may be a
vagueness there that makes it difficult to interpret just what might be
expected when some sort of modifications are made or perhaps just
limiting it as I think you alluded to earlier to those defined items
that are called performance requirements.

DR. CYR: A very good point. I\'m going to have to defer to our Office of
Compliance people who have the expertise and the wording of that
particular amendment. I\'m not sure what was meant in those particular
words. Your point is very well taken unless somebody here from
compliance would want to address those two words. Let\'s just say we
will deal with that.

DR. CASWELL: Dr. Cyr, do you have any concern over the wording about the
fact that the warning label needs to be legible? Do you think that might
be stretched to limits? Do we need to indicate a font size for example?
How detailed do we need to get in terms of the warning label?

DR. CYR: That I hadn\'t thought of. Certainly you want to be able to
read it and have adequate light to read it. We had no discussion on size
of font or that.

CHAIRMAN ROTHENBERG: Could you just review exactly where we are in this
process and what you\'re asking us to guide you on?

DR. CYR: Okay. Because many of the comments pertain to things which are
coming down the road. I guess they were anticipating that perhaps I was
going to bring up those items. Per se I did not bring up some of those
things in terms of exposure schedules and the use of an action spectrum
other than erythemal. They pertain peripherally to maybe the definition
of a manufacturer. Per se we weren\'t going to present those as new
proposals at this particular TEPRSSC meeting.

Right now we were limiting ourselves merely to those things we thought
we are ready to go forward with. That was a revised warning statement
which is the bulleted one you have. We were focusing on that
particularly the language that goes into that statement and the
inclusion of that statement into the advertising materials and
catalogues, *et cetera*.

The third one was putting language about significantly modifying a
product and assuming the responsibilities of a manufacturer. That\'s
requirements that are already in the Medical Device Act and something
that\'s already been spelled out in the laser standard. We\'re thinking
of putting very similar requirements and language into the standard as
it pertains to sunlamps. Not a major change, something that\'s already
there.

The last one was to put things in there about the eyewear. That was the
sole things that we were going to present today.

CHAIRMAN ROTHENBERG: Okay. But it sounded like you were going to go back
and look at some further things related to the eyewear.

DR. CYR: I think in light of the comments today we need to do that. I
also think that between now and the time that we write those proposals
that there were some very good comments about who constitutes a
manufacturer and what things will be covered about that. I think we can
do that within the course of the next year too.

The measurements in terms of measuring a lamp versus the measurements of
an entire bed that Don Smith brought up is also something that we\'ve
talked about before and pretty much agreed needs to be done. Again
that\'s for things down the road. I have no problem with going forth
with those kinds of meetings and determining how one can measure an
entire sunbed.

DR. LIPOTI: I have one more suggestion on the warning statement since
you want specifics on the warning statement. I was flipping back and
forth between the old warning statements and the revised warning
statements. I do think that the bulleted warning statement is much
clearer and really helps you to understand.

But there\'s one phrase that I believe that you have dropped that was in
the previous warning statement. That was the phrase \"avoid
overexposure.\" It\'s been replaced by \"read instructions carefully.\"
Do you no longer want people to avoid overexposure?

DR. CYR: I think overexposure pertained to the amount of dosage you got
not so much about reading. What was the comment you said about reading?

DR. LIPOTI: It says \"read instructions carefully.\"

DR. CYR: Right.

DR. LIPOTI: It no longer says avoid overexposure. That phrase is
completely dropped from the warning label. Yet to me that\'s the real
warning you want to give people. Avoid overexposure.

DR. CYR: We got into a tremendous debate about what constitutes
overexposure. I think maybe in terms on the limit of overexposures you
don\'t want people to burn.

DR. LIPOTI: Right.

DR. CYR: So that warning came in there, injury to the skin. I think I do
like the comment about maybe per se putting in a warning about sunburn.
That may solve the problem of overexposure.

DR. LIPOTI: Do you want them to just read the instructions carefully or
obey them?

DR. CYR: I would hope they read them and take them to heart, yes.

DR. LIPOTI: I think I\'d like to see something that says obey the
exposure schedule or to avoid overexposure. I think dropping that really
gets rid of the main purpose for having a warning statement.

DR. CYR: Right. Thank you.

MS. MILLER: The only thing I would say about that is the common person
using a tanning bed may not know what an overexposure is. Since if
you\'re getting a burn you don\'t see it for several hours, you won\'t
realized that you have been overexposed until much later. I guess we
felt that having that in there didn\'t really add useful information to
tanning salon patrons.

DR. BENSON: On the other hand, I think that the public may take this
idea of going into a tanning bed as ensuring them against overexposure.
It looks so controlled. It looks so scientific. How can they be
overexposed? So just having that in the warning label just reinforces
the idea that overexposure can happen.

DR. CYR: I think it\'s easy to define overexposure in terms of sunburn
and eye damage, easy but not completely easy because particularly with
sunburn it depends on skin type. You can make a wrong guess on skin type
and burn somebody thinking that you gave a proper dose when in fact it
turns out not to be. This person is much more sensitive than you
thought.

Overexposure in terms of skin cancer is another entire thing. Again for
the majority of people who never come down with skin cancer, it\'s not
an issue. There\'s no overexposure. There are unfortunate people who for
genetic reasons or what-have-you will end up getting skin cancer from
the sun and maybe from salons. We\'re less sure about that.

By definition if they got the cancer, they got the overexposure. I
wouldn\'t know where to begin with saying what constitutes an
overexposure in terms of skin cancer. I just wouldn\'t know how to do
that.

MR. SMITH: Your questions are apropos. That\'s why the form that I
showed you and the label that going to go on the bed is not going to be
read by anybody. It\'s dark in the room. They go in and get their
clothes off. I think these additions that were suggested adding don\'t
sunburn and avoid overexposure are helpful, but it\'s that client
release and informed consent form that we believe that we owe the client
the obligation to have them read and sign it before he goes into the
tanning bed is what\'s important. I\'ll make copies for you if you\'d
like. It has a lot more information.

CHAIRMAN ROTHENBERG: Yes.

MS. FAHY-ELWOOD: Another comment about the new warning label. The last
bullet that talks about the photosensitizers increasing sensitivity to
UV radiation. I thought maybe a better wording for that would be
something like certain medicines and cosmetics increase chance of skin
injury. The way that the bullet is written now, I don\'t know if the
general public would know what that means. Increases their sensitivity
to UV radiation. That\'s just a thought I had for the group.

Additionally I had another comment about the manufacturing definition. I
think that some of the data we saw about the compatibility of lamps
feeds into that issue that we\'re talking about because there could be a
salon owner for instance who is changing out a lamp that they believe to
be compatible but when in fact they are changing the output of the
device. I don\'t know that those two items are mutually exclusive and
that you could wait until the next TEPRSSC meeting to talk about lamp
compatibility and come to some consensus on this manufacturing issue
today. That\'s just a thought I had on that.

DR. CASWELL: I don\'t like the word injury there. The reason why is that
in the bullet points we have the word injury. I would be afraid that
maybe consumers would see that as it might increase injury but it\'s not
going to increase photoaging. It\'s not going to increase my risk of
skin cancer.

We know that that\'s not true. We know that photosensitizers will
increase the risk of skin cancer. So I would prefer to keep it along the
lines of sensitivity in order to avoid any perception that photoaging or
skin cancer are not affected by photosensitizers.

CHAIRMAN ROTHENBERG: We need a motion as to how they proceed. Would you
like to?

DR. CASWELL: Yes. I move that we recommend that the revised warning
statement as proposed by Dr. Cyr be recommended.

CHAIRMAN ROTHENBERG: Okay. Is there a second?

(Dr. Lambeth seconds by raising his hand.)

CHAIRMAN ROTHENBERG: Okay. Any further discussion on that aspect?

DR. LIPOTI: You mean as is?

DR. CASWELL: Yes.

MS. FAHY-ELWOOD: Then I would still have the comment that I think people
might have questions about the last bullet from a consumer perspective.
I don\'t know that it has real meaning for a consumer.

DR. NELSON: You could try may increase your harm from ultraviolet
radiation. Would that cover everything?

DR. CASWELL: In a tanning salon, the salon operators are well aware of
the possibility of increased sensitivity due to cosmetics and
medication. Reliable salon operators actually screen medications prior
to allowing somebody into the bed. The risk of sensitization of damage
due to UV from sensitizing medicines or chemicals is real. In fact the
percent is very low of this occurring. I think adverse drug reactions in
the MEDWATCH program point that out.

CHAIRMAN ROTHENBERG: Yes.

DR. LIPOTI: I\'m just going to say that I cannot vote for the motion
because I think there have been a number of relevant suggestions raised
about revising the revised warning statement. I think that the
opportunity for a public input here should be taken by FDA. There should
be further revision done for the statement.

DR. BENSON: I agree with that. I think that we\'ve made some good
suggestions. The countering to what we\'ve raised here is that reliable
salon owners have that in hand. I\'m thinking more of the label that
goes on a box that someone takes home and sets up a tanning bed in their
garage. So we need to make the warning label relevant to that person,
not so much to the tanning salon owner.

MS. LOSCOCCO: I have to agree with that because I think it\'s a two-fold
process. I think the tanning bed salons have it under control. What
we\'re trying to also make sure is that the owner understands.

CHAIRMAN ROTHENBERG: Well, the proposed rules are not yet \-- So maybe
we should recommend that there be a revised warning label, and it also
should take into account the various suggestions. Then we\'ll see what
they come back with. Can we accept that as an amendment?

DR. CASWELL: Sure.

CHAIRMAN ROTHENBERG: So then with the amended proposal, any other
comments?

(No response.)

CHAIRMAN ROTHENBERG: All in favor?

(Chorus of ayes.)

CHAIRMAN ROTHENBERG: Eleven in favor, none opposed. We\'ve lost one of
our members. Now with regard to other aspects of the presentation. Does
anyone want to make a motion? Dr. Cyr has indicated that they would take
into account a number of the suggestions made already with regard to
modifications, equipment, what constitutes a manufacturer and other
aspects of what he\'s presented. Do we want to make any further motions?

DR. NELSON: I don\'t know if I want to make a motion yet but you\'ve
mentioned that you would look into this idea of modifying the
eyeglasses, eye goggles, transmission spectrum. It sounds like it\'s
important that people be able to see the controls, and yet it\'s not
clear to me that this higher level that people are talking about is
safe. I\'m wondering if there\'s some level ground perhaps that will go
with the five percent transmission right now with the idea that perhaps
another regulation down the road would be that the manufacturers put the
controls in different colors. I guess my question would be is it too
premature to move on the eyeglasses issue.

MS. MILLER: Well, I guess one option is that we could move ahead with
the five percent and when the proposed rule is published in the Federal
Register which will still be quite a ways away, anyone can submit
comments and data if they want to oppose that or support it or argue
against it. We could go ahead with five percent and then once we get
comments back there\'s still time to revise that if we feel there\'s
enough evidence that we could go a little higher and still be safe and
provide a safe pair of eyewear for the consumer.

DR. LAMBETH: On the eyewear and the visible transmissions, it seems like
the objective is the simply allow the user to be able to see and yet not
be so bright inside this box that one is blinded by it. I don\'t have a
perspective on these bulbs as to really how bright this is from a
practical standpoint. I must admit I\'ve not been inside one.

If someone came along with a new bulb that met all the UV standards to
produce tanning without harming but actually had a very bright or
extremely bright line in the visible, it seems like your standards go
out the window. They\'re no good if there was actually a line at the 500
nanometer region. Specifying transmission without knowing what the bulb
puts out doesn\'t seem to be the appropriate way to do it. I know where
you\'re coming from. I understand your logic.

MS. MILLER: Yes. It\'s very difficult to do an analysis for every
conceivable type of light source. We can only base it on what we know is
the worst case condition right now.

DR. LAMBETH: Maybe you could just inform me a little bit. If I have a
five percent transmission at 500 nanometers, how bright is it? Is it
comparable to this room?

MS. MILLER: No. It would be much dimmer.

DR. LAMBETH: It\'s much darker. Right?

MS. MILLER: It\'s five percent so it\'s reducing the light that you\'re
getting from these sources down five percent.

DR. LAMBETH: No, but I\'m inside the bed. The light inside the bed is
much brighter than these lights.

MS. MILLER: Right. So you\'re saying how much would you be seeing.

DR. LAMBETH: Can I see as well as I can see you right now?

MS. MILLER: I don\'t think so. I actually haven\'t done that test. I
would say it\'s much dimmer. Maybe Don or someone who\'s done a lot of
testing \--

DR. LAMBETH: Is it equivalent to turning all the lights out here except
for the ones by the door? I don\'t have a perspective. I\'m just trying
to get a perspective.

MS. MILLER: I can\'t tell you specifically but it\'s fairly dim. You
don\'t want it to be too bright because of the potential hazards. It\'s
just supposed to be \--

DR. LAMBETH: This is visible. There\'s no hazard in the visible to speak
of. Right?

MS. MILLER: No, there is a hazard actually to the retina from visible
light.

DR. LAMBETH: But it\'s visible light. My eye is designed to look at the
visible light.

MR. MYERS: Let me say something, Dr. Lambeth.

CHAIRMAN ROTHENBERG: Could you please identify yourself.

MR. MYERS: I\'m Dave Myers from Light Sources. I have in fact been
inside of a tanning bed before. I can tell you that my analogy would be
it\'s similar to wearing welder\'s goggles if you\'ve ever looked
through welder\'s goggles.

DR. LAMBETH: Yes.

MR. MYERS: It\'s very similar to that. It\'s very dark.

DR. LAMBETH: I can\'t see a thing through welder\'s goggles until I
strike an arc.

MR. MYERS: Well, exactly. If you have a bright enough light source, you
can still see. It would be to me like welder\'s goggles. Most of these
beds are in the order of 2,000 watts.

DR. LAMBETH: Okay.

MR. MYERS: Does that mean something to you?

DR. LAMBETH: Yes.

MR. MYERS: It\'s relatively bright. Much brighter than the chandelier.
Don\'t forget your face is only inches away from the bulbs.

DR. LAMBETH: So when you\'re saying it\'s like welder\'s goggles looking
at a welder\'s arc.

MR. MYERS: Yes.

DR. LAMBETH: Okay.

MR. MYERS: I personally don\'t have any problem seeing controls with the
current standard as it is right now.

DR. LAMBETH: I would say for those who haven\'t welded. That\'s sort of
the equivalent of turning out all the lights in here except for the ones
along the wall. Wouldn\'t you agree?

MR. MYERS: I don\'t know.

DR. LAMBETH: Something on that scale.

MR. MYERS: Yes.

DR. SANDRIK: It sounds like maybe even there\'s an evolution going on
here in how these tanning beds are devised because it sounds like from
an answer to an earlier question that these controls were lit up by the
sunlamps. There was a very high level of illuminance on the controls so
you could have a fairly dark opaque kind of eyeware and still see the
controls.

Mr. Smith has mentioned that they\'re moving the controls into a more
darkened environment. It seems in that case then you have to readjust
the transmission or transmittance that you allow based on the
illuminence of the controls. Maybe it\'s not the preferred thing but it
gets back to what\'s the purpose that you want to achieve or perhaps
linking the eyeware to the source. With this source you have to be able
to get a certain level of transmittance for the illuminence of the
controls or something. It probably just complicates things. It sounds
like a specific transmittance may be going too simplistic for the
variety of equipment out there.

CHAIRMAN ROTHENBERG: I think Mr. Levin has something.

DR. LEVIN: Bob Levin again. A couple of comments. One is with regard to
welder\'s goggles. They\'re often an optical density of six which means
about a 10,000th of one percent. That\'s a far cry from what\'s proposed
here.

More important, I think Sharon made the key comment when she said the
standard was set by the high pressure discharge lamps because those are
very compact, very high radiance, and they are an extreme hazard. If
your eyes were not protected, it would be like looking at the sun with
the consequences following along.

Probably two standards could be used. One would be for flourescent
systems where you do not have this extreme hazard. The other would be
for the discharge lamps. Also it\'s not completely adequate to talk
about military requirements on sunglasses because you still have the
aversion reflex. It would not protect you against sunlight. People
generally can\'t stare at the sun.

In the bed with a very high intensity source immediately in front of the
face, there\'s no way to control and prevent people from doing that.
There are standard safety requirements, various ANSI standards that will
let you determine the hazard from any given source. These can be applied
to determine a safe level.

CHAIRMAN ROTHENBERG: So it just seems like you have to look into this
further particularly with these discharge lamps to see what the problems
might be. In addition with trying to harmonize with the other
regulation, you need to look at that.

DR. CYR: And it looks like we need to go back to the international
community with the things that we\'ve heard here. They need to know that
input too.

CHAIRMAN ROTHENBERG: Yes.

MR. PLEASURE: Again, I reflect on how this particular change is
connected to the overall regulatory scheme that you have in the sunlamp
regulation where you have a warning label which now is required to be
affixed in the place that will be seen by the person to be exposed
immediately before exposure. We hear now that the room is dark and you
can\'t see it. So the way people are operating and they\'re basically
getting undressed, they can\'t see it. Apparently Bob Levin is correct
there\'s non-compliance as a matter of practice with the existing
regulation.

Then there\'s an additional requirement that instructions to the users
be distributed at cost by the manufacturers. We\'re working with very
limited devices to obtain a result. We have a darkened room. We have a
warning label that apparently can\'t be seen. The practice is to give
the person a release in some cases. They sign off on the release. That
contains some information.

Yet there\'s no regulation requiring that the person to be exposed get
that kind of detailed explaination. Maybe they should. Maybe they should
get what every construction worker can get which is a material safety
data sheet on a product that they\'re going to be installing in a
building and that\'s present on the job-site so they can go look and see
whether this particular product presents hazard and what to do about the
hazard.

I ask that when we take up an issue like this that it be linked up to
the various other pieces of the regulation; in this case, manufacturers
instructions, the existing regulation that requires that it be affixed
in such a place that it can be definitely seen immediately prior to use.
So that it all fits together for us and we can determine whether it\'s
achieving its result and whether something more might be required.

In this case, I happen to think that what\'s required is something like
what Bob Levin was talking about, that you give the person a piece of
paper that has some detailed warnings and some explanations on it. You
make sure that they read it before they lie down and they\'re exposed in
this darkened room rather then relying on them to spot this thing on the
machine or the manufacturer to somehow get to the user enough
information which may now be lost. Let me stop at that. I think what
I\'m asking for is some more contextual discussion so that we can see
how this really works which Bob Levine was trying to provide I thought.

MR. SCHUSTER: A couple of comments. Joe Schuster again from Light
Sources. I think what I would encourage all of you to do is step into a
tanning salon. I\'m getting the image that you have somebody that\'s
fumbling around in the dark and can barely see. That\'s not the case.

By the standard, you have to have that warning label clearly visible at
a particular distance on the front of the bed. It can\'t be hidden.
It\'s not behind the bed. It\'s clearly legible on the front. In
addition to, salons then have a client warning statement that they have
to read these people to show them the hazards as well which is a
replication of that warning label that\'s on the bed. There are a
variety of measures. They\'re not walking into a dark room where they
can\'t see anything. I don\'t agree with that analogy.

MR. PLEASURE: I was just repeating Bob\'s \--

MR. SCHUSTER: Okay. I just want to make it clear so that we all know. Go
to a tanning salon and see how it\'s done in actuality. In the reality
of it, they\'re not darkened rooms. You can clearly see the warning
label. Find out how a salon owner would take you through the various
hazards because people that tan don\'t think that there are any hazards.
They realize it. It\'s in clear print right in front of their face.

MR. PLEASURE: Now it\'s your understanding that the person under the
regs must be supplied with a copy and read a copy of the warning
regulation or is it only visually present.

MR. SCHUSTER: It\'s visually and audibly. They are reading it to them
and they see it on the warning label.

MR. PLEASURE: That\'s good. Is that required by the regulation now that
they read it to them?

MR. SCHUSTER: The standard supports that the warning label be on every
bed. I guess you could say that the industry takes it a step further and
shows them this warning statement in writing and has them sign off that
they\'ve read it.

MR. PLEASURE: That\'s good. Maybe it should be required across the
board.

MR. SCHUSTER: Not a bad idea.

MR. LEVY: I just wanted to concur. I\'m Joe Levy from Indoor Tanning
Association. The standard educational protocol in the industry today is
to walk the customer through and show them the equipment, show them how
it works, and show them the warning label. That is a standard operating
procedure.

CHAIRMAN ROTHENBERG: So if I went to a tanning salon, what would be the
probability that it would happen?

MR. LEVY: On your first visit, you\'d be shown the entire facility and
how the equipment works, how you are to use it, what the warning label
is. As Joe mentioned you are already given a much more specific consent
form to sign that has the same language as the FDA warning label that
currently exists.

CHAIRMAN ROTHENBERG: Are you saying this would be true at 95 percent of
the places I went, 100 percent, 80 percent, 20 percent?

MR. LEVY: I think that\'s going to be true at any professional facility.
I don\'t have a number for that. A salon would be foolish to not have
someone sign their consent form just out of a liability situation.

CHAIRMAN ROTHENBERG: Maybe one more quick comment on this.

MR. SMITH: Maybe some of the confusion comes to answer your question is
that the FDA regulations are to the manufacturer. The tanning salon
owners are under the jurisdiction of the state regulatory agencies. Most
of the regulated states require that these informed consent and client
release forms be used. So that\'s a state reg.

DR. CASWELL: I\'m probably the only panelist who\'s been in a tanning
bed before. My experience mirrors what Joe Schuster said. You go in. You
take off whatever clothing you\'d like to take off. It\'s well lit. You
get all the controls set. There\'s a button that\'s available.

When you\'re ready, you can turn it on. Before that happens, I set
everything up. I get my goggles or eyeware in place. Then I reach up and
I turn on the on button. I stay there until it\'s off. As soon as the
machine shuts off then I take off my eyeware, get dressed and leave.
It\'s not in the dark. I\'ve never seen a darkened room. I think that\'s
a misrepresentation that somehow you\'re fumbling around in the
darkness. I think it\'s a well-lit environment. I think the controls can
be set well before you turn on the bed. Does that help at all?

MR. PLEASURE: It does help me but let\'s be clear that one of our
witnesses was reflecting on this, not the Committee. I think if he\'s
reflecting that it is a common experience then what you described may be
optimal and what he describes may be something else. That raises a
question as to the necessity of regulation that incorporates some of the
best practices that go beyond simply affixing a label.

That may require giving the person an informed consent form. It may
require that it be read to them if that\'s the practice. It doesn\'t
sound like the industry in general would be opposed to that. They\'re
doing this now they say.

DR. CYR: I was going to attempt to clarify but maybe I would only
confuse. I think what they were saying is it\'s dark inside the canopy,
inside the bed to look at controls out there, not outside in the room.
It\'s once you\'re inside the bed with your eye goggles on, then it can
be dark and you may not be able to see controls which are already inside
the bed. These are new gadgets that they have inside the beds. The
warning statements and labels are outside on the outside of the machine
and the room is lit.

MR. PLEASURE: Yes. In practice apparently they\'re read to the people.
They have an informed consent form. None of which is required now under
the existing regulations. It might be advisable having discovered this
optimal practice. We wouldn\'t be so anxious then about the very limited
parameters of the warning label. If there was more information provided
on the equivalent of an MSDS that I\'m familiar with for workers then
the consumer could be protected by information that was more adequate
than just a label.

DR. CYR: I think it was Don Smith who said the actual regulations of
salons is done at the state and local level. We have worked as I said in
my presentation with the Conference of Radiation Control Program
Directors. They have a suggested state regulation and as part of that
they have these informed consent statements. I think it is something we
should press the states to do.

MR. PLEASURE: Yes. But right now the manufacturers are required to have
produced a detailed set of instructions. The manufacturers are required
to have a label that must be readily seen by the person to be exposed.
So what you say that the FDA has not taken up the issue of what
experience the person has and that the FDA doesn\'t take cognizance of
what the manufacturer must do that relates to the user is not so. The
regulation does get into those issues right now.

MS. LOSCOCCO: What percentage of states have regulations that would
apply? What percentage of tanning beds are owned by just single-users?

DR. CYR: I can let somebody else answer that who knows it exactly. I
think it\'s a little over half the states. It\'s 27 states. The second
part was what?

MS. LOSCOCCO: How many beds are just owned by single-users?

DR. CYR: How many home units are there?

MR. LEVY: I won\'t go to home units. I let someone else answer that.
I\'m Joe Levy again. We did a survey last August of compliance because I
know where you\'re going in states with whether or not their customers
are sunburning and whether or not they\'re complying with the main rules
that are pretty much set up by what the FDA requires the manufacturers
to stick to; eyeware, sunburn, the exposure schedule and that type of
thing.

What we found is that compliance is just as high and success rate is
just as high in the states that don\'t have these supplemental
regulations. The industry is doing a great job of self-regulation. We
agree with these standards. Obviously as I mentioned from a liability
standpoint we are getting that warning statement to customers.

I disagree with the assessment made earlier that the customer is not
seeing that warning label because that\'s part of the protocol that we
teach in our education courses that are at the industry. It\'s part of
the protocol to show them how the bed works and show them the warning
label. So we\'re doing that ourselves.

CHAIRMAN ROTHENBERG: Okay. I think what we\'re going to do now is to
take a break at this point. We can have some further discussion this
afternoon. We\'re getting way behind schedule. We\'re going to take a
lunch break now with possibly one brief comment by Dr. Cyr.

DR. CYR: Question. You said additional questions. Would that be when we
come back or after the next presentation? When we come back, we\'ll
finish up sunlamps?

CHAIRMAN ROTHENBERG: Yes.

DR. CYR: Because some of the people here are anxious.

CHAIRMAN ROTHENBERG: We\'ll have a brief period when we come back.

DR. CYR: Because they\'re not anxious to sit for the whole next
presentation.

CHAIRMAN ROTHENBERG: Right. No. We\'ll do that before we get to the
people scanners.

DR. CYR: Okay.

CHAIRMAN ROTHENBERG: So please reassemble at 2:00 p.m. instead of the
initial schedule of 1:45 p.m. Off the record.

(Whereupon, at 1:02 p.m., the above-entitled matter recessed to
reconvene at 2:05 p.m. the same day.)

CHAIRMAN ROTHENBERG: On the record. I\'d like to call the meeting to
order again. I\'ll also remind any of you that may have come in late if
you didn\'t sign in on one of the sheets outside the door, we would
appreciate if you would do so. That way we will know who was here and
whom you\'re representing.

It seemed like as we broke for lunch we had pretty much given Dr. Cyr
and his group \-- There was a lot of discussion. They agreed to take
things under advisement as they proceed forward and then will come back
with revisions. So I think unless there is some really urgent comment,
we\'ll proceed with the rest of the meeting. Yes.

DR. NELSON: Actually I would like to ask Dr. Cyr a question about the
goggles. Then hopefully we can move on.

CHAIRMAN ROTHENBERG: Okay. One question about the goggles.

DR. NELSON: Yes. My question is my understanding is you picked this five
percent transmission level because you have good or at least reasonable
data to suggest that\'s a safe level. If I heard testimony correctly
earlier today, my understanding is there are goggles out there now that
no longer meet the old Federal guidelines. Is that right?

MS. MILLER: Yes. The five percent which is in the IEC standard was based
on some analysis done by an engineer at Philips Lighting using a 400
Watt high intensity lamp. That showed that if you had a five percent
limit with that type of light source, you would be below occupational
safety levels for retinal damage. Like I said, it\'s not really a fine
line between a safe and dangerous exposure, but we feel it\'s a
practical number.

DR. NELSON: Okay. So if we don\'t pass your resolution, it\'s possible
that there would be eyeglasses out there that would have higher
transmission, and we don\'t know the safety about those. Is that true?

MS. MILLER: Yes. And they\'re already are eyewear out there that have a
higher transmission.

DR. NELSON: That seems to me not an ideal situation.

MS. MILLER: Currently the FDA standard doesn\'t have any limit on the
visible transmission. That\'s why this has occurred. I don\'t know how
much testing is done in other countries. If they are sold in other
countries, they are supposed to meet this five percent limit. It\'s a
very small percentage of tanning beds that have these high intensity
discharge lamps. That\'s not a huge problem, but we would like to
incorporate something in the standard that would ensure safety.

DR. NELSON: Yes. So my understanding is if we pass this resolution
today, you still have some procedures that you would go through. It
doesn\'t close the door on potentially upping the threshold at another
time. Is that right?

MS. MILLER: That\'s true.

CHAIRMAN ROTHENBERG: Right. The idea was that we were going to go back
and look into this further and also look into the special problems
associated with the high pressure, high intensity lamps.

MS. MILLER: Yes. But what she\'s asking is if you were to approve five
percent, that wouldn\'t preclude us changing that before it goes to a
final rule which is true.

DR. NELSON: Yes.

CHAIRMAN ROTHENBERG: Do you have something?

DR. SULEIMAN: Yes. Just to clarify. That\'s exactly right. We\'re in the
rules making process. This is still way ahead. If you were to formally
recommend and we bought into very specific wording and then three weeks
later or two months later we learn some new things, then some people say
should we change it, shouldn\'t we change it. I think as long as the
issues that the Committee has raised are considered and even after we
come out with the official proposed rule, then we go to this 90 or 120
day comment period. Then we have the opportunity or option to change
even then. We\'re way ahead of the curve. I think a simple go or no go
type recommendation would be appreciated by us.

DR. NELSON: Okay. All right.

CHAIRMAN ROTHENBERG: Do you want to make that motion?

DR. NELSON: Okay. I think what you\'re asking me is to suggest that we
\--

CHAIRMAN ROTHENBERG: That they go ahead with the proposed eyeglass
standard pending. Unless there are reasons to change the limits based on
knowledge of what we gain soon.

DR. NELSON: Okay. What you said.

CHAIRMAN ROTHENBERG: Okay. Does someone want to second that?

DR. BENSON: Second.

CHAIRMAN ROTHENBERG: Okay. Any further discussion?

(No response.)

CHAIRMAN ROTHENBERG: All in favor?

(Chorus of ayes.)

CHAIRMAN ROTHENBERG: Eleven unanimous. Eleven for. Okay. The next item
that was on our agenda was a welcome from Dr. Feigal, but he\'s unable
to attend this afternoon. We will then proceed with the next item of
business which is the Personnel Security Screening Systems. Mr. Cerra
will present. We thank you all who are leaving for your interest and
input.

MR. CERRA: Good afternoon. I am Frank Cerra from the Office of Science
and Technology of CDRH. I will be speaking about products to x-ray
people for security reasons, better known as people scanners. The
presentation will be in two parts. I will first give an update on the
progress on a consensus standard. Dan Kassiday will follow with some
discussion on new systems and new developments.

The consensus standard is the American National Standards Institute
N43.17, Radiation Safety for Personnel Security Screening Systems Using
X-rays. I am glad to announce that the standard has been approved by
ANSI and adopted as of April 2 of this year. I would also like to thank
this Committee for its role in spurring this project.

The products that are covered by this standard have been in use in this
country for several years. The one that\'s pictured here is the Secure
1000 model. It consists of an enclosed cabinet. The person is asked to
stand in front of it, and a narrow beam of X-rays scans left to right,
top to bottom.

It works on backscatter technology, that is, there are radiation
detectors behind the front panel which sense the radiation that\'s
scattered back from the body into the cabinet. Then a computer image is
generated. Typically the individual is asked to turn around and a back
view is taken.

This is another model, the Bodysearch by another manufacturer. Again, it
works on the same principle. The backscatter units are very efficient at
looking through clothing. You can imagine there are some concerns about
privacy as well as the radiation safety concerns which we are interested
in. Also backscatter imaging is not very useful for looking at objects
inside the body.

A summary of the chronology of events leading up to the standard. Back
in September 1998, there were several presentations before this
Committee on this subject. The members had enough radiation safety
concerns to recommend that FDA adopt a mandatory performance standard to
cover the products. One of the main concerns was that there might be an
escalation of the dose levels to the general public if the technology
went unchecked.

FDA considered the recommendation very carefully. We considered the
public health risks involved and weighed that against the available
resources and other Center priorities. At the time we decided that maybe
FDA could be most effective by promoting a consensus standard rather
than writing a mandatory standard.

There were some advantages to the consensus standard. In the first
place, we thought it could be completed sooner and be in place in a
timely manner. Also, we could include requirements for the user
facilities whereas a mandatory standard from FDA could only include
performance standards relating to the product. In addition to that, if a
mandatory standard was deemed to be necessary at a later date, we
thought we can take the performance requirements from the consensus
standard and incorporate them into the mandatory standard.

In April 1999, we proposed a new project to the ANSI N43 Committee on
non-medical uses of radiation. The project was approved. In November of
that year, the newly formed N43.17 Task Group convened for the first
time. In June 2001, we had a draft standard which we submitted to the
main committee. Finally, we received final approval from ANSI in April
of this year. The standard is due to be published on the Health Physics
web site shortly.

The next three slides summarize the main requirements of the standard.
The standard is innovative in that the dose limits for the subjects are
in terms of effective dose. Effective dose was defined by the
International Commission on Radiation Protection in the ICRP Report 60.

It takes into account the risk to the whole body based on the
vulnerability of key organs from a known exposure condition. There are a
list of 12 key organs. We thought that is really the quantity of
concern. We also thought that we could make accurate measurements and
assess it properly for these types of systems. So we used it.

The first limit is a maximum dose of 0.1 microSieverts per scan, that
is, per scan from the front. The reason for the limit is that it was
what the technology can do easily. We didn\'t see any reason why we
should increase the risk to the individuals being screened.

The second limit is 250 microSieverts per year from one facility to any
one individual. That is based on the National Council for Radiation
Protection and Measurement\'s recommendations of NCRP 116. The idea
behind the second limit is that the general public should not receive
1,000 microSieverts of radiation from non-medical, man-made exposure
from all sources in a year. It\'s limited to 250 from one source.

That may present some problems when you have more than just a few known
sources. If these things were to show up at many different places then
there would be some problems with that limit.

Also, another benefit of the per scan limit is that the second annual
limit is more difficult to assess compliance with than the first limit
because you need to keep track of individuals. As you can see, it takes
2,500 scans to reach the annual limit. That\'s seven scans per day. You
only need to consider those individuals who show up at the facility very
often, several times a day. That\'s an additional reason for the first
limit.

The standard requires that there be a benefit from every exposure. This
is an intentional non-medical exposure. It better be needed. In this
case, the benefit is security. We also require that subjects are
informed that X-rays are involved and the dose that they\'re getting.
They need to be given an understanding of the associated risk based on a
comparative example.

The standard has a radiation leakage requirement that is similar to the
requirement for cabinet X-rays in the mandatory standard. It\'s 2.5
microSieverts per hour at 30 centimeters from the surface. This is not
including the front surface where the primary beam comes out of. This is
not effective dose but it\'s entrance skin dose.

For bystander protection, the standard requires that an inspection zone
be identified and well marked. People other than the person being
scanned are not allowed to be in the zone at any time. The maximum limit
outside of the zone is 20 microSieverts per hour.

We have requirements for safety interlocks on all access panels to the
interior of the cabinet and also operational interlocks in case the beam
should stop moving. This standard also has a requirement for a label
which identifies the product and requirements for indicators and
controls, the main ones being that there must be a lighted indicator to
show that the scan is in progress. By the way, the scan lasts about five
to seven seconds, maybe less. This indicator should be visible from
anywhere close to the inspection zone.

We also have a requirement that the exposure technique factors,
kilovoltage, mA and so forth, must be fixed for any mode of operation.
The reason for that is we didn\'t think that we could require a certain
level of sophistication from the operator of these systems.

There is a requirement for operator training listing a number of topics
that must be covered by the training. There is also a requirement that
the operator demonstrate proficiency upon completion of the training.
Also, there must be annual refresher training.

The requirements for records to be kept by the manufacturer are similar
to the ones required of cabinet X-ray units. Mostly they are for keeping
track of products in case there should be a recall. The user facility is
required to keep records to show that they conform to the standard, for
example, the results of periodic radiation surveys and also a list of
individuals who may exceed or approach the annual limit.

Besides the normative requirements of the standard, we have two
appendices that are for information only. The first appendix is a
discussion of radiation risks and the rationale for those limits in the
standard. The second appendix is a discussion of measurement techniques.
It includes a measurement protocol for measuring the exposure or air
kerma (PH) and then a protocol for converting that measurement to
effective dose.

In order to do that we had to generate some charts with conversion
coefficients. These were derived from the conversion coefficients
published in ICRU 57 which are for monoenergetic sources. The chart
allows the conversion of a measurement of exposure by simply knowing the
kilovoltage on the tube and the total aluminum equivalent filtration.
The first chart is for a front scan. The second chart is for a rear
scan.

The measurement protocol was tested at several facilities. The photos
illustrate one of these tests at the Customs facility at Los Angeles
Airport. As we look at the next two slides, I will ask Dan to step up to
the podium.

MR. KASSADAY: Hello. I\'m Dan Kassaday with the Office of Compliance.
Several months ago the Center for Devices and Radiological Health
received a submission for a product intended to detect contraband
concealed within a subject as well as under the subject\'s clothing. We
are bringing this product to the Committee\'s attention because the
subjects receive a significantly higher dose than from the previously
discussed backscatter systems which are exclusively for under clothing
analysis. During this talk I plan to describe the product and CDRH\'s
proposed response. We look forward to your discussion and advice
regarding our proposed response after this talk.

This is the product that we received the submission for, the Conpass
Body Scanner. It\'s a transmission X-ray. The tube is under the
operator\'s desk underneath the monitor. It goes through the fan
collimator. It goes through the subject who stands on the platform with
the handles here. That moves them across the beam.

These are some example images. As you can see, you see all the way
through unlike with the backscatter systems. The system has a roughly
equivalent scanning time. It\'s peak tube potential ranges from 70 to
200 kilovolts. Both the tube potential and the tube current technique
factors are adjustable. A dose to a subject is five microSieverts as
reported to us although I\'m not sure that\'s effective dose. We\'ve
received at least one or two other inquires about similar systems but
have not received any reports at this time.

This mission identifies the intended use of this product as passenger
control; security at airports or train stations and similar facilities.
The advertising however included with the report indicated that there
are many other places where this type of system might be used, for
example, diamond mines. In a brief discussion with a regulator from
South Africa, they do indeed have three different systems in use there
as well as backscatter units for the diamond mines.

It could possibly be used in prisons. The backscatter units have been
used in prisons for checking visitors to the prisoners. It has been used
by U.S. Customs on people coming into the country. But it\'s a choice
between the backscatter and a pat down search. This advertising goes on
with the idea of public offices and banks and stadiums and all sorts of
other facilities might be appropriate for it. Proliferation of this type
of product would no doubt lead to individuals receiving multiple doses
from it.

Other products might expose people near them to incidental radiation.
These products intentionally expose people to ionizing radiation. Based
on the linear, no threshold model of radiation risk, any increase in
your dose results in an associated increase and a risk of an adverse
health effect. Unlike medical X-ray, the dose from these systems
provides no direct benefit to the individual being examined. Therefore,
the use of these types of products must be justified only if there is a
sufficiently large societal benefit from their use, for example,
security.

Our response to all of these products intended to X-ray people for
security purposes has been based pretty much on these four principles.
In turn, the first two principles are based on recommendations from the
National Council for Radiation Protection and Measurement from their
report 116: [Limitation of Exposure to Ionizing Radiation]{.underline}
which was published in 1993.

The first principle is that below a certain point doses become
negligible and aren\'t worth tracking for cumulative dose total per
year. The NCRP set that as a 10 microSievert cumulative dose for one
year from one source of practice. A practice that results in individual
doses that are less than negligible individual dose, but that will be
probably used enough times in a year to exceed the 10 microSievert limit
cannot be considered to be negligible. NCRP also recommends a 1,000
microSievert per year annual limit for any doses that are continuous or
frequent. This recommended limit applies to all doses that are not from
medical or naturally occurring sources.

Additionally we believe the evaluation of the benefit from such a system
will require understanding of the security threat being averted as well
as the risk from the radiation being used to detect that threat. Of
course we expect that any product that exposes people to ionizing
radiation intentionally will be designed and operated to ensure that the
dose is as low as reasonably achievable to product the intended benefit.

Just a few more details about the negligible individual dose. That\'s
the basis for where NCRP set the dose based on measurement difficulty
and the magnitude of the dose. For comparison, average background
radiation results in a dose of approximately 3,000 microSieverts per
year. This is 300 times the negligible individual dose. Negligible
individual dose is 100 times the limit set in the ANSI N43.17 standard
of one-tenth of a microSievert per front exposure.

Hypothetically 101 exposures to a product that meets the ANSI standard
would result in exceeding the negligible individual dose. It would
require 10,000 exposures from such a system to reach the recommended
annual limit of 1,000 microSieverts.

The transmission units which provide internal inspection as well as
external are being compared to the backscatter units which are
essentially an under clothing search. But because it\'s transmission or
because it\'s backscatter isn\'t the reason we\'re developing a new
response. They\'re merely convenient descriptors for existing products.

We are developing a new response to transmission products because of the
increased dose and other associated increases in complexity of the
product. For example, a transmission image is significantly more
complex. The system submitted has adjustable technique factors unlike
the fixed ones for the backscatter units. It\'s approximately 100 times
more dose to each subject for each scan.

Where we are today. FDA as we\'ve discussed earlier today doesn\'t have
the authority to regulate the use of these products, only over the
manufacturers and product performance. None of these products are
regulated as medical devices. They are all products that are electronic
products that emit radiation and are covered by Title 21 1010 through
1050. At this time no Federal performance standard applies to these
products.

FDA\'s proposed response to the transmission systems is to develop a
guidance for manufacturers of all of these types of systems, take the
recommendations for user safety and safe use probably based on N43.17\'s
recommendations and publish that as a safety recommendation, develop a
mandatory performance standard which will include dose limits and other
performance aspects that will apply to all of these types of systems.
We\'re in the process of encouraging new instruments to be developed
both for these systems and for cabinet X-ray to allow easier field
testing of all these systems. We would like to work with the states to
possibly establish use regulations in the suggested state regulations
through CRCPD.

The proposed standard as I said will have a dose limit, will include a
discussion of interlocks for beam motion or in the case of other systems
motion of the subject, labelling, indicator lights, controls, *et
cetera*. Fortunately, N43.17 laid the groundwork for a good starting
place for any kind of discussion on those.

The evaluation of benefit versus risk requires that people analyze the
threat being avoided versus the threat to public health from the
radiation risks needed to thwart the security risk. A possible questions
that needs to be asked when considering this risk/benefit equation would
be is there a sufficient increase in the quantity and the quality of the
information developed to justify the increase in dose. Appropriate use
of these sorts of systems requires consideration of the population dose,
possible retakes and the potential for many exposures occurring as these
products proliferate. These are just a few ideas to maybe spur your
discussion. Thank you.

CHAIRMAN ROTHENBERG: Okay. Thank you. Questions from the Committee for
either of our presenters?

DR. LAMBETH: Do I understand \--

CHAIRMAN ROTHENBERG: Oh, okay. We\'re also going to have a member of the
public give a short presentation. Maybe we should have that too. Sorry.
This is Mr. Tom Wiggins.

MR. WIGGINS: Yes, sir. Thank you.

CHAIRMAN ROTHENBERG: Tom Wiggins from Compass.

MR. WIGGINS: And I have extras of those as well. I apologize for
speaking so loud. I have a loud voice. I do have 30 extras so there are
enough.

CHAIRMAN ROTHENBERG: We need one more for the Committee if possible.

MR. WIGGINS: Good day. My name is Thomas J. Wiggins. I represent X-ray
Equipment Company of Miami, Florida. Thank you to the distinguished
members for allowing my company to discuss with you a revolutionary
security body scanner labelled Conpass. Conpass to signify Controlled
Passage. My primary objective today is to briefly describe operational
use while by colleague, Keith Carter, will use his expertise to discuss
our field-based established standards to control the emission of the
electronic product\'s radiation.

The Conpass security body scanner is a revolutionary digital technology
for low-dose radiographic security scanning. It has been developed as a
spin-off of a low-dose medical radiographic device. The Committee will
no doubt learn more about this device in the coming year. Truly the
Conpass technology will prove to extremely lower the health risk from
X-ray use while simultaneously improving security at our nation\'s
secured locations.

The principle operation of Conpass is based on the use of a very narrow
collimated low-dose X-ray beam. A highly sensitive, linear,
multi-element semiconductor detector then receives the low-dose X-ray
beam and downloads its output to a proprietary software interpolation
and enhancement process. Within ten seconds of the start of the scan, a
full head-to-toe, high-resolution, low-dose X-ray image displays on the
operators workstation allowing for the identification of metal as well
as non-metal items externally or more importantly, internally with no
privacy issues for which competitive technologies are being criticized.

Our work in Washington on political fronts has labelled the internal
threat of plastic explosives as real and credible. This type of
verification of hidden internal threats from plastic explosives is the
driving force for the Transportation Security Administration to desire
to conduct testing of the Conpass to overcome this menace to aviation
security.

In the words of Aviation Subcommittee Chairman John Mica from a
\"Crossfire\" interview on CNN, \"We\'re facing a new type of terrorist
threat. And we found terrorists are willing to blow themselves up. And
they can conceal explosives even within body cavities. So we\'re going
to have to have equipment that will detect those explosives if we want
people to be able to fly with security and safety.\"

The United States Government is proving they will not overlook any
possiblity of threats, internal or external. The tragic, unthinkable
events of September 11, 2001, guaranteed that we as a nation need to be
aware of all devious possibilities that are at a terrorist\'s disposal.

No average individual would have ever dreamed that four planes could be
simultaneously hijacked and flown into buildings as missiles. It is
unfortunate that this event opened the eyes of the World. However, it is
our mission as a technology vendor to try to overcome all future events
while keeping the American public informed and safe with regards to
ionizing radiation.

Currently, we are working on a nationwide PR campaign to educate the
public, politicians, and policy makers concerning using our new
technology to overcome the threat of internal plastic explosives. Our
equipment has been compared to the \"shoe-fitting\" machines of the
past. Unlike those unregulated devices, we have already implemented
radiation control measures to prohibit the reckless use of ionizing
radiation.

In addition in the past eight months, the position of the FAA was that
\"they\" felt that the American public would not tolerate being exposed
to radiation for security. However, our initial polling shows
overwhelming support for using new technology, radiation included, to
overcome the threat of terrorist activities. We cannot underestimate the
American public by comparing our new technology to older, unmonitored,
higher dosage equipment. It is a new world which requires new standards
and monitors.

The current radiation security devices on the market, ours included, do
not have the same in-depth requirements of the medical arena. We welcome
the interaction of the FDA to provide improved and more in depth
standards for our industry. This accomplishes two goals: (1) Improved
safety for the individuals being scanned and (2) higher acceptance of
the products by the American people, thus improving safety of the
secured areas due to lower resistance to use.

We are here today to help initiate the standards of this Board within
the industry. The technology of Conpass has been tested and deployed in
over 51 locations worldwide. It currently holds Health Certificates in
France, Germany, Belarus, The Netherlands, South Africa, Saudi Arabia
and Kuwait. The system is in daily operational use by airports in France
and Africa, diamond mines in South Africa and government buildings in
Saudi Arabia. India has requested a substantially larger order for all
facets of security in their country.

Again, thank you for the opportunity to address this FDA Committee, and
we are available for questions at anyone\'s request. It is now my
pleasure to introduce to you Keith Carter who has headed up the
validation and electrical safety testing conducted by Intertek Testing
Services and radiation testing conducted by Dr. Gossam Jamshidi of New
York.

MR. CARTER: First off, I would like to start my statement by thanking
the Board for allowing us the opportunity to address this growing issue
in America. We as a nation are facing more and more threats of terrorism
every day, some cannot be caught and stopped. However, most that would
occur at a secured location such as an airport can be prohibited. The
Conpass, we feel is the product that can accomplish that task. However,
we are aware of the issues with radiation, and we want to do all that is
possible to educate and to eliminate those fears.

The way to overcome the fears of both the FDA and the public is to
aggressively pursue the following avenues: (1) education and training of
the operator, (2) hardware safety measures, and (3) software safety
measures. I would like to briefly speak a little more in depth on the
standards we have set for each of the above.

On number one, education and training of the operator. It is imperative
to have mandatory training and education for all operators of the
Conpass device. Just because radiation has a stigma already attached to
it with the public, we must be diligent in our efforts to be
professional and intelligent with the use of this product.

Based on field use and development outside of the United States,
training and re-certification of operators is required. We have put in
place a 40-hour initial team based training and certification for the
Conpass device. The mandatory minimum operator qualifications are as
follows: (1) a high school diploma or equivalent GED, (2) one year as a
security screener in the airports or in the jails or whatever the
facility may be, and (3) accomplishment of current and future Federal
guidelines regarding background checks.

The 40-hours are then broken up as follows. Day one is an instructional
course of what ionizing radiation is and what it can do to the human
body if used inappropriately. Day two is focusing on anatomy training.
Since we perform internal searches at a skeletal level, we must train
the operator as to what they are looking at. A radiological background
is not necessary as we do not show individual organs. Day three is a
breakdown of what the Conpass consists of on a components level, and how
the safety measures of those components fit into operational practice.

Day four consists of software applications. The Conpass core operation
is 90 percent software driven. There are very few mechanical components
to the Conpass. This course will explain all of the software functions,
capabilities, and limitations.

It will also focus on both organic and inorganic materials recognition.
This includes the obvious weapons that are attempted to be smuggled
outside of the human body on a regular basis. However, it also shows the
materials and methods that a terrorist would use to smuggle items
internally. Some examples would be drugs, bio-terrorist weapons in a
glass vile that have been inserted into cavities, detonators, plastic
explosives, and whatever that we haven\'t crossed at this point.

Day five then continues with hands-on applications of the system as will
as a closing of the training with a certification exam. If the operator
does not pass the exam with at least an 80 percent success rate, then he
or she must retake the course. Due to the nature of the output of the
device, no operator will be allowed to be certified if they fail the
certification test twice.

Every year it is expected that a software driven device will have at
least one update or upgrade. Because of this fact, we recommend annual
re-certification on the Conpass unit. This certification will consist of
a two day course. Day one will cover general use and advanced features
of the Conpass device as well as an overview of the product updates and
upgrades that are to be installed. Day two will continue the hands on
training for the updates and upgrades and end in a re-certification
exam. The same policy of 80 percent pass is required as well as not
failing more than two re-certification exams.

Moving into hardware safety measures. In order to prevent over exposure
of an individual being scanned by the Conpass, certain hardware
radiation control measures have already been implemented in the system:
(1) radiation warning labelling on the actual unit, (2) a six foot \"no
walk zone\" around the system to keep everyone except the individual
being scanned from being exposed to radiation, (3) a light to notify
when the system is energized, (4) emergency stop switches on the
scanning platform, if the passenger needs to stop it for whatever
reason, operator control desk and at that supervisor area which can be
remote, (5) a built in radiation dosimeter to check and balance the
radiation output of the system, and (6) a \"dead man\'s\" switch on the
X-ray tube which automatically closes the shutter for the tube when the
software kills the power to the scanning platform.

The software safety measures. As stated before the Conpass is 90 percent
software driven. As such, we have implemented the following control
measures into the system: (1) a kV and mA lockout. The system will not
scan at any other kV or mA other than that which is pre-programmed at
the factory. After testing and extensive results, we\'ve seen that we
can use 160 kV and 2.5 mA on every individual no matter what their size
is without having to fluctuate. So because of that, we have locked the
system out where it will only scan at that rate.

Number (2) is an internal dosimeter monitor, which gives warnings and
shuts down the scanning of the system if the radiation changes above
pre-set limits. Number (3) is the ability to implement a database which
logs all persons scanned and track total exposures. This can be done
through bar codes. This can be hooked into any database that the
Government may want to use, the jail may want to use or any other
location. That runs into privacy issues. Whether or not that will be
finally implemented is not our decision, but the capability is there.

Number (4) is a NEAL recording device which videos the entire scanning
process of all persons automatically, and then can be reviewed by a
supervisor for the possibility of repeated scans by an operator which is
trying to deliberately over expose an individual. Number (5) is control
of the \"dead man\'s\" switch by the software. The system will not
release radiation without movement of the platform. If something is not
ready or out of calibration, the software will not open the shutter on
the tube.

Number (6) is the system automatically records the radiation output of
every scan and generates a log for this as well as putting that output
with each image. It\'s on the image in the header. All those logs are to
be filed for review by the FDA at any time. Number (7) is in addition,
all service events, calibrations and complaints are to be kept on file
for FDA audits at any time, just as the 510(k) for medical devices are
required to do.

In conclusion, we welcome the interaction and opportunity to assist the
FDA in establishing effective radiation control measures for all
ionizing radiation security devices. If more information is required, we
are available now or later for further discovery of our product and
procedures by the FDA.

I have enclosed this entire prepared statement in the information
packets in front of you. There\'s also a CD with sample images and a
brochure. There\'s the copy of the testing reports done by ITS as far as
process validation. Our radiation reports are completed. They are going
through their final review at this time. They should be available in
about a week and a half of which I will forward those to Mr. Kassady and
he can forward them to you. Any questions?

DR. BENSON: You mentioned that the system is locked in 160 kV and 2.5
mA.

MR. CARTER: That\'s correct.

DR. BENSON: And that\'s for all persons.

MR. CARTER: Yes.

DR. BENSON: Large, small, in between.

MR. CARTER: That\'s correct.

DR. BENSON: Okay. And the dose calculation that you have is for an
average size person or for your top size person.

MR. CARTER: As far as the point \--

DR. BENSON: The effective dose.

MR. CARTER: The effective dose at 0.5 millirems was done on an average
size individual. In the radiation report because of the nature of the
way the system works using a thin collimated beam, we cannot put a
conventional R meter in front of that because you have to cover a large
area. We can\'t do that.

Due to that, the radiation physicists built a mannequin or phantom that
has movable channels so that you can move the TLDs to register the
radiation at different depths. They did it at both the skin and the
absorption and the exit doses. But it was based on an average sized
individual.

DR. BENSON: Thank you.

MR. CARTER: The radiation is from seven foot down. If you have a shorter
person, yes, they\'re being exposed but they\'re only being exposed on
their body. The scatter is not such where you\'re going to get a ton of
backscatter at their head.

MS. LOSCOCCO: And that was for the new 160 kV and 2.5 mA.

MR. CARTER: That\'s correct. Outside the U.S. they kept it in a flexible
manner. The product has been deployed for over two years now. It\'s
actually approaching it\'s third year at the Shiphold (PH) Airport in
Amsterdam. At that point, they saw that it was getting too confusing to
say I have this kV and this mA and there was no difference in image
quality.

So we just came down to say this is the bottom threshold. This is as low
as we can go and still produce an effective image that will detect
glass, that will detect plastic explosives, obviously metal even if
you\'re hiding it in very dense areas under a fold of skin under your
arms. That\'s how we came up with that dose.

DR. NELSON: Any risks to pregnant women and fetuses?

MR. CARTER: You know. Any time you expose anyone to radiation there are
risks. What you have to look at (1) is the product is not going to take
the place of metal detectors. It\'s not going to be implemented where
you\'re herding everybody through the product instead of a metal
detector. It\'s going to be used on a selective basis for secondary
screening. If you have a pregnant woman that you want him to send
through it, yes you can send her through it. It\'s not going to be an
issue because the regulations already state that you can expose a
pregnant woman or an unborn fetus to if I remember correctly it\'s 100
millirems per year.

DR. LIPOTI: (Away from microphone.)

MR. CARTER: Correct. But on the flip side in an airport, you\'re not
going to have a pregnant woman that\'s going to be travelling usually
all the way up until date of delivery. It can happen, but usually they
say don\'t travel past a certain gestational period.

DR. LIPOTI: But the hazard to the fetus is greater in the early stages
of the pregnancy.

MR. CARTER: True. That\'s correct.

MR. WIGGINS: Just a quick side note on that. One of the issues that\'s
been coming up with the Transportation Security Administration is the
standards that are being set are based on percentages of what type of
passengers and the outlook of profiling and things like that which will
take place in aviation settings. So 30 percent is the number that
they\'re throwing out of what ultimately of passengers being run through
this thing over a year period. But pregnant women is a big issue in
TSA\'s mind as well. It\'s not something they\'re just going to say
we\'re going to run everybody through.

MR. CARTER: Yes.

DR. LAMBETH: I want to make sure you said it was 0.5 millirems.

MR. CARTER: What\'s in the brochure and before we locked it down to 160
and 2.5, it was 0.5 millirems.

DR. LAMBETH: What\'s in your brochure here says less than two
microSieverts. Right?

MR. CARTER: Right. That\'s what I\'m saying. At the 160 and 2.5 \--

DR. LAMBETH: It\'s 5.

MR. CARTER: No. We have generated 0.22 to 0.33 millirems worth of
radiation as the effective dose per scan.

DR. LAMBETH: Do I have my conversion correct? That\'s roughly the
equivalent of an eighth of a chest X-ray.

MR. CARTER: Correct. A chest X-ray runs anywhere from 30 to 100
millirems depending upon the size of the individual. Then you have
fluoroscopy studies that go all the way up to in the thousands of
millirems. If you look at what was passed out this morning the CTs were
in the multiple hundreds. Yes, it is significantly lower than any
medical application. It\'s about the equivalent of about a one hour
flight in an airplane.

DR. LAMBETH: But at 5 if I did it right, it\'s a quarter of a chest
X-ray. Right?

MR. CARTER: Right.

DR. LAMBETH: So your upper limit of yearly exposure represented many
chest X-rays. Right?

MR. CARTER: Correct. Here\'s an extreme example. If you were taking
somebody that was commuting to work. They lived in one part of a state
and they flew to another part every morning and then back at night.
It\'s an extreme example, but if you scanned them twice a day every day
for a year, that\'s over 700 scans that you would expose them to. At
0.22 millirems which is what we\'re putting out as an effective dose,
that\'s roughly 219 millirems. That\'s about two and a half chest
X-rays.

DR. LAMBETH: I came up with a much higher number. I came up with
something like 50. Did I do it wrong?

MR. CARTER: 365 times 2 times 0.22.

DR. LAMBETH: A quarter of a chest X-ray per exposure. Right?

MR. CARTER: It depends on what you\'re calling a chest X-ray. If you\'re
calling 30 to 100 \--

DR. LAMBETH: I\'m calling 20 microSieverts.

MR. CARTER: Okay. But you\'re talking in microSieverts, I\'m talking in
millirems.

DR. LAMBETH: All right.

MR. CARTER: If you want to convert it back to microSieverts, it\'s 2.2
microSieverts is what 0.22 millirems equates to.

DR. LAMBETH: That\'s fine. I think we\'re okay.

MR. CARTER: Yes.

DR. LAMBETH: We\'re just multiplying by a factor of 100.

MR. CARTER: It\'s approximately two and a half chest X-rays if you went
through it twice a day every day.

DR. LAMBETH: I don\'t come up with that. I come up with more like 50. I
did the number when it was at 5 which was what was in this literature.
This literature says less than 2 microSieverts. Right? Yes. But the
original handout was 5 microSieverts. So 5 microSieverts is one-quarter
of a chest X-ray.

MR. CARTER: Okay.

DR. LAMBETH: So if I went through this thing 100 times, I have 25 chest
X-rays. If I do that every day like you said, I\'m talking about doing
it 250 days a year going to work only going in, not coming out.

MR. CARTER: Right.

DR. LAMBETH: I\'m up to 50.

MR. CARTER: At the 20 millirem level you\'re talking about on a chest
X-ray, yes, that\'s accurate. If you run up the scale for somebody
larger, obviously that number drops down.

DR. LAMBETH: So the issue is what is a chest X-ray.

MR. CARTER: Correct. The issue is exactly what is a chest X-ray.
Probably an easier one is something along the fluoro scale as to what a
GI series would be. Those are a little bit \--

DR. LAMBETH: If I were working in a diamond mine and I was having to do
this once or twice a day for my life, I would think that\'s a pretty
heavy dosage.

MR. CARTER: That\'s true. Again in the airport scenario, they\'re not
running everybody through it all the time. They\'re averaging 30
percent. In a diamond mine, what they implemented was the ability to do
random scans without the operator knowing it. It was an external
software that we loaded on that would give a dummy scan if necessary.
That was to help reduce it for that very reason. You\'re going through
it everyday. We don\'t estimate that anybody\'s going to be going
through it twice a day everyday.

DR. LIPOTI: I have a question for Frank Cerra, not for the industry.

DR. MABUCHI: I have a question to you. Could you explain to me this
report here?

MR. CARTER: Sure.

DR. MABUCHI: How was this done?

MR. CARTER: Hold on one second. Which one are you looking at?

DR. MABUCHI: You have seven charts.

MR. CARTER: Right.

DR. MABUCHI: Five and six.

MR. CARTER: On the top it says five of seven, four of seven. Which one
are you looking at so that we\'re on the same one?

DR. MABUCHI: A number of items were checked by one person and scanned 20
times?

MR. CARTER: What they did when they did the process validation was if
you notice there\'s seven different pages of it.

DR. MABUCHI: Right.

MR. CARTER: It was seven different individuals.

DR. MABUCHI: Seven different inspectors.

MR. CARTER: Right. They then took the different products and scanned
them through the 20 times. What these different numbers correlate to was
the ease of visualization of what was being looked for.

DR. MABUCHI: A five is the best and one is the lowest.

MR. CARTER: Right.

DR. MABUCHI: There seems to be some variation among inspectors. If you
take a gun it\'s quite \--

MR. CARTER: These are all non-radiographic meaning these were not
radiologists that were looking at these. These were engineers that ITS
hired to actually do this, so they were looking at what they saw on the
monitor and that\'s how they were coming up with the \--

DR. BENSON: Were these items simply in a tray or were they embedded \--

MR. CARTER: They were actually placed into a box to hold them and then
placed behind two five-gallon jugs of water that had a gelatin and salt
mixture to represent the same density as a human body. It would be
equivalent of placing the items behind your back and then scanning
through. We only require one scan. You run through and whatever you have
on you or in you is what we\'re looking for.

DR. MABUCHI: Now my question is some people rated wooden knife to be
difficult to identify but a couple of persons thought it was quite easy
to identify. There seems to be some variation.

MR. CARTER: Correct. The people that were hired, that\'s what they came
up with as far as what they could see. A wooden knife is difficult to
see because of its density. When you\'re talking behind quite a large
mass that has the same density as an average size individual, certain
things are going to be harder to see.

DR. MABUCHI: How do you cope with that? Do you train inspectors?

MR. CARTER: Well, part of the training is to go over the materials that
they would encounter in a normal environment and to show them how to
identify them. The systems has the ability to do enhancement of images.
What we want to do is keep this as quick as possible. The actual
scanning time is ten seconds. Your image is up right after that. We
don\'t want somebody spending four minutes looking at an image trying to
figure out all that is in that image. We go through what is obvious and
the basics of what they would encounter.

This is not the be all end all for security. This has to be used in
conjunction with good law enforcement. It\'s not just automatically pick
anybody out of a line and run them through this. There\'s no rhyme or
reason for that. Running a 90 year old individual through this is
probably not going to help them in any way, shape or form as far as
security goes. This has to be used in conjunction with other effective
law enforcement methods.

DR. SANDRIK: Just a further clarification on this study. Were there any
conflicting other objects in this thing or was it basically the uniform
water bottles and only this object was there?

MR. CARTER: No. Everything was placed into the box. They were having to
decipher through all the things that were in there.

DR. SANDRIK: All these different things were there at one time.

MR. CARTER: Correct. Images from these tests will be attached with the
radiation report as well. You can look at them. No, it wasn\'t just one
item in a box and say find the one item. It was multiple items of which
you would encounter in actual daily use. Somebody\'s probably not going
to have just one thing on them.

DR. SANDRIK: Right.

MR. CARTER: They\'re going to have multiple things that you have to
decipher through.

DR. SANDRIK: But you\'re likely to have a skeletal structure that\'s
obscuring a lot of what might be there as well as opposed to your water
bottle phantom which is rather uniform.

MR. CARTER: The water like I said had a mixture in it that was
equivalent in density to a human body.

DR. SANDRIK: Right. That\'s not the \--

MR. CARTER: It\'s not the same.

DR. SANDRIK: The confusing things of ribs and attenuating,
less-attenuating, lungs versus heart versus ribs and all these other
kinds of structures that could obscure.

MR. CARTER: Correct. The system will pick up a single razor blade. It is
effective. After proper training of an operator, they will learn to use
their eyes similar to what a radiologist does to scan. What\'s not
supposed to be there stands out to them. Further developments are
underway to add autoscanning capabilities that would take a normal clean
body that had normal anatomy structures and compare against the image
that was scanned to help aid in that process. It is not there yet.

CHAIRMAN ROTHENBERG: Any other questions?

DR. CASWELL: Yes. In terms of the validation study that you\'re
presenting here, did I hear you correct? These were engineers that did
this study.

MR. CARTER: Correct.

DR. CASWELL: So these aren\'t the type of individuals conducting the
study that might be operating this unit when it\'s in place.

MR. CARTER: These, meaning these were engineers hired by the testing
facility. They did not necessarily have an engineering background. The
testing facility actually used some of their own people that were
working there. Some of them were engineers meaning that\'s what they did
for a living. Others just worked at this engineering facility as
secretaries and other things.

DR. CASWELL: Okay. Had they been through your training course at all?

MR. CARTER: Actually no, they had not. This was just a here, take a look
at it. They had not been certified by us as far as explaining what to
look for. We kind of threw them to the wolves if you will that find what
is in here and point it out and tell me what you see and how easy is it
to see that.

DR. LAMBETH: I think your question was whether or not these people were
educated. Did they have a Bachelor of Science degree when you say the
word \"engineer?\"

MR. CARTER: Some of them did and some of them did not. They were working
at an engineering facility, at ITS. Some of them were secretaries. They
were high school graduates but they were not Ph.D.s or Masters.

DR. CASWELL: That may account for some of the variation that we see in
the results of this study. It might. I don\'t know.

CHAIRMAN ROTHENBERG: I just wouldn\'t refer to them as engineers. So
you\'re going to further provide us with copies of the radiation reports
and some images.

MR. CARTER: Well, the images are on the CD that\'s in front of you.
There are numerous formats that you can look at those images. They are
already there as well as scans of both male and female to show that
there are no privacy issues. The only thing that stands out on a female
is the underwire of a bra. That\'s it. It\'s very hard to distinguish
other than looking at the structure of the bones that they are females.
Yes, we will forward those to Mr. Kassaday and he will forward them to
you.

MS. FAHY-ELWOOD: I\'m just trying to understand this. The ANSI standard
that we talked about before, your system doesn\'t meet the dose limits
of that.

MR. CARTER: As far as for backscatter devices, no, it does not. We are
higher than that. We kind of fall in between we\'re higher than a
backscatter device but lower than a medical device. We\'re not in the
resolution to be considered a medical device for 510(k).

MS. FAHY-ELWOOD: Okay. Are there any other portions of that standard
that you would not comply with? You must be familiar with it.

MR. CARTER: Not that I\'m aware of off-hand. It has all the interlocks
and all of the requirements. As far as for safety goes, the only one
that I\'m aware of is the actual radiation levels.

MS. FAHY-ELWOOD: That standard isn\'t just for backscatter though or is
it. It\'s just called security screening systems using X-rays.

DR. LIPOTI: That\'s a question for the Agency, not for him.

CHAIRMAN ROTHENBERG: Is that your question, Jill? You had a question for
Mr. Cerra.

DR. LIPOTI: Yes. Go ahead.

MR. CERRA: The standard is not specifically for backscatter. If these
units would meet the limits, they would fall under the scope of the
standard. However, the issue that just came up about training, the
standard was written again with the backscatter units in mind. It\'s
pretty obvious when there\'s an object sitting on the surface of the
skin as opposed to when the object is inside the body, so that the
requirements that we have for training are pretty limited.

That is also the reason why we didn\'t want the operator to have control
over contrast kV and mA and scan time and that type of thing. We felt
that a limited set of training would be sufficient to detect all the
items that would be detectable on the surface of the skin. When you go
inside the body then I would think that we would want to alter the
standard to include some imaging capability on the part of the operator.
Radiologists go through years of schooling and they still miss tumors.
There will always be something that is missed.

You will have to take a rescan if you think that there may be something
but you\'re not sure. Those types of things are all to be considered.
It\'s not an easy thing. It\'s not black and white. There may be that
instance where the technology is useful if used appropriately.
Unfortunately, that\'s a risk/benefit type of thing. FDA does not
regulate the decision making of the benefit. It\'s not a medical device.
We can only regulate the product.

If states do it, then the regulations would differ from state to state.
If we do come up with a standard, there is a mechanism that Dan can
address where a variance can be obtained for certain uses of the
product. Even though they do not meet the standard if it\'s used for
those types of instances where there is an actual benefit, FDA will
allow those products to be sold to those customers.

DR. LIPOTI: I\'m still not getting to the question. The ANSI standard
N43.17 which was adopted April 2, 2002, is entitled [Radiation Safety
for Personnel Security Screening Systems Using X-rays]{.underline}. I
understand that Federal Agencies are under some sort of directive if
there is a national consensus standard that you are to use that in your
regulatory function. So you would naturally use this ANSI standard. If
you were to propose a mandatory standard based on that ANSI standard,
the Conpass system would be precluded from being sold in the United
States. Am I correct?

MR. CERRA: Right. It would not meet the standard. Like I said, there is
a mechanism for variances. They would have to go through the process of
having a variance approved. It would not be sold.

DR. LIPOTI: And can you elaborate just a bit on the directive, is it an
OMB directive or whatever, that requires a Federal Agency to adopt a
standard equivalent to a consensus standard?

MR. CERRA: I am not sure that applies for this particular product. Maybe
someone else from FDA can address that.

DR. SHOPE: I think the directive would be to consider carefully the
consensus standard to see if it meets the needs for what we perceive is
needed in a mandatory standard. If we had a reason to go beyond what\'s
in the consensus standard, I\'m sure we could try to make our case and
do the benefit/risk analysis and the supporting impact statements and
perhaps implement a standard either less severe or more severe than a
consensus standard. The idea is we should carefully consider what\'s in
the consensus standard and use it if appropriate.

CHAIRMAN ROTHENBERG: I didn\'t hear the answer to one previous question
which was other than meeting the dose limit, was there any other aspect
of the standards that this device would not meet.

MR. CERRA: At first, I though it would not meet the requirement that the
kV and mA would be fixed, but from the talk it seems that they might
meet that.

CHAIRMAN ROTHENBERG: So then they would fix it.

MR. CERRA: Right. The main problem I see again is the annual limit which
is based on a few sources. If a number of facilities, for example, movie
theaters, sports arenas, airports, court rooms, places of employment,
any high security area, if they all would start scanning, then the
standard does not make much sense anymore because you need to look at
the total exposure to any one individual. It would be impossible to
track.

The NCRP recommendations in fact do have some wording to that effect. If
a facility which delivers a certain amount of dose, they would have to
ensure that the total dose from all other sources of man-made radiation
does not exceed 100 millirem a year. They also include an alternative
method of sticking to the 25 millirem for the one facility which is
reasonable when you consider up to four sources. When you have 50
sources, that doesn\'t make much sense anymore.

CHAIRMAN ROTHENBERG: But it\'s still the dose. Other than the dose, all
the other aspects once they fix the kV and mA \--

MR. CERRA: Right. Off-hand it would probably meet the other
requirements.

MR. PLEASURE: I\'d like to make a follow up question to your question.
The summary of main requirements that you set out included first the
dose level effective dose for each and per year, then secondly benefit
versus risk and negligible individual dose less than then, then subject
informed of the X-ray exposure and associated risks. So the latter two
are also not met in that as I understand the use of this, for example,
in a diamond mine, you don\'t even tell the individual whether they\'re
being exposed or not and extensively to protect them.

Then the benefit versus risk and negligible individual dose doesn\'t
apply because as we\'ve discussed this is not negligible on an
individual basis. I would add that I\'m somewhat troubled by this
association of risk to property, that is platinum, diamonds, precious
minerals and its use in those circumstances with security of people and
terrorist situations. The two are not comperable.

MR. CERRA: I can\'t address the current practices of the users of the
Conpass in other countries.

MR. PLEASURE: Well, the witness has spoken to that.

MR. CERRA: But assuming that they do tell every employee that they are
being exposed to so much radiation, they might meet the standard. The
negligible individual \--

MR. PLEASURE: Oh, they don\'t. They say you may be exposed, so the
individual can say to himself or herself maybe I\'ve gone through 50
times but I probably only got exposed once because of the randomness of
it. They really don\'t know. They might have drawn a positive four or
five times when they thought they didn\'t draw any. Do you know what I
mean?

MR. CERRA: Again, FDA does not have control over the way it\'s used. If
that requirement were written in the standard, we would have no
jurisdiction to verify that. First of all, we wouldn\'t have that
requirement in an FDA standard because it\'s a use requirement.

MR. PLEASURE: As I understand you, you\'re saying that you apply certain
principles in the development of the standard. The risk/benefit analysis
is one of the standards or principles that you must apply.

MR. CERRA: Right.

MR. PLEASURE: So for you to say that we have no concern about its actual
use and its purposes, I don\'t follow that.

MR. CERRA: No. I didn\'t say we have no concern.

MR. PLEASURE: You do have jurisdiction in developing the standard to
consider risk and benefit. Do you not?

MR. CERRA: Do you want to address that?

MR. KASSADAY: Yes. We have jurisdiction to consider the risk and
benefit, but any mandatory standard that we write can only address the
machine performance. That\'s why we\'re going to publish \--

MR. PLEASURE: Well, let me follow up on that. We\'ve talked about this
before today. If the manufacturer is recommending it for use in let\'s
say Tiffany\'s to check all personnel as they\'re leaving randomly like
a South African diamond mine, then that is within the scope of your
purview. Is it not? That it\'s a recommended use.

MR. KASSADAY: That would be why we would want to set the dose per
screening very low so it doesn\'t become a problem.

MR. PLEASURE: But of course this product is not at that lower level.

MR. KASSADAY: We can\'t actually tell Tiffany\'s that they can\'t use
the product.

MR. PLEASURE: No. You\'re dealing with the manufacturer. This
manufacturer is recommending its use in situations where diamonds and
other minerals are being \-- And putting out to purchasers that this is
an appropriate use. This was within the range of purposes. That gets you
back to a risk/benefit analysis. I don\'t see why this is beyond your
purview.

MR. KASSADAY: We simply don\'t have jurisdiction. We do have interest in
that. That\'s why we\'re going to write a recommended use safety
statement to go along with that.

MR. PLEASURE: You have jurisdiction over instructions that the
manufacturer prepares, for example. You can review the instructions to
see whether the instructions are consistent with your standard. If the
instructions recommend its use every day as a worker goes in and out of
a workplace, then that\'s within your purview. You do that already with
sunlamps.

MR. KASSADAY: Oh, okay. Now I understand what you\'re saying. Yes. That
will be probably in at least the first draft of the mandatory standard,
to describe what we would expect to see in their user instructions. We
have written letters back to folks advertising for inappropriate uses
before and asked them that they stop. The regulatory authority there is
very weak which is why we would want to write the use guideline as well
as a standard which would hopefully give some support to states
developing regulations to prohibit those sorts of uses.

MR. PLEASURE: Yes. Of course the instructions have impact. If the
instructions say it\'s not appropriate for a particular use, then the
state liability standards hook in. The user then is violating the
manufacturer\'s instructions which you have reviewed and created for
themselves an intolerable liability situation. You say it\'s
ineffective. I\'m not so sure it\'s so ineffective if you\'re actually
reading these instructions and adopting standards relating to the
quality of the instructions. That is a very powerful tool and you do it
with sunlamps presumably.

MR. KASSADAY: I see where you\'re going now. Yes, that\'s part of the
intent of why we\'re going to publish a guideline on safe use based on
the N43 standard which will allow people to do exactly what you\'re
saying. The user instructions we can prescribe what they must put in
there. Once it gets to the use issues and advertising honestly it
depends on how it plays out.

DR. SULEIMAN: Let me clarify one thing. The television receiver standard
assumed that the product was going to be used a certain amount of
viewing time. The sunlamps you\'re assuming are being used in a certain
way. I think the question the dose that the public should receive is
established by other regulatory agencies or whatever. I mean we pay
attention to that, but I think that shouldn\'t be driving this issue.

The question in front of the Committee was is this voluntary standard
sufficient for some of the new technology. Should there be some changes?
Is the dose limit appropriate? For example, let\'s say it turns out you
give 25 millirem per exposure. Then somebody would argue and say you
could only use that once a year on an individual. The standards would
eventually determine how it\'s used.

Just like in medicine, you may have limits or guidelines per examination
but there\'s nothing to prevent it from being used over and over again.
I think we\'ve discussed this previously. This really falls into a very
grey area. This is not medical use. This is not occupational use. You do
now have a benefit associated with technology. So maybe the answer
isn\'t evident right now.

I think we need to know should FDA consider a mandatory standard for
this thing. Should the voluntary consensus standard that\'s been
developed be adopted lock, stock and barrel or do we now have a
situation here where that\'s not the case? I think the Committee ought
to address that rather than how often it\'s going to be used.

MR. CERRA: I just would like to clarify one point from the previous
question about whether the systems other than the dose limits would
comply to the present ANSI standard. I was not considering instructions
to the effect that the systems would be used for something other than
security. Of course if the manufacturer would make that claim, then the
standard is for security screening systems and we do define security in
the standard. So it would not meet the standard.

CHAIRMAN ROTHENBERG: Thank you. Yes.

DR. LAMBETH: I think it\'s important to note that when we use the word
\"security\" we have certain things in mind. This is a fabulous
instrument. It looks like it does fantastic things. On the other hand,
if I go to the inner-city schools, there are places where implementing
this would be very advantageous. If that were done, these students would
be over-exposed in my opinion severely because they might even be going
through it more than once a day, more than three times a day. If the
standards were not written to specify the usage in certain environments,
it would be very deceiving.

MR. CERRA: That\'s exactly where we are limited because FDA only has
certain jurisdiction as to the usage. We can regulate the manufacturer
but not so much the user.

DR. LIPOTI: Larry, I was on TEPRSSC in 1998 when TEPRSSC recommended a
mandatory standard. I feel that if the mandatory standard were here now
that we wouldn\'t even be hearing about this Conpass system or other
systems like it. So I feel very strongly that FDA should move forward
with their proposed response as outlined in your presentation to develop
mandatory performance standards to base them on ANSI N43.17 and to
include in those use covered in a radiation safety recommendation. I\'ll
make that in the form of a motion if you\'d like.

CHAIRMAN ROTHENBERG: Is there a second?

DR. LAMBETH: I second it.

CHAIRMAN ROTHENBERG: Okay. Some discussion. This unit is being brought
to our attention due to events related to 9/11 and similar terrorist
activities. It does provide the capability that the previously
considered systems don\'t. The question then is where does this fit.

We\'ve heard informal discussion yesterday that for instance the Customs
Agency has a capability to take a suspicious person even to a medical
facility and subject them to medical level X-rays in order to do
whatever investigation they want. This would certainly be a lower dose
than that situation. So I think we have to be careful about how we\'re
dealing with the system and be aware that there may not be an
alternative system that can provide this level of information at this
low-level of dose even though it\'s a much higher level of dose than the
other system. Yes.

DR. LIPOTI: I think that as part of any rule making that it would be
encumbant upon the Agency to investigate alternatives. As part of that
investigation they would certainly look into situations where a
different system might be useful. In that case a different standard or
variance to the particular standard could be granted. But for the
overall general standard, I believe that the ANSI N43 Committee did a
very good job and put together the standards that TEPRSSC was looking
for at the time.

CHAIRMAN ROTHENBERG: But as also Mr. Cerra said this type of unit did
not exist at that time. So your motion is they go ahead with the
standards. Where does this consideration of this unit fit in?

DR. LIPOTI: Consideration of the other unit would be as either a
variance to the particular standard that they put in if it is proved
that it will have some benefit in certain instances. In that case, you
can very carefully frame the use that it would be allowed for. That it
not be in general service for security screening so that we would
preclude things like P.S. 105 and New York City installing it at their
gates or banks or public buildings or court houses and so forth.

CHAIRMAN ROTHENBERG: Any other comments?

MR. PLEASURE: Other than I agree with that. Dr. Lipoti described
opportunities potentially for variance. That might be discussed. This
has been years in the making. I\'ve been here for years too. I remember
earlier discussions. While we have needs growing out of 9/11, there are
alternatives. We also have a recognized hazard here and a way of dealing
with that recognized hazard in a reasonable period of time. If we
continue to put this off, I\'m concerned that we\'re doing a disservice
to the purposes of the Committee. I think it is time.

DR. SULEIMAN: I want to add one thing. The concerns of the Committee
several years ago was not that the doses were very low, not that there
wasn\'t a benefit, but there was concern that over time this
technology\'s doses would start getting higher and it was safer to put a
lid on it while we could. So that\'s why your job is so much more
challenging today.

MR. WIGGINS: Am I allowed to add to that?

CHAIRMAN ROTHENBERG: Sure. Why don\'t you make a statement.

MR. WIGGINS: I think one of the things that\'s being misconceived here
is its use. While on the brochure it states that it looks for bags and
things like that which is a European based model, we as a company really
don\'t feel that it\'s going to be used in arenas and things like that.
We\'re specifically looking for it to be used in security instances such
as prisons and the Transportation Security Administration. So I agree
that standards need to be set for the product in that arena to keep it
away from diamond dealers scanning their employees. I think that\'s
probably the wrong idea. I do believe that the standards need to be set
for the security arena.

CHAIRMAN ROTHENBERG: Okay. Well, we have a resolution on the floor, and
we\'ve had some discussion. I think unless someone else on the Committee
has a comment we\'re ready to vote at this time. So, all in favor \--

DR. LAMBETH: Would you repeat?

CHAIRMAN ROTHENBERG: Which was to go ahead with establishing a standard
consistent with the current ANSI recommendations which would also allow
for in the consideration of adoption of the standard the Agency should
consider whether there might be a need for variances. Is that right?

DR. LIPOTI: Yes. I think I can say it\'s on the handout FDA\'s proposed
response that they move forward with a mandatory performance standard
based on ANSI N43.17 that also deals with use as covered in a radiation
safety recommendation, that they include a discussion of alternatives
and that they consider the requirements for variants to their standard.

CHAIRMAN ROTHENBERG: Okay. Are we ready to vote? All in favor?

(Chorus of ayes.)

CHAIRMAN ROTHENBERG: Opposed?

(No response.)

CHAIRMAN ROTHENBERG: Abstains? Okay. We had one abstention. I think we
had ten for. Any other abstentions or opposed?

(No response.)

CHAIRMAN ROTHENBERG: I guess we had ten in favor and one abstention.
Thank you for your presentation, all of you. We\'re now ready to move on
to the next item. We\'re basically finished with the substantive
discussions of various issues which were on the agenda. Does anybody on
the Committee have any additional items? We\'re going to talk about date
for a future meeting. But in terms of items for discussion. Yes.

DR. NELSON: I wanted to follow up my question. I don\'t know if Dr. Cyr
is here anymore. I wanted to follow up on my question this morning about
what types of outcomes are being evaluated in the cellular phone
radiation studies. It\'s not necessary that the question be answered
right now. I\'d like to at least propose that at our next meeting
perhaps \-- Oh, you are here.

DR. CYR: I missed the first part of your question.

DR. NELSON: Okay. Well, earlier this morning \--

CHAIRMAN ROTHENBERG: With Ms. Gill.

DR. NELSON: Right. Ms. Gill reported on the safety inquiries into
cellular phones. I had asked her what sorts of outcomes were being
evaluated. She didn\'t know.

DR. CYR: We have an agreement with industry, a CREDA, in which we are
monitoring several kinds of studies. Right now there are three different
levels of that. The first part is out and the studies are beginning.
They are studies on micronuclei. There were cell culture studies in
which they found changes in terms of micronuclei. We wanted to repeat
those studies in various laboratories paying particular emphasis on the
dosimetry and making sure that there were no hot spots, no possible
thermal effects and doing it on a large scale. There are three labs all
set up and ready to go to do micronuclei studies.

The second part will be to look at the dosimetry that was reported,
epidemiology effects, namely brain tumors and things like that. The
requirements have been written but there has been no call for proposals.
That\'s the next step. We hope to get along with that. In a year or so,
we\'re supposed to convene a panel of experts and figure out whether
there are other studies that need to be done in addition to the
micronuclei studies and the exposure assessment studies.

As you know, I\'ve done sunlamps and just recently I\'ve taken over cell
phones because our leading expert didn\'t retire but he moved on to
another job at EPA. They asked me to take this on temporarily. We are in
the process of trying to find a full-time replacement person who will
take over the issue on cell phones.

DR. NELSON: Thank you.

CHAIRMAN ROTHENBERG: Okay. Anything else? Okay. Then Dr. Suleiman wanted
to try to find some dates at least maybe a couple of dates or
approximate time to consider for our next meeting.

DR. SULEIMAN: All right. Let me propose February 6th which is a
Thursday. Let\'s put 5th and 6th. The other one I would propose at this
point would be I guess March 5th and 6th. I don\'t see any conflicts on
our calendar at this point in time. You can check back. We can
communicate with E-mail unless somebody knows right now that there is a
conflict with any of those.

CHAIRMAN ROTHENBERG: Those are what days of the week?

DR. SULEIMAN: Those are both Wednesday and Thursday.

CHAIRMAN ROTHENBERG: I think it was Dr. Lambeth who said Thursday is
better than Wednesday.

DR. LAMBETH: That\'s okay.

DR. BENSON: Could I be the naive new person and make a proposal that we
perhaps meet more often or perhaps have some kind of consensus thing
going on by E-mail? For instance, the revised wording of the warning
label from the sunlamp people, does that have to wait until next
February or could we circulate it by E-mail and consider it and discuss
it? Just move the time table up for some of those things that we\'ve
already talked about and just need a little buffing up.

CHAIRMAN ROTHENBERG: I think first of all with regard to having more
frequent meetings, we do have some budget limitations, at least we have
had in the past.

DR. BENSON: Okay.

CHAIRMAN ROTHENBERG: With regard to E-mail \--

DR. BENSON: E-mail is still free as far as I know.

DR. SULEIMAN: What I would propose is that literally we don\'t have to
run the wording by you. If we had to formally, then we\'d have to
convene the meeting and go through a lot of logistical problems.
However, I don\'t see anything wrong with sending draft proposals of the
wording to all the Committee members and getting their comments. You\'ll
have the same effect, same impact and we don\'t have to go through the
formalities. I\'ll promise you that. I know Howard would be more than
willing to do that. That way you can keep informed on some of the
developing issues.

DR. BENSON: Okay.

CHAIRMAN ROTHENBERG: Okay. Well, I think there are no further issues at
this point. Oh, sorry. Dr. Shope.

DR. SHOPE: Just one comment. I was passing around a copy of the web site
for the CT whole-body screening issue. I just want to mention if anybody
hadn\'t seen that and wanted to, it\'s somewhere on the table there.

CHAIRMAN ROTHENBERG: It was a color printout.

DR. SHOPE: Yes, a color printout.

CHAIRMAN ROTHENBERG: Here it is. So anybody who would like to see it,
we\'ll pass it around. It is available.

DR. SULEIMAN: Let me mention something Dr. Caswell just reminded me of.
He said that you had sent us a copy. I had sent a copy with a link to
the Committee members. I forgot about that. It should be in your
E-mails. We can resend it out again.

CHAIRMAN ROTHENBERG: Okay. Since there are no further items. Oh, there
is one further item.

DR. SULEIMAN: I think we\'re losing five of you, but I don\'t remember
which five. Alice, you\'re on another year. Right?

MS. FAHY-ELWOOD: I think so.

DR. SULEIMAN: Who\'s the Government person we\'re losing?

MS. FAHY-ELWOOD: I think Greg Lotz.

DR. SULEIMAN: That\'s right and he left at noon. Who is it?

MS. FAHY-ELWOOD: Yes, I think Q. Balzano.

DR. SULEIMAN: That\'s right. Quirino Balzano from Motorola.

MR. KACZMARCK: And John Sandrik.

DR. SULEIMAN: John, thanks an awful lot. We\'re not sure I think you may
be on \--

MR. PLEASURE: One more year?

DR. SULEIMAN: Yes. But you may want to resign. We were talking about
that.

MR. PLEASURE: We\'ve talked about that.

CHAIRMAN ROTHENBERG: Not because we don\'t want you.

MR. PLEASURE: Right.

CHAIRMAN ROTHENBERG: We haven\'t asked you to go.

DR. SULEIMAN: Usually, I would have the names in front of me. To make it
faster, I figured I would ad lib it this way. Clearly those of you who
are going off, we appreciate what you have done. Those of you who
aren\'t rotating off, we\'re still appreciative of what you\'re doing.

CHAIRMAN ROTHENBERG: Let me also thank all of you for taking time out of
your busy schedules to participate in this. Those of you that are going
off, it\'s been a pleasure for me to have served with you. We really
appreciate your effort. Okay. I guess the meeting is adjourned. Thanks
everyone. Off the record.

(Whereupon, the above-entitled matter concluded at 3:48 p.m.)